Politics and Regulation

Archive for Politics and Regulation

April Fool Cannot Surpass SCAM

Stick some coffee up the tailpipe and you've got yourself some complementary and alternative auto care!

Stick some coffee up the tailpipe and you’ve got yourself some complementary and alternative auto care!

It’s April Fools’ day in the US of A. One of the internet traditions is to come up with a story that is weird or unlikely, but not so weird or unlikely that it is not believable, in order to fool people that the story is real.

I gave it the old SBM try, I really did, but I couldn’t do it. I wanted to come up with a SCAM therapy so weird, so unlikely, that I could not find an example of it actually being practiced.

It can’t be done. Like a Trump utterance*, you can’t invent a SCAM (Supplements, Complementary and Alternative Medicine) that someone, somewhere, has already pulled out of, er, well, thin air and are using it on patients.

Of course, what would you expect given that many SCAMs were in fact, pulled out of, er, well thin air. Think chiropractic and DD Palmer, iridology by August von Peczely, and reiki by Mikao Usui. Making up fantastical stuff is what they do.

But even within the spectrum of pseudo-medicine there are those are practices and papers that are so bizarro they should be an April Fools’ joke. But are not. It may be a matter of taste, what one person considers wack-a-loon another would find imminently reasonable. There are certainly assigned delegates that prove that assertion. But even within the wack-a-loon world of SCAM, there are those practices and papers that are more wack-a-loon than others and should be April Fools’ jokes. Maybe it is like more unique. Unique is one of a kind, so something can’t be more one of a kind. More wack-a-loon? Such is the world of SCAM. (more…)

Posted in: Acupuncture, Energy Medicine, Homeopathy, Medical devices, Naturopathy, Politics and Regulation, Science and Medicine

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Regulating CAM Aussie Style

640px-Flag_of_Australia.svg
CAM proponents view National Health Interview Surveys recording the supposed popularity of CAM, an amorphous conflation of anything from conventional medical advice to mythical methods, as an invitation to unleash even more unproven remedies on the public. My interpretation is quite different. I see the same figures as proof that we are doing too little to protect the public from pseudoscience.

In fact, state and federal governments are acting as handmaidens to the CAM industry by legalizing practices and products that have insufficient proof of safety and efficacy and, in some cases, are so scientifically implausible that they can never meet that standard. The federal government keeps “integrative” medicine centers at major academic institutions and private foundations afloat with taxpayer money by funding research that has failed to improve public health or the treatment of disease, despite seemingly endless trials, because “more research is needed”.

As we shall see, Australia has a more effective regulatory system for dealing with CAM. And the advocacy group Friends of Science in Medicine (FSM), an organization with goals similar to our own Society for Science-Based Medicine, is keeping the government on its toes, investigating violations of the law on its own and reporting them. We in the US could learn something from their two recent successful campaigns attacking misleading health claims. (more…)

Posted in: Chiropractic, Diagnostic tests & procedures, Guidelines, Legal, Naturopathy, Politics and Regulation

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The hijacking of evidence-based medicine

One of our heroes at SBM: John Ioannidis.

One of our heroes at SBM: John Ioannidis.

It’s no secret that I’m a fan of John Ioannidis. So, I daresay, are pretty much all of the editors and regular contributors to this blog. (If you don’t believe me, just type Ioannidis’ name into the blog search box and see how many posts you find.) Over the last couple of decades, Ioannidis has arguably done more to reveal the shortcomings of the medical research enterprise that undergirds our treatments, revealing the weaknesses in the evidence base and how easily clinical trials can mislead, than any other researcher. Indeed, after reading what is Ioannidis’ most famous article, “Why Most Published Research Findings Are False“, back in 2005, I was hooked. I even used it for our surgical oncology journal club at the cancer center where I was faculty back then. This was long before I appreciated the difference between science-based medicine (SBM) and evidence-based medicine (EBM). So it was with much interest that I read an article by him published last week and framed as an open letter to David Sackett, the father of evidence-based medicine, entitled “Evidence-based medicine has been hijacked: a report to David Sackett.” Ioannidis is also quoted in a follow-up interview with Retraction Watch.

Before I get to Ioannidis’ latest, I can’t help but point out that, not surprisingly, quacks and proponents of pseudoscientific and unscientific medicine often latch on to Ioannidis’ work to support their quackery and pseudoscience. They’ve been doing it for years. Certainly, they’re already latching on to this article as vindication of their beliefs. After all, their reasoning—if you can call it that—seems to boil down to: If “conventional” medicine is built on such shaky science, then their pseudoscience isn’t wrong after all, given that the same scientific enterprise upon which conventional medicine is based produces the findings that reject their dubious claims and treatments. Of course, whenever I hear this line of argument, I’m reminded of Ben Goldacre’s famous adage, seen in one form on Twitter here:

The adage can be generalized to all EBM and SBM as well. Just because big pharma misbehaves, EBM has flaws, and conventional medicine practitioners don’t always use the most rigorous evidence does not mean that, for example, homeopathy, acupuncture, or energy medicine works.

Still, when Ioannidis publishes an article with a title provocatively declaring that EBM has been “hijacked,” we at SBM take notice. (more…)

Posted in: Basic Science, Clinical Trials, Medical Academia, Pharmaceuticals, Politics and Regulation

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Patient Beware: Off-label drug promotion by pharmaceutical companies

In truth, physicians are rarely this happy to see a drug rep.

In truth, physicians are rarely this happy to see a drug rep.

Pharmaceutical companies and their sales reps can distribute information, such as medical journal articles, about unapproved (“off-label“) uses of their drugs as long as they adhere to FDA guidelines. However, the FDA takes the position that this information must be distributed separately from information that is “promotional in nature,” i.e., for marketing purposes, a position that is now open to question.

Off-label promotion of a drug for a use that has not been approved by the FDA is, in the FDA’s view, a violation of the federal Food, Drug & Cosmetic Act (FDC Act). It is subject to criminal prosecution, because promoting a drug for new, unapproved uses is evidence of an intent that the drug be used before it has gone through the extensive process of clinical trials and a review of the evidence of safety and efficacy by a panel of experts, as required by law before a drug can be marketed. Thus, off-label promotion is seen as an end-run around the approval process that perverts the purpose of the FDC Act, which is to protect the public from ineffective and unsafe drugs.

Studies show that personal sales visits to physicians by pharmaceutical reps (called “detailing”) drives prescriptions in favor of the drugs being promoted. This is true even though physicians’ view of detailing ranges from neutral to highly negative, a “necessary evil,” and physicians are aware of potential conflicts of interest these visits precipitate.

While there are restrictions on off-label promotion, off-label prescribing by a physician is not illegal. Physician practice is regulated by the states and not within the jurisdiction of the FDA. In fact, off-label prescribing is considered both ethical and within the standard of care in appropriate circumstances. (I am currently taking a drug for an off-label use, and was informed of this, plus the risks and benefits, by my physician prior to his prescribing it.) It is also common, according to an article by law professors Ryan Abbot and Ian Ayers in the Duke Law Journal, which is well worth reading:

for the 3 leading drugs in each of the 15 leading drug classes, off-label use accounts for approximately 21% of prescriptions. Moreover, off-label uses may be the norm in some areas of practice, such as oncology, pain management, and palliative care, and in some patient populations, such as children, the elderly, and the severely ill. For example, about 80 percent of all drug prescriptions for children are off-label, and between 80 and 90 percent of all drug prescriptions for rare diseases are off-label. [Footnotes omitted.]

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

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Reporting results from clinical trials is vital for science-based medicine

Real medicine is built on high quality data. That’s one lesson I learned through my rehabilitation as a former naturopath. I can assure you that this principle does not apply to naturopathy or any of the other types of alternative medicine, which are mostly based on anachronistic traditions, magical thinking, and poor academic integrity. I now know that real medicine incorporates any therapy scientifically demonstrated to be effective and safe, regardless of origin. Therapies that fail to demonstrate effectiveness remain alternative for good reason.

I made a sharp turn in my career when I realized this, but I was recently surprised to learn that a failure to respect the data can sometimes also characterize medicine. I’m not trying to fool anyone with an appeal to hypocrisy (often used by alternative medicine zealots to argue that their beliefs are somehow valid simply because medicine has problems). But I do want to draw attention to a problem with medical research, which has the potential to undermine science-based medicine and take us down the dark path of misinformed medicine — medicine based on incomplete data.

pills

Most people probably don’t realize that a majority of clinical trials do not report their findings.[1–3] About half of trials conducted before 2007, before it was legally required to register and report clinical trials, have never been published.[4, 5] Even since stronger legal mandates were enacted, most clinical trials still are not registered or reported.[1–3] As a result, there is a huge amount of clinical data unknown to the medical community and not available to clinicians or patients.

This effectively means that medical decisions can be based on incomplete information, not only diminishing the effectiveness of treatments but also eroding the perceived plausibility of medical interventions over time. This is what Sense About Science’s AllTrials campaign is all about: ensuring that all clinical trials register and report results in a publicly-available database. I see it as an obvious and straightforward means to improve medicine. (more…)

Posted in: Clinical Trials, Ethics, Naturopathy, Politics and Regulation, Quality Improvement, Science and Medicine

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Chiropractors, Naturopaths, Concussions and Senate Bill 1535

Concussion small
There is a bill before the Oregon Legislature, Senate Bill 1535, that:

Allows chiropractic physicians and naturopathic physicians to provide release for athlete who sustained concussion or is suspected of sustaining concussion.

Unfortunately, the Oregon legislature has already granted naturopaths primary care physician status, so I expect this may well pass, despite the fact neither chiropractors nor naturopaths have much reality-based education and training in medicine.

You may wonder, why you should care about what is going on in Oregon? Well, it is likely similar laws are being considered in your state. You might be surprised at the shenanigans going on in your legislature. I was when I looked. To keep informed, go to Legislative Update at the Society for Science-Based Medicine for weekly updates.

Let’s go through the issues: why is it a bad idea for the athletes of the state, most of whom will be children, to be cared for by NDs and DCs? (more…)

Posted in: Chiropractic, Naturopathy, Politics and Regulation

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Zika virus, microcephaly, and calls to bring back DDT

zika-virus-mosquito

If there’s one thing I’ve learned over the last decade-plus of blogging about medicine and alternative medicine, it’s that any time there is an outbreak or pandemic of infectious disease, there will inevitably follow major conspiracy theories about it. I saw it during the H1N1 pandemic in the 2009-2010 influenza season, the Ebola outbreak in late 2014, and the Disneyland measles outbreak last year, when cranks of many stripes claimed that either the outbreaks themselves were due to conspiracies (usually, but not limited to, conspiracies to promote the “depopulation” vaccination agenda of—who else?—Bill Gates) or that nefarious forces were seizing on the outbreak to take away our freedom. The second thing I’ve learned is that inevitably people will try to impose their ideology on to the disease and try to use outbreaks to push their own ideological agenda. Indeed, the Ebola outbreak, for example, was rapidly seized on by politicians to promote quarantines and to halt immigration from the affected countries. This year, the biggest infectious disease-related story thus far is the Zika virus outbreak in Brazil that has been linked to microcephaly and other birth defects, and it’s a case of the same stuff, different year.

The Zika virus is a mosquito-borne flavivirus related to dengue virus and transmitted primarily by Aedes aegypti mosquitoes. On the surface, this virus would appear to be relatively benign, with 80% of those infected by it remaining asymptomatic, while the other 20% suffer from what is usually a self-limited, relatively mild illness characterized by fever, rash, arthralgias (joint aches), and conjunctivitis. In the grand scheme of things, after decades of being endemic in many tropical areas Zika virus infection probably didn’t seem so bad and didn’t appear to be much of a public health priority in the regions where Aedes aegypti mosquitoes live, mainly tropical regions in South and Central America, Africa, southeast Asia, and the Pacific islands. Then came the evidence that prenatal infection might cause microcephaly, and everything changed. Not surprisingly, conspiracy theories galore arose with social media speed, as did the ideologically motivated overselling of proposed solutions, such as bringing back DDT to combat the mosquito carrying the disease.
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Posted in: Basic Science, Epidemiology, History, Politics and Regulation

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Is it ethical to sell complementary and alternative medicine?

Legal to sell, yes. But ethical to sell?

Legal to sell, yes. But ethical to sell?

Complementary and alternative medicine (CAM) is no longer fringe, and anything but the mom-and-pop image that manufacturers carefully craft. CAM is big business, and most Americans today take some sort of supplement. The impetus for my blogging (and tilting at CAM windmills) emerged from years spent working in a pharmacy with a heavy reliance on CAM sales. If it was unorthodox, this store probably sold it. Conventional drug products (the ones I was familiar with) were hidden off in a corner, and the store was otherwise crowded with herbal remedies, homeopathy, and different forms of detox kits and candida cleanses. All of this was unlike anything I’d ever seen or heard about in pharmacy school – so I started researching.

I looked at CAM from a scientific evidence perspective, the one I was taught in pharmacy school, using the same approach I’d take when assessing a new drug. Did the evidence support the claims made about these products, or not? The answers, as you might expect, were often the same. There was little or no credible evidence to demonstrate CAM had any meaningful benefits. I started blogging my own reviews as a way of documenting my own research, while offering some information to anyone on the Interwebs who might be searching for evidence.

Over time my blogging focus expanded, as I asked myself the inevitable questions: How could implausible products with no scientific backing even be approved for sale at all? I discovered the regulatory double-standard allowed for anything considered a dietary supplement (or in Canada, a “natural health product“) and the history and politics that have made CAM the “Wild West” of health care, with a marketplace that prioritizes a manufacturer’s right to sell over a consumer’s right to purchase a product that is safe and effective. Given the retail marketplace that’s been established by regulators like the FDA and Health Canada, I’ve turned my focus on to health professionals, who have an ethical responsibility to put patient interests above that of commercial interests. From a professional practice and medical ethics perspective, I have argued that health professionals that sell or promote CAM are on ethically shaky ground, and compromise the credibility of the profession.

Despite the lack of evidence that CAM (in general) offers any health benefits at all, it’s been remarkable to watch its popularity grow, to the point where even large pharmacy chains now sell aisles of products that are implausible and often highly questionable. Generally meeting these changes with a collective shrug, the pharmacy profession has even tried to lower its own ethical standards. While I do get the occasional encouragement from some of my peers, most just say “it’s business” or “the customer wants it, and these are legal products.” My argument today is CAM fails even this lower ethical bar. (more…)

Posted in: Ethics, Herbs & Supplements, Homeopathy, Medical Ethics, Politics and Regulation

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Pseudoscience sneaks into Ohio guidelines for non-drug pain treatment

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.

Ohio recently issued Acute Pain Prescribing Guidelines as part of an effort to reduce the epidemic of opioid abuse and death from overdose. They were drafted under the auspices of the Governor’s Cabinet Opiate Action Team (GCOAT), assisted by medical organizations and other groups.

The guidelines include recommendations for non-pharmacologic treatment, a typical feature of pain treatment guidelines and a worthy effort to avoid prescribing opioids for pain. Unfortunately, the guidelines include treatments that are not evidence based and potentially harmful. We’ll return to that issue shortly.

But first, a brief look at the extent of the opioid problem. According to the CDC, opioids are used to treat moderate-to-severe pain and are often prescribed following surgery, injury, or for painful health conditions, like cancer. In the past few years, there has been a dramatic increase in the acceptance and use of prescription opioids for the treatment of chronic, non-cancer pain, such as back pain or osteoarthritis. From 1999 to 2013, opioid prescription and sales in the U.S. have nearly quadrupled, and overdose deaths have quadrupled right along with them. (more…)

Posted in: Acupuncture, Chiropractic, Guidelines, Pharmaceuticals, Politics and Regulation

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