353
NEWS & COMMENT
Washington Perspective Making waves at NIH Until last
April, a gentle managerial style-some would say drowsy-had long been the tradition at the National Institutes of Health, the world’s preeminent performer of biomedical research. In that month, Dr Bernadine Healy, a cardiologist and head of research at the Cleveland Clinic, became director of NIH. Since then, the biomedical research community has rumbled with rumours of conflict at NIH and wonderment about what’s going on there. The national press, which usually limits its recognition of NIH to scientific matters, appears fascinated with indications of strife in science at the great centre of research. The Boston Globe, for example, headlined an account of the new NIH director with: "Is American Science Ready for Bernadine Healy?" The New York Times Magazine, showcase of the establishment, included a description of Healy’s hair tint in a discussion of her biomedical policies and administrative style. The grist for the mill-a congressional clash, abrupt staff
changes, and, most recently, an unprecedented "Strategic Plan", still gestating-would stir little notice if they emanated from the Pentagon or the State Department. In these regions of government, weighty matters, real or trumped up, are conventional fare. But Director Healy has brought a flamboyant personal style to a traditionally quiet backwater of government. That contrast alone has drawn attention, though great substance is difficult to locate in some of these matters of journalistic fascination. Generally unnoted about the Healy regime is that it was preceded by a decade of light hands on the tiller at NIH. Dr James B. Wyngaarden, director from 1982 to 1989, looks back with pride upon the generous financial growth that Congress provided for biomedical research, despite the domestic austerity demanded by the Reagan administration. No one would accuse Wyngaarden of shaking up the place, a la Healy, or personally attracting attention outside the biomedical community. Following Wyngaarden’s departure, the directorship was filled for nearly two years by NIH’s no 2, William Raub, while the Bush White House sought a candidate acceptable to the anti-abortion camp. In limbo status, Acting-director Raub could do little more than maintain a holding pattern. He was finally succeeded by Healy, who adroitly navigated the ideological minefield. Declaring that she personally opposed the administration’s anti-abortion restrictions on fetal-tissue research-in fact, she had advised against the restrictions as a member of a panel convened under Reagan-Healy also said she felt bound to obey her government. The NIH that Healy came to last spring is an anomalous institution of the US Government. Though it is part of the Executive Branch and nominally under the authority of the President and his budget planners, NIH has been a special
ward of the Congress since the early 1950s. From Eisenhower through Bush, presidents have sought to restrain the fiscal appetites of biomedical research. With only occasional exceptions, however, they have been thwarted by NIH’s congressional guardians, in alliance with distressed citizen campaigners against specific dreadful diseases, sectors of the health-care industry, and the medical-school lobby. Surrounded by constituencies that demand only that NIH do more of what it’s doing, the enterprise has enjoyed a relatively simple political existence. With few questions asked, Congress dished out the money-around$9 billion this year, twice the figure of 1984. About 12% of the money has been regularly assigned to NIH’s own headquarters offices and laboratories, concentrated in Bethesda, Md; the balance has been awarded in grants and contracts for research at universities, hospitals, and other organisations throughout the country and abroad. In its well-financed isolation from many of the customary rigours of government, NIH has developed a culture of its own, except for pesky government-wide personnel and contracting regulations. Put it all together, and NIH tends to be slow, deliberate, collegial, and inertia-bound-no ball of fire, but pleasant and predictable in its ways. Healy, however, tends to be impatient, confident of her own judgment, and, most precedent-breaking of all, indifferent to the old-boy loyalties that produced long tenures in the upper ranks of NIH management. A few weeks after her arrival last spring, Edward Rall, a senior, popular veteran of NIH service, was abruptly removed from the important position of chief of intramural research on the NIH campus. Last fall, the axe fell on William Raub, who had reverted to the no 2 post in the NIH hierarchy when Healy became director. With no ceremonials, he left NIH for a job with the White House science office. In her short tenure at NIH, Healy has openly clashed with Congressman John Dingell over NIH’s management of scientific misconduct. Bristling at Dingell’s insinuations that she’s soft on misconduct because of her selfacknowledged early bumbling of a misconduct inquiry at the Cleveland Clinic, Healy combatively violated a basic rule of NIH-Congressional relations: don’t antagonise the powerful Dingell, the irascible chairman of the committee that writes NIH basic legislation. When Dingell in mock modesty asserted at a public hearing, "I am just a poor, foolish laywer from Detroit and I get a little befuddled in some of these difficult questions", Healy answered: "I am just a poor girl from New York". Dingell persisted, noting that Healy had signed a grant application by a scientist under suspicion of misconduct. "He signed second and you signed first", Dingell charged. Healy responded: "Who’s on third?". "I’m just trying to understand this", the congressman said. "I’m trying to understand your concern, Mr Dingell, and I’m afraid that I don’t", Healy responded--drawing gasps for her
impertinence.
354
Possibly the most important, though certainly the least understood, item on Healy’s agenda is the composition of a long-term strategic plan for NIH. A draft version, the product of several months of deliberation by NIH’s in-house staff, has been taken on the road by Healy, with meetings with scientists scheduled at five points around the country from Feb 2 through March 5. A background document for these meetings, Framework for Discussion, contains a mishmash of high-sounding goals and declarations of goodness, plus careful confrontations with NIH’s political devils. Thus, in the Framework paper NIH is described as a "national resource engaged in a noble enterprise: improving and safeguarding the health of every man, woman, and child in this
country". The Framework commits NIH to "Secure the maximal return on the public investment in the enterprise" and to strive to "earn the public’s respect, trust, and confidence as we carry out our mission". However, it proceeds beyond these homilies to ask: "What is the appropriate role of the NIH in dealing with broad social, legal, and ethical issues that touch on biomedical research? How should we engage these issues? Should we avoid them?" Opinions, usually strongly voiced, differ about Director Healy’s biomedical values, administrative techniques, and longevity in office. But there’s no doubt that she possesses a style of her own for leading the National Institutes of Health. Among the several reasons she offers for preparing a strategic plan is the following: "Most importantly, a strategy for NIH is an expression of our ordo amorum-an idea expressed by St Augustine-the order of our loves, or, in short, our priorities". No one else in the US Government says such things. Daniel S.
Greenberg
Round the World France: Gender tests for athletes
of the genetic programme of sex and the mishaps in its execution is "an important scientific error and can lead to decisions that are entirely arbitrary in physiological terms." These scientists appealed to the French state authorities to persuade the Olympic officials to give up their plan. Their plea soon had the support of two renowned French institutions-the Comite National d’Ethique pour les Sciences de la Vie et de la Sante, and the Conseil National de l’Ordre des Medecins, whose presidents are Prof Jean Bernard and Dr Louis Rene. These critics did not mince their words: disclosure of information on a genetic characteristic, said the president of the Ordre des Medecins, "is a blow to privacy and dignity, and can do irremediable damage to an individual". The scheme, he added, was contrary to the notion of society as a protector of liberty and human rights. Despite the number and prestige of its members, this lobby was not powerful enough to win its point. The Government, though expressing sympathy with the arguments of the anti-testers, refused to take a position against the International Olympic Committee; it contented itself with asking the committee for a series of assurances (on free consent, strict confidentiality, and complementary examinations in positive cases), all of which had been decided already by the Olympic medical authorities. Thus, despite the continuing controversy, 250 of 800 competitors at Albertville will have to submit themselves to the sry tests, the others already having been awarded a "certificate of femininity" by other methods. The matter, however, will not rest there. Learning lessons from the confrontation, the French Government has decided to modify the text of the law on bioethics that it will present to Parliament during the spring session. The text will now include a series of measures imposing severe constraints on the dissemination of genetic tests, which, except in criminal investigations and paternity disputes, will be allowable only for medical or scientific purposes. At present, France is isolated on the international stage in adopting this position; but it hopes to persuade others to follow suit in the name of human rights, beginning with its European partners.
Preparations for the Olympic Winter Games, which begin on Feb 8 at Albertville (Savoie), have sparked a lively debate in France between proponents and opponents of new methods of gender determination in athletes. For the first time, we see the French national ethics committee, the Conseil de l’Ordre des Medecins, and some leading French geneticists (including Nobel prizewinners Jean Dausset and Francois Jacob) joining forces to oppose the international
Olympic authority. The whole thing came about from a decision last summer by the medical commission of the International Olympic Committee to introduce a new gender test for athletes entering for women’s events. A decision was made to replace the Barr-body test (an indirect indicator for the presence of two X chromosomes) with a polymerase chain reaction test for the sry (masculinity) gene whose presence would a priori exclude an athlete from women’s events. Beginning discreetly in the international scientific press, the debate suddenly hotted up with the publication on Jan 24 of a pronouncement from 22 specialists who were violently opposed to implementation of the sry method. In a series of lengthy scientific arguments the specialists explained that such a test could in no way answer the concerns expressed by the Olympic authorities; they drew attention to several circumstances in which "genetic" sex and "hormonal" sex are dissociated. To confuse the nature
Jean-Yves Nau
USA: Supreme Court ruling Science therapy
on
Christian
Physical illness, as defined by the First Church of Christ Scientist, is an illusion to be overcome by the mind. Shunning medical care, its members, known as Christian Scientists, rely on prayer to heal disorders. They risk
prosecution only when their children become ill and die and the doctor has not been called. In recent years, authorities have obtained manslaughter convictions in such circumstances against couples in Massachusetts and California. In a third conviction, in Florida, one charge was third-degree murder. Penalties have included a requirement to allow medical care for the remaining children, but no one has gone to jail. A recent US Supreme Court ruling (Jan 13) has interrupted this prosecutorial momentum by approving a Minnesota court decision exonerating Christian Scientist parents from manslaughter charges following the death of their son. Church officials believe the court’s action should be a warning to prosecutors to abide by child neglect laws in more than 40 states, which exempt spiritual treatment from criminal charges.
NEWS & COMMENT
Washington Perspective Making waves at NIH Until last
April, a gentle managerial style-some would say drowsy-had long been the tradition at the National Institutes of Health, the world’s preeminent performer of biomedical research. In that month, Dr Bernadine Healy, a cardiologist and head of research at the Cleveland Clinic, became director of NIH. Since then, the biomedical research community has rumbled with rumours of conflict at NIH and wonderment about what’s going on there. The national press, which usually limits its recognition of NIH to scientific matters, appears fascinated with indications of strife in science at the great centre of research. The Boston Globe, for example, headlined an account of the new NIH director with: "Is American Science Ready for Bernadine Healy?" The New York Times Magazine, showcase of the establishment, included a description of Healy’s hair tint in a discussion of her biomedical policies and administrative style. The grist for the mill-a congressional clash, abrupt staff
changes, and, most recently, an unprecedented "Strategic Plan", still gestating-would stir little notice if they emanated from the Pentagon or the State Department. In these regions of government, weighty matters, real or trumped up, are conventional fare. But Director Healy has brought a flamboyant personal style to a traditionally quiet backwater of government. That contrast alone has drawn attention, though great substance is difficult to locate in some of these matters of journalistic fascination. Generally unnoted about the Healy regime is that it was preceded by a decade of light hands on the tiller at NIH. Dr James B. Wyngaarden, director from 1982 to 1989, looks back with pride upon the generous financial growth that Congress provided for biomedical research, despite the domestic austerity demanded by the Reagan administration. No one would accuse Wyngaarden of shaking up the place, a la Healy, or personally attracting attention outside the biomedical community. Following Wyngaarden’s departure, the directorship was filled for nearly two years by NIH’s no 2, William Raub, while the Bush White House sought a candidate acceptable to the anti-abortion camp. In limbo status, Acting-director Raub could do little more than maintain a holding pattern. He was finally succeeded by Healy, who adroitly navigated the ideological minefield. Declaring that she personally opposed the administration’s anti-abortion restrictions on fetal-tissue research-in fact, she had advised against the restrictions as a member of a panel convened under Reagan-Healy also said she felt bound to obey her government. The NIH that Healy came to last spring is an anomalous institution of the US Government. Though it is part of the Executive Branch and nominally under the authority of the President and his budget planners, NIH has been a special
ward of the Congress since the early 1950s. From Eisenhower through Bush, presidents have sought to restrain the fiscal appetites of biomedical research. With only occasional exceptions, however, they have been thwarted by NIH’s congressional guardians, in alliance with distressed citizen campaigners against specific dreadful diseases, sectors of the health-care industry, and the medical-school lobby. Surrounded by constituencies that demand only that NIH do more of what it’s doing, the enterprise has enjoyed a relatively simple political existence. With few questions asked, Congress dished out the money-around$9 billion this year, twice the figure of 1984. About 12% of the money has been regularly assigned to NIH’s own headquarters offices and laboratories, concentrated in Bethesda, Md; the balance has been awarded in grants and contracts for research at universities, hospitals, and other organisations throughout the country and abroad. In its well-financed isolation from many of the customary rigours of government, NIH has developed a culture of its own, except for pesky government-wide personnel and contracting regulations. Put it all together, and NIH tends to be slow, deliberate, collegial, and inertia-bound-no ball of fire, but pleasant and predictable in its ways. Healy, however, tends to be impatient, confident of her own judgment, and, most precedent-breaking of all, indifferent to the old-boy loyalties that produced long tenures in the upper ranks of NIH management. A few weeks after her arrival last spring, Edward Rall, a senior, popular veteran of NIH service, was abruptly removed from the important position of chief of intramural research on the NIH campus. Last fall, the axe fell on William Raub, who had reverted to the no 2 post in the NIH hierarchy when Healy became director. With no ceremonials, he left NIH for a job with the White House science office. In her short tenure at NIH, Healy has openly clashed with Congressman John Dingell over NIH’s management of scientific misconduct. Bristling at Dingell’s insinuations that she’s soft on misconduct because of her selfacknowledged early bumbling of a misconduct inquiry at the Cleveland Clinic, Healy combatively violated a basic rule of NIH-Congressional relations: don’t antagonise the powerful Dingell, the irascible chairman of the committee that writes NIH basic legislation. When Dingell in mock modesty asserted at a public hearing, "I am just a poor, foolish laywer from Detroit and I get a little befuddled in some of these difficult questions", Healy answered: "I am just a poor girl from New York". Dingell persisted, noting that Healy had signed a grant application by a scientist under suspicion of misconduct. "He signed second and you signed first", Dingell charged. Healy responded: "Who’s on third?". "I’m just trying to understand this", the congressman said. "I’m trying to understand your concern, Mr Dingell, and I’m afraid that I don’t", Healy responded--drawing gasps for her
impertinence.
354
Possibly the most important, though certainly the least understood, item on Healy’s agenda is the composition of a long-term strategic plan for NIH. A draft version, the product of several months of deliberation by NIH’s in-house staff, has been taken on the road by Healy, with meetings with scientists scheduled at five points around the country from Feb 2 through March 5. A background document for these meetings, Framework for Discussion, contains a mishmash of high-sounding goals and declarations of goodness, plus careful confrontations with NIH’s political devils. Thus, in the Framework paper NIH is described as a "national resource engaged in a noble enterprise: improving and safeguarding the health of every man, woman, and child in this
country". The Framework commits NIH to "Secure the maximal return on the public investment in the enterprise" and to strive to "earn the public’s respect, trust, and confidence as we carry out our mission". However, it proceeds beyond these homilies to ask: "What is the appropriate role of the NIH in dealing with broad social, legal, and ethical issues that touch on biomedical research? How should we engage these issues? Should we avoid them?" Opinions, usually strongly voiced, differ about Director Healy’s biomedical values, administrative techniques, and longevity in office. But there’s no doubt that she possesses a style of her own for leading the National Institutes of Health. Among the several reasons she offers for preparing a strategic plan is the following: "Most importantly, a strategy for NIH is an expression of our ordo amorum-an idea expressed by St Augustine-the order of our loves, or, in short, our priorities". No one else in the US Government says such things. Daniel S.
Greenberg
Round the World France: Gender tests for athletes
of the genetic programme of sex and the mishaps in its execution is "an important scientific error and can lead to decisions that are entirely arbitrary in physiological terms." These scientists appealed to the French state authorities to persuade the Olympic officials to give up their plan. Their plea soon had the support of two renowned French institutions-the Comite National d’Ethique pour les Sciences de la Vie et de la Sante, and the Conseil National de l’Ordre des Medecins, whose presidents are Prof Jean Bernard and Dr Louis Rene. These critics did not mince their words: disclosure of information on a genetic characteristic, said the president of the Ordre des Medecins, "is a blow to privacy and dignity, and can do irremediable damage to an individual". The scheme, he added, was contrary to the notion of society as a protector of liberty and human rights. Despite the number and prestige of its members, this lobby was not powerful enough to win its point. The Government, though expressing sympathy with the arguments of the anti-testers, refused to take a position against the International Olympic Committee; it contented itself with asking the committee for a series of assurances (on free consent, strict confidentiality, and complementary examinations in positive cases), all of which had been decided already by the Olympic medical authorities. Thus, despite the continuing controversy, 250 of 800 competitors at Albertville will have to submit themselves to the sry tests, the others already having been awarded a "certificate of femininity" by other methods. The matter, however, will not rest there. Learning lessons from the confrontation, the French Government has decided to modify the text of the law on bioethics that it will present to Parliament during the spring session. The text will now include a series of measures imposing severe constraints on the dissemination of genetic tests, which, except in criminal investigations and paternity disputes, will be allowable only for medical or scientific purposes. At present, France is isolated on the international stage in adopting this position; but it hopes to persuade others to follow suit in the name of human rights, beginning with its European partners.
Preparations for the Olympic Winter Games, which begin on Feb 8 at Albertville (Savoie), have sparked a lively debate in France between proponents and opponents of new methods of gender determination in athletes. For the first time, we see the French national ethics committee, the Conseil de l’Ordre des Medecins, and some leading French geneticists (including Nobel prizewinners Jean Dausset and Francois Jacob) joining forces to oppose the international
Olympic authority. The whole thing came about from a decision last summer by the medical commission of the International Olympic Committee to introduce a new gender test for athletes entering for women’s events. A decision was made to replace the Barr-body test (an indirect indicator for the presence of two X chromosomes) with a polymerase chain reaction test for the sry (masculinity) gene whose presence would a priori exclude an athlete from women’s events. Beginning discreetly in the international scientific press, the debate suddenly hotted up with the publication on Jan 24 of a pronouncement from 22 specialists who were violently opposed to implementation of the sry method. In a series of lengthy scientific arguments the specialists explained that such a test could in no way answer the concerns expressed by the Olympic authorities; they drew attention to several circumstances in which "genetic" sex and "hormonal" sex are dissociated. To confuse the nature
Jean-Yves Nau
USA: Supreme Court ruling Science therapy
on
Christian
Physical illness, as defined by the First Church of Christ Scientist, is an illusion to be overcome by the mind. Shunning medical care, its members, known as Christian Scientists, rely on prayer to heal disorders. They risk
prosecution only when their children become ill and die and the doctor has not been called. In recent years, authorities have obtained manslaughter convictions in such circumstances against couples in Massachusetts and California. In a third conviction, in Florida, one charge was third-degree murder. Penalties have included a requirement to allow medical care for the remaining children, but no one has gone to jail. A recent US Supreme Court ruling (Jan 13) has interrupted this prosecutorial momentum by approving a Minnesota court decision exonerating Christian Scientist parents from manslaughter charges following the death of their son. Church officials believe the court’s action should be a warning to prosecutors to abide by child neglect laws in more than 40 states, which exempt spiritual treatment from criminal charges.
