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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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Alternative medicine use and breast cancer

Of all the posts I and my cobloggers have written for SBM over the last 15 months, most provoke relatively few comments. However, a few stand out for having provoked hundreds of comments. The very first post that provoked hundreds of comments was Harriet’s excellent discussion of the International Network of Cholesterol Skeptics. In fact, Harriet seems to be quite good at writing posts that provoke a lot of comment, as another of her posts, specifically the one in which she discussed circumcision, also garnered hundreds of comments. However, to my great surprise, the one post that stands out as having received the most comments thus far in the history of SBM is one that I wrote. Specifically, it was a post I called Death by “alternative” medicine: Who’s to blame?, which has collected an astonishing 611 comments thus far. The topic of the post was a case report that I had heard while visiting the tumor board of an affiliate of my former cancer center describing a young woman who had rejected conventional therapy for an eminently treatable breast cancer and then returned two or three years later with a large, nasty tumor that was much more difficult to treat and possibly metastatic to the bone, which would make it no longer even potentially curable. My discussion centered on what the obligation of a physician is to such patients who utterly refuse the science- and evidence-based medicine that we know to be able to cure them of a potentially fatal disease, and I was not only surprised but somewhat taken aback by the vehemence of the discussion.

Since that post, I’ve always been meaning to take a look at what, exactly, the effect of choosing “alternative” medicine over “conventional” medicine is on the odds of survival for breast cancer patients. Even though intuitively one would hypothesize that refusing scientific medicine and relying on placebo medicine instead would have a detrimental effect on survival, it turns out that this question is not as easy to answer as you might think. For example, if you do a search on PubMed using terms like “alternative medicine,” “breast cancer,” and “survival,” the vast majority of the hits will be studies of complementary and alternative medicine (CAM) and breast cancer with little reference to what possible effect these therapies might have on survival. I can envision several reasons for this, the first being that–thankfully–relatively few women actually use alternative medicine exclusively to treat their breast cancer. Also, those that do probably drop off the radar screen of their science-based practitioners, and it is difficult, if not impossible, to capture data regarding their outcomes, given that they all too often stick with their alternative healers until the end. True, they may pop up again in their surgeon’s or primary care doctor’s office with huge, fungating tumors, only to be told that they have to undergo chemotherapy to shrink the tumor before any surgery is possible, after which they will often disappear again. Another important reason is that the natural history of breast cancer is extremely variable, from nasty, aggressive tumors that kill within months to indolent, slow-growing tumors that, even when metastatic, women can survive with for several years. (It is, of course, these women who usually show up in “alternative medicine” testimonials, because they can survive a long time with little or no treatment before their tumors progress.)
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Posted in: Cancer, Herbs & Supplements, Science and Medicine, Surgical Procedures

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Welcome another new blogger for SBM

I’d like to take this opportunity to announce the arrival of another new blogger for SBM. Please wecome Dr. John Snyder.

John Snyder, M.D., is Chief of the Section of General Pediatrics and Medical Director of Pediatric Ambulatory Care at Saint Vincent’s Hospital in New York City. He is also Assistant Professor of Pediatrics at New York Medical College. Since 1994 Dr. Snyder has been active in pediatric resident and medical student education with a particular interest in evidence based pediatrics. His main area of interest is medical myth and the ways in which parents utilize information in making medical decisions for their children. One area of focus has been vaccine myth, and he lectures frequently on this subject in both academic and community settings. Dr. Snyder graduated form Mount Sinai School of Medicine and completed his residency training in pediatrics at The Mount Sinai Hospital in New York City. He is board certified in Pediatrics, and is a Fellow of The American Academy of Pediatrics. He is the founding partner of Pediatric Associates of Saint Vincents, a mutli-specialty pediatric faculty practice in New York City.

I first encountered Dr. Snyder on the HealthFraud mailing list, where, along with our very own Harriet Hall, he’s done yeoman’s work in the discussions there. Given how much the antivaccine movement has figured into the topics discussed here, I’ve also been looking for a skeptical pediatrician for quite a while now, which is why I’m very glad we’ve landed Dr. Snyder, who will be posting approximately once or twice a month. His first contribution to SBM will be posted later this week.

Please welcome him and be sure to comment on his first post, which will likely appear by Wednesday afternoon.

Posted in: Announcements

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CAM on campus: Naturopathy

The latest event sponsored by “integrative medicine” proponents on my medical school campus featured the naturopath “Dr.” PB, a 2003 graduate and valedictorian from Bastyr University. Advertisements all over campus billed the lecture as “Stress, nutrition, and the GI tract,” which seemed innocuous enough. However, the lecture title as written on PB’s slide show was “Naturopathic apologetics for treating the gut.” He explained “treating the gut” to mean that for a wide variety of symptoms the naturopath’s diagnosis inevitibly focuses on the intestine and interventions nearly always involve dietary changes or supplements. Apparently some critics find this preoccupation to be excessive; hence “apologetics,” a word that connotes rational defense of articles of faith. This word choice was appropriate, as the lecturer wove snippets of basic physiology, but never any direct evidence, into a just-so story about how nearly all disease is caused by the modern lifestyle and can be ameliorate with dietary intervention.

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Posted in: Medical Academia, Science and Medicine

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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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Placebo Therapies: Are They Ethical?

Is it ethical to overstate the efficacy of a treatment option, if it might lead to a patient’s enhanced experience of that treatment? Your response to this question may reveal the degree to which you favor Complementary and Alternative Medicine (CAM). Let me explain.

As far as I can tell, no CAM treatment has been proven effective beyond placebo. (If you’re not convinced of this, I suggest you take a look at Barker Bausell’s book on the subject.) That means that treatments like acupuncture, homeopathy, Reiki, energy healing, Traditional Chinese Medicine (such as cupping), and others (like “liver flushes”) perform about as well as placebos (inert alternatives) in head-to-head studies. Therefore, the effects of these treatments cannot be explained by inherent mechanisms of action, but rather the mind’s perception of their value. In essence, the majority of CAM treatments are likely to be placebo therapies, with different levels of associated ritual.

For the sake of argument, let’s assume that CAM therapies are in fact placebos – the question then becomes, is it ethical to prescribe placebos to patients?  It seems that many U.S. physicians believe that it is not appropriate to overstate potential therapeutic benefits to patients. In fact, the AMA strictly prohibits such a practice:

“Physicians may use [a] placebo for diagnosis or treatment only if the patient is informed of and agrees to its use.”

Moreover, a recent article in the New England Journal of Medicine concludes:

“Outside the setting of clinical trials, there is no justification for the use of placebos.”

However, there is some wavering on the absolute contraindication of placebos. A recent survey conducted by researchers at the Mayo Clinic asked physicians if it was permissible to give a dextrose tablet to a non-diabetic patient with fibromyalgia if that tablet was shown to be superior to no treatment in a clinical trial. In this case 62% of respondents said that it would be acceptable to give the pill.

The authors note:

“Before 1960, administration of inert substances to promote placebo effects or to satisfy patients’ expectations of receiving a prescribed treatment was commonplace in medical practice. With the development of effective pharmaceutical interventions and the increased emphasis on informed consent, the use of placebo treatments in clinical care has been widely criticized. Prescribing a placebo, it is claimed, involves deception and therefore violates patients’ autonomy and informed consent. Advocates of placebo treatments argue that promoting the placebo effect might be one of the most effective treatments available for many chronic conditions and can be accomplished without deception.”

How do you feel about placebos? Are they a legitimate option in some cases, or a violation of patient autonomy and informed consent?
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Posted in: Medical Ethics, Science and Medicine

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Acupuncture – Disconnected from Reality

The primary goal of science-based medicine (SBM) is to connect the practice of medicine to the best currently available science. This is similar to evidence-based medicine (EBM), although we quibble about the relative roles of evidence vs prior plausibility. In a recent survey 86% of Americans said they thought that science education was “absolutely essential” or “very important” to the healthcare system. So there seems to be general agreement that science is a good way to determine which treatments are safe and work and which ones are not safe or don’t work.

The need for SBM also stems from an understanding of human frailty – there are a host of psychological effects and intellectual pitfalls that tend to lead us to wrong conclusions.  Even the smartest and best-meaning among us can be lead astray by the failure to recognize a subtle error in logic or perception. In fact, coming to a reliable conclusion is hard work, and is always a work in progress.

There are also huge pressures at work that value things other than just the most effective healthcare. Industry, for example, is often motivated by profit. Institutions and health care providers may be motivated by the desire for prestige in addition to profits. Insurance companies are motivated by cost savings. Everyone is motivated by a desire to have the best health possible – we all want treatments that work safely, often more so than the desire to be logical or consistent. And often personal or institutional ideology comes into play – we want health care to validate our belief systems.

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Posted in: Acupuncture, Science and Medicine

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Shame on PBS!

I used to have a high opinion of PBS. They ran excellent programs like Nova and Masterpiece Theatre and I felt I could count on finding good programming when I tuned into my local PBS channel. No more.

It was bad enough when they started featuring Deepak Chopra, self-help programs, and “create your own reality” New Age philosophy, but at least it was obvious what those programs were about. What is really frightening is that now they are running programs for fringe medical claims and they are allowing viewers to believe that they are hearing cutting edge science.

Neurologist Robert Burton has written excellent articles for salon.com pointing out the questionable science presented by doctors Daniel Amen and Mark Hyman in their PBS programs. Please click on the links and read what he wrote. These programs are being shown during fundraising drives as if they were examples of the best PBS has to offer. (more…)

Posted in: Science and the Media

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