A Doctor’s Dilemma: When Crucial New-Drug Data Is Hidden
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As the title of his column, “Bad Science,” for the U.K.’s Guardian would suggest, Dr. Ben Goldacre is no slouch when it comes to rooting out the flaws in scientific studies, analyzing clinical trial data and recognizing when it’s been manipulated or fudged. His definition of productive discussions of data: “bloodbaths” during which researchers engage in “consensual intellectual sadomasochism” to get to the truth. If you’re a scientist, you don’t want to be on the receiving end of one of his critiques.
But even Goldacre has been fooled by bad science. In the Guardian‘s recent excerpt from his forthcoming book, Bad Pharma, which was just published in the U.K. and will be released in the U.S. in January, Goldacre describes how he ended up prescribing the antidepressant reboxetine to his patients based on insufficient data.
The research overwhelmingly finds the drug to be ineffective, but it was still approved in the U.K. How? Europe generally has similar drug-approval laws as the U.S., requiring proof of safety and efficacy before market approval. But there’s one important difference: since 2007, the U.S. Food and Drug Administration (FDA) has required that all clinical trials of drugs be registered with the government — whether or not they are published — and that apparently is what prevented the approval of riboxetine in the U.S. In order to get approval of the drug in Europe, the manufacturer had simply not published its negative data.
(MORE: Q&A: Dr. Ben Goldacre Wants His Book to Ruin Your Christmas)
Seven trials had been conducted comparing reboxetine against a placebo. Only one, conducted in 254 patients, had a neat, positive result, and that one was published in an academic journal, for doctors and researchers to read. But six more trials were conducted, in almost 10 times as many patients. All of them showed that reboxetine was no better than a dummy sugar pill. None of these trials was published. I had no idea they existed.
It got worse. The trials comparing reboxetine against other drugs showed exactly the same picture: three small studies, 507 patients in total, showed that reboxetine was just as good as any other drug. They were all published. But 1,657 patients’ worth of data was left unpublished, and this unpublished data showed that patients on reboxetine did worse than those on other drugs.
In case you were to assume that the FDA’s 2007 requirement that companies submit all data to the agency is sufficient to protect Americans, Goldacre has more bad news. He writes:
In 2010, researchers from Harvard and Toronto found all the trials looking at five major classes of drug — antidepressants, ulcer drugs and so on — then measured two key features: were they positive, and were they funded by industry? They found more than 500 trials in total: 85% of the industry-funded studies were positive, but only 50% of the government-funded trials were.
The positive spin surrounding industry-funded studies — which are, after all, the studies that the government uses to approve drugs — isn’t the only ongoing problem. Goldacre further describes how drug companies hide data about medication risks that affect children, how they attempt to intimidate the employers of researchers who produce results they don’t like, and how they routinely withhold safety data in various other ways that do harm to patients.
You might want to take your meds before you read the rest of the excerpt here — or maybe not.