WFAA had an article about the continued use of dangerous medications to chemically restrain nursing home residents. See Part 5 (See Parts 1, 2, 3 and 4 of WFAA’s continuing investigation of nursing home abuse and neglect.) Despite the FDA’s warning to stop using anti-psychotics for dementia patients, the majority of nursing homes still uses them — more than 25 percent of the residents continue to take them for uses not approved by the FDA.
The story begins in 1993. Risperdal had just gained FDA approval for use in treating schizophrenia and bipolar disorder. But that’s a relatively small market. Dementia patients, however, comprise about half of nursing home residents.
Federal and state attorneys argued that Johnson & Johnson “developed a scheme to turn the drug into a blockbuster,” court documents show. In testimony, the attorneys claimed Johnson & Johnson used Texas as the “model state” to promote the drug “locally and nationally.”
The goal, according to federal and Texas attorneys: Get doctors to prescribe Risperdal over other drugs and for conditions – like dementia – for which it was not FDA-approved. It’s known as “off-label use.”
“An off-label use of a drug is not illegal,” said Michael Elliott, a former assistant U.S. attorney who specialized in health care fraud. “What is inappropriate is for a drug company to market that drug for off-label uses.”
Texas court records and exhibits show Johnson & Johnson recruited influential doctors like Steven Shon, then medical director of the now defunct Texas Department of Mental Health & Mental Retardation. Texas Attorney General attorneys alleged Johnson & Johnson “made a series of illegal payments to Dr. Shon that effectively turned him into a salesman for Risperdal,” court documents show.
Dr. Shon testified in the case that the money did not influence him. Sure….
The company also paid lucrative fees to a major pharmacy provider to promote the drug in nursing homes, court documents show.
Despite the FDA’s warning that using Risperdal to treat elderly dementia patients was dangerous, business plans in federal court filings show Johnson & Johnson created a sales force they called “ElderCare.”
The alleged objective? Target dementia patients, federal court records show.
From the late 1990’s to 2004, sales reps made thousands of calls promoting the drug “as safe and effective” for treating “behavior problems” in elderly dementia patients, court documents show.
As a result, court exhibits show, domestic sales of Risperdal increased from $892 million to $2 billion per year.
According to Johnson & Johnson’s own market research, as much as “75 percent of the prescriptions for Risperdal were for off-label uses.”