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Archive for Politics and Regulation

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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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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Harvard Medical School: Veritas for Sale (Part IV)

HMS Puts the Messenger in its Crosshairs

When, during the fall and winter of 2001-02 I first approached Dean Daniel Federman of the Harvard Medical School (HMS) with evidence that the HMS “CAM” program was promoting pseudomedicine, I gave him some materials that I thought would be adequate to make the case: ‘CAM’ Director David Eisenberg’s dubious funding sources and his failure to disclose them to the Massachusetts Special Commission; the website of the Caregroup/Harvard Medical School Center for Alternative Medicine Research and Education (CAMRE), which urged anonymous websurfers to “consult your local telephone yellow pages” for ‘naturopathic physicians’ and other quacks; the presence on the ultra-PPO American Association for Health Freedom (AAHF) Advisory Board of attorney Michael H. Cohen, the Harvard CAMRE’s “Director of Legal Programs” (at the time, Dr. Federman agreed with me that the mere existence of such a position was curious, if the CAMRE’s purpose was ”research and education”); that Dr. Eisenberg and Atty Cohen had contributed to a report to the Massachusetts State Legislature recommending a formal state imprimatur for the practice of pseudomedicine; and other embarrassing findings. A bit later, in March 2002, I sent him a draft of the essay that I posted in Parts I and II of this series.

That material proved not to be adequate, for on March 20, 2002, Dr. Federman sent me the following letter:

Dear Kim,

I ready to undertake a formal review of the Harvard Medical School’s Division of Research and Education in Complementary and Alternative Medicine, and of its leadership to investigate the charges outlined in your letter of November 4, 2001, subsequent emails, and our meeting of January 22, 2002 in my office. I have read almost all of the voluminous literature you sent me and am writing to ask you to assist our efforts. Specifically, I am asking you to prepare a one to three page summary of the specific portions of the material you sent me that you consider erroneous, duplicitous, misleading, or fraudulent.* I do not feel I should summarize your views. Please be specific and give sources, where you can, in support of your statements.

I am committed to achieving a careful and balanced review of the issues you raise.

Sincerely,

Daniel E. Federman, M.D.

* [These are terms that I had used in my communications with Dr. Federman; the only one from which I backed away, after he reacted with considerable alarm, was "fraudulent."]

That was the first real suggestion that the fix was in. The pertinent literature that I’d sent Dr. Federman did not consist of “my views” or even my words. It consisted of statements copied from CAMRE publications and other public sources. Why did Dr. Federman now seem to be framing the issue as a matter of (my) opinion? Why weren’t the points that I’d already presented and documented (they were specific and I gave sources) sufficient to trigger an independent, formal review? What about the summary that I’d already written in the form of a letter to Harvard Magazine, which Dr. Federman had also read? No matter: I was still confident that he would do the right thing when he saw the totality of the evidence, abundantly and overwhelmingly supporting my contention that the CAMRE and other HMS affiliates were promoting pseudomedicine—dangerously, unethically, and in contrast to their stated purpose.

It was then that I resolved to write the essays that I posted in Parts I, II and III of this series.‡ I also prepared the summary that Dr. Federman had requested, which is reprinted below. In June, 2002, I sent these together with this letter:

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Posted in: Health Fraud, Medical Academia, Politics and Regulation, 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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IRBs, Conflicts of Interest, and Witch Hunts

When beginning a discussion of a controversial topic I like to establish the common ground upon which most or all people can agree. Everyone seems to agree that real conflicts of interest in medical research and practice is a bad thing and steps should be taken to minimize, eliminate, and illuminate any such conflicts. The controversy revolves around what constitutes a real conflict of interest.

There is broad agreement that researchers should not have a personal financial stake in the outcome of their own research – they should not make more money if their research is positive than if it’s negative. That creates a clear and powerful bias.  There is also now broad agreement and adoption of standards that speakers, authors, and researchers should disclose any potential conflicts of interest – primarily the source of their funding. If someone is being paid by a drug company to say that their drug is effective for a particular disease, they should disclose that up front.

These same standard are now being applied to IRBs – institutional review boards, and that seems apprpriate. Every institution that does biomedical research must have an IRB, which is a committee of appropriate professionals (and there are rules as to the IRB’s constitution) that review all human research proposals to make sure they meet ethical guidelines and that subjects are adequately protected. This is a good system that generally works.

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

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Involuntary Treatment – Civil Rights or Civil Wrongs?

In the 1950s, 558,000 people were in mental institutions in the U.S. Many were there against their will and were being warehoused or treated badly. Deinstitutionalization was intended to restore their civil rights and improve their lot. Did it? By 2006, there were only 40,000 people in institutions. What happened to the other 518,000?

Some of them are living in the community with supportive family members, taking their medications, and contributing to society. Some of them have been ghettoized in halfway houses or group homes in crime-ridden and run-down neighborhoods. Some of them are homeless, living on the streets and eating out of garbage cans. Some of them are in jail. Some of them have killed family members or have killed multiple people in “rampage” murders provoked by their psychotic delusions.

Accurate numbers are difficult to obtain. By some estimates, as many as 30-50% of the homeless (and even more of the hard-core homeless) and as many as 40-50% of the jail population are mentally ill. There are more mentally ill people in jails than in hospitals. The mentally ill are more likely to be victims of violence and rape and are more likely to be shot by the police in “justifiable homicide” incidents.

Mentally ill people who are adequately treated are no more violent than the non-mentally ill, but a disproportionate number of murders are committed by the mentally ill. The risk of violence increases with past history of violence, substance abuse, anosognosia with medication noncompliance, antisocial personality disorder, paranoid symptoms, and male sex. (more…)

Posted in: Neuroscience/Mental Health, Politics and Regulation

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Naturopathy and Liberal Politics: Strange Bedfellows

Yesterday’s post by Wally Sampson and an offline discussion with David Gorski have moved me to post something that I wrote in 2001. At the time, I was a member of the Massachusetts Special Commission on Complementary and Alternative Medical Practitioners. I’ve previously mentioned that experience here.

During that tenure I wrote a treatise on the tenets and practices of ‘naturopathic medicine,’* hoping to change the opinions of several others on the Commission (no such luck). In an early draft I included a section titled “The Political Philosophy of Naturopathy.” My ally on the panel, emeritus New England Journal of Medicine Editor Arnold “Bud” Relman, advised me to remove it, citing its tangential relevance and the possibility of it irritating rather than persuading. He was right, of course, but it now seems reasonable to hall it out of the mothballs. Here it is, with minor revisions and, I hope, a provocative postscript.

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Posted in: Faith Healing & Spirituality, Health Fraud, Politics and Regulation

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A View to the Past

The quackery political map has changed over the last three decades. I recently took a historial look over the landscape at characteristics and forms of quackery that could yield some perspective, and understanding.

Pseudoscience and quackery were identifiable long before we were here. Mesmer was deposed by Franklin and Lavoisier & Co.  Samuel Hahnemann’s homeopathy was recognized as false by contemporaries, and by 1840s Oliver W. Holmes, Sr. had a merry time deriding the entire theory. Despite the ability of good scientists to recognize medical nonsense, much of 19th century medicine practiced was by school of thought or philosophy – sectarian practice. Some of these were homeopathic, herbal, hydropathic (water, baths) osteopathic, medicinal, surgical, empiricist, eclectic and naturopathic. Much of this was indistinguishable from quackery.

In 1911, most institutions of sectarian and ideological approaches were demolished by the Flexner recommendations, resulting in reform of medical schools. Quackery became the separate ideas of individuals – Hoxsey, Ivy, Gerson, Binkley. Some schools like homeopathy and sects like osteopathy and chiropractic continued separate from medicine.

After WW II quackery began to be promoted by political activity. Sects and schools began to lobby for licensure, recognition, and later, insurance payments. In the 1970s-80s sectarianism/quackery became recognized by political groups as vehicles for their political causes. The movement started in right wing causes. Not conservative, but high emotion, radical, scofflaw behavior. People who had to leave the country to do their things. Laetrile became a political symbol for anti-regulation and far right politics. The John Birch Society, then more prominent and radical than it is today, was one of the main support orgs. Most supporters berated regulatory agencies. They bore bumper stickers, “Go to Health, FDA.“

Left met right over the Laetrile conflicts, as both extremes considered Laetrile to be effective and wanted it available. (Laetrile was a science and commercial fraud, its biochemistry and biology made up by its creator, E. Krebs.)

The rhetoric then was near-revolutionary, paranoid, anti-government and anti-regulatory. Laetrile popularity was a product of anti-regulatory rhetoric. Steve Barrtett, Victor Herbert and a few others worked as experts for government agencies and boards against the problem. At that time, the agencies were largely free of both industry and ideological pressures. We exchanged information, we testified in court. There was general agreement regarding what constituted knowledge, good practice and quackery. Most elected officials were on the side of regulation and law enforcement.
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Posted in: Health Fraud, Medical Academia, Politics and Regulation

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Evidence-Based Legislation? Lessons From Abroad

President Obama appears to be refreshingly pro-science in his outlook, publicly lauding objectivity and careful analysis. He has even been credited with saying that “we need evidence-based legislation” in regards to public policy. The New York Times reports:

Agencies will be expected to pick science advisers based on expertise, not political ideology, the memorandum said, and will offer whistle-blower protections to employees who expose the misuse or suppression of scientific information.

The idea, the president said in remarks before an audience of lawmakers, scientists, patients advocates and patients in the East Room, is to ensure that “we make scientific decisions based on facts, not ideology”: a line that drew more applause than any other.

But when it comes to healthcare reform, many policy decisions put us in uncharted territory, with intelligent arguments on both sides of many legislative options and no American historical frame of reference to help us determine the best course of action. In times like these, perhaps the best we can do (to promote “evidence-based legislation”) is to study similar policy decisions made by our Canadian and European counterparts.

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Posted in: Politics and Regulation

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The GAO Report on Supplement Regulation

We advocate for Science-Based Medicine partly because science incorporates various generic intellectual virtues to which everyone should aspire. These include logical and clear thinking, unambiguous definitions, and internal consistency. In fact it is demonstrably true that opposing science often equates to promoting muddied and sloppy thinking, ambiguous language, and self-contradiction.

Last week I wrote about that latter virtue – consistency – and its lack when dealing with regulating physicians vs regulating so-called complementary and alternative medicine (CAM). In fact CAM exists, in my opinion, specifically to create a double-standard to disguise contradictory standards. It is institutionalized compartmentalization to minimize public cognitive dissonance.

This week, as promised, I will discuss how the same double standard has been made to apply to the regulation of supplements vs pharmaceuticals. The recently published Government Accountability Office (GAO) report on supplement regulation by the FDA brings this to light.

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Posted in: Herbs & Supplements, Politics and Regulation

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