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Human subjects protections and research ethics: Where the rubber hits the road for science-based medicine

Arguably the most difficult aspect of science-based medicine is where the rubber hits the road, so to speak. That’s where scientists and physicians take the results of preclinical studies performed in vitro in biochemical assays and cell culture models and in vivo in animal models to humans. There are numerous reasons for this, not the least of which that preclinical models, contrary to what animal rights activists would like you to believe, do not predict human responses to new therapeutic agents as much as we would like. However, the single biggest reason that we cannot answer questions in human studies as easily as we can in cell culture and animal studies is ethics. Of course, answering questions using cell culture and animal studies is not “easy,” either, but performing studies using human beings as subjects is an order of magnitude (at least) more difficult because the potential to cause harm exists, and if harm is caused by the experimental treatment under study, that harm will be done to human beings, rather than cells in a dish or mice bred for research.

The “gold standard” type of study that we do to test the efficacy of a new drug is known as the randomized, placebo-controlled, double-blinded study, often abbreviated RCT. Indeed, this remains the gold standard and is accorded the highest level of “power” in the framework of evidence-based medicine. Of course, as we have argued time and time again, using the RCT to test therapies that are incredibly implausible on a strictly scientific basis (homeopathy or reiki, for instance) inevitably leads to numerous “false positives” in which the therapy appears to produce results statistically significantly better than the control. John Ioannidis has done numerous clever analyses that demonstrate how easily clinical research is led astray if it is not grounded in scientific plausibility. Indeed, the probability of false positive studies increases, the more improbable the modality. It is for these very reasons that we have proposed the concept of science-based medicine, which takes into account estimates of prior probability based on preclinical studies and basic scientific principles, rather than evidence-based medicine, which does not. Indeed, Wally Sampson has even proposed a “plausibility scale” for rating RCTs, and Steve Novella has pointed out how difficult it can be to interpret the medical literature.
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Posted in: Clinical Trials, Medical Ethics, Politics and Regulation, Surgical Procedures, Vaccines

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J.B. Handley, Generation Rescue, and attacks on critics

I am writing this because a colleague of mine has been attacked, specifically, our fearless leader Steve Novella. J.B. Handley, Founder of “Jenny McCarthy and Jim Carrey’s Autism Organization – Generation Rescue” (whose usurpation by Jenny and Jim was apparently done in an opportunistic fashion but has had a consequence that must be galling to J.B., namely that some interviewers apparently think that Jenny McCarthy and Jim Carrey, not J.B. and his wife, are the true founders of Generation Rescue), did not like something that Steve wrote and in his characteristic fashion, has responded with a vicious ad hominem attack. Normally I wouldn’t feel obligated to put my two cents in, as Steve is more than capable of taking care of himself in a scientific argument and quite able to refute anything J.B. can throw at him. Moreover, whenever J.B. Handley attacks someone in a fashion this nasty, it is an excellent indication that the person he is attacking has scored some serious points against him. Indeed, I have twice been on the receiving end of J.B.’s tirades on the Generation Propaganda blog Age of Autism. On one occasion, he referred to me as the “worldwide wanker of woo,” and on another occasion seemed to think that I criticized Generation Rescue so harshly because I “don’t like full page ads,” rather than because I hate pseudoscience and anti-vaccine nonsense. When criticism really hits a nerve with J.B. Handley, he lashes out in a characteristic fashion. Clearly Steve’s reasoned, level-headed criticism of the latest Generation Rescue anti-vaccine propaganda initiative did just that.

In this case, however, I feel some explanation is in order because I feel a bit responsible for having brought J.B.’s wrath down upon Steve. First, a little history (albeit recent history) is in order. As I described in detail last week and the week before, Generation Rescue, with Jenny McCarthy and Jim Carrey at the fore, sometimes with J.B. himself, has mounted an impressive anti-vaccine propaganda effort. It started with a media tour promoting her most recent paean to anti-vaccine pseudoscience and autism quackery written with “co-author” Dr. Jerry Kartzinel. The book is entitled Healing and Preventing Autism: A Complete Guide, and three weeks ago Jenny McCarthy and her boyfriend Jim Carrey showed up on Larry King Live to tout a truly incompetent and intellectually dishonest “study” that purported to find that U.S. children are the “most highly vaccinated children in the world” and that that’s correlated with our higher autism rates. I would have none of it. Next, Generation Rescue introduced its equally intellectually dishonest “Fourteen Studies” website, which launched dubious attacks from pseudoexperts on fourteen of the major studies that failed to find a correlation between vaccines and autism or thimerosal-containing vaccines and autism. I wrote a lengthy post for SBM describing the utter intellectual and scientific bankruptcy of the entire enterprise.
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Posted in: Public Health, Science and the Media, Vaccines

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Mathematically modeling why quackery persists

ResearchBlogging.orgIt’s often puzzled me (and, I daresay, many other skeptics and boosters of science- and evidence-based medicine) why various forms of quackery and woo that have either about as close to zero prior probability as you can get and/or have failed to show evidence greater than placebo in clinical trials manage to retain so much traction among the public. Think homeopathy. Think reiki. The former is nothing more than sympathetic magic prettied up with science-y sounding terms, while the latter is nothing more than faith healing given a slant based on Eastern mysticism and religion instead of Christianity. Indeed, reiki was even inspired by stories of Jesus’ healing powers, complete with a trip into the wilderness for fasting and prayer, resulting in revelation. Or consider acupuncture, a modality that is seemingly more popular than ever, even invading the very sanctum sanctorum of the ivory towers of academic medicine, yet every study of which that is done under rigorous conditions with proper placebo controls shows it to be no more efficacious than a placebo. It’s easy enough to shake one’s head and chalk it up to irrationality, ignorance of science, or even religious faith, but I’ve always been dissatisfied with such glib explanations, even though admittedly I have myself used them on occasion.

That’s why a study released last week in PLoS One by Mark M. Tanaka, Jeremy R. Kendal, Kevin N. Laland out of the Evolution & Ecology Research Centre, School of Biotechnology & Biomolecular Sciences, University of New South Wales, the Department of Anthropology, University of Durham, and the School of Biology, University of St Andrews, Fife, respectively, entitled From Traditional Medicine to Witchcraft: Why Medical Treatments Are Not Always Efficacious. Besides loving the title, I also like the methodology, which in essence adapts the tools of modeling evolution and the spread of traits throughout a population and asks the question: Why do ineffective or even harmful (or, as the authors characterize them, “maladaptive”) treatments for various illnesses persist in populations? The results are surprising and counterintuitive, yet ring true. In essence, the authors conclude that the most efficacious self-treatments are not always the ones that spread and that even harmful treatments can spread. Both of these observations are entirely plausible based on the prevalence of usage of common woo and quackery, and what the authors have done, in essence, is to model mathematically why quackery persists.

Indeed, the authors set the stage:
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Posted in: Basic Science, Clinical Trials, Science and Medicine

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Welcome back, my friends, to the show that never ends, part II: Generation Rescue, the anti-vaccine propaganda machine, and “Fourteen Studies”

I hadn’t planned on writing about the antivaccine movement again this week, so soon after having had to subject myself to yet another round of Jenny McCarthy on Larry King Live and a truly execrable Generation Rescue “study.” I really hadn’t. For one thing, there’s just so much nonsense laid down by antivaccinationists these days that it’s utterly impossible for one blogger to keep up with it all. I could write about them every single day and still not counter the sheer mass of pseudoscience, misinformation, and general ignorance that antivaccine activists spout each and every day, and because this is Autism Awareness Month lately the misinformation has been coming particularly fast and furiously. Sometimes, however, there arrives a bit of misinformation that is so egregious that it requires some response, regardless of how burned out on the topic I might be; so I guess I’ll just have to suck it up and plunge into the morass again.

The reason is that, in retrospect, I now realize that the Jenny and Jim antivaccine propaganda tour was clearly merely phase I of Generation Rescue’s April public relations offensive. In rapid succession last week, courtesy of J.B. Handley, the founder of Generation Rescue, who in order to have a couple of famous faces fronting his organization has allowed himself to be displaced, so that Generation Rescue has now been “reborn” as Jenny McCarthy and Jim Carrey’s Autism Organization (the better to capitalize on her D-list celebrity yoked to Jim Carrey’s formerly A-list (but rapidly plunging) celebrity), announced Generation Rescue’s latest initiative in a post on its antivaccine blog Age of Autism entitled Fourteen Studies? Only if you never read them.:
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Posted in: Politics and Regulation, Public Health, Science and the Media, Vaccines

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This one’s for you, Dana

As you may have noticed, everybody’s “favorite” homeopath, Dana Ullman, has made a return visit to our humble little blog, where he is laying down his usual list of logical fallacies and irrelevencies (such as attacking Oliver Wendell Holmes) in defense of homeopathy. Consequently, now’s as good a time as any to unveil what is perhaps the best ready-for-a-poster criticism of homeopathy I’ve ever seen:

HN09poster1A

Clicking on the picture will lead you to a blog post where you can download a high resolution version suitable for printing up and either distributing or posting on a bulletin board or wall. I particularly like that it was made by The American Institute for the Destruction of Tooth Fairy Science. Truly, a nod to SBM blogger extraordinaire Harriet Hall!

My only objection to the poster is the use of the word “shit.” Don’t get me wrong here. Yes, it’s accurate. No, I’m not some sort of prude who never uses the word and wilts at the very sight or sound of it. My problem with it is that its inclusion on the image means that I can’t actually print up and post this beautiful (and brief) mockery of homeopathy on my lab door or on the bulletin board in my office. I can’t put something like that up in public at work. It also made me a little leery of posting it here, which led me to check with our fearless leader before doing it. So I started thinking of alternatives that get the message across but without any curse words.

Clearly, a version of the poster suitable for a G (or at least PG) audience is required.

How about something like:

If water has a memory, then homeopathy is full of crap
Homeopathy: Potentizing poo by flushing.

After all, flushing should “succuss” the remedy as well as hitting it against a Bible.

Yes, I do watch Dirty Jobs a lot, with its host, Mike Rowe, who likes to use the word “poo” a lot. Come to think of it, perhaps Mike Rowe should do a segment of Dirty Jobs segment at a manufacturer of homeopathic remedies. Why? Think of the potentized poo!

Posted in: Homeopathy, Humor

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Welcome back, my friends, to the show that never ends: The Jenny and Jim antivaccine propaganda tour has begun


As hard as it is to believe, 2009 started out very promising from the perspective of actually countering the misinformation of the antivaccine movement. Antivaccine hero Andrew Wakefield, who with the help of the credulous and sensationalistic media started the entire MMR-autism scare in the U.K. a decade ago, was revealed as not just having been in the pocket of trial lawyers suing vaccine manufacturers and having been an incompetent scientist but as a scientific fraud, thanks to the investigative tenacity of Brian Deer. Thanks to Wakfield, the measles, once declared conquered in the U.K. in the mid-1990s, has come roaring back to the point where it has been declared endemic again by the ealth Protection Agency (HPA), the public health body of England and Wales. This was rapidly followed by the rejection by the Special Masters of the Vaccine Court of the claims of all the test cases in the Autism Omnibus case. It was a one-two body blow to the antivaccine movement.

Unfortunately, the antivaccine movement is nothing if not resilient. After all, the science has consistently been against each of its favorite claims, namely that the mercury in the thimerosal used as a preservative in vaccines or that the MMR vaccine causes autism. They simply move the goalposts and pivoted effortlessly to much harder to falsify ideas, such as blaming “toxins” in vaccines or proclaiming that our current vaccine schedule is “too many too soon.” After scientific setback after scientific setback that have revealed the antivaccine movement to be nothing more than the 2009 equivalent of creationists or the flat Earth movement, why would it matter to them that Andrew Wakefield has been thoroughly discredited and their signature legal action, the Autism Omnibus, has gone donw in flames? It doesn’t. Certainly it didn’t stop David Kirby from duping Keith Olbermann into chastising Brian Deer for nonexistent conflicts of interest; a group proclaiming loudly “We Support Dr. Andrew Wakefield” with a petition; David Kirby, Generation Rescue, and Robert F. Kennedy, Jr. from trying to distract attention from the defeat of the antivaccine movement in the Autism Omnibus ruling; or Andrew Wakefield himself from “complaining” to a press board about Brian Deer’s alleged misbehavior and errors. After all, science doesn’t matter to the antivaccine movement.
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Posted in: Neuroscience/Mental Health, Public Health, Science and the Media, Vaccines

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Sunday fun: On being “open minded”

One of the most common refrains from advocates of quackery and “complementary and alternative medicine” (CAM) is the charge of being “close-minded,” that they reject out of hand any idea that does not fit within their world view. Of course, this is a canard, given that science, including science-based medicine, thrives on the open and free exchange of ideas, and it is not “close-mindedness” that (usually) leads to the rejection of dubious claims. Rather, it is the knowledge that, for many of such claims to be true, huge swaths of our current scientific understanding would have to be in error to such an extent that a major paradigm shift in various basic science would be necessary. While such paradigm shifts occasionally occur, they do not occur without the confluence of huge amounts of evidence, often coming from different fields and directions. In other words, to show that a paradigm is wrong or seriously incomplete requires evidence even more compelling than the evidence supporting the paradigm.

This video, via The World’s Fair, explains why when woo-meisters wrap themselves in the mantle of “open-mindedness” it’s almost always a crock:

I’ll have to keep this video around for my medical students to help them counter the inevitable charge of “close-mindedness” by CAM advocates. In fact, the part at the end, with the blond guy letting all sorts of rubbish into his brain because he has no critical thinking filter while demanding that others accept his views without evidence reminds me very much of a male version of Jenny McCarthy, full of the arrogance of ignorance. If the cartoon weren’t of such a good-looking young man, I’d say it was J.B. Handley, although the video does get the cartoonishness right.

Posted in: Science and Medicine

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In Jenny McCarthy’s own words

Jenny McCarthy, regular readers of SBM know, has been a frequent target of criticism here. The reasons, of course, are very simple. She has become the most famous public face of the antivaccine movement, releasing a book every year or so since 2007 about how her son Evan has been “cured” of autism through the dubious biomedical treatments she’s given him and how it was vaccines that supposedly caused her son’s autism. Most recently, she’s releasing a paean to antivaccine views and autism quackery entitled Healing and Preventing Autism: A Complete Guide, co-authored by Dr. Jerry Kartzinel. Dr. Kartzinel, some may recall, wrote the foreword to Jenny McCarthy’s very first paean to autism quackery back in 2007 and was properly lambasted by Autism Diva and Kevin Leitch for writing
things like:

Autism, as I see it, steals the soul from a child; then, if allowed, relentlessly sucks life’s marrow out of the family members, one by one…”

Sometimes, in order to appreciate just how wrong antivaccinationist are, it’s best to let them speak in their own words. Nowhere recently have I seen a better example of this than in an interview with Jenny McCarthy published on the TIME Magazine website. In it, along with the usual invocation of the “toxins gambit” and appeals to anecdotal evidence over science, Jenny reveals that she clearly thinks it’s regrettable but acceptable that infectious diseases will return because of the efforts of her and her fellow antivaccine activists:
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Posted in: Science and the Media, Vaccines

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When “CAM” is mandatory: A science-based medical student’s dilemma

Early in the history of this blog, I wrote a rather long post expressing my dismay at the infiltration of unscientific “complementary and alternative medicine” (CAM) or “integrative medicine” (IM) modalities into American medical schools. In it, I listed the medical schools that had embraced pseudoscience through having started a CAM/IM program (a list desperately in need of an update). Moreover, we have also complained vociferously here about a clear effort on the part of advocates of faith-based medicine to infiltrate bastions of science-based medicine and to piggyback their agenda onto President Obama’s health care reform initiative in a clear political strategy to slip CAM/IM into any health care reform legislation as a form of “preventative medicine.” It’s all part of a multi-pronged strategy to claim popular and legal legitimacy in the absence of scientific legitimacy. At one point I even despaired because of the apparent success of half physician, half CAM huckster Dr. Andrew Weil at developing a CAM/IM curriculum that would be part of the mandatory training program in several family medicine residencies, while the rest of us watch Senator Tom Harkin try to promote pseudoscience in the halls of the Senate.

However, since one of our newest co-bloggers, medical student Tim Kreider, arrived, I’ve come to appreciate that medical schools and medical school curriculae are ground zero in the battle for science- and evidence-based medicine. Besides the infiltration of non-science-based modalities into the standard curriculum, another technique for making medical students believe that woo is equal to science is the student “campus CAM group” that invites, for example, homeopaths and naturopaths to give talks to medical students, too many of whom are too timid to challenge them on their pseudoscience. However, a reader of a “friend” of mine wrote me an e-mail that truly appalled me. In fact, it appalled not just me, but all of my co-bloggers who read it. It’s from a medical student in an American medical school. It’s not Harvard or a huge famous medical school. However, it is in medical schools like this one where the vast majority of medical students are trained in this country. If the infiltration of CAM/IM into medical schools continues in this way, we’ll have more than just “integrating” woo into the medical school curriculum from day one. We’ll have more tales like this; eventually, no one will find such tales unusual or even unacceptable anymore. The shruggies will no longer even shrug anymore. Such clinics will become simply the way medical students are educated. The following e-mail is de-identified, and I’ve edited it a bit to make as sure as I can that it is not traceable:
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Posted in: Acupuncture, Medical Academia, Medical Ethics

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Alternative medicine use and breast cancer

Of all the posts I and my cobloggers have written for SBM over the last 15 months, most provoke relatively few comments. However, a few stand out for having provoked hundreds of comments. The very first post that provoked hundreds of comments was Harriet’s excellent discussion of the International Network of Cholesterol Skeptics. In fact, Harriet seems to be quite good at writing posts that provoke a lot of comment, as another of her posts, specifically the one in which she discussed circumcision, also garnered hundreds of comments. However, to my great surprise, the one post that stands out as having received the most comments thus far in the history of SBM is one that I wrote. Specifically, it was a post I called Death by “alternative” medicine: Who’s to blame?, which has collected an astonishing 611 comments thus far. The topic of the post was a case report that I had heard while visiting the tumor board of an affiliate of my former cancer center describing a young woman who had rejected conventional therapy for an eminently treatable breast cancer and then returned two or three years later with a large, nasty tumor that was much more difficult to treat and possibly metastatic to the bone, which would make it no longer even potentially curable. My discussion centered on what the obligation of a physician is to such patients who utterly refuse the science- and evidence-based medicine that we know to be able to cure them of a potentially fatal disease, and I was not only surprised but somewhat taken aback by the vehemence of the discussion.

Since that post, I’ve always been meaning to take a look at what, exactly, the effect of choosing “alternative” medicine over “conventional” medicine is on the odds of survival for breast cancer patients. Even though intuitively one would hypothesize that refusing scientific medicine and relying on placebo medicine instead would have a detrimental effect on survival, it turns out that this question is not as easy to answer as you might think. For example, if you do a search on PubMed using terms like “alternative medicine,” “breast cancer,” and “survival,” the vast majority of the hits will be studies of complementary and alternative medicine (CAM) and breast cancer with little reference to what possible effect these therapies might have on survival. I can envision several reasons for this, the first being that–thankfully–relatively few women actually use alternative medicine exclusively to treat their breast cancer. Also, those that do probably drop off the radar screen of their science-based practitioners, and it is difficult, if not impossible, to capture data regarding their outcomes, given that they all too often stick with their alternative healers until the end. True, they may pop up again in their surgeon’s or primary care doctor’s office with huge, fungating tumors, only to be told that they have to undergo chemotherapy to shrink the tumor before any surgery is possible, after which they will often disappear again. Another important reason is that the natural history of breast cancer is extremely variable, from nasty, aggressive tumors that kill within months to indolent, slow-growing tumors that, even when metastatic, women can survive with for several years. (It is, of course, these women who usually show up in “alternative medicine” testimonials, because they can survive a long time with little or no treatment before their tumors progress.)
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Posted in: Cancer, Herbs & Supplements, Science and Medicine, Surgical Procedures

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