“While it is important that we correct false assertions about how Lilly manages its data, it is even more important to set the record straight for patients who rely on our medicines for their daily well-being,” said Sidney Taurel, chairman, president and CEO of the company.
“It is simply wrong to suggest that information on Prozac was ever missing or that important research data on the benefits and possible side effects of the drug were not available to doctors and regulators.”
In an open letter to the public, Taurel asserted that the British Medical Journal (BMJ) article and “misleading” reports in other media “needlessly spread fear among patients.” Lilly continues to defend the drug, and has branded the claims as false allegations.
Lilly also said in a statement that conclusions drawn from tables of adverse event data in the documents obtained by BMJ were erroneous and fiercely denied the allegation that Prozac is 12 times more likely to cause suicide than other, older antidepressants.
Spontaneous adverse event reports have been the subject of significant research in the scientific community, and it is widely agreed that only controlled clinical trials can achieve valid comparisons between medications. Drawing conclusions about causality from spontaneous adverse event reports is invalid due to a number of limitations, the company said.
Lilly is currently in the process of talking to all parties – the FDA, Congressman Maurice Hinchey, and the BMJ – in an effort to resolve the situation. Additionally, Lilly is calling on the BMJ to make the full documents available to media and other interested parties. Lilly obtained the documents from the office of Congressman Hinchey.