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【drug-news】美国专家呼吁对避孕药的更好数据
US experts call for better data on contraceptives
23 Jan 2007 21:53:09 GMT
Source: Reuters
WASHINGTON, Jan 23 (Reuters) - Drugmakers should use more realistic methods for evaluating the effectiveness of birth control pills, patches and other other hormonal contraceptives, a U.S. panel of experts said on Tuesday.
Of particular concern is finding out how well such products work for obese women at a time when a growing number of Americans are struggling with their weight, the panel of gynecologists, researchers and other medical experts told the Food and Drug Administration.
Overweight women, smokers and those already at risk for blood clots -- a common side of the drugs -- are often excluded from company studies on how well such contraceptives work.
"These women, like all women, need contraceptives," said panelist Dr. Julia Johnson of the University of Vermont.
Panel chairman Dr. Charles Lockwood of Yale University, said the panel agreed "that real world testing is necessary."
The FDA called on the outside advisers as it takes a closer look at how it evaluates most hormonal contraceptives in light of how they are actually used once approved. It did not seek advice on implanted or injected products.
"The pregnancy rates obtained from clinical trials may be markedly better than the actual pregnancy rates observed when women in the general population use the product, often in a less consistent and reliable manner," FDA staff said in a summary released before the meeting.
The panel meeting came as a variety of contraceptives are entering the U.S. market.
Makers of birth control pills include Johnson & Johnson <JNJ.N>, Bayer AG <BAYG.DE> and Barr Pharmaceuticals Inc. <BRL.N>. J&J also sells a contraceptive skin patch, while Akzo Nobel NV <AKZO.AS> unit Organon BioSciences markets a contraceptive ring that is inserted into the vagina.
Wyeth <WYE.N> is awaiting FDA approval to sell its new Lybrel pill, designed to eliminate monthly bleeding.
At the meeting, panelists said the FDA should work with the industry to find better ways to include a wider range of women in studies without making it too burdensome for manufacturers.
Still, panelist and Maryland physician Bruce Stadel said it was imperative for companies to "test what they propose to market in the people they're proposing to market to."
Likewise, they called on drugmakers to compare new products against other widely-used, recently-approved contraceptives, rather than against use of no contraceptive at all.
Also at issue is the rising pregnancy rate among contraceptives studied in the last decade.
FDA officials have said they have seen higher pregnancy rates in recent trials, but it is unclear whether that is due to lower hormone doses, improper use, or other factors.
Birth control pills approved from 1960 to 1970 saw less than one pregnancy for every 100 women who took them for a year. In the past 10 years, however, some were approved with rates above two per 100 women.
FDA staff have been divided over whether to limit acceptable pregnancy rates from new products.
Panelists said estimating the risk per 100 women, although widely used, was a "crude" way to establish pregnancy risk and manufacturers should move toward a more comprehensive method.
On Wednesday, the panel is expected to discuss contraceptives that prevent bleeding, post-marketing studies and other issues. (Additional reporting by Lisa Richwine) 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。 美国专家呼吁对避孕药的更好数据
US experts call for better data on contraceptives
23 Jan 2007 21:53:09 GMT
Source: Reuters
2007年1月23日 格林尼标准时间21：53：09
WASHINGTON, Jan 23 (Reuters) - Drugmakers should use more realistic methods for evaluating the effectiveness of birth control pills, patches and other other hormonal contraceptives, a U.S. panel of experts said on Tuesday.
华盛顿，1月23日（路透社）－美国的小组专家们在星期二说到，制药者们应该使用更加现实的方法来评估避孕药片或者贴剂和其它激素避孕药的效果。
Of particular concern is finding out how well such products work for obese women at a time when a growing number of Americans are struggling with their weight, the panel of gynecologists, researchers and other medical experts told the Food and Drug Administration.
妇科医师专家小组、研发人员以及其他的医学专家对FDA建议：目前越来越多的美国人考虑到她们的体重，因此当前的一个迫切的要求就是研发针对肥胖女性的药物。
Overweight women, smokers and those already at risk for blood clots -- a common side of the drugs -- are often excluded from company studies on how well such contraceptives work.
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作者:admin@医学,生命科学 2011-08-24 17:16
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