Grassley, Baucus bill would enhance research on pharmaceutical safety and effectiveness
WASHINGTON â€” Responding to growing concerns about the safety of pharmaceuticals, Sens. Chuck Grassley and Max Baucus introduced legislation today to improve the study of medical treatments, including the effectiveness and safety of drugs.
Their proposal would give researchers at federal agencies and university-based and other research organizations highly controlled access to data on hospital, physician and prescription drug benefits that are provided to Medicare beneficiaries.
â€œThe situation thatâ€™s unfolding this week with the popular diabetes drug Avandia emphasizes the value of making this sort of rich source of information available to experienced and credentialed researchers,â€ Grassley said. â€œThe drug trials that go on before the Food and Drug Administration approves a drug are no match for the wealth of information thatâ€™s available after a drug is on the market and millions of people start taking it. This legislative initiative will tap that valuable information on behalf of public safety and public health. And, it does so in a way that makes sure the strongest safeguards are in place to protect privacy and confidentiality.â€
â€œKnowledge is power, and this bill will empower our health system to serve Americans better,â€ said Baucus. â€œThe secure and efficient sharing of Medicareâ€™s vast data among a number of Federal agencies will enable researchers to accurately examine the safety and effectiveness of many treatments patients receive. The data this bill would make available provides information that can create more watchdogs. More eyes might have helped us spot a situation like we learned about just this week with the FDAâ€™s handling of the diabetes drug Avandia. This bill provides for this information-sharing with no other goal than to promote the publicâ€™s health and the public good.â€
Medicare processes 500 million claims for benefits every year, and millions of prescriptions are filled annually through the new Medicare prescription drug benefit. Grassley said information about these benefits would be a tremendous resource for qualified health services researchers, and it would help them conduct rigorous studies on the safety and effectiveness of various medical treatments.
Grassley and Baucus said that researchers could help policy makers better understand why services that we know can help people maintain good health are not being used and to develop policies to promote their use, for example.
Indeed, knowledge is power. But information without context and power without perspective is dangerous.
Let's watch this one and see where it goes.