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Is “harnessing the power of placebo” worthwhile to treat anything?

Placebonex
We frequently write about placebo effects here on Science-Based Medicine. The reason is simple. They are an important topic in medicine and, at least as importantly, understanding placebo effects is critical to understanding the exaggerated claims of advocates of “complementary and alternative medicine” (CAM), now more frequently called “integrative medicine” (i.e., integrating pseudoscience with science). Over the years, I (and, of course, others) have documented how CAM advocates have consistently moved the goalposts with respect to the efficacy of their pseudoscientific interventions. As larger and better-designed clinical trials have been done demonstrating that various CAM therapies without a basis in science—I’m distinguishing these from science-based modalities that have been co-opted and “rebranded” as CAM, such as exercise and nutrition—have no specific effects detectable above placebo effects, CAM advocates move the goalposts and claim that CAM works through the “power of placebo” and do their best to claim that “harnessing” that “power of placebo” is a justification to use their treatments. It turns out, however, that when placebo effects are examined rigorously there’s just not a lot of there there, so to speak. Results are underwhelming, and trying to “harness the power of placebo” without an intervention that actually impacts the pathophysiology of disease can even be dangerous. That’s not to say that learning to maximize placebo responses (whatever they are) while administering effective medical treatments isn’t important; rather, it’s to point out that, by themselves, placebo effects are not of much value.

Unfortunately, none of this has stopped what Steve Novella refers to as the “placebo narrative” from insinuating itself into lay discussions of medicine. That narrative proclaims in breathless terms (as Steve put it) the “surprising power of the placebo effect” without putting it into reasonable perspective or even really defining what is meant by “placebo effect.” First, as we have tried to explain time and time again here, there is no single “placebo effect.” There are placebo effects. Second, the only really correct reference to “the placebo response” or “placebo effect” is the outcome measured in the placebo arm of a clinical trial. The problem is that, all too often, discussions of placebo responses conflate the placebo effect measured in a clinical trial with all the other various placebo effects that add up to the response that is measured in that trial. Those effects include reporting biases, researcher biases, regression to the mean, conditioning, and many other components that contribute to what is measured in the outcome of a clinical trial. Another common misconception about placebo effects is that they are somehow “mind over matter,” that we can heal ourselves (or at least reduce our symptoms) through the power of will and mind. This is not true. Placebo effects are not the power of positive thinking.
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Posted in: Acupuncture, Basic Science, Clinical Trials, Homeopathy, Science and the Media

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You’ve been diagnosed with breast cancer. How soon do you need treatment?

Breast Cancer Surgery
A new year is upon us yet again, and Science-Based Medicine has been in existence for eight years now. It seems only yesterday that Steve Novella approached me to ask me to be a contributor. Our part-serious, part-facetious predictions for 2016 notwithstanding, one thing about 2016 is certain: I will almost certainly encounter some form of cancer quackery or other and deconstruct it, probably multiple forms. In any case, a topic I’ve been meaning to write about is based on a couple of studies that came out three weeks ago that illustrate why, even if a patient ultimately comes around to science-based treatment of his cancer, the delay due to seeking out unscientific treatments can have real consequences.

When a patient with breast cancer comes in to see me, not infrequently I have to reassure her that she doesn’t need to be wheeled off to the operating room tomorrow, that it’s safe to wait a while. One reason, of course, is that it takes years for a cancer to grow from a single cell to a detectable mass. The big question, of course, is: What is “a while”? Two studies published online last month attempt to answer that question. One study (Bleicher et al) comes from Fox Chase Cancer Center and examines the effect of time to surgery on breast cancer outcomes; the other (Chavez-MacGregor et al) is from the M.D. Anderson Cancer Center and examines the effect of time to chemotherapy on outcome. Both find a detrimental effect due to delays in treatment.
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Posted in: Cancer, Surgical Procedures

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The fine line between quality improvement and medical research

Quality

As I’ve mentioned before, the single biggest difference between science-based medicine (SBM) and what I like to call pseudoscience-based medicine, namely the vast majority of what passes for “complementary and alternative medicine” (CAM) or “integrative medicine” is that SBM makes an active effort to improve. It seeks to improve efficacy of care by doing basic and clinical research. Then it seeks to improve the quality of care by applying the results of that research to patient care. Yes, the process is complicated and messy, and it frequently doesn’t progress as fast as we would like it to. Sometimes it goes down blind alleys or takes wrong turns, such as when a treatment is adopted too rapidly and determined later to be ineffective. Overall, however, improvement does occur, and it continues to occur. New treatments that work better are discovered. Old treatments that don’t work as well (or that don’t work at all) are abandoned.

There is, however a blurry line between what constitutes medical research and what constitutes quality improvement (QI). A couple of years ago, in one of those unexpected turns that a career can take, an opportunity presented itself for me to become co-director of a statewide quality improvement consortium for breast cancer care in my state. As I’ve alluded to before, it was a case of unexpectedly being in the right place at the right time, of seeing an opportunity and being willing to take it. How I ended up making quality improvement a large part of my career is unimportant. What is important is that it puts me in a unique position among all the other SBM contributors to discuss the interface between science and quality. (It’s also important that I lay down a disclaimer here that this post represents my opinion and my opinion alone; it does not represent the views of the QI with which I’m affiliated, my cancer center, or my university.) In particular, there are ethical considerations that are not obvious, apparently even to someone as brilliant as Steven Pinker, who Tweeted yesterday:
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Posted in: Clinical Trials, Medical Ethics, Quality Improvement

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Is scientific peer review a “sacred cow” ready to be slaughtered?

Peer Review

I’ve frequently noted that one of the things most detested by quacks and promoters of pseudoscience is peer review. Creationists hate peer review. HIV/AIDS denialists hate it. Anti-vaccine cranks like those at Age of Autism hate it. Indeed, as a friend of mine, Mark Hoofnagle, pointed out several years ago, pseudoscientists and cranks of all stripes hate it. There’s a reason for that, of course, namely that it’s hard to pass peer review if you’re peddling pseudoscience, although, unfortunately, with the rise of “integrative medicine,” it’s nowhere near as difficult as it once was.

Be that as it may, peer review, the process by which scientific papers are evaluated by scientific “peers” to look for problems with the science and decide if the paper is appropriate for publication in a scientific journal, is a concept that dates back hundreds of years. However, for the most part, before the middle of the 20th century, the ultimate determination of whether a paper was appropriate for scientific publication was made by editors or editorial committees. Opinions of external reviewers were sometimes sought when deemed appropriate by journal editors, but by no means was this the practice for most manuscripts. Over the last six or seven decades, external peer review by scientists chosen by the journal editor evaluating a submission has become the standard. Similarly, decisions regarding whether or not to fund grant applications are now generally made by a panel of external reviewers. In the case of the NIH, these panels are called study sections and consist of scientists with expertise in the types of applications being referred to the study section for evaluation, along with (usually) a statistician or two and officials from the NIH who take care of organizing and running the meetings of the panel. The scientific members of a study section usually include “permanent” members, who are assigned to fixed terms on the study section, and ad hoc members, called in for one or a few meetings as needed and deemed necessary by the NIH.
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Posted in: Basic Science, Clinical Trials, Science and Medicine

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Michigan HB 5126: Who thought it was a good idea to make it easier for parents to obtain nonmedical exemptions to school vaccine mandates and harder for local county health officials to do their jobs?

The Michigan House of Representatives: Not the sharpest knives in the drawer.

The Michigan House of Representatives: Not the brightest bulbs on the Christmas tree.

We have a problem with antivaccinationists here in Michigan. It’s a problem that’s been going on a long time that I first started paying attention to in a big way a few years ago when we started seeing pertussis outbreaks again due to low vaccine uptake. It’s a problem that’s persisted as last year we suffered from outbreaks of pertussis and measles, again because of pockets of low vaccine uptake. And what is the reason for these pockets of low vaccine uptake? Well, consistent with what we already know, namely that the risk of pertussis outbreaks is elevated in states where exemptions to school vaccine mandates are easier to get, it’s because our state is one of the worst in the country when it comes to nonmedical exemptions to vaccines. Indeed:

Michigan has one of the highest vaccine-waiver rates for kindergartners in the country, three times the national median, according to the Centers for Disease Control and Prevention. And the number of kindergartners getting vaccine waivers is growing. In five years, it’s increased 23 percent, the CDC says.

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Posted in: Politics and Regulation, Public Health, Vaccines

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Worshiping at the altar of the Cult of the Brave Maverick Doctor

Death of Cancer

One of my favorite television shows right now is The Knick, as I described before in a post about medical history. To give you an idea of how much I’m into The Knick, I’ll tell you that I signed up for Cinemax for three months just for that one show. (After its second season finale airs next Friday, I’ll drop Cinemax until next fall.) The reason why I’m bringing up The Knick (besides I love the show and need to bring it up at least once a year) is because an article by Malcolm Gladwell in The New Yorker entitled “Tough Medicine“, which is a commentary based on a new book on cancer by a veritable god of cancer research, Vincent T. DeVita, Jr., immediately resonated with a storyline in this season of The Knick. I haven’t yet read The Death of Cancer: After Fifty Years on the Front Lines of Medicine, a Pioneering Oncologist Reveals Why the War on Cancer Is Winnable–and How We Can Get There by Vincent T. DeVita and Elizabeth DeVita-Raeburn, but I want to. I can tell, though, that there will be parts of the book I find annoying just from Gladwell’s take on it, which approvingly describes DeVita as railing against the cautiousness and incremental nature of today’s cancer research. To give you an idea of where Gladwell’s coming from, I note that his article shows up in the title bar of my web browser not as “Tough Medicine” but rather “How To Cure Cancer”, even as the title on the web page itself remains “Tough Medicine”. On the other hand, the article does conclude with Gladwell demonstrating a better understanding of the disadvantages of what DeVita is proposing than it seems that he will in the beginning. In fact, it is Gladwell who is more reasonable than his subject, although he does appear share DeVita’s apparent assumption that potentially all cancer patients are savable if only we try hard enough. (more…)

Posted in: Cancer, Clinical Trials, History, Medical Ethics

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“Electromagnetic hypersensitivity” and “wifi allergies”: Bogus diagnoses with tragic real world consequences

Is there such a thing as an "allergy to wifi"? Lots of people claim there is; science, not so much.

Is there such a thing as an “allergy to wifi”? Lots of people claim there is; science, not so much.

I debated about writing about this topic, given that I just wrote about it last week on my not-so-super-secret other blog. However, as I thought about it during the weekend, I realized that the tragic story that so saddened and disturbed me to prod me to discuss so-called “electromagnetic hypersensitivity” or “electro-hypersensitivity” (EHS) was so horrific that a more detailed, SBM-level discussion was indicated, particularly in light of a similar case electromagnetic hypersensitivity that didn’t end so tragically discussed by Harriet Hall in September. I’m referring, of course, to the case of Jenny Fry, a British teen who hanged herself in June and whose mother has been claiming that her “allergy to wifi” was what drove her to suicide. So, while there will be some overlap with my previous discussion, I will try to step back and take a broader view of the evidence regarding the fake diagnosis of EHS, interspersed with examples (hopefully) illustrating my point. Think of this as the post I wished I had written the first time around but, due to time constraints, couldn’t.

Bogus science and lawsuits over EHS

By way of background, it’s worth briefly revisiting the case that Harriet discussed. Indeed, if you Google “lawsuit” and “electromagnetic hypersensitivity” and “wifi” the first two pages of results consist mostly of articles discussing it. That’s probably because this is just the latest lawsuit that made the news. It happened in Massachusetts, where the parents of a 12-year-old boy (designated “G” in court records) who was attending Fay School in Massachusetts alleged that the school violated his rights under the Americans with Disabilities Act by failing to make accommodations to protect G from electromagnetic radiation from the school’s wifi routers. From the complaint’s summary statement:
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Posted in: Basic Science, Neuroscience/Mental Health, Public Health

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How not to debate a “pro-vaxer”

When people debating against vaccines win, children lose.

When people debating against vaccines win, children lose.

To say that the relationship that antivaccine activists have with science and fact is a tenuous, twisted one is a major understatement. Despite mountains of science that says otherwise, antivaccinationists still cling to the three core tenets of their faith, namely that (1) vaccines are ineffective (or at least nowhere near as effective as health officials claim; (2) vaccines are dangerous, causing autism, autoimmune disease, neurodevelopmental disorders, diabetes, sudden infant death syndrome, and a syndrome that is misdiagnosed as shaken baby syndrome; and, of course, (3) the Truth (capital-T, of course!) is being covered up by a nefarious combination of big pharma, the medical profession, and the government (in the US, primarily the Centers for Disease Control and Prevention, which works with pediatricians to produce the recommended schedule of vaccines). Because vaccine rejectors don’t have science on their side, they have to resort strategies common to science denialists like those who reject the scientific consensus about evolution or human-caused global climate change. These fallacious strategies include (but are not limited to) selective citation of evidence (i.e., cherry picking), misrepresentation and logical fallacies, impossible expectations about what science can deliver (e.g., vaccine denialists expecting 100% efficacy and 100% safety from vaccines or cancer quacks expecting 100% cure rates and no side effects from chemotherapy); fake experts (e.g., Andrew Wakefield); and, of course, conspiracy theories. Add to that appeals to personal freedom and “health choiceüber alles and painting any form of vaccine mandate as incipient totalitarianism, with those rejecting vaccines taking on the role of the Jews in Hitler’s Germany, and you have a pretty good idea of the sorts of arguments antivaccine activists resort to.

Not surprisingly, even the most diehard antivaccine advocate can get frustrated. After all, it must be very frustrating to have one’s posterior handed to one in arguments on the science of vaccines time and time again. Of course, for that purpose, like most science denialists, antivaccine activists have the Internet. In particular, they’ve taken full advantage of Facebook, and, more recently, Twitter. One such online gathering place is the public group known as Vaccine Resistance Movement (VRM). I encourage pro-science advocates to peruse this group, just to see that when I refer to people being anti-vaccine, there is no doubt that that is what they are. It was there that I found a rather telling document posted, for the benefit of antivaccine advocates everywhere.
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Posted in: Critical Thinking, Vaccines

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Stanislaw Burzynski and Robert O. Young: How two quacks of a feather illustrate how poorly states regulate medical practice

Stanislaw Burzynski (upper panel) and Robert O. Young (lower panel), two quacks whose activities reveal the weaknesses in how the practice of medicine is regulated.

Stanislaw Burzynski (upper panel) and Robert O. Young (lower panel), two quacks whose activities reveal the weaknesses in how the practice of medicine is regulated.

One of the weaknesses in our system of regulating the practice of medicine in the United States is that, unlike most countries, we don’t have one system. We have 50 systems. That’s because the functions of licensing physicians and regulating the practice of medicine are not federal functions, but state functions. Each state sets its own laws and regulations governing the practice of medicine, making for wide variability from state to state. Some states are lax in their regulation (cough, cough, I’m talking to you, Texas), others are not so lax.

Given how often state medical boards and the other enforcement bodies states use to protect the public from professional misconduct and quackery, I thought I’d take this opportunity to update our readers on two men who have been frequent topics of discussion on this blog, Stanislaw Burzynski and Robert O. Young. The reason is that, through some bizarre confluence of events, both of them faced justice last week, in the form of a hearing due to action against Burzynski by the Texas Medical Board, and in the form of the trial of Robert O. Young in southern California.

What these two quacks share in common is that they’ve gotten away with their cancer quackery for a very long time, two decades in the case of Robert O. Young and nearly four decades in the case of Stanislaw Burzynski, with attempts by the law to bring them to heel having been largely ineffective. They are different in that one is a physician (Dr. Burzynski) and one is not (Young) and therefore different legal considerations come into play. Young, for instance, is a self-proclaimed naturopath known for his “pH Miracle Living” cure, which, he claims, can be used to cure basically any disease by “alkalinizing” the body. After two decades of running, he is being tried for practicing medicine without a license, and, of course, fraud. Burzynski, although not an oncologist, is a licensed physician in Texas and has been administering an unproven and almost certainly ineffective “natural” treatment consisting of substances derived from blood and urine that he dubbed “antineoplastons” (ANPs) back in the 1970s. He is also different in that he’s gotten away with this largely through abuse of the clinical trial process, which is regulated at the federal level through the FDA and the HHS. It is not, however, the federal government that is pursuing action against Burzynski, but rather the Texas Medical Board (TMB). Thus, while Young is on trial and could go to jail if he loses, if Burzynski loses he will only lose his license to practice medicine in the state of Texas.

Despite their differences, both Stanislaw Burzynski and Robert O. Young illuminate major shortcomings in how the legal system deals with quacks.
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Posted in: Health Fraud, Politics and Regulation

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On “integrative medicine” and walking and chewing gum at the same time

Walk and chew gum at the same time

I didn’t think I’d be discussing Dr. David Katz again so soon. In fact, when Mark Crislip (who clearly hates me, given how often he sends me links to articles like this) sent me a link to Dr. Katz’s latest article, “Cleaning the House of Medicine“, published—where else?—in The Huffington Post, that home for “reputable” quack-friendly bloviation since 2005, when I first read the article, my first reaction was that Katz must surely be trolling us here at SBM. At first, I wasn’t going to respond to him again. However, Katz’s article represents a very common misconception about science-based medicine that is worth refuting. It is not my intention to be arguing back and forth with Dr. Katz every couple of weeks, but I did think it worth one more round. I think you’ll understand why by the end of this post.

First, however, a brief recap is in order for readers who might not have been following the discussion over the last month or so. It all started a couple of weeks ago, when Jann Bellamy, in response to a special issue of the American Journal of Preventative Medicine edited by Katz and dedicated to making the case for integrative medicine in preventive medicine training, quite correctly discussed how “integrative medicine” is always all about the “potential.” Indeed, after having spent considerable sums of federal grant money studying the “integration” of pseudoscience into medicine with respect to preventive care, the journal couldn’t come up with any concrete examples how integrative medicine adds anything (other than quackery) to medicine. Dr. Katz, who is well-known in the world of quackademic medicine for his infamous 2008 speech in which he asserted that physicians need to use a “more fluid concept of evidence” in evaluating treatments, particularly “complementary and alternative medicine” (CAM), responded with another HuffPo article entitled “Science and Medicine, Fools and Fanatics: The ‘Fluidity’ of Woo“. In lieu of reasonable, science-based arguments, Dr. Katz’ article was little more than a rant that consisted mainly of outrage that mere mortals lacking his awesome academic credentials had had the temerity to question his awesomeness and dedication to science coupled with an accusation that we are just too rigid and simplistic in our thinking to understand the subtle complexities of how different standards of evidence must be applied to complex patients. Steve Novella and I both responded that we understand just fine, explained how doctors do this all the time without using quackery like naturopathy and homeopathy (both of which Katz has advocated), and pointed out his argumentum ad ignorantiam with respect to energy medicine.

There’s where I thought it would end. Unfortunately, I was mistaken. On Friday, Katz launched another broadside at us, couched in the form of an argument that medicine must “clean its own house” before worrying about his quackademic medicine. It’s something I hear often enough that I thought it would be worth responding to, even if Dr. Katz was indeed trolling us.
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Posted in: Critical Thinking, Medical Academia, Quality Improvement, Surgical Procedures

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