And they do this with vaccines and every other drug too.
>Date: Fri, 24 Sep 2004 06:52:44 -0700
>From: Michael Belkin
FDA Told Its Analyst to Censor Data on Antidepressants
By Shankar Vedantam
Washington Post Staff Writer
Friday, September 24, 2004; Page A08
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.
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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
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
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
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
"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.