Avandia's Manufacturer Failed to Report Important Clinical Data to the FDA
The US Department of Justice has released a press release about the manufacturer of Avandia (rosiglitazone), a diabetes drug that has been in the headlines repeatedly over the past few years. (Over the years, I have blogged about Avandia eleven times: What is on the market that is comparable to Avandia?, Avandia is Gone, Avandia in Europe, Avandia's TIDE is Turning, The Avandia Votes, What to do if you are now on Avandia, Avandia and the Advisory Committee meeting next week, Avandia Attacked Again, FDA Advisors advise continued access to Avandia, Another anti-Avandia article, FDA Issues Safety Alert on Avandia.)
The DOJ's press release, GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data, includes the following comments about Avandia and GSK:
- The United States alleges that, between 2001 and 2007, GSK failed to include certain safety data about Avandia, a diabetes drug, in reports to the FDA that are meant to allow the FDA to determine if a drug continues to be safe for its approved indications and to spot drug safety trends. The missing information included data regarding certain post-marketing studies, as well as data regarding two studies undertaken in response to European regulators' concerns about the cardiovascular safety of Avandia. Since 2007, the FDA has added two black box warnings to the Avandia label to alert physicians about the potential increased risk of (1) congestive heart failure, and (2) myocardial infarction (heart attack). GSK has agreed to plead guilty to failing to report data to the FDA and has agreed to pay a criminal fine in the amount of $242,612,800 for its unlawful conduct concerning Avandia.
- In its civil settlement agreement, the United States alleges that GSK promoted Avandia to physicians and other health care providers with false and misleading representations about Avandia's safety profile, causing false claims to be submitted to federal health care programs. Specifically, the United States alleges that GSK stated that Avandia had a positive cholesterol profile despite having no well-controlled studies to support that message. The United States also alleges that the company sponsored programs suggesting cardiovascular benefits from Avandia therapy despite warnings on the FDA-approved label regarding cardiovascular risks. GSK has agreed to pay $657 million relating to false claims arising from misrepresentations about Avandia. The federal share of this settlement is $508 million and the state share is $149 million.
The DOJ spokesman claims that the settlement "proves the effectiveness of the strong relationships we've forged with our partners to help ensure the health and safety of the American people, and to safeguard the integrity of our health care system."
Baloney. Three billion dollars is chump change for GSK. Why don't the executives spend a bit of time behind bars? In Europe, the chief safety officer for drug companies (called the Qualified Person for Pharmacovigilance or QPPV) is at risk of jail time if they foul up - we should do the same in the US. Until we do, the pharmaceutical industry can continue to overcharge patients and insurance companies, and just might choose to overlook inconvenient safety findings.