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Conflicts of interest in science-based medicine

The topic of conflicts of interest among medical researchers has recently bubbled up to the public consciousness more than usual. The catalyst for this most recent round of criticism by the press and navel-gazing by researchers is the investigation of Senator Charles Grassley (R-IA) of nine psychiatric researchers, one of which held $6 million in stock in a company formed to bring a drug for depression to market, but had allegedly concealed this, even though he was an investigator on an NIH grant to study the drug he was developing. From my perspective, there is more than a little politics going on in this story, given that for the last decade federal law, specifically the Bayh-Dole Act, and policy have actually encouraged investigators and universities to co-develop drugs and treatments with industry, but it does bring into focus the issue of conflicts of interest, in particular undisclosed conflicts of interest. There are two articles of note that recently appeared in the scientific literature discussing this issue, one in Science in July (about the Grassley investigation) and an editorial in the Journal of Psychiatry and Neuroscience by Simon N. Young, PhD, the Co-Editor-in-Chief of the journal and faculty at McGill University. I was more interested in the latter article because it takes a much braoder view of the issue. Science-based medicine (SBM) depends upon the integrity of the science being done to justify treatments; so it’s useful to discuss how conflicts of interest intersect medical research.

In most public discussions of conflicts of interest (COIs), Young notes, the primary focus is on payments by pharmaceutical companies to investigators. Make no mistake, this is a big issue, but COIs are not just payments from drug companies. Indeed, I’ve written about just such COIs that have arguably impacted patient care negatively right her on this very blog, for example seeding trials (in which clinical trials are designed by the marketing division of pharmaceutical companies), a case of fraud that appeared to have been motivated by COIs. What needs to be understood is that every single scientific and medical investigators have COIs of one sort or another, and many are not financial. That’s why I like Young’s introduction to what COIs are:
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Posted in: Clinical Trials, Medical Academia, Politics and Regulation, Vaccines

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The NCCAM Seeks Comments for its “Strategic Plan: 2010.” Part I

The National Center for Complementary and Alternative Medicine (NCCAM) has posted three essays about its latest “strategic planning process,” and has invited “stakeholders” to make comments. I have previously made my own opinions clear,* as have fellow bloggers Gorski, Novella, Lipson, and Sampson: the best strategic plan for the NCCAM would be to extinguish itself. Since politics makes that plan unlikely, there are strategies that could minimize the considerable harm now done by the Center, while possibly offering a modest benefit. In summary:

  • For both scientific and ethical reasons the NCCAM must dispense with trials of highly implausible claims. It should start by abandoning the ongoing Trial to Assess Chelation Therapy (TACT), its largest and most expensive trial yet, and one that has proven to place experimental subjects in considerable danger. It should publicly acknowledge such mistakes and explain why they must not be repeated—no matter how much political pressure there may be to do so.
  • The Center should use its website’s Health Information function to explain what’s known, rather than continue its customary practice of putting the best possible slant on most “CAM” claims, no matter how absurd or disproven.
  • The Center should address aspects of “CAM” advocacy that it has previously avoided, the most important being the close affiliation of such advocacy with the anti-vaccination (and autism quackery) movement. The NCCAM should consider itself an important source of rational information for a public that is currently, and dangerously, misled about immunizations. A related example of mischievous “CAM” advocacy, so far also ignored by the Center’s website, involves an imagined, sinister cartel of physicians, the AMA, pharmaceutical companies, and the FDA. The NCCAM should vigorously debunk such myths by providing facts and data.
  • The Center should pursue the question of why some people are stubbornly attracted to implausible, unproven, and/or inert treatments. Wally Sampson suggested this idea years ago. It is one of many legacies of the late Barry Beyerstein, among others, whose writings could serve as a template for legitimate NCCAM research topics.

The NCCAM’s Charter and its boosters in Congress make such strategies exceedingly unlikely, as explained here. Therefore, in this and two subsequent postings I’ll address a few of the assertions made in each of the Center’s three “big picture” essays. These will not be comprehensive critiques of those essays, which would require deconstructions of nearly every sentence.

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

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Talking Science With Patient Advocates

Laurie Edwards has a rare chronic disease called primary ciliary dyskinesia. Her symptoms are quite similar to those associated with cystic fibrosis, and her young life has been punctuated by numerous hospitalizations, physical limitations and the occasional near-death experience. She is a remarkably upbeat woman, and attributes her self confidence and optimistic outlook to her loving friends and family.

Laurie is part of the patient blogging community online. She reads physician blogs with interest, and wants to protect others like her from snake oil and misinformation. She recently interviewed me about my pro-science views for a new book that she’s writing. People like Laurie play a critical role in accurate health communication, and I welcome the chance to discuss science-based medicine with them. Here are some excerpts from our chat: (more…)

Posted in: Science and the Media

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“The mother is the factory”

Who said: “the mother is the factory, and by education and care she can be made more efficient in the art of motherhood”?

That was written in 1942 by Grantly Dick-Read, widely considered to be the father of modern natural childbirth. Most people don’t realize that natural childbirth was invented by a man to convince middle and upper class women that childbirth pain is in their minds, thereby encouraging them to have more children. Read’s central claim was that “primitive” women do not have pain in childbirth. In contrast, women of the upper classes were “overcivilized” and had been socialized to believe that childbirth is painful.

In Holistic obstetrics: the origins of “natural childbirth” in Britain, O Moscucci, PMJ 2003;79:168-173, Dr. Ornella Moscucci explains the backdrop against which the philosophy of “natural” childbirth was promulgated:

Health policy became the subject of intense public debate in the aftermath of the Boer war, when Britain’s near defeat at the hands of a barely trained army focused the attention on the physical fitness of new recruits… Adherents to the new science of eugenics on the other hand blamed heredity. In their view, health policy should aim to prevent reproduction among “low quality” human stock .., and encourage reproduction among “good” stock…

The development of “natural childbirth” owed much to the activities of physicians and health professionals who were in sympathy with the aims of reform eugenics…

[T]hese health reformers were concerned about the differential birth rate—the tendency of poorer, less healthy sections of society to have larger families than their “betters”. Thus, as well as endorsing plans for the sterilisation and detention of “degenerates”, they also sought to encourage the middle classes to have more children… Female education and employment were seen as a particular evil, insofar as they led women to regard motherhood a burden and to neglect hearth and home…

One obvious way to reverse the falling birth was to entice women of “superior stock” back into the home, where they would fulfill their functions as wives and mothers. Health reformers took up the challenge by developing an ideology of childbirth that emphasised the “naturalness” of pregnancy and birth. This ideology functioned at a number of levels. It was prescriptive, in that it rooted woman’s social role in her biological capacity for reproduction… Motherhood was not only a woman’s supreme fulfilment and reward, but also her civic duty…

Read himself stated:

“Woman fails when she ceases to desire the children for which she was primarily made. Her true emancipation lies in freedom to fulfil her biological purposes”..

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Posted in: Obstetrics & gynecology

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Closing the Door on Homeopathy

Homeopathy, as a cultural phenomenon, remains an enigma. In the two centuries since its invention it has failed to garner significant scientific support. In fact, developments in physics, chemistry, biology, and medicine have shown the underlying concepts of homeopathy to be wrong – guesswork and speculation that lept in the wrong direction.

It turns out, like does not cure like. This is nothing more than sympathetic magic – popular at the time but now considered nothing more than superstition without any scientific basis.

It also turns out that diluting a substance does not make it more potent – this nonsensical idea (ridiculed even in the 19th century) violates the laws of thermodynamics, and the chemical principle of mass action. This is especially true when you dilute a substance beyond the point where chance would have even a single molecule of active ingredient left behind. The background noise of chemicals in homeopathic water is orders of magnitude greater than the signal of whatever had previously been diluted in it.

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Posted in: Homeopathy

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The Mythbusters of Psychology

Karl Popper said “Science must begin with myths and with the criticism of myths.” Popular psychology is a prolific source of myths. It has produced widely held beliefs that “everyone knows are true” but that are contradicted by psychological research. A new book does an excellent job of mythbusting: 50 Great Myths of Popular Psychology: Shattering Widespread Misconceptions about Human Behavior by Scott O. Lilienfeld, Steven Jay Lynn, John Ruscio, and the late, great skeptic Barry L. Beyerstein.

I read a lot of psychology and skeptical literature, and I thought I knew a lot about false beliefs in psychology, but I wasn’t as savvy as I thought. Some of these myths I knew were myths, and the book reinforced my convictions with new evidence that I hadn’t seen; some I had questioned and I was glad to see my skepticism vindicated; but some myths I had swallowed whole and the book’s carefully presented evidence made me change my mind. (more…)

Posted in: Book & movie reviews, Neuroscience/Mental Health

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Pseudo-expertise versus science-based medicine

I am a skeptic.

My support for science-based medicine, as important as it is and as much time, sweat, and treasure I spend supporting it, is not the be-all and end-all of my skepticism, which derives from a scientific world view. That’s why, every so often, I like to step back from medicine a bit and look at the broader picture. It’s a good idea to do this from time to time, because to me, many of the topics that I and my fellow SBM bloggers write about are not just manifestations of anti-science and pseudoscience in medicine, but rather of a broader problem of anti-science and pseudoscience in society at large. I concentrate on medicine because it’s what I do and because manifestations of pseudoscience in medicine have the potential to harm or even kill large numbers of people.

Look no further than the anti-vaccine movement if you don’t believe me. Already, a mere decade after Andrew Wakefield’s lawyer-funded, incompetent, and perhaps even fraudulent “study” about a supposed relationship between the MMR vaccine and autism, uptake of MMR vaccines have plummeted throughout the U.K., with some areas of London reporting only 50% uptake, far too low for effective herd immunity. Thanks to J.B. Handley, Jenny McCarthy, Jim Carrey, and the know-nothing band of celebrities and activists, we are in serious danger of having the same sort of thing happen right here in the U.S. Indeed, Jenny McCarthy herself has even acknowledged that, although in her characteristically self-absorbed and vulgar manner, she refused to take responsibility for her part in this impending public health debacle, dismissing her role by saying, “I do believe sadly it’s going to take some diseases coming back to realize that we need to change and develop vaccines that are safe. If the vaccine companies are not listening to us, it’s their fucking fault that the diseases are coming back. They’re making a product that’s shit. If you give us a safe vaccine, we’ll use it. It shouldn’t be polio versus autism.” Meanwhile autistic children suffer from the quackery to which they are subjected in a futile attempt to “recover” them from “vaccine injury”-induced autism.

But it’s not just the anti-vaccine movement. It’s cancer quackery, promoted by “luminaries” such as Suzanne Somers and Bill Maher, given aid and comfort by doctors gone bad such as Dr. Rashid Buttar and Dr. Nicholas Gonzalez, “bioidentical hormone” woo promoted by the aforementioned Suzanne Somers and Dr. Christiane Northrup. It’s all manner of other faith-based and definitely non-science-based medicine so called “complementary and alternative medicine” (CAM, which is neither complementary nor medicine, although there is no doubt that it’s “alternative”) or “integrative medicine” (which “integrates” pseudoscience with effective medicine to the detriment of patients) finding its way into our academic medical schools, even to the point of being mandatory at at least one medical school and being a strongly touted option at many others. Meanwhile, the misbegotten behemoth of woo, funded by your tax dollars and mine, the National Center for Complementary and Alternative Medicine (NCCAM) promotes remedies based on a prescientific understanding of how the body works and what causes diseases, even going so far as to promote “integrative medicine” residencies. Meanwhile science-based medical students face a serious dilemma: Go with the flow or fight.
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Posted in: Politics and Regulation, Public Health, Science and the Media, Vaccines

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Yes, But. The Annotated Atlantic.

Reposted on 11/8 with multiple typo corrections.

The Atlantic recently published an article called “Does the Vaccine Matter?.” The quick answer is “yes”. If you want to know more, keep reading. They concluded, based on a narrow interpretation of a small subset of the data, that vaccines probably do not matter. The tone suggests that the vaccine is a vast boondoggle perpetuated on the American people by frightened doctors and greedy pharmaceutical companies. At least that is my take on the article, your mileage may vary. Lets look at that article, and its review of the influenza vaccine, and see whatthe authors  say, how they say it, and, perhaps more importantly, what they don’t say.

Unfortunately, I do not have a good story to tell with protagonists and antagonists and lone voices protesting the evil medical industrial complex. I don’t have a morality tale to tell, with good guys and bad guys. I have the medical literature, with its numbers and uncertainties and nuance. I also have patients I have to treat and have to apply the medical literature to as best I can.
This entry may be a bit of a repetition for those who read my previous entry on vaccine efficacy, but my entry hit the blogosphere a few days before the Atlantic article, so I did not get a chance to incorporate it into my entry. (more…)

Posted in: Science and the Media, Vaccines

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What’s the right C-section rate? Higher than you think.

Editor’s Note: Dr. Mark Crislip has been kidnapped by anti-vaccinationists. Fortunately, we have sent our black Illuminati, pharma-funded, vaccine-wielding helicopters to rescue him, but unfortunately, as a result of his trauma, his usual Friday post is likely to be delayed either until this afternoon or Saturday. In any case, fortunately for us our latest addition to the SBM crew, Dr. Tuteur, was willing to fill in on short notice; so here she is. Dr. Crislip will post by tomorrow. To whet your appetite for his patented sarcasm, let me just say that he will be having a little fun with a certain article from The Atlantic about flu vaccines. There, now doesn’t that make you want to check back tomorrow to find out what his take is on the article? I thought it would.

Buried in the midst of it new report, Monitoring emergency obstetric care; a handbook, the World Health Organization acknowledges what obstetricians have been saying for some time. The WHO’s goal of a 10-15% C-section rate lacks any empirical basis.

Earlier editions of this handbook set a minimum (5%) and a maximum (15%) acceptable level for caesarean section. Although WHO has recommended since 1985 that the rate not exceed 10–15%, there is no empirical evidence for an optimum percentage or range of percentages …

Of course, they’re not going to give up their recommendation simply because there is no science that supports it, insisting that “a growing body of research that shows a negative effect of high rates.”

Dr. Marsden Wagner, former head of the Perinatal Division of the WHO, appears to be responsible for the purported optimal C-section rate of 10-15%, the level at which both maternal and neonatal mortality rates are supposedly the lowest. Ironically, Dr. Wagner is a co-author of a recent study that actually demonstrates the opposite.
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Posted in: Obstetrics & gynecology, Science and Medicine

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The Tragic Death Toll of Homebirth

More than 10,000 American women each year choose planned homebirth with a homebirth midwife in the mistaken belief that it is a safe choice. In fact, homebirth with a homebirth midwife is the most dangerous form of planned birth in the US.

In 2003 the US standard birth certificate form was revised to include place of birth and attendant at birth. In both the 2003 and 2004 Linked Birth Infant Death Statistics, mention was made of this data, but it was not included in the reports. Now the CDC has made the entire dataset available for review and the statistics for homebirth are quite remarkable. Homebirth increases the risk of neonatal death to double or triple the neonatal death rate at hospital birth.

As this chart shows, the neonatal mortality rate for DEM (direct entry midwife, another name for homebirth midwife) assisted homebirth is almost double the neonatal mortality rate for hospital birth with an MD. This is all the more remarkable when you consider that the hospital group contains women of all risk levels, with all possible pregnancy complications, and all pre-existing medical conditions. An even better comparison would be with the neonatal mortality rates for CNM assisted hospital birth. The risk profile of CNM hospital patients is slightly higher than that of DEM patients, but CNMs do not care for high risk patients. Compared to CNM assisted hospital birth, DEM assisted homebirth has TRIPLE the neonatal mortality rate.
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Posted in: Obstetrics & gynecology

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