Politics and Regulation

Archive for Politics and Regulation

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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In which we are accused of “polarization-based medicine”


A little over a month ago, I wrote about how proponents of “complementary and alternative medicine” (CAM), now more frequently called “integrative medicine,” go to great lengths to claim nonpharmacological treatments for, well, just about anything as somehow being CAM or “integrative.” The example I used was a systematic review article published by several of the bigwigs at that government font of pseudoscience, the National Center for Complementary and Integrative Health (NCCIH) about CAM approaches for the management of chronic pain. You can read my whole post for yourself if you want the details (and read Edzard Ernst and Steve Novella for more), but the CliffsNotes version consists of two main points. First, the review didn’t really show that any CAM approach worked, given how the authors included so many studies with no placebo or sham control and didn’t systematically assess the quality of the studies. Second, this study is the best publicized example of how NCCIH, looking for a reason to justify itself, has latched on to the opioid addiction crisis in this country and gone “all in” with CAM for chronic pain. Of course, the problem is that none of the real “alternative” treatments show any convincing evidence of efficacy; so NCCIH has to claim exercise (in the form of yoga and Tai Chi, for instance) and various other modalities that aren’t really “alternative” as being part of CAM. True, the authors did try to claim that acupuncture works for back pain and osteoarthritis of the knee, but the flaw of including mostly studies with no placebo/sham control completely undermined that claim. Basically, taken in its entirety, the NCCIH’s systematic review failed to find convincing evidence that any CAM therapy really works for chronic pain.

So I wrote my post, noting also how this review article and its framing of CAM as equivalent to any nonpharmacologic treatment were clearly in line with the last two NCCIH strategic plans, perused the comments our readers left, and pretty much forgot about the study, because fortunately, it didn’t seem to get much traction. (Releasing it right before the Labor Day weekend probably didn’t help NCCIH much.) However, there is one person who did not forget, and that person is John Weeks. Last week, he published a response to the criticisms of the NCCIH review in the Journal of Alternative and Complementary Medicine (JACM) entitled “Polarization-Based Medicine: Protests Against the Mayo-NCCIH Pain Guidance Evoke the Bigotry of the Political Season.”

As they say, it’s on.

Posted in: Clinical Trials, Critical Thinking, Medical Academia, 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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The stem cell hard sell, Stemedica edition

The stem cell hard sell returns.

The stem cell hard sell returns.

I first became more interested in dubious stem cell clinics nearly two years ago, when I learned that hockey legend Gordie Howe was undergoing stem cell therapy in Mexico to treat his stroke. Prominent in stories about Howe were two companies: Stemedica Cell Technologies, a San Diego company marketing stem cell treatments for all manner of ailments, and Novastem a partner company in Mexico that uses Stemedica products. Also prominent in the stories was Clínica Santa Clarita, the Tijuana-based clinic where Howe received his stem cell infusion. As far as I was able to glean, it’s a clinic to which Novastem supplies Stemedica stem cells. Basically, what happened is that Stemedica CEO Dr. Maynard Howe (no relation to Gordie Howe’s family) and VP Dave McGuigan contacted the Howe family late 2014, after having seen news stories about how poorly Gordie Howe was doing, to offer Howe its stem cell therapy.

Unfortunately, Gordie Howe was not eligible for Stemedica’s US-based clinical trial of its stem cell product for stroke because it had not yet been over six months since his last neurologic event and he was not yet neurologically stable. So Maynard Howe and McGuigan steered the Howe family to Novastem, one of Stemedica’s international partners. As a result, under the auspices of a highly dubious “clinical trial” conducted by physicians utterly unqualified to run a decent clinical trial under Mexican regulations that basically allowed “approved” clinics to do anything they want with stem cells, (whose details I discussed at the time), Gordie Howe received Stemedica stem cell infusions at Clínica Santa Clarita.

Because of Gordie Howe’s celebrity and the admiration Howe and McGuigan had for him, Novastem even waived the normal $30,000 per infusion charged to typical patients. From my viewpoint, they used Gordie Howe as a marketing tool, with the waived $30,000 an investment in publicity. Unfortunately Gordie Howe’s son Murray Howe, who happens to be a radiologist, was all too happy to go along, expressing an extreme sense of obliviousness and entitlement in response to questions about whether Clinica Santa Maria treated his father Gordie for free, responding, “You betcha. They were thrilled and honored to treat a legend. Would you charge Gordie Howe for treating him? None of his doctors ever do. I certainly am not going to criticize them for being generous.” Let’s just put it this way. I doubt that Gordie Howe’s other physicians refrained from charging Medicare and whatever insurance Howe had at the time for their services or collecting their copays.

Posted in: Clinical Trials, Politics and Regulation, Science and the Media

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Fixing the supplement market for consumers

vitamins and supplements

Unsubstantiated claims could be on their way out in Canada

When it comes to regulating and selling dietary supplements, should consumer interests be higher priority than those of manufacturers? While regulations are seemingly created to protect consumers, governments around the world have consistently given manufacturers the upper hand, prioritizing a company’s desire to sell a product over a consumer’s right to a marketplace with safe, effective products. Nowhere is this more the case than in Canada and the United States, where similar regulatory approaches have led to an industry boom and massive sales, but also a confusing marketplace for consumers and no persuasive evidence that all those supplements have any meaningful effects on our health. Drug store shelves in 2016 are packed with hundreds of products with unsubstantiated claims and untested products, and little credible information to guide selection. Since its beginnings, the contributors to this blog has been consistent in calling for more appropriate regulation: one that puts consumers first, not manufacturers, and evaluates all products (drugs, supplements or otherwise) with a consistent standard of science and evidence. Today, it looks like one regulator is preparing to move in that direction. Health Canada, Canada’s equivalent to the FDA, has proposed a new regulatory approach that is expected to block manufacturers from selling products with unsubstantiated and often misleading health claims. And they are asking for your input. Carly Weeks in The Globe and Mail writes: (more…)

Posted in: Herbs & Supplements, Politics and Regulation

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The Fluoride Dragon Cometh! Or does he?

Fluorine atom with SP3 hybridized 2S22P5 orbitals

Fluorine atom showing its 1S and 2S/2P electron orbitals (hybridized) with atomic nucleus at centre

[Editor’s note: With no further ado, and with no introduction necessary, here is a second post from Craig Pearcey; Witness his science and despair, quacks of the world!]

First for the basic chemistry

There is one particular word that tends to get many CAM supporters very vocal and the conspiracists thinking about running for their home-made bunkers in a basement somewhere. It is the word “fluorine” or any of its analogues. However, before getting into their anti-fluorine claims, we need to briefly review it properties as both an element and in various molecular forms. Without this background it may be possible to make certain assumptions about fluorine that are baseless for a given molecular structure and application. It is this very type of error that the antivaxxers and many in the CAM field make in regards thimerosal – i.e. Ethyl(2-mercaptobenzoato-(2-)-O,S) mercurate(1-) sodium, methyl-mercury, and elemental mercury. All three have significantly differing chemical properties based on their molecular structure, but some individuals/groups continue to attribute the toxicity and chemical properties for elemental mercury to thimerosal (Ethyl(2-mercaptobenzoato-(2-)-O,S) mercurate(1-) sodium). Similarly, drawing conclusions on thimerosal toxicity from methyl mercury is equally flawed. In addition, in their instance in equating the three they refuse to provide any viable mechanism how thimerosal is converted into either elemental mercury of methyl mercury, or how they can be attributed the same chemical properties. (more…)

Posted in: Politics and Regulation, Public Health

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The Cancer Moonshot: Hype versus reality

Joe Biden promotes the Cancer Moonshot initiative.

Joe Biden promotes the Cancer Moonshot initiative.

The Cancer Moonshot. It’s a topic that I’ve been meaning to address ever since President Barack Obama announced it in his State of the Union address this year and tasked Vice President Joe Biden to head up the initiative. Biden, you’ll recall, lost his son to a brain tumor. Yet here it is, nearly eight months later, and somehow I still haven’t gotten around to it. The goal of the initiative is to “eliminate cancer as we know it,” and to that end, with $195 million invested immediately in new cancer activities at the National Institutes of Health and $755 million proposed for FY 2017. My first thought at the time was that that wasn’t nearly enough money to achieve the ambitious goals set out by the President. That has now become particularly clear now that the National Cancer Institute has released the report from the initiative’s blue ribbon panel suggesting ten ways to speed up progress against cancer.

Posted in: Basic Science, Cancer, Clinical Trials, Politics and Regulation

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FDA Looks At Dubious Stem Cell Clinics

Using stem cells to treat disease or improve recovery is an exciting area of research. The potential is undeniably great – these are cells that have the potential to differentiate into mature cells of a specific type. They can be used to replace damaged cells or improve the environment for cell function and recovery. Ideally stem cells can be developed from cells harvested from the patient themselves, so there is no issue of rejection.

Stem cell technology, however, is tricky and currently in its infancy. One challenging hurdle is to prevent transplanted stem cells from turning into tumors. We also need the cells to do what we want and to survive long enough to be useful. Research is progressing, but the potential for stem cells has not yet been realized.

Quackery in the gap

Into this gap between the hype and potential of stem cells and the current reality of the research there is a space where dubious stem cell clinics can thrive. I first wrote about dubious stem cell clinics debuting in China nine years ago. Despite various regulatory efforts these clinics continue to thrive.


Posted in: Health Fraud, Politics and Regulation

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Alternative Medicine Is Infiltrating Veterinary Continuing Education

We want the veterinarians who care for our animals to continue their education and keep up to date by learning about new developments in science. A new proposal for veterinary continuing education would encourage them to learn to use questionable treatments based on pseudoscience and fantasy.

We want the veterinarians who care for our animals to continue their education and keep up to date by learning about new developments in science. A new proposal for veterinary continuing education would encourage them to learn to use questionable treatments based on pseudoscience and fantasy.

My friend Carmen Czachor is a science-based veterinarian practicing in Port Angeles, Washington. She has alerted me to a disturbing development that she fears will “put veterinary medicine back in the dark ages.” The Washington State Department of Health is contemplating a rule change in the regulations requiring continuing education for veterinarians. Current requirements are for 30 hours of continuing education every 3 years; the only restriction is that no more than 10 hours can be earned in practice management courses. The Veterinary Board of Governors had observed an increase in the volume of continuing education courses related to CAVM (complementary and alternative veterinary medicine) and they wanted to provide some guidance. They explain:

The board originally proposed a ten hour limit on the number of veterinary CAVM CE hours that can be earned in any three year reporting period. After stakeholder feedback from multiple veterinary practitioners who practice solely in CAVM, the board decided to revisit the proposal. The board now proposes to establish a twenty hour limit on CAVM continuing education and add a ten hour minimum requirement for conventional medicine. The board finds that doing so would not result in a reduction in the quality of care provided and supports the consumer’s choices about what kind of care they seek.

Note: “stakeholder feedback from multiple veterinary practitioners who practice solely in CAVM.” I find this alarming. Veterinarians are licensed to practice veterinary medicine, not CAVM. Alternative medicine is called “alternative” because it is not supported by the kind of evidence that would earn it a place in conventional medicine. What does it mean that veterinarians are “practicing solely in CAVM”? Does that mean they have abandoned the conventional veterinary medicine that they were licensed to practice?

And how on earth did they determine that the proposal “would not result in a reduction in the quality of care provided”? They just made that up because they wanted to believe it and because they believe alternative medicine constitutes quality care. (more…)

Posted in: Politics and Regulation, Veterinary medicine

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