GlaxoSmithKline deliberately hid evidence of Avandia harm, says Senate report

Source

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/Gpr...)

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.

Do the math on this: If Avandia is linked to 83,000 heart attacks, and if
roughly 50% of those are fatal (that's just an estimate), then Avandia
could conceivably be the cause of 40,000 deaths. The terrorist
attacks of 9/11 killed roughly 3,000 Americans, and yet just one drug
that has been mysteriously kept on the market by the FDA appears to
have killed more than ten times as many Americans as the terrorists.

So what does that make the FDA? More dangerous than the terrorists, of course!

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.

Diabetes has a cure, you know. You can reverse it in as little as four days by changing your diet. Read
the books on diabetes by Dr Gabriel Cousens or Dr Julian Whitaker. Or
read more about diabetes right here on NaturalNews: http://naturalnews.com/diabetes.html

Here's the full report from the U.S. Senate (PDF):
http://finance.senate.gov/press/Gpr...

Sources for this story include:
CNN
http://edition.cnn.com/2010/HEALTH/...

NY Times
http://www.nytimes.com/2010/02/20/h...

PharmaTimes
http://www.pharmatimes.com/WorldNew...

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