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Archive for Medical Academia

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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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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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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Science-Based Medicine Conference

My colleagues and I will be holding a Science-Based Medicine conference on Thursday, July 9th. This is an all-day conference covering topics of science and medicine. The conference is designed for both a professional and general audience.

The conference will be at the Southpoint Casino and Hotel in Las Vegas, Nevada. It is also part of The Amazing Meeting 7 (TAM7) which is run by the James Randi Educational Foundation (JREF). You can register for the conference either separately or packaged with TAM7.  You can register for both here.

Physicians can earn 6 hours of category 1 CME credits for attending the conference.

Below is the list of speakers and the titles of their talks, and below that is the bio for each speaker.

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Posted in: Medical Academia, 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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Fakin’ it

Last week the Times of London revealed inside information from the General Medical Council (UK, responsible for physician licensing) of an ongoing investigation of Dr. Andrew Wakefield and from its own investigation. This revelation recalled other instances of fakery from reports of sectarian medicine (“CAM”) successes. The Medical Council information contained evidence that the data from the now famous Wakefield cases used to claim an association of the MMR vaccine with childhood autism and inflammatory bowel disease were misinterpreted, altered, and to some extent, faked. The report and history were reviewed by David Gorski last week. In eight of twelve cases, the dates of autism onset were “rearranged” to fit the needed time association, and many small bowel biopsies were “reinterpreted” to show inflammation.

The Wakefield claims were long suspected by reputable medical scientists and skeptics  as being erroneous or fraudulent.  Note: the Council hearings are still in progress, and the Times report is subject to legal complaint.  The original details can also be seen in the Times articles.

This expose’ adds to a growing list of reports with erroneous and faked information in medical journals used either for economic reward, undeserved fame, or to promote ideological claims for medical sects and cults. Although history of erroneous or false claims goes back hundreds of years, the altering or synthesizing of data passing the recently conceived peer review system is new,  illuminating defects in the journal peer review and editing system.

If journals were invented in the 18th century, and operated like journals of today, Mesmer’s demonstrations might have been published, and the Ben Franklin and Antoine Lavoisier and French Academy’s disproof might have been rejected. (Laughter here.) But journals continue to make major goofs in publishing implausible results despite the popularity of a famous specialty journal for that purpose.

Examples vary from acceptance of language manipulation – “alternative,” “healing,” “integrative,” etc., to the fakery of recent papers showing effects of prayer. The two famous studies of prayer in the cardiac care unit ranged from the unadmitted breaking of the blind in the Bird study (So Med J 1988; 81:826-826) to unadmitted imbalances of subject and control groups (Harris, Arch Int Med 1999;159:2273-2278.) And from those to the likely fakery of the distant prayer study of in vitro fertilization (Cha, Wirth, Lobo; J Reprod Med 2001:46;781-786) in which three separate prayer groups on two continents improved pregnancy rates in a group of women on a third continent by an implausible 100 percent. In all of these cases, the papers passed peer or editorial review despite the methodological defects that were picked up by us skeptics (K. Atwood, K.Courcey [an RN] B. Flamm, and others.)

Adding insult to the above, Annals of Internal Medicine published a systematic review of intercessory prayer (Astin et al, Ann Int Med, 2000;132: 903-910) containing not only the Bird and Harris studies counted as positive, but also the Targ study on brain tumors, found by reporter Po Bronson to have had its end point altered by the authors when the primary one showed no effect.
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Posted in: Basic Science, Clinical Trials, Faith Healing & Spirituality, General, Health Fraud, Medical Academia, Science and Medicine, Vaccines

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Yes We Can! We Can Abolish the NCCAM! Part III

A Reminder…

…of why we keep harping on this. A couple of days ago The Scientist reported that the “economic stimulus package” may include a windfall for the NIH:

Senate OKs big NIH bump

Posted by Bob Grant

[Entry posted at 4th February 2009 04:12 PM GMT]

The US Senate, which is furiously debating the details of the economic stimulus package making its way through Congress, passed an amendment yesterday (Feb. 3) to add $6.5 billion in National Institutes of Health funding on top of the $3.5 billion already allotted to the agency in the bill…

Exactly how an NIH funding increase will be spent remains to be determined.

You can bet that if this happens, the NCCAM will be licking its chops for some of that lettuce. Let’s continue to explore why it shouldn’t get any…

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

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Some Good News on the Academic Front

There is a recent trend in UK Universities to close programs offering science degrees for various forms of so-called alternative medicine (CAM), such as homeopathy, crystal healing, and traditional Chinese medicine. This occurs amid growing scientific criticism of these programs.

This is a very good thing, and something I would like to see replicated in the US. The scientific community is appropriately concerned about such programs for a number of reasons. We have also been highly critical of them here at SBM – for example take a look as Wallace Sampson’s excellent analysis of academic medicine here and here, and David Gorski’s summary of Medical Academic Woo here.

Academic institutions have an implied contract with society – they are given resources (donations, scholarships), power (the ability to grant recognized degrees), and respect (the institutions and their members are often given the assumption of credibility and knowledge), and in exchange they agree to follow a code of professional ethics.  This contract is similar to many professions, like physicians or lawyers.

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Posted in: Medical Academia

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Dismantling NCCAM: A How-To Primer

Two of the earliest posts I wrote for Science-Based Medicine were entitled The infiltration of complementary and alternative medicine (CAM) and “integrative medicine” into academia and The National Center for Complementary and Alternative Medicine (NCCAM): Your tax dollars hard at work. Both were intended as a lament over how not only is pseudoscientific quackery, much of it based on a prescientific understanding of how the human body works and disease occurs, finding its way into some of the most prestigious academic medical centers in the U.S. (for example, Georgetown and Beth Israel) but it’s even finding its way into the heart of the U.S. military.

Worse, aiding and abetting this infiltration is the federal government itself in the form of NCCAM. As I discussed in my usual excruciating detail in my original post and as Steve Novella, Kimball Atwood, and I have subsequently discussed many times on this very blog, particularly recently (so much so that I’m thinking of giving NCCAM its very own category here on SBM), NCCAM not only funds studies of dubious “alternative” therapies, such as reiki and homeopathy, that estimates of prior probability alone would argue to be so close to impossible as to be not worth spending millions, much less thousands, of dollars upon, but it also promotes quackery by funding “fellowships” at various institutions to teach “complementary and alterantive medicine” (CAM) sometimes also called “integrative medicine” (IM). Given that it spends over $120 million a year on mostly dubious studies and CAM promotion, we all have called for NCCAM to be defunded and disbanded.

Nearly a year has passed since I wrote those two posts. Ironically enough, at the time I wrote my first post about NCCAM for this blog, I pointed out that at first I had disagreed with my co-blogger Wally Sampson and his call to “defund” the NCCAM in an article published on Quackwatch nearly five years ago. My original reason was that I thought that there was value in studying these therapies to find out once and for all whether these therapies do anything greater than placebo or not. I now admit that I was very naive, and this was how I admitted it:

Two developments over the last several years have led me to sour on NCCAM and move towards an opinion more like Dr. Sampson’s. First, after its doubling from FY 1998-2003, the NIH budget stopped growing. In fact, adjusting for inflation, the NIH budget is now contracting. NCCAM’s yearly budget remains in the range of $121 million a year, for well over $1 billion spent since its inception as the Office of Alternative Medicine in 1993. Its yearly budget contains enough money to fund around 75 to 100 new five year R01 grants, give or take. In tight budgetary times my view is that it is a grossly irresponsible use of taxpayer money not to prioritize funding for projects that have hypotheses behind them that have a reasonable chance of being true. Scarce NIH funds should not be for projects that have as their basis hypotheses that are outlandishly implausible from a scientific standpoint. Second, I’ve seen over the last few years how NCCAM is not only funding research (most of which is of the sort that wouldn’t stand a chance in a study section from other Institutes or Centers)) but it’s funding training programs. Indeed, that was the core complaint against NCCAM: that it facilitates and promotes the infiltration of nonscience- and nonevidence-based treatments falling under the rubric of so-called “complementary and alternative” or “integrative” medicine into academic medicine.

Nothing has changed since I wrote those words–except for one thing. We now have a new President who stated in his inaugural address:

We will restore science to its rightful place, and wield technology’s wonders to raise health care’s quality and lower its cost. We will harness the sun and the winds and the soil to fuel our cars and run our factories. And we will transform our schools and colleges and universities to meet the demands of a new age. All this we can do. And all this we will do.

As Kimball Atwood put it, Yes We Can! We Can Abolish the NCCAM! The big and as yet unasked (and unanswered) question is: How? Neither defunding nor dismantling NCCAM will be easy, and we have to think about how to preserve the functions of NCCAM that might be worth saving.
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Posted in: Medical Academia, Politics and Regulation, Public Health, Science and Medicine

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Yes We Can! We Can Abolish the NCCAM!

…and in so doing, President Obama, you and we would abolish the NIH’s second most prodigious squanderer of precious research funds! Surprise: The National Cancer Institute (NCI) spends slightly more on humbug than does the Center created for that purpose. All told, the NIH squanders almost 1/3 of a billion dollars per year promoting pseudoscience.

I’ve decided to add my two cents to the recent groundswell of demand to stop this sordid and embarrassing chapter in NIH history—even more sordid and embarrassing, in its way, than NIH researchers being on the take: pseudoscience is exactly antithetical to the mission of the NIH, which sponsors it repeatedly, officially, overtly, unethically, and dangerously. At least, in the case of Big Pharma greasing the palms of NIH researchers, those involved generally prefer to obscure the transactions, as good sense and traditional mores dictate.

My comments will be somewhat different from others’, not because I disagree with theirs but because it’s worthwhile to stress points that have not been stressed or even mentioned. I won’t bother to justify the assertion that “promoting pseudoscience” is an accurate description of what the NCCAM and the OCCAM do, because I’ve done that several times in the past, beginning here and here, and more recently here. I will plagiarize myself a bit, but only to introduce certain points.

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

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