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When impressive science fails to impress patients

One of the greatest challenges in medicine can sometimes be to convince patients that the results of scientific and medical research apply to them, or, at the very least, to explain how such results apply. One of the reasons that medicine based not on science or evidence fluorishes is because it can be so hard to explain to patients why a particular intervention is viewed as effective. My co-blogger Steve Novella wrote about some of the fallibilities of human perception that lead to perceiving correlations and treatment effectiveness where there are none. R. Robert Bausell wrote about the same thing in his recent book Snake Oil Science. While it is undoubtedly true that people tend to pay more attention to anecdotes than to studies and statistics, there is also another reason why doctors often have problems convincing patients of the value of health interventions, and that’s the difference in perception and how we value different kinds of evidence.

A couple of years ago, I came across an article that explains this gulf between how those of us trying to practice science- and evidence-based medicine perceive the world and how most human beings not trained in medicine or science perceive it. The article, which was published in 2006 in the New York Times and written by Dr. Abigail Zuker, proposed one reason why this might be, beginning with a discussion with her mother in which she tries to convince her of the benefit of exercise, even in the elderly, a concept that her mother would have none of and dismissed contemptuously:

“Studies,” she says, dripping scorn. “Don’t give me studies. Look at Tee. Look at all the exercise she did. She never stopped exercising. Look what happened to her.”

End of discussion. Tee, her old friend and contemporary, took physical fitness seriously, and wound up bedbound in a nursing home, felled by osteoporosis and strokes, while my mother, who has not broken a sweat in the last 60 years, still totters around on ever-thinning pins. So much for exercise. So much for studies. So much for modern clinical medicine, based on the randomized allocation of treatment and placebo. All that beautiful science, stymied by the single, incontrovertible, inescapable image of Tee, the one who exercised but grew hunched and crippled anyway.

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Posted in: Clinical Trials, Public Health, Science and Medicine

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The ultimate in “integrative medicine”: Integrating the unscientific into the medical school curriculum

For the second week in a row I find myself throwing out the original post that I had planned on doing in favor of a different topic. The reason this week is, quite simply, having read Dr. Atwood’s excellent two part post Misleading Language: The Common Currency of “CAM” Characterizations (Part I; Part II). I don’t at this time intend to expand on what Dr. Atwood said, although I may do so at one future time. What caught my attention in his lengthy deconstruction was his segment on the “woo-ification” of health care, which very much echoed my post a while back in which I lamented the creeping infiltration of non-science-based modalities into academic medical centers, as well as the credulous teaching of such modalities in medical schools. What I wanted to explore was just how far this might go and what the end result might be. It turns out that we are already witnessing an experiment in just such a thing.

About a year and a half ago, I first became aware of just how far this infiltration of unscientific “medicine” has infiltrated academia when I saw this brochure published by the Georgetown University School of Medicine. If you’re scientifically inclined, as I am, it ought to make you shudder. Reading this brochure, I truly have to worry whether woo really is the future of American medicine, as has been suggested in some quarters. Certainly, if other medical schools start following Georgetown’s lead, it will be. Not content to offer so-called complementary and alternative medicine (“CAM”) modalities as part of electives that interested students can take if they are so inclined, Georgetown is taking the next logical step that I feared: It’s dedicating significant educational resources and time to teaching “CAM” in its mandatory general medical curriculum, where every student has to learn it:
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Posted in: Medical Academia, Science and Medicine

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The Hannah Poling case and the rebranding of autism by antivaccinationists as a mitochondrial disorder

Regular readers of this blog may have noticed that I seem to have taken on the role of the primary vaccine blogger of this little group of bloggers trying desperately to hold the forces of pseudoscience and magical thinking at bay in the face of powerful forces trying to “integrate” prescientific belief systems with science- and evidence-based medicine, a process that would be unthinkable in just about any other field of applied science, such as aeronautics or the physics used in engineering, just as creationists try to “integrate” religion with biology. Although I do have a strong interest in the antivaccination movement in general and the claim that vaccines, or the mercury in the thimerosal preservatives that was in many childhood vaccines in the U.S. until late 2001 or early 2002 (when they were taken out) are a major cause or contributor to autism, such had not been my intention. When I started here on SBM, I had intended to be a lot more diverse. Indeed, I had even had another topic entirely in mind for this week’s post, but, as happens far too often, news events have overtaken me in the form of a story that was widely reported at the end of last week. It was all over the media on Thursday evening and Friday, showing up on CNN, Larry King Live, the New York Times, and NPR. It happens to be the story of a girl from Georgia named Hannah Poling whose case before the Vaccine Injury Compensation Program (VICP), which had originally part of a much larger proceeding known as the Autism Omnibus in which nearly 5,000 parents are petitioning the VICP for compensation based on the claim that their children’s autism were caused by vaccines, was settled by the government. This settlement was based on the observation that Poling had a rare genetic mitochondrial disease that may have been exacerbated by a series of vaccines that she had, after which, among many other problems, Hannah regressed and developed some autism-like symptoms and then months later a seizure disorder. Instantly, it was being trumpeted all over the Internet, blogosphere, and media that the government had “admitted” that vaccines cause autism. One particularly excitable antivaccinationist named Kent Heckenlively (whom we’ve met before), even went so far as to foreshadow the propaganda blitz that was to come as he wrote on the antivaccine blog Age of Autism a full week before this news blitz began:

It’s official.  The sky has fallen.  The fat lady has sung.  Pigs are flying.

[...]

In a settlement, the settling party tries to admit as little as possible.  It’s like what I imagine the settlement claim against Bill Clinton in the Paula Jones case must look like.  Nowhere in the document does he admit to dropping his pants in a hotel room and asking her to kiss it.  It likely says something along the lines of he concedes they were in a hotel room together, they were alone, and something happened which formed the basis of her law suit.

But we all know what happened there.  And we know what this settlement means.

The government just dropped its pants.

One thing this shows us is just how the blogosphere can be bubbling with information that lets one predict a public relations blitz like this. The mainstream press seemed to have been totally blindsided by this story, but if reporters had only been checking the right blogs, they would have known about it a full week before, if not longer. In any case, since Thursday, there has been a very well orchestrated public relations campaign to frame this settlement as the government “admitting” that vaccines cause autism. It’s not, as I will try to explain, but framing it that ways has thus far been a very effective PR strategy for antivaccinationists. In my nearly three years of following this topic, I thought that I had never seen anything like it before.

But I had.

This case is nothing more than a demonstration that everything old is new again and that, no matter what the science says, it’s always all about the vaccines, the claims of antivaccinationists otherwise notwithstanding, as I will now show. What we are seeing now, as we did a few years ago, is the rebranding of autism as a condition in order to serve the purposes of the antivaccination movement.
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Posted in: Public Health, Science and Medicine, Science and the Media, Vaccines

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Bad scientific arguments in the service of animal rights activism

One of the greatest threats to the preclinical research necessary for science-based medicine today is animal rights activism. The magnitude of the problem came to the forefront again last week with the news that animal rights terrorists tried to enter the home of a researcher at the University of California Santa Cruz (UCSC) whose research uses mice to study breast cancer and neurologic disease while she and her husband were having a birthday party for one of their children and assaulted her husband, who had gone to the front of the house to confront them. Fortunately, the license plate number of the car fleeing the scene was reported to police, leading to a raid on a house by police and the confiscation of computers and other materials. This attack appeared to be the latest crescendo in an increasing campaign of harrassment and intimidation by animal rights “activists” that has also been observed in nearby Berkeley.

This sort of threat to researchers is not a problem just in Santa Cruz and the Bay area, but in particular has been a problem in southern California as well. Just earlier this week, the University of California Los Angeles announced that it was suing several animal rights groups and individuals suspected of attacks on researchers who use animals, including UCLA Primate Freedom Project, the Animal Liberation Front (ALF), and the Animal Liberation Brigade (ALB), as well as several individuals believed to affiliate with these groups. The inciting event for this action was the second attack on the home of Edythe London, Professor of Psychiatry and Bio-behavioral Sciences and of Molecular and Medical Pharmacology at the David Geffen School of Medicine at UCLA, in early February. Her research involves the use of primate models to study nicotine addiction. In this most recent attack, an attempt was made to set her house on fire. This came on the heels of a previous attack in October, in which animal rights activists flooded her house. Prior to that, animal rights terrorists had indeed succeeded in their aim of intimidating a scientist sufficiently that he gave up animal research after a fellow researcher was targeted with a Molotov cocktail meant for her home that was mistakenly placed on the porch of an elderly neighbor. Also, we in the U.S. often forget how much more radical animal rights extremists are in the U.K., where the campaign of intimidation takes the form of death threats, intimidation of personnel of companies that supply researchers, and even in one case digging up the grave of Gladys Hammond, whose family ran a farm that raised Guinea pigs for use in medical research, and stealing her remains.

Readers may make the argument that my introduction to this discussion is unfairly inflammatory, but I have my reasons for starting this way, and I think they are good ones. First, make no mistake, the aim of the most radical of these activists is nothing short of the cessation of the use of all animals in biomedical research. Second, sooner or later, someone will be hurt or killed. As a researcher who on occasion uses mouse models of cancer myself, I state up front that I could be on the firing line just as much as the UCSC researcher or others and am justifiably disturbed when I hear spokesperson for the ALF Dr. Jerry Vlasak, for example, repeatedly advocate violence against researchers who use animals. In this article, I am not going to discuss the moral issues involved in animal research. What I am going to discuss is the seemingly scientific arguments that some opponents of animal research and animal rights activists like to invoke, arguments increasingly used in addition to the moral arguments that extremists use to justify their actions. If the arguments of opponents of animal rights research were indeed good science, then their appropriation by extremists would not allow me to do much other than bemoan the misuse of valid science as a justification for extremism. Unfortunately, such is not the case, and the bad scientific arguments used by opponents of animal research are often piled onto the extreme moral arguments that fuel actions such as those earlier this week at UCSC. Consequently, given the events of the last month or so, I thought I would take this opportunity to look at some of the common scientific indictments of animal research by its opponents.
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Posted in: Basic Science, Clinical Trials, Politics and Regulation, Science and Medicine

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When the popularity of new surgical procedures outpaces science

ResearchBlogging.orgIn science- and evidence-based medicine, the evaluation of surgical procedures represents a unique challenge that is truly qualitatively different from the challenges in medical specialties. Perhaps the most daunting of these challenges is that it is often either ethically unacceptable or logistically impossible to do the gold-standard clinical trial, a double-blind, randomized placebo trial for an operation. After all, the “placebo” in a surgical trial involves patients to anaesthesia, making an incision or incisions like the ones used for the operation under study, and then not doing the operation. Clearly, even leaving the ethics aside, it’s impossible to blind the surgeons and operative team involved to which treatment, real surgery or placebo, the patient is receiving without having a different surgeon do the surgery from the one overseeing the postoperative care of the patient, with the operative surgeon barred from communicating to the postoperative surgeon what happened in the operating room and from participating in the postoperative care of the patient upon whom he operated. This sort of restriction, besides being also highly dubious ethically speaking, goes against the grain of surgical culture, in which a surgeon is expected to provide the postoperative care for his patients almost as a matter of surgical honor. A final problem that complicates any surgical trial is that surgeons of differing technical operating skill will necessarily be involved, and surgical skill is indeed very important in determining outcome. Although there have been examples of double-blinded trials with sham surgery as placebo, for example, in injecting dopamine-producing cells into the brain to treat Parkinson’s disease, difficulties doing such studies tend to force us as surgeons in many cases either to rely on retrospective data, prospective non-randomized data, or, when we’re lucky, a prospective randomized (but not double-blinded) trial of one surgical procedure versus another.
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Posted in: Clinical Trials, Medical Ethics, Science and Medicine, Surgical Procedures

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Toxic myths about vaccines

Ever since there have been vaccines, there has been an antivaccination movement. It began shortly after Edward Jenner discovered how to use the weaker cowpox virus to induce long-lasting immunity to smallpox, there has been resistance to the concept of vaccination, a resistance that continues to this very day. Reasons for this resistance have ranged from religious, to fear of injecting foreign substances, to simple resistance to the government telling people what to do. Some fear even the infitessimally small risk that vaccines pose for the benefit of resistance to disease far more than they fear the diseases themselves, a result of the very success of modern vaccines. Of course, vaccines, like any other medical intervention, are not without risks, making it easy for them to jump on any hint of harm done by vaccines, whether real or imagined, even though vaccines are among the very safest of treatments.

One of the biggest myths that antivaccinationists believe and like to use to stoke the fear of vaccines is the concept that they are full of “toxins.” The myth that mercury in the thimerosal preservative commonly used in vaccines in the U.S. until early 2002 was a major cause of autism is simply the most recent bogeyman used to try to argue that vaccines do more harm than good, as was the scare campaign engineered in response to Andrew Wakefield’s poor science claiming a link between the MMR vaccine and autism. Now that study after study have failed to find or corroborate a link between thimerosal in vaccines or vaccines in general and autism to the point where even the most zealous of zealots are having a hard time defending the claim that mercury in vaccines cause autism any more, predictably the campaign against vaccines has fallen back on the old “toxins” myth. If you peruse antivaccinationist websites, it won’t take long to find articles claiming that vaccines are full of the most terrifying and nasty toxins. Examples in the media abound as well. For example, Jenny McCarthy, comic actress and former Playboy Playmate who has been doing the talk show and publicity circuit lately to plug her book in which she claims that vaccines caused her son’s autism and that she was able to cure it with “biomedical” interventions and diet, recently gave an interview in which she said:

What I really am is “anti-toxins” in the vaccines. I do believe that there is a correlation between vaccinations and autism. I don’t think it’s the sole cause, but I think they’re triggering–it’s triggering–autism in these kids. A really great example is…is, sometimes obesity can trigger diabetes. I do believe that vaccines can trigger autism…It’s so much more than just mercury. That is one ingredient in the recipe of autism…I’m talking about all of them. I’m calling for cleaning out the toxins. People don’t realize that there is aluminum, ether, antifreeze, still mercury, in the shots…People are afraid of secondhand smoke, but they’re OK with injecting the second worst neurotoxin on the planet in newborns.

Another example of what I sometimes call the “toxin gambit” comes from Deirdre Imus, wife of shock jock Don Imus, with both husband and wife being well-known and reliable media boosters of the claim that vaccines somehow cause autism:

So, where are the evidenced based (conflict free) studies that prove the safety of these “trace” amounts and proof that there are “no biological effects” of any amount of mercury being injected into our children and pregnant moms? Also, where are the evidence based studies proving the safety of vaccines given to pregnant moms and our children that contain other toxins such as aluminum and formaldehyde?

The most recent example of this tactic comes from an organization called Generation Rescue, which just last week ran a full-page ad in USA Today, paid for in part by Jenny McCarthy and her present boyfriend Jim Carrey:

antivaxgradvertisement.jpg

Besides being one of the most egregious examples of a post hoc ergo propter hoc fallacy that I’ve ever seen from an antivaccination site, this Generation Rescue ad demonstrates clearly a new strategy (or, more properly, a resurrection of an old technique) now that science is coming down conclusively against mercury in vaccines as a cause of autism, a strategy of propagating fear by linking vaccines with “toxins.” So what’s the real story? Are there really deadly toxins in vaccines that parents should be worried about?
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Posted in: Public Health, Science and Medicine, Science and the Media, Vaccines

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Hype over science: Does acupuncture really improve the chances of success for in vitro fertilization?

There it was on Friday greeting me on the ABC News website: “Study: Acupuncture May Boost Pregnancy” in bold blue letters, with the title of the webpage being “Needles Help You Become Pregnant.” The story began:

It sounds far-fetched sticking needles in women to help them become pregnant but a scientific review suggests that acupuncture might improve the odds of conceiving if done right before or after embryos are placed in the womb.

The surprising finding is far from proven, and there are only theories for how and why acupuncture might work. However, some fertility specialists say they are hopeful that this relatively inexpensive and simple treatment might ultimately prove to be a useful add-on to traditional methods.

By the end of the day, the story was all over the media, including radio, TV, news websites, the blogosphere, and various other outlets, all trumpeting the message that a scientific study says that acupuncture can help infertile couples conceive. Nary a skeptical word seemed to be found. Knowing very well just how far parents will go to conceive, I was curious: Did this study actually say what the media says it said? What was so new and radical about this study that it rated a press release and a lot of promotion? Do we here at SBM (particularly Steve) need to rethink our extreme skepticism about acupuncture, given the poor quality evidence and lack of even a glimmer of a convincing physiologic mechanism to explain its supposed activities?
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Posted in: Acupuncture, Clinical Trials, Energy Medicine, Science and Medicine, Surgical Procedures

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The National Center for Complementary and Alternative Medicine (NCCAM): Your tax dollars hard at work

What’s an advocate of evidence- and science-based medicine to think about the National Center for Complementary and Alternative Medicine, better known by its abbrevation NCCAM? As I’ve pointed out before, I used to be somewhat of a supporter of NCCAM. I really did, back when I was more naïve and idealistic. Indeed, as I mentioned before, when I first read Wally Sampson’s article Why NCCAM should be defunded, I thought it a bit too strident and even rather close-minded. At the time, I thought that the best way to separate the wheat from the chaff was to apply the scientific method to the various “CAM” modalities and let the chips fall where they may.

Two developments over the last several years have led me to sour on NCCAM and move towards an opinion more like Dr. Sampson’s. First, after its doubling from FY 1998-2003, the NIH budget stopped growing. In fact, adjusting for inflation, the NIH budget is now contracting. NCCAM’s yearly budget remains in the range of $121 million a year, for well over $1 billion spent since its inception as the Office of Alternative Medicine in 1993. Its yearly budget contains enough money to fund around 75 to 100 new five year R01 grants, give or take. In tight budgetary times my view is that it is a grossly irresponsible use of taxpayer money not to prioritize funding for projects that have hypotheses behind them that have a reasonable chance of being true. Scarce NIH funds should not be for projects that have as their basis hypotheses that are outlandishly implausible from a scientific standpoint. Second, I’ve seen over the last few years how NCCAM is not only funding research (most of which is of the sort that wouldn’t stand a chance in a study section from other Institutes or Centers)) but it’s funding training programs. Indeed, that was the core complaint against NCCAM: that it facilitates and promotes the infiltration of nonscience- and nonevidence-based treatments falling under the rubric of so-called “complementary and alternative” or “integrative” medicine into academic medicine. However, NCCAM cannot do otherwise, given its mission:

  • Explore complementary and alternative healing practices in the context of rigorous science.
  • Train complementary and alternative medicine researchers.
  • Disseminate authoritative information to the public and professionals.

If, in fact, NCCAM actually did devote itself solely to “rigorous science” with regard to “alternative” healing practices, I would have much less problem with it than I do. However, it broadly interprets the second and third parts of its mission. For example, it views part of its mission as promotion, rather than study: “Supporting integration of proven CAM therapies. Our research helps the public and health professionals understand which CAM therapies have been proven to be safe and effective.” This would be all well and good if NCCAM had as yet actually proven any CAM therapies to be at least effective, but it has not. Worse, it has not even managed to demonstrate any of them to be ineffective, either, thus leading to endless studies of modalities that either do not work or at the very least would have marginal efficacy.

Still, I thought; All questions of promotion of CAM modalities aside, least there’s the science. Surely, under the auspices of the NIH, NCCAM must be funding some high-quality studies into CAM modalities that couldn’t be done any other way. That thought died when NCCAM announced last week the studies that it had funded during FY 2007.
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Posted in: Basic Science, Clinical Trials, Medical Academia, Politics and Regulation, Science and Medicine

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Science by press release: A helmet to fight Alzheimer’s disease?

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Recently, I’ve had a number of people bring to my attention a news story that has apparently been sweeping the wire services and showing up in all sorts of venues. It is, on its surface, a story of hope, hope for the millions of elderly (and even the not-so-elderly) who are or will be afflicted by that scourge of the mind, memory, and personality, Alzheimer’s disease. This disease is one of the most feared of diseases. A progressive and fatal disease of the brain, it robs a person of his memory and personality, until he no longer recognizes loved ones and becomes too demented to care for himself. The pathophysiology involves the accumulation in the brain of a protein known as β-amyloid, which forms plaques outside of cells, while neurofibrillary tangles believed to be due to the hyperphosphorylation of a protein known as tau develop in dying cells. The exact mechanism by which neuron death occurs is not fully understood, but over time this process leads to a decrease in the amount of gray matter in the cortex. There is no known cure, and the current treatments that we have result in at best a modest delay of the inevitable dementia that accompanies progression of the disease.

Given this grim backdrop and the general aging of the population in developed nations, it is expected that there will be a large increase in the number of people developing Alzheimer’s disease over the next few decades. Naturally, this provides a great deal of incentive to develop more effective treatments. Not surprisingly, sometimes the treatments proposed may sound somewhat outlandish and may even be somewhat outlandish. The treatment about which people were e-mailing me falls into this category, and I haven’t decided yet whether it’s science or pseudoscience. It could be legitimate. What I do know, however, is that I don’t like the way its inventors are promoting it by press conference before any evidence of its clinical efficacy in humans has been accepted by a peer-reviewed publication, leading to a flurry of stories about a new possible “miracle cure” for Alzheimer’s disease grounded in not a lot of science. I’m referring, of course, to the “Alzheimer’s helmet” developed by Dr. Gordon Dougal and his colleagues Dr. Paul Chazot and Abdel Ennaceur at Durham University. Dr. Dougal is a director of Virulite, a medical company based in County Durham in the U.K. Here’s a widely cited article from the Daily Mail that describes the device:
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Posted in: Basic Science, Medical devices, Medical Ethics, Neuroscience/Mental Health, Science and Medicine, Science and the Media

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The infiltration of complementary and alternative medicine (CAM) and “integrative medicine” into academia

A few years back, my co-blogger Wally Sampson wrote a now infamous editorial entitled Why the National Center for Complementary and Alternative Medicine (NCCAM) Should Be Defunded. When I first read it, I must admit, I found it to be a bit harsh and–dare I say?–even close-minded. After all, plausibility aside, I believed at the time that the only way to demonstrate once and for all in a way that everyone would have to accept that many of these “alternative” therapies were no more effective than a placebo would be to do high-quality randomized clinical trials to test whether they worked, and NCCAM seemed to be the perfect funding agency to see that this occurred. Yes, this attitude in retrospect was quite naïve, as I have since learned the hard lesson over several years that no amount of studies will convince advocates of complimentary and alternative medicine (CAM) that their favored therapy doesn’t work, be it chelation therapy for autism or cardiovascular disease, homeopathy, reiki, or various other “energy” therapies that invoke manipulation of qi as a means of “healing,” such as acupuncture, but that is what I believed at the time.
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