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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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The consumer lab rat: More questions about supplement safety

Laboratory Rats
Do you take a vitamin or dietary supplement? Over half of all American adults do, making this a $30 billion dollar business. Many of us even take supplements in the absence of any clear medical or health need. I’m often told it’s a form of nutritional “insurance” or it’s being taken for some presumed beneficial effect – like Steven Novella outlined in yesterday’s post on antioxidants. We love the idea of a risk-free magic bullet that improves our health and wellness. Especially one that avoids what are presumed to be toxic, unnatural drugs. Supplements are marketed as safe, natural and effective, and there is no question that messaging has been effective.

I used to take supplements. For me it was multivitamins. But as I’ve taken a closer look at the evidence for supplementation, my personal behaviors changed. The primary reason is a lack of evidence. There is no evidence to suggest that vitamins offer any health benefits in the absence of deficiency. The balance of evidence suggests that routine multivitamins are unnecessary for most people. Vitamins should come from your food, not from supplements. More generally, looking at the broader category of supplements that range from probiotics to herbal remedies, there is little evidence to support most of them. With a few exceptions, the research done on dietary supplements is unconvincing and largely negative. If you don’t supplement, you don’t seem to be missing out on any tremendous health benefits.

Going beyond the lack of evidence, there’s an even more compelling need for consumers to be wary of them. The safety of supplements is increasingly being called into question. Evidence has emerged demonstrating that quality standards for supplements sold in many countries are erratic and unpredictable. The root cause seems to be regulatory systems that prioritize manufacturer interests ahead of consumer protection. With supplements, products are effectively being tested for safety after they are marketed, and the consumer is the unwitting research subject. (more…)

Posted in: Herbs & Supplements, Politics and Regulation

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Science-based medicine versus the Flint water crisis

This is exactly the sort of cover story you don't want to see about your city in TIME.

This is exactly the sort of cover story you don’t want to see about your city in TIME.

One aspect of science-based medicine that is not covered frequently on this blog, aside from vaccines and antivaccine pseudoscience, but perhaps should be, is the intersection of SBM and public health. Unfortunately, living as I do in southeast Michigan right now, I’ve been on the receiving end of an inescapable lesson in what happens when the government fails in its mission to enforce science-based public health issues. I’m referring, of course, to what has become known worldwide as the Flint water crisis. The Flint water crisis has become so famous that unfortunately it now has its very own Wikipedia page. That is not an “honor” I like to see for my state, and I’m sure the residents of Flint, which is an hour’s drive north of where I live, would agree. This crisis provides an unfortunate illustration of what can easily happen when multiple layers of government fail in a science-based public health task as basic as providing clean water to the citizens they ostensibly serve.

For those of you who haven’t heard of it yet, the Flint water crisis refers to the ongoing contamination of the tap water in Flint, MI with unacceptably high levels of lead that resulted from change in its water supply nearly two years ago to Flint River water. Because river water is more corrosive than the previous supply that came from Lake Huron (why I’ll explain later) and Flint river water was not properly treated to decrease that corrosiveness, the new water leached lead from old pipes. This resulted in the contamination of the drinking water with dangerous levels of lead in many homes in the city. In addition, there has been a marked increase in the number of cases of Legionnaires’ disease thought to be linked to the new water supply.

I was born and raised in Detroit. My parents didn’t move to the suburbs until I was ten years old, and I stayed in southeast Michigan until I graduated from medical school and ended up in Cleveland for my surgical residency and, ultimately, my PhD work. From there I bounced to Chicago and New Jersey. Then, in 2008, nearly twenty years after I had left my hometown, I ended up back in the Detroit area. The point of this story is that my roots in the Detroit area run deep. Michigan is my state, for better or for worse, which is why I get annoyed when bad things happen here. I particularly become outraged when a preventable tragedy occurs here, one that science told us how to prevent but the government went ahead and did anyway. It’s a horrific tale of how science was basically ignored because of politics, and legitimate scientific concerns about a policy that changed the water source for an entire city were downplayed, derided, and even denied by state officials at every level of government. The story has now gone international. Indeed, our state and the city of Flint are featured on the cover of this week’s TIME Magazine.
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Posted in: Politics and Regulation, Public Health

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