A disturbing aspect of the growing litigation
crisis is its potential for harming the health of Americans.
This threat comes in part from class action lawsuits against
pharmaceutical companies over prescription drug side effects.
At first glance, this may seem to be
an issue of little concern. After all, most drug makers have
famously "deep pockets," and the arguments of trial
lawyers that they serve a valuable public purpose in driving
unsafe products off the market and compensating victims would
also seem to apply. However, the reality is somewhat more complicated.
To start with, such suits distort the
public understanding of drug safety. In fact, no drug is ever
completely "safe." Even aspirin is harmful if taken
in the wrong dose or by the wrong person. A drug is only "safe"
to the extent that it poses less risk of harm than the condition
it is used to treat or the risks associated with alternative
therapies for the same condition. It is this concept of "relative"
safety, based on scientific data, which the FDA employs in deciding
whether a drug is allowed on the market. This relative safety
standard means that drugs used to treat minor conditions must
have a very clean safety profile to be considered "safe."
Conversely, drugs used to treat a life threatening condition,
such as cancer, can have very serious, or even deadly, potential
side effects and still be considered "safe."
In reality, most drugs fall between these
two extremes. They target serious, though not immediately life-threatening,
illnesses and have varying side effect risks. Drug researchers
keep working to bring both more effective and safer drugs to
market and the FDA is constantly reassessing the efficacy vs.
safety balance for existing drugs in light of new information
and the new drugs developed.
A good example of how this works, and
how class action lawsuits can interfere, is the case of the diabetes
drug Rezulin. The FDA approved Rezulin in January 1997, despite
evidence of some potentially serious side effects, because it
was a significant improvement in treating a serious illness.
After Rezulin was on the market, more evidence emerged of dangerous,
and even deadly, liver toxicity side effects.
In response to the new data, the FDA
took several actions in 1997, 1998 and 1999 to make doctors more
aware of the potential harm and to encourage them to be careful
in prescribing Rezulin. These steps included requiring the manufacturer
to put stronger warnings on the drug's label. In the summer of
2000, the FDA approved two new drugs similar to Rezulin that
did not appear to have side effects as serious as Rezulin's.
When data from post-market use confirmed these drugs did have
better side effect profiles, the FDA had Rezulin's manufacturer
withdraw the drug from the market in March of 2001.
In the meantime, trial lawyers had filed
class action suits against the manufacturer on behalf of Rezulin
patients. The suits created concern among thousands of patients
who had been successfully taking Rezulin with very positive results
and probably encouraged many more to drop or avoid the drug,
to the detriment of their health. Commendably, the FDA waited
to take Rezulin off the market until there were better, similarly
effective alternative drugs available.
Today, the trial lawyers are targeting
a new class of drugs used to treat schizophrenia. These drugs,
Zyprexa, Clozaril, Geodon, Seroquel and Risperdal, are not only
better than older antipsychotics in treating the symptoms of
schizophrenia, but are also free of the side effects that discouraged
patients from taking the older drugs. In many cases the older
drugs made patients appear and act flat, emotionless and even
almost catatonic, leading them to stop using the drugs. In contrast,
the principal issue with the new drugs is a tendency for patients
to gain weight. In addition, recent reviews of these drugs' post-market
experience also indicate that some might -- only might -- exacerbate
a well-documented and long observed tendency toward diabetes
and diabetic complications among schizophrenics.
However, instead of waiting for more
conclusive scientific evidence and responsible FDA action, the
lawyers are suing. The danger is that by ginning up a "safety"
scare about these drugs, schizophrenics will discontinue or avoid
them, leaving their highly self-destructive condition untreated.
The more general danger is that, if these
types of suits become more common, the process for developing
and approving new drugs will slow. Manufacturers and the FDA
will raise the standard for relative safety and keep promising
new drugs off the market until even more extensive testing is
completed, leaving millions of Americans without access to beneficial,
or even life-saving new treatments.
Rather than suing over drug safety, the
better solution is to work with Congress, the FDA, manufacturers
and doctors to continue improving the existing processes for
encouraging ever-safer drug prescribing, patient monitoring and
the dissemination of scientifically sound and balanced post-market
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Edmund F. Haislmaier is a member
of the board of directors of the National Center for Public Policy
Research and a Washington, D.C.-based health policy consultant.