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Archive for Politics and Regulation

Antivaccinationists and the Nation of Islam protest in front of the CDC, but don’t you dare call them “antivaccine”

Flyer for "CDC Truth" Rally. Apparently a bunch of antivaccine activists showed up in Atlanta on Saturday to annoy CDC employees and try to use the manufactured "scandal" of the so-called "CDC whistleblower" to attack vaccines. Same as it ever was.

Flyer for “CDC Truth” Rally. Apparently a bunch of antivaccine activists showed up in Atlanta on Saturday to annoy CDC employees and try to use the manufactured “scandal” of the so-called “CDC whistleblower” to attack vaccines. Same as it ever was.

If there’s one thing that’s guaranteed to anger most antivaccine activists, it’s a skeptic calling them “antivaccine.” The reason, of course, is that (1) many of them actually believe they are “not antivaccine” but rather “pro-vaccine safety,” even though their words and actions proclaim otherwise and (2) they crave legitimacy. They want desperately to be taken seriously by the government and scientific community. The problem is that, again, by their very words and actions they make it almost impossible for anyone who knows anything about vaccines to take them seriously, except as a threat to public health. They have no one but themselves to blame, as a critical perusal of Age of Autism, The Thinking Moms’ Revolution, VacTruth (and VaxTruth), or any number of antivaccine websites and blogs will indicated to anyone of a scientific bent who has the intestinal fortitude to plunge down any or all of those rabbit holes of magical thinking and pseudoscience.

Another thing that I’ve come to understand over the more than a decade that I’ve been doing this is that there is a profound tension between what I like to call the two wings of the antivaccine movement. Basically, as is the case in most political or ideological movements, antivaccine activists gravitate towards one of two views. The first (and most prominent view) tends to be the pragmatic view. These are the antivaccinationists who deny vociferously that they are “antivaccine” and instead portray themselves as “pro-safe vaccine.” They want to appear reasonable and are willing to take partial victories on an incremental path towards achieving their ends. Then there are the “loud and proud” antivaccine activists. They don’t eschew or hide from the term “antivaccine.” They embrace it and proudly proclaim that they believe that vaccines are irredeemably toxic, that they don’t protect against disease, that big pharma is a criminal syndicate intent on poisoning their children and turning them autistic, and that the CDC is complicit in the whole plot. Of course, like all ideological movements, there is not a dichotomy; rather, there is a continuous spectrum between the two. Also, in this case, the two groups differ more on tactics than actual beliefs. As I’ve found many times, push a “reasonable” antivaccinationist, one who proclaims herself “not antivaccine” but “pro-vaccine safety,” and it’s usually not hard to get them to say things indistinguishable from the hard core antivaccinationists. They’ll basically cling to their self-perception as “pro-safe vaccine, while making the same evidence-free claims that vaccines cause autism, sudden infant death syndrome (SIDS), autoimmune diseases, diabetes, and all the other conditions on which antivaccinationists blame vaccines.
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Posted in: Politics and Regulation, Public Health, Religion, Vaccines

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Choosing Wisely: Changing medical practice is hard

OK, so Choosing Wisely isn't quite like this, but it's still very important.

OK, so Choosing Wisely isn’t quite like this, but it’s still very important.

We here at Science-Based Medicine like to point out that arguably the most striking difference between science-based medicine (and the evidence-based medicine from which we distinguish it) and alternative medicine, “complementary and alternative medicine” (CAM), or (as it’s called now) “integrative medicine” is a concerted effort to change for the better. In other words, in SBM, we are continually doing studies to improve practice. These studies take on two general forms: Comparing new treatments with old to determine if the new treatments work better and, as has become an imperative over the last several years supported by more research dollars, comparing existing treatments in order to determine which ones work better. In the case of the former, we are trying to add to our knowledge and thereby add more effective treatments, while in the case of the latter we are trying to weed out treatments that are less effective and/or less safe or that cost more money to produce the same results. Indeed, the rise of an explicit framework, evidence-based medicine, is a result of the desire of medicine as a profession to improve what it is doing. (Yes, I know this blog frequently criticizes EBM, but in the case of treatments that have science behind them EBM and SBM should be—and usually are—synonymous.) This is in marked contrast to CAM, where treatments based on prescientific vitalism never, ever go away, no matter how many clinical trials show them to be no better than placebo and basic science shows them to be ludicrously disconnected from reality.

An example of this imperative to make things better is Choosing Wisely. This is an initiative launched in 2012 in which the American Board of Internal Medicine (ABIM) Foundation challenged specialty societies to produce lists of tests and interventions that doctors in their specialty routinely use but that are not supported by evidence. The explicit goal of Choosing Wisely was to identify and promote care that is (1) supported by evidence; (2) not duplicative of other tests or procedures already received; (3) free from harm; and (4) truly necessary. In response to this challenge, medical specialty societies asked their members to “choose wisely” by identifying tests or procedures commonly used in their field whose necessity should be questioned and discussed. The resulting lists of “Things Providers and Patients Should Question” was designed to spark discussion about the need—or lack thereof—for many frequently ordered tests or treatments.
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Posted in: Clinical Trials, Politics and Regulation, Quality Improvement

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“Safe” dietary supplements can land you in the emergency room

Dietary supplements
If there’s one thing I’ve been consistent about, it’s that, however ridiculous all the other woo I routinely discuss here is—homeopathy, reiki, reflexology, I’m talking to you and your friends—herbal medicine and supplements might have value because they might have a physiological effect that is beneficial in treating or preventing disease. Of course, if that’s the case, it’s because the herb or supplement contains chemicals that act as drugs. They’re “dirty” drugs in that they are mixed with all sorts of other substances in the herb or supplement that might or might not have effects, which means that different lots of the herbs or supplements often have different activity, but they are drugs nonetheless. That’s why, for instance, doctors don’t tell patients to chew on foxglove leaves when they want a patient to get digoxin. Digoxin is a powerful drug with a relatively narrow “therapeutic window,” meaning that the difference between the levels of the drug in the blood needed for therapeutic effect are not very far from toxic levels; so predictable, reliable drug content is essential. I just learned a while ago that within the living memory of some older physicians digoxin actually was prescribed as crude extracts, which was very difficult and dangerous, hence the necessity of purification. In other cases, (such as Artemisinin, for which Youyou Tu was recently awarded the Nobel Prize in Physiology or Medicine), crude plant extracts do not contain sufficient quantities of the active component, necessitating its isolation, purification, and, in some cases, chemical modification to increase its absorption, stability, or activity.

One thing that proponents of herbal medicine and supplements often forget, though, is that if herbs or supplements can have potentially beneficial effects (albeit difficult to regulate effects due to the crude, impure nature of the extracts often used) because they contain drugs, then herbs and supplements can also produce adverse events, again, because they contain drugs. You can overdose on herbs and supplements. This point was recently reinforced by a new study by Geller et al. published last week in the New England Journal of Medicine (NEJM), entitled “Emergency Department Visits for Adverse Events Related to Dietary Supplements.” It was carried out by investigators from the Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, and Chenega Government Consulting; and the Center for Food Safety and Applied Nutrition and the Division of Public Health Informatics and Analytics and the Division of Dietary Supplement Programs, Food and Drug Administration. The title pretty much tells you what the study is about, and what the study is about is that dietary supplements cause a lot of visits to the emergency room every year; 23,005 (95% confidence interval [CI], 18,611 to 27,398) emergency department visits per year can be attributed to adverse events related to dietary supplements.
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Posted in: Herbs & Supplements, Politics and Regulation

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The Amarin case: off-label promotion and a double standard for prescription drugs vs. dietary supplements

Screenshot 2015-10-14 23.04.19

A recent court decision enjoined the FDA from threatening prosecution against a drug manufacturer for off-label promotion of a prescription drug. Based on this and an earlier decision by an appellate court, it appears that the FDA can no longer prosecute a pharmaceutical manufacturer for a truthful and non-misleading off-label promotion to health care professionals, at least within the jurisdiction of the United States Court of Appeal for the Second Circuit, which covers Connecticut, New York and Vermont.

For this reason, the case, Amarin Pharma, Inc. v. FDA (Amarin), received a good deal of attention in the world of drug regulation. (Here is an excellent analysis by two attorneys who practice in the area of drug regulation.) First, we’ll take a look at the issue of off-label promotion. Then we’ll look at an issue that really didn’t engender much comment, but that I find fascinating: how the same substance can be subject to very different regulatory treatment, depending on whether it is sold as a dietary supplement or prescription drug.

Background: Initial approval of Vascepa and subsequent research

In 2012, the pharmaceutical manufacturer Amarin received FDA approval for a new drug, Vascepa, as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia (triglycerides ≥ 500mg/dL). Approval was based on a single phase 3 clinical trial.

Following that approval, Amarin designed a second single phase 3 clinical trial to look at the effect of Vascepa on triglyceride levels among statin-treated patients with persistently high triglycerides (≥ 200 and ≤ 500 mg/dL). Pursuant to an agreement with the FDA that, if it met certain conditions, Vascepa would obtain approval for this use, Amarin proceeded with an FDA-approved protocol. As a further condition of the agreement, it also began enrolling patients in a third trial to see if Vascepa actually reduced major cardiac events. (more…)

Posted in: Clinical Trials, Herbs & Supplements, Legal, Nutrition, Pharmaceuticals, Politics and Regulation

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Sarah Hershberger: “Health freedom” and parental rights vs. child welfare

Sarah Hershberger, pictured with her family in a 2014 Reason.tv video.

Sarah Hershberger, pictured with her family in a screenshot from a 2014 Reason.tv video.

One of the more depressing topics that I regularly write about on this blog includes of analyses of news stories of children with cancer whose parents decided to stop science-based treatment (usually the chemotherapy) and use quackery instead. There are, of course, variations on this theme, but these stories take form that generally resembles this outline: A child is diagnosed with a highly treatable cancer with an excellent cure rate. Standard science-based treatment is begun, but the child suffers severe side effects from the chemotherapy. After an incomplete course of chemotherapy, the parents, alarmed at their child’s suffering, start balking at further chemotherapy, either because the child refuses further treatment or because they do. At some point in this process the parents become aware of the claims of practitioners of this or that alternative medicine, who tell them that their child’s cancer can be cured without toxic chemotherapy, and, wooed by the siren song of a promise of a cure without suffering, the parents choose that instead. At this point, physicians, alarmed at the parents’ choice, call in their state’s child protective services team, and a court battle ensues. Sometimes the court battle results in an order that the child complete conventional therapy, as it did with, for example, Daniel Hauser or Cassandra Callender. Sometimes it ends with a compromise in which the child and/or parents can choose an unconventional practitioner, as in the case of Abraham Cherrix. All too often the courts utterly fail to protect children with cancer, as the Canadian courts did in the cases of Makayla Sault and JJ. Not infrequently, if the court rules against the parents, the parents flee with their child to avoid treatment, as happened with Daniel Hauser, Abraham Cherrix, and Sarah Hershberger. Usually, they ultimately come back.

However they turn out, over the years of looking into them I’ve found that these stories tend to bear a depressing similarity and predictability. For example, if the child does well, it is always attributed to the alternative treatment, even when the child received a significant amount of conventional therapy. This attribution derives from a fundamental misunderstanding of how the treatment of cancer works in that the problem with incomplete cancer treatment is not that it can’t cure the cancer but that it has less of a chance of doing so. As I’ve explained many times, the reason that treatment regimens for many pediatric cancers involve two years’ worth of chemotherapy is that over time pediatric oncologists learned the hard way that, although the first cycle of chemotherapy (usually called induction chemotherapy) can lead to remission, without the additional cycles the chances of recurrence are very high—unacceptably so. Consequently, children who stop chemotherapy early can be in remission; they’ve just been put at a high risk of recurrence.
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Posted in: Cancer, Herbs & Supplements, Naturopathy, Politics and Regulation

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Presidential candidate Ben Carson: Shilling for Mannatech with his very own alternative cancer cure testimonial?

Ben Carson fires up the Mannatech faithful by telling them how it helped him cure his prostate cancer. Well, that and the nerve-sparing prostatectomy he underwent and the fact that the spine lesions he thought to be metastases were really not metastases at all.

Ben Carson fires up the Mannatech faithful by telling them how it helped him cure his prostate cancer. Well, that and the nerve-sparing prostatectomy he underwent and the fact that the spine lesions he thought to be metastases were really not metastases at all.

Over the years, mainly at my not-so-super-secret other blog, I’ve frequently made the points that the vast majority of physicians are not scientists and, in fact, that many of them suffer from a severe case of Dunning-Kruger when it comes to science outside of biomedical sciences—or even biomedical sciences outside of their medical field of expertise. The most common science I’ve seen physicians embarrass themselves attacking has generally been evolution, with a disturbingly high number of physicians denying evolution and embracing creationism. Of these, the doctor I wrote about most frequently back in the day was the creationist neurosurgeon Michael Egnor, but with the onset of the 2016 Presidential race there’s been a new creationist neurosurgeon in town with arguably even more ignorant attacks on evolution. I’m referring, of course, to noted neurosurgeon Ben Carson, whose creationist stylings have been so bad that I had to use him as a poster child to demonstrate how the vast majority of physicians are not scientists and all too many of us have an inordinate and unjustified confidence in medicine as a “check on BS.”

Over the last couple of weeks since my post on the second Republican debate, in which Donald Trump spewed antivaccine nonsense and Ben Carson pandered to antivaccine views, even though past statements by him demonstrate that he knows better, unfortunately Carson has continued to spew statements that are nothing but downright embarrassing, be they his statement in the wake of the Oregon mass shooting that it would be better to attack an armed gunman during a mass shooting “because he can’t get us all” (complete with a seeming attitude that those who died were cowardly), his doubling down on that by claiming that if the Jews had been armed maybe things would have turned out differently in the Holocaust (neglecting the fact that Jews did resist), or his many other statements that make me wonder how someone with so little critical thinking skills could get through medical school and a neurosurgery residency to become such a respected surgeon.
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Posted in: Cancer, Herbs & Supplements, Nutrition, Politics and Regulation

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Chiropractors Lobby for Acceptance by the VA and TRICARE

Should TRICARE become TRICHIROPRACTIC?

Should TRICARE become TRICHIROPRACTIC?

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…)

Posted in: Chiropractic, Politics and Regulation

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More Lyme ‘Guidelines’

The black-legged tick responsible for spreading the bacteria that causes Lyme disease

The black-legged tick responsible for spreading the bacteria that causes Lyme disease

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…)

Posted in: Guidelines, Lyme, Politics and Regulation, Quality Improvement

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“Female Viagra?” Misleading Headlines and Regulatory Dilemmas

addyiThe 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.

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Posted in: Pharmaceuticals, Politics and Regulation

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Keep Naturopathy Out of the VA!

Let's not change the eagle into a duck

Let’s not change the eagle into a duck

AMVETS has joined with The American Association of Naturopathic Physicians in seeking to “promote natural, non-pharmacological approaches to treating patients suffering from chronic pain.” They are petitioning Congress and the VA to authorize bringing licensed NDs into the VA system. As a veteran myself, a retired Air Force Colonel and an MD, I find this appalling. During my twenty years service in the U.S. Air Force as a family physician and flight surgeon, I took pride in the high-quality science-based medical care my colleagues and I were able to provide. This proposal would jeopardize the welfare of our veterans by exposing them to substandard care with irrational, untested, and potentially harmful treatments. Letting naturopaths into the VA would be a grave mistake. (more…)

Posted in: Naturopathy, Politics and Regulation

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