美国会就克隆人问题向FDA提出质疑
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2001年3月12日
NEW YORK (Reuters Health) - Following a spate of high profile news reports about research aimed at cloning human beings, Congressman James Greenwood (R-PA) has asked the US Food and Drug Administration (news - web sites) (FDA) to outline its plans for regulating trials of the controversial technology.
Greenwood, who is chairman of the House Energy and Commerce Subcommittee on Oversight and Investigations, sent a letter this week to Dr. Bernard Schwetz, acting principal deputy commissioner of the FDA, informing him that ``the subcommittee is examining the adequacy of federal oversight'' of human cloning research.
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The congressman cited recent news articles--including a Time magazine cover story published late last month--reporting that some scientists are nearly ready to begin attempts at human cloning.
``The very fact that at this moment, the research is proceeding underground, unaccountable, poses a real threat,'' his letter states.
In addition to safety concerns and the potential for scams aimed at bereaved parents and infertile couples, ``the immediate risk is that a backlash against renegade science might strike at responsible science as well,'' the congressman maintained.
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In 1998, the FDA issued a statement asserting its jurisdiction over human cloning trials. The agency stressed that sponsors of such trials, like sponsors of other medical research on humans, must receive FDA approval before beginning their research.
To gain such approval, sponsors must convince the agency that the studies are reasonably safe--a feat that seems unlikely in the near future, as it is generally agreed that the current technology carries unacceptably high risks of miscarriages and birth defects.
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In his letter, Greenwood asked the FDA to elaborate on the ''full extent of the agency's claimed legal authority,'' how it has exercised that authority and whether it perceives ``gaps in statutory or regulatory authority'' that could make human cloning difficult to control. The congressman also has requested that the agency report on any human cloning research of which it is aware and detail the contact it has had with the scientists involved.
The FDA has been asked to reply to the letter by March 19, as well as to participate in a briefing to discuss the issues in depth with members of the subcommittee.
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Pete Sheffield, a spokesman for the House Energy and Commerce Committee, told Reuters Health that the committee has ''total jurisdiction over the Food and Drug Administration'' and has followed the cloning issue closely since the birth of the cloned sheep Dolly.
``We're trying to collect detailed information to get a better sense of how the FDA has proceeded in this field,'' he said. ``At this point, it's kind of a fact-finding mission--we want to get a sense of how things have proceeded at FDA since their 1998 proclamation--and from there I think you could expect an evaluation of the procedures and guidelines that FDA follows.''
, 百拇医药
But while Congress seems intent on defining the agency's role in overseeing human cloning research, the effort may have few practical effects. Researchers are almost certain to conduct their human cloning projects outside the US in countries where regulatory oversight tends to be more lax.
The Raelians, the Canadian cult at the center of the recent media frenzy, has established a for-profit cloning company in the Bahamas, while a scientific coalition founded by fertility experts Drs. Panos Zavos and Severino Antinori plans to conduct its human cloning efforts in an unnamed Mediterranean country., 百拇医药
Greenwood, who is chairman of the House Energy and Commerce Subcommittee on Oversight and Investigations, sent a letter this week to Dr. Bernard Schwetz, acting principal deputy commissioner of the FDA, informing him that ``the subcommittee is examining the adequacy of federal oversight'' of human cloning research.
, http://www.100md.com
The congressman cited recent news articles--including a Time magazine cover story published late last month--reporting that some scientists are nearly ready to begin attempts at human cloning.
``The very fact that at this moment, the research is proceeding underground, unaccountable, poses a real threat,'' his letter states.
In addition to safety concerns and the potential for scams aimed at bereaved parents and infertile couples, ``the immediate risk is that a backlash against renegade science might strike at responsible science as well,'' the congressman maintained.
, http://www.100md.com
In 1998, the FDA issued a statement asserting its jurisdiction over human cloning trials. The agency stressed that sponsors of such trials, like sponsors of other medical research on humans, must receive FDA approval before beginning their research.
To gain such approval, sponsors must convince the agency that the studies are reasonably safe--a feat that seems unlikely in the near future, as it is generally agreed that the current technology carries unacceptably high risks of miscarriages and birth defects.
, http://www.100md.com
In his letter, Greenwood asked the FDA to elaborate on the ''full extent of the agency's claimed legal authority,'' how it has exercised that authority and whether it perceives ``gaps in statutory or regulatory authority'' that could make human cloning difficult to control. The congressman also has requested that the agency report on any human cloning research of which it is aware and detail the contact it has had with the scientists involved.
The FDA has been asked to reply to the letter by March 19, as well as to participate in a briefing to discuss the issues in depth with members of the subcommittee.
, http://www.100md.com
Pete Sheffield, a spokesman for the House Energy and Commerce Committee, told Reuters Health that the committee has ''total jurisdiction over the Food and Drug Administration'' and has followed the cloning issue closely since the birth of the cloned sheep Dolly.
``We're trying to collect detailed information to get a better sense of how the FDA has proceeded in this field,'' he said. ``At this point, it's kind of a fact-finding mission--we want to get a sense of how things have proceeded at FDA since their 1998 proclamation--and from there I think you could expect an evaluation of the procedures and guidelines that FDA follows.''
, 百拇医药
But while Congress seems intent on defining the agency's role in overseeing human cloning research, the effort may have few practical effects. Researchers are almost certain to conduct their human cloning projects outside the US in countries where regulatory oversight tends to be more lax.
The Raelians, the Canadian cult at the center of the recent media frenzy, has established a for-profit cloning company in the Bahamas, while a scientific coalition founded by fertility experts Drs. Panos Zavos and Severino Antinori plans to conduct its human cloning efforts in an unnamed Mediterranean country., 百拇医药