Schizophrenia

...ba href=/schizophrenia/a/b or bipolar disorder, and yet they are some of the most widely prescribed drugs in the world.

In 2006, Zyprexa sales were $4.3 billion, Seroquel's earned $3.4 billion, and Risperdal had sales of $4.1 billion, according to SEC filings.

A July 2006, report by Decision Resources, a leading advisory firm on healthcare issues, listed antipsychotics in 2005, as the fourth-highest-ranking class of drugs, and said two of the top ten drugs in worldwide sales were atypicals.

According to the lawsuit, the defendant drug makers concealed the risks of atypicals and exaggerated their benefits while persuading doctors to prescribe the drugs off-label for dementia, attention deficit disorders, and mood and behavior disorders.

When the FDA approves a drug it also approves the label, which lists the indications for which the drug can be prescribed, along with instructions for use and warnings about the risks associated with the drug.

Once a drug is approved to treat one condition, doctors may prescribe it for others if they think it will be effective, but by law drug companies are not allowed to influence physicians to prescribe a drug for indications other than those listed on the label.

On March 1, 2007, four days after the Pennsylvania lawsuit was filed, two of the three drug companies became the target of another investigation, when Representative, Henry Waxman (D-Cal), the chairman of the House Oversight and Government Reform Committee, sent letters to Eli Lilly and AstraZe...

...ba href=/schizophrenia/a/b and bipolar disorder.

Photo: Illustration of ba href=/schizophrenia/a/b's effect on the brain: While patients performed a working memory task, the less the prefrontal cortex (red) activated, the more dopamine increased in the striatum (green).

(National Institutes of Health) TEXT OF STORYMARK AUSTIN THOMAS: $100 million.

It's the biggest award ever given for psychiatric disease research.

The recipient is the Broad Institute, the 4-year-old offshoot of Harvard and MIT.

From the Health Desk at WGBH, Helen Palmer has more.

HELEN PALMER: This award comes from the Stanley Medical Research Institute, a family philanthropy.

With $10 million a year for the next 10 years, the new center can analyze thousands of genetic samples from people with ba href=/schizophrenia/a/b and bipolar disorder.

PAMELA SKLAR: For both disorders, we know virtually nothing about what causes them.

That's Pamela Sklar, director of genetics for the new institute.

She says both disorders have a strong genetic component.

Finding the exact genes involved is vital.

Another task, says Sklar, is gathering DNA samples.

SKLAR: Currently, there don't exist in the world enough to really convincingly do all the kinds of experiments that we need to do.

They'll test the samples with thousands of chemicals to see how the disease genes are affected.

But, says Sklar, it's impossible to say how soon any therapies might emerge.

In Boston, I'm Helen Palmer for Marketplace.

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...ba href=/schizophrenia/a/b, a disorder characterized by hallucinations that affects 24 million people worldwide, according to the World Health Organization in Geneva.

The pills also are gaining wider use for adolescents with depression, autism and hyperactivity, dementia in the aged and even insomnia.

Almost half of Seroquel sales in 2006 were for disorders for which AstraZeneca has yet to gain regulatory approval, according to Datamonitor Plc, a London-based market research firm.

The other half was for approved indications such as treating ba href=/schizophrenia/a/b and for bi-polar disorder, also known as manic depression, according to Terence McManus, a Datamonitor analyst.

The amount of off-label use is ``across the class,'' McManus said in an interview March 6.

Seroquel sales increased 24 percent in 2006 to $3.4 billion.

Revenue may jump 30 percent more this year to $4.4 billion, according to David Seemungal, an analyst at Standard & Poor's Equity in London.

He estimates that Seroquel sales of London- based AstraZeneca will peak in 2010 at $5.75 billion.

`Policies in Place' ``We have policies in place that provide direction around the appropriate promotion of our product,'' said Jim Minnick, an AstraZeneca spokesman.

Lilly's spokeswoman Carole Puls said the drugmaker doesn't promote off-label use.

Johnson & Johnson spokesman Srikant Ramaswami declined to comment on why off-label use is increasing.

``We promote our products only for their...