To summarize her findings.... Eli Lilly manufactures the selective serotonin reuptake inhibitor (SSRI) duloxetine under the brand name Cymbalta to treat depression in the US. However, Lilly also was developing the same compound, duloxetine, under the brand name Yantreve as a treatment of urinary stress incontinence.
During a trial of Yantreve, Traci Johnson, a young study participant who had no history of depression, committed suicide. An FDA investigation of her death was done, but could not determine whether it was due to the drug. Lilly later abandoned its testing of Yantreve as a treatment of depression.
Under current FDA procedures, data submitted to the FDA about drugs that are never marketed are considered "trade secrets," and cannot be revealed even under the Freedom of Information Act. The rationale, as described by Lenzer, is that "failed efforts at drug development need protection lest entrepreneurs suffer a competitive disadvantage when other companies aren't forced to expend the same time and money exploring dead ends." The FDA apparently applies this policy even when the withdrawn drug is chemically identical to other drugs on the market (and hence data about adverse effects of the withdrawn drug ought to apply to the same compound marketed under different names.)
Lenzer was able to obtain information, at least partially from anonymous sources, about suicides by patients in trials of Yantreve or Cymbalta that were not available publicly from the manufacturer or the FDA. Her anonymous sources also told her that "duloxetine causes suicidal tendencies in patients who took the drug for incontinence - and who were not depressed."
Only after Lenzer published an article in The Independent (UK) about the issue, did the FDA add information to its web-site that the rate of suicide attempts by patients taking duloxetine in trials of stress urinary incontinence was double that of patients taking placebo.
Lenzer's conclusion is worth quoting:
The use of trade-secret laws to conceal deaths and serious side effects linked to drugs has the obvious flaw of putting profits before public health. It also subverts the covenant between researchers and study volunteers. Subjects like Traci Johnson are told that even if they do not personally benefit from a new drug, the scientific knowledge gained from the study in which they've participated will benefit others. The volunteers should be told instead that scientists will learn about their experiences only if it's good news for the drug they're helping to test.Please see our related posts on keeping drug trials secret here.
Post Title → More Drug Secrets: the Cymbalta/ Yantreve Case
