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Archive for Politics and Regulation

FDA approval of drugs and transparency in clinical trial results

ResearchBlogging.orgNote: The reason that I am posting today rather than my usual Monday slot is because the article I discuss here was embargoed until last night. Consequently, I asked Harriet if she would trade days with me this week, and she was kind enough to do so.

One thing that science relies on almost absolutely is transparency. Because one of the most important aspects of science is the testing of new results by other investigators to see if they hold up, the diligent recording of scientific results is critical, but even more important is the publication of results. Indeed, the most important peer review is not the peer review that occurs before publication. After all, that peer review usually consists of an editor and anywhere from one to four peer reviewers on average. Most articles that I have published were reviewed by two or three reviewers. No, the most important peer review is what occurs after a scientist’s results are published. Then, all interested scientists in the field who read the article can look for any weakness in methodology, data analysis, or interpretations. They can also attempt to replicate it, usually as a prelude to trying to build on it.

Arguably nowhere is this transparency quite as critical as in the world of clinical trials. The reason is that medications are approved on the basis of these trials; physicians choose treatments; and different medications become accepted as the standard of care. Physicians rely on these trials, as do regulatory bodies. Moreover, there is also the issue of publication bias. It is known that “positive” trials, trials in which the study medication or treatment is found to be either efficacious compared to a placebo or more efficacious than the older drug or treatment it is to replace, are more likely to be published. That is why, more and more, steps are being taken to assure that all clinical trial results are made publicly available. For example, federal law requires that all federally-funded clinical trials be registered at ClinicalTrials.gov at their inception, and peer-reviewed journals will not publish the results of a clinical trial if it hasn’t been registered there. Also, beginning September 27, 2008, the US Food and Drug Administration Amendments Act of 2007 (FDAAA) will require that clinical trials results be made publicly available on the Internet through an expanded “registry and results data bank,” described thusly. Under FDAAA, enrollment and outcomes data from trials of drugs, biologics, and devices (excluding phase I trials) must appear in an open repository associated with the trial’s registration, generally within a year of the trial’s completion, whether or not these results have been published. Although there are some practical issues over this law, for example determining how much information can be disseminated this way without constituting prior publication, which is normally a reason to disqualify a manuscript from publication.
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Posted in: Clinical Trials, Medical devices, Politics and Regulation, Science and Medicine

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Pitfalls in Regulating Physicians. Part 1

I had intended today’s posting to be a summary of a real case faced by a state medical board. It is a case of licensed physicians treating patients with a substandard, dangerous, and unequivocally illegal method. My intent was to use it as an illustration of how difficult it can be for medical boards to discipline such practitioners, even when the treatment involved is obviously, blatantly bad. Only yesterday, I was informed by the pertinent board that because this case has yet to be resolved, I may not discuss it. So be it: I’ll save the specifics for another time. Instead I’ll offer a general example of a dubious treatment as a prelude to Part 2 of this series,† which will attempt to discover some of the reasons that medical boards might, under such circumstances, be ineffectual.

Intravenous Hydrogen Peroxide

Hydrogen peroxide (H2O2) is a highly reactive compound that is caustic to living tissues. It spontaneously decomposes to water and oxygen, a reaction that is greatly accelerated in the presence of peroxidases (mainly catalase), which are ubiquitous in human blood and tissues. It has been used as a disinfectant for superficial skin wounds and in the mouth, and also for fabric and medical equipment. It has been used as a bleaching agent for teeth and hair. When used as an irrigant in surgical fields, in other large wounds, or consumed in any form (including intravenously), however, it has resulted in predictable, catastrophic complications: arterial and venous gas emboli, emphysema, respiratory arrest, strokes, multiple cerebral infarcts, seizures, colonic ulcers, intestinal gangrene, acute hemolytic crises, shock, cardiac arrest, and death.[1-7]

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Posted in: Health Fraud, Politics and Regulation, Science and Medicine

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Bisphenol A in Plastics – Should We Worry?

Bisphenol A (BPA) is a chemical used in the manufacture of hard plastics which can be found in a wide range of products, including baby bottles, plastic utensiles, and plastic food containers. It has been the focus of some controversy over its safety, and the resulting debate reveals much about how the current system deals with such issues.

The concern is that BPA can leech from plastic containers into the food or liquid it contains, and when consumed can have negative health effects. The debate is over how to interpret existing evidence about BPA safety, which gives conflicting results. Essentially it is a debate about how to weight different kinds of evidence, and where safety thresholds should be.

The Science of Toxins

Toxicity is always a function of dose. Anything is toxic at high enough dose, and safe at a low enough dose.  Regulatory agencies concerned with protecting the public health, therefore, typically use scientific evidence to establish doses that are likely to cause toxicity in humans and then set safe levels of exposure significantly below that level to create a buffer of safety. But what kind of evidence is used?

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Posted in: Politics and Regulation, Public Health

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Threats to science-based medicine: When clinical trials for new drugs are designed by the marketing division

ResearchBlogging.orgTHREATS TO SCIENCE-BASED MEDICINE

The theme of this blog is science-based medicine. It’s even the name given the blog by our fearless leader, Steve Novella. By “science-based” medicine we generally mean medicine that is both grounded in scientific plausibility based on our best understanding of human physiology and disease as well as in strong evidence from well-designed clinical trials, both of which are extremely important We SBM bloggers tend to concentrate mainly on so-called “alternative,” “complementary and alternative,” or “integrative” medicine because it does indeed represent a major threat to the consensus among medical professionals that medicine should be science- and evidence-based. Moreover, the infiltration of pseudoscientific and antiscientific woo into medical schools, academic medical centers, and medicine at large, coupled with large amounts of money going to promote CAM, both from the government and wealthy private foundations, does represent an extremely worrisome trend that makes all of us, who range from mid-career to retired physicians, fear for the future generation of physicians and their ability to apply science and critical thinking to the evaluation of implausible health claims, such as reiki, homeopathy, applied kinesiology, and the large variety of woo that falls under the rubric of CAM. Worse, this trend began not long after a concerted push to make medicine more science- and evidence-based and less dogma- and authority-based.

Unfortunately, though, the antiscience of implausible health claims is not the only threat that science-based medicine faces. We bloggers here at Science-Based Medicine concentrate on it because its resurgence and infiltration into the very heart of academic medicine represent a sea change in the culture of scientific medicine, which once rightly and without reservation rejected much of what CAM represents as quackery. Also, I can’t speak for others, but pseudoscience interests me; it brings up questions of why people believe irrational and clearly false propositions. That being said, at the risk of ruffling a few feathers among my co-bloggers, I have observed that, if there is one thing that this blog has not to this point emphasized sufficiently, it’s that the commerce of medicine, the very manner in which we develop new therapies, can, if not carefully observed and regulated, represent a threat to science-based medicine even more potent than Andrew Weil, David Katz, and their all-out assault on the very foundations of scientific medicine and drive to return medicine to the days of anecdote-based rather than science-based medicine.

I’m talking about pharmaceutical companies. I’m also about to destroy any opportunity I might ever have to work for or receive any funding from Merck & Company. C’est la vie. A skeptical doc’s got to do what a skeptical doc’s got to do. Not that I won’t at least partially protect myself by adding the disclaimer that the following represents my opinion, and my opinion alone. It does not represent the opinion of my university, cancer institute, or partners.

Now that that’s taken care of, let’s start with a little primer on a pernicious phenomenon known as the “seeding trial.”
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Posted in: Clinical Trials, Medical Ethics, Pharmaceuticals, Politics and Regulation

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Science, Reason, Ethics, and Modern Medicine, Part 5: Penultimate Words

My Discussion with Dr. P

After last week’s post, Dr. Peter Moran answered with more salient points. I’ll spend this week discussing those, because I share Dr. Moran’s “interest in examining the kind of messages we are putting out.” Acknowledging the inequality inherent in his not being the blog author, I’ll offer the last word to Dr. Moran by ending this series* and letting whatever comments he may have in response to today’s post be the last, at least for now.

Here is Dr. Moran’s response to my response:

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

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Politics of N of 1 pseudoscience

More Politics

Medicine’s ethics and basis in science hang by a thread at times. At least in the US of A. I will present a few examples and illustrate them with correlates from other fields in which decisions with wide effects are sometimes made by the whim of one person. And that’s not just the declaring of war or whatever we call it these days.Start with an anecdote of mine from the mid-1970s or so. I somehow got involved in a dispute with the staff of then Gov. Jerry Brown over his proposal to de-license medical practice. He sent out early holistic medicine vibes and viewed health and medicine as fields open to anyone to practice by simply hanging out a shingle. I asked to meet with my state assemblyman and complained about the situation. I stated that physicians determined what medical practice is. He smiled benevolently and broke the news. “No, doc, we (in state government) do.“

I immediately recognized what he was saying. All licensure is granted by the state, and all regulations and laws referring to each occupation’s license are determined essentially by a majority vote and a governor’s signature. All those heroes in the history of medicine and science not withstanding. It was an awakening.

Jerry Brown’s vision did not materialize and he came to recognize holistic and alternative medicines as so much goofy stuff and quackery, as he later confided at a fund-raiser (yes, I went.)

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

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Animal rights terrorists endanger science-based medicine

I’m a bit ticked off right now, enough that I thought I’d break with tradition and do an extra post today. Don’t worry; it’ll be brief. It will also be angry, more so than you are perhaps used to hearing on this blog. However, I think my anger is justified, and I hope that Steve Novella–and you–will understand. I view the problem that I am about to discuss to be at least as serious a threat to science-based medicine as any infiltration of woo into medical schools or residency programs.

Remember back in February, when I discussed how animal rights terrorists had been harassing a researcher at the University of California Santa Cruz (UCSC)? At the time, protesters attempted a home invasion of a researcher, leading to a police response where a home was searched by the police. This time around, however, these animal rights thugs have turned violent–again:

SANTA CRUZ — The FBI today is expected to take over the investigation of the Saturday morning firebombings of a car and of a Westside home belonging to two UC Santa Cruz biomedical researchers who conduct experiments on animals.

Santa Cruz police officials said Sunday the case will be handed to the FBI to investigate as domestic terrorism while local authorities explore additional security measures for the 13 UCSC researchers listed in a threatening animal-rights pamphlet found in a downtown coffee shop last week.

“The FBI has additional resources and intelligence into groups and individuals that might have the proclivity to carry out this kind of activity,” police Capt. Steve Clark said. “The FBI has a whole other toolbox of tools for this kind of investigation.”

The front porch of a faculty member’s home on Village Circle off High Street was hit with a firebomb about 5:40 a.m. Saturday, police said. The bomb ignited the front door of the home and filled the house with smoke, police said. About the same time, a Volvo station wagon parked in a faculty member’s on-campus driveway on Dickens Way was destroyed by a firebomb, police said.

Clark described the bombs as devices, which he said investigators have seen used by animals rights activists in the past, as “Molotov cocktail on steroids.”

That no one was seriously injured or died, especially the researcher’s children, is incredibly fortunate. As in previous cases, these two firebombing attacks were the culmination of a campaign of intimidation:

This appears to be the latest in a string of incidents targeting UCSC researchers and others in Santa Cruz.

Fliers identifying 13 UCSC scientists, some of whom use mice, fruit flies and other nonprimate creatures in their research, were discovered at a downtown coffee shop Tuesday. The fliers say, “Animal abusers everywhere beware; we know where you live; we know where you work; we will never back down until you end your abuse.” The names, home addresses, home phone numbers and photos of researchers were published on the fliers.

Fruit flies? Drosophila? How messed up do you have to be to threaten violence over Drosophila experiments? Why aren’t they threatening violence over the trillions upon trillions of E. coli or yeast that die in the name of science in molecular biology labs every day?
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Posted in: Basic Science, Medical Academia, Politics and Regulation, Science and Medicine

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HPV vaccination misinformation and bias in Medscape

Like many physicians, I often peruse Medscape. It’s generally been a convenient and quick way to catch up on what’s going on in my field not directly related to my research, for which I tend to rely on pre-configured RSS feeds for PubMed searches to highlight any articles related to my areas of interest. Since these searches routinely flag hundreds of articles a week whose titles and abstracts I end up perusing, sometimes only cursorily to identify the articles I might want to read, it is impractical for me to rely on this approach for areas that are even only a bit out of my field. That’s where, at least so I thought, services like Medscape came in handy. I could look over stories and quickly find out about research and medical of interest to me, only occasionally needing to look up the actual journal articles. Like a fair number of physicians, I rely on it fairly regularly. I should also point out that Medscape sometimes even tries to go against the tide of woo, as it did when it published an article by authored by two of my co-bloggers, along with two others. The article, authored by Kimball C. Atwood IV, MD; Elizabeth Woeckner, AB, MA; Robert S. Baratz, MD, DDS, PhD; and Wallace I. Sampson, MD, entitled Why the NIH Trial to Assess Chelation Therapy (TACT) Should Be Abandoned, was a tour de force deconstruction of why TACT is bad science and unethical to boot.

So how to explain an article published in Medscape last week and authored by Alison Gandey entitled HPV Vaccine Adverse Events Worrisome Says Key Investigator?
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Posted in: Politics and Regulation, Public Health, Science and the Media, Vaccines

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Parody beats political analysis

When out of town this past week I was bereft of tantalizing subjects, with our 5 other bloggers covering so many topics so well. I was about to toss in an empty towel, when two news absurdities fell into my driveway in the pages of the SF Chronicle. One was this morning’s (7/23) report that one Dragan Dabic, an alternative medicine healer had been captured in Belgrade, Serbia. He was Radovan Karadzic, former Serbian Prime Minister and acknowledged immediate archtect of the 1990s massacres of Bosnia-Herzagovena Muslims. Like Saddam Hussein, he had been a fugitive for years, and was found in an unusual place in an unusual disguise. What more need be said about this former psychiatrist and presumed war crimes mass murderer changing occupations in midlife to alternative healing? Complete with full beard and pony tail, yet. Does this give some clue to some personality types that drift toward junk medicine? One could say the disguise was intentional and had nothing to do with personality. Perhaps. Perhaps. But the situation reinforces my theory that most “CAM”mers are at least intellectual psychopaths – renegades from reason. The picture of Karadzic brings to mind pictures of others with full beards and hidden finger salutes to reason and authority.

The second absurdity was in a recent cartoon subtitled, “The lies behind the truth and the truth behind those lies that lie behind that truth…” So reads the title explanation for Don Asmussen’s “Bad Reporter” comic in the SF Chronicle.

Asmussen parodies headlines by combining them absurdly with commentaries that “explain” the absurd headlines with even more absurd hypothetical events. In these days of absurd happenings, I find Asmussen the right stuff remedy for us perplexed realists who “…cannot believe this is happening.” My mental health now depends on Asmussen and nighttime doses of Phil Hendrie Show. Nothing like satire to put into perspective interest in “alternative medicine” and qualifications and characteristics of presidential candidates.

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

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Resistance is futile? Hell, no! (A call to arms)

Well, I won’t back down
No, I won’t back down
You can stand me up at the gates of hell
But I won’t back down

Gonna stand my ground
Won’t be turned around
And I’ll keep this world from draggin’ me down
Gonna stand my ground
And I won’t back down

From “I Won’t Back Down” by Tom Petty, 1989

This week, in a little bit of a departure, I have a minor bone to pick with our fearless leader and his podcast partner in crime Rebecca Watson (a.k.a. the Skepchick), who both managed to annoy me a bit the other day. (Don’t worry, Steve and Rebecca, I still love you guys…)

I’ll explain. You see, I had originally had a much different topic in mind for this week. Indeed, I even had my post mostly written by Saturday morning, when I had to take care of some mundane personal business, namely getting an oil change and some minor work done on my car. Since I need my car to commute to work and the maintenance needed was relatively minor, I decided to wait for the work to be done. As is my wont when sitting in waiting rooms with nothing much else to do, I decided to plug my earphones into my iPhone and catch up on some podcasts. Since the dealer also had free wifi, I brought my laptop along as well, the better to finish up my originally intended post.

The first thing I realized as I perused the list of unlistened-to podcasts was that I had fallen far behind in listening to one of my favorite podcasts, The Skeptics’ Guide to the Universe. To begin catching up, I decided to start with what was at the time the most recently available episode, specifically the July 9 podcast, figuring I could work my way back to through the earlier ones and thereby catch up with at least two episodes before my car was ready. In the second segment (beginning around 14:31 minutes into the podcast), Steve Novella and crew discussed a bit the recent news that the National Institute of Mental Health was trying to resurrect a dubious and highly unethical clinical trial proposed to test chelation therapy as a treatment for autism, referencing his excellent post on this very blog about why the trial is scientifically dubious (at best) and totally unethical. So far, so good.

Then the conversation veered into another area that I agree with, namely the utter uselessness of National Center for Complementary and Alternative Medicine (NCCAM) and how its main purpose is more proselytization for “alternative” and “complementary” medicine than actual rigorous scientific research, as I pointed out before in one of my earliest posts for SBM. As Steve pointed out that, for all the hundreds of millions of dollars spent by NCCAM, not a single new medicine or treatment has been added to the armamentarium of modern medicine, nor, even more importantly, have CAM practitioners abandoned a single bit of unscientific medicine due to any of the negative studies. Indeed, their enthusiasm hasn’t been dampened in the least. This line of discussion led to the question of whether we, as skeptics and advocates of science- and evidence-based medicine need to rethink and refocus our efforts.
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Posted in: Medical Academia, Politics and Regulation, Science and Medicine, Science and the Media

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