# 496  

October 2003




Fighting Disease is Better Than Suing Over It


by Amy Ridenour

The FDA may have severely undermined a group of personal injury attorneys looking to sue the makers of a new class of wonder drugs for schizophrenia. It turns out that the nation's premier drug regulatory agency recently agreed with the makers that there is no scientific proof the new and improved anti-psychotic drugs actually cause diabetes. Instead, it said the jury is still out.

Then again, contrary scientific evidence has never prevented lawsuits from being filed in the past. So, it's not clear what effect the FDA opinion is going to have on the plaintiffs' attorneys.

Notwithstanding the lawyers' reactions, the FDA's assessment may at least have the benefit of allaying the fears of patients who unfortunately began to question whether the medication is worth the perceived risk.

Certainly every drug carries risks, and everyone taking a new drug should consider those risks. But, that consideration should be based on medical studies and discussions with one's doctor - not on unsubstantiated claims in a personal injury attorney's advertisement.

This is especially the case with an illness such as schizophrenia.

Schizophrenia is a severe and debilitating disease that causes hallucinations, disordered thinking and delusions, making it difficult for patients to hold down a job or maintain a relationship. As a result, those who suffer from the illness are not its only victims. Family members suffer, too.

Fortunately, much of this suffering is being eased by medications, and new drugs are almost a miracle for many.

The new drugs - known to consumers under the brand names Abilify, Clozaril, Geodon, Risperdal, Seroquel and Zyprexa - are widely believed to be far more effective, with far fewer side effects, than the older generation of antipsychotics. Their effect lasts longer and they have fewer side effects reducing the quality of patients' daily lives.

However, some studies have shown that a greater percentage of patients taking the new drugs have tested positive for diabetes than those who took the older ones. And, for that reason, lawyers have circled around the drug makers like piranhas.

But the lawyers conveniently fail to grasp an important point. Just because a drug is associated with a particular illness does not prove that the drug actually causes that illness.

Consider the fact that long before the anti-psychotic drugs went to market, studies revealed that people with schizophrenia were up to four times more likely to develop diabetes than the general population. One logical medical explanation is that weight gain is a risk factor linked to diabetes and that drugs used to treat schizophrenia are known to cause weight gain in some patients. In other words, it is unlikely that the drugs themselves are causing diabetes, since the diabetes link existed before the drugs were invented.

But the lack of evidence hasn't stopped many trial attorneys from trolling for plaintiffs, perhaps scaring them off their medication and possibly doing great harm to a vulnerable community in the process. Legal hysteria has serious implications across the entire health care industry.

As Dr. Mark McClellan, head of the FDA, recently noted, our nation's litigious habits are having a negative impact on drug makers by "increasingly threatening the development of badly needed cures for physicians to use."

According to Dr. McClellan, "The legal system is altering the practice of medicine and the development of medicines themselves, in ways that harm patients."

Imagine if the manufacturers decided they were sick of the lawsuits, and stopped making the drugs. Literally millions of patients with schizophrenia would no longer be able to function as well in society. That's why it is a good thing that the FDA is seeking to set the record straight. The agency took a prudent step, deciding to notify physicians about the possible risk of diabetes associated with taking drugs to treat schizophrenia.

But the FDA wisely noted that there is an "increased background risk of diabetes" in schizophrenia patients to begin with and an "increasing incidence of diabetes" in the general population.

As a solution the FDA suggested that doctors should pay greater "attention to the signs and symptoms of diabetes" in these patients. Imagine that. Rather than having to march into court, patients and doctors just have to watch out for certain symptoms and, if they detect diabetes, treat it.

Now that makes sense. It's no wonder that fighting disease with the proper medical care is far better than suing over it.

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Amy Ridenour is president of the National Center for Public Policy Research. Comments may be sent to [email protected].





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