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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When the pain reliever Vioxx was Withdrawn from the market last fall after the announcement that it increased patients’ risk of heart attacks and strokes, millions of Americans panicked.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 robber-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 ten-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 During that same period, eight drugs were withdrawn for reasons of safety, such as the diet drug fenfluramine (fen-phen, associated with heart-valve disease) and the allergy drug Seldane (linked to heart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 "meds", 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 Physicians and Surgeons in New York City. "Sometimes a company may not want to show data that are negative till they really know what’s going on. But it’s ridiculous to suggest that they would suppress things willy-nilly, because if a drug is going to cause severe side effects, it’s not in their best interest to hide that."
How Side Effects Emerge
How can dangerous side effects take years, or even decades, to become known A new drug is first tested on animals. If the results indicate that it’s likely to be both safe and effective, the company applies to the FDA for permission to begin testing it in humans. Human studies have three phases: to evaluate safety, to determine effectiveness, end to verify safety, dosage and effectiveness. Although a trial may extend as long as five years and often includes between 3,0DO and 10,000 people, each participant may only receive the medication for a period of weeks or months. Statistically, rare and dangerous side effects may not emerge until millions of people have used the drug, after FDA approval.
So why don’t we test drugs on more people and for longer periods of time For one thing, quicker approvals may save lives, as with drugs for AIDS or a vaccine for a newly emerging flu pandemic. Another reason is cost. "It already costs a billion dollars to get a drag from an idea to the market," rays Corr. "If we had to study a million patients before we took a drug to market, there would never be another drug."
Monitoring after Approval
After a drug is approved, it is subject to post-market surveillance(监督). The FDA analyzes reports of "adverse events", or drug side effects, which come from the industry, from ongoing clinical trials and through its Mad Watch program, to which consumers, physicians, pharmacists and other health professionals voluntarily report problems.
Negative reports about a drug that’s on the market can yield crucial new information. "Clinical trials that are negative are, many times, just as important as the trials that show positive results," says Marvin Lipman, MD, chief medical adviser for Consumer Reports. Legislation was introduced in both the House and Senate in October 2004 to establish a registry of all clinical trials and their results. "We are the most regulated industry in the world," rays Corr. "And frankly, that’s how it should be. If there is a problem with a drug, We want to know about it sooner rather than later."
Consumers may know sooner too. In February the FDA announced the creation of an independent Drug Safety Oversight Board to provide expanded and faster drug-safety information to doctors and patients. While there will always be risks, the Public may be better equipped to judge and act on them.
"We still need to be willing to take personal responsibility for assessing the risk-benefit ratio of a medication," says Legato. "Yes, you have to be completely informed to do it. And, yes, it’s complex. But if we don’t do this, ifs like going back to the Middle Ages when there were no risks, except of dying by the age of 26. We have nearly doubled life expectancy since the beginning of the 20th century. That did not happen by accident. Prescription drugs have played a huge role."
How You Can Make Informed Decisions
Since there is no such thing as a pill that is completely safe, including aspirin, consumers have to accept the dichotomy (二分法) that the same medicines that extend and enhance our lives may hurt us; some of them may merely have minor side effects, while others con. be lethal. So how should you and your doctor proceed
· Weigh the risks and benefits of any drug. As a smart consumer you must decide whether a drug is "safe enough" for you. The greater the benefit, the more risk you may be willing to take. If your illness is mild and not very bothersome, you may decide that any risk is too big and opt against taking any medication at all. Conversely; if your illness is serious or potentially life threatening, you may even be willing to try an experimental drug with greater risk for serious side effects.
· Be especially cautious about new drugs. New drugs are inherently risky. So if you’re taking one, monitor yourself carefully. Have your eating and digestive habits changed Are you feeling unusually tired or conversely agitated(激动的) Have your breathing patterns or skin color changed If so, call your doctor immediately, who may tell you to stop taking the drug. How does a consumer know that a drug is new Ask your doctor or pharmacist.
· lf you have a choice between two equally effective drugs, choose the one with a longer track record of safety. If you ere taking a drug in the same class as one that, has been recalled, it is prudent to ask your doctor if that drug places you at greater risk.
· Know if you’re in a high-risk group. Although scientists still don’t know precisely why, certain individuals have bad reactions to a drug or to a particular dose of a drug, while others don’t—taco metabolize drugs differently than women do, for example—be especially vigilant (警惕的) if you are very young, very old or pregnant. Drugs usually aren’t tested on these groups. "I worry the most about the elderly," says Avorn. "They are vastly under-represented in trials of drugs, yet they ere the most likely to be taking the drugs when they ere approved."
· Ask the right questions. When you get a new prescription, never leave the doctor’s office without a deer understanding of why you’re taking the drug, how to take it, end how you’ll know if it’s working. Even if it makes you a bit uncomfortable, ask. You are responsible for your own health and safety. "If the doctor doesn’t want to answer questions, you should probably find another doctor," says Avorn. After your visit; if you still have questions, call or e-mail the doctor. Use your pharmacist as an expert consultant for any additional concerns you have about the drug or its side effects. You can also call the drag company’s toll-free number for more information, or go to its website. Many people expected the medicines they took to be safe when the medicines cost a lot.