Calls For Stricter US Drug Safety Process

By Melinda Smith
Washington
01 June 2007

It takes an average of 12 years for a drug to make its way through laboratory and clinical testing, government approval, and finally to the pharmacy. Drug companies invest millions of dollars in the long process. And that is just the beginning.

A report published in the New England Journal of Medicine indicates that U.S. drug advertising to consumers rose by almost 300 percent from 1997 to 2005. Spending by pharmaceutical companies to promote their products to doctors increased by 86 percent. Money spent on drug research and development was up by at least 100 percent.

Critics say the massive investment to sell these drugs is part of the problem. At present the U.S. Food and Drug Administration, the government agency which approves drugs and regulates their safety, has no power to block the marketing of new drugs before safety studies have been completed. There is a bill pending in the U.S. Congress to give that power to the FDA.

But critics say the Food and Drug Administration's handling of older drugs on the market is also flawed. Recent studies showing the risk of heart attacks associated with the diabetes drug Avandia – as well as the 2004 voluntary withdrawal of the pain reliever Vioxx – have been cited as failures of the drug approval process.

Even Dr. Janet Woodcock, a senior official with the FDA, admits the situation is troublesome. "We are finding more problems with marketed medications, but not just with recently marketed medications, with drugs that were approved long ago."

One report indicates at least half of drugs already approved have needed further safety labeling. In some cases, drugs were considered so unsafe they were removed from the market.

Dr. Jerry Avorn of Brigham and Women's Hospital in Boston, Massachusetts says the regulations are out of date. "We don't have a good system for finding out if a drug is dangerous until it's been on the market for many years. And that's not acceptable."

Another problem: participants in human trials are often healthier than patients for whom the drug is designed. Again Dr. Avorn , "A drug that works well in hand-picked patients who are guaranteed not to be terribly sick is not likely to have the same safety or efficacy as it does in typical patients."

There are also concerns the duration of drug trials are often too short and too few people are tested. After a new drug winds up on drugstore shelves, the FDA requires pharmaceutical companies to continue studies on that drug. The FDA acknowledges that companies routinely fail to complete that process.

Dr. Brian Strom of the University of Pennsylvania says the U.S. Congress needs to give greater enforcement authority to the FDA. "Congress hasn't given the FDA the authority to force companies to do such studies."

Before the AIDS scare 20 years ago, the Food and Drug Administration had been criticized for taking too long to approve new medications. Now it is criticized for not taking long enough.