A Food and Drug Administration medical officer was told by top agency officials to delete material on the risks of antidepressant drugs from records he was submitting to Congress and then to conceal the deletions, according to documents released yesterday at a hearing on Capitol Hill.
A bipartisan House panel said the FDA also repeatedly prevented Andrew D. Mosholder from disclosing his conclusions that the medications increase the risk of suicidal thoughts and behavior among children, potentially delaying the issuance of a public warning. During the day-long hearing, legislators repeatedly accused the agency of obfuscating the risks, slowing action and subjecting Mosholder to harassment.
The disclosures added a new dimension to a year-old controversy over the use of antidepressant drugs in children, which led a government advisory panel to recommend last week that the FDA require a strongly worded “black box” warning on the medications. While depression itself is known to increase the risk of suicidal behavior, two FDA analyses, including one by Mosholder, have concluded that the drugs may double the risk of suicide among some children.
After revelations that Mosholder was asked not to present his findings at a public forum in February led to an outcry, the agency’s internal investigative arm told Mosholder he might be subject to disciplinary action, the documents showed. He was asked whether he had leaked his findings to the news media and denied doing so.
He then prepared a sworn statement about his findings and stated that he had been targeted by the internal inquiry. When investigators working for Senate Finance Committee Chairman Charles E. Grassley (R-Iowa) sought a copy of his records, Donna Katz of the FDA’s Office of Chief Counsel urged him to delete material from the statement and submit a cleaned-up version.
“I don’t think it’s necessary to indicate this document represents a version of the earlier one by noting that things have been omitted; that simply invites the committee to ask further questions about what was omitted,” Katz wrote in an e-mail to Mosholder on May 4.
Among Katz’s suggested edits was a section where Mosholder stated: “I understand this statement is part of the Office of Internal Affairs investigation and have been informed that I may be subject to disciplinary proceedings.”
Investigators from Grassley’s committee, as well as the House Energy and Commerce subcommittee on oversight and investigations, which conducted yesterday’s hearing, have said they were outraged to learn that Mosholder had been the subject of an internal inquiry and disciplinary threats.
Mosholder declined to make the changes Katz requested, saying they would be tantamount to perjury. He asked instead to black out the material, which would have let congressional investigators know there had been deletions. The FDA said the deletions were required because agency rules require that ongoing investigations be kept secret.
The hearing produced new demands from legislators to know why the FDA did not respond sooner to concerns about the widely used antidepressants. Mosholder said he found as early as last September that drugs such as Paxil, Zoloft and Effexor were associated with an increased risk of suicide among children.
Agency officials praised his work but did not act on it, citing a lack of confidence in the data. Even after British regulators warned doctors not to prescribe most antidepressants to children last December, the FDA declined to make Mosholder’s findings public. Instead, they had the data reanalyzed by Columbia University scientists. That evaluation resulted in a report last month largely identical to Mosholder’s findings a year ago.
“Was the public health served by a longer deliberative process in this case?” asked Rep. Greg Walden (R-Ore.).
Robert J. Temple, the FDA’s associate director for medical policy, defended the agency’s cautious approach. He said regulators are days from issuing new warnings about the drugs and perhaps “a couple of weeks” from “probably” acting on the recommendation that the labels carry a prominent warning. Regulators are weighing whether to add to the labels information about studies that found most of the drugs to be no more effective than sugar pills.
Another document released yesterday showed that as far back as 1996, an FDA official had suggested an increased risk of suicide among children taking Zoloft. Rep. Joe Barton (R-Tex.) asked why the finding had not been followed up.
“When did the FDA first become aware of a potential link between antidepressants and suicidality in children, and what did they do to get to the bottom of it?” asked Barton, who chaired the hearing.
FDA officials acknowledged that a letter sent at the time to Zoloft’s manufacturer, Pfizer Inc., is no longer in the agency’s files.
Agency officials repeatedly said that they were worried that the controversy would needlessly frighten parents and families away from useful drugs. Many clinicians believe the drugs are effective against depression. Shankar Vedantam, Washington Post