Politics and Regulation

Archive for Politics and Regulation

FTC Homeopathy Win

homeopathy-air-guitar
I love to see a regulatory agency actually do its job. Especially within medicine, where it is most important, the lack of political will seems to get in the way of properly regulating health care products and services in the way that most consumers assume they are regulated.

Homeopathy is perhaps the best example. Homeopathy is pure unadulterated pseudoscience and witchcraft. There is no legitimate scientific debate about this. Homeopaths create their potions by starting with fanciful substances that can’t work and then dilute them out of existence. The result is plain water that they claim has magical properties. Yes – that’s really what it is.

Unsurprisingly, rigorous clinical trials have shown that homeopathic potions in fact do not work. (more…)

Posted in: Homeopathy, Politics and Regulation

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Medical science policy in the U.S. under Donald Trump

When Dr. Oz met Donald Trump: Somehow this photo just seemed appropriate for this post.

When Dr. Oz met Donald Trump: Somehow this photo just seemed appropriate for this post.

Last week, in an unexpected upset, Donald Trump won the Presidential election in the Electoral College while losing the popular vote and is now President-Elect. Regular readers of my not-so-super-secret other blog know my opinion of this; so I won’t belabor it too much here. If you’re curious, I have written about Donald Trump’s antivaccine views here before in the context of last year’s Republican debates, and, amusingly, I’ve even been at the receiving end of criticism from an “integrative medicine” activist in which my snark was compared to that of Donald Trump and my criticism labeled “Trumpism.” As you might imagine, I was not pleased.

Leaving all that aside and leaving aside how we’ve now had two Presidential elections out of the last five in which the candidate with fewer popular votes became President (no, I’m not a fan of the Electoral College), Donald Trump won fair and square and will be our next President. As an advocate of science-based medicine, naturally I wondered: What can we expect in terms of medical science under President Trump next year? Jann Bellamy already began the discussion on this blog by undertaking a fairly comprehensive overview of the disturbing anti-science positions Donald Trump and many now coming into his new administration espouse. I’m going to do a bit of the same, but I’m going to drill down and focus solely on medical science. While I agree that Trump’s position on human-caused climate change and his stated intent to pull out of important climate treaties and, in essence, cease any attempt to mitigate the effects of human activity on climate change is a looming disaster that our grandchildren and great-grandchildren and beyond will likely curse our generation for, this blog is Science-Based Medicine.
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Posted in: Basic Science, Clinical Trials, Medical devices, Pharmaceuticals, Politics and Regulation

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“Donald Trump’s presidential election win stuns scientists”

Trump is OK with pseudoscience

Trump is OK with pseudoscience

Scientists in the U.S. and from around the world are weighing in on Donald Trump’s election as the next president of the most powerful country on earth:

Trump will be the first anti-science president we have ever had . . . The consequences are going to be very, very severe.

Michael Lubell, director of public affairs for the American Physical Society in Washington, DC:

I am simply stunned. . . Trump’s election does not bode well for science or most anything else of value.

Neal Lane, a Democrat who led the National Science Foundation and served as White House science adviser under President Bill Clinton, now a physicist and university professor at Rice University in Houston, Texas:

It’s going to be critically important for researchers to stand up for science.

Jennifer Zeitzer, director of legislative Relations at the Federation of American Societies for Experimental Biology in Bethesda, Maryland:

I do breast cancer research for my PhD . . . Scared not only for my future but for the future of research and next years @NIH budget.

Sarah Hengel, a graduate student at the University of Iowa in Iowa City:

This is terrifying for science, research, education, and the future of our planet . . . I guess it’s time for me to go back to Europe.

María Escudero Escribano, a postdoc studying electrochemistry and sustainable energy at Stanford University in California:

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Posted in: Critical Thinking, Herbs & Supplements, Legal, Obstetrics & gynecology, Politics and Regulation, Public Health, Science and the Media, Vaccines

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Cancer quackery from Germany to Australia

Quack, quack

Last week, I wrote about alternative medicine clinics in Germany that offer a combination of alternative cancer cures plus experimental therapeutics administered improperly outside the auspices of a clinical trial. In particular, I discussed two cases. The first was British actress Leah Bracknell, who is raising money to go to one of these alternative cancer clinics to treat her stage IV lung cancer. the second was a British woman named Pauline Gahan, who was diagnosed with metastatic stomach cancer and has thus far spent £300,000 for a combination of vitamin infusions, “detox,” and Keytruda (generic name: pembrolizumab). This is a drug belonging to a new class of promising anticancer therapies known as immune checkpoint inhibitors. It’s FDA-approved for some cancers, but hasn’t yet been shown to be effective against stomach cancer, although there is one phase I trial that is promising and thought to be sufficient evidence to justify phase II and III trials. None of this stopped the clinic to which both Bracknell and Gahan traveled, the Hallwang Private Oncology Clinic.

One thing I noticed about the Hallwang Private Oncology Clinic when I wrote about it is that nowhere did it list the doctors who own and operate it or who consult there. I did find one name, Dr. Jens Nolting, mentioned on patient discussion boards as working at Hallwang. The lack of mention of who runs the clinic and who practices there was an enormous red flag to me, I think for obvious reasons. Fortunately, a commenter with more knowledge than I and thus a better idea of what to Google for, jumped in to comment and helped out. So I thought I’d do a follow-up post and then segue to a report that aired on Australian TV on alternative medicine for cancer there to show the consequences of clinics like this, which are, unfortunately, a problem in many advanced countries. Thus, this post might be a bit “odds and ends”-ish, but it’s a topic that’s been of intense interest to me ever since I discovered the depths of alternative medicine applied to cancer, and I didn’t want to leave last week’s post, in essence, unfinished. Also, there is at least one interesting connection that I hadn’t realized as I wrote my post last week.
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Posted in: Cancer, Health Fraud, Naturopathy, Politics and Regulation, Science and Medicine

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California legislature should repeal naturopathic licensing

california-state-seal
On January 1, 2018, the California Naturopathic Doctors Act will be automatically repealed unless the California Legislature deletes or extends that date during the 2017 legislative session, which convenes on December 5, 2016. In addition, according to California law, the Naturopathic Medicine Committee of the Osteopathic Medical Board of California, which regulates naturopathic doctors (NDs), is subject to review by “appropriate policy committees of the Legislature” in the upcoming session.

The California Legislature should not extend the date of the Naturopathic Practice Act. Currently licensed naturopathic doctors could be allowed to continue their practices under a substantially revised practice act but no new licenses should be issued. Frankly, I do not think naturopaths, whether they claim they are “doctors” or not, should be allowed to practice at all. However, the political realities of getting a bill passed completely doing away with the practice of naturopathy may require some accommodation to currently licensed NDs. (more…)

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

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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”

hillary-clinton-donald-trump-presidential-debate

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

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