Ebola Outbreak: A Teachable Moment for Scientists

The media frenzy surrounding the Ebola crisis in West Africa shows that many journalists don’t understand that an experimental drug is just that – a scientific experiment. It is not a “breakthrough” drug or a “cutting-edge treatment” or a prize to be envied, unless or until it is proven to be safer and more effective than nothing. Continue reading

Johnson & Johnson Praised for Taking Uterine Surgery Tools Off Market

Johnson & Johnson, which has come under withering criticism for its response to problems with some of its medical devices, won cautious praise from critics on Thursday for its decision to withdraw three products used in uterine surgery because of a risk of spreading cancerous tissue, only months after the safety issue became widely known. Continue reading

Big Data Peeps At Your Medical Records To Find Drug Problems

No one likes it when a new drug in people’s medicine cabinets turns out to have problems — just remember the Vioxx debacle a decade ago, when the painkiller was removed from the market over concerns that it increased the risk of heart attack and stroke. To do a better job of spotting unforeseen risks and side effects, the Food and Drug Administration is trying something new — and there’s a decent chance that it involves your medical records.
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Lawmakers Respond To Advocates’ Concerns About Innovation Initiative

Lawmakers appeared to respond to concerns that the House Energy & Commerce Committee is receiving a one-sided, industry-backed patient perspective as part of its 21st Century Cures Initiative by soliciting comments July 11 from other groups and calling for a balance between the push for more expedited approvals and public health safeguards. Continue reading

Health Care Advice That Can Save Your Life

My friend Barry just got out of the hospital, four months after having an almost deadly reaction to a prescription medication. Talking to him about his experience has made me realize how overwhelming it is for most people to figure out what medical treatments are best for them, which doctors to trust, and how to recover from a serious illness. Continue reading

Letter to the Editor: “FDA’s compassionate-use program offers early access without compromising drug trials”

Washington Post, April 24, 2014   The April 22 front-page article “FDA relents in battle against a cruel disease,” about parents urging the Food and Drug Administration to approve a promising drug for Duchenne muscular dystrophy, pulled on the heartstrings. However, there … Continue reading