fda probability, page-8

GlaxoSmithKline Covered up Negative Trial Data for 11 Years

As it turns out, GlaxoSmithKline spent 11 years covering up trial data that showed Avandia was a risky drug for the heart. In 1999, drugmaker SmithKline Beecham began a study to compare Avandia with another diabetes drug, Actos. The results showed that Avandia worked no better than Actos and had greater risks to the heart.

The study results were buried at the request of GlaxoSmithKline executives and were not reported to federal regulators, as is typically required by law.

In documents uncovered by the New York Times, the company stated they could lose $600 million from 2002 to 2004 if Avandia's heart risks were made public. The New York Times also obtained a sealed deposition that included testimony from Dr. Rosemary Johann-Liang, a former supervisor in the FDA's drug safety office who "left the FDA after she was disciplined for recommending that Avandia's heart warnings be strengthened."

GlaxoSmithKline not only hid negative study data, they also manipulated study data to fit their agenda.

According to the Times:

"An F.D.A. reviewer who closely examined a landmark Avandia clinical trial called "Record," found at least a dozen instances in which patients taking Avandia suffered serious heart problems that were not counted in the trial's tally of adverse events, mistakes that further obscured Avandia's heart risks."

Incidentally, a two-year long Senate investigation released in 2010 also found Avandia causes about 500 more heart attacks and 300 more cases of heart failure than Actos (Actos may also damage your heart -- just "not as much").