Daily Archives: August 25, 2008

Allegations halt drug recommendations

The Daily Texan
By Stephany Garza

The Texas Attorney General’s Office has halted a guideline that lists preferred psychiatric drugs for children in light of allegations of drug companies influencing researchers.

UT researchers based the children’s guideline on an adult version called the Texas Medication Algorithm Project, which came under scrutiny after the state of Texas filed a lawsuit in 2004 against the pharmaceutical company Janssen. The suit alleges that Janssen provided state mental health program decision makers with grants, trips, perks, travel expenses and other payments. Companies also paid decision makers to promote their medications.

The lawsuit states that some “proponents” who worked on the adult project began to work on the children’s version.

“[Janssen’s] product, Risperdal, received a preferential recommendation as a medication of choice on the [project] algorithms used to treat children and adolescents,” according to the lawsuit. “Defendants’ product did not have an FDA-approved indication for use in children and adolescents when it was placed on the TCMAP algorithms.”

The research is state-funded but also includes money from private sponsors. The Robert Wood Johnson Foundation, an arm of Johnson & Johnson, donated $2.4 million for the initial creation of the Texas Medication Algorithm Project. Johnson & Johnson is the parent company of Janssen Pharmaceutica, maker of Risperdal. The program also received $191,183 from Janssen, $146,500 from Pfizer and $103,000 Eli Lily.

UT Pharmacy Dean Miles Crismon received grant support from at least 10 companies, including Eli Lily, Forest, Janssen and Shire, according to the procedural manual of Schizophrenia Treatment Algorithms found on the Department of State Health Services’ Web site.

Crismon was not available for comment.

According to the court document, Janssen experienced an increase in prescriptions and sales of Risperdal throughout Texas after it was made the preferred drug through new programs in the state.

“TMAP and TCMAP proved to be powerful marketing tools for Risperdal,” the lawsuit states. “Driven by these gains and revenues, defendants turned to developing a concerted marketing plan to replicate these programs, and the dramatic revenue and market share generated by TMAP and its progeny in other states.”

Whistle-blower Allen Jones worked as a state official for Pennsylvania and discovered that the state’s chief pharmacist pocketed money from Janssen while designing a similar drug plan for Texas.

The Texas Attorney General’s Office will not comment due to pending litigation.

Because of restraints on information from officials and researchers, there is only speculation that researchers who worked on the adult health plan were paid by pharmaceutical companies, and the court document mentions the possibility of a conflict of interest.

A spokesman on behalf of two researchers with the UT Southwestern Medical Center at Dallas who worked on the children’s project said they were not influenced by drug companies. The anonymous spokesman also said most of the researchers who worked on the children’s version of the state mental health plan were not involved with the adult plan.

The UT System required all four researchers who worked on the child algorithm to fill out an extensive disclosure form about who supports their work. All researchers mention financial support or work as a consultant or speaker for a list of pharmaceutical companies, according to publications separate from the children’s algorithm project.

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Antipsychotic Drug Use Up in Elderly Despite Warnings

U.S. News & World Report

Safety warnings slowed the use of antipsychotic drugs in seniors with dementia. But the overall use of the drugs in the elderly increased, a finding which suggests that warnings may not be sufficient to protect patients, Canadian researchers say.

Between late 2002 and June 2005, Health Canada issued three warnings that three new atypical antipsychotic drugs increased the risk of stroke and death in elderly patients with dementia.

The researchers analyzed prescription drug data in the province of Ontario and found that antipsychotic drug use among the elderly increased 20 percent from the month prior to the first warning in September 2002 to February 2007. About 70 percent of the seniors receiving antipsychotic drugs lived in nursing homes, and about 40 percent of them were 85 or older.

“This finding highlights the limited impact of warnings and suggests that more effective approaches are needed to protect vulnerable populations from potentially hazardous medications,” wrote Dr. Geoffrey Anderson, of the University of Toronto, and colleagues.

The study was published in the Canadian Medical Association Journal.

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