Diabetes drug safety: Avandia maker’s guilty plea and Actos whistleblower lawsuit raise concerns (Part 2 in a series)

(Part 2 in a series)

Part 1 in this series about diabetes drug safety listed some of the illegal conduct that the maker of Avandia admitted to when it agreed to plead guilty to a felony count of violating U.S. law and pay a $3 billion fine. But

Part 1 didn’t give the details. The details are shocking.

GSK lied to medical doctors to increase sales of Avandia.

The Justice Department said:

  • GSK lied to medical doctors about Avandia’s safety, making them believe it was safer than it really was.
  • GSK said Avandia had a positive cholesterol profile, despite having no controlled studies to support that claim.
  • GSK sponsored programs telling doctors that Avandia had cardiovascular benefits despite warnings on the FDA-approved label that the drug actually had cardiovascular risks.

The last allegation alone is enough to call into question the value of FDA labels. It’s almost unbelievable: GSK invited doctors to programs where GSK told medical doctors that Avandia was safe for patients’ hearts even though the FDA label said Avandia was risky for patients’ hearts.

What made GSK believe it could boost sales of Avandia by hosting programs for doctors and telling them lies that contradicted the FDA label? Two possibilities come to mind:

  • GSK believed

    that medical doctors don’t read FDA labels

    . This seems to be the most likely explanation. Most doctors are busy, and some of them prescribe dozens of different drugs every day. FDA labels are long. It would be time-consuming to read all of them. (The current version of the official Actos FDA warning label for doctors is 43 pages long). So GSK thought it could lie to these busy doctors and get away with it, or

  • GSK believed it had “bought” the loyalty of the doctors, so they would prescribe GSK drugs even if they were riskier than other drugs. It’s worth noting that some doctors got Hawaiian vacations and other perks from GSK (more on that below).

Avandia’s manufacturer bribed medical doctors.

Carmin M. Ortiz, the U.S. attorney in Massachusetts. was quoted in an article that GSK spent millions of dollars bribing doctors to prescribe its drugs:Businessman hands over cash

“GSK’s sales force bribed physicians to prescribe GSK products using every imaginable form of high priced entertainment, from Hawaiian vacations to paying doctors millions of dollars to go on speaking tours to a European pheasant hunt to tickets to Madonna concerts, and this is just to name a few,”

GSK failed to report congestive heart failure to the FDA.

Federal prosecutors said GSK failed to report data from studies detailing safety risks to the FDA.

[End of Part 2. Check back tomorrow for Part 3 of the series.]

AVANDIA is a registered trademarks of GlaxoSmithKline. ACTOS is a registered trademark of Takeda Pharmaceutical Company Limited.

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