The Medical Letter recently evaluated “bioidentical” hormones and concluded

There is no acceptable evidence that “bioidentical” hormones are safe or effective. Patients should be discouraged from taking them.

“Bioidenticals” include progesterone, estrogens (estriol, estradiol, and estrone), and testosterone. They have mainly been promoted as a safer, more natural alternative to menopausal hormone replacement therapy (HRT), but they are also claimed to increase energy, well-being, and quality of life, and to have an anti-aging effect. Suzanne Somers recommends them for all age groups and both sexes. There is no evidence to support any of those claims.

The whole “bioidentical” thing is a pseudoscientific concept: it is a marketing term rather than a scientifically meaningful one. Bioidenticals are promoted by celebrities like Suzanne Somers, a few maverick medical doctors like Kent Holtorf, proponents of “natural” medicine, patients who were frightened by the Women’s Health Initiative study of hormone replacement therapy, and critics of Big Pharma. The mainstream scientific community is in consensus: a number of medical organizations, from the American Cancer Society to the Mayo Clinic, have issued statements similar to that of The Medical Letter.

The terminology is confusing. Bioidenticals are plant extracts modified to have the same molecular structure as endogenous hormones. But there are FDA-approved Big Pharma hormones that are just as “bioidentical”: they are also plant extracts modified to have the same molecular structure as hormones produced by the ovary. Only one bioidentical hormone, estriol, has no corresponding FDA-approved version. It is only present in large amounts during pregnancy: its safety and efficacy as a supplement have not been tested. Proponents of “bioidenticals” make much of the difference between “artificial” Big Pharma progestins and “natural” progesterone, but that same progesterone molecule is also sold as a prescription drug. (Progestins were originally developed because progesterone is poorly absorbed, but now Big Pharma has developed a micronized version of progesterone that is absorbed adequately.)

One of the biggest concerns is that “bioidenticals” are prepared in compounding pharmacies that are not regulated. The FDA has long been concerned about these pharmacies. In a 2006 survey, the potency ranged from 67.5% to 268.4% of the amount specified on the label, and there were variations within the same samples. Contaminants have also been found, including bacteria. Package inserts describing risks are required for FDA approved products but not for compounding pharmacy products.

From 1990 to 2005, FDA learned of at least 240 serious illnesses and deaths associated with improperly compounded products. Because pharmacists are not required to report adverse events to FDA, there may be additional deaths and injuries of which the agency is unaware.

Another big concern is that dosage is usually guided by salivary hormone levels, which are unreliable. Suzanne Somers even advocates that the patient adjust her own dosage from day to day just depending on how she feels.

Advocates claim that bioidenticals are safer than pharmaceuticals, but since they are essentially the same compounds, there is every reason to think they would have the same side effects. At least 3 cases of endometrial cancer have been reported in women taking bioidentical hormone replacement therapy.

Critics complain that Big Pharma is profit-motivated. Interestingly, bioidenticals are more expensive than the Big Pharma versions of the same hormones and they are not covered by insurance.

Proponents speak of individualizing dosage to “balance” the hormones, but I can’t understand how they could ever hope to do that. The body produces several different hormones and the amount of each varies according to the stage of the menstrual cycle. With each constantly going up or down, how could you define balance or hope to mimic the natural state?

“Bioidentical” hormones may satisfy some of the psychological needs of people like Suzanne Somers, but they don’t satisfy the requirements of science-based medicine or even of common sense.

Yes, despite the best efforts of Jake Crosby, Age of Autism, and AoA commenters, I’m still standing.

Stay tuned tomorrow for as much of the story as I can tell you.

How the Food and Drug Administration came to be is a story that is filled with death, intrigue and dubious characters. It also, like most stories, has its share of heroes and vindications. The list of those who have died to bring us the agency we know today is long, but even today, the death-toll continues. Now this is not the horrible thing it may at first seem. People are all born with a terminal disease known as life, and they will die. The goal of Medicine is to forestall that death as long as possible and to give people good, long, healthy and safe lives. This is where the Food and Drug Administration comes into play. They help guide the pharmaceutical world in the safest manner possible.

The legal quagmire that is the Food and Drug Administration (FDA) is a result of a series of laws which it behooves the Science-Based Medical community, to understand. Many of these laws were a result of deaths, which were themselves the result of either poor safeguards, or, as we will see in one case, lack of information on the part of a company. It began with the Division of Chemistry inside the U.S. Department of Agriculture. The original concern of this group was the misbranding and adulteration of both food and drugs. The first of the laws which came into effect, to give the Bureau of Chemistry as it became known, was the Biologics Control Act of 1902. As is so often the case with FDA regulations, this was a result of deaths in the populous.

The Biologics Control Act of 1902 came about after children had died from vaccines for both diphtheria and smallpox. In the first case, a horse named Jim, who had been used to produce some 30 quarts of diphtheria antitoxin, was found to have contracted tetanus. This was after additional diphtheria antitoxin had been produced, packaged and shipped and resulted in the death of 13 children in St. Louis, Missouri. The second case, which involved a contaminated smallpox vaccine, claimed the lives of nine children in Camden, New Jersey. The BCA of 1902 directly led to the creation of the Center for Biologics Evaluation and Research or CBER. This act set the precedent for regulating drug products, specifically Biologics. 

This was followed, in 1906 by the “Wiley Act” which is also known as the Pure Food and Drug Act of 1906 which prohibited the “manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors, and for regulating traffic therein, and for other purposes.”¹ During this time, the enforcement for this act was given to Harvey Washington Wiley (Yes, the same Wiley the Act was named after) and the USDA Bureau of Chemistry. Slowly, the Food & Drug Administration is being born. One of the first major legal tests to this was United States v. Johnson²in which the Supreme Court held that “misbranding” did not attach to the therapeutic claims of the drug product but only to the ingredients. The case involved containers of medicinal product bearing labels that stated or implied that the contents were effective in curing cancer, when the creator knew that such representations were false. To quote Justice Holmes, “One may say with some confidence that, in idiomatic English, this half at least, is confined to identity, and means a false statement as to what the ingredients are.” This ruling was a serious blow for the fledgling agency and Congress responded with the Sherley Amendment in 1912 which clarified the authority to enforce the Wiley Act based on fraud in the therapeutic claim. In 1927, the government underwent a reorganization and the Bureau of Chemistry was folded into the Food, Drug and Insecticide organization within the USDA. Three years later, this became the Food & Drug Administration.

In the 1930’s we had another major event which influenced the laws surrounding the FDA. One of the important things to understand is that the Pure Food and Drug Act of 1906 did not regulate, in any way, the safety of new drugs, and was mainly concerned with those drugs already on the market. This is where the story of Elixir Sulfanilamide enters the picture. Created in 1937 by the S. E. Massengill Company, this sulfanilamide concoction was prepared with diethylene glycol (DEG) as a solvent. DEG was at this point known to be toxic, although the exact extent of its toxicity was not known.³In September of 1937, Elixir Sulfanilamide was being sold in the U.S. Markets and by October the American Medical Association had begun receiving complaints about possible deaths resulting from it. An important name for later appears here for the first time. Frances Oldham Kelsey, during her Ph.D. in Pharmacology studies at the University of Chicago, assisted in the research project which showed that the 100 deaths from Elixir Sulfanilamide were due to the DEG which was used as a solvent.⁴These deaths were classified as fatal adverse events. The FDA at this time was hampered in its authority as to what action it could take. Under the Pure Food and Drug Act of 1906, the ability of the FDA to regulate this “medication” was reduced to labeling. According to the regulations, an “Elixir” was required to contain some percentage of alcohol to be permitted to be labeled as such. Elixir Sulfanilamide contained none. The end result of this was that the S. E. Massengill Company paid a small fine and their chief Chemist, Harold Watkins, committed suicide⁵. But, as with most regulations, it didn’t end there. Congress now passed the Food, Drug and Cosmetic Act of 1938.

The Food, Drug and Cosmetic Act of 1938 was a major leap forward for the FDA. Now, for the first time, the Agency had an ability to regulate a drug before it came onto the markets. A key part of the Act mandated that safety data had to be collected and reviewed prior to marketing of a New Chemical Entity (NCE). Additionally the FDA no longer needed to prove fraudulent intent before intervening with false or misleading labeling. These were major steps forward for the FDA and with the additional inspection authorities that the FDA gained, the Agency that we know today was basically formed. This Act also saw Homeopathic Nostrums classified as a “drug” by the FDA. They are protected under Section 201(g) and 201(j) of the act and this was the FDA’s first serious attempt at regulating these products.

In 1951 we see the next major step in the process with the Durham-Humphrey Amendment. This Amendment had the effect of basically creating a class of drug which must be taken under the supervision of a medical practitioner, the so called “prescription only” drugs. In addition, the 1940’s had seen two Amendments, the Insulin and Penicillin Amendments added a requirement for potency testing. During this time the Public Health Services Act of 1944 expanded the Agency’s scope to cover biological products as well.

This brings us to 1959 and to a tragedy on a global scale which was, through decisive action on the part of one FDA reviewer, greatly minimized in the United States. Although the tragedy would take a few years to manifest itself, 1959 saw the US Senate try to put in place regulations to have pharmaceutical companies demonstrate the efficacy of their product. There was a great deal of push back from both the public and the pharma industry, but this stopped in 1962 when thalidomide appeared.

As this is one of the true pivotal moment in the history of the FDA, we will examine it in a bit more detail. Thalidomide came on to the European Markets in 1957 and was used as a pain killer and tranquilizer⁶. Another key reason for its use was that it was found to combat morning sickness in pregnant women. That was to be Thalidomide’s ultimate downfall. During the 1950’s and 1960’s, after Thalidomide made it onto the Market, more than 10,000 children in 46 countries were born with deformities. This alarmed two European Doctors who began investigating the reasons⁷. Now we meet Frances Oldham Kelsey again. Remember her from earlier? By this time she had completed both her PhD and her M.D. and was working as a reviewer at the FDA. When Thalidomide, also known as Kevadon, came across her desk she decided that the safety documentation was not sufficient to support the requested indication of relief from morning sickness. The Application was rejected⁸. Richardson Merrell (Now Marion Merrell Dow), the manufacturer, then attempted to apply pressure to have their drug approved, but Dr. Kelsey remained firm in her desire for safety studies. What Richardson Merrell did manage to do was distribute 2.5 million pills to approximately 1,200 doctors in the US with the understanding that this product was not approved and still “under investigation”. As Dr. Kelsey dug deeper into the product, the 10,000 birth defects became publically known and Richardson Merrell rescinded their Application. Seventeen (17) children in the US were born with birth defects as a result of Thalidomide. Currently it is marketed in the United States by Celgene under the name Thalomid and is part of a RiskMAP known as S.T.E.P.S.

The Thalidomide incident led directly to the Kefauver-Harris Amendment of 1962. This is also known as the “Drug Efficacy Amendment”⁹. The main effect of this Amendment on the FDA was that they now had the authority to mandate clinical studies to show that a Drug is both safe and effective. 

As we draw to the close of the establishment of the FDA, a few more milestones should be noted. In 1976 the Medical Device Amendments expanded the FDA’s reach to cover medical devices. 1983 saw the Orphan Drug Act which makes it easier to conduct studies and research drugs for rare diseases. The Food and Drug Administration Act of 1988 makes the FDA part of the Department of Health and Human Services. Finally, in 2007, the Food and Drug Administration Amendments Act (FDAAA) put in place the ability for the FDA to being mandating Risk Management and Evaluation Strategies (R.E.M.S.) for products which have a high risk to patient populations, which was brought about, in part by the death related to Class II Extended Release Opioid Products.

This is how the FDA grew out of a few small offices to the true Agency that it is today. It has, through trial and error, learned to deal with death, unscrupulous marketing and outright contempt. The FDA will not be going anywhere soon, and with the recent appointment of Dr. Hamburg as the Commissioner the focus on Safety will once again be brought to the forefront as we are already seeing in some of the more recent enforcement actions the Agency has undertaken. 

• United States Statutes at Large (59th Cong., Sess. I, Chp. 3915, p. 768-772)
• United States v. Johnson 221 U.S. 488 (1911)
• Schep LJ, Slaughter RJ, Temple WA, Beasley DM (July 2009). “Diethylene glycol poisoning”. Clin Toxicol (Phila) 47 (6): 525–35.
• Bren, Linda (March/April 2001). “Frances Oldham Kelsey: FDA Medical Reviewer Leaves Her Mark on History”. FDA Consumer. 
• Mihm, Stephen (2007-08-26). “A tragic lesson”. The Boston Globe. 
• Moghe, Vijay V; Ujjwala Kulkarni, Urvashi I Parmar (2008). “Thalidomide”. Bombay Hospital Journal (Bombay: Bombay Hospital) 50 (3): 446. 
• Anon. “Widukind Lenz”. Who named it?. Ole Daniel Enersen. http://www.whonamedit.com/doctor.cfm/1002.html.
• 1986. “Frances Kelsey”. Canada Heirloom Series. Heirloom Publishing Inc.
• Peltzman, Sam. An Evaluation of Consumer Protection Legislation: The 1962 Drug Amendments. The Journal of Political Economy, Vol. 81, No. 5. (Sep. – Oct., 1973), pp. 1051. 

Martin A. Lessem is a Regulatory Attorney with eight years of working in the Pharmaceutical Industry. Although currently working for a Generic manufacturer, Martin has worked for Innovator companies as well. His current area of expertise is Risk Management, specifically the new R.E.M.S. guidelines, Promotional Compliance and the Regulatory aspects of Clinical Trials. The views that he expresses in his posts are his own and do not necessarily reflect those of his current or previous companies.

Some chiropractors also practice homeopathy. According to Frank King, D.C., many more should be doing just that:

Homeopathy is an energetic form of natural medicine that corrects nerve interferences, absent nerve reflexes, and pathological nerve response patterns that the chiropractic adjustment alone does not correct. The appropriate homeopathic remedies will eliminate aberrant nerve reflexes and pathological nerve responses which cause recurrent subluxation complexes.

Not only does homeopathy correct nerve interferences, it empowers the doctor of chiropractic to reach the entire nervous system. What this means is that we can now better affect the whole person, and all of the maladies that affect us. Homeopathy’s energetic approach reaches deep within the nervous system, correcting nerve interferences where the hands of chiropractic alone cannot reach. Homeopathy is the missing link that enables the chiropractor to truly affect the whole nervous system!

But that’s not all:

Financial Rewards

Homeopathy means a multiple increase in business. Personally, I have been able to see and effectively help more patients in less time. The additional cash flow from broadening your scope of practice, increasing your patient volume and selling the homeopathic remedies is a wonderful adjunct. Better yet are the secondary financial benefits:

• Homeopathy is like an extension of you that the patient can take with them to apply throughout each day in between visits. The actual therapeutic benefits of homeopathy along with the inner comforts of the patient as they connect you with each dose they take.
• The dynamic broadening of your effective scope of practice multiplies the number of patients you can help and the multiple problems that each patient usually has. As you correct one set of problems, there are commonly other problems most patients don’t even tell their chiropractors. This doesn’t have to be the case anymore. Homeopathy empowers the chiropractor to correct conditions ranging from allergies to warts with incredible effectiveness!
• Obviously, the rule of multiples will exponentially increase when a homeopathic procedure is properly implemented into your practice. Many of the conditions people are suffering with have no viable solution without the dynamic duo of chiropractic and homeopathy.

You can be the doctor people will seek out, travel long distances to see, and pay cash for your valuable services. Take it from someone who has experienced it first hand, it’s a great position to be in.

This is no surprise. Most chiropractors relinquished whatever ethical integrity they might have had when they bought into the “subluxation” myth, and the field as a whole has a fine tradition of “practice building.”

Naturopaths, likewise, don’t mind winking at practice ethics in order to make an extra buck. Nor do MD quacks, of course. Hey, it’s getting harder and harder to make a living just by slogging through the morass of needy patients, onerous third-party billing requirements, diminishing payments, increasingly cumbersome practice guidelines, next-to-impossible-to-keep-up-with (nothing to say of tedious and technical!) medical literature, and all the rest. Why not sprinkle your practice with a little ‘diagnostic’ sugar that will appease those clingy patients—for a while, anyway—and that you won’t have to find billing codes for (because there aren’t any)? Heck, why not check out this offering from “bio-pro, inc. Amazing Anti-Aging Solutions (Healthier Patients, More Patients)”:

HOWW TOOOO ….
The “must do” seminars for those who own or are managing a
Complimentary [sic] Medicine Practice.

Three day course teaches you:
How to relate to the patient, evaluate, test and diagnose
How to use solutions, mixtures, methods, supplies and equipment
How to protocol administration for Chelation, Oxidation, Chelox, TriOx, Ascorbates, UVBI
How to design and organize your office
How to hire and fire staff and to computerize
How to use public relations and marketing
How to manage compliance with Medicare, State Medical Boards and governmental regulatory agencies
 
Manuals included…
Each attendee receives one set of training materials, including:

Protocol Manual
Physicians Manual
Office Procedure Manual
Forms Book
Marketing Manual
Patient Results Manual
Employee Manual
Audio tapes
and other related material.

Bio-pro was founded in 1978 by the late Charles H. Farr, MD, PhD, the self-styled “father of oxidative medicine,” who was also a founder of the American College for Advancement in Medicine, the Mother of All Pseudomedical Pseudoprofessional Organizations (PPO).

But none of this is surprising, right? After all, quacks quack.

What may have come as a surprise to beleaguered physicians who still play by the rules was this offering, just a few days ago, from Medscape Business of Medicine: 

Six Ways to Earn Extra Income From Medical Activities

You’re chasing after claims but watching reimbursement sink.

It’s a common story, and primary care doctors and even specialists are keeping their ears to the ground for other ways to boost their bottom line. Luckily, doctors have some fairly lucrative options that can help them maintain their income — and perhaps even increase it.

We looked at 6 avenues that physicians have taken to earn extra revenue. None of these activities require a tremendous amount of time. Participating in just 1 or 2 activities can put enough money in your pocket to allow you to breathe a little easier when the bills come in. Here are several popular ones for consideration.

So what are those ‘6 avenues’? Let’s see:

• Work with Attorneys
• See Nursing Home Patients
• Serve as a Medical Director 

So far, so not necessarily bad…

• Team Up with Pharmaceutical Companies

What??! Team up with pharmaceutical companies? Couldn’t that mean, like, just doing legitimate research and trying like hell to do it right? Uh, nope:

Drug and device companies spend billions of dollars each year to discover and promote new medicines and treatments, and they rely heavily on doctors to participate in these endeavors whether through clinical trials or serving as a speaker or consultant. It’s not uncommon for physicians to earn a minimum of 5 figures a year either speaking or doing clinical studies within their medical practice. Some doctors make in excess of $100,000 annually — on top of their income from seeing patients.

O’course, you gotta watch out for those pesky ethics killjoys, warns Medscape: 

Although some extra money is nice, too much can turn heads — and not in a good way. In late January, The Boston Globe reported on an allergy and asthma specialist who was issued an ultimatum by his hospital, the prestigious Brigham and Women’s Hospital (Boston, Massachusetts): Stop moonlighting on behalf of pharmaceutical companies or resign from your staff position.

What it all comes down to is this:

Pros: With typical payments running about $1500-$2500 for a single talk, there’s substantial opportunity to supplement your regular income…

Cons: These arrangements are coming under increasing scrutiny from hospitals, legislators, regulators, and the media. In fact, some of the doctors whom we contacted for this article declined to talk about their involvement with drug companies.

Uh, no kiddin’. Funny that the “increasing scrutiny” doesn’t seem to come from organized medicine, medical schools, mainstream medical journals, state medical boards, or doctors in general. A couple of years ago I lamented the publication of a couple of book reviews, in the lofty New England Journal of Medicine, that had celebrated trendy pseudomedicine. Shortly thereafter I received this from an emeritus editor:

I think the incursion into the bastions of medicine has to do with the fact that everything nowadays—absolutely everything—has become a market. If quackery appeals to the readers of the NEJM, it will be there. ”Is it true?” is no longer the question anyone asks, but “Will it sell?” And I think that applies to the editors of most major journals, as well. 

True, dat. As for Medscape, this isn’t its first ethical gaff, and I agree with Bernard Carroll that it seems to have “a right hand – left hand problem.” Oh yeah: what were the other 2 “avenues”? Those would be: 

• Become a Media Personality
• Consult for Wall Street

The International Society for Stem Cell Research (ISSCR) is a professional organization of stem cell researchers. I am happy to see that they see it as their responsibility to respond to the growth of dubious stem cell clinics offering unproven treatments to desperate patients.

In a recently published handbook for patients, they write:

The International Society for Stem Cell Research (ISSCR) is very concerned that stem cell therapies are being sold around the world before they have been proven safe and effective.
Stem cell therapies are nearly all new and experimental. In these early stages, they may not work, and there may be downsides. Make sure you understand what to look out for before considering a stem cell therapy.
Remember, most medical discoveries are based on years of research performed at universities and companies. There is a long process that shows first in laboratory studies and then in clinical research that something is safe and will work. Like a new drug, stem cell therapies must be assessed and meet certain standards before receiving approval from national regulatory bodies to be used to treat people.

This is good advice for any new treatment.

The problem with dubious stem cell clinics has been growing in recent years. In China, Mexico, India and elsewhere clinics promise “cutting edge” stem cell transplants for a long list of fatal or incurable diseases, like ALS, spinal cord injury, or stroke. They seem to be deliberately targeting affluent Westerners – although many of their victims have to raise money or mortgage their house to pay for the travel and cost of the treatment. The cost is often in the 10s of thousands of dollars, at time more than 100k dollars.

Such clinics typically advertise for customers over the internet. A survey of such sites indicates that most present their stem cell treatments not as experimental, but as “routine.” They offer testimonials to support their treatments, rather than published research.

These clinics are not doing proper science – publishing rigorous research and treating patients only with proper experimental protocols and informed consent. They are exploiting the public’s interest in a potential future therapy to prey on the desperate.

Such clinics are allowed to practice because of lax regulations in the countries in which they reside. Because of some bad press, Costa Rica, India and other countries are starting to take a look at such clinics – but official efforts to regulate them has been half-hearted at best.

It is therefore most welcome that professional and research organizations are seeing it as part of their mission to educate the public and directly address the misleading claims of snake oil peddlers. We need much more of this. Engaging with the public about misinformation and especially dubious health claims and products should be considered a core mission of medical professional societies.

The Internet is a wonderful new medium for communicating ideas and information in a rapid and interactive way. Many articles are followed by a “comments” section. Like so many things in this imperfect world, comments are a mixed blessing. They can enhance the article by correcting errors, adding further information, and contributing useful thoughts to a productive discussion. But all too often they consist of emotional outbursts, unwarranted personal attacks on the author, logical fallacies, and misinformation. They provide irrational and ignorant people with a soapbox for promoting prejudices and false information.

To illustrate, let’s look at the responses to something I wrote about a weight loss product called Isagenix that is sold through a multilevel marketing scheme. To quote the website,

The Isagenix cleanse is unique because it not only removes impurities at the cellular level, it builds the body up with incredible nutrition. Besides detoxing the body, Isagenix teaches people a wonderful lesson that they don’t need to eat as much as they are accustom to and eating healthy choices are really important and also a lot of the food we are eating is nutritionally bankrupt. [errors are in the original]

I didn’t set out to write an article about this. It started when I received an e-mail inquiry about Isagenix. I posted my answer on a discussion list and it was picked up and published on the healthfraudoz website.  Sandy Szwarc approved of it and kindly reposted it on her Junkfood Science blog. 

As I write, the comments on the healthfraudoz website have reached a total of 176. A few commenters approved of what I wrote, but the majority of commenters tried to defend Isagenix. Their arguments were irrational, incompetent, and sometimes amusing.

It was as if no one had actually read what I wrote. No one bothered to address any of my specific criticisms. No one even tried to defend Isagenix’s false claims that toxicity accounts for most disease, that the body protects itself from toxins by coating them with fat, and that internal organs become clogged and deteriorate if you don’t “cleanse.” No one offered any evidence that “detoxification” improves human health. No one tried to identify any of the alleged toxins or show that they are actually removed. No one tried to provide any rationale for the particular combination of ingredients in Isagenix products (242 of them!). No one questioned my assertion that “no caffeine added” was inaccurate because green tea was added and it contains caffeine. No one commented on my observation that the amount of vitamin A in the products was dangerous and went against the recommendations of The Medical Letter. No one offered any evidence that more weight was lost by adding Isagenix to a low calorie diet and exercise. I offered some alternative explanations that might account for people believing it was effective when it wasn’t; no one commented on that. The medical advisor on the Isagenix website argued that at $5 a day Isagenix is less expensive than open heart surgery. I pointed out that that was a laughable false dichotomy: it’s not a matter of choosing between open heart surgery and diet supplements. No one commented on that. Instead of rational responses, we got …

Testimonials

The greatest number of comments were testimonials: “I took it and I lost weight.” They claimed not just weight loss, but a variety of improvements. It allegedly cured fibromyalgia, osteoarthritis, and hemorrhoids. It facilitated getting off sleeping pills and caffeine, balanced brain chemistry (what does that mean?), improved focus and mental clarity, allowed running longer marathons with less fatigue, saved a failing marriage, stopped irritability and crankiness, kept arm from getting sore after pitching, “Made my son interact appropriately with peers, take care of himself, and want to be hugged and kissed,” and “I made money selling it.” One said, “My out of control Irritable Bowel Syndrome disappeared and I had the healthiest BM in about 6 years! … you can’t brainwash POO!!” Two commented that the Isagenix program provides motivation; one said he needs “structer” (structure?) to stay on a diet.

The plural of anecdote is not data. Two commenters appropriately objected to all this testimonial evidence. They pointed out that testimonials are unreliable and subject to post hoc ergo propter hoc errors, that all the “it works for me” comments can be attributed to low calorie diet and exercise, and that the testimonials are almost exclusively from people who are selling the product.

Anti-Testimonials

Quite a few commenters reported that they had tried it and it either didn’t work or caused side effects such as 5 days of violent diarrhea. One reported gaining a lot of weight while taking it; many reported losing weight just as well without it. Several reported credit card disputes with the company and failure to get their money refunded. One reported that his parents are using it and it seems to be slowly killing them: they have decreased energy, declining health, mood swings, and poorer control of diabetes.

Rebuttals to Negative Testimonials

Supposedly the people it hasn’t helped haven’t been following the program right.
Apparent bad reactions are just signs that it is working: “When one is cleansing out years of accumulation of toxins, chemicals, jet fuel, gasoline, arsenic, heavy metals, radiation poisoning – one will have reactions.”

“Evidence” that it works:

One commenter heard a doctor speak who cited all kinds of studies to support the theory behind Isagenix — environmental toxicity, depletion of nutrients in the food supply, malabsorption, our incessant food cravings, and how Isagenix cleansing could supposedly solve these problems.

A former Hare Krishna was impressed by the array of nutrients in the products and believed that the doctor on the website had integrity and cared about her patients.

Several people claimed that we need nutritional supplements because the ground has been depleted of nutrients.

“There have been many valid scientific research [sic] to back the claims of Isagenix.” [I couldn’t find any, and they provided no clues as to where to look.]

Lots of MDs are recommending Isagenix, and they can’t all be quacks.[Apparently they can. And lots of MDs recommend homeopathy, and some of them believe in astrology.]

Isagenix has paid for independent studies [Where are they? What did they show? If Isagenix was paying, were they truly independent?]

Mainstream physicians are starting to realize cleansing is important.[Not any of the ones who practice science-based medicine.]

Cleansing makes sense because one of the main ingredients of pesticides and insecticides is estrogen. It makes women fat and causes ED in men. Toxicity is a bigger cause of obesity than most people realize.

These products are “designed and formulated by professionals and advocated by professionals.”

One MD commenter claimed “I have the before and after pictures and the lab tests to prove it.”

“Most people only absorb 8% to 12% of what we eat – the rest is waste which we flush down the toilet. With Isagenix we can absorb up to 94% of what is ingested with less waste going down the toilet. Isagenix is full of good probiotics which help rebuild our digestive systems, fights candida. Isagenix also helps the body become alkaline, which is a healthy body. John Hopkins 2008 Cancer Report stated that cancer cannot live in an alkaline body only acidic bodies. Processed food makes our bodies acidic — thus the epedemic [sic] of cancer and diabites [sic] in the USA along with heart disease.” [This is all nonsense.]

Isagenix is food. Regular food is from depleted soils. Organic food made children behave better at lunch in a school study. Genetically modified food is lacking in nutrition. “The majority of people fill their stomachs with foods void of natural nutrition and the evidence supports that they behave poorly, learn less, mis-behave more and commit more crimes than those who fill their stomachs with highly nutritious organic produce and meats.” [Wow! Instead of the Twinkie defense, criminals can claim their non-organic lunch made them do it!]

“Isagenix is a divine blessing in this toxic sick world.”

These people apparently expect us to believe unsubstantiated assertions. They have no concept of what constitutes scientific evidence or why controlled studies are needed.

Defense of Multi-Level Marketing

“MLM is not a scam, but one of the last bastions of free enterprise.” MLM is good because FDA products don’t work. MLM is “the most legitimate business out in the world today.” All corporations are a pyramid, anyway.

But one commenter called it an “exploitative business model” and pointed out that the average yearly income for Isagenix distributors is only $116.87. And another pointed out that 97% of MLM schemes fail.

Personal Attacks on Me

“A Dr Harriet Hall wrote a very funny one sided arguement [sic] against it (Isagenix) but omitted to inform the world how much money she has made conning patients into taking drugs she should know are harmful to you.”

I am arrogant: “If it were up to know-it-all MDs like Harriet Hall, I’d still be in chronic pain.”

“To [sic] bad when you look up Dr. Hall in Washington no such person is licensed to practice medicine. Sad day when you have to lie to get people to pay attention to anything you say…” [It took me about one minute to locate verification of my license at https://fortress.wa.gov/doh/providercredentialsearch/SearchResult.aspx.]

One commenter questions whether I am really a doctor and says I have a small brain and a big mouth.

I only write to feed my ego.

I shouldn’t make comments without doing any research.

I should try it for myself.

I should have learned more by attending a meeting for the product, talking to company representatives or talking to the press.

Instead of writing for the public I should have contacted the doctors at the company and discussed my concerns with them.

Don’t try to convince us, Dr. Hall, that you necessarily have “the answer.” [Did I say I did?]

One alleges that I came to a conclusion without any research whatsoever: this from a doctor who says “Cleansing is now my first choice for my patients.” One wonders what research he did to reach that conclusion.

“Going out of her way to trash Isagenix this way is pathetic.”

“PS ‘Dr.Hall’ your little family practice designation really doesnt buy alot of cred.”

“Real doctors don’t waste their time sitting on the internet making bogus posts about different health products….I could sign as doctor and no one would know.”

“this article is and the author is full of crap. I know it and he knows it.” [I know I’m not a “he.”]

I don’t know anything and I should just shut up.

“This is just another doctor that stands to loose [sic] their income by the masses becoming healthy.” “What ever Dr. Harriet Hall is selling, I’m not interested.” [For the record, I’m retired and the only thing I’m “selling” is critical thinking. Profit margin? Low.]

I probably drink Diet Coke and eat at McDonald’s.

Just because I went to medical school doesn’t mean I’m a smart person.

Kudos

A few commenters offered agreement and praise, pointed out that no one had actually addressed any of the points I made, much less offered any evidence that what I wrote was wrong, and reprimanded other commenters for resorting to ad hominem attacks.

Attacks on the Medical Profession

Doctors know nothing about nutrition. They put band-aids on problems. They sell pills that mask symptoms and wreak havoc on your body instead of treating underlying causes. There are lots of malpractice suits. They only want to make money. They want to keep people sick so they won’t lose their kickbacks. [What kickbacks? Where are my kickbacks?!]

“Most MD’s will not even take the death dealing treatments they inflict upon the rest of the population.”

If evidence showed it worked, conventional medicine still wouldn’t adopt it because of competition from drugs. Many doctors are out of shape. The majority of ER doctors are lacking the skills in emergency procedures.

MD’s keep American’s addicted to drugs! MD’s also fancy themselves as God like. They think that being an MD allows them to keep American’s [sic] from seeking nutrition.

Doctors are typically overweight.

Our medical doctors have failed us.

“So sad that people in our medical profession have no idea what they are talking about!!!”

Attacks on Science

Instead of listening to science, one should listen to one’s own body.

Even if it’s only a placebo, why not use it?

Western medicine is trying to squash Eastern Medicine

“Things work for different people. Chiropractic and acupuncture work. If you ask for everything to be backed by studies, they just tailor the studies to benefit industry. Research things for yourself and don’t be a sheep taking pills from an MD.”

Two commenters attacked the scientifically impeccable website Quackwatch, asserting that Stephen Barrett is paid by Big Pharma and the AMA and the FDA to say those things, literally funded by them to produce dis-information aimed at discrediting alternative health. [He has no ties to any of those organizations.]

“See how herbs can treat people, not drugs.”

“Did any of you see Sicko? If you did how could you possibly take one physicians [sic] ‘opinion’ about something she didn’t even try over the many testimonials.”

I choose to observe how my own body feels and reacts to what I ingest.

If you think it’s going to help it will.

The real answer is to integrate Eastern with Western medicine.

Prayer helps.

It is unfair to say Isagenix is making unsubstantiated claims and then to make the unsubstantiated claim that it doesn’t work. [I didn’t claim that it didn’t work: I said there was no evidence that it did, and no reason to think it would.]

Attacks on FDA and Big Pharma

The FDA disclaimer is meaningless.

We shouldn’t take FDA warnings seriously: “it is a terrorist organization that lies, cheats steals, and intimidates anyone who stands between them and the targets of their wrath.”

Dr Hall if you think the FDA is doing a good job you must love some of the poison they approve, such as Aspartame.

Doctors get commissions for prescribing drugs.

A conspiracy of JD Rockefeller is behind the pharmaceutical industry: many prescriptions are made from manipulation of petroleum.

People die from drugs.

“My doctor wanted me to start beta blockers, after much investigation I decided that I was to [sic] young to have my liver contaminated by these pills…”

Natural remedies work just as well and are safer than prescriptions.

Pharmaceuticals are the ultimate money-making scam.

Off-the-Wall False Claims

“The FDA (yes, those great friends of ours) just recently put a new advisement out there [It did not!] that we will soon be required to irradiate ALL raw vegetables and fruits. Do you all know what irradiation does to food? It not only kills “bad” things like e. coli, but it kills nutrients from your foods as well.”

Try It for Yourself

Numerous commenters seemed to think the best way to determine if a treatment works is to try it yourself. But one commenter rightfully pointed out that the try it yourself argument was fallacious and condescending. “One does not have to experience snake venom to know to stay away from snakes.”

Haven’t Tried It But Plan To

Several were planning to try it after reading the article and comments. One of these said he knows firefighters who use it and he “would rather have one of the firefighters doing brain surgery on me, than let the average physician tell me what is going on in my body.” [Wow! Does this guy even have a brain to operate on?]

It’s a Scam

Quite a few people agreed with what I wrote. Several were outspoken in calling Isagenix a scam.

“People would rather rave about this crap than admit that they were fooled into wasting their money.”

“Without even considering the science, common sense helped me spot this as bullshit.”

“Isagenix is a freakish cult perpetrated on the uncritical, by the unscrupulous, using the desperate search for the ever-elusive ‘easy solution.’”

One reported that a cousin and her boyfriend are “making a TON of money selling this stuff to all of you morons stupid enough to buy it and make them rich. ISAGENIX only “works” for the people selling it. Diet and exercise WORKS for everyone!”

Concerns

A few commenters expressed concerns about the product. The Isagenix rep couldn’t answer questions about origin of ingredients and quality control. There have been no controlled studies. Where is the evidence? How do we know it is safe? Long-term results remain to be seen. How many can maintain this restrictive lifestyle for years? Why isn’t it being regulated by the FDA?

“I am a little concerned about the way some people discuss this product in almost cult-like fashion. It makes me wonder if there are mind-control drugs in this stuff.”

2 Jokes

“I got a refund check from IRS after starting Isagenix.”

“I have some magic beans for sale. Try eating right and exercising instead.”

Funny, Unhelpful, and Bizarre Comments

“Who cares whether it works or not. This stuff tastes like 9-day old garbage mixed with water from a sewer.”

One man took it on the recommendation of his chiropractor; he now distrusts both Isagenix and his chiropractor. “I have been feeling better ever since I stopped having my head wrenched and being put on a rack and practically decapitated week after week, except for the apparently permanent click in my neck that wasn’t there before.”

“We fertilize our soil with fake nutrients and usually do not replace with all 60 nutrients the plants need to be healthy so they are prone to diesease [sic – a disease that they die from?] and incests [sic].” [Gotta watch out for those incestuous plants!]

“I never hear anything from the medical field about elevating the PH level in the human body to keep in from being to acidic. That study was done by Dr Lioness Paulings medical reseacher and nobel prize winner.” [Yet more amusing errors in original. Lioness?!]

“Whoever started this blog is an idiot.”

“I am amazed at the amount of ingnorance [sic] on this Blog. Whom [sic] ever allows this should be ashamed.”

My favorite comment of all was “Dr Harriet Hall is a refrigerator with a head.” I don’t know what that means, but its whimsical imagery appeals to my sense of humor.

In looking back at this whole kerfuffle, it became clear to me that there had been a colossal barrier to communication. The person who originally asked me about Isagenix and the blog owner and I were all operating in the arena of science and evidence. Most of the commenters were operating in a whole different universe of discourse based on belief, hope, hearsay, and personal experience. Science is like a foreign language to them, and they were incapable of understanding my points. Pearls before swine…

On “wholistic” medicine

If there’s one aspect of so-called “alternative medicine” and “complementary and alternative medicine” (CAM) is that its practitioners tout as being a huge advantage over what they often refer to sneeringly as “conventional” or “scientific” medicine is that — or so its practitioners claim — alt-med treats the “whole patient,” that it’s “wholistic” in a way that the evil reductionist “Western” science-based medicine can’t be. Supposedly, we reductionistic, unimaginative physicians only focus on disease and ignore the “whole patient.” Of course, to me this claim is belied by the hectoring to which my own primary care physician has subjected me about my horrible diet and lack of exercise on pretty much every visit I’ve had with her, but then maybe she’s an anomaly, along with Dr. Lipson on this very blog and pretty much every other primary care doctor I’ve ever dealt with. Anecdotal experience, I know, but since alt-med mavens appear to value anecdotal evidence above pretty much all else I thought it appropriate to mention here. Also belying the claim of alt-med practitioners that they “individualize” treatments to their patients in a way that science-based medicine does not is the maddening tendency of various alt-med modalities to settle on just One True Cause of All Disease, be it liver flukes as the One True Cause of Cancer, heavy metal toxicity as the One True Cause of cancer, autism, and various other diseases, or “allergies,” acid, or obstruction of the flow of qi as the One True Cause of All Disease.

Given the claim of “wholism” that is such an advertising gimmick among many of the varieties of woo, I’m always interested when I see evidence that alt-med is imitating its envied and disliked reductionistic competition. True, this is nothing new, given how alt-med has tried to seek legitimacy by taking on the mantle of science-based medicine wherever it can. Examples include the National Center for Complementary and Alternative Medicine (NCCAM), various organizations that try to confer legitimacy to pseudoscience by providing “certification” in various flavors of woo, and moves to push state medical boards to go further than that and confer legally protected status to practitioners by actually licensing them. This latter tactic has been very successful in that many states now license acupuncturists, while some states even license naturopaths and “homeopathic physicians,” the latter of which I find quite amusing because the term perfectly encapsulates what must remain of such a physician’s medical training after being diluted to 30C with woo. The only difference is that, unlike what is claimed with homeopathy, diluting MD medical knowledge with woo does not make it stronger. In terms of naturopathy, though, one of the most alarming aspects of the infiltration of naturopaths into the health care system is that some states in the U.S. and provinces in Canada are seriously considering allowing them to prescribe real pharmaceutical medications, even though they lack the training and knowledge to use such drugs safely.

Imagine my combination of bemusement and alarm, then, when I learned of a new specialty of pseudoscience, namely the field of naturopathic oncology.

Be afraid. Be very afraid. (I know I was when I first encountered this specialty.)

Naturopathic oncology

It’s not surprising that I first discovered the “discipline” of naturopathic oncology at the Seattle Cancer Treatment and Wellness Center, which is affiliated with the Cancer Treatment Centers of America. As a science-based physician and surgeon I really detest CTCA because it is expert at combining state-of-the-art science-based medicine with pseudoscience like naturopathy, chiropractic, and acupuncture, as well as scientifically tested modalities known not to be particularly helpful in the clinical management of cancer, such as chemotherapy resistance testing (which could be the topic of an entire post). Suffice it to say that the last of these was prominently featured in Suzanne Somers’ cancer book last year. In any case, CTCA covers a continuum from the boringly “conventional” (traditional surgery, chemotherapy, and radiation) to the questionable (chemotherapy resistance testing), to pure pseudoscience (naturopathy, acupuncture, homeopathy) mixing them together to the point where it is impossible for the average consumer to know which is science-based and which is not.

We’ve written about naturopathy on multiple occasions here on SBM, but what is naturopathic oncology? Apparently it’s an “emerging field” within naturopathy concerned with applying naturopathy to cancer. I don’t know about you, but to be an “emerging field” within naturopathy is akin to being an emerging new paranormal phenomenon in the field of parapsychology. But, then, I’m just one of those nasty, reductionistic, skeptical, scientific physicians, so what do I know? On the other hand, Kimball Atwood characterized naturopathy as a “pseudoscientific cult“; so maybe I’m not that nasty, at least not in comparison. Be that as it may, let’s take a look at a couple of definitions, written by naturopaths themselves. First, there’s the Oncology Association of Naturopathic Physicians (OncANP) (yes, there is an Oncology Association of Naturopathic Physicians). This is how OncANP defines “naturopathic oncology“:

Naturopathic oncology is the application of the art and science of naturopathic medicine to the field of cancer care and treatment. Naturopathic oncologists work both in hospital oncology settings and in private practices bringing their wisdom, perspective and experience to aid oncology treatment teams that seek the best positive outcomes for their patients.

It all sounds relatively benign; that is, unless you know what naturopathy is. OncANP tries to justify the “need” for naturopathic oncology thusly:

Aware that modern medicine has made little advance in its War on Cancer, many people with cancer choose to also include complementary and alternative medicine in their fight against cancer. They reach out and employ a wide range of therapies including meditation, prayer, acupuncture, herbal, botanical, nutritional, homeopathic, dietary and other holistic practices seeking benefit.

Naturopathic doctors and physicians are trained in accredited naturopathic medical schools in modern scientific nature cure. They are trained in both modern science and natural medicine. They emerge from their training well versed in the use of botanical medicine, homeopathy, diet, fasting, nutritional supplementation, orthomolecular medicine, psycho-immunology and other complementary and alternative medical techniques; they serve as capable guides for patients interested in exploring alternative medicine.

Those naturopathic doctors who choose to specialize in naturopathic oncology understand both the standard treatments employed by medical oncologists and how best to work with them in a collaborative model of cancer co-treatment. They are well aware of the multitude of ‘alternative therapies’ promoted to cure cancer and can help patients understand which might be useful and why.

Note the common CAM claim that we have made “little advance” in the War on Cancer used as a justification for offering pseudoscience. Most of the “therapies” offered are fairly benign, such as meditation and prayer, although I can’t figure out why meditation and prayer are represented as “therapies” rather than manifestations of religion. Of course, much of what else falls under rubric of “naturopathic medicine” and “naturopathic oncology” is pure pseudoscience, in particular, orthomolecular medicine, a construct popularized by the late Nobel Prize winner gone woo Linus Pauling, is pure quackery, advocating as it does megadoses of various vitamins and supplements. Given how late in his life Pauling had come to believe that megadoses of vitamin C would cure cancer (they don’t, alas), it’s not surprising that Pauling was attracted to this particular form of quackery.

Then there’s acupuncture, the Jack of All Trades in CAM. It’s one of those modalities that, it seems, can do anything. Treat pain? Acupuncture. Improve the success rate of in vitro fertilization? Acupuncture. Reduce menopausal symptoms in women with breast cancer requiring anti-estrogen therapy. Acupuncture. Got migraines? Acupuncture. Asthma, allergies, bronchitis, sinusitis, sore throat, laryngitis, colds and flu? Acupuncture. Irritable bowel, colitis, constipation, diarrhea, gastritis, heartburn, food allergies, ulcers? Acupuncture. Cystitis, menstrual cramps, irregular or heavy periods, infertility, menopausal symptoms? Acupuncture.

I think you get the idea.

Naturopathic oncologists even have their own board certification, just like real oncologists. They even put the letters after their name, FABNO, which stands for “Fellow of the American Board of Naturopathic Oncology.” (Personally, I think it stands for “FAB? NO!”) Of course, given the panoply of dubious therapies, some of them contradictory to each other, that naturopaths use, I really wonder what the certifying test is like. When, for instance, do you choose megadoses of vitamin C over acupuncture or vice-versa? When do you choose live cell therapy over this supplement or that supplement? And what is the scientific evidence that any of it does cancer patients any good whatsoever? Especially homeopathy. (More on that in the next section.)

The mind boggles that this “specialty” has its own board certification. How long before naturopathic oncologists push for special privileges in the states that license naturopaths? It’s not even beyond my imagination to visualize them applying for, and getting, the prescribing power to administer chemotherapy along with their herbs, supplements, and other woo. Why would naturopathic oncologists even want this? Easy. For the same reason that naturopaths in general seem to be seeking prescribing power: Real drugs work, and if one mixes real drugs with naturopathy then patients will tend to attribute the success not to the evil pharmaceutical drug but rather to the naturopathic nostrum.

The Cancer Treatment Centers of America, naturopathic oncology, and other woo

I and other SBM bloggers have complained about the infiltration of what sometimes refer to as “quackademic medicine” into medical academia. Quackademic medicine, as you recall, is the term we use to describe how so many medical schools have taken to studying fairy dust treatments like reiki and acupuncture as though they are science-based, often justifying this study with the rationale that they are “ancient” treatments and that lots of people use them. Promoters of pseudoscience have even managed to carve out a whole center at that bastion of science-based medicine, the crown jewel of the biomedical research effort of the United States the National Institutes of Health. That center is the National Center for Complementary and Alternative Medicine (NCCAM).

While we’ve spent a lot of time on SBM lamenting and doing our part to combat the infiltration of pseudoscience into medical academia, we’ve spent comparatively little time on what is arguably an equally serious threat to science-based medicine. That is the infiltration of “integrative medicine” into private medical institutions that use integrative medicine as a marketing tool in order to distinguish themselves from the rest of the pack. Arguably, no hospital chain has been more successful at this than The Cancer Treatment Centers of America. Over more than 20 years, CTCA has built up a network of hospitals in suburban Chicago, Philadelphia, Tulsa, and suburban Phoenix, as well as a network of physician practice groups in Seattle and elsewhere. CTCA was founded in 1988 after its founder’s mother lost her battle with cancer, its mission being to “change the face of cancer.” Unfortunately, at least in its hospitals it is succeeding, and not in a good way. This is how CTCA describes its founder, Richard J. Stephenson’s, mission to find treatment for his mother:

After his mother’s diagnosis, Mr. Stephenson embarked on a mission to find the most advanced and effective cancer treatments available. He hoped his efforts would enable his mother to recover and remain an integral, irreplaceable part of his life and the lives of his children.

The Stephensons were sorely disappointed by what they found. What were regarded as world-renowned cancer treatment facilities were singularly focused on the clinical and technical aspects of cancer treatment, ignoring the individual needs of the patient and the multi-faceted nature of the disease. Tragically Mrs. Stephenson did not live to watch her grandchildren grow and mature.

To keep his mother’s memory and spirit alive, Richard vowed to change the face of cancer care. He selected a group of outstanding oncologists and challenged them to find a way to deliver whole-person cancer treatment in a compassionate, nurturing environment.

Death from cancer is tragic; it’s often painful and slow, and the sense of helplessness and loss that accompany watching the decline of a loved one to cancer is sometimes more than a person can bear. Mr. Stephenson might have done more good if he had dedicated his grief to founding truly science-based cancer hospitals that had ingrained in their culture caring and the “human touch.” Unfortunately, he appears to have confused compassion and the human touch with “integrating” pseudoscience into science-based medicine. Instead of producing an institution that could really transform cancer care by preventing the tendency of large institutions to become impersonal, he’s created a Frankenstein monster cobbled together using a lot of perfectly sound science-based treatments, including surgery, chemotherapy, and radiation with pure pseudoscience like naturopathy and traditional Chinese medicine bolted on like the head of the Frankenstein monster.

Let me show you what I mean. I happen to have a few quick-and-dirty rules of thumb that allow me to rapidly identify a practice that is full of woo. These are just my opinion, but I find them fairly useful, much like identifying the weasel words of woo can be for Dr. Atwood. One of these rules of thumb states that, if a CAM practitioner offers “detox foot baths” as one of his services, he’s a quack until proven otherwise (and he’s unlikely to be proven otherwise if he’s actually cynical enough or enough of a true believer to charge for quackery like “detox foot baths”). I haven’t seen a naturopathic oncologist, either at CTCA or elsewhere, offer detox foot baths (yet), but I have seen them offer homeopathy, and I’ve seen them advertise it at CTCA. In my opinion, homeopathy is rank quackery; there’s just no other way to put it. In fact, these are the treatments that the naturopaths at CTCA offer:

• Nutritional supplements, including vitamins, minerals and amino acids
• Botanical medicine (the use of herbs)
• Homeopathic medicine
• Hydrotherapy

I’m always irritated when I see nutrition co-opted this way. If you go to the nutrition page of CTCA, you’ll find a lot of verbiage that sounds perfectly reasonable and science-based (albeit with exaggerated claims that science-based physicians don’t pay any attention to nutrition). It’s also claimed that malnutrition is one of the main causes of cancer death, accounting for perhaps one third of them, which is one of those claims that is superficially true but also ignores the fact that many cancers cause cachexia (wasting syndrome) by mechanisms that are poorly understood. Cachexia can’t be reversed just by providing nutritional support, nor can it be so easily prevented. Worse, CTCA uses the term “superfoods,” which is a marketing term designed to make claims about various foods far beyond what science will support. Certainly, it’s not a medical or scientific term, and it’s particularly annoying when CTCA claims that “superfoods” actually “fortify the immune system,” as that’s the same trivially meaningless claim made by woo peddlers of all stripes. In any case, the claim that CTCA is any better than any other cancer center at nutrition falls apart when I see things like this on its website:

According to the National Cancer Institute, 20% to 40% of cancer patients die from causes related to malnutrition, not from the cancer itself. CTCA chef Kenny Wagnor suggests loading your diet with anti-oxidants, which are found in bright colored foods such as berries. Chef Wagnor prepares a blackberry strudel packed with tasty berries and pecans — a great combination of cancer fighting foods!

At the risk of annoying certain readers, I will point out the logical fallacy here: non sequitur. It does not follow from the observation that 20-40% of cancer deaths are related to malnutrition that eating lots of antioxidants will help you beat cancer. In fact, it’s controversial whether antioxidants help or hinder chemotherapy, as I’ve written about before. My pet peeve about how CAM practitioners abuse nutrition as being somehow “alternative” and not considered important by scientific medicine, note how CTCA naturopaths actually offer homeopathy to cancer patients. Yes, cancer patients are being given magic water in order to relieve the side effects of their cancer therapy.

The coopting of science-based modalities like nutrition at CTCA doesn’t end there. It’s everywhere. For instance, look at the CTCA webpage on Oncology Rehabilitation. In addition to standard physical and occupational therapy treatments, CTCA also offers:

• Swedish Massage
• Reflexology
• Lymphedema Massage
• Myofascial Release

I certainly don’t have any problem with Swedish massage. It’s not a “therapy” per se, but there’s little doubt that it makes patients feel better. Lymphedema massage, if done according to science-based principles and not according to some “alternative” medicine techniques, is a valid technique to try to reduce the lymphedema that can occur as a complication of lymph node dissections performed for breast cancer and melanoma. However, reflexology is pseudoscience, as is myofascial release. Once again, CTCA is “integrating” woo with science. This is not surprising, given that its entire website is permeated with what Dr. Atwood would call the Weasel Words of Woo. Here is an example from the Bone Cancer Treatment page:

Your body is designed to inherently establish, maintain, and restore health. The healing process is ordered and intelligent; nature heals through the response of the life force. The role of the naturopathic practitioner is to facilitate and augment this process, to identify and remove obstacles to your health and recovery, to help your body maintain its healthy equilibrium, and to support the creation of a healthy internal and external environment for you.

Note the vitalism inherent in this brief passage, in which nature heals through the “life force.” This is not science. It has no place in science-based medicine.

Naturopathic oncologists versus science-based medicine

Given the vitalism that permeates naturopathy, it’s not surprising that naturopathic oncologists, like naturopaths in general, are not too receptive to scientific testing of their “art.” Sure, they say they are, but when it comes right down to it, in contrast to science-based physicians, naturopaths can’t accept negative clinical trials. For example, take a look at what naturopath Timothy Birdsall, FABNO, who is Vice President of Integrative Medicine for CTCA, says about research finding that his favored therapies don’t work. In the American Association of Naturopathic Physicians’ blog, he wrote an essay earlier this month entitled The Problem With Research in response to clinical trial results showing that selenium doesn’t help patients with lung cancer. Here are some choice quotes:

To top it off, the reason I was out of the office last week was that I was attending the National Advisory Council for Complementary and Alternative Medicine, the advisory body to NIH’s NCCAM. On that council, we have talked about just this issue — why do therapies which seem to make biological and physiological sense, which have some epidemiologic data to support their use, and which naturopathic physicians (and other alternatively-minded practitioners) have been using for decades (or much longer), seem to fail in double blind, randomized clinical trials?

We science-based physicians ask ourselves the very same question time and time again. Many are the seemingly plausible therapies that, when tested in humans, failed to show benefit in cancer. Here’s the difference: when we see therapies, no matter how plausible, that fail in randomized clinical trials, we abandon them. True, it may take more time than we’d like. The process may be messier than we like, as some physicians who are wedded to these therapies are reluctant to give them up when science doesn’t support them. We then move on to try to figure out where our understanding of the biology went wrong. But abandon them we do. We don’t blame science and the randomized clinical trial (RCT), as Birdsall does. First, he trots out the favored canard of CAM practitioners everywhere and argues that RCTs “answer simple, straightforward questions” and (presumably) his woo isn’t simple. Of course, the question of whether selenium can, as he believes, be useful in treating lung cancer is actually a pretty simple, straightforward question not unlike the question of whether a certain chemotherapy can prolong survival or increase the cure rate of a cancer. Instead of realizing that, Birdsall attacks science:

And so I began to ponder the question, “What’s wrong with research?” A part of me becomes enraged at the reductionistic, allopathic, biomedical model, which breaks things down into components so small that all synergism, all interdependence is stripped away, and then declares those components to be ineffective. Another part argues that the wrong component was selected, or was a synthetic form (although in the lung cancer study, they used selenium yeast). But ultimately, I find myself becoming offended because I believe that these therapies work… Whoa! Believe? OK, but where is the role for evidence? I used to believe that stress caused gastric ulcers. And then along came Helicobacter pylori, and I had to change my belief to match the evidence.

Note the standard attack on “reductionism” and “allopathy” and the “biochemical model.” Then note the irony as Birdsall, while declaring that naturopathic oncologists must become science-based and train the next generation of naturopaths to be “great scientists” (I spit up my iced tea when I read that line), he proposes in essence destroying science in order to save it for naturopathy — or, more precisely, to use it to legitimize naturopathy:

Third, we should collaborate with other professions and institutions to craft the research models necessary to adequately perform “whole systems” naturopathic research. There are examples of this type of approach already existing in the health systems research literature which can be adapted to our needs. In the end, we must create and validate the tools to dethrone the randomized controlled trial as the gold standard, and construct new ways to validate clinical approaches to health issues. Much as the homeopaths of 2+ centuries ago created the proving as a way to better understand and utilize their remedies, we must refuse to be limited by the way conventional medicine views health and disease.

I would argue that invoking the magical techniques of people who believe that diluting a remedy makes it stronger and that water remembers all the good bits that have been in it but forgets all the urine and poo (as Tim Minchin so hilariously put it) is not the way to argue for science. Of course, the short version of this is: If RCTs don’t show that naturopathy works, we need to dethrone RCTs and make up our own research methods. Yes, I know RCTs have problems and limitations, but those problems and limitations don’t include not being able to answer the question of whether selenium and antioxidants can improve survival in lung cancer patients.

Sadly, it’s not just academia that is under siege by unscientific medical philosphies and treatment systems. True, academia sets the stage and promotes the spread of pseudoscience-based medicine because it is medical academia that does the research and trains the next generation of physicians. However, most medical care in this country is still provided by private physicians and private hospitals, and some private hospitals like CTCA have discovered that “integrating” pseudoscience-based medicine with science-based medicine can be a recipe for success. As “alternative” medicine infiltrates academia more and more, I fear that the stigma for offering these therapies will decrease more and more, leading to more hospitals and clinics like CTCA.

One of the recurring themes of Science-based medicine is that we live in the age of misinformation. The internet and social networking have made everyone their own expert – by democratizing information (which I favor, as it has many benefits to society) the field has been leveled for various types and sources of information. But this has the very negative effect of equalizing information in terms of quality as well – so low quality and even outright incorrect or fraudulent information can compete on equal footing with more reliable, vetted, and professionally sourced material. That is exactly why one of the primary goals of SBM is to be a resource for consumers and professionals to help sort through it all.

Recently David Gorski sent around a link to an e-book, Natural Cancer Treatments, that epitomizes the dark underbelly of health misinformation on the internet.

The book opens up with the standard disclaimer that ostensibly is to protect the public but in reality is simply legal cover for the purveyors of misinformation – it says to seek the advice of your physician and that this book is not meant to discourage anyone from seeking standard therapy for cancer. This is boiler plate CYA for quacks. It is also utter hypocrisy as it is placed immediately below two quotations that set the tone for the book:

“It should be forbidden and severely punished to remove cancer by cutting, burning, cautery, and other fiendish tortures. It is from nature that the disease comes, and from nature comes the cure, not from physicians.”
Paracelsus, (1493-1541 AD)

“…. never take defeat. When all is lost, try something new. Life is too precious to let it slip away from lack of initiative or plain inertia.”
Hulda Regehr Clark, Ph.D.,N.D. “The Cure for All Advanced Cancers”

The Paracelsus quote essentially says to forgo standard therapy, and don’t trust your doctor – in direct contradiction to the disclaimer. I would also point out that, while Paracelsus was an interesting figure in the history of medicine, he did practice in an essentially pre-scientific era. He fought with the establishment medicine of his time, but this was a fight between two pre-scientific systems. He was criticizing Galenic medicine – which bears no resemblance to modern medicine. The medicine of his time was largely worse than doing nothing, and so the often magical interventions of Paracelsus (he was first and foremost an alchemist) were an improvement. He is also an ironic person to quote, as he focused his attention on using toxic minerals to treat disease. The “natural” cures he was talking about were horrible toxins long out of favor as part of medicine.  For example he favored the use of mercury to treat syphilis.

The second quote essentially encourages acting out of desperation. There is, of course, a kernel of reasonable advice in the notion of not giving up. But it must be tempered by reality – whereas Hulda Clark and other cancer quacks take these words of encouragement to their absurd extreme – try anything, especially the implausible treatment that they are trying to sell. Clark, who recently died of cancer, believed that all cancer, and in fact all disease, is caused by a liver fluke.

The introduction is far worse, in which the authors state:

The consensus of the majority of alternative cancer therapists is that, the chance of full recovery using alternative therapies is almost 100%. with a newly diagnosed condition of early cancer, before any traumatic or toxic treatments have been received. Unfortunately, by the time most patients consider alternative treatments, they have already undergone other treatments.

The consensus of practitioners of X is that X works. Well that’s comforting. The notion that “alternative” treatments are almost 100% effective for cancer is a great example of telling a lie so great that people will tend to believe it – because no one could be that bold and outrageous a liar. No evidence, of course, is presented to back up this absurd claim. But further, this claim directly contradicts their disclaimer – essentially they are saying that you need to consult an alternative practitioner before you subject yourself to standard (i.e. evidence-based) treatment. This is also another attempt at preemptively blaming the patient for treatment failures. If your goal were to kill and harm as many cancer sufferers as possible, you could give no more effective advice than what is found in this book.

The book itself, while selling itself as a source of “natural cancer cures that work” – is really a collection of cancer cures that do not work. The term “natural” is there purely for marketing, as the book contains disproved and implausible treatments of every type, to the point that the vague concept of “natural” loses all meaning.

You can go to just about any page on the book and find gems like this one, under the entry for colloidal silver:

“Naturopathic Medicine regards Cancer as a viral and fungal [candida septicemia] process. Microorganisms depend on a specific enzyme to breathe. Colloidal Silver is a
catalyst that disables these enzymes, and as a result they die. To this day, there has been no recorded case of adverse effects from it when it is properly prepared. There also has been no recorded case of drug interaction with any other medication. Unlike pharmaceutical antibiotics which destroy beneficial enzymes, Colloidal Silver leaves the tissue-cell enzymes intact.”

I like that – “Naturopathic Medicine regards.”  What does that mean, exactly – that they just made it up?  It’s a clever way to make a claim without making a claim – no appeal to scientific evidence, plausibility, or basic science. Naturopaths just choose to believe that cancer is really a viral or fungal infection – despite the overwhelming scientific evidence that cancer is a category of disease caused by various mutations that cause cells to grow unrestrained by the usual mechanisms that limit cell growth. Some viral infections may increase the risk of developing certain cancers (like HPV and cervical cancer), but the cancer itself is not an infection. So of course, treating it like an infection is useless.

Further, colloidal silver is not a safe or effective treatment for infections. Silver can be used as a bacteriostatic compound to prevent contamination of equipment, but it is not safe and effective when used internally. It is also highly misleading to say that there are no recorded adverse effects “when it is properly prepared.” This is a lie – there are numerous case reports of argyria, a permanent skin disease resulting from use of colloidal silver. Developing argyria also has nothing to do with how the colloidal silver is prepared – it is a matter of dose. But what they are trying to do is dismiss adverse effects as being due to improper use. This is like saying that there are no adverse effects to any surgical procedure properly performed, because all adverse effects from surgery were due to improper technique. It’s a semantic game meant to mislead.

Finally the quote takes a swipe at standard antibiotics (again betraying the lie that the authors do not intend to discourage standard therapy). Antibiotics are designed to affect bacterial enzymes, proteins, or structures without affecting Eukaryotic cells – they do not disrupt “beneficial enzymes”.

We could spend a year and write an encyclopedia examining every claim collected in the book, but let me just give one more example. I literally flipped to a random page and found:

In Japan, Dr. Hasumi claims outstanding success in curing cancer with a vaccine made from the patient’s own urine; however, it works only if the immune system is still
sufficiently strong.

Here we see the common strategy of preparing an excuse for failure – if the treatment does not work, it is the patient’s fault because their immune system was not strong enough. Dr. Hasumi’s treatment is over 50 years old. He is a typical guru running his own clinic, claiming that science is behind his genius. The book also offers this quote from Dr. Hasumi’s website:

“To date, more than 130,000 people have been treated with the Hasumi Vaccine and today approximately 16,000 people in Japan and 6,000 people overseas are continuing treatment with the vaccine. The therapeutic advantage of the Hasumi Vaccine has been demonstrated to prevent recurrence after cancer surgery.”

What does that mean? Did the other 108,000 patients die? Are the 22,000 people still being treated cured or improved in any way by the treatment? Those figures are entirely unhelpful, except, perhaps to potential investors. The book provides only one reference to back up the claim that the treatment prevents recurrence – Hasumi’s website from which the claim was taken, and which itself contains no reference.

Hasumi has only two publications, in 2003 and 2008. The first one is simply an examination of T-cell function, and has nothing to do with any intervention. The second only demonstrates that T-cell activity is increased in response to “anti-CD3 and anti-CD28 coated beads.” Essentially, if you stimulate the immune system, the immune system is stimulated. This is typical quack cancer pseudoscience – trump up some sciencey sounding results by looking at some marker of immune function, which always seem to be elevated in response to any intervention. These results say absolutely nothing about the plausibility of the Hasumi vaccine and of course they do not provide any clinical data to show that the vaccine is safe and effective for anything. These types of studies are for marketing – to provide a patina of science to bamboozle the innocent and desperate.

Conclusion

The people at Natural Health International who published this e-book have, at least, provided a resource by putting just about every form of cancer quackery in one place. They just need to change the title of their book to “Dangerous Cancer Quackery to Avoid.”

On March 30th, President Obama signed the final piece of healthcare reform legislation concluding an epic battle that ultimately lead to the passage of the Patient Protection and Affordable Care Act (PPACA). The bill enforces the largest change to US healthcare for decades and has provided an opportunity for Complementary and Alternative Medicine (CAM) advocates to be federally endorsed in our future healthcare system. This entry is an attempt to present excerpts from the PPACA itself that could lay the groundwork for incorporating CAM into the future healthcare system.

CAM proponents tout a few sections in the PPACA as a victory for their cause. One of these sections is 3502, entitled Establishing Community Health Teams To Support The Patient-Centered Medical Home, which endorses government grants “to establish community health teams,” which are defined as “community-based interdisciplinary, interprofessional teams.” It goes on to say that such a ‘team’ may include, “doctors of chiropractic, [and] licensed complementary and alternative medicine practitioners.”¹

The requirements of such a health team are listed and one of them reads, “to provide support necessary for local primary care providers… [and] to provide coordination of the appropriate use of complementary and alternative (CAM) services to those who request such services.” What this entails, is that there will be an influx of federal spending into CAM services with the enactment of the new bill.

Fortunately, the section provides other requirements for ‘health teams’ such as,

to support patient-centered medical homes, defined as a mode of care that includes… safe and high-quality care through evidence-informed medicine, appropriate use of health information technology, and continuous quality improvements.

Health teams will also be required to (bear with me here),

provide support necessary for local primary care providers to… provide quality-driven, cost-effective, culturally appropriate and patient- and family-oriented healthcare… [and] collect and report data that permits evaluation of the success of the collaborative effort on patient outcomes, including collection of data of patient experience of care and identification of areas for improvement.

This could mean that, although CAM will be supported by our federal plan, there will be some restrictions in place requiring it to adhere to an ‘evidence-informed’, ‘quality-driven’ and ‘cost-effective’ form of medicine. Guidelines may be implemented to track the progress and efficacy of health teams using CAM therapies. If this were true, I would suspect an initial rise in government-funded CAM but a downfall in the long run. A new surge of government-sponsored data should separate cost-effective treatments from sham if CAM therapists are held to such standards.

Unfortunately, the government has a poor track record of declaring therapies ineffective. Nowhere has this been more obvious than in The National Center for Complementary and Alternative Medicine (NCCAM), which has been criticized for spending hundreds of millions of tax dollars on studies of CAM and never confirming the efficacy of a single therapy nor declaring any as ineffective. This shows that federally funded data gathered about CAM might similarly never actually lead to meaningful conclusions or changes in our healthcare. If this were true, CAM incorporated into the healthcare system would stay for the ride regardless of its efficacy and cost-effectiveness.

Another section of the PPACA, supported by herbalists, is number 4206: Demonstration Project Concerning Individualized Wellness Plan[2]². The section describes the establishment of “a pilot program to test the impact of providing at risk populations an individualized wellness plan… that is designed to reduce risk factors for preventable conditions.” The program will include nutritional counseling and will provide dietary supplements that have health claims approved by the FDA. Examples include calcium supplementation for those at risk of osteoporosis and prenatal folic acid to decrease the incidence of neural tube defects. Seeing as this is guided by the FDA’s recommendations I can only join in with the approval of such a “wellness plan”, and expect it to be a big hit in the new healthcare system. Since herbalists see this as an opportunity for the government to incorporate their therapies into these wellness plans, I hope that the program will continue to adhere to FDA recommendations, especially if it is approved for wide-scale use.

On other fronts, chiropractors have found a niche in the soon-to-be National Healthcare Workforce Commission as described in section 5101 of the PPACA. “The Commission,” as it is referred to, will be responsible for analyzing and disseminating information to the federal government, state and local agencies, Congress, healthcare organizations, and professional societies about the US healthcare workforce. It will develop “evaluations of education and training activities to determine whether the demand for healthcare workers is being met.”

In so doing, it will recommend to the government which institutions deserve grants in order to “develop a fiscally sustainable integrative workforce that supports a high-quality, readily accessible healthcare delivery system that meets the needs of patients and populations.” It will also “study effective mechanisms for financing education and training for careers in healthcare.” Put more simply: the Commission will be channeling tax dollars to different healthcare institutions based on their analysis of demand in our healthcare system.

The Comptroller General, Gene L. Dodaro, will appoint the members of the Commission no later than September 30^th of this year. It will consist of 15 members representative of the healthcare workforce, employers, third-party payers, representatives of consumers, State or local workforce investment boards, and educational institutions. It seems like there will be a host of different viewpoints and interests influencing the recommendations that this commission will be making.

Therein lies the problem. The section about the Commission specifically defines the ‘healthcare workforce’ as, “all healthcare providers with direct patient and support responsibilities,” and specifically includes licensed CAM practitioners and chiropractors within the definition. If proponents of such CAM therapies infiltrate the Commission, taxpayers could end up funding disproportionate amounts of money to medical institutions unsupported by science.

Another section of the PPACA that has been hailed as a victory by CAM proponents, especially chiropractors, is section 2706³, which prohibits health insurance discrimination against any “health care provider who is acting within the scope of that provider’s license or certification under applicable state law.” Chiropractors, who feel that they are being ‘discriminated’ against within the medical community, see this as an end to their problems. Interestingly, section 2706 is colloquially dubbed the “Harkin amendment”, after it was introduced by the Iowa Senator himself. David Gorski has written about him on a number of occasions. Tom Harkin is the man most responsible for the creation of the aforementioned NCCAM and also the Dietary Supplement Health and Education Act (DSHEA) of 1994, which allows “herbal supplement” manufacturers to make dubious health claims with little or no regulation.

The section itself is simply entitled Non-Discrimination in Health Care and prevents insurance companies from discriminating against particular medical modalities. At first glance this seems like a free pass for CAM, especially with the American Chiropractic Association s (ACA) claims that the inclusion of this provision has “potential for positive, long-range impact on [their] profession and the patients [they] serve.”  But the provision itself makes a point to address that, “nothing in this section shall be construed as preventing a group health plan, a health insurance issuer, or the Secretary [of Health & Human Services] from establishing varying reimbursement rates based on quality or performance measures.”

If this provision is calling for an end to discrimination of health modalities that is not based on quality or performance, than I don’t understand why CAM proponents are so happy about this. Don’t they understand that it’s their quality and performance that is under scrutiny and that these characteristics are determined by science? It’s as if the ACA believes the main reasons they are ‘discriminated against’ are not based on evidence at all. I actually agree with the proposition that heath care modalities shouldn’t be discriminated against for unscientific reasons.

On a more positive note, the PPACA bill has in it a section on immunization ⁴and describes a new program that will come into effect to maximize vaccinations throughout the country. This is a huge blow to the anti-vaccine movement, which has been surprisingly quiet about this. Hopefully, it will help more patients to be vaccinated, especially those without the resources to do so.

In summary, we should be prepared for an infiltration of CAM therapies into the new healthcare system that will come into effect starting this year. The PPACA healthcare bill is not a disaster for science-based medicine by any means but it is not bulletproof either. The bill specifically mentions its endorsement of CAM and the more it acts on this, the more difficult it will be to eradicate passionately advocated therapies with no evidence supporting them in the years to come. Now is the time to ensure that the US healthcare system does not begin to excessively promote sham therapies. Otherwise, we will risk developing a new foundation to our healthcare system that incorporates scientifically unsound medicine.

References

1. Page 395 of the PPACA (http://democrats.senate.gov/reform/patient-protection-affordable-care-act-as-passed.pdf )
2. p458 of the PPACA
3. p42 of the PPACA
4. p453 of the PPACA

ABOUT THE GUEST BLOGGER: Matt Roman is a Polish-American, who immigrated to the Unites States in 1985 and studied neuroscience and chemistry at Franklin and Marshall College. He is currently enrolled as a medical student at Jagiellonian University in Cracow, Poland. His interest in complementary and alternative medicine began with his involvement in courses and research at The Institutes for the Achievement of Human Potential in Philadelphia before he became immersed in the skeptical movement and a science-based approach to medicine. He hopes to specialize in internal medicine in the United States and enjoys blogging about a diverse range of general science topics. A different version of this post first appeared on the blog Science-ology in March 2010.

Autism and autism spectrum disorders (ASDs) actually represent a rather large continuum of conditions that range from very severe neurodevelopmental delay and abnormalities to the relatively mild. In severe cases, the child is nonverbal and displays a fairly well-characterized set of behaviors, including repetitive behaviors such as “stimming” (for example, hand flapping, making sounds, head rolling, and body rocking.), restricted behavior and focus, ritualistic behavior, and compulsive behaviors. In more mild cases, less severe compulsion, restriction of behavior and focus, and ritualistic behaviors do not necessarily preclude functioning independently in society, but such children and adults may have significant difficulties with social interactions and communication. Because ASDs represent a wide spectrum of neurodevelopmental disorders whose symptoms typically first manifest themselves to parents between the ages of two and three, the idea that vaccines cause autism and ASDs has been startlingly difficult to dislodge and has fueled an anti-vaccine movement, both here in the U.S. and in other developed nations, particularly the U.K. and Australia. This movement has been stubbornly resistant to multiple scientific studies that have failed to find any link between vaccines in autism or the other favorite bogeyman of the anti-vaccine movement, the mercury-containing thimerosal preservative that used to be in many childhood vaccines in the U.S. until the end of 2001. Add to that the rising apparent prevalence of ASDs, and, confusing correlation with causation, the anti-vaccine movement concludes that vaccines must be the reason for the “autism epidemic.”

In reality, autism and ASDs appear to be increasing in prevalence due to diagnostic substition, better screening, and the broadening of the diagnostic criteria that occurred in 1994. Autism prevalence does not appear to be rising, at least not dramatically, at all, as the prevalence of ASDs, when assessed carefully, appears to be similar in adults as it is in children. If the true prevalence rate of autism and ASDs has increased, it has not increased by very much. In reality autism appears to have a major and probably predominant genetic component, and several scientific studies over the last few years have linked autism with various genetic abnormalities. Not surprisingly, given the varied presentation and severity of ASDs, these studies have not managed to identify single genes that produce autism or ASDs with a high degree of penetrance (probability of causing the phenotype if the gene is present). Indeed, one can argue that the state of current evidence is that ASDs are due to multiple genes, perhaps dozens or hundreds. Again, this is not surprising given the heterogeneity of ASD severity, presentation, and symptoms.

One of the more surprising studies supporting a genetic basis for autism appeared to much fanfare in Nature last week. The study by Pinto et al, looks at the functional impact of global rare copy number variation in autism spectrum disorders. Its results are rather surprising in that the large team of investigators (studies of this type take a lot of people to carry out) found that it may be relatively uncommon copy number variations in various genes that lead to the phenotype of autism or ASDs.

Before you can understand what this paper found, you need to know what copy number variation is. In basic genetics and biology classes, many of you probably learned, depending on how long ago you took the courses, that we have two copies of each gene, one on each chromosome, one inherited from the father and one inherited from the mother. The exception is that men have a Y-chromosome instead of a second X chromosome and therefore have only one copy of genes on the X and Y chromosome, the X-linked genes inherited from the mother, the Y-linked genes inherited from the father. Of course, nature is seldom quite so neat, and now that we have powerful tools for sequencing the entire genome and probing its entire DNA to seek out anomalies, we’re finding that things aren’t quite so simple. (Sometimes I marvel that we ever did think things to be that simple.) It turns out that there is considerable variation in the copy numbers of some genes in normal people. This is due to the rare duplication or deletion of a stretch of chromosome during replication. Such errors can leave a person with, for example, one copy on one chromosome and two on another. Although these events are rare for individual stretches of chromosomal DNA, over time and over many generations they can lead to some genes having several. Moreover, there appear to be “hot spots” in various chromosomes that are more prone to duplications or deletions than other regions of DNA.

Because I’m a cancer surgeon and biologist, I’m mostly familiar with variations in gene copy number associated with cancer, and there are many of these. Duplications and amplifications of stretches of DNA are practically the sine qua non of cancer. Often in cancer the amount of gene product in the form of protein that a given gene makes is proportional to the copy number. For instance, in breast cancer, there is a stretch of DNA known as the 8p11-12 amplicon. Basically, it’s a stretch of DNA on the p arm of chromosome 8 that is commonly amplified in breast cancer. This region of chromosome 8 is under active study, and there appear to be a number of candidate oncogenes there. One consequence of our learning about such amplified regions is that a formerly popular (about 30 years ago) and somewhat simplistic idea that single oncogenes would explain carcinogenesis, an idea that was later supplanted by a less simplistic but still too simple idea of multistage carcinogenesis in which a series of mutations in key oncogenes led to cancer. Now we understand that it is many genes that cause cancer. Whole networks of genes are usually perturbed, and, although there are commonalities in many of the networks purturbed among different cancers, the specifics can vary widely from cancer to cancer.

Cancer is one extreme, though, and obviously ASDs are not cancer (or, more appropriately, cancers, given that cancer is not just one disease). ASDs do, however, appear to require multiple genetic changes in order to manifest themselves. Although CNVs are associated with many diseases and conditions, the abnormalities in are not as dramatic or numerous as they are in cancer. In the study under discussion, Pinto et al undertook an a survey of as many CNVs as they could identify in autistic children. Basically, they genotyped 1,275 children with ASD and 1,981 neurotypical controls and compared the frequency of single nucleotide polymorphisms (SNPs) according to the following scheme:

It’s not necessary for you to understand in detail what SNPs are. Basically they are variations in single nucleotides within a gene that are useful because by examining them scientists can estimate CNVs and other genetic variants in various genes. This allows the performance of what is known as a genome wide association study (GWAS), which can look at genetic variation over the entire genome, which is what Pinto et al did using a technique that can look for SNPs in 1.2 million loci per sample. Genetic variations that are more common in people with a disease are said to be associated with that disease. GWAS can be very powerful, but, like much of modern genomic medicine, these studies produce incredible amounts of data, with all the attendant difficulties, both computational and scientific, in interpreting what all the associations that are found may or may not mean.
As the authors note in their introduction, previous attempts at GWAS for autism have identified candidate genetic loci at 5p14.1 and 5p15.2. However, variations in these loci can only account for a relatively small percentage of the heritibility of ASD, hence the desire to examine the entire genome in a large number of children with ASD.

What Pinto et al found was this:

The autism spectrum disorders (ASDs) are a group of conditions characterized by impairments in reciprocal social interaction and communication, and the presence of restricted and repetitive behaviours1. Individuals with an ASD vary greatly in cognitive development, which can range from above average to intellectual disability². Although ASDs are known to be highly heritable (~90%)³, the underlying genetic determinants are still largely unknown. Here we analysed the genome-wide characteristics of rare (<1% frequency) copy number variation in ASD using dense genotyping arrays. When comparing 996 ASD individuals of European ancestry to 1,287 matched controls, cases were found to carry a higher global burden of rare, genic copy number variants (CNVs) (1.19 fold, P = 0.012), especially so for loci previously implicated in either ASD and/or intellectual disability (1.69 fold, P = 3.4?×?10^-4). Among the CNVs there were numerous de novo and inherited events, sometimes in combination in a given family, implicating many novel ASD genes such as SHANK2, SYNGAP1, DLGAP2 and the X-linked DDX53-PTCHD1 locus. We also discovered an enrichment of CNVs disrupting functional gene sets involved in cellular proliferation, projection and motility, and GTPase/Ras signalling. Our results reveal many new genetic and functional targets in ASD that may lead to final connected pathways.

One interesting finding was that 5.7% of the CNVs discovered appeared not to be inherited; i.e., they were de novo, meaning, basically, new CNVs. More important, though, was the bioinformatic and systems biology analysis of the CNVs. If there’s one thing that the Human Genome Project has taught us it’s that single genes are rarely that important in disease. Usually, it’s genes that encode for various proteins in discrete functional classes and intracellular signaling pathways, something that can be analyzed by systems biology and network analysis, something I’m increasingly having to do for my cancer research. The result are “bubble diagrams,” which map out various networks and network “hubs” that are important in differences observed between normal and the condition being studied. To come up with such maps and pathway identification requires large numbers of specimens, terrabytes of computer storage space, and a lot of processing power, power that didn’t exist until this decade. In Pinto et al, such an analysis led to the identification of potential new pathways whose function in ASDs may be abnormal compared to the control group. These pathways are mapped out in the following illustration:

Candidate pathways for ASD identified by this method included genes involved with the cytoskeleton and microtubules, as well as genes involved in cell projection and motility, all of which are involved in cell migration. Other candidate pathways included genes involved in cell adhesion. It is not difficult to imagine how defective or altered migration and adhesion of neurons might result in the creation of abnormal neural pathways and thus result in the differences in cognition and behavior observed in ASDs. Of course, I’m putting things very simply. Even if this is true and these pathways are involved in ASDs, we know so little about how neural networks result in cognition and behavior that it will take a very long time and a lot of work to figure out exactly why and how abnormalities in these pathways result in ASDs. The same is true of other potential pathways implicated by these studies. These include GTPase and ras signaling pathways, as well as other kinase pathways. It’s not necessary for the lay reader to understand the full significance of these pathways. I don’t even know the full significance of these pathways in neurons, although I am familiar with them in cancer. Rather, it’s necessary only to know that they are involved in the transmission of signals from protein receptors on the cell surface into the cell, with the result being a number of processes, such as proliferation, migration, and the transmission of signals between neurons, among others.

Almost as important as the candidate pathways implicated by this study that clearly need further study to validate whether they are truly involved in the pathogenesis of ASDs or not are the pathways that were not implicated. One of the major claims of the “autism biomed” movement, the group of quacks who claim that they can treat autism with all manner of woo ranging from chelation therapy to various antioxidants and supplements, is that there are significant defects in pathways involved in countering the effects of oxidative stress, particularly pathways that result in glutathione production. (Glutathione is one of the major scavengers of reactive oxygen species–a.k.a. free radicals–in the cell.) Such claims were prominently featured by the lawyers for the complainants in the Autism Omnibus. Treatments allegedly targeting “detoxification” pathways involving “Glutathione, Cystathionine, Homocysteine, Methionine” figure prominently on the website of many a quack and are a favorite among the “vaccines cause autism” crowd. Don’t ask me how “vaccine injury” somehow causes oxidative stress sufficient to “cause autism.” Anti-vaccine “scientists” have long and convoluted pseudoscientific explanations that are implausible and unconvincing.

Guess what? Not a single one of the common “detoxification” or oxidative stress pathways implicated in ASDs by the “autism biomed” movement showed up in the analysis of the SNP data by Pinto et al. Big surprise, there. Well, not really. Of course, the fact that Pinto et al failed to find any of these pathways in ASDs in their analysis will no doubt be seized upon as “proof” that their analysis is hopelessly flawed. Just you wait. It’s coming. Because everything old is new again when it comes to the anti-vaccine movement I predict that Mark Blaxill will resurrect the same sorts of dubious criticisms of autism genetics studies that he made in this post from a year ago about an autism genetics study that predated Pinto et al:

But if the de novo CNV theory was plausible at one level, it was absurd at another. The genetic mutations the theory proposed (because this was the best the available evidence could support) were completely non-specific. The copy variants were spread widely (even randomly) over the genome, the theory went. No individual mutation was responsible for autism, just the unhappy presence of the wrong one. And these non-specific mutations were not only widely spread, they were virtually undetectable in the infant: no dysmorphic features; generally normal birth and (in many cases development); and the beautiful children we so often see affected by autism.

In other words these CNVs were a case of immaculate mutations.

And it was the perfect new project for the genetics research community. A wide open field of research opportunities. Lots of new money. And a chance to explain past failure away as part of the inexorable march towards genetic understanding.

Ah, yes. Likening science to religion. It’s a favorite canard of cranks of all stripes, be they anti-vaccinationists, creationists, alt-med promoters, 9/11 Truthers, and Holocaust deniers. I’ve heard anti-vaccine zealots refer to “Vaccinianity“; creationists refer to the “Church of Darwin“; and Holocaust deniers refer to “Holocaustianity” (warning: source is a French Holocaust denial website), among others. The intent is obvious: Try to paint the science detested as being faith-based rather than science-based.

The other favored attack, as those of you who read my post earlier today know, is to claim “conflicts of interest,” even when there aren’t any by any reasonable definition of the term. Although Blaxill hadn’t tried his hand at a pseudoscientific deconstruction of this study as of Sunday afternoon, John Stone over at the anti-vaccine propaganda blog Age of Autism has already pulled this gambit. In a post entitled Scherer of Nature Autism Gene Study Fails to Disclose Pharma Funding As Competing Interest, Stone opines:

Prof Stephen Scherer who is the senior author of the autism gene study launched in Nature last week holds the ‘GlaxoSmithKline-CIHR Pathfinder Chair in Genetics and Genomics at the Hospital for Sick Children and University of Toronto. The title used to be ‘GlaxoSmithKline-CIHR Endowed Chair”, GSK being one of the defendant companies in the UK MMR litigation

Mr. Stone is clearly ignorant of just what an endowed chair is. Basically, a company or wealthy donor gives a university a lot of money, and the university sets up an endowed chair using that money. The interest and dividends from the fund used to set up the chair are put at the disposal of the holder of the chair to do research and scholarship as he or she sees fit. The reason such chairs are desirable is because an endowed chair gives a researcher a reliable supply of funding without the need to write grant proposals or a department chair a source of funds for various projects that doesn’t have to come out of the departmental budget. It often allows a researcher to do more exploratory work or a department chair to engage in various research and educational activities by doling out funds from the chair to his faculty, for example, to support pilot projects by young faculty. Once an endowed chair is set up, the donor usually has no say over who gets the chair or how the money for the chair is spent. Claiming that Professor Scherer’s holding the GSK chair at his institution is an insurmountable COI that needed to be reported is, quite simply, ridiculous to anyone in academia who knows what an endowed chair is. Clearly, Mr. Stone does not although one commenter going by the ‘nym of Werdna does try to set Mr. Stone straight. It’s a rare thing indeed on AoA for a commenter to take a blogger to task like that, something that usually only happens when an AoA blogger makes a mistake so egregious even for some AoA readers.

Equally ridiculous is Mr. Stone’s lack of understanding of what a corresponding or first author is on a biomedical research paper:

While Prof Scherer’s departmental colleague Dalila Pinto is listed as lead author of the paper Scherer is listed as ‘correspondence author’ and he identifies himself as ‘senior author’ in Kevin Leitch’s LeftBrain/RightBrain blog.

Here’s a hint for Mr. Stone. The lead author of the paper is an honor usually reserved for the person who had the most to do with designing and doing the research. Most of the time the first author is the person who actually wrote the manuscript. On the other hand, the corresponding author of a scientific paper (at least a biomedical paper) is usually the author listed last or near last. More importantly for Mr. Stone’s criticism, the corresponding author and the senior author are nearly always one in the same, namely the author in whose laboratory and using whose funding the research described in the paper was performed. That’s it. That’s all those terms mean. There’s no inconsistency there. The terms are interchangeable. Mr. Stone would do well to learn a little bit about what he speaks before embarrassing himself so.

I’d be happy to educate him.

Mr. Stone’s follies aside, no doubt when Blaxill or whoever at AoA decides to attack Pinto et al shows up to do it, he’ll repeat the same breathtaking combination of ignorance and binary thinking that he did a year ago. As a pre-emptive rebuttal, I’ll cite popular science blogger P.Z. Myers, who put it well when he pointed out that these things are very complicated. So did Pinto et al:

Our findings provide strong support for the involvement of multiple rare genic CNVs, both genome-wide and at specific loci, in ASD. These findings, similar to those recently described in schizophrenia, suggest that at least some of these ASD CNVs (and the genes that they affect) are under purifying selection. Genes previously implicated in ASD by rare variant findings have pointed to functional themes in ASD pathophysiology. Molecules such as NRXN1, NLGN3/4X and SHANK3, localized presynaptically or at the post-synaptic density (PSD), highlight maturation and function of glutamatergic synapses. Our data reveal that SHANK2, SYNGAP1 and DLGAP2 are new ASD loci that also encode proteins in the PSD. We also found intellectual disability genes to be important in ASD. Furthermore, our functional enrichment map identifies new groups such as GTPase/Ras, effectively expanding both the number and connectivity of modules that may be involved in ASD. The next step will be to relate defects or patterns of alterations in these groups to ASD endophenotypes. The combined identification of higher-penetrance rare variants and new biological pathways, including those identified in this study, may broaden the targets amenable to genetic testing and therapeutic intervention.

The problem is that none of this sort of research is easy, and none of it is likely to result in effective treatments for ASDs very soon. Autism quacks and anti-vaccine zealots, however, can’t accept this. Again, like Blaxill, they demonstrate binary thinking. If a study doesn’t find a single, clear-cut gene or small set of genes causing autism or ASDs 100% of the time, then to them almost invariably the study is crap, autism is not genetic in origin, and vaccines (or other “environmental factors”–not vaccines, you know, nudge, nudge, wink, wink) cause autism. They also seem completely oblivious to developmental biology. It bothers them that a child with ASD appears normal at birth and then only manifests symptoms between the ages of 2 and 4. Anti-vaccine zealots who attack genetic linkage studies will frequently point this out as though this observation is a slam dunk argument against a genetic etiology for autism. Development proceeds, however, according to predictable, sequential steps that are under genetic control, and genetic variations and abnormalities can have a profound impact on development that may not manifest itself until previous parts of the developmental program are complete. For example, Tay-Sachs disease is one of thoes rare diseases for which a single gene is the known cause. Babies with Tay-Sachs usually appear normal at birth and develop normally for the first six months of life. Then the neurologic deterioration begins. There are also a number of inborn errors of metabolism that don’t manifest themselves at birth. In other words, it’s not unusual for purely genetic diseases to exhibit delayed manifestation of symptoms. Otherwise, why would we need to test for phenylketonuria (PKU) shortly after birth?

Antivaccine zealots also seem unable to understand that most chronic diseases and conditions with a strong genetic component are due to changes in activity of multiple genes, sometimes many genes. Due to functional redundancy in our cells, there are also often multiple abnormalities that can produce similar phenotypes; it is therefore not surprising that there might be many different gene abnormalities that contribute to ASDs. Systems biology gives us the tools to start to understand these exceedingly complex processes, as Pinto et al did in the study under discussion and as my collaborators try to do for cancer. The problem is that biology is really complex. Frustratingly to those waiting for treatments, it is far more complex than even scientists realized before the Human Genome Project and the dawn of genomic medicine.

While it is possible–even likely–that there is an environmental component to ASDs, the evidence to date has not convincingly implicated any, except for, ironically enough given how anti-vaccine zealots believe that the MMR vaccine causes autism, maternal rubella infection while the fetus is still in utero, as a cause of autism. Moreover, as P.Z. pointed out, no transient exposure or exposures to an external agent (such as a vaccine) is known to be able to produce such a consistent pattern of gene duplications and deletions in human cells like the sets detected in Pinto et al. Thus far, the preponderance of evidence points to primarily a genetic cause for autism and ASDs, and Pinto et al is another solid study supporting a genetic basis for autism. It also suggests potential cell signaling pathways that might be abnormal in autism and thus targets for therapeutic intervention. That’s all we can ask of such a study. It does not rule out an environmental component, although this study is not consistent with vaccines as an etiology of autism. More importantly, it has failed to provide any validating evidence for the frequently claimed abnormalities touted by autism biomeddlers, abnormalities allegedly targeted by all manner of quack nostroms, from chelation therapy to antioxidants to hyperbaric oxygen to “detoxification.”

Now remains the hard work of validating and replicating these findings and then figuring out which pathways can be targeted for therapy. What I’m afraid of now is that the quacks will look at the pathways identified by Pinto et al and try to come up with new pseudoscientific “biomed treatments” for autism based on these results, after (of course) “showing” how vaccine “injury” can create these same CNVs in children. It wouldn’t surprise me if I were to see this sort of “science” presented at Autism One next year.

On the other hand, maybe not. For quacks to try to use the results of Pinto et al to “treat” autism, they’d first have to accept the results of the study.

REFERENCE:

Pinto, D., Pagnamenta, A., Klei, L., Anney, R., Merico, D., Regan, R., Conroy, J., Magalhaes, T., Correia, C., Abrahams, B., Almeida, J., Bacchelli, E., Bader, G., Bailey, A., Baird, G., Battaglia, A., Berney, T., Bolshakova, N., Bölte, S., Bolton, P., Bourgeron, T., Brennan, S., Brian, J., Bryson, S., Carson, A., Casallo, G., Casey, J., Chung, B., Cochrane, L., Corsello, C., Crawford, E., Crossett, A., Cytrynbaum, C., Dawson, G., de Jonge, M., Delorme, R., Drmic, I., Duketis, E., Duque, F., Estes, A., Farrar, P., Fernandez, B., Folstein, S., Fombonne, E., Freitag, C., Gilbert, J., Gillberg, C., Glessner, J., Goldberg, J., Green, A., Green, J., Guter, S., Hakonarson, H., Heron, E., Hill, M., Holt, R., Howe, J., Hughes, G., Hus, V., Igliozzi, R., Kim, C., Klauck, S., Kolevzon, A., Korvatska, O., Kustanovich, V., Lajonchere, C., Lamb, J., Laskawiec, M., Leboyer, M., Le Couteur, A., Leventhal, B., Lionel, A., Liu, X., Lord, C., Lotspeich, L., Lund, S., Maestrini, E., Mahoney, W., Mantoulan, C., Marshall, C., McConachie, H., McDougle, C., McGrath, J., McMahon, W., Merikangas, A., Migita, O., Minshew, N., Mirza, G., Munson, J., Nelson, S., Noakes, C., Noor, A., Nygren, G., Oliveira, G., Papanikolaou, K., Parr, J., Parrini, B., Paton, T., Pickles, A., Pilorge, M., Piven, J., Ponting, C., Posey, D., Poustka, A., Poustka, F., Prasad, A., Ragoussis, J., Renshaw, K., Rickaby, J., Roberts, W., Roeder, K., Roge, B., Rutter, M., Bierut, L., Rice, J., Salt, J., Sansom, K., Sato, D., Segurado, R., Sequeira, A., Senman, L., Shah, N., Sheffield, V., Soorya, L., Sousa, I., Stein, O., Sykes, N., Stoppioni, V., Strawbridge, C., Tancredi, R., Tansey, K., Thiruvahindrapduram, B., Thompson, A., Thomson, S., Tryfon, A., Tsiantis, J., Van Engeland, H., Vincent, J., Volkmar, F., Wallace, S., Wang, K., Wang, Z., Wassink, T., Webber, C., Weksberg, R., Wing, K., Wittemeyer, K., Wood, S., Wu, J., Yaspan, B., Zurawiecki, D., Zwaigenbaum, L., Buxbaum, J., Cantor, R., Cook, E., Coon, H., Cuccaro, M., Devlin, B., Ennis, S., Gallagher, L., Geschwind, D., Gill, M., Haines, J., Hallmayer, J., Miller, J., Monaco, A., Nurnberger Jr, J., Paterson, A., Pericak-Vance, M., Schellenberg, G., Szatmari, P., Vicente, A., Vieland, V., Wijsman, E., Scherer, S., Sutcliffe, J., & Betancur, C. (2010). Functional impact of global rare copy number variation in autism spectrum disorders Nature DOI: 10.1038/nature09146

It’s boring to try to ferret out reliable health information from dry medical journals. It’s easier and more fun to watch a movie. A new movie promises to change the way you think about your health. To bring you breakthroughs that will transform your understanding of how to get well and stay well. To share the discoveries of leading researchers and health practitioners about miracle cures that traditional medicine can’t explain.

If this makes your baloney detector light up, good for you!

The Living Matrix: A Film on the New Science of Healing is an atrociously bad movie that falls squarely in the tradition of What the Bleep Do We Know? In his book Nonsense on Stilts, Massimo Pigliucci characterized the “Bleep” movie as “one of the most spectacular examples of a horribly tangled mess of science and nonsense,” and this new movie is more of the same. Bleep was just silly, but The Living Matrix is potentially dangerous because it might persuade patients to make poor decisions about their medical care.

It purports to be a documentary about the “new science of healing” but really amounts to an infomercial for various forms of quackery based on so-called “energy medicine.” It’s not about science, but about pseudoscience and mythical misinterpretations of physics and quantum theory. It says things that are simply not true and misrepresents them as indisputable scientific facts. The film features interviews with patients, with non-scientists, and with a veritable Who’s Who roster of infamous fringe scientists like Rupert Sheldrake and Dean Radin. But it doesn’t offer a single word of comment by any mainstream scientist or by the many skeptics who have examined the “evidence” for so-called energy medicine and found it pathetically inadequate. It doesn’t even acknowledge that dissent is possible.

I’m going to give this movie more attention than it deserves. It wouldn’t merit taking seriously if it weren’t for the fact that legions of energy medicine practitioners are promoting these same false ideas to justify bogus treatments, relieve customers of their hard-earned money, and sometimes even contribute to a premature demise by convincing patients that lifesaving science-based treatments are unnecessary. For that reason alone, the movie’s claims demand a skeptical rebuttal.

The concept of energy healing is vague and incoherent, so poorly thought out that it is nearly impossible to explain. It involves quantum holistic energy fields that somehow hold all kinds of information, that unite us with everything in the universe but also somehow govern the functioning of our individual bodies, and that respond to thought and intention. “The Field” encompasses the entire universe, but there is also a hierarchy of smaller fields for our bodies and for each of our limbs and organs. There is no hypothesis to explain how our thoughts know what to do to which field, much less how they might actually do it. It also has something to do with morphogenetic influences and with static scalar waves. Trying to make sense out of all this is as unedifying as trying to make sense out of a schizophrenic’s word salad. One interviewee says

We’re not in this field, we are this field… we’re denser, we’re lighter in between.

What does this even mean?

There are so many things wrong with the film that it’s hard to know where to start. The testimonials are as good a place as any.

1. A 5-year-old with cerebral palsy was allegedly healed by “reconnective healing” by a chiropractor who is shown waving his hands a few inches away from the child’s body. Problem: There was no medical evaluation before and after to determine whether anything had objectively changed, and video of the child after treatment shows that his gait is still abnormal.
2. After a motorcycle accident, a woman was told there was a possibility her injured leg might require amputation. She visualized her immune system and rallied it with her thoughts, claiming she could feel the healing happening. The idea for trying this came to her directly through a noetic process: she just knew intuitively that her mind was important to her body. Problem: There is no reason to think this woman would not have healed just as well without any imaginative mumbo-jumbo. Injuries usually do heal.
3. A woman who wanted children was diagnosed with prolactinoma, a brain tumor that causes infertility. She believed that she had somehow created the tumor. She refused drugs and surgery and relied on neurolinguistic programming (NLP), a discredited psychological therapy. It helped her discover that deep down some part of her unconscious did not want to be a mother. She let go of that, and let go of the anger against her tumor. She realized that having a tumor had taken her on a journey she would not have taken otherwise, and she liked herself better. So the tumor wasn’t totally bad — what if it had a purpose for being here? She gave it permission to stay for the rest of her life, and 6 months later her prolactin blood tests were normal. Her doctor said “This can only mean one thing: your tumor has gone.” He didn’t bother confirming that with follow-up imaging studies. Problem: A change in hormone levels is not proof that the tumor had resolved. Prolactinomas have been known to spontaneously stop producing excess prolactin, to infarct, and to otherwise resolve without treatment. Microadenomas frequently shrink or disappear and spontaneous regression has been observed even in macro-adenomas. So there’s no reason to attribute her improvement to anything she did.
4. A woman was so impaired by chronic fatigue syndrome and fibromyalgia that her husband had to feed and carry her. A Nutri-Energetics System (NES) practitioner found that she was “allergic to almost all foods” and that her energy fields were weak, with distortions in the body field. For 6 months she took drops that the practitioner had imprinted with an information pattern, and she was cured. Hard to believe even if you are the White Queen and have practiced believing six impossible things before breakfast.
5. Former astronaut Edgar Mitchell (who is notorious for believing in strange things like UFOs and ESP) had an MRI that showed an “irregularity” on one kidney. His doctors wanted to do a biopsy, but he refused. Instead he was treated by a teenage intuitive healer, Adam Dreamhealer. Adam’s healing ability developed after a vision directed him to go to the forest where he met a big black bird. The bird imparted complex information to him from the field of information. Adam can look at a photograph and perceive a holographic image of the body and see where energy flow is blocked, indicating illness or injury; then he clears these blockages using only his intention to heal. On follow-up tests 6 months later, Mitchell’s kidney irregularity had disappeared. Unlike all the other fields and energies known to physics, the healing energy fields are undetectable by scientific instruments and do not diminish with distance according to the inverse square law: in this case the healer was in Vancouver, BC, and the patient stayed in Florida. Problem: We have no way of knowing what the “irregularity” was. Could it have been an insignificant lesion that was likely to resolve on its own? Could it have been some kind of imaging artifact? Even if it was kidney cancer, that is a disease with a known propensity for spontaneous remission.

The plural of anecdote is not data: all these testimonials add up to no evidence at all. They are not properly documented and have other natural explanations. And they are a mish-mash of different techniques with no commonalities and no coherent explanatory mechanism. If healing can occur across thousands of miles by intention, why would the chiropractor need to wave his hands over the patient and why would the nutritionist have to administer information via drops? Do they ever try to compare these different energy healing methods to see if one is superior to another? Or to try to investigate their parameters or study what features they have in common? Of course not. Scientists would do that, but this isn’t science.

The movie claims that there are amazing healings taking place all the time that mainstream medicine can’t explain. In fact, medical science has not tried to explain them because it hasn’t seen any credible evidence that there is anything to explain. These alleged healings are poorly documented and/or have other natural explanations. True, conventional medicine can’t explain everything; but neither can these guys. Their “explanation” amounts to a confused, untestable hypothesis that a quantum holistic information-containing energy field can do strange and miraculous things. It pretends to explain everything but it actually explains nothing.

They try to make their belief system sound like science. It isn’t. They get the science spectacularly wrong, using words like “quantum,” “field,” and “energy” in nonscientific ways. Physicist Eugenie Mielczarek recently educated Science-Based Medicine readers about fields, alternative medicine and physics. She explained that

Studies of equations for these forces and the enumeration of the strength of their fields underlie our current technology. When energy fields are used as a medium for conveying information, scientists ask and answer the following key questions: How large is the signal? What is the transmitter located in the source, and what and where is the receiver? How can the device be tuned and detuned? Lastly, how can one replicate this by a device to be used for medical intervention?

The “scientists” of energy medicine don’t even ask such questions, much less answer them. Their “field” concept has no real explanatory power. For instance, they say that we don’t have a full understanding of how wound healing occurs. In fact, we do know plenty of scientific details about the healing process, while they offer no details about how the “field” might cause healing. They just offer vague generalities that “information” is somehow transmitted to the body. The information field is apparently all-knowing and all-powerful, like God. This is essentially a version of the “God of the gaps” excuse of creationists. If you don’t understand something, you just claim God or The Field did it — somehow.

Many of their arguments are versions of the logical fallacies “argument from ignorance” and “argument from personal incredulity.” How could the body know to heal itself? They find it inconceivable that the entire gamut of physiology and human behavior could be explained by a physical brain and nervous system. They claim that the coherence of neuron firing is faster than the ability of the cells to communicate and that this proves that the brain is communicating at a higher level than is possible through physical factors. They can’t imagine how molecules could find each other in the cell for a chemical reaction to occur. They say we can’t explain how the body maintains homeostasis or how DNA guides development of the embryo unless we realize that the body field turns the knobs. They say we may understand how cells work but we don’t understand how they talk to each other and how they deal with information. They say the coordinated turning of a flock of birds could only occur with the help of fields that transfer information with no time delay.

Scientists are working on these problems, have made considerable progress, and are confident that the remaining mysteries are ultimately explainable. Believers in energy healing don’t want to work on trying to explain the mysteries: they are content with the pseudo-explanation of invoking “The Field.”

Intention, belief — can these factors influence healing? They fall back on the “you create your own reality” myth. “If you think you have an incurable disease, you are right. If you think your problem is curable, then you are also right.” This is nothing but wishful thinking.

They make many statements that are distorted misrepresentations of scientific facts or are simply false. Here are some examples:

• You can read the mind with EEG or magnetoencephalography.
• The brain is not the central repository of information.
• DNA doesn’t explain much. Chimps and humans have similar DNA, so that couldn’t explain the difference between them. The explanation is the morphogenetic field that informs which parts of DNA the body will access for its development.
• Genes do not control our biology.
• Children adopted into families with a genetic tendency to cancer will have the same risk of cancer.
• Beliefs and attitudes shape cancer, not genetics.
• Chemotherapy only works 9% of the time, and works only if you believe in it.
• “Modern physics understands that it is not matter but mind or spirit [defined as intelligent energy fields] which is primary.”
• The body can’t distinguish between action and thought.
• A belief can override biology.
• Epigenetics is proof that DNA doesn’t matter. It can cause 30,000 different variations of each gene, so we have unlimited potential.
• Properties like memory are diffuse throughout our brain and we access them from the field. Memory might not exist in the brain at all – it might be somewhere out in the field.
• Illness is just a lack in the information system. Disease is scrambled information.
• Matter is compressed energy.
• The acupuncture system is a system of information flow in the body itself, arranged in a certain order, that communicates in a certain direction.
• Thought field therapy instantly healed 100% of cases of PTSD in Kosovo.
• We have a resonant frequency and coherence is its natural state.
• A scientist has shown that when you start using reconnective healing, enough excess free thermodynamic energy is released that it could raise the room temperature over 300 degrees C. But our temperature doesn’t rise because we’re accessing something new and different.
• By changing your mind, you change your biology and your genetics.
• The heart is a functional brain. It may be the master organ for imprinting information into the holographic body field.

Edgar Mitchell, the astronaut, tells us that it has been proven in the lab that intention has physical effects. In one study, spouses of cancer patients got compassionate intention training. When their partners sent loving intentions, the patients’ physiology showed changes. They put the subjects in different rooms and shielded the rooms and thought they had ruled out conventional explanations; but they allowed the receiver to watch the sender on a video monitor, so they didn’t rule out subtle visible signals from body language. Another study allegedly showed that the heart has precognition and responds before an anticipated good or bad picture can register on the brain and even before it is randomly selected by a computer.

Ioannidis has shown us that most published research findings are false; and energy medicine research consists mainly of poorly designed, poorly controlled, isolated demonstrations like these that have low prior probability and have not merited attempts at replication by less credulous researchers. Real science gradually builds an edifice of experiments that confirm each other and achieve progress and fuller understanding. Energy medicine research is usually hit-and-run. They find an apparent phenomenon and instead of checking for flaws and seeing if it can be falsified, instead of trying to better define it and study its properties, they quickly move on to another kind of experiment to demonstrate another phenomenon. The totality of their research is an unconnected mishmash that proves nothing and that has resulted in no progress.

They say that 1/3 of all healings (drugs, surgery, etc.) have nothing to do with the treatment but are due to the placebo effect. That we could cut health care costs by exactly 1/3 by just using the placebo effect. That an inert substance is somehow able to manage a whole cascade of responses in a complex system to target the liver or the kidney: it’s a great mystery. That what medicine calls the placebo effect is really a phenomenon of energy fields.

This is a complete misunderstanding of what science has learned about placebos. It’s an absurd distortion of the fact that in a controlled study, 1/3 of the patients in the placebo control group typically report improvement. That improvement is mostly due to factors like regression to the mean and the natural course of the disease, and when those other factors are controlled for by adding a no-treatment group, most of the apparent placebo response disappears. And while placebos may reduce pain perception, they have never cured cancer or pneumonia.

Mitchell asks us to walk into any cathedral and feel the palpable experience of awe and reverence. He says we have this experience because for hundreds of years the people going in have been in such a state of mind that the quantum emissions from the body-brain were emitted, absorbed into the cathedral, and now are being transmitted back to us. Yeah, sure. Or maybe it’s angels. It couldn’t possibly have anything to do with any natural explanations like psychology, conditioning, suggestion, environmental influences, sensory effects, aesthetic responsiveness, and expectation, could it?

They suggest one possible mechanism for our body’s connection to the field: the biophoton. Biophotons are a random by-product of cellular metabolism; they can only be detected by powerful photomultipliers. Energy healing advocates claim that biophotons create some kind of dynamic coherent web of light within our bodies. But how could they measure that and what would it even mean? They think this web might be regulating the body’s metabolism, since molecules can’t regulate themselves. But it’s not plausible that these ultraweak photons could have any significant effect, or that a whole-body coherent web could result; and it’s even less plausible that it could carry information.

A good rule of thumb is to never accept any new claim without first asking who disagrees with it and why. The movie doesn’t ask such questions. These people are not seeking the truth: they are certain that they already know the truth and they are only seeking to persuade others to accept their belief system. The Living Matrix made my brain hurt. It was only worth watching as an appalling demonstration of the human capacity for self-deception and as a reminder of how badly our error-prone human brains need the discipline of rigorous science and critical thinking.

The movie claims that informational medicine is going to be the future of medicine. Yes, it is; but it’s going to be real information from advances in fields like neurophysiology and genomics. It’s not going to be mystical information transmitted by thought and intention and quantum holistic flapdoodle.

One of the very favorite and most commonly used tactics to attack criticism in the armamentarium of pseudoscientists, cranks, and quacks (not to mention politicians) is the ad hominem fallacy. In this fallacy, rather than addressing the actual evidence and science that demonstrate their favorite brand of woo to be nothing more than fairy dust, the idea is to preemptively attack and discredit the person. The ad hominem is not just insults or concluding that someone is ignorant because, well, they say ignorant things and make stupid arguments (in which case calling someone stupid or ignorant might just be drawing a valid, albeit impolitic, conclusion from observations of that person’s behavior), but rather arguing or insinuating that you shouldn’t accept someone’s arguments not because their arguments are weak but because they have this personal characteristic or that or belong to this group or that. Truly, the ad hominem is right up there with demanding public “debates” with skeptics as a favored defense strategy of cranks of all stripes.

Among the very favorite flavors of ad hominem attack used by quacks, cranks, and pseudoscientists is the fallacy of poisoning the well. This particular fallacy alludes to the medieval European myth that the Black Plague was caused by Jews poisoning town wells. Not surprisingly, this myth was used as a justification for pogroms and the persecution of the Jews. The idea is to poison how others view your opponent by preemptively attacking them. Well do I know this fallacy, having been at the receiving end of it many times! Basically, it involves invoking something bad or biased about a person’s situation or personality and then using a phrase something like, “Of course he (or she) would say that” to dismiss a person’s arguments, the implication being that the person receives such benefits from holding the position being attacked or has such a personality that he couldn’t argue otherwise regardless of the evidence. In my admittedly anecdotal experience, far and away the most common use of the ad hominem from quacks and pseudoscientists is what I once described as “the pharma shill gambit.” The idea behind this gambit when it comes to attacking those of us who promote science-based medicine is to tar one’s opponent as being a “shill” for big pharma or claiming that we have a conflict of interest so blatant that “of course we would say that.” In most cases, the bogey man is big pharma, in whose pockets we SBM bloggers are supposed to be safely (and profitably) ensconced, blogging away in our underwear for big bucks and, following the orders of our supposed paymasters, attacking anything that has even a whiff of being “alternative” or that “questions” the safety and/or efficacy of vaccines.

While I realize that there is such a thing as an “astroturf” campaign, in the vast majority of cases, the pharma shill gambit is nothing more than the variant of the ad hominem fallacy known as poisoning the well. I also realize that conflicts of interest (COIs) matter, particularly undisclosed COIs. Indeed, I wrote a rather lengthy post (I know, I know, do I write any other length of post?) about 8 months ago laying out my views regarding COIs in science-based medicine. The short version is that we all have COIs of some sort or another, be they financial, belief-based, or emotional, and more disclosure is usually better, to let the reader decide for himself. As far as COIs related to big pharma or finances, I think Mark Crislip put it quite well in his most recent Quackcast when he said that if a study is funded by big pharma, he decreases the strength of the evidence in his mind by a set amount. However, evidence is evidence, and, although it is reasonable to increase one’s level of skepticism if there is a major COI involving the authors, be it big pharma or otherwise, it is not reasonable to use that COI as the sole reason for rejecting its findings out of hand. That’s just an intellectually lazy excuse to dismiss the study, nothing more. Indeed, one prominent difference between a scientist and a pseudoscientist or quack is that in general scientists understand this and struggle to assign the correct degree of skepticism due to a COI when analyzing scientific studies, while quacks and pseudoscientists do not. It’s far easier for them just to put their fingers in their ears and scream “Conflict of interest! Conflict of interest!” and then use that to dismiss completely their opponent’s argument. It’s simple, neat, and it doesn’t require all that nasty thinking and weighing of evidence..

Yes, quacks, cranks, and pseudoscientists really, really like their “poisoning the well”-style ad hominem attacks. So much do they rely on such attacks that, when they can’t find a real COI to use, abuse, and exaggerate, they’ll make one up, hence the pharma shill gambit. Certainly they’ve tried it on me many times. Over the last six years I’ve lost track of how many times anti-vaccine zealots, homeopaths, Suzanne Somers and Jenny McCarthy fans, HIV/AIDS denialists, and supporters of “alternative medicine” have asked me accusingly, “Who do you work for?” or outright accused me, “I bet you work for Merck” or [insert most hated pharmaceutical company here — I used Merck because of the whole Vioxx issue]. Then they don’t believe me when I point out to them that, sadly, the amount of funding I receive from any medical or pharmaceutical company is…..[drum roll, please]….zero!

That’s right. Zero. Nada. Zip. Sadly, being a high-ranking mouthpiece of big pharma doesn’t pay what people think it pays. Clearly, I need a new agent. Or just an agent.

Of all the brands of pseudoscience-supporters who’ve attacked me over the years, none have been as persistent or nasty as the merry band of anti-vaccine activists at Generation Rescue (GR) and its wholly owned subsidiary propaganda blog Age of Autism (AoA). Usually, it’s J.B. Handley who’s been on the attack, beginning two years ago with the usual sort of title J.B. comes up with David Gorski, MD: The Worldwide Wanker of Woo, Dr. David Gorski and His Merry Band of Idiots Don’t Like Full Page Ads, and Dr. David Gorski Jumps the Shark over Desiree Jennings Case. He also apparently hates Steve Novella, too, and there are other anti-vaccine activists out there just as vitriolic, including one named Craig Willoughby, who apparently started a blog one of whose major purposes appears to be to savage yours truly’s alter ego.

All of this is my usual logorrheic style of introducing my notification that AoA is about to launch yet another such attack. I know this because on Saturday morning I woke up to find this in my e-mail:

Dr. Gorski,

This is Jake Crosby. I am doing a piece about your acknowledgment that disclosure of conflicts of interest is important, yet your lab at Wayne State University stands to benefit from Sanofi-Aventis money for the breast cancer research you are conducting on a drug the company manufactures and markets, Riluzole, which is also being studied for the treatment of autism. Why isn’t any of this disclosed on your blogs? I await your reply.

Sincerely,

Jake Crosby
Age of Autism
Contributing Editor with Autism
http://www.ageofautism.com/jake-crosby/

Oh, dear. It would appear that Jake has found a “gotcha.” At least, he clearly thinks he does. He is sadly mistaken, which is why I sent back an e-mail saying that I couldn’t respond on Saturday with anything other than a brief message pointing out that I receive no money from Sanofi-Aventis or any other pharmaceutical company, nor am I likely to any time in the foreseeable future. Then on Sunday I wrote this post.

In any case, clearly, Jake didn’t bother to read my disclaimer:

Dr. Gorski has been funded over the last decade by institutional funds, the Department of Defense, the National Cancer Institute, the ASCO Foundation, and the Breast Cancer Research Foundation. He currently receives no funding from pharmaceutical companies, although he did once receive a modest payment for an invention from such a company back in the mid-1990s. Indeed, so bereft of pharmaceutical funding is Dr. Gorski that before his talks, when he is required to make his disclosures of conflicts of interest, he often jokes that no pharmaceutical company is interested enough in his research to want to give him any money. Maybe one day that will change, but for now, like most biomedical scientists in academia, he must beg the NIH and other granting agencies for the money to keep his lab going.

It’s true, too. Being a pharma shill apparently just doesn’t pay, although being an Associate Professor of Surgery at Wayne State University at least pays well enough to live on. Depressingly, it’s nowhere near as comfy as sitting back in my underwear, sipping coffee and typing screeds against quacks, cranks, and pseudoscientists. I actually have to work for a living! The indignity! You’d think the pharma overlords who rule the world with David Icke’s reptilians, the Illuminati, the Masons, and the Bilderberg Group could at least slip me a few hundred thousand every now and then to keep my lab churning out reductionist, non-wholistic “Western” science (or at least spring for a really good dinner at The Rattlesnake Club or Michael Symon’s Roast from time to time — now that would be worth selling my scientific soul for). But no. Not even a ride in their famed Black Helicopter (just ask David Ayoub), leaving me feeling as dissed and ignored as Mark Crislip. I continue to submit grant application after grant application to the NIH and various other funding agencies in a very hostile funding environment, hoping against hope to keep my lab going but suffering rejection after rejection. Where’s that filthy lucre? I’m tired and beat, with a severely bruised scientific ego right now.

Sanofi-Aventis and your fellow Pharma Lords, take me away!

But I digress. Clearly, a preemptive strike is indicated — nay, demanded against Jake’s impending attack. After all, the best defense is a good offense. However, something still gave me pause. I wondered whether I should bother to respond or, if I respond, it would be perceived as being too “mean” to beat up on Jake, particularly in the wake of a post I did a couple of weeks ago about Julie Obradovic. After all, Jake is young and inexperienced, a college student who’s “on the spectrum,” and it might initially appear unseemly to be too hard on him. Heck, although I’m sure he doesn’t believe it, I actually even kind of like Jake. He seems like basically an otherwise decent kid who’s clearly fallen in with the wrong crowd, namely J.B. Handley’s band of merry anti-vaccinationists at Generation Rescue and Age of Autism. Sadly, they’re corrupting him. Whenever I see Jake do stuff like this, I feel a fatherly impulse to try to set him straight, given that I am actually old enough to be his father. I want to sit him down, look him in the eye, and calmly ask him in the most fatherly manner I can muster what the hell he’s thinking doing stuff like this and hanging out at AoA promoting pseudoscience. My desire to try to correct a young man’s descent into pseudoscience aside, though, Jake is also now an adult, and as an adult he needs to be learn to face the consequences of his words and deeds.

Sadly, Jake’s words and deeds do require some consequences. Since he’s joined AoA, Jake has made the conscious decision to adopt “poisoning the well”-style ad hominem attacks against anyone whom he perceives as opposing the scientifically discredited notion that vaccines cause autism as his personal modus operandi, apparently having learned at the feet of masters of the ad hominem, such as J.B. Handley, David Kirby, and Dan Olmsted. For example, last year Jake wrote an amazingly conspiracy-filled attack on Adam Bly, founder and CEO of Seed Magazine and creator, of course, ScienceBlogs, which is another home to Peter Lipson and one other SBM blogger, he who must not be named, if you know what I mean (and I think that most of you do).

The attack came in two parts. The first part was “Science” Blogs: Seed Media’s Aggressive Weed, Part I: Fertilizer From Pharma. In it, Jake insinuated that, because Seed and ScienceBlogs accept ads from pharmaceutical companies, both are clearly propaganda outlets for the pharmaceutical industry. Most hilariously, though, Jake claimed that, because Adam Bly had “served at the age of sixteen as the youngest guest researcher at the National Research Council — a Canadian government body that overseas scientific progress, studying ‘cell adhesion and cancer,’” and because of corporate sponsorship of the NRC by Sanofi-Aventis (damn, them, they have their tendrils everywhere!), apparently Adam Bly had been indoctrinated into the Dark Order of Pharma at the tender age of 16 and turned through some sort of dark Satanic ritual into a willing pawn doing the bidding of his pharma masters ever since. (Trust me, I exaggerate only slightly for dramatic effect. or don’t trust me and go read Jake’s original post) Then in part II, because apparently there are members of Seed’s board of directors who have also either worked for or consulted for pharmaceutical companies that Seed and ScienceBlogs must exist only to promote big pharma propaganda, while conflating Steve Novella (who does not blog for ScienceBlogs) and the Discover blog network with ScienceBlogs as though they had anything to do with each other whatsoever.

Since then, Jake has become a very skilled young Padawan who is being corrupted by the Sith and developing into a master of the pharma shill (or the closely related “minion of the CDC”) gambit. He’s applied it to promoters of science over anti-vaccine pseudoscience as varied as Chris Mooney (author of The Republican War on Science, Storm World, and Unscientific America, as well as the journalist who wrote an excellent article on the anti-vaccine movement about a year ago entitled Why does the vaccine/autism controversy live on?); Amy Wallace (who wrote the excellent WIRED article An Epidemic of Fear: How Panicked Parents Skipping Shots Endangers Us All, which resulted in misogynistic attacks on her by J.B. Handley); Trine Tsouderos (the Chicago Tribune journalist who has written multiple excellent articles on vaccine-autism pseudoscience and quackery over the last year or so); the producers of the FRONTLINE documentary on the anti-vaccine movement (SBM commentary here); and, of course, Paul Offit. Perhaps the most tortured use of the pharma shill gambit by Jake occurred when he tried to paint New York Times journalist Gardiner Harris as a hopeless shill for big pharma because — get this — Harris’ brother once worked for pharmaceutical companies (as recently as November 2004, yet!) and now works for a device manufacturer, meaning, as Jake put it, “Gardiner Harris’ brother still deals with pharmaceutical companies.” I kid you not. You just can’t make stuff like this up. (At least I can’t.)

So, with that background in mind, I asked my fellow SBM bloggers whether I should respond, ignore this, or hold back. The unanimous (at least among those who responded to my e-mail) consensus?

Go, get ‘im!

So I will. Let me also say this to Jake: I do not receive any money from Sanofi-Aventis (or any other pharmaceutical company) to fund my research (or my blogging, for that matter). If you had bothered to read my disclaimer you’d know that. Sadly, I’m not likely to be getting any of that filthy lucre from Sanofi-Aventis any time soon. Again, read my disclaimer. My lab work is entirely funded by grants I’ve gotten through competitive applications and institutional start up funds I received when I accepted my current position. Indeed, Sanofi-Aventis doesn’t even supply me with the drug Rilutek (the trade name of Riluzole) to use for my clinical trial or experiments using mouse tumor models. That’s all funded by grants and startup funds too. Moreover, prior to Jake’s e-mail I had been completely unaware that Riluzole had even been considered for, much less tried as, a treatment for autism. I’m not a neurologist or pediatrician; so it’s unlikely that I would know about that, although I can say, knowing what I know about Riluzole, that it doesn’t strike me as a particularly promising approach.

At this point, no doubt my readers want to know just what on earth Jake is talking about as he tries to paint me as a willing sycophant, toady, and lackey of Sanofi-Aventis; so let me explain. I normally don’t discuss my own research very much on SBM, other than relatively vaguely, because to do so just seems entirely too self-serving to me. (Maybe my lack of self-promotion skills is one reason why the Dark Lords of Pharma want no part of me; or maybe it’s some of my posts, like the one likening vertebroplasty to acupuncture or this one lamenting a pharmaceutical company paying a publisher to publish a fake journal.) However, so that you and Jake understand why his approach is utter nonsense, I have to provide you with a brief primer of my work.

The reason Jake mentioned Riluzole is because it’s one drug I study as a potential therapy for breast cancer. In fact, if I do say so myself, the project looking at Riluzole in breast cancer is an example of why science-based medicine is so cool compared to the fairy dust of “alternative” medicine or the pseudoscience that is the anti-vaccine movement. It all began a while back with a basic scientist at Rutgers named Suzie Chen, who wanted to make a transgenic mouse to study adipogenesis. So she used standard techniques to insert a gene she wanted to study, but after the transgenic mice were born the mice in one of the strains all developed skin lesions that looked like melanoma by the age of two to four months. Being a good and careful scientist, Dr. Chen realize that she had inadvertently created something really interesting, a mouse model of melanoma. So, teaming up with Dr. James Goydos, my surgical partner at The Cancer Institute of New Jersey (which is where I was at the time), Dr. Chen went back and looked at what had happened and figured out that the transgene had disrupted part of the regulatory region of a gene known as Grm1 (GRM1 in the human), which codes for a gene known as metabotropic glutamate receptor-1 (mGluR1), in such a manner that mGluR1 was being made at a level far higher than normal.

A word of explanation is in order here. Glutamate is a major neurotransmitter in mammals that functions by binding to either ionotropic or metabotropic receptors (genes: GRM1-GRM8; receptors: mGluR1-mGluR8). I’m not going to talk about ionotropic glutamate receptors. mGluRs belong to a family of G-protein-coupled seven transmembrane domain receptors (GPCRs), which mediate responses to a diverse array of signaling molecules, including hormones, neurotransmitters, chemokines, and autocrine and paracrine factors. In the mammalian CNS, mGluRs, which are categorized into either group I, II, or III receptors based on sequence, what compounds they bind, and how they signal in the cell, are essential for normal neuronal function, and have been implicated in diverse neurological pathology, particularly ALS. Their existence and importance in melanoma had previously been unsuspected.

Again, being a careful scientist, Suzie Chen went back and made a new transgenic mouse, this time using Grm1 engineered in such a way that it is only expressed in the melanocytes of the mouse strain created and observed very close to the same thing. Now here’s where things get really interesting. It turns out that there is already an FDA-approved drug that blocks glutamate release and signaling. This drug is Riluzole, and it’s used to treat amyotropic lateral sclerosis (ALS, a.k.a. Lou Gehrig’s disease). In fact (and Steve will correct me if I’m wrong) Riluzole is the only currently known drug that prolongs the life of ALS patients, albeit not by a lot. Truly, this was serendipity of the sort that most scientists never see in their lifetimes.

Why is Riluzole so important in this story, even though it doesn’t specifically inhibit the activity of mGluR1? Because it was already FDA-approved. Thus, testing it in cancer didn’t require a new drug approval, only an approval to test the off-label use of Riluzole against melanoma, which is what Drs. Goydos and Chen did, demonstrating that Riluzole inhibits the growth of melanoma in cell culture and in mouse tumor models, that it is an oncogene in melanoma, and that it showed promise against melanoma in a small pilot clinical trial. Dr. Goydos is currently running a clinical trial to test Riluzole in melanoma patients, one for patients with unresectable melanoma.

In the meantime, about three years ago I started collaborating with Dr. Goydos to see if mGluR1 is expressed in breast cancer. It turns out that it is and that it is active. Indeed, our first paper reporting these results has been submitted, and I’m busily putting together a paper to report our results in animal models, results that I reported at the recent ASCO meeting. I also have a small pilot clinical trial, funded by The ASCO Foundation and the Breast Cancer Research Foundation, that is going on right now. In the meantime, while my collaborators keep working on melanoma and some other tumor types, I’m working on figuring out how mGluR1 functions in breast cancer with the hope that the knowledge will lead to a treatment for breast cancer that can be taken as a pill and that has very low toxicity. Riluzole meets both criteria. If it passes clinical trials, it may well be a very useful drug for potentiating the effects of other cancer therapies, such as chemotherapy and radiation.

If this research works out, I’d like to think I did something good, building on the work of Drs. Chen and Goydos, to benefit breast cancer patients. In fact, I’m quite excited that we’re on the verge of publishing our first paper on our work and currently deep into the process of writing our second paper. Both, I hope, will appear before the end of 2010.

The bottom line is that, for Jake’s insinuation to represent a true COI that needs to be reported up front when I write about vaccines and autism, at least three things would have to be true. First, I would have to be receiving money from Sanofi-Aventis. I am not. Second, I would have to have the reasonable expectation to receive money from Sanofi-Aventis. I do not. I’m not even angling for money from Sanofi-Aventis to run my lab. Third, I would have to know that Riluzole is being tested as a treatment for autistic children. I did not until Jake wrote to me. In fact, Jake isn’t even correct. I searched ClinicalTrials.gov, and all I could find was a study called Riluzole to Treat Child and Adolescent Obsessive-Compulsive Disorder With or Without Autism Spectrum Disorders. It’s clear that the primary purpose of this trial is to test Riluzole in children with obsessive-compulsive disorder and they just happen to be including children with ASD as well. I really don’t know why; it seems to me that including children with ASDs would only make the results of the study more difficult to interpret.

In any case, even if I had known that, it still wouldn’t have been a COI. I’m not a neurologist, and I don’t treat ASD or OCD. I’m never going to be doing research with Riluzole in children with ASD, OCD, or both. I’ll attempt to follow Jake’s tortured logic. Apparently, because Jake buys into the AoA-promoted myth that autism is in reality due to “vaccine injury,” to him anything that is used to treat autism is in fact equivalent to treating “vaccine injury.” Apparently it follows that, because I’m doing research involving Riluzole and there is a clinical trial using Riluzole to treat children with OCD, some of whom will also have an ASD, I must be defending vaccines and arguing against the idea that vaccines cause autism because I’m heavily invested in Riluzole as a treatment for “vaccine injury” as well as cancer. Either that, or Sanofi-Aventis must be paying me big bucks or because I stand to make money off of Riluzole if it’s found to be a good treatment for OCD and/or breast cancer.

I must admit, Jake’s “logic” confuses me. But, then, I don’t see conspiracies everywhere. (Well, most of the time, anyway.)

As I come to the end of one of my typically logorrheic magnum opi, I wonder two things. First, I wonder if anyone’s reading anymore or if everyone’s gone to sleep. Second, and more importantly, I wonder once again if I’ve been too hard on Jake. I don’t think so. If Jake did not have a documented history stretching well into last year of trying to slime everyone he can who has the temerity to argue against the scientifically discredited idea that vaccines cause autism or to criticize GR and AoA for promoting that myth with charges of either being in the pay (and therefore thrall) of big pharma, I probably would have written a shorter and friendlier version of this post and sent it to Jake as a private e-mail. Unfortunately, Jake does have a history of trying to slime anyone he thinks he can dig some “dirt” on with the charge of an undisclosed COI or of being in the thrall of big pharma and clearly has me in his sights as his next target. Sadly, Jake has learned from J.B. Handley and others at AoA.

Jake’s conspiracy-laden posts finding tenuous connections between his enemies that he trumpets as “undisclosed COIs” that to him apparently completely invalidate the science being argued, indicate to me that Jake fancies himself an investigative journalist and wants to play in the big leagues. Unfortunately, Jake isn’t even ready to play Class A ball yet. He’s probably out of his depth in Little League. Even more unfortunately, as long as Jake stays affiliated with AoA, I don’t think he ever will be ready for the big leagues. It’s a shame, because Jake seems like a smart and ambitious kid who could have an impressive career at something and actually contribute to society rather than spreading conspiracy theories. What a waste.

If there’s one thing the media love, it’s a “bungling bureaucrats” story. Yep, the FDA, wrapped up with their science dogma, enslaved to Big Pharma, pushing toxic, unnatural chemicals and ignoring safety data. And that’s the story being told about sunscreens:

“Study: Many Sunscreens May Be Accelerating Cancer”
“Did The FDA Ignore Proof That Sunscreens May Speed Up Cancer?”
“FDA Coverup Of Sunscreen Cancer Risk”

What’s a consumer to do? If you only read the headlines, you may get the impression that sunscreens do more harm than good. The impetus was the release of the Environmental Working Group’s (EWG) 2010 Sunscreen Guide. EWG is an environmental advocacy organization that focuses on consumer products, and has been conducting annual reviews of sunscreens since 2007. Of the 500 products it reviewed, it only recommends 8%, or 39 products in total. Why were so many products deemed “not recommended”? Reasons for negative ratings included the following:

• any product containing retinyl palmitate (vitamin A), which is described as a photocarcinogen
• any product containing oxybenzone, called a “potential hormone disrupter”
• any sunscreen packaged as a spray or powder, due to inhalation concerns

EWG also raised concerns about nano-sized particles in sunscreens. But before we dive into the report, let’s consider what we’re trying to do with sunscreen.

Effects of UV Radiation

Ultraviolet radiation that reaches the earth may be divided into UVA (320–400 nm) and UVB (290–320 nm). UVA is further subdivided into UVA I, II and III. A simplified way to differentiate between the two types is to think of UVA as the aging radiation, and UVB as the burning radiation. Your exposure to UV radiation depends on factors such as latitude, altitude, time of year/day, and atmospheric conditions such as clouds and pollution. For example, if you’re on the Mediterranean coast at noon in the summer, the radiation mix is about 95% UVA, and 5% UVB.

UVB has been the traditional focus — stop the sunburn. UVA wasn’t scrutinized. But not only can UVA pass through glass, its rays can penetrate deeper into the skin and are responsible for skin breakdown and thickening. Both UVA and UVB are now implicated as cancer-causing, and UV radiation is considered a carcinogen.

Acutely, we see the effects of UVB. Sunburns can range from mild redness to life-threatening situations. Long term, the skin will show signs of both UVA and UVB damage. Degenerative changes including skin thickening as well as fibrous tissue and circulatory changes follow chronic exposure. And then there’s the big worry: cancer.

Why use Sunscreen?

Sunscreens reduce UV damage by reflecting or absorbing UV radiation:

• Physical (inorganic) barriers (i.e., zinc oxide and titanium dioxide) physically block the skin from sunlight with particulate matter, reflecting and scattering UV rays. Physical barriers are near-perfect sunscreens: they protect against UVA and UVB, they start working immediately, they’re stable and don’t break down in the sun, and they are safe. Their use has traditionally been limited by aesthetic qualities, with formulas that are greasy, white, and opaque.
• Chemical (organic) barriers filter and absorb UV radiation. Their chemical structure converts UV radiation to heat. They vary in their chemical properties, as well as their ability to absorb UVA, UVB, or both.

The Sun Protection Factor (SPF) is a estimate of how effectively a sunscreen will reduce the time to a sunburn. For example, a sunscreen that extends burning time from 10 minutes to 150 minutes has an SPF of 15. Because sunburn is the endpoint measured, SPF is a measure of UVB protection, not UVA protection. While UVA is implicated as a carcinogen, along with UVB, there are currently no well-established short-term endpoints for measuring UVA protection. But this is changing, with the FDA proposing a new set of rules for labeling UVA protection.

There is little difference in sunscreens beyond SPF 15. Consider the following:

• SPF 15 will allow 7% of UVB radiation through to the skin
• SPF 30 will allow 4% of UVB radiation through to the skin
• SPF 60 will allow 2% of UVB radiation through to the skin

SPF values are calculated based on a dose of about 1oz (30mL, or 2 tablespoons) for the entire body — much more than is typically used. In general, insufficient amounts of sunscreen are applied to achieve the labeled UV protection. In real-world observations of use, actual protection is limited far more by the amount applied, and how often it is reapplied, than by the SPF. The EWG report illustrates the consequences of inadequate use of sunscreens, based on applying one-quarter of the recommended amount:

When used properly, SPF 15 provides more than adequate UVB protection for most individuals. EWG recommends that higher SPF products should be avoided if they contain higher concentrations of ingredients they deem potentially hazardous. While it’s unclear how much risk these ingredients truly represent, it’s a fair statement that higher SPF products are more about marketing, rather than meaningful differences in potential sun protection. You get better protection using a sunscreen properly.

Sunscreens and Cancer

There are three major types of skin cancer. Basal cell carcinoma and squamous cell carcinoma are common, but rarely fatal. They often appear on sun-exposed areas like faces and ears, and can be removed easily (though it may be disfiguring). It’s clear that sun exposure is a risk factor for basal cell carcinoma and squamous cell carcinoma, and that sun avoidance can reduce this risk. The third cancer, melanoma, is rare (about 3% of all skin cancers) but frequently fatal, causing 75% of the deaths). When it comes to melanoma, the data on sun exposure are not as clear. There isn’t good evidence to demonstrate that reducing sun exposure has an effect, as chronic sun exposure seems to have a protective effect. However, there is good evidence linking sunburns, and particularly intermittent sun exposure to melanoma. The data with indoor tanning also seem to support a dose-response relationship. Overall, the data points to an association between intentional sun exposure and melanoma, non-intentional sun exposure with squamous cell carcinoma, and basal cell carcinoma likely related to both. (Source)

When it comes to the efficacy of sunscreen to reduce cancer risk, the data are less clear. Most sunscreens didn’t offer UVA protection until recently, confounding studies examining relationships between sunscreen use and cancer risk. Consequently, the evidence linking sunscreen use to reduced melanoma risk isn’t convincing. Studies are confounded by the long latency period for melanoma, the challenges with recall studies, and the changing formulations of sunscreens. One hypothesis for the lack of link is that sunscreen could confers a false sense of security, increasing overall exposure through more time in the sun, and possibly less use of protective clothing. Compounding this would be a relative lack of protection against UVA. Overall, however, there’s good evidence to demonstrate sunscreen use can reduce precursors to cancer, and the incidence of squamous cell cancer. On balance, the data suggest that sunscreens provide protective effects against cancer.

Pharmaceutical Elegance: The Importance of Formulation

One consideration I frequently discuss when counseling consumers about sunscreens are questions and concerns about aesthetics — particularly in products for children. If the product is greasy, opaque, or thick, it won’t be used properly, no matter how effective the product might be. Aesthetics are a function of the vehicle (what the active ingredients are mixed in) as well as the specific characteristics of the compound. Alcohol-based and “dry” versions are also available, but must rely on a smaller number of ingredients because of manufacturing issues.

A related problem is photostability — the ability of sunscreens to remain effective when irradiated by UV rays. Photostability is a function of the vehicle, and the type and concentrations of the different ingredients. Inorganic sunscreens don’t have this problem: not only are they photostable, they are also ideal for those with sensitive skin that may be allergic to organic chemicals.

In general, if the final product doesn’t have great aesthetics, it probably won’t be used properly. And this compromises the point of using sunscreens in the first place.

Sunscreen Risks

Acute side effects of sunscreens are rare and are generally limited to hypersensitivity reactions, such as skin rashes to the chemical (organic) sunscreens. Longer term effects can be categorized into two categories: long term toxicities from the constituents of the sunscreen (the bulk of the Environmental Working Groups’s concerns) and the potential for reduced vitamin D absorption.

While vitamin D production is blocked when UVB-blocking sunscreens are used, the real-world impact isn’t clear. Deficiency is plausible, but there’s little evidence to suggest meaningful deficiencies in vitamin D are related to typical use of sunscreens.

Is Retinyl Palmitate Causing Cancer?

The EWG report evaluates the different ingredients and formulations of sunscreens and uses its own ranking system to assign a score. Their scoring system is internally developed, and has not been validated, but the methodology is reasonably transparent.

Based on the coverage of the EWG’s report, you might get the impression that sunscreens containing retinyl palmitate are causing cancer. Retinyl palmitate is a form of vitamin A commonly used in cosmetic products to reduce wrinkles and fine lines. The EWG points to a 2009 study of retinyl palmitate on mice as their main cause for concern. Treated mice, and a control group were exposed to the equivalent of nine minutes of noontime Florida sun daily, for a year. Compared to the control group, the RP group developed more tumours. That’s adequate evidence to avoid the product says the EWG. But is this finding relevant? The mice were treated with retinyl palmitate — not sunscreen that contained retinyl palmitate. It’s known that retinyl palmitate can be a photosensitizer. When used as a single ingredient cream, as with other forms of vitamin A, you must wear sunscreen, or you’ll burn more easily. So how relevant is this mouse study to human subjects, wearing sunscreens containing retinyl palmitate? It’s difficult to say. Study completion and peer review is expected by 2011. What’s the best approach until then? Well, given that retinyl palmitate isn’t approved as a sunscreen, there’s no compelling rationale for it to be in these products. It’s not unreasonable to avoid it if desired, but there’s no persuasive evidence to suggest its presence is a sound reason to skip sunscreen.

Oxybenzone: Disrupting our Hormones?

Oxybenzone, or more properly, 2-hydroxy-4-methoxybenzophenone, is naturally found in flower pigments and is commercially synthesized as a sunscreen agent and UV stabilizer. Oxybenzone provides UVB and some UVA protection, and stabilizes avobenzone, an effective (but less chemically stable) UVA-sunscreen agent. It has been the target of criticism by those asking for more long-term safety assurances. The CDC recently reported that oxybenzone was detected in 97% of urine samples in a representative sampling of Americans. So it’s in our bodies and in our environment. Is it harmful?

EWG says yes, calling it a “potential hormone disrupter”. Yet oxybenzone hasn’t been linked conclusively to negative health effects. But absence of evidence isn’t evidence of absence, so do consumers have cause for concern? The CDC notes, “Human health effects from benzophenone-3 at low environmental doses or at biomonitored levels from low environmental exposures are unknown.” The European Union’s review is online [PDF], which asks for more information on dermal absorption, yet concludes that in vitro and in vivo data indicate oxybenzone does not possess photo-mutagenic or photo-genotoxic properties.

EWG recommends that oxybenzone should be avoided in sunscreens. However, evidence isn’t yet persuasive that meaningful hazards have been documented. It’s important to recognize that EWG takes a strict perspective on ingredients that is not shared by other organizations. Because something is in the environment at very low doses, it does not mean it is harmful. In addition, the ubiquity of oxybenzone in personal care products makes it very difficult to avoid, as the CDC sampling showed. As the American Cancer Society points out in its discussion of cosmetics,

It’s important to have a sense of the difference between the hazard an ingredient may pose and the risk a person faces from being exposed to it. Scientists use the term hazard to describe the potential of a chemical to cause unwanted health effects. Risk is used to describe the chances of an unwanted health effect in a person from normal use of the ingredient. A substance may be deemed to be potentially hazardous for some reason, but it may pose very little risk to people during normal use.

When it comes to oxybenzone and sunscreens, the myriad of alternatives available mean that it’s possible to avoid oxybenzone if desired, while still finding products that provide good UV protection.

Nano, Nano

If we want to avoid organic (chemical) sunscreens, the inorganic options, titanium and zinc are the attractive alternative. But EWG raises further concerns about new formulations of these products — those that contain nanoparticles. Nanoparticles are a new innovation to deal with the aesthetic drawbacks of the physical sunblocks: Make the particles small enough, and they become translucent and even transparent. Traditional titanium dioxide and zinc oxide have particle sizes of over 200 nm — large enough to reflect visible light, giving the traditional white appearance. Make the particles small enough, and they won’t scatter visible light. (This chart [pdf] nicely illustrates the effect.) EWG is concerned about the risk of absorption of nano-particles and is calling for more research. However, they note the following:

Although we expected to reach a different conclusion at the outset of our sunscreen investigation, when we balanced all factors important in sunscreen safety, our analysis shows that many zinc and titanium-based sunscreens are among the safest and most effective sunscreens on the market.

This statement is evidence-based. Measurable systemic absorption does not seem to occur with titanium and zinc nano-material sunscreens. EWG does flag sprays and powder forms of sunscreens as potentially problematic, particularly the nano-formulations, due to inhalation risks of sunscreen ingredients. While the risk of absorption is certainly greater with aerosols, compared with creams, this can be mitigated by selecting liquid sprays instead of dry powders, and avoiding spraying directly on the facial area. Probably the biggest drawback to nanomaterials is that as the particles get smaller, the UVA protection diminishes. Consequently, ultrafine particles may need to be combined with chemical sunscreens to provide complete (broad spectrum) protection. On balance, the inorganic sunscreens, whether they are nano-sized or not, are excellent sunscreens.

Conclusion

Sunscreen is not a panacea for skin protection. Sun avoidance and physical barriers remain the best approaches to minimizing the acute and long-term effects of UV radiation. The data on sunscreen use and cancer risk are complex, but on balance suggest that the short-term and long-terms benefits of sunscreens significantly outweigh their risks when used during periods of unavoidable exposure. There’s no evidence that vitamin D deficiency is a consequence of safe sun behaviours, and given there are safe and inexpensive methods of obtaining vitamin D (oral supplementation) the rationale for intentional, unprotected sun exposure remains unclear.

Sunscreens remain an important option to help avoid unwanted UV exposure. Overall, the EWG report makes it easy for consumers to differentiate between sunscreens, and make selections based on UV spectrum protection and ingredient preferences. While I’m personally not convinced about the hazards of the current FDA-approved products, I agree with the group’s overall recommendation that physical barriers, containing titanium and/or zinc, have superior risk/benefit profiles. When you look past the headlines, the Environmental Working Group’s analysis isn’t bad. It’s cautious but pragmatic. The bad probably isn’t as bad as they say, but they take a good perspective related to risk/benefit overall.

The scientific understanding of vitamins has evolved over time, from the identification of frank deficiencies, to exploring the value of supplements to prevent chronic diseases. Among health professionals, taking a multivitamin “for insurance” has long been considered to be a reasonable strategy. But as more robust evidence has emerged about the benefits and possible harms of vitamins, even that advice is facing scrutiny.

This Friday, June 11, I’ll be appearing on the Skeptically Speaking radio show, giving a science-based perspective on vitamins. Call in, listen online, or submit your questions in advance. The show is live at 6pm MST (find your time here).

On June 11, 2009 Dr Margaret Chan, the director general of the World Health Organization (WHO) declared that the H1N1 flu that was then spreading around the world was an official pandemic. This triggered a series of built-in responses in many countries, including stockpiling anti-viral medications and preparing for a mass H1N1 vaccination program. At the time the flu was still in its “first wave” and the fear was that subsequent waves, as the virus swept around the world, would become more virulent and/or contagious – similar to what happened in the 1918 pandemic.

This did not happen. At least our worst fears were not realized. The H1N1 pandemic, while serious, simmered through the winter of 2009-2010, producing a less than average flu season, although with some worrisome difference.

The Centers for Disease Control (CDC) estimates:

• CDC estimates that between 43 million and 89 million cases of 2009 H1N1 occurred between April 2009 and April 10, 2010. The mid-level in this range is about 61 million people infected with 2009 H1N1.
• CDC estimates that between about 195,000 and 403,000 H1N1-related hospitalizations occurred between April 2009 and April 10, 2010. The mid-level in this range is about 274,000 2009 H1N1-related hospitalizations.
• CDC estimates that between about 8,870 and 18,300 2009 H1N1-related deaths occurred between April 2009 and April 10, 2010. The mid-level in this range is about 12,470 2009 H1N1-related deaths.

The regular flu season kills about 30,000 Americans every year, and about 250,000 – 500,000 world wide (according to WHO estimates). H1N1 was not as bad as the seasonal flu from pure numbers, but while the seasonal flu kills mainly the elderly, H1N1 had a higher fatality among young adults, pregnant women, and children (partly because older adults were partially protected from flu epidemics earlier in the 20th century).

Interestingly, experts expected the H1N1 pandemic to be in addition to the regular seasonal flu, but the seasonal flu did not show up this year. There were essentially no cases of seasonal flu. There is still no clear answer as to why, and it will probably take a couple of years to sort that out.

The low numbers for H1N1 left much of the public with the perception that the pandemic was a bit of a fizzle, and perhaps the WHO, CDC, and other national centers overreacted. This is more than just a bit of Monday morning quarterbacking, however. But the disconnect has led to questions about the decisions made by the WHO and also to the question of whether or not their decision-making was free of conflicts of interest.

A report in the British Medical Journal last week by features editor Deborah Cohen and investigative journalist Phillip Carter has raised the accusation that the WHO did not handle potential conflicts of interest adequately when dealing with H1N1. This has set off a fresh round of criticism, leading at the extreme end to accusations of a deliberate conspiracy on the part of the pharmaceutical industry.

Several legitimate questions are now being raised (although I must point out that raising a question does not equal guilt, unless you are engaged in a witch hunt). Was the decision by the WHO to declare H1N1 2009 a pandemic justified? Were there any real conflicts of interest among the experts the WHO relied upon? Did the WHO adequately disclose potential conflicts of interest?

Decision to Declare a Pandemic

The WHO actually began its flu pandemic preparedness plans in 1999, when it stated:

“It is impossible to anticipate when a pandemic might occur. Should a true influenza pandemic virus again appear that behaved as in 1918, even taking into account the advances in medicine since then, unparalleled tolls of illness and death would be expected.”

This became the guiding principle of the WHO – flu pandemics are inherently unpredictable, and potentially very serious. They also recognized that any effective action would have to be taken before the full scale of any pandemic was fully realized. Flu viruses have a tendency to mutate throughout an epidemic or pandemic, creating the potential for a virus to suddenly become more virulent. This has happened before, most significantly during the 1918 flu pandemic. But no one can know how bad an epidemic or pandemic will become until it is largely too late to do anything about it. Vaccines take several months, at least, to produce. And medication supplies also will run out quickly during a pandemic unless they are stockpiled.

The precautionary principle therefore holds – prepare for the worst, even while hoping for the best. With H1N1 the pandemic was real and serious, with many deaths, and a higher proportion of deaths among the otherwise young and healthy. But the dreaded mutation to a more virulent strain never happened. There was also the unexpected no-show of the seasonal flu. There was no way for anyone to predict these outcomes.

It seems to me that it is irresponsible for politicians and leaders to scapegoat the WHO now because of their lack of a crystal ball. In attacking the WHO in order to seek political cover themselves they are perhaps making it more difficult for proper precautions to be taken the next time the world is threatened with a pandemic. Experts will be unwilling to stick their necks out if they will get them chopped off if their worst predictions are not realized.

This would be like suing a surgeon for malpractice every time they took out a healthy appendix. This would not be a good thing for future patients with possible appendicitis.

What will best serve the public interest is for world experts to think carefully about how to deal with potential pandemics, given the inherent uncertainties. We don’t want to declare a pandemic every flu season, but we also don’t want to be caught with our pants down. It’s a delicate balance, and it is perfectly reasonable to take a generally cautious approach – meaning to declare more pandemics than will actually manifest as serious killers. The world would rather have a few false alarms than to be caught unprepared for another 1918 pandemic.

One specific point raised by critics is that the WHO changed their definition of pandemic for the 2009 H1N1 declaration – removing the criterion that an epidemic must cause serious harm. The reason for this given by the WHO is that pandemics can become increasingly virulent but preparations cannot wait for that to happen. However, this opened the door for accusations of a conspiracy.

I must also point out that the dire predictions of the critics of the H1N1 vaccine also did not come to fruition. Remember the alarmist warnings about the flu vaccine and Guillaine Barre Syndrome (GBS)? As a result of these fears, the UK and US put in place a careful monitoring system. In the end there were no additional cases of GBS tied to the H1N1 vaccine – no cases of vaccine-induced GBS.

Were There Conflicts of Interest?

The BMJ article raises concerns that many of the experts whose advice lead the WHO to declare a pandemic had undisclosed conflicts of interest. The question of conflicts of interest can be tricky – it is somewhat of a judgment call and different people may have different opinions as to what constitutes a conflict. For this reason medical journals have largely moved to the policy of having authors disclose all potential conflicts and letting readers decide for themselves which are real conflicts.

This kind of policy should be a minimum for an organization like the WHO, but may not be sufficient. There needs to be an assurance that decisions are as free of conflicts as possible, not just disclosed.

But the real question is – what is a conflict of interest. There is a spectrum, and no place to draw a clear line of demarcation.

For example, if an expert is being paid a bribe or kickback in order to give an opinion that is favorable to a company, everyone is likely to agree that is an unambiguous conflict of interest. If an expert owns stock in a company whose profit is affected by the advice or decisions of that expert – that is also a clear conflict of interest. And I think if an expert derives a significant portion of their income, or a large sum of money in any case, from a company, that produces a conflict. There are other similar clear conflicts – any case in which the advice or decisions of an expert will directly affect their income or career.

But there is then a vast gray zone between these clear conflicts and having no industry ties at all. Academics and experts, precisely because they are experts, are often paid to give lectures, are consulted for their expertise, or are paid to design and conduct research for industry. While these are “ties to industry” they are not clear conflicts, because they do not necessarily create a situation where future advice or opinions given by experts with such ties will affect their own income or careers. These are often tenuous ties – even being given a few hundred dollars to give a lecture is often characterized by critics has creating “ties to industry.”

In the case of the experts who advised the WHO on H1N1 the potential conflicts of interest are all of the gray zone variety. There have been no bribes or kickbacks, and no experts who stood to earn or lose money based upon their advice. But many of the experts were previously consulted by industry and some have conducted clinical trials for pharmaceutical companies who make vaccines or anti-virals.

This, of course, has not stopped the most shrill and hysterical critics to distort the situation. Mike Adams of Natural News, for example, falsely asserts that the BMJ exposed “kickbacks” and an actual conspiracy to defraud the public over the H1N1 pandemic (they reported nothing even close to this). If the e-mail I have been receiving over the last two weeks in any indication, the public’s perception of the situation is unfortunately closer to Adams’ distorted version than what the BMJ actually reported.

Just as with the Monday morning quarterbacking, there are potential harms that could flow from treating every tenuous industry connection as if it were a sinister conflict. The public benefits when the best experts in the field are advising both industry and regulatory and other government agencies. They help industry spend their research dollars most effectively. And they help governments make rational evidence-based policy decisions. Again we come to a matter of balance – we want to allow experts to give the public the full benefit of their expertise, without creating real conflicts of interest which compromise their advice. I think the scientific community and governments are still working out how to achieve the optimal balance, and thoughtful reflection is therefore a good thing. But the basics appear to be covered.

Full Disclosure

This brings us to the final question – where to draw the line between conflicts and non-conflicts may be tricky, but it is generally agreed that full disclosure and transparency is appropriate. This is where the WHO seems to have genuinely fallen down. Experts disclosed their potential conflicts to the WHO, but the WHO did not make them public. About this decision, Director Chan explains the purpose:

“is to protect the integrity and independence of the members while doing this critical work — but also to ensure transparency by publicly providing the names of the members as well as information about any interest declared by them at the appropriate time.”

That explanation is not compelling and comes off as tone deaf to the real concerns. Chan is essentially saying – trust us, we will let you know what we think you need to know when we think you need to know it. This attitude just does not cut it in the 21st century.

Conclusion:

We can debate endlessly about the decision to declare the H1N1 2009 pandemic – hindsight, as they say, is 20/20. But the decision was reasonable at the time. More importantly if in the future we find ourselves in the same situation with an impending flu pandemic, a similar response (perhaps there can be some useful tweaks) will be appropriate. Think about the alternatives – would you rather have the world governments overprepare for a pandemic that never fully manifests, or would you rather have millions of preventable deaths because those governments were shying away from possible criticism?

The conversation about conflicts of interest needs to continue. It seems as if the pendulum has swung too far towards considering any industry connection a genuine conflict, making the issue more of a witch hunt than a reasonable precaution. It needs to swing back to a better balance – so that the public can fully benefit from out best experts in important disciplines.

But in any case, there is no downside to full disclosure. True transparency is a starting point.

Birds of a feather flock together. As they investigated the risk factors for cardiovascular disease and diabetes, medical detectives observed that the usual suspects liked to hang out together. Obesity, high blood pressure, abnormal blood lipids, and elevated blood sugars regularly appeared together in the same patient. It looked like a syndrome that might boil down to one underlying cause. They called it “metabolic syndrome” and started applying the concept to clinical practice.

It seemed like a good idea at the time, but now skeptical scientists are expressing their doubts.

What Is Metabolic Syndrome?

A “syndrome” is defined as a group of symptoms and signs that together are characteristic of a specific disorder or disease. All syndromes are not created equal. Some syndromes are well-defined, with known causes, such as Down syndrome, a specific constellation of congenital abnormalities that can be confirmed by genetic tests demonstrating the presence of an extra chromosome (or related chromosomal abnormalities). Others are less well defined, like chronic fatigue syndrome, which consists of fatigue in association with a variable list of symptoms and signs like pain and enlarged lymph nodes. There is no lab test for it, the cause is not known, and the diagnosis itself is controversial.

Metabolic syndrome is a combination of factors that increase the risk of cardiovascular disease and diabetes. It’s also known by other names including syndrome X and insulin resistance syndrome. It has gotten a lot of press in recent decades, but some scientists have questioned whether it really exists. We know many risk factors for cardiovascular disease and diabetes, but when does a group of risk factors become a “syndrome” and when does it become useful for diagnosis, prevention, or treatment?

Metabolic syndrome is differently defined by different organizations. The worldwide consensus definition of the International Diabetes Federation requires central obesity plus any two of: raised triglycerides, reduced HDL cholesterol, elevated blood pressure, and increased fasting blood sugar. The World Health Organization requires diabetes or impaired glucose tolerance along with two of the following: HBP, dyslipidemia, central obesity, and microalbuminemia. The US National Cholesterol Education Program requires three of: central obesity, elevated triglycerides, decreased HDL cholesterol, elevated blood pressure, and elevated fasting blood sugar. The key feature is central obesity in one definition and diabetes in another, but neither is required at all in the third. This is disturbing, to say the least. A patient with elevated blood pressure, low HDL, and elevated triglycerides who is not obese or diabetic would be classified as having metabolic syndrome by the NCEP, but not by the IDF or the WHO!

And so the prevalence of this syndrome varies considerably depending on which definition is used. The overall prevalence of metabolic syndrome is around 25% in the US population. It varies by age and race, and is over 43% for those older than 65.

A New Study

A new study found that metabolic syndrome was associated with a two- to three-fold increased risk of MI, but the same risk was conferred by having either hypertension or diabetes alone. The authors said,

People who advocate for the metabolic syndrome concept believe that when the component risk factors occur together this would have an additive or greater effect on risk, and therefore it is important to identify these individuals. But we didn’t find that. So our study adds to the evidence that a diagnosis of metabolic syndrome is not useful. It is better just to treat the actual risk factors.

They pointed out that there is a dose-response relationship between risk-factor severity and MI risk and that a standard definition of metabolic syndrome loses information because it converts continuous variables into categorical variables. And there are other significant risk factors that metabolic syndrome fails to consider, like sedentary life style and smoking. It would make more sense to replace the categorical definition of metabolic syndrome with a scoring system that assigns a weight based on the level of each risk factor and that uses a regression formula.

A Joint Statement

This is not a new concern. Five years ago, the American Diabetes Association and the European Association for the Study of Diabetes issued a joint statement entitled “The Metabolic Syndrome: Time for a Critical Appraisal.” They reviewed the literature and concluded that

the metabolic syndrome has been imprecisely defined, there is a lack of certainty regarding its pathogenesis, and there is considerable doubt regarding its value as a CVD risk marker. Our analysis indicates that too much critically important information is missing to warrant its designation as a “syndrome.” Until much needed research is completed, clinicians should evaluate and treat all CVD risk factors without regard to whether a patient meets the criteria for diagnosis of the “metabolic syndrome.

They acknowledged that the metabolic syndrome had been a useful paradigm for drawing attention to the fact that some CVD risk factors tend to cluster in patients. But now it is time for a

…serious examination of whether medical science is doing any good by drawing attention to and labeling millions of people with a presumed disease that does not stand on firm ground.

Conclusion

The concept of a metabolic syndrome originally seemed promising: it carried the hope of better identifying patients at risk, contributing to establishing an etiology related to insulin resistance, and determining better routes to prevention and treatment. These ideas haven’t panned out. It is still unclear whether obesity causes the associated findings or whether an underlying condition causes the obesity along with the other findings or whether something else is going on. It is becoming increasingly clear that identifying and managing individual risk factors is the way to go.

Should the concept of metabolic syndrome be abandoned? Probably. But human nature makes us reluctant to abandon any idea after it has rooted itself in our consciousness. The metabolic syndrome has become so well established in the popular medical mind that it will not go without a struggle.

When Daniel David Palmer, the inventor of chiropractic, and his acolytes first took up the practice of chiropractic, around the turn of the last century, they were jailed for the unlicensed practice of medicine. If history had left them there, we might not be fighting a continuing battle with the pseudoscience that is “alternative” medicine today.

Unfortunately, the Kansas legislature intervened on the chiropractors’ behalf and passed the first chiropractic practice act in 1913. Over the years, state by state, the notions that subluxations interfere with nerve flow, causing ill health, and that only chiropractors could “correct” these subluxations, thereby restoring health, were incorporated into state law. As well, chiropractors were given a broad scope of practice and allowed to call themselves “doctor.” In 1974, Louisiana’s passage of a chiropractic practice act made chiropractic legal in all 50 states.

Acupuncturists and naturopaths copied this successful formula by convincing state legislatures to incorporate their pseudoscientific ideas directly into practice acts, thereby managing to become licensed health care providers. Legislative fiat triumphed over scientific facts time after time.

Laws allowing the practice of “alternative” medicine did not totally eliminate resistance to pseudoscientific practices from some quarters. Insurance companies, for example, refused to pay for treatments they considered experimental. Medicare did not cover chiropractic. Labs and x-ray facilities wouldn’t allow use of their services. But for each roadblock science tried to put in the way, state and federal legislators were there to remove it, paving the way toward “acceptance.”

Finally, even medical doctors were unable to resist the enticing smell of money wafting over from “alternative” clinics. Again legislators smoothed the transition from medicine to “alternative” medicine by effectively doing away with a science-based standard of care.

Still, this was not enough in the eyes of some. It deprived those seeking “health freedom” the “right” to choose whatever health care they wanted from whatever practitioner they wanted. So the legislatures of three states — Minnesota (2000),Rhode Island (2002) and New Mexico (2009 ) — came up with an equitable solution by essentially setting up a separate health care profession: the unlicensed practice of health care. In fact, the laws of both Rhode Island and New Mexico are titled the “Unlicensed Health Care Practice Act.” At least they’re up front about it.

(Arizona, California, Idaho, Louisiana and Oklahoma also provide some legal cover for unlicensed practitioners, mainly by protecting them from prosecution for the practice of medicine.)

Ironically, these laws are promoted as public safety measures, so that the state can exercise some control over health care practices not officially licensed. Perhaps some legislators really believe this is effective — as opposed to, say, requiring that all practices have a plausible basis in science and maybe even some evidence of effectiveness.

The acts passed by Rhode Island and Minnesota are almost identical. New Mexico’s is more liberal, but contains many of the same provisions. This suggests these laws are based on templates fed to drafters by promoters of “health freedom” and are passed with few changes.

The statutes contain various provisions common to licensed health care practice acts: a supervisory authority, a bill of rights for the consumer, reporting requirements, confidentiality requirements, prohibitions on sex with patients (who are called “clients” in Minnesota and Rhode Island), and penalties for violations.

On the other hand, no malpractice insurance is required nor is there a specific provision for informed consent of the patient/client. As is common with other licensed “alternative” practitioners, unlicensed practitioners can’t perform surgery, prescribe drugs, invade the human body, use medical devices, or practice dentistry. They also cannot manipulate or adjust the articulations of joints or the spine, obviously in deference to the chiropractic lobby.

Then things get really weird.

First, other than as stated above, there is virtually no limitation on what these unlicensed practitioners can do, as long as it falls into “the broad domain of complementary and alternative healing methods and treatments.” Given the facts that (1) these “healing methods” are made up, and (2) some are of fairly recent origin (e.g., cranial sacral therapy), it appears reasonable to conclude that one can simply create a “healing method,” call it “alternative,” and set up shop. The unemployed should take note.

Specifically mentioned in the statutes as permissible treatments are acupressure, Alexander technique, aroma therapy, ayurveda, craniosacral therapy, crystal therapy, detoxification practices and therapies, energetic healing (as opposed to the lethargic kind, I guess), Rolfing, Gerson therapy, colostrum therapy, therapeutic touch, herbology, herbalism, polarity therapy, homeopathy, nondiagnostic iridology, Qi Gong, culturally traditional healing practices, anthroposophy, folk practices, healing practices utilizing food, dietary supplements, nutrients, and the physical forces of heat, cold, water, touch, and light, healing touch, homeopathy, body work, massage, meditation, mind-body healing practices, naturopathy, noninvasive instrumentalities, holistic kinesiology and other muscle testing techniques. However, it’s made clear in the statutes that this list is not meant as a limitation on the therapies which can be legally offered to the public.

Minnesota and Rhode Island add an extra layer of practitioner protection: having already ok’d unlicensed alternative medicine “healing methods,” these states assure practitioners on the cutting edge of pseudo-medicine that use of a “less customary approach” will not per se subject them to discipline. So now we have conventional alternative medicine and alternative alternative medicine? If the “less customary approach” is used with conventional alternative medicine, should we call it complementary alternative alternative medicine? So much to figure out!

Unlicensed practitioners cannot provide a “medical diagnosis,” or, as New Mexico puts it, the practitioner cannot “make a specific conventional medical diagnosis,” which is “a medical term that is commonly used and understood in conventional western medicine.” In another dig at “conventional western medicine,” plain old prescription drugs become “dangerous drugs” under New Mexico law. A “dangerous drug” is defined as “a drug that is required by applicable federal or state law or rule to be dispensed pursuant to a prescription.” Thus unlicensed practitioners are prohibited from prescribing or dispensing “dangerous drugs.”

To make sure unlicensed practitioners don’t pull one over on the public, Minnesota and Rhode Island (but not New Mexico) list as “prohibited conduct:”

• “Advertising that is false, fraudulent, deceptive or misleading;” and
• “Conduct likely to deceive, defraud, or harm the public.”

Good luck with that!

As further public protection, these states require their own version of a written quack Miranda warning. For example:

THE STATE OF MINNESOTA HAS NOT ADOPTED ANY EDUCATIONAL AND TRAINING STANDARDS FOR UNLICENSED COMPLEMENTARY AND ALTERNATIVE HEALTH CARE PRACTITIONERS BUT WE ARE GOING TO LET THEM PRACTICE MEDICINE ANYWAY.

Actually, I made up that last part, after “PRACTITIONERS.” The rest is right out of the statutes.

As part of disclosure requirements, this must be followed by,

THIS STATEMENT OF CREDENTIALS IS FOR INFORMATION PURPOSES ONLY.

These “credentials” are “the degrees, training, experience, or other qualifications of the practitioner regarding the complementary and alternative health care being provided.” Considering this, the reader might look into investing in the diploma mill industry.

And note that credentials aren’t required — it’s just that if you have some you must let the client know what they are.

Perhaps to prevent their states from becoming havens for parents who want unrestricted access to “alternative” practices for their children, both Minnesota and Rhode Island (but, again, not New Mexico) make clear that “a parent who obtains complementary and alternative health care for the parent’s minor child is not relieved the duty to seek necessary medical care [for the child].” In fact, unlicensed practitioners are required to report to the authorities that a child is not receiving necessary medical care, although if the practitioner’s world view dictates that medical care is unnecessary, what happens then?

Minnesota prevents the unlicensed practitioner from using the title “doctor,” “Dr.” or “physician.” Rhode Island prevents “false or misleading” use of these terms. New Mexico simply prevents the practitioner from describing himself as a “licensed doctor or physician.”

That New Mexico! Here’s what else they do there. The other two states, as might be expected, prevent a person from providing unlicensed services if he has been convicted of a felony. Not New Mexico! The convicted felon is prevented from practicing only until he satisfies the terms of his sentence. After that, it’s back to aromatherapy, iridology, polarity therapy, or whatever else he was up to before his unfortunate encounter with the criminal justice system.

I must ask: Is it really good public policy to allow a convicted thief such easy access to a person’s wallet?

And here’s the best part, saved for last: Minnesota and Rhode Island require the practitioner to provide, in writing, “a brief summary, in plain language, of the theoretical approach used by the practitioner in providing services to clients.” What we wouldn’t give to see that! In fact, if you are ever in either of these states, be sure to have a complementary or alternative health care treatment from an unlicensed practitioner, and be sure to get your written, plain language summary of her “theoretical approach.” Send it to me here. [After, of course, signing a complete release absolving me of all liability for anything bad that happens to you at the hands of the unlicensed practitioner.] If my SBM editors agree to it, I’ll write a post about them. And bonus points for any summary containing the phrase “on a quantum level.”

Jann J. Bellamy is a Florida attorney.  She left the active practice of law in 2006 to form a non-profit, the Campaign for Science-Based Healthcare, which educates the public about “alternative” healthcare claims and advocates for a state law requiring that all healthcare offered in Florida meet a basic scientific standard.  She is also a columnist for Health News Florida.

I don’t want knowledge. I want certainty!

If there’s a trait among humans that seems universal, it appears to be an unquenchable thirst for certainty. It is likely to be a major force that drives people into the arms of religion, even radical religions that have clearly irrational views, such as the idea that flying planes into large buildings and killing thousands of people is a one-way ticket to heaven. However, this craving for certainty isn’t expressed only by religiosity. As anyone who accepts science as the basis of medical therapy knows, there’s a lot of the same psychology going on in medicine as well. This should come as no surprise to those committed to science-based medicine because there is a profound conflict between our human desire for certainty and the uncertainty that is always inherent in so much of our medical knowledge. The reason is that the conclusions of science are always provisional, and those of science-based medicine arguably even more so than many other branches of science.

In fact, one of the hardest things for many people to accept about science-based medicine is that the conclusions of science are always subject to change based on new evidence, sometimes so much so that even those of us “in the biz” can become a bit disconcerted at the rate at which knowledge we had thought to be secure changes. For example, think of how duodenal peptic ulcer disease was treated 25 years ago and then think about how it is treated now. Between 1984 and 1994, a revolution occurred on the basis of the discovery of H. pylori as the cause of most of the gastric and peptic ulcer disease we see. Where in 1985 we treated PUD with H₂-blockers and other drugs designed to block gastric acid secretion, now antibiotics represent the mainstay of treatment and are curative at a much higher success rate than any treatment other than surgery and without the complications of surgery. I’m sure any other physician here could come up with multiple other examples. In my own field of breast cancer surgery, I look back at how we treated breast cancer 22 years ago, when I first started residency, and how we treat it now, and I marvel at the changes. If such changes can be disconcerting even to physicians dedicated to science-based medicine, imagine how much more disconcerting they are to lay people, particularly when they hear news reports of one study that produces one result, followed just months later by a report of a different study that gives a completely different result.

We see this phenomenon of craving certainty writ large and in bold letters in huge swaths of so-called “alternative” medicine. Indeed, a lot of quackery, if not most of it, involves substituting the certainty of belief for the provisional nature of science in science-based medicine, as well as the uncertainty in our ability to predict treatment outcomes, particularly in serious diseases with variable biology, like several types of cancer.

Examples abound. Perhaps my favorite two examples include Hulda Clark, who attributed all cancer and serious disease to a common liver fluke, and Robert O. Young, who believes that virtually all disease is due to “excess acid.” So prevalent is this tendency that Harriet Hall once skewered it in a delightful post entitled The One True Cause of All Disease, where she listed a rather large samplings of things that various quacks have implicated as “the one true cause” of various diseases — or all diseases.

Time and time again, if you look carefully at “alt-med” concepts and the therapies that derive from those concepts, you find utter simplicity (or, more appropriately in many cases, simple-mindedness) tarted up with complicated-sounding jargon. Homeopathy, for instance, is at its heart nothing more than sympathetic magic, with its concept of “like cures like,” combined with the principle of contagion, with its concept that water somehow has a “memory” of the therapeutic substances with which it’s come in contact but, as Tim Minchin so hilariously put it, “it somehow forgets all the poo it’s had in it.” Reiki and other “energy healing” modalities can be summed up as “wishing makes it so,” with “intent” having the power to manipulate some fantastical life energy to heal people. It’s faith healing, pure and simple.

The simplicity of these concepts at their core makes them stubbornly resistant to evidence. Indeed, when scientific evidence meets a strong belief, the evidence usually loses. In some cases, it does more than just lose; the scientific evidence only hardens the position of believers. We see this very commonly in the anti-vaccine movement, where the more evidence is presented against a vaccine-autism link, seemingly the more deeply anti-vaccine activists dig their heels in to resist, cherry picking and twisting evidence, launching ad hominem attacks on their foes, and moving the goalposts faster than science can kick the evidence ball through the uprights. The same is true for any number of pseudoscientific beliefs. We see it all the time in quackery, where even failure of the tumor to shrink in response can lead patients to conclude that the tumor, although still there, still can’t hurt them. 9/11 Truthers, creationists, Holocaust deniers, moon hoaxers — they all engage in the same sort of desperate resistance to science.

Even those who in general accept science-based medicine can be prone to the same tendency to dismiss evidence that conflicts with their beliefs. A while back, I saw an article by Christie Aschwanden discussing just this problem. The article was entitled Convincing the Public to Accept New Medical Guidelines, and I feel it could almost have been written by Mark Crislip or myself, only minus Mark’s inimitable self-deprecating yet cutting sarcasm, or my own alleged talent for nastiness and ad hominem. (I guess I need to become more cuddly.) To set up its point that persuading people to accept the results of new medical science is exceedingly difficult, the article starts with the example of long distance runners who believe that taking ibuprofen (or “vitamin I”) before a long run reduces their pain and inflammation resulting from the run:

They call it “vitamin I.” Among runners of ultra-long-distance races, ibuprofen use is so common that when scientist David Nieman tried to study the drug’s use at the Western States Endurance Run in California’s Sierra Nevada mountains he could hardly find participants willing to run the grueling 100-mile race without it.

Nieman, director of the Human Performance Lab at Appalachian State University, eventually did recruit the subjects he needed for the study, comparing pain and inflammation in runners who took ibuprofen during the race with those who didn’t, and the results were unequivocal. Ibuprofen failed to reduce muscle pain or soreness, and blood tests revealed that ibuprofen takers actually experienced greater levels of inflammation than those who eschewed the drug. “There is absolutely no reason for runners to be using ibuprofen,” Nieman says.

The following year, Nieman returned to the Western States race and presented his findings to runners. Afterward, he asked whether his study results would change their habits. The answer was a resounding no. “They really, really think it’s helping,” Nieman says. “Even in the face of data showing that it doesn’t help, they still use it.”

As is pointed out, this is no anomaly. Aschwanden uses as another example a topic that’s become a favorite of mine over the last six months or so since the USPSTF released revised guidelines for mammographic screening. Take a look at what she says about the reaction:

This recommendation, along with the call for mammograms in women age 50 and older to be done every two years, rather than annually, seemed like a radical change to many observers. Oncologist Marisa C. Weiss, founder of Breastcancer.org, called the guidelines “a huge step backwards.” If the new guidelines are adopted, “Countless American women may die needlessly from breast cancer,” the American College of Radiology said.

“We got letters saying we have blood on our hands,” says Barbara Brenner, a breast cancer survivor and executive director of the San Francisco advocacy group Breast Cancer Action, which joined several other advocacy groups in backing the new recommendations. Brenner says the new guidelines strike a reasonable balance between mammography’s risks and benefits.

I discussed the guidelines in considerable detail twice. Let’s put it this way: I’m in the business, so to speak, and even I was shocked at the vehement reactions, not just from patients and patient advocacy groups, whose reaction I could completely understand (after many years of hearing that beginning mammography at age 40 was critical to save lives), but even from some of my very own colleagues. I was particularly disgusted by the reaction of the American College of Radiology, which was nothing more than blatant fear mongering that intentionally frightened women into thinking that the new guidelines would lead to their deaths from breast cancer. As much as we’d like to pretend otherwise, even science-based medical practitioners can fall prey to craving the certainty of known and accepted guidelines over the uncertainty of the new. And if it’s so hard to get physicians to accept new guidelines and new science, imagine how hard it is to get patients to accept them.

There is abundant evidence of how humans defend their views against evidence that would contradict them, and it’s not just observational evidence that you or I see every day. Scientists often fall prey to what University of California, Berkeley, social psychologist Robert J. MacCoun calls the “truth wins” assumption. This assumption, stated simply, is that when the truth is correctly stated it will be universally recognized. Those of us who make it one of our major activities to combat pseudoscience know, of course, that the truth doesn’t always win. Quite the contrary, actually, I’m not even sure the “truth” wins a majority of the time — or even close to a majority of the time. Moreover, most recommendations of science-based medicine are not “truth” per se; they are simply the best recommendations physicians can currently make based on current scientific evidence. Be that as it may, the problem with the “truth wins” viewpoint is that the “truth” often runs into a buzz saw known as a phenomenon that philosophers call naive realism. This phenomenon, boiled down to its essence is the belief that whatever one believes, one believes it simply because it’s true. In the service of naive realism, we all construct mental models that help us make sense of the world. When the “truth wins” assumption meets naive realism, guess what usually wins? It ain’t the truth.

At the risk of misusing the word, I’ll just point out something about our “truth”: that we all filter everything we learn through the structure of our own beliefs and the mental models we construct to support those beliefs. I like to think of science as a powerful means of penetrating the structure of those mental models, but that’s probably not a good analogy. That’s because, for science to work at changing our preconceptions, we have to have the validity of science already strongly incorporated into the structure of our own mental models. If it’s not, then science is more likely to bounce harmlessly off of the force field our beliefs create to repel it. (Sorry, I couldn’t help it; I’m a hopeless geek.) As a result, all other things being equal, when people see studies that confirm their beliefs they tend to view them as unbiased and well-designed, while if a study’s conclusions contradict a person’s beliefs that person is likely to see the study as biased and/or poorly done. As MacCoun puts it, “If a researcher produces a finding that confirms what I already believe, then of course it’s correct. Conversely, when we encounter a finding we don’t like, we have a need to explain it away.”

There’s also another strategy that people use to dismiss science that doesn’t conform to their beliefs. I hadn’t thought of this one before, but it seems obvious in retrospect after I encountered a recent study that suggested it. That mechanism is to start to lose faith in science itself as a means of making sense of nature and the world. The study was by Geoffrey D. Munro of Towson University in Maryland and appeared in the Journal of Applied Social Psychology under the title of The Scientific Impotence Excuse: Discounting Belief-Threatening Scientific Abstracts.

There were two main hypotheses and two studies included within this overall study. Basically, the hypothesis was that encountering evidence that conflicts with one’s beliefs system would tend to make the subject move toward a belief that science can’t study the hypothesis under consideration, a hypothesis known as the “scientific impotence” hypothesis or method. In essence, science is dismissed as “impotent” to study the issue where belief conflicts with evidence, thus allowing a person to dismiss the science that would tend to refute a strongly held belief. The problem, of course, is that the major side effect of asserting scientific impotence discounting is that it leads a person to distrust all science in general, or at least far more science than the science opposing that person’s belief.

Munro makes the implication of scientific impotence discounting plain:

The scientific impotence method of discounting scientific research that disconfirms a belief is certainly worrisome to scientists who tout the importance of objectivity. Even more worrisome, however, is the possibility that scientific impotence discounting might generalize beyond a specific topic to which a person has strong beliefs. In other words, once a person engages in the scientific impotence discounting process, does this erode the belief that scientific methods can answer any question? From the standpoint of the theory of cognitive dissonance (Festinger, 1957), the answer to this question could very well be “Yes.”

Not surprising, the scientific impotence discounting strategy of denying science permits one to dodge the charge of hypocrisy:

Using the scientific impotence excuse for one and only one topic as a result of exposure to belief-disconfirming information about that topic might put the individual at risk for having to acknowledge that the system of beliefs is somewhat biased and possibly hypocritical. Thus, to avoid this negative self-view, the person might arrive at the more consistent — and seemingly less biased — argument that science is impotent to address a variety of topics, one of which happens to be the topic in question.

To test these hypotheses, basically Munro had a group of students recruited for his study read various abstracts (created by investigators) that confirmed or challenged their beliefs regarding homosexuality and whether homosexuality predisposes to mental illness. It turned out that those who read belief-challenging abstracts were more prone to use scientific impotence discounting as an excuse to reject the science, while those who read belief-confirming abstracts were less likely to subscribe to the scientific impotence excuse. Controls that substituted other terms for “homosexual” demonstrated that it was the belief-disconfirming nature of the abstracts that was associated with use of scientific impotence discounting as a reason to reject the conclusions of the abstract. A second study followed up and examined more subjects. The methodology was the same as the first study, except that there were additional measures performed to see if exposure to belief-disconfirming abstracts was associated with generalization of belief in scientific impotence.

In essence, Munro found that, relative to those reading belief-confirming abstracts, participants reading belief-disconfirming abstracts indicated more belief that the topic they were reading about could not be studied scientifically and more belief that a series of other unrelated topics also could not be studied scientifically. In other words, scientific impotence discounting appears to represent a generalization of discounting of science from just science that challenges a person’s beliefs to more areas of science, if not all science. Munro concluded that being presented with belief-disconfirming scientific evidence may lead to an erosion of belief in the efficacy of scientific methods, also noting:

A number of scientific issues (e.g., global warming, evolution, stem-cell research) have extended beyond the scientific laboratories and academic journals and into the cultural consciousness. Because of their divisive and politicized nature, scientific conclusions that might inform these issues are often met with resistance by partisans on one side or the other. That is, when one has strong beliefs about such topics, scientific conclusions that are inconsistent with the beliefs may have no impact in altering those beliefs. In fact, scientific conclusions that are inconsistent with strong beliefs may even reduce one’s confidence in the scientific process more generally. Thus, in addition to the ongoing focus on creating and improving techniques that would improve understanding of the scientific process among schoolchildren, college students, and the general population, some attention should also be given to understanding how misconceptions about science are the result of belief-resistance processes and developing techniques that might short-circuit these processes.

On a strictly anecdotal level, I’ve seen this time and time again in the alt-med movement. A particularly good example is homeopathy. How many times have we seen homeopaths, when confronted with scientific evidence finding that their magic water is no more effective at anything than a placebo, claiming that their magic cannot be evaluated by randomized, double-blind clinical trials (RCTs)? The excuses are legion: RCTs are too regimented; they don’t take into account the “individualization” of homeopathic treatment; unblinded “pragmatic” trials are better; or the homeopaths’ anecdotal evidence trumps RCT evidence. Believers in alt-med then often generalize this scientific impotence discounting to many other areas of woo, claiming, for example, that science can’t adequately measure that magical mystical life energy field known as qi or even, most incredibly, that subjecting their woo to science will guarantee it to fail because belief is required and skepticism results in “negative energy.” Another common strategy I’ve seen for scientific impotence discounting is to dismiss science as “just another religion,” just as valid as whatever woo science is refuting, or to label science as “just another belief system,” as valid as any other. In other words, postmodernism!

Sadly, though, even physicians ostensibly dedicated to science-based medicine all too easily fall prey to this fallacy, although they usually don’t dismiss science as being inadequate or unable to study the question in question. Rather, they wield their preexisting belief systems and mental frameworks like a talisman to protect them from having to let disconfirming data force them to change their beliefs. Alternatively, they dismiss science itself as “just another belief.” Perhaps the most egregious example I’ve seen of this in a long time occurred, not surprisingly, over the mammogram debate from six months ago, when Dr. John Lewin, a breast imaging specialist from Diversified Radiology of Colorado and medical director of the Rose Breast Center in Denver, so infamously said, “Just the way there are Democrats and Republicans, there are people who are against mammography. They aren’t evil people. They really believe that mammography is not important.”

Wow! A straw man argument (that those who support the USPSTF guidelines are “against mammography”) combined with likening science to just another political viewpoint, and a condescending disclaimer that those who disagree with him “aren’t evil”! Mike Adams couldn’t have said it better. I wonder if Dr. Lewin thinks that Dr. Susan Love is “against mammography,” given that in the very same article it was pointed out that Dr. Love supports the USPSTF guidelines.

I get it. I really do. I get how hard it is to change one’s views. I even understand the tendency to dismiss disconfirming evidence. What I like to think distinguishes me from pseudoscientists is that I do change my mind on scientific issues as the evidence merits. Perhaps the best example of this is the aforementioned USPSTF mammography screening kerfuffle. For the longest time, I agreed enthusiastically with the prevailing medical opinion that screening for breast cancer with mammography beginning at age 40 was almost completely a universal good. Then, over the last two or three years, I’ve become increasingly aware of the problem of lead time and length bias, the Will Rogers effect, and overdiagnosis. This has led me to adjust my views about screening mammography. I haven’t adjusted them all the way to the USPSTF recommendations, but I am much more open to changes in the guidelines published late last year, even to the point that encountering the resistance of my colleagues led me to feel as though I were an anomaly.

Skepticism and science are hard in that they tend to go against some of the most deeply ingrained human traits there are, in particular the need for certainty and an intolerance of ambiguity. Also in play is our tendency to cling to our beliefs, no matter what, as though having to change our beliefs somehow devalues or dishonors us. Skepticism, critical thinking, and science can help us overcome these tendencies, but it’s difficult. Perhaps that’s the most important contribution of the scientific method. It creates a structure that allows us to change our beliefs about the world based on evidence and experimentation without the absolute necessity of taking being proven wrong personally.

When the scientific method is really embedded in the culture of scientists, it leads to the sorts of behavior described by Richard Dawkins where a scientist gives a talk with very solid evidence supporting his conclusions. That evidence, it just so happened, completely disconfirmed the long-held hypothesis championed by a very senior and respected member of his department. When the talk was over, everyone waited to see what this senior scientist would say. Instead of challenging the speaker, the scientist got up and thanked him for having shown him that he had been wrong for these many years because a phenomenon he was interested in was now better understood. True, the story may have been apocryphal or exaggerated, but that is the ideal of science. It is an ideal that is very hard, even for scientists, to live up to, and it’s even harder for non-scientists even to understand.

In the end, though, we need to strive to live up to the immortal words of Tim Minchin when describing how he’d change his mind about even homeopathy if presented with adequate evidence. Actually, as much as I love Tim Minchin’s humorous take on dealing with a woman espousing a panoply of woo that would rival Whale.to’s collection, I’m forced to realize that Minchin is a bit too flippant about the difficulty in changing one’s mind. I know, I know, he’s a comic musician (or a musical comedian); flippancy is part of his job. Even so, show me, for example, strong evidence that vaccines are associated with autistic regression, and I might not “spin on a dime” and change my beliefs, as Minchin put it, but eventually, if the evidence is of a quality and quantity to cast serious doubt on the existing scientific evidence that does not support a vaccine-autism link, I will adjust my views to fit the evidence and science. I’m also under no illusion about how difficult that would be to do or that I might even be prone to using some of the defense mechanisms described by psychologists to avoid doing that, at least at first. But I’ve changed my mind before based on science disconfirming medical dogma that I had long believed on more than one occasion. I can (and no doubt will) do it again.

In the end, I want knowledge, both to provide the best care possible for my patients and just for knowledge’s sake. Science is the best way to get that knowledge about the natural world, and no other methodology has improved the treatment of human disease as fast as science-based medicine. The price is one that I’m willing to pay: Uncertainty and the expectation that much of what I “know” now will one day have to change. What they told me my first day in medical school really is true. Twenty years after I graduated, at least half of what I was taught in medical school has changed or is no longer applicable to patient care, and that’s a good thing.

Certainty is nice, but I’ve learned to live without it.

REFERENCE:

Munro, G. (2010). The Scientific Impotence Excuse: Discounting Belief-Threatening Scientific Abstracts Journal of Applied Social Psychology, 40 (3), 579-600 DOI: 10.1111/j.1559-1816.2010.00588.x

Some of the most rewarding interactions we have with our pets involve food. Most dogs respond with gratifying enthusiasm to being fed, and this activity is an important part of the human-animal bond. Providing food is also part of the parent/child dynamic that in many ways characterizes our relationships with our pets. Giving food is an expression of affection and a symbol of our duty of care to our pets.

Because of these emotional resonances, pet owners are often very concerned about giving their pets the “right” food to maintain health and, if possible, to prevent or treat disease. This has allowed the development of a large, and profitable commercial pet food industry that aggressively markets diets with health-related claims. This industry resembles in some ways the pharmaceutical industry. It is regulated by the FDA, and also by individual states, according to a somewhat Byzantine set of standards established by the FFDCA (the guiding document governing the FDA) and by the Association of American Feed Control Officials (AAFCO), a private organization made up primarily of state and federal feed control officials. Thanks to this regulatory structure, imperfect though it is, there is a good deal of solid science and research behind the products and claims the industry produces.

Like all for-profit concerns, the pet food industry also has its share of flaws. Some of these are relatively subtle, such as the probably unavoidable tendency for industry-funded research to come up with findings favorable to the funder’s products. Others are more serious, including rare but devastating instances of malfeasance. One example of the latter is the incident in 2007 in which melamine was substituted for wheat gluten as a protein source in pet food manufacturing, leading to the deaths of hundreds, possibly thousands of pets who ate contaminated commercial foods.

And like “Big Pharma,” the pet food industry is often demonized by those who wish to promote unscientific or alternative veterinary medical treatments or theories. Anyone who has ever accepted a dime in research funding or a bagel at a conference (with or without cream cheese) from a pet food company is automatically an industry lackey whose opinion is worthless regardless of their credentials or expertise. This demonization of the pet food manufacturers is often used as a marketing tool for alternative nutritional theories and products.

One of the most popular unscientific notions sold to pet owners these days is that of feeding diets based on raw meat, typified by the BARF diet. According to the a leading proponent of this idea, Dr. Ian Billinghurst, BARF stands for Bones and Raw Foods or Biologically Appropriate Foods (though I confess other interpretations have occurred to me). Raw diets are frequently recommended by veterinarians and other who practice homeopathy, “holistic” veterinary medicine, and other forms of CAM. This is not surprising since, as you will see, the arguments and types of reasoning used to promote the BARF concept are also commonly used to defend other forms of alternative veterinary medicine. Let’s take a look at the arguments some BARF proponents make for this diet.

Dogs are Wolves

Dr. Billingurst refers to the principle behind the BARF diet as “evolutionary nutrition.”

“It is now generally agreed that the ancestor of the modern dog is the wolf…[the] process of domestication where our ancestors removed the ‘wildness’ from the wolf, involved thousands of years of selective breeding…In this process, our ancestors produced hundreds of ‘different looking wolves’…our ancestors made only two basic changes to the wolf. They changed the wolf’s appearance and they changed its mind. What they did not change, was the basic internal workings or physiology of the wolf…As a result, the basic workings or physiology of modern dogs is no different or very little different to their ancestor the wolf…The basic environment which the modern dog requires in terms of food and exercise is exactly the same as it was (and still is) for the wolf.”

Having established that, despite appearances, dogs are essentially wolves, Dr. Billinghurst goes on to describe the wolf diet.

Raw bones with meat are a major part of their diet… They eat offal such as liver and heart. They eat raw eggs. They eat decaying material…They eat a wide variety of foodstuffs. Insects, bark, soil, birds – complete with their tiny bones and feathers – whatever. Every meal they eat is totally raw. Not one skerrick of it is cooked. Ever. They eat vegetables including herbs, from the gut of their prey. This vegetable material is raw, totally crushed and partly digested. They eat feces. A wolf’s diet contain almost no grains… For a wolf – not one single meal consists of dry dog food. They don’t eat canned dog food either.

Finally, he makes the connection between this version of canine natural history and the feeding of pet dogs.

How do you feed a dog properly? You feed it the diet that it evolved to eat. It’s [sic] evolutionary diet. A Biologically Appropriate Raw Food diet. A BARF diet…A biologically appropriate diet for a dog is one that consists of raw whole foods similar to those eaten by the dogs’ wild ancestors. The food fed must contain the same balance and type of ingredients as consumed by those wild ancestors…Please note that modern dogs of any breed are not only capable of eating the food of their wild ancestors, but actually require it for maximum health. This is because their basic physiology has changed very little with domestication despite obvious and dramatic changes in their current physical appearance and mindset…

Certainly a clear, simple, and pretty persuasive argument on the face of it. Taxonomically and phylogenetically, dogs are carnivores and their ancestors ate live prey and carrion, so they must be designed for a diet as close as reasonably possible to that for which they were designed by evolution.

Some raw diet advocates extend this basic argument by claiming that the domestic dog’s gastrointestinal tract is anatomically identical to that of the wolf and so the same dietary needs can be assumed. Others contribute additional arguments in favor of raw foods, such as the well-known homeopathic and holistic veterinarian Dr. Richard Pitcairn:

“All processed pet foods…are missing something that seems to me to be the most important “nutrient” of all. This key ingredient is practically ignored by nutritional scientists, but we can sense it when it’s there. It is a quality found only in freshly grown, uncooked whole foods: Life energy!¹

But while there are variations on the theme, and there are frequent and often bitter arguments over precisely which ingredients are best, and in what form or proportion, the basic “evolutionary nutrition” argument is advanced by all proponents of raw diets.

Processed Commercial Diets are Unhealthy

The other major component to the argument for raw diets is that the commercial diets most of us feed our dogs are inadequate, and possibly outright unhealthy. According to Dr. Billinghurst’s web site,

“as a practicing veterinary surgeon, I constantly see the enormous difference in health between pets raised on commercial pet food compared to those raised on a biologically appropriate raw food diet. I see the enormous change for good in the health of pets switched from cooked to a raw whole food diet…Most degenerative disease processes in pet animals are the direct result of a lifetime being fed cooked and/or processed foods…”

He goes on to claim that the nutritional deficiency diseases seen in the early 20th century, when most pets were fed table scraps, were simple and easily treated, but thanks to processed foods these have been replaced by “vast array of complex and insidious degenerative diseases which now afflict our pets and fill our textbooks and waiting rooms.” He further claims that,

“Processed pet foods contain barely adequate levels of the known vitamins…Many contain biologically inappropriate antioxidants, enormous levels of refined sugars and masses of salt together with other chemicals used as colorings and flavorings. This chemical cocktail is a lethal brew which is a major factor in producing the epidemic of degenerative disease leading to the early death and suffering we see in pet animals fed such rubbish, including cancer, arthritis and a range of allergies and auto immune diseases…Cooking renders these products biologically inappropriate in a fundamental way…The vast majority of these products are based on cooked grains. This makes them biologically inappropriate. At no time in their evolutionary history (except in the last 50 to 150 years) have cats and dogs been subjected to cooked grain in any amount, and certainly not as the basis of their diet.”

Commercial foods are also denigrated for a variety of supposedly dangerous ingredients, including (according to Dr. Pitcairn):

Toxic products from spoiled foodstuffs
Drug residues
Hormone levels comparable to amounts that have produced cancer in laboratory animals
Artificial colors, flavors, and preservatives, all of which he claims are responsible for an epidemic of cancer and degenerative diseases
And even euthanized dogs and cats, which he claims “are routinely rendered by veterinary hospitals or shelters and recycled into pet food.”¹

Cancer, arthritis, allergies, autoimmune disease, and many other conditions are frequently claimed to be the result of eating commercial pet foods. But, of course, proponents of raw diets don’t always limit their critique of commercial foods to claims about nutrition and health which could be empirically examined. Some also paint commercial pet food manufacturers as villains killing pets for profit and veterinarians as their willing, or at least duped, accomplices. A blog entry on Dr. Billinghursts’s website asks,

What is the primary motive of kibble manufactures? Is it profit or nutritional value? … The inferior quality and poor utilization of ingredients is masked by the addition of heat, flavor enhancers, and harmful fat sprays. The kibble manufactures are aware of the potential dangers and potential harm to our dogs but it all boils down to producing an inexpensive product that can sustain and maintain the life of our dogs…for the kibble manufactures it all boils down to profit with a capital P.

Another proponent of raw diets, Dr. Tom Lonsdale, claims he is

selling plenty of his book Raw Meaty Bones in the US but the Australian media seems to have blacked [sic] him out because the multinational pet food companies don’t want their dodgy doggy tucker exposed [web article 1]…Natural pet food is cheaper, pets live healthier longer lives, vet bills reduce [sic] and the environment gets a better deal. Except for the artificial pet food companies and their veterinary allies it’s a win, win, win situation…junk food is responsible for the majority of pet diseases there are both upstream and downstream implications worth $billions. Upstream those that run the systems – pet-food makers, veterinary profession, veterinary schools, animal welfare bodies, governments, retailers, and consumers — conspire to maintain the racket… The full extent of the junk pet-food fraud may never be fully known. [web article 2]

Some Inconvenient Truths

Now let’s have a look at the problems with this raw dog food marketing propaganda. To begin with, the concept of “evolutionary nutrition” ignores the simple fact that taxonomy and phylogeny are not destiny, nor do they reliably predict the specific details of a species’ biology, including its nutritional needs. Sure, dogs are in the order Carnivora, but so are giant pandas, which are almost exclusively herbivorous. Functionally, dogs are omnivores or facultative carnivores, not obligate carnivores, and they are well-suited to an omnivorous diet regardless of their taxonomic classification or ancestry.

Domestic dogs did branch off from a wolf ancestor, and current DNA evidence suggests this occurred some 100,000-135,000 years ago.^2,3 Though the data are unclear as to what morphologic or ecological changes might have occurred following this initial divergence, and while it is likely that there was much ongoing genetic exchange between dogs and wolves even after they diverged, it is still the case that dogs have not been wolves for a very long time. However, a distinct phenotypic divergence of dogs and wolves followed the development of more sedentary agricultural habits by many human groups some 10-15,000 years ago, which placed new selection pressures on our canines companions.³¹ Since then numerous anatomic and behavioral changes that have occurred first as a result of living with humans and sharing our food. And even more dramatic changes have been wrought on dogs in the last about 3000 years as a consequence of intensive selective breeding. Domestic dogs exhibit many features of neoteny, the retention of juvenile characteristics into adulthood. They have smaller and less robust skulls and dentition, and numerous features of their skeleton, GI tract, and other anatomic structures are significantly different from wolves. ^4-6

Of course, anatomy does not always correlate with function anyway. All humans have essentially the same GI tract from an anatomical perspective, but when someone who is lactose intolerant chugs a glass of milk, he or she may be treated to a visceral demonstration of the fact that anatomy doesn’t necessarily predict function. But in the case of dogs and wolves, the claim that they are anatomically identical with respect to what is an appropriate diet is simply not true. If you try to picture a pack of Chihuahuas bringing down and savaging an elk, the impact of thousands of years of artificial selection is obvious. Other breeds may be more like wolves in appearance, but they are none of them truly wolves. Dogs have lived with humans, eaten our table scraps, and been intensively bred for features we desire, none of which is likely to make them ideally designed for the diet of a wolf.

Of course, even if BARF advocates could demonstrate that dogs were functionally equivalent to wolves in terms of diet, the evolutionary nutrition argument would still fail because at its heart it is nothing but a form of the naturalistic fallacy.

The average life expectancy of wolves in the wild is considerably lower than that of captive wolves, and disease, parasitism, and malnutrition are important factors in the mortality of wild populations.^7-9 Captive wolves live longest and are healthiest when fed — guess what? — commercial dog food! This is the recommendation of the leading specialists in captive wolf husbandry and medicine, and it is largely the result of evidence that the previous practice of feeding raw meat based diets to captive wolves led to poorer quality nutrition and health than the current practices. Certainly, raw meat and bones are often used as enrichment items or bait for husbandry purposes, but always with an awareness of the risks they pose, and never as the primary diet. ^10-12

BARF proponents persistently confound ingredients with nutrients. They imagine that because wild canids get their nutrients from raw whole carcasses that this must be the only appropriate source of nutrition for all canids, including domestic dogs despite the fact they have been eating our cooked leftovers for tens of thousands of years. This is contradicted, however, by extensive research in canine nutrition and by the generations of dogs who have lived long, healthy lives eating commercial pet foods.

Which leads to the second pillar of the BARF argument, the safety and nutritional adequacy of commercial pet foods. Like all knowledge based on science, our understanding of the nutritional needs of dogs is incomplete and always evolving. However, admitting that we do not know everything is not tantamount to admitting we know nothing. The basic nutrient requirements of our pets are well-established by decades of research, and despite the claims of BARF proponents there is no evidence that nutritional disease are widespread among pets fed balanced commercial diets.
Commercial dog foods are formulated according to AAFCO standards based on extensive nutritional research. These foods are testing through laboratory methods for nutrient content before and after processing, and many are subjected to feeding trials to determine their digestibility and the adequacy of their nutritional content as fed to healthy dogs. These reference standards and limited feeding trials are, like the basic pharmacology and preclinical testing of pharmaceuticals, not perfect, and it is certainly likely that advances in our understanding of dogs’ nutritional needs as well as epidemiologic studies of dogs fed commercial diets will uncover changes that need to be made in the formulations of commercial diets. But the data we do have strongly supports the nutritional appropriateness of these foods. ^13,14
By contrast, homemade and commercial raw diets are seldom tested for nutritional adequacy, and when they have been tested they have usually failed to meet known nutrient requirements. ^15-18. The knowledge of established nutritional science concerning the adequacy of commercial pet diets, imperfect though it may be, is certainly superior to the near total ignorance of the nutritional adequacy of most homemade of commercial raw diets.
There are many specific criticisms of commercial dog foods made in support of the BARF concept, but there is little evidence to support most of them, and some are clearly false. There are far more than I can deal with in a reasonable space, but I will address a few of the more common of these claims.

1. Commercial Dog Food Makes Dogs Sick: There is no evidence to support the claim that degenerative and immune-mediated diseases or cancers are caused by commercial pet foods. These conditions are the usual targets of alternative medicine proponents because the gaps in our knowledge about the etiology of these diseases leave room for them to insert their favorite bogeymen, in this case commercial pet food. The likelihood is that the prevalence of these categories of disease reflects, at least to some extent, the aging of the pet population, which is the result of the reduction in historic causes of mortality such as infectious diseases, trauma, and of course malnutrition.
2. Commercial Dog Foods are Toxic: The insinuation that commercial pet foods are full of “toxins” is also unsupported. Common preservatives, such as ethoxyquin, butylated hydroxytoluene, and others with scary-sounding chemical names, have been in use in human and animal foods for decades and studied extensively, and there is no published evidence to support the many claims and anecdotes that indicate these are responsible for disease.^19,20 Synthetic preservatives are more effective than “natural” anti-oxidants, and they are an important tool for reducing food-borne illness.
   Anti-vaccine activists have mercury, aluminum, and anti-freeze, and BARF advocates have preservatives and artificial flavoring and coloring agents. What neither have is solid evidence to support their fear-mongering regarding these substances
3. Dogs Can’t Digest Grain: It is frequently claimed, based primarily on the fallacious logic of “evolutionary nutrition,” that dogs are incapable of digesting grains or that these make poor nutrient sources in dog foods. Extensive evidence from laboratory research and feeding trials illustrates this is false and that cooked grains are excellent energy sources and can also provide protein and other important nutrients to dogs.^21,23 Grains are also often blamed for food allergies, but while some dogs may develop allergies to plant proteins, the evidence suggests that the vast majority of food sensitivities in dogs are to animal proteins.²⁴
4. Cooking Destroys Nutrients: BARFers like to claim that cooking destroys nutrients, so processed foods must be nutrient deficient. It is true that some nutrients are destroyed by cooking, but the relationship between temperature and cooking time and the final level of these nutrients in the food is well established, and commercial foods are supplemented to account for this and extensively tested in vitro and in vivo to ensure adequate nutrient levels. Other nutrients, particularly carbohydrates, are made more available by cooking.^22,23 And cooking destroys many parasites and bacterial organisms responsible for serious foodborne illness.
   Our ancestors ate raw food for millennia prior to the discovery of fire, and our nearest living relatives, chimpanzees, don’t cook their food. Yet for some reason even most advocates of BARF diets for dogs don’t eat primarily raw plants, insects, and the occasional bit of scavenged or deliberately killed raw meat that “evolutionary nutrition” would suggest they should be eating.
5. Commercial Dog Food is Made from Dead Pets: One of the most repulsive accusations made concerning commercial diets is that manufacturers routinely include the rendered carcasses of euthanized pets in their products. Such a practice would be illegal and has been specifically disavowed by dog food manufacturers and the plants that slaughterhouses and rendering plants that provide them with their ingredients. The FDA has investigated this story and has not found evidence to support it.

It is true that miniscule levels of pentobarbital, an anesthetic used to euthanize animals, have been found in some foods. The source of this has not been identified, though no trace of dog or cat DNA was found in the contaminated food. The most likely source of the contaminant is horses who were euthanized with pentobarbital and improperly rendered along with approved sources of meat for pet foods, though this has not been clearly proven. And it is also true that a few rare cases of dog remains being processed by rendering plants that also supplied pet food manufacturers with ingredients have been documented. However, for this to be a common practice, rather than a rare exception, would require a truly enormous and perfect conspiracy of manufacturers, rendering plants, and government, and as of yet no whistle-blower, journalist, or undercover animal rights activist has yet come forward to reveal evidence of any such conspiracy.

The Bottom Line

The argument that dogs are designed by their evolutionary history to eat raw meat based diets is riddled with errors and fallacies and ignores the impact of tens of thousands of years of domestication and cohabitation with humans on the physiology of our canine friends. The accusations that commercial dog foods are nutritionally inadequate or unsafe are not supported by any objective or scientific evidence, only anecdotes, intuition, and conspiracy theories. There is, in contrast, significant evidence that commercial dog foods are nutritious and healthy and that they have contributed to greater longevity and reduced nutritional and infectious disease morbidity of dogs fed these diets.
The benefits promised by advocates of BARF diets for dogs are numerous. Greater health, less disease, better quality of life, and much more. Dr. Billinghurst’s web site even claims, “Eating bones for a dog is a joyous experience. It is so enjoyed by dogs that it actually of itself boosts their immune system.” However, there is absolutely no scientific evidence to support these claims. BARF proponents have no shortage of opinions and anecdotes to demonstrate the benefits of their diets, but they have a severe shortage of data.

The risks of raw meat based diets, however, are well-documented. Homemade diets and commercial BARF diets are often demonstrable unbalanced and have severe nutritional deficiencies or excesses.^16-18 Dogs have been shown to acquire and shed parasitic organisms and potentially lethal infectious diseases associated with raw meat, including pathogenic strains of E. coli and Salmonella.^25-27 Many other pathogens have been identified in raw diets or raw meat ingredients, and these represent a risk not only to the dogs fed these diets but to their owners, particularly children and people with compromised immune systems.^29-30 The bones often included in such diets can cause fractured teeth and gastrointestinal diseases, including obstructed or perforated intestines, and the FDA recently warned pet owners against feeding bones to their canine companions.
?So with a dodgy theory behind it, no sound evidence of benefits, and clear risks, there is no justification for recommending raw meat based diets for dogs. As always, I remain open to the possibility that new evidence may emerge to document benefits from such diets that might justify the risks they present, but for now this feeding approach appears to be simply another form of CAM mythology supported only by anecdote and unsound logic.

References

1. Pitcairn RH, Pitcairn SH. Dr. Pitcairn’s complete guide to natural health for dogs and cats. 3rd ed. Rodale; 2005.
2. Vila C, Maldonado JE, Wayne RK. Phylogenetic relationships, evolution, and genetic diversity of the domestic dog. Journal of Heredity 1999;90(1):71-77.
3. Wayne RK. Molecular evolution of the family dog. Trends in Genetics 1993;9(6);218-224.
4. Serpell J (editor). The domestic dog: Its evolution, behavior and interactions with people. New York, NY, US: Cambridge University Press; 1995.
5. Ziesenis A, Wissdorf H. [The ligaments and menisci of the femorotibial joint of the wolf (Canis lupus L., 1758) — anatomic and functional analysis in comparison with the domestic dog (Canis lupus f. familiaris)]. Gegenbaurs Morphol Jahrb 1990;136(6):759-73.
6. Lauer BH, Kuyt E, Baker BE. Wolf milk. I. Arctic wolf (Canis lupus arctos) and husky milk: gross composition and fatty acid constitution. Canadian Journal of Zoology 1969;47(1):99-102.
7. Maia OB, Gouveia AM. Birth and mortality of maned wolves Chrysocyon brachyurus in captivity. Brazilian Journal of Biology 2002; 62(1):25-32.
8. Smith DW, Stahler DR, Albers E, Metz M, Williamson L, et al. Yellowstone Wolf Project: Annual Report, 2008. 2009. National Park Service, Yellowstone Center for Resources, Yellowstone National Park, Wyoming, YCR-2009-03.
9. Max Planck Institute for Demographic Research. Longevity records; Lifespans of mammals, birds, reptiles, amphibians and fish. Accessed 05/07/2010 at http://www.demogr.mpg.de/longevityrecords/0203.htm
10. Waddell W. Nutrition. In: Red Wolf Husbandry Manual Guidelines for Captive Management. Red Wolf SSP Management Group American Association of Zoos and Aquariums. 1998.
11. Newton K. Nutrition. In: Mexican Wolf Husbandry Manual. Mexican Wolf SSP Management Group. American Association of Zoos and Aquariums. 1995.
12. Allen ME. Maned wolf nutritional management. In: Husbandry Manual for the Maned Wolf Chrysocyon brachyurus. N.B. Fletchall, M. Rodden and S. Taylor, Eds. American Association of Zoos and Aquariums. 1995.
13. Crane SW, Griffin RW, Messent PR. Introduction to commercial pet foods. In: Hand MS, Thatcher CD, Remillard RL, Roudebush P, editors. Small animal clinical nutrition. 4th ed. Topeka, KS, US: Mark Morris Institute; 2000. p. 111-126.
14. Cowell CS, Stout NP, Brinkman MF, Moser EA, Crane SW. Making Commercial Pet Foods. In: Hand MS, Thatcher CD, Remillard RL, Roudebush P, editors. Small animal clinical nutrition. 4th ed. Topeka, KS, US: Mark Morris Institute; 2000. p. 127-146.
15. Freeman L, Michel K. Nutritional analysis of 5 types of “Raw Food Diets.” Journal of the American Veterinary Medical Association. 2001;218(5):705.
16. Lauten SD, Smith TM, Kirk CA, Bartges JW, Adams A, Wynn SG. Computer Analysis of Nutrient Sufficiency of Published Home-Cooked Diets for Dogs and Cats. Proceedings of the American College of Veterinary Internal Medicine Forum 2005.
17. Roudebush P, Cowell CS. Results of a hypoallergenic diet survey of veterinarians in North America with a nutritional evaluation of homemade diet prescriptions. Veterinary Dermatology 1992;3:23-28.
18. Taylor MB, Geiger DA, Saker KE, Larson MM. Diffuse osteopenia and myelopathy in a puppy fed a diet composed of an organic premix and raw ground beef. Journal of the American Veterinary Medical Association 2009;234(8):1041-8.
19. Wortinger A. Nutritional myths. Journal of the American Animal Hospital Association 2005;41:276.
20. Dzanis DA. Safety of ethoxyquin in dog foods. Journal of Nutrition 1991;121:S163-S164.
21. Walker JA, Harmon DL, Gross KL, Collings GF. Evaluation of nutrient utilization in the canine using ileal cannulation technique. Journal of Nutrition 1994;124(12 Suppl):2672S-2676S.
22. Trân ðình Quang. Extrusion processing effects on dry canine diets. 2008 Ph.D. Thesis, Wageningen University and Research Centre, Wageningen, the Netherlands.
23. Gross KL, Wedekind KJ, Cowell CS, Schoenherr WD, Jewell DE, et al. Nutrients. In: Hand MS, Thatcher CD, Remillard RL, Roudebush P, editors. Small animal clinical nutrition. 4th ed. Topeka, KS, US: Mark Morris Institute; 2000. p. 21-107.
24. Roudebush P, Guilfor WG, Shanley K. Adverse reactions to food. In: Hand MS, Thatcher CD, Remillard RL, Roudebush P, editors. Small animal clinical nutrition. 4th ed. Topeka, KS, US: Mark Morris Institute; 2000. p. 431-453..
25. Chengapappa, M., et al. Prevalence of Salmonella in raw meat diets used in racing greyhounds. Journal of Veterinary Diagnostic Investigations 1993;5:372-7.
26. Finley, R. et al. The risk of Salmonella shedding by dogs fed Salmonella-contaminated commercial raw food diets. Canadian Veterinary Journal 2007;8:69-75.
27. Joffe, D., Schlesinger, D. Preliminary assessment of the risk of Salmonella infection in dogs fed raw chicken diets. Canadian Veterinary Journal 2002;43:441-442.
28. Weese, J. et al. Bacteriological evaluation of commercial canine and feline raw diets. Canadian Veterinary Journal 2005;46:513–516.
29. Strohmeyer, R.A., et al., Evaluation of bacterial and protozoal contamination of commercially-available raw meat diets for dogs. Journal of the American Veterinary Medical Association 2006;228:537-542.
30. LeJeune JT, Hancock DD. Public health concerns associated with feeding raw meat diets to dogs. Journal of the American veterinary Medical Association 2001;219(9);1222-25.
31. Vila C, Savolainen P, Maldonado JE, Amorim IR, Rice JE, et al. Multiple and ancient origins of the domestic dog. Science 1997;276:1687-9.

ABOUT THE AUTHOR:

Brennen McKenzie, MA, VMD is a 2001 graduate of the University of Pennsylvania School of Veterinary Medicine, and he works as a small animal veterinarian in private practice in California. He has a special interest in promoting science-based veterinary medicine and is currently chair of the Practitioner Committee for the Evidence-Based Veterinary Medical Association. He has published articles on evidence-based medicine in veterinary science journals, and he also writes about both science-based and “alternative” veterinary medicine as the SkeptVet.

Prior to becoming a veterinarian, Dr. McKenzie completed a Master’s Degree in animal behavior, studying captive chimpanzees and working as a specialist in environmental enrichment for captive primates. He reads too much, with a predilection for science fiction, philosophy, linguistics, and of course skepticism. He travels too much and has climbed Mt. Kilimanjaro and run with the bulls in Pamplona. He also plays the Irish pennywhistle and the mandolin and has been known to wear the kilt on occassion, though he does not claim to do any of these well.

Perhaps the most heavily studied of “alternative medicine” modalities is acupuncture. Although it’s hard to be sure as to the reason, I tend to speculate that part of the appeal to trying to do research in this area is because acupuncture is among the most popular of actual “alt-med” modalities, as opposed to science-based medical modalities co-opted by believers in alt-med and rebranded as “alternative” (diet and exercise, for instance, to which is all too often added the consumption of huge quantities of unproven nutritional supplments) or activities that make people feel better, whether they’re healthy or ill (massage, for instance). In contrast, acupuncture involves actually sticking needles into the skin. Never mind that the rationale for acupuncture, namely “redirecting” the flow of the “life energy” known as qi when it is blocked by sticking needles in “meridians” like some electrodes in some imaginary qi battery, is pure bunkum, as we’ve pointed out here at SBM time and time again. Somehow the image of needles sticking out of the skin, apparently painlessly and making some extreme acupuncture practices resemble Pinhead from the Hellraiser movie series, seems “sexy” as far as “alternative” therapies go, particularly since it’s “Eastern” as opposed to that reductionistically evil “Western medicine,” and, as we all know at SBM, “Western” is bad and “Eastern” is good.

So the fascination with acupuncture remains, so much so that an inordinate amount of research dollars are spent on studying it. Unfortunately, that money is largely wasted. As Steve Novella has pointed out, in general in medicine (at least these days), the trajectory of research is usually from bench research to animal models to small scale, less rigorous, pilot studies in humans to large scale, rigorously designed studies using many subjects. True, this order doesn’t always hold. For instance, if physicians make a compelling observation “at the bedside” of response to therapy or how a disease progresses, frequently, after making closer observations to confirm the initial observation, researchers will jump back to animal models and bench top research to try to figure out what’s going on. For such a progression to be useful, though, scientists have to be sure that the phenomenon in human patients under study actually exists.

Unfortunately, in acupuncture, the evidence is still unconvincing that there is any “there” there in that acupuncture effects appear to be no greater than placebo effects. As larger, more well designed studies using real placebo or sham acupuncture techniques, have increasingly shown that acupuncture does not function any better than placebo in human beings (and sometimes even worse), acupuncturists and acupuncture believers have been reversing the usual order of things, doing smaller studies and “pragmatic” (i.e., uncontrolled) clinical trials, where the placebo effect is not controlled for. Never mind that it doesn’t matter where the needles are placed (thus blowing the whole “meridian” idea out of the water) or even if the needles puncture the skin. Toothpicks work just as well as needles. Also never mind that the mythology of acupuncture as having been routinely practiced for over two thousand years (or, sometimes, four thousand years, is largely a creation of Chairman Mao, who elevated what was a marginal practice at the time to a modality that the state supported and promoted (1,2,3,4). Unfortunately, even the National Center for Complementary and Alternative Medicine (NCCAM) falls for this mythology.

Every so often, I’m amazed when an acupuncture study ends up in a high impact journal like Nature Neuroscience. Of course, when I read such articles, virtually inevitably I discover that what is being studied is not really “acupuncture” per se, but rather sticking needles into either people or animals. Sometimes, “electroacupuncture” (which is in reality not acupuncture at all, given that there was no source of electricity hundreds of years ago in China when acupuncture was supposedly invented) is misrepresented as acupuncture. Since a bunch of readers, both here and at my other blog, have deluged my mail box with this particular study, I felt obligated to have a look at it, even if Steve Novella has already weighed in with his excellent deconstruction. This particular study is especially annoying, because it’s been hyped to the nth degree, and even some news sources where the reporters should know better have fallen for it.

Before I get to the study itself, though, let’s take a look at the press release:

The research focuses on adenosine, a natural compound known for its role in regulating sleep, for its effects on the heart, and for its anti-inflammatory properties. But adenosine also acts as a natural painkiller, becoming active in the skin after an injury to inhibit nerve signals and ease pain in a way similar to lidocaine.

In the current study, scientists found that the chemical is also very active in deeper tissues affected by acupuncture. The Rochester researchers looked at the effects of acupuncture on the peripheral nervous system – the nerves in our body that aren’t part of the brain and spinal cord. The research complements a rich, established body of work showing that in the central nervous system, acupuncture creates signals that cause the brain to churn out natural pain-killing endorphins.

The new findings add to the scientific heft underlying acupuncture, said neuroscientist Maiken Nedergaard, M.D., D.M.Sc., who led the research. Her team is presenting the work this week at a scientific meeting, Purines 2010, in Barcelona, Spain.

“Acupuncture has been a mainstay of medical treatment in certain parts of the world for 4,000 years, but because it has not been understood completely, many people have remained skeptical,” said Nedergaard, co-director of the University’s Center for Translational Neuromedicine, where the research was conducted.

I’ll cut to the chase before proceeding with my usual infamously in depth and long-winded discussion of the study. Nedergaard’s study is interesting, but it really doesn’t show that “acupuncture works” any more than it really shows compelling evidence for a specific mechanism behind acupuncture. Unfortunately, as is commonly the case, much of the press reporting this study earns a big fat F for the spin being put on it. The Guardian, for instance, states:

The discovery challenges a widely held view among scientists that any benefit patients feel after having acupuncture is purely due to the placebo effect.

“The view that acupuncture does not have much benefit beyond the placebo effect has really hampered research into the technique,” said Maiken Nedergaard, a neuroscientist at the University of Rochester Medical Centre in New York, who led the study.

“Some people think any work in this area is junk research, but I think that’s wrong. I was really surprised at the arrogance of some of my colleagues. We can benefit from what has been learned over many thousands of years,” Nedergaard told the Guardian.

I love the “arrogance” gambit, don’t you? This time, it’s even coupled with the “appeal to ancient wisdom” fallacy. Nice. If you want to irritate me, pull the “arrogance” gambit and then couple it with appeals to ancient wisdom. After all, physicians from ancient civilizations were heavily into bleeding and purging, not to mention treating with toxic heavy metals. Go back to the ancient Egyptians, and you’ll see that praying and believing that the gods were responsible for diseases, with physicians and priests often serving the same purpose, were the rule fo the day. Does that mean such treatments were “wise” or efficacious. Meanwhile The Daily Mail entitled its report Let’s get straight to the point, acupuncture DOES ease pain, and The Telegraph entitled its report Acupuncture does work as it stimulates a natural pain killer, scientists find, while The Raw Story exulted, Researchers prove acupuncture’s effectiveness in pain therapy and the Wall Street Journal opined How Acupuncture May Work: Adenosine is Key to Acupuncture’s Effectiveness. Perhaps the silliest and most credulous commentary on this study comes from Elizabeth Armstrong Moore on CNET, who even entitled her post Think Acupuncture’s a hoax? Think again (Scientific research shows natural healing compounds), where Moore represented herself as a “skeptic” being “converted” to believing that acupuncture works, while Ars Technica writer Yun Xie laps this story up credulously. Even what I would normally consider more scientifically rigorous sources were not immune to the woo. For example, ScienceNow entitled its article on the study How Acupuncture Pierces Chronic Pain; The New Scientist’s blog Short Sharp Science, How acupuncture eases pain – maybe (which, despite the slightly skeptical title, was pretty much completely accepting of the spin placed on the study); and Nature’s blog The Great Beyond, Acupuncture ‘works in mice’.

So, with all this hype going on, even during a holiday weekend in the U.S. and the U.K., what does this overhyped study actually show? Are the headlines of “acupuncture works” and “scientists discover how acupuncture works” justified? Not so fast, there, pardner.

Perhaps the most infuriating aspect of all the hype is that the study being hyped actually describes a fair bit of interesting biochemistry behind the pain response. Unfortunately, what it doesn’t show is that “acupuncture works,” despite all the whining about “arrogance” from the study’s lead investigator. All it shows are two things: (1) that a chemical called adenosine is released when needles are stuck into the skin of mice and twisted and (2) that adenosine decreases the pain response. These are actually very interesting findings, albeit, as people I’ve corresponded with have pointed out to me, nothing new at all. Contrary to the way these results are being spun, they in now way validate the belief system behind acupuncture or show that “acupuncture works.”

Let’s get to the science in more detail, although I hate to do it by pointing out the Weekly Waluation of the Weasel Words of Woo-worthy credulous and annoying opening paragraph of the paper that reviewers should have shot down in flames but didn’t:

Acupuncture is a procedure in which fine needles are inserted into an individual at discrete points and then manipulated, with the intent of relieving pain. Since its development in China around 2,000 B.C., acupuncture has become worldwide in its practice. Although Western medicine has treated acupuncture with considerable skepticism, a broader worldwide population has granted it acceptance. For instance, the World Health Organization endorses acupuncture for at least two dozen conditions and the US National Institutes of Health issued a consensus statement proposing acupuncture as a therapeutic intervention for complementary medicine. Perhaps most tellingly, the U.S. Internal Revenue Service approved acupuncture as a deductible medical expense in 1973.

This is yet another example of an appeal to ancient wisdom, but this time it’s coupled with argumentum ad populum, better known as the appeal to popularity. I never thought I’d see the introduction to a scientific article appeal to, much less mention, the fact that the IRS allows a modality to be a deductible medical expense, but here it is. Where the hell were the reviewers? I could equally point out that the IRS allows medical deductions for the services of Christian Science prayer healers. Does that mean that Christian Science prayer is an effective treatment for anything? No, it does not. Add to that the whole false dichotomy between “Western” and “Eastern” medicine (yes, I know I mentioned it at the beginning of this post), a particularly odious and borderline racist construct in which the mythical “East” is represented as more “wholistic” and “spiritual” compared to the “reductionistic” and scientific brand of medicine. True, in the second paragraph, Nedergaard does mention the possibility of the release of opiod receptors, but there is zero discussion of the evidence for and against acupuncture, not even much of an acknowledgment other than that nasty “Western medicine” being so nastily “skeptical” of the practice, as though that were a bad thing.

The model used by Nedergaard is a model of inflammation that involves injecting complete Freund’s adjuvant (CFA) into the mice’s paws. As a result, the mice’s paws would become inflamed by the irritant properties of the CFA and thus more sensitive to innocuous stimuli, with a decreased latency period for withdrawal to painful or innocuous stimuli; in other words, the mice’s paws would be more sensitive, and the mice would react more strongly and rapidly to the stimuli of heat or touching. This sensitivity peaked at day four or five and then decreased. As a preliminary experiment, the investigators noted that, after the insertion of acupuncture needles into the mouse limb at the “Zusanli point,” which is located near the knee a microdialysis probe inserted less than a millimeter away registered a spike in extracellular adenosine levels, as well as ATP (which is broken down to adenosine outside of the cells), ADP, and AMP, that peaked at around 30 minutes.

Having established that adenosine was increased within 30 minutes of an acupuncture stimulus, Nedergaard then injected an chemical that binds to the cell receptor activated by adenosine, the A1 receptor agonist, 2-chloro-N(6)-cyclopentyladenosine (CCPA). Injecting CCPA into the Zusanli point greatly improved touch sensitivity and in essence reversed the increased sensitivity to heat. So far, so good. Apparently in the mouse adenosine has a lot to do with modulating pain response in peripheral nerves, and apparently a fair number of pharmaceutical companies are interested in developing adenosine agonists to take advantage of this effect in humans. Even better, this effect was not observed in mice genetically engineered not to make the adenosine A1 receptor, known as A1 receptor knockout mice, strong evidence that it was the A1 receptor that was responsible for the observed blunting of the pain response. Investigators also tested CCPA in a model of neuropathic pain (pain due to nerve dysfunction) and found it worked as well as it did in their model of inflammatory pain.

So what’s the link to acupuncture? Actually, that’s what I was wondering myself. Up until now, this paper was a fairly straightforward neuroscience paper looking at some interesting results. However, I doubt this paper would have gotten into Nature Neuroscience if all the investigators did was to show that a bit of local inflammation resulted in the secretion of adenosine into the extracellular fluid and then showed that that adenosine blunted the pain response in nearby nerve endings. That would have been much less interesting, because there is already a fair amount of literature implicating the A1 receptor as a target for the relief of neuropathic pain. But add the acupuncture to it, and you sex it up and get a paper into a high impact journal, which is apparently what happened here.

The unfortunate “bait and switch” of this paper is that it failed to mention that the Zusanli acupuncture point that the investigators used, apparently to the exclusion of all others, is not actually a leg or a pain acupuncture point. Although it is located on the leg, just inferior and lateral to the knee, the Zusanli point is described among traditional Chinese medicine (TCM) practitioners as the leg portion of the stomach meridian. According to TCM, this point is also known as Stomach-36 and its current indications are:

The current standard indications for zusanli, as reviewed in Advanced Textbook of Traditional Chinese Medicine and Pharmacology (21) are: stomach ache, abdominal distention, vomiting, diarrhea, dysentery, indigestion, appendicitis, flaccidity and numbness of the lower limbs, edema, mastitis, mania, epilepsy, cough, vertigo, palpitation, and emaciation due to consumptive disease. This latter indication corresponds to the concept that needling this point can tonify the sea of qi and thereby help to stop the wasting disease and restore ones body weight and vitality.

To illustrate the uniformity of indications amongst the Chinese authorities, the following were listed in Chinese Acupuncture and Moxibustion (22, 23), with slight differences on translation between the original Chinese and later Western publications: gastric pain, hiccup, abdominal distention, vomiting, diarrhea, dysentery, emaciation due to general deficiency, constipation, mastitis, intestinal abscess (acute appendicitis), numbness (motor impairment) and pain of the lower extremities, edema (beriberi), manic depressive psychosis.

Thus, according to acupuncturists, most associated with stomach and abdominal problems far more than lower extremity pain. Strange that the investigators didn’t mention that. I must say, though, it’s such a multipurpose acupuncture point, that I suppose I can’t harp on the investigators too much for using it for this indication, although I can’t help but note that the point seems mighty close on the mouse to where the sciatic nerve divides in the leg.

Be that as it may, here’s a concise summary of what the investigators found:

• In normal mice of adenosine, acupuncture reduced discomfort by two-thirds.
• In A1 receptor knockout mice, acupuncture had no effect on the reactions of the mice to the stimuli of touch or heat.
• During and after an acupuncture treatment, adenosine levels in the tissues near the needles was 24 times greater than before the treatment.
• Deoxycoformycin, a drug that inhibits the removal of adenosine by the tissues, increased the length of time that the adenosine remained in the tissues (surprise! surprise! given its known mechanism of action) but also appeared to increase the length of time that acupuncture treatment was effective.
• In mice who had acupuncture but in which the needle wasn’t rotated every five mintues, acupuncture had no effect.

So what does this all mean? First of all, this study is actually interesting for its implications for adenosine as a mediator of both inflammatory and neuropathic pain. I can’t fault its methodology, at least as far as it implicates the adenosine A1 receptor as a mediator of neuropathic and inflammatory pain in the lower extremity. It’s pretty clear in supporting the conclusion that mimicking the action of adenosine or somehow increasing its local concentration around a nerve might be a good strategy for relieving pain in humans. But do the results of this study actually support the efficacy of acupuncture, as Nedergaard claims?

Not so fast, there again, pardner.

This study actually says very little about acupuncture. What this study shows is that sticking needles in mice causes adenosine production and that that adenosine can blunt the pain response in nerves by binding to the A1 receptor. Nothing more. That’s all well and good, but it doesn’t validate acupuncture. The only thing in common with acupuncture in this study is the needle sticking part, and the investigators might as well conclude that this study validates ear piercing for pain relief. (Egads! Battlefield acupuncture strikes back!) So, it’s quite possible that needles twisted in the area near a nerve might release a flood of adenosine that might bind to A1 receptors in nearby neurons and blunt the pain sensation. No “meridians” or qi is needed to explain that. Moreover, this study notwithstanding, Nedergaard seems at a loss to explain how her results might be reconciled with numerous studies in humans that show clearly that (1) it does not matter where you stick the needles and (2) it doesn’t even matter if the needles are stuck through the skin. As I’ve pointed out before, just twisting the end of a toothpick against the skin produces the same effect as acupuncture. She does, however, give it the old college try to explain this result, although she does so using the hated term “allopathic” to describe “Western” medicine:

One may speculate that other non-allopathic treatments of chronic pain, such as chiropractic manipulations and massage, modalities that involve the mechanical manipulation of joints and muscles, might also be associated with an efflux of cytosolic ATP that is sufficient to elevate extracellular adenosine. As in acupuncture, adenosine may accumulate during these treatments and dampen pain in part by the activation of A1 receptors on sensory afferents of ascending nerve tracks. Notably, needle penetration has been reported to not confer an analgesic advantage over nonpenetrating (placebo) needle application, as opposed to our observations (Supplementary Figs. 2 and 3) and those of others. However, it is possible that ATP release from keratinocytes in response to mechanical stimulation of the skin results in an accumulation of adenosine that transiently reduces pain, as A1 receptors are probably expressed by nociceptive axon terminal in epidermis. In fact, vibratory stimulation applied to the skin depressed the activity of nociceptive neurons in the lower lumbar segments of cats by release of adenosine. However, this effect differs from the anti-nociceptive effect of acupuncture, which does not depend on the afferent innervation of the skin. Acupuncture is typically applied to deep tissue, including muscle and connective tissue, and acupoints may better overlap with their proximity to ascending nerve tracks than to the density of cutaneous afferents.

This is pure speculation without any compelling evidence, no more convincing than saying that rubbing a boo-boo makes it feel better, which is in essence what she’s saying. Worse, her speculations would also have been easy enough to test, given that she had the experimental model up and apparently running smoothly. Contrary to her implication, Supplemental Figures 2 and 3 do not refute the results showing that non-penetrating acupuncture works as well as penetrating acupuncture. In Figure S2, all that is shown is that using acupuncture at the Zusanli point on the contralateral leg doesn’t affect the reaction of ipsilateral leg receiving the acupuncture. All Figure S3 shows is that failing to rotate the needle results in loss of the analgesic effect. Neither refute findings in humans that non-penetrating acupuncture “works” just as well as penetrating acupuncture, where the needles are inserted to the “correct” points. Absent evidence from the current study showing that stimulating the skin results in the release of adenosine and subsequent blunting of the pain response in the extremities of these mice, Nedergaard would have been better off leaving this entire paragraph out of the paper. Moreover, contrary to the claim that “merdians” map to ascending nerve tracts is stretching it a bit, if you look at these maps. For instance, the kidney, stomach, and spleen acupuncture points line up somewhat with nerves at certain points in the body but are nowhere near ascending nerves in other parts.

Finally, there are two remaining huge problems with this paper. Here’s the second biggest first. Mice are much, much smaller than humans. The Zusanli point in a mouse is going to be within a couple of millimeters of the sciatic nerve or one of its major branches. In the human, it’s going to be at least a couple of centimeters away, possibly considerably further. In the mouse, the size of the needle relative to the size of the leg and distance from the sciatic nerve, as well as the nerve’s branches, the tibial and peroneal nerves, is going to be very close. The tissue damage, virtually no matter where the needle is stuck, is going to be close to these nerves. In humans, this is unlikely to be the case, particularly since the nerves are much further beneath the skin than they are in mice; that is, unless we want to start scaling things up and sticking nails into people’s knees. Thus, there is no good reason to think that these results will be unlikely to translate easily to humans.

What really bugs me about this article, though, is that it’s actually pretty cool science, for the most part. It’s not as new as I thought it was before some of my readers corresponded with me and I did a few PubMed searches, but in general its conclusions about the role of the A1 receptor and local adenosine release in response to tissue trauma seem sound. These guys have found something that may even have a potential clinical application. For instance, they found that local injection of A1 receptor agonists works the same as the “acupuncture” and that adding compounds that slow the removal of adenosine from the tissues improves the efficacy of the adenosine released into the tissues by minor trauma. Scientists can work with that. Scientists could take these observations and use them as the scientific justification to work on better, more specific, and longer acting A1 agonists. Perhaps they could even develop oral drugs that are broken down into adenosine or A1 receptor agonists in the peripheral tissues. If this paper’s conclusions regarding the importance of adenosine in pain signaling are correct, these would represent stragies that could very well work and very well improve pain control. One could even envision implantable pellets that could be placed in wounds or near relevant nerves to release A1 receptor agonists right where they’re needed over a long period of time.

Unfortunately, Nedergaard and her team are too enamored of the woo that is acupuncture to emphasize the true significance and potential usefulness of their findings. Worse, they were rewarded for their infatuation with acupuncture with not just a paper in a high impact neuroscience journal but with all sorts of publicity around the world. Instead of working to turn these observations into usable therapies, now Nedergaard and her collaborators will likely use their preliminary data to apply to NCCAM for a grant to study adenosine in acupuncture further, rather than pursuing this observation in a manner far more likely to lead to a clinical benefit in human beings. So much the pity. Woo poisons the real science it touches.

Finally, when you see aficionados of acupuncture cite this paper as “evidence” that acupuncture “works,” remember this: This study says absolutely nothing at all about all the other myriad claimed benefits of acupuncture in fertility treatments, headache, or hot flashes after menopause, to name a few. Sadly, it doesn’t even say that much about the use of acupuncture for chronic pain.

REFERENCE:

Goldman, N., Chen, M., Fujita, T., Xu, Q., Peng, W., Liu, W., Jensen, T., Pei, Y., Wang, F., Han, X., Chen, J., Schnermann, J., Takano, T., Bekar, L., Tieu, K., & Nedergaard, M. (2010). Adenosine A1 receptors mediate local anti-nociceptive effects of acupuncture Nature Neuroscience DOI: 10.1038/nn.2562

OTHER COMMENTARY:

1. Acupuncture Works, Say Scientists
2. A biological basis for acupuncture, or more evidence for a placebo effect?. (In this post, Ed Yong notes that one of the coauthors of this paper, Jurgen Schnermann, is married to Dr. Josephine Briggs. Dr. Briggs is the director of the National Center for Complementary and Alternative Medicine.
3. Why was a study on ‘acupuncture’ reported so badly?