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Check When the pain reliever Vioxx was withdrawn from the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period, eight drugs were withdrawn for reasons of safety, such as the diet drug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 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, and to verify safety,
dosage and effectiveness. Although a trial may extend as long as five years mad
often includes between 3,000 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 drug
from an idea to the market," says 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 Med 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," says 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 ifwe don’t do this, it’s 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 drags 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 can 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 drags. New drags 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 ) 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. · If you have a choice between two equally effective
drugs, choose the one with a longer track record of safety. If you are 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
drag, while others don’t-men 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 are the most likely to be taking the drugs when they are
approved." · Ask the right questions. When you get a new
prescription, never leave the doctor’s office without a clear understanding of
why you’re taking the drug, how to take it, and 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 drug company’s toll-free number for more
information, or go to its website. Corr thinks that if there is any problem with a drug, it’s better to know it ______.