Archive for Politics and Regulation

Do Helmets Prevent Head Injuries?

A cycling enthusiast asked me about helmets. It seems compellingly obvious to me that a head impacting the pavement without a helmet is likely to sustain more damage than a head protected by a helmet. He challenged that, citing a BMJ article by Ben Goldacre that questioned whether the evidence showed that helmets do any good. He said I was making a non-evidence-based assumption and challenged me to actually look at the evidence, so I did.

Goldacre says there is a:

complex contradictory mess of evidence on the impact of bicycle helmets. Like most places where there’s controversy and disagreement, this is a great opportunity to walk through the benefits and shortcomings of different epidemiological techniques, from case control studies to modeling.

He proceeds to give a lesson in epidemiology. He points out that there are a lot of emotion involved, and that epidemiologic studies, because of their inherent imperfections, are probably not capable of resolving the debate.

There are basically two questions:

  1. What is the effect of wearing a helmet for the individual?
  2. What is the effect of a public policy that promotes or requires helmet use?


Posted in: Epidemiology, Politics and Regulation

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As in 2014, “right-to-try” laws continue to metastasize in 2015

As in 2014, “right-to-try” laws continue to metastasize in 2015

Last year, I did several posts on what I consider to be a profoundly misguided and potentially harmful type of law known as “right-to-try.” Beginning about a year and a half ago, promoted by the libertarian think tank known as the Goldwater Institute, right-to-try laws began popping up in state legislatures, which I likened to Dallas Buyers Club laws. Both Jann Bellamy and I wrote about how these laws are far more likely to do harm than good, and that is a position that I maintain today. The idea behind these laws is to give terminally ill patients access to experimental drugs—in some cases drugs that have only passed phase I testing—that might help them. It’s an understandable, albeit flawed argument. After all, it’s perfectly understandable why terminally ill patients would fight for drugs that give them hope, and it’s just as understandable why politicians and the public would see such a goal as a good thing. In practice, as I will explain again in the context of this update, such laws are far more likely to harm patients than help them. Indeed, as you will see, in the year since the first wave of right-to-try laws have passed, not a single patient that I can find has obtained access to experimental drugs under a right-to-try law, much less been helped by them.

Unfortunately, given how effectively “right to try” has been sold on grounds of providing terminally ill patients hope and as a matter of personal freedom, it’s clear that this wave is not going to abate. Since Colorado passed the very first right-to-try law almost exactly a year ago today, a total of 17 more states now have passed passed similar legislation, the most recent being Tennessee, and 22 others have introduced legislation. It’s a good bet that right-to-try will pass in all of those states, because, as I’ve explained many times before and in many interviews, if you don’t understand clinical trial ethics and science, opposing the concept of right-to-try comes across like opposing Mom, apple pie, and the American flag, and leaves opponents open to false—but seemingly convincing—charges of callousness towards the terminally ill on the order of enjoying drop kicking puppies through flaming goalposts.

Posted in: Clinical Trials, Pharmaceuticals, Politics and Regulation

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Lyme Testimony

The Lyme tick

The Lyme tick

As the saying goes, when you do not have the facts, argue the law. This tried and (?) true approach was successful in New York where a law was passed protecting those who are, shall we say, creative in treating patients with Lyme and ‘chronic’ Lyme.

The bill protects those from investigation of misconduct:

based solely on treatment that is not universally accepted by the medical profession.

The major bone of contention has been extended courses of IV antibiotics for ‘chronic’ Lyme, but there are a wide variety of treatments that may be used by so called “Lyme literate” doctors.

The number of therapies divorced from reality that are offered to Lyme patients is remarkable. I do not know if chronic Lyme patients have greater use of pseudo-medical therapies than other pseudo-diagnoses, but I am impressed by the offerings in a recent review:

Results. More than 30 alternative treatments were identified, which fell into several broad categories: these included oxygen and reactive oxygen therapy; energy and radiation-based therapies; nutritional therapy; chelation and heavy metal therapy; and biological and pharmacological therapies ranging from certain medications without recognized therapeutic effects on Borrelia burgdorgeri to stem cell transplantation. Review of the medical literature did not substantiate efficacy or, in most cases, any rationale for the advertised treatments.

Conclusions. Providers of alternative therapies commonly target patients who believe they have Lyme disease. The efficacy of these unconventional treatments for Lyme disease is not supported by scientific evidence, and in many cases they are potentially harmful.


Posted in: Lyme, Politics and Regulation, Science and Medicine

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ACA: Six Key Elements of A Modern Chiropractic Practice Act

Screenshot 2015-05-13 22.46.07

In February, 2015, the American Chiropractic Association House of Delegates ratified “Six Key Elements of A Modern Chiropractic Practice Act.” For what it’s worth, this means that the “Six Elements” are part of the official “Public Policy” of the ACA.

1. “Chiropractic Physician” and “Chiropractic Medicine” as the Regulatory Terms of Licensure.

2. Scope of Practice Determined by Doctoral and Post-Doctoral Education, Training and Experience Obtained Through Appropriately Accredited Institutions.

3. Full Management, Referral and Prescription Authority commensurate with contemporary chiropractic education for Patient Examination, Diagnosis, Differential Diagnosis and Health Assessment.

4. Full Management, Referral and Prescription Authority commensurate with contemporary chiropractic education for the Care and Treatment of Neuromusculoskeletal and Other Health Conditions or Issues.

5. Full Authority for the Delivery of Information, Advice, Recommendations and Counseling Regarding General Health Matters, Wellness and Health Optimization.

6. Full Authority and Adaptable Requirements for the Management and Training of Health Care Teams and the Participation in Collaborative or Integrative Health Care Groups.


Posted in: Chiropractic, Legal, Politics and Regulation

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Legislative Alchemy: Naturopathic licensing and practice expansion 2015

Naturopathic genetics: a new specialty?

Naturopathic genetics: a new specialty?

Naturopathy is chock-full of quackery. No doubt about it. Here at SBM and elsewhere, the seemingly limitless nonsense that can be incorporated into naturopathic practice has been documented time and again: detoxification, food “sensitivities,” anti-vaccination ideology, fake diseases (chronic yeast overgrowth, adrenal fatigue, chronic Lyme disease), bogus tests (also here), homeopathy, chelation therapy, assorted other odd-ball treatments, lack of ethical standards, and just general wackiness.

So, let’s give naturopaths licenses to practice primary care! What a good idea.

This affinity for nonsense is perfectly understandable, given their pseudoscience-filled education and foundation in vitalism. Once the scientific method is chucked in favor of “philosophy,” what’s to stop them from simply making things up? As far as I can tell, nothing. But why inflict this on the public under the guise of promoting health, safety and welfare?

To be fair, naturopaths aren’t the only ones who incorporate quackery into their practices. There are chiropractors, acupuncturists, reiki masters, doctors of Oriental Medicine, and “integrative medicine” practitioners. But what sets naturopaths apart, in my mind, is the sheer range of pseudoscience they will accommodate without the slightest hint of doubt in its efficacy or safety and their unwavering belief in their ability to diagnose and treat patients with the expertise and skill of medical doctors. “Delusional” is not too strong a word to describe their utter lack of awareness of their ignorance or the danger to patients they may pose. (more…)

Posted in: Herbs & Supplements, Homeopathy, Legal, Naturopathy, Politics and Regulation, Vaccines

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Anesthesia-Assisted Rapid Opioid Detox

Legitimately prescribed drugs can be stolen from a medicine cabinet a few at a time, usually without notice. From the Iowa Governor's Office of Drug Control Policy.

Legitimately prescribed drugs can be stolen from a medicine cabinet a few at a time, usually without notice. From the Iowa Governor’s Office of Drug Control Policy.

Opioids are widely available as prescription drugs for pain: hydrocodone (e.g., Vicodin), oxycodone (e.g., OxyContin, Percocet), morphine (e.g., Kadian, Avinza), and codeine. Heroin, which has no medically approved use, is also an opioid. Unfortunately, opioids are also widely abused.

How enticing it is to imagine a magic bullet for opioid drug addiction. Addiction causes huge social problems. Yet it is hard to treat and suffers from a stigma that does not attach to other chronic diseases, like diabetes. Drugs like naltrexone, methadone and buprenorphine, as well as behavioral therapies, are common opioid addiction treatments, although the relapse rate for addiction treatment is high.

One of the barriers to treatment is the addict’s fear of the side effects of withdrawal, which can be extremely uncomfortable, including nausea, cramping and vomiting. It is no wonder, then, that the opioid addict and his family would be drawn to a detoxification procedure advertised as both rapid, to speed up the initiation of relapse-prevention therapy, and relatively painless: anesthesia-assisted rapid opioid detox (AAROD), sometimes called ultra-rapid detox, or even just plain rapid detox, although the latter also refers to detox under lighter sedation.


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

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Supplements are the Wild West of health. One Attorney General is out to change that.


Bold moves from the New York State attorney general’s (AG) office are shaking up the supplement industry. In February, the AG accused four retailers (GNC, Target, Walmart, and Walgreens) of selling supplements that failed to contain their labelled ingredients. Using a testing method called “DNA barcoding“, the AG’s office concluded that few of the products it tested actually contained the labelled ingredient, and some contained undisclosed ingredients. It demanded that they stop the sale of those products. All four retailers complied.

When the recall occurred, I noted that the AG may not have had an airtight case: manufacturers and other critics challenged the AG’s methodology, claiming that DNA barcoding was unvalidated, inappropriate, and insufficient. They also stated that the DNA may not survive processing, so the absence of DNA didn’t imply a lack of the original product. Some claimed that the “contaminants” that AG found could have been acceptable fillers. The Attorney General refused to release further information about the testing methods it used, raising further questions about its validity. (more…)

Posted in: Herbs & Supplements, Politics and Regulation

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Wikipedia vs Quackery – Standards vs Chaos


Wikipedia’s front page

Wikipedia, an online open-source encyclopedia, can boast 470 million visitors each month, making it one of the most popular websites on the internet. It is an incredibly useful resource – I think it’s fair to say it is the online reference of record. For that reason people care how topics important to them are represented in Wikipedia.

Wikipedia, in fact, has become no less than a battleground over certain controversial topics. In essence people generally want Wikipedia to reflect their opinions on controversial topics, and if it doesn’t then there must be something wrong with Wikipedia (rather than there being something wrong with their opinions). I don’t mean to imply that Wikipedia always gets it right – it is a crowdsourced reference and the content is only as good as the editors. But at least they make honest efforts to be neutral and to have standards.

Those standards are the real conflict here, and it is part of a broader conflict over standards. In medicine there is a standard of care, which in turn is based on an underlying system of professional and scientific standards. Medical education is standardized, students have to pass standardized exams, post-graduate clinical training is standardized, there are standardized exams for specialty certification, there are ethical standards enforced by institutions, hospitals, professional organizations, and the state boards of health, and peer-reviewed journals have standards.

This is all meant to ensure that individual patients receive the highest quality of care.


Posted in: Politics and Regulation, Science and Medicine

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How should the FDA regulate homeopathic remedies?

Hyland's "4 Kids Complete Allergy" homeopathic preparation (not for use with food allergies)

Hyland’s “4 Kids Complete Allergy” homeopathic preparation (not for use with food allergies), one of many unregulated, unproven over-the-counter preparations sold in the United States

The FDA announced recently that it is holding a public hearing on April 21 and 22,

to obtain information and comments from stakeholders about the current use of human drug and biological products labeled as homeopathic, as well as the Agency’s regulatory framework for such products. These products include prescription drugs and biological products labeled as homeopathic and over-the-counter (OTC) drugs labeled as homeopathic. FDA is seeking participants for the public hearing and written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, and industry.

It’s about time. We know that homeopathic remedies are not, and cannot be, effective. I will not plough that ground again here. Unfortunately, the FDA does not have any authority to bar these fraudulent products from sale altogether. Only Congress can do that.

In this post, I review the current regulatory framework for homeopathic products. I then explore the possibilities, given the opportunities for regulatory change presented by the FDA at this time. In doing so, I answer some of the questions posed by the FDA in its formal notice of the hearing, printed in the Federal Register.

I argue that the FDA has no statutory authority for the manner in which it currently regulates (or, actually, doesn’t regulate) homeopathic drugs. I further argue this system, largely controlled by the homeopathic industry, must be abandoned, and that there is no reason why homeopathic drugs should not be regulated just like any other OTC or prescription drug.

(Note to those wanting to submit written comments or attend the hearing: there are deadlines and other requirements for participation. You can read those in the Federal Register.)

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

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Should the FDA crack down on homeopathic “remedies”?

In the category of potentially dangerous complementary or alternative medicine, I can think of few products worse than ones claimed to relieve asthma, yet don’t actually contain any medicine. Yet these products exist and are widely sold. Just over a year ago I described what might be the most irresponsible homeopathic treatment ever: A homeopathic asthma spray. If there was ever a complementary or alternative product that could cause serious harm, this is it:


Photo Credit Ryan Meylon


Among the different treatments and remedies that are considered “alternative” medicine, homeopathy is the most implausible of all. Homeopathy is an elaborate placebo system, where the “remedies” lack any actual medicine. Based on the idea that “like cures like” (which is sympathetic magic, not science), proponents of homeopathy believe that any substance can be an effective remedy if it’s diluted enough: cancer, boar testicles, crude oil, oxygen, and skim milk are all homeopathic “remedies”. (I think Berlin Wall may be my favorite, though vacuum cleaner dust is a runner-up). The dilution in the case of homeopathy is so significant that there’s mathematically no possibility of even a trace of the original ingredient in the typical remedy – they are chemically indistinguishable from a placebo. To homeopaths, this is a good thing, as dilution is claimed to make the medicine-free “remedy” more potent, not less. As would be expected with inert products, rigorous clinical trials confirm what basic science (and math) predicts: homeopathy’s effects are placebo effects. Recently Steven Novella blogged about the Australian Government’s National Health and Medical Research Council’s (NHMRC) comprehensive report on homeopathy which concluded the following: (more…)

Posted in: Homeopathy, Politics and Regulation

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