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Supplements, Lies, and a Lengthy Transcript

Thanks, Congress, for making bull testicles available as a dietary supplement!

Thanks, Congress, for making bull testicles available as a dietary supplement!

On October 21, 1993, there was a hearing before the U.S. Senate Committee for Labor and Human Resources, with the long-winded title:

Examining How the Federal Government Should Regulate the Marketing and Use of Dietary Supplements and Related Measures, Including S. 784, To Strengthen Federal Standards with Respect To Dietary Supplements.

S. 784, sponsored by Sen. Orrin Hatch, would eventually be enacted as the Dietary Supplement Health and Education Act of 1994 (DSHEA).

I discovered this bit of Congressional theater when doing research for my recent talk at NECSS. Scott Gavura and I joined forces to present “Natural Disaster: Dietary Supplements.” Scott focused on pharmacology, while I talked about FDA regulation of dietary supplements (or lack thereof). Thanks to him, I now have a rudimentary knowledge of pharmacokinetics, the science behind how a drug or supplement works (or doesn’t) in the body. If you haven’t read his post from last week explaining this, and more, you should.

Reading the lengthy hearing transcript (well, ok, a lot of it) confirmed my suspicions that the fix was in even before the gavel went down to begin the hearing. What I had not realized was, at least according to some proponents of DSHEA, part of the deal was that consumers would have access to accurate information backing efficacy claims made for supplements and their safety. Nor had I realized that the weaknesses of DSHEA, which have become painfully obvious in the 20-plus years since the law was passed, were anticipated from the get-go and that Congress was well-informed of what they were. Finally, I was not previously aware of the provenance (shall we say) of the “experts” asked to testify at the behest of Sen. Hatch.

First, let’s set the stage on which this drama plays out, according to two excellent books on dietary supplements, Natural Causes and Vitamania. In 1991, Congress passed the Nutrition Education and Labeling Act (NELA). Most famously, NELA, for the first time, required that all foods bear the now-familiar nutrition label. It also required that any health claims made for foods be backed by “significant scientific agreement.” Rep. Henry Waxman and others wanted the same standard applied to dietary supplement health claims. After all, if food companies had to meet a certain standard to make health claims for, say, calcium in their products, why shouldn’t claims for the health benefits of calcium in dietary supplement form be held to the same standard? But the supplement industry knew it couldn’t survive under such stringent rules and Sen. Hatch made sure it didn’t happen. All parties agreed to let the FDA decide what standard should be required of supplement health claims and left it at that. (more…)

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

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Change.org Petition: “Naturopaths are not physicians: stop legitimizing pseudoscience”

change.org

Britt Hermes, a graduate of the naturopathic college at the alternative medicine-focused Bastyr University, renounced her practice as a naturopathic doctor when she could no longer tolerate the pseudoscience and patient harm that characterizes naturopathy. On this blog and her own, Naturopathic Diaries, she has chronicled the insufficient education and training students receive before being allowed to practice as naturopathic doctors, deficiencies which all too readily can result in patient harm.

Her activism is not confined to blog posts. Her advocacy helped prevent an expansion of naturopathic prescribing privileges in North Dakota in 2015. Just this past Friday, she participated, as did I, in a presentation via conference call to the Colorado Department of Regulatory Affairs (DORA), organized by the Colorado Citizens for Science in Medicine. DORA will soon issue a report on the continued registration of naturopaths in that state. In her testimony, Britt told how her own naturopathic education and training made her woefully unprepared to practice.

A number of SBM commenters have wondered how they could do more to combat naturopathic efforts to become licensed as health care providers in all 50 states, as well as participating in Medicare, Medicaid and other publicly-funded programs. Britt just started a Change.org petition urging policy makers and legislators to “stop legitimizing pseudoscience.” She also posted some excellent talking points to rebut the misleading information naturopaths give lawmakers when lobbying. You can help by using the talking points in combating legitimization of naturopathy through licensing and inclusion in public insurance programs. You can also help by signing the petition and sending it around to others on your social media accounts.

Posted in: Announcements, Legal, Naturopathy, Politics and Regulation

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

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.

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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Legislative Alchemy: Michigan House Bill 4531 gives naturopaths a broad scope of practice

Legislative Alchemy

Legislative Alchemy

Michigan House Bill 4531, if passed, would give naturopaths one of the broadest scopes of practice in the U.S., essentially equaling that of a family practice MD or DO. The bill made it through all the necessary House committees and is now before the House for an initial vote determining whether it will proceed further in that body. If it passes there, it will move to the Senate and its committee process.

Most naturopathic licensing bills fail, even in those states where attempts are made year after year. Michigan is no exception. Both David Gorski (a Michigan resident) and I discussed the previous licensing attempts there. In the two states where naturopathic licensing or registration has succeeded in the last few years, they have been able to get only a much more limited scope of practice than the full primary care scope they desire. For example, in Colorado, there are severe limitations on naturopaths’ seeing pediatric patients. They must disclose they are not physicians, recommend to parents that their children have a relationship with a licensed pediatric practitioner, and give parents the CDC-recommended vaccination schedule. All this is to thwart their efforts to talk parents out of vaccinating their children by giving them “balanced” information that is actually full of anti-vaccination dog whistles.

In Maryland, where naturopaths are regulated by the Maryland Board of Physicians, they cannot call themselves physicians or claim to practice primary care. They must have a collaboration and consultation agreement with an MD or DO and attest to the Board that the ND will “refer patients to and consult with physicians and other health care providers.” NDs must also have patients sign a consent form stating that the ND’s practice is limited to the scope of practice allowed by law. They cannot deviate from what is termed “safe care of patients” whether or not actual injury to a patient is established.

If passed, HB 4531 would be a radical departure from that trend. This newfound success in moving the ball forward may be due to an influx of funds from Emerson Ecologics, a company that sells dietary supplements and homeopathic remedies to naturopaths for resale to their patients. The company also sells the sort of dubious diagnostic tests used by naturopaths in their practice. For example, they offer a test for “adrenal stress” (to discover, not just “adrenal fatigue,” but actual “exhaustion”) and a saliva test for hormone levels as an indicator of the need for “bio-identical hormones.” (Neither the test nor “bio-identical hormones,” which is actually a marketing, and not medical term, are recommended in evidence-based medical practice.) In March, Emerson Ecologics announced a “grant” to the Michigan Association of Naturopathic Physicians (MANP) of $10,000 to support the effort to obtain full licensure for naturopathic doctors in Michigan.
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Posted in: Legal, Naturopathy, Politics and Regulation

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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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What (if anything) does “natural” mean?

"When I use a word," said Humpty Dumpty said in a rather scornful tone, "it means just what I choose it to mean -- neither more, nor less." Lewis Carroll, "Through the Looking Glass"

“When I use a word,” said Humpty Dumpty in a rather scornful tone, “it means just what I choose it to mean — neither more, nor less.”
Lewis Carroll, “Through the Looking Glass”

What does the term “natural” mean on a label? Does it mean anything? Should it mean anything? Good questions. And complicated ones, judging from the list of questions the FDA needs your help in answering.

The FDA has resisted defining “natural” in food product labeling, including whether foods that are genetically engineered, or contain genetically engineered ingredients, can use the term. Back in 1991, the agency set out to issue regulations but abandoned the effort and has since held to an informal policy that “natural” means

nothing artificial or synthetic (including color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in the food.

The only official legal requirement for using the description “natural” on a food label is that it not be misleading or false, which is forbidden by the Food, Drug & Cosmetics Act of 1938. In that appetite-suppressing way of statutory language, “food” is defined by the Act as

articles used for food or drink for man or other animals, chewing gum, and articles for used for components of any such article.

For regulatory purposes, dietary supplements are also considered foods in most cases. (more…)

Posted in: Genetically modified organisms (GMOs), Legal, Nutrition, Politics and Regulation

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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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NCCIH Strategic Plan 2016-2021, or: Let’s try to do some real science for a change

NCCIH
It’s no secret that we at Science-Based Medicine (SBM) are not particularly fond of the National Center for Complementary and Integrative Health (NCCIH). Formerly known as the National Center for Complementary and Alternative Medicine (NCCAM) and before that the Office of Alternative Medicine, NCCIH has been the foremost government agency funding research into quackery for the last 24 years, and, of course, that’s the reason we at SBM have been harshly critical of NCCIH since SBM’s inception. Basically, NCCIH not only funds studies of dubious “alternative” therapies, but it also promotes quackery by funding “fellowships” at various institutions to teach “integrative medicine,” or, as we like to call it, “integrating” quackery with real medicine.

Indeed, back in 2009, when President Barack Obama first took office, Steve Novella and I both suggested that the time was ripe for NCCIH to be defunded and its functions allowed to revert back to the already existing Institutes and Centers of the National Institutes of Health. We were under no illusions that this would happen, given that NCCIH always had a powerful protector in the man who was arguably more responsible for creating NCCIH and guarding it against all attempts at defunding or, even worse, forcing it to do more rigorous science, woo-loving Senator Tom Harkin (D-IA). Harkin is no longer in the Senate, having retired at the end of 2014, but NCCIH is still with us, and the nature of government makes it very much that, unless someone with power is willing to expend serious political capital to eliminate it, NCCIH will be with us always, no matter how much it tries to change its name to eliminate anything implying pseudoscience.

So those of us who recognize that NCCIH was created to promote the “integration” of “outside of the mainstream” or “unconventional” treatments (the vast majority of which are quackery) into real medicine have to learn to live with NCCIH and, as much as it might gall us, to try make lemonade out of the lemon by prodding it to doing some actual rigorous science on “complementary and alternative medicine” that have at least a modicum of biological plausibility and avoid wasting taxpayer money on fairy dust treatments whose precepts either violate the laws of physics (e.g., reiki, homeopathy, and other “energy” medicine) or depend on nonexistent anatomy or physiology (e.g., reflexology, craniosacral, traditional Chinese medicine tongue diagnosis).

This brings me to something I saw on the NCCIH Director’s Blog late last week, a post by the director Josephine Briggs, Requesting Comments on NCCIH’s Draft Strategic Plan. Patriotic US citizen and advocate of SBM that I am, how could I turn down such a request? Kimball Atwood didn’t shirk from such a request back when Dr. Briggs was asking for comments on the NCCAM 2011-2015 strategic plan, nor did I.

In fact, you, too, can comment as well. The deadline is April 15.
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Posted in: Basic Science, Clinical Trials, Politics and Regulation

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April Fool Cannot Surpass SCAM

Stick some coffee up the tailpipe and you've got yourself some complementary and alternative auto care!

Stick some coffee up the tailpipe and you’ve got yourself some complementary and alternative auto care!

It’s April Fools’ day in the US of A. One of the internet traditions is to come up with a story that is weird or unlikely, but not so weird or unlikely that it is not believable, in order to fool people that the story is real.

I gave it the old SBM try, I really did, but I couldn’t do it. I wanted to come up with a SCAM therapy so weird, so unlikely, that I could not find an example of it actually being practiced.

It can’t be done. Like a Trump utterance*, you can’t invent a SCAM (Supplements, Complementary and Alternative Medicine) that someone, somewhere, has already pulled out of, er, well, thin air and are using it on patients.

Of course, what would you expect given that many SCAMs were in fact, pulled out of, er, well thin air. Think chiropractic and DD Palmer, iridology by August von Peczely, and reiki by Mikao Usui. Making up fantastical stuff is what they do.

But even within the spectrum of pseudo-medicine there are those are practices and papers that are so bizarro they should be an April Fools’ joke. But are not. It may be a matter of taste, what one person considers wack-a-loon another would find imminently reasonable. There are certainly assigned delegates that prove that assertion. But even within the wack-a-loon world of SCAM, there are those practices and papers that are more wack-a-loon than others and should be April Fools’ jokes. Maybe it is like more unique. Unique is one of a kind, so something can’t be more one of a kind. More wack-a-loon? Such is the world of SCAM. (more…)

Posted in: Acupuncture, Energy Medicine, Homeopathy, Medical devices, Naturopathy, Politics and Regulation, Science and Medicine

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