Science isn’t the only game in town. Literature can teach us things about the world that science can’t. It can give us vicarious experience and insight into other minds. Two recently published novels illuminate why perfectly rational people might reject the help of scientific medicine and prefer to die a little sooner but to die on their own terms. (more…)
Archive for Medical Ethics
For a number of reasons, well-argued many times here on SBM, it would be beneficial to American citizens if the National Center for Complementary and Alternative Medicine (NCCAM) were abolished. This does not seem to be in the cards anytime soon. Here, then, are my suggestions for making the Center less dangerous and less of a marketing tool for pseudomedicine than it has been since its inception. Some suggestions might even make the Center somewhat useful. They are listed in order of priority. The Center should:
1. Abandon all unethical trials, beginning with the Trial to Assess Chelation Therapy (TACT, which is under the joint auspices of the NHLBI). This should be done in a very public manner. The reasons for abandoning the TACT, in summary, are as follows.
The Main Event: Novella vs. Katz
The remainder of the Symposium comprised two panels. The first was what I had come to see: a Moderated Discussion on Evidence and Plausibility in the Context of CAM Research and Clinical Practice, featuring our Founder, Steve Novella, who is also Assistant Professor of Neurology at Yale; and David Katz, the speaker who had borne the brunt of the criticism after the 2008 conference (as I wrote in Part I). According to the Symposium syllabus, he is:
David L. Katz, MD, MPH, FACPM, FACP, an internationally renowned authority on nutrition, weight management, and the prevention of chronic disease, and an internationally recognized leader in integrative medicine and patient-centered care. He is a board certified specialist in both Internal Medicine, and Preventive Medicine/Public Health, and Associate Professor (adjunct) in Public Health Practice at the Yale University School of Medicine. Katz is the Director and founder (1998) of Yale University’s Prevention Research Center; Director and founder of the Integrative Medicine Center at Griffin Hospital (2000) in Derby, CT; founder and president of the non-profit Turn the Tide Foundation; and formerly the Director of Medical Studies in Public Health at the Yale School of Medicine for eight years. He currently serves as Chair of the Connecticut Chapter of the Partnership to Fight Chronic Disease and represents Yale University on the Steering Committee of the Consortium of Academic Health Centers for Integrative Medicine.
The syllabus had excerpted that statement from a much larger, remarkable document, which I urge you to review.
I will attempt to report the Moderated Discussion as neutrally as possible, as though I were a disinterested journalist (don’t worry: later I’ll rail).
March 4, 2010
Today I went to the one-day, 2nd Yale Research Symposium on Complementary and Integrative Medicine. Many of you will recall that the first version of this conference occurred in April, 2008. According to Yale’s Continuing Medical Education website, the first conference “featured presentations from experts in CAM/IM from Yale and other leading medical institutions and drew national and international attention.” That is true: some of the national attention can be reviewed here, here, here, and here; the international attention is here. (Sorry about the flippancy; it was irresistible)
I’ve not been to a conference promising similar content since about 2001, and in general I’ve no particular wish to do so. This one was different: Steve Novella, in his day job a Yale neurologist, had been invited to be part of a Moderated Discussion on Evidence and Plausibility in the Context of CAM Research and Clinical Practice. This was not to be missed.
I must admit, I never saw it coming.
At least, I never saw it coming this fast and this dramatically. After all, this is a saga that has been going on for twelve solid years now, and it’s an investigation that has been going on at least since 2004. Yes, I’m referring to that (possibly former) hero of the anti-vaccine movement, the man who is arguably the most responsible for suffering and death due to the resurgence of measles in the U.K. because of his role in frightening parents about the MMR vaccine.
I’m referring to the fall of Andrew Wakefield
The news is finally filtering out to the rest of the world.
As Steve Novella and my good buddy pointed out a few days ago (and as Steve pointed out in an interview on NPR), Dr. Steven Laureys admitted that Rom Houben, the unfortunate victim of a car crash that left him in what had been diagnosed as a persistent vegetative state, was in fact not able to communicate through the woo known as facilitated communication. This came as no surprise to anyone who has followed FC over the years. In fact, what had come as a surprise is that Dr. Laureys could have been so easily taken in by pseudoscience that had been so thoroughly debunked in the 1990s. To his credit, though, after a period of initially stubbornly defending FC, he relented and allowed objective testing, and the result was predictable. It took a few days, but the English language world is learning of the failure of FC in Houben’s case:
The sceptics said it was impossible – and it was. The story of Rom Houben of Belgium, which made headlines worldwide last November when he was shown to be “talking”, was today revealed to have been nothing of the sort.
Dr Steven Laureys, one of the doctors treating him, acknowledged that his patient could not make himself understood after all. Facilitated communication, the technique said to have made Houben’s apparent contact with the outside world possible, did not work, Laureys declared.
“We did not have all the facts before,” he said. “To me, it’s enough to say that this method doesn’t work.” Just three months ago the doctor was proclaiming that Houben had been trapped in his own body, the victim of a horrendous misdiagnosis, and only rescued from his terrible plight thanks to medical advances.
On Science-Based Medicine, several of us have at various times criticized state medical boards for their tolerance of unscientific medical practices and even outright quackery. After all, Dr. Rashid Buttar still practices in North Carolina and the medical board there seems powerless to do anything about it. However, state medical boards have other functions, one of which is to respond to complaints of unethical and dubious behavior about doctors. Key to this function is protection; i.e., if someone reports a doctor, that person needs to be sure that the state will protect her from retaliation from that doctor of the hospital. About five months ago, I reported a true miscarriage of justice, the sort of thing that should never, ever happen. In brief, it was the story of two nurses who, disturbed at how a local doctor was peddling his dubious “herbal” concoctions in the emergency room of the local hospital when he came in to see patients, reported him to the authorities. Moreover, they had gone up the chain of command, first complaining to hospital authorities. After nothing happened for months, they decided to report the physician, Dr. Rolando Arafiles, to the Texas Medical Board because they honestly believed that this physician was abusing his trust with patients and behaving unethically by improperly hawking herbal supplements that he was selling in the rural health clinic and the emergency room of Winkler County Memorial Hospital.
Even though under whistleblower laws the identities of these nurses should have been kept secret, after he learned that a complaint had been filed against him Dr. Arafiles went to his buddy the Winkler County Sheriff Robert L. Roberts, who left no stone unturned in trying to find out who had ratted out Dr. Arafiles:
To find out who made the anonymous complaint, the sheriff left no stone unturned. He interviewed all of the patients whose medical record case numbers were listed in the report and asked the hospital to identify who would have had access to the patient records in question.
At some point, the sheriff obtained a copy of the anonymous complaint and used the description of a “female over 50″ to narrow the potential complainants to the two nurses. He then got a search warrant to seize their work computers and found a copy of the letter to the medical board on one of them.
The result was this:
In a stunning display of good ol’ boy idiocy and abuse of prosecutorial discretion, two West Texas nurses have been fired from their jobs and indicted with a third-degree felony carrying potential penalties of two-to-ten years’ imprisonment and a maximum fine of $10,000. Why? Because they exercised a basic tenet of the nurse’s Code of Ethics — the duty to advocate for the health and safety of their patients.
On Saturday, the New York Times reported on the story, as there have been significant developments since August. Specifically, although the charges against one of the nurses has been dismissed, Anne Mitchell, RN, is going to stand trial beginning today:
“Ridiculing RCTs and EBM”
Last week Val Jones posted a short piece on her BetterHealth blog in which she expressed her appreciation for a well-known spoof that had appeared in the British Medical Journal (BMJ) in 2003:
Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials
Dr. Val included the spoof’s abstract in her post linked above. The parachute article was intended to be humorous, and it was. It was a satire, of course. Its point was to call attention to excesses associated with the Evidence-Based Medicine (EBM) movement, especially the claim that in the absence of randomized, controlled trials (RCTs), it is not possible to comment upon the safety or efficacy of a treatment—other than to declare the treatment unproven.
A thoughtful blogger who goes by the pseudonym Laika Spoetnik took issue both with Val’s short post and with the parachute article itself, in a post entitled #NotSoFunny – Ridiculing RCTs and EBM.
Laika, whose real name is Jacqueline, identifies herself as a PhD biologist whose “work is split 75%-25% between two jobs: one as a clinical librarian in the Medical Library and one as a Trial Search Coordinator (TSC) for the Dutch Cochrane Centre.” In her post she recalled an experience that would make anyone’s blood boil:
I remember it well. As a young researcher I presented my findings in one of my first talks, at the end of which the chair killed my work with a remark that made the whole room of scientists laugh, but was really beside the point…
This was not my only encounter with scientists who try to win the debate by making fun of a theory, a finding or …people. But it is not only the witty scientist who is to *blame*, it is also the uncritical audience that just swallows it.
I have similar feelings with some journal articles or blog posts that try to ridicule EBM – or any other theory or approach. Funny, perhaps, but often misunderstood and misused by “the audience”.
Jacqueline had this to say about the parachute article:
I found the article only mildly amusing. It is so unrealistic, that it becomes absurd. Not that I don’t enjoy absurdities at times, but absurdities should not assume a life of their own. In this way it doesn’t evoke a true discussion, but only worsens the prejudice some people already have.
The National Center for Complementary and Alternative Medicine (NCCAM) has posted three essays about its latest “strategic planning process,” and has invited “stakeholders” to make comments. I have previously made my own opinions clear,* as have fellow bloggers Gorski, Novella, Lipson, and Sampson: the best strategic plan for the NCCAM would be to extinguish itself. Since politics makes that plan unlikely, there are strategies that could minimize the considerable harm now done by the Center, while possibly offering a modest benefit. In summary:
- For both scientific and ethical reasons the NCCAM must dispense with trials of highly implausible claims. It should start by abandoning the ongoing Trial to Assess Chelation Therapy (TACT), its largest and most expensive trial yet, and one that has proven to place experimental subjects in considerable danger. It should publicly acknowledge such mistakes and explain why they must not be repeated—no matter how much political pressure there may be to do so.
- The Center should use its website’s Health Information function to explain what’s known, rather than continue its customary practice of putting the best possible slant on most “CAM” claims, no matter how absurd or disproven.
- The Center should address aspects of “CAM” advocacy that it has previously avoided, the most important being the close affiliation of such advocacy with the anti-vaccination (and autism quackery) movement. The NCCAM should consider itself an important source of rational information for a public that is currently, and dangerously, misled about immunizations. A related example of mischievous “CAM” advocacy, so far also ignored by the Center’s website, involves an imagined, sinister cartel of physicians, the AMA, pharmaceutical companies, and the FDA. The NCCAM should vigorously debunk such myths by providing facts and data.
- The Center should pursue the question of why some people are stubbornly attracted to implausible, unproven, and/or inert treatments. Wally Sampson suggested this idea years ago. It is one of many legacies of the late Barry Beyerstein, among others, whose writings could serve as a template for legitimate NCCAM research topics.
The NCCAM’s Charter and its boosters in Congress make such strategies exceedingly unlikely, as explained here. Therefore, in this and two subsequent postings I’ll address a few of the assertions made in each of the Center’s three “big picture” essays. These will not be comprehensive critiques of those essays, which would require deconstructions of nearly every sentence.
Last week I discussed the dismal results of the “Gonzalez Trial” for cancer of the pancreas,* as reported in an article recently posted on the website of the Journal of Clinical Oncology. I promised that this week I’d discuss “troubling information, both stated and unstated [in the report],” and also some ethical issues. More has come to light in the past few days, including Nicholas Gonzalez’s own voluminous, angry response to the JCO article. I’ll comment upon that below, but first a brief review.
The trial was begun in 1999 under the auspices of Columbia University, after Rep. Dan Burton had pressured NCI Director Richard Klausner to fund it. It was originally conceived as a randomized, controlled trial comparing the “Gonzalez Regimen” to standard chemotherapy for cancer of the pancreas. In the first year, however, only 2 subjects had been accrued, purportedly because those seeking Gonzalez’s treatment were not willing to risk random assignment to the chemotherapy arm. In 2000, the protocol was changed to a “prospective, cohort study” to allow potential subjects to choose which treatment they would follow. Gonzalez himself was to provide the ‘enzyme’ treatments.
After that there was little public information about the trial for several years, other than a few determination letters from the Office of Human Research Protections and a frightening account of the experience of one subject treated by Gonzalez. By 2006 or so, those of us who pay attention to creeping pseudomedicine in the academy were wondering what had become of it. About a year ago we found out: the trial had been quietly “terminated” in 2005 after it met “pre-determined stopping criteria.” As explained here, that meant that the Gonzalez group had not fared well.
Four years after the trial’s ‘termination,’ the report was finally published: The Gonzalez cohort had not only fared much worse than the cohort that received chemotherapy, but it had fared worse than a comparable group of historical controls. Here, again, is the survival graph from the JCO paper:
The Gonzalez group had also fared much worse in ‘quality of life’ scores, which included a measure of pain.
Now let’s read between the lines. Forgive me for taking shortcuts; I’m a little pressed for time. (more…)