Your Life your connection to The Boston Globe
White Coat Notes: News from the Boston-area medical community
Send your comments and tips to

Elizabeth Cooney is a health reporter for the Worcester Telegram & Gazette.
Boston Globe Health and Science staff:
Scott Allen
Alice Dembner
Carey Goldberg
Liz Kowalczyk
Stephen Smith
Colin Nickerson
Beth Daley
Karen Weintraub, Deputy Health and Science Editor, and Gideon Gil, Health and Science Editor.
 Short White Coat blogger Ishani Ganguli
Week of: May 20
Week of: May 13
Week of: May 6
Week of: April 29
Week of: April 22
Week of: April 15

« Today's Globe: funding slowdown, trans fats, stents, Walter Reed woes, Cheney blood clot, painkillers, smoking | Main | On the blogs »

Tuesday, March 6, 2007

Researchers urge drug companies to make safety data public

Keeping drug safety data from clinical trials confidential to protect trade secrets can delay the discovery of dangerous side effects, two Boston researchers write in the current issue of Health Affairs.

Aaron S. Kesselheim, a clinical fellow in medicine in the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women's Hospital, and Michelle M. Mello, associate professor of health policy and law at the Harvard School of Public Health, point to Vioxx and other cases of drugs with problems that came to light after their approval by the Food and Drug Administration.

The two urge the FDA to place a greater burden of proof on drug companies to show how they would be harmed by release of their data, they recommend more comprehensive public documents from drug companies on safety, and they ask Congress to act if the FDA doesn't.

"Disclosing safety data from clinical trials would allow protection of most commercially valuable information and better balance our interests in drug innovation and patient safety," they wrote.

Posted by Elizabeth Cooney at 09:00 AM
Sponsored Links