On September
30, 2004, pharmaceutical giant Merck announced that it was
withdrawing its arthritis medication Vioxx from the market.
Approved by the FDA in May of 1999, Vioxx quickly became a
blockbuster drug for Merck and generated $2.5 billion in annual
sales.
By the time the drug was withdrawn from the market more than
20 million Americans had been exposed to Vioxx, and the FDA
has estimated that as many as 140,000 of them may have had
suffered heart attacks, strokes or other serious cardiovascular
problems as a result of the drug.
What happened with Vioxx, unfortunately, is not an isolated
occurrence. In the early 1990s, major pharmaceutical companies
lobbied Congress aggressively to reduce the time it takes
to bring a drug to market. In the case of Vioxx that meant
the drug was approved in only six months, when it would have
taken years under the previous regulations.
The problem with quick approval is that clinical trials are
limited in both size and duration. If a side effect of a drug
is not going to be apparent before 18 months -- the length
of time Merck claims is necessary before the cardiovascular
risks of Vioxx become apparent -- it is simply not going to
be discovered during briefer clinical trials.
Essentially, after a new drug is approved for marketing the
general public serves as guinea pigs, at risk for serious
side effects that went undetected in clinical trials. That
problem is exacerbated when drug companies intentionally design
their studies so that the results will understate the risks
of a drug, as happened with Vioxx.
Perhaps the most egregious problem with prescription drugs
today is the relatively recent phenomenon of direct-to-consumer
marketing. Until the late 1990s, drug companies primarily
marketed their drugs through sales visits to doctors. Doctors
can ask the important questions about side effects that their
patients probably would not think to ask.
In the case of Vioxx, Merck spent over $500 million per year
in an aggressive television advertising campaign that was
targeted directly to the general public. That advertising
campaign was a huge success for Merck and an important driver
of the billions of dollars of profit Vioxx generated for the
company. The problem is that it is difficult to accurately
describe the risks of side effects in a 30-second television
commercial, and in fact the FDA sent a reprimand letter to
Merck warning that its television ads were understating the
cardiovascular risks of Vioxx.
U.S. laws regulating drug companies have traditionally been
among the strongest in the world, but those safety regulations
have been significantly weakened in recent years. Given the
current political climate and the huge amounts of money pharmaceutical
companies can pour into lobbying efforts, the situation seems
unlikely to improve in the near future. Patients taking new
prescriptions drugs will continue to serve as guinea pigs
and will continue to experience serious side effects that
could have been avoided if adequate regulations were in place,
or if drug companies acted in a more responsible manner to
protect the public health.
It is ironic that one of the few remaining guarantees of
public safety is precisely the tort system which has come
under attack in recent years: if drug companies will not voluntarily
act in an ethical manner to protect the public health, one
of the last remaining safeguards is the threat of lawsuits.
Merck faces billions of dollars in liability from the lawsuits
that will be filed over the next few years. It can only be
hoped that the risk of being held financially accountable
for injuries caused by bad drugs will serve as some deterrent
for other drug companies in the future, because the safety
regulations that currently exist in this country are no longer
getting the job done.
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