If you go to the website of the National Center for Complementary and Alternative Medicine (NCCAM), you’ll find that one of its self-identified roles is to “provide information about CAM.” NCCAM Director Josephine Briggs is proud to assert that the website fulfills this expectation. As many readers will recall, three of your bloggers visited the NCCAM last April, after having received an invitation from Dr. Briggs. We differed from her in our opinion of the website: one of our suggestions was that the NCCAM could do a better job providing American citizens with useful and accurate information about “CAM.”

We cited, among several examples, the website offering little response to the dangerous problem of widespread misinformation about childhood immunizations. As Dr. Novella subsequently reported, it seemed that we’d scored a point on that one:

…Dr. Briggs did agree that anti-vaccine sentiments are common in the world of CAM and that the NCCAM can do more to combat this. Information countering anti-vaccine propaganda would be a welcome addition to the NCCAM site.

In anticipation of SBM’s Vaccine Awareness Week, I decided to find out whether such a welcome addition has come to fruition. The short answer: nope.

Go where the Money Is(n’t)

I looked on the NCCAM website in places where common sense would dictate that such content might be found:

• Health Topics A-Z
• Be an Informed Consumer
• Complementary and Alternative Medicine Use in Children
• Resources for Health Care Providers
• Alerts and Advisories
• For your patients

In each case I searched for the terms “vaccine,” “vaccination,” “immunization,” “autism,” “MMR,” “thimerosal,” “mercury,” and variations of those words. No dice. I found a couple of mentions of vaccinations by using the general NCCAM website search function; Drs. Novella, Gorski, and I had been aware of these when we visited Dr. Briggs in April, but for completeness’ sake I’ll cite them here. One is in an essay titled Colds and Flu and CAM: At a Glance, dated January, 2010. It states, correctly, that “Vaccination is the best protection against contracting the flu,” but it offers no further comment. There is no rebuttal of vaccine myths, nor even an acknowledgment that such myths exist. Another is in a Message from the Director from October, 2009, which appears to be the precursor of the “Colds and Flu” essay. Here, Dr. Briggs briefly acknowledges vaccine myths:

Vaccination is the best protection against contracting the flu. I know that many people are very concerned about the safety of the flu vaccines, but let me echo the Centers for Disease Control and Prevention, as well as other prominent public health leaders, in assuring you that the vaccines for both the seasonal flu as well as H1N1 have a very good safety track record. Over the years, hundreds of millions of Americans have received the flu vaccine, and the development of the H1N1 vaccine followed the same path of safety and effectiveness testing and approval.

One wonders why that language is absent from the subsequent, larger essay. Not that including it would have addressed the problem of vaccine myths in general, as suggested by the search terms that I chose.

“Whole Medical Systems” lack Whole Discussions

On the NCCAM website there are other notable failures to respond to public misinformation about immunizations. In the Homeopathy treatise there is no mention that homeopaths have famously railed against vaccinations ever since Constantine Hering, the “father of American homeopathy,” called them “always a poisoning.” Nor is there any mention of Hering’s invention, “homeopathic nosodes,” also called “homeopathic vaccinations,” which homeopaths such as Dana Ullman claim to be effective in preventing infectious diseases.

A similar failure exists in the Naturopathy treatise. Many influential naturopaths are anti-vaccine; they advocate “homeopathic nosodes” or other implausible measures. I wonder if Dr. Briggs had any inkling of this when she flattered the American Association of Naturopathic Physicians—whose Position Paper on Childhood Vaccinations is certain to mislead and frighten parents—with her presence at their annual convention in August.

Credentialing Nonsense

Linked from the “Be an Informed Consumer” page on the NCCAM website is an essay titled Credentialing CAM Providers: Understanding CAM Education, Training, Regulation, and Licensing. In it we are told that

A physician’s credentials—the licenses, certificates, and diplomas on the office walls—tell us about that person’s professional qualifications to advise and treat us. We seek similar assurances when we choose a complementary and alternative medicine (CAM) practitioner…

The essay hedges a bit, but is careful to suggest that “CAM” credentials are every bit as trustworthy as those held by real doctors:

Regulations, licenses, or certificates do not guarantee safe, effective treatment from any provider—conventional or CAM.

We are told that “naturopathic physicians” are licensed in 15 states and the District of Columbia, that they have undergone apparently rigorous training in “natural sciences and clinical sciences,” and that they have passed an apparently rigorous, standardized exam offered to “graduates of accredited programs” by their national organization, the American Association of Naturopathic Physicians. The essay makes similar statements about homeopaths and chiropractors—another group with a well-documented distaste for vaccinations.

Such claims of training and credentialing are deceptive, because the fields are bastions of pseudoscience. In the words of Edzard Ernst, “the most meticulous regulation of nonsense must still result in nonsense.” Yet an unsuspecting person looking for responsible information about “CAM” on the NCCAM website would be led to believe, along with all the other nonsense, that the anti-vaccination views of naturopaths, homeopaths, and chiropractors are valid and based on science.

It is no surprise that the NCCAM “Credentialing” essay relies heavily upon the writings of attorney Michael H. Cohen, a champion of quackery about whom we’ve heard before on SBM.

Why?

I used to suppose that the NCCAM website ignoring vaccination hysteria was a matter of naïveté: most NCCAM functionaries know little of the practices and practitioners with which they are expected to be familiar. This probably remains true to a large extent, but we know that Dr. Briggs, at least, is aware of the intimate relation between “CAM” advocacy and the anti-vax movement. Perhaps she hasn’t got around to making the promised changes on the website, but if so, why not? Widespread fear mongering about vaccines being poisons and causing autism is a far more important public health issue than whether or not glucosamine is useful for osteoarthritis, or whether acupuncture might be useful for fibromyalgia, or any of the rest of the standard, breezy, NCCAM fare. The refutation of dangerous myths about vaccines ought to be a priority.

During our visit, Dr. Briggs, who has been at the NCCAM only since 2008, made a point of denying that she feels pressure from Congressional “CAM” demagogues such as Dan Burton and Tom Harkin. That may seem true in the day-to-day grind of her job, but such pressure has permeated the culture of the NCCAM since before its formal inception, as documented many times here on SBM and elsewhere. Rep. Burton conducted numerous pro-quack hearings during his tenure as chairman of the House Committee on Government Reform. His bullying of NIH directors is largely responsible for two of the most unethical trials ever funded by the NCCAM, the Gonzalez trial for cancer of the pancreas and the Trial to Assess Chelation Therapy. Burton is also a champion of quacks who claim that vaccines cause autism.

Sen. Harkin was the creator of both the NCCAM and its predecessor, the Office of Alternative Medicine (OAM). He famously stacked the OAM advisory panel with four pseudoscientific zealots who would be become known as “Harkinites.” He worries that the NCCAM hasn’t spent its time “seeking out and approving [alternative methods].” He hypes “integrative medicine” as the Next Big Thing, the answer to

the dogmas and biases that have made our current health care system – based overwhelmingly on conventional medicine – in so many ways wasteful and dysfunctional.

In particular, assert Sen. Harkin and other advocates, “integrative medicine” will mean preventative medicine. I’ve discussed this deception previously: it’s worse than a Damned Lie. I can’t help but restate, for the occasion of Vaccine Awareness Week, an unending source of ironic amusement for your SBM bloggers and for rational thinkers everywhere: immunizations, also called vaccinations (for the first of their kind, made from cowpox exudate), are the most effective preventative health measures ever devised; yet “alternative medicine” pushers of every stripe, who claim special, proprietary knowledge about achieving ‘wellness,’ can dependably be counted on to oppose them.

A Web of Misinformation

The NCCAM, whether Dr. Briggs would like to admit it or not, is heavily influenced by such sentiments. We’ve already seen how the Center’s website whitewashes naturopaths, homeopaths, and chiropractors. We’ve seen how Dan Burton has single-handedly forced the NCCAM to fund horrible trials and to employ investigators who are charlatans and even criminals. We know that National Advisory Council for Complementary and Alternative Medicine (NACCAM) has been and continues to be, as a matter of law, a bastion of naturopaths, chiropractors, and other quacks.

“Wait a minute,” someone might be thinking, “you can’t conclude from your cited evidence that Harkin himself is anti-vax.” That’s true, but it doesn’t matter. What’s important, for the purposes of this discussion, is the company that he and the NCCAM keep. Let’s illustrate this by citing an example from the current membership of the Advisory Council.

Janet Kahn is the Executive Director of the Integrated Healthcare Policy Consortium (IHPC). The organization was founded in 2001 at the completion of the “National Policy Dialogue to Advance Integrated Health Care: Finding Common Ground,” whose report was co-authored by two naturopaths. As was true of that report, the IHPC agenda and beliefs are exactly in line with those of Harkin and other “integrative medicine” enthusiasts. The IHPC has a Federal Policy Committee whose goal is to fearlessly and tirelessly “transform the very architecture of the US healthcare system.” This, the IHPC intends, will be accomplished by legislative fiat: practitioners of implausible methods will simply be shoehorned into mainstream health care, bypassing science and rational practice standards.

Now let’s close the anti-vax/NCCAM circle. If you’ve looked at the many documents linked from this post, you might have noticed the name Michael Traub. He is a naturopath and homeopath who is on the IHPC’s Board of Directors, Federal Policy Committee, and Steering Committee. He was co-author of the “National Policy Dialogue” report cited just above. He is a past-President of the American Association of Naturopathic Physicians, and last summer shared the podium with NCCAM Director Briggs.

In 1994, Traub published an article, titled “Homeopathic prophylaxis,” for the Journal of Naturopathic Medicine. As previously explained,

[The] article suggests that homeopathic products are safer and more effective than vaccination for preventing disease. The article’s author (Michael Traub, N.D.) taught public health at the National College of Naturopathic Medicine and helped formulate the AANP’s position papers on immunization and homeopathy. He recommends tetanus vaccine but advises against measles, mumps, rubella, and diphtheria. After paying homage to a homeopathic treatise on “vaccinosis” published more than 100 years ago, Traub’s article details the use of homeopathic nosodes for preventing diphtheria, whooping cough, polio, influenza, tuberculosis, and pneumoccal pneumonia. Nosodes are products made by repeatedly diluting samples of pathological tissues, bacteria, fungi, ova, parasites, virus particles, yeast, disease products (such as pus), or excretions. The protocol Traub describes uses “200C potencies” which means that the nosodes are made by serially diluting the original substance 1-to-100 a total of 200 times. (After the 12th dilution, no molecule of original substance remains.) Traub states that he no longer recommends nosodes but uses other “preventive” homeopathic strategies.

That Traub hasn’t substantially changed his tune since 1994 is suggested by the title of a 2004 article, “Alternatives to Flu Shots”—I won’t pay to read it, but you can find it linked from here—and by Traub’s recent report of his own bout with apparent H1N1 flu, which can most generously be described as ditzy. Circle closed; there are many more.

Conclusion

Is it possible that the ubiquitous influence of “CAM” and its fellow traveler, anti-vaccination hysteria, is the real reason that the NCCAM website lacks responsible, definitive information about immunizations and pseudo-immunizations? If this is not the case, and if Dr. Briggs reads this, I hope she’ll be reminded of our discussion in April and consider this a challenge to show us that she is a player. I also hope that she’ll remember that her constituents are approximately 300 million American citizens, not merely tiny fringe groups of homeopaths, naturopaths, and Jenny McCarthy.

We write a lot about vaccines here at Science-Based Medicine. Indeed, as I write this, I note that there are 155 posts under the Vaccines category, with this post to make it 156. This is third only to Science and Medicine (which is such a vague, generic category that I’ve been seriously tempted to get rid of it, anyway) and Science and the Media. There is no doubt that vaccines represent one of the most common topics that we cover here on SBM, and with good reason. That good reason is that, compared to virtually any other modality used in the world of SBM, vaccines are under the most persistent attack from a vocal group of people, who, either because they mistakenly believe that vaccines caused their children’s autism, because they don’t like being told what to do by The Man, because they think that “natural” is always better to the point of thinking that it’s better to get a vaccine-preventable disease in order to achieve immunity than to vaccinate against it, or because a combination of some or all of the above plus other reasons, are anti-vaccine.

“Anti-vaccine.” We regularly throw that word around here at SBM — and, most of the time, with good reason. Many skeptics and defenders of SBM also throw that word around, again with good reason most of the time. There really is a shocking amount of anti-vaccine sentiment out there. But what does “anti-vaccine” really mean? What is “anti-vaccine”? Who is “anti-vaccine”?

Given that this is my first post for SBM’s self-declared Vaccine Awareness Week, proposed to counter Barbara Loe Fisher’s National Vaccine Information Center’s and Joe Mercola’s proposal that November 1-6 be designated “Vaccine Awareness Week” for the purpose of posting all sorts of pseudoscience and misinformation about “vaccine injury” and how dangerous vaccines supposedly are, we decided to try to coopt the concept for the purpose of countering the pseudoscience promoted by the anti-vaccine movement. To kick things off, I thought it would be a good idea to pontificate a bit on the topic of how to identify an anti-vaxer. What makes an anti-vaxer different from people who are simply skeptical of vaccines or skeptical of specific vaccines (for instance, the HPV vaccine)? I don’t pretend to have the complete answer, which is why I hope we’ll have a vigorous discussion in the comments.

Believe it or not, I’m actually a relative newcomer to the task of taking on the anti-vaccine movement. Ten years ago, I was blissfully unaware that such a movement even existed; indeed, I doubt the concept would even have entered my brain that anyone would seriously question the safety and efficacy of vaccines, which are one of the safest and most efficacious preventative medical interventions humans have ever devised, arguably having saved more lives than any other medical intervention ever conceived. Even six years ago, although I had become aware of the existence of the anti-vaccine movement, I considered them a small bunch of cranks so far into the woo that they weren’t really worth bothering with. Yes, I was a shruggie.

All of that changed not long after I started my first blog in December 2004. Approximately six months later, to be precise. That was when someone as famous as Robert F. Kennedy, Jr. published an infamous screed simultaneously in Rolling Stone and Salon.com entitled Deadly Immunity that was so full of misinformation, pseudoscience, and conspiracy mongering that it altered the course of my blogging forever. Although I had already been becoming less and less of a “shruggie” about the anti-vaccine movement before RFK’s propaganda piece, “Deadly Immunity” resulted in a significant percentage of my blogging turning to discussions of the anti-vaccine movement and the scientifically-discredited myth that vaccines cause autism.

Anti-vaccine, not pro-safe vaccine

Before I try to define “anti-vaccine” in more detail, I should take a moment to point out that, if there’s one thing I’ve learned in nearly six years blogging about vaccines and the pseudoscience used to attack them, it’s that no one — well, almost no one — considers himself “anti-vaccine.” This is very easily verifiable in the outraged reaction elicited from people like J.B. Handley (who simultaneously gloats about the decline in confidence in vaccines among parents), Jenny McCarthy, and Dr. Jay Gordon when they are described as “anti-vaccine. Jenny McCarthy, for instance, will reliably retort, “I’m not ‘anti-vaccine.’ I’m pro-safe vaccine.” An alternative response is, “What I really am is ‘anti-toxins’ in the vaccines.” Meanwhile, Dr. Gordon will say the same thing while simultaneously saying that he doesn’t give a lot of vaccines and foolishly admitting in the comments of a blog post that some parents have actually had to persuade him to vaccinate “reluctantly.”

The rule that those holding anti-vaccine views will rarely admit that they are anti-vaccine is a good one, although there are exceptions. It is not uncommon to find in the comments of anti-vaccine propaganda blogs like Age of Autism and anti-vaccine mailing lists comments proclaiming explicit anti-vaccine views loud and proud, with declarations that “I am anti-vaccine.” This dichotomy has at times caused problems for the more P.R.-savvy members of the anti-vaccine movement, as demonstrated two years ago at Jenny McCarthy’s “Green Our Vaccines” rally, where images of vaccines as toxic waste and weapons of mass destruction were commonplace. Even so, the “Green Our Vaccines” slogan and coopting the “vaccine safety” mantle have been very effective for the anti-vaccine movement. In particular, Barbara Loe Fisher has successfully portrayed her National Vaccine Information Center (NVIC) as being a “vaccine safety watchdog” group looking out for parents’ rights, this despite hosting an online memorial for vaccine victims and a deceptive and disingenuous vaccine ingredient calculator.

“I know it when I see it”

In a concurring opinion in Jacobellis v. Ohio, regarding possible obscenity in a movie, Justice Potter Stewart once famously wrote:

I shall not today attempt further to define the kinds of material I understand to be embraced within that shorthand description ["hard-core pornography"]; and perhaps I could never succeed in intelligibly doing so. But I know it when I see it, and the motion picture involved in this case is not that.

From my perspective, defining what is “anti-vaccine” is a lot like defining obscenity: I know it when I see it. However, as in the case of pornography, even though it’s quite true that what is anti-vaccine is in general easily identifiable to those of us who pay attention to such matters, it’s much more difficult to define in a way that those who don’t pay attention to the issue can recognize. This difficulty is complicated by the fact that there are a number of different flavors of anti-vaccine views ranging from (I kid you not) the view that vaccines are a tool of Satan to depopulate the earth to much milder views. It’s also important to realize that most parents who buy into anti-vaccine views do so out of ignorance, because they have been misled, rather than due to stupidity. When I “go medieval” on anti-vaccine activists, my ire is almost always reserved for the leaders of the anti-vaccine movement, who spread misinformation.

When I’m actually in an exchange with someone whom I suspect of having anti-vaccine views, one rather reliable way of differentiating fear from real anti-vaccine views is to ask a simple question: Which vaccines do you think that, barring medical contraindications, children should receive? If the answer is “none,” then I’m pretty much done. I know I’m almost certainly dealing with an anti-vaccinationist. Be aware that this question may require some pushing to get an answer. Rarely am I able to get a definitive answer on the first try, because most anti-vaccine advocates are cleverer than that. They realize that I’m trying to get them to admit that they are anti-vaccine. Even so, if I ask something like, “If you had it to do all over again, would you vaccinate your child?” or “If you have another child, will you vaccinate that child?” I will usually get the candid response I’m looking for.

“Vaccines don’t work”? “Vaccines are dangerous”? They’re both!

If you look at the types of arguments used to oppose vaccination, they will almost always boil down to two different flavors, either that vaccines don’t work or that vaccines are somehow dangerous. Of course, we discuss the latter argument here all the time when we point out studies that refute the alleged link between vaccines and autism. Like the slogan “Tastes great, less filling,” both of these claims often co-exist to differing degrees, with some anti-vaccinationists arguing that both are true: Vaccines don’t work and they are dangerous.

This being the real world, one has to remember that vaccines are not perfect. They are not 100% effective, and there can be rare serious side effects. What differentiates anti-vaccine cranks from, for example, scientists who deal with issues of efficacy versus side effects and potential complications all the time, is exaggeration far beyond what the scientific data will support. For example, if the influenza vaccine is less efficacious than perhaps we would like (which is true), then it must be useless. This is, in essence, the Nirvana fallacy, wherein if something is not perfect it is claimed to be utterly worthless. Part and parcel of this approach involves the complement, namely vastly exaggerating the potential side effects and complications due to vaccines to paint them as being far more dangerous than the diseases they prevent. In addition, anti-vaccine activists frequently attribute harms to vaccines that the existing scientific data definitely don’t support as being reasonable or legitimate. The claim that vaccines cause autism is the most famous, but far from the only one of these sorts of claims. It’s not uncommon to hear fallacious claims that vaccines cause autoimmune diseases, asthma, and a general “weakening” of the immune system, among others.

One of the most famous examples of exaggerated harm or nonexistent risks is the infamous “toxin” gambit. This fallacious argument claims that there are all sorts of scary chemicals in vaccines. Of course, there are all sorts of chemicals with scary names in vaccines, just as there are all sorts of chemicals with scary names in almost everything, from food to clothing to household cleaners, among others. The dose makes the poison, and the amounts of these chemicals, such as formaldehyde, are tiny. As we’ve pointed out time and time again, for instance, the amount of formaldehyde in vaccines is so tiny that it’s overwhelmed by the amount of formaldehyde made as a byproduct of normal metabolism. Then, of course, there are the chemicals claimed to be in vaccines that are, in fact, not in vaccines. The most famous of these is undoubtedly the infamous “antifreeze in vaccines” gambit. Finally, there is the claim that there are “aborted fetal parts” in vaccines. This particular claim comes from the fact that, for some vaccines, the viruses used to make the vaccines are grown in a human cell line derived from an aborted fetus.

Overall, the “tastes great, less filling”-type anti-vaccine claims that vaccines are dangerous and don’t work, can be differentiated from scientifically valid concerns about the efficacy and safety of vaccines on the basis of how evidence is treated and the types of arguments that are used. Scientists, of course, tend to be a lot more measured and express the level of uncertainty in their claims; anti-vaccine activists are under no such constraints. When, for example, scientists debated how to respond to the H1N1 pandemic last year, there was considerable uncertainty about how to do it, when to do it, and how to formulate the vaccines. Which adjuvants? Should we use squalene in order to decrease the amount of antigen used? Contrast this to the anti-vaccine arguments, which tended to argue that H1N1 wasn’t harmful, that the vaccine was toxic and wouldn’t work, and even that it was a New World Order plot.

Approaching the evidence

If there’s one thing that distinguishes science from the way movements like the anti-vaccine movement approach evidence, it’s that the anti-vaccine movement values anecdotes over careful science. If you check out Generation Rescue’s website or any of a number of anti-vaccine websites, you will find numerous stories using the classic post hoc ergo propter hoc fallacy that in essence argues that, because one thing happened before another, that thing must have caused it. Because Generation Rescue preaches that its various forms of biomedical woo can “recover” autistic children, not surprisingly, there are a number of testimonials on its website touting stories of children who regressed after vaccination and then appeared to recover after whatever woo du jour was tried on them. On the surface, these testimonials seem convincing. However, given that millions of children who undergo vaccination each year, the number of vaccinations in the currently recommended schedule, and the fact that approximately 1% of children will eventually be diagnosed with an autistic spectrum disorder, it is not surprising, given the law of large numbers, that there will be a significant number of children who regress in fairly close temporal proximity to a vaccination by random chance alone. Even though such cases are random, though, to a single observer, they appear all the world as though the vaccine caused the regression. What’s difficult for non-scientists (and even many scientists) to accept is that it’s impossible to tell if vaccines are actually correlated with regression unless careful studies are done comparing large populations to determine whether children who are vaccinated really do have a higher chance of autism. Those studies have been done, and the answer is a resounding no. To the anti-vaccine movement, anecdotes trump evidence. Indeed, even physicians, like Jenny McCarthy’s son Evan’s pediatrician Dr. Jay Gordon, fall for touting their own anecdotal experience over careful epidemiology and science.

Perhaps one of the most characteristic aspects of the anti-vaccine movement is the same one that is shared by virtually every denialist movement, be it denying the science of climate change, evolution, or scientific medicine. That is the use of logical fallacies, cherry picking of the evidence, and distortion of the science. Perhaps the best example of cherry picking and distortion of evidence engaged in by anti-vaccine activists is a set of graphs I discovered earlier this year by a man named Raymond Obomsawin, in which he tried to represent as “proof vaccines didn’t save us.” As I pointed out in my response, this was intellectual dishonesty at its most naked. Basically, Obomsawin deceptively conflated mortality and incidence. Worse, he also chose his graphs in a way that parts of the data were left out. Indeed, less than a month ago, the Australian anti-vaccine activist Meryl Dorey approvingly cited Obomsawin’s graphs. When it was pointed out how Obomsawin had cherry picked his graphs to deceptive purpose, his response was beyond pathetic:

The software that I was using to create the graph did not allow for the creation of either a blank space or a dotted line between 1959 and 1968. There was no intent to be dishonest about this, and thanks to your blog, I will make it a point to specifically note on the graph that there is an absence of incidence data in this period.

I note that, not only have the graphs not been changed as far as I can tell, but Dr. Obomsawin is going to be giving a webinar tomorrow in which he is apparently going to argue the same nonsense. I’m half tempted to sign up and see what he says. It’d make for more blogging material, and an update to the Obomsawin Technique of vaccine denialism (yes, I named it after him) is probably overdue anyway. After all, I never took on several other of the graphs he included in his collection. My guess is that Obomsawin won’t change his graph. Obomsawin’s disingenuous approach to the evidence is mirrored by naturopath David Mihalovic, who wrote the infamous 9 Questions That Stump Every Pro-Vaccine Advocate and Their Claims. Dr. Crislip answered each and ever one of these “nine questions” without difficulty. The result was that Medical Voices (which published Mihalovic’s post) challenged us to a “public debate.” We said we’d be happy to debate them in blog posts but that a “public debate” would be counterproductive and allow them to engage in the Gish Gallup. The result? Like Brave Sir Robin, Medical Voices bravely turned its tail and fled. “9 Questions” remains on the impressively named International Medical Council on Vaccination’s website, formerly known as Medical Voices.

Another example of how anti-vaccine activists approach the evidence landed with a huge thud in the blogosphere last year when the Jenny McCarthy-fronted anti-vaccine group Generation Rescue decided to try to discredit the studies that show no link between vaccines and autism. As Steve Novella, Mark Crislip, and I all showed, Generation Rescue’s arguments were fallacious at best and deceptive at worst. The result was that J.B. Handley launched a broadside at Steve Novella.

Which brings us to another characteristic of the anti-vaccine movement.

Conspiracy mongering and reaction to criticism

Science is, if you’ll forgive the term, a highly Darwinian process. To be a scientist, you have to have a thick skin, because you’ll need it. Reviewers, mentors, other scientists, and virtually anyone to whom you present your results will be picking away at them, looking for flaws, looking for reasons to invalidate your conclusions. There’s nothing personal in it (usually); it’s how the process of science works. Similarly, those who have an appreciation for science understand that it’s a rough-and-tumble world where scientists have to be able to defend their work. Yes, it’s messy as hell, but it works. It may take a lot longer than we’d like and be a lot more confusing than the public likes, but over time hypotheses that don’t hold up are weeded out, to be replaced by those that do. Scientists understand this, and most know not to become too distressed by criticism. True, scientists are human too and can’t always separate themselves from their science; sometimes they lash out at criticism. However, for the most part, they don’t react the same way as denialists do when criticized. More importantly, contrary to scientists, it’s very rare indeed for an anti-vaccinationist to change his mind due to the evidence.

The anti-vaccine movement shares another characteristic with denialists of all stripes, and that’s an intolerance to criticism. Instead of answering it with science (which they can’t do), they tend to answer criticism with vitriol and conspiracy mongering. After all, when it’s all a conspiracy between the government and big pharma to “suppress” the data that allegedly show that vaccines cause autism, then anyone who speaks out for that viewpoint must be a pharma shill. If that critic is a woman, then she must have been the victim of a date-rape drug. Or he must be hopelessly compromised by relationships between big pharma and his university, even if such relationships need to be made up or extrapolated beyond all relationship to reality.

Perhaps the best way of describing how anti-vaccine groups react to criticism is to point out that their first response tends to be to try to suppress criticism rather than to answer it. Usually, this is accomplished through ad hominem attacks and poisoning of Google reputations. One particularly egregious example occurred when Age of Autism Photoshopped the faces of Steve Novella, Trine Tsouderos, Alison Singer, Paul Offit, Amy Wallace, and Tom Insel into a photo of people sitting down to a Thanksgiving feast of dead baby. Yes, likening enemies to cannibals wasn’t going too far. Sometimes attacks on critics can escalate to legal thuggery, which happened when the British Chiropractic Association sued Simon Singh and Barbara Loe Fisher sued Paul Offit. That such lawsuits nearly always fail, at least in the U.S., where the libel laws aren’t as draconian as in the U.K., doesn’t matter. The goal is not to recover damages; it’s to intimidate critics into silence. Unfortunately, even I’m not immune to being at the receiving end of this tactic.

Conclusion

Distinguishing true anti-vaccine rhetoric from cluelessness is not always easy. To help, I’ll recap the eight characteristics I’ve just discussed:

1. Claiming to be “pro-safe vaccine” while being unrelentingly critical about vaccines
2. The “vaccines don’t work” gambit
3. The “vaccines are dangerous” gambit
4. Preferring anecdotes over science and epidemiology
5. Cherry picking and misrepresenting the evidence
6. The copious use of logical fallacies in arguing
7. Conspiracy mongering
8. Trying to silence criticism, rather than responding to it

Someone who is anti-vaccine will almost certainly use at least three or four of these techniques. The cranks at Age of Autism use all eight and then some. Indeed, when these eight techniques fail to suffice, they make up more.

One other thing that’s important to mention, particularly since I’ve been guilty of this sin on occasion, is that we have to be careful about leaping to the conclusion that someone is anti-vaccine. That’s where the “I know it when I see it” test can backfire. For example, I was quite distressed at some of the statements coming from Dr. Marya Zilberberg on vaccines, in particular her referring to defenders of the current vaccine schedule as “rabid” and arguments that are reminiscent of the same sorts of arguments that the anti-vaccine movement uses for the HPV vaccine and the chickenpox vaccine, mixed with a question about combinations of vaccines being of concern that sounded uncomfortably like the “Too Many Too Soon” slogan beloved of Generation Rescue. Although I did not explicitly call her “anti-vaccine” in another forum and even went out of my way (as did Steve) to point out that I don’t think she’s anti-vaccine, I did try to point out to Dr. Zilberberg that, if you’re skeptical of some aspect of our current vaccination schedule, it’s important to be aware of how anti-vaccine cranks argue, so that you don’t inadvertently sound like one.

In the end, the anti-vaccine movement is another denialist movement, very similar to denialists of global climate change, science-based medicine, and evolution. As such, it uses many of the same fallacious strategies and distortions of science to promote its agenda and reacts the same way to criticism. Similarly, in the end, the anti-vaccine movement is also far more about ideology rather than science, which is why it remains so stubbornly resistant to reason and science. Finding an effective means to counter its message will likely require developing effective general strategies to counter science denialist movements of all types.

Let the discussion begin! What are the characteristics of anti-vaccine arguments and organizations that allow us to identify and characterize them as “anti-vaccine”?

American Family Physician, the journal of the American Academy of Family Physicians, has a feature called AFP Journal Club, where physicians analyze a journal article that either involves a hot topic affecting family physicians or busts a commonly held medical myth. In the September 15, 2010 issue they discussed “Vaccines and autism: a tale of shifting hypotheses,” by Gerber and Offit, published in Clinical Infectious Diseases in 2009.  

The article presented convincing evidence to debunk 3 myths:

1. MMR causes autism.
2. Thimerosal (mercury) causes autism.
3. Simultaneous administration of multiple vaccines overwhelms and weakens the immune system, triggering autism in a susceptible host.

Gerber and Offit reviewed 13 large-scale studies that demonstrated no association between the MMR vaccine and autism. These included ecologic studies, retrospective observational studies and prospective observational studies.  The findings were consistent; the only outlier in all the studies of MMR was Dr. Andrew Wakefield’s small, discredited 1998 study, which was fully retracted by The Lancet in early 2010.

They reviewed 7 large-scale studies (again, ecologic, retrospective, and prospective) that consistently demonstrated no association between thimerosal and autism. They showed that the hypothesis was not biologically plausible, since the symptoms of mercury poisoning are distinct from those of autism and are not produced by the thimerosal in vaccines.

They showed that the overload hypothesis is not credible because

1. The immunologic load has dropped from 3000 components in the 7 vaccines used in 1980 to less than 200 in the 14 vaccines recommended today.
2. An infant’s immune system is capable of handling the thousands of antigens it is exposed to early in life.
3. Vaccinated children are not more susceptible to infections.
4. Autism is not an autoimmune disease.

The discussants ask “Should we believe this study?” and their answer is a resounding “yes.” They say “This month’s article clearly provides the science and statistics to dispel the theory that childhood vaccinations induce autism. A Cochrane review came to the same conclusion in October 2005.”

They ask “What should the family physician do?” They point to evidence that information and assurance provided by health care professionals can make a difference. They even suggest that physicians get a copy of the Gerber/Offit article and keep it handy for when parents are apprehensive about immunizing their child.

The Journal Club doctors evaluated the evidence rationally and accepted the logical conclusions. The anti-vaccine activists didn’t: instead, they have endangered our public health by rejecting or postponing immunizations and repeating myths. Shame on them!

Over the last couple of days I have been engaged at NeuroLogica in a discussion with a fellow blogger, Marya Zilberberg who blogs at Healthcare, etc. Since the topic of discussion is science-based medicine I thought it appropriate to reproduce my two posts here, which contain links to her posts.

A Post-Modernist Response to Science-Based Medicine

I receive frequent commentary on my public writing, which is great. The feature that most distinguishes blogs is that they are conversations. So I am glad to see that science-based medicine (a term I coined) is getting targeted for criticism in other blogs. One blogger, Marya Zilberberg at Healthcare, etc., has written a series of posts responding to what she thinks is our position at Science-based medicine. What she has done, however, is make many of the logical fallacies typically committed in defense of unscientific medical modalities and framed them as one giant straw man.

She is partly responding to this article of mine on SBM (What’s the harm) in which I make the point that medicine is a risk vs benefit game. Ethical responsible medical practice involves interventions where there is at least the probability of doing more benefit than harm with proper informed consent, so the patient knows what those chances are. Using scientifically dubious treatments, where there is little or no chance of benefit, especially when they are overhyped, is therefore unethical. And further, the “harm” side of the equation needs to include all forms of harm, not just direct physical harm.

Zilberberg’s response is the typical tu quoque logical fallacy — well, science-based medicine is not all it’s cracked up to be either, so there. She writes:

Now, let’s get on to “proof” in science-based medicine. As you well know, while we do have evidence for efficacy and safety of some modalities, many are grandfathered without any science. Even those that are shown to have acceptable efficacy and safety profiles as mandated by the FDA, are arguably (and many do argue) not all that. There is an important concept in clinical science of heterogeneous response to treatment, HTE, which I have addressed extensively on my blog. I did not make it up, it is very real, and it is this phenomenon that makes it difficult to predict how an individual will respond to a particular intervention. This confounds much of what we think is God’s own word on what is supposed to work in allopathic medicine.

This is also the fallacy of the perfect solution — since science-based medicine is not perfect, there is no legitimate basis for criticism of any modality. This is also premised on the false dichotomy of “allopathic medicine” (a derogatory term only used, in my experience, by defenders of dubious medicine) vs “alternative” medicine (which I will refer to as CAM for short). I and others at SBM have been clear that we eschew this false dichotomy. There is only medicine with varying degrees of plausibility and evidence — there is a continuum, and we advocate always using the best that is available. We also think there should be a minimum standard, a fuzzy line of plausibility and evidence below which treatments should only be given with proper informed consent as part of an approved clinical trial. And a further line below which even research is unethical because there is no plausible potential for benefit.

These principles are, in fact, already part of ethical medicine. We did not invent these concepts. It is, rather, the proponents of CAM who wish to do away with this ethical standard — to create a false dichotomy in order to establish a double standard. We are not trying to create a new standard, just to do away with the double standard of CAM.

She refers to the heterogeneous response to treatment, again as if realization of this basic fact is not already part of science-based medicine. I, in fact, explain this to patients all the time. Our knowledge of treatments is based upon statistics, but we can never know ahead of time how an individual patient will respond. What’s the alternative? Until we get better at predicting individual response (which really will just be another application of statistics), this is the best we can do. That is why you monitor the individual response to any treatment, and act accordingly. This is basic medical student stuff, but Zilberberg acts as if this is a big revelation for science-based medicine.

We at SBM advocate for the highest scientific standards of medicine, and apply that across the board — including with pharmaceutical companies, surgeons, and anything else that is labeled as “mainstream.” Again — we do not make false categories and distinctions. It is all medicine.

The reference to “God’s own word” is an obvious allusion to the bad-old-days of paternalistic medicine (dead and buried for decades now), or the TV caricature of a doctor with a God complex. This is a typical ploy — portray any attempt at defending a scientific standard in medicine as paternalistic arrogance. In fact, Zilberberg dedicates an entire blog post to this fallacy. She writes:

First of all, it is my belief that all interventions should be approached with equanimity, if not equipoise. Although I am quite dubious that either healing crystals or Reiki can produce actual results, I do not want to confuse the absence of any evidence to this effect with the evidence of absence of the effect. Although I am not that interested in allocating resources to studying these fields, it would be paternalistic of me to bar their further investigation. So the society can decide what it wants to do with them, and in the meantime every individual can make her/his own choice whether to spend their money on them.

This is clearly where we differ. I do think, from reading her writing, that Zilberberg means well and is sincere in her positions (unlike some I criticize who I feel are just trying to sell something). But notice the logical contortions in her position — she wants “equipoise” with regard to all interventions, and would not dare dictate how research money is spent. I should point out that there is a range of opinions on SBM when it comes to regulation — so we are not a united front on this score. We range from libertarians who think that we should educate the public and professionals, but are against laws that would restrict access to unscientific modalities. Essentially, people have the right to make stupid decisions. Others believe that there needs to be a minimum safety net against fraud and quackery, and in fact the public wants there to be one and believes there already is one. I don’t want to get bogged down in this debate on this blog entry — I am just pointing out that Zilberberg’s premise is overly simplistic and paints with too broad a brush.

But the real point here is that she is taking an almost post-modernist position that we need to approach all claims in medicine with “equipoise.” She says that society can decide how research money is spent, even if she would not personally research an implausible topic. Depending upon how you slice it, this is not necessarily far off from my position. If people want to raise money to research an implausible question they should go right ahead. I never proposed banning implausible research. My position, rather, is that we should not waste limited public/government research resources on highly implausible modalities.

I would also add, however, that once you start doing research on humans there is a host of ethics that also come into play. In human research it is the accepted ethical standard that subjects should at least have a chance of benefiting from the treatments being studied, or at least there should be a greater chance of benefit than harm. I don’t see how this ethical standard can be met with homeopathy, for example, where there is essentially zero chance of benefit. At some point you pass a line of infinitessimal plausibility where the ethics become problematic.

Zilberberg then makes the “absence of evidence vs evidence of absence” mistake — really an oversimplification of this concept to the point of being wrong. While it is true that the absence of evidence if not necessarily evidence of absence — it can be, depending upon how thoroughly you have looked. If I search my house for a specific item and don’t find it, that is pretty good evidence that it’s not there. It is not “proof” of absence, but it is evidence. With many of the modalities that Zilberberg admits she is personally dubious about there is evidence of absence of an effect. This evidence comes in two forms — all of the science that tells us the modalities are highly implausible, and often there is clinical evidence of lack of an effect. To pretend otherwise is dishonest — it is hiding from the facts out of political correctness.

Further, our patients do not want equipoise from us. They want our informed opinion. When patients ask me if they should take a homeopathic remedy I don’t give them a wishy washy answer. I give them my informed opinion, and they are grateful to have it. In the comments to her blog a commenter speculates about my bedside manner, assuming, essentially, that I must be a paternalistic ass. This is the typical cardboard caricature I encounter, and it has no relationship to reality. It is possible to give patients useful information without being judgmental. To give them informed consent (how do you do this, by the way, without giving them information?) but understand that they will make up their own minds. Patients are in charge of their own health care, and our job as clinicians, more than ever, is to give them the information and perspective they need to make good decisions. This does not demand “equipoise”, but evidence and perspective. In my opinion equipoise in the face of ridiculously implausible claims and evidence of lack of efficacy is a disservice to patients and a violation of trust.

Ironically, Zilberberg concludes:

Bottom line, we need to appreciate that none of the science is all that straightforward. Let us not dumb down the arguments and create false dichotomies. If we do, no one wins.

Does she actually read science-based medicine? I am left to wonder — since we regularly argue for the complexity of the science of medicine. I want people to understand how complex the relationship is, so they are not shocked every time conflicting studies come out. Medical science is a messy business, and it is challenging often to infer what the best approach is. I want the profession and the public to have a much more nuanced understanding of medical science, and for the media to do a better job of representing it.

This is especially true since we do not have a paternalistic system. Patients are partners in their own health care, and therefore it helps me do my job when they understand the science that underpins medicine.

Zilberberg’s position is anti-science, although perhaps not deliberately so. It is anti-science in a post-modernist sense. She points out all the limitations of science, as if that means we cannot come to any meaningful decision, and therefore must treat all claims as equal. But all claims are not equal. Even the best are imperfect, but we can still apply science and evidence to make informed decisions about the probability of risk vs benefit. And there are some claims that are so against science and evidence (like homeopathy) that any stance other than rejection is a violation, in my opinion, of medical ethics and the trust that society places in medical professionals.

In Zilberberg’s world, however, any such judgments are the equivalent of pronouncing that these treatments over here in pile A are deemed “scientific” (as if by the word of God) and are accepted. And these over here in pile B are deemed “nonsense” and are to be ridiculed. But the false dichotomy is in her mind, not in science-based medicine. We are the ones railing against the false dichotomy — that of CAM which seeks to create a double standard. All we advocate is one consistent standard of science and evidence when evaluating all medical claims, and the rational application of science to the practice of medicine.

One final note — I would much prefer to have a conversation with the critics of science-based medicine that does not constantly involve defending SBM and myself from false accusations of arrogance and paternalism. I think it says a lot about their intellectual position when that is constantly the best they have.

Dr. Zilberberg Responds

Dr. Zilberberg responded to my original post and significantly modified her tone, to her credit. (She was simultaneously responding to Orac’s analysis of her posts as well.) Here is my analysis of that post.

The Tone Thing

I will address her main points below, but first my final thoughts on the “tone” thing. While she admits fault in setting the “confrontational tone,” I don’t think she quite gets what Orac and I were objecting to. I actually don’t mind a confrontational approach — as long as it is substantive (that’s the way science works — if you have a point to make, bring it on). We were objecting to her mischaracterizing our position and making ad hominem attacks in place of substantive criticism — essentially using the “arrogant” gambit with which we are all too familiar. Her readers obviously picked up on this, and piled one, accusing us of being bullies and thanking her for slapping us down. We objected to her logical fallacies, not her tone.

Interestingly Zilberberg’s initial response was dismissive, and she reiterated the charge of paternalism and arrogance, writing: “If the shoe fits?” At least now she seems to realize that if we are going to have a productive discussion, focusing on ad hominem attacks will be counterproductive.

Incidentally, having written about medicine for years I have definitely seen a strong pattern. When I criticize the logic and factual premises of another person’s argument I am frequently accused of being mean by people who then attack me personally. It seems many people do not understand the difference between a strong but substantive criticism and a personal attack. Zilberberg was falling into this category, but has significantly (if incompletely) backed off from that with her latest post.

One more minor point — “allopathic” is derogatory and does not apply to modern medicine (it was coined by Samuel Hahneman to refer to the poisons that passed for medicine in his time, and was definitely meant to be a criticism). I would suggest she drop this term rather than defend it.

Evidence in Medicine

Zilberberg then launches into a meaty discussion of what her position actually is. She observes that perhaps we are not that far off in our positions, which I think is true. There is a meaningful difference in spin — the final conclusions drawn from the analysis, but her analysis of the role of evidence in medicine is reasonable. But again, to clarify, Orac and I were not objecting to the point that evidence in medicine is messy and complex. We were objecting to the accusation that we do not understand this, and that we are promoting an overly simplistic and cheerleading approach to science in medicine. This left me with the impression that Zilberberg has not read deeply into the Science-Based Medicine website, or at least has failed to grasp what it is we are actually saying.

If she had she would have seen post after post in which SBM authors were pointing out all of the complexities and deficiencies of evidence in medicine that she and others might also point to. That is core to the point of SBM — evidence is complex. She might, in fact, have read my series of posts on evidence in medicine. We do spend a great deal of time pointing this out in the context of so-called CAM, because CAM proponents are the ones who most profoundly take a simplistic approach to the evidence. They engage in black-and-white thinking, display intolerance of ambiguity, and frequently advocate for the reliance on very problematic low-grade evidence to support their claims. But we also consistently apply the same standards to surgery and the pharmaceutical industry, and anything “mainstream.’

Zilberberg reviews the relative roles of experimental evidence vs observational evidence. Her analysis is reasonable, but I think she overstates the utility of observational data a bit (and she admits to a fondness for this type of data). The bottom line is that each type of evidence (basic science, observational, and experimental — and even anecdotal) has its own strengths and weaknesses, and the best result comes from analyzing all kinds of scientific evidence and looking for a consensus of evidence. That is, in fact, OUR criticism of evidence-based medicine -over reliance on randomized controlled clinical trials and undervaluing other forms of scientific evidence. That is why we advocate for “science”-based medicine, and not just “evidence”-based medicine.

Each type of evidence, in fact, is abused. We criticize the inappropriate extrapolation from basic science to clinical claims, assuming causation from observational correlation, failure to realize the limits of clinical trials, and the use of pragmatic studies as if they were evidence for efficacy.

Zilberberg also clarifies her position by saying that she feels there is good scientific evidence for some of medicine, but it seems she differs from my position in how evidence-based modern medicine actually is.

We can argue endlessly about this question — how much of modern medicine is based upon solid evidence — each pointing to limited examples and essentially giving our bias. But there are some facts we can point to. Zilberberg writes:

While it is true that the oft-cited 5-20% number representing the proportion of medical treatments having solid evidence behind them is very likely outdated, the kind of evidence we are talking about is a different matter.

The “5-20% number” is not outdated — it’s a myth. Actually, I had previously heard 15% as the low end, but I guess that number keeps dropping. I wrote previously about this myth here. The 15% number was based upon an extremely small survey of primary care practices in the north of England — in 1961. That’s almost 50 years ago. The number was never very relevant, and now it’s a joke.

More recent surveys of medical practice come to very different numbers. Bob Imrie reviewed the published evidence:

Thus, published results show an average of 37.02% of interventions are supported by RCT (median = 38%). They show an average of 76% of interventions are supported by some form of compelling evidence (median = 78%).

Of course, where you draw the line for “supported by compelling evidence” will determine what the percentage figure is. But the bottom line is that the 15% figure is basically an urban legend, and “5%” is nothing short of propaganda. More reasonable estimates range much higher.

And — the point of EBM and SBM is that we can and should do better. We also need to do better in adhering to EBM guidelines where they exist, and in utilizing continuing medical education and other mechanisms of quality control to improve adherence to the evidence where it does exist.

The difference in spin is not subtle. We can look at the evidence and say: modern medicine has a culture of science, endeavors to be scientific, and basically the system works but the process is complex and messy and there are multiple ways in which we can do better. Meanwhile someone else can look at the same data and conclude: modern medicine is broken, it is based upon arrogance, authority, and greed, and we can just throw up our hands and conclude that any treatment is as likely to be of value as any other, no matter how silly it may seem scientifically.

My position is essentially the former. Zilberberg came off originally as being close to the latter (and judging by the comments, many readers took her position to be supportive of the latter), but now has clarified that she is somewhere in the middle.

CAM

Zilberberg also clarifies her position on CAM. She had previously written that she advocates a position of “equipoise” towards clinical claims. Even though she might not use certain modalities herself, she sees no basis to condemn the use of them by others. I characterized this position as political correctness gone wild — to the point of practical post-modernism. Now she writes:

My belief is that all modalities that may impact what happens to public’s health need to be evaluated for safety, not question. I think we both agree, since there is really no reason to think that something like homeopathy has anything that can help, by the same token we do not believe that it have anything that can hurt. Same with healing crystals, reiki and prayer. So, if a person wants to engage in these activities, and they are perfectly safe physically, be my guest. Other modalities, such as chiropractic, acupuncture, herbalism and the like, definitely need to be evaluated more stringently, as there is reason to think that they may cause harm.

This is a common position to take. Val Jones at SBM coined the term “shruggie” to refer to this position — in essence, if there is no direct harm, then who cares what people do. First, as I discussed very recently on SBM, there are many types of harm from unscientific medical modalities other than direct physical harm. So I do not find this position tenable for that reason alone.

Further, context is everything. There are actually a variety of positions that authors at SBM take when it comes to regulating medical practice. We all generally believe that medical professionals should not engage in nor promote unscientific methods. In fact, we should oppose their adoption and promotion, we should oppose their inclusion in universities and mainstream hospitals, and spending public funds on researching extremely implausible or already disproven modalities. That seems to be a point of difference between myself and Zilberberg.

I personally do not oppose individuals doing whatever they want when it comes to their own health. If you want to chew on tree bark (a vivid example given to me by someone else), go right ahead. What I object to is someone selling the tree bark and claiming that it cures cancer based upon nothing but legend and anecdote, and scaring their customers away from proven therapies in order to make the sale. I object to distortions of logic and science in order to confuse the public so as to better market worthless or harmful products. And I object to medical professionals looking the other way out of misguided political correctness, or simply a naivete as to the significant harm that is done.

SBM has a huge consumer protection mission, and it puzzles frustrates me that this mission is so often and so thoroughly misrepresented. This misrepresentation is deliberate — part of the “health freedom” movement — and seeks to portray all health care consumer protection activity as arrogant elitism and protectionism. This is identical to the intelligent design movement’s representation of all attempts at quality control in education as arrogant elitism.

What I don’t understand is Zilberberg’s apparent position that, while she knows homeopathy is utterly worthless, a physician should refrain from telling her patients exactly that.

Vaccine Skepticism

Zilberberg goes on to argue that she is not anti-vaccine, as she has been accused (not by me). I have no reason not to accept her word on this, and it is good that she has clarified her position.

But I do think she is displaying a lack of appreciation for the nature of the anti-vaccine movement. As an example, if one publicly expresses doubt about an aspect of currently accepted Darwinian evolution it would be nice if they understand the many ways in which the scientific discourse is exploited by creationists, so that they don’t accidentally give succor to an anti-scientific movement.

Likewise, any public discussion about vaccines, while it should be candid and completely honest, should ideally be done with an adequate familiarity with the anti-vaccine movement’s propaganda so that one’s words and positions are not easily exploited. In fact, while expressing skepticism about a particular vaccine or vaccine program, I would recommend specifically clarifying one’s position to distance themselves from the extremists. Otherwise you are inviting misinterpretation.

Conclusion

The take home message from this exchange is that, in my opinion, accusations of using harsh tone or of arrogance are an ad hominem distraction from the real issue — what is the optimal relationship between the practice of medicine and the underlying science of medicine.

Zilberberg engaged fully in this distraction, but is now slowly backing away (but not enough, in my opinion). I think this was largely due to the fact that she has been taken in by the very active and sophisticated propaganda campaigns of CAM proponents. She seems to have bought into their rhetoric, and did not read carefully enough into our writing at SBM to see through it.

We are approaching 1000 blog posts at SBM. I don’t expect critics to read every post, but a tiny bit of scholarly due diligence would be nice, before essentially buying into the lies and distortions of our critics.

We at SBM write frequently about the complexity and limitations of the science of medicine. That is our mantra — a nuanced and sophisticated approach to evidence is needed. But at the end of the day, some treatments are better than others. We can accept and reject practices based upon plausibility and evidence, even while there is a vast gray zone in the middle where we just don’t know yet.

It is misleading and ironic in the extreme to criticize promoters of SBM for taking a simplistic approach to evidence. That is the opposite of the truth. Meanwhile, promoters of all sorts of so-called CAM do take a simplistic and highly distorted approach to evidence, display an intolerance of uncertainty, systematically misrepresent the evidence to their clients and the public, think in stark black-and-white terms, engage in bait-and-switch deceptions, distort the positions of their critics, rely upon low grade evidence and logical fallacies for their claims, and then hide behind political correctness, post-modernism, distractions about “health care freedom”, special pleading (science can’t test my claims), and accusations of arrogance and paternalism.

All of this behavior is carefully documented in the pages of Science-Based Medicine. Would-be critics of SBM should try reading some of them before launching into misguided criticism of what is ultimately a straw man of our actual positions.

I take Zilberberg at her word that she is interested in genuine discussion, and she has at least moved in that direction. I recommend she step back, read some more of SBM and see what we actually have to say about science and medicine.

One of the realities of being a pharmacist is that we’re easily accessible. There’s no appointment necessary for consultation and advice at the pharmacy counter. Questions range from “Does this look infected?” (Yes) to “What should I do about this chest pain?” to more routine questions about conditions that can easily be self-treated. Part of the pharmacist’s role is triage — advising on conditions that can be self-managed, and making medical referrals when warranted. Among the most common questions I receive are related to stress and fatigue. Energy levels are are down, and patients want advice, and solutions. Some want a “quick fix,” believing that the right combination of B-vitamins are all that stand between them and unlimited energy. Others may ask if prescription drugs or caffeine tablets could help. Evaluating vague symptoms is a challenge. Many of us have busy lifestyles, and don’t get the sleep and exercise we need. We may compromise our diets in the interest of time and convenience. With some simple questions I might make a few basic lifestyle recommendations, talk about the evidence supporting supplements, and suggest physician follow-up if symptoms persist. Fatigue and stress may be part of life, but they’re also symptoms of serious medical conditions. But they can be hard to treat because they’re non-specific and may not be easily distinguishable from the fatigue of, well, life.

This same vague collection of symptoms is called something entirely different in the alternative health world. It’s branded “adrenal fatigue,” an invented condition that’s widely embraced as real among alternative health providers. There’s no evidence that adrenal fatigue actually exists. The public education arm of the Endocrine Society, representing 14,000 endocrinologists, recently issued the following advisory:

“Adrenal fatigue” is not a real medical condition. There are no scientific facts to support the theory that long-term mental, emotional, or physical stress drains the adrenal glands and causes many common symptoms.

Unequivocal words. But facts about adrenal fatigue neatly illustrate why a science-based approach is a consumer’s best protection against being diagnosed with a fake disease.

The adrenals are a pair of glands that sit on the kidneys and produce several hormones, including the stress hormones epinephrine and norepiniephrine that are associated with the “fight or flight” response.  Can you tire these glands out? In the absence of any scientific evidence, chiropractor and naturopath James Wilson coined the term “adrenal fatigue” in his 1998 book of the same name. Take a look at the James’ own questionnaire, at adrenalfatigue.org, to see if you have have it. Do you ever experience the following?

1. Tired for no reason?
2. Having trouble getting up in the morning?
3. Need coffee, cola, salty or sweet snacks to keep going?
4. Feeling run down and stressed?
5. Crave salty or sweet snacks?
6. Struggling to keep up with life’s daily demands?
7. Can’t bounce back from stress or illness?
8. Not having fun anymore?
9. Decreased sex drive?

If you answered yes to any of these questions, you may have adrenal fatigue.

Some lifestyles are apparently more vulnerable to adrenal fatigue, including single parents, shift workers, an “unhappily married person”, and the “person who is all work, no play.” There’s no information provided to substantiate the quiz, qualify the vague terminology, or link to any relevant literature. (Of course there is the usual Quack Miranda warning which makes all of this possible: “These statements have not been evaluated by the Food & Drug Administration … etc.”)

Based on this quiz, it’s safe to assume that adrenal fatigue is the most prevalent fake disease in the world. And sure enough, that’s what its proponents think, too:

Dr. John Tinterra, a medical doctor who specialized in low adrenal function, said in 1969 that he estimated that approximately 16% of the public could be classified as severe, but that if all indications of low cortisol were included, the percentage would be more like 66%. This was before the extreme stress of 21st century living, 9/11, and the severe economic recession we are experiencing.

So let’s look into the medical literature on adrenal fatigue. There’s no entry in Dorland’s medical dictionary, nor does the ICD classify it as a medical condition. Pubmed lists only one relevant paper which is a review by two naturopaths, and published in the Alternative Medicine Review. But there’s no evidence for them to review.

Fake diseases are compilations of various symptoms into conditions without any scientific basis. Peter Lipson has examined this in detail here at SBM. As Dr. Lipson points out, it’s human nature to want answers and to understand patterns of symptoms. Defining a cluster of symptoms in general terms is the first mistake. Symptoms need to be collated in a rational way to understand the parameters of the disorder. With adrenal fatigue, there’s no objective operational description, nor is there a validated symptom score. Using a vague list of symptoms to identify patients is the second mistake. While laboratory tests are advertised for identifying adrenal fatigue, there’s no persuasive data to demonstrate that blood or saliva tests provide any meaningful information, or are correlated with any underlying pathology.

Adrenal fatigue shouldn’t be confused with adrenal insufficiency, a legitimate medical condition that can be diagnosed with laboratory tests and has a defined symptomatology. Addison’s disease causes primary adrenal insufficiency and usually has an autoimmune cause, with symptoms appearing when most of the adrenal cortex has been destroyed. Secondary adrenal insufficiency is cause by pituitary disorder that gives insufficient hormonal stimulation to the adrenals. Some liken adrenal fatigue to a milder form of adrenal insufficiency — but there’s no underlying pathology that has been associated with adrenal fatigue. That’s actually a common method of disease invention: take a real disease and claim that it exists in a subclinical form, though of course it lacks a single unambiguous sign or symptom. We are supposed to believe that it’s still a serious problem even though it is, by definition, so mild that it is undiagnosable by any physician.

While adrenal fatigue may not exist, the same can’t be said for the treatments. When you’re treating a fake disease, anything goes. Everything from homeopathy to herbal remedies to hydrotherapy, to traditional Chinese medicine and vitamin supplements are advocated for treatment. The endpoints of treatment are as nonspecific as the criteria for diagnosis. Young, conveniently, has his own supplement programs. The Adrenal Fatigue Institute (apparently unrelated to Young) sells a supplement called Cylapril via TV infomercials and online ads. Disappointingly but perhaps not suprisingly, there are a number of health professionals that offer adrenal fatigue services, from labs that will diagnose it with scientific-looking lab reports [PDF], to pharmacies that offer specialty-compounded adrenal fatigue products.

Conclusion

While adrenal fatigue may not exist, this doesn’t mean the symptoms people experience aren’t real. These same symptoms could be caused by true medical conditions such as sleep apnea, adrenal insufficiency, or depression. Accepting a fake disease diagnosis from an unqualified practitioner is arguably worse. Patients don’t receive a science-based evaluation of their symptoms, and they may be sold unnecessary treatments that are probably ineffective and potentially harmful. There’s no question that it would be frustrating to be experiencing fatigue symptoms and then to be told by a health professional that there is nothing medically wrong. But that is arguably better than the distraction of treating a fictitious condition.

Although I’m one of the few non-clinicians writing here at SBM, I think about clinical trials a great deal – especially this week.

First, our colleague, Dr. David Gorski, had a superb analysis and highly-commented post on The Atlantic story by David H. Freedman about the work of John Ioannadis – more accurately, on Freedman’s misinterpretation of Ioannadis’s work and Dr. Gorski’s comments. While too rich to distill to one line, Dr. Gorski’s post struck me in that we who study the scientific basis of medicine actually change our minds when new data become available. That is a GoodThing – I want my physician to guide my care based on the latest data that challenges or proves incorrect previously held assumptions. However, this concept is not well-appreciated in a society that speaks in absolutes (broadly, not just with regard to medicine), expecting benefits with no assumption of risk or sacrifice in reaping those benefits. Indeed, the fact that we change our minds, evolving and refining disease prevention and treatment approaches, is how science and medicine move forward.

Then, I had the opportunity to hear an excellent talk on pharmaceutical bioethics by Ross E. McKinney, Jr., MD, Director of the Trent Center for Humanities, Bioethics, and History of Medicine at Duke University School of Medicine. McKinney is a pediatrics infectious disease specialist who led and published landmark Phase I and Phase II trials zidovudine (AZT) for pediatric AIDS patients. While he continues working in this realm, McKinney also studies clinical research ethics, conflicts of interest, and informed consent. I was absolutely fascinated and refreshed by hearing from an expert who while describing and citing major ethical lapses in our system of drug development is also willing to propose solutions and do the hard thinking required for us to maximize the benefits we derive from pharmaceuticals while minimizing unethical behavior.
From his presentation abstract:

The system the United States uses to develop and approve new drugs and devices is fraught with ethical problems. On the one hand, tremendous strides have been made in the treatment of HIV, cancer, and heart disease. Drug development can work and save human lives. On the other hand, drug companies have repeatedly withheld vital information that directly affects human health. Sins of omission that cost human lives have become part of the cost of doing business. Why have we allowed this situation to evolve, and what can we do to improve ethical behavior on the part of the pharmaceutical and device industry.

(Related: See this Dr. Peter Lipson SBM post on our “tremendous strides” in heart disease.)

Evil drug companies

The primary case for discussion was the well-known Avandia episode where GlaxoSmithKline was shown in a 2007 NEJM paper by Steven Nissen to have knowledge of the increased cardiovascular risk of their PPAR? agonist diabetes drug, rosiglitazone, effects not reported for pioglitazone (Actos), a similar drug from Takeda. He then cited the 2008 Winklemeyer article in Archives of Internal Medicine that retrospectively assessed the risks of the two drugs in 28,000+ patients over 29,000+ patient-years and concluded that rosiglitazone was associated with 15% greater mortality and 13% more cases of congestive heart failure than in patients taking pioglitazone. It was in the public’s best interest that a prospective trial of the two drugs be done and while GSK ultimately tried to launch such a study, patient recruitment was hindered by news of rosiglitazone’s safety.

McKinney began by noting that we need to accept the fact that a pharmaceutical company’s primary mission is to produce a return for shareholders by bringing the most effective drugs to market for the largest population whose benefits far outweigh their adverse effects.  While sitting there, I also began to think about this concept more braodly: for readers who think that “drug companies” are evil profit-mongers, I encourage you to take a look at the precise stock holdings in the mutual funds of your 401(k) or 403(b) retirement accounts.

These are my words, not Dr. McKinney’s: It’s disingenuous and intellectually lazy to say that all “drug companies” care about is profits when many, many folks – including those objectors who populate the comment threads of this blog and others – benefit financially from the business practices of the industry. Let he without fault cast the first stone.

What would YOU do?

What I enjoyed next was that McKinney challenged the audience to declare what they would have done next if they were working for the company and their jobs and the jobs of others depended on the sales of what had become a $3 billion/year drug. He wouldn’t just let us sit passively and – for just a brief moment – you had to really think about being in the decision making shoes. I took a moment during the talk to pull up the Nissen paper and look at the actual numbers and look at the absolute risk of adverse effects instead of the relative numbers.  I encourage you right now to go to Table 3 and look at the actual numbers of myocardial infarctions and deaths from cardiovascular causes in control patients versus patients taking rosiglitazone in each of the trials. Yes, the analysis of the data as a whole showed that rosiglitazone exhibited significant risk but can you see how easy it might be to convince yourself that there wasn’t really a problem with your drug?

In another part of his talk, he challenged us (still as hypothetical company employees) to come up with designing a study to test our hypothetical new drug for mild-to-moderate pain and expressing whether we thought it best to compare against aspirin, ibuprofen, codeine, or celecoxib (Celebrex). What’s the right comparison drug to test yours against if you want to do the study correctly? Do you want to chance your $200/month drug against the pennies-per-dose aspirin or ibuprofen? Do you want to play hardball against equally-expensive Celebrex and risk that your drug might not perform better?

What’s the right study to do in the interest of patients?

What’s the right study to do in the interest of your continued employment?

Solutions?

McKinney also spent time talking about how the need for stronger disincentives for pharma management to behave unethically. The $2.4 billion that GSK had to set aside for Avandia litigation may not be large enough of a penalty. For a drug that had such a huge market, this might simply be viewed as the cost of doing business. Recent legislation to reward inside whistle-blowers personally might increase the revelations of wrongdoing similar to this week’s award, also related to GSK, to a drug manufacturing quality manager.

Finally, McKinney also spoke of the unavoidable conflicts of interest by academic investigators conducting industry-sponsored clinical trials – again reminding the uninitiated in the audience that the NIH funds vanishingly small numbers of clinical trials and that Pharma’s total clinical trial expenditures are roughly twice that of the entire NIH budget.

Caring too much can also be a COI

McKinney noted that conflicts of interest are not necessarily always nefarious or driven by money. As a physician who treats infants and kids with HIV/AIDS, McKinney stated that he has a conflict of interest in just simply wanting a new drug to work for his patients. Trying to keep kids from suffering is a strong motivator. In fact, the desire is so strong that if an investigator is not blinded, some bias may creep in on variables that are more subjective.

What can we do? We’re only addressing half the job by simply pointing out problems with the system. We have to propose and experiment with solutions. We have to work hard to minimize the introduction of any bias into studies. We have to provide strong disincentives to companies to behave unethically. But solutions will also have their own costs we must also be willing to accept. For example, if fines are levied that drive a major multinational company to bankruptcy, we must accept the loss of innovation to the collective worldwide drug discovery effort.

The solutions are not easy. The discussions are difficult. It’s just as easy to bleat that doctors don’t care if they kill patients because they take drug company money as it is to say that rainbows and unicorns flow forth from drug company research campuses. Having the discussions, pushing others to evaluate their own ethics, and thinking through tough financial and clinical decisions is grueling. I was delighted to have the opportunity this week to be pushed outside my comfort zone. It should happen more often.

I realize that in the question-and-answer session after my talk at the Lorne Trottier Public Science Symposium a week ago I suggested in response to a man named Leon Maliniak, who monopolized the first part of what was already a too-brief Q&A session by expounding on the supposed genius of Royal Rife, that I would be doing a post about the Rife Machine soon. And so I probably will; such a post is long overdue at this blog, and I’m surprised that no one’s done one after nearly three years. However, as I arrived back home in the Detroit area Tuesday evening, I was greeted by an article that, I believe, requires a timely response. (No, it wasn’t this article, although responding to it might be amusing even though it’s a rant against me based on a post that is two and a half years old.) Rather, this time around, the article is in the most recent issue of The Atlantic and on the surface appears to be yet another indictment of science-based medicine, this time in the form of a hagiography of Greek researcher John Ioannidis. The article, trumpeted by Tara Parker-Pope, comes under the heading of “Brave Thinkers” and is entitled Lies, Damned Lies, and Medical Science. It is being promoted in news stories like this, where the story is spun as indicating that medical science is so flawed that even the cell-phone cancer data can’t be trusted:

Let me mention two things before I delve into the meat of the article. First, these days I’m not nearly as enamored of The Atlantic as I used to be. I was a long-time subscriber (at least 20 years) until last fall, when The Atlantic published an article so egregiously bad on the H1N1 vaccine that our very own Mark Crislip decided to annotate it in his own inimitable fashion. That article was so awful that I decided not to renew my subscription; it is to my shame that I didn’t find the time to write a letter to The Atlantic explaining why. Fortunately, this article isn’t as bad (it’s a mixed bag, actually, making some good points and then undermining some of them by overreaching), although it does lay on the praise for Ioannidis and the attacks on SBM a bit thick. Be that as it may, clearly The Atlantic has developed a penchant for “brave maverick doctors” and using them to cast doubt on science-based medicine. Second, I actually happen to love John Ioannidis’ work, so much so that I’ve written about it at least twice over the last three years, including The life cycle of translational research and Does popularity lead to unreliability in scientific research?, where I introduced the topic using Ioannidis’ work. Indeed, I find nothing at all threatening to me as an advocate of science-based medicine in Ioannidis’ two most famous papers, Contradicted and Initially Stronger Effects in Highly Cited Clinical Research and Why Most Published Research Findings Are False. The conclusions of these papers to me are akin to concluding that water is wet and everybody dies. It is, however, quite good that Ioannidis is there to spell out these difficulties with SBM, because he tries to keep us honest.

Unfortunately, both papers are frequently wielded like a shibboleth by advocates of alternative medicine against science-based medicine (SBM) as “evidence” that it is corrupt and defective to the very core and that therefore their woo is at least on equal footing with SBM. Ioannidis has formalized the study of problems with the application of science to medicine that most physicians intuitively sense but have not ever really thought about in a rigorous, systematic fashion. Contrast this to so-called “complementary and alternative medicine” (i.e., CAM), where you will never see such a questioning of the methodology and evidence base behind it (mainly because its methodology is primarily anecdotal and its evidence base nonexistent or fatally flawed) and most practitioners never change their practice as a result of any research, and you’ll see my point.

Right from the beginning, the perspective of the author David H. Freedman is clear. I first note the title of the article (Lies, Damned Lies, and Medical Science) is intentionally and unnecessarily inflammatory. On the other hand, I suppose that entitling it something like “Why science-based medicine is really complicated and most medical studies ultimately turn out to be wrong” wouldn’t have been as eye-catching. Even Ioannidis restrained himself more when he entitled his PLoS review an almost as exaggerated Why Most Published Research Findings Are False, which has made it laughably easy for cranks to the misuse and abuse of his article. My annoyance at the title and general tone of Freedman’s article notwithstanding, coupled with the sorts of news coverage it’s getting notwithstanding, there are still important messages in Freedman’s article worth considering, if you get past the spin, which begins very early in describing Ioannidis and his team thusly:

Last spring, I sat in on one of the team’s weekly meetings on the medical school’s campus, which is plunked crazily across a series of sharp hills. The building in which we met, like most at the school, had the look of a barracks and was festooned with political graffiti. But the group convened in a spacious conference room that would have been at home at a Silicon Valley start-up. Sprawled around a large table were Tatsioni and eight other youngish Greek researchers and physicians who, in contrast to the pasty younger staff frequently seen in U.S. hospitals, looked like the casually glamorous cast of a television medical drama. The professor, a dapper and soft-spoken man named John Ioannidis, loosely presided.

I’m guessing the only reason Freedman didn’t liken this team to Dr. Greg House and his minions is because, unlike Dr. House, Ioannidis is dapper and soft-spoken, although like Dr. House’s team apparently Ioannidis’ team is full of good-looking young doctors. After describing how Ioannidis delved into the medical literature and was shocked by the number of seemingly important and significant published findings that were later reversed in subsequent studies, Freedman boils down the what I consider to be the two most important messages that derive from Ioannidis’ work:

This array suggested a bigger, underlying dysfunction, and Ioannidis thought he knew what it was. “The studies were biased,” he says. “Sometimes they were overtly biased. Sometimes it was difficult to see the bias, but it was there.” Researchers headed into their studies wanting certain results—and, lo and behold, they were getting them. We think of the scientific process as being objective, rigorous, and even ruthless in separating out what is true from what we merely wish to be true, but in fact it’s easy to manipulate results, even unintentionally or unconsciously. “At every step in the process, there is room to distort results, a way to make a stronger claim or to select what is going to be concluded,” says Ioannidis. “There is an intellectual conflict of interest that pressures researchers to find whatever it is that is most likely to get them funded.”

Perhaps only a minority of researchers were succumbing to this bias, but their distorted findings were having an outsize effect on published research. To get funding and tenured positions, and often merely to stay afloat, researchers have to get their work published in well-regarded journals, where rejection rates can climb above 90 percent. Not surprisingly, the studies that tend to make the grade are those with eye-catching findings. But while coming up with eye-catching theories is relatively easy, getting reality to bear them out is another matter. The great majority collapse under the weight of contradictory data when studied rigorously. Imagine, though, that five different research teams test an interesting theory that’s making the rounds, and four of the groups correctly prove the idea false, while the one less cautious group incorrectly “proves” it true through some combination of error, fluke, and clever selection of data. Guess whose findings your doctor ends up reading about in the journal, and you end up hearing about on the evening news? Researchers can sometimes win attention by refuting a prominent finding, which can help to at least raise doubts about results, but in general it is far more rewarding to add a new insight or exciting-sounding twist to existing research than to retest its basic premises—after all, simply re-proving someone else’s results is unlikely to get you published, and attempting to undermine the work of respected colleagues can have ugly professional repercussions.

Of course, we’ve discussed the problems of publication bias before multiple times right here on SBM. Contrary to the pharma conspiracy-mongering of many CAM advocates, more commonly the reason for bias in the medical literature is what is described above: Simply confirming previously published results is not nearly as interesting as publishing something new and provocative. Scientists know it; journal editors know it. In fact, this is far more likely a problem than the fear of undermining the work of respected colleagues, although I have little doubt that that fear is sometimes operative. The reason is, again, because novel and controversial findings are more interesting and therefore more attractive to publish. A young investigator doesn’t make a name for himself by simply agreeing with respected colleagues. He makes a name for himself by carving out a niche and even more so if he shows that commonly accepted science has been wrong. Indeed, I would argue that this is the very reason that comparative effectiveness research (CER) is given such short shrift in the medical literature, so much so that the government has decided to encourage it in the latest health insurance reform bill. CER is nothing more than comparing already existing and validated therapies head-to-head against each other to see which is more effective. To most scientists, nothing could be more boring, no matter how important CER actually is. Until recently, doing CER was a good way to bury a medical academic career in the backwaters. Hopefully, that will change, but to my mind the very problems Ioannidis points out are part of the reason why CER has had such rough sledding in achieving respectability.

More importantly, what Freedman appears (at least to me) to portray as a serious, nigh unfixable problem in the medical research that undergirds SBM is actually its greatest strength: it changes with the evidence. Yes, there is a bias towards publishing striking new findings and not publishing (or at least not publishing in highly prestigious journals) less striking or negative findings. This has been a well-known bias that’s been bemoaned for decades; indeed, I remember learning about it in medical school, and you don’t want to know how long ago I went to medical school.

Even so, Freedman inadvertently echoes a message that we at SBM have discussed many times, namely that high quality evidence is essential. In the article, Freedman points out that 80% of nonrandomized trials turn out to be wrong, as are “25 percent of supposedly gold-standard randomized trials, and as much as 10 percent of the platinum-standard large randomized trials.” Big surprise, right? Less rigorous designs produce false positives more often! Also remember, in an absolutely ideal world with a perfectly designed randomized clinical trial (RCT), by choosing p<0.05 as the cutoff for statistical significance, we would expect that at least 5% of RCTs will be wrong by random chance alone. Add type II errors to that and the number is expected to be even higher, again, just by random chance alone. When you consider these facts, then having only 10% of large randomized trials turn out to be incorrect is actually not too bad at all. Even if only 25% of all randomized trials turn out to be wrong, that isn’t all that bad either; these include smaller trials. After all, the real world is messy; trials are never perfect, nor is their analysis. The real messages should be that lesser quality trials that are unrandomized are highly unreliable and that even randomized trials should be replicated if at all possible. Unfortunately, resources are such that such trials can’t always be replicated or expanded upon, which means that we as scientists need to do our damnedest to work on improving the quality of such trials. Also, don’t forget that the probability of a trial being wrong increases as the implausibility of the hypothesis being tested increases, as Steve Novella and Alex Tabarrok have pointed out in discussing Ioannidis’ results. Unfortunately, with the rise of CAM, more and more studies are being done on highly implausible hypotheses, which will make the problem of false-positive studies even worse. Is this contributing to the problem overall? I don’t know, but that would be a really interesting hypothesis for Ioannidis and his group to study, don’t you think?

Another important lesson from Ioannidis’ work cited by Freedman is that hard outcomes are much more important than soft outcomes in medical studies. For example, death is the hardest outcome of all. If a treatment for a chronic condition is going to claim benefit, it behooves researchers to demonstrate that it has a measurable effect on mortality. I discussed this issue a bit in the context of the controversy over Avastin and breast cancer, where the RCTs used to justify approving Avastin for use against stage IV breast cancer found an effect on disease-free survival but not overall survival. However, this issue is not important just in cancer trials, but in any trial for an intervention that is being used to reduce mortality. “Softer” outcomes, be they disease-free survival, reductions in blood lipid levels, reductions in blood pressure, or whatever, are always easier to demonstrate than decreased mortality.

Unfortunately, one thing that comes through in Freedman’s article is something similar to other work I’ve seen from him. For instance, when Freedman wrote about Andrew Wakefield back in May, he got it so wrong that he was not even wrong when he described The Real Lesson of the Vaccines-Cause-Autism Debacle. To him the discovery of Andrew Wakefield’s malfeasance is as nothing compared to what he sees as the corruption and level of error present in the current medical literature. In other words, Freedman presented Wakefield not as a pseudoscience maven, an aberration, someone outside the system who somehow managed to get his pseudoscience published in a respectable medical journal and thereby caused enormous damage to vaccination programs in the U.K. and beyond. Oh, no. To Freedman, Wakefield is representative of the system. One wonders, given how much he distrusts the medical literature, Freedman actually knew Wakefield was wrong. After all, all the studies that refute Wakefield presumably suffer from the same intractable problems that Freedman sees in all medical literature. In any case, perhaps this apparent view explains why, while Freedman gets some things right in his profile of Ioannidis, he gets one thing enormously wrong:

Ioannidis initially thought the community might come out fighting. Instead, it seemed relieved, as if it had been guiltily waiting for someone to blow the whistle, and eager to hear more. David Gorski, a surgeon and researcher at Detroit’s Barbara Ann Karmanos Cancer Institute, noted in his prominent medical blog that when he presented Ioannidis’s paper on highly cited research at a professional meeting, “not a single one of my surgical colleagues was the least bit surprised or disturbed by its findings.” Ioannidis offers a theory for the relatively calm reception. “I think that people didn’t feel I was only trying to provoke them, because I showed that it was a community problem, instead of pointing fingers at individual examples of bad research,” he says. In a sense, he gave scientists an opportunity to cluck about the wrongness without having to acknowledge that they themselves succumb to it—it was something everyone else did.

To say that Ioannidis’s work has been embraced would be an understatement. His PLoS Medicine paper is the most downloaded in the journal’s history, and it’s not even Ioannidis’s most-cited work—that would be a paper he published in Nature Genetics on the problems with gene-link studies. Other researchers are eager to work with him: he has published papers with 1,328 different co-authors at 538 institutions in 43 countries, he says. Last year he received, by his estimate, invitations to speak at 1,000 conferences and institutions around the world, and he was accepting an average of about five invitations a month until a case last year of excessive-travel-induced vertigo led him to cut back.

Yes, my ego can’t resist mentioning that I was quoted in Freedman’s article. My ego also can’t help but be irritated that Freedman gets it completely wrong in how he spins my anecdote. Instead of the interpretation I put on it, namely that physicians are aware of the problems in the medical literature described by Ioannidis and take such information into account when interpreting studies (i.e., that Ioannidis’ work is simply reinforcement of what they know or suspect anyway), Freedman instead interprets my colleagues’ reaction to Ioannidis as “an opportunity to cluck about the wrongness without having to acknowledge that they themselves succumb to it—it was something everyone else did.” I suppose it’s possible that there is a grain of truth in that — but only a small grain. In reality, at least from my observations, the reason that scientists and skeptics have not only refrained from attacking Ioannidis but in actuality have embraced him and his findings of deficiencies in how we do clinical trials is for the right reasons. We want to be better, and we are not afraid of criticism. Try, for instance, to imagine an Ioannidis in the world of CAM. Pretty hard, isn’t it? Then picture how a CAM-Ioannidis would be received by CAM practitioners? I bet you can’t imagine that they would shower him with praise, publications in their best journals, and far more invitations to speak at prestigious medical conferences than one person could ever possibly accept.

Yet that’s how science-based practitioners have received John Ioannidis.

In the end, Ioannidis has a message that is more about how little the general public understands the nature of science than it is about the flaws in SBM:

We could solve much of the wrongness problem, Ioannidis says, if the world simply stopped expecting scientists to be right. That’s because being wrong in science is fine, and even necessary—as long as scientists recognize that they blew it, report their mistake openly instead of disguising it as a success, and then move on to the next thing, until they come up with the very occasional genuine breakthrough. But as long as careers remain contingent on producing a stream of research that’s dressed up to seem more right than it is, scientists will keep delivering exactly that.

“Science is a noble endeavor, but it’s also a low-yield endeavor,” he says. “I’m not sure that more than a very small percentage of medical research is ever likely to lead to major improvements in clinical outcomes and quality of life. We should be very comfortable with that fact.”

We should indeed. On the other hand, those of us in the trenches with individual patients don’t have the luxury of ignoring many studies that conflict (as Ioannidis suggests elsewhere in the article). Moreover, it is science that gives us our authority with patients. If patients lose trust in science, then there is little reason not to go to a homeopath. Consequently, we need to do the best we can with what exists. Nor does Ioannidis’ work mean that SBM is so hopelessly flawed that we might as well all throw up our hands and become reiki masters, which is what Freedman seems to be implying. SBM is our tool to bring the best existing care to our patients, and it is important that we know the limitations of this tool. Contrary to what CAM advocates claim, there currently is no better tool. If there were, and it could be demonstrated conclusively to be superior, I’d happily switch to using it.

To paraphrase Winston Churchill’s famous speech, many forms of medicine have been tried and will be tried in this world of sin and woe. No one, certainly not those of us at SBM, pretends that SBM is perfect or all-wise. Indeed, it has been said (mainly by me) that SBM is the worst form of medicine except all those other forms that have been tried from time to time. I add to this my own little challenge: Got a better system than SBM? Show me! Prove that it’s better! In the meantime, we should be grateful to John Ioannidis for exposing defects and problems with our system while at the same time expressing irritation at people like Freedman for overhyping them.

A salesman is demonstrating a new product at a sports store in the local mall. He has a customer stand with his arms extended horizontally to the sides; he presses down on an arm and the customer starts to fall over. Then he puts a bracelet on the customer and repeats the test; this time he is apparently unable to make the customer lose his balance. He has the customer turn his head as far as he can without the bracelet, and shows that he can turn his head a few degrees more after he puts on the bracelet. (Try this yourself: if you turn your head, wait a couple of seconds and try again, you will always be able to turn it further on the second trial). He similarly shows that the customer is stronger when he wears the bracelet. The customer and the onlookers are mightily impressed by the demonstration, by the salesman’s testimonials, and by the endorsements of famous athletes: they buy the bracelets to improve their athletic performance.

These so-called energy bracelets (also pendants and cards) allegedly contain a hologram embedded with frequencies that react positively with your body’s energy field to improve your balance, strength, flexibility, energy, and sports performance; and they also offer all sorts of other benefits (such as helping horses and birds and relieving menstrual cramps and headaches). The claims and the language on their websites are so blatantly pseudoscientific it’s hard to believe anyone would fall for them. Here are just a few examples from the Power Balance website:

• We react with frequency because we are a frequency.
• Your body’s energy field likes things that are good for it.
• Why Holograms? We use holograms because they are composed of Mylar—a polyester film used for imprinting music, movies, pictures, and other data. Thus, it was a natural fit.
• A primitive form of this technology was discovered when someone, somewhere along the line, picked up a rock and felt something that reacted positively with his body.

People have actually been convinced that this gobbledygook is a scientific explanation. Many sports celebrities swear by the bracelets. Millions have been sold.

Recently an account executive from a public relations/marketing communications firm contacted me about energy bracelets, asking if I would like free samples to check out for myself and if I would be interested in writing about the topic and maybe interviewing his “C-levels,” whatever those are. He represents one of at least 8 companies marketing such devices, but this company, EFX, is allegedly unique because it’s the only one that is embracing scientific studies. He says the other competing brands are avoiding any and all medical/scientific analysis, but EFX currently has “many independent studies being conducted, and is in the process of gathering funds to have an independent double-blind study implemented with seniors.” Are you impressed? They don’t have any evidence that their product works, but they are “in the process of gathering funds” to test it. After selling how many of them?

I don’t know how I got on his list, but he initially addressed me as “Ms.” rather than “Doctor” and he apparently had no idea that I had debunked (actually, ridiculed) a similar product, “Power Balance,” in an article in Skeptical Inquirer some time ago. An expanded version of that article is available online on Device Watch, a Quackwatch affiliate.I am not the only one to pick on them. Richard Saunders, the prominent Australian skeptic, has written about them and has even conducted a double blind test for Australian TV,where they failed miserably. He and Rachael Dunlop also produced their own video about applied kinesiology, explaining the simple biomechanical and psychological tricks that salesmen use to give people the false impression that the products improve their balance, strength, and flexibility. Brian Dunning has debunked energy bracelets on Skepticblog. And Time magazine recently did a story explaining that there is no science behind them but that users don’t seem to care and continue to use them as a kind of mechanized superstition.

When I wrote the Power Balance article, I pointed out that you can’t have a frequency in isolation. A frequency requires a periodic process; you can’t have “33 1/3 per minute” by itself but you can have “33 1/3 revolutions per minute.” A radio wave and a vibrating tuning fork can have a frequency: an armadillo and a tomato can’t. A person can’t “be” a frequency. I e-mailed the company and asked some simple questions like “How do you measure the frequency of a rock?” They didn’t answer.

So when I heard from the EFX account executive, I jumped at the chance to get some answers. I asked if he could ask a company representative

1. How are the frequencies chosen? How do you determine which ones are beneficial?
2. Why would one frequency work for different individuals? Aren’t we unique?
3. What do they mean by frequencies, since a frequency can’t exist alone but has to refer to a number of repetitions of a periodic process per period of time. What is the periodic process that generates the frequency involved in the bracelet technology?
4. How are frequencies embedded in a hologram? Yes, I know there are proprietary secrets, but perhaps you could provide a general answer that would give me a clue.

The proffered answers to my questions were revealing:

1. We choose the frequencies based upon research. The electromagnetic spectrum is vast, but there are specific frequencies that have an immediate positive effect on the human body. We determine which ones are the best to use through a lot of trial and error.
2. We are unique, and we think that no two people react exactly the same to our holograms. However, some frequencies are universal to the human body, which is why our holograms work with 95% of the people that try the product. Some have a relatively mild reaction, and with others the reaction to our holograms is profound.
3. Yes, a frequency is the number of waves that pass a fixed point in a period of time. It is quite possible (I do it when I program) to use a frequency generating machine, modified to work for our needs to “embed” frequencies onto a hologram (that includes a metallic substance) that will hold those frequencies. You are not going to find much support for this “theory” in mainstream science. Many will say that it is “impossible.” I say that there is still much that science does not know. I have been doing this long enough to know that it does work, it is real, and I don’t worry about the people saying that the idea makes no sense. Time is on my side.
4. Not going to give you any information about how we embed frequencies in a hologram. That is a trade secret.

The account executive was personally convinced because the headaches he used to get after 3-hour (!) cardio workouts vanished, and since he didn’t anticipate that, he can’t accept it as a placebo effect. He commented

My only estimation is that these frequency generating machines are somehow able to embed a self-sustaining frequency onto the mylar material. I haven’t had the opportunity to do in depth research on the theory personally, but from what I understand, this isn’t a theory that has much research discrediting or supporting it for that matter.

A self-sustaining frequency? In Mylar? I asked if he believed in perpetual motion. He answered

I’m not a scientist and I don’t know enough about how they “embed” the frequencies to verify how it works. All I know is that the team that I’ve met with internally at EFX are very adamant about the product, which is why they are willing to submit to the peer reviewed/double blind studies. “If this doesn’t work, we want to be proven wrong” was something the president once said to me. If he were a scam artist, I doubt very highly that he would be eager to submit his product to these tests.

I had asked if they could supply me with a bracelet that had not had the frequencies embedded, so I could use it as a placebo control to test the “active” bracelet. They couldn’t, because

We are currently engaged in independent peer reviewed double blind studies and would prefer to conclude those before sending blanks if you don’t mind.

I don’t think I need to point out what’s wrong with these answers and this type of thinking. The energy bracelet phenomenon is just one more demonstration that humans are a superstitious lot and that consumers can’t tell science from bullshit. This amounts to a high-tech version of carrying a rabbit’s foot for luck. At least the energy bracelets don’t require killing innocent bunnies: can this be considered progress of a sort?

I really have to give those guys at McGill University’s Office for Science and Society credit. They’re fast. Remember how I pointed out that I’ve been away at the Lorne Trottier Public Science Symposium? This year, the theme was Confronting Pseudoscience: A Call to Action, and I got to share the stage with Michael Shermer, Ben Goldacre, and, of course, our host, “Dr. Joe” Schwarcz. Sadly, I couldn’t stay to see The Amazing Randi do his thing yesterday evening, but at least I did get to have breakfast with him before I left.

In any case, the reason I have to hand it to Dr. Joe and his team at McGill is because they’ve already uploaded all the videos for symposium events. Here’s the main page with the videos (the 2010 Trottier Symposium occurred on October 17, 18, and 19), and here are the individual links:

• 2010 Lorne Trottier Roundtable (moderated by Dr. Joe Schwarcz)
• 2010 Lorne Trottier Public Syposium (Drs. Ben Goldacre, Michael Shermer, and David Gorski; note that my talk is the second talk)
• Investigating Pseudoscientific & Paranormal Claims with James Randi

And, because I can’t resist, here are some photos taken with various people’s cell phone cameras. First, we have a lovely poster of woo that I saw at the restaurant where we had lunch on Sunday and just had to snap a quick picture of:

Bummer that we missed the event.

Sadly, even the McGill University Bookstore is not entirely immune to woo. Fortunately, the alternative medicine section was quite tiny compared to the science and medicine sections, and Dr. Joe is around McGill to try to make sure that things don’t get too far out of hand. But it did exist, and Michael Shermer and I couldn’t resist mugging a bit with a reflexology book while Dr. Joe observed off camera with a bemused look on his face:

I also got to hang out a bit with Ben Goldacre, who is a really fun guy. Sadly, our schedule was so packed that I never got a chance to hit a pub and hoist a pint with him. I did, however, manage to persuade Ben that he really does need to check out a certain obscure British SF show from the late 1970s/early 1980s that continues to inspire a “friend” of mine:

I also got to meet Dr. Richard Margolese, who is a huge name in breast surgery, having been a major player in many of the classic NSABP studies that defined how we treat breast cancer today. Foolishly, I never got my picture taken with him, but you can see him in the roundtable discussion we had as proof that I was in the same room with him, at least.

Finally, here’s the crew:

Not pictured is Emily Shore, who did incredible work organizing the event, herding the cats, and making sure speakers got to where they needed to be when they needed to be there. A great time was had by all, and I can’t begin to express how grateful I am to Dr. Joe Schwarcz, Dr. Ariel Fenster (to whose chemistry class I gave a talk on Tuesday), Dr. David Harpp, Emily Shore, and, of course, Lorne Trottier, who funds this conference every year and, I hope, will continue to fund it for years to come.

Sixty years ago, the world was full of miracles. Western Europe was recovering from the devastation of World War II, an agricultural revolution promised to banish the fear of starvation in large parts of the world, and the mythical Mad Men era gave Americans a taste of technology-dependent peace and prosperity unlike any in the past. Despite the technological progress that would soon send animals into space and return them relatively unharmed, Americans, and westerners in general, were still dying of heart disease at a frightening rate. If you, as a middle aged American, experienced chest pain and were lucky enough to make it to a hospital (about 20% of all sufferers would die immediately), you would probably be given nitroglycerin and morphine to control you pain, put on bed rest, and could expect to live a few more years, with limited physical activity.

Heart disease continues to be a top killer of Americans, but there has been a dramatic decline in heart disease mortality in the last 60 years, with age-specific mortality rates dropping 60%. Fewer people are developing heart disease, and those that have it are living longer. It is estimated that in 2000 alone, there were 341,745 fewer heart disease deaths than would have been expected if rates had remained unchanged.  This decline has not been driven by a renaissance of alternative medicine.  It has been driven by science.

The trend has been going on for many decades, and has been accelerating, although current trends in diabetes and obesity put us at risk for more overall cases of heart disease in the future. So what are we doing right? How have we managed to cut the death rate from heart disease so dramatically?

So-called alternative medicine practitioners seem hell-bent on finding evidence-free ways to prevent and fight disease. No lie is too blatant in the pursuit of their ideology. For example, one chiropractic website claims that everything we think we know about prevention of heart disease is wrong:

The tyical risk factors include high cholesterol, smoking, high blood pressure, and diabetes.  Prescription drugs serve as these programs’ centerpiece, with counseling and education as adjunct treatments.  They are spearheaded by the American Heart Association, the American Medical Association, local and state governments, and even the federal government.

Yet 10 years ago study results by the Cochrane Heart Group and The Cochrane Collaboration (http://www.cochrane.org/) showed that treating risk factors was “ineffective in achieving reductions in total or cardiovascular disease mortality (death).”

Of course, we don’t get a real citation to follow.    One of the most offensive investigations into heart disease prevention is the TACT trial, an unethical trial asking a question that doesn’t require an ethics-free clinical trial to answer.  We know a lot about heart disease.  And we know this because of well-designed trials and studies that ask the right questions.  The medical literature over the last 30 years has seen a flood of studies of heart disease. As would be expected, most are incomplete, answering only one or two questions, and studies often conflict.  But over time, trends emerge, and the truth precipitates from the noise.

In reducing heart disease mortality, there have been different relative contributions from primary prevention (preventing new cases of heart disease) and secondary prevention (preventing recurrent cases).  A recent study in the American Journal of Public Health analysed data from 1980-2000. The authors found that most of the reduction in deaths from heart disease (nearly 80%) were due to primary prevention, specifically decreasing smoking rates, and improvements in blood pressure and cholesterol levels. Society-wide reductions in smoking, blood pressure, and cholesterol are saving hundreds of thousands of lives in the U.S. every year.  This is a different conclusion than that of the Virginia chiropractors who once read an un-citable Cochrane review.

What’s best about these data is they give us guidance;  real science gives us real predictions.  The smoking rate in the US is still hovering around 24%. More than half of people with known high blood pressure do not have their blood pressure under control. Evidence shows us that we can easily prevent more heart attack deaths through education and through better adherence to extant treatment guidelines.  Behavioral changes such as smoking cessation, diet and exercise, and the proper use of medications can all contribute to the fight against heart disease.  Reducing heart disease deaths isn’t all that complicated, and it won’t take miracles. We just have to follow the evidence.

*Similar trends have been seen in other English-speaking countries

References

Hurlburt CW (1927). THE CARDIAC CRIPPLE. Canadian Medical Association journal, 17 (11), 1305-9 PMID: 20316574

Sytkowski PA, Kannel WB, & D’Agostino RB (1990). Changes in risk factors and the decline in mortality from cardiovascular disease. The Framingham Heart Study. The New England journal of medicine, 322 (23), 1635-41 PMID: 2288563

FRY J (1964). CORONARY HEART DISEASE IN GENERAL PRACTICE: NATURAL HISTORY OVER TWELVE YEARS (1950-1961). Proceedings of the Royal Society of Medicine, 57, 39-42 PMID: 14114173

Centers for Disease Control and Prevention (CDC) (1999). Decline in deaths from heart disease and stroke–United States, 1900-1999. MMWR. Morbidity and mortality weekly report, 48 (30), 649-56 PMID: 10488780

Young, F., Capewell, S., Ford, E., & Critchley, J. (2010). Coronary Mortality Declines in the U.S. Between 1980 and 2000 Quantifying the Contributions from Primary and Secondary Prevention American Journal of Preventive Medicine, 39 (3), 228-234 DOI: 10.1016/j.amepre.2010.05.009

Wijeysundera HC, Machado M, Farahati F, Wang X, Witteman W, van der Velde G, Tu JV, Lee DS, Goodman SG, Petrella R, O’Flaherty M, Krahn M, & Capewell S (2010). Association of temporal trends in risk factors and treatment uptake with coronary heart disease mortality, 1994-2005. JAMA : the journal of the American Medical Association, 303 (18), 1841-7 PMID: 20460623

I have been involved in infection control and in what is now called quality for my career. Since infection control issues can occur in any department, my job involves being on numerous quality related committees (Medical Executive, Pharmacy and Therapeutics, etc) where I have witnessed or participated in what seems to be innumerable quality initiatives.

It always gripes my cookies when someone says “Get your own house in order,” because that is a person who evidently is arguing from ignorance. Since To Err is Human was published at the turn of the century, the hospital systems in Portland and across the country have invested significant time and money into quality improvement. Do a Pubmed on ‘Hand Hygiene Compliance’ in the last decade; there are over 400 references. Or ‘deep venous thrombosis prophylaxis’ — over 5,000 references. Or ‘ventilator associated pneumonia prevention’ — over 750 references. Pick a topic related to safety and quality and search the literature, and you will find a remarkable amount of research into the best ways to decrease morbidity and mortality in the hospital.

Hospitals, at least those in my city, take safety and quality very seriously, and by applying the results of these studies, there has been a marked decrease in mortality and morbidity in my institutions. Compared to historical controls, we estimate we have, in the last 2 years, prevented about 600 hospital acquired infections and over 200 deaths. Those numbers are not fudged, but real progress. I make, or made, a large chunk of mortgage payment from hospital acquired infections. Not any more.

Not a single intervention we have implemented has required the use of a SCAM. We did not need to introduce reiki or homeopathy or acupuncture into the hospitals to get these benefits. Nope. Not a one. Just the application of science-based medicine. It did require an immense amount of time and energy, because human behavior and hospital systems are complex and making changes that are effective and can be incorporated into in the busy work environment of the hospital is not as easy as one would think.

Not only has the implementation of all our quality initiatives not required the input of any SCAMs, it is difficult to find a reference where the SCAM community is making any efforts to improve their quality. Take hand hygiene, probably the most important intervention you can do to decrease the spread of infectious diseases.

In the chiropractic literature there is one study. Acupuncture and naturopathy? None. These are the three fields that are often associated with Institutions of <sarcasm> Higher Learning </sarcasm> and they are not publishing in areas of quality. Of course, evaluating quality interventions requires a firm understanding of the scientific method, not, given their curricula, one of their strong points.

There is one quality indicator where we still lag: influenza vaccine compliance. Locally and nationally, it is rare to get influenza vaccine rates above 50%. It is a condition of employment in health care, or at least in hospitals, that all the workers are vaccinated, or immune from prior illness, to a number of infections including chicken pox, mumps, hepatitis B, and measles. Most of the infections are those that can be transmitted from the health care providers (HCP) to their vulnerable patients. All the employees are immune to these diseases and, if at the time of employment they refuse the vaccines, they get the opportunity to find employment elsewhere. No exceptions.

The influenza vaccine is different; at most institutions it is not mandated and compliance is low. In recent years I have gone on the wards with the flu cart and given influenza vaccinations to the staff. It is fun and you get the opportunity to talk with your colleagues about the importance of vaccination and answer their questions. There are always one or two who will not make eye contact and avoid me so they do not need to get the shot or to engage in conversation with me. But most people, even those who may refuse the vaccine, will talk to me and, even if I do not convince them on the spot, I will give them something to think about. Some websites trumpet the low compliance of health care workers (HCW) as evidence that the HCW’s know something that the rest of us do not, and that is why they are not vaccinated. I have yet to hear a compelling reason outside of Guillian Barre and anaphylaxis. Instead I hear a variety of myths or misunderstandings. I address those arguments with a slightly more snarky tone over on my Medscape blog, A Budget of Dumb Asses. It is worth the every penny of the free registration for the opportunity to read it.

There is a movement to make flu vaccine mandatory, a condition of employment, for health care providers as well. The Society for Healthcare Epidemiology of America (SHEA) released a position paper, supported by the Infectious Disease Society of America, that recommends the influenza vaccine be mandatory for HCP’s. To the surprise, I am sure, of no one, I would support such a move.

There are three reasons to make the vaccine mandatory: two evidence-based, one philosophical.

There are careers where you are expected to place the needs of others ahead of your own. The most extreme example is the military or the secret service, where it is expected that you might die as a result of your job. Less extreme examples include policemen, firemen, and, yes, health care providers.

Medicine is more than a job. It is a calling, which is a weird thing for me to say, because it is a calling to what? Or whom? Got me. But it is. In medicine the expectation is that I will care for anyone who comes my way and that I will place the patients needs before my own.

I remember the old days, standing at the bedside of AIDS patients, with no idea what caused the disease or how it was spread, hoping that the (it turned out excessive) gowns and gloves would prevent transmission of the disease to me. But I, and my colleagues, did the work. And should plagues, known and unknown, strike again, as they will, I expect that most of my colleagues will be at my side, tending to the ill, regardless of the personal risk. Society expects that we will be there.

HCP’s have an moral obligation to minimize the chance that will harm will occur to patients, many of whom are particularly vulnerable. This duty is summed up in the three laws of health care:

1. A HCP may not injure a human being or, through inaction, allow a human being to come to harm.
2. A HCP must obey any orders given to it by SBM, except where such orders would conflict with the First Law.
3. A HCP must protect its own existence as long as such protection does not conflict with the First or Second Law.

SHEA summed it up:

Those in support of mandatory programs argue that influenza vaccination is an ethical responsibility of HCP, because HCP have a duty to act in the best interests of their patients (beneficence), to not place their patients at undue risk of harm (nonmaleficence), and to protect the vulnerable and those at high risk of infection. The duty to put patient interests first is outlined in nearly every professional code of ethics in medicine, nursing, and other healthcare fields.

The influenza vaccine is safe. Serious side effects are extremely rare and the risks from influenza are much greater. The vaccine is far safer than driving (30,000 deaths a year), taking a bath (450), or standing under a coconut tree (130). Of course people are not good at evaluating relative risks. I had a patient with a heart valve infection from heroin use who smoked 2 packs a day, drank a fifth a day, and rarely showered; but when he came in with new shortness of breath and I wanted to get a chest x-ray, he refused because he was worried about the radiation exposure. So it is with vaccine. Some people have a feeling, unsupported by the literature, that vaccines are unsafe, and if they were unsafe, I would not and could not recommend mandatory vaccination.

In adults

In placebo-controlled studies among adults, the most frequent side effect of vaccination was soreness at the vaccination site (affecting 10%–64% of patients) that lasted less than 2 days. These local reactions typically were mild and rarely interfered with the recipients’ ability to conduct usual daily activities. Placebo-controlled trials demonstrated that among older persons and healthy young adults, administration of TIV is not associated with higher rates for systemic symptoms (e.g., fever, malaise, myalgia, and headache) when compared with placebo injections. One prospective cohort study indicated that the rate of adverse events was similar among hospitalized persons who either were aged 65 years and older or were aged 18–64 years and had one or more chronic medical conditions compared with outpatients. Among adults vaccinated in consecutive years, reaction frequencies declined in the second year of vaccination. In clinical trials, serious adverse events were reported to occur after vaccination with TIV at a rate of less than 1%. Adverse events in adults aged 18 years and older reported to VAERS during 1990–2005 were analyzed. The most common adverse events reported to VAERS in adults included injection-site reactions, pain, fever, myalgia, and headache. The VAERS review identified no new safety concerns. Fourteen percent of the TIV VAERS reports in adults were classified as serious adverse events, similar to proportions seen overall in VAERS. The most common serious adverse event reported after receipt of TIV in VAERS in adults was GBS. The potential association between TIV and GBS has been an area of ongoing research (see Guillain-Barré Syndrome and TIV). No elevated risk for prespecified events after TIV was identified among 4,773,956 adults in a VSD analysis.

Then there is efficacy. I have discussed the efficacy of the flu vaccine before. In the hospital, there is no single intervention that will prevent the spread of infection. One of the hallmarks of anti-science/anti-vaxers is a binary approach: either the medical intervention is 100% effective or it is 100% useless. It is rare to see a nuanced discussion of the science behind the efficacy of the flu vaccine on the anti-vax web sites. Success in decreasing transmission of disease is always multifactorial: hand hygiene, cough etiquette, not coming to work when ill (an all-too-common problem), proper isolation for those who may have influenza, and more are part of a multifaceted approach to prevent the spread of infection in hospitals. Vaccines are like Captain Crunch: only part of a healthy breakfast.

The rationale for vaccinating HCW’s is also multifaceted.

We do not want health care providers to be disease vectors for our patients, most of whom are at high risk for bad outcomes from influenza.
Many of our patients may not be vaccinated or be unable to respond to the vaccine (the old and immunoincompetent) and are not protected from influenza.

There are 4 studies that demonstrate when HCW’s are vaccinated, mortality declines in residents of long term care facilities (the current phrase for nursing home). While similar studies have yet to be done in hospitals, there are multiple lines of data that converge on the same conclusion: the more people that are vaccinated against the flu, the fewer people who die.

The Cochrane review, as always with influenza, gets it wrong. While noting that “pooled data from three C-RCTs showed reduced all-cause mortality in individuals >/= 60.”, they go on to say “The key interest is preventing laboratory-proven influenza in individuals >/= 60, pneumonia and deaths from pneumonia, and we cannot draw such conclusions.” No, it is not the key interest. Most deaths from influenza are secondary deaths from exacerbation of underlying medical problems. All-cause mortality is an important endpoint, especially if you are the one dying.

The recent Skeptics Guide to the Universe podcast (#274) had an interview with Ben Goldacre, author of Bad Science and discussed big pharma malfeasance, of which there are endless examples. They noted that the makers of olsetamivir (Tamiflu) did not want to give the unpublished data from clinical trials to the Cochrane group for fear they would make a botch of the data. For once I am sympathetic to big pharma, given the bias and spin (i.e. they do not agree with me) of the Cochrane reviews on influenza treatment and prevention. I would not give my influenza data to the current crop of Cochran flu reviewers if I were a drug company, and I am no fan of the shenanigans that so often define the interactions of pharmaceutical companies and science.

I can, at some level, understand the opposition to mandatory vaccination as a philosophical position, although I see it on par with opposition to mandatory sterile technique in the OR. Many philosophical positions are at odds with reality. But you will excuse me if I neither let you operate in my hospital nor take care of my patients. I cannot see where your philosophy gets to triumph the material safety of patients.

Several institutions and health care systems have instituted mandatory vaccination with good results, achieving 96% and greater vaccination rates.

I get the sense that those who rail against the morbidity and mortality of modern medicine are the same who would decry mandatory vaccination, even though it would improve the safety in the hospital that they so fret about.

I completely support the SHEA/IDSA position. The vaccine is safe, effective, and HCP’s have a ethical and professional imperative to prevent the spread of infection to their patients.

SHEA views influenza vaccination of HCP as a core patient and HCP safety practice with which noncompliance should not be tolerated. It is the professional and ethical responsibility of HCP and the institutions within which they work to prevent the spread of infectious pathogens to their patients through evidence-based infection prevention practices, including influenza vaccination. Therefore, for the safety of both patients and HCP, SHEA endorses a policy in which annual influenza vaccination is a condition of both initial and continued HCP employment and/or professional privileges.

Sounds good to me.

Tonight (Friday Night) we will be moving SBM to a new faster host. This will improve the performance of SBM, which has been sluggish recently, and give us the ability to increase our resources as needed as SBM continues to grow.

Comments posted between Friday night and approximately Sunday morning may be lost in the gap as the location of the new servers propagates through the internet. The site will be up throghout this process, but comments may be lost during this period. We are making the move over the weekend because that is when traffic is lowest. SBM should be fully functional by Monday morning, and in any case I will update this post when it appears that the move is complete.

Thanks for your patience.

In my group practice, the Yale Medical Group, drug-company sponsored lunches and similar events have been banned. This is part of a trend, at least within academic medicine, to create some distance between physicians and pharmaceutical companies, or at least their marketing divisions. The justifications for this are several, and are all reasonable. One reason is the appearance of being too cozy, which compromises the role of academic physicians as independent experts.

But the primary reason is the belief that “detailing” by pharmaceutical sales representatives has a negative effect on the prescribing habits of physicians. There is reason to believe this may be the case because of cases of bad behavior on the part of pharmaceutical marketing divisions – ghost writing white papers, for example. The concern, backed by evidence, is that pharmaceutical companies introduce spin and bias into the information they provide to physicians, whether though CME, detailing, literature, or sponsored lectures. Even when the information itself is not massaged, it is cherry picked, so in the end physicians are not getting a thorough and unbiased assessment of the facts.

The FDA does heavily regulate the marketing of information about pharmaceuticals, but marketers are very clever about exploiting loopholes and seem to be one step ahead of the regulators.

On the other hand there are those who argue that physicians can handle access to information and they are equipped to take it with a grain of salt and put it into context. Certainly most physicians I speak to believe this about themselves. Further, information provided by pharmaceutical companies may actually improve prescribing habits if it makes physicians aware of new products on the market and new information about the drugs they prescribe. The information itself is FDA approved (or at least should be), even if it is selective and wrapped in spin.

You can defend either position based upon plausibility, which is why I have always been most interested in direct evidence of the effect of pharmaceutical detailing on physician prescribing habits. Mark Crislip has written about this issue before, pointing out that the evidence supports a negative effect of pharmaceutical company contact on physician prescribing. While I generally agree with Mark’s opinion, the evidence seemed a bit preliminary to me. More definitive evidence would be useful in both forming my own opinions and advocating for change.

A new  systematic review of the literature has been published in PLOS Medicine – an excellent opportunity to discuss what the actual state of the evidence is. The authors scoured several databases and came up with 58 studies meeting inclusion criteria. These studies looked at amount of prescribing, prescribing cost, and prescribing quality. They found:

Of the set of studies examining prescribing quality outcomes, five found associations between exposure to pharmaceutical company information and lower quality prescribing, four did not detect an association, and one found associations with lower and higher quality prescribing. 38 included studies found associations between exposure and higher frequency of prescribing and 13 did not detect an association. Five included studies found evidence for association with higher costs, four found no association, and one found an association with lower costs. The narrative synthesis finding of variable results was supported by a meta-analysis of studies of prescribing frequency that found significant heterogeneity. The observational nature of most included studies is the main limitation of this review.

There is definitely a trend in the data, skewed toward a negative effect in each of the three areas. The data seems to be the most clear with regard to frequency of prescribing, which makes sense. Physicians cannot prescribe drugs they are not aware of. There is also the availability effect – we will tend to think of things that are accessible, and that is exactly why pharmaceutical reps want to put their drug names all over promotional material. There is likely also an effect from having free samples available to give to patients. When choosing among equivalent drug options, a prescriber might go with the one that they can give as samples to their patient.

More prescribing is not necessarily bad, if it leads to better care. Underprescribing, in fact, is as much of a problem as overprescribing.

The other two measures were less definitive. Five studies showed increased cost, while five showed no association or decreased cost. Also, five studies showed decreased prescribing quality, while five studies showed no association or ambiguous results. To me these are weak outcomes, without a clear answer. While it is difficult to argue for an improvement in either outcome, these distributions of effects are compatible with there being no net association.

The authors are also careful to point out that most of these studies are observational, not experimental, and so inferring cause and effect is not straightforward. Perhaps there is something inherently different about the quality and prescribing habits of physicians who allow themselves to be detailed more often by pharmaceutical reps.

Further, there may be some situation in which detailing improves prescribing, and others where there is a detrimental effect. We cannot assume a homogeneous effect, and if these differences can be teased out this may inform ways in which regulations and policies can be improved.

Conclusion

After reading this review I am still left with the sense that the data on this important question is currently insufficient – it is mostly observational, and on the two most important questions (cost and quality) the evidence (while trending to the negative) is unclear. What is obvious is that better data would be helpful. Larger and better controlled studies are needed to really look deeply into these important questions, and the research needs to go the next step of trying to identify factors that influence the net effect of pharmaceutical companies being a source of information to prescribers.

Meanwhile I think it is prudent to limit access of drug reps to physicians and their offices, including (especially) in the academic setting. If for no other reason such limitations might motivate pharmaceutical companies to improve their behavior. Perhaps they will figure out that it is in their best interest to provide fair and accurate information about their approved drugs, rather than no information at all.

Since the industry is going through a great deal of change over these types of issues recently, it is also a good opportunity to think of ways to change the system. Like it or not, we have a capitalistic system of drug development. This system has many positives, but frustrating negatives as well. I am in favor of careful and thoughtful regulation (not necessarily more regulation) to keep the industry honest and transparent. Some obvious flaws have been exposed, like ghostwriting articles, and this behavior needs to be banned. But perhaps there are ways to allow pharmaceutical companies to fund the distribution of information about their products, and contribute to physician education about the diseases and disorders for which they sell drugs, while providing a layer of insulation from the bias and spin of those who stand to make money from physician prescribing habits.

Regardless of how we move forward, I would like to see better research data on the question of the impact of pharmaceutical marketing on medical care to help guide whatever future course we take.

I have to apologize. There won’t be one of my usual epic posts this week. Fear not, however. I did get another SBM blogger to pinch hit for me in a post that will appear later today. I also had time to write a quick post announcing an initiative we here at SBM are planning for early November.

The reason for the rare occasion of my missing a week, of course, is that I’m participating in the 2010 Lorne Trottier Public Science Symposium in Montreal. Between all the travel, a two hour roundtable discussion featuring Michael Shermer, Ben Goldacre, and yours truly, among others, all organized by the McGill University’s Office for Science and Society. The event was videotaped, and a webcast of the event will be available, as will a webcast of our talks tomorrow. You can trust that I will certainly post links to them after they have been posted on the McGill website, in particular the symposium itself, so you can for yourselves see how much better speakers Michael Shermer and Ben Goldacre are when compared to me.

I’ll also be on the radio on CJAD AM 800 at 10 AM Monday morning with Michael Shermer and “Dr. Joe” Schwarcz to talk about pseudoscience in medicine and other areas.

Yes, I’m having a blast here, having had the opportunity at a leisurely dinner to discuss differences between the quackery situation in England compared to the U.S. and to meet Lorne Trottier. Now I have to fine tune my talk for tomorrow, and it’s late. Oh, well…

Make the lie big, make it simple, keep saying it, and eventually they will believe it

It seems that just about every article about acupuncture makes some reference to it having been used in China for thousands of years. The obvious reason for such a statement is to make the implication that since it’s been around for so long, it must therefore also be effective. Of course, longevity doesn’t argue for efficacy, otherwise everyone would likely agree that astrology is the way to chart one’s life; astrology has been practiced for many more years than acupuncture.

What’s maddening about the acupuncture longevity myth is that it isn’t true, and demonstrably so. In human medicine, “needling” was illustrated in the 17th century by western observers: no points, no “meridians,” just a big awl-like “needle,” driven in with an ivory-handled circular hammer. In addition, the rationale for hammering these little spikes into various spots (of the practitioner’s choosing) was said to be “exactly the same” as Greek humoral medicine (see, Carruba, RW, Bowers, JZ. The Western World’s First Detailed Treatise on Acupuncture: Willem ten Rhijne’s De Acupunctura. J Hist Med Allied Sci (1974) XXIX (4): 371-398).

The same fallacious assertion is repeated (repeatedly) in veterinary medicine. Acupuncture proponents may assert, for example, that acupuncture is “4,000 years old.” While the assertion isn’t true, it’s also ridiculous, since the Chinese hadn’t invented writing 4,000 years ago. Even if the assertion were true, there would be no way to possibly know about it, since no one could have written anything down about the practice.

Regardless, recently, we published the first detailed research paper on the history of veterinary medicine in China. The paper was published in July, in the historical journal Sudhoffs Archiv (Buell, P, May, T, Ramey, D. Greek and Chinese Horse Medicine: Déja Vu All Over Again. Sudhoffs Archiv. 2010: 94: 31-60). It is one of the first papers published that looks at the actual historical source material, and the only one that compares the veterinary medicine of ancient China to contemporary practices in the ancient world.

Based on the historical source material, it can be stated that Chinese veterinary medicine isn’t unique, and it isn’t even particularly Chinese. That is, what is presented to the eager public as the essence of Chinese thought and practice is, in fact, just an adaptation of contemporaneous practices in Greece and the Middle East. In fact, most Chinese practices, such as bleeding, and burning at points, appear in Greek, Egyptian, and Arabic sources long before they were ever mentioned in China. Such practices first appear in China during a period of maximal western influence on China, corresponding with regular traffic on the Silk Road (during Han times, approx. 200 BCE – 200 AD), as well as with the coming of Buddhism, which brought in influences from Indian traditions.

It’s remarkable – and particularly so in the face of all of the modern crowing about the antiquity of acupuncture in animals – that there is no reference to what can even be remotely considered as modern acupuncture in any of the pre-modern Chinese veterinary works (which deal mostly with horses, camels, and water buffalo). This may be due to incorrect translation of the Chinese word zhen, which means “incision” or “penetration,” and also used to describe cauterization and bleeding, but which has been apparently somehow morphed into “acupuncture” anytime that the word appears in Chinese sources. It’s absolutely clear that zhen has nothing to do with modern acupuncture, even as it’s equally clear that acupuncture proponents will insist on misinterpreting the Chinese language to suit their preconceived notions.

The Chinese, as with every other ancient culture, didn’t have much of an idea of horse physiology, and their treatments were based on anecdote and tradition. The fact is that the Chinese didn’t have any better idea about what caused conditions such as colic (abdominal distress) or foot pain than did other cultures, and they really didn’t treat them much differently. Until scientific investigations came along, people didn’t really know what they were doing when it came to practicing medicine. There’s no reason to try to go back to such traditions; there’s especially no reason to do so when they didn’t exist in the first place.

As I pointed out earlier, a rare thing happened this week, namely I don’t have a full post ready for Science-Based Medicine because I’m at the Lorne Trottier Symposium. Not only have the organizers have packed my day with skeptical and science goodness, but I only have Internet access when I’m back at the hotel, which isn’t very often. I suppose I could pay outrageous international roaming charges by activating international roaming on my iPhone, but why on earth would I do that except in urgent circumstances? Fortunately, David Ramey stepped in with his usual excellent work.

The trials and tribulations of actually trying to do more than be at home, work, and blog aside, I couldn’t let this one pass. The ever-observant Mark Crislip sent his fellow SBM bloggers this little tidbit from the website of that well-known promoter of quackery Joe Mercola. Buried near the bottom of Mercola’s “newsletter” is an announcement of this intriguing (from a blog fodder perspective) initiative:

Mercola.com & NVIC Dedicating November 1-6 Vaccine Awareness Week

In a long-scheduled joint effort to raise public awareness about important vaccination issues during the week of November 1-6, 2010, Mercola.com and NVIC will publish a series of articles and interviews on vaccine topics of interest to Mercola.com newsletter subscribers and NVIC Vaccine E-newsletter readers.

The week-long public awareness program will also raise funds for NVIC, a non-profit charity that has been working for more than two decades to prevent vaccine injuries and deaths through public education and protecting informed consent to vaccination.

The November 1-6 Vaccine Awareness Week hosted by Mercola.com and NVIC will follow a month-long vaccine awareness effort in October that was recently announced on Facebook by parents highlighting Gardasil vaccine risks.

The six-week-long focus this fall on vaccine issues will help raise the consciousness of many more Americans, who may be unaware that they can take an active role in helping to prevent vaccine injuries and deaths and defend the legal right to make voluntary vaccination choices.

And remember, you can always visit Vaccines.Mercola.com and NVIC.org for the latest vaccine news updates and other important vaccine information.

“Six week” focus? Methinks Dr. Mercola meant “six days.”

Be that as it may, Mercola and Fisher apparently think that their simply declaring the first week of November to be “Vaccine Awareness Week” will make it so. Of course, there actually is an Immunization Awareness Week here in Canada, but it was six months ago. In the U.S., August is National Immunization Awareness Month. Still, if anti-vaccine loons want to make the first week of November “Vaccine Awareness Week” in order to peddle their pseudoscientific and dangerous misinformation claiming that vaccines cause autism and various maladies, I say we let them have it.

Just not in the way they expected.

So, given the power invested in me as editor of Science-Based Medicine and the power of my fellow partners in crime at SBM (which is the same power Joe Mercola and Barbara Loe Fisher, except that we have science on our side), we at SBM hereby second the call to declare November 1-6, 2010 “Vaccine Awareness Week.” As part of the activities that week, we at SBM plan on spending more time than usual–perhaps even all of our posts that week–emphasizing the dangers of the anti-vaccine movement and providing science-based rebuttals of the lies of the anti-vaccine movement. In particular, we will concentrate on whatever propagandistic misinformation Joe Mercola and Barbara Loe Fisher decide to publish that week. Given whatever persuasive power we have as bloggers at what is a well-respected medical blog, I now request that any and all medical and skeptical bloggers out there also take advantage of Vaccine Awareness Week to do the same. I’ve already taken advantage of proximity here in Montreal to speak with Ben Goldacre and will be contacting other bloggers after I arrive home from Montreal. Tomorrow I’ll have a chance to meet with Randi.

Joe Mercola and Barbara Loe Fisher want to declare a week “Vaccine Awareness Week” in order to bury readers in a deluge of pseudoscience? Let them! Surely we can do better than they can and make sure that when anyone Googles “vaccine awareness,” what is found is not the current list of anti-vaccine pseudoscience but rather a flood of rational, science-based discussions of vaccines and refutations of the lies of the anti-vaccine movement. What I’d love to see from November 1-6 are a tsunami (word choice intentional) of posts that:

• Include science-based discussions of the safety and efficacy of vaccines
• Include science-based refutations of anti-vaccine misinformation
• Specifically refute posts by Joe Mercola and Barbara Loe Fisher during that week. (You can throw in Age of Autism, too, if you like.)

Spread the word and join the crusade. Anti-vaccine pseudoscience is pseudoscience that hurts and kills children.

Dr. Novella  has recently written about this year’s seasonal flu vaccine and Dr. Crislip has reviewed the evidence for flu vaccine efficacy.

There’s one little wrinkle that they didn’t address — one that I’m more attuned to because I’m older than they are.  I got my Medicare card last summer, so I am now officially one of the elderly. A recent review by Goodwin et al. showed that the antibody response to flu vaccines is significantly lower in the elderly.  They called for a more immunogenic vaccine formulation for that age group. My age group.

One manufacturer has responded. Fluzone High-Dose vaccine contains 60 mcg of hemagglutinin antigen from each strain, compared to 15 mcg in the standard dose vaccine. This high-dose preparation has been tested in three clinical studies (here, here, and here) of 4453 healthy people aged 65 years and older.   In each of these studies the high-dose vaccine produced significantly higher antibody levels than the standard dose vaccine. There was a dose-related increase in minor local side effects (arm pain, redness and swelling at the injection site) but no increase in serious adverse effects. Most recipients had minimal or no adverse effects. We don’t yet have data to prove that the increase in antibody titers will result in fewer clinical influenza illnesses and complications, but it seems logical that it would. A study comparing the effectiveness of Fluzone High-Dose to Fluzone is expected to be completed in 2012. The high-dose vaccine is more expensive, but Medicare pays for it.

 The Medical Letter recently covered the 2010-2011 flu vaccines and did not recommend (or advise against) the high-dose formulation for older patients, because the clinical efficacy data are not yet available. Neither the CDC nor the ACIP has been willing to express a preference for one vaccine over another at this time. I asked our own infectious disease expert, Dr. Crislip, and he recommends the high-dose in view of its improved immunogenicity and biological plausibility. 

I’m 65 and my husband is older: we opted for the high-dose vaccine. Not everyone will agree, but shouldn’t older patients be given the facts and the option?

A couple of weeks ago, in a review of the Mayo Clinic Book of Home Remedies, Harriet Hall expressed relief that she hadn’t found any “questionable recommendations for complementary & alternative medicine (CAM) treatments” in that book:

Since “quackademic” medicine is infiltrating our best institutions and organizations, I wasn’t sure I could trust even the prestigious Mayo Clinic.

The Home Remedies book may be free of woo, but Dr. Hall was right to wonder if she could trust the Mayo Clinic. About a year ago I was asked to comment on an article in the American Journal of Hematology, in which investigators from the Mayo Clinic reported that among a cohort of lymphoma patients who were “CAM” users,

There was a general lack of knowledge about forms of CAM, and about potential risks associated with specific types of CAM…

This suggests the need to improve access to evidence-based information regarding CAM to all patients with lymphoma.

No surprise, that, but I couldn’t help calling attention to the paradox of one hand of the Mayo Clinic having issued that report even as the other was contributing to such ignorance:

The Mayo Clinic Book of Alternative Medicine details dozens of natural therapies that have worked safely for many patients in treating 20 top health issues. You may be surprised that Mayo Clinic now urges you and your doctor to consider yoga, garlic, acupuncture, dietary supplements and other natural therapies. Yet the record is clear. Many of these alternative therapies can help you achieve reduced arthritis pain, healthier coronary arteries, improved diabetes management, better memory function and more.

Nor could such a paradox be explained by the right hand not having known what the left was doing: Brent Bauer, MD, the Director of the Mayo Clinic Complementary and Integrative Medicine Program, is both the medical editor of the Book of Alternative Medicine (MCBAM) and a co-author of the article in the AJH.

As chance would have it, I had picked up a copy of the latest (2011) edition of the MCBAM only a couple of days before Dr. Hall’s post. Does it live up to its promises? Do its “straight answers from the world’s leading medical experts” respond to “the need to improve access to evidence-based information regarding CAM?” Let’s find out. In some cases I’ll state the implied questions and provide the straight answers.

The Introduction

In the Introduction, Dr. Bauer asserts that “an opportunity has risen that may hold the promise of a new paradigm for better health.” He makes several, implicit or explicit assertions that are repeated throughout the book:

The best way to manage an illness is to prevent it from happening in the first place…It’s in this environment—one in which Americans are seeking greater control of their health—that we’ve seen explosive growth in the field of alternative medicine. People are looking for more “natural” or “holistic” ways to maintain good health…

The implied question: Should people be looking for such things? Is there anything useful in “alternative” (or “natural” or “holistic” or “integrative”) medicine, different from what modern medicine and public health have learned by rational inquiry, for preventing an illness?

The straight answer: No.

Dr. Bauer goes on:

By combining the best of complementary and conventional health care practices to meet your individual needs, you’ll be practicing integrative medicine.

The implied question: Do the world’s leading medical experts know which are the “best complementary” practices, or even if any of them work?

The straight answer: No. Most “alternative” or “complementary” practices are known not to work or are vanishingly unlikely to work. Exceptions are a few botanical medicines, but these are overhyped and are disadvantageous compared to purified, precisely dosed, well-studied pharmaceuticals. Other claimed exceptions, such as rational diets, exercise, manual techniques for musculoskeletal complaints, and relaxation techniques, are not “alternative” at all.

Dr. Bauer again:

…an increasing number of treatments once considered “on the fringe” are slowly being incorporated into conventional medicine.

The implied question: If this true, is it because those treatments have been shown to be effective?

The straight answer: No. Over the past several years, an increasing number of treatments once considered promising by naïve “alternative medicine” proponents have been tested in clinical trials and shown to be ineffective. R. Barker Bausell, the former Director of Research at the University of Maryland Complementary Medicine Program, reviewed this literature for his 2007 book, Snake Oil Science; the Truth About Complementary and Alternative Medicine:

Because of its emphasis upon high-quality scientific evidence, this book could not have been written in April 1999…Now, however, enough evidence has accumulated to permit the first scientific evaluation of complementary and alternative medicine. [p. xv]

And what did Bausell’s evaluation reveal?

There is no compelling, credible scientific evidence to suggest that any CAM therapy benefits any medical condition or reduces any symptom (pain or otherwise) better than a placebo. [p. 254]

Edzard Ernst, the most prolific “CAM” researcher of the past 20 years, offered similar conclusions in his 2008 book, co-authored with Simon Singh, Trick or Treatment: the Undeniable Facts about Alternative Medicine:

The bottom line is that none of the above treatments (herbal medicine, chiropractic, acupuncture, homeopathy) is backed by the kind of evidence that would be considered impressive by the current standards of medical research. Those benefits that might exist are simply too small, too inconsistent and too contentious. Moreover, none of these alternative treatments (apart from a few herbal medicines) compare well against the conventional options for the same conditions. This dismal pattern is repeated [for] many more alternative therapies. [pp. 238-9]

Back to the Mayo Clinic’s Bauer:

…what’s considered alternative today may be conventional tomorrow. In addition, using a particular therapy to treat one condition may be an accepted medical practice, but using it to treat another condition may not. A case in point is chiropractic care. There are numerous studies to back up the effectiveness of chiropractic therapy for low back pain. However, use of chiropractic techniques to treat high blood pressure would still be considered an alternative practice by many because there’s not sufficient evidence that it’s effective.

The implied question: Does this mean that there is likely to be sufficient evidence in the future? In other words, is there any anatomic or physiologic basis for predicting that chiropractic “care” might treat high blood pressure?

The straight answer: No. The idea is so implausible (and dangerous, in the case of neck manipulation) that it would be unethical to perform trials.

In the introduction, Bauer also makes these promises:

The purpose of Mayo Clinic Guide to Alternative Medicine 2011 isn’t only to inform you about various products and practices, but to guide you as to which appear to be of benefit and may help treat or prevent disease and which are of no benefit and could even be dangerous.

Let’s see whether those promises are fulfilled as we move on to a few specific treatments.

“Our Top 10″

Sorry that the picture below didn’t come out sharply enough, but here are the two paragraphs at its top—a weasel wordfest similar to the book as a whole:

Here’s a brief rundown of what we consider to be the best integrative therapies at this point in time.

Research into complementary and alternative medicine is rapidly evolving. New studies are coming forward on an increasingly frequent basis and, many times, new studies conflict with older studies. To complicate matters even more, different forms can have different effects. This makes it difficult to state with authority which therapies are truly “the best.” However, we’ve listed what we consider to be the top 10.

Notice that the list is in alphabetical order, so we’re not told which of these ‘therapies’ the Mayo Clinic really likes. Notice, also, that the column on the right has to do with popularity, not validity. Most of the Top 10 are not “CAM” at all, as long as they’re used for rational purposes: guided imagery, hypnosis, meditiation, music therapy, spirituality and yoga for “stress” or pain, spinal manipulation for low back pain, massage for pain, and Tai chi for “balance and strength.”

On the other hand, aren’t most people expecting more for their “CAM” dollars? Can’t guided imagery, for example, recruit lymphocytes to fight cancer? Doesn’t massage remove toxins and “increase cytotoxic capacity“? Can’t intercessary prayer improve outcomes of serious diseases? Isn’t spinal manipulation also for health maintenance and for treating ADHD, asthma, infantile colic, otitis media, and many other problems? The Mayo Clinic Book of Alternative Medicine offers no straight answers—if it offers answers at all—to such questions.

The book has a system of “stop-lights” to let readers know whether it considers various methods to be “generally safe for most people to use, and studies show it to be effective” (green), “use the therapy with caution” (yellow), or “not to use the treatment or to use it very carefully and only under a doctor’s supervision” (red). The last recommendation is repeated throughout the book:

Even when a green light is present, it’s still important that you discuss the treatment with your doctor and use it appropriately.

Hmmm. Readers are also told in this book that “a naturopathic physician is a primary health care provider trained in a broad scope of naturopathic practices in addition to a standard medical curriculum” (the straight answer: No), and will have been assured elsewhere that “The proper title for a doctor of chiropractic is ‘doctor’ as they are considered physicians under Medicare and in the overwhelming majority of states.”

Let’s briefly look at the book’s discussions of a few methods.

Acupuncture

The book gives this Top Tenner a “shining green light”:

Our Take

Acupuncture has been used at the Mayo Clinic since the 1970s. Mayo Clinic has licensed acupuncturists on staff. When performed properly by trained practitioners using sterile needles, acupuncture has proved to be a safe and effective therapy. A review of acupuncture by the World Health Organization found it was an effective treatment for 28 conditions and there was evidence to suggest it may be effective for several more.

The straight answer: No.

Chiropractic

The “Hands-on Therapies” chapter was written by Ralph Gay, MD, DC. Here is his entire description of the conceptual basis of chiropractic:

Chiropractic treatment is based on the concept that restricted movement in the spine may lead to pain and reduced function. Spinal adjustment (manipulation) is one form of therapy chiropractors use to treat restricted spinal mobility. The goal is to restore spinal movement and, as a result, improve function and decrease back pain.

Dr. Gay has somehow omitted any discussion of the central dogma of chiropractic: the subluxation. He is aware of it, of course; elsewhere he calls it “a good theory.”

Here, Dr. Gay comments on reflexology:

Among most conventional doctors, the theory behind reflexology is a little difficult to grasp.

Uh, no kidding, but that doesn’t stop him from asserting that “preliminary evidence” for reflexology reducing menopause symptoms requires “further research.” What the hay, asks Dr. Gay, “Why does any form of treatment work?”

Energy Therapies

Nurse Susanne Cutshall informs us that

Energy based therapies may be among the most controversial practices because of the difficulty in convincingly using any biophysical means to measure the effects of some therapies. However, active investigations are being conducted at academic medical centers, including Mayo Clinic, and energy medicine, in general, is gradually gaining popularity.

Ah, the magical effects of the euphemism (”difficulty”), the pseudoscientifc (”biophysical means”), the weasel words (”convincingly,” “some”), and the bait-and-switch (”active investigations” begets ”popularity”). You won’t learn, in this discussion, of the diffculty in convincingly using any human means to measure the effects of some therapies.

Homeopathy

Rheumatologist Nisha Manek discusses “other approaches”: Ayurveda, homeopathy, naturopathy, and Traditional Chinese Medicine:

Treatments that comprise alternative medical systems focus on prevention and on achieving a healthy ‘balance.’ They promote diet, exercise, sleep, and daily routines to maintain wellness and encourage healing.

Jeez, there musta been something other than their alternative medical systems to explain why China and India have suffered from terrible plagues and other ills, even within the last few decades. Not to put too fine a point on it.

What about those medical systems that we honkies can call our own? We’ve already heard from the Mayo regarding naturopaths. Homeopathy gets a “yellow light” (how responsibly cautious!):

Homeopathic medicine is popular. However, it lacks good studies to prove its effectiveness. Studies that have been done have generally been small and have produced conflicting results. In general, the scientific community also finds the theories on which homeopathic medicine is based questionable and difficult to accept. These factors have kept it from being widely accepted into mainstream medicine.

Phew. Such language—with its suggestion that it is the lack of good studies that holds homeopathy down, its implicit call for more studies, its coy suggestion that it isn’t so much that the “theories are questionable” but that the scientific community is, well, too closed-minded to accept them—is so prevalent in this book that it makes me weary, so let’s quickly wrap this up. The straight answer: No.

The Need to Obfuscate

I should mention that not every method discussed in this book is given a green or even a yellow light. I can imagine that proponents are accusing me of selective quoting, and that’s true to an extent. It is a justifiable extent, however, because what I’ve discussed is more than sufficient to disqualify the Mayo Clinic authors from any claim to responsible reporting.

What’s most noticeable about the tone of the book is it’s ponderous, ditzy blandness (if there is any hope that woo-philic readers will tire when they finally realize that they are being treated like small children, this book will be invaluable). Such blandness, of course, is common to apologetic, quackademic expositions. So are the misleading language devices mentioned above (and more: chiropractic becomes “chiropractic care”; homeopathy becomes “homeopathic medicine,” which “seeks to stimulate the body’s ability to heal itself by giving small doses of highly diluted substances [that] are derived from natural substances,” and so forth).

“Today’s New Medicine,” as the Mayo book also calls it, is thus new because, well, it’s promoters call it “new“. No surprise that the authors tout the Bravewell Collaborative’s Consortium of Academic Health Centers for Integrative Medicine, a great wellspring of Quackademic Newspeak. But we’ve known that the Mayo Clinic has been in bed with Bravewell for years.

Bloodletting, of course, was a major aim of early vessel therapy and is frequently described in the Su wen.¹

Paul U Unschuld

“Cargo cult” is a metaphor that describes the act of imitating an activity or a practice without any insight into the underlying principles. In the literal sense, it refers to a magico-religious practice observed in tribal societies, where the members ritually imitate the activities of a technologically-advanced society they had contact with, so that they can magically draw their material wealth. For instance, after WWII, indigenous tribes in New Guinea who had come in close contact with cargo planes, started to build landing strips and populated them with plane-like effigies that were made of straw, bamboo, and coconuts, so that they can magically lure the passing planes.² The term “cargo cult science” was introduced by Richard Feynman in a speech at Caltech in 1974 to describe pseudoscientific studies in which all the superficial aspects of a scientific inquiry are adhered to, but the underlying principles are not scientific. He classified many educational and psychological studies as such, for having the appearance of academic research but lacking the principles of a scientific inquiry.³

Another example of cargo cult science is the plethora of two-arm acupuncture studies that compare a needling regimen using the traditional concepts, and compare it with a non-interventional placebo. These studies might have the appearance of clinical research, but they are inherently flawed and inconclusive, because they do not rule out the possibility that the observed results are mainly due to the painful stimulus and injury caused by a needle, which can occur regardless of the insertion point. Indeed, an acute noxious stimulus from a prickle, heat, or any other painful stimulus – almost anywhere on the skin – can attenuate the perception of pain in another area of the body through a reflex called “counter-irritation,” also called the “pain-inhibiting-pain effect” or “diffuse noxious inhibitory control” (DNIC).⁴ DNIC was extensively studied by Fauve et al. in the 1980s, who showed in mice that it has an effect equivalent or superior to that of glucocorticoids.^5,6

Counter-irritation has been known since antiquity, and is at the base of many noxious folk remedies, such as the application of cautery, blistering and moxibustion (the burning of dried Artemisia annua on the skin) to name but a few, whereby “one pain masks another.”⁷ These modalities were once widely used, generally in an attempt to reduce inflammation.⁹ It is therefore plausible that the nonspecific effects observed in some types of acupuncture are also linked to DNIC, since some authors have reported that acupuncture is only effective in producing analgesia when the stimulation itself is of a sufficient intensity to cause an unpleasant sensation. The DNIC induced by needles is believed to be mediated by the release of endogenous opioid neuropeptides and/or monoaminergic neurotransmitters, mainly because naloxone, a central and peripheral opioid receptor antagonist, is reported to reverse its effects.^10,11 A true interpretation of this finding invalidates the traditional lore of the meridian-and-points system, and indicates that any needling regimen can lead to outcomes associated with DNIC. This finding echoes the position of Felix Mann, MD, the founder of the British Medical Acupuncture Society, who after decades of practice reached the conclusion that putting needles in “wrong” places was as effective as a “correct” treatment. He therefore wrote that “traditional acupuncture points are no more real than the black spots a drunkard sees in front of his eyes.”¹²

There is also credible evidence that the stimulation of a myofascial trigger point (TrP), meaning a localized, hyperirritable nodule nested within a palpable taut band of skeletal muscle or fascia,¹³ can evoke short-term anti-nociceptive effects on the same segmental dermatome.¹⁴ This local hypoalgesic effect is reported to be greater than stimulation at remote dermatomes.¹⁵ It is based on this finding, that Janet Travell, MD, (1901-1997) began needling hyperirritable points with syringes in in the 1940s, injecting them first with procaine.¹⁶ Procaine was later replaced by saline solution,¹⁷ which was later replaced by “dry needling” (TrP-DN ) — without any fluid in the syringe.^18,19 Although the dermatomal distributiosn of anti-nociceptive effects do not correspond to the distribution of the Chinese meridians, they do affect the outcome of two-arm studies because any needling regimen in the same dermatome should lead to similar results. Therefore, two-arm studies cannot rule out the possibility that the observed results are due to anti-nociceptive effects on the same segmental dermatome, which can occur regardless of the classical theories for point selection and means of stimulation.²⁰

In addition, both laboratory and clinical evidence have recently shown the existence of two-way interactions between the nervous system and the innate immunity. There is experimental evidence showing that percutaneous and transcutaneous neurostimulation can inhibit macrophage activation and the production of pro-inflammatory cytokines.²¹ Kevin J Tracey, MD and his collogues at Feinstein Institute for Medical Research have shown that an increase in the production of Acetylcholine (ACh) can inhibit the synthesis of TNF and other pro-inflammatory cytokines in organs rich in cells of the monocyte-macrophage system.²² Tracey argues that Ach interacts with members of the nicotinic ACh receptor (nAchr) family, in particular with the alpha-7 subunit (?7nAchr), which is expressed not only by neurons, but also macrophages and other cells involved in the inflammatory response.²³ It is therefore conceivable that the anti-inflammatory actions that have been associated with needling – and have been used to justify the traditional concepts of acupuncture – are directly or indirectly mediated by neurostimulation and inflammatory macrophage deactivation, and can occur with transcutaneous or percutaneous neuromodulation anywhere proximal to nerves.²⁴ This is consistent with the hypothesis of George A. Ulett and Songping Han, who argued that certain effects of needling, especially in the ear, might be explained by a “broad parasympathetic effects” due to the stimulation of vagus nerve, which also innervates the ear.²⁵ Again, two-arm studies cannot rule out the possibility that the observed results are due to the broad neurostimulatory effects of needling, and regardless of the needling regimen.

In sum, for the reasons stated above, two-arm acupuncture studies that compare a traditional regimen with a non-interventional placebo are inherently inconclusive. I would further argue that the regimen used in these studies is not even reflective of the traditional methods, because the loci of cautery, blistering, cupping, moxibustion and acupuncture might have been selected simply because they were particularly sensitive and painful, and the alleged analgesic and anti-inflammatory effects of traditional regimens are not achievable by the “soft needling” technique used in clinical studies today. These studies unequivocally use quasi-unperceivable, painless, filiform, silicon-coated needles for ethical reasons and to prevent dropouts. This type of “acupuncture without tears” amounts to what Arthur Taub has suitably called “nonsense with needles.”²⁶

Finally, the most compelling argument to qualify acupuncture of a cargo cult, is the fact that its apostles remain obstinately faithful that someday, someone will prove that “astrology with needles” is a panacea that can naturally restore health and longevity. This is despite the fact that well-conducted three-arm clinical trials that used sham controls with needle insertion at “wrong” points (points not indicated for the condition) or non-points (locations that are not known acupuncture points) along with a non-interventional control group, have failed to demonstrate that there is a reliable difference between sham and “true” needling. Three well-designed three-armed randomized controlled clinical trials with 302, 270, and 1007 patients, respectively, have demonstrated that acupuncture and sham acupuncture treatments were more effective than no treatment at all, but there was no statistically significant difference between true and sham acupuncture,^27,28,29 suggesting that it does not have unique effects on the central nervous system, or on pain and pain modulation.³⁰ These studies indicate that the “meridional theory” is of low importance, and does not lead to specific therapeutic effects.^31,32 The most recent challenge came from a review article in the New England Journal of Medicine which concluded that acupuncture’s specific therapeutic effects – if any – are small, and its benefits are mostly attributable to “contextual and psychosocial factors, such as patients’ beliefs and expectations, attention from the acupuncturist, and highly focused, spatially directed attention on the part of the patient.”³³

I see the pointless studies that aim to validate notions that date of Galen’s era, and hear the irrational narrative of the apostles of this cargo cult at the twilight of a dying hope, and I think of Baudelaire’s morose elegy to “The Swan:”

A swan which from its cage had made escape
Patting the torrid blocks with webby feet,
Trailing great plumes of snow, while beak agape
Tumbled for water in the parching street;

Wildly it plunged its wings in dust again,
Mourning its native lake, and seemed to shrill:
“Lightning, when comest thou? and when, the rain?”
Strange symbol! wretched bird, I see it still.³⁴

Charles Baudelaire (1821 – 1867), Flowers of Evil

---

1. Unschuld PU. Huang Di Nei Jing Su Wen: Nature, Knowledge, Imagery in an Ancient Chinese Medical Text. University of California Press. 2003
2. Lawrence P. Road belong cargo: a study of the Cargo Movement in the Southern Madang District, New Guinea. Manchester University Press, 1964.
3. Feynman RP. Surely You’re Joking, Mr. Feynman! (Adventures of a Curious Character). W. W. Norton & Company. 1997.
4. Follett K. Neurosurgical Pain Management. Elsevier Health Sciences. 2004
5. Fauve RM, Fontan E, Hevin MB, Saklani H, Parker F. Remote effects of inflammation on non-specific immunity. Immunol Lett. 1987;16(3-4):199-203.
6. Fauve RM. Endogenous counterinflammation and immunostimulation [in French]. Pathol Biol (Paris). 1987;35(2):190-194.
7. Wand-Tetley JI. Historical methods of counter-irritation. Ann Phys Med 1956;3:90–8
8. Le Bars D, Dickenson AH, Besson J-M, Villaueva L. Aspects of sensory processing through convergent neurons. In: Yaksh TL, ed. Spinal afferent processing. New York: Plenum, 1986: 467–504.
9. Holden AV, Winlow W. The Neurobiology of Pain: Symposium of the Northern Neurobiology Group, Held at Leeds on 18 April 1983. Manchester University Press. 1984.
10. Pomeranz B, Chiu D. Naloxone blockade of acupuncture analgesia: endorphin implicated. Life Sci. 1976;19:1757-1762.
11. Zhou ZF, Du MY, Wu WY, Jiang Y, Han JS. Effect of intracerebral microinjection of naloxone on acupuncture- and morphineanalgesia in the rabbit. Sci Sin. 1981;24:1166-1178.
12. Mann F. Reinventing Acupuncture: A New Concept of Ancient Medicine. Butterworth-Heinemann; 2 edition. 2000.
13. Simons DG. Review of enigmatic MTrPs as a common cause of enigmatic musculoskeletal pain and dysfunction. J Electromyogr Kinesiol 2004; 14: 95–107.
14. Srbely JZ, Dickey JP, Lee D, Lowerison M. Dry needle stimulation of myofascial trigger points evokes segmental anti-nociceptive effects. J Rehabil Med. 2010 May;42(5):463-8.
15. White PF, Craig WF, Vakharia AS, Ghoname E, Ahmed HE, Hamza MA. Percutaneous neuromodulation therapy: does the location of electrical stimulation effect the acute analgesic response? Anesth Analg. 2000 Oct;91(4):949-54.
16. Travell J, Rinzler S, Herman M. Pain and disability of the shoulder and arm: treatment by intramuscular infiltration with procaine hydrochloride. JAMA. 1942;120:417-422.
17. Sola AE, Kuitert JH. Myofascial trigger point pain in the neck and shoulder girdle. Northwest Med. 1955;54:980-984.
18. Kraus H. Clinical Treatment of Back and Neck Pain. New York, NY:McGraw-Hill; 1970.
19. Dommerholt J, Huijbregts P. Myofascial Trigger Points: Pathophysiology and Evidence-Informed Diagnosis and Management. Jones & Barlett Learning. 2009.
20. Baldry PE. Acupuncture, Trigger Points and Musculoskeletal Pain. Edinburgh, UK: Churchill Livingstone, 2005.
21. Wang H, Yu M, Ochani M, et al.Nicotinic acetylcholine receptor alpha7 subunit is an essential regulator of inflammation. Nature. 2003;421:384-8.
22. Tracey KJ. The inflammatory reflex. Nature. 2002;420:853-859.
23. van Maanen MA, Vervoordeldonk MJ, Tak PP. The cholinergic anti-inflammatory pathway: towards innovative treatment of rheumatoid arthritis. Nat Rev Rheumatol. 2009 Apr;5(4):229-32.
24. Tracey KJ. Physiology and immunology of the cholinergic antiinflammatory pathway. J Clin Invest. 2007;117(2):289-296.
25. Ulett GA, Han S. The Biology of Acupuncture. St Louis, MO:Warren H. Green; 2002.
26. Taub A. Nonsense with Needles. In Barrett S and Jarvis W. The Health Robbers: A Close Look at Quackery in America. Prometheus Books, Amherst, NY. 1993. Article available online at http://www.acuwatch.org/general/taub.shtml
27. Linde K, Streng A, Jurgens S, Hoppe A, Brinkhaus B, Witt C, Wagenpfeil S, Pfaffenrath V, Hammes MG, Weidenhammer W, Willich SN, Melchart D. Acupuncture for patients with migraine: A randomized controlled trial. JAMA 2005;293:2118-2125.
28. Melchart D, Streng A, Hoppe A, Brinkhaus B, Witt C, Wagenpfeil S, Pfaffenrath V, Hammes M, Hummelsberger J, Irnich D, Weidenhammer W, Willich SN, Linde K. Acupuncture in patients with tension-type headache: Randomised controlled trial. BMJ 2005;331(7513):376-382.
29. Scharf HP, Mansmann U, Streitberger K, Witte S, Kramer J, Maier C, Trampisch HJ, Victor N. Acupuncture and knee osteoarthritis: A three-armed randomized trial. Ann Intern Med 2006;145:12-20.
30. Campbell A. Point specificity of acupuncture in the light of recent clinical and imaging studies. Acupunct Med 2006;24(3):118-122.
31. Moffet HH. Sham acupuncture may be as efficacious as true acupuncture: a systematic review of clinical trials. J Altern Complement Med. 2009 Mar;15(3):213-6.
32. Moffet HH. Acupuncture trial lacks a priori rationale to refute null. hypothesis. Arch Intern Med. 2008 Mar 10;168(5):550-1.
33. Berman BM, Langevin HH, Witt CM, et al. Acupuncture for chronic low back pain. N Engl J Med 2010 Jul 29; 363(5):454-61.
34. Shanks LP. Flowers of Evil. Ives Washburn. New York, 1931.

Any promoter of science-based medicine often faces the question – what’s the harm? What is the harm if people try treatment modalities that are not based upon good science, that are anecdotal, or provide only a placebo benefit? There are generally two premises to this question. The first is that most “alternative” placebo interventions are directly harmless. The second is that direct harm is the only type worth considering. Both of these premises are wrong.

The pages of SBM are filled with accounts of direct harm from unscientific treatments: argyria from colloidal silver, death from chelation therapy, infection or other complications from acupuncture, burns from ear candling, stroke from chiropractic neck manipulation – the list goes on. You can read anecdotal accounts of such harm on the website, whatstheharm.net. Of course, as we often point out, harm and risk is only one end of the equation – one must also consider benefit. It is the risk/benefit ratio of an intervention that is important. But generally we are talking about interventions that lack any evidence for benefit, and therefore any risk of harm is arguably unacceptable.

But perhaps the far greater harm comes from indirect causes. I was reminded of this with the publication of a study looking at flu vaccine uptake in 9 countries. They found that among older individuals who did not get the flu vaccine there was an increase in negative attitudes toward the vaccine, but also there was an increase in the use of traditional unscientific interventions. Cause and effect here is likely to be complicated. People who rely upon folk remedies may feel that they do not need the flu vaccine. Also, those who do not trust in the vaccine may then seek out alternatives. It is likely also true that the subculture of “alternative” medicine simultaneously fosters both a belief in unscientific treatments and a mistrust of mainstream science-based interventions.

The study authors conclude:

The hypothetical framework can be used to guide healthcare providers in developing strategies to foster normative beliefs of older people in vaccination, provide effective action cues and promote vaccine access.

“Normative beliefs” is a technical way of referring to the fact that promoters of “alternative” modalities tend to foster bizarre and unscientific beliefs in the public. Dubious treatments are often marketed with false notions about biology, physiology, and anatomy. It turns out, the iris of the eyes do not contain a functional map of the body (nor does the bottom of the foot). There is no human energy field or biofield or chi. Acupuncture points have not basis in reality. Magnets do not attract the iron in our blood. And toxins do not build up in our tissues, causes most diseases.

The consequences of fostering incorrect notions about human physiology and the nature of health and disease are difficult to measure or quantify, but they should not be ignored as a significant source of indirect harm from unscientific treatments.

The marketing of unscientific treatments often involves warning potential customers away from mainstream medicine, or at least downplaying the effectiveness of science-based treatments or overstating their risks. One does not have to look beyond any pro-CAM website to see articles scaring the public off science-based treatments side by side with advertisements for unscientific alternatives. The internet is unfortunately full of commercialized websites working directly against efforts to create “normative beliefs” in the public.

Belief in ineffective treatments and mistrust of science-based treatments may lead to delay in effective treatment and worse outcomes. In addition they create financial harm, which is increasingly important as health care costs rise. Financial harm can be extreme in cases of the desperation caused by serious illnesses. Tens of thousands of dollars are spent, for example, to send one patient to a fraudulent stem cell clinic. This financial harm is not limited to the patient or their family, as often such treatments are funded by charity from extended family, friends, and colleagues.

There is further psychological harm from creating false hope. I have personally seen the crushing effects such false hope can create when reality finally sets in. This can also significantly delay the process of psychologically dealing with a serious illness, which further affects important decision making about care. Wasting time of worthless treatments can also rob the terminally ill of precious time spent with loved-ones.

Further, the allure of unrealistic treatments diverts scarce resources (hospital space, research time and money) away from more fruitful modalities.

Conclusion

The ripple effect of harm that flows from  unscientific medical beliefs is multifarious and significant, but often neglected by those who are not familiar with the phenomenon. “What’s the harm” is therefore a question we will have to answer frequently and for the foreseeable future.