Politics and Regulation

Archive for Politics and Regulation

“Complementary and Integrative Health” at the VA: Integrating pseudoscience into the care of veterans


I was originally going to write this post for the 4th of July, given the subject matter. However, as regular readers know, I am not unlike Dug the Dog in the movie Up, with new topics that float past me in my social media and blog reading rounds serving as the squirrel. Then I got a copy of the movie VAXXED to review last week, and before I knew it this post had been delayed two weeks. Never let it be said, though, that I don’t circle back to topics that interest med. (Wait, strike that. Sometimes, that actually does happen. It just didn’t happen this time.) This time around, I will be using documents forwarded to me by a reader as a means of revisiting a discussion that dates back to the early days of this blog, before discussing the broader problem, which is the infiltration of pseudoscientific “complementary and alternative medicine” (CAM) into VA medical centers.

The return of the revenge of “battlefield acupuncture”

Today’s topic is the Veterans Health Administration (VHA) and its embrace of pseudoscience. VA Medical Centers (VAMCs) provide care for over 8 million veterans, ranging from the dwindling number of World War II and Korean War veterans to soldiers coming home now from our wars in Iraq and Afghanistan. Although there have been problems over the years with VAMCs and the quality of care they provide, including a recent scandal over hiding veterans’ inability to get timely doctor’s appointments at VAMCs, a concerted effort to improve that quality of care over the last couple of decades has yielded fruit so that today the quality of care in VA facilities compares favorably to the private sector. Unfortunately, like the private sector, the VA is also embracing alternative medicine in the form of CAM, or, as its proponents like to call it these days, “integrative medicine,” in order to put a happy label on the “integration” of pseudoscience and quackery with conventional medicine.

Posted in: Acupuncture, Naturopathy, Politics and Regulation, Traditional Chinese Medicine

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Reviewing Andrew Wakefield’s VAXXED: Antivaccine propaganda at its most pernicious


I’ve finally seen it. I’ve finally seen Andrew Wakefield and Del Bigtree’s “documentary” VAXXED: From Cover-up to Catastrophe, and I didn’t even have to pay to see it! Now, having watched Wakefield and Bigtree’s “masterpiece,” I can quite confidently say that it’s every bit as accurate and balanced a picture of vaccine benefits and risks as Eric Merola’s two movies about the quack Stanislaw Burzynski and his Second Opinion: Laetrile at Sloan-Kettering are about cancer and cancer research, The Beautiful Truth is about the Gerson protocol for cancer, Simply Raw: Reversing Diabetes in 30 Days is about diet and diabetes, Expelled! No Intelligence Allowed is about evolution, and The Greater Good is about…vaccines! Of course, based on what I knew of the story, saw of the VAXXED trailer (which deceptively edited together statements by William Thompson), and have discussed about the efforts of Andrew Wakefield, Del Bigtree, and Polly Tommey to use VAXXED as a tool in a publicity campaign to try to spread fear, uncertainty, and doubt (FUD) about vaccines using the “CDC whistleblowerconspiracy theory (about which a primer can be found here), I shouldn’t have been surprised, but I was actually surprised (slightly) at the manipulative depths to which this film sinks.

On the plus side, its production values are better than those Eric Merola’s films (although I, with no experience, could probably make a film with better production values than Merola), but that just makes it somewhat more effective propaganda. In my review and discussion of the movie and its claims, I will discuss the claims made by Bigtree and Wakefield as well as the movie as a movie. Unfortunately, there is so much misinformation in this 91 minute documentary that I will only be able to hit the “high” points without going far, far beyond even a Gorski level of logorrhea in this post. Worse, there is a considerable amount of dishonest framing, in which actual facts and events are presented in a deceptive manner to tell a distorted narrative. Before that, though, let’s meet the key players.

Posted in: Book & movie reviews, Politics and Regulation, Science and the Media, Vaccines

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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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Forget stem cell tourism: Stem cell clinics in the US are plentiful

Snake Oil Salesman & Wagon
I had planned on writing about something else this week, but late last week another story caught my eye, because it served as a perfect follow-up to what I wrote about last week. To recap, I wrote about a man named Jim Gass, a former chief legal counsel for Sylvania, who had suffered a debilitating stroke in 2009 that left him without the use of his left arm, and weak left leg. He could still walk with a cane, but was understandably desperate to try anything to be able to function more normally in life. Mr. Gass was both driven enough, credulous enough, and wealthy enough to spend $300,000 pursuing stem cell tourism in China, Mexico, and Argentina over the course of four years. The result is that he now has a tumor growing in his spinal column, as reported in The New England Journal of Medicine (NEJM) and The New York Times (NYT). Genetic analysis has demonstrated that the cells in this tumor mass did not come from Jim Gass, and the mass has left him paralyzed from the neck down, except for his right arm, incontinent, and with severe chronic back pain. Worse, although radiation temporarily stopped the tumor from growing, apparently it’s growing again, and no one seems to know how to stop it. Given that the traits that make stem cells so desirable as a regenerative treatment, their plasticity and immortality (ability to divide indefinitely), are shared with cancer, scientists doing legitimate stem cell research have always tried to take precautions to stop just this sort of thing from happening in clinical trials. Clearly, “stem cell tourist” clinics, which intentionally operate in countries where the regulatory environment is—shall we say?—less than rigorous are nowhere near as cautious, as they charge tens of thousands of dollars a pop for stem cell treatments that might or might not actually have real stem cells in them.

At the time I wrote that article, I emphasized primarily clinics outside of the US, where shady operators locate in order to be able to operate largely unhindered by local governments. You’d think that such a thing couldn’t possibly be going on in the US. You’d be wrong. Last week, Paul Knoepfler, a stem cell scientist who has previously contributed to Science-Based Medicine, teamed up with Leigh Turner to publish a paper in Cell Stem Cell estimating the number of stem cell clinics in the US. The number they came up with astonished me. (more…)

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

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Australia’s New Antiscience Party

HAPIn a perfect world, high quality science would inform politics and policy. Science cannot determine policy by itself because there are also value judgments and trade-offs that need to be negotiated. At the least, however, policy should be consistent with the best available science.

We, of course, don’t live in a perfect world. Too often politics and ideology seem to inform, or corrupt, science. It is so much easier to just cherry pick the science that seems to confirm what you already believe, than to go through the process of changing your beliefs to accommodate the evidence. The stronger the ideology, the greater the motivated reasoning used to defend it, without apparent practical limit. For core ideologies that are part of someone’s identity, there does not appear to be any amount of evidence that will change their beliefs.

Anti-scientific motivated reasoning is often codified in specific organizations, institutions, or professions. Political parties are essentially organized ideologies, and when that ideology is predominantly pseudoscientific, you have organized pseudoscience. (more…)

Posted in: Politics and Regulation

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Whither the randomized controlled clinical trial?

Whither the randomized controlled clinical trial?

One of the most frequent complaints about evidence-based medicine (EBM), in contrast to science-based medicine (SBM), is its elevation of the randomized clinical trial as the be-all and end-all for clinical evidence for an intervention for a particular disease or condition. Unknown but enormous quantities of “digital ink” have been spilled explaining this distinction right here on this blog, beginning with our founder’s very first post, continuing with Kimball Atwood’s series of posts explaining the shortcomings of EBM’s reliance on clinical trials über alles using homeopathy as his example, to my referring to this aspect of EBM as “methodolatry,” defined as profane worship of the randomized controlled clinical trial (RCT) as the only valid method of clinical investigation. The problem, of course, with methodolatry, is that it completely ignores prior plausibility, and when that prior plausibility is as close to zero as you can imagine (e.g., for clinical trials of homeopathy), then the only positive results that you see in such trials can reasonably be concluded to be due to noise, shortcomings in trial design, and bias. Unfortunately, a failure to realize this has led to many pointless clinical trials and contributed to the rise of a whole new “specialty” known as integrative medicine, dedicated to “integrating” quackery and pseudoscience into science-based medicine.

So we know that practitioners of “complementary and alternative medicine” (CAM), now referred to more frequently as integrative medicine, don’t like RCTs. They love pragmatic trials, because such trials are usually unblinded, often not randomized, and generally face a lower bar of evidence. That pragmatic trials are intended to test the “real world” use of medical and surgical interventions that have already been shown to be safe and effective in RCTs and that the vast majority of CAM nostrums have not met that standard appears not to concern them in the least. However, CAM practitioners are not the only ones critical of RCTs, as I learned when, via Steve Novella, I came across an article in The New England Journal of Medicine entitled “Assessing the Gold Standard — Lessons from the History of RCTs” by Bothwell et al. Given that the article is two weeks old, I wonder how I missed it. Be that as it may, although Bothwell et al make some good points, I tend to agree with Steve that the overall gist of the article is overly critical, to the point of, as Steve put it, portraying the RCT as broken rather than flawed and advocating revolution rather than reform.

Posted in: Clinical Trials, Pharmaceuticals, Politics and Regulation

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Is there a reproducibility “crisis” in biomedical science? No, but there is a reproducibility problem

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.

Journal of Irreproducible ResultsMost scientists I know get a chuckle out of the Journal of Irreproducible Results (JIR), a humor journal that often parodies scientific papers. Back in the day, we used to chuckle at articles like “Any Eye for an Eye for an Arm and a Leg: Applied Dysfunctional Measurement” and “A Double Blind Efficacy Trial of Placebos, Extra Strength Placebos and Generic Placebos.” Unfortunately, these days, reporting on science is giving the impression that the JIR is a little too close to the truth, at least when it comes to reproduciblity, so much so that the issue even has its own name and Wikipedia entry: Replication (or reproducibility) crisis. It’s a topic I had been meaning to write about again for a while. Fortunately, A recent survey published in Nature under the somewhat clickbaity title “1,500 scientists lift the lid on reproducibility” finally prodded me to look into this question again. Before I get to the survey itself, though, I can’t help but do my usual pontificating to provide a bit of background.

Posted in: Basic Science, Pharmaceuticals, Politics and Regulation, Science and Medicine

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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”


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

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.

Posted in: Homeopathy, Naturopathy, Politics and Regulation

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