Politics and Regulation

Archive for Politics and Regulation

Science-Based Politics: Lyme, Zika, and the Green Party.

And now if you excuse me, I'm going to get back to trying to hit Infernape with golf balls. That's how Pokémon works, right?

And now if you excuse me, I’m going to get back to trying to hit Infernape with golf balls. That’s how Pokémon Go works, right?

I don’t have much to write about this week. Yeah, yeah, I know. How is that different than the last 50 blog entries? And I will have even less to say next time.

But nothing of real interest has crossed my screen the past two weeks, not that I have really been looking. One of my favorite stories as a kid was Ray Bradbury’s All Summer in a Day. It takes place in the Oregon of my memory.

It is summer in the great Pacific NW and the outdoors and sunshine beckon. Who wants to skim the SCAM when there is hiking, biking, and golf? Golf has become more interesting this year. I tend to hit the links late and we play until dark. It has been a challenge not no kill the Pokémon Go players who wander the course at sunset, roaming in the gloaming clueless as to the dangerous projectiles flying by. Fore! Those are Titleists, not Poké Balls.

Once the sun goes down it has been the conventions that have trumps my attention, so why not a short entry touching on a few aspects exploring issues and controversies in science, medicine, and politics? (more…)

Posted in: Lyme, Politics and Regulation, Public Health

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Kratom: another dangerous “natural” remedy

Mitragyna_speciosa111
Kratom (Mitragyna speciose) is a tropical tree from Southeast Asia whose leaves are traditionally chewed or prepared as a powder. Native populations chew the leaves to reduce fatigue when doing manual labor, such as working on rubber plantations. It is also used in cultural performances and consumed as a drink prepared from kratom powder. When the Second World War caused an increase in the price of opium, Thai addicts forced to cut back on opium consumption used kratom to ease their withdrawal symptoms. Thailand and other Southeast Asian countries have passed laws controlling its use and other countries have followed suit, including Australia and New Zealand where it is banned.

In the past several years, kratom consumption has spread beyond traditional uses and the confines of Southeast Asia. In the U.S., it is widely available in head shops, kava bars, and on the internet. It is touted as a legal, psychoactive alternative to other sedative and stimulant-type drugs, both legally and illegally obtained. It is marketed for opioid and alcohol withdrawal symptoms, chronic pain and appetite reduction, among other things. There is also anecdotal evidence of naturopaths prescribing it for opioid withdrawal and depression. (more…)

Posted in: Herbs & Supplements, Politics and Regulation

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Dealing with vaccine hesitancy and refusal

How do we deal with parents who would rather their babies face diseases than vaccines?

How do we deal with parents who would rather their babies face diseases than vaccines?

As long as there have been vaccinations, there has been an antivaccine movement, and as long as there has been an antivaccine movement, there have been parents who refuse to vaccinate. In a past that encompasses the childhood of my parents, polio was paralyzing and killing children in large numbers in yearly epidemics, the fear of which led to the closure of public pools every summer. In such an environment, the new polio vaccine introduced by Jonas Salk in the mid-1950s wasn’t a hard sell. In fact, satisfying the initial demand for it was the problem, not parents refusing to vaccinate their children. Since then, more and more vaccines have been developed to protect more and more children from more and more diseases, to the point where the incidences of most vaccine-preventable diseases is so low that, unlike 60 years ago, most parents today have never seen a case or even known other parents whose child suffered from a case. Even as recently as the 1980s, Haemophilus influenza type B was a dread disease that could cause meningitis, pneumonia, sepsis, and death. Since the introduction of the the Hib vaccine a mere quarter century ago, Hib has been virtually eliminated. Most pediatricians in residency now have never seen a case.

As much of a cliché as it is to say so, unfortunately vaccination has been a victim of its own success, at least in developed countries. Parents no longer fear the diseases childhood vaccines protect against, which makes it easy for antivaccine activists to provide what I like to call “misinformed consent,” by spreading misinformation that vastly exaggerates the risk of vaccines compared to the benefit of vaccinating. Parents who believe the misinformation conclude, based on a warped view of the risk-benefit ratio of vaccines, that not vaccinating is safer. Add to the mix fear mongering against the MMR based on Andrew Wakefield and his dubious 1998 case series that popularized the then-recent idea that vaccines cause autism, and it’s no wonder that parents decide that not vaccinating is safer than vaccinating. If you believe the misinformation, it’s not an entirely unreasonable conclusion. Then add to that the easy availability of “personal belief exemptions” to school vaccine mandates in many states, which include anything from religious exemptions to parents just signing a form that says they are “personally opposed” to vaccination, and it isn’t a huge surprise that vaccine uptake has fallen in some areas to the point where outbreaks can occur. It was happening in California and my own state of Michigan. (more…)

Posted in: Politics and Regulation, Public Health, Vaccines

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CARA: Integrating even more pseudoscience into veterans’ healthcare

VA logo
The pixels were barely dry on David Gorski’s lament over the expansive integration of pseudoscience into the care of veterans when President Obama signed legislation that will exacerbate this very problem. The “Comprehensive Addiction and Recovery Act of 2016” (“CARA”) contains provisions that will undoubtedly keep Tracy Gaudet, MD, and her merry band of integrative medicine aficionados at the VA busy for the next few years integrating even more quackery into veterans’ medical care.

CARA is intended to address the serious prescription drug abuse problem in the U.S. It provides grants for local communities dealing with drug abuse crises and for drug abuse programs, improves access to overdose reversal medication and medication-assisted treatment for drug addiction, and assists in training first responders, among other things. It also includes provisions related to pain management, such as development of best practices to treat pain. None of that is the problem.

Deep in the Act, almost at the end, is “Subtitle C – Complementary and Integrative Health,” which begins with “Expansion of research and education on and delivery of complementary and integrative health to veterans.” I am not sure who stuck this into the new law, but it is only tangentially related to addiction and recovery. It establishes the “Creating Options for Veterans’ Expedited Recovery” Commission or, in the acronym-rich language of government, “COVER.” (more…)

Posted in: Acupuncture, Clinical Trials, 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.

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

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

BattlefieldAcupuncture

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.
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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

VAXXED

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.
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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

herbs-nd1
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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