:gREG:

RALEIGH -- Drugs have been big news lately. Not cocaine or heroin. Not illegal drugs. Of late the spotlight has been on prescription drugs, including Prozac and Vioxx, Accutane and Crestor. Turns out they're not all they've been cracked up to be. Allen Roses could have told us. Dr. Roses is international vice president of genetics at GlaxoSmithKline. Addressing a scientific meeting in December 2003, he dared to say what many in the drug industry wished he had kept to himself. When it comes to benefits derived from prescription drugs, the overall record is modest at best. "The vast majority of drugs," Dr. Roses declared, more than 90 per cent (of them), only work in 30 or 50 per cent of the people." In other words, most drugs don't help most patients most of the time. When it comes to the harmful effects of using these medicines, the odds are worse. The federal Food and Drug Administration is charged with ensuring the safety and effectiveness of medical procedures and products. A comparatively small staff (approximately 100) is responsible for monitoring the 3,200 drugs currently available at the local drug store. Total costs for monitoring and evaluation represent only 4 percent of the FDA's annual budget. Even if the methods the agency used to ensure safety and effectiveness were adequate, too few people are given too little money to do too much work.As it happens, the FDA's methods are anything but adequate. The FDA defines an "adverse event" as "any undesirable experience associated with the use of a medical product in a patient." Specific examples of "undesirable experience" are "death, disability, hospitalization,...congenital anomal(ies), or (a condition that) requires treatment to prevent permanent damage." In other words, "adverse events" involve more than a runny nose or itchy feet. By definition, then, adverse events precipitated by prescription drugs (adverse drug reactions or ADRs) are quite serious. Among the adverse reactions patients have to prescription drugs, some are fatal. The drugs people take sometimes kill them, more often than the public might suspect. A controversial study published in 1998 found that more than 100,000 hospitalized patients die annually because of ADRs, making prescription drugs the fourth leading cause of death in America, ranking behind only cancer, heart attack and stroke. According to FDA guidelines, adverse events, including all ADRs, "should be reported." The problem is, what "should" be done often is not. The FDA's voluntary system of reporting, called Medwatch, receives upwards of a thousand reports each working day, approximately 260,000 a year. Yet David Kessler, former director of the FDA, estimates that only 1 per cent of ADRs are reported. If true, that figure of 260,000 does not reflect anything like the true dimensions of the problem. Several factors help explain why ADRs are so underreported. First, as noted above, the reporting system is voluntary. No law requires that anyone do anything, just as no punishment awaits those health care professionals who do nothing. Most of these professionals are conscientious people, no doubt. However, like the rest of us, there must be some who are lazy, others, irresponsible. For those who are the one or the other, reporting a known or suspected ADR might be a rare occurrence. Second, pharmaceutical companies sometimes are willing to spend considerable sums to influence the drug-prescribing habits of their clients. Writing in the June 27, 2004 edition of The New York Times, Gardiner Harris described "the shadowy system of financial lures that pharmaceutical companies" use to buy brand name loyalty. In a $400 billion industry that now spends more marketing its products than it spends researching them, physicians sometimes receive unsolicited checks, sometimes in six-figure amounts, from pharmaceutical companies. Health care providers who are the beneficiaries of such industry largess understand the unwritten rules of the game. You promote our drugs, you win. You do anything to reduce our sales, you lose. Within this nexus of financial rewards and punishments, one can understand why some physicians might pass when it comes to reporting known or suspected ADRs among their patients. Finally, the FDA itself has proven to be reluctant to take proactive steps to encourage reports of drugs with documented toxic effects. Vioxx is the bad drug du jour. Last September, Merck & Co., its manufacturer, made front-page news when it voluntarily withdrew the drug because its use was associated with increased risk of heart attack and strokes, something FDA's own scientists had been telling their bosses. David J. Graham, associate director of science in the FDA's Drug Center's Office of Drug Safety, raised a red flag about the safety of Vioxx. And how did his peers at the FDA treat Dr. Graham? "Dr. Graham...was ostracized, subjected to veiled threats and intimidation," observed Sen. Chuck Grassley, R-Iowa. "Raising safety concerns within the agency is extremely difficult," Graham told The Associated Press.In response to the Vioxx scandal and the recent recall and relabeling of other drugs, members of Congress and public health care advocates are calling for fundamental changes in how the FDA does business. Grassley is among those lobbying for an independent drug safety board, a finger in the dike at best unless it has the power to make reporting ADRs mandatory and to stop pharmaceutical companies from bribing medical professionals. In the meantime, the FDA's response has been to dismiss structural change as unnecessary. As Lester M. Crawford, acting FDA commissioner, recently told reporters, "the agency's stamp of approval means America's drugs are the safest in the world." And a good thing too. Otherwise we would be risking our health and life by buying drugs from Canada.(Tom Regan is emeritus professor of philosophy at N.C. State University. His most recent book is "Empty Cages: Facing the Challenge of Animal Rights.")THIS IS THE REALITY. ANIMAL TESTING DOES NOT MAKE SENSEMONSTERS DO EXIST