GlaxoSmithKline deliberately hid evidence of Avandia harm, says Senate report
By Mike Adams
GlaxoSmithKline, maker of the diabetes drug Avandia, knew the drug was linked to tens of thousands of heart attacks but went out of its way to hide this information from the public, says a 334-page report just released by the Senate Finance Committee. (http://finance.senate.gov/press/Gpress/2010/prg022010a.pdf)
This report also accuses the FDA of betraying the public trust, explaining that FDA bureaucrats intentionally dismissed safety concerns found by the agency’s own scientists.
The report says that Big Pharma’s drugs “put public safety at risk because the FDA has been too cozy with drug makers and has been regularly outmaneuvered by companies that have a financial interest in downplaying or under-exploring potential safety risks.” Sales of Avandia were $3.2 billion (yes, billion) in 2006.
According to a statistical analysis in the report, if all the diabetics currently taking Avandia were put on a “safer” drug, it would avert 500 heart attacks and 300 cases of heart failure every month in the United States alone. Presently, hundreds of thousands of Americans are still taking this drug, and hundreds will continue to die each month as a result, according to the report estimates.
This report, championed by U.S. Senators Grassley and Baucus, is the result of investigators pouring through more than 250,000 pages of documentation gathered from GlaxoSmithKline and the FDA. The document reveals some rather startling facts about the dangers of Avandia, including evidence from the FDA’s own scientists who concluded that Avandia was associated with 83,000 heart attacks.
GlaxoSmithKline intimidates scientists
This investigative report also reveals that GSK engaged in the intimidation of physicians, saying: “GSK executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk and sought ways to downplay findings that a competing drug might reduce cardiovascular risk.”
“Patients trust drug companies with their health and their lives, and GlaxoSmithKline abused that trust.” said Sen. Baucus. (Gee, really? Is anyone really surprised that GSK put its own financial interests ahead of a few thousand human lives?)
A separate letter sent to FDA Commissioner Margaret Hamburg by Senators Baucus and Grassley added, “the totality of evidence suggests that GSK was aware of the possible cardiac risks associated with Avandia years before such evidence became public.”
The FDA’s own research also showed Avandia to be associated with a significant increase in heart attack risk, yet the FDA did nothing to protect the public. The agency’s own scientists wrote in 2008, “There is strong evidence that rosiglitazone [Avandia] confers an increased risk of [heart attacks] and heart failure compared to pioglitazone [a rival drug on market].” This evidence went completely ignored at the FDA.
The FDA’s famous Dr David Graham — the key whistleblower on the Vioxx scandal — concluded from his own research, “Rosiglitazone should be removed from the market.”
Even the American Medical Association — a long-time defender of Big Pharma’s drugs — admitted Avandia was dangerous. Its journal, JAMA, wrote in 2007: “Among patients with impaired glucose tolerance or type 2 diabetes, rosiglitazone use for at least 12 months is associated with a significantly increased risk of myocardial infarction and heart failure, without a significantly increased risk of cardiovascular mortality.”
The New England Journal of Medicine also warned about the safety of the drug in an article published in 2007.
Despite these multiple warnings, an FDA panel voted 22 - 1 in favor of keeping Avandia on the market. This is no surprise, of course, to those who know how the FDA really operates (and where its priorities really lie).
Analysis: What does it all mean?
Are you kidding me? A drug company hid data that its high-profit drug was linked to increased risk of heart attacks? A drug company intimidated physicians and got away with hoodwinking the public while raking in billions of dollars in sales for a drug that the FDA’s own scientists said should be pulled from the market?
Sounds like business as usual at the FDA, the “sweep it under the rug” division of the pharmaceutical industry. Once again, Dr David Graham turns out to be the sharpest guy in the room while having the courage to tell the truth even when surrounded by an agency full of morons and criminals.
The drug industry must hate this guy. But they can’t get rid of him because he’s one of the very few scientists in the FDA who is actually committed to protecting the public. Gee, what a concept, huh? The FDA as a whole abandoned that idea so long ago that virtually nobody there even remembers what it means. Protect the public? What do you mean? As in, lose profits by banning dangerous drugs that just happen to be making big money?
That’s unthinkable at the FDA as we know it today. The agency exists to promote pharmaceuticals, not to limit their sales just because a hundred thousand people happen to drop dead each year from taking FDA-approved drugs.
When it comes to safety vs. profits, the FDA chooses profits for Big Pharma time and time again.
So why is the FDA still allowed to operate in America if it’s such a dangerous organization that’s killing so many American citizens? Because it’s profitable, of course!
There’s one thing that’s true about both WAR and MEDICINE: As long as the right corporations are making money, it really doesn’t matter how many people die in the process.
And for all those diabetic Americans struggling to find improved health right now, there’s something you desperately need to know: There’s a price to putting your faith in the FDA, the drug companies and your pill-pushing doctor. That price may very well be your own life.