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Elizabeth Cooney is a health reporter for the Worcester Telegram & Gazette.
Boston Globe Health and Science staff:
Karen Weintraub, Deputy Health and Science Editor, and Gideon Gil, Health and Science Editor.
Short White Coat blogger Ishani Ganguli
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.