Johnson Johnson (JNJ) 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 JJ, 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
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 JJ and Janssen to pay
at least $579 million in damages over the companies’ Risperdal
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.
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.
JJ 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
The case is Texas v. Janssen LP, D-1GV-04-001288, District
Court, Travis County, Texas (Austin).
To contact the reporters on this story:
Jef Feeley in Wilmington, Delaware, at
Margaret Cronin Fisk in Detroit at
David Voreacos in Newark, New Jersey, at
To contact the editor responsible for this story:
Michael Hytha at