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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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CFS: Viral vs somatization

On 10/08/09, the NIH and Science through press releases announced the following remarkable information:  Consortium of Researchers Discover Retroviral Link to Chronic Fatigue Syndrome (CFS.) From Science on line:

Scientists have discovered a potential retroviral link to chronic fatigue syndrome, known as CFS, a debilitating disease that affects millions of people in the United States. Researchers from the Whittemore Peterson Institute (WPI), located at the University of Nevada, Reno, the National Cancer Institute (NCI), part of the National Institutes of Health, and the Cleveland Clinic, report this finding online Oct. 8, 2009, issue of Science.

“We now have evidence that a retrovirus named XMRV is frequently present in the blood of patients with CFS. This discovery could be a major step in the discovery of vital treatment options for millions of patients,” said Judy Mikovits, Ph.D., director of research for WPI and leader of the team that discovered this association. Researchers cautioned however, that this finding shows there is an association between XMRV and CFS but does not prove that XMRV causes CFS.

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Posted in: History, Medical Academia, Neuroscience/Mental Health, Science and Medicine

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Infiltration of Quackademic Medicine into Mainstream: A pernicious influence

Editor’s note: Kausik Datta, Ph.D. is postdoctoral research fellow at the Johns Hopkins School of Medicine. He works in immunology, specifically as related to two major mycoses (Aspergillosis and Cryptococcosis). Rationality and skepticism have been his long-standing interests, which led him into science- and evidence-based medicine. This is his first contribution to this blog.

Quackademic ‘Medicine’* is a collective of pseudoscientific, data-free, evidence-less, nonsensical therapeutic modalities (the so-called “alternative” therapies) – otherwise known as “complementary and alternative” medicine (CAM) or integrative or holistic medicine. These include, among other things, chelation therapy (for autism and cardiovascular diseases); chiropractic; use of random nutritional supplements; abuse of various prescription drugs; coffee enemas; naturopathy; homeopathy; reiki; energy healing that invokes manipulation of ‘life force’ or qi; acupuncture; ‘healing touch’, and intercessory prayer – the list goes on, since there is essentially no limit to human stupidity and no depth that the human mind cannot plumb.

Qualified professionals – those who are in the business of doing the hard work of science to gather critical evidence regarding the action of a therapy, as well as those who implement those modalities routinely and save lives – may perhaps find it easy to dismiss the proponents of quackademic medicine as an ill-informed, misguided, or downright lunatic, fringe. However, much like a bad case of household mold infestation, this community with its myrmidons continues to thrive and grow, impervious to reason, immune to evidence, unable to comprehend the danger they pose (and the harm they cause) to themselves, their children and millions of others on the planet. As discussed in the science blog Respectful Insolence, a large part of that harm derives from their promotion of unfounded (and repeatedly proven to be untrue) fears of vaccines causing autism, discouraging a lot of parents from vaccinating their children and prompting many of them to seek quack treatments (some of which are potentially dangerous) to try to ‘cure’ autistic
children. But still another part – a far more pernicious and pervasive one – has to do with the growing presence (and, it seems, acceptance) of quackademic pseudoscience in establishments of mainstream academic medicine.
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Posted in: Medical Academia

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HIV/AIDS denialists do it too!

Remember my post from Monday about fake scientific conferences organized by the anti-vaccine movement that are designed to paint a picture of legitimate science being done, so much so that they even fool some academics into speaking there? (I realize that the server issues we had from Monday through Wednesday that rendered the site completely FUBAR may have prevented some of you from reading it.)

Well, it turns out that HIV/AIDS denialists do it too!

Why am I not surprised?

Posted in: Medical Academia, Science and Medicine, Science and the Media

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Crank “scientific” conferences: A parody of science-based medicine that can deceive even reputable scientists and institutions

If there’s one thing that purveyors of pseudoscientific medical modalities crave, probably above all else, it’s legitimacy. They want to be taken seriously as Real Scientists. Of course, my usual reaction to this desire is to point out that anyone can be take seriously as a real scientist if he is able to do science and that science actually shows that there is something to his claims. In other words, do his hypotheses make testable predictions, and does testing these predictions fail to falsify his hypotheses? That’s what it takes, but advocates of so-called “complementary and alternative medicine” (CAM) or “integrative medicine” (IM, or, as I like to refer to it: “integrating” quackery with scientific medicine) want their woo to be considered science without actually doing the hard work of science.

There are several strategies that pseudoscientists use to give their beliefs the appearance of science, a patina of “science-y” camouflage, if you will. One, of course, is the cooptation and corruption of the language of science, which has been a frequent topic on this blog, particularly in posts written by Drs. Atwood and Sampson. Another is to produce journals that appear to be science, but are anything but. I’ve discussed one example, the Journal of American Physicians and Surgeons and Medical Acupuncture, but others include Homeopathy, the Journal of Alternative and Complementary Medicine, and Medical Hypotheses, which recently was forced to retract a horrible paper by arch-HIV/AIDS denialist Peter Duesberg. What’s worse is that some of these journals are even published by what are considered major publishers, such as Mary Ann Liebert, Inc., and Elsevier.

There is, however, a third strategy. How do scientists communicate their findings to other scientists, as well as meeting and mingling with other scientists? Why, they hold scientific meetings, of course! These meetings can be small or even as large as the American Association for Cancer Research meeting, which is attended by around 15,000 cancer researchers each year. So, too, do cranks hold meetings. These meetings often have all the trappings of scientific meetings, with plenary sessions, smaller parallel sessions, poster sesssions, and an exhibition hall, complete with exhibits by sponsoring companies. Sometimes these meetings can even appear so much like the real thing that they take in legitimate researchers and legitimate universities. Here, I present two examples of such conferences.
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Posted in: Medical Academia, Public Health, Science and the Media, Vaccines

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“Gonzalez Regimen” for Cancer of the Pancreas: Even Worse than We Thought (Part II: Loose Ends)

Last week I discussed the dismal results of the “Gonzalez Trial” for cancer of the pancreas,* as reported in an article recently posted on the website of the Journal of Clinical Oncology. I promised that this week I’d discuss “troubling information, both stated and unstated [in the report],” and also some ethical issues. More has come to light in the past few days, including Nicholas Gonzalez’s own voluminous, angry response to the JCO article. I’ll comment upon that below, but first a brief review.

The trial was begun in 1999 under the auspices of Columbia University, after Rep. Dan Burton had pressured NCI Director Richard Klausner to fund it. It was originally conceived as a randomized, controlled trial comparing the “Gonzalez Regimen” to standard chemotherapy for cancer of the pancreas. In the first year, however, only 2 subjects had been accrued, purportedly because those seeking Gonzalez’s treatment were not willing to risk random assignment to the chemotherapy arm. In 2000, the protocol was changed to a “prospective, cohort study” to allow potential subjects to choose which treatment they would follow. Gonzalez himself was to provide the ‘enzyme’ treatments.

After that there was little public information about the trial for several years, other than a few determination letters from the Office of Human Research Protections and a frightening account of the experience of one subject treated by Gonzalez. By 2006 or so, those of us who pay attention to creeping pseudomedicine in the academy were wondering what had become of it. About a year ago we found out: the trial had been quietly “terminated” in 2005 after it met “pre-determined stopping criteria.” As explained here, that meant that the Gonzalez group had not fared well.

Four years after the trial’s ‘termination,’ the report was finally published: The Gonzalez cohort had not only fared much worse than the cohort that received chemotherapy, but it had fared worse than a comparable group of historical controls. Here, again, is the survival graph from the JCO paper:

Snapshot 2009-09-11 16-16-15

The Gonzalez group had also fared much worse in ‘quality of life’ scores, which included a measure of pain.

Now let’s read between the lines. Forgive me for taking shortcuts; I’m a little pressed for time. (more…)

Posted in: Clinical Trials, Health Fraud, Herbs & Supplements, Medical Academia, Medical Ethics, Science and Medicine, Science and the Media

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An open letter to Dr. J. Douglas Bremner

Peter Lipson wrote a post last week entitled Before You Trust That Blog…, which was a criticism of Dr. J. Douglas Bremner’s blog Before You Take That Pill. Dr. Bremner was not pleased, and posted a rebuttal entitled Response to Peter Lipson MD of “Science” Based Blogs, My Blog Does Not Suck, Yours Does. Given the kerfuffle and my role as managing editor of SBM, I felt the need to put my two cents in, which is why I’m posting this open letter to Dr. Bremner. This letter started as a much briefer response that I was going to e-mail to Dr. Bremner, but as I wrote it grew and grew to the point where I decided that, given the public nature of the disagreement between Dr. Lipson and Dr. Bremner, I might as well make my commentary public too. Consider it a bonus post from me. I still plan a post for my usual slot on Monday. In the meantime, here’s my open letter:
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Posted in: Medical Academia, Pharmaceuticals, Public Health, Science and the Media, Vaccines

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“Gonzalez Regimen” for Cancer of the Pancreas: Even Worse than We Thought (Part I: Results)

ResearchBlogging.org

Review

One of the more bizarre and unpleasant “CAM” claims, but one taken very seriously at the NIH, at Columbia University, and on Capitol Hill, is the cancer “detoxification” regimen advocated by Dr. Nicholas Gonzalez:

Patients receive pancreatic enzymes orally every 4 hours and at meals daily on days 1-16, followed by 5 days of rest. Patients receive magnesium citrate and Papaya Plus with the pancreatic enzymes. Additionally, patients receive nutritional supplementation with vitamins, minerals, trace elements, and animal glandular products 4 times per day on days 1-16, followed by 5 days of rest. Courses repeat every 21 days until death despite relapse. Patients consume a moderate vegetarian metabolizer diet during the course of therapy, which excludes red meat, poultry, and white sugar. Coffee enemas are performed twice a day, along with skin brushing daily, skin cleansing once a week with castor oil during the first 6 months of therapy, and a salt and soda bath each week. Patients also undergo a complete liver flush and a clean sweep and purge on a rotating basis each month during the 5 days of rest.

Veteran SBM readers will recall that in the spring of 2008 I posted a series of essays* about this regimen and about the trial that compared it to standard treatment for subjects with cancer of the pancreas. The NIH had funded the trial, to be conducted under the auspices of Columbia, after arm-twisting by Rep. Dan Burton [R-IN], a powerful champion of quackery, and much to the delight of the “Harkinites.”

In the fall of 2008 I posted an addendum based on a little-known determination letter that the Office for Human Research Protections (OHRP) had sent to Columbia during the previous June. The letter revealed that the trial had been terminated in October, 2005, due to “pre-determined stopping criteria.” This demonstrated that Gonzalez’s regimen must have been found to be substantially worse than the current standard of care for cancer of the pancreas, as ineffective as that standard may be. I urge readers who require a review or an introduction to the topic to read that posting, which also considered why no formal report of the trial had yet been made available.

Now, finally, the formal report has been published online by the Journal of Clinical Oncology (JCO):

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Posted in: Cancer, Clinical Trials, Health Fraud, Herbs & Supplements, Medical Academia, Medical Ethics, Politics and Regulation, Science and Medicine

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SBM in primary practice: one student’s experience

EDITOR’S NOTE: Dr. Jones is off this week; fortunately, we have this guest post by Tim Kreider, our science-based medical student. Enjoy!

My first clerkship of my third year of medical school was Family Medicine, and I had a great experience. After the first two years spent mostly with books and then a three-year interlude in a basic science lab, these past five weeks were my first extended foray into the world of patient care. I had a few lectures and seminars on campus, but most days were spent in a primary care office learning on the job. I was assigned to an office attached to a community hospital with a Family Medicine residency program, so I was able to work with both attending physicians and residents in training. I learned a lot and gained some much needed confidence regarding my clinical exam skills, which were rather rusty after grad school.

I have heard as a criticism of the SBM mission that practicing medicine “in the real world” is different from what evidence-obsessed, ivory tower dwellers think it should be. Therefore I approached my Family Medicine clerkship as my first chance to see the challenges and realities of practice outside the university setting. How would the practice of community-based physicians compare to the perhaps lofty ideals espoused by academics? (more…)

Posted in: Medical Academia, Science and Medicine

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