Healing the Mind, Punishing the Body

Doctors beginning to warn mental patients about psychiatric drug side effects

(July 8, 2005) - Whenever Dr. Ken Duckworth starts treating someone for a severe mental illness like schizophrenia or bipolar disorder, one of the first things the Massachusetts psychiatrist does is weigh the patient and warn about the health risks of putting on pounds while taking psychiatric medication for the problem.

Nobody did that 10 years ago, and I mean nobody," says Duckworth, medical director of the National Alliance for the Mentally Ill and an assistant professor of psychiatry at Harvard Medical School.

But that routine weigh-in is a sign of what Duckworth calls a "sea change" in how doctors have come to recognize that many of the drugs they prescribe for mental illnesses may have some serious and even life-threatening side effects.

"People are starting to get it," he said recently. "All compounds have risks."

It wasn't always that clear. Potential side effects may not show up until long after a drug is on the market, giving patients and doctors a false sense of confidence. Just last month, Eli Lilly & Co. agreed to pay $690 million to settle lawsuits alleging harm caused by Zyprexa, a widely prescribed antipsychotic drug on the market since 1996.

Acknowledging criticism for its slowness in reacting to safety concerns, the Food and Drug Administration has taken steps to alert the public early on when regulators are taking a closer look at a particular medication. The agency announced in May that it would create a "Drug Watch" Web site where researchers' reports of potential side effects would be posted before the FDA or pharmaceutical industry have verified them.

The recent history of antipsychotic drugs is a cautionary tale.

When first developed 15 years ago, a new type of medication appeared to hold great promise of freeing schizophrenic and bipolar patients from the unpleasant side effects of the older drugs such as Haldol that they had been taking to control their debilitating delusions and extreme mood swings.

The newer drugs, known as "atypical antipsychotics," act to block excessive production of two brain chemicals, serotonin and dopamine, which control thought processes and emotion. While highly effective in treating mental illness, they also carried some serious side effects.

Clozapine, the first of the "atypical" drugs, came with a potentially severe complication - loss of the white blood cells that fight infection. Because it has proven capable of curbing psychosis when other drugs cannot, its use continues, though patients must have their blood monitored closely.

The drugs that followed, such as risperidone and olanzapine (Zyprexa), seemed to have fewer obvious side effects, and so were greeted with "great enthusiasm," recalls Dr. Anthony F. Lehman, professor and chairman of psychiatry at the University of Maryland School of Medicine.

"They became very widely used," Lehman said, to treat the more than 4 million American adults believed to suffer from bipolar disorder or schizophrenia.

Indeed, with encouragement from studies sponsored by the drugs' manufacturers, some doctors even began prescribing them to treat conditions for which the FDA had not approved their use, such as dementia in the elderly.

Troubling side effects

But in the past few years, the "atypical" drugs have been buffeted by research linking them to increased risk of life-threatening health problems, such as diabetes and stroke.

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While most doctors recognized that many patients gained weight taking antipsychotics, researchers found evidence suggesting that patients taking Zyprexa and similar drugs were more likely to develop diabetes and hyperglycemia, a related failure of the body to process sugar, which can lead to coma and death if left untreated.

The FDA responded to these and other problems by requiring that warnings be posted on product labels for the entire class of drugs. By that time, Lilly, which sells olanzapine under the name Zyprexa, had been hit with lawsuits filed by patients and their families.

One of those was Ellen Liversidge, a Silver Spring speech pathologist whose 39-year-old son, Rob, died suddenly three years ago of severe hyperglycemia. While taking Zyprexa, he had recovered enough from a long bout with bipolar disorder to resume work, his mother recalled, but also had gained up to 100 pounds. Though such weight gain can lead to diabetes and hyperglycemia, no one had warned him, she contended, to have his blood-sugar level tested.

In the settlement announced last month, Lilly agreed to pay as many as 8,000 plaintiffs, clearing a legal cloud that had helped depress U.S. sales of its biggest money earner, which had surpassed even the well-known antidepressant Prozac.

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