Baucus Statement Regarding the Finance Committee Investigation of Avandia
We place a great deal of trust in pharmaceutical companies to make safe and effective products.
The health of millions of Americans, from young children to retirees, depends on the careful
work of these drug manufacturers.
Today, Senator Grassley and I are placing in the Congressional Record a Senate Finance
Committee staff report which describes a very disturbing series of events related to the safety of
the diabetes drug Avandia.
The report presents evidence that a pharmaceutical company allegedly tried to intimidate a doctor who raised concerns about Avandia’s link to heart problems. This occurred after the doctor gave speeches at two scientific meetings where he warned of the cardiovascular risks to those using Avandia, a drug designed to control glucose levels in diabetics.
To make matters worse, the company in question denied trying to intimidate the doctor in the
press. That claim is seriously challenged by emails presented in the staff report.
It appears that the company labeled the doctor as a “renegade” and all but silenced him by
complaining to his department chairman and threatening a lawsuit.
In an email contained in the report the doctor in question describes signing a legal document in
which he agreed not to discuss the issue in public. He goes on to say that he felt intimidated by
the actions of the pharmaceutical company.
Is this the tip of the iceberg or just an isolated case – nobody really knows. But just three years
ago the Senate Finance Committee uncovered a similar situation connected to the drug Vioxx. A
clinical professor at Stanford University said Merck scientists had tried to intimidate him after he
raised questions in public about the effects of Vioxx.
It was later discovered that Vioxx increased the risk of heart attacks and the drug was withdrawn
from the market. Just last week Merck agreed to pay $4.8 billion to settle Vioxx lawsuits.
As in the Vioxx case, the concerns raised by the doctor in the Avandia case were followed by
complaints by other researchers. And yesterday the FDA added an additional “black box”
warning to the Avandia label.
With the Finance Committee’s continued spotlight on this behavior I hope we can deter similar
abuses in the pharmaceutical community.
Again, it is critical that our prescription drugs be developed based on rigorous experimentation,
facts and science, not on intimidation and threats of lawsuits.
I recommend this report to my Senate colleagues.
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