Science-Based Medicine

Few awards in anything have the cachet and respect the Nobel Prizes in various disciplines possess. In my specialty, medicine, the Nobel Prize in Physiology or Medicine is quite properly viewed as the height of achievement. In terms of prestige, particularly in the world of science, the Nobel Prize is without peer. To win the Nobel Prize in Medicine or another scientific field, a scientist must have made a discovery considered fundamentally important to the point that it changes the way we think about one aspect of science or medicine. Winning the Nobel Prize in a scientific field instantly elevates a scientist from whatever he or she was before to the upper echelons of world science.

So how, one might ask, is it that seemingly so frequently Nobel Laureates embrace crankery or pseudoscience in their later years? They call it the Nobel Disease, and, indeed, it’s a term listed in the Skeptics’ Dictionary (where the term is attributed to me based on this post about Linus Pauling from four years ago, but I can’t claim credit for coining the term; it existed before I wrote that post) and Rational Wiki, complete with examples. What inspired me to take on this topic, dusting off some old knowledge and writings, is that we apparently have a new victim of the Nobel Disease. Well, perhaps “new” is not the right word, but he is the most recent example. I’m referring to Luc Montagnier, who with Françoise Barré-Sinoussi was awarded the Nobel Prize in Medicine for the discovery of HIV in 2008.

Unfortunately, it didn’t take Montagnier very long to devolve into crankery. Until 2009, to be precise. Since then, Montagnier has embraced concepts like DNA teleportation and ideas very much like homeopathy. And then, just last month, his journey to the dark side was complete. Yes, Luc Montagnier presented at the yearly quackfest I discussed last week, the one in which there was much enthusiasm among the attendees for a treatment that involves administering bleach enemas to autistic children. He presented at Autism One, a coup that caused much rejoicing in the antivaccine movement.

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Several of the bloggers here at SBM have repeatedly criticized various clinical trials for so-called “complementary and alternative medicine” interventions for various conditions and diseases (or should I say dis-eases?) for being completely unethical. Examples include the misbegotten clinical trial for the Gonzalez protocol for pancreatic cancer, which — surprise, surprise! — ended up showing that patients undergoing Dr. Gonzalez’s combination of 150 supplements a day, dietary manipulations, and coffee enemas, actually did much worse than those undergoing standard of care, despite how depressingly poor the results of standard of care are; clinical trials of homeopathy in Honduras and other Third World countries, which both Wally Sampson and I lambasted; and ongoing clinical trial of chelation therapy for cardiovascular disease. I’ve also criticized the “autism biomed” movement, that amalgamation of parents who believe that vaccines cause autism and yet are willing to subject their children to all sorts of quackery to “cure” the “vaccine injury” of uncontrolled and unethical experimentation on autistic children. As valid as all these criticisms are, it is important to recognize that science-based medicine is not free of its own abuse of ethics.

A couple of weeks ago, I wrote about the concept of clinical equipoise. Clinical equipoise is a critical concept in any clinical trial. Basically, a state of clinical equipoise exists when there is genuine scientific uncertainty over which of the options being tested in/on living, breathing human beings is better, and any clinical trial in which a state of clinical equipoise does not exist is at the very least ethically dodgy and probably downright unethical. For example, when the occasional anti-vaccine activist argues for a randomized controlled clinical trial comparing vaccinated children and unvaccinated children, it’s easy to shoot that idea down as unethical because there is no clinical equipoise. The children receiving placebo vaccines would be put at a much higher risk of suffering harm compared to the vaccinated children because they would be left unprotected against life-threatening diseases. In the realm of conventional medicine, the reason that few cancer clinical trials involve a placebo control group anymore but instead test a new therapy either against the standard of care or with the standard of care is because in many, if not nearly all, cases placebo use in a cancer patient is unethical when there exists effective therapy, even if the therapy is not all that effective. What all this boils down to is that science is only part of the basis of science-based medicine. Medical ethics must take precedence. After all, arguably the most efficacious way to test a new antibiotic would be to infect people with the bacteria the antibiotic treats and then divide these people up into a placebo control group and a group receiving the antibiotics to see how each group does. After all, this is the sort of thing that the Nazis and Japanese did during World War II, and the same sort of dehumanization and abuse of research subjects that every ethical precept regarding human subjects research that has been developed since then, such as the Helsinki Declaration of 1964, has been designed to prevent.

Unfortunately, medical scientists in the U.S. have not always lived up to these precepts. The most famous example is arguably the Tuskegee syphilis experiment, in which poor black men with syphilis were studied and the control group denied effective therapy for syphilis even after it was known that penicillin was an effective treatment for syphilis. This study spanned 40 years, from 1932 to 1972, and is justifiably held up as one of the worst examples of research misconduct in American history, if not the history of the world. The shock the revelation of this study to the American public in 1972, when it learned of men dying of syphilis, women contracting syphilis, and babies being born with congenital syphilis, all unnecessarily, led to Belmont Report and the establishment of the Office for Human Research Protections (OHRP).

It turns out that there was an even worse atrocity against medical science perpetrated by U.S. investigators in Guatemala over 60 years ago that only now has come to light in stories in the New York Times, MSNBC, and elsewhere. So bad was the offense that Secretary of State Hillary Clinton and Secretary of Health and Human Services Kathleen Sebelius have issued a formal apology to the Guatemalan government for the experiments in which Guatemalan prisoners were intentionally infected with syphilis and then treated with antibiotics, an apology that President Obama reiterated in a personal telephone call to Guatemalan President Alvaro Colom on Friday.
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Ever since I first discovered the anti-vaccine movement, first on Usenet, specifically on a Usenet newsgroup devoted to discussing alternative medicine (misc.health.alternative, or m.h.a. for short) and then later on web and on blogs, there have been two things that have horrified me. First, there are the claims that children suffer all sorts of harm from vaccines, be it being made autistic (with the attendant “autism epidemic” caused by vaccines), suffering neurological damage, immune system damage, and all manner of other adverse consequences. There is no good evidence for these claims (although, as has been documented right here on this very blog time and time again, anti-vaccine activists will trot out all manner of awful studies to support their contentions), but that doesn’t keep useful celebrity idiots like Jenny McCarthy, Jim Carrey, Don Imus, or Bill Maher from repeating the same myths over and over again. Worse, the permeation of society with these myths about vaccines has led to declining vaccination rates and the resurgence of potentially deadly vaccine-preventable diseases. It began first in the U.K. in the wake of Andrew Wakefield’s trial lawyer-funded, incompetent, and possibly fraudulent “research,” and has spread to the U.S., thanks to Jenny McCarthy and her ilk, who won’t take responsibility for their words and actions.

Even worse, the myth that vaccines cause autism has led to ideas. Dangerous ideas, and not because they “challenge” medical orthodoxy. These ideas are dangerous because they have direct consequences for children with autism. These consequences take the form of subjecting children to unscientific treatments that are ineffective at best and harmful at worst, sometimes even life-threatening. Indeed, I have written about case histories in which children were subjected to injections of “stem cells” into their cerebrospinal fluid by lumbar puncture and various other “treatments,” as well as chemical castration in combination with chelation therapy. That latter bit of quackery is something I wrote about years ago, but that the mainstream press only just noticed earlier this year. Better late than never, I guess. Even better than that, though, the same reporting team at the Chicago Tribune that reported on Mark and David Geier’s advocacy of Lupron to treat autistic children back in May. Sadly, the result of that story does not appear to have been actions by the State of Maryland to take away Dr. Mark Geier’s medical license or to go after his son David for practicing without a license. Neither does it appear to have resulted in insurance companies going after them for prescribing an expensive drug for an indication for which it is not appropriate. What it does appear to have done, however, is to inspire the same journalist, Trine Tsouderos, along with another journalist from the Chicago Tribune, Patricia Callahan, to pursue an even bigger target that Mark and David Geier, namely the entire “autism biomed movement,” which is for the most part rank quackery, in the following articles:

• Autism treatments: Risky alternative therapies have little basis in science
• Autism treatment: Success stories more persuasive to some than hard data
• Questionable treatments for children with autism

This is another rare case of excellent reporting on this issue, and I hope that this report (another installment of which was published early this morning after I had written this post) will grab the attention of more reporters and news outlets, leading to shining a light on the dark underbelly of the autism biomed movement.
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If there’s one thing that purveyors of pseudoscientific medical modalities crave, probably above all else, it’s legitimacy. They want to be taken seriously as Real Scientists. Of course, my usual reaction to this desire is to point out that anyone can be take seriously as a real scientist if he is able to do science and that science actually shows that there is something to his claims. In other words, do his hypotheses make testable predictions, and does testing these predictions fail to falsify his hypotheses? That’s what it takes, but advocates of so-called “complementary and alternative medicine” (CAM) or “integrative medicine” (IM, or, as I like to refer to it: “integrating” quackery with scientific medicine) want their woo to be considered science without actually doing the hard work of science.

There are several strategies that pseudoscientists use to give their beliefs the appearance of science, a patina of “science-y” camouflage, if you will. One, of course, is the cooptation and corruption of the language of science, which has been a frequent topic on this blog, particularly in posts written by Drs. Atwood and Sampson. Another is to produce journals that appear to be science, but are anything but. I’ve discussed one example, the Journal of American Physicians and Surgeons and Medical Acupuncture, but others include Homeopathy, the Journal of Alternative and Complementary Medicine, and Medical Hypotheses, which recently was forced to retract a horrible paper by arch-HIV/AIDS denialist Peter Duesberg. What’s worse is that some of these journals are even published by what are considered major publishers, such as Mary Ann Liebert, Inc., and Elsevier.

There is, however, a third strategy. How do scientists communicate their findings to other scientists, as well as meeting and mingling with other scientists? Why, they hold scientific meetings, of course! These meetings can be small or even as large as the American Association for Cancer Research meeting, which is attended by around 15,000 cancer researchers each year. So, too, do cranks hold meetings. These meetings often have all the trappings of scientific meetings, with plenary sessions, smaller parallel sessions, poster sesssions, and an exhibition hall, complete with exhibits by sponsoring companies. Sometimes these meetings can even appear so much like the real thing that they take in legitimate researchers and legitimate universities. Here, I present two examples of such conferences.
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The anti-vaccine movement is a frequent topic on the Science-Based Medicine blog. There are a number of reasons for this, not the least of which being that the anti-vaccine movement is one of the most dangerous forms of pseudoscience, a form of quackery that, unlike most forms of quackery, endangers those who do not partake of it by breaking down herd immunity and paving the way for the resurgence of previously vanquished diseases. However, anti-vaccine beliefs share many other aspects with other forms of quackery, including the reliance on testimonials rather than data. Even so, although the intelligentsia (and I do use the term loosely) of the anti-vaccine movement realizes and exploits the power of anecdotes and testimonials and how human beings tend to value such stories over dry scientific data, leaders of the anti-vaccine movement realize that science is overwhelmingly against them and that testimonials alone are not adequate to counter that science in the realm of public policy and relations.

That’s why, over the years, various anti-vaccine “scientists” (and I use that term very loosely as well) have produced poor quality, sometimes even fraudulent studies, which are then touted as evidence that vaccines cause autism or at least as evidence that there is actually still a scientific controversy when in fact from a scientific standpoint the vaccine-autism hypothesis is pining for the fjords. Examples abound, including the work of Mark and David Geier, whose studies led the to use chemical castration to treat autistic children; Andrew Wakefield, whose small case series almost certainly included fraudulent data; a truly incompetent “phone survey” commissioned by Generation Rescue designed to compare “vaxed versus unvaxed” children; and an even more incompetent “study” in which Generation Rescue used a cherry picked group of nations to try to argue that nations that require more vaccines have higher rates of infant mortality. These efforts continue. For example, last year Generation Rescue requested $809,721 from the Airborne settlement to set up a “vaxed versus unvaxed” study, despite the known difficulties with such a study and the low likelihood of finding anything without huge numbers of children.

Last week, they were at it again.
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I was asked to review the book Make an Informed Vaccine Decision for the Health of Your Child by Mayer Eisenstein with Neil Z. Miller. Fortunately my public library had it so I didn’t have to buy a copy. Reading it was a painful déjà vu experience. I can honestly say it met all my expectations: I expected that its concept of “informed decision” would equate to deciding not to vaccinate, and that it would rely on the same tired old fallacious arguments that have been heard before and rejected by knowledgeable scientists. The only thing that surprised me was a warning/disclaimer statement that admitted

this book tends to find fault with vaccines, therefore readers are advised to balance the data presented here with data presented by “official” sources of vaccine information, including vaccine manufacturers, the FDA, CDC and World Health Organization.

The fact that the book omitted all that balancing data undermines its pretense that it is intended to help readers make a truly informed decision.

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Countering ideologically motivated bad science, pseudoscience, misinformation, and lies is one of the main purposes of this blog. Specifically, we try to combat such misinformation in medicine; elsewhere Steve and I, as well as some of our other “partners in crime” combat other forms of pseudoscience. During the nearly five year existence of this blog, we’ve covered a lot of topics in medicine that tend to be prone to pseudoscience and quackery. Oddly enough, there’s one topic that we haven’t really written much about at all, and that’s genetically modified organisms (GMOs). GMOs, as you know, are proliferating, and it’s quite worth discussing the potential and risks of this new technology, just as it is worthwhile to discuss the potential benefits versus the risks of any new technology that can impact our health, not to mention the health of the planet. Unfortunately, GMOs have become a huge political issue, and, I would argue, they have become just as prone to pseudoscience, misinformation, and bad science as vaccines, with a radical group of anti-GMO activists who are as anti-science as any antivaccinationist or quack.

Leave it to that quackery promoter to rule all quackery promoters, Mike Adams, to give me just the opportunity to show you what I mean. Over the last couple of weeks, Mike has been in a fine lather about GMOs, with multiple posts with titles such as The GMO debate is over; GM crops must be immediately outlawed; Monsanto halted from threatening humanity and The evil of Monsanto and GMOs explained: Bad technology, endless greed and the destruction of humanity. In other words, it’s a series of post with Adams’ typical hyperbole. If you were to believe him, GMOs are the product of a plot by Satan, Monsanto, big pharma, and the government, and he’s not sure which one of these is the most evil of the bunch.
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Over the last decade there has been a needed discussion about the relationship between politics and science. This has mostly been spawned by the perceived “Republican War on Science,” at the center of which is the global warming debate. In reality, both ends of the political spectrum (as evidenced, for example, by the Huffington Post) tend to trump science with ideology. That is the nature of politics. But at least the issue has been raised.

Briefly, defenders of science have pointed out that science should inform politics, not the other way around. Ideologues should not be allowed to put their thumb on the scale of science in order to get the result their ideology demands. Further, the optimal policy emerges from an honest assessment of the relevant science. Values still come into play for many issues, so science alone is not enough, but the science has to be right.

Within medicine this issue often involves the regulation of the standard of care and public health policy. An example of the former is the law passed last year is Connecticut that essentially exempts professionals who treat “chronic Lyme disease” from the standard of care – the department of health cannot act against their license for treating this controversial condition with unproven therapies.Rather than allowing experts to determine the standard of care, which is an ever moving target, this law locks into place a very controversial, and in my opinion dubious, practice.

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Just when I thought I was out… they pull me back in.

Michael Corleone in The Godfather, Part 3

I hadn’t planned on doing two vaccine posts with such a short interval between them, but all too often, as the they say in the weakest of the Godfather movies, I get pulled back in again. So, after noting last week that 2009 was shaping up–fortunately–to be a very bad year for antivaccinationists, I should have expected a counterattack from the antivaccine fringe. Indeed, the only thing that surprised me after the twin blows of the revelations about scientific fraud on the part of the originator of the claim that the MMR vaccine causes autism, Andrew Wakefield, and the resounding defeat of the first three test cases of the Autism Omnibus proceedings, was that it took longer than I had expected. True, a group had formed, proclaiming that “we support Dr. Andrew Wakefield.” Also true, the antivaccine activists at the Age of Autism have been working overtime to attack the Autism Omnibus as being hopelessly rigged. Indeed, our “old friend” Dr. Jay Gordon has even likened attempts to refute antivaccine pseudoscience to tobacco companies’ P.R. and astroturf campaigns back in the 1950s through 1980s to cast doubt on the strong scientific and epidemiological evidence showing that cigarettes cause lung cancer.

But those contortions of science, epidemiology, law, and logic were merely a warmup for the real counterattack. On February 25, Generation Rescue purchased this full page ad in USA Today:

Unfortunately, the advertisement above was only the beginning. Generation Rescue managed to team up the chief progagandist for the antivaccine movement, David Kirby, along with Robert F. Kennedy, Jr., whom I have discussed before for his total support of the antivaccine movement. The question then becomes: Where would these two team up to spread their message against vaccines? Do you even have to ask?

Their twin articles appear on that repository of all things antivaccine, The Huffington Post, under the title Vaccine Court: Autism Debate Continues. As I will explain, these twin articles represent yet another example of what I have at times referred to as the “incredibly shrinking vaccine-autism hypothesis.”
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The core information supporting science-based medicine resides in the scientific literature. There, scientists and physicians publish the results of experiments and clinical trials that seek to understand the biological mechanisms by which the human body functions and through which disease forms and to apply this understanding to test new treatments for diease. Consequently, the quality and integrity of the biomedical literature are topics of utmost importance to supporters of science-based medicine. We’ve discussed problems with the scientific literature before here, ranging from how pseudoscientific “complementary and alternative medicine” journals have insinuated themselves into the medical literature and how drug companies have managed exercise undue influence over clinical trials and journals.

One question that perhaps we have not dealt with so much is the question of the very nature of a good scientific journal, particularly what is suitable material for such a journal. For purposes of this discussion, I will focus mainly on the biomedical literature, which spans a range from basic science journals dealing with biomedical science to clinical journals, which mainly report the results of clinical trials and clinical research. Of these journals, there are in general two types, journals that primarily report original research and those that present reviews of existing research. Most journals do a mix of the two, the majority tending towards a form where most of the articles are reports of orginal research mixed in with a much smaller number of review articles.

There is one journal, however, that is different. It is a journal known as Medical Hypotheses. It is a journal that (or so it claims) exists to present radical scientific ideas, the more radical the better. Here is how the journal is described on its website:
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