01 Feb 2003 Lawyers in Your Medicine Cabinet May Keep Needed Drugs Out, by Edmund F. Haislmaier

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 drug information.

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.