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Archive for Politics and Regulation

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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NCCAM is a victim of its own history

Let me begin with a story. An assistant professor submits a reasonable application to NCCAM to investigate the potential metabolic and pharmacodynamic interactions of St. Johns wort with conventional chemotherapy. This was the year or year-and-a-half before SJW was known to have significant CYP3A4 inductive activity due primarily to its component, hyperforin. Said investigator used this preliminary data, not explicitly required for theNIH funding mechanism (called an R21), to question whether St. John’s wort used by depressed cancer patients might interfere with chemotherapy. The original proposal earned a priority score of 228 (as with golf, the lower the better: the best is 100, the worst is 500.)

The major reviewer critique was that the assistant professor, Your Humble Pharmacologist, lacked, at the time, significant natural products chemistry expertise. YHP was then doing his sabbatical in the NC Research Triangle area and wisely sought the support and expertise of the now-late Dr. Monroe Wall and surviving Dr. Manuskh Wani. These gentlemen discovered and solved the structures of taxol from Taxus brevifolia and camptothecin from Camptotheca acuminata. Taxol itself became a blockbuster drug for Bristol-Myers Squibb while camptothecin required water-soluble modifications to foster topotecan (Hycamptin) and irinotecan (Camptosar) that collectively saved or prolonged the lives of thousands of men and women subjected to breast, ovarian, lung, and gastrointestinal tumors. In 2003, they received the designation of an American Chemical Society National Historic Chemical Landmark for their three decades of work in this area. (Sadly, they received none of the profits from these drugs as their discoveries pre-dated the Bayh-Dole Act that allowed NIH funded researchers to share in the revenues of intellectual property emerging from their work.).

Being a savvy young investigator, I sought and enlisted the assistance and support of Dr. Wall and colleagues to provide my team with world-class, natural products expertise. Stunningly, the subsequent application was awared a score of 345 (*much worse than the original) with the criticism from reviewers that all Dr. Wall did was to lend a drug development aspect to an otherwise “herbal” applicaton.

To this day, I cannot fathom who better I could have sought for natural products expertise on this grant application.

Since then, three of my colleagues and I have submitted 13 applications to NCCAM, including an application for a comprehensive Botanical Research Center grant. All 13 received unfundable scores. Among these was a 279-page application for a NCCAM Botanical Research Center – reviewed but not discussed by the evaluation panel.

Nonetheless, I have taken the approach that if NCCAM were to continue its existence, I would try to be part of the solution.  I have accepted several invitations to review research and training grants for NCCAM and I am pleased to say that one or two projects that I ranked highly ended up being very productive, specifically in the area of natural products and traditional herbal medicines.  I also have some friends and valued colleagues who contribute to the scientific integrity of NCCAM. However, my collective experiences lead me to believe that they are voices quenched by the vast wilderness of the promotion and advocacy of “integrative medicine” and CAM.
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Posted in: Basic Science, Herbs & Supplements, Politics and Regulation, Science and Medicine

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Lies, Damned Lies, and ‘Integrative Medicine’

Last week, two events took place in Washington that ought to inspire trepidation in the minds of all who value ethical, rational, science-based medicine and ethical, rational, biomedical research. One was the Senate Panel titled Integrative Care: A Pathway to a Healthier Nation, previously discussed by my fellow bloggers David Gorski, Peter Lipson, and Steve Novella, and also by the indefatigable Orac (here and here); the other was the ”Summit on Integrative Medicine and the Health of the Public“ convened by the Institute of Medicine (IOM) and paid for by the Bravewell Collaborative, previewed six weeks ago by fellow blogger Wally Sampson. This post will make a few additional comments about those meetings.

Senator Harkin and the Scientific Method

Thanks to Dr. Lipson, I didn’t have to listen to the Senate Panel video to find out that Senator Tom Harkin (D-Iowa) made this statement of disappointment regarding his own creation, the National Center for Complementary and Alternative Medicine (NCCAM):

One of the purposes of this center was to investigate and validate alternative approaches. Quite frankly, I must say publicly that it has fallen short. It think quite frankly that in this center and in the office previously before it, most of its focus has been on disproving things rather than seeking out and approving. (from last week’s hearings, time marker approx. 17:20)

Are scientists at the NIH really too afraid of Harkin to explain to him how science works? Apparently so. Otherwise Harkin might learn that his statement is more wrong-headed than it would be for one of us to complain that the Supreme Court ought to assume that a defendant is guilty until proven innocent, rather than the other way around. In scientific inquiry, for those who don’t know, good experimental design is always directed at disproving a hypothesis, even one that pleases its investigator. The rest of Harkin’s sentiment—”seeking out and approving”—is incoherent.

The Selling of ‘Integrative Medicine’: Snyderman Trumps Weil

Spin doctors shilling for ‘integrative medicine,’ which the NCCAM defines as “combining treatments from conventional medicine and CAM,” appear to have now decided that subtler language is more likely to sell the product. We’ve previously seen an example offered by ‘integrative’ Mad Man Andrew Weil:

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Posted in: Medical Academia, Medical Ethics, Politics and Regulation, Public Health, Science and Medicine, Science and the Media, Vaccines

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Wyeth Vs. Levine: Joe Six Pack Trumps The FDA

The New York Times has called today’s US Supreme Court ruling in the Wyeth vs. Levine suit the “most important business case in years.” I have been following this case for many months, astonished that a medical malpractice suit had gotten all the way to the Supreme Court. But even more shocking is the fact that the court actually ruled that lay juries may evaluate the accuracy of FDA-approved drug labels written for healthcare professionals.

In other words, after a team of FDA regulators decide on the very best language to describe potential risks of a drug -  Joe Six Pack can overrule their expertise and hold the drug company liable for any deficit (as he interprets it) in label language, awarding millions to anyone who experiences harm, no matter how well disclosed that risk is.

I reached out to Wyeth’s attorney, Bert Rein, for comment. Here are the highlights from the interview (a podcast is available here)…

Dr. Val: The New York Times is calling Wyeth vs. Levine the most important business case in years. Can you summarize what just happened?

Rein: The court determined that Wyeth’s liability for Ms. Levine’s injury was not preempted by the FDA-approved drug label warnings. They were not convinced that the FDA had declined to strengthen the warning language on the label prior to Ms. Levine’s injury, though Wyeth had in fact requested a label change. In addition, the court held that the FDA’s regulatory regime was insufficient to preempt Ms. Levine from suing Wyeth, because the FDA doesn’t have a regulational requirement for all label updates to undergo federal approval. The court therefore ruled that the suit was well founded and that the state of Vermont should decide whether or not Wyeth’s conduct was appropriate.

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Posted in: Pharmaceuticals, Politics and Regulation

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Double Standards – Newsweek and Tom Harkin

There has been a flurry of news relevant to science-based medicine in the last week – more than enough to keep a bevy of bloggers busy. More important than the individual news items themselves is the striking pattern they bring into focus when viewed together – the growing and pernicious double-standard between mainstream medicine and so-called CAM.

Begley vs Doctors

Science editor Sharon Begley wrote an interesting piece in Newsweek with the provocative title: Why Doctors Hate Science.  I was not particularly impressed with the article – it took a rather narrow approach to a complex problem and ran with it. She writes:

It’s hard not to scream when you see how many physicians, pharmaceutical companies, medical-device makers and, lately, hysterical conservatives seem to hate science, or at best ignore it. These days the science that inspires fear and loathing is “comparative-effectiveness research” (CER), which is receiving $1 billion under the stimulus bill President Obama signed. CER means studies to determine which treatments, including drugs, are more medically and cost-effective for a given ailment than others.

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Posted in: Politics and Regulation, Public Health

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Tom Harkin’s War on Science (or, “meet the new boss…”)

This was cross-posted at White Coat Underground, despite the topic having been covered by Dr. Gorski yesterday. The topic is important enough that many of us in the medical blogosphere are going to be talking about this.

Remember when President Obama said something about returning science to it’s rightful place? Well, our new president has a real tough climb ahead of him. The previous administration shoved science aside for political expediency and religious ideology. Now, forces in the president’s own party are trying to insert their own quasi-religious beliefs into health care reform, leaving science in a whole different place altogether.

Here’s the deal. Some years back, Senator Tom Harkin (D-IA) helped set up the National Center on Complementary and Alternative Medicine (NCCAM). The whole idea of setting up such an agency is a bit quixotic—after all, the National Institutes of Health already study health science. As my colleagues and I have written many times before, the very idea of the agency seems ridiculous. Many, many studies have been funded which fail basic tests of plausibility and ethical propriety. Also, a huge percentage of the studies funded fail to ever publish their results. Still, some studies have been published, and more often than not, they find that the “alternative” modality being studied fails to behave better than placebo. That’s probably the sole redeeming quality of the agency, but not enough to keep it open, as these studies could have been done under the auspices of the NIH.

It turns out that Senator Harkin agrees with me on one point: NCCAM is failing to validate many alternative modalities. The difference is that I find it heartening and Harkin finds it disturbing:

“One of the purposes of this center was to investigate and validate alternative approaches. Quite frankly, I must say publicly that it has fallen short. It think quite frankly that in this center and in the office previously before it, most of its focus has been on disproving things rather than seeking out and approving.”(from last week’s hearings, time marker approx. 17:20)

Well, at least he’s honest. He comes right out and bemoans the fact that science hasn’t upheld his quasi-religious medical beliefs. He just doesn’t get it. If you choose to investigate a scientific question, you have to be prepared for “bad news”. You don’t get to decide the outcome before the fact.

But Harkin makes his goals very clear, from his prepared statement, to the “experts” from whom he took testimony.
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Posted in: Politics and Regulation, Science and Medicine

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