J&J Hid 3 Risperdal Diabetes Studies From FDA, Texas Jury Told

J&J Hid 3 Risperdal Diabetes Studies From FDA, Texas Jury Told

January 19th, 2012 // 1:39 pm @

Johnson & Johnson officials hid three studies showing some patients using Risperdal developed diabetes while claiming the antipsychotic drug didn’t cause the disease, a witness testified.

As early as 1999, Johnson & Johnson’s Janssen unit had researchers’ findings that about half the patients taking Risperdal in a study comparing its risks to those of Eli Lilly & Co.’s Zyprexa antipsychotic drug developed diabetes after a year on the medication, Joseph Glenmullen, a psychiatrist and Harvard Medical School instructor, told a Texas jury yesterday.

That study concluded Risperdal caused “medically serious weight gain” that led study subjects to develop diabetes, Glenmullen testified in the trial of the state of Texas’s lawsuit over Janssen’s marketing of the drug. At the same time, Janssen salespeople were telling doctors that researchers concluded the drug didn’t cause the disease, Glenmullen added.

Texas contends New Brunswick, New Jersey-based J&J, the world’s largest health-care products company, defrauded the Medicaid program by promoting Risperdal for uses not approved by U.S. regulators, including for children with psychiatric disorders, and misleading doctors and regulators about the drug’s risks.

Whistle-Blower Suit

The state joined a lawsuit filed by a whistle-blower, Allen Jones, a former Pennsylvania health-care fraud investigator. Lawyers for Texas Attorney General Greg Abbott are asking jurors in state court in Austin, Texas, to order J&J and Janssen to pay at least $579 million in damages over the companies’ Risperdal marketing practices.

Michael Clements, a Janssen spokesman, didn’t immediately return a call for comment yesterday on Glenmullen’s testimony about the company’s handling of the studies.

Glenmullen, testifying as an expert for the state, told jurors Janssen officials didn’t turn over Study 113, which found Risperdal posed a higher diabetes risk than Zyprexa, to the U.S. Food and Drug Administration when regulators began probing links between anti-psychotic medications and the disease in 2000.

The drugmaker also didn’t turn over the results of two other later studies that found Risperdal and Zyprexa posed comparable diabetes risks to the FDA.

Stronger Warnings

At the time, regulators were gathering information to decide whether to order all makers of anti-psychotic medicines to beef up warnings about the disease on their products’ labels, Glenmullen said. The FDA ordered stronger warnings in 2003.

Texas officials contend internal company records show that for more than a decade, Janssen salespeople falsely touted Risperdal as superior to rival drugs in sales calls with doctors because it wasn’t linked to diabetes.

J&J officials contend they didn’t turn the studies over to regulators or publish them because they were flawed, Glenmullen said. He disputed that claim, describing Study 113 as “high quality” and a “superb” example of scientific research into Risperdal’s and Zyprexa’s effectiveness.

The withheld studies were cited last year by a South Carolina judge who ordered Janssen to pay more than $327 million in damages over its Risperdal marketing practices in that state. The drugmaker has vowed to appeal that award.

“It is apparent to this court that this information was not disclosed because if did not fit the marketing department’s vision for the promotion and marketing of this drug,” Judge Roger Couch in Spartanburg, South Carolina, concluded in June.

The director of Texas’s Medicaid program testified earlier yesterday that the state was duped into spending more money than it should have to cover the costs of Risperdal prescriptions because of Janssen’s false statements about the drug’s diabetes risk and its aggressive efforts to market the medication for unapproved uses.

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