Cong Hearing Re: Disclosure Pediatric SSRI Trials

Cong Hearing Re: Disclosure Pediatric SSRI Trials

Wed, 7 Jul 2004

A hearing has been tentatively set for July 20th by the House subcommittee on oversight and investigations, chaired by Congressman James Greenwood. The hearing will address issues of disclosure involving pediatric antidepressant drug trials–or more accurately, non-disclosure of adverse findings. The unpublished evidence comes from concealed company data.

Questions, will no doubt be raised about the responsibility of drug manufacturers (ie., trial sponsors), of those who conducted the trials, and prominent psychiatrists whose names appear in published reports that fail to disclose negative findings–neither the drugs’ failure to demonstrate a benefit nor the most severe adverse effects.

Recently, concealed findings have been brought to public attention, such as, evidence of severe drug withdrawal symptoms, evidence of drug-induced agitation/ aggression / hostility / mania/ and even a two-fold suicidal behavior in children /adolescents testing an SSRI antidepressant compared to those given a placebo.

As disturbing as company suppression of vital information about drug safety and benefit is, the uncovering of suppression by FDA officials–who are paid to protect the public health–is a stunning betrayal of public trust.

On February 1, 2004, Rob Waters of the San Francisco Chronicle revealed that senior FDA officials were suppressing the agency’s own medical expert, Dr. Andrew Mosholder, a child psychiatrist, from presenting his analysis of the unpublished company data and recommendations at a public FDA advisory committee meeting (February 2, 2004) that had convened for that purpose.

The advisory committee heard compelling testimony from more than 50 families whose children had suffered because the risks have been concealed from physicians and the public. Their testimonies corroborated the data analyzed by Dr. Mosholder. His analysis and recommendations were in harmony with those of the British Medicines authority. Although the advisory committee did not hear Dr. Mosholder’s recommendations, they reached the same conclusion, urging the FDA to issue “Black Box” warning labels.

As noted, the suppression of Dr. Mosholder’s report was first revealed by the San Francisco Chronicle, Feb. 1–the day before the advisory committee meeting. I personally informed the committee of the report and its suppression in my comments. Not a single reporter present at the meeting saw fit to enquire of FDA officials why Dr. Mosholder was prevented from presenting his findings. Two months passed before someone in the major media understood the significance of such suppression of vital information. On March 30, Sharyl Attkisson of CBS evening News reported the issue. See: http://www.cbsnews.com/stories/2004/03/30/eveningnews/main609491.shtml

Contact: Vera Hassner Sharav
Tel: 212-595-8974

http://news.ft.com/servlet/ContentServer?pagename=FT.com/StoryFT/FullStory&c=StoryFT&cid=1087373496224

Financial Times

Anti-depressant hearings set for this month By Christopher Bowe in New York Published: July 5 2004 18:41 |

A House of Representatives subcommittee is planning to hold hearings in the first half of this month to address questions on the potential for anti-depressants to cause suicidal behaviour in children.

The Oversight and Investigation subcommittee, led by James Greenwood, the Pennsylvania Republican on the House Energy and Commerce committee, intends to gather information on the use of anti-depressants by children, potential safety consequences and US regulatory research into safety issues.

Also, the subcommittee will gather information on the circumstances of an internal recommendation made by a Food and Drug Administration researcher. Considerable interest has focused on allegations that FDA senior officials barred Dr Andrew Mosholder, an FDA scientist, from releasing his recommendation that anti-depressants increased the risk of suicidal tendencies in young people. He also recommended immediate further regulatory warnings about their use by minors.

Dr Mosholder found that the drugs, particularly selective serotonin reuptake inhibitors (SSRIs), continue to pose questions about risk of side- effects, especially in children.

He also raised questions about the regulators’ review of trial data and safety warnings from such data.

In May, Columbia University’s Division of Child and Adolescent Psychiatry released a study showing parents’ worries about depression medication. About 68 per cent of parents feared that anti-depressants were over- prescribed to young people, according to the study conducted by the Carmel Hill Center for Early Diagnosis and Treatment at the university.

However, while 31 per cent of parents considered anti-depressants harmful to adolescents, 69 per cent thought the drugs were not harmful or did not know. More than half the parents responded that teenagers received treatment for depression without being clinically depressed.

Prior to a February regulatory advisory committee meeting to weigh the risks of anti-depressants and suicide, Dr Mosholder completed a review of clinical trials. He concluded that anti-depressants could be linked to increased suicidal tendencies in children and recommended regulators act.

But he was prevented from presenting that view to the advisory panel. Senator Charles Grassley, Republican from Iowa, wrote to regulators that Dr Mosholder was given a “script to read”.

The FDA began an investigation aimed at identifying the leak of the Mosholder report, according to a congressional source.

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