Anna Maria S
Big Pharma Plays Hide-the-Ball With Data
But if Tamiflu does nothing, and there’s even a slight chance of life-threatening side effects, why was it approved?
And why continue to prescribe it?
That’s what the Cochrane Collaboration argued in a report it published in April.
The most infamous case of publication bias is a 1980 study in which heart attack patients were split into two groups: One group received a drug called lorcainide, while the other group received a placebo. Researchers wanted to find out whether lorcainide cures dangerous abnormal heart rhythms, which it does. But during the study, nine of the lorcainide patients died, compared with just one of the placebo patients. Lorcainide’s maker stopped production soon after for unrelated commercial reasons, and consequently the researchers never published their report. They believed the deaths to be “an effect of chance.”
But physicians continued prescribing drugs similar to lorcainide. Finally, in 1993, the researchers apologized for withholding the study, which they said could have “provided an early warning of trouble ahead.” But the damage was done: Throughout the ’80s, an estimated 20,000 to 75,000 people died in the U.S. each year from the inappropriate prescription of antiarrhythmic drugs, according to a 2003 editorial by Kay Dickersin and Drummond Rennie in The Journal of the American Medical Association.
In 2001, Ellen Roche, a 24-year-old technician at Johns Hopkins University, volunteered for a study to find out how healthy people’s bodies avoid asthma attacks. Doctors would give her a dose of the drug hexamethonium to induce a mild attack, her healthy body would fend off that attack, and doctors would observe how her body did it. Instead, she began to cough, her lung tissue broke down, and her kidneys failed. She was dead within a month. A study performed way back in 1978 had discovered this kind of reaction to hexamethonium—but the paper that was published didn’t mention it.