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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.

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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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Don’t supplement users deserve consumer protection, too?

Canada's Parliament buildingThe Canadian Parliament, hypothetically protecting consumers since Confederation.

One of the most pervasive yet appealing health myths is the idea that natural equals safe. It’s a statement that’s repeated constantly by manufacturers of supplements and “natural” health products. It’s been the primary argument used, with considerable success, to give these products completely different regulatory structures than exist for drug products. Weaker regulation of supplements and natural health products has been a boon to manufacturers, but the same can’t be said for consumer protection. It’s effectively a buyer-beware marketplace in most parts of the world, with little accurate information available to consumers. But supplement manufacturers aren’t content with the minimal regulation that’s currently in place – they want health “freedom”. In this case, “freedom” means the right to sell any product, while being exempted from safety and regulatory requirements. New Canadian legislation is poised to raise safety standards for drugs and enhance the ability of regulators to recall dangerous products, yet consumers of natural health products are left behind. The legislation proposes to exempt anything considered a “natural health product”. This is not only bad public policy, but it has the potential to cause avoidable harm. After all, shouldn’t users of supplements and natural health products be entitled to the same safety and quality standards as those that use prescription drugs? If the supplement industry gets its way, the answer will be “no”. (There is an opportunity until June 10 for you to provide feedback on this legislation – see below.) (more…)

Posted in: Herbs & Supplements, Politics and Regulation, Science and Medicine

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