- Email: [email protected]
Poggiolini's possessions
security of the person except in accordance with the principles of fundamental justice; the right not to be subjected to cruel and unusual treatment or punishment; and the right to equal protection and equal benefit of the law without discrimination. : But the court said that while the prohibition deprives Rodriguez "of autonomy over her person and causes her physical pain and psychological stress... any resulting deprivation, however, is not contrary to the principles of fundamental justice". "Fundamental justice required that a fair balance be struck between the interests of the state and those of the individual. The respect for human dignity, while one of the underlying principles upon which our society is based, is not a principle of fundamental justice" under the Charter. Similarly, the right to be free from cruel and unusual treatment is not violated because
a
prohibition against physiciannot constitute a form
assisted suicide does
of "treatment". And even if the prohibition they are physically unable to do so, prevenviolated Rodriguez’ right to equality in law, ting them from exercising the autonomy a separate provision of the Charter allows over their bodies available to other people". Also dissenting was Justice Peter Cory, for such violations in cases where they are "demonstrably justified" as a reasonable who noted that "the right to die with limitation prescribed by law. : dignity should be as well protected as is any In dissent, Supreme Court Chief Justice other aspect of the right to life. State Antonio Lamer argued that Rodriguez’ prohibitions that would force a dreadful, physical disability creates an inequality painful death on a rational but incapabecause it prevents her from citated terminally ill patient are an affront suicide, which is not illegal in Canada. For to human dignity". "There is no difference between permitting a patient of sound people like her, "the principles of selfdetermination and individual autonomy, mind to choose death with dignity by which are of fundamental importance in refusing treatment and permitting a patient out legal system, have been limited" and of sound mind who is terminally ill to : choose death with dignity by terminating they are thus victims of discrimination. Madam Justices Claire L’Hereux-Dube life preserving treatment, even if, because and Beverly McLachlin argued that Rodriof incapacity, that step has to be physically taken by another on her instructions", he guez’ right to security of the person was infringed because the effect of a distinction added. between lawful suicide and unlawful assisted suicide "is to deny to some people the choice of ending their lives solely because Wayne Kondro
committing
Anencephalic baby’s right to life? In a decision that has surprised many legal and ethics experts in the United States, a US District Court Judge has ruled that a hospital must provide aggressive life-
sustaining treatment to an anencephalic infant, including mechanical ventilation, if the infant’s mother requests it. The ruling issued last July, but because of an order sealing the court documents, details of the : case became public only recently, when the judge, Claude M Hilton, published his : opinion.
was
The case concerns the care of an infant, referred to in the judge’s opinion as Baby K, who was bom on Oct 13,1992, at Fairfax Hospital, a 656-bed facility in the Washington DC suburb of Falls Church, Virginia. The anencephaly had been diagnosed prenatally, but the mother, referred to as Ms H, had refused to have the pregnancy terminated. The child was delivered by caesarean section and, because of
respiratory distress, was immediately placed on a mechanical ventilator. Within a few days of the birth, hospital medical personnel asked the child’s mother for permission to issue a "Do Not Resuscitate Order" to allow withdrawal of the ventilator support, arguing that such treatment was futile and inappropriate in a case in which
no cure or
palliation
was
possible.
The mother, however, refused. "Ms H has a firm Christian faith that all life should be protected", Judge Hilton wrote. "She believes that God will work a miracle if that is His will. Otherwise, Ms H believes God, : and not other humans, should decide the moment of her daughter’s death." : Over the past year, the child has
repeatedly required mechanical ventilation, reportedly spending a total of four months in the hospital’s paediatric inten- : sive care unit. After consultation with an : ethics committee, the hospital went to court .
seek a judicial declaration that it would be in violation of a number of Federal and State laws forbidding discrimination against the handicapped, if they were to refuse to treat Baby K despite the mother’s wishes. Judge Hilton, however, concluded that not only did Federal antidiscrimination statutes say that the hospital could not refuse the mother’s request for aggressive medical support but also found that the mother’s right to insist on treatment was protected by the US Constitution. The Fourteenth Amendment to the US Constitution protects the right of parents to bring up their children, Hilton said. "These constitutional principles extend to the right of parents to make medical treatment decisions for their minor ren." Hilton concluded that the First Amendment, which guarantees the free exercise of religion, also applied, because the mother’s decision was based on a religious conviction that all life is sacred. : Dr Michael Grodin, head of the Program of Medical Ethics at Boston University School of Medicine, calls the case "outrageous". Grodin says that, parents should have enormous discretion in making decisions about their children’s medical care, they do not have the right to make demands of this extreme. "If we accept this argument, then, I would argue, : this mother has the right to demand a heart transplant, a liver transplant, dialysis, as well as the ventilator," Grodin said. George Annas, director of the Law, Medicine and Ethics Program at Boston University, predicted that the ruling, which is v being appealed to the Fourth Circuit of the US Court of Appeals, would be overturned. "In all the statutes cited, Congress made it clear and the courts that have interpreted them have made it clear that ... doctors are supposed to follow reasonable to
not
nedical judgments. That’s what doctors tre there for", Annas said. But Robert M Veatch, director of the Kennedy Institute )f Ethics at Georgetown University, distgrees. "What is at stake is the value of unconscious life and that seems to me not to be a medical-scientific question but a philosophical or religious question." Veatch :ontends that until society arrives at a :onsensus on this issue, the decision to treat or not to treat in cases such as these should be left to the parent. "I think the core issue s whether physicians who are acting privately and as individuals can be so sure that i baby should be dead that they can make :he baby dead against the mother’s wishes." Michael McCarthy
child- IPoggiolini’s possessions
although
now 18 months old, the murky drama of corrupton in Italian public life is hardly beyond its first act. The name coined by the press, "Tangentopoli" ("Bribe City"), as a convenient term with which to refer to the apparently limitless skulduggery now being uncovered, has sired a subtitle "Sanitopoli" for the shady dealings in the area of medicine and public health. The case of ex-minister Francesco De Lorenzo (see Lancet July 17, p 166), pales before the latest revelations about Duilio Poggiolini. Poggiolini, 64, has enjoyed a meteoric career, with professorial appointments in microbiology (in 1963 at age 34), chemotherapy (1966), and hygiene (1972 in the Faculty of Pharmaceutical Science, Rome). In 1973 he became director-general of the Pharmaceutical Service. Subsequently he became a member of the CIP, which establishes drug prices in Italy, and president of European Committee for Proprietary Medicinal Products (CPMP). All this
Although
919
placed him in an ideal position to follow the itinerary of drugs from the pharmaceutical
Savings by French GPs
: The EC’s Committee for Propriefirms to the chemists’ counters. On his way : tary Medicinal Products has elected he also picked up awards, prizes, a medal. Prof Jean-Michel Alexandre of The negotiations took 4 years and would Recently he was arrested in Switzerland France to be its president until : still be going on if Simone Veil, France’s in Italian is now the by agents Poggiolini January 1, 1995, when the new Minister of Social Affairs had not fixed Poggioreale prison in Naples, awaiting : Sept 30 as the deadline. Only 24 hours pharmaceutical registration system interrogation by five different judges. : before that date did the negotiators agree on and European Medicines Agency When the carabinieri requested permission start Duilio was Poggiolini means of lowering health expenditure up. to search his villa, he told them the combinto term out his unable see 2-year : ation of the safe with the words: "There’s generated by doctors, even though two he until Oct because has been 1994, : unions did not sign the contract. The not much inside, just a few objects of value, : removed from the Italian his at : post National Disease Insurance Board for more". The search, conducted in nothing health ministry. the presence of his wife, revealed a heap of Wage Workers and the Farmers Mutual Social Insurance have signed a contract ECUs and silver of ingots, special gold with the Confederation of French Medical rare and issue, antique coins, including Unions and the Union of Liberal Doctors roubles minted under Tsar Nicholas solid gold objects, jewellery, and precious have already been named in connection (Syndicat des Medecins Liberaux). This stones. The inventory drawn up by the with the money that enabled Poggiolini to contract allows for only a 3-4% rise in next police ranges to 11 pages. According to establish his sumptuous collection. And, year’s health expenditure generated by general practitioners. The two unions will Poggiolini all these things are presents from perhaps even more distressingly, his colleagrateful companies or colleagues. Other gue Gaetano Frajese, also a member of CIP submit the contract to their respective investigators have found bank accounts in and also arrested, has spoken to judges of a boards on Oct 17. With this agreement the his and his wife’s name in Switzerland and : link with the Vatican. : government expects to save some FFr 10.7 billion. The contract also extends to the to tens of with Italy, deposits amounting next four years the restriction on eligibility billions of lire. Various drug companies Timothy Keates for the free wages sector, to which only 18-8% of GPs and 33-7% of specialists are now entitled to belong. There will be a mandatory medical file for every patient to which reference will be in the London would hospitals gramme In the UK consist of 25 to 30 fractions, whereas in an made before reimbursement (ie, no reanalogous programme in the north of imbursement will be made for anything not England, 15 larger fractions would be recorded in this file). There will also be a What is wrong with radiation treatment in given. "We can’t all be right", he says, and list of items allowable for reimbursement. the UK? Is it bad practice or merely if the 15-fraction schedules are sufficient Claims for management procedures that Between 1982 and 1991,1000 bad publicity ? then London hospitals should change their are not in keeping with agreed practice patients receiving isocentric radiation therprotocols will be refused. Michael Bouton, policies--or vice versa. 10 to 15 years apy at the North Staffordshire Royal Inpresident of MG France, opposes the plan radiology was an unpopular and underfimfirmary received a substantial underdose of ded profession. The specialty may have because "the bulk of the effort to reduce radiation; the clinical report on this inciimproved in status over the past decade or health expenditure will fall on the GPs". dent was published last week. The operator The Federation des Medecins de France so, but it has inherited the lack of resources had been using a correction factor for was the other union that did not sign the from the past. Sikora believes that the tumour-to-skin distance, unaware that this RAGE campaign and North Staffordshire contract. To induce the medical unions to factor had already been applied by the the contract the government agreed case, together with the attendant publicity, accept to raise medical fees in 1994, by FFr 105 for computer system. Although the report will force the Department of Health to pointed out that it is unsurprising that the increase investment in cancer services, : a GP consultation and by FFr 145 for a clinicians were not alerted to the underespecially in resolving the current lack of specialist consultation. But doctors will were no it also noted that there treatment, : remain under strict scrutiny-if the exdata on radiotherapy. resources at the hospital to audit the outBut, according to Dr Jill Bullimore, dean pected financial impact of the reform is not come of radiotherapy and "in this respect of the faculty of oncology at the Royal attained, the contract will be replaced by a the department ... is no different from College of Radiologists, something is being law. That threat might not be easy to carry out: the medical lobby is well represented many departments of clinical oncology done. The Department of Health has re: cently provided the College with :l;200 000 in Parliament. elsewhere in the country". Last month, media attention surrounded for the first 2 years of a 3-year project-the : a survey by Radiotherapy Action Group Information Network Jean-Michel Bader Clinical
II,
Radiotherapy
ago,
Oncology (COIN). The first part of COIN is to be a nationwide clinical audit. A simple software package is being developed that oncology centres can use to collect core data. Data collected will cover: number of group wants standardisation of the various different treatments given each year, outprotocols used in the UK, and an indepencomes, types of treatment schedules, dent inquiry into the incidence of severe disease-free survival, overall survival, and side-effects. : complications. Bullimore believes that had Prof Karol Sikora of the Royal Postgrasuch a core data reporting system already duate Medical School, London, echoes the been in place, the collators would have been RAGE group’s demands. A frequent and : alerted that something was awry with the vocal critic of radiation therapy in the UK, cancer treatment in North Staffordshire. : he draws attention to the diversity of treatment schedules in the country. For example, a typical radical treatment pro- Sarah Ramsay Exposure (RAGE), an organisation representing women with severe side-effects of radiation therapy. Of 150 women questioned so far, three-fifths were treated at one-fifth of the 60 hospitals involved. The
920
Condom standards
controversy France’s national standards organisation AFNOR has voted against the adoption of the proposed European condom standard on grounds that it is inadequate to safeguard against HIV transmission. The postal ballot closes today, but since the European Committee for Standardisation’s (CEN) other 17 members are expected to back the draft standard, it will become a
a
prohibition against physiciannot constitute a form
assisted suicide does
of "treatment". And even if the prohibition they are physically unable to do so, prevenviolated Rodriguez’ right to equality in law, ting them from exercising the autonomy a separate provision of the Charter allows over their bodies available to other people". Also dissenting was Justice Peter Cory, for such violations in cases where they are "demonstrably justified" as a reasonable who noted that "the right to die with limitation prescribed by law. : dignity should be as well protected as is any In dissent, Supreme Court Chief Justice other aspect of the right to life. State Antonio Lamer argued that Rodriguez’ prohibitions that would force a dreadful, physical disability creates an inequality painful death on a rational but incapabecause it prevents her from citated terminally ill patient are an affront suicide, which is not illegal in Canada. For to human dignity". "There is no difference between permitting a patient of sound people like her, "the principles of selfdetermination and individual autonomy, mind to choose death with dignity by which are of fundamental importance in refusing treatment and permitting a patient out legal system, have been limited" and of sound mind who is terminally ill to : choose death with dignity by terminating they are thus victims of discrimination. Madam Justices Claire L’Hereux-Dube life preserving treatment, even if, because and Beverly McLachlin argued that Rodriof incapacity, that step has to be physically taken by another on her instructions", he guez’ right to security of the person was infringed because the effect of a distinction added. between lawful suicide and unlawful assisted suicide "is to deny to some people the choice of ending their lives solely because Wayne Kondro
committing
Anencephalic baby’s right to life? In a decision that has surprised many legal and ethics experts in the United States, a US District Court Judge has ruled that a hospital must provide aggressive life-
sustaining treatment to an anencephalic infant, including mechanical ventilation, if the infant’s mother requests it. The ruling issued last July, but because of an order sealing the court documents, details of the : case became public only recently, when the judge, Claude M Hilton, published his : opinion.
was
The case concerns the care of an infant, referred to in the judge’s opinion as Baby K, who was bom on Oct 13,1992, at Fairfax Hospital, a 656-bed facility in the Washington DC suburb of Falls Church, Virginia. The anencephaly had been diagnosed prenatally, but the mother, referred to as Ms H, had refused to have the pregnancy terminated. The child was delivered by caesarean section and, because of
respiratory distress, was immediately placed on a mechanical ventilator. Within a few days of the birth, hospital medical personnel asked the child’s mother for permission to issue a "Do Not Resuscitate Order" to allow withdrawal of the ventilator support, arguing that such treatment was futile and inappropriate in a case in which
no cure or
palliation
was
possible.
The mother, however, refused. "Ms H has a firm Christian faith that all life should be protected", Judge Hilton wrote. "She believes that God will work a miracle if that is His will. Otherwise, Ms H believes God, : and not other humans, should decide the moment of her daughter’s death." : Over the past year, the child has
repeatedly required mechanical ventilation, reportedly spending a total of four months in the hospital’s paediatric inten- : sive care unit. After consultation with an : ethics committee, the hospital went to court .
seek a judicial declaration that it would be in violation of a number of Federal and State laws forbidding discrimination against the handicapped, if they were to refuse to treat Baby K despite the mother’s wishes. Judge Hilton, however, concluded that not only did Federal antidiscrimination statutes say that the hospital could not refuse the mother’s request for aggressive medical support but also found that the mother’s right to insist on treatment was protected by the US Constitution. The Fourteenth Amendment to the US Constitution protects the right of parents to bring up their children, Hilton said. "These constitutional principles extend to the right of parents to make medical treatment decisions for their minor ren." Hilton concluded that the First Amendment, which guarantees the free exercise of religion, also applied, because the mother’s decision was based on a religious conviction that all life is sacred. : Dr Michael Grodin, head of the Program of Medical Ethics at Boston University School of Medicine, calls the case "outrageous". Grodin says that, parents should have enormous discretion in making decisions about their children’s medical care, they do not have the right to make demands of this extreme. "If we accept this argument, then, I would argue, : this mother has the right to demand a heart transplant, a liver transplant, dialysis, as well as the ventilator," Grodin said. George Annas, director of the Law, Medicine and Ethics Program at Boston University, predicted that the ruling, which is v being appealed to the Fourth Circuit of the US Court of Appeals, would be overturned. "In all the statutes cited, Congress made it clear and the courts that have interpreted them have made it clear that ... doctors are supposed to follow reasonable to
not
nedical judgments. That’s what doctors tre there for", Annas said. But Robert M Veatch, director of the Kennedy Institute )f Ethics at Georgetown University, distgrees. "What is at stake is the value of unconscious life and that seems to me not to be a medical-scientific question but a philosophical or religious question." Veatch :ontends that until society arrives at a :onsensus on this issue, the decision to treat or not to treat in cases such as these should be left to the parent. "I think the core issue s whether physicians who are acting privately and as individuals can be so sure that i baby should be dead that they can make :he baby dead against the mother’s wishes." Michael McCarthy
child- IPoggiolini’s possessions
although
now 18 months old, the murky drama of corrupton in Italian public life is hardly beyond its first act. The name coined by the press, "Tangentopoli" ("Bribe City"), as a convenient term with which to refer to the apparently limitless skulduggery now being uncovered, has sired a subtitle "Sanitopoli" for the shady dealings in the area of medicine and public health. The case of ex-minister Francesco De Lorenzo (see Lancet July 17, p 166), pales before the latest revelations about Duilio Poggiolini. Poggiolini, 64, has enjoyed a meteoric career, with professorial appointments in microbiology (in 1963 at age 34), chemotherapy (1966), and hygiene (1972 in the Faculty of Pharmaceutical Science, Rome). In 1973 he became director-general of the Pharmaceutical Service. Subsequently he became a member of the CIP, which establishes drug prices in Italy, and president of European Committee for Proprietary Medicinal Products (CPMP). All this
Although
919
placed him in an ideal position to follow the itinerary of drugs from the pharmaceutical
Savings by French GPs
: The EC’s Committee for Propriefirms to the chemists’ counters. On his way : tary Medicinal Products has elected he also picked up awards, prizes, a medal. Prof Jean-Michel Alexandre of The negotiations took 4 years and would Recently he was arrested in Switzerland France to be its president until : still be going on if Simone Veil, France’s in Italian is now the by agents Poggiolini January 1, 1995, when the new Minister of Social Affairs had not fixed Poggioreale prison in Naples, awaiting : Sept 30 as the deadline. Only 24 hours pharmaceutical registration system interrogation by five different judges. : before that date did the negotiators agree on and European Medicines Agency When the carabinieri requested permission start Duilio was Poggiolini means of lowering health expenditure up. to search his villa, he told them the combinto term out his unable see 2-year : ation of the safe with the words: "There’s generated by doctors, even though two he until Oct because has been 1994, : unions did not sign the contract. The not much inside, just a few objects of value, : removed from the Italian his at : post National Disease Insurance Board for more". The search, conducted in nothing health ministry. the presence of his wife, revealed a heap of Wage Workers and the Farmers Mutual Social Insurance have signed a contract ECUs and silver of ingots, special gold with the Confederation of French Medical rare and issue, antique coins, including Unions and the Union of Liberal Doctors roubles minted under Tsar Nicholas solid gold objects, jewellery, and precious have already been named in connection (Syndicat des Medecins Liberaux). This stones. The inventory drawn up by the with the money that enabled Poggiolini to contract allows for only a 3-4% rise in next police ranges to 11 pages. According to establish his sumptuous collection. And, year’s health expenditure generated by general practitioners. The two unions will Poggiolini all these things are presents from perhaps even more distressingly, his colleagrateful companies or colleagues. Other gue Gaetano Frajese, also a member of CIP submit the contract to their respective investigators have found bank accounts in and also arrested, has spoken to judges of a boards on Oct 17. With this agreement the his and his wife’s name in Switzerland and : link with the Vatican. : government expects to save some FFr 10.7 billion. The contract also extends to the to tens of with Italy, deposits amounting next four years the restriction on eligibility billions of lire. Various drug companies Timothy Keates for the free wages sector, to which only 18-8% of GPs and 33-7% of specialists are now entitled to belong. There will be a mandatory medical file for every patient to which reference will be in the London would hospitals gramme In the UK consist of 25 to 30 fractions, whereas in an made before reimbursement (ie, no reanalogous programme in the north of imbursement will be made for anything not England, 15 larger fractions would be recorded in this file). There will also be a What is wrong with radiation treatment in given. "We can’t all be right", he says, and list of items allowable for reimbursement. the UK? Is it bad practice or merely if the 15-fraction schedules are sufficient Claims for management procedures that Between 1982 and 1991,1000 bad publicity ? then London hospitals should change their are not in keeping with agreed practice patients receiving isocentric radiation therprotocols will be refused. Michael Bouton, policies--or vice versa. 10 to 15 years apy at the North Staffordshire Royal Inpresident of MG France, opposes the plan radiology was an unpopular and underfimfirmary received a substantial underdose of ded profession. The specialty may have because "the bulk of the effort to reduce radiation; the clinical report on this inciimproved in status over the past decade or health expenditure will fall on the GPs". dent was published last week. The operator The Federation des Medecins de France so, but it has inherited the lack of resources had been using a correction factor for was the other union that did not sign the from the past. Sikora believes that the tumour-to-skin distance, unaware that this RAGE campaign and North Staffordshire contract. To induce the medical unions to factor had already been applied by the the contract the government agreed case, together with the attendant publicity, accept to raise medical fees in 1994, by FFr 105 for computer system. Although the report will force the Department of Health to pointed out that it is unsurprising that the increase investment in cancer services, : a GP consultation and by FFr 145 for a clinicians were not alerted to the underespecially in resolving the current lack of specialist consultation. But doctors will were no it also noted that there treatment, : remain under strict scrutiny-if the exdata on radiotherapy. resources at the hospital to audit the outBut, according to Dr Jill Bullimore, dean pected financial impact of the reform is not come of radiotherapy and "in this respect of the faculty of oncology at the Royal attained, the contract will be replaced by a the department ... is no different from College of Radiologists, something is being law. That threat might not be easy to carry out: the medical lobby is well represented many departments of clinical oncology done. The Department of Health has re: cently provided the College with :l;200 000 in Parliament. elsewhere in the country". Last month, media attention surrounded for the first 2 years of a 3-year project-the : a survey by Radiotherapy Action Group Information Network Jean-Michel Bader Clinical
II,
Radiotherapy
ago,
Oncology (COIN). The first part of COIN is to be a nationwide clinical audit. A simple software package is being developed that oncology centres can use to collect core data. Data collected will cover: number of group wants standardisation of the various different treatments given each year, outprotocols used in the UK, and an indepencomes, types of treatment schedules, dent inquiry into the incidence of severe disease-free survival, overall survival, and side-effects. : complications. Bullimore believes that had Prof Karol Sikora of the Royal Postgrasuch a core data reporting system already duate Medical School, London, echoes the been in place, the collators would have been RAGE group’s demands. A frequent and : alerted that something was awry with the vocal critic of radiation therapy in the UK, cancer treatment in North Staffordshire. : he draws attention to the diversity of treatment schedules in the country. For example, a typical radical treatment pro- Sarah Ramsay Exposure (RAGE), an organisation representing women with severe side-effects of radiation therapy. Of 150 women questioned so far, three-fifths were treated at one-fifth of the 60 hospitals involved. The
920
Condom standards
controversy France’s national standards organisation AFNOR has voted against the adoption of the proposed European condom standard on grounds that it is inadequate to safeguard against HIV transmission. The postal ballot closes today, but since the European Committee for Standardisation’s (CEN) other 17 members are expected to back the draft standard, it will become a