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Against secrecy in drug regulation
1283
Cipollone cigarette case dismissed The
case
of the late Rose
Cipollone against cigarette
manufacturers in the Liggett Group (Cipollone vs Liggett Inc, DC
NJ, no 83-2864) has been dismissed by agreement of all parties. Three more lawsuits against other cigarette makers that were being handled by the law firm that acted for the Cipollone family have also been dismissed.
According to the US Supreme Court decision in the Cipollone case, a 1965 law requiring warning labels on cigarette packages does not shield tobacco companies from all lawsuits based on state personal injury laws. The Court also decided that tobacco company advertisements touting safety are actionable under a breach of warranty theory if smokers believed the advertisements to be to their detriment. But the court said that plaintiffs need to do more than prove that cigarette advertisements and promotions tend to minimise health hazards. Harvard law professor Laurence H. Tribe, who re-argued the Cipollone case before the Supreme Court, said that the Supreme Court decision opened the way for people to sue the tobacco industry (see Lancet July 25, p 230). However, industry executives and stock analysts argue the opposite, since the Supreme Court opinion acknowledges that compliance with federal warning requirements provides some degree of protection from suits. Many lawyers have speculated that the cost of pursuing well-financed tobacco companies led to the withdrawal of the lawsuits. Generally in such lawsuits, firms are paid only if damages are awarded to their clients. Lawyers for the Cipollones said that their firm had out-of-pocket costs alone of between$500 000 and$1 million. Thomas Cipollone did not wish to pursue the lawsuit after the firm, Budd, Lamer, Gross, Rosenbaum, Greenberg & Sade,
decided to withdraw.
Triazolam in Texas US newspapers last Friday carried a Dallas jury’s verdict in a civil arising out of a conviction for murder. In a decision which has "confused" Upjohn Co, the manufacturer of halcion, the jury apportioned responsibility 50% to the convicted man, a former Texas policeman now serving a jail sentence; 30% to the prescribing physician, who, it is reported, had already settled the claim against him; and only 20% to Upjohn, on the ground, the Wall Street Journal reports, that the company "failed to warn doctors adequately of potentially violent side effects" of triazolam.1 Under Texas law Upjohn could be responsible for the whole of the award of$1800 000 to the man’s family. The company seems likely to appeal. Testimony revealed that the convicted man had, in the mid-1980s, taken triazolam at a dose of 0mg daily for over two years. This dose strength and duration exceeds current practice with this drug. In Europe a policy of restricting the prescribing of this and other benzodiazepine-like drugs is emerging. Tablet strength lies at the heart of the controversial decision of the UK’s Medicines Control Agency on July 17,1992, to go against part of the advice of the Medicines Commission. Both bodies agreed that UK product licences for 0.25 mg tablets should be revoked. The Medicines Commission felt that problems with the 0-125 mg dosage form could be dealt with less drastically but the MCA did not. case
1. Wall Street
Journal Nov 13,
1992.
Against secrecy in drug regulation neami Acuon international
(t1.1U)
nas launcnea a
campaign
against secrecy in medicines control. Members of its network will be
contacting their national regulatory agency, members of parliament and government officials, physicians’ and pharmacists’ associations, and consumer organisations about the need for greater openness in drug control. HAI has also expressed its support for a UK initiative for greater public access to drug registration information, in the form of the Medicines Information Bill being introduced by Giles Radice, MP, and supported by the UK National Consumer Council, the Campaign for Freedom of Information, and Social Audit. HAI wants full public access to reports of animal and clinical trials of drug safety and efficacy submitted to regulatory authorities
by pharmaceutical manufacturers, as well as the reasons for decisions about drug approvals, refusals of marketing licences, withdrawals, and product information: only legitimate trade secrets, such as manufacturing processes, and information that affects personal privacy, such as personal medical records, should be kept confidential. Withdrawal of artificial
feeding
For two days last week Sir Stephen Brown, the senior judge in the Family Division of the High Court, heard arguments for and against the withdrawal of artificial feeding from a 22-year-old man who had been in a persistent vegetative state since April, 1989. Opposition to such an action was put on behalf of the Official Solicitor, a device to ensure that both sides were heard. The judge was to have announced on Nov 19 his decision, on an application from Airedale NHS Trust (a west Yorkshire hospital) that to stop feeding via a mechanically driven tube would be lawful. For the hospital it was argued that such feeding should be considered as a medical treatment ; as such it could be withdrawn in certain carefully defined circumstances. Not so, argued the barrister appointed by the court to represent the patient. Taking the action suggested would be a "breach of a doctor’s duty". Food, like air, is a "basic necessity for the continuation of existence" and withholding it
would be unlawful. "In the present circumstances, where death is it is murder."1
intended, there is no point in being mealy-mouthed about it, 1.
Times, Nov 14, 1992.
Tuberculosis survey in
England and Wales
A national survey of tuberculosis notifications throughout 1993 in England and Wales is to be conducted jointly by the Public Health Laboratory Services, the British Thoracic Society, and the Department of Health. The previous 5-yearly surveys (in 1978/79, 1983, and 1988) were conducted by the Medical Research Council. The Joint Committee on Vaccination and Immunisation has postponed discussion about the future of the schools’ BCG vaccination programme until 1996, when the results of next year’s survey become available. An additional feature of the 1993 survey is the investigation of prevalence of HIV infection among notified cases in adults (aged 16-54 years); unlinked anonymous HIV testing, will be used but named testing, with appropriate counselling, will be available for those who request it or when clinically indicated. The study coordinator (PHLS) is appealing to all doctors to notify cases of tuberculosis-puhnonary and extrapulmonary. The protocol is available from Dr Deepti Kumar, PHLS Communicable Surveillance Centre, 61 Colindale Avenue, London NW9 5EQ (tel 081-200 6868 x 4452).
Decision
on
Dr Cox
Nigel Cox, a consultant rheumatologist at the Royal Hampshire County Hospital, has been admonished by the professional conduct committee of the General Medical Council for his actions to hasten the death of a 70-year-old terminally ill patient with rheumatoid arthritis. Cox was convicted on Sept 19,1992, on a charge of attempted murder; he was given a suspended 12 month prison sentence (see Lancet Sept 26, p 782). But the GMC, in its published judgment, noted that, although his actions had "fallen short of the high standards which the medical profession must uphold", the decision was to temper "justice with mercy". The GMC commented that he clearly "acted in good faith" and that his "purpose was to relieve her intolerable suffering by expediting her death". The committee expressed its "profound sympathy" for the patient, her family, and for Cox. Dr
Bower award for Burkitt Dr Denis P. Burkitt has been awarded US$373 000 for his work the link between the Epstein-Barr virus and Burkitt’s lymphoma. The Bower award is administered by the Franklin Institute of Philadelphia. on
Cipollone cigarette case dismissed The
case
of the late Rose
Cipollone against cigarette
manufacturers in the Liggett Group (Cipollone vs Liggett Inc, DC
NJ, no 83-2864) has been dismissed by agreement of all parties. Three more lawsuits against other cigarette makers that were being handled by the law firm that acted for the Cipollone family have also been dismissed.
According to the US Supreme Court decision in the Cipollone case, a 1965 law requiring warning labels on cigarette packages does not shield tobacco companies from all lawsuits based on state personal injury laws. The Court also decided that tobacco company advertisements touting safety are actionable under a breach of warranty theory if smokers believed the advertisements to be to their detriment. But the court said that plaintiffs need to do more than prove that cigarette advertisements and promotions tend to minimise health hazards. Harvard law professor Laurence H. Tribe, who re-argued the Cipollone case before the Supreme Court, said that the Supreme Court decision opened the way for people to sue the tobacco industry (see Lancet July 25, p 230). However, industry executives and stock analysts argue the opposite, since the Supreme Court opinion acknowledges that compliance with federal warning requirements provides some degree of protection from suits. Many lawyers have speculated that the cost of pursuing well-financed tobacco companies led to the withdrawal of the lawsuits. Generally in such lawsuits, firms are paid only if damages are awarded to their clients. Lawyers for the Cipollones said that their firm had out-of-pocket costs alone of between$500 000 and$1 million. Thomas Cipollone did not wish to pursue the lawsuit after the firm, Budd, Lamer, Gross, Rosenbaum, Greenberg & Sade,
decided to withdraw.
Triazolam in Texas US newspapers last Friday carried a Dallas jury’s verdict in a civil arising out of a conviction for murder. In a decision which has "confused" Upjohn Co, the manufacturer of halcion, the jury apportioned responsibility 50% to the convicted man, a former Texas policeman now serving a jail sentence; 30% to the prescribing physician, who, it is reported, had already settled the claim against him; and only 20% to Upjohn, on the ground, the Wall Street Journal reports, that the company "failed to warn doctors adequately of potentially violent side effects" of triazolam.1 Under Texas law Upjohn could be responsible for the whole of the award of$1800 000 to the man’s family. The company seems likely to appeal. Testimony revealed that the convicted man had, in the mid-1980s, taken triazolam at a dose of 0mg daily for over two years. This dose strength and duration exceeds current practice with this drug. In Europe a policy of restricting the prescribing of this and other benzodiazepine-like drugs is emerging. Tablet strength lies at the heart of the controversial decision of the UK’s Medicines Control Agency on July 17,1992, to go against part of the advice of the Medicines Commission. Both bodies agreed that UK product licences for 0.25 mg tablets should be revoked. The Medicines Commission felt that problems with the 0-125 mg dosage form could be dealt with less drastically but the MCA did not. case
1. Wall Street
Journal Nov 13,
1992.
Against secrecy in drug regulation neami Acuon international
(t1.1U)
nas launcnea a
campaign
against secrecy in medicines control. Members of its network will be
contacting their national regulatory agency, members of parliament and government officials, physicians’ and pharmacists’ associations, and consumer organisations about the need for greater openness in drug control. HAI has also expressed its support for a UK initiative for greater public access to drug registration information, in the form of the Medicines Information Bill being introduced by Giles Radice, MP, and supported by the UK National Consumer Council, the Campaign for Freedom of Information, and Social Audit. HAI wants full public access to reports of animal and clinical trials of drug safety and efficacy submitted to regulatory authorities
by pharmaceutical manufacturers, as well as the reasons for decisions about drug approvals, refusals of marketing licences, withdrawals, and product information: only legitimate trade secrets, such as manufacturing processes, and information that affects personal privacy, such as personal medical records, should be kept confidential. Withdrawal of artificial
feeding
For two days last week Sir Stephen Brown, the senior judge in the Family Division of the High Court, heard arguments for and against the withdrawal of artificial feeding from a 22-year-old man who had been in a persistent vegetative state since April, 1989. Opposition to such an action was put on behalf of the Official Solicitor, a device to ensure that both sides were heard. The judge was to have announced on Nov 19 his decision, on an application from Airedale NHS Trust (a west Yorkshire hospital) that to stop feeding via a mechanically driven tube would be lawful. For the hospital it was argued that such feeding should be considered as a medical treatment ; as such it could be withdrawn in certain carefully defined circumstances. Not so, argued the barrister appointed by the court to represent the patient. Taking the action suggested would be a "breach of a doctor’s duty". Food, like air, is a "basic necessity for the continuation of existence" and withholding it
would be unlawful. "In the present circumstances, where death is it is murder."1
intended, there is no point in being mealy-mouthed about it, 1.
Times, Nov 14, 1992.
Tuberculosis survey in
England and Wales
A national survey of tuberculosis notifications throughout 1993 in England and Wales is to be conducted jointly by the Public Health Laboratory Services, the British Thoracic Society, and the Department of Health. The previous 5-yearly surveys (in 1978/79, 1983, and 1988) were conducted by the Medical Research Council. The Joint Committee on Vaccination and Immunisation has postponed discussion about the future of the schools’ BCG vaccination programme until 1996, when the results of next year’s survey become available. An additional feature of the 1993 survey is the investigation of prevalence of HIV infection among notified cases in adults (aged 16-54 years); unlinked anonymous HIV testing, will be used but named testing, with appropriate counselling, will be available for those who request it or when clinically indicated. The study coordinator (PHLS) is appealing to all doctors to notify cases of tuberculosis-puhnonary and extrapulmonary. The protocol is available from Dr Deepti Kumar, PHLS Communicable Surveillance Centre, 61 Colindale Avenue, London NW9 5EQ (tel 081-200 6868 x 4452).
Decision
on
Dr Cox
Nigel Cox, a consultant rheumatologist at the Royal Hampshire County Hospital, has been admonished by the professional conduct committee of the General Medical Council for his actions to hasten the death of a 70-year-old terminally ill patient with rheumatoid arthritis. Cox was convicted on Sept 19,1992, on a charge of attempted murder; he was given a suspended 12 month prison sentence (see Lancet Sept 26, p 782). But the GMC, in its published judgment, noted that, although his actions had "fallen short of the high standards which the medical profession must uphold", the decision was to temper "justice with mercy". The GMC commented that he clearly "acted in good faith" and that his "purpose was to relieve her intolerable suffering by expediting her death". The committee expressed its "profound sympathy" for the patient, her family, and for Cox. Dr
Bower award for Burkitt Dr Denis P. Burkitt has been awarded US$373 000 for his work the link between the Epstein-Barr virus and Burkitt’s lymphoma. The Bower award is administered by the Franklin Institute of Philadelphia. on