A Dose of RealityMajor Reality Check When the pain reliever Vioxx was withdrawn from the m
A Dose of Reality
Major Reality Check
When the pain reliever Vioxx was withdrawn from the market last fall after the announcement that it increased patients' risk of heart attacks and strokes, millions of Americans panicked. The sometimes sensationalized headlines didn't help. People wondered, "Should I trust my doctor?" "Could a medication that I thought would help me actually kill me?" "Is our drug safety system broken?"
Suddenly, ads for the drug were replaced with ads looking for Vioxx "victims". Law firms across the nation began recruiting anyone who had ever taken the drug as plaintiffs (原告) for class-action (公诉) suits. Merck, the company that developed the drug, could be liable for billions of dollars, making it one of the costliest liability cases ever. No surprise, then, that Merck's stock plummeted(垂直落下) 40 percent in just six weeks.
But the real cost was even greater. Not only did patients stop taking Vioxx but, doctors say, many people stopped taking their other medicines, too-sometimes putting their health at serious risk.
Vioxx was the first pebble in the pharmaceutical rock slide. Soon, accusations about a spate of other drugs were making headlines, including all COX-2 inhibitors which, like Vioxx, relieve pain. The charges didn't stop there. The FDA was accused of simply rubber-stamping new drugs; drug companies were blamed for hiding information about unsafe products; and the efficacy(功效) of clinical trials that did not reveal how large numbers of people would react was questioned. But one question that was rarely asked could determine whether or not pharmaceutical companies continue to develop and produce breakthrough medications that can save or extend lives and help people live without pain. The question: do Americans expect drugs to be risk-free? And, if someone suffers a bad reaction, will lawyers rather than doctors be the first people we call?
Panic over Pills: Overreaction?
During the tan-year period between 1994 and 2004, the FDA approved 321 completely new drugs (this doesn't include approvals for changes to existing medicines ), bringing the total to more than 10,000 drug products on the market. During that same period, eight drugs were withdrawn for reasons of safety, such as the diet drug fenfluramine (fen-phen, associated with heart-valve disease) and the allergy drug Seldane (linked to heart arrhythmias). But the Vioxx recall created a shock wave for the American consumer like no other. Many people had come to depend on their "meals", and they expected them to be safe, too, especially when they cost so much. Prescription drugs account for, some say, the fastest growing segment (about one-tenth) of all health expenditures, with some specialty drugs costing hundreds of dollars per dose.
"With Vioxx, the real shock and outrage came when there was a suggestion that people in authority may have known about these harmful side effects and not shared them with doctors or the public," says Anne Woodbury, chief health advocate for the Center for Health Transformation, a think tank founded by Newt Gingrich. It made people question their faith in the pharmaceutical industry, federal regulators and physicians-those we trust to make sure our drugs are safe. Before, taking a newly prescribed pill with a slug of water was as routine as brushing your teeth. For many people, this is no longer the case.
People have reason to worry. In clinical trial data submitted to-the FDA, Vioxx showed no connection to heart problems. The drug was approved in May 1999. But after Vioxx hit the market and grew in popularity, heart problems were revealed- lots of them. Tens of thousands of people may have been affected, and Merck was accused of hiding that information.
"The system is not perfect," comments Marianne J. Legato, MD, professor of clinical medicine at Columbia University College of Physi
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