Medical doctor and Guardian writer Ben Goldacre has been busy promoting his new book, Bad Pharma: How drug companies mislead doctors and harm patients. You can watch him in What doctors don’t know about the drugs they prescribe, listen to him in a Nature interview podcast, and read the edited excerpt The drugs don’t work: a modern medical scandal. I haven’t read the book but that excerpt is long, terrifying, and definitely worth reading. Goldacre leads with a story about an antidepressant:
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 But 1,657 patients’ worth of data was left unpublished, and this unpublished data showed that patients on reboxetine did worse than those on other drugs. If all this wasn’t bad enough, there was also the side-effects data. The drug looked fine in the trials that appeared in the academic literature; but when we saw the unpublished studies, it turned out that patients were more likely to have side-effects, more likely to drop out of taking the drug and more likely to withdraw from the trial because of side-effects, if they were taking reboxetine rather than one of its competitors.
This blatant manipulation of published research is perfectly legal because the individual studies are performed correctly, according to scientific standards. However, the large variance in statistical medical studies is a notorious loophole for junk science, and pharma companies were quick to exploit this loophole so as to systematically misrepresent the performance of their new drugs.
When trials throw up results that companies don’t like, they are perfectly entitled to hide them from doctors and patients, so we only ever see a distorted picture of any drug’s true effects. Regulators see most of the trial data, but only from early on in a drug’s life, and even then they don’t give this data to doctors or patients, or even to other parts of government.
Goldacre goes on to provide many more details – surveys showing that industry-funded trials routinely favor the sponsor’s drug, non-disclosure agreements routinely signed by academics to prevent publication of unfavorable results – and concludes that we need “wider access to all trial reports, for all medicines.” Otherwise even experts may have no idea how much good or harm any given drug is likely to do.
2014-07-09: Philip Greenspun wrote a favorable review with more excerpts from the book.