by

Major Fraud Plea Has University Scientists Regretting Journal Article

Just days after federal prosecutors concluded one of the nation’s largest fraud settlements involving a single drug, at least some university researchers are retreating from a medical-journal article that helped sell the medicine to children.

Denis Daneman, a professor and chair of pediatrics at the University of Toronto, said he had asked the Journal of Clinical Psychiatry, which published the 2003 article evaluating the schizophrenia medication Risperdal, to remove his name from it.

And one of his co-authors, Robert L. Findling, a professor of psychiatry and behavioral sciences at the Johns Hopkins University, said Johnson & Johnson’s acceptance of the settlement also had prompted him to reconsider the 2003 article.

“In light of recent events,” Dr. Findling said in a written statement, “I am concerned about the questions raised and, if there are errors, am committed to determining what they may be and to correcting them.”

Johnson & Johnson, one of the world’s biggest corporations, this month reached a $2.2-billion settlement with the U.S. Justice Department over the company’s efforts to market some of its drugs, primarily Risperdal, beyond its federally approved uses.

Dr. Daneman, who is also pediatrician in chief at the Hospital for Sick Children, which is affiliated with the University of Toronto, initially responded to the Johnson & Johnson settlement by saying he was surprised by any suggestion that his work might have been part of an effort to mislead consumers about Risperdal.

After investigating it further, Dr. Daneman said he had asked the publisher of the Journal of Clinical Psychiatry, John S. Shelton, to either retract the article or remove his name from it. Mr. Shelton declined, saying that it had been peer-reviewed and that there was no evidence of any misrepresentation, Dr. Daneman said.

Mr. Shelton did not respond to repeated requests for comment. The journal’s editor in chief, Alan J. Gelenberg, a professor and chair of psychiatry at the Pennsylvania State University’s medical school, in Hershey, Pa., also did not respond to repeated requests for comment.

Risperdal was not approved for any use with children before 2006. The drug was known to have a series of negative side effects on children, including instances of boys’ growing breasts, the Justice Department said in court filings. Yet Johnson & Johnson aggressively marketed the drug to child psychiatrists and others treating children, said the U.S. attorney general, Eric H. Holder Jr.

In the 2003 article in the Journal of Clinical Psychiatry that they wrote with three colleagues at Johnson & Johnson, Dr. Findling and Dr. Daneman said that levels of prolactin, a hormone that can stimulate breast development and milk production, tended to rise in boys taking Risperdal but then fall again within a few months. The article also included a mathematical error that cut by half the actual rate at which young boys taking Risperdal developed breasts.

The paper was among a group of 44 scientific articles that were “being managed” by Johnson & Johnson to help encourage sales of Risperdal, according to a company document cited in an investigative report compiled by David A. Kessler, a former head of the U.S. Food and Drug Administration.

Dr. Findling has extensive industry collaborations, listing some three dozen companies, including Johnson & Johnson, in his recent financial disclosures. Dr. Gelenberg lists more than a dozen. Dr. Daneman said he only rarely participated in clinical trials, and relied in the 2003 article on data provided by others. A sixth author of the 2003 paper, Thomas Moshang Jr., who was a pediatrics professor at the University of Pennsylvania, is deceased.

Dr. Daneman said he still believes academic physicians should help pharmaceutical companies evaluate their products. But, he said, “there is sometimes a line crossed, obviously, and that’s happened here, in terms of what the drug company has expected its physicians to sign off on—and that scares the living daylights out of me.”

Dr. Findling has declined to be interviewed, though he did agree to answer some questions relayed by a Johns Hopkins spokeswoman. At the time the manuscript for the 2003 article was submitted, Dr. Findling said in one response, “I was confident in the accuracy of the information provided and in the interpretation of the study results.”

He said he was not ready to join Dr. Daneman in asking for his name to be removed from the article. “At this time,” Dr. Findling said, “I do not have sufficient scientific evidence that would lead me to ask for a retraction.”

Stephen A. Sheller, a lawyer whose firm has been representing families suing Johnson & Johnson over Risperdal and helped the government develop its fraud case against the company, lavished praise on Dr. Daneman for his efforts to correct the record.

“He may be a true hero in this litigation and to me also,” Mr. Sheller said. “We need doctors like him to set this example of leadership and integrity.”

He was more cautious regarding Dr. Findling, noting his role as editor of Child & Adolescent Psychopharmacology News, which published an article just this month saying that it was known as early as 2002 that Risperdal increased prolactin levels more than other atypical antipsychotic medications.

About $1.4-billion of the $2.2-billion settlement concerned Risperdal, making it one of the largest such deals for a single drug, Mr. Sheller said. Dr. Daneman said he had been paid about $5,000 for his work on the 2003 article. He now plans to donate that amount to charity, he said.

Return to Top