Josephine P. Briggs, M.D.

Director, National Center for Complementary and Alternative Medicine

Dear Dr. Briggs,

As you know, we’ve met twice. The first time was at the Yale “Integrative Medicine” Symposium in March. The second was in April, when Drs. Novella, Gorski and I met with you for an hour at the NCCAM in Bethesda. At the time I concluded that you favor science-based medicine, although you are in the awkward position of having to appear ‘open-minded’ about nonsense.

More about that below, but first let me address the principal reason for this letter: it is disturbing that you will shortly appear at the 25th Anniversary Convention of the American Association of Naturopathic Physicians (AANP). It is disturbing for two reasons: first, it suggests that you know little about the tenets and methods of the group that you’ll be addressing; second, your presence will be interpreted as an endorsement of those methods and of that group—whether or not that is your intention. If you read nothing more of this letter or its links, please read the following articles (they’re “part of your education,” as my 91 y.o. mother used to say to me):

Naturopathy: A Critical Appraisal

Naturopathy, Pseudoscience, and Medicine: Myths and Fallacies vs Truth

The first article is an introduction to the group to which you will be speaking; the second is my response to complaints, from that group and a few of its apologists, about the first article. It was a surprise to me that the editor, George Lundberg, preferred that I make my response a comprehensive one.

Thus the second article inevitably became the crash course—call it CAM for Smarties—that your predecessors never offered you, replete with examples of useless and dangerous pseudoscientific methods, real science being brought to bear in evaluating such methods, proponents’ inaccurate or cherry-picked citations of biomedical literature, bits of pertinent but little-known history, the standard logical fallacies, embarrassing socio-political machinations, wasteful and dangerous ‘research’ (funded—unwittingly, I’m sure—by the NCCAM), bait-and-switch labeling of rational methods as “CAM,” vacuous assertions about ‘toxins’ and ”curing the underlying cause, not just suppressing the symptoms,” anti-vaccination hysteria, misleading language, the obligatory recycling of psychokinesis claims, and more.

Please excuse me if this sounds preachy; I admit that it does, but understand that I’m writing in good faith. My own views of “CAM” did not dawn on me overnight, but were the result of years of research. My ‘internship,’ as it were, consisted of sitting on a state commission from the fall of 2000 until the spring of 2002, listening to AANP members (including at least one with whom you will share the podium), reading about ‘naturopathic medicine,’ and attempting (unsuccessfully) to engage its advocates in rational discussion. I began that task open to forming opinions based on whatever information became available; by its end it had become abundantly clear that the group is best characterized as a pseudoscientific cult, and nothing since has altered that opinion.

Regarding your presence at the convention being tantamount to an endorsement of ‘naturopathic medicine,’ this is so obviously true that it ought not be necessary to mention it. Previous experience, however, has taught me to expect an air of—please don’t take this personally—utter cluelessness whenever I’ve raised such an issue. If you’ve read the second naturopathy article linked above, you already know that according to proponents,

The validity of naturopathic medicine is demonstrated by its support in government (including accreditation of its schools and NIH-funded research), on medical school Web sites, and in other parts of the public domain.

An appearance at their annual convention by the most important “CAM” administrator at the NIH surely has the political arm of the AANP licking its chops. NDs, as they call themselves, are currently licensed in 14 or 15 states and a couple of provinces, and aggressively seek licensure throughout the U.S. and Canada. They appear to wield political clout well out of proportion to their numbers, no doubt thanks in part to the legislative language that created the NCCAM’s National Advisory Council for Complementary and Alternative Medicine (NACCAM): 

Of the 18 appointed members…Nine…shall be practitioners licensed in one or more of the major systems with which the Center is involved. Six of the members shall be appointed by the Secretary from the general public and shall include leaders in the fields of public policy, law, health policy, economics, and management. Three of the six shall represent the interests of individual consumers of complementary and alternative medicine.

Thus there have been 1-3 NDs on the NACCAM since its inception in 1999, although their numbers in general are, by any measure, miniscule: I reckoned there were about 2500 in the U.S. in 2003; the AANP now places that number at 6000. By comparison, there are about 800,000 MDs and 50,000 DOs in the U.S.

NDs claim to be well trained to practice what most people think of as family medicine or primary care medicine, although their version of training is chock full of pseudoscientific nonsense and lacks a true residency program. They began by purporting to use only “natural medicines,” but in regions where they’ve become politically connected they’ve sought, and been granted, the license to prescribe numerous drugs. Predictably, they’ve recently begun to bump people off with such exotic choices as intravenous colchicine and disodium ethylenediaminetetraacetic acid (that pesky TACT drug), in addition to more folksy nostrums such as acupuncture, vitamin B12, and an “herbal tincture” for a teenage girl who would shortly die of asthma.

I see that your talk is titled “Complementary and Alternative Medicine: Promising Ideas from Outside the Mainstream.” I imagine that it will cover some of the material that you covered at the Yale Symposium, where you used the similar phrase, “Quirky Ideas from Outside the Mainstream.” Without reading more into that word substitution than is warranted, let me assure you that there are no promising ideas emanating from naturopathy, even if there are plenty of quirky ones, e.g., inflating balloons in the nasopharynx to effect a “controlled release of the connective tissue tension to unwind the body and return it toward to its original design.”

Regarding the implicit requirement of your office that you appear open-minded even to medical absurdities, you made that clear in your own account of our NCCAM meeting and of another that you’d had a few weeks earlier, involving a group of homeopaths and associated crackpots who called themselves “the leading scientists in the field”:

Recently, I hosted two meetings with groups that represent disparate views of CAM research. These meetings have given me a renewed appreciation for the value of listening to differing voices and perspectives about the work we do.

My NCCAM colleagues and I know there are differing views of the value of doing CAM research. On one side, we have stakeholders who are staunch CAM advocates, and on the other side, we have CAM skeptics.

Each group has its own beliefs and opinions on the direction, importance, and value of the work that NCCAM funds. The advocates would like to see more research dollars supporting various CAM approaches while the skeptics see our research investment as giving undue credibility to unfeasible CAM modalities and want less research funding.

As I’ve stated before, our position is that science must remain neutral, and we should be strictly objective. There are compelling reasons to explore many CAM modalities, and the science should speak for itself. (emphasis yours)

Certainly science must remain neutral in the face of not-yet-seen data from rigorous studies, but that is different from what you, in your dual roles as “CAM” Explicator-in-Chief and Steward of Public Funds, must remain. You typically face questions that are, for all purposes relevant to the NIH, to modern medicine, and to the American citizenry, already settled—whether by basic science, clinical studies, rational thinking, or all three. I’ve offered several examples in the two naturopathy articles linked above.

Consider homeopathy, a core claim of “naturopathic medicine” and the subject of your meeting with the “staunch CAM advocates.” It makes no more sense for you to remain neutral on that topic than it would for the NIMH Director to remain neutral on exorcisms, or for the NCI Director to remain neutral on Krebiozen. Edzard Ernst, a one-time homeopath whose own portfolio of “CAM” investigations dwarfs the entire output of the NCCAM, puts it this way:

Should we keep an open mind about astrology, perpetual motion, alchemy, alien abduction, and sightings of Elvis Presley? No, and we are happy to confess that our minds have closed down on homeopathy in the same way.

Science and skepticism, moreover, are not distinct. Good science involves, first and foremost, skepticism. This is true for the design of any experiment, in which the primary goal is to attempt to falsify the hypothesis, and also for scientific thinking in general. Bruce Alberts, the editor of Science, discussed this in a 2008 editorial titled “Considering Science Education”:

…society may less appreciate the advantage of having everyone acquire, as part of their formal education, the ways of thinking and behaving that are central to the practice of successful science: scientific habits of mind. These habits include a skeptical attitude toward dogmatic claims and a strong desire for logic and evidence. As famed astronomer Carl Sagan put it, science is our best “bunk” detector. Individuals and societies clearly need a means to logically test the onslaught of constant clever attempts to manipulate our purchasing and political decisions. (emphasis added)

I believe that you know all this at some level, but that your current job demands that you bend over backwards to frame skeptics as extreme—distinguishing them from “neutral” scientists. Thus you, like many reporters, have placed skeptics of homeopathy or naturopathy at one end of a contrived belief spectrum, and “staunch CAM advocates” at the other. Please indulge me while I compare this version of ‘neutrality’ with others that exist in the popular domain:

• Some people feel strongly that the moon landings were a collective hoax. Others feel just as strongly that they really happened.
• Some people believe that the Holocaust didn’t happen. Others believe that it did.
• Some people believe that the variety of species on earth is a product of Intelligent Design (ID). Others believe in the theory of evolution by variation and natural selection.

This could go on and on, but you probably get the point. The last bullet is more pertinent to your tacit endorsement of the AANP than you might imagine. What follows is a representative view of herbalism offered by Thomas Kruzel, with whom you will also share the podium at the convention (he will discuss “Emunctorology”; don’t ask). Kruzel is Past President of the AANP and the former Vice President of Clinical Affairs and Chief Medical Officer at the Southwest College of Naturopathic Medicine. He was selected Physician of the Year by the AANP in 2000, and Physician of the Year by the Arizona Naturopathic Medical Association in 2003:

Herbal Medicine: Naturopathic physicians have been trained in the art and science of prescribing medications derived from plant sources. The majority of prescription drugs are derived as well from plants but are often altered and used as single constituents. What makes herbal medicine unique is that plants have evolved along with human beings and have been used as non-toxic medications for centuries.

If there is any problem with herbal medicines it is that unless one knows how to prescribe them, they may not be effective. Herbal medications should be prescribed based on the symptoms that the person presents rather than for the name of the disease. Herbal medications are much more effective at relieving the patients symptoms when prescribed in this manner. When prescribed the medicines act with the body’s own innate healing mechanism to restore balance and ultimately allows healing to occur.

What’s nice about plant or herbal medicines is that because they are derived from the whole plant they are considerably less toxic to the body. The plant medicine has evolved to work in harmony with the normal body processes rather than taking over its function as many drug therapies do. Because of this herbal medicines may be taken for longer periods of time without the side effects so often experienced with drugs.

You are particularly impressed, I hope, by the magical, ID-like claim that “plant medicine has evolved to work in harmony with the normal body processes.” Other curious assertions include the conflation of herbal medicine with the core claims of either homeopathy or the non-existent ‘allopathy’ (we can’t tell which)—”…should be prescribed based on the symptoms…”—demonstrating that the author doesn’t know much about even the fanciful methods for which he claims expertise; and the dangerously false statement that medicines “derived from the whole plant are considerably less toxic” (than are well-researched and precisely dosed “prescription drugs”).

Dr. Briggs, please consider the possibility that you no longer must hide your considerable scientific prowess in order to be a good NCCAM Director. Your ’stakeholders’ include not only very small numbers of naturopaths, homeopaths, and other fringe practitioners, but also far larger numbers of citizens who wonder about the validity of what those practitioners are peddling. It is to those citizens that you should be directing your efforts, which ought to begin with sober, objective, skeptical, scientific considerations of the various claims, the vast majority of which can, like balloons in the nasopharynx, be dismissed in milliseconds by anyone with even a modest understanding of nature. They don’t require clinical trials.

Things are changing elsewhere. My colleague Steve Novella has just written about substantial efforts to deny insurance coverage for homeopathy in the land of its birth, Germany. In the UK, homeopathy has been far more popular than it is here, even to the point of its being funded by the National Health Service. One of the “staunch CAM advocates” who reportedly attended your meeting by teleconference was Peter Fisher, Homeopath to the Queen. Yet both the British Medical Association and the House of Commons Science and Technology Committee have seen through the ruse of pseudoscience that is homeopathy, the former declaring it “witchcraft” and latter making this statement:

The Committee concurred with the Government that the evidence base shows that homeopathy is not efficacious (that is, it does not work beyond the placebo effect) and that explanations for why homeopathy would work are scientifically implausible.

American citizens want and deserve, for their tax money, exactly that sort of definitive evaluation of such claims. Your first responsibility, Dr. Briggs, is to them—it is not to the AANP, other “CAM stakeholders,” Tom Harkin, Orrin Hatch, or Dan Burton, and certainly not to the members of the NACCAM. Yes, we “skeptics see [the NCCAM] research investment as giving undue credibility to unfeasible CAM modalities,” because the evidence is overwhelming that this is the case. We also see your appearing at conventions of pseudomedical pseudoprofessional organizations as giving undue credibility to unfeasible and dangerous claims.

Sincerely yours,

Kimball C. Atwood, M.D.

Skeptic

I’m certain by now many of our readers have come across news of the current pertussis, aka whooping cough, epidemic in California.  Beginning this February and accelerating dramatically through May and June, California has so far seen a ~500% increase in pertussis cases compared to last year, and only two days ago announced the death of a sixth baby from infection.  Public health officials in California are currently working to control its spread and determine the factors that allowed this outbreak to occur, unfortunately, at this time the available data is very rough.

The number of confirmed cases as of 6/30/2010 is growing rapidly (1,377), with an additional ~700 cases pending investigation.  General geographic location, ages, and ethnicity have been identified, and general vaccination rates and exemption rates are known, but other important demographic and epidemiologic data, including vaccination status of infected children and adults, has yet to be fully described.  Lack of data notwithstanding, I have read equally hasty stories and comments blaming the outbreak on vaccine refusal, a large immigrant population, an inadequate adult vaccination program, and normal cyclical variation in pertussis incidence, among other factors.  Finding where the system has broken down enough to allow this resurgence is exceedingly important, but in this situation pointing fingers is not as important as taking action.

Pertussis

A bit of background first.  Pertussis is a highly contagious infection of the respiratory tract by a bacteria Bordetella pertussis.  After an incubation period of 7-10 but up to 42 days, the disease progresses through three stages.  The catarrhal stage is often indistinguishable from the symptoms of the common cold, with runny nose, mild cough, and lasts 1-2 weeks.  During the second or “paroxysmal” stage infected people will have fits or “paroxysms” of uncontrollable rapid-fire coughing.  Examples can be seen here (caution, may be disturbing to watch). At the end of these paroxysms people take a large, rapid intake of breath through raw and often partially closed vocal cords, producing a high-pitched “whoop.”  The paroxysmal stage can last anywhere from 1-6 weeks.  The final stage is one of prolonged convalescence with a persistent dry cough lasting weeks to months (this is where pertussis got its other name, the “hundred day cough”).

A persistent cough isn’t the worst of pertussis.  60% of children under 6 months of age infected with pertussis need to be hospitalized, 5-10% get pneumonia, 1 in 125 have seizures, and 1 in 1000 suffer from an encephalopathy (inflammation of the brain) that frequently causes permanent brain damage.  And of course pertussis can kill.  Children under 3 months of age are at the greatest risk, and make up 84% of all pertussis related deaths.

Treatment is possible, but limited in utility.  Even though pertussis is bacterial and we have multiple antibiotics that reliably kill it, treatment after the first stage (when it becomes clear someone has more than a cold) only limits the ability of a person to spread it to others, it does not reduce the severity or length of the disease.  Once symptoms start, we are forced to ride out the illness.  Prevention is far better than treatment.  And speaking of prevention…

The Vaccine

The first vaccine to prevent pertussis was licensed in the US in the 1940s.  At that time we had an average yearly of 157 per 100,000 people, though this is likely to be a low-ball figure, given the state of medicine at the time and under-reporting.  From its release through the 1970s we saw a steady drop in cases from the pre-vaccination rate of 157 down to <1 infection per 100,000 people per year.  Though effective, the original vaccine had multiple side effects, including inducing a febrile seizure in 1 in 10,000 children.  These serious complications were enough to begin to undermine the public trust in the vaccine in the US, and to prompt several countries to stop pertussis immunization entirely.

In the 1980s and 90s several countries ceased or severely curtailed their use of DTP, including Japan, Sweden, and the UK.  Each of them saw a sharp and immediate rise in pertussis incidence to levels 10-100 times that of countries that continued to have high rates of vaccination with DTP.  This is a pattern we see repeated time and again when vaccines are withdrawn; it represents one of the best and most tragic demonstrations of vaccine efficacy you could ask for.

Effectiveness aside, the original DTP vaccine had legitimate problems, so a new vaccine was developed, tested, and eventually licensed for use.  By 1997 DTaP had fully replaced the original DTP vaccine.  Subsequent testing confirmed that it was just as effective as its predecessor, and induced significantly fewer side effects.  DTaP replaced DTP in the US before significant outbreaks could occur, and when instituted in countries that had stopped vaccination with DTP, quickly brought pertussis back under control.

DTaP, like all vaccines, continues to be studied, and is holding up very well to scrutiny.  Just this month, a self-controlled case series study in Pediatrics including 433,654 children and 7191 seizure events failed to find any significant association between DTaP and febrile seizures.

That the current pertussis vaccine is effective is beyond any serious contention, and its safety profile is excellent, but it’s not perfect.  The immune response the vaccine generates is relatively weak, necessitating multiple doses at 2, 4, 6, 15-18 months and 4-6 years to generate an adequate response (this isn’t unique to the vaccine; natural pertussis infection isn’t capable of providing long-lasting immunity either), and protection wanes after 5-10 years.

These characteristics predispose the vaccine, when used exclusively in childhood, to leave a couple of populations susceptible to infection.  First, the children most at risk of death from pertussis, those under the age of 3 months, have little to no direct protection from the vaccine or from maternal antibodies; this population relies heavily on herd immunity for protection.  The second vulnerability is that since neither the childhood vaccine nor natural infection provides lasting immunity, adults can become repeatedly infected, and serve as the primary reservoir of disease.  This is grimly illustrated by the fact that infants are most frequently infected not by other children, but by their parents.

Of course, this has been known for some time, and the vaccination schedule isn’t focused exclusively on early childhood.  A late childhood booster dose of TDaP (a reformulation of DTaP) at 11-18 years has been recommended since 2005, and adults are supposed to receive TDaP once between the ages of 19-64 to address this very problem.  Unfortunately, these doses are infrequently given for a variety of reasons, creating vulnerable populations to act as reservoirs for pertussis.

Though I may wish to have a vaccine that is somewhat less burdensome to use, it’s hard to complain about the current pertussis vaccine’s safety record, and properly administered, it’s capable of controlling and preventing epidemics (some even optimistically speculate the possibility of eradication).  To be fully effective though, it requires the dedicated support of both public health officials and the community.

The California Epidemic

Without a doubt, the relatively high-maintenance vaccination schedule contributes to our inability to fully control pertussis, but even if we had a vaccine capable of inducing lifelong immunity from birth onward, we would still have sections of the population that remain vulnerable to infection.  An embarrassingly large fraction of our fellow citizens lack access to health care.  Some immigrant populations may not have had the benefit of a modern medical system and immunization before arriving in the US, and some again lack access to health care after arrival.  A relatively small number of people are unable to be vaccinated or are immunocompromised due to medical conditions.  Finally, there are people who utilize California’s notoriously lax Personal Belief Exemption (PBE) policy to opt out of vaccination.

To what degree each of these factors is to blame for the current epidemic is not yet clear.  While it is true that some of the counties with the highest attack rates also happen to be counties where PBEs are common and vaccination rates low, other counties with reasonable vaccination rates are also being heavily affected.  (The attack rates of individual California counties can be found here.)  We simply do not yet have the entire epidemiologic picture, and it appears likely that several, if not all of these factors are in play.  That doesn’t mean, however, that we don’t know what action needs to be taken.

The California Department of Public Health is approaching this problem in the right way by addressing all of these elements at once, educating the public and expanding their TDaP program (TDaP program FAQ here, CDPH’s current activities and news releases here, and local California public health services here), though I think they may need to be even more aggressive.  In particular, I’d like to see a heavy revision of California’s PBE policy to make PBEs more difficult to obtain.

At the beginning of this post I said that in this pertussis epidemic, pointing fingers isn’t as important as taking action; to some this may have sounded hasty, but I hope you now understand my rationale.  An increase in size of any of any vulnerable group pushes the population as a whole closer to that nebulous cliff where herd immunity can no longer prevent an outbreak from becoming an epidemic.  No matter what the underlying cause(s) turns out to be, the single best intervention to control the spread of the current epidemic is the same: Vaccination. There may be multiple reasons for an outbreak of pertussis… but in our society there really is no excuse for it.

One of my goals in writing for this blog is to educate the general public about how to evaluate a scientific study, specifically medical studies. New studies are being reported in the press all the time, and the analysis provided by your average journalist leaves much to be desired. Generally, they fail to put the study into context, often get the bottom line incorrect, and then some headline writer puts a sensationalistic bow on top.

In addition to mediocre science journalism we also face dedicated ideological groups who go out of their way to spin, distort, and mutilate the scientific literature all in one direction. The anti-vaccine community is a shining example of this – they can dismiss any study whose conclusions they do not like, while promoting any horrible worthless study as long as it casts suspicion on vaccines.

Yesterday on Age of Autism (the propaganda blog for Generation Rescue) Mark Blaxill gave us another example of this, presenting a terrible pilot study as if we could draw any conclusions from it. The study is yet another publication apparently squeezed out of the same data set that Laura Hewitson has been milking for several years now - a study involving macaque infants and vaccinations. In this study Hewitson claims a significant difference in brain maturation between vaccinated and unvaccinated macaque infants, by MRI and PET analysis. Blaxill presents the study without noting any of its crippling limitations, and the commenters predictably gush.

The first (and really only) thing you need to know about this study is that it involves 9 vaccinated monkeys and 2 controls. That’s right – just 2 controls. The fact that Hewitson bothers to do statistical analysis on such a small set of subjects is laughable. Let’s keep in mind that most pilot studies turn out to be wrong – they are called pilot studies because they are intended to point the way to further research, not as a basis for any conclusions. Serious researches recognize that pilot studies are shots in the dark – and that counts even for good pilot studies, which this is not.

If the outcome were something hard and dramatic – like survival vs death, then 2 subjects would be a reasonable pilot study. But in this case Hewitson is doing a somewhat tricky measurement of brain volume changes over time and binding of opioid ligands in the amygdala. It is also worth noting that there were originally 4 controls, but one was eliminated due to improper protocol. We never learn what happened to the third monkey, we are just told there is data on two controls. This kind of missing data, especially when the overall numbers are so pathetically low, is very concerning.

She is also making multiple analyses (another red flag by itself), which means she can compare multiple variables looking for any difference. Then she invokes the sharpshooter fallacy and declares any change she does find to be clinically meaningful. So while there is no difference in brain volume or amygdala volume between exposed and unexposed monkeys, she finds differences in the change over time. We don’t know if still other variables were looked at and not reported – this is another weakness of pilot studies and why follow up studies replicating the specific effects reported are necessary before any conclusions can be drawn.

As further evidence of looking for any difference then declaring that the outcome of interest, we can look back to Hewitson’s 2008 reporting of her monkey data, in which she wrote:

“Compared with unexposed animals, exposed animals showed attenuation of amygdala growth and differences in the amygdala binding of [11C]diprenorphine.”

But in the current study she finds increased amygdala growth in exposed monkeys:

Not surprisingly, given the different maturational trajectories in exposed vs. unexposed animals, (unexposed decreasing and exposed increasing) there was a statistically significant interaction between exposure and time on total amygdala volume (Wald ?2=10.93; P=0.001). However, there were no significant main effects on total amygdala volume of either exposure (Wald ?2=0.75; P=0.39) or time (Wald ?2=1.14; P=0.29).

So which is it? Reading the results of the current study, especially in light of previous publications, gives the overall impression of a random scatter of data with incredible cherry picking in order to make the argument that there are any meaningful results at all.

Taken by itself, this is a worthless study. The numbers of subjects is too small to do any meaningful analysis. The results are all over the place, and not even consistent with prior publications by the same authors. The analysis is also far-fetched. Hewitson argues that both thimerosal-containing vaccine and MMR (which does not contain thimerosal) contribute to the alleged brain changes she is reporting. While the word “autism” does not appear in her report, Blaxill is concluding in his reporting that these brain changes are the same as those found in autism (an absurd conclusion given how non-specific these changes are, even if real, which cannot be concluded from this study). The anti-vaccine agenda is now clear – they get to have their cake and eat it too. They can now argue that an interaction between thimerosal and MMR cause or contribute to autism, through completely independent mechanisms, apparently.

To put this study further into context, this research is being conducted by the Thoughtful House Center for Children – Andrew Wakefield’s home after he was essentially kicked out of the UK and subsequently struck off. Wakefield’s name, however, does not appear anywhere on the current study, although he was listed as final author on previous publications from the same research. Apparently his name has become too toxic for the Thoughtful House.

The current study also appears in a obscure journal, Acta Neurobiologiae Experimentalis – which dedicated an entire issue to publishing dubious research on autism. The same issue includes two articles by the father and son Geier team – other vaccine and autism researchers who are off in their own world and whose research cannot be replicated.

Conclusion

This current study, as well as the entire macaque research program by Hewitson, is a good example of terrible research. The subject numbers are far too small for any meaningful statistics, and the outcomes being followed are numerous and tricky with a random scatter of results not even consistent between different publications of the same research.

What we have is far worse than ideological reporting and spinning of the scientific research – apparently we have the ideological conduction of research in the first place. This is similar to the research program of Benveniste on homeopathy.

In general it is a good rule to be suspicious of research that seems to be unique to one researcher or research team and is out of step with the broader research community. Unfortunately, such research contaminates the literature and is easily exploited to confuse the media and the public who often do not distinguish crank research from legitimate science.

___________________

Crossposted on NeuroLogicaBlog

Others reporting on this study:

Respectful Insolence – Orac also points out that Hewitson failed to disclose her COI – that she has a child with autism who is part of the Autism Omnibus suit.

Ibrb – Author, Sullivan, also points out that amygdala size should increase in macaques, so it is especially odd that the non-exposed monkeys’ amygdalas shrank. That makes no sense, and is likely due to the quirkiness of having only two controls. So the authors conclusions are entirely based upon a weird result in their tiny control group – i.e. this is completely bunk science.

There are two topics about which I am a crank. The first, as you might have guessed, is alternative medicine. The other is pharmaceutical reps. Drug companies are somewhat schizophrenic. They have amazing scientists who invent drugs that treat an astounding array of diseases. Then, they take these drugs and turn them over to marketing, to be sold with all the enthusiasm and truthiness of a late night infomercial.

In the spirit of openness, I will say that I have not talked to a drug rep in 20 years. As far as industry supported gifts and food, I have not taken a pen or eaten pizza from industry in almost 30 years, since I was a fourth year medical student. I have accepted one gift over the years. Years ago, when the Pfizer rep left, he sent me Fleets enema with a Unasyn sticker on it. I still have it in my office, unused. But you never know when it might come in handy.

Being an absolutist about industry gifts does have downsides. It is distracting to sit in an auditorium filled with the smell of pizza and not eat any; somehow the PB&J I bring with me doesn’t smell as sweet. Administration has received one letter complaining about me that was ostensibly from an employee, but curiously was printed from a windows folder that had the same name as the levofloxacin rep. Just a coincidence, I am sure.

As an Infectious Diseases fellow I was the on call physician for the hospitals antibiotic stewardship program where expensive or problematic drugs had to be approved before they could be released from pharmacy. It was curious how there would be spikes in approval requests, often for drugs that the surgical resident couldn’t pronounce correctly. Ain’t no drug called ciprofloxacillin, although there should be. Investigation revealed that these spikes often occurred shortly after a service was treated to a good dinner by the drug rep. Hmm. Funny thing, that. Probably just another coincidence. I remember once as an intern late at night trying to decide what antibiotic to give a patient and I decided to prescribe what was embossed on my pen. Turned out Bic was not on the formulary.

Over the years it has been rare to find a physician as extremist as I am. It is curious, since the literature supports the concept that interaction with pharmaceutical reps is detrimental to patient care: docs who interact with reps are more likely to prescribe expensive and/or inappropriate drugs after being detailed. When pointed out, every doctor tells me the same thing: That may be true of others, but I am not swayed by information provided by drug reps. It is the one area of science-based medicine to which most physicians are immune, and understandably so: who wants to jeopardize free pizza? Most of the literature on the topic is collected at nofreelunch.org, which appears to be under construction. It all may be publication bias, but I know of no reference that demonstrates improved patient care as a result of physicians interacting with drug companies.

So imagine my surprise when someone came out in favor of physicians learning from drug companies. Over at Slate.com is “Appetite for Instruction. Why Big Pharma should buy your doctor lunch sometimes,” by Jessica Wapner.

It starts out sedately enough “The war against industry-sponsored medical education is in full tilt.” War? It is an interesting choice of words. I might have started by writing “physicians are finally reclaiming their integrity after whoring for 50 years,” but I have a dog in the fight.

But with the mounting concern about ties between doctors and the pharmaceutical industry, commercially supported medical education is being axed from hospitals and university medical centers around the country. Not only is this change unfortunate for anyone with a doctor, but it also doesn’t make any sense.

It does make sense if you bother to read the extensive literature. The preponderance of data strongly suggests that medical practice and research is altered, and not for the better, by interaction with pharma. She quotes only one reference in her article in support of drug company sponsored education.

There is no substitute for a small group of people listening to a doctor talk about how to treat a disease. And there is no substitute for the commercial support required to run such programs. In a recent study, academic researchers were paid a modest honorarium to travel around the country teaching more than 14,000 doctors about new treatment guidelines for high blood pressure. Each researcher met with small groups of doctors to educate them about the latest advances. In counties where the most sessions took place, adherence to the guidelines rose by more than 8 percent. In counties with the fewest such sessions, adherence decreased by 2 percent. The approach that the pharmaceutical industry has been taking for years is actually an effective way to educate doctors.

The “recent study” refers to “Impact of the ALLHAT/JNC7 Dissemination Project on thiazide-type diuretic use.”

I pulled the article, and it does not say what the author thinks it says. What a surprise. The academic researchers were educating physicians about generic medications, it was “was supported by contract N01-HC-35130 from the National Heart, Lung, and Blood Institute (NHLBI), as well as an NHLBI mentoring award (RSS, K24HL086703),” not pharmaceutical money, and if they were paid an honorarium it is not mentioned in the reference.

Academic detailing, or counter-detailing, is what is done to try and give evidenced based, minimally unbiased information about treatments in an attempt to give practitioners information free from pharmaceutical company spin and bias.

Academic detailing incorporates many of the approaches used in pharmaceutical marketing. By using persuasive, individualized small group or one-on-one communication of key points, detailing can summarize findings, suggest concrete changes in practice patterns, and explore potential barriers to change. In addition, by targeting specific physicians recognized as opinion leaders, resources can be concentrated on locally influential prescribers.

Several systematic reviews have examined the effectiveness of academic detailing in changing clinical practice and found this type of intervention to be effective. The effectiveness of academic detailing is described as ranging from small to strong with results that are consistently favorable. The effectiveness of academic detailing in affecting prescribing practices is particularly prominent. In this situation, even small changes in prescribing may be important when the population affected is large or where large cost differences exist between alternative medications.

Academic detailing is the Spock without the goatee.

The effects of the intervention was modest:

The ALLHAT/JNC7 Dissemination Project was associated with a small effect on thiazide-type diuretic use consistent with its small dose and the potential of external factors to diminish its impact.

What external factors may have impacted the results?

…There was substantial questioning of the ALLHAT findings by recognized hypertension authorities, as well as by the pharmaceutical industry, that likely reduced the potential impact of the results on clinical practice.

So the authors suggest that using inexpensive, effective generic drugs for hypertension are being undermined by drug companies.

The take home message is that academic detailing, using the methods of drug reps but not their funding, is an effective alternative to pharma-financed education. It so irritates me when I read the original reference and discover it was almost completely misrepresented or misunderstood. I suppose she will be writing for Medical Voices next.

When Consumer Reports discusses cars, it is education. When Chrysler discusses cars, it’s an advertisement, even if they are having Dale Earnhardt Jr. as the discussant.

She also says the lack of pharmaceutical-sponsored education has lead to an increase in the misuse of drugs. No reference. So I went looking. Pubmed? Nothing. Google? The only reference is her article.

Stephen Hanauer, one of the clinical investigators who developed Remicade and who has been paid to speak to doctors about it, explains that as Remicade teaching sessions have been nixed, misuse of the drug has risen and Hanauer thinks that the two phenomena are connected.

The basis of the increased misuse is the experience of Dr. Hanauer. Well. Good enough for me. Lets get him back on the paid speaker trail, ASAP. Patient care depends on it. Even if the literature suggests that it is interaction with drug companies that more commonly leads to more medication mis-prescribing. Who are you going to believe, the published literature or the anecdotes of Dr. Hanauer?

He has been paid to speak. I wonder how much, because the money can be substantial.

However, the largest median payments were for research ($6593; range, $109-$922,239), speakers ($1430; range, $118-$154,188), consulting ($1000; range, $121-$334,180), and unspecified purposes ($1000; range, $100-$331,947).

I have always thought as part of mentioning conflicts of interest at the start of a talk, speakers should be required to give a dollar amount of direct and indirect (food, hotels, airfare etc) payments they have received. Does anyone think $154,188 isn’t going to buy something? I know if I were making that kind of cash as a speaker in this economy, I would want to keep the cash cow alive. But I really shouldn’t suggest others are subject to base motivations for their actions — I sound too much like Mike Adams.

Of course, if the drug company doesn’t provide food, no one will come to the talks.

But surely there must be other options. Can’t doctors meet with the experts in the absence of fancy cheese? Not necessarily. Teaching sessions often take place during the lunch hour. As Hanauer, who practices at the University of Chicago School of Medicine, describes, the elimination of paid lunches sent hungry doctors to the cafeteria instead of the lecture hall. “But the lines were so long that they missed the conference,” he says. “So attendance at our grand rounds conferences went to miniscule.” Now the doctor has a sandwich but isn’t up to date on how to treat a serious disease. That may sound silly, but it’s often the mundane reality. “There are sometimes times when residents have to choose between lunch and a conference,” Richard Goldberg, an oncologist at the University of North Carolina, wrote in an e-mail.

I just had to laugh. At my hospital system, administration takes education seriously and there is lunch provided at Grand Rounds. We get a sandwich and a lecture. University of Chicago is evidently not all that serious about the ’school’ part of their title. Or, I don’t know, try planning ahead: it is Wednesday and we’ve had Grand Rounds every Wednesday at noon for the last 100 years, maybe I will pack a sandwich. Pu-lease. If my doc doesn’t have enough on the ball to plan for eating at conference, I don’t want them prescribing my Remacaid.

Of course, I don’t know how I manage to keep up in my field with no pharmaceutical support. I can’t read journals, can’t use websites like Medscape (I am a paid blogger for Medscape, so of course I suggest them), can’t go to conferences, can’t listen to podcasts, can’t attend meetings, can’t do the MKSAP. There is such a wealth of educational opportunities in medicine to keep up you have to be either lazy or stupid not to find them. It does takes discipline and time to keep up. I spend a minimum of 24 hours a month on CME. If you want job that requires no continuing medical education, perhaps you should be a naturopath or homeopath. Part of being an MD is the endless education it takes to stay current.

The problem is that drugs have more and different uses than the FDA approved indications and the only way that information can be disseminated is pharma sponsored education.

Only way? Sure worked for Neurontin.

…ParkeDavis executive reportedly told Franklin,

I want you out there every day selling Neurontin. . . . We all know Neurontin’s not growing for adjunctive therapy, besides that’s not where the money is. Pain management, now that’s money. Monotherapy [for epilepsy], that’s money. . . . We can’t wait for [physicians] to ask, we need [to] get out there and tell them up front. Dinner programs, CME programs, consultantships all work great but don’t forget the one-on-one. That’s where we need to be, holding their hand and whispering in their ear, Neurontin for pain, Neurontin for monotherapy, Neurontin for bipolar, Neurontin for everything. I don’t want to see a single patient coming off Neurontin before they’ve been up to at least 4800 mg/day. I don’t want to hear that safety crap either, have you tried Neurontin, every one of you should take one just to see there is nothing, it’s a great drug…

The Neurontin marketing plan consisted of both general strategies such as the promotion of Neurontin use among high-prescribing physicians and cultivation of thought leaders and tactical programs. Local physicians were recruited, trained, and paid to serve as speakers in “peer-to-peer selling” programs, which the company saw as “one of the most effective ways to communicate our message.” Academic leaders were solicited with educational grants, research grants, and speaking opportunities; some received up to $158,250 over a 4-year period. Advisory boards and “consultants” were convened so that the firm could cultivate relationships with them and deliver “a hard-hitting message about Neurontin.

Marketing “tactics” included education, publications, and research whose promotional intent was disguised, in addition to more transparent activities, such as advertising and sales visits. “Educational programs” reflected the belief that “medical education drives this market!” Teleconferences involving practicing physicians were moderated by physicians who were paid as much as $176,100 over 4 years. ParkeDavis formed speakers bureaus and sought “strong Neurontin advocates and users to speak locally for Neurontin.” “Unrestricted educational grants” were made to for-profit medical-education companies that produced programs to discuss unapproved uses of Neurontin and to grant credit approved by the Accreditation Council for Continuing Medical Education.

Yep. That’s what I want for continuing medical information, programs that resulted in payments “of more than $430 million to resolve criminal charges and civil liabilities.” Of course, industry has learned their lesson. I can trust industry, and my patients life and health, with information about off-label indications provided by an industry that stands to profit from giving me the information. “There’s an old saying in Tennessee — I know it’s in Texas, probably in Tennessee — that says, fool me once, shame on, shame on you. Fool me, you can’t get fooled again.”

She concludes:

But the entanglement caused by for-profit drug development can’t be undone by eliminating the free lunch. As one physician suggested, perhaps pharmaceutical companies should be required to pay for medical education. After all, if companies are going to unleash new drugs into the world, shouldn’t they be responsible for teaching people how to use it? Ousting commercial support is creating a huge chasm in medical education, leaving doctors not only hungry but also starved for knowledge.

No, but it is a start. Physicians can take responsibility for their own education. And lunch isn’t free. In the end, our patients pay for it. The price of drugs, in part, takes into account the cost of advertisement. Maybe you feel it is fine for the underinsured to pay $1500 out of pocket for a 10-day course of linezolid, but I can’t justify my patients indirectly subsidizing my pizza and education.

While we are at it, let’s have MacDonalds be responsible for teaching nutrition, Nintendo teach us about fitness, lobbyists determine congressional voting, tobacco companies provide research cancer and oil companies tell us the cause of global warming. “The only way that information can be disseminated is ‘fill in the industry’ sponsored education” indeed.

Perhaps as professionals, doctors should be responsible for their own education, especially when the lives and health of their patients may depend on it.

The conclusion of the only other journal article referenced sums it up:

… attending sponsored CME events and accepting funding for travel or lodging for educational symposia were associated with increased prescription rates of the sponsor’s medication. Attending presentations given by pharmaceutical representative speakers was also associated with non rational prescribing.

That’s the chasm being created by banning pharma-sponsored education: more rational prescribing, more physician integrity and patient trust, better education and information. I can live with that, and so can my patients.

NB: I posted this on Health Care Renewal a couple of days ago, figuring that Dr. Gorski’s post would suffice for the SBM readership (he and I had discussed the topic while at TAM8 last week). But Managing Editor Gorski has asked me to repost it here, which I’m happy to do. I am especially pleased to demonstrate that I am capable of writing a shorter post than is Dr. Gorski.

…

On July 7, President Obama appointed Dr. Donald Berwick as Administrator of the Centers for Medicare and Medicaid Services (CMS). Dr. Berwick, a pediatrician, is well known as the CEO of the non-profit Institute for Healthcare Improvement (IHI), which “exists to close the enormous gap between the health care we have and the health care we should have — a gap so large in the US that the Institute of Medicine (IOM) in 2001 called it a ‘quality chasm’.” Dr. Berwick was one of the authors of that IOM report. His IHI has been a major player in the patient safety movement, most notably with its “100,000 Lives Campaign” and, more recently, its “5 Million Lives Campaign.”

Berwick’s CMS gig is a “recess appointment”: it was made during the Senate’s July 4th recess period, without a formal confirmation hearing—although such a hearing must take place before the end of this Senate term, if he is to remain in the position. A recent story suggested that Obama had made the recess appointment in order to avoid a reprise of “last year’s divisive health care debate.” The president had originally nominated Berwick for the position in April, and Republicans have opposed “Berwick’s views on rationing of care,” claiming that he “would deny needed care based on cost.”

A “Patient-Centered Extremist”

If there is a problem with the appointment, it is likely to be roughly the opposite of what Republicans might suppose: Dr. Berwick is a self-described “Patient-Centered Extremist.” He favors letting patients have the last word in decisions about their care even if that means, for example, choosing to have unnecessary and expensive hi-tech studies. In an article for Health Affairs published about a year ago, he explicitly argued against the “professionally dominant view of quality of health care”:

I think it wrong for the profession of medicine—or any other health care profession, for that matter—to “reserve to itself the authority to judge the quality of its work.” I eschew compromise words like “partnership.” For better or worse, I have come to believe that we—patients, families, clinicians, and the health care system as a whole—would all be far better off if we professionals recalibrated our work such that we behaved with patients and families not as hosts in the care system, but as guests in their lives. I suggest that we should without equivocation make patient-centeredness a primary quality dimension all its own, even when it does not contribute to the technical safety and effectiveness of care.

A new definition. My proposed definition of “patient-centered care” is this: The experience (to the extent the informed, individual patient desires it) of transparency, individualization, recognition, respect, dignity, and choice in all matters, without exception, related to one’s person, circumstances, and relationships in health care.

Does this mean that Dr. Berwick would also eschew professional, i.e., expert, judgment in favor of patients’ wishes? In a word, yes:

Evidence-based medicine sometimes must take a back seat. First, leaving choice ultimately up to the patient and family means that evidence-based medicine may sometimes take a back seat. One e-mail correspondent asked me, “Should patient ‘wants’ override professional judgment about whether an MRI is needed?” My answer is, basically, “Yes.” On the whole, I prefer that we take the risk of overuse along with the burden of giving real meaning to the phrase “a fully informed patient.”

Dr. Berwick is not so naive as this opinion might suggest. He envisions a “mature dialogue” in such a case, and argues that “if, over time, a pattern emerges of scientifically unwise or unsubstantiated choices…then we should seek to improve our messages…” He also admits that there might be an occasional patient whose demands are so unreasonable that “it is time to say, ‘No’.” That exception, he argues, should not dictate the rule.

There are situations in which most civilized people would agree with Dr. Berwick’s view of ‘patient-centeredness’. In both the Health Affairs article and in his recent address to the 2010 graduating class of the Yale School of Medicine, he offered real examples of petty, arbitrary hospital rules causing unnecessary sorrow for patients and their loved ones. It is in such contexts that he makes a convincing case that health professionals ought to behave “as guests in their lives.” In an interview for the New York Times, he argued:

We don’t have a standard of services or processes that are comfortable for patients. We have built a technocratic castle, and when people come into it, they are intimidated.

Nothing to disagree with there. To create that standard, moreover, would not undermine settled medical practice ethics—it would celebrate them, even as it rightly embarrasses the profession for having taken so long to do so.

Enter the Woo

Eschewing the scientific basis for modern medical practice, however, is another matter. In February of 2009, Dr. Berwick gave a ‘keynote’ address at the IOM and Bravewell Collaborative-sponsored Summit on Integrative Medicine and the Health of the Public. He shared the podium with Mehmet Oz, Dean Ornish, Senator Tom Harkin, and other advocates of pseudoscientific health claims. I wrote about the conference at the time, mainly to call attention to its misleading use of the term “integrative medicine“: literature emanating from the Summit characterized it as “preventive” and “patient-centered,” whereas the only characteristic that distinguishes it from modern medicine is its inclusion of various forms of pseudomedicine.

I noticed that Dr. Berwick was on the speaker roster, which I found disappointing: I imagined that he had either gone over to the Dark Side or, perhaps, was sufficiently naive about the topic to have been duped; or, more likely, that he had cynically accepted the offer to further his ambitions. I didn’t bother to listen to his speech until the CMS appointment was announced a few days ago.

It is troubling, to say the least. Dr. Berwick did not argue, as he had in the NYT piece, that “If we doctors feel a person is going to make unwise choices, we have to take on the responsibility of being teachers, educators and informers.” Rather, he praised his fellow speakers, most of whom were spouting nonsense, for their “reach” and “eloquence.” He praised the IOM for its “glorious record…in pursuit of better designs in health care…traditional, allopathic curative care and now migrating into this distinguished and important new arena.” He mentioned homeopathy and acupuncture, not to wonder why they should be promoted as effective, but merely to warn that they will fail—presumably in some economic sense—if they try to compete with each other for reimbursement.

Such language, and Dr. Berwick’s very presence at the Summit, were a far cry from advocating “patient-centeredness.” What they amounted to was a generous endorsement of pseudoscientific practices and of the socio-political movement that promotes them. Even granting some naivete on his part (he called himself “an amateur at this topic”), he must have known this. Such an endorsement, unlike tearing down the “technocratic castle,” has ethical implications at least as profound as those that Dr. Berwick tacitly or explicitly relies upon to support his arguments for patient-centeredness.

“Physicians have no Immunity to Moral or Ethical Constraints”

The relevant medical ethics treatises (reviewed here) are in substantial agreement that it is unethical for physicians to prescribe scientifically implausible methods or to refer patients to other practitioners for the same purpose. They are also in agreement that it is unethical to prescribe a placebo to a patient while claiming that the treatment has specific biologic activity—a point that has been vigorously argued in the UK this year, with regard to homeopathy. These ethical tenets are not mere odes to nerdy, sciency thinking; they are matters of honesty and integrity—fundamental bases for ethical interactions between physicians and patients.

In 1983, philosophers Clark Glymour and Douglas Stalker published an article in the New England Journal of Medicine titled “Engineers, cranks, physicians, magicians.” They framed modern medicine as follows, comparing it to what was then called “holistic medicine” (the article is quoted extensively here):

Medicine in industrialized nations is scientific medicine. The claim tacitly made by American or European physicians, and tacitly relied on by their patients, is that their palliatives and procedures have been shown by science to be effective. Although the physician’s medical practice is not itself science, it is based on science and on training that is supposed to teach physicians to apply scientific knowledge to people in a rational way.

The practice of medicine in the United States and in other industrialized nations is a form of consultant engineering…

That statement is just as accurate now—even more so, in this era of Evidence-Based Medicine—as it was nearly 30 years ago, even if some might find the likening of medicine to engineering displeasing. Nor is it at odds with almost any definition of “patient-centeredness,” other than one that presumes that the patient’s desires trump the physician’s ethics:

A physician engineer can act as consoler; nothing in either logic or social psychology forbids it. But certain combinations are impossible or extraordinarily unlikely. A physician engineer cannot honestly claim powers of magic or occult knowledge. The principles governing scientific reasoning and belief are negative as well as positive, and they imply that occult doctrines are not worthy of belief. Moreover, physician engineers have no immunity to moral or ethical constraints. On the contrary, they are by training and by culture enmeshed in a tradition of rational thought about the obligations and responsibilities of their profession.

Dr. Berwick—if he really believes what his presence and words at the “Integrative Medicine” Summit imply—is playing with ethical fire. (If, as I hope, he doesn’t really believe those things, he’s playing with ethics of another kind). Will we begin to see pseudomedicine “integrated” into Medicare and Medicaid? That is certainly the expectation of those who observed Dr. Berwick’s performance at the Summit, and who appear intent to hold him to his word.

I was a bit torn when trying to figure out how to approach this piece.  A reader emailed me about an article in the Huffington Post, and there is so much wrong with it that I felt overwhelmed.  My solution is to focus on a few of the problems that can help illuminate broader points.

There is a small but vocal movement of people who refuse to believe that skin cancer caused by sunlight is a significant health risk.  These people tend to also believe that the risk is being purposely hyped by others, and that our current approach to skin cancer prevention is causing an epidemic of vitamin D deficiency. Leaving aside the seemingly insane denialism regarding sunlight and cancer, there are two broad problems with this article.  The first is pretty bad.

With the summer months upon us I wanted to find out firsthand what exactly the mantra is that dermatologists are telling patients. So I went undercover to several San Francisco dermatologists in order to see if there is legitimate concern about the sun-scare media hype. Are these doctors being sensible or going overboard when it comes to advice on sunscreen use and skin cancer prevention? Is the sky falling with dangerous UV rays or are we being induced into a media panic?

He goes on to give links to recorded conversations, and prints out partial transcripts.  He does not specify whether or not he received permission to record these conversations, as required by California law.  Whether or not the law requires it, the writer should have disclosed to his readers whether or not he had received permission.  This information is important in interpreting the conversations he reports to us.

The next problem is broader, and deals with physicians’ willingness to lie on behalf of patients.  The author’s presumably-clandestine recordings of his deceptive visits to dermatologists (catching my breath—this is striking and requires a digression.  The act of deceiving these doctors is not only unethical, but can influence the outcome of the visit.  Doctors make the assumption that most patients are interacting with them out of good faith, and are not intentionally deceiving them.)

In the first conversation the author has with a doctor, the interviewer makes it clear that he wants a mole removed, and the doctor essentially leads him to say “the right thing” so that insurance will cover the procedure.  One thing the author seems to miss is that the dermatologist is going to be paid whether or not insurance covers the procedure.  If the insurance company says “no”, the patient will be billed.  The doctor is lying for the patient, not for herself.

Data have shown that physicians are willing to lie on behalf of patients. There are a number of reasons that this poses ethical problems.  It could be argued that the doctor is lying to help get the patient something that they need, and that lying is a peccadillo compared to the benefit.  This can backfire in a number of ways, not least of which is that both the doctor and the patient can probably be prosecuted for fraud, something that is unlikely to be of benefit to either one.

But there is a fine line between a lie and a truth, one that anyone familiar with the intimacies of the exam room will often experience.  As a doctor, your overall impression may be that the patient is at high risk for coronary artery disease, but perhaps the patient doesn’t quite meet the insurance company’s criteria.  You can then lay out the cost of the test and the risks and benefits for the patient, but I wouldn’t be surprised if some doctors took the short cut of asking, “are you sure you’ve never had any chest pain or difficulty breathing?”

He begins his second dermatology visit by telling the doctor that he has a family history of melanoma, and finds fault in the doctor’s description of the statistics of the disease.  The problem of properly rendering statistics is a common one, and he links to an excellent piece by Ivan Oransky explaining the difference between relative risk and absolute risk.  Unfortunately, he uses this to spin a tale of some sort of dermatology conspiracy to inflate cancer numbers.  Skin cancers (including melanomas and non-melanoma skin cancers) are very, very common, and though many are not fatal, their diagnosis and treatment can be expensive and disfiguring.

His visit continues and the doctor tells him that insurance won’t cover his mole removal because it’s not necessary, and refuses to lie in the medical record. The doc then gives some sound medical advice about how to prevent skin cancers.

I then ask what measures I should take to prevent skin cancer. I’m told to apply sunscreen 24/7, wear a hat and sunglasses, as well as avoid the sun as much as possible. (The only thing she doesn’t mention is to live underground with the mole people.)

“Mole people”?  He asked the doc how to prevent skin cancer, the doc gave the correct answer.  It’s up to the patient to decide if the application of sunscreen is too onerous for the potential benefit.

Last week at TAM8 some SBM colleagues (David Gorski, Kimball Atwood, Harriet Hall, Rachel Dunlop) and I gave two workshops on how to find reliable health information on the web. As part of my research for this talk I came across a recent and interesting study that I would like to expand upon further – Quality and Content of Internet-Based Information for Ten Common Orthopaedic Sports Medicine Diagnoses.

The fact that the article focuses on orthopedic diagnoses is probably not relevant to the point of the article itself, which was to assess the accuracy of health information on the web. They looked at 10 orthopedic diagnoses and searched on them using Google and Yahoo, and then chose the top results. They ultimately evaluated 154 different sites with multiple reviewers for quality of content and also for their HON rating.

For background, the HON rating comes from an independent organization, the Heath on the Net Foundation, that rates health care sites on a number of criteria. These include assessment of how authoritative the sources are, the level of transparency, and if opinions expressed are justified with evidence and references. While generally reasonable, the HON assessment does not necessarily involve a thorough assessment of the quality of the science on a given website, and many sites with what I would consider dubious information have earned the HON seal of approval.

Among other things, this new study evaluated how scientifically accurate health information on the websites they reviewed was, and also compared them to their HON ratings. They divided the websites evaluated into various types – non-profit, academic, commercial, and individually run. What they found was that the quality of information was significantly better on non-profit and academic sites than on commercial and individually run sites. This is not surprising – commercial sites are likely to be compromised by a desire to advertise or sell product. But “commercial” also refers to sites that monetize content – not necessarily selling products, but simply providing content as their product in order to sell advertising. This includes sites such as WebMD.

It is also not surprising that individual sites also scored relatively low on average. An individually run site is only as good as the individual running it, so there is bound to be a great deal of variability. Also, individuals are more likely to make mistakes or have missing information than groups.

Non-profit and academic sites are more likely to have editorial policies that emphasize quality and integrity of content. But also they are more likely to have some vetting process for information. At SBM (a non-profit site) for example, we carefully guard our editorial integrity and also provide some layer of editorial oversight.

But the study also provides reason to be cautious, even about the best sites. They rated quality of information on a 100 point scale and found a range of 45-61%. So even the best sites had a mediocre score. This is likely due to the fact that health information is complex and rapidly changing. Nothing short of a thorough editorial and peer-review process is likely to generate both reliable and thorough up-to-date information. This study is therefore reason for all providers of health information on the net to raise their game. There is definitely room for improvement.

The study also found that having the HON seal of approval did significantly correlate with higher quality and integrity scores. So the code does mean something, even if it is still not a guarantee of science-based content.

Conclusion

Further study of health information on the net is warranted as the results of this one study argue for caution. For providers it suggests we need to improve our filters and editorial process to improve the quality of our content. For consumers the results suggest that non-profit and academic health information sites are most reliable, while commercial and individual sites should be viewed with caution.

But further I would suggest to consumers of health information on the net that no single site or article should ever be relied upon for information. The best way to get a thorough and accurate treatment of a health topic is to look at multiple sites. Try to determine what the consensus of opinion and information is, and be very wary of outliers. This is generally good advice for any research, not just health information.

Wouldn’t it be great if we could find a way to prolong our lives and to keep us healthy right up to the end? Ponce de León never found that Fountain of Youth, but science is still looking. What are the chances science will succeed? How’s it doing so far?

In his new book The Youth Pill: Scientists at the Brink of an Anti-Aging Revolution, David Stipp tries to answer those questions. From the title of the book, I expected hype about resveratrol or some other miracle pill; but instead it is a nuanced, levelheaded, entertaining, informative account of the history and current state of longevity research. It makes that research come alive by telling stories about the people involved, the failures and setbacks, and the agonizingly slow process of teasing out the truth with a series of experiments that often seem to contradict each other.

Anti-aging can mean several things. Extending the average lifespan is not the same as extending the maximum life span. Extending lifespan is not the same as preventing the degenerative changes characteristic of aging.

We don’t even have a handle on why we die, why we deteriorate over time, or how it could benefit “selfish genes” for women to live past menopause. Several contradictory evolutionary explanations have been proposed. Comparisons with other species have not been helpful: every hypothesis has run up against counter-examples. Generally, the lifespan of animals correlates with body size; humans live longer for their size than expected. Some animals appear not to age. Naked mole rats are a fascinating anomaly: these animals that live in colonies underground and look like saber-toothed sausages live a long life for their size and appear not to show the usual changes of aging even though they have high levels of free radical damage and low levels of antioxidants (70 times less glutathione activity than mice).

Scientists hoped to find an aging gene that they could turn off. It’s not that simple. A large number of genes are involved in aging processes, and there are unpredictable interactions between them. Studying centenarians has provided inconsistent clues.

Antioxidants neutralize the free radicals that cause cell damage. They sounded promising, but their effect is modified by many factors, they can harm as well as help, and raising their levels with supplements may even turn off some of the body’s natural defenses.

Telomerase (the enzyme that keeps the ends of chromosomes from fraying as they age) was another false lead. Drugs that slow aging by boosting telomerase may cause cancer, and it turns out that telomere shortening isn’t the chief driver of body-wide aging.

The most promising idea is severe calorie restriction (CR). It prolongs life in several species, but this effect has not yet been verified in humans. And it is inconsistent and may have different effects at different ages and in different individuals. CR lowers body temperature and fertility and has other side effects. It is not an option most people would willingly choose.

Scientists have studied the chemical changes in CR humans and are looking for a pill that will cause those same changes while allowing people to eat unrestricted calories. Two main candidates have surfaced. Resveratrol (a substance found in red wine) seems to work: it allows overfed mice to live longer and stay healthier. It appears to have a number of benefits in lab animals, but human studies have not been done and it appears that very large doses will be required (comparable to the amount you would get by drinking 200 bottles of wine a day). Rapamycin extends the life of mice and prevents various diseases, but it also inhibits protein synthesis in the brain, suppresses immune function, and raises cholesterol. Researchers are trying to find related compounds that offer the benefits without the harms.

There are all too many variables that can interfere with the results of a study. In one experiment, the female mice lived longer with treatment but the males didn’t. They finally figured out that was because the males’ cagemates were killing them! Stipp does an excellent job of presenting the theoretical underpinnings, the experiments, and the difficulties of anti-aging research. The subject is overwhelmingly complicated, but he simplifies it enough to at least help the reader understand how very complicated it is.

There are longevity clinics and anti-aging products on the market offering all kinds of promises that go way beyond the knowledge. Futurist Ray Kurzweil takes handfuls of supplement pills and spends one day a week getting IVs and other treatments at a longevity clinic and he is convinced this regimen will keep him alive until science finds a way to keep him alive forever. The author of The Youth Pill is more conservative. He is enthusiastic about the promising research on pills like resveratrol and rapamycin, but he’s reluctant to start taking them “until enough clinical data are available to let me make a reasonably well-informed decision about optimal dosing.” Me too.

There’s been a bit of buzz in the health blogs over President Obama’s decision last week to use the mechanism of a recess appointment to be the director of the Centers for Medicare and Medicaid Services (CMS). Recess appointments, for those who may not be aware, allow a President to put a nominee in place when Congress is in recess in order to have him in place without the messy process of having him approved by the Senate. True, the Senate still has to approve a recess appointment by the end of its term, or the seat goes vacant again, but it’s an excellent way to avoid having nasty confirmation fights during election years. Of course, both parties do it, and the reaction of pundits, bloggers, and politicians tend to fall strictly along partisan lines. If you support the President, then a recess appointment is a way to get around the obstructionism of the other party. If you don’t support the President, it’s a horrific abuse of Presidential power. And so it goes. Either way, I don’t really care much about the politics of how such officials are appointed so much as who is being appointed.

The man who was appointed last week to head CMS is Donald Berwick, M.D., CEO of the Institute for Healthcare Improvement. His being placed in charge of CMS will likely have profound consequences not just for how the recent health care/insurance reform law is implemented but for how the government applies science-based medicine to the administration of the this massive bill. Most of the criticism of his views that I’ve seen thus far comes from conservatives, who do not like Berwick’s apparent penchant for health care systems like the British NHS. Ironically, it’s views held by Berwick that will likely come into direct conflict with his mandate to hold down costs that are the problem with Dr. Berwick, at least to me. It is in these views where there is much that is admirable. Unfortunately, I also fear that there is much about Berwick’s views that are very friendly to the possibility of allowing the infiltration of woo into the U.S. health care system as well, and these fears begin with what Berwick is most known for, a term he calls “patient empowerment.”

What a grand word! After all, who doesn’t want to be “empowered”? Certainly not me. Perhaps that’s the reason why it’s become the new buzzword in a movement known as “patient-centered” care. Old fart that I am, when I first encountered the term I was a bit puzzled by exactly what “patient empowerment” means. After all, I’ve always thought I have been practicing patient-centered care, ever since my first days in medical school. Apparently these days it means something different, at least if this article from about a year ago in the New York Times is any indication. It’s an interview with Dr. Donald Berwick, who advocates what he himself calls a “radical” patient-centered care, having at the time recently published an article in Health Affairs entitled What ‘Patient-Centered’ Should Mean: Confessions Of An Extremist. It was unclear to me then and it’s unclear to me now whether Berwick was being sarcastic or flippant in his characterization of himself as an “extremist.”

What is “patient-centered care”?

Patient-centered care seems, at least from the wording of the term, like an unequivocal good, like mom and apple pie, but is it? Let’s start with the good. In his Health Affairs article from a year ago, Dr. Berwick attacked some aspects of the health care system that richly deserve attacking, specifically the inflexibility of so much of it:

Three years ago, a close friend began having chest pains. She headed for a cardiac catheterization, and, frightened, she asked me to go with her. As I stood next to her gurney in the pre-procedure room, she said, “I would feel so much better if you were with me in the cath lab.” I agreed immediately to go with her.

The nurse didn’t agree. “Do you want to be there as a friend or as a doctor?” she asked.

“I guess both,” I replied. “I am both.”

“It’s not possible. We have a policy against that,” she said.

The young procedural cardiologist appeared shortly afterward. “I understand you want to have your friend in the procedure room,” she said. “Why?”

“Because I’d feel so much more comfortable, and, later on, he can explain things to me if I have questions,” said my friend.

“I’m sorry,” said the cardiologist, “I am just not comfortable with that. We don’t do that here. It doesn’t work.”

“Have you ever tried it?” I asked.

“No,” she said.

“Then how do you know it doesn’t work?” I asked.

“It’s just not possible,” she answered. “I am sorry if that upsets you.”

Moments later, my friend was wheeled away, shaking in fear and sobbing.

What’s wrong with that picture?

Most doctors and nurses, I fear, would answer that what is wrong with that picture is the unreasonableness of my friend’s demand and mine, our expecting special treatment, our failure to understand standard procedures and wise restrictions, and our unwillingness to defer to the judgment of skilled professionals.

I disagree. I find a lot wrong with that picture, but none of it is related to unreasonable expectations, special pleading, or disrespect of professionals. What is wrong is that the system exerted its power over reason, respect, and even logic in order to serve its own needs, not the patient’s. What is wrong was the exercise of a form of violence and tolerance for untruth, and–worse for a profession dedicated to healing–needless harm.

To the extent that hospital policies are rigid, inflexible, and not necessarily in the patient’s best interest, Dr. Berwick remains on firm ground. In counterpoint, I will admit that I’ve had the occasional request by a family member to be in the operating room when I’m working and personally I don’t in general think it’s a good idea to allow friends and family in the operating room. I do, however, think it would be acceptable for everyone, as is done with pediatrics, to allow a family member or friend into the O.R. until the patient has gone to sleep. Be that as it may, I don’t disagree at all that many hospitals have policies and procedures that are not patient-friendly, much less patient-centered. Indeed, I’ve at times referred to such policies as “patient-hostile” and encountered them when visiting family members in the hospital. Coming from that perspective, I can say unequivocaly that Dr. Berwick was perfectly correct to castigate such policies. He even described three maxims of patient-centered care that are indeed quite admirable:

1. “The needs of the patient come first.”
2. “Nothing about me without me.”
3. “Every patient is the only patient.”

The first maxim is self-explanatory. The second refers to the need to collaborate with the patient, not to make decisions without informing the patient and discussing them with him. The third is more or less a restatement of the first, at least in my book. Dr. Berwick, however, takes it farther:

The experience (to the extent the informed, individual patient desires it) of transparency, individualization, recognition, respect, dignity, and choice in all matters, without exception, related to one’s person, circumstances, and relationships in health care.

While this sounds on the surface quite reasonable, as in many things the devil is in the details, more specifically in the interpretation of what these things mean. There is no doubt that the age of the paternalistic, “doctor knows best” model of health care is gone. For the most part, this is a good thing, although at times I’ve discovered that there are actually quite a few patients who actually want their doctors to tell them what to do. They become uncomfortable, sometimes even angry, when I present options to them, discuss the pros and cons of each option, and in essence leave the choice to them with my advice as to which option I consider the best. Indeed, early in my career, I actually got feedback from my division chief that I was perceived as being too wishy-washy and indecisive by some patients, as though presenting options suggested indecision. Maybe back then I just wasn’t that good at doing it yet, and I got better with time. At least, I hope so. In any case, it’s a fine balance, and, I suspect, patients expect more decisiveness from surgeons, who are going to cut into their bodies, than from internists, who are not. Be that as it may, I fully accept that every doctor-patient relationship should represent a collaborative effort in which patient needs and wants need to be taken into account and, wherever it doesn’t conflict with science- and evidence-based medicine, patients’s wishes should be paramount.

That’s where Dr. Berwick and I part company. He doesn’t think that clear science- and evidence-based guidelines should trump patient desires:

First, leaving choice ultimately up to the patient and family means that evidence-based medicine may sometimes take a back seat. [Emphasis mine.] One e-mail correspondent asked me, “Should patient ‘wants’ override professional judgment about whether an MRI is needed?” My answer is, basically, “Yes.” On the whole, I prefer that we take the risk of overuse along with the burden of giving real meaning to the phrase “a fully informed patient.” I contemplate in this a mature dialogue, in which an informed professional engages in a full conversation about why he or she–the professional–disagrees with a patient’s choice. If, over time, a pattern emerges of scientifically unwise or unsubstantiated choices–like lots and lots of patients’ choosing scientifically needless MRIs–then we should seek to improve our messages, instructions, educational processes, and dialogue to understand and seek to remedy the mismatch.

I’ll give Dr. Berwick credit. He’s an idealist. I’ll test his idealism in a minute.

What “patient-centered” medicine means: Patients as consumers

In order to find out more about what “patient-centered” care means, let’s move on to an interview in the NYT with Dr. Berwick from June 2009:

When you are in a position of having to deny and exclude patients, it is draining on the spirit. I actually think the mode I am counseling would be more satisfying or joyous for caregivers. Not all of the time or always, but it would be a better place to be. You would be putting yourself at more of a level with the patient, as more of a peer. And you wouldn’t have to carry on as if you were mythical. Medicine is imperfect and doctors know that.

I wasn’t sure I liked where Dr. Berwick’s train of thought was going then, and now, a year later, I’m sure I have some serious misgivings about it. First off, these days it’s a bit of a straw man. Physicians, by and large, have come down off their pedestals, at least in part. Even so, I would posit that professional expertise still matters. Dr. Berwick seems to think that it should take a back seat to patient wants, which is reasonable occasionally but most definitely not in many situations. In fact, Dr. Berwick seems to view patients as consumers more than anything else and physicians as service providers whose primary purpose is to satisfy these consumers, just like any other service provider or merchant. Worse, my impression at the time I read his interviews was that Dr. Berwick seems to think that medicine is easy:

Medicine is not nuclear physics. Most adults and kids can basically understand. There can be uncertainty in medicine, but if there’s mystery, something is wrong.

Medicine’s so easy, even kids get it? Is that like “So easy, even a caveman can do it?” I wonder what Dr. Berwick would make of the case of Daniel Hauser, the 13-year-old who, with the indulgence of his parents, refused life saving chemotherapy and radiation for his Hodgkin’s lymphoma. Perhaps I’m not Dr. Berwick’s intellectual equal (being nothing more than just a dumb surgeon and all), but personally I don’t find medicine that easy at all, at least not keeping up with the science and evidence and applying it to individual patients. Heck, and I’m a subspecialist. The breadth of knowledge that I have to keep up with isn’t nearly what it is for an internist like Dr. Lipson, although, granted, I’m supposed to substitute depth for breadth. Maybe my communication skills are simply inferior to those of Dr. Berwick, but I don’t think it’s easy (as Dr. Berwick seems to be implying that it is) to explain complex medical issues in language a patient with no background in medical science can grasp. Indeed, I always wonder if and how I can do better. In essence, Dr. Berwick is advocating that we move away from a professional model of medicine to a more consumerist model. In this view, he is the perfect enabler for pseudoscience in medicine. After all, if evidence-based medicine should “sometimes” take a back seat to patient desires, then there’s no reason to deny patients quackery if they request it, is there? Certainly Dr. Berwick doesn’t provide any guidance on this score that I’ve been able to find. How far outside of evidence-based medicine does a patient desire have to be before a physician can properly refuse to acquiesce to it? It would seem there are no limits.

Then there’s the word “sometimes.” I wonder what Dr. Berwick means by that word. He seems to argue that, if patients make choices that conflict with science-based medicine, then over time we physicians should be able to persuade them why such choices are not in their best interest. If not, he is saying, then it is our fault for not getting the message through well enough. While there’s some merit to the contention that it is our responsibility as physicians to present science-based medicine in a way that patients can understand and explain to them why certain choices are not justified by the evidence and that we all too often fail in that task, what should we do when patients have heard the message, tell us that they understand, but reject the message? For example, take the example of the patient asking for an MRI that isn’t indicated. What would Dr. Berwick do if he had explained to the patient that the MRI wasn’t indicated, laid out the evidence for that position, and the patient said he completely understood but wanted the MRI anyway? There’s nothing in Dr. Berwick’s writings or statements that indicate to me any guidelines whatsoever that allow a physician practicing his brand of “patient-centered” care to decide when it is acceptable to refuse a patient’s request for non-science-based medical interventions. The best he can come up with is this:

I can imagine just as easily as my critics can a crazy patient request–one so clearly unreasonable that it is time to say, “No.” A purely foolish, crazy, or venal patient “want” should be declined. But my wife, a lawyer, told me long ago the aphorism in her field: “Hard cases make bad law.” So it is in medicine: “Exceptional cases make bad rules.” You do not successfully rebut my plea for extreme patient-centeredness by telling me that, on rare occasions, we ought to say, “No.” I say, “Your ‘rare occasions’ make for very bad rules for the usual occasions.”

See what I mean? Dr. Berwick dismisses exceedingly unreasonable requests as “rare.” They’re not. I’ll give him an example of one such unreasonable, non-science-based request that is not at all rare and wonder how he would respond to it. Regular readers of this blog can probably guess where I’m going with this. Of course, before I get there, I could always ask what Dr. Berwick would do if a patient wanted him to zap his liver flukes “zapped” à la Hulda Clark to cure his cancer, but I hope that he would consider such a request to be a request “so clearly unreasonable that it is time to say, ‘No.’” One hopes that Dr. Berwick’s vision of patient empowerment would have at least that as a limit. I’m not so sure, though, because Dr. Berwick has given no examples for a patient-centered physician to use as guidance for when it would be acceptable to say “no,” presumably because he considers such examples to be so rare. Unfortunately, there is another request that thousands of pediatricians all over the nation face each and every day that is not evidence-based and, even worse, endangers public health.

That’s right. I’m talking about the antivaccine movement, which has placed so much misinformation in the public sphere that thousands upon thousands of parents have been sufficiently frightened that vaccines will make their children autistic, thanks to propaganda efforts by useful idiots like Jenny McCarthy, that they refuse vaccines for their children. Let’s say that a Berwick-like physician has used every tool in his patient-centered armamentarium of “education” and “information exchange” to try to persuade these parents that vaccination is safe and effective. Let’s say they still refuse. What would Dr. Berwick do then? He is, after all, a pediatrician, and this is a common problem that pediatricians face. Come to think of it, the fact that Berwick seems blissfully unaware of this particular threat to public health does not leave me with the impression that he’s actually hooked into what’s going on “in the trenches,” so to speak.

The problem to which Berwick seems oblivious is that this is an example of a non-science-based patient request that is not at all rare and that is incredibly resistant to the “information exchange” that he touts above all. It is also a request that doesn’t just affect that patient; it endangers public health. What would Dr. Berwick do about that? It doesn’t even have to be the anti-vaccine movement. Patients ask for or even demand non-science-based care all the time. Antibiotics for viral infections is an excellent example, and thanks to physicians’ overuse of antibiotics, among other factors, bacteria are becoming more and more resistant to once powerful antibiotics. These are issues that don’t just affect individual patients who demand care not based on science; declining vaccination rates and bacterial resistance to antibiotics potentially endanger everyone.

I believe in the collaboration between me and my patients in order to solve their problems if we can. However, contrary to Dr. Berwick’s belief, most patients are not my “peers,” at least not in the professional sense. They may be my peers in the human sense, but working together to try to treat their medical problem is not the same thing as their being my professional peers. I view the collaborative nature of the doctor-patient as a consultation. The patient is coming to me for my expert opinion, and I try to deliver, at the same time trying to educate the patient about her disease process and why science-based medicine recommends what it does. I try as much as possible to take into account what the patient wants and provide science-based options acceptable to the patient. For example, a while back I very strongly advised against a bilateral mastectomy on a patient who had been diagnosed with a very tiny pre-invasive breast cancer (ductal carcinoma in situ), had no family history of breast cancer, no risk factors, and a bilateral MRI that showed no suspicious lesions in the opposite breast. I spent an hour explaining my recommendation for a lumpectomy and radiation therapy and why bilateral mastectomies were not indicated. Even though I likened it to killing a mouse with a Howitzer, because it is within the range of evidence-based practice I expressed a willingness to do a simple mastectomy of the side with the DCIS with immediate reconstruction by a plastic surgeon if that was what the patient really wanted, while again explaining why removing the other breast without evidence that it has cancer would not prolong her life or even lessen her chance of dying of breast cancer. In the end, she seemed to understand, but she clearly did not accept. She never came back.

Of course, regardless of where I’ve practiced, there have always been other surgeons in the area who are more than happy to do bilateral mastectomies on almost woman with cancer or DCIS who wants the procedure, regardless of how tenuous or nonexistent the evidence supporting such an option is in a specific patient’s case. It is easier just to say yes, as Dr. Berwick suggests. In fact, it’s more profitable, too; a surgeon can bill a lot more for a bilateral mastectomy than for a lumpectomy. In academia, I’m fortunate in that my salary doesn’t depend on the number of operations I perform; the same is not true in private practice. Indeed, Dr. Berwick’s “patient is always right” sort of misreading of patient-centered medicine could easily lead to the vast overutilization of resources beyond what we see now. How Berwick will be able to implement such a view and at the same time keep costs down, as is a major stated purpose of the new health care reform law, I have no idea. Worse, patient=centered care, at least as I interpret it from Dr. Berwick, can cause a major conflict of interest in that physicians and hospitals often make more money by delivering more care. There’s already a huge incentive in the medical system to give the patient what he wants, if what he wants is more tests, more procedures, more medicine. Dr. Berwick’s vision, if realized as he envisions it, would vastly exacerbate that conflict of interest.

I also can’t help but wonder about liability concerns. If a doctor orders an unnecessary test or provides an unnecessary treatment that causes harm, he’s still on the hook for malpractice. Indeed, he should be even more on the hook for malpractice for the very reason that the test or medical intervention was not medically indicated and not evidence-based! Lawyers would have a field day: “Why did you order that test that caused my client harm? Because my client asked for it? Do you believe the test was indicated based on scientific evidence and the standard of care? No? Then why did you order it anyway? Who has the MD? You or my client? My client depended on you for your best evidence-based medical advice, and you failed him.”

And the lawyer starts counting his share of the judgment.

In the end, I cannot agree with Dr. Berwick that science-based medicine should “take a back seat” to patient “empowerment.” Indeed, upon reading Dr. Berwick’s ideas, I wondered if he actually practices medicine. It turns out that he has not, as Dr. Douglas Farrago found out at the time:

He ends his interview by stating that “we have to fix the health care system so that it gives doctors the time to do the job they want to do”. Funny, nothing he recommends saves time or saves money or makes the job any easier. This begs the question: does Dr. Berwick actually see patients anymore and how many? I called his office and it turns out that he does not. If fact, the person answering the phone states he hasn’t “in years”. Maybe it is time for him to get his hands dirty again?

Or not. Berwick strikes me as a very well-meaning person with some good ideas about how to make our health care system less rigid and more responsive to patients’ needs, both medical and nonmedical. Unfortunately, he also appears to be naive to the point of my wondering whether he has any clue what it’s like to practice medicine in the real world or even in the idealized world of academics.

Berwickian “patient-centered care”: An enabler of woo?

Berwick’s “patient-centered care,” as we have seen, is an idea that has the potential to improve our health care system if implemented properly. Unfortunately, Berwick’s vision of it would in essence give the patient what he or she wants all the time. Not only would it be very expensive, but it provides no rationale for leaving out woo. In fact, in February 2009, Dr. Berwick participated in the Institute of Medicine’s Summit on Integrative Medicine, where Dr. Berwick was featured with luminaries of the movement trying to infiltrate unscientific medicine into the then embryonic health reform bill such as Dr. Dean Ornish, Dr. David “a more fluid concept of evidence” Katz, Dr. Mehmet Oz, and Senator Tom Harkin, creator of NCCAM. All they lacked was Rustum Roy and Deepak Chopra. Some of the slides in Dr. Berwick’s presentation are not reassuring. For instance:

Integrative Medicine is health care that offers you the best shot at getting what you really, really want.

Dr. R.W., the physician who coined the term “quackademic medicine” described Berwick’s contribution to the conference thusly:

Even without regard to what he had to say it’s significant enough that Donald Berwick, M.D., CEO of the prestigious and (up to now!) very mainstream Institute for Healthcare Improvement, lent his good name to this woo fest. But what he had to say was rich. After introductory remarks about how happy and honored he was to be there he mentioned homeopathy and acupuncture, not to criticize them as health claims, but only to warn that they shouldn’t compete with each other, or with other modalities, for limited health care resources. In other words, let’s stop fighting and work together. (Groan). He praised the IOM for its contributions to the design of health care, starting (now get this) with “traditional, allopathic and curative care and now migrating into this distinguished and important new arena.”

But here’s the bomb. Berwick, who seems to believe that healthcare should be like any consumer industry, said that quality is defined by patients’ perceptions. This is his idea of patient centered care which he defines as the patient having all the control. The IHI’s metric for quality, he said, is (watch this, now, emphasis mine) “…give me exactly the help I need and want exactly when I need and want it.”

Think about that for a moment. The woosters and quackademicians of the world point to surveys like these which show that patients, in large numbers, really seem to want woo. They support their unscientific promotions by saying that because so many patients seek it out it must be valid. Adherents of science based medicine often point out the silliness of such thinking. Now, though, this argumentum ad populum is given new life and legitimacy because the Institute of Medicine and the Institute for Health Care Improvement endorse it!

Unfortunately Dr. Berwick’s philosophy is custom-made to be an enabler of the very woo that we so frequently rail against on this blog. After all, if patient empowerment and “patient-centeredness” trump science- and evidence-based medicine (except in “rare” circumstances that Dr. Berwick declines to define), then there really is no reason not to give the people what they want when they want it, how they want it, all the time, so to speak. In fact, Berwick even has a slide that says:

They give me exactly the help I need and want exactly when and how I need and want it.

Berwick’s philosophy could so easily be turned to say: Patients want woo? Give it to them! They don’t want to vaccinate? No problem. Just keep trying to “educate” them. And if you want to try to use education and “information exchange” to persuade a patient who is unpersuadable, good luck with that. Unfortunately (and I do mean that; it is truly unfortunate), insurance companies don’t exactly bend over backwards to pay for lots of time spent educating patients. I wish they did, but they don’t. Truly, Dr. Berwick is, as I said, an idealist, and it is true that the current medical system is, all too often, not patient centered in any meaningful sense of the term. Sadly, his idealism is not grounded in the real world and, worse, it does not place science- and evidence-based medicine on even close to the same level as it does to turning patients into “consumers” and physicians into people who cater to those consumers no matter what.

No matter John Weeks at The Integrator Blog is so happy.

With this post, I’m happy to return to Science-Based Medicine on a regular basis, at least monthly and perhaps more depending upon how often commentary is required on natural products, whether they be herbal medicines or single-agent pharmaceuticals derived from natural sources. Next week, I’ll be attending the 2010 Annual Meeting of the American Society of Pharmacognosy being held jointly with the Phytochemical Society of North America in St. Petersburg, Florida. I hope to bring back the latest on novel natural products in preclinical development.

But today, I bring recent news that revisits a timeworn folly of the young (and some older folks): recreational use of toxic plants for the purpose of hallucination.

Toxicity reports are re-emerging in southern California this week after a dozen hospitalizations of kids using teas made from a fragrant flowering plant called Angel’s Trumpet. The tea is used to produce hallucinations, but they can progress to extremely unpleasant experiences. Moreover, Angel’s Trumpet can be deadly, accelerating the heart rate and causing fatal cardiac rhythmic disturbances and bronchoconstriction that can trigger asthma attacks in sensitive individuals.

Angel’s Trumpet is one of a series of plants in the Brugmansia genus that make a variety of muscarinic cholinergic antagonists such as atropine (dl-hyoscyamine, pictured to the right) and scopolamine (l-hyoscine). These compounds are also known chemically as tropane alkaloids or belladonna alkaloids, the latter derived from their classical isolation from Atropa belladonna. The belladonna name derives from the use of eye drops made from the plants that prevent constriction of the pupils (mydriasis), back when the size of a woman’s pupils was a sign of beauty and arousal.

The tropane alkaloids are ubiquitous in plants and fungi and act as classic hallucinogens when used in high doses. Their legend goes back to witches brews and beyond. A wonderfully colorful history of tropane alkaloids by Robert S. Holzman of Children’s Hospital and Harvard Medical School was offered in this free 1998 paper in the journal, Anesthesiology (1998; 89:241-249).

However, the aftermath of Angel’s Trumpet use is far from colorful. In cases like these, I like to turn to the Erowid site, a respected, user-supported site that offers non-judgmental information on plant-derived and synthetic psychoactive agents. The Erowid Experience Vault has several descriptions of the use of Angel’s Trumpet but this one is the most detailed and representative of the downsides of this plant. (Note that the colloquial term for Angel’s Trumpet in Australia is sometimes “Tree Datura,” although Brugmansia is a closely-related but distinct genus from Datura within the Solanaceae family.)

I also came across a poorly-documented 2003 news article cited a German teenager cutting off his penis and tongue with garden shears after using Angel’s Trumpet.

While I’m NOT a physician, emergency personnel stumbling upon this post would do well to note that physostigmine or pilocarpine are typical antidotes for anticholinergic poisonings with Angel’s Trumpet, Atropa, Datura, and other similar plants that cause dilated pupils with loss of accommodation, xerostomia (dry mouth), and tachycardia. Click on this paragraph to access the Medscape poisoning article with more details on when and where specific treatments should be employed.

From the eMedicine article linked to in the above paragraph:

Remember common signs and symptoms with the mnemonic, “red as a beet, dry as a bone, blind as a bat, mad as a hatter, and hot as a hare.” The mnemonic refers to the symptoms of flushing, dry skin and mucous membranes, mydriasis with loss of accommodation, altered mental status (AMS), and fever, respectively.

I encourage all clinicians to be vigilant about anticholinergic poisonings in the weeks to come. In some cases in the past, I have found that reports such as these from southern California will often give rise to attempts to use the hallucinatory plant elsewhere despite the risks detailed.

Last year Ben Kavoussi published an interesting article on SBM called Astrology with Needles in which he purported a historical connection between acupuncture and bloodletting. I had previously thought that bloodletting was a uniquely Western cultural invention – part of Galenic medicine involving the balancing of the four humors, one of which being blood. (In the West bloodletting faded away with the advent of science-based medicine in the 19th century.) I was intrigued by this connection and have since been doing my own reading on the topic. It turns out that bloodletting was common throughout ancient cultures and not unique to the west.

In fact acupuncture was originally a form of bloodletting – the “needles” were really lances and the acupuncture points locations over veins to be opened. Chi, or the Chinese concept of the life force, was believed to be partly in the blood, and blood letting could be used to free the flow of chi. This was closely related to the Galenic concept of using bloodletting to free the flow of static blood in the tissue.

For example, in the ancient medical text of Suwen, we find:

When heaven is warm and when the sun is bright,
then the blood in man is rich in liquid
and the protective qi is at the surface
Hence the blood can be drained easily, and the qi can be made to move on easily…

We also see in the text the connection of the functions of the body to celestial events. The concepts of blood, life force, and astrology all came together in acupuncture, but also in the ancient medical traditions of the West, just with different names and specific variations. The main concepts were balance and flow – lancing or needling were used to restore balance and flow to the natural rhythms dictated by the heavens.

You may be surprised to learn that these concepts have a continuous cultural connection to the present. In general the concept of bloodletting has fallen out of popularity because it seems barbaric and because the real physiological function of blood is now understood, and so are the dangers of bloodletting. But the techniques that were originally developed for bloodletting have been “rebranded” to be more acceptable to modern sensibilities (at least to a degree). And so acupuncture is now purely about chi and no longer about blood, and even more scientific explanations for how it might work are being sought. In my opinion, this is all a fool’s errand – chasing the bloodletter’s craft.

Cupping was also developed as a method of drawing out the blood. But now it is used to draw out imaginary toxins.

I had thought this “rebranding” was complete and all traces of bloodletting removed from the modern variants of these practices. But the cultural roots go deep, and even modern practitioners, relying on ancient texts, still adhere to some of the bloodletting concepts. They talk about treating blood “stasis”, which is a very Galenic concept.

The Japanese version of acupuncture, Shiraku, which survives today also closely ties together bloodletting and acupuncture (Shiraku means bloodletting). They combine cupping with lancing within an “acupuncture framework.”

The Institute for Tradition Medicine online has this gem, which extols the therapeutic benefits of “bleeding points.”

Peripheral blood-letting today is mainly carried out at the fingers and toes. At the tips of the toes, for example, are the qiduan points, located 0.1 cun behind the nails. These are said to be useful for emergency treatment for stroke or for numbness of the toes, also for redness, swelling, and pain of the instep of the foot.

I will have to remember that the next time a patient comes in with a stroke. It seems that the amount of blood drawn has been significantly reduced, which is good, but the ancient bloodletting concepts are all there unchanged.

Further, Acupuncture Today contains an article describing the use of bloodletting in modern acupuncture. The author, Skya Abbate, DOM, writes:

However, bleeding is a specialized technique for specific conditions that can produce effective and dramatic results when the patient’s condition is diagnosed properly and the bleeding method expertly executed.

As an example of the use of bloodletting, Abbate writes:

It can invigorate the smooth flow of qi and blood, thereby picking up and facilitating its flow when the qi and blood need invigoration. An example of this scenario occurs when a patient presents with a wiry pulse and mild feelings of stagnation that indicate qi stagnation.

The concepts of the flow of qi and blood are alive and well. I could have told you that was a quote from a medieval text and you probably would not have questioned it.

Conclusion:

When the actual history of acupuncture, bloodletting, cupping, and similar techniques are investigated we find that there are many modern myths about these practices. One myth is that there were completely different traditions in the various cultures, especially East and West. In reality, these were only cultural variations on the same themes – restoring balance and flow to blood and life energy in accordance to some astrological principles.

There is also evidence of direct cultural contact – not just reinventing the same concepts. For example, the iceman is the frozen remains of a 5200 year old man found in the Alps. He was covered with tattoos of points and lines over traditional acupuncture points. This was probably an example of therapeutic tattooing – the tattoos themselves were meant to be therapeutic. There are also needle punctures as some of these points. Think about the implications of a person living near the Alps (what is now Europe) 5200 years ago being tattooed over what later were known as acupuncture points.

It is further a myth that what we know today as acupuncture or cupping were developed in line with their modern incarnations. In reality, these techniques were just variations of bloodletting and were very deliberately and fairly recently distanced from their bloodletting roots to make them more acceptable.

And finally it is a myth that bloodletting itself has been eliminated from traditional practice. It survives in muted form in various traditions.

I’ve previously described the consequences of acute and chronic sun exposure, and the rationale for topical sunscreen products. But wouldn’t it be easier to just take a pill that can boost our skin’s resistance to to the harmful effects of the sun? Is it possible to get all the benefits of sunscreen without the bother of creams, or even clothing?

Protecting your skin from ultraviolet (UV) damage is the central claim with products like Heliocare, Fernblock, and Sunpill. All contain extracts of Polypodium leucotomos (cabbage palm fern), a plant native to Central America. Like many plants, there are some interesting biological compounds inside. The active ingredients seem to be in the rhizome (rootstalk), and they include calagualine, ecdysone, ecdysterone, and several phenolic compounds that may provide antioxidant effects. There is some preliminary evidence to suggest that these chemicals may reduce oxidative damage caused by UV light. In animal models that have looked at simulated UV radiation, inflammation and irritation have been reduced.[1]

During a decade of clinical trials, FernBlock® has shown remarkable effectiveness in shielding skin against dangerous ultraviolet exposure [source]

So let’s look at this evidence, and start with a focused clinical question: In typical sunscreen users, does consuming Polypodium leucotomos supplements provide UVA and UVB skin protection that is comparable to, or a substitute for, topical sunscreen products?

A search of the literature identified four semi-relevant trials. There are no published studies that directly compare oral supplements to topical sunscreens.

Villa studied the effect of Polypodium leucotomos on a marker for chronic UVA-initiated skin damage.[2] Ten volunteers were recruited, and all underwent pre-study skin biopsies and UVA exposure to identify baseline values. One week later, five participants took two doses of a Polypodium leucotomos supplement (8 hours and 2 hours before UVA exposure), and the others received no treatment. Then all received another dose of UVA radiation, at 2-3x the minimum dose determined to produce a sunburn. More biopsies were taken to evaluate UVA damage.

The authors reported that the control group experienced large increases in the marker for UVA damage, while the Polypodium leucotomos group experienced decreases, compared to control. However, these results were not statistically significant. Further, the authors noted that Polypodium leucotomos did not prevent inflammatory infiltrates associated with UVA damage.

The limitations to this study are numerous: The sample size of 10 is modest, and no information is provided to demonstrate the groups are well matched, or how they were allocated. No rationale for the dose used is provided. Two patients were dropped from the control group. The study was not blinded for participants. There is no information about the product used, other than it was a 240mg dose. Without standardization, it’s impossible to extrapolate the observed effects to any commercially available product. Finally, given it appears to be a letter to the editor, it may not have been subject to peer review. The results should properly be called hypothesis-generating — at best. They look promising, but should be followed by more study – not routine use.

Middelkamp-Hup studied Polypodium leucotomos in the prevention of sunburn.[3] In this small open-label study, nine volunteers were given different doses of UV radiation, and then the radiation was repeated after two days of taking Fernblock. A small skin biopsy was taken  before and after treatment, and the samples were compared. Researchers found less evidence of skin damage, and concluded that Fernblock protected the skin from inflammation and the effects of sunburn. This was an interesting preliminary study, but not one that helps us understand its effectiveness compared to sunscreen. The study was not blinded, the effects were modest, and long-term effects were not studied.

Another study by the same author examined the effect of Polypodium leucotomos in ten volunteers that were given sensitizers that accelerate UV damage.[4] There was no blinding. Volunteers received simulated sun exposure before and after 7.5mg/kg of Polypodium leucotomos. The author concluded that Polypodium leucotomos was an effective skin protector against the simulated sun exposure. As this study examined the products effectiveness in patients given UVA sensitizers, it’s difficult to draw conclusions about its usefulness in typical consumers seeking protection from regular or intermittent sun exposure.

González studied both topical and oral forms of Polypodium leucotomos in 21 people.[5] Some patients were given sensitizers to accelerate UVA damage, some were untreated. Skin was evaluated to measure the protective impact of the product. The author observed that the time to initial reddening increased significantly, and reduced other initial signs of skin damage. He concluded that both versions offered some degree of skin protection. This was a small study, with no blinding. No comparison was made to sunscreen.

That’s the extent of the published research that’s relevant to our question. There are some other trials, that are suggestive, but not conclusive, that Polypodium leucotomos supplements may provide some benefit to people who have atypical skin reactions to sunshine. Without double-blind trials, we are left with considering this lesser-quality evidence. That doesn’t mean we ignore the published data, but we should remain skeptical, and look for confirming evidence.

Unfortunately, the manufacturer’s websites have little in the way of objective clinical information. The Sunpill manufacturer links to this clinical study summary [PDF], but there’s not enough information to evaluate the results. There is also a laboratory report [PDF] of a Sunpill evaluation designed to follow the FDA’s standard for sunscreen testing. An eight week evaluation, it measures the efficacy of the supplement in conjunction with daily sunscreen use. While the results look promising, it’s difficult to draw conclusions from the data when presented in this format.

Dosing and Use

If you read the marketing, these products sound pretty impressive:

Fernblock: For the first time you can achieve essential protection from dangerous sun exposure in a pill.

Heliocare works to turn back the sun.

Sunpill protects the skin from the harmful rays of the sun, but still allows your body to receive the benefits that sunshine gives you.

Clearly there’s a gap between the marketing copy and what the evidence says. In light of the limited clinical data, let’s look closer at the dosing recommendations. Are manufacturers telling consumers to put away their topical sunscreen? Not quite:

• Fernblock’s dose is 240-480mg in the morning, 30 minutes before sun exposure, and “for extended sun exposure take one additional capsule at noon.” The manufacturer also recommends use with SPF 30 sunscreen, and cautions, “Use topical sunscreens whenever exposed to sunlight. This product is not a sunscreen.”
• Heliocare has a similar dose: two 240mg capsules daily before exposure to sun, with a third capsule for prolonged exposure to the sun. There is a caution: “Do not exceed the stated recommended daily consumption of three Heliocare capsules per day.” The manufacturer also notes, “Heliocare is definitely NOT a substitute for good sunscreens and protective clothing.”
• Sunpill is packaged as a 639 mg dose of Polypodium leucotomos and several other ingredients including green tea, aloe, pomegranate, and beet root, all without persuasive evidence of effectiveness for UVA/UVB sun protection. It’s not clear how much Polypodium leucotomos is in the product. The manufacturer states, “New research from the University of Miami School of Medicine shows that the fern extract in these pills significantly reduced UVA-related DNA damage that leads to wrinkling and brown spots. For best results, pop one each day starting a week before you plan on fun in the sun.” It also adds, “It is alway (sic) advisable to use a topical sunscreen when you are going to be out in the sun for an extended period of time.”

Safety

The most common side effect reported in the limited research is stomach upset. Advertisers repeatedly use the statement, “has been safely used for over 20 years in Europe,” but I can find no published evidence of this. Based on the the evidence above, these products seems to be safe when taken for a week – the longest trial that’s been published. There is no published information showing these Polypodium leucotomos products are safe if taken for a longer period. [1] Another formulation of the same ingredient appears to be safe when taken for up to five months, however. [1] In light of the small studies that have been conducted, the full safety profile may not yet be well understood. There’s no information about the supplement’s safety in children, or in pregnant or breastfeeding women.

Bottom line

The consequences of unprotected exposure to UV light can be severe.  Physical barriers and sunscreen in the forms of creams and other topical products have been demonstrated to reduce acute and chronic consequences of UV exposure. The idea of a well-tolerated, safe, oral supplement that protects against UVA and UVB without the need for topical products is an attractive one – but it’s not clear we have the evidence yet.  Oral sunscreens, taking the most optimistic view of the data, may slightly reduce some of the severity of a sunburn, and may provide some UVA protection. González, one of the researchers cited above, has suggested Polypodium leucotomos offers an SPF of about 3 – insufficient for most people that need sunscreen. Most importantly, these products are still recommended for use in combination with topical sunscreen. Given most sunscreens offer an SPF of 15 or more (when properly applied), it’s not clear if the incremental benefits would be meaningful. So do the potential benefits outweigh the unanswered questions and additional cost? Until better effectiveness and longer-term safety data emerges, a risk-benefit evaluation suggests we’re better off seeking shade behind, instead of eating, Polypodium leucotomos.

References

[1] Natural Medicines Comprehensive Database [database on the Internet]. Stockton (CA): Therapeutic Research Faculty; 1995-2010 [cited 4 July 2010] Available from: http://www.naturaldatabase.com. Subscription required to view – Sorry.

[2] Villa, A., Viera, M., Amini, S., Huo, R., Perez, O., Ruiz, P., Amador, A., Elgart, G., & Berman, B. (2010). Decrease of ultraviolet A light–induced “common deletion” in healthy volunteers after oral Polypodium leucotomos extract supplement in a randomized clinical trial Journal of the American Academy of Dermatology, 62 (3), 511-513 DOI: 10.1016/j.jaad.2009.05.045

[3] Middelkamp-Hup MA, Pathak MA, Parrado C, Goukassian D, Rius-Díaz F, Mihm MC, Fitzpatrick TB, & González S (2004). Oral Polypodium leucotomos extract decreases ultraviolet-induced damage of human skin. Journal of the American Academy of Dermatology, 51 (6), 910-8 PMID: 15583582

[4] Middelkamp-Hup MA, Pathak MA, Parrado C, Garcia-Caballero T, Rius-Díaz F, Fitzpatrick TB, & González S (2004). Orally administered Polypodium leucotomos extract decreases psoralen-UVA-induced phototoxicity, pigmentation, and damage of human skin. Journal of the American Academy of Dermatology, 50 (1), 41-9 PMID: 14699363

[5] González S, Pathak MA, Cuevas J, Villarrubia VG, & Fitzpatrick TB (1997). Topical or oral administration with an extract of Polypodium leucotomos prevents acute sunburn and psoralen-induced phototoxic reactions as well as depletion of Langerhans cells in human skin. Photodermatology, Photoimmunology & Photomedicine, 13 (1-2), 50-60 PMID: 9361129

A few weeks ago I posted an article about bogus diagnostic tests. I cited Doctor’s Data, Inc. (DDI), as “a company with a long history of dubious offerings.” I also wrote:

You can’t help but have noticed that many of the links in this post are to articles on Quackwatch. That’s because the site is chock full of useful information about bogus tests, far more than can be found elsewhere. There you will find a more comprehensive list of bogus tests than I’ve mentioned here, and a larger list of laboratories peddling them. You’ll also find an article on “Dubious Genetic Testing” co-authored by the Quackwatch founder, Stephen Barrett, and our own Harriet Hall, and an article about bogus “biomedical treatments” for autism showing that—surprise!—Doctor’s Data and Genova Diagnostics are major players there, too.

I stand by all of those statements. It turns out that Doctor’s Data is not pleased that Dr. Barrett has so thoroughly blown the company’s cover.

As he describes on Quackwatch, about a month ago Dr. Barrett received this letter from a representative of the law firm Augustine, Kern and Levens, Ltd. of Chicago:

Dear Dr. Barrett:

It has recently come to the attention of our client, Doctor’s Data, Inc., an Illinois corporation, that you have, on a continuing basis, harmed Doctor’s Data by transmitting false, fraudulent and defamatory information about this company in a variety of ways, including on the internet and in other publications. Doctor’s Data is shocked that you would intentionally try to harm its business and its relationship not only with doctors but also with the public. Doctor’s Data has also learned that you have apparently conspired with and encouraged individuals to seek litigation against it, and have filed false complaints at various government and regulatory agencies against Doctor’s Data.

“It is never libelous,” you have said, “to criticize an idea.” However, you have gone way beyond the idea stage, and our client will not tolerate it. You apparently have carried on this conduct in an intentional manner and with the assistance of others. It is clear that you have a specific intent to harm Doctor’s Data, and this conduct must stop immediately.

We demand that you cease and desist any and all comments regarding Doctor’s Data, which have been and are false, fraudulent, defamatory or otherwise not truthful, and make a complete and full retraction of all statements you have made in the past, including those which have led in some instances to litigation. Such comments include, but are not limited to, those made in your article entitled, “How the ‘Urine Toxic Metals’ Test Is Used to Defraud Patients,” which you authored and posted on Quackwatch.com. “The best evidence for reckless disregard,” you have written, “is failure to modify where notified.” Consider this notice to you that if you do not make these full and complete retractions within 10 days of the date of this letter, in each and every place in which you have made false and fraudulent, untruthful or otherwise defamatory statements, Doctor’s Data will proceed with litigation against you and any organizations, entities and individuals acting in common cause or concert with you, to the full extent of the law, and will seek injunctive relief and monetary damages, both compensatory and punitive.

Doctor’s Data is a CLlA-certified company in full compliance with all state and federal regulatory and CLlA standards, and your false, fraudulent, defamatory and otherwise untruthful comments have been made to intentionally damage Doctor’s Data, Inc. This conduct will no longer be tolerated and if the retractions are not made as written above, the lawsuit shall be filed imminently.

Very truly yours,

Algis Augustine

Dr. Barrett’s reply included this:

I take great pride in being accurate and carefully consider complaints about what I write. However, your letter does not identify a single statement by me that you believe is inaccurate or “fraudulent.” The only thing you mention is my article about how the urine toxic metals test is used to defraud patients… The article’s title reflects my opinion, the basis of which the article explains in detail.

If you want me to consider modifying the article, please identify every sentence to which you object and explain why you believe it is not correct.

If you want me to consider statements other than those in the article, please send me a complete list of such statements and the people to whom you believe they were made.

Rather than sending Dr. Barrett such a list, the firm replied:

Dr. Barrett,

You have been making false statements about Doctor’s Data and have damaged this company’s business and reputation, and you have done so for personal gain and your own self-interest, disguised as performing a public service. Your writings and conduct are clearly designed to damage Doctor’s Data. If you don’t retract your false claims and issue a public apology, the lawsuit will be filed.

Today is June 14th, which is the deadline that was in our letter of June 2nd. Because you responded, you have until Thursday, June 17th, to post your retractions. If you do so and show good faith immediately, this will be taken into account in proceeding.

Jeff Levens
Augustine, Kern and Levens, Ltd.

Once again, Dr. Barrett asked the firm to cite the purported false statements:

Dear Mr. Levens:

My letter asked you to identify the claims that you believe are false. You have not identified a single sentence that you believe is inaccurate. Since you have failed to do so, I have no choice but to assume that you cannot. My offer remains open, as it is to anyone who is criticized on any of my sites. If you identify anything that you consider inaccurate, I will seriously consider what you say and act accordingly.

Thank you,

Stephen Barrett, MD

The result was predictable:

On June 18th, Doctor’s Data filed suit against me, the National Council Against Health Fraud, Inc., Quackwatch, Inc., and Consumer Health Digest, accusing us of restraint of trade; trademark dilution; business libel; tortious interference with existing and potential business relationships; fraud or intentional misrepresentation; and violating federal and state laws against deceptive trade practices…The complaint asks for more than $10 million in compensatory and punitive damages.

It also asks the court to prohibit Dr. Barrett and others from exercising their freedom of speech:

WHEREFORE, DOCTOR’S DATA, INC., Plaintiff, prays that this court enter an order granting Doctor’s Data a permanent injunction; direct them to remove or delete all disparaging statements and remarks pertaining to Doctor’s Data from these or any web sites under their control; and prohibit them from publishing these or any other or additional such remarks on blogs, the aforesaid websites, or any other web sites pending the outcome of this litigation.

Sounds eerily similar to the Simon Singh case in the UK. The U.S., of course, has libel laws that are far more protective of freedom of speech than those in the UK; but any lawsuit at all, no matter how unfounded, is burdensome to the defendant, who must spend considerable time and money on his defense. Thus a corporation with means can easily cripple an individual such as Stephen Barrett, who realizes no “personal gain”  from what he writes on Quackwatch and lives on little more than a modest retirement pension. Roy Poses, referring to Scot Silverstein’s post over at Health Care Renewal about this lawsuit, observed:
 

Note that the Quackwatch publications which the suit addressed included one that simply described a lawsuit (filed by others), and another that simply summarized an article in Slate (written by others). Sounds like a SLAPP to me. 

Scot himself wrote:

This seems like a case of legal intimidation and may be a case for Senator Grassley’s whistleblower hotline (whistleblower@finance-rep.senate.gov).

Dr. Barrett is well aware of this, but he is not about to surrender:

Very few people provide the type of information I do. One reason for this is the fear of being sued. Knowledgeable observers believe that Doctor’s Data is trying to intimidate me and perhaps to discourage others from making similar criticisms. However, I have a right to express well-reasoned opinions and will continue to do so.

Yes, it is true that very few people or places provide the type of information that he does. That’s why I linked to so many of his articles from my own recent post. You can’t find that kind of information on virtually any mainstream website that claims to give reliable information about “complementary and alternative medicine”: not on WebMD, not on InteliHealth, not on the NCCAM website—even though most people would probably expect to find it in those places, if they were aware of it at all. You won’t find on any of those sites, for example, that being “a CLlA-certified company in full compliance with all state and federal regulatory and CLlA standards” is no guarantee against peddling bogus diagnostic tests.

Dr. Barrett needs both money and publicity to fight this. Please go here to donate money. Please spread this story around and keep plugging at it. Let’s turn this into an opportunity to expose both the sordid reality of present-day quackery and the perversion of law that the suit represents, exactly as has now happened in the Simon Singh case.

Editor’s note: It’s still a holiday weekend in the United States. I had considered simply taking the day off altogether, particularly since I’m busily working on my talk for TAM8–which (holy crap!) is in a mere three days–but then I figured today’s a good time to resurrect a “classic” (if you will) post that I wrote a few years ago, dust it off, and post it. I decided to do this mainly because I had been planning on bringing this post to SBM at some point right from the very beginning of SBM.

Regular readers of this blog are probably familiar with a certain homeopath named Dana Ullman. So persistent is he in his pseudoscientific arguments for the magic that is homeopathy that fellow SBM blogger Kimball Atwood once postulated a humorous law he dubbed the Dull-Man Law:

In any discussion involving science or medicine, being Dana Ullman loses you the argument immediately…and gets you laughed out of the room.

Kimball then pointed to a number of studies that Ullman likes to cite ad nauseam that supposedly “prove” the efficacy of homeopathy. One study Kimball didn’t mention, however, is a favorite of Ullman’s, one he likes to trot out time and time again. Specifically, it’s a study of homeopathy in the ICU that was published, in all places, in Chest, a respectable journal that, as you might expect, is dedicated to research on diseases of the chest, such as chronic obstructive pulmonary disease (COPD), cardiac disease, and basically any disease that manifests its pathology in the chest, although it primarily deals with critical care. I first learned of this study way back in 2007 from Dr. R. W., who at the time commented quite aptly that the article impressed him with just how far into the medical mainstream woo has penetrated, while retired doc also expressed his dismay.

Although I do feel a bit guilty not providing you with more original peerless prose pontificating on medical pseudoscience that you know and (hopefully) love, this article is constantly trotted out by homeopaths, even five years later, and that makes it worth updating an older post from another source. So here’s the abstract:

Influence of Potassium Dichromate on Tracheal Secretions in Critically Ill Patients.

Michael Frass, MD; Christoph Dielacher, RN; Manfred Linkesch, MD; Christian Endler, PhD; Ilse Muchitsch, PhD; Ernst Schuster, PhD and Alan Kaye, MD. Chest. 2005;127:936-941.

* From the Ludwig Boltzmann Institute for Homeopathy (Drs. Frass, Endler, and Muchitsch), Vienna, Austria; II Department of Internal Medicine (Mr. Dielacher and Dr. Linkesch); Department of Medical Computer Sciences (Dr. Schuster), University of Vienna, Vienna, Austria; and Department of Anesthesiology (Dr. Kaye), Texas Tech University Lubbock, TX.

Background: Stringy, tenacious tracheal secretions may prevent extubation in patients weaned from the respirator. This prospective, randomized, double-blind, placebo-controlled study with parallel assignment was performed to assess the influence of sublingually administered potassium dichromate C30 on the amount of tenacious, stringy tracheal secretions in critically ill patients with a history of tobacco use and COPD.

Methods: In this study, 50 patients breathing spontaneously with continuous positive airway pressure were receiving either potassium dichromate C30 globules (group 1) [Deutsche Homöopathie-Union, Pharmaceutical Company; Karlsruhe, Germany] or placebo (group 2). Five globules were administered twice daily at intervals of 12 h. The amount of tracheal secretions on day 2 after the start of the study as well as the time for successful extubation and length of stay in the ICU were recorded.

Results: The amount of tracheal secretions was reduced significantly in group 1 (p < 0.0001). Extubation could be performed significantly earlier in group 1 (p < 0.0001). Similarly, length of stay was significantly shorter in group 1 (4.20 ± 1.61 days vs 7.68 ± 3.60 days, p < 0.0001 [mean ± SD]).

Conclusion: These data suggest that potentized (diluted and vigorously shaken) potassium dichromate may help to decrease the amount of stringy tracheal secretions in COPD patients.

Holy homeopathy, Batman! Does this study mean that homeopathy actually works for critically ill patients in the ICU? Not so fast there, Robin. Let’s take a look.

First off, the title is interesting. Note how the word “homeopathy” or “homeopathic” does not appear. In fact, no derivative of the word “homeopathy” appears anywhere in the abstract. True, the Ludwig Boltzmann Institute for Homeopathy is mentioned in the institutional affiliations, but that would be easily missed by someone perusing the abstract. It’s almost as though the writers were trying to get this in under the radar. After all, most doctors don’t know much about homeopathy, which means that they don’t know much about what a “30C” dilution is or that such a dilution dilutes a substance to the point where there almost certainly isn’t a single molecule left.

First a word about the methods: Apparently in homeopathy lore, potassium dichromate is useful for treating thick respiratory secretions. On what basis, I don’t know. From where I come from, potassium dichromate is a nasty chemical; it’s a powerful oxidizing agent. Indeed, it’s sometimes used to clean laboratory glassware, although I never used it for that. It’s also used in photography and screen printing. It’s pretty toxic stuff and can cause a nasty dermatitis. Given all that, it’s a good thing that this stuff was diluted to nonexistence before being administered to patients sublingually (under the tongue)! If it weren’t, it could have caused some damage.

This all makes me wonder how this study ever got past the Institutional Review Board (IRB). After all, if there’s active ingredient left over, then the study would be proposing to give a toxic substance to patients on ventilators in an ICU. If the investigators made it very clear to the IRB that the dilution would be such that there would be no potassium dichromate left, then the IRB should have asked about the ethics of giving both experimental groups what is, in essence, a placebo. More disturbing is that the investigators stopped the administration of ?-agonist bronchodilators to these patients before they were started on placebo or treatment, in order “to avoid any potential influence and/or interaction.” Again, if there is potassium dichromate in the homeopathic remedy, then why did the IRB allow the investigators to administer it in the first place with no supporting evidence, either in clinical or animal models, that it might have an effect? If there is no potassium dichromate in the homeopathic remedy, then stopping effective medications in both study groups strikes me as unethical. In fact, the investigators essentially admit that it is diluted to nothing:

In homeopathic concentrations, potassium dichromate acts primarily by its mucolytic properties. In this study, we used a preparation of C30, which is equivalent to a potentiation of 30 dilutions, in which each of the 30 dilution steps is followed by subsequent vigorous succussions. Therefore, the above-described toxic effects were eliminated. In addition, the original orange-red color disappeared during the preparation. Onset of action may vary from patient to patient but is generally observed within 24 to 48 h.

What “above described toxic effects,” you ask? None, really. The investigators didn’t describe any potential toxic effects from potassium dichromate until the discussion section. Apparently, the reviewers didn’t read this study too carefully (which is, of course, one possible explanation for such woo making it into a journal with an impact factor of 4.008). Be that as it may, let’s look at the patient characteristics, shall we?

First, there were only 25 patients in each group, which is a pretty small number for anything other than a pilot study. You have to remember that, when studies are small, spurious results are more likely to occur. At first glance, the patient characteristics in this table appear pretty well balanced. At first glance. Actually, this is a good example of when statistical nonsignificance doesn’t necessarily mean clinically nonsignificant. For one thing, the stage of COPD in the control group was higher than that of the treatment group (1.20 ± 0.5 versus 1.08 ± 0.4, p=0.178). This seems very odd, because both groups are listed as having mild COPD by this criteria, given that the COPD stages run from 0 to 3, with 0 being normal lung function and 1 being the least severe. If the average COPD stage for each group was close to 1, then why did the patients have such difficulty coming off the ventilator? Something’s odd there, since the mean FEV1 (forced expiratory volume in 1 second) was 54.0 ± 5.3% in the potassium dichromate group and 52.4 ± 5.5% in the control group, both of which are very close to the range of stage 2 COPD (FEV1 between 35% and 49%). In other words, it would seem that most of the patients were bad stage 1 patients.

A more interesting difference, however, and potentially more likely to influence the results of the study comes when you look at the number of patients who were on home oxygen before being hospitalized and developing respiratory failure. In the control group, 9/25 patients were on chronic home oxygen, whereas in the potassium dichromate group, only 5/25 were on home oxygen. Leaving aside that both numbers seem very high for two groups whose COPD scores are 1.2 or below given that it’s usually patients with stage 3 COPD who require home oxygen, it is clear that the control group had nearly twice the number of patients who were on home oxygen before admission. This seems inconsistent with a small difference in the COPD score, and the low COPD scores seem inconsistent with such severe exacerbations. After all, the definition of stage 1 COPD is:

Often minimal shortness of breath with or without cough and/or sputum. Usually goes unrecognized that lung function is abnormal.

Essentially no patients with stage 1 COPD need home oxygen. Ditto stage 2 COPD, which is defined:

Often moderate or severe shortness of breath on exertion, with or without cough, sputum or dyspnea. Often the first stage at which medical attention is sought due to chronic respiratory symptoms or an exacerbation

By the measurements listed, the average patient in both groups had at worst slightly worse than stage 1 COPD, which makes it odd indeed that 36% and 20% of the control and potassium dichromate groups, respectively, were on home oxygen. Let’s just put it this way. Needing home oxygen is a good marker for one of two things: either more severe COPD or other concurrent lung conditions. Those four extra patients on home oxygen could potentially account for the longer time to extubation and longer length of stay in the hospital in the control group. We can’t tell if they do or not because the data isn’t presented in such a way to allow us to do so. It’s possible that the differences in patients on oxygen before admission made a difference. It’s also possible that this is just a spurious result from a relatively small study. Or, it’s possible that it might be correct and there might really be an effect, but this latter scenario is unlikely given the flaws in the study and the fact that no homeopath has yet explained a mechanism by which something like homeopathic potassium dichromate might do a single thing to eliminate secretions–or anything else, for that matter.

The bottom line is that, contrary to Dana Ullman’s representation of this study as slam-dunk evidence of the efficacy of homeopathy, it’s nothing more than a very questionable study in which it is unclear whether the treatment and control groups were truly comparable. The homeopaths’ conclusion would be hilarious were it not so sad that such woo has found its way into otherwise reputable journals:

The present study suggests that potassium dichromate C30 may be able to minimize the amount of tracheal secretions and therefore to allow earlier extubation when compared to placebo. Since the potentiation (dilution and vigorously shaking) of the study drug beyond the Avogadro number imposes no interaction with the patient’s metabolism, and due to the low cost of the drug, its use in the ICU may be beneficial, minimizing morbidity and mortality. Studies give some insight into the potential way of action of homeopathically prepared drugs. Cluster-cluster aggregation phenomena in aqueous solutions of fullerene-cyclodextrin conjugates, ?-cyclodextrin, sodium chloride, sodium guanosine monophosphate, and a DNA oligonucleotide revealed that there are larger aggregates existent in dilute aqueous solutions than in more concentrated solutions.²⁰ In another study, ultra-high dilutions of lithium chloride and sodium chloride (10-30 g cm^-3) have been irradiated by x-rays and gamma-rays at 77 K, then progressively rewarmed to room temperature. During that phase, their thermoluminescence has been studied and it was found that, despite their dilution beyond the Avogadro number, the emitted light was specific of the original salts dissolved initially.

This is the first scientific study of the effect of potassium dichromate on tracheal secretions. While the mechanism of potentized (diluted and vigorously shaken) drugs still remains subject to research, several articles describe its clinical usefulness. The effect may be best explained by cybernetics, which means that the information of the homeopathic drug acts consensually on the regulator. Thereby, the body regains its original property to regulate physical parameters.

First off, it’s nice to see that the investigators essentially admit that diluting above Avogadro’s number eliminates any trace of the compound. It is, however, unclear why they brought up ultrahigh dilution solutions irradiated at 77 Kelvin (or -196° C) and then rewarmed. First off, 10 to 30 molecules per cc is an incredibly concentrated solution in homeopathic terms. Second, homeopaths don’t cool their solutions down to the temperature of liquid nitrogen, irradiate them, and then slowly rewarm them, making me doubt very much the relevance of the experiment to anything that homeopaths do. But the part about cybernetics cracks me up. That one was clearly pulled out of someone’s hat (or perhaps out of their nether regions); yet it got by the reviewer.

As much fun as I have deconstructing such studies, hoping in vain for a good study but inevitably being disappointed, it is still disconcerting to see this sort of study published in Chest. More disturbing still is that an IRB allowed such a study of a useless medication on intubated ICU patients with COPD. It just goes to show that peer review is not perfect. It may remain the best bulwark against pseudoscience, but it’s only as good as the reviewers, and it’s not a foolproof guarantee against pseudoscience. As you can see from this study, it’s making its way into even the ICU, which is one place where evidence-based medicine should rule supreme and in which there should be no place for woo or quackery. What I fear is that, as more and more pseudoscience and non-evidence-based woo invades medical school, the dividing line between evidence-based medicine and woo will blur even more, and, as the older generations of physicians retire, the newer generation, who has been exposed to woo in medical school, will be less willing or able to call a duck a duck when they see it. Quack quack.

REFERENCE:

Frass, M. (2005). Influence of Potassium Dichromate on Tracheal Secretions in Critically Ill Patients Chest, 127 (3), 936-941 DOI: 10.1378/chest.127.3.936

Back in January, the Connecticut Board of Chiropractic Examiners held a four-day hearing to decide whether chiropractors must, as a part of the informed consent process, (1)warn patients about the risk of cervical artery dissection and stroke following neck manipulation and (2) give patients a discharge summary listing the symptoms of stroke.¹ On June 10th, the Board of issued a written opinion that stroke or cervical artery dissection is not a risk of cervical spine manipulation, so no warning is necessary. Presumably, although it is not specifically mentioned in the decision, no discharge summary is required because, if there is no risk of a stroke after neck manipulation, what would be the point?

Background

Janet Levy and Britt Harwe are two Connecticut women who suffered strokes resulting from neck manipulation by chiropractors. That’s not just their lay opinion, it’s the opinion of their respective treating physicians, right there in the medical records.

Each decided that some good should come of their unfortunate situations, so each formed a non-profit and began warning patients of the risk of stroke following manipulation. Victims of Chiropractic Abuse, Levy’s organization, put giant ads on the sides of busses in Bridgeport, CT., much to the chagrin of the folks at the University of Bridgeport. Within the hallowed halls of the University (Go Purple Knights!) is a College of Chiropractic, a College of Naturopathic Medicine, and the Acupuncture Institute. The chiropractors demanded that the ads be taken down, which got exactly nowhere.

Some chiropractors also began harassing Levy and Harwe, calling them Nazis and KKK members, for example, and threatening their personal safety and that of their families.(What is it with the pseudoscience crowd and calling people Nazis? Perhaps, having used up their entire supply of imagination creating their nostrums, they are reduced to these tired tropes.) The FBI recommended Levy and Harwe have one of the harassers arrested, which they did, and that calmed things down for a while.

Levy and Harwe knew that most chiropractors were not warning patients on their own, so they pushed for a state law requiring them to do so. After a great deal of effort they got before the state legislative Public Health Committee with the help of Sen. Len Fasano. At the committee hearing a compromise was reached between the proponents for a required warning and the chiropractic faction.

Sen. Fasano described this agreement in his testimony at the hearing before the Chiropractic Board:

I proposed legislation to the Public Health Committee, which legislation sought that some sort of informed consent be given by chiropractors to patients upon the … manipulation of the neck.

There were numerous discussions on both sides of that legislation, if I may, and it was sort of determined that perhaps the best way of handling this would be what we call a Take Away Form, where, for the first time that you [are] treated [with] the manipulation of a neck, the chiropractor would give you a Take Away Form, which discussed the risks and, also, symptoms, should you have some issues with respect to a stroke. These are the things you look at, and you should seek treatment right away.

However, it was impressed upon Senator Harris, [who] is Chairman of the Public Health Committee and myself, as the proponent, that rather than putting [it] in a state statute, the better way of doing this is to allow this Board [of Chiropractic Examiners] to govern itself, and, as a result, the matter was not pressed forward at the senate ….

Both sides agreed that a Take Away once a year upon the manipulation of the neck is reasonable, however, we did not put [it] in [a] state statute, because we believe it was better governed by the policing body [i.e., the Board].

(From Levy, I learned that she lived up to her part of the agreement, which was to take down her ads and not speak out against chiropractic while the matter was before the Board for consideration.)

Upon questioning by one of the attorneys, Sen. Fasano reiterated his understanding that “the chiropractors and the victims were coming to this Board in unison to ask for a Declaratory Ruling.” Sen. Fasano confirmed that this was Sen. Harris’s understanding as well. But by the time of the hearing, it was clear to Sen. Fasano that the chiropractors had no intention of living up to their end of the bargain and that they were dead set against any sort of discussion of the risks with patients and against giving patients a list of stroke symptoms to take home.

The Hearing

The hearing began with a bang on January 5th when the Connecticut Chiropractic Association and the Connecticut Chiropractic Council made a motion to disqualify the only public member of the Board participating in the proceeding, Jean Rexford, because they thought she might be in cahoots with one of the stroke victim organizations. This allowed the lawyers to warm up their vocal cords. By the end of almost 30 pages of transcript on this topic alone they were in fighting form. The chiropractors lost round one and Rexford remained to become the only dissenting vote in the Board’s ruling.

I attended the first two days of the hearing and it was clear to everyone from the get-go that the chiropractors would fight tooth and nail against a rule requiring any disclosure of risk. It was one of those “kumbayah” moments in chiropractic history when a temporary truce is declared in their internecine war and chiropractic organizations of all stripes circle the wagons.

This was no better exemplified than by the fact that J. David Cassidy, D.C., Ph.D., Dr.Med.Sc., lead author of the study, “Risk of Vertebrobasilar Stroke and Chiropractic Care,” Spine 33 (2008) S176-S183 [the “Cassidy study”] was required, in order to testify, to appear as a representative of the International Chiropractors Association (ICA), the organization of the super-straight-Daniel-David- Palmer- Innate-Intelligence chiropractors. I’ll bet he doesn’t put that on his C.V.

Here’s the testimony of George Curry, D.C., Chairman of the Board of ICA’s state affiliate, the Connecticut Chiropractic Council, describing the ICA’s beliefs:

Chiropractic science, as taught in the chiropractic curriculum in an accredited chiropractic college, involves the scientific aspects of the study of the human body and the science of detection and correction of the vertebral subluxation complex.

The art refers to the particular technique that a Doctor of Chiropractic would choose to reduce or correct a subluxation, and the philosophy is the where by [sic] or rationale that someone would investigate the spine as a cause of ill health.

The very basis upon which the profession was founded was that the body is a self-healing, self-regulating mechanism and has inherent recuperative powers, and that if those recuperative powers are interfered with, then it could cause of a loss of health.

Dr. Cassidy should hope and pray that this hearing transcript never, ever gets into the hands of an attorney who is preparing to cross-examine him.

Dr. Cassidy was plopped down into the middle of the hearing as a witness for the chiropractors, even though no one had listed him as a witness, as was required, prior to the hearing. This is why he had to pretend to be speaking for the ICA, as they were allowed to substitute him for the previously listed ICA witness. Apparently, we had done enough damage that the chiropractors felt they needed to bring in the man himself to defend his study.

The problems with the Cassidy study were explained on SBM  in an excellent post by Dr. Crislip (which, this being Dr. Crislip, also discusses hangings, The Who v. Motorhead, and being over age 50). The study’s hypothesis is that the association between chiropractic care and stroke can be explained by patients going to the chiropractor for headache and neck pain caused by a pre-stroke vertebral artery dissection. In other words, the pre-existing dissection causes the stroke, not the chiropractor’s twisting the patient’s neck. Dr. Crislip slices and dices the study nicely to show how this conclusion is not supported by the data.

So what did the chiropractors say, under oath, about the need for informed consent regarding neck manipulation and stroke? To quote one chiropractic witness (which is pretty much to quote them all, as their testimony on this point varied little): “There is no scientific evidence of a cause and effect relationship between a chiropractic neck treatment and a subsequent stroke.” That’s right — “no scientific evidence.”

Irony of ironies! The profession that has studiously avoided the scientific method for over 100 years suddenly discovers the value of science. A sort of jailhouse conversion, if you will.

And how did they know this? The Cassidy study. Even though the Cassidy study says, right there on page S181, that “[o]ur results should be interpreted cautiously and placed into clinical perspective. We have not ruled out neck manipulation as a potential cause of VBA strokes.” (Emphasis added.)

In another big dose of irony, decades of case reports of stroke following neck manipulation introduced into evidence were dismissed by one chiropractor, who testified that these constituted mere anecdotal evidence. This from the profession for which anecdotal evidence, dressed up as “clinical experience,” repeatedly trumps scientific plausibility.

I was permitted to give testimony before the Board as a “lay witness” on behalf of the non-profit Campaign for Science-Based Healthcare. My testimony consisted of channeling the post by Dr. Crislip and another post by Dr. Hall about how chiropractors and their trade associations were misrepresenting the study’s results to the public.

I also quoted from two neurology texts which addressed the anatomical aspects of cervical manipulation and artery dissection, both concluding that manipulation could indeed cause dissection:

The extracranial VA (vertebral artery) is also susceptible to traumatic injury because of its encasement in the bony part of the cervical canal. Either spontaneously or after minor trauma from neck manipulation, the VA may be injured, and dissection with luminal compromise and clot embolization may occur. This is a common cause of stroke, especially in younger patients without other vascular risk factors.

Samuels, Office Practice of Neurology (2nd ed. 2003), 372. (Emphasis added.)

Dissection of the extracranial carotid and vertebral arteries accounts for approximately 80% to 90% of all cervicocephalic dissections…. The vertebral artery is most mobile, and most susceptible to mechanical injury, at the C1-C2 level, as it leaves the transverse foramen of the axis and abruptly turns to enter the intracranial cavity …. The C1-C2 site is involved in one half to two thirds of all vertebral artery dissections and in 80% to 90% of rotation-related dissections.

Mohr, Stroke: Pathophysiology, Diagnosis, and Management (4th ed. 2004), 1059. (Emphasis added.)

Also testifying for “our side” was the indefatigable Canadian pediatrician and chiropractic critic, Dr. Murray Katz. If you are not familiar with Dr. Katz’s work, suffice it to say that chiropractors like Dr. Katz every bit as much as anti-vaxers like Dr. David Gorski. He undermined the Cassidy study’s methodology and hammered on the susceptibility of the vertebral and carotid arteries to injury from manipulation.

Three survivors of stroke after manipulation and three relatives of patients who died also testified. You could hear a pin drop.

The most compelling aspect of their testimony was how remarkably similar each story was to the others:

• the nonsensical reasons for having neck manipulation (sore shoulder, “maintenance care,” lower back pain);
• the youth of the victims, all under 45 years old, one only 20 years old;
• symptoms of stroke appearing within minutes to hours after manipulation;
• clueless chiropractors who had no idea what was going on while their patients were experiencing stroke symptoms, and who gave their patients ridiculous advice (toxins were being released, take Advil) or did nothing at all instead of sending them straight to the hospital;
• the patients’ and emergency doctors’ frustrations at not being able to figure out the source of the patients’ symptoms — the patients were not connecting symptoms with manipulation because they had not been informed of the risk of stroke;
• the “aha!” moments of hospital doctors when they learned their patients had undergone chiropractic manipulation;
• the lingering neurological deficits of the patients who survived and the devastation suffered by the victims and their families.

There could have been no better summation for the victims and their allies than the testimony of Douglas Fellows, M.D., chairman of Diagnostic Imaging and Therapeutics at the University of Connecticut Health Center, a member of the Connecticut Medical Examining Board, and himself a former physical therapist who had used cervical manipulation in his practice. He appeared in support of the Medical Examining Board’s previously filed statement urging that patients be informed of the risk of stroke following manipulation.

Dr. Fellows confirmed the Medical Board’s opinion that vertebral artery dissection can be caused by cervical manipulation. He also testified that, although the risk of stroke and death were remote in the procedures he performs as an interventional radiologist, he always tells patients of this possibility. In response to a question from a Chiropractic Board member — which contained the assertion that “we haven’t established any causality. At most, we’ve established a temporal relationship” — he replied:

We don’t know what the risk is, as far as the percentage risk, but it’s the harm that we worry about, the potential, the devastating effect of paralysis or death, and that’s what we do [referring to warning his patients of the risk of stroke from certain procedures, even thought the risk is remote].

The Decision

Although the Board had previously voted 4-1 against the necessity of a warning, the written “Declaratory Ruling Memorandum of Decision” was not issued until June 10th.

In its decision, the Board correctly stated that, under Connecticut law, “[t]he materiality of a risk is determined by weighing the benefits of a procedure, against the frequency and severity of the potential harm.” But, this being chiropractors, who simply discard facts not fitting their paradigms, that was the last mention of “benefits” and “severity.” From then on, the decision focused solely on “frequency.”

The Board relied heavily on the Cassidy study in making its decision that “the evidence is sufficient to establish that a stroke or cervical arterial dissection is not a risk or side effect of a joint mobilization, manipulation or adjustment of the cervical spine performed by a chiropractor.”² It is worth repeating that the study itself states “[w]e have not ruled out neck manipulation as a potential cause of some VBA strokes.” However, the Board explained this away by noting that “Dr. Cassidy credibly testified ‘this is a study that raises real doubt about the association being a risk …’” In fact, according to Dr. Cassidy’s testimony, he’s become so doubtful he has absolved himself from a previous admission that he caused a patient’s stroke by manipulating her neck.

The Board went on to explain that “[s]tatistically, what scant evidence exists of the incidence of stroke following a … manipulation … of the cervical spine was found primarily in persons under age 45. As provided in the Rothwell study, ‘it remains to be explained why an association between chiropractic manipulation and [vertebrobasilar accident] was observed only in the young. If an association were to exist, one would expect that it would exist regardless of age.’”

If only the Connecticut Board of Chiropractic Examiners had read Science-Based Medicine before issuing its ruling!
Dr. Crislip, who has answered many questions here recently, had an answer to this very question months ago in his SBM post on the Cassidy study.

In the over 45 age group, strokes due to chiropractic could be lost in the sea of strokes due to other reasons, and since we do not know if there were a dissection or blood clot as a cause of strokes, it is hard to conclude that there were no extra strokes from chiropractic. The study was not powered to determine the rare event of a chiropractic event against the background to usual stokes in the elderly. The mean age in this study was 63 ….

Young people should not have any stroke. In the young, vertebral artery dissection is a common cause of a rare event. It is also the worry from chiropractic neck manipulation. If you could find an effect of chiropractic, it would be in the young. And they do. The people who have an increase in stroke are those under age 45. And it is a big association: odds ratios from 3 to 12.

The association is most noticeable in the first 24 hours after seeing a chiropractor. Usually if you rip an artery it is symptomatic right away. Again, we do not know if these people had dissection or not. We only know they had stroke of some sort, within a day after seeing a chiropractor. One would predict that if there were an association between chiropractic and stroke you would most easily find it in the young and the effect would be most noticeable in the first day or so after the chiropractic visit.

And this article confirms this association.

I even cited to Dr. Crislip’s post in my brief and provided a link! So much for Board’s self-proclaimed “careful and thorough review of all of the testimony and documentary evidence.”

And speaking of said “careful and thorough review,” the decision did not explain how Board managed to avoid the basic anatomy of the human neck, which strongly suggests that twisting it forcefully is really not a good idea.

The Board did allow that “the evidence is sufficient to establish that spinal manipulation on persons who are having an acute stroke or cervical arterial dissection is not within the standard of care.” Well, that’s certainly a relief!

The Board also said that a chiropractor who wanted to “discuss these issues” [presumably, the non-existent stroke risk] with a patient could do so without being in violation of the standard of care.

So, even though the Cassidy study says that patients with headache and neck pain can be presenting with vertebral artery dissection, and that there is no screening procedure to determine whether patients presenting with headache or neck pain are at risk of VBA stroke, chiropractors should feel free to manipulate the neck without warning of the risk of stroke. Why didn’t the Board decide that the evidence they find so compelling dictated the much safer option of not using manipulation on anyone with headache or neck pain?

Post-hearing

What does this ruling mean?

Unfortunately, young people will continue to have debilitating strokes and some will die following cervical manipulation.

But the fight was not for naught. Many TV viewers saw scary videos of necks popping at the hands of chiropractors during media coverage of the hearing. Awareness of the risk of stroke was raised — not everyone believes the chiropractors when they deny it. “Our side” got great press.

Janet Levy can resume her bus ads in Bridgeport. Sen. Fasano will again introduce legislation making chiropractors inform their patients of risk. It failed this year but he vows to re-introduce it next year. And Levy has just filed suit in Connecticut against two state chiropractic organizations citing them for, among other things, failure to warn patients of the risk of stroke following manipulation.

The Board’s declaration that there is no risk of cervical artery dissection and stroke following manipulation is a finding of fact and not binding on the courts. As is their ruling that informed consent does not require a warning. Under Connecticut law, whether a warning of risk is required is determined by the “reasonable patient” standard, that is, what would a reasonable patient consider important in making his decision whether to undergo a particular procedure. One of the very purposes of the reasonable patient standard is to prevent practitioners from setting low standards and then claiming they’ve abided by their profession’s standard of care. Imagine the chiropractor sued for failure to warn who erroneously thinks he’s been inoculated against malpractice claims by following the Board’s ruling. Surprise!

As a matter of fact, the hearing transcript and videotape are now in the hands of plaintiffs’ personal injury attorneys, who will mine it for useful information. A couple of years ago the American Justice Society (formerly known as the Association of Trial Lawyers of American) started a chiropractic interest group (that is, interest in suing chiropractors for personal injury). The section collects and distributes such information for AJS members.

The chiropractors may have won this battle, but they could be losing the war.

Notes

1. The Petition for Declaratory Ruling filed by the Connecticut Chiropractic Association, which set this proceeding into motion, used the term “cervical artery dissection” in describing the risk of cervical manipulation at issue before the Connecticut Board of Chiropractic Examiners. The Board also used the term “cervical artery(ies)” in its ruling and otherwise during the proceeding, as did some of the other participants. “Cervical artery” is an imprecise term as there is no such anatomic structure. Apparently, its use refers collectively to the vertebral and carotid arteries.
2. At least I think that is the Board’s decision, as it is repeated several times and is made “Finding of Fact” number 3 in the Memorandum of Decision. But the Board also states a couple of times, once in its actual “Order” at the end of the written decision, that the “evidence is insufficient to conclude that stroke or cervical artery dissection is a risk or side effect of” cervical spine manipulation. Deciding that the evidence is sufficient to establish there is no risk is quite a different thing than deciding the evidence is insufficient to establish there is a risk.

Some Universities have more cachet than others. On the West coast it is Stanford that has the reputation as the best. There is Oxford, Yale, MIT, and maybe Whatsamatta U. I would wager that in most people’s mind the crème de la crème is Harvard. Harvard is where you find the best of the best. If Harvard is involved, a project gains an extra gobbet of credibility. Brigham and Women’s Hospital also has a similar reputation in the US as one of the hospitals associated with only Harvard and the New England Journal of Medicine. Premier university, premier hospital, premier journal.

So if Brigham and Women’s Hospital and Harvard Medical School are offering continuing medical information (CME) for acupuncture, there must be something to it, right? A course called “Structural Acupuncture for Physicians” must have some validity.

Brigham and Women’s Hospital, which is a teaching affiliate of Harvard Medical School, includes the Oscher Clinical Center for Complementary and Integrative Medical Therapies. The Oscher center offers acupuncture, yoga, chiropractic and a variety of other modalities including craniosacral therapy.

There are few things, in a world of alternative nonsense, as nonsensical as craniosacral therapy .

A craniosacral therapy session involves the therapist placing their hands on the patient, which they say allows them to tune into what they call the craniosacral system. The practitioner gently works with the spine and the skull and its cranial sutures, diaphragms, and fascia. In this way, the restrictions of nerve passages are said to be eased, the movement of cerebrospinal fluid through the spinal cord is said to be optimized, and misaligned bones are said to be restored to their proper position.

Cranial Sacral therapists think they can improve the flow of spinal fluid flow by gently massaging the skull. Really. I can’t make this stuff up. I operate under the assumption that you can judge a person by the company they keep, although guilt by association is problematic in medical institutions. Programs are often started in hospitals for financial reasons without the benefit of scientific or medical input. It is one of the many prices we pay in the US for a for-profit medical system. But if there is a institution whose scientific standards are such that they allow craniosacral therapy, well, they lose a major chunk of credibility. As the saying goes, you lie down with pigs, you come up smellin’ like garbage.

On the other hand, it would be much easier to participate on committee work. The Pharmacy and Therapeutics committees in which I participate spends significant time evaluating the literature to decide how best to utilize new drugs and therapies. If only we offered craniosacral therapy: I would never have to justify a treatment based on science and reality again. So now I realize, sadly, that Brigham and Women’s and, by extension Harvard, has questionable scientific standards, or, if they have standards, they apply them selectively.

The brochure states

This unique course provides practical, hands-on training in acupuncture. The training program is designed to bring together Eastern and Western views of health and disease into a result-oriented acupuncture style. You will learn to evaluate and treat patients using modern Japanese acupuncture techniques that link classical Chinese theory to concrete, understandable clinical diagnostic and treatment techniques.

Whenever I hear about the Eastern views of health and disease I always think of General Westmoreland in the movie “Hearts and Minds.” I know, cheap shot. But an Eastern heart attack is different from a Western heart attack how?

What, I wonder, is a “result-oriented acupuncture style.” Since acupuncture has little, if any, efficacy, it cannot have therapeutic results. Maybe the key word is style. There is style and there is substance. I suppose they could be suggesting that the acupuncture they are teaching will only look like it is working?

Style probably refers to the type of acupuncture, as in Kiiko Style acupuncture. Like the kung fu movies I watched as a teen, there are various acupuncture styles that need to compete in a winner take alltournament, to determine once and for all whose acupuncture is strongest.

Modern Japanese acupuncture differs from Chinese acupuncture in that they use finer needles that are not placed as deeply. Japanese acupuncture does seem to share one feature with Chinese acupuncture, at least to judge from the videos of the procedure I can find searching YouTube: a complete lack of understanding of sterile technique. I you want to get the willies watch a video on acupuncture, Japanese or otherwise. Barehanded, no hand washing, the practitioner touches the area to be pierced, no alcohol wipe is used, and the junction of needle/skin is manipulated. The Kiiko style, to judge from the photographs on the website, does not include gloves. These videos should be entitled “How to transmit infectious diseases.”

I assume they will use sterile technique at the course, since “emphasis is given to “hands-on” point location and needling techniques based upon palpatory feedback” although one cannot be sanguine in regards to a hospital system that uses craniosacral therapy. Germ theory is, after all, just a theory.

The didactic portion of the course will focus on bridging the gap between acupuncture practice and science. The scientific basis of acupuncture and the methodological problems with acupuncture research is presented as part of the discussion of specific clinical conditions throughout the course.

That will be an interesting discussion. Since the acupuncture literature, as discussed at length on this blog, is such that the best studies show no effect and the science is only barely applicable to acupuncture and pain treatment, it would be fun to be a fly on the wall and see how they ‘bridge the gap” for the justification of the covered uses: Pain Control, Hormonal Imbalances, OB/GYN Problems, GI Disorders, Scar Treatments, Structural and Orthopedic Problems, Cardiac and Vascular Disorders, Autoimmune and Autonomic Disorders, Mood Disorders, Myofascial and Neuroanatomic Treatment.

Not only will they be teaching Japanese acupuncture and classic Chinese acupuncture, but also auricular acupuncture and the German Microsystem approach (MAPS: Mikro-Aku-Punkt-Systeme). That last one

… is based on the Somatotopic fields comprising of specific points of correspondence in the Auricle (Ear), Scalp, Oral Cavity etc. A micro system is like a Map of the body — somatotope or a cartography of the whole organism similar to the homunculus discovered in the sensory motor cortex of the brain. Each of the Micro system points have a clearly defined correlation to and interrelation with a particular organ or function…For Example EAR Acupuncture is one such Micro-system. It was discovered by the french doctor Nogier who decoded the functional correspondences of the respective ear points. The punctual cartography of the Ear resembles an upside down embryo.

MAPS is apparently the result of the unholy mating of acupuncture and phrenology.

I am surprised they did not include Korean Hand Acupuncture, foot acupuncture and tongue acupuncture. They are leaving out three key styles of acupuncture. One wonders how six styles of acupuncture can all be valid, share similar physiology, and be supported by the same science, given their differences. I suppose it is like asking which is the valid style of astrology: Indian, Western, or Mayan. It is a trick question. They are all nonsense.

The best constructed study to date on acupuncture demonstrated that sham acupuncture by twirling toothpicks on the skin is arguably more effective and definitely has fewer side effects when compared to ‘real’ acupuncture. I can use quotes with the best of them. I wonder it they will pass out a box of toothpicks. Since twirling toothpicksgives similar results with fewer complications, one wonders how they justify teaching acupuncture styles that are less efficacious and more dangerous than toothpicks. Can you ethically offer an equivalent therapy with more side effects than a known competitor?

Let’s see, cost of the class: $6650. For that kind of cash, who needs ethics? That’s right, if you are a Harvard-affiliated hospital you can charge the cost of two loaded, top-of-the-line MacBook Pros to teach magic. I bet they get it. “Harvard-trained acupuncturist” would look great on a business card and provide instant credibility. A quick google finds practitioners whose websites mention the Harvard course for their training. Premium price for premium nonsense.

I am only disappointed they did not charge ten dollars more. $6660. Now there’s a number.

As the web page for the Oscler center says

The market for complementary and integrative medicine is vast and shows no sign of diminishing. This trend must be guided by scientific inquiry, clinical judgment, regulatory authority, and shared decision-making. – Dr. David Eisenberg.

The market. Not the need. The market. It is depressing when good institutions promote worthless nonsense.

Next time I read the NEJM and see an article from Harvard or Brigham and Women’s, I will not be as accepting of the result as I was in the past. They have lost some of their credibility with me. It is sad. Great institutions can have feet of clay. At least there are still institutions you can believe in. Mom. Apple Pie. Baseball. Go Barry Bonds.

Shingles (herpes zoster) is no fun. It usually begins with a couple of days of pain, then a painful rash breaks out and lasts a couple of weeks. The rash consists of blisters that eventually break open, crust over, and consolidate into an ugly plaque. It is localized to one side of the body and to a stripe of skin corresponding to the dermatomal distribution of a sensory nerve. Very rarely a shingles infection can lead to pneumonia, hearing problems, blindness, brain inflammation (encephalitis) or death. More commonly, patients develop postherpetic neuralgia (PHN) in the area where the rash was. The overall incidence of PHN is 20%; after the age of 60 this rises to 40%, and after age 70 it rises to 50%. It can be excruciatingly painful, resistant to treatment, and can last for years or even a lifetime.

Shingles is caused by the varicella zoster virus, the same virus that causes chickenpox. In fact, you can’t get shingles unless you’ve had chickenpox (or, rarely, chickenpox vaccine). Some of the virus hides in a dorsal root ganglion and remains dormant for years, then travels down the nerve to affect the associated area of skin. Shingles itself is not contagious, but it is possible to get chickenpox from contact with a shingles patient.

By various estimates somewhere between one out of five and one out of three Americans will get shingles in their lifetime; it’s more common after age 50 due to an age-related decline in cell-mediated immunity, and it’s more common in patients who are immunosuppressed. If you live to be 85, there is a 50% chance that you will have had shingles by then.

Since 2006, a shingles vaccine (Zostavax) has been available. It contains a live attenuated virus. It is recommended for everyone over the age of 60, even those who have already had shingles. There are a few contraindications like allergy to neomycin, immunosuppression, or contact with a pregnant woman who has not had chickenpox. But how safe is it? A new study is reassuring.

Pre-marketing tests showed that it was safe, but now a post-marketing study has expanded our knowledge. The VA did a randomized double-blind trial of Zostavax with over 38,000 subjects and followed them for 3.4 years. Serious adverse events occurred in 1.4% of patients who got the vaccine, but they also occurred in 1.4% of those who got a placebo! There was no indication that any of these reactions were actually caused by the vaccine. The incidence of minor inoculation-site effects (redness, swelling, pain and tenderness at the injection site) was higher in the vaccine (48%) than in the placebo group (16%), as would be expected.

How effective is it? Zostavax has been demonstrated to prevent 51% of shingles and 67% of postherpetic neuralgia. By one estimate, the number needed to treat (NNT) to prevent one case of shingles over a 3 year period is 58 and the NNT to prevent one case of PHN is 364. It is estimated that this vaccine could prevent 250,000 cases of shingles a year in US plus reduce the severity of the disease in another 250,000.

The public health implications of varicella vaccines are controversial. People living with children are less likely to get shingles — about 25% of cases are prevented. Apparently this is because adults are re-exposed to the virus and this boosts their immunity. As more children are vaccinated against chickenpox, this protective re-exposure effect will disappear; hence, more cases of shingles in the short term. In the long term, vaccinating children could drastically reduce the incidence of shingles in the population.

Only about 7% of eligible patients have received the vaccine. It costs around $200 and must be kept in a freezer. It’s covered under Medicare part D, but not part B.

For more information, see the CDC website.

Conclusion

Zostavax is safe and effective. Although not as effective as we could wish, it can significantly reduce the burden of a serious disease in the elderly population. It is recommended for everyone age 60 and over by the CDC and by many medical organizations like the American Academy of Family Physicians. Admittedly, the arguments for this vaccine are nowhere near as compelling as the arguments for polio, DPT and MMR vaccines for children. After learning the facts, not everyone will choose to take Zostavax. I chose to take it, and so did my husband.

Mark Hyman, a proponent of so-called “functional medicine” promoting himself over at the Huffington Post (an online news source that essentially allows dubious medical infomercials to pass as news) has posted a particularly egregious article on personalized medicine for dementia. In the article Hyman distorts the modern practice of medicine, the current state of genetic science, and the very notion of “disease.” It is, as usual, a fine piece of medical propaganda sure to confuse many a reader.

Hyman starts with some standard epidemiology of dementia – it is a common and growing disorder – but then descends quickly into distortion and pseudoscience.

Conventional Medicine Strawman.

Hyman creates what readers are likely to recognize by now as the standard straw man of conventional or science-based medicine, and then uses that caricature to create a false dichotomy with his “functional” medicine. He writes:

But first I want to explain why just naming a disease — whether it is dementia or anything else — is becoming increasingly unhelpful (unless you just want to match the drug to the disease which is the only thing doctors are trained to do).

and

In fact, disease and diagnosis as we know it will soon be an obsolete concept, an artifact of medical history, like bloodletting or phrenology (the art of diagnosis based on the shape of your skull, popular in the 19th century). The reason is simply this: Naming a disease does nothing to help us identify and treat the underlying causes of the disease. We must address these causes if we have any hope of helping individuals heal.

As a neurologist who treats dementia, his straw man is more than a bit offensive. Hyman does not seem qualified, if his writings and videos are any indication, to offer an opinion on medical training. Hyman would have you believe that the science-based approach is going the way of bloodletting. But what he is really indicating is that he does not understand the label of dementia, the concept of disease, or the complex relationship between science and medical practice.

What is a disease?

Hyman uses the term “dementia” quite loosely in his article, so let me explain what we actually mean by this term. Dementia is a clinical syndrome (not a disease) – it is the term applied to a condition of chronic cognitive impairment, regardless of cause.

On the other hand, Alzheimer’s disease is a specific disease – a pathophysiological entity with specific changes to the brain on biopsy and markers in the blood and spinal fluid (although at present only biopsy is useful for diagnosis).

When a patient presents with dementia (actually they present with cognitive symptoms and are diagnosed with dementia based upon history and exam, distinguishing it from other entities, like delirium, psychosis, or specific disorders like language dysfunction) the first order of business is to rule out treatable or reversible forms. This may include depression, medication side effects, nutritional deficiencies, anatomical lesions, strokes, inflammatory diseases, toxicities, and other causes. This is done by history, physical, MRI scan of the brain, EEG, and blood tests.

If an underlying treatable cause is found, it is treated. Patients may then stabilize, improve, and even be entirely cured, depending on the cause and if any permanent damage has already occurred.

If the workup for reversible causes is negative then the patient is not given the diagnosis of Alzheimer’s disease – rather they are diagnosed with an Alzheimer’s-like dementia, or a related but still irreversible cause of dementia.

It is true that simply attaching a label to a syndrome does not necessarily lead to effective treatment or even better understanding, as I have pointed out myself previously. In fact, some syndrome labels are over-used. But the same is not true of a genuine disease label – a diagnosis that carries with it a host of information about epidemiology, risk factors, underlying causes, genetic predispositions, and treatment outcomes.

Hyman hopelessly confuses these two situations, demonstrating a profound lack of understanding of how medical thinking has progressed over the last couple of centuries. Hyman demonstrates his confusion by using the term “dementia” as if it were interchangeable with “Alzheimer’s disease.” He writes:

“There is no effective known treatment for dementia.”

This statement is flawed on many levels. Some dementias are treatable, even curable, if the cause is reversible. It is true there is no cure for Alzheimer’s disease, and no disease-modifying treatment, but there are treatments. Currently available treatments for Alzheimer’s disease, however, are symptomatic only – they improve function but do not alter the course of the disease. Hyman’s sloppy language reflects his sloppy thinking, the likely result is that his readers will end up as confused as he appears to be.

Hyman’s Anecdotes

Hyman’s article goes from bad to worse – after distorting the current state of neuroscience and medical practice regarding dementia, his infomercial for his own idiosyncratic methods begins. He offers, of course, just anecdotes – two patients whom he treated and who we are told improved.

Of course, we are given no information to confirm a diagnosis. Since Hyman appears not to know the difference between dementia and Alzheimer’s disease, it is quite possible that either or both of these patients had a reversible cause of dementia, and their improvement may or may not have had anything to do with his ministrations. But they are useless as evidence for any superiority of Hyman’s approach to the science-based approach.

For example – despite the fact that Hyman would have you believe my training was restricted to pharmacotherapy,  I routinely will check patients who present with dementia for folate and vitamin B12 deficiency (this is standard practice). In addition I check homocysteine and methylmalonic acid levels, because these markers may be elevated even with low normal levels of folate and B12. If this blood work indicates a functional deficiency of either vitamin, then I supplement and monitor the blood work to see how they respond.

This is the evidence-based approach. Scientific doctors are good at asking meaningful questions and then doing research to answer them. Is the B12 and folate level enough? Turns out, the other metabolic markers may be a more sensitive indicator of a relative deficiency. Should we treat every dementia patient with folate and or B12? Turns out, there is no clinical response to routine treatment – so treatment should be targeted at those with a documented deficiency.

Gurus like Hyman, however, are not evidence-based. Rather, in my opinion, they seem to search for any tenuous evidence to support their philosophy or marketing strategy and then make huge hand-waving extrapolations from the evidence to their practice. Hyman, for example, writes:

George had another gene called MTHFR(viii) that made him require very high doses of folate to lower his blood levels of homocysteine, which is a substance very toxic to the brain.

This is part of his genetic “personalized medicine” marketing. But what I described above is true personalized medicine – using markers that have been shown to be useful in individualizing treatment – who needs folic acid and who doesn’t.

But looking at genes sounds more cutting edge – better for marketing. Hyman seems to be cherry picking the evidence. At present there is inconclusive evidence linking the MTHFR gene to an increased risk of dementia in the elderly, and a recent large study showed:

MTHFR genotypes or alleles also did not show any correlation (with dementia).

But worse, Hyman confuses the role of risk factors, markers for diagnosis, and markers for treatment. Some genotypes correlate with an increased risk of developing a disease, but are not helpful in diagnosis. Other genes are useful in diagnosis, but only some of these genes are useful in predicting outcome to specific treatments.

Now, it is true that we hope one day to usher in a phase of medicine where we use genetic testing to tailor our treatments. This is theoretically possible, and we are making progress, but we are not there yet. Just as we hope one day to cure many diseases with stem cells, but I would not pay to go overseas to a stem cell clinic today.

Hyman is misusing current research to determine treatment – but this is simply not evidence-based. It is not “functional” medicine, it is bad medicine. Science-based doctors want to know what markers actually mean – and for treatments that means they need to be tied to treatment outcomes. None of the studies Hyman references actually support the genetics-based treatment decisions he is advocating.

I would also point out that he mixes in some advice that is based on evidence, but that is already part of standard evidence-based practice (or is being incorporated in response to published evidence). For example, here is a study which concludes:

CONCLUSION: Vegetables, unsaturated fats, and a high MeDi score may be beneficial to cognitive function.

MeDi is short for a Mediterranean diet. The evidences shows decreased risk and better long term outcomes for patients who eat plenty of vegetables, have low saturated fats, and generally eat a Mediterranean diet (which has lots of vegetables and low saturated fats). This is a generally healthful diet in many ways – and we don’t need to test your genes to recommend it.

Hyman also recommends exercise – and there is evidence that exercise reduces risk and improves outcome in vascular dementia and other dementias. So that is also part of conventional treatment. I wonder who Hyman thinks is doing all these studies on diet and exercise, since he believes physician training only includes matching drugs to diseases.

Conclusion

Science-based medicine includes many modalities of intervention, including diet, targeted supplementation, exercise, risk modification, symptomatic treatment, and where possible disease modification. The research on any particular medical topic, like dementia, is very deep and nuanced and requires understanding of the complex relationship between syndrome, disorders and diseases, the relationship between biomarkers and pathophysiology, the differences among markers for risk, diagnosis, and treatment outcomes, and the types of evidence that are useful in determining which treatments work and are appropriate for specific patients.

Mark Hyman, in advocating for his “functional” medicine, appears to understand none of this. Instead he whitewashes over all this complexity and would have his readers believe that science-based practitioners take a simplistic knee-jerk pharmacological approach to all patients. The evidence clearly puts the lie to this caricature.

Meanwhile he himself takes what appears to be an overly simplistic approach – extrapolating tenuously and inappropriately from various different kinds of evidence to ultimate treatment decisions. Specifically in this essay he abuses preliminary evidence on the relationship between various genetic markers and disease risk factors to give the illusion of personalized medicine – prematurely declaring the death of the indispensable notion of “disease.”

He seems to have failed to notice that the very evidence he is citing is often closely tied to, or even dependent upon, the concept of a pathophysiological disease.

He further borrows from legitimate science in order to argue for the inadequacy of the scientific tradition that created the evidence in the first place. We know about the legitimate benefits of exercise and a healthful diet because of science-based medicine – not the slick marketing of self-promoting gurus.

Dietitians are a critical part of modern medicine. In the hospital, dieticians not only educate patients on dietary treatment of diseases such as diabetes and heart disease; they also evaluate the nutritional status of critically ill patients and develop nutrition plans that may involve tube feeding or intravenous feeding. This is complicated, and takes into account a patient’s nutritional needs, medical conditions, etc. They are highly trained professionals.

If you want to see a dietitian lose it, call them a “nutritionist”. “Dietitian” is a specific profession governed by specific educational and licensing requirements. A dietitian can call themselves a nutritionist, but so can just about anyone else. As with other health care professions, dietitians have good reason to protect their profession. Protecting their profession protects their patients. Dietary fads are among the most prolific of medical scams and good information can be hard to find. Registered dietitians explicitly strive to utilize evidence to guide their practice. And critically, they have a published Code of Ethics.*

As is not uncommon, there are those who, in the name of “health freedom” (and profit), object to the dietitian “monopoly” on nutritional therapy.   One way they have done this is to claim the title “nutritionist” and set up a certification system. Once this structure is in place, it’s easier to get states to approve them as licensed professionals.  In this second area—state licensing—they are enlisting allies that comprise many of  ”the usual suspects”.

Clinical Nutritionists

One group that is attempting to create an alternative path to nutritional therapy is the Clinical Nutrition Certification Board. Upon first learning of “clinical nutritionists” my first question was why would anyone want a second, parallel route to dietary science?  What’s wrong with the system we already have in place?

First let’s review the basic qualifications for registered dietitians (RDs):

• Earned a bachelor’s degree with course work approved by ADA’s Commission on Accreditation for Dietetics Education. Coursework typically includes food and nutrition sciences, foodservice systems management, business, economics, computer science, sociology, biochemistry, physiology, microbiology and chemistry.
• Completed an accredited, supervised practice program at a health-care facility, community agency or foodservice corporation.
• Passed a national examination administered by the Commission on Dietetic Registration.
• Completes continuing professional educational requirements to maintain registration.

The requirements for the clinical nutrition board look superficially similar.  But looking a little deeper reveals some disturbing trends.  For example, rather than the real-world training program required for an RD, they require online coursework.   And they explicitly court naturopaths, a group of doctor-wannabes who claim to be “integrative” but who actually practice magic rather than medicine, including in their practices such nonsense as homeopathy and reiki.  And as we’ve seen time and time again, once you open the door on one disproved or implausible practice, anything can (and will) walk through.

It would appear that the CNCB is not only encouraging fake doctors to apply, but also explicitly requiring “training” in fake medicine.   In the description of their examinations, they require:

Knowledge of alternative evaluation techniques (i.e., homeopathic interrogation, acupuncture meridian interrogation, kinesiology, chelation therapy, Herbology, reflexology, allergic food provocation testing electromagnetic frequency challenge) as related to nutritional assessment

Any certification process that requires a knowledge of  ”electromagnetic frequency challenge” without mentioning it as a wallet-emptying magic trick is not worthy of official recognition.

But official recognition is exactly what they want.

State Licensing

The state of Michigan is currently working on regulations for the licensing of dietitians and nutritionists.  A Michigan naturopath is rather concerned about this process and is helping campaign on behalf of the “Michigan Nutrition Association”.

Our mission is to serve the interests of the public and Michigan professionals who incorporate human nutrition in their practice and patient care. We envision a vibrant community of CNS, CCN, CNC, CN, DACBN, Pharmacists, Medical Doctors, Nurses, Chiropractors, Naturopathic Doctors and many other professionals working in the interest of public health.

What this essentially means is that they are lobbying to allow pseudo-professionals such as chiropractors and naturopaths to be “licensed dietitians and nutritionists”.  In addition to giving them a patina of legitimacy (but no more than a patina), it might allow them to order laboratory tests (and there is no shortage of profit to be found in these).

This tactic of seeking legal rather than professional legitimacy is a growing and disturbing trend.  Hopefully, the legal process will be informed more by evidence than by the lobbying of pseudo-professionals, but I’m not terribly optimistic.

_________________

*This code is much more sophisticated and transparent than that offered by the CNCB, and includes this statement:

6. The dietetics practitioner does

not engage in false or misleading

practices or communications.

a. The dietetics practitioner does

not engage in false or deceptive

advertising of his or her

services.

b. The dietetics practitioner promotes

or endorses specific goods

or products only in a manner

that is not false and misleading.

c. The dietetics practitioner provides

accurate and truthful information

in communicating

with the public.

EDITOR’S NOTE: This post is a followup to a post from two weeks ago entitled In which Dr. Gorski once again finds himself a target of the “pharma shill” gambit. If you haven’t read that post before, you might want to go back and read it now before proceeding with this post. Please also note the disclaimer.

I want to beg your indulgence this week, hoping that my history as a blogger here on SBM and then as managing editor allows me that. Today’s post will be a little different because last week was really, really, hectic. First and foremost, I was busy writing a preapplication for a Susan J. Komen Foundation grant for a deadline of last Friday. The Komen Foundation, it turns out, has changed its procedures this year so that the preapplication is now evaluated much more rigorously. It’s no longer looked at just to make sure that the proposed project matches the subject matter and criteria for the request for applications (RFA). This year, the preapplication actually matters! Moreover, it’s so long that writing it is practically like writing the entire grant, other than the budget. But I got it done, and it looks pretty good, if I do say so myself. None of that is any guarantee that Komen will invite us to submit a full application, but I’m hopeful because if it does we should have a good shot at the grant.

Then, this weekend I had to pivot on a dime and return to writing the R01 I had been working on with my collaborator. To make the July resubmission deadline, it has to be done, in the can, and submitted by this Friday. In any case, these are the reasons why this post is likely to be uncharacteristically personal in nature.

Oh, those reasons plus a little bit of character assassination launched at me on Monday by Jake Crosby over at the Age of Autism, entitled David Gorski’s Financial Pharma Ties: What He Didn’t Tell You.

So ridiculous were Jake’s charges that I’m not going to bother rebutting them in detail. That is not my purpose, given that I’ve already taken them on preemptively. After all, when Jake first wrote me asking me about my “conflicts of interest” (COIs), I saw what was coming and decided that the best defense is a good offense. That’s why two weeks ago I wrote a rather detailed rebuttal to what I expected to be coming. In my usual inimitable fashion, I entitled my post In which Dr. Gorski once again finds himself a target of the “pharma shill” gambit, because, well, that’s exactly what I saw coming from Jake, a pharma shill-style attack. He didn’t disappoint, although nothing in his post actually shows that I have a COI, nor does it refute anything I wrote in my preemptive rebuttal. Boy, oh, boy, though, did Jake try to make the proverbial mountain out of a molehill! Actually, scratch that. It’s a bad metaphor. Molehills actually exist, in marked contrast to Jake’s imaginary COI.

Jake also provided a new twist so bizarre that I must admit that I hadn’t expected it, if only because it revealed such a shocking ignorance of how science and academia works — nay, how the world works — that I would never have even thought of it. It never would have occurred to me in a million years. Basically, Jake’s argument was that because my university has received grants from Sanofi-Aventis and because I work on receptor in breast cancer that I view as a promising molecular target for therapy that can be targeted with a drug made by Sanofi-Aventis that I’m testing in a small pilot clinical trial, that all means that I’m hopelessly compromised. Why? Because apparently, by Jake’s logic, part of my salary and/or lab startup expenses must be coming from big pharma, so I’m actually a pharma shill who’s hiding his pharma shill nature from the public when I blog. Yes, it’s utter nonsense, and I would point out that by the same reasoning if, for example, J.B. Handley’s investment company handles any pharmaceutical company accounts, then J.B. Handley must be a pharma shill, too, because he would also getting his paycheck from a company that receives money from pharmaceutical companies. Indeed, Jake’s research and reasoning were so sloppy that a professional journalist with whom I correspond expressed utter amazement at Jake’s writings and commented that, if Jake keeps it up, some day he will be sued for libel by someone. I wouldn’t be surprised to see that happen, although I’ll assure Jake right here that it won’t be by me, at least not over this attack. I simply have better things to do, particularly now, given the multiple grants I’m writing and the fact that next weekend I’m going to have to pivot again and finish up my talk for the Science-Based Medicine workshop at TAM8.

As I’ve written before, I’ve been the subject of online attacks on and off for my activities here and under a pseudonym elsewhere. Before I was “outed” multiple times, people would sometimes ask why I blogged under a pseudonym elsewhere. Does anyone need to ask anymore? What happened as a result of Jake’s post should limn very starkly the reasons why many skeptic and supporters of science-based medicine decide to blog pseudonymously or anonymously, and I feel that you, SBM readers, deserve to know what happened. If in describing what happened, I manage to send a friendly little rejoinder to our ideological opponents at AoA, well, far be it from me to pass up such an opportunity

Online attacks against me are nothing new, of course; I’ve even linked to a whole bunch of them in my profile. In fact, they began nearly a decade ago, four solid years before I ever even started my first blog. Those were the days before I became interested in quackery, but I was interested in Holocaust history and active on Usenet in refuting Holocaust denial. As a reward for my efforts countering online denial on Usenet, a Holocaust denier impersonating a man named Kenneth McVay, who has maintained a website dedicated to refuting Holocaust denial (The Nizkor Project) since the 1990s, circulated a list on multiple Usenet newsgroups under the subject header Visit/call them! The NIZKOOK List! In other contexts the list later became known among neo-Nazis and Holocaust deniers as the “Nizkor/NAMBLA list.” The anonymous neo-Nazi Holocaust deniers posting this risible list represented it as a list of what it claimed were members of Nizkor who were also members of NAMBLA, and, among many tireless fighters of online Holocaust denial who were also on the list.

Yes, the first online defamation campaign against me came from Holocaust deniers trying to smear me as a pedophile. Lovely. Obviously I was appalled. Still, in a moment of gallows humor, I must admit that one particularly hilarious aspect of the list was that it had a listing for me at two different addresses, one in Chicago and one in New Jersey. Apparently I had a really long commute to work. The explanation, of course, was that at the time the list first surfaced I been at my first academic job (which happened to be in New Jersey) about a year, after having finished a fellowship at the University of Chicago. Fortunately for me, the Holocaust denier circulating the list was too clueless to have figured out that I didn’t live in Chicago anymore. He also got the wrong David Gorski in Chicago and apparently had no idea that I’ve never had any association with Nizkor, although I did and do have an association with The Holocaust History Project.

I suppose I should have taken it as a mark of honor that my efforts against Holocaust deniers were successful to be smeared as a pedophile by neo-Nazis and Holocaust deniers, but somehow I didn’t see it that way at the time.

There were no online attacks after that for years, although I remained active on Usenet. Then I started my first blog in late 2004. In April 2005, a certain Canadian by the name of William P. O’Neill of the Canadian Cancer Research Group first discovered my identity and sent e-mails threatening to sue me because I had linked to some of Australian skeptic Peter Bowditch’s posts, apparently because O’Neill really, really hates Bowditch. Fortunately, my then department chair, division chief, and cancer center director recognized O’Neill immediately for the crank he is. From then on out, whenever a new O’Neill threat arrived, I would politely respond with an offer to put him in touch with my lawyer, cc’ing my response, of course, to my aforementioned department chair, division chief, and cancer center director. To some extent it was a bluff, because back then I didn’t actually have a lawyer, but if O’Neill ever took me up on it I had no doubt that I could find one. Over the five years since then, I’ve had anti-vaccine activists take periodic shots at me, HIV/AIDS denialists trying to get me into “debates,” and the odd crank or quack express extreme unhappiness with me. Last year, I even had someone who read an attack on me by J.B. Handley posted to AoA write to my cancer center director. I suppose I should be grateful that no one dug up the old neo-Nazi pedophile smear, although I have no doubt that they will at some point.

The response of AoA commenters after Jake’s post about me took the attacks to another level, far beyond the mere poisoning my Google reputation that certain bloggers excel at. In the comments, a commenter by the ‘nym of MAKE AUTISM STOP posted my work address and e-mail addresses. Then a commenter going by the ‘nym sos posted a link to the contact information for the board of directors of my university. MAKE AUTISM STOP then made it even more explicit by posting a list of their e-mail addresses, the implication clearly being that anti-vaccine activists were launching a campaign to try to get me fired. This got to the point where a commenter by the name of Craig Willoughby, someone who detests me enough to have dedicated a fair number of posts on his blog to attacking me, complained:

Come on, guys. I despise Dorkski as much as the rest of you, but is it necessary to post information about his place of employment? I know he’s a megalomoniacal douche-bag, but calling his place of work to try to get him fired is petty, people. That’s bringing yourselves down to his level.

Craig even made it clearer on his own blog.

Of course, I’ve never tried to get anyone fired for blogging or posting anti-vaccine screeds or even for not having their children vaccinated, nor encouraged anyone to do so. But I’ll let that pass. At least Craig realizes that there was no rational justification for writing and calling the board of directors of my university. Despite his extreme dislike — hatred, even — for me, he recognized a line and knew when “his side” was crossing it. That is very much to his credit. What were the responses to Craig’s reasonable complaint? Lots of disagreement and rants about how I need to be taken down by “any means necessary.” A commenter named Julie made this explicit:

Yes Craig, it is necessary. By any means necessary.

The cancer scam and the autism scam. The more I read the more I see the similarities. If there is a silver lining to my son’s illness it is that both he and I are DONE with mainstream medicine.

They come up with a drug, then try to find a disease for it? Hello? And they call homeopathy witchcraft?

Actually, I call homeopathy sympathetic magic, which is what its concepts appear to be based on. But enough of examples of the level of vitriol directed at me. I may be harsh in my assessment of the pseudoscience behind the anti-vaccine movement and the “autism biomed” quackery movement, but if there’s one thing I try never to do: Attack parents who have been frightened of vaccines by the anti-vaccine movement. What I do do is to criticize the leaders of the anti-vaccine movement, using science and medicine to back up my criticisms. Be that as it may, what SBM readers are probably most interested in knowing is what the fallout of this campaign was.

Fortunately, not much bad and quite a bit more quite good.

Don’t get me wrong. I’d be lying if I said that when I started finding out about these e-mails to the board of directors at my university I wasn’t disturbed and quite concerned. After all, the vaccine wars are not widely known among academics, and the issues involved can appear puzzling to an outsider unfamiliar with them. I had no way of knowing how the administration would react to an e-mail campaign orchestrated by commenters on AoA. Many of these people are easily identified as cranks, but others are not, at least not to people unfamiliar with the issues involved, and I had no way of knowing whether the university or my cancer center would shut down my blogging activity. As the campaign continued, other bloggers offered to try to get their readers to write e-mails of support. With gratitude I accepted their offers, although also with uncertainty. I honestly didn’t know whether such e-mails would make the situation better or worse.

So when I got a phone call from one of my bosses asking me just what the heck was going on, I admit that there was quite a bit of trepidation involved as I explained the situation. Fortunately, all the administration seemed to be concerned with was whether I actually had an undisclosed COI. Was I being funded by Sanofi-Aventis and not disclosing it? When I showed the administration definitive evidence in the form of my grants and the clinical trial protocol that I’m running demonstrating conclusively that I do not receive one red cent from Sanofi-Aventis for my research — or anything else for that matter — the questions disappeared, and the administration pivoted from information gathering mode to support mode, reassuring me that I have its support on the basis of free speech and academic freedom.

In the end, the only bad things that happened to me were the agita that I suffered after learning of the e-mail campaign and the time I wasted having to gather the information necessary to show my administration that there was nothing of substance to Jake’s charges. This latter problem was not entirely minor, either, given that I was in the midst of trying to get together the Komen preapplication that I mentioned at the beginning of this post. Far outweighing the bad was the good, though. For example, I learned that Wayne State University and the Barbara Ann Karmanos Cancer Institute are even better places to work as an academic physician than I had appreciated before this campaign began. I also learned that the administration of the Wayne State University School of Medicine was actually concerned about my safety, which implied to me that the level of vitriol in some of the e-mails must have been intense indeed, making me wonder if I should be concerned. Fortunately, given that no one ever actually threatened me during this campaign, either by phone, e-mail, or letter, I doubt I have definite reason to be worried. At least not this time. But I do wonder. Be that as it may, what I do know now is that the campaign against me backfired spectacularly, and that is a very good thing indeed.

I also learned a little bit about the price for standing up for science-based medicine. Prior to last week, it hadn’t been brought home with quite such drama. Now it has. Yes, I had suffered the slings and arrows of online criticism and the odd e-mail to my bosses over the last five years, but nothing, for example, to compare with the death threats and frivolous lawsuits endured by Paul Offit, the misogynistic attacks launched against Amy Wallace, attempts by quacks to silence various bloggers such as Andy Lewis, or the frivolous subpoena targeting Kathleen Seidel. Even so and even with the attempt to get me fired from my job, I don’t feel right putting myself into quite the same category as other skeptics who have suffered repercussions for their activities. After all, what are three days of agita and worry about my job compared to Simon Singh’s being placed in danger of bankruptcy and ruin by the the British Chiropractic Association’s lawsuit against him, Paul Offit’s having to endure death threats and threats against his family, or what animal researchers Edythe London or Dario Ringach had to endure at the hands of animal rights zealots?

But I think I understand at least a little bit better now.

Unfortunately, I’m under no illusion that this sort of thing won’t happen again some day, probably when I least expect it or am least prepared, like this time. Failing to win on science, evidence, or reason, lashing out against their critics in manners like this is all that the forces of anti-science can seemingly do. I also don’t blame Jake himself quite so much for the attempts to get me fired as I do adults commenting on his post who really should know better and who, ironically enough, for all the complaints about my using a pseudonym elsewhere, post under pseudonyms or their first names themselves. I only hope that Jake figures out just how misguided and wrong he’s been before the time comes for him to look for a job and join the world as a productive member of society. Youth only works as an excuse for such behavior for so long, and, besides, Jake may have inadvertently done me a great favor. I didn’t know how my administration would react if the anti-vaccine movement made a run at me. Now I do, and I know that there isn’t a problem. It may have been a bit embarrassing, but that embarrassment was transient, a price I now see as worth paying for freedom from fear.

In the meantime, I soldier on, shorn of any illusion of online invincibility but comforted by the new knowledge that I have support where I would not previously have counted on support and also realizing that the support of my administration will no doubt be viewed by the orchestrators of the campaign against me as “evidence” that they were right all along and that my university is protecting me because of my value to pharma.