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The British Chiropractic Association versus Simon Singh

Simon SinghIf there’s one thing I’ve learned in my years promoting skepticism and science in medicine and writing critically about various forms of unscientific medical practices and outright quackery, it’s that there will always be pushback. Much, if not most, of the time, it’s just insults online. However, occasionally, the pushback enters into the realm of real life. I can remember the very first time this happened to me. It was in 2005, and a man by the name of William P. O’Neill of the Canadian Cancer Research Group sent legal threats to my Department Chairman, my Division Chief, and my Cancer Center Director. The legal threat was clearly vacuous, as Mr. O’Neill seemed upset mainly that I had praised his arch-nemesis, Australian skeptic Peter Bowditch (who even keeps a running tally of threats he receives from Mr. O’Neill under the heading The GAL Chronicles, where GAL stands for “gutless anonymous liar”). I must admit, at the time it scared the crap out of me, but the reaction of my Chairman at the time, Dr. Stephen Lowry, was classic in that he said he did not care what I did in my spare time and referred to Mr. O’Neill as a “cowardly bully.” From then on, every time Mr. O’Neill tried something similar, I simply replied that I was forwarding his e-mail to Dr. Lowry (who was amused by all this) and thanked him for his concern.

More recently, J.B. Handley wrote a rather ugly screed (one of two, actually) about me. Somehow, this screed was e-mailed to my cancer center director. Whether Mr. Handley, one of the crew at Age of Autism, or an AoA reader did it, I don’t know. However, it is typical behavior of the anti-vaccine movement. Based on this history, I’ve concluded that, if you’re going to be a skeptic you’d better be prepared for this sort of thing, and if you’re going to blog under a pseudonym you’d better expect that sooner or later someone will try very, very hard indeed to “out” you and use that against you–which is of course blogging at SBM is in a way liberating in that it removes that threat.

However, whatever obnoxiousness or attempts to harass me at my job I may on occasion have to worry about, one thing I don’t have to worry about (much) is legal threats, at least as long as I keep all my ducks in a row, so to speak. In the U.S., libel is a very difficult charge to prove. The First Amendment gives wide latitude to free speech, and that places the burden of proof on the plaintiff to show that a statement is defamatory, with libel being in essence written defamation. In general, this is what constitutes defamation in the U.S.:

In order for the person about whom a statement is made to recover for libel, the false statement must be defamatory, meaning that it actually harms the reputation of the other person, as opposed to being merely insulting or offensive.

The statement(s) alleged to be defamatory must also have been published to at least one other person (other than the subject of the statement) and must be “of and concerning” the plaintiff. That is, those hearing or reading the statement must identify it specifically with the plaintiff.

The statement(s) alleged to be defamatory must also be a false statement of fact. That which is name-calling, hyperbole, or, however characterized, cannot be proven true or false, cannot be the subject of a libel or slander claim.

The defamatory statement must also have been made with fault. The extent of the fault depends primarily on the status of the plaintiff. Public figures, such as government officials, celebrities, well-known individuals, and people involved in specific public controversies, are required to prove actual malice, a legal term which means the defendant knew his statement was false or recklessly disregarded the truth or falsity of his statement. In most jurisdictions, private individuals must show only that the defendant was negligent: that he failed to act with due care in the situation.

A defamation claim — at least one based upon statements about issues that are matters of public interest — will likely fail if any of these elements are not met.

As you can see, it is a high bar of evidence to overcome to prove libel. Of course, that is a two-edged sword in that it allows J.B. Handley to slime me whenever he wishes, with little I can do about it, but I am also allowed, as I see fit, to respond or not to such attacks. I can also continue to criticize anti-vaccine propagandists like Mr. Handley as I see fit. Unfortunately, for my U.K. colleagues, the same is most assuredly not true in British courts, where the rules are very much weighted against the defendant. Witness this travesty of a ruling on the libel case against Simon Singh, coauthor with Edzard Ernst of Trick or Treatment: The Undeniable Facts about Alternative Medicine (which Harriet Hall reviewed last year) by the British Chiropractic Association, as related by Jack of Kent. This ruling came about because the BCA did not like an article that Singh wrote for The Guardian entitled Beware the spinal trap.
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Posted in: Chiropractic, Medical Ethics, Politics and Regulation, Science and the Media

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Threats to science-based medicine: Big pharma pays a publisher to produce a fake journal

It’s times like these when I’m happy that I haven’t published in too many Elsevier Journals during the course of my career. Actually, I’m not sure if I’ve ever published in an Elsevier journal, although I have reviewed manuscripts for them. In any case, I say that because on Thursday, it was revealed that pharmaceutical company Merck, Sharp & Dohme paid Elsevier to produce a fake medical journal that, to any superficial examination, looked like a real medical journal but was in reality nothing more than advertising for Merck. As reported by The Scientist:

Merck paid an undisclosed sum to Elsevier to produce several volumes of a publication that had the look of a peer-reviewed medical journal, but contained only reprinted or summarized articles–most of which presented data favorable to Merck products–that appeared to act solely as marketing tools with no disclosure of company sponsorship.

“I’ve seen no shortage of creativity emanating from the marketing departments of drug companies,” Peter Lurie, deputy director of the public health research group at the consumer advocacy nonprofit Public Citizen, said, after reviewing two issues of the publication obtained by The Scientist. “But even for someone as jaded as me, this is a new wrinkle.”

The Australasian Journal of Bone and Joint Medicine, which was published by Exerpta Medica, a division of scientific publishing juggernaut Elsevier, is not indexed in the MEDLINE database, and has no website (not even a defunct one). The Scientist obtained two issues of the journal: Volume 2, Issues 1 and 2, both dated 2003. The issues contained little in the way of advertisements apart from ads for Fosamax, a Merck drug for osteoporosis, and Vioxx. (Click here and here to view PDFs of the two issues.)

This is wrong on so many levels that it’s hard to know where to begin.
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Posted in: Basic Science, Clinical Trials, Medical Ethics, Science and the Media

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Harvard Medical School: Veritas for Sale (Part VI)

Loose Ends: Dr. Koh and More

After Dr. Federman’s letter and my reply, posted in Part V of this series,† there seemed little point in pursuing the matter further. Although Dr. Federman never answered my reply, he did send, at my request, a copy of Commissioner of Public Health Howard Koh‘s written “construction of the events in the Massachusetts Special Commission.” As you may recall, those events had occurred at meetings that Dr. Koh never attended:

July 29, 2002

Dear Dr. Federman:

I have had an opportunity to review Dr. Kimball Atwood’s characterizations of the role Dr. David Eisenberg played as an advisor and designee of the Department of Public Health (DPH) and I am writing to clarify several misrepresentations of that role. As you may know, I personally selected Dr. Eisenberg as my designee for the Massachusetts Special Commission on Complementary and Alternative Medical Practitioners based on his high level of scientific and clinical expertise in the field, as well as his international reputation for evidence-based research. I felt at that time, as I do now, that he was the appropriate choice to represent the Department and I am extremely grateful for his advice and his integrity during this most contentious process.

During the course of the Commission, Dr. Eisenberg brought to my attention some of the conflicts that had arisen among the members, despite his attempts to diffuse the hostility and to engage the members in collegial debate. In an effort to overcome these difficulties and deflect unwarranted criticism, Nancy Ridley, Assistant Commissioner for Health Quality Management, attended the meetings over the last six months as the DPH voting designee, with Dr. Eisenberg as an advisor. She also organized a DPH workgroup of the Commission in an attempt to bring consensus and closure to what had become a very polarized and highly personalized process.

I need to state emphatically that the approval of the final Commission report is my responsibility, and is largely a product of the DPH workgroup that Assistant Commissioner Ridley chaired. Dr. Eisenberg had actually not been supportive of either the “majority” or “minority” reports that were originally presented, and neither was Ms. Ridley. She attempted to address as many of Dr. Eisenberg’s concerns as possible but knew he still had issues with the final document. She feels very strongly that there needs to be regulatory oversight of non-physician practitioners of complementary and alternative naturopathic practice. Assistant Commissioner Ridley, on behalf of the Department and with my consent, signed the report that included a significant number of revisions which narrowed the scope of practice, ensured collaborative relationships between physician and non-physician practitioners, and broadened the scope of any proposed regulatory oversight required. Dr. Eisenberg’s advice to DPH was delivered in a fair and balanced manner based his outstanding experience as a clinician and scientist.

I believe that one of the contributing factors for the polarization within the Commission had little to do with Dr. Eisenberg’s participation rather than that of his staffperson, Michael Cohen, who attended Commission meetings in his absence. Mr. Cohen was repeatedly characterized as the alternate DPH designee, which he was not.

In summary, Dr. Eisenberg’s expertise and professionalism throughout this difficult process have been greatly appreciated by the Department. DPH was truly fortunate to be represented and advised by a person of Dr. Eisenberg’s stature and character. I would be more that pleased to speak to you or Dean Martin on his behalf. Please feel free to contact me at xxx.xxx.xxxx if you need any additional information.

Sincerely,

Howard K. Koh, MD, MPH

The range of self-serving misrepresentations in that letter is wide, and is worrisome in someone who will be “responsible for the major health agencies, including the CDC, FDA and NIH, and [will be] the leading health advisor to the Secretary of HHS.” I have already discussed some of the facts here and here, and will add more now.

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Posted in: Medical Academia, Medical Ethics, Politics and Regulation, Science and Medicine

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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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Harvard Medical School: Veritas for Sale (Part V)

September 26, 2002

Kimball Atwood, M.D.
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Dear Kim,

I have now had time to look into the allegations in your letter of June 14th which, incidentally, I shared with Dr. David Eisenberg and he with several others. I have sought consultation about our exchanges and the gist of my response follows.

Some of your concerns and allegations are very helpful and constructive. Perceptions are particularly important in controversial fields where there is limited objective proof. Your cautions and interpretations in this area have been very useful to us.

Some of what you said is just plain wrong. This includes the allegation the Harvard has “a stake” in the area and therefore would not look into your allegations objectively. Relatedly, Dr. Howard Koh has written us a construction of the events in the Massachusetts Special Commission that is strikingly different from yours. And Dr. Anthony Komoroff has pointed out that many of your comments about the InteliHealth treatment of CAM are now grossly out of date as the material inherited from another provider has been reviewed by HMS faculty and modified. [Indeed, you have referred in other correspondence to modifications you have noticed.] Dr. Komaroff also commented on the misleading way your citation the treatment of homeopathy was disconnected from the rest of the paragraph.

Some of what you said is a matter of taste or interpretation, where even well intentioned people may disagree. In this particular area I have weighed your arguments carefully and, in places, learned from them.

But I think the biggest difference may be in a misperception about what our purposes are. The Council of Academic Deans of Harvard Medical School approved beginning a Division of Research and Education in Complementary and Alternative Therapies with exactly the focus described. Our goal is to do peer-reviewed basic and clinical research on the claimed, but unproven, efficacies of complementary and alternative approaches to therapeutics. The recent scientific sessions and requests for proposal held by the Division are clear testament to this intent. In addition, in common with the Association of American Medical Colleges and most of the allopathic schools of medicine, we intend to teach our students something about CAM and in particular how to assess its claims rigorously. We do not, repeat NOT, have any intention of making our students CAM practitioners. They have enough to do learning what we have always focused on.

Sincerely,

Daniel D. Federman, M.D.

cc: David M. Eisenberg, M.D.

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Posted in: Health Fraud, Medical Academia, Medical Ethics, Science and Medicine, Science and the Media

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Response to a “CAM on campus” post

I only recently began contributing to SBM, bringing not any particular expertise or scholarship but rather the perspective of a student. My goal in blogging is not to focus on issues specific to my school, of which I am quite fond and proud in general. Instead I hope to use my experiences, which SBM editors and readers tell me are not unique, to illustrate how CAM can interact with medical education. When writing, I constantly remind myself, “Everything you know about homeopathy and naturopathy was heavily influenced by the SBM docs, so try not to parrot their arguments lest you look like a brainwashed fanboy. Focus on relaying your experiences and trust readers to reach their own conclusions.” As a result, some have called my critiques a bit mild, but I can accept blandness to avoid seeming arrogant beyond my qualifications.

I was surprised, therefore, to be told by leaders of a campus CAM group that my most recent SBM post was full of personal attacks. (more…)

Posted in: Medical Ethics, Politics and Regulation

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Harvard Medical School: Veritas for Sale (Part III)

In Parts I and II of this series* we saw that from 2000 to 2002, key members of the Harvard Medical School “CAM” program, including the Director, had promoted quackery to the legislature of the Commonwealth of Massachusetts. We also saw other explicit or tacit promotions by Harvard institutions and professors, and embarrassing examples of such promotions on InteliHealth, a consumer health website ostensibly committed to “providing credible information from the most trusted sources, including Harvard Medical School….”

Those points were made in an essay that I sent in the spring of 2002 to Daniel Federman, the Senior Dean for Alumni Relations and Clinical Teaching at Harvard Medical School (HMS). I also sent Dr. Federman a treatise on homeopathy, including several examples of credulous Harvard professors and misrepresentations aimed at students, patients, and the public. Much of the content of that treatise has been covered by the series on homeopathy† with which I began my stint here on SBM, so here I’ll post only the parts relevant to promotions by academic physicians, including those at Harvard. There is a bit of redundancy involving InteliHealth, but please bear with me if you’ve made it this far; the discussion will be meatier than the short summary in Part II.

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Posted in: Health Fraud, Medical Academia, Medical Ethics, Science and Medicine, Science and the Media

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Harvard Medical School: Veritas for Sale (Part II)

In Part I of this series† we saw that in 2001 Dr. David Eisenberg, the Director of the Harvard Medical School Center for Alternative Medicine Research and Education (CAMRE), and Atty Michael Cohen, the CAMRE’s Director of Legal Programs, had contributed to a report commissioned by the Commonwealth of Massachusetts that would, if accepted as valid by the legislature, provide state protection for a group of quacks to practice ‘medicine.’ We also saw that Dr. Eisenberg had accepted funds from this very group, without having disclosed that information to the relevant state Commission. We saw examples of the quackery that the group espouses, including methods advocated by Thomas Kruzel, the Chief Medical Officer of the school that had contributed money to Dr. Eisenberg’s Harvard “Complementary and Integrative Medicine” course.

We continue now with the essay that I sent in the spring of 2002 to Dr. Dan Federman, the Senior Dean for Alumni Relations and Clinical Teaching at Harvard Medical School (HMS). As before, I’ve provided hyperlinks to many of the citations that I included in my original essay; some, however, are no longer available.

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The American Association of Health Freedom

Kruzel and Harvard’s Michael Cohen are listed as key figures—Kruzel the Secretary, Mr. Cohen the only lawyer on the Advisory Board—in a lobbying organization known as the American Association of Health Freedom (AAHF). Formerly known as the American Preventive Medical Association (APMA), it was founded by Julian Whitaker, MD, a former orthopedic surgical resident who decided that “natural therapies” offered a more lucrative career path. Its purpose, as suggested by the standard euphemism, is to convince government of the validity of dubious medical claims through political influence rather than science. The AAHF lobbies heavily for the passage of the annually defeated federal “Access to Medical Treatment” act, which would allow quacks to prey freely on unwary consumers.

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Posted in: Health Fraud, Medical Academia, Medical Ethics, Science and Medicine

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Medical students actively recruited for CAM

Here at Science-Based Medicine we’ve been getting a lot of letters from medical students.  This is a good thing and a bad thing.   I’m glad people see us a a resource for SBM, but I’m unhappy that medical students: 1) need us; 2) don’t have someone to approach on campus.  Let’s explore some of the more subtle ways cult medical practices infiltrate medical education.

Outpatient Rotations

In order to give all of their students experience in outpatient medicine, most med schools must reach out to the community.  Sure, some med schools have big enough clinics to support an experience for all of their students, but that’s the minority.  For their internal medicine, pediatrics, and family medicine rotations, med students often spend time at private doctors’ offices.  These offices are minimally vetted, and I’d venture to guess that the vetting does not include checking for non-standard practices.   In fact, schools are so desperate for spots, that almost any office will do.  It’s good for students to see how medicine is practiced in the “real world” but that real world often involves cult medicine practices.  Along the same lines, many practitioners are not up to date on the most recent best practices.  I remember a family doc I worked with who used to give huge doses of intramuscular steroids to people for seasonal allergies.  This isn’t the best idea, but I was a student. Who was I to tell him how to practice medicine?

We don’t police our colleagues very effectively—we have surrendered that duty largely to the courts.  However, if doctors want a medical school affiliation, it seems a small price to allow the school to come in and see if the office practices medicine  according to the standard of care.  In addition to checking for the most minimal quality standards, it would rule out docs who are offering voodoo in place of medicine.
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Posted in: Medical Academia, Medical Ethics, Science and Medicine

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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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