NY Times: GSK concealed negative Avandia study

Update: The Senate Finance Committee has released its letter to FDA leaders and documents it unearthed about the missing Avandia trials. GSK issued a response.

GSK began a study comparing the safety of rosiglitazone (Avandia) to pioglitazone (Actos) back in 1999 and spent the next 11 years keeping the study a secret, according to a report in the New York Times by Gardiner Harris.

The Times quotes an email message from 2001 written by a SmithKline executive, Dr Martin Freed, “This was done for the U.S. business, way under the radar. Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK.”

The documents obtained by the Times “demonstrate that the company had data hinting at Avandia’s extensive heart problems almost as soon as the drug was introduced in 1999, and sought intensively to keep those risks from becoming public.” A GSK spokeswoman told the Times that the company had not provided the results of its study because they “did not contribute any significant new information.”

The Times further reports that John Jenkins, the FDA’s director of the office of new drugs, believes that Avandia should remain on the market and that he “briefed the company extensively on the agency’s internal debate.” (It is unclear from the Times story when Jenkins spoke with GSK, since the incident was recounted in a deposition by a former FDA official, Rosemary Johann-Liang, who is no longer with the FDA.)

The Times reports that GSK also conducted a trial comparing Avandia with glyburide:

When Rhona A. Berry, a company official, asked about publishing two of the trials, Dr. Freed responded in an e-mail message dated July 20, 2001, that referred to Avandia by the abbreviation of its generic name, rosiglitazone: “Rhona — Not a chance. These put Avandia in quite a negative light when folks look at the response of the RSG monotherapy arm,” the message said. “It is a difficult story to tell and we would hope that these do not see the light of day.”