New Drug Panel Needed
New drug panel needed
If Americans are becoming increasingly alarmed over their use of prescription and over-the-counter anti-inflammatory drugs, no one can blame them. Least of all, the officials at the Food and Drug Administration who consumers have trusted to ensure that their drugs are safe.
The evidence now appears too overwhelming to ignore: It’s time for the federal government to overhaul the drug approval and monitoring process. And that, we believe, includes creating a new drug safety monitoring board independent of the FDA, the agency that now approves drugs.
The idea of an independent drug safety board has been proposed in the past. But it is properly gathering momentum. The editors of the Journal of the American Medical Association endorsed it last month. The board would monitor the safety of drugs already on the market.
The latest bad news came Monday when federal officials announced that naproxen, a painkiller sold by prescription and over the counter as Aleve, might increase the risk of heart attack or stroke.
That brings to three the number of anti-inflammatory drugs singled out recently by researchers for their possible role in increasing heart attacks or strokes. Vioxx was pulled from the market this fall and Celebrex was linked last week to heart attacks and strokes.
FDA officials admit they don’t know what to make of the preliminary findings for naproxen or other drugs. They point out that some of the warning signs now emerging may turn out to be false alarms which is, of course, possible and that more study is needed. But they also acknowledge that no one seems to have studied the long-term effects of naproxen or any of the other non- steroidal, anti-inflammatory medications, including the highly popular drug ibuprofen, sold over the counter as Advil.
Nor is the FDA the only culpable party. Some experts believe that many doctors have prescribed anti-inflammatory drugs such as Vioxx and Celebrex indiscriminately.
Drug companies, meanwhile, have spent huge sums of money to promote sales. Pfizer spent almost $71.2 million advertising Celebrex in the first nine months of this year nearly 55% more than it did for the same period in 2003. With that kind of promotion, it’s little wonder a growing number of patients ask their doctors for the drugs by name and if their doctors don’t give in, many shop until they find one who will accommodate them.
FDA officials point out, quite correctly, that new drugs are helping to ease suffering and they deny that safety is being compromised.
But there can be no denying that the regulatory picture in the United States has changed. Only a few decades ago, most new drugs came on the market first in Europe, prompting criticism in this country that the FDA was being too stringent.
But that has changed. A majority of new drugs are now introduced here while Europeans have adopted stricter drug testing and approval procedures. Great Britain carefully monitors all new drugs after they go on the market to see how patients react.
The U.S. needs to do that, too. But as the editors of JAMA said, it’s unreasonable to think that the same agency that approves drugs, the FDA, also can be charged with the responsibility of proving itself wrong. The better approach, from a standpoint of checks and balances, seems to be to give that monitoring job to a new board.
FDA officials believe creating the new board which would require an act of Congress is not necessary. Meanwhile, the evidence continues to build that it is.
Copyright 2004, Journal Sentinel Inc. All rights reserved. (Note: This notice does not apply to those news items already copyrighted and received through wire services or other media.)