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Check When the pain reliever Vioxx was Withdrawn from the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eight drugs were withdrawn for reasons of safety, such as the diet drug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. Vioxx showed no connection to heart problems in its clinical trial.