作为美国的立法机构, 国会有很大的监控权利, 它可以在任何时候发信给FDA(政府), 药厂(商家)和医生（个人）, 要求提供信息,配合调查. 以确定是否有违法违规行为. 没有人敢怠慢或置之不理.
以下是几份美国国会要求厂家提供详细资料的信件
Greenwood Seeks Clinical Trial Data on Antidepressants
February 3, 2004
Mr. Bernard J. Poussot
President
Wyeth Pharmaceuticals
500 Arcola Road
Collegeville, PA 19426
Dear Mr. Poussot:
As part of its continuing oversight of the public health and the safety of prescription drugs, the Committee is examining the safety of antidepressants in children. The January 29, 2004 Washington Post reported that "akers of popular antidepressants such as Paxil, Zoloft and Effexor have refused to disclose the details of most clinical trials involving depressed children, denying doctors and parents crucial evidence as they weigh fresh fears that such medicines may cause some children to become suicidal." The Washington Post notes that researchers familiar with the unpublished data said the majority of these unpublished trials show that children taking the medicines did not get any better than children taking dummy pills. Some doctors and advocates are concerned that the lack of publication of these studies distorts the scientific record.
The Washington Post further reports that concerns over the safety of anti-depressants among children have heightened after a December warning by British regulators that the drugs may trigger suicidal thoughts and increase the rate of self-injury. I note that at an FDA advisory committee meeting on February 2, 2004, the FDA stated for the first time that clinical trials of popular antidepressants such as Prozac, Paxil, and Zoloft show a greater risk of suicide among children taking the drugs compared with those taking the dummy pills. Before taking any further regulatory action, however, the FDA has requested a second analysis of the data by Columbia University researchers. According to the Washington Post, this new review is likely to be completed by summer.
The controversy over the use of antidepressants in children is of great public interest. On the one hand, there appears to be substantial support in the medical community for the use of antidepressants in children, and that these drugs save children's lives. The U.S. psychiatric establishment has repeatedly assured the public that the drugs are very safe. On the other hand, some psychiatrists and advocates are concerned that mainstream psychiatry is biased by widespread financial ties to the pharmaceutical industry. The new FDA analysis of the clinical trials of these drugs seems to be at odds with the assurances of safety. The public interest in this issue is underscored by the fact that an FDA advisory panel and Columbia University researchers are examining safety data, and that critics and even some supporters of antidepressants for children want clinical trial information put in the public domain.
In light of protecting the public health of children and/or the need to expedite public and physician confidence in the use of antidepressants for children, the Committee seeks data and background information of unpublished clinical trials involving depressed children. To assist this investigation, pursuant to Rules X and XI of the U.S. House of Representatives, the Committee requests the following by February 17, 2004:
A briefing to Committee staff on all unpublished studies involving children and any of your antidepressant products. This briefing should cover the results of the studies and address at least the following questions:
Identify any of the unpublished studies with results that could be interpreted as showing that children taking the antidepressants did not get any better than children taking dummy pills and explain the details of these studies.
Identify any of the unpublished studies with results that could be interpreted as showing that children taking the antidepressants did get better than children taking dummy pills and explain the details of these studies.
Identify any of the unpublished studies with results that could be interpreted as increasing the risk of depression, suicide ideation, and the rate of self-injury. Explain the details of these studies.
Identify any of the unpublished studies with results that could not be interpreted as increasing the risk of depression, suicide ideation, and the rate of self-injury. Explain the details of these studies.
Copies of study reports existing before February 3, 2004 that summarize the results of each unpublished study involving children and any of your antidepressant products. These reports should cover all studies submitted to the FDA advisory panel examining antidepressants and children, and any studies not submitted to this FDA advisory panel.
If you have any questions, please contact Alan Slobodin of the Committee Staff at (202) 225-2927.
Sincerely,
James C. Greenwood
Chairman
Subcommittee on Oversight and Investigations
cc: The Honorable W.J. "Billy" Tauzin, Chairman
The Honorable John D. Dingell, Ranking Member
The Honorable Peter Deutsch, Ranking Member
Subcommittee on Oversight and Investigations
国会议员给先灵和默克CEO的信, 要求解释为什么延迟公布临床试验数据?
Schering_Merck.ltr.pdf (168.21k)
以下是几份美国国会要求厂家提供详细资料的信件
Greenwood Seeks Clinical Trial Data on Antidepressants
February 3, 2004
Mr. Bernard J. Poussot
President
Wyeth Pharmaceuticals
500 Arcola Road
Collegeville, PA 19426
Dear Mr. Poussot:
As part of its continuing oversight of the public health and the safety of prescription drugs, the Committee is examining the safety of antidepressants in children. The January 29, 2004 Washington Post reported that "akers of popular antidepressants such as Paxil, Zoloft and Effexor have refused to disclose the details of most clinical trials involving depressed children, denying doctors and parents crucial evidence as they weigh fresh fears that such medicines may cause some children to become suicidal." The Washington Post notes that researchers familiar with the unpublished data said the majority of these unpublished trials show that children taking the medicines did not get any better than children taking dummy pills. Some doctors and advocates are concerned that the lack of publication of these studies distorts the scientific record.
The Washington Post further reports that concerns over the safety of anti-depressants among children have heightened after a December warning by British regulators that the drugs may trigger suicidal thoughts and increase the rate of self-injury. I note that at an FDA advisory committee meeting on February 2, 2004, the FDA stated for the first time that clinical trials of popular antidepressants such as Prozac, Paxil, and Zoloft show a greater risk of suicide among children taking the drugs compared with those taking the dummy pills. Before taking any further regulatory action, however, the FDA has requested a second analysis of the data by Columbia University researchers. According to the Washington Post, this new review is likely to be completed by summer.
The controversy over the use of antidepressants in children is of great public interest. On the one hand, there appears to be substantial support in the medical community for the use of antidepressants in children, and that these drugs save children's lives. The U.S. psychiatric establishment has repeatedly assured the public that the drugs are very safe. On the other hand, some psychiatrists and advocates are concerned that mainstream psychiatry is biased by widespread financial ties to the pharmaceutical industry. The new FDA analysis of the clinical trials of these drugs seems to be at odds with the assurances of safety. The public interest in this issue is underscored by the fact that an FDA advisory panel and Columbia University researchers are examining safety data, and that critics and even some supporters of antidepressants for children want clinical trial information put in the public domain.
In light of protecting the public health of children and/or the need to expedite public and physician confidence in the use of antidepressants for children, the Committee seeks data and background information of unpublished clinical trials involving depressed children. To assist this investigation, pursuant to Rules X and XI of the U.S. House of Representatives, the Committee requests the following by February 17, 2004:
A briefing to Committee staff on all unpublished studies involving children and any of your antidepressant products. This briefing should cover the results of the studies and address at least the following questions:
Identify any of the unpublished studies with results that could be interpreted as showing that children taking the antidepressants did not get any better than children taking dummy pills and explain the details of these studies.
Identify any of the unpublished studies with results that could be interpreted as showing that children taking the antidepressants did get better than children taking dummy pills and explain the details of these studies.
Identify any of the unpublished studies with results that could be interpreted as increasing the risk of depression, suicide ideation, and the rate of self-injury. Explain the details of these studies.
Identify any of the unpublished studies with results that could not be interpreted as increasing the risk of depression, suicide ideation, and the rate of self-injury. Explain the details of these studies.
Copies of study reports existing before February 3, 2004 that summarize the results of each unpublished study involving children and any of your antidepressant products. These reports should cover all studies submitted to the FDA advisory panel examining antidepressants and children, and any studies not submitted to this FDA advisory panel.
If you have any questions, please contact Alan Slobodin of the Committee Staff at (202) 225-2927.
Sincerely,
James C. Greenwood
Chairman
Subcommittee on Oversight and Investigations
cc: The Honorable W.J. "Billy" Tauzin, Chairman
The Honorable John D. Dingell, Ranking Member
The Honorable Peter Deutsch, Ranking Member
Subcommittee on Oversight and Investigations
国会议员给先灵和默克CEO的信, 要求解释为什么延迟公布临床试验数据?
Schering_Merck.ltr.pdf (168.21k)