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Archive for Politics and Regulation

Home birth tragedies lead to changes in Oregon

Pregnant1
Oregon Health Plan (OHP), the state’s Medicaid insurer, will no longer cover planned home and birth center births for women whose pregnancies aren’t classified as low risk, based on newly-established criteria. The Health Evidence Review Commission (HERC), a group of experts designated by the state, came up with criteria that will exclude women with a substantial list of conditions, such as high blood pressure, diabetes, previous cesarean section, multiple gestation (more than one fetus), and various complications in previous pregnancies. Feelings ran high on both sides of the issue, which was described as the most contentious ever to come before the HERC.

The HERC’s decision was based on an exhaustive 100-page evidence review; a review, according to them, hampered by the low quality of the evidence on the safety of planned out-of-hospital births. Actually, there is a paucity of evidence altogether. Studies and statistics from other countries, like the Netherlands, were of limited utility because those countries have more stringent midwifery education and training requirements and non-hospital births are better integrated into the health care system.

Most planned out-of-hospital births in Oregon are attended by what are known as direct-entry midwives (DEM), as opposed to nurse midwives, and a few naturopathic doctors. (We’ll look at the many variations of midwifery in a minute.) Since OHP pays for 23% of Oregon births, the economic impact on direct-entry midwives could be substantial. This effect will be amplified when other insurers, who are expected to follow OHP’s new criteria, change their own coverage rules. (more…)

Posted in: Guidelines, Legal, Naturopathy, Obstetrics & gynecology, Politics and Regulation, Public Health

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Holding the supplement industry to account: Can we learn from tobacco regulation?

When it comes to supplements, you can't trust what's on the label

When it comes to supplements, you can’t trust what’s on the label

The idea that “natural” products are safe and effective has been so effectively marketed to us that many don’t recognize it as a fallacy. Much of the supplement industry is built around an appeal to nature. Supplements are described as natural, gentle, and “holistic”. Medicine, especially prescription drugs, is the opposite. They’re “chemicals”. They’re risky and dangerous – just look at that list of side effects! Supplements are packaged beautifully, have impressive claims, and are for sale at Whole Foods. Drugs are hazardous: They may come in a plain vial, with warning labels, detailed information sheets, and cautious statements about their effectiveness. Is it any wonder that many consumers, when faced with health concerns or medical issues, instinctively think of supplements as a safer alternative? Purveyors of supplements and alternative medicine have leveraged this fallacy so effectively that it’s even guided the regulations that allow their sale. Regrettably, the result is a marketplace that puts consumers’ interests last. The supplement industry has completely stacked the odds against the consumer, challenging their ability to make informed decisions about their health. Most supplements on the market have never been properly tested for safety or effectiveness. And those that have been tested have largely been shown to be ineffective – or in the case of products like vitamins, often unnecessary. And while there are undoubtedly some ethical companies out there, the industry is regularly revealed to resemble a wretched hive of scum and villainy. Despite this, the industry has gone from success to success – in terms of sales, at least. In 1994 supplement sales were about $4 billion in the US. It’s now a $37 billion industry that is remains only lightly regulated – or largely unregulated. With recent action taken against fraudulent products, there are more questions than ever about how to force the supplement industry to make consumer protection a priority. A new paper in Drug Testing and Analysis makes a provocative suggestion: Local and state governments already regulate another hazardous product: tobacco. Can lessons learned from the tobacco wars improve the safety of supplements? (more…)

Posted in: Epidemiology, Health Fraud, Herbs & Supplements, Politics and Regulation, Public Health

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Brian Clement claims Hippocrates treatments “reverse” multiple sclerosis

Brian Clement

Brian Clement

American charlatan Brian Clement made another trip to Canada recently and was caught on audiotape claiming multiple sclerosis could be “reversed” at the Hippocrates Health Institute (HHI), where he serves as Director. This is yet another in a series of his misrepresentations about the effectiveness of the quack treatments offered at HHI. Indeed, Clement calls to mind the old joke about inveterate liars:

Q: Know how can you tell this guy is lying?

A: His lips are moving.

Once again, the Canadian Broadcasting Corporation (CBC), which has done an outstanding job exposing Clement and his mendacity, caught him in this particular fabrication. (The American media, by contrast, has largely ignored the story, even to the point of printing credulous puff pieces about Clement.) According to the CBC, it:

obtained a recording of a lecture Clement gave in September in Montreal where he said, “Last week, we had somebody at the institute that reversed multiple sclerosis.”

He went on to claim that many other people who visited his Florida spa, the Hippocrates Health Institute, saw similar results.

“A nurse that came to us two years ago was crippled, had braces on. By the time she left Hippocrates, she reversed the multiple sclerosis.

“And mainstream medicine, they think it’s remarkable. I’ve seen lots and lots of people over the years did that.”

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Posted in: Cancer, Health Fraud, Legal, Politics and Regulation, Science and the Media

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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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The DC as PCP: the battle resumes

Daniel David Palmer, creator of the nebulous subluxation and father of chiropractic.

Daniel David Palmer, creator of the nebulous subluxation and father of chiropractic.

It has been almost five years to the day since I wrote my first post in “The DC as PCP” series. These posts (listed here) chronicle the continuing battles among various factions within the chiropractic profession over the subluxation and its many iterations, educational requirements for chiropractic colleges, their legal scope of practice, and whether chiropractors are – or are not—primary care physicians (PCPs). At its heart, the controversy boils down to this essential issue: what is “chiropractic” and what is it that chiropractors do? Or, perhaps, should do.

At one end of the spectrum is the straight chiropractor, who wants to make his living detecting and correcting subluxations for all manner of problems. These are the chiropractors who claim newborns need adjustments for “birth trauma” and maintenance care is necessary to good health. At the other end are those promoting the idea that chiropractors are primary care physicians capable of seeing the undifferentiated patient, form a differential diagnosis, and either treat the patient or coordinate the patient’s care with other health care professionals.

Neither has any basis in reality. The subluxation is a chiropractic fiction. And the notion that chiropractors have the necessary education and training to act as primary care physicians is no less a fiction.

Apparently unrepresented in this battle is the chiropractor who wants to see the profession as evidence-based spine care specialists based on a model of specialty care like podiatry and dentistry. (more…)

Posted in: Chiropractic, Politics and Regulation

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Matt Ridley’s not-so-mythical “myth” of basic science

Matt Ridley: Specious arguments against government research funding.

Matt Ridley: Specious arguments against government research funding.

I’m a clinician, but I’m actually also a translational scientist. It’s not uncommon for those of us in medicine involved in some combination of basic and clinical research to argue about exactly what that means. The idea is translational science is supposed to be the process of “translating” basic science discoveries in the laboratory into medicine, be it in the form of drugs, treatments, surgical procedures, laboratory tests, diagnostic tests, or anything else that physicians use to diagnose and treat human disease. Trying to straddle the two worlds, to turn discoveries in basic science into usable medicine, is more difficult than it sounds. Many are the examples of promising discoveries that appeared as though they should have led to useful medical treatments or tests, but, for whatever reason, didn’t work when attempted in humans.

Of course, if there’s one thing that the NIH and other funding agencies have been emphasizing, it’s been “translational research,” or, as I like to call it, translation über alles. Here’s the problem. If you don’t have basic science discoveries to translate, then translational science becomes problematic, virtually impossible even. Translational research depends upon a pipeline of basic science discoveries to form the basis for translational scientists to use as the starting point for developing new treatments and tests. Indeed, like many others who appreciate this, I’ve been concerned that in recent years, particularly with tight budgets, the NIH has been overemphasizing translational research at the expense of basic research.
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Posted in: History, Politics and Regulation, Science and Medicine

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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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