Archive for Politics and Regulation

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:

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.


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

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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.

Posted in: Politics and Regulation, Public Health, Science and the Media, Vaccines

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When Loud Wins: Will Your Tax Dollars Pay For Prayer?

Today the LA Times described a bizarre and troublesome healthcare reform bill provision that would require Medicare to pay for Christian Science Prayer as a medical treatment:

…a little-noticed provision in the healthcare overhaul bill would require insurers to consider covering Christian Science prayer treatments as medical expenses.

The provision was inserted by Sen. Orrin G. Hatch (R-Utah) with the support of Democratic Sens. John F. Kerry and the late Edward M. Kennedy, both of Massachusetts, home to the headquarters of the Church of Christ, Scientist.


Posted in: Faith Healing & Spirituality, Politics and Regulation, Science and the Media

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Join CFI in opposing funding mandates for quackery in health care reform

Not long ago, I wrote a post warning about how funding for non-science-based modalities and, indeed, modalities that are purely religion-based, have found their way into various versions of health care reform bills that are currently wending their way through both houses of Congress. In other words, purveyors of faith healing and purely religious woo are trying to do what purveyors of “alternative” medicine have already done through Senator Tom Harkin, and hijack the health care reform process to codify their preferred unscientific health care modalities as legitimate after science has rejected them.

Now, the Center for Inquiry has launched a campaign to inform and educate our legislators. You can participate by using its talking points (or paraphrasing them or voicing your own objections) to protest:

Congress is considering health care legislation that would in part mandate coverage of non-evidenced based medical treatments such as prayer and therapeutic touch. This would raise the cost of health care for all Americans and represent a violation of the principle of separation of church and state.

CFI continues:

The Center for Inquiry asks you to contact your Senators and Representative to voice your strong opposition to the proposal in the Heath Care bills that would mandate coverage of non evidence-based “alternative” medical treatments including spiritual and prayer based healing under the guise of nondiscrimination.

Talking Points

  • America needs a health care system that focuses on increasing the health of individuals and reducing the cost of coverage.
  • This type of health care system is not possible if insurers are required to pay for medical treatments with questionable at best results.
  • If Congress requires that insurers cover alternative treatments such as Christian Science prayer, therapeutic touch, or other non-evidence based medical procedures, the cost of health care for all Americans will go up. This runs counter to the goal that Congress has laid out: to make health care more affordable for all Americans. – If the final version of health care reform includes a public option, this mandate would also force the public insurance plan to cover these treatments. Because the public option is federally funded, the inclusion of the mandate would represent an egregious violation of the principle of separation of church and state.

I agree. It’s time to try to stop the insertion of faith-based quackery like Christian Science “prayer” treatments as reimbursable medical expenses in whatever health care reform bill(s) is/are passed by Congress. You can help by going here and writing to your Congressional representatives and Senators.

Posted in: Politics and Regulation, Religion

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Beware religious meddling in the latest version of health care reform

Every so often, as the health care reform initiative spearheaded by the Obama Administration wends its way through Congress (or, more precisely, wend their ways through Congress, given that there are multiple bills coming from multiple committees in both Houses), I’ve warned about various chicanery from woo-friendly legislators trying to legitimize by legislation where they’ve failed by science various “alternative” medicine practices. This began much earlier this year, when I pointed out how Senator Tom Harkin (D-IA) invited the Four Horsemen of the Woo-pocalypse to the Senate to testify. These included Dr. Andy Weil, Director, Arizona Center for Integrative Medicine, University of Arizona, Vail, AZ; Dr. Dean Ornish, Founder and President, Preventive Medicine Research Institute, Sausalito, CA; Dr. Mark Hyman, Founder and Medical Director, The UltraWellness Center, Lenox, MA; Dr. Mehmet C. Oz, Director, Cardiovascular Institute and Complementary Medicine Program, New York-Presbyterian Hospital, New York, NY. This occurred after Harkin had famously complained about the National Center for Complementary and Alternative Medicine, the Center in the NIH that he, more than anyone else, had created, because it had not validated enough quackery. (Yes, I know he didn’t use those words, but that was what he had done.) Most recently, Harkin tried to insert language that would mandate that the government and health insurers pay for quackery, as long as it was from licensed practitioners. Given that some states license naturopaths and even “homeopathic physicians,” such an amendment, if it stayed in place, would open the way for paying for all manner of nonscientific quackery.

However, there is another bit of chicanery that legislators are pulling, this time with the Senate version of the bill, that I have been made aware of by Rita Swan of CHILD and fellow SBM blogger Kimball Atwood. This time, the threat is religious, with Senators trying to insert measures into the health care reform initiatives that will pay for “religious” treatments, such as Christian Science prayer. Indeed, one of these, S.1679, entitled Affordable Health Choices Act requires the government or private party insurers to pay for faith-based therapies:

Posted in: Faith Healing & Spirituality, Politics and Regulation, Religion

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“Oh, come on, Superman!” (Part II): Bill Maher meets Kryptonite over vaccines and “Western medicine”

It’s rather amazing how sometimes the best laid plans of mice and men (and bloggers) come to naught. I had planned on doing a followup post to my previous post about the cancer quackery known as the German New Medicine by discussing a particularly nasty French variant of it. Unfortunately (or fortunately, depending upon your point of view), events conspired to move my blogging ire towards another target, particularly since I had addressed this isse before. Specifically, I’m talking about 2009 Recipient of the Richard Dawkins Award, comedian and HBO talk show host Bill Maher.

As you may recall, about a month ago, I wrote a rather long post (par for the course for me, I know) detailing ad nauseam how Bill Maher not only embraces germ theory denialism, anti-vaccine nonsense, and alternative medicine, in particular his apparent belief that “aggregate toxicity” or the typical unnamed “toxins” that alternative medicine mavens are so fond of blaming most disease on or, as Maher likes to call it, the “poisons” that we are eating and otherwise exposed to every day, but has been preaching this pseudoscience since at least 2005. Maher then followed this up a mere week before receiving his award named after a famous scientist with a hideously irrational promotion of cancer quackery. At that point, I thought I was done with the topic, at least as far as this particular blog goes (others know that elsewhere I’ve not been so quiet). At least, I had intended not to deal with this again on SBM.

Unfortunately, Bill Maher had other ideas. This is the perfect description for how I felt having to blog about this again:

Yes, it fits, particularly after Maher Tweeted to his fans:

If u get a swine flu shot ur an idiot.


Posted in: Politics and Regulation, Science and the Media, Vaccines

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Health Care Bills: More Mischief in Washington

Forgive the departure from my usual verbosity. I’m on my way to a meeting, and I don’t have the time. Today I’ll report disturbing content found in health care bills that are competing for passage in Washington. Thanks to Linda Rosa for keeping our attention on language in one of the Senate bills: S.1679 – Affordable Health Choices Act,” sponsored by (guess who?) Senator Tom Harkin (D-IA). According to Linda, Harkin and supporters will attempt to merge his bill with Baucus’s. Here are some of the choice passages in Harkin’s 800+ page bill (emphasis added):


A group health plan and a health insurance issuer offering group or individual health insurance coverage shall not discriminate with respect to participation under the plan or coverage against any health care provider who is acting within the scope of that provider’s license or certification under applicable State law. This section shall not require that a group health plan or health insurance issuer contract with any health care provider willing to abide by the terms and conditions for participation established by the plan or issuer. Nothing in this section shall be construed as preventing a group health plan, a health insurance issuer, or the Secretary from establishing varying reimbursement rates based on quality or performance measures.


…(4) ensure that the health team established by the entity includes an interdisciplinary, interprofessional team of health care providers, as determined by the Secretary; such team may include medical specialists, nurses, nutritionists, dieticians, social workers, behavioral and mental health providers (including substance use disorder prevention and treatment providers), doctors of chiropractic, licensed complementary and alternative medicine practitioners, and physicians’ assistants;

…(c) Requirements for Health Teams- A health team established pursuant to a grant under subsection (a) shall–

(1) establish contractual agreements with primary care providers to provide support services;

(2) support patient-centered medical homes, defined as mode of care that includes–

(A) personal physicians;

(B) whole person orientation;

…(F) provide coordination of the appropriate use of complementary and alternative (CAM) services to those who request such services;

…(H) provide local access to the continuum of health care services in the most appropriate setting, including access to individuals that implement the care plans of patients and coordinate care, such as integrative health care practitioners; (more…)

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

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Head-In-The-Sand Consumer Affairs

Editor’s Note: Please be aware that Ben is deployed in Iraq right now. What that means is that his Internet access is somewhat sporadic. He will show up from time to time to answer comments, however.

– To err is human, but to persist
diabolical –

Lucius Annaeus Seneca (c. 4 BC – 65 AD)

The California (CA) Department of Consumer Affairs (DCA) has an informational booklet on Acupuncture and Asian Medicine that besides depicting many New Age fantasies about prescientific medicine, also makes the unfounded claim that based on a 1997 consensus panel, the NIH formally “endorses” the use of acupuncture for a set of specific conditions, and that there is “clear evidence” that it is effective for some of them. This booklet is available at:

Wondering about this “clear evidence,”  I wrote a letter a few months ago to the National Center for Complementary and Alternative Medicine (NCCAM) and asked for a clarification.

Their candid response explicitly stated that the CA booklet “misstates the purpose of the 1997 consensus panel on acupuncture.” The NCCAM also added that as a “Federal research agency, the NIH does not endorse any product, service or treatment, nor are NIH consensus documents statements of policy.”

Posted in: Acupuncture, Politics and Regulation, Public Health, Science and Medicine

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Report a doctor’s dubious practices, go to jail?

Althought I and other SBM bloggers have criticized state medical boards for not doing enough to protect patients from physicians who practice pseudoscientific medicine and quackery, they do nonetheless serve a purpose. Moreover, critical to medical boards doing even the limited amount of enforcement that they do is the ability of health care providers or other citizens to submit anonymous complaints against physicians who are not practicing up to the standard of care or who may be in other ways taking advantage of patients. Unfortunately, the other day I found out via one of the that I frequent of a very disturbing case in Kermit, Texas. Two nurses who were dismayed and disturbed by a physician peddling all manner of herbal supplements reported him to the authorities. Now, they are facing jail:

In a stunning display of good ol’ boy idiocy and abuse of prosecutorial discretion, two West Texas nurses have been fired from their jobs and indicted with a third-degree felony carrying potential penalties of two-to-ten years’ imprisonment and a maximum fine of $10,000. Why? Because they exercised a basic tenet of the nurse’s Code of Ethics — the duty to advocate for the health and safety of their patients.

The nurses, in their 50s and both members of the American Nurses Association/Texas Nurses Association, reported concerns about a doctor practicing at Winkler County Memorial Hospital in Kermit. They were unamused by his improperly encouraging patients in the hospital emergency department and in the rural health clinic to buy his own herbal “medicines,” and they thought it improper for him to take hospital supplies to perform a procedure at a patient’s home rather than in the hospital. (The doctor did not succeed, as reportedly he was stopped by the hospital chief of staff.)

How can this be? This is how:

Posted in: Herbs & Supplements, Politics and Regulation, Public Health

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