DRUG BUST by Alan Cassels
• The people’s briefing note on prescription drugs
What is “Eminence-based Medicine”? It means relying on the opinion of a medical specialist or other prominent health official when it comes to health matters, rather than relying on a careful assessment of relevant research evidence. You might be asking, “Who am I to question an ‘expert,’ especially a physician, a specialist or a prominent medical researcher who knows so much more than me?” Here are a few recent examples of Eminence-based Medicine in the real world, which hopefully will leave you questioning.
Recently, an Australian journalist shared with me the thoughts of a very prominent professor of medicine concerning cholesterol-lowering drugs. This national expert is one of the authors of Australia’s lipid guidelines – guidance for doctors on cholesterol-lowering or statin drugs – and he weighed in with his opinion around the benefits and harms of statins.
His answers sounded very authoritative, citing studies and reports that buttressed an unmistakable love of statins. He also cherry-picked his data, selecting and presenting research evidence that supported his love affair, concluding that most people, even people at moderate risk for heart disease, should be taking a statin. Saying that double-blind trials provide incontrovertible proof that statins reduce the risk of heart attacks and are among the “safest class of drug ever developed,” he maintained that more people needed to take these drugs. Risks? He said that the “risks of side effects are less than 0.1%.”
If you prefer evidence to expert testimony, you’d look for the most reliable research studies out there and compile them into an analysis that made sense, using methods that are clear and replicable. Above all, referring to single studies is bad, bad, bad because a single study only represents a small slice of research. If you present a study and I counter with a study that found the opposite, the resulting ping-pong game would leave us both exhausted, but no smarter. Instead of single studies, you need to demand, and depend upon, overviews of all available research in an area, such as a systematic review of the literature. This is the kind of stuff produced by the Cochrane Collaboration (www.cochrane.org) and on statins it tells a very different story.
The Cochrane review says statins for primary prevention – drugs to prevent a person’s first heart attack – might have some benefit but they can’t say for sure. The story is incomplete. Their overview of the best quality research is hampered by the fact that some companies refuse to release the full set of adverse event data. Other research suggests that 0.1% risk of side effects is a gross underestimate in the real world and as many as 20% of patients experience muscle weakening when taking statins. So whom do you trust – the expert claiming these are the safest drugs in the world or the evidence that says we actually don’t have a full picture of the safety of these drugs? As one doctor once told me, “In God We Trust, all others must show data.” To which I say, Amen.
Exhibit B: flu drugs
BC launched a very aggressive anti-flu policy this fall, with health care workers being forced to get the flu shot or wear a mask. The rationale is that anyone caring for patients shouldn’t also be passing on viruses to them and making them sick. Fair enough. But does the evidence support mandatory flu shots for healthcare workers? Does the vaccine even work to prevent the spread of the virus?
BC Provincial Health Officer Dr. Perry Kendall thinks so and so do some of his colleagues, including Dr. Paul Van Buynder, Chief Medical Office of Fraser Health. A researcher friend of mine asked Dr. Van Buynder for the evidence used to support this new policy. He received a reference list that fits into the ‘shotgun’ category of literature reviews, containing dozens and dozens of references, some relevant studies as well as editorials, commentaries, eminent opinions and other detritus. Hmm. And this is somehow supposed to placate us as a reasonable ‘evidence base?’
When you use a shotgun, you’re likely to hit something – maybe. Included in the province’s ‘evidence’ to support the new policy was a whole range of studies and outcomes, including some deemed “biologically implausible, ” such as vaccinating health workers reduces death by all causes, which is to say the flu shot also prevents death by strangulation, gun shots and zombies.
To counter this, I looked for the sniper rifle and spoke to Dr. Tom Jefferson, a Rome-based researcher who produces flu vaccine reviews for the Cochrane Collaboration. He’s been doing systematic reviews of flu vaccines and flu drugs for over a decade so he has more than a passing interest in the subject. Jefferson’s team examined four large cluster randomized trials and one cohort trial of nearly 20,000 health care workers. The flu vaccine showed “no effect on specific outcomes: laboratory-proven influenza, pneumonia or deaths from pneumonia.”
In other words, the flu policy, while eminently agreeable, is unsupported by evidence that has been systematically collected, critically evaluated and properly synthesized. BC is not the only jurisdiction to adopt a “trust us, we’re experts” pose, but, in my opinion, that response is only fit for underlings, not intelligent, responsible healthcare workers facing the pointy end of a syringe this season.
When my book came out last year, the Vancouver Sun asked me if I’d like to publicly debate the PSA test, a blood test used to detect signs of prostate cancer. “Whoopee,” I said. I jumped at the chance to step in the ring with a prominent urologist at UBC over the value of a very controversial test for a disease that although occasionally fatal, mostly isn’t, while the PSA test can make many men incontinent or impotent due to unnecessary treatment. The motto for the PSA test, synthesized by the United States Preventive Services Task Force, (google USPSTF), which uses strong systematic evidence gathering and synthesis is this: “Just Don’t Do It.” That drove the urologists nuts.
I really wanted to hear the urologist stand up and tell me the USPSTF evidence is wrong and we need to keep subjecting men to the PSA test. Two days before the debate, the urologist backed out and I understand why: Eminence-based medicine can look very silly in a public debate. He probably felt I was going to wipe the floor with him, but if you know any urologists who would like to debate the PSA with me, please contact me via www.alancassels.com
A final note
A recent study from US Public Citizen found that, since 1991, there have been 239 legal settlements, totalling $30.2 billion in federal and state penalties levied against US pharmaceutical companies. There’s a real laundry list of crimes, but defrauding the government, hiding drug safety information and hawking drugs for purposes beyond which they are approved are the main ones. Drug companies have pledged to change, signed ‘corporate integrity agreements’ and indicated they want to move on, promising a better future. We can be hopeful, but we also have to be realistic. Paying huge fines for illegal activity is one thing, but will they be still playing the Eminence game? Will they continue to fund their own experts and do research that goes through a selective reporting of ‘the evidence?’ Sadly, that’s probably going to be the case so you must immunize yourself: keep asking questions and questioning answers.
Alan Cassels is the author of Seeking Sickness: Medical Screening and the Misguided Hunt for Disease. Follow him on Twitter @AKECassels or www.alancassels.com
November 17: Alan will give a talk on this subject at TEDx in Victoria: Victoria Conference Centre, 720 Douglas Street. http://tedxvictoria.com