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

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FDA Looks At Dubious Stem Cell Clinics

Stamina-protest
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.

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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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“Non-pharmacological treatments for pain” ≠ CAM, no matter how much NCCIH wishes it so

NCCIH #TalkPain

I’ve had the Monday spot on this blog for quite a long time now. While there are many advantages to posting on Monday, not the least of which is having more time to put a post together (although that is also a disadvantage because it incentivizes my taking more time than I sometimes should), one distinct disadvantage is that all the Monday holidays are mine. That leaves me a choice on, for example, Memorial Day and Labor Day every year. It’s a choice with three options: The first is: Don’t post. (Do stop laughing, please. I know it’s me.) The second is: Use a guest post. I thought about this, and there are guest posts in the pipeline, but I don’t like to use a guest post just because I’m feeling lazy. It strikes me as an abuse of being the managing editor. Finally, I could post, which is what I decided to do.

I mainly decided to do a post because late last week there was something to blog about that was pretty important and interesting, courtesy of the National Center for Complementary and Integrative Health (NCCIH), which was formerly known as the National Center for Complementary and Alternative Medicine (NCCAM). Basically, on September 1, the NCCIH published a press release, “Review Examines Clinical Trial Evidence on Complementary Approaches for Five Painful Conditions.” Elsewhere, NCCIH Lead Epidemiologist and first author of the review, Richard Nahin, PhD, MPH, bragged on the NCCIH blog, “New Review Offers Providers and Researchers Evidence-Based Information on Complementary Health Approaches for Pain.” It didn’t take long for headlines to start appearing that said things like:
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Posted in: Acupuncture, Clinical Trials, Medical Academia, Politics and Regulation

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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.

And:

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.

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

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The cruel sham that will not die: Right-to-try marches on in California and beyond

The cruel sham that will not die: Right-to-try marches on in California and beyond

We here at SBM, particularly Jann Bellamy and myself, frequently write about naturopathic licensing laws, noting that naturopaths are relentless. They keep trying and trying to get states to pass laws granting their specialty licensure, and, like the Terminator trying to kill Sarah Connor or her son, they absolutely will not stop, ever, until science-based medicine is dead there are naturopathic licensing laws in all 50 states by 2025. Part of their strategy is that they never give up. No matter how many times a given state legislature denies them what they want, they are soon back, and they keep coming back again and again and again and again until they get the law they want passed. It’s the problem with playing defense, naturopaths can fail as many times as they have resources for, defenders of science-based medicine can’t afford to fail once. Worse, once such laws are passed, naturopaths are back again and again and again and again to keep trying to expand their scope of practice. It never ceases to amaze me that physicians’ groups go ballistic protecting their turf when advance practice nurses lobby to expand their scope of practice to encompass what they are trained for but remain more or less silent when naturopathic quacks push to have the state place its imprimatur on their pseudoscience.

Sadly, I’ve come to the conclusion that “right to try” laws are a lot like naturopathic licensing laws in that respect, only worse. Why worse? Unlike naturopathic licensing bills, right-to-try bills rarely die; most of them pass. In fact, only one right-to-try bill that I’m aware of has ever been successfully resisted and blocked from becoming law, and that required a veto by the governor. I’m referring, of course, to the California right-to-try bill vetoed last fall by Governor Jerry Brown. Amazingly, Brown’s veto held. Well, a new right-to-try bill is back in California, less than a year after the old right-to-try law had been vetoed. Passed in the legislature by overwhelming margins, it’s now back on Gov. Brown’s desk, and he has to decide what to do with it.

Its supporters hope that this time will be different, that this time Gov. Brown will sign the bill. They might be right. The rationale Gov. Brown used when vetoing the bill was that he wanted to wait to see what happened with reform of the FDA Expanded Access (sometimes called “Compassionate Use”) program. It’s quite possible that, despite the FDA moving forward with such reform, right-to-try advocates might persuade the governor that it isn’t enough. They’re wrong. In any case, given the resurrection of the California right-to-try law, now seemed like a good time to review what’s been happening with these laws since last year and discuss the situation in California and at the federal level. It isn’t good for patients or drug development. On the other hand, now that it’s been nearly two and a half years since the first right-to-try law was passed in Colorado, we have time to see just what a sham these laws are.

But first, since it’s been nearly a year since I last discussed right-to-try, let’s review why these laws are so pernicious.
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Posted in: Clinical Trials, Ethics, Politics and Regulation

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Good Thinking Society’s successful challenge to NHS homeopathy

[Editor’s note: For no reason whatsoever other than to share great news, we bring you this contribution from Michael Marshall, project director of the Good Thinking Society and vice president of the Merseyside Skeptics Society.]
Homeopathy in the UK, flag, smallAs regular readers of this blog may know, skeptics here in the UK have been campaigning for some time to end the funding of homeopathic remedies by the National Health Service. This is a campaign that we at the Good Thinking Society – the charity I work for full-time, led by science writer Simon Singh (yes, that Simon Singh) – have been at the forefront of over the last couple of years, and we recently secured a significant victory as NHS Liverpool brought their homeopathy service to a close, as a direct result of the legal challenge we brought in 2014.

While the background to our project was ably and generously described by Harriet Hall here at Science Based Medicine following her appearance at the QED conference last year, it is perhaps worth detailing the progress we’ve made in the last year, and how this success came about. After a series of Freedom of Information requests allowed us to determine where in the country homeopathy is funded by public funds, we were able to monitor for new funding decisions being made – knowing that any decision to spend public funds can be subjected to scrutiny and to legal challenges if not carried out correctly. (more…)

Posted in: Announcements, Homeopathy, Politics and Regulation

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