Sen. Grassley’s floor statement regarding the intimidation of scientists in drug-safety deliberations
Mr. President, just about three years ago on November 18, 2004, I convened a hearing on the worldwide withdrawal of Vioxx, a blockbuster pain medication.
That hearing turned the spotlight on systemic problems at the Food and Drug Administration.
We found that the FDA maintained a cozy relationship with the drug industry and suppressed scientific dissent regarding agency actions on drug-safety.
At that Vioxx hearing, we also heard about Merck using its power, influence, and access to try and discredit FDA safety expert, Dr. David Graham.
Merck also tried to intimidate Stanford researcher Dr. Gurkirpal Singh. The company warned him to stop asking for more safety data on Vioxx, despite the fact he was one of their consultants.
What is troubling is that three years later, I am here with my colleague, Senator Baucus, to talk about another case where pharmaceutical executives used power, influence, and access to intimidate a medical researcher.
In essence, another company wanted to put an end to another scientist who was voicing concerns about the cardiovascular risks associated with a drug.
In this case, we are talking about the diabetes drug, Avandia.
Today, Senator Baucus and I are releasing a staff report showing how executives at GlaxoSmithKline intimidated Dr. John Buse, a medical researcher at the University of North Carolina.
Together, our respective staffs reviewed documents provided by the company and others, and they found bothersome internal emails that reveal how these pharmaceutical executives
think.
In these emails, high level company officials discussed the possibility of threats against Dr. Buse.
These threats included the possibility of filing a lawsuit.
Company executives called Dr. Buse an “Avandia Renegade” and had him sign a retraction letter they wanted to give to financial analysts.
These analysts were evaluating the company’s products for investors.
So what we have here are three cases where companies intimidated researchers who dared to express concerns about risky drugs. And in the case of both Vioxx and Avandia the drugs actually turned out to carry some serious risks.
What I am here to say today, is that attacks on medical researchers by the pharmaceutical industry must stop. And stop now.
Until this practice ends, I want to let America's scientists know that I am very interested in their concerns.
Scientists should feel free to contact my office if a pharmaceutical company threatens their career or attacks their reputation when they raise the alarm about a possibly dangerous drug.
They can also anonymously provide information and documents by mail or by fax to the Committee. Here’s the fax number: 202-228-2131.
I ask unanimous consent that this report be printed in the record.
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