FDA to create board to monitor drug safety
By Diedtra Henderson, Globe Staff |
February 16, 2005

ROCKVILLE, Md. -- The Food and Drug Administration said yesterday it will create an independent drug safety board -- as critics have demanded -- that would quickly direct the agency how to respond to drugs on the market that are suspected to be unsafe.

The board reflects a major shift in the FDA's approach. To date, most of the agency's focus has been on testing a drug's effectiveness and safety prior to its approval. But once a drug was on the market, the agency relied primarily on the drug industry to alert it to problems. Now the agency is pledging to look for safety problems on its own.

The new safety panel would be made up of agency experts who were not involved in approving the drug and other scientists inside and outside of government. While the drug would remain on the market during deliberations, the panel could act within days, instead of the weeks or months that the FDA has taken to respond to the recent spate of problems first with antidepressants and then with Vioxx, Celebrex, and other painkillers.

The launch of the safety board received both praise and criticism from Congress. It comes as the agency begins three days of hearings today on the risks and benefits of the painkillers, a session triggered by the withdrawal of Vioxx from the market last fall. Agency critics say the FDA is too closely tied to the drug industry it regulates. There also have been internal conflicts, with FDA employees who approve drugs having more clout than the side of the agency that reviews potential problems with the same products.

Meanwhile, the New England Journal of Medicine yesterday published studies showing Vioxx and Celebrex triggered heart problems much more quickly than previously known. One study, a completed review of the trial that led to the withdrawal of Vioxx, indicates that small doses of that drug began to harm hearts within just six months.

Another study indicates that larger doses of Celebrex caused excess deaths due to heart attack and stroke in as little as 12 months. The lead author of the study said the heart risk may actually be greater.

''Had we had more people, it's very possible we would have seen a risk earlier," said Dr. Scott Solomon, director of non-invasive cardiology at Brigham and Women's Hospital. ''So, to conclude from this that there is no risk before one year would be wrong."

Celebrex, Vioxx, and similar drugs in their class, called cox-2 inhibitors, were introduced with much fanfare at a time when drug advertising rules were relaxed. As safety concerns grew, prescriptions steadily dropped.

Solomon said his results do not suggest Celebrex should be withdrawn from the market, as the FDA has been pressured to do. He said that within several months, studies pointing to Celebrex's potential benefit in shrinking tumors are expected to be complete. For now, what's clear is that high doses of the painkiller more than tripled the risk of serious cardiovascular events.


more at: http://www.boston.com/business/globe...528539/?page=2