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Is there a role for speculative journals like Medical Hypotheses in the scientific literature?

The core information supporting science-based medicine resides in the scientific literature. There, scientists and physicians publish the results of experiments and clinical trials that seek to understand the biological mechanisms by which the human body functions and through which disease forms and to apply this understanding to test new treatments for diease. Consequently, the quality and integrity of the biomedical literature are topics of utmost importance to supporters of science-based medicine. We’ve discussed problems with the scientific literature before here, ranging from how pseudoscientific “complementary and alternative medicine” journals have insinuated themselves into the medical literature and how drug companies have managed exercise undue influence over clinical trials and journals.

One question that perhaps we have not dealt with so much is the question of the very nature of a good scientific journal, particularly what is suitable material for such a journal. For purposes of this discussion, I will focus mainly on the biomedical literature, which spans a range from basic science journals dealing with biomedical science to clinical journals, which mainly report the results of clinical trials and clinical research. Of these journals, there are in general two types, journals that primarily report original research and those that present reviews of existing research. Most journals do a mix of the two, the majority tending towards a form where most of the articles are reports of orginal research mixed in with a much smaller number of review articles.

There is one journal, however, that is different. It is a journal known as Medical Hypotheses. It is a journal that (or so it claims) exists to present radical scientific ideas, the more radical the better. Here is how the journal is described on its website:
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Posted in: Medical Academia, Science and Medicine, Science and the Media

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The fall of Andrew Wakefield

I must admit, I never saw it coming.

At least, I never saw it coming this fast and this dramatically. After all, this is a saga that has been going on for twelve solid years now, and it’s an investigation that has been going on at least since 2004. Yes, I’m referring to that (possibly former) hero of the anti-vaccine movement, the man who is arguably the most responsible for suffering and death due to the resurgence of measles in the U.K. because of his role in frightening parents about the MMR vaccine.

I’m referring to the fall of Andrew Wakefield
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Posted in: Medical Ethics, Neuroscience/Mental Health, Vaccines

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The Winkler County nurse case and the problem of physician accountability

A MISCARRIAGE OF JUSTICE THAT HAD A (SORT OF) HAPPY ENDING

Back in September and then again last week, I wrote briefly (for me) about an incident that I considered to be a true miscarriage of justice, namely the prosecution of two nurses for having reported the dubious and substandard medical practices of a physician on the staff of Winkler County Hospital in Kermit, Texas. The physician’s name is Dr. Rolando Arafiles, and he happened to be a friend of the Winkler County Sheriff, Robert Roberts, who also happened to have been a patient of Dr. Arafiles and very grateful to him for having saved his life. The nurses, Anne Mitchell and Vickilyn Galle, were longtime employees of Winkler County Hospital, a fifteen bed hospital in rural West Texas. Although some of you may have seen extensive blogging about this before, I thought it very important to discuss some of the issues involved on this blog. Moreover, there is an aspect to this case that the mainstream media reporting on it has missed almost completely, as you will see. Finally, this case showed me something very ugly about my profession, not just because a doctor tried to destroy the lives of two good nurses through his connections to the good ol’ boy network in Winkler County

Let’s recap what happened, a story that reached its climax last Thursday. In 2008, Dr. Arafiles joined the staff of Winkler County Hospital (WCH). It did not take too long for it to become apparent that there were serious problems with this particular doctor. Mitchell and Galle, who worked in quality assurance were dismayed to learn that Dr. Arafiles would abuse his position to try to sell various herbal remedies to patients in the WCH emergency room and the county health clinic and to take supplies from the hospital to perform procedures at a patient’s home rather than in the hospital. No, it wasn’t the fact that Dr. Arafiles recommended supplements and various other “alt-med” remedies, it’s that he recommended supplements and various other “alt-med” remedies that he sold from his own business–a definite no-no both ethically and, in many states, legally. Mitchell reported her concerns to the administration of WCH, which did pretty much absolutely nothing. Consequently, on April 7, 2009, Mitchell and Galle anonymously reported their concerns to the Texas Medical Board (TMB). In June, WCH fired the two nurses without explanation.
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Posted in: Health Fraud, Homeopathy, Politics and Regulation, Science and the Media, Vaccines

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The anti-vaccine movement strikes back against Dr. Paul Offit

In my five years in the blogosphere, two years blogging for SBM, and over a decade in Internet discussion forums about medicine and “alternative” medicine, I’ve learned a few things. One thing that I’ve learned is that one of the biggest differences between those whose world view is based on science and who therefore promote science-based medicine and those promoting pseudoscience, quackery, and anti-science is that science inculcates in its adherents a culture of free, open, and vigorous debate. Indeed, to outsiders, this debate can seem (and sometimes is) vicious. In other words, if you’re going to be a scientist, you need to have a thick skin because you will have to defend your hypotheses and conclusions, sometimes against some very hostile other scientists. That same attitude of a Darwinian struggle between scientific ideas, with only those best supported by evidence and with the most explanatory power surviving, is a world view that those not steeped in science have a hard time understanding.

Among those who don’t understand science, few have a harder time with the rough-and-tumble debate over evidence and science that routinely goes on among scientists than those advocating pseudoscience. Indeed, in marked contrast to scientists, they tend to cultivate cultures of the echo chamber. Examples abound and include discussion forums devoted to “alternative” medicine like CureZone, where never is heard a discouraging word — because anyone expressing too much skepticism about the prevailing view on such forums invariably finds himself first shunned by other members of the discussion forums and then, if he persists, booted from the forum by the moderators. In marked contrast, on skeptical forums, most of the time almost anything goes. True, the occasional supporter of woo who finds his way onto a skeptical forum will face a lot of criticism, some of it brutal. However, rarely will such a person be banned, unless he commits offenses unrelated to his questioning of scientific dogma, such as insulting or abusive behavior towards other forum participants or trolling. Such people may annoy the heck out of us skeptics sometimes, but on the other hand, they do actually from time to time challenge us to defend our science and prevent us from becoming too complacent. Indeed, that’s what I like about skeptics and being a scientist. Nothing or no one is sacred.
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Posted in: Chiropractic, Politics and Regulation, Public Health, Vaccines

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The “pharma shill” gambit

Editor’s note: Since I happen to be on vacation (sort of–in reality I plan on spending most of next week holed up in my Sanctum Sanctorum at home writing a grant that’s due in February) and because readership tends to be down during the week between Christmas and New Years’ Day, I thought I’d resurrect something from well over three years ago and revise it to fit this particular blog. In doing so, I hope to provide you with something amusing to read, as well as something to link to time and time again whenever you want to refer to a particular gambit beloved by promoters of quackery and pseudoscience. I present here….The “Pharma Shill” Gambit! Enjoy!

I’ve mentioned before on this blog at least once that I cut my skeptical teeth, so to speak, on Usenet, that vast untamed and largely unmoderated territory full of tens of thousands of discussion newsgroups which used to be a lot more active before the rise of the World Wide Web and then later blogs. These days, few ISPs even offer much in the way of Usenet access; it’s become pretty much irrelevant since Google archived Usenet in the form of Google Groups. My forays into skepticism started out with combatting Holocaust denial on a newsgroup known as alt.revisionism (as good an excuse as any to remind you that nearly all Holocaust “revisionism” isn’t historical revisionism but is actually denial) and then branched out into more general skepticism, particularly about the claims of creationists and, of course, promoters of “alternative” medicine, the latter of which ultimately led me to being the editor of this wild and woolly thing we call the Science-Based Medicine blog. After I began to participate in the debates in the main newsgroup where alternative medicine is discussed, misc.health.alternative, it didn’t take me long to encounter a favorite tactic of promoters of alt-med who were not happy with one who insists on evidence-based medicine and who therefore questions claims that are obviously not based in valid science: The “Pharma Shill” Gambit. This is a technique of ad hominem attack in which a defender of “alternative” medicine, offended by your questioning of, for instance, his/her favorite herb, colon or liver flush technique, zapper, or cancer “cure,” tries to “poison the well” by implying or outright stating you must be in the pay of a pharmaceutical company, hired for nefarious purposes.

Since I entered the blogosphere several years ago under another guise, I’ve only occasionally checked back at my old stomping ground, mainly because blogging is so much less constraining than posting to Usenet, where mostly I used to respond to the posts of others, rather than writing about what I wanted to write about. A while back, though, out of curiosity I checked back and found this interesting little tidbit from a poster calling himself PeterB that demonstrated such a perfect example of the “pharma shill” gambit that I thought it might serve as a perfect example of the sort of thing I’ve had to put up with ever since I started speaking out against quackery:
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Posted in: Humor, Science and Medicine, Science and the Media, Vaccines

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Yet another nail in the coffin of the myth that the MMR vaccine causes autism

Arguably, the genesis of the most recent iteration of the anti-vaccine movement dates back to 1998, when a remarkably incompetent researcher named Andrew Wakefield published a trial lawyer-funded “study” in the Lancet that purported to find a link between “autistic enterocolitis” and measles vaccination with the measles-mumps-rubella (MMR) trivalent vaccine. In the wake of that publication was born a scare over the MMR that persists to this day, 11 years later. Although peer reviewers forced the actual contents of the paper to be more circumspect, in the press Wakefield promoted the idea that the MMR vaccine either predisposes, causes, or triggers autistic regressions. Even though over the next several years, investigations by investigative journalist Brian Deer revealed that not only was Wakefield’s research funded by trial lawyers looking to sue vaccine manufacturers for “vaccine injury” when he did his research (for which he is now being charged by the U.K.’s General Medical Council with scientific misconduct), but during the Autism Omnibus trial testimony by a world-renowed expert in PCR technology showed that he was incompetent. Even worse for Wakefield, in February 2009 Brian Deer published a news expose based on strong evidence that Wakefield may very well have falsified data for his Lancet paper.

None of this mattered. Andrew Wakefield still enjoys a cult of personality among the anti-vaccine crowd that no revelation seems able to dislodge, even the revelation that at the time he was both in the pay of trial lawyers and working on his study, Andrew Wakefield was also applying for a patent for a rival measles vaccine. Indeed, the anti-vaccine propaganda blog Age of Autism bestowed upon him last year its “Galileo Award” as the “persecuted” scientist supposedly fighting for truth, justice, and anti-vaccinationism against the pharma-funded or brainwashed minions of the “Church of the Immaculate Vaccination.” In the meantime, MMR uptake rates in the U.K. have plummeted over the last decade, far below the level needed for herd immunity, to the point where, last year the Health Protection Agency declared measles to be once again endemic in the U.K., 14 years after the local transmission of measles had been halted.

Since Wakefield’s study was released, a number of studies have shown that there is no epidemiologically detectable link between vaccination with MMR and autism, including one by a researcher who once appeared to be a believer in the idea that vaccines are somehow linked with autism, Mady Hornig. Hornig actually tried very hard to replicate Wakefield’s 1998 Lancet study, only this time with more children, and she found no link between MMR and autism using methodology similar to Wakefield’s. None of these studies has had any effect on the anti-vaccine movement, except to motivate them to circle the wagons even more, as J.B. Handley of Generation Rescue did when he launched a website called Fourteen Studies, whose purposes are to launch fallacious and pseudoscientific attacks on studies failing to find a link between vaccines and autism (often involving accusations of being a “pharma shill”), to promote the lousy science that gives the appearance of supporting the hypothesis that there is a link between the MMR vaccine and autism, and then slime anyone who points out how deceptive their attacks were.

Now, yet another study has been released studying whether there is a link between MMR vaccination and autism. Yet another study has failed to find a link between MMR vaccination and autism. Yet another study is all set to be attacked by Generation Rescue and the anti-vaccine movement. The sad and sordid history of reactions of the anti-vaccine movement to studies that do not support its belief in the unsinkable rubber duck of a myth that vaccines cause autism. This study was published online in The Pediatric Infectious Disease Journal by a group from Department of Epidemiology and Preventive Medicine, Jagiellonian University, Collegium Medicum, Krakow, Poland (a Polish group, my people!) and entitled Lack of Association Between Measles-Mumps-Rubella Vaccination and Autism in Children: A Case-Control Study. It’s yet another nail in the coffin of the myth that the MMR causes or contributes to autism. Indeed, this study not only shows that MMR vaccination is not associated with autism but that it may even be protective against autism. True, for reasons I will discuss shortly, I doubt that that latter interpretation is true, but there’s no doubt that this study is powerful evidence against the view that there is an association between MMR and autism. Unfortunately, I fear that all the nails in my local Home Depot would not be enough to keep the zombie of this pseudoscience from rising from its grave yet again.
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Posted in: Clinical Trials, Vaccines

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A temporary reprieve from legislative madness

While doctor visits for influenza-like illnesses seem to be trending downward again, and ”swine flu” is becoming old news, I’d like to draw attention to an H1N1 story that has received very little coverage by the mainstream media.

Doctors in several states can now protect their most vulnerable patients from the H1N1 virus without worrying about breaking the law. In order to save lives, several states have announced emergency waivers of their own inane public health laws, which ban the use of thimerosal-containing vaccines for pregnant women and young children.

Legislators in California, New York, Illinois, Missouri, Iowa, Delaware, and Washington state have enacted these science-ignoring laws in response to pressures from the anti-vaccine lobby and fear-struck constituents. Except for minor differences, each state’s law is essentially the same, so I will focus on the one from my state of New York.

New York State Public Health Law §2112 became effective on July 1, 2008. It prohibits the administration of vaccines containing more than trace amounts of thimerosal to woman who know they are pregnant, and to children under the age of 3. The term “trace amounts” is defined by this law as 0.625 micrograms of mercury per 0.25 mL dose of influenza vaccine for children under 3, or 0.5 micrograms per 0.5 mL dose of all other vaccines for children under 3 and pregnant women. Because thimerosal (and thus, mercury) exists only in multi-dose vials of the influenza vaccines (both seasonal and novel H1N1), this law really only applies to these vaccines. The mercury concentration of the influenza vaccines is 25 micrograms per 0.5 mL, which therefore makes their use illegal. Unfortunately, the only form of the H1N1 vaccine initially distributed, and that could be used for young children and pregnant women, was the thimerosal-containing form. The thimerosal-free vaccine was the last to ship, and in low supply, and the nasal spray is a live-virus vaccine, not approved for use in pregnancy or children under 2. That meant, without a waiver of the thimerosal ban, these groups could not be vaccinated.
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Posted in: Politics and Regulation, Public Health, Science and Medicine, Vaccines

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Naturopaths and the anti-vaccine movement: Hijacking the law in service of pseudoscience

Time and time again, we’ve seen it. When pseudoscientists and quacks can’t persuade the scientific and medical community of the validity of their claims, they go to the law to try to gain the legitimacy that their claims can’t garner through proving themselves by the scientific method. True, purveyors of pseudoscience and unscientifically-derived medical practices do crave the respectability of science. That’s why they try so hard to take on the trappings of science. The problem is that they just can’t do it right, try as they might, or when they do it right their methods are shown to be no more effective than a placebo, aside from the occasional seeming “positive” results that would be expected based on random chance alone. However, failing to achieve the respectability that the mantle of science provides, practitioners and advocates of pseudoscience frequently try to codify their woo into the law.

The reason that they would do this is not too hard to discern. Few legislators and politicians are scientists, and even fewer are scientifically inclined. Back when I still lived in New Jersey, I may have been lucky enough to have had a Congressional Representative who really was a rocket scientist (well, a physicist, actually), but now that I live in Michigan I’ve gone from having a scientifically inclined Congressional representative to having one of the dimmest bulbs in Congress representing me. What that means is that it’s far easier to persuade politicians that this woo or that woo deserves to be permitted or even licensed. That’s how we now have many states licensing acupuncturists, naturopaths, and even “homeopathic physicians,” as Arizona does. The pressure for this sort of acceptance of unscientific medical modalities is building, as well, as Kimball Atwood has documented. Another example is the Dietary Supplement Health and Education Act (DSHEA), which was passed in 1994 and in essence ties the FDA’s hands when it comes to regulating most supplements. Indeed, the very existence of the National Center for Complementary and Alternative Medicine (NCCAM) is a testament to the success of this approach, as a powerful Senator (Tom Harkin, D-IA) almost single-handedly foisted this scientific atrocity on the NIH against the desires of scientists. The results have included a $30 million scientific boondoggle of a trial to test chelation therapy and a profoundly unethical trial of Dr. Nicholas Gonzalez’s “protocol” for pancreatic cancer patients that a recent clinical trial has shown to be worse than useless. The most recent example of this trend is the way that CAM supporters have tried to hijack President Obama’s health insurance reform initiative to insert coverage for everything from any licensed “alternative medicine” practitioner to Christian Science prayer healing.

Recently, two new fronts have been opened up in this battle. One is disturbingly close to me, as it involves the Canadian province of Ontario whose north shore on the Detroit River is less than two and a half miles from my office, the other in Oregon, which, although it’s happening nearly 2,000 miles away from where I live and practice, could portend a new and disturbing tactic of the anti-vaccine movement to do what various other purveyors of pseudoscience have done before and try to win in state legislatures where they can’t win in science or the courts. Of course, in a democratic republic, it is the right of everyone, even supporters of quackery, to try to petition his or her legislators, but it is equally the responsibility of those of us supporting science-based medicine to try to educate legislators why allowing them to alter the law to protect their pseudoscience has the potential to result in great harm.
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Posted in: Herbs & Supplements, Politics and Regulation, Public Health, Vaccines

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The autism “biomed” movement: Uncontrolled and unethical experimentation on autistic children

Ever since I first discovered the anti-vaccine movement, first on Usenet, specifically on a Usenet newsgroup devoted to discussing alternative medicine (misc.health.alternative, or m.h.a. for short) and then later on web and on blogs, there have been two things that have horrified me. First, there are the claims that children suffer all sorts of harm from vaccines, be it being made autistic (with the attendant “autism epidemic” caused by vaccines), suffering neurological damage, immune system damage, and all manner of other adverse consequences. There is no good evidence for these claims (although, as has been documented right here on this very blog time and time again, anti-vaccine activists will trot out all manner of awful studies to support their contentions), but that doesn’t keep useful celebrity idiots like Jenny McCarthy, Jim Carrey, Don Imus, or Bill Maher from repeating the same myths over and over again. Worse, the permeation of society with these myths about vaccines has led to declining vaccination rates and the resurgence of potentially deadly vaccine-preventable diseases. It began first in the U.K. in the wake of Andrew Wakefield’s trial lawyer-funded, incompetent, and possibly fraudulent “research,” and has spread to the U.S., thanks to Jenny McCarthy and her ilk, who won’t take responsibility for their words and actions.

Even worse, the myth that vaccines cause autism has led to ideas. Dangerous ideas, and not because they “challenge” medical orthodoxy. These ideas are dangerous because they have direct consequences for children with autism. These consequences take the form of subjecting children to unscientific treatments that are ineffective at best and harmful at worst, sometimes even life-threatening. Indeed, I have written about case histories in which children were subjected to injections of “stem cells” into their cerebrospinal fluid by lumbar puncture and various other “treatments,” as well as chemical castration in combination with chelation therapy. That latter bit of quackery is something I wrote about years ago, but that the mainstream press only just noticed earlier this year. Better late than never, I guess. Even better than that, though, the same reporting team at the Chicago Tribune that reported on Mark and David Geier’s advocacy of Lupron to treat autistic children back in May. Sadly, the result of that story does not appear to have been actions by the State of Maryland to take away Dr. Mark Geier’s medical license or to go after his son David for practicing without a license. Neither does it appear to have resulted in insurance companies going after them for prescribing an expensive drug for an indication for which it is not appropriate. What it does appear to have done, however, is to inspire the same journalist, Trine Tsouderos, along with another journalist from the Chicago Tribune, Patricia Callahan, to pursue an even bigger target that Mark and David Geier, namely the entire “autism biomed movement,” which is for the most part rank quackery, in the following articles:

This is another rare case of excellent reporting on this issue, and I hope that this report (another installment of which was published early this morning after I had written this post) will grab the attention of more reporters and news outlets, leading to shining a light on the dark underbelly of the autism biomed movement.
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Posted in: Health Fraud, Herbs & Supplements, Public Health, Vaccines

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A Not-So-Split Decision

For those who battle tirelessly against the never ending onslaught of anti-vaccine propaganda, misinformation, and fear, there was great news the other day from Merck. The pharmaceutical company, and maker of the MMR vaccine against measles, mumps, and rubella, has decided not to resume production of the individual, or “split”, components of the vaccine. A Merck representative made the announcement during a meeting of the CDC Advisory Committee on Immunization Practices (ACIP) on Tuesday. During previous ACIP meetings, science experts on that committee presented compelling arguments against  continued, large scale production of the monovalent components of the MMR vaccine, which were echoed by scientists in Merck’s vaccine division. In a moment, I’ll discuss the arguments against the split vaccine, and why this is so important a decision. First, some background on the issue of splitting the MMR.
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Posted in: Science and Medicine, Vaccines

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