FDA Told Its Analyst to Censor Data on Antidepressants]

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FDA Told Its Analyst to Censor Data on Antidepressants

 

By Shankar Vedantam

 

Washington Post Staff Writer

 

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.

 

 

 

 

 

 

 

 

 

 

 

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