Lawyers Exploiting the Mentally Ill

By Michael Fumento

Scripps Howard News Service, June 26, 2003
Copyright 2003 Scripps Howard News Service

This is how schizophrenia is still treated in some countries.

But frivolous lawsuits have sullied the reputation of many a safe and critical drug. This time, schizophrenics and others with severe mental illness could suffer horribly when frightened away from their medication.

These newer medicines, called "atypicals," are more effective and have fewer side effects than the "typical" drugs that often cause stiffness and repetitive involuntary movements. Often these symptoms never disappear.

There is genuine concern over the association between atypicals and type 2 diabetes, in which (unlike type 1) the body produces insulin but can't fully utilize it. It was the topic of many formal discussions in May at the American Psychiatric Association Annual Meeting.

But scientific debate doesn't concern these lawyers. Their interest is deep pockets and something – ANYTHING – they can grab to recruit clients. For vast numbers of personal injury Web sites the "evidence" comprises a single study, which appeared in the July 2, 2002 issue of Pharmacotherapy.

Allegedly it "documented nearly 300 cases of diabetes in people using (the atypical drug) Zyprexa," as one lawyer referral site puts it. Further, the site claims, "there is no warning about these dangers on Zyprexa's label or product information." It concludes: "Lawyers believe this negligence has caused unnecessary deaths and injury."

Lawyers? That's impressive! But what do medical researchers believe and why is Zyprexa being singled out?

Among the numerous atypicals, Zyprexa has by far the largest sales and the most patients. That explains the sharks circling Zyprexa's maker, Eli Lilly.

The "smoking gun" Pharmacotherapy study comprised 288 cases over an eight year period of Zyprexa users who also had type 2 diabetes. These came from the Food and Drug Administration's surveillance system and medical journals and don't provide critical personal information such as diet and family medical history.

Yet during those eight years, about 6 million Americans were diagnosed with type 2. Since about 12 million Americans (over 4 percent of the population) took Zyprexa in that time, about a quarter million Zyprexa users would develop type 2 diabetes by chance alone.

It's long been known that schizophrenics taking no medication have two to four times the rate of type 2 diabetes of the general population. Therefore, the actual expected rate for type 2 in Zyprexa users could actually be a million – rather higher than 288.

To some lawyers these represent dollar signs. But to those suffering the demons of madness, they're miracle drugs.

Finally, it's widely accepted - including by the Pharmacology researchers – that many people found to have diabetes soon after starting an atypical medicine already had the disease, but their schizophrenia had prevented them from being diagnosed.

Based on all this, two studies from the University of Buffalo presented at medical conferences in May led the researchers to conclude that atypicals "may actually have a protective effect" against diabetes.

Research from University of North Carolina at Chapel Hill endocrinologist John Buse also shows no greater diabetes association between atypicals than typicals.

The main theory as to how atypicals might cause type 2 diabetes is that they often promote weight gain. Generally, and with Zyprexa specifically, it averages only nine pounds. But a fourth of Zyprexa users gain a worrisome 25 pounds.

Nevertheless, "Troglitazone (a former diabetes drug) causes weight gain and has been shown to prevent diabetes," says Buse. So medicine-induced pounds don't necessarily increase diabetes risk.

Ultimately we don't know whether atypicals contribute to developing type 2 diabetes, much less how large that risk may be. Physicians are awaiting preliminary results from a massive federally funded study.

Meanwhile doctors could pre-screen patients for diabetes and related risk factors and monitor them thereafter. Further, lawyers' claims aside, several atypicals including Zyprexa already do list diabetes on the label as possible side effects.

Nashville psychiatrist Dr. Beth Baxter is emphatic, however, that labels must not go beyond merely informing patients to outright discouraging them, as an FDA "black box" warning label would do.

Baxter not only treats cases of severe mental illness, but herself uses an atypical for a schizophrenia-related disorder. "Atypicals not only have far fewer side effects (compared with typicals) but also help with mood problems and cognitive problems," says Baxter. "That's why they should be the first line of treatment."

Not that the trial lawyers care about any of this. All they know is that some people have developed diabetes after taking anti-psychotics and big drug companies have big budgets. They could as easily claim that aspirin causes tens of thousands of motor vehicle deaths yearly, because many people die in cars and trucks after taking pain relievers.

But let's not give them any ideas.

Read Michael Fumento's additional work on frivolous lawsuits and such as topics as ADHD and breast implants. Michael Fumento is the author of numerous books.