1214
it may be expected that Clinton will push hard on this issue. Failure to win fairly quick delivery of something tangible would undermine his credibility and portend a difficult relationship with Congress. Victory would crown him as a
presidential wizard. While these cosmic issues dominate health-policy speculations, the biomedical grapevine is fixated by another topic-the future of Bernadine Healy, director of the National Institutes of Health, in a Clinton administration. Opinions differ widely, law provides no guidance, and precedent is mixed. Healy has repeatedly rattled the drowsy NIH bureaucracy since her arrival as a Bush appointee in April, 1991. She has ousted several deeply rooted members of the NIH administration. She both cultivates and admonishes Congress, where she is admired by many. In length of news column inches and TV time, Healy is, by a big margin, the most celebrated director in the 105-year history of NIH, gushingly described by the Washington Post as the occupant of "the most powerful position in American science". She is fawned upon and disliked. A nasty quality permeates much of the inner-circle talk about Healy. Tongues wag about unbridled ambition extending far beyond the mere directorship of the world’s greatest biomedical research establishment. Early in her reign, rumour had it that she aspired to the cabinet position of Secretary of Health and Human Services, or possibly science adviser to the President, a not-so-elevated post. A White House staff member recently asserted that Healy had struck up a working relationship with Vice President Dan Quayle in a scheming design to be the vice-presidential candidate in Quayle’s 1996 presidential campaign-if true, surely one of the longest shots in political history. It is also said that Healy, unlike her predecessors at NIH, is identified with the party of the president who appointed her, though she’s not been involved with partisan political affairs, and is on record as being personally opposed to the fetal-tissue restrictions. The buzz about Healy was heightened during the campaign when Ross Perot, during one of the televised presidential debates, uttered her name as a possible vice presidential running mate on his ticket. On October 20, USA Today quoted the chief of Perot’s vice-presidential search as saying that, of 100 possible candidates under consideration, Healy was the only one who had met with Perot to discuss the matter. A spokeswoman in Healy’s office initially denied that the meeting had taken place, but refused to reply when questioned again about persistent reports that Healy had indeed met with Perot. The thought of her doing so is appalling to many at NIH. In any case, the NIH director is a presidential appointee, subject to confirmation by the Senate, serving at the pleasure of the president. There are long-ago precedents for exempting the post from the evictions that routinely occur with changes of administration, same party as well as opposing party. In recent years, an interval of about six months has been allowed, followed by a change of command at NIH. Just days after the election, Washington was showing signs of recovery from the dank mood that the dispirited Bush administration had long been spreading throughout the Government. It is understood that miracles are not on the way and that Clinton, after all, may flop. But his optimism and confidence about the Government’s capacity to remedy problems are a zesty tonic after the flat brew of recent years.
Daniel S.
Greenberg
Round the World Canada: Controversy over Royal Commission on Reproductive Technologies Years of bitter, internal squabbling have forced the most expensive, explosive, ethics roadshow in Canadian medical
history-the Royal Commission on Reproductive Technologies-to miss its reporting deadline. Chairman Dr Patricia Baird last week announced that the Commission, whose work has already been slowed down by a year and is projected to cost Can$24-7 million, has been given another 9 months to reach its conclusions. "The Commission’s difficulties in the first two years of our mandate meant that we lost time. In addition, we need to incorporate the wealth of information and insight our research and consultations have generated. It takes time to interpret and make sense of this data in a way that does justice to the complexity of the issues", Baird said in her announcement. Struck in 1989 to examine the social, ethical, legal, health, research, and economic implications of more than 50 medical techniques, including in-vitro fertilisation and the genetic screening of embryos for diseases and disabilities, the Commission soon became embroiled in a series of controversies: over its budget, its research programme, office space, and, of course, its purpose. Was it to develop safeguards against the abuse of reproductive techniques, an essentially pro-technology view held by chairman Baird, former head of the University of British Columbia’s medical genetics department? Or was it to examine whether such techniques should be entirely banned because they threaten women’s control over their own lives, a so-called "feminist anti-technology" view championed by commissioner Maureen McTeer, lawyer and wife of federal constitutional affairs minister Joe Clark? As troublesome was a conflict over the interpretation of the original August, 1990, order-in-council creating the Commission. It had identified Baird as chair but thereafter referred to the$500 per diem commissioners in plural, as in "the commissioners shall be authorised to adopt such procedures and methods as they may consider expedient for the proper conduct of the inquiry". Three commissioners, McTeer, Montreal sociologist Dr Louise Vandelac, and Montreal medical law specialist Martin Hebert took that to mean that all commissioners had an equal say in the proceedings. By March, 1991, Baird had to request a year’s extension of the Commission’s reporting deadline to October, 1992. And by mid-summer, Prime Minister Brian Mulroney was forced to issue an unprecedented second order-in-council spelling out Baird’s authority and appointing two new commissioners. Feminist groups had charged that the Commission was being stacked with pro-technology advocates. In December, 1991, McTeer, Hebert, Vandelec, and University of Calgary professor of medicine Dr Bruce Hatfield had asked the Federal Court to set aside the order-in-council on the grounds that the quartet had been misled, intimidated, and illegally stripped of their right to equal involvement in the Commission. Cabinet promptly fired the dissenters and thereby essentially squelched the
challenge. Throughout the conflict, the Commission continued to collect data and extremely divergent opinion on the various reproductive issues. Fears were raised that in-vitro fertilisation was the thin edge of a fetal harvesting wedge for court
research
or
commercial purposes. The Roman Catholic
1215
church, an anti-abortion association, and the nation’s largest feminist group, the National Action Committee (NAC) on the Status of Women lined up to demand severe constraints on the use of reproductive techniques. But an army of desperate, infertile couples who view the new reproductive techniques as their only hope of having a child countered that all manner of high-tech conception should be allowed because every woman has a "right" to bear a child. Meanwhile, the medical and scientific communities, especially the Medical Research Council of Canada, have sought to tread a fine line between the competing interests, arguing that existing research guidelines and institutional mechanisms for protocol review by ethics boards serve as a better curb on potential abuse than any form of legislative restriction. "Research is not only ethical: it is in fact an ethical necessity", the MRC argued. "Legislative interventions that would unduly limit the present freedom within which physicians and researchers interact with patients and research subjects should be considered most carefully to ensure that they really will correct practices that afford insufficient protection. Freedom in research and therapy should be curtailed only for compelling reasons, which are not apparent from present evidence." Indirectly, that view raises what many contend are the crucial issues facing the Commission-ie, the questions of demand and cost-effectiveness. With one in six Canadian couples reportedly having difficulty conceiving, it is widely believed that the Commission simply cannot prohibit research into the new techniques. But it remains to be seen whether the Commission will steer a moderate course and whether its recommendations will ultimately be viewed as credible, given the years of controversy and polarised debate. Of late, the Commission’s credibility has not been helped by ongoing dispute over its "secretive"$13,7 million research programme. Social Sciences Federation of Canada president Dr Robert Stebbins has demanded a "detailed description of the Commission’s activities, including the research projects and the solicitation and peer-review processes". Therein, the SSFC is essentially accusing the Commission of skewing its research programme to focus primarily on the medical aspects of the new techniques. Baird has flatly denied the charge, arguing that ethical issues are "absolutely integral" to the Commission’s work. But despite the recent release of a list of researchers, complete with title, institutional affiliation, and research activity, the SSFC say that it lacks the detail to assess whether the programme meets scientific methodological and peer-review standards.
Wayne Kondro
USA: Victory over gag rule for family
planning groups Nov 3, 1992, was not a good day for President Bush. his resounding defeat at the hands of the American electorate was the ruling by the US Court of Appeals for the District of Columbia Circuit against the Administration’s continuing efforts to enforce a "gag rule" on health-care professionals working in federally funded family planning clinics. The gag rule, issued in 1988 by the Department of Health and Human Services (HHS), states that clinics "may not provide counselling concerning the use of abortion as a method of family planning or provide referral for abortion as a method of family planning". After several lower court challenges, the US Supreme Court in
Compounding
May, 1991, upheld the constitutionality
of the gag rule in
Rust v Sullivan (Lancet 1991; 337:1337 and 1991; 338: 303). "Pro-choice" advocates, realising that they had exhausted legal recourse on the grounds that the gag rule violated First Amendment freedom of speech, argued-and won-the
present case on procedural grounds alone. The argument for restricting Federal funding for clinics offering abortion counselling and referral was first engaged in the late 1970s. But it was not until the 1980s and the Republican presidency that it became policy. Promulgation of the gag rule did not, however, close the discussion. Nor did Rust v Sullivan. Indeed, almost immediately after the decision was handed down, the tenor of debate heightened considerably. The AMA called the gag rule "frightening" and "abhorrent" and the American College of Obstetricians and Gynecologists, in a statement endorsed by twenty-one national medical and nursing societies representing 425 000 members, implored Congress "to take action quickly to restore the patient’s right to receive full information and permit health professionals to fulfill their duty to give that information". Pro-choice leaders in Congress moved on many legislative fronts to overturn the gag rule. Mr Bush vowed repeatedly to rebuff their efforts. Undeterred, Congress persisted. In Nov, 1991, with both the House and Senate poised to pass a massive appropriations bill (HR 2707)-into which Prochoice leaders had tucked an anti-gag rule measure-Mr Bush issued a memorandum to HHS Secretary Louis Sullivan intended to soften (some say undermine) his critics. In the memorandum, the President restored the doctor’s right to discuss abortion with patients, but he specifically did not exempt other health-care workers from the gag rule. "Bush panicked", says David J. Andrews, acting president of Planned Parenthood of America. "He tried to assure Congress and doctors that the gag rule would not apply to doctors, knowing full well that most of the counsellors in these clinics are not MDs." The memorandum convinced few and Congress passed HR 2707. The President vetoed the measure. An override attempt, which Mr Bush was anxious to avoid for fear of political embarrassment, failed after a close vote. But pressure on the Administration continued. In response, HHS ordered its regional officials in March, 1992, to comply with the President’s Nov, 1991, directives. Ironically, this "llth hour move"-in the words of one observer-may have been his undoing. Less than a month later, Pro-choice advocates filed National Family Planning and Reproductive Health Association, Inc, et al v Louis W. Sullivan, MD. Their strategy was both esoteric and pragmatic. They argued that since the original HHS gag rule was promulgated by "notice and comment" rulemaking under the Federal Administrative Procedures Act, and since Rust v Sullivan upheld only the original gag rule and not the recent directives, the directives constituted new rules and must be subject to "notice and comment" rulemaking-a process that requires months of public discussion and debate. By winning their case, Pro-choice supporters have forced Mr Bush into the untenable position of either enforcing the original gag rule-a pre-election political impossibility-or complying with the temporal constraints of "notice and comment" rulemaking on his directives. "Timing is everything", said Andrews. And with little more than two months left in office, time is running out on Mr Bush. He is unlikely to have another chance on this issue. President-elect Clinton is likely to repeal the gag rule as one of his first acts in office (see p 1213). David H. Frankel
it may be expected that Clinton will push hard on this issue. Failure to win fairly quick delivery of something tangible would undermine his credibility and portend a difficult relationship with Congress. Victory would crown him as a
presidential wizard. While these cosmic issues dominate health-policy speculations, the biomedical grapevine is fixated by another topic-the future of Bernadine Healy, director of the National Institutes of Health, in a Clinton administration. Opinions differ widely, law provides no guidance, and precedent is mixed. Healy has repeatedly rattled the drowsy NIH bureaucracy since her arrival as a Bush appointee in April, 1991. She has ousted several deeply rooted members of the NIH administration. She both cultivates and admonishes Congress, where she is admired by many. In length of news column inches and TV time, Healy is, by a big margin, the most celebrated director in the 105-year history of NIH, gushingly described by the Washington Post as the occupant of "the most powerful position in American science". She is fawned upon and disliked. A nasty quality permeates much of the inner-circle talk about Healy. Tongues wag about unbridled ambition extending far beyond the mere directorship of the world’s greatest biomedical research establishment. Early in her reign, rumour had it that she aspired to the cabinet position of Secretary of Health and Human Services, or possibly science adviser to the President, a not-so-elevated post. A White House staff member recently asserted that Healy had struck up a working relationship with Vice President Dan Quayle in a scheming design to be the vice-presidential candidate in Quayle’s 1996 presidential campaign-if true, surely one of the longest shots in political history. It is also said that Healy, unlike her predecessors at NIH, is identified with the party of the president who appointed her, though she’s not been involved with partisan political affairs, and is on record as being personally opposed to the fetal-tissue restrictions. The buzz about Healy was heightened during the campaign when Ross Perot, during one of the televised presidential debates, uttered her name as a possible vice presidential running mate on his ticket. On October 20, USA Today quoted the chief of Perot’s vice-presidential search as saying that, of 100 possible candidates under consideration, Healy was the only one who had met with Perot to discuss the matter. A spokeswoman in Healy’s office initially denied that the meeting had taken place, but refused to reply when questioned again about persistent reports that Healy had indeed met with Perot. The thought of her doing so is appalling to many at NIH. In any case, the NIH director is a presidential appointee, subject to confirmation by the Senate, serving at the pleasure of the president. There are long-ago precedents for exempting the post from the evictions that routinely occur with changes of administration, same party as well as opposing party. In recent years, an interval of about six months has been allowed, followed by a change of command at NIH. Just days after the election, Washington was showing signs of recovery from the dank mood that the dispirited Bush administration had long been spreading throughout the Government. It is understood that miracles are not on the way and that Clinton, after all, may flop. But his optimism and confidence about the Government’s capacity to remedy problems are a zesty tonic after the flat brew of recent years.
Daniel S.
Greenberg
Round the World Canada: Controversy over Royal Commission on Reproductive Technologies Years of bitter, internal squabbling have forced the most expensive, explosive, ethics roadshow in Canadian medical
history-the Royal Commission on Reproductive Technologies-to miss its reporting deadline. Chairman Dr Patricia Baird last week announced that the Commission, whose work has already been slowed down by a year and is projected to cost Can$24-7 million, has been given another 9 months to reach its conclusions. "The Commission’s difficulties in the first two years of our mandate meant that we lost time. In addition, we need to incorporate the wealth of information and insight our research and consultations have generated. It takes time to interpret and make sense of this data in a way that does justice to the complexity of the issues", Baird said in her announcement. Struck in 1989 to examine the social, ethical, legal, health, research, and economic implications of more than 50 medical techniques, including in-vitro fertilisation and the genetic screening of embryos for diseases and disabilities, the Commission soon became embroiled in a series of controversies: over its budget, its research programme, office space, and, of course, its purpose. Was it to develop safeguards against the abuse of reproductive techniques, an essentially pro-technology view held by chairman Baird, former head of the University of British Columbia’s medical genetics department? Or was it to examine whether such techniques should be entirely banned because they threaten women’s control over their own lives, a so-called "feminist anti-technology" view championed by commissioner Maureen McTeer, lawyer and wife of federal constitutional affairs minister Joe Clark? As troublesome was a conflict over the interpretation of the original August, 1990, order-in-council creating the Commission. It had identified Baird as chair but thereafter referred to the$500 per diem commissioners in plural, as in "the commissioners shall be authorised to adopt such procedures and methods as they may consider expedient for the proper conduct of the inquiry". Three commissioners, McTeer, Montreal sociologist Dr Louise Vandelac, and Montreal medical law specialist Martin Hebert took that to mean that all commissioners had an equal say in the proceedings. By March, 1991, Baird had to request a year’s extension of the Commission’s reporting deadline to October, 1992. And by mid-summer, Prime Minister Brian Mulroney was forced to issue an unprecedented second order-in-council spelling out Baird’s authority and appointing two new commissioners. Feminist groups had charged that the Commission was being stacked with pro-technology advocates. In December, 1991, McTeer, Hebert, Vandelec, and University of Calgary professor of medicine Dr Bruce Hatfield had asked the Federal Court to set aside the order-in-council on the grounds that the quartet had been misled, intimidated, and illegally stripped of their right to equal involvement in the Commission. Cabinet promptly fired the dissenters and thereby essentially squelched the
challenge. Throughout the conflict, the Commission continued to collect data and extremely divergent opinion on the various reproductive issues. Fears were raised that in-vitro fertilisation was the thin edge of a fetal harvesting wedge for court
research
or
commercial purposes. The Roman Catholic
1215
church, an anti-abortion association, and the nation’s largest feminist group, the National Action Committee (NAC) on the Status of Women lined up to demand severe constraints on the use of reproductive techniques. But an army of desperate, infertile couples who view the new reproductive techniques as their only hope of having a child countered that all manner of high-tech conception should be allowed because every woman has a "right" to bear a child. Meanwhile, the medical and scientific communities, especially the Medical Research Council of Canada, have sought to tread a fine line between the competing interests, arguing that existing research guidelines and institutional mechanisms for protocol review by ethics boards serve as a better curb on potential abuse than any form of legislative restriction. "Research is not only ethical: it is in fact an ethical necessity", the MRC argued. "Legislative interventions that would unduly limit the present freedom within which physicians and researchers interact with patients and research subjects should be considered most carefully to ensure that they really will correct practices that afford insufficient protection. Freedom in research and therapy should be curtailed only for compelling reasons, which are not apparent from present evidence." Indirectly, that view raises what many contend are the crucial issues facing the Commission-ie, the questions of demand and cost-effectiveness. With one in six Canadian couples reportedly having difficulty conceiving, it is widely believed that the Commission simply cannot prohibit research into the new techniques. But it remains to be seen whether the Commission will steer a moderate course and whether its recommendations will ultimately be viewed as credible, given the years of controversy and polarised debate. Of late, the Commission’s credibility has not been helped by ongoing dispute over its "secretive"$13,7 million research programme. Social Sciences Federation of Canada president Dr Robert Stebbins has demanded a "detailed description of the Commission’s activities, including the research projects and the solicitation and peer-review processes". Therein, the SSFC is essentially accusing the Commission of skewing its research programme to focus primarily on the medical aspects of the new techniques. Baird has flatly denied the charge, arguing that ethical issues are "absolutely integral" to the Commission’s work. But despite the recent release of a list of researchers, complete with title, institutional affiliation, and research activity, the SSFC say that it lacks the detail to assess whether the programme meets scientific methodological and peer-review standards.
Wayne Kondro
USA: Victory over gag rule for family
planning groups Nov 3, 1992, was not a good day for President Bush. his resounding defeat at the hands of the American electorate was the ruling by the US Court of Appeals for the District of Columbia Circuit against the Administration’s continuing efforts to enforce a "gag rule" on health-care professionals working in federally funded family planning clinics. The gag rule, issued in 1988 by the Department of Health and Human Services (HHS), states that clinics "may not provide counselling concerning the use of abortion as a method of family planning or provide referral for abortion as a method of family planning". After several lower court challenges, the US Supreme Court in
Compounding
May, 1991, upheld the constitutionality
of the gag rule in
Rust v Sullivan (Lancet 1991; 337:1337 and 1991; 338: 303). "Pro-choice" advocates, realising that they had exhausted legal recourse on the grounds that the gag rule violated First Amendment freedom of speech, argued-and won-the
present case on procedural grounds alone. The argument for restricting Federal funding for clinics offering abortion counselling and referral was first engaged in the late 1970s. But it was not until the 1980s and the Republican presidency that it became policy. Promulgation of the gag rule did not, however, close the discussion. Nor did Rust v Sullivan. Indeed, almost immediately after the decision was handed down, the tenor of debate heightened considerably. The AMA called the gag rule "frightening" and "abhorrent" and the American College of Obstetricians and Gynecologists, in a statement endorsed by twenty-one national medical and nursing societies representing 425 000 members, implored Congress "to take action quickly to restore the patient’s right to receive full information and permit health professionals to fulfill their duty to give that information". Pro-choice leaders in Congress moved on many legislative fronts to overturn the gag rule. Mr Bush vowed repeatedly to rebuff their efforts. Undeterred, Congress persisted. In Nov, 1991, with both the House and Senate poised to pass a massive appropriations bill (HR 2707)-into which Prochoice leaders had tucked an anti-gag rule measure-Mr Bush issued a memorandum to HHS Secretary Louis Sullivan intended to soften (some say undermine) his critics. In the memorandum, the President restored the doctor’s right to discuss abortion with patients, but he specifically did not exempt other health-care workers from the gag rule. "Bush panicked", says David J. Andrews, acting president of Planned Parenthood of America. "He tried to assure Congress and doctors that the gag rule would not apply to doctors, knowing full well that most of the counsellors in these clinics are not MDs." The memorandum convinced few and Congress passed HR 2707. The President vetoed the measure. An override attempt, which Mr Bush was anxious to avoid for fear of political embarrassment, failed after a close vote. But pressure on the Administration continued. In response, HHS ordered its regional officials in March, 1992, to comply with the President’s Nov, 1991, directives. Ironically, this "llth hour move"-in the words of one observer-may have been his undoing. Less than a month later, Pro-choice advocates filed National Family Planning and Reproductive Health Association, Inc, et al v Louis W. Sullivan, MD. Their strategy was both esoteric and pragmatic. They argued that since the original HHS gag rule was promulgated by "notice and comment" rulemaking under the Federal Administrative Procedures Act, and since Rust v Sullivan upheld only the original gag rule and not the recent directives, the directives constituted new rules and must be subject to "notice and comment" rulemaking-a process that requires months of public discussion and debate. By winning their case, Pro-choice supporters have forced Mr Bush into the untenable position of either enforcing the original gag rule-a pre-election political impossibility-or complying with the temporal constraints of "notice and comment" rulemaking on his directives. "Timing is everything", said Andrews. And with little more than two months left in office, time is running out on Mr Bush. He is unlikely to have another chance on this issue. President-elect Clinton is likely to repeal the gag rule as one of his first acts in office (see p 1213). David H. Frankel
