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Lawyers in your medicine cabinet may keep needed drugs out

By Edmund F. Haislmaier
web posted May 19, 2003

The growing litigation crisis is harming our health.

Case in point: Class action lawsuits against pharmaceutical companies over prescription drug side effects.

At first glance, this may seem to be an issue of little concern. Most drug makers have deep pockets and the trial lawyers' arguments that they serve a valuable purpose in driving unsafe products off the market and compensating victims seems to apply. However, the reality is somewhat more complicated.

To start with, such lawsuits distort the public understanding of drug safety. 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 that the FDA uses to decide whether a drug is allowed on the market. Drugs used to treat minor conditions must have a very clean safety profile, while 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 risks. Researchers work to bring both more effective and safer drugs to market while the FDA constantly reassesses 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 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, the FDA took actions in 1997, 1998 and 1999 to make doctors 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 2000, the FDA approved two new similar drugs that did not appear to have such serious side effects. When 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 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 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 alternatives 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, 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 of 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. Also, 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, lawyers are suing. The danger is that by ginning up a safety scare about these drugs, schizophrenics will 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 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, even life-saving, new treatments.

Edmund F. Haislmaier is a member of the board of directors of the National Center for Public Policy Research and CEO of Strategic Policy Management, a Washington, D.C. health policy consulting firm. Contact the author at legalbriefs@nationalcenter.org.

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