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Is there a reproducibility “crisis” in biomedical science? No, but there is a reproducibility problem

NOTE: Anyone who has seen several derogatory articles about me on the web and is curious about what the real story is, please read this and this.

Journal of Irreproducible ResultsMost scientists I know get a chuckle out of the Journal of Irreproducible Results (JIR), a humor journal that often parodies scientific papers. Back in the day, we used to chuckle at articles like “Any Eye for an Eye for an Arm and a Leg: Applied Dysfunctional Measurement” and “A Double Blind Efficacy Trial of Placebos, Extra Strength Placebos and Generic Placebos.” Unfortunately, these days, reporting on science is giving the impression that the JIR is a little too close to the truth, at least when it comes to reproduciblity, so much so that the issue even has its own name and Wikipedia entry: Replication (or reproducibility) crisis. It’s a topic I had been meaning to write about again for a while. Fortunately, A recent survey published in Nature under the somewhat clickbaity title “1,500 scientists lift the lid on reproducibility” finally prodded me to look into this question again. Before I get to the survey itself, though, I can’t help but do my usual pontificating to provide a bit of background.
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Posted in: Basic Science, Pharmaceuticals, Politics and Regulation, Science and Medicine

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False balance about Stanislaw Burzynski and his disproven cancer therapy, courtesy of STAT News

Stanislaw Burzynski: 40 years of failure to prove that his antineoplastons are effective against cancer.

Stanislaw Burzynski: 40 years of failure to prove that his antineoplastons are effective against cancer.

One common theme that has been revisited time and time again on this blog since its very founding is the problem of how science and medicine are reported. For example, back when I first started blogging, years before I joined Science-Based Medicine in 2008, one thing that used to drive me absolutely nuts was the tendency of the press to include in any story about vaccines an antivaccine activist to “tell the other side” or to “balance” the story. So in a story on vaccines, on one side you would have Paul Offit, a bona fide, legitimate vaccine expert, and on the other side you would have J.B. Handley, Jenny McCarthy, Andrew Wakefield, or a lesser light of the antivaccine movement. This same trope included stories about autistic children in which a reporter does a human interest story about a family struggling with raising an autistic child in which he lets the parents spout antivaccine misinformation, providing only a brief token quote by a scientist for “balance.” Thus, whether they intended it or not, the reporter would let the emotional impact of the story serve as persuasion to believe the parents’ antivaccine views. So, even though there was not (and hasn’t been at least since 2001 or probably much earlier) anything resembling legitimate scientific controversy over the question of whether vaccines cause or contribute to autism, the press aided the antivaccine movement in keeping alive the appearance of a controversy. It was, as I like to call these things, a manufactroversy, a controversy manufactured by the antivaccine movement to give the appearance of an actual scientific controversy. It’s a time-dishonored journalistic failing that is still a major problem with reporting on, for example, anthropogenic global climate change and genetically modified organisms (GMOs).

Sometimes, however, the press is teachable. A few years ago, after already having blogged about vaccines and autism for several years, I started noticing fewer stories with false “balance” and more stories that simply treated the antivaccine movement like the fringe movement it was, either not bothering to mention it or, if it had to mention it, basically letting scientists explain why it’s bad science and dangerous to public health. These days, false balance and stories that are antivaccine propaganda are relatively rare, aside from stories by fringe journalists like Sharyl Attkisson and Ben Swann. That’s a good thing. Unfortunately, I wish I could say that I really believe it was due to the efforts of skeptics and science advocates more than it was due to the discrediting of a major antivaccine figure, Andrew Wakefield, but even six years after Wakefield lost his medical license and saw his infamous 1998 Lancet paper linking the MMR vaccine to bowel disease in autistic children (the one that ignited the MMR scare in the UK) retracted, I’m not entirely sure. Be that as it may, there still remain blind spots in the press. (more…)

Posted in: Cancer, Clinical Trials, Science and the Media

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No, a rat study with marginal results does not prove that cell phones cause cancer, no matter what Mother Jones and Consumer Reports say

The zombie story that cell phones cause cancer has risen from the grave yet again.

The zombie story that cell phones cause cancer has risen from the grave yet again.

There are certain myths that are frustratingly resistant to evidence, science, and reason. Some of these are basically medical conspiracy theories, where someone (industry and/or big pharma and/or physicians and/or the government) has slam-dunk evidence for harm but conspires to keep it from you, the people. For example, despite decades worth of negative studies, the belief that vaccines are harmful, causing conditions ranging from autism to sudden infant death syndrome, to all varieties of allergies and autoimmune diseases, refuses to die. Fortunately, this myth is one that, after more than a decade of hammering by scientists, skeptics, and public health advocates, has finally taken on enough of the patina of a fringe belief that most mainstream news sources no longer feel obligated to include the antivaccine side in stories about vaccines for “balance.” It is a zombie myth, one that, no matter how often it is “killed,” always seems to rise again. Unfortunately, the same cannot be said for the myth that cell phones cause cancer, as some very credulous reporting late last week demonstrated in the form of headlines like this:
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Posted in: Cancer, Public Health, Science and the Media

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Tai Chi versus physical therapy for osteoarthritis of the knee: How CAM “rebranding” works

Tai Chi versus physical therapy for osteoarthritis of the knee: How CAM “rebranding” works

“Complementary and alternative medicine” (CAM), now more frequently referred to as “integrative medicine” by its proponents, consists of a hodge-podge of largely unrelated treatments that range from seemingly reasonable (e.g., diet and exercise) to pure quackery (e.g., acupuncture, reiki and other “energy medicine”) that CAM proponents are trying furiously to “integrate” as coequals into science-based medicine. They do this because they have fallen under the sway of an ideology that posits a false dichotomy: To practice true “holistic” and “preventative” medicine, physicians and other health care professionals must embrace the pre-scientific, pseudoscientific, or anti-scientific ideas about medicine that underlie much of the “alternative medicine” being “integrated.”

Unfortunately, they’ve been largely successful over the last 25 years or so. From my perspective, the strategy that has been the most effective in mainstreaming quack practices as part of “integrative medicine” has been what I like to call the “rebranding” of practices that could and should be part of standard, science-based medicine. I’m referring, of course, to nutrition and dietary interventions, as well as lifestyle interventions, specifically exercise. To the extent that standard medicine might have undervalued such interventions over the past few decades, we practitioners of science-based medicine might be said, to some extent at least, to have brought this on ourselves. On the other hand, it is not as though doctors haven’t been advising our patients to quit smoking and moderate their drinking and to lose weight through altering their diet and exercising more for many decades. We do this because we know it works. For instance, when some naturopathic quack touts “curing” type II diabetes with a vegan diet plus exercise, we know that can work because we know that losing weight can normalize blood sugar values in many cases of type II diabetes. Heck, the Endocrine Society itself even says so, declaring “lifestyle optimization” as “essential for all patients with diabetes” and recommending that all patients with type II diabetes “strive to attain and maintain an optimal weight through a primarily plant-based diet high in polyunsaturated and monounsaturated fatty acids, with limited intake of saturated fatty acids and avoidance of trans fats,” that they lose weight through physical activity, and get enough rest. A vegan diet just takes that dietary advice to an unnecessary extreme, and any supplements recommended are almost always unnecessary.
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Posted in: Clinical Trials, Traditional Chinese Medicine

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CAM use and chemotherapy: A negative correlation

It turns out that the use of certain forms of CAM makes it less likely that breast cancer patients will receive the chemotherapy they need.

It turns out that the use of certain forms of CAM makes it less likely that breast cancer patients will receive the chemotherapy they need.

So-called “alternative” medicine is made up of a hodge-podge of health care practices and treatments based on beliefs that are unscientific, pre-scientific, and pseudoscientific. These modalities include practices as diverse as homeopathy, traditional Chinese medicine, reflexology, reiki and other forms of “energy medicine” based on vitalism, chiropractic, and naturopathy, and that’s a short list of the quackery that falls under the rubric of the term “alternative medicine.” Unfortunately, this unscientific, pre-scientific, and pseudoscientific hodge-podge of treatments rooted in nonsense is rapidly being “integrated” into real medicine, thanks to an unfortunately influential movement in medicine whose members have been seduced into thinking that there might be something to them and view “integrating” them into medicine as means of practicing more “holistic” and “humanistic” medicine. This “integration” started out by being called “complementary and alternative medicine” (CAM) but now among believers the preferred term is usually “integrative medicine,” largely because it eliminates the word “alternative,” which implies (correctly) that the modality is not real medicine, and “complementary,” which implies a subsidiary status, a status of being nice to have but not essential.

Particularly harmful is the hostility towards conventional medicine that often strongly correlates with use of alternative medicine. Indeed, some people even choose to rely on alternative medicine instead of real medicine to treat cancer. Unsurprisingly, the results of such a decision are generally not very good. Actually, they are almost always terrible. Very, very terrible indeed. Not surprisingly, the use of alternative medicine is associated with bad outcomes. Cancer patients who might have survived die because of it. It’s not as though it hasn’t been studied either, although the main studies I’m aware of tend to look at the bad outcomes in patients who choose alternative medicine. There is another question, and it’s one that a new study published in JAMA Oncology last week seeks to answer. It’s a study that briefly made the news, producing headlines like:
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Posted in: Cancer, Herbs & Supplements

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Nobody licenses quacks in my state! HB 4531 and the licensing of naturopaths in Michigan

Just as nobody steps on a church in Peter Venkman's Manhattan, nobody licenses quacks in my state...I hope.

Just as no giant marshmallow man steps on a church in Peter Venkman’s Manhattan, nobody licenses quacks in my state…I hope.

Over the years, I’ve taken care of women with locally advanced breast cancer so advanced that it’s eroded through the skin, forming huge, nasty ulcers filled with stinky dead cancer tissue that’s outgrown its blood supply, leaving the patient in chronic pain. If the patient is fortunate, her cancer has not metastasized beyond her axillary lymph nodes (the lymph nodes under her arm), and her life might still be saved by a combination of chemotherapy, radical surgery, and radiation. If the patient is not fortunate, either the cancer has metastasized and she is doomed or hasn’t metastasized yet, but it’s invaded into the chest wall and the nerves in her axilla (the structures under the arm), making it impossible to remove surgically but not likely to kill her any time soon. In the latter case, chronic pain, infection, and blood loss is what the patient will look forward to until the cancer either metastasizes or invades a vital structure. Fortunately, I’ve only seen a handfull of these patients over the last 20 years. Fortunately, the number of such patients I’ve seen and taken care of has been small.

I fear that, before long, I’m going to bee seeing a lot more of them. Leave it to Jann Bellamy to wake me up to that possibility.

I’m referring, of course, to her post last week about yet another attempt by naturopaths to expand their scope of practice. Worse, this is happening in my state through Michigan House Bill 4531, which has been approved by the Michigan Committee on Health Policy and referred to the full House for consideration. Yes, of these patients I’ve seen with horrific neglected breast cancers, at least half of them had relied on naturopaths before they came to the attention of real oncologists and surgeons. The last time I wrote about naturopaths trying to expand their scope of practice in my state was in 2013 in the form of a bill that was not as broad as HB 4531, namely HB 4152. Fortunately, it went nowhere and, in contrast to HB 4531, didn’t even make it out of the Committee on Health Policy.

Although Jann has already ably discussed the bill and occasional Science-Based Medicine (SBM) contributor Peter Lipson has referred to naturopaths as fake doctors in white coats (which is true), as well as why naturopathy is unscientific and how he as a primary care internist not infrequently has to clean up the messes left when local naturopaths treat patients incompetently, this is my state, and I can’t help but chime in myself. What I will try to do is to predict what the potential consequences will be if HB 4531 passes and expands the scope of practice to be nearly as broad as that of MDs practicing primary care medicine. I will do that by looking at real world examples of naturopathic shenanigans and disasters both within our very own state, because these are the people with whom the reins of primary care will be shared if HB 4531 were to pass.
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Posted in: Homeopathy, Naturopathy, Politics and Regulation

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“Integrative” medicine versus “alternative” medicine

“Integrative” medicine versus “alternative” medicine

I’ve written a lot about the language issue with respect to alternative medicine. As I like to put it (at least in shortened form), first there was quackery. Quacks did not like that name at all, and thus was born alternative medicine. And the quacks did think it good—for a while. There was a problem, however. “Alternative” medicine implied (correctly, of course) that what was being discussed was not real medicine, and the quacks could not abide that. Thus was born “complementary and alternative medicine” (CAM).

And the quacks thought this very good indeed.

Unfortunately, it was not long before the problem with the term CAM became apparent. It had the word “complementary” in it. The implication of that word, of course, is that what they were doing was still somehow not real medicine. It was complementary to real medicine, the icing on the cake, if you will. Real medicine could do without it, and having that implication in the very name that their evolving specialty had taken on was offensive to the quacks.

So they changed it.
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Posted in: Basic Science, Critical Thinking, Science and the Media

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Are medical errors really the third most common cause of death in the U.S.?

NOTE: Anyone who has seen several derogatory articles about me on the web and is curious about what the real story is, please read this and this.

Dr. Martin Makary claims that medical errors are now the third leading cause of death in the US. Is he correct?

Dr. Martin Makary claims that medical errors are now the third leading cause of death in the US. Is he correct?

It is an unquestioned belief among believers in alternative medicine and even just among many people who do not trust conventional medicine that conventional medicine kills. Not only does exaggerating the number of people who die due to medical complications or errors fit in with the world view of people like Mike Adams and Joe Mercola, but it’s good for business. After all, if conventional medicine is as dangerous as claimed, then alternative medicine starts looking better in comparison.

In contrast, real physicians and real medical scientists are very much interested in making medicine safer and more efficacious. One way we work to achieve that end is by using science to learn more about disease and develop new treatments that are as efficacious or more so than existing treatments with fewer adverse reactions (clinical equipoise). Another strategy is to use what we know to develop quality metrics against which we measure our practice. Indeed, I am heavily involved in just such an effort for breast cancer patients. Then, of course, we try to estimate how frequent medical errors are and how often they cause harm or even death. All of these efforts are very difficult, of course, but perhaps the most difficult of all is the last one. Estimates of medical errors depend very much on how medical errors are defined, and whether a given death can be attributed to a medical error depends very much on how it is determined whether a death was preventable and whether a given medical error led to that death.
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Posted in: Politics and Regulation, Public Health, Quality Improvement, Science and Medicine

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Medical exemptions to vaccine mandates for sale after SB277! Get ’em before they’re gone!

NOTE: Anyone who has seen several derogatory articles about me on the web and is curious about what the real story is, please read this and this.

SB277, which eliminates nonmedical exemptions to school vaccine mandates in California, is a very good law, but it's not perfect. Unfortunately, one provision allows the issuance of medical exemptions based on the say-so of doctors using antivaccine misinformation and pseudoscience.

SB277, which eliminates nonmedical exemptions to school vaccine mandates in California, is a very good law, but it’s not perfect. Unfortunately, one provision allows the issuance of medical exemptions based on the say-so of doctors using antivaccine misinformation and pseudoscience.

I realize that it’s a cliché to say so, but some clichés are true. Time really does fly. It’s hard to believe that a year ago California—and, by proxy, the rest of the country—was in the throes of a major political war over the bill SB277. SB277, you will recall, was a bill introduced into the California Assembly in the wake of the Disneyland Measles outbreak in early 2015 that eliminated non-medical exemptions to school vaccine mandates beginning with the 2016-2017 school year. Ultimately, SB277 passed and was signed into law by Governor Jerry Brown last July. It was an uncommon victory for science and public health, and already appears to be having a positive effect on vaccine uptake in kindergarten children.

Unfortunately but not unexpectedly, to say that the proposal and passage of SB277 into law drove the antivaccine movement into even greater fits of crazy in response is to put it mildly. It became a common trope on antivaccine websites and blogs to see SB277 compared to fascism, in particular the Holocaust. Robert F. Kennedy, Jr. and “Dr. Bob” Sears explicitly compared SB277 to the Holocaust. Truly, the Godwin was strong in the antivaccine movement. One particularly offensive meme that went around at the time consisted of antivaccinationists suggesting that SB277 was a major step in the direction of requiring unvaccinated children to wear a badge or armband to identify themselves, the way that the Nazis required Jews to wear badges or armbands with a yellow Star of David on them. One, Heather Barajas, even went so far as to be photographed with her children wearing such an “unvaccinated” badge and juxtapose that photo with photos of Jews from the Third Reich wearing yellow Stars of David.
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Posted in: Homeopathy, Politics and Regulation, Public Health, Vaccines

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Reclassifying thyroid cancer and the willful misunderstanding of overdiagnosis

This is a panel showing some of the pathologic criteria for distinguishing invasive encapsulated follicular variant of papillary thyroid carcinoma from noninvasive. This is real science. Sayer Ji's rant is not.

This is a panel showing some of the pathologic criteria for distinguishing invasive encapsulated follicular variant of papillary thyroid carcinoma from noninvasive. This is real science. Sayer Ji’s rant is not.

If there’s one lesson that we here at Science-Based Medicine like to emphasize, it’s that practicing medicine and surgery is complicated. Part of the reason that it’s complicated is that for many diseases our understanding is incomplete, meaning that physicians have to apply existing science to their treatment as well as they can. The biology of cancer, in particular, can be vexing. Some cancers appear to progress relentlessly, meaning that it’s obvious that all of them must be treated. Others, particularly when detected in their very early stages through screening tests, have a variable and therefore difficult to predict clinical course if left untreated. Unfortunately, some people, such as Sayer Ji, don’t understand that. They like their medicine black and white, and if physicians ever change guidelines in order to align them more closely with scientific understanding, they write blisteringly ignorant articles like “‘Oops… It Wasn’t Cancer After All,’ Admits The National Cancer Institute/JAMA.”

Not exactly. An expert panel recommended reclassifying a specific thyroid lesion as not cancerous based on recent science. It’s called medicine correcting itself. Admittedly, this reclassification was probably long overdue, but what would Mr. Ji rather have? Medicine not correcting itself in this situation? In any case, when last I met Mr. Ji, he was happily abusing the science of genetics to argue that Angelina Jolie and other carriers of deleterious cancer-causing mutations don’t need prophylactic surgery because lifestyle interventions will save them through epigenetics, which to “natural health” enthusiasts like Mr. Ji seems to mean the magical ability to prevent any disease. Most recently, he has appeared on the deeply dishonest “documentary” about alternative medicine cancer cures, The Truth About Cancer, to expound on how chemotherapy is evil. His rant about the reclassification of a non-encapsulated follicular variant of papillary thyroid cancer as not cancer is more of the same, as you will see.
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Posted in: Cancer, Politics and Regulation, Public Health

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