Archive for Legal

Natural Health Products: Loosely regulated, little evidence of benefit, and an industry intent on preserving the status quo

Shouldn't you know that the pills you are paying for are safe, and actually do something?

Shouldn’t you know that the pills you are paying for are safe, and actually do something?

This week’s post will revisit a topic I recently covered, but it’s time-sensitive and needs your input. Health Canada, the Canadian equivalent to the US Food and Drugs Administration, is considering revisions to the way in which it regulates dietary supplements, which are called “natural health products” in Canada. It is rare that a regulator acknowledges that a regulatory system isn’t working, and publicly expresses a commitment to being more science-based. There is a time-limited opportunity for the public (including all of you non-Canadians!) to provide comment on how supplement regulation could be more closely aligned around scientific principles, rather than the supplement industry’s priorities. Whether you take dietary supplements or not, we can probably all agree that consumers should have access to safe products as well as credible, relevant information about these products, in order to make informed health decisions. It will likely not surprise you that these ideas are seen as threats to supplement manufacturers, who benefit from little regulatory oversight and few restrictions on what can currently be claimed about any product’s effectiveness. Since my last post, there have been some new reactions to the consultation that are worth discussing. (more…)

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

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Is there a distinct standard of care for “integrative” physicians? The Woliner case

Board certification in family medicine and "integrative" medicine: different standards of care?

Board certification in family medicine and “integrative” medicine: different standards of care?

Florida Atlantic University student Stephanie Sofronsky was diagnosed with Hodgkin’s lymphoma in 2011, after review of her case by oncologists and pathologists at Moffitt Cancer Center in Tampa, the NIH/National Cancer Institute, and the Mayo Clinic in Jacksonville. By June of that year, a PET scan showed the cancer had progressed to her pelvic region. She decided to be treated locally by oncologist Neal Rothschild, MD, and met with him to discuss chemotherapy and ongoing management of her cancer. At this point, with Stage III Hodgkin’s lymphoma, she had an 80-85% chance of being in complete remission with appropriate treatment.

Unfortunately, at the same time, Sofronsky was also seeing Kenneth Woliner, MD, a family medicine practitioner. Despite the fact that world-renowned cancer specialists agreed that Sofronsky had Hodgkin’s lymphoma, and knowing that she was about to start chemotherapy, Dr. Woliner told Sofronsky that cancer was “low on his list” of possible medical concerns and that increased lymphoctyes shown in her tests were not indicative of cancer, insinuating that oncologists “often overreact” to the presence of lymphocytes and recommend chemotherapy before making an actual diagnosis. Dr. Woliner suggested instead that Sofronsky have her house tested for mold, which could be causing allergies, and therefore her symptoms. Convinced, Sofronsky pursued treatment for her allergies and cancelled her follow-up appointment with Dr. Rothschild.

Sofronsky complained repeatedly to Dr. Woliner of symptoms that were, as our good friend Orac points out, consistent with progressing lymphoma – back pain and pain and swelling in her lymph nodes, abdomen and legs, to the point of having to use a cane. Yet, Dr. Woliner, over the next couple of years, continued to attribute her symptoms mostly to her allergies and also thyroid issues and some other minor illnesses. On February 7, 2013, at her last visit to his office and in significant distress from pain and severe leg swelling, he ordered a 100 mg shot of iron, despite the fact that her blood tests showed she was not iron deficient. She rapidly decompensated and died in the hospital three days later of from complications of untreated Hodgkin’s lymphoma. (more…)

Posted in: Cancer, Ethics, Health Fraud, Herbs & Supplements, Legal, Politics and Regulation

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Personal Care Products Safety Act: Facelift for FDA Regulation or Lipstick on a Pig?

Ad from the 1930s, when cosmetics regulation was last addressed by Congress.

Ad from the 1930s, when cosmetics regulation was last addressed by Congress.

The U.S. cosmetics industry, the largest in the world, is expected to reach $62 billion in revenues in 2016. Yet, despite the fact that its products are regularly applied to, and absorbed by, the body’s largest organ (the skin) and even ingested in small amounts, the cosmetics industry is largely self-regulating.

There are over 57,000 different chemicals used in cosmetics. According to one research report, on average, women use 12 personal care products every day, exposing themselves to 168 chemical ingredients. Men use about half that, but still expose themselves to 85 unique chemicals a day. Many of these may be perfectly safe, we just don’t know which ones because most have not been tested for safety.

Increasing concerns about everything from contact dermatitis to carcinogens led Senators Dianne Feinstein (D-California) and Susan Collins (R-Maine) to introduce the Personal Care Products Safety Act, giving the FDA greater regulatory oversight of the cosmetics industry. The Senate Committee on Health, Education, Labor & Pensions held a hearing, “Exploring Current Practices in Cosmetic Development & Safety” last Thursday. A similar bill has been introduced in the House of Representatives. At least one other House bill was introduced in 2013 attempting to strengthen FDA regulatory authority over cosmetics, but it went nowhere. (more…)

Posted in: Cancer, Legal, Politics and Regulation

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FTC Sues Predatory Journal

Pictured: Peer review; something that doesn't happen in predatory journals

Pictured: Peer review; something that doesn’t happen in predatory journals

Because I have a university e-mail address I frequently get spam from journals I have never heard of soliciting submissions, and even offering editorial positions. I have generally ignored them, and it’s probably a good thing.

Over the last decade we have seen the rise of open-access science journals. The idea is a good one – journals charge a moderate fee to publish an article to cover costs, and then make all articles freely available online. It is a great way to leverage the power of the internet and make published science freely available. This contrasts to the subscription model where published research often sits behind a very expensive paywall.

The problem with the open-access model is that it created the means to easily generate income through predatory behavior. All you need is a website and minimal infrastructure and you can look like a real journal. Since authors are paying you to publish each article, just publish anything that gets submitted.


Posted in: Legal, Medical Academia

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Nada for NADA: “acudetox” not effective in addiction treatment

NADA auricular acupuncture
The National Acupuncture Detoxification Association (NADA) teaches and promotes a standardized auricular acupuncture protocol, sometimes called “acudetox.” NADA claims acudetox

encourages community wellness . . . for behavioral health, including addictions, mental health, and disaster & emotional trauma.

I do not know what “community wellness” is or how one measures whether wellness has been successfully “encouraged.” In any event, in the NADA protocol, acupuncture needles are inserted bilaterally into the auricle (outer portion) of the ear at a depth of 1-3 mm at five specific points (sympathetic, shen men, lung, liver, and kidney) and left in place for 45 minutes.


Beyond the actual needling treatment, a key element of the protocol specifies qualities of behavior and attitude on the part of the clinician, consistent with what is known as the Spirit of NADA.

NADA claims there is

strong evidence for the effect of the NADA protocol in improving patient outcomes [in addiction treatment] in terms of program retention, reductions in cravings, anxiety, sleep disturbance and need for pharmaceuticals.


Posted in: Acupuncture, Clinical Trials, Legal, Politics and Regulation

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Legislative Alchemy 2016 Update: Acupuncturists win; naturopaths and chiropractors don’t (so far)

Legislative Alchemy

Legislative Alchemy

Legislative Alchemy is the process by which state legislatures transform pseudoscience and quackery into licensed health care practices. By legislative fiat, chiropractors can detect and correct non-existent subluxations, naturopaths can diagnose (with bogus tests) and treat (with useless dietary supplements and homeopathy) fabricated diseases like “adrenal fatigue” and “chronic yeast overgrowth,” and acupuncturists can unblock mythical impediments to the equally mythical “qi” by sticking people with needles. In sum, by passing chiropractic, naturopathic, acupuncture, and Traditional Chinese Medicine (TCM) practice acts, states license what are essentially fraudulent health care practices and give them an undeserved imprimatur of legitimacy.

Only 6 of the 50 state legislatures are in regular session now. Many have ended two-year (2015-2016) consecutive sessions in which legislation from one year carries over into the next. The Texas, Montana, and North Dakota legislatures didn’t meet at all in 2016.

During 2015-2016, over a dozen naturopathic licensing or registration bills and at least 15 naturopathic practice expansion bills were introduced. (In some states, companion bills were introduced in each house. These were counted as one bill.) At least 19 chiropractic practice expansion bills were introduced in the same period. Four acupuncture/TCM practice acts were introduced, as were 14 practice expansion bills. This count does not include bills trying to force public and private insurers to cover CAM practitioner services.


Posted in: Acupuncture, Chiropractic, Legal, Naturopathy, Politics and Regulation

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FDA efforts to improve compounded drug safety upsets naturopaths

Favorite naturopathic treatments comprise pumping patients full of dubious mixtures by injection, including IV drips. Naturopaths also employ topicals (salves, ointments and creams), rectal, and vaginal suppositories, and oral medications, such as bio-identical hormone replacement therapy, all made from “natural” substances.

According to the American Association of Naturopathic Physicians (AANP)

these nutritional, herbal and homeopathic remedies are compounded to meet unique patient needs and are not typically available from the large drug manufacturers that don’t make small batches of such specialized products.

Not to mention the fact that it is highly doubtful these questionable remedies could make it through the FDA drug approval process, which requires proven safety and efficacy.

The FDA’s recent steps to improve drug compounding safety is a welcome curb on these practices. Draft Guidance issued in April addresses both compounding for office use and by prescription. (“Office use” refers to creating a supply of a compounded drug to be used by a health care practitioner as needed, as opposed to compounding a drug per a specific prescription for an individual patient.) In June, the FDA also issued an Interim Policy on substances that can be used in compounding a drug. We’ll discuss how these affect naturopathic practice in a moment. (more…)

Posted in: Guidelines, Herbs & Supplements, Homeopathy, Legal, Naturopathy, Politics and Regulation

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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

Leave a Comment (0) → Petition: “Naturopaths are not physicians: stop legitimizing pseudoscience”

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 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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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.

Posted in: Legal, Naturopathy, Politics and Regulation

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