Recently, Dr. Ben Goldacre (@bengoldacre), a prominent critic of drug studies, wanted to find out how often side effects reported by users of cholesterol-lowering drugs called statins were genuinely caused by the medications.
The study he co-authored concluded that most reported side effects of statins aren’t often due to the drugs themselves, but to other causes. The study generated front-page headlines in the U.K., with an article in The Telegraph declaring, “Statins have virtually no side effects, study finds.”
Outcry ensued. Patients who experienced side effects on statins begged to differ, and Goldacre’s fans wondered if he had suddenly gone soft on pharmaceutical companies.
In response, Goldacre penned a nuanced explanation of the study findings, explaining* that its conclusions were flawed because it was based on incomplete data.
The statin study controversy aside, his blog post makes some key points about how side effects are reported in medical journals that are helpful for health reporters to keep in mind when covering the downsides of new drugs. I’ve boiled some important points down and included them in this tip sheet for AHCJ members.
*Editor’s note: An earlier version of this post used the word “admitting.”
Reporters who cover medical studies often take great care not to be fooled by the spin put on research by drug companies, universities and even government agencies.
But sometimes the spin is the study itself, and that’s a serious problem. It’s a big story that’s hiding in plain sight, to borrow a phrase Steven Brill likes to use.
By some estimates, half of clinical trials are unpublished. Half. And because positive studies are far more likely to be published than negative studies – a phenomenon called publication bias – the studies that don’t get published often throw some seriously cold water on how good a treatment looks.
If this research hasn’t been published, how do we know it exists? Some of these trials have been released because of lawsuits; others can be found in standardized documents called clinical study reports that drug companies file with the FDA and its counterpart, the European Medicines Agency. Regulatory agencies use them for their reviews, but because they’re never published in medical journals, they remain hidden to the medical community and general public.
For a case in point, consider the antidepressant reboxetine. Unpublished studies that were brought to light in a stunning 2010 meta-analysis in the British Medical Journal showed that Pfizer had failed to publish data – all of it negative – on 74 percent of patients who had participated in the clinical trials of the medication.
“Not only does the drug not work, it really doesn’t work,” wrote the blogger SciCurious in a guest post for Scientific American on the reboxetine revelations. Continue reading