Science-Based Medicine

Note from the editor: Since today is a holiday in the U.S., I had planned on taking the day off. Then I saw the subject of today’s post and had to respond. Also, please remember that, as always, the usual disclaimers apply. This letter represents my opinion, and my opinion alone. It does not represent the view or opinion of my university or cancer center—or anyone else, for that matter, other than me.

Francis S. Collins, MD, PhD
Director, National Institutes of Health

Dear Dr. Collins:

I am normally not one for writing open letters, but in this case I feel compelled to make an exception. This letter will have little or nothing to do with what seems to be the usual criticism leveled against you, namely your intense religious faith and claims. Personally, as a physician and scientist I don’t much care about what religion you follow and, unlike some writers such as Sam Harris, most definitely do not consider your strong Christian faith a disqualification for holding the position that you now hold. All I care about in an NIH director is how well he or she shepherds the scientific mission of the NIH and runs the organization. As a past (and hopefully future) NIH grantee, I want the NIH to fund and support only the most rigorous science and to be a well-run organization. Thus far in your tenure, I haven’t seen any anything major to worry about on that score.

Recently, however, I was very disappointed to discover that you will be the keynote speaker at the 8th International Conference of the Society of Integrative Oncology (SIO) in November. I hope that, when you agreed to accept this speaking engagement, you didn’t know just what it is that what you were accepting or what the Society for Integrative Oncology is, other than a professional society that was interested in hearing your views on faith and spirituality in cancer. In brief, it is our position that “integrative oncology” is a discipline that, at its core, is dedicated to “integrating” pseudoscience with science. No doubt you will think I am exaggerating, but I am not, as I hope to demonstrate. Worse, by agreeing to speak to the SIO, you will be providing it with the imprimatur of your position as NIH director. The NIH, as you know, is the most respected biomedical research institution in the U.S., if not the world, and that respect rubs off wherever you speak.
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I graduated from the University of Michigan Medical School in the late 1980s. If there’s one thing I remember about the four years I was there, it’s that U. of M. was really hardcore about science back then. In fact, one of the things I remember is that U. of M. was viewed as being rather old-fashioned. No new (at the time) organ system approach for us! Every four weeks, like clockwork, we’d have what was called a concurrent examination, which basically meant that we were tested (with multiple choice tests, of course) on every subject on the same morning. The medical curriculum for the first two years had been fairly constant for quite some time, with a heaping helpin’ of anatomy, histology, biochemistry, and physiology in the first year and the second year packed full of pharmacology, pathology, and neurosciences. Nowhere to be found was anything resembling “energy medicine” or anything that wasn’t science-based!

Of course, back in the 1980s, the infiltration of quackademic medicine into medical schools and academic medical centers hadn’t really begun in earnest yet, although the rumblings of what is now called “complementary and alternative medicine” (CAM) and, more frequently these days, “integrative medicine” (IM) were starting to be heard in East Coast and West Coast schools. Even there, though, the incipient CAM movement was viewed as fringe, not worthy of the attention of serious academic physicians. Indeed, in the late 1980s, even at what are now havens of quackademic medicine if someone had suggested that diluting substances until there is nothing left, as in homeopathy, or waving your hands over a patient in order to channel the “universal source” of energy into a patient in order to heal a patient, as in reiki, had any place in scientific medicine, he’d have been laughed out of medical school–and rightly so.

Not so today, unfortunately. Although the problem of infiltration of quackademic medicine into academic medical centers goes way beyond this example, I can point out that faith healing based on Eastern mystical beliefs instead of Christianity is alive and well and ensconced in academic medical centers such as the University of Maryland School of Medicine Center for Integrative Medicine, where reiki masters are roaming the halls of the University of Maryland R. Adam Cowley Shock Trauma Center and Bonnie Tarantino, a Melchizedek practitioner, holographic sound healer, and an Usui and Karuna Reiki Master holds sway. Meanwhile, all manner of woo, such as acupuncture, homeopathy, craniosacral therapy, reiki, and reflexology are offered. Truly, you know that when an academic medical center has gone so far as to offer homeopathy, reflexology, and reiki, it’s all over as far as academic credibility is concerned, and it has become a center of quackademic medicine. Sadly, even a hospital where I trained, MetroHealth Medical Center, has succumbed to the temptation to add the quackery that is reiki to its armamentarium. That aside, I had never expected that my old, hardcore University of Michigan would go woo in such a big way.

I was wrong.
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NB: This is a partial posting; I was up all night ‘on-call’ and too tired to continue. I’ll post the rest of the essay later…

Review

This is the fourth and final part of a series-within-a-series* inspired by statistician Steve Simon. Professor Simon had challenged the view, held by several bloggers here at SBM, that Evidence-Based Medicine (EBM) has been mostly inadequate to the task of reaching definitive conclusions about highly implausible medical claims. In Part I, I reiterated a fundamental problem with EBM, reflected in its Levels of Evidence scheme, that although it correctly recognizes basic science and other pre-clinical evidence as insufficient bases for introducing novel treatments into practice, it fails to acknowledge that they are necessary bases. I explained the difference between “plausibility” and “knowing the mechanism.”

I showed, with several examples, that in the EBM lexicon the word “evidence” refers almost exclusively to the results of clinical trials: thus, when faced with equivocal or no clinical trials of some highly implausible claim, EBM practitioners typically declare that there is “not enough evidence” to either accept or reject the claim, and call for more trials—although in many cases there is abundant evidence, other than clinical trials, that conclusively refutes the claim. I rejected Prof. Simon’s assertion that we at SBM want to “give (EBM) a new label,” making the point that we only want it to live up to its current label by considering all the evidence. I doubted Prof. Simon’s contention that “people within EBM (are) working both formally and informally to replace the rigid hierarchy with something that places each research study in context.”

In Part II I responded to the widely held assertion, also held by Prof. Simon, that there is “societal value in testing (highly implausible) therapies that are in wide use.” I made it clear that I don’t oppose simple tests of basic claims, such as the Emily Rosa experiment, but I noted that EBM reviewers, including those employed by the Cochrane Collaboration, typically ignore such tests. I wrote that I oppose large efficacy trials and public funding of such trials. I argued that the popularity gambit has resulted in human subjects being exposed to dangerous and unethical trials, and I quoted language from ethics treatises specifically contradicting the assertion that popularity justifies such trials. Finally, I showed that the alleged popularity of most “CAM” methods—as irrelevant as it may be to the question of human studies ethics—has been greatly exaggerated.

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A couple of weeks ago, both Steve Novella and I criticized Dr. Mehmet Oz (a.k.a. “America’s doctor”) for not only hosting a man I consider to be a major supporter of quackery, but going far beyond that to defend and promote him. After that, I considered Dr. Oz to be a lost cause, with nothing to excuse him for his having embraced a man whose website is a wretched hive of scum and quackery almost as wretched as NaturalNews.com (in my opinion, of course). Unfortunately, apparently Dr. Oz’s defense of Dr. Mercola was only the beginning of the end of whatever minimal credibility Dr. Oz had left as a practitioner of evidence-based medicine.

This week, Dr. Oz put the final nails in the coffin of his credibility as a practitioner of science-based medicine. I realize that some would argue that he did that long ago. Fair enough. However, I always held out some hope that he might stop mixing pseudoscience like reiki with science. Then he embraced Dr. Joseph Mercola. Strike one! Unfortunately, strikes two and three followed over the last week or so.
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This is the third post in this series*; please see Part II for a review. Part II offered several arguments against the assertion that it is a good idea to perform efficacy trials of medical claims that have been refuted by basic science or by other, pre-trial evidence. This post will add to those arguments, continuing to identify the inadequacies of the tools of Evidence-Based Medicine (EBM) as applied to such claims.

Prof. Simon Replies

Prior to the posting of Part II, statistician Steve Simon, whose views had been the impetus for this series, posted another article on his blog, responding to Part I of this series. He agreed with some of what both Dr. Gorski and I had written:

The blog post by Dr. Atwood points out a critical distinction between “biologically implausible” and “no known mechanism of action” and I must concede this point. There are certain therapies in CAM that take the claim of biological plausibility to an extreme. It’s not as if those therapies are just implausible. It is that those therapies must posit a mechanism that “would necessarily violate scientific principles that rest on far more solid ground than any number of equivocal, bias-and-error-prone clinical trials could hope to overturn.” Examples of such therapies are homeopathy, energy medicine, chiropractic subluxations, craniosacral rhythms, and coffee enemas.

The Science Based Medicine site would argue that randomized trials for these therapies are never justified. And it bothers Dr. Atwood when a systematic review from the Cochrane Collaboration states that no conclusions can be drawn about homeopathy as a treatment for asthma because of a lack of evidence from well conducted clinical trials. There’s plenty of evidence from basic physics and chemistry that can allow you to draw strong conclusions about whether homeopathy is an effective treatment for asthma. So the Cochrane Collaboration is ignoring this evidence, and worse still, is implicitly (and sometimes explicitly) calling for more research in this area.

On the other hand:

There are a host of issues worth discussing here, but let me limit myself for now to one very basic issue. Is any research justified for a therapy like homeopathy when basic physics and chemistry will provide more than enough evidence by itself to suggest that such research is futile(?) Worse still, the randomized trial is subject to numerous biases that can lead to erroneous conclusions.

I disagree for a variety of reasons.

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(NOTE: There is now an addendum to this post.)

(NOTE #2: The videos of Robert O. Young’s interview with Kim Tinkham have been removed, as I predicted in this post that they would be. Fortunately, I downloaded copies before he managed to do that. Part 6 appears to be still there–for now.)

(NOTE #3: It was announced on the Facebook page Caring for Kim that the subject of this post, Kim Tinkham, passed away on December 7, 2010 in the late afternoon. Although it was not revealed what kind of cancer she died of, Tinkham almost certainly died from metastatic breast cancer. Quackery appears to have claimed another victim.)

I hate stories like this. I really do. I hate them with a burning passion that makes it hard for me to see straight when I first find out about them.

In fact, you might even say that stories like this are a major part of the reason why I do what I do, both here and elsewhere. They’re a major part of the reason why I’ve recently branched out into public speaking, something that used to terrify me beyond belief but that lately I’ve become at least competent at–sometimes even not bad at all. Sadly, the story I’m about to tell is one I’ve told before, most recently at the Lorne Trottier Science Symposium, where I gave a talk on cancer cure “testimonials,” although at the time I gave the talk the story’s outcome, although predictable, was not yet known.

Now it is.

The woman to whom I refer is named Kim Tinkham, who was diagnosed with breast cancer over three and a half years ago. Regular readers may recall that Kim Tinkham achieved fame not long after that when she was featured on The Oprah Winfrey Show in an episode about The Secret, an episode I discussed posts entitled The Oprah-fication of Medicine and On the nature of “alternative” medicine cancer cure testimonials. I don’t want to discuss the utter nonsense that is The Secret in any detail here. However, for those unfamiliar with this particular bit of New Age woo, it’s important to point out that The Secret’s “Law of Attraction” takes the germ of a reasonable idea (namely that one’s attitudes and wishes influence whether one gets what one wants in life, something that’s been known for millennia) and goes off the deep end of woo by proclaiming that, in essence, you can get anything you want by wanting it badly enough and thinking positive thoughts. Basically “The Secret” is that you have the power to “attract” good to yourself by thinking happy thoughts (hence “the law of attraction,” which, according to Secret adherents always works). It’s an idea that resonates in so much of “alternative medicine,” such as German New Medicine or Biologie Totale. Of course, the implication of “Secret” thinking is that, if you don’t get what you want, it’s your fault, an idea that also resonates with so much “alternative” medicine, where a frequent excuse for failure is that the patient either didn’t follow the regimen closely enough or didn’t want it badly enough.

Basically, The Secret is what inspired Kim Tinkham to eschew all conventional therapy for her breast cancer and pursue “alternative” therapies, which is what she has done since 2007. Before I discuss her case in more detail, I’m going to cut to the chase, though.

This weekend, I learned that Kim Tinkham’s cancer has recurred and that she is dying. On Saturday, a reader of my other blog sent me an e-mail that informed me:
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Dad always thought laughter was the best medicine, which I guess is why several of us died of tuberculosis.

We have a saying in medicine that you can’t kill a jerk.  Not that we try to kill anyone, but that particularly unpleasant individuals, rife with psychopathology, survive whatever illness comes their way.  The corollary is that particularly nice people are prone to having horrible diseases with unpleasant outcomes.  We all know intellectually that it is not true, but there is an ongoing feeling in health care providers that somehow patient personality determines the consequences of their diseases.  As an aside, I am often  left with the explanation for patients that the reason for their odd infection comes down to bad luck.  Everyone responds something to the effect that “Typical. I get all the bad luck.”  I have never had a patient say, “That’s odd, I am usually so lucky.”

On the question of nurture versus nature, raising two children has convinced me of the relative lack of importance of nurture in the personalities of my children.  While abusive/pathologic environments will certainly lead to pathologic personalities,  for the average child raised in middle class America I can’t help but think that, to quote Popeye, “I yam what I yam and that’s all what I yam.”  I expect to be schooled in the comments on that subject.  Yes, I read the Blank Slate and have some understanding of the literature.  And yet.  My kids, my friends kids.  I watch them grow in what is (and isn’t) a similar environment and end up with diverse personalities that often appear present before they can speak.  I am well aware of the multiple logical fallacies that lead to that conclusion.  Parenthood and medical practice (where people seem to do the same damn stupid things over and over) have lead me to the conclusion that free will is mostly a myth and we are mostly programmed to behave the way we do. Discuss.  It is not the main point of the post, but my bias.

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Back in 2008 I wrote on Near Death Experiences (NDE’s). I have an interest in this topic as I have frequent exposure to near death; my wife has a predilection for watching Judge Judy. Since 2008 there have been a few studies on the topic of NDEs as researchers try and find evidence that consciousness transcends the brain, if that is what a NDE represents. I have also been ill for most of the last week and have not had the usual time to spend generating typos to drive some readers to distraction. Fortunately, I have a miracle cure that is 100% effective in resolving all my self-limited illnesses: time. It passed and with it the illness. As a result I am about 10 days behind in the commitments in my life, so this will be a shorter than usual post.

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Faith healing is based on belief and is about as far as you can get from science-based medicine, but it is not exempt from science. If it really worked, science would be able to document its cures and would be the only reliable way to validate its effectiveness. Miraculous cures continue to be reported on a regular basis: what are we to make of them? In the Healing Rooms Ministry of Bethel Church in Redding, California, people regularly claim to be healed of cancer, broken bones, multiple sclerosis and many other ailments. Page after page of testimonials of cures are listed on their website. Are these cures real? If not, what is going on?

Amanda Winters, a journalist doing a series of articles on Bethel Church, interviewed me for a scientific view of these faith healings. She asked me some very incisive questions and understood my answers. She wrote what I thought was a balanced article, quoting me fairly and at more length than reporters usually allow.

Her article features a patient who believed his flat feet would be healed (bones would crack and form an arch). Healers poked him, blew a shofar at his feet, and covered him with a blanket when he collapsed on the floor. When he got up, his feet were unchanged. But

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A “Double Standard”?

Last week I had planned to write a comprehensive critique of a recent comment by Larry Dossey. He had posted it on Val Jones’s betterhealth website in response to Dr. Val’s essay, “The Decade’s Top 5 Threats To Science In Medicine,” originally posted here on SBM. Much of what Dr. Val had identified as the top threats involved recent dalliances, by government, medical schools, and the media, with the collection of implausible and mostly nonsensical health claims that advocates have dubbed “CAM.” As uncontroversial as Dr. Val’s assertions ought to have been—similar to suggesting that closing one’s eyes and “using the force” would be a threat to safe driving (even if some might quibble over the top threats to science in medicine)—Dr. Dossey demurred by distraction:

Your article implies that conventional medicine is grounded in evidence-based research and that CAM is not. This is grossly overstated, and suggests that a double standard is being applied to these fields.

Dossey trotted out familiar arguments: “Much, if not most, of contemporary medical practice still lacks a scientific foundation”; “the Congressional Office of Technology Assessment (OTA) found that only an estimated 10 to 20% of the techniques that physicians use are empirically proven”; hospital care is “the third leading cause of death in the United States,” accounting for hundreds of thousands of deaths each year.

He concluded with an appeal to fairness, rationality, and collegiality:

Overwhelming evidence reveals that conventional medicine is, on the whole, woefully unscientific. It’s fashionable and easy to deny this, but the facts say otherwise. So, by all means, Dr. Val, be critical of CAM – but do not fall into a double standard. Let us ruthlessly apply science to ALL we do as physicians. Let us challenge ALL areas of medicine to a higher standard. On that, I’m pretty sure we can agree.

Keep up the good work.

Sincerely yours,
Larry Dossey, MD

I procrastinated with my own rebuttal, and in the meantime David Gorski responded to similar language found in an article by Dossey (and two other magical thinkers) titled “The Mythology of Science-Based Medicine,” published by the Huffington Post. I’ll not repeat Dr. Gorski’s able rebuttal in any detail, and I’ve already written about much of what this matter brings to mind. Examples are here, here, and here on the perils of conflating science-based medicine and Evidence-Based Medicine (EBM); here on the false dichotomy of modern medicine vs. “CAM”; here on a concise definition of “CAM”; here and here on the mischief spawned by demands to “ruthlessly apply science,” in the narrow, EBM sense of the word, to implausible health claims; here (point #7) and here regarding the tu quoque fallacy, the “10-20% empirically proven” claim, and the risks of modern health care; here (scroll down to “this week’s entry”) and here, regarding some of Dossey’s own opinions about science and the future of medicine.

For now I’ll elaborate on a few points. These pertain not only to Dr. Dossey but also to myths common to the advocacy of pseudomedicine, so I hope to provide some useful information.

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