In 1999, a study by the drugmaker SmithKline Beecham strongly suggested that its diabetes drug Avandia increased the risk of heart problems.
But rather than reporting its findings to federal regulators or publishing them, the company, now known as GlaxoSmithKline, spent the next 11 years covering up any trace of the study, according to documents obtained by The New York Times.
“This was done for the U.S. business, way under the radar,” SmithKline executive Dr. Martin I. Freed said in a March 29, 2001 email message. “Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK.”
The new documents raise questions about whether experts at the Food and Drug Administration are missing out on critical information as they decide on Tuesday and Wednesday if Avandia is safe enough to stay on the market.
Meanwhile, word came Tuesday that Glaxo has agreed to a $460 million settlement with about 10,000 plaintiffs who claim that the company hid the drug’s increased chance for heart attack and stroke, Bloomberg reported. In May, Glaxo settled about 700 other cases for $60 millino. At least 3,000 Avandia cases are still pending, and Glaxo will face its first trial in a federal court in Pennsylvania this October.
After Avandia’s heart risks became public in 2007, Glaxo officials admitted that they had known of the issue since 2005 and reported their findings to the FDA. The new documents, however, suggest that the company was aware of the problem as soon as it introduced the drug.
On Monday, Sen. Charles Grassley (R-Iowa), the top Republican on the Senate Finance Committee, sent a letter to the FDA detailing the sealed deposition of a former FDA official, who said Glaxo withheld negative drug trial evidence from federal regulators. The Senate committee is currently investigating Glaxo and its handling of Avandia.
The official left the FDA in 2007 and said she was disciplined for recommending that Avandia’s warning labels ought to be stronger. An FDA spokeswoman declined to comment on the deposition.
A GlaxoSmithKline spokeswoman said the company did not report the 1999 results because the findings “did not contribute any significant information.” She also told The Wall Street Journal that Grassley’s documents were cherry-picked out of over 14 million pages of submitted evidence, and do not paint a complete picture of the company’s efforts to evaluate Avandia.
Related Links: Ahead of FDA Hearings, New Reports of Avandia Risks
FDA Scientist Takes Avandia To Task
Massive Settlement Reached by Glaxo in Avandia Litigation
This is only a partial victory for me and my family. I am the administrator of my brother’s estate. He began having all sorts of medical problems like edmea, swelling, poor eye site and a severe foot infection shortly before his death and within months of taking the advandia drug. One week before his death, he went into a diabetic seizure (never happened before in his life) as a result of taking advandia. He finally had to go to surgery to have the wound on his foot cleaned. The infection was so severe, doctors had to remove his entire leg below the knee. He only lived a few hours following his surgery, heart attack. Our only consulation at that time was that we delayed telling him his leg was taken off in surgery. My beloved brother was only 51, in the prime of his life, otherwise healthy but for non-insulin dependent type II diabetes.
I began to investigate this death drug right after his death in 2005, attorneys brushed me aside up until the medical profession began to make noise about their patients who were experiencing some of the same symptoms. Then there you go, lawyers out of the wood work. While I am grateful they finally took notice, I hope and pray that the monies recovered will be trickled down to the victims and not the attorneys.
Glaxso Smith-Kline should not only have this drug taken off the market, they sould face criminal charges, executives and the like who knew the truth and covered it up: how about contributory negligence, voluntary manslaughter and yes…murder charges, as they knew this drug was dangers.I’ll bet none of their family members took this death drug! It isreported that as early as 1999 they knew this drug was dangerous yet hid this fact for the sake of their bottom line, the almighty dollar. Well, my almighty God un the name of Jesus has heard my cry. My beloved brother is smiling down from Heaven above!!! He is at rest, maybe my family can rest in the fact that hopefully no other families will go through what we have once avandia is taken off the market.
You read about the settlement amounts and Glaxso has settled all these claims
but you never hear of anyone getting paid….is it real or just a lot on internet talking.
My husband died after taking advandia among other drugs for diabetes, chf, high blood,
kidney failure, liver and finally death after taking this primary drug.