Industry ties a prescription for conflict on FDA panels

Posted: March 16, 2013

James McGough might be a highly qualified psychiatrist, but he served on an FDA advisory committee Thursday in part because his conflict-of-interest issues were less disturbing than seven other doctors the agency tried to recruit.

McGough and another committee member offered two more examples of the conflicting interests inherent in parts of the U.S. drug-approval process. As required by law, the pediatric advisory committee was reviewing applications for several drugs to be used for children or for wider groups of children. One drug was Invega, already approved for some patients with schizophrenia and made by Janssen Pharmaceuticals, a Titusville, N.J.-based subsidiary of Johnson & Johnson.

Federal Drug Administration officials retain authority for drug approval, but advisory committees of non-agency experts in areas of care are asked to review applications and safety studies, and offer recommendations. The FDA often follows committee opinions, but is not required to do so.

Picking committee members can be challenging for the FDA because it tries to find members without conflicts of interest - such as doctors who do not take money from drug companies. At the end of September 2012, 22 percent of committee spots were vacant.

McGough, who works at the University of California, Los Angeles, and could not be reached for comment, needed a waiver from an FDA lawyer.

"The Office of Pediatric Therapeutics invited eight specialists in psychiatry to this meeting," Walter Ellenberg, the FDA official coordinating the committee meeting, wrote in a letter requesting the waiver of normal conflict-of-interest concerns. "Seven are unable to attend because of conflicts judged to be more substantial than Dr. McGough's financial interest as a consultant to [company name redacted]."

In a published paper, McGough listed Eli Lilly & Co. and Shire Plc as companies from which he had received fees for consulting and research. Lilly makes Zyprexa, a schizophrenia drug that is a competitor to Invega.

Also at issue was the advisory committee's acting industry representative, Dr. Samuel Maldonado, who is a J&J vice president and leads its Pediatric Drug Development Center of Excellence.

Philadelphia lawyer Stephen Sheller, whose clients have sued J&J over allegedly harmful side effects of drugs including Invega and another antipsychotic, Risperdal, has appealed to the FDA to withdraw approval of Risperdal. He also sent letters to Ellenberg - and the committee members - seeking to have Maldonado removed from the committee.

Maldonado, Sheller wrote, "does not appear to hold the 'essential expertise' required by the committee," and the industry representative should be "someone without this obvious and clear conflict of interest."

Maldonado recused himself from the Invega discussion and left the room before it began, according to FDA spokeswoman Sandy Walsh.

"Many of our scientists and researchers are regarded as leaders in their field and from time to time represent industry within their area of expertise," Janssen spokeswoman Teresa Mueller said in a statement.

Contact David Sell at dsell@ or 215-854-4506. Read his blog at and on Twitter @phillypharma.

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