The 2015 Nobel Prize in Physiology or Medicine was awarded Monday, acknowledging the developers behind two drugs used to treat parasite infections. In a shared award, William C. Campbell and Satoshi Ōmura won for the discovery of avermectin, and Youyou Tu won for the discovery of artemisinin. Given both of these products are derived from natural substances, and “natural” remedies are used in different alternative medicine philosophies, it is perhaps not surprising that advocates claimed that this somehow validates practices like Traditional Chinese Medicine (TCM) and naturopathy. The Association of Accredited Naturopathic Medical Colleges (AANMC) made the following announcement on their Facebook page:
Which if you follow the link to the CNN story and actually read it, is surprising. It doesn’t mention naturopathy at all. In fact, when you look closer at the two drugs and their development, this year’s Nobel Prize is actually an excellent case study that illustrates the inherent limitations and weaknesses in alternative medicine systems like naturopathy, herbalism or TCM, while reinforcing just what science-based medicine is capable of delivering. (more…)
On September 30, the U.S. District Court for the Southern District of Florida granted Dr. Novella’s motion for summary judgment, ending the lawsuit against him by Dr. Edward Tobinick and two of his companies. Earlier in the case, all of the other defendants had filed successful motions to dismiss or for summary judgment and were no longer parties to the case.
That he won the remaining issues in the case on a motion for summary judgment is highly significant. Summary judgment motions are granted sparingly by the courts. In granting his motion, the judge was required by law to view the facts in the light most favorable to Tobinick and the other plaintiffs and draw all reasonable inferences from those facts in their favor. Dr. Novella had to convince the judge that there was no dispute as to any of the relevant facts and that those undisputed facts entitled him to prevail. Because of this ruling, the case will not go to trial.
For a quick background, Tobinick filed a suit against Dr. Novella, the Society for Science-Based Medicine (SFSBM), Yale University and SGU Productions. The subject of his suit was an article Dr. Novella wrote here critical of his claims that perispinal etanercept can treat a variety of neurological conditions, as well as a second article, posted after suit was filed.
It seems alternative medicine is infiltrating into more and more organizations that should be based on science. We have quackademia in medical schools, integrative medicine clinics in hospitals and medical centers, government funding for alternative medicine research and education, coverage of alternative medicine by government and private health insurance, and acceptance of alternative practitioners in the VA and in military hospitals. Two weeks ago I wrote about an ill-advised effort to get naturopathy into the VA. Now it seems chiropractors have been lobbying to give all veterans and TRICARE beneficiaries access to chiropractic care. On the Society for Science-Based Medicine blog, Jann Bellamy has provided the details.
There are several bills pending: S. 398 and H.R. 1170 for the VA and H.R. 802 for TRICARE. There is also a bill (H.R. 542) that would include chiropractors in the National Health Services Corps. The American Chiropractic Association has issued statements in support of those bills. In their statements, they misrepresent what chiropractic is and what it can do. (more…)
Having written about pseudoscience and quackery continuously for over a decade and having engaged in conversations about it online for over 15 years, I’ve come to recognize a number of traits that are virtually the sine qua non of quacks and pseudoscientists and their believers. Obviously, one of them is a severe case of the Dunning-Kruger effect, a tendency of those with low expertise in a topic to overestimate their expertise and express far more confidence in their conclusions than warranted while those with high expertise know enough to know how much they don’t know about a topic and thus tend to express more uncertainty and caveats. Basically, the Dunning-Kruger effect describes how unskilled individuals express an illusory superiority, mistakenly believing their knowledge, competence, and ability to be much higher than it really is.
As a result of the Dunning-Kruger effect, coupled with other cognitive shortcomings suffered by all human beings (but seemingly amplified in believers in quackery and pseudoscience) that lead them to believe in pseudoscience, such as confusing correlation with causation, motivated reasoning, and the like, believers in pseudoscience are often so absolutely rock-solid in their beliefs that they are virtually impossible to reason with. It is incredibly difficult to change their minds, and disconfirming evidence often causes them to dig in all the more deeply to defend their beliefs. Not uncommonly, this leads them to commission studies designed to support their beliefs. But what happens when such a study does not actually support their belief? What happens when such a study backfires spectacularly and not only fails to support their belief, but emphatically so? Skeptics were re-treated to just such a spectacle last week when SafeMinds and other antivaccinationists were burned by a study they funded (subscription required):
Between 2003 and 2013, SafeMinds provided scientists from the University of Texas Southwestern School of Medicine, the University of Washington, the Johnson Center for Child Health & Development and other research institutions with approximately $250,000 to conduct a long-term investigation evaluating behavioral and brain changes of baby rhesus macaques that were administered a standard course of childhood vaccines. (The National Autism Association, another organization that has questioned vaccine safety, also provided financial support for this research.) The latest paper in the multiyear project was published Monday in the Proceedings of the National Academy of Sciences (PNAS). In it, the researchers concluded that vaccines did not cause any brain or behavioral changes in the primates.
Astute readers will recognize that I’ve written about similar papers before reporting that pediatric vaccines cause changes in behavior and/or brain structure in macaque monkeys. Specifically, way back in 2008, I noted the initial report of this ongoing study, first when preliminary results were reported as a poster presentation and then later another publication from the same group published in 2009. Steve Novella and a certain well-known friend of the blog have also described how poor experiments published from these studies in 2010 were, the latter of whom cited several other major criticisms of the study, not the least of which was some reporting of changes in the size of a part of the brain known as the amygdala that were…hard to believe. There were also a lot of issues with the control group chosen.
Basically, these abstracts and papers reported the results of an ongoing study looking at infant vaccines in macaque monkeys to see if there was an effect on socialization or changes in brain anatomy, the key hypothesis seeming to be that thimerosal-containing vaccines cause autism. (The investigators even added thimerosal to some of the vaccines because they weren’t being made with thimerosal anymore!) You can read the links I cited just now if you want the gory details; suffice to say that these were not good studies and not particularly good evidence that vaccines cause autism, as shown by the fact that homeopaths loved the study, and ultimately the paper examining hepatitis B specifically was withdrawn. Yet these reports were flogged for quite a while by the antivaccine movement as proof positive primate data that vaccines are Evil.
Fast forward to 2015. Now we have a much larger, much better study. It’s even by the same people. And guess what? It’s as negative as negative can be. No wonder SafeMinds and other antivaccinationists are unhappy. Let’s take a look. (more…)
I noted with understanding that the Doubtful News can’t take it anymore. The relentless tsunami sewage slurry of pseudo-science (who says I can’t alliterate?) has worn her down. She is:
currently experiencing a phase in which I can’t seem to bring myself to promote another ridiculous story in the media about a haunted location, scary sounds from the sky, or the latest outrage fueled by ancient superstition. You might call that… jaded. It’s been over four years now of nearly daily effort to keep track of the weird world of woo. It can wear one down when virtually or literally the same thing appears and reappears over and over as if it hasn’t already been passed around a million times.
I sympathize. I have had a touch of SCAM ennui of late. It is a bit due to the repetitiveness of the SCAMs. I still find the variations on the theme of pseudo-sciences curious. It is like infectious diseases where every case has unique and subtle diversity so no two SCAMs are the same. But there are almost 4,000 clinical trials on acupuncture and I would wager that they all have several of the same half-dozen fatal errors. It is like hand hygiene at work. We have known for, oh what, 160 years, that hand hygiene prevents the spread of disease but people still can’t do it right. We know how to do a good clinical trial but the SCAMsters just can’t seem to figure it out.
The ennui is not the seeming futility of the endeavor. I have always been comfortable with futility, secure, as an example, in the knowledge that someday I will be consumed by the bacteria I spent a career killing. Unless, of course, they get me cremated right away. I keep looking for a motto for the SfSBM; I am attracted to “Sisyphus had it easy.” (more…)
October is National Chiropractic Health Month (NCHM) and chiropractors can’t resist the opportunity to overstate, obfuscate, and prevaricate in celebration.
They do this in the face of some unfortunate (for them) statistics revealed by a recent Gallup Poll. The Poll was paid for by Palmer College of Chiropractic as part of an effort to increase the chiropractic share of the health care pie. (There is also a secondary analysis of the poll in the Journal of Manipulative and Physiological Therapeutics.) We’ll get to those stats in a few minutes.
But first, in celebration of NCHM, the American Chiropractic Association (ACA) has produced a set of six graphics chiropractors can download and display. Four of them fudge on the facts. Let’s take a look at these graphics, compare them to the evidence cited in support of their claims, and see where the ACA went astray. (The ACA also hosted a twitter chat yesterday with the hashtag #PainFreeNation.)
The study cited as evidence for this graphic actually compared both manual thrust manipulation (MTM) and mechanical-assisted manipulation (MAM) to each other as well as manipulation versus usual medical care (UMC). Although MAM, such as the Activator Method, is the second most common manipulation technique used by American chiropractors, is increasing in popularity among them, and is touted to be a safe and effective alternative to MTM, this study found that MTM is more effective (at 4 weeks) than MAM and that MAM had no advantage over UMC. But you don’t see that in this graphic.
The overall goal of science-based medicine is to maintain and improve the standard of science in the practice of medicine at every level. At the heart of the scientific basis of medical knowledge and practice is a process known as peer-review. We have occasionally written about peer-review on SBM, and once again the process is under the microscope over a specific question – should peer review be open or blinded?
What is peer review
The term peer-review refers to a pre-publication process in which a journal editor will send a submitted manuscript to 2-3 experts in a field relevant to the paper to carefully examine every aspect of the paper. They then provide a detailed analysis of the paper: is the research question relevant and appropriate, did the study design properly address the question, were the methods rigorous, was the statistical analysis appropriate, was the data presented fairly, are the conclusions supported by the data, did the authors account for other publications addressing the same issue, and did they address every possible question or objection?
The reviewers’ reports will make specific recommendations for changes that would be necessary to improve the paper, and also make their bottom-line recommendation: accept as is, accept with revisions, or deny. The journal editor(s) then rely upon those reviews, plus their own assessment, to make a final decision.
The FDA recently approved flibanserin (brand name Addyi) for the treatment of hypoactive sexual desire disorder (HSDD) in pre-menopausal women. The story of flibanserin illustrates several of the issues we have confronted on this blog:
- It was hyped in the media.
- Misleading headlines called it the female Viagra.
- It was initially rejected by the FDA and was approved only after extensive lobbying efforts.
- The drug is only minimally effective and has a lot of drawbacks.
- Two of the three supporting scientific studies claimed effectiveness based a surrogate measure but failed to show any measurable improvement in sexual desire.
- A campaign to support “women’s sexual health equity” pushed for approval, framing it as a step towards correcting what they perceived as gender bias (they claimed the FDA was biased because it had provided Viagra to help men have sex but hadn’t done anything to help women have sex).
- And the validity of the diagnosis of HSDD itself has been questioned.
“Liquid biopsies” for cancer screening: Life-saving tests, or overdiagnosis and overtreatment taken to a new level?
I’ve written many times about how the relationship between the early detection of cancer and decreased mortality from cancer is not nearly as straightforward as the average person—even the average doctor—thinks, the first time being in the very first year of this blog’s existence. Since then, the complexities and overpromising of various screening modalities designed to detect disease at an early, asymptomatic phase have become a relatively frequent topic on this blog. Before that, on my not-so-super-secret other blog, I noted that screening MRI for breast cancer and whole body CT scans intended to detect other cancers early were not scientifically supported and thus were far more likely to cause harm than good. That was well over ten years ago. Now we have a company offering what it refers to as a “liquid biopsy” for the early detection of cancer. I fear that this is the recipe for the ultimate in overdiagnosis. I will explain.
The problem, of course, is that disease progression, including cancer progression, is not always a linear process, in which the disease progresses relentlessly through its preclinical, asymptomatic phase to symptoms to complications to (depending on the disease) death. There is such a thing as disease that remains asymptomatic and never progresses (at which point it’s hard to justify actually calling it a disease). As I pointed out in my first SBM post on the topic, at least three-quarters of men over 80 have evidence of prostate cancer in autopsy series. Yet nowhere near three-quarters of men in their 80s die of prostate cancer—or ever manifest symptoms from it. This is what is meant by overdiagnosis, the diagnosis of disease that doesn’t need to be treated, that would never cause a patient problems.
When teaching medical students and residents, I frequently emphasize that overdiagnosis is different from a false positive because overdiagnosis does diagnose an actual abnormality or disease. For example, ductal carcinoma in situ (DCIS) diagnosed by mammography leading to a biopsy is a real pathological abnormality; it is not a false positive. We just do not know which cases of DCIS will progress to cancer and which will not, leading to a question of how DCIS should be treated or at the very least whether we should treat it as aggressively as we do now, particularly given that the apparent incidence of DCIS has increased 16-fold since the 1970s, all of it due to mammographic screening programs and the increased diagnosis of DCIS and early stage breast cancer has not resulted in nearly as much of a decrease in the diagnosis of advanced stage breast cancer as one would expect if early diagnosis were having an impact in reducing the diagnosis of late stage disease.
Overdiagnosis would not be such an issue if it didn’t inevitably lead to overtreatment. DCIS, for instance, is treated with surgery, radiation, and anti-estrogen drugs. Early stage prostate cancer used to be treated with radical prostatectomy, but now more frequently with radiation. Many of these men and women didn’t actually need treatment. We just don’t know which ones. This is why over the last six or seven years a significant rethinking of screening for breast and prostate cancer has occurred. There has been a backlash, of course, but the rethinking seems to have taken hold.
Not everywhere, of course. (more…)
Much of what is discussed in this article has been said before in previous articles I have written for Science-Based Medicine. But since the audience for SBM has greatly increased over the past few years, some subject matter should be repeated for the new readers and researchers coming to this site for reliable information on health care.
Many consumers now search SBM for articles dealing with controversial alternative treatment methods that have been shown to be ineffective or to be loaded with fraud and quackery. Chiropractic in particular continues to be problematic for its failure to renounce the scientifically indefensible, nonfalsifiable subluxation theory that defines the profession as a whole. A review of chiropractic web sites reveals that many chiropractors continue to base their treatment methods on subluxation theory, encompassing a broad scope of health problems. Some chiropractors are now including use of “functional medicine” which uses “natural tools” to treat diabetes, thyroid disease, neuropathy, and other diseases best treated by conventional medical care. Most alarming of all is the treatment of infants and children by “pediatric chiropractors.” Chiropractors are being certified in 10 different specialties, including a diplomate in Diagnosis and Internal Disorders.
As long as chiropractic is licensed as a health-care profession based on subluxation theory or some other unscientific approach, it will continue to be subjected to scrutiny and criticism by the science-based community. It is, in fact, the moral and ethical responsibility of science-based practitioners to oppose any form of unscientific health care, wherever it might exist, separating sense from nonsense without being influenced by politics, special interest, pseudoscience, or belief systems.