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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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Are the recommended childhood vaccine schedules evidence-based?

The vaccine schedule: Safe and efficacious.

The vaccine schedule: Safe and efficacious.

We write about vaccines a lot here at SBM, and for a very good reason. Of all the medical interventions devised by the brains of humans, arguably vaccines have saved more lives and prevented more disability than any other medical treatment. When it comes to infectious disease, vaccination is the ultimate in preventive medicine, at least for diseases for which vaccines can be developed. We also know that when vaccination rates fall, it opens the door for diseases once controlled to come roaring back. We saw this phenomenon with the measles a year ago in the Disneyland measles outbreak. We’ve seen it around the country, with measles outbreaks occurring in areas where a lot of antivaccine and vaccine-averse parents live. Perhaps the most spectacular example occurred in the UK, where prior to Andrew Wakefield’s fraudulent case series in The Lancet that was used to link the MMR vaccine to autism, measles was under control; it came roaring back as MMR uptake plummeted in the wake of the publicity his research engendered. By 2008, ten years after Wakefield’s case series was published, measles was again endemic in the UK. Measles outbreaks flourished. Although MMR uptake is improving again in the UK, there remains a reservoir of unvaccinated children aged 10-16 who can transmit the virus.

Thanks, Andy.

Fortunately, Wakefield has been relegated to sharing the stage with crop circle chasers, New World Order conspiracy theorists, sovereign citizen cranks, and other antivaccine cranks like Sherry Tenpenny. Unfortunately, the damage that he has done lives on and has metastasized all over the developed world. Given the persistence of the antivaccine movement, which fuels concerns about vaccines in parents who are not themselves antivaccine but are predisposed to the antivaccine message because they distrust government and/or big pharma or have a world view that overvalues “naturalness,” I was quite interested in an article that appeared in The BMJ last week. Basically, it asked the question “Is the timing of recommended childhood vaccines evidence based?
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Posted in: Clinical Trials, Epidemiology, Public Health, Vaccines

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New evidence, same conclusion: Tamiflu only modestly useful for influenza

Tamiflu

Does Tamiflu have any meaningful effects on the prevention or treatment of influenza? Considering the drug’s been on the market for almost 15 years, and is widely used, you should expect this question has been answered after 15 flu seasons. Answering this question from a science-based perspective requires three steps: Consider prior probability, be systematic in the approach, and get all the data. It’s the third step that’s been (until now) impossible with Tamiflu: Some data was unpublished. In general, there’s good evidence to show that negative studies are less likely to be published than positive studies. Unless unpublished studies are included, systematic reviews are more likely to miss negative data, which means there’s the risk of bias in favor of an intervention.

The absence of a full data set on Tamiflu (oseltamivir) and the other neuraminidase inhibitor Relenza (zanamivir) became a rallying point for BMJ and the AllTrials campaign, which seeks to enhance the transparency and accessibility of clinical trials data by challenging trial investigators to make all evidence freely available. (Reforming and enhancing access to trial data was one of the most essential changes recommended by Ben Goldacre in his book, Bad Pharma.) In 2009, Tamiflu’s manufacturer, Hoffman-La Roche committed to making the Tamiflu data set available to investigators. Now after four years of back-and-forth between BMJ, investigators, and Roche, the full clinical trials data set has been made freely available. An updated systematic review was published today in BMJ (formerly The British Medical Journal), entitled “Oseltamivir for influenza in adults and children: systematic review of clinical study reports and summary of regulatory comments.” This will be a short post covering the highlights. As the entire study and accompanying data are freely available, I’ll await continued discussion in the comments. (more…)

Posted in: Clinical Trials, Pharmaceuticals, Public Health

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