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Archive for Politics and Regulation

Autism’s false prophets revealed

appIn the brief time that Science-Based Medicine has existed, I’ve become known as the vaccine blogger of the group. True, Steve Novella sometimes posts about antivaccine pseudoscience and fear-mongering (unlike me, he’s even been directly attacked by David Kirby) and both Mark Crislip and Harriet Hall have each done one post about it, but, at least this far, hands down I’ve done more posts about the misinformation, pseudoscience, and outright quackery spread by antivaccine activists such as J. B. Handley’s Generation Rescue and his recently recruited empty-headed celebrity spokesperson Jenny McCarthy, not to mention a number of others who promote the resurgence of infectious disease by sowing doubts about the safety of the most effective weapon the mind of humans have ever devised against it. Truly, few uses of “alternative” medicine bother me as much as the antivaccine orientation of so much of the movement supporting it, a movement that has also led to all manner of “biomedical” treatments (quackery).

What you might not know is how I developed my interest in this particular area of dangerous pseudoscience. After all, I’m a cancer surgeon and an NIH-funded cancer investigator, not a pediatrician, immunologist, or neurologist. As hard as it is for me to believe, given that it seems today that I’ve always been refuting this nonsense, I only first discovered the antivaccine movement about three and a half years ago. True, I had been a regular on certain Usenet newsgroups for at least four or five years before that and had encountered antivaccinationists there before, but my contact with them online had been sporadic, and they seemed “out there” even in comparison to the usual run-of-the-mill alt-med maven. But then in the spring of 2005 I started to notice in a big way the cadre of pseudoscientists, parents of autistic children, and others who pushed the myth that thimerosal-containing vaccines or vaccines in general cause autism. Oddly enough, it started out with the Huffington Post, of all places. In May 2005, Arianna Huffington started a large group blog, chock full of famous pundits and celebrities writing blog posts. Within three weeks of its formation, I had noticed a very disturbing aspect of the Huffington Post, and that was that it appeared to be providing a major soapbox for antivaccinationists, including a post by Janet Grilo of Cure Autism Now, two posts by that propagandist of antivaccinationists David Kirby (with whom our fearless leader Steve Novella has managed to get into a bit of a tussle), and posts by that Santa Monica pediatrician to the children of the stars, Dr. Jay Gordon, a man who assiduously denies being “antivaccine” but parrots the most blatantly obvious talking points of the antivaccine movement and is currently best known as being the pediatrician for Jenny McCarthy’s son Evan. At the very least, Dr. Gordon is an apologist for the antivaccination movement, and he has become one of the “go-to” guys for the media looking for physicians who are “vaccine skeptics,” making numerous radio and TV appearances to promote his “skepticism.”

The next phase of my “awakening” to just how pervasive antivaccine fearmongering and pseudoscience were came when Robert F. Kennedy, Jr. wrote an incredibly dishonest and deceptive screed that got wide coverage in the summer of 2005. His article, called, charmingly enough, Deadly Immunity was a rehash of all the misinformation about thimerosal in vaccines and autism wrapped up with in a bow of conspiracy-mongering worthy of a 9/11 Truther with a penchant for quote-mining that would make a creationist blush. The article appeared simultaneously on Salon.com (which normally doesn’t publish such nonsense) and Rolling Stone, a magazine that really should stay away from science and stick to covering entertainment and politics. It was followed by a media blitz by RFK Jr. and antivaccine propagandist David Kirby, best known for his credulous treatment of the thimerosal/autism link, Evidence of Harm: Mercury in Vaccines and the Autism Epidemic: A Medical Controversy, published a few months before RFK, Jr.’s article, and his subsequent activities posting antivaccine nonsense on Huffington Post and, more recently, on the quackery-promoting antivaccine blog Age of Autism.

I’ve alluded to the fact before that I have quite a bit of blogging experience under another guise. Indeed, I’m sure many of the readers here know what that guise is. Suffice it to say that at the time I prefaced a post about RFK, Jr.’s article by saying that Salon.com had “flushed its credibility down the toilet” and referred to the article itself as the “the biggest, steamingest, drippiest turd Salon.com has ever published.” Clearly (and fortunately), I use much less–shall we say?–colorful language on this blog, but I bring this up so that the reader knows where I am coming from. Indeed, since that time in the summer of 2005, I’ve been wondering when scientists, public health officials, and physicians supporting science-based medicine would finally wake up and start to push back against this tide of antivaccine nonsense, which is starting to result in the resurgence of measles and other vaccine-preventable diseases. This year, I’ve seen some hopeful signs, including organizations like Voices for Vaccines and Every Child By Two, as well as other signs of push-back against the antivaccine movement, which, I hate to admit, has been clearly winning the P.R. war. What there hasn’t been yet is a book written from a scientific viewpoint that directly addresses the history of the recent resurgence of the antivaccine movement and refutes the pseudoscience that it promotes.

Until now, that is.
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Posted in: Book & movie reviews, Neuroscience/Mental Health, Politics and Regulation, Public Health, Vaccines

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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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