Diabetes drugs: Avandia maker’s guilty plea and Actos whistleblower lawsuit raise safety concerns (Part 1 in a series)

 

Competition between the makers of diabetes drugs Avandia and Actos has been deadly serious. Are global drug companies out of control?

(Part 1 of a series.)

On July 2, 2012, t

he U.S. Justice Department announced that the maker of Avandia, GlaxoSmithKline (“GSK”), had agreed to plead guilty to a felony and pay a $3 billion fine for violating U.S. prescription drug laws. GSK violated the laws by refusing to tell the FDA about Avandia patients who developed congestive heart failure. GSK also used illegal tactics, including bribery of medical doctors, to convince medical doctors to prescribe Avandia, Paxil, and Wellbutrin.

The FDA severely restricted sales of Avandia in 2010 after a study showed the drug had a serious risk of causing congestive heart failure in patients taking Avandia.

It would be understandable if GSK’s admissions about its illegal marketing of Avandia were to cause concern about the safety of Actos, the main competitor of Avandia.

Actos safety concerns became public in 2011 when studies showed bladder cancer and congestive heart failure risks. Those safety concerns were enough to cause an Actos recall in both France and Germany in June 2011. Later that month, the FDA updated the Actos label to include bladder cancer warnings.

The news that GSK fraudulently marketed Avandia and covered-up congestive heart failure risks raises this question:

Did the maker of Actos stoop to the level of GSK to compete with Avandia in the profitable diabetes drug market?

That’s a claim made by

a medical researcher who participated in tests of Actos before the drug obtained FDA approval.

Dr. Helen Ge, a former employee of Actos maker Takeda Pharmaceuticals, filed a whistleblower lawsuit that alleges Takeda refused to tell the FDA about cases of bladder cancer and congestive heart failure because it wanted to make Actos appear safer than Avandia, the biggest rival of Actos. (Here are links to the 116-page Actos whisteleblower lawsuit PDF file and a shorter page with Actos whistleblower lawsuit excerpts.)

Dr. Ge claims that the cancer risks of Actos were known to Takeda as early as the 1990s, after the drug was tested on rats and mice. But, according to Dr. Ge, her superiors insisted that some cases of bladder cancer and congestive heart failure be classified as “unrelated” to the Actos, even though that was false.

Is this simply “how the game is played” by global pharmaceutical companies?

We won’t know whether Dr. Ge is telling the truth about a cover-up of Actos bladder cancer and congestive heart failure risks until her lawsuit goes to trial, or the lawsuit is settled.

The facts of the Avandia case are bad enough. It leaves us asking whether the FDA is up to the job of protecting American citizens from the greed of global drug companies.

[End of Part 1. Please visit tomorrow to read Part 2.]

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


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