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kyoto Evidence mounts over Japan's tainted-blood allegations
THE LANCET
DISPATCHES
LONDON
Risk reports push up pregnancies in Britain
A
key Health of the Nation target—a 50% reduction in pregnancies among the under–16s in a decade—is looking unachievable. Official figures released last week show that pregnancies within this group have started to rise again: from 8·1 to 8·3 per 1000 women between 1993 and 1994. Britain had the highest rates in Europe when it set itself the target of reducing the 1989 figure of 9·6 to 4·8 by the year 2000. Family planners again pointed to Britain’s reluctance to accept teenage sexuality and sexual activity. The Brook Advisory Service, a leading family planning agency, called for more openness at home, more relaxed sex education at school, and easier access to confidential advice and contraception services. Ministers were keen to reduce the numbers but reluctant to introduce measures that would reduce pregnancies, even placing restrictions on sex education in schools. Of the 7754 pregnancies to girls under 16 in 1994 (up from 7243 in 1993), 52·8% ended in abortion. But it is not just the under–16s at risk of unwanted pregnancies. The latest in a series of national opinion poll surveys done for an oral-contraceptive manufacturer shows a drop in the proportion of sexually active women using any form of birth control. The survey of 1000 women aged 16 to 44 found 25% who were not
KYOTO
using any contraception; 32% of this group were sexually active. The pill remains the most popular form of contraception but the proportion of women aged 25 to 29 using the pill dropped from 45% to 35% between 1993 and 1996. A key reason for this drop was last year’s scare over the safety of third-generation oral contraceptives, billed as
“. . . a key difficulty for decision-makers is not when the evidence is clear, but when it is weak or incomplete” “killer pills” by the tabloid press, there was an immediate 14% fall in their use and this year’s figure is still 4% below last year’s. Yet, as the Chief Medical Officer, Kenneth Calman, noted in his annual report on public health last week, the increase in risk from venous thromboembolism posed by the new pills was merely raised from 15 to 30 per 100 000 women per year. Pregnancy posed a much bigger risk. All of which led Calman to seek new ways of improving the reporting of risk by health journalists. In his annual report he set out a possible classification that if adopted, would provide the public and patients with a clearer guide to the potential risks of particular conditions.
Calman conceded that a key difficulty for decision-makers is not when the evidence is clear, but when it is weak or incomplete. In these circumstances it is crucial that policy-makers are open about what they know—and do not know—so that they can establish trust with the public. Calman said that the public—and professionals—were confused by the range of words currently used to describe risk: negligible, minimal, remote, very small, small. The adjectives used to qualify these definitions made communication even more confusing: avoidable-unavoidable; justifiable-unjustifiable; acceptableunacceptable; serious-not serious. Pressed by reporters, Calman said eventually that an agreed classification system might be used for new drugs or new clinical procedures to give patients a better picture of the risks involved. Meanwhile, the problem for reporters remains their news desks. All news editors were agog last year to learn that the new contraceptive pills “had doubled the chance of a blood clot”. Hence the splash headlines and extensive radio and television reports. Not many would have been interested in a story that said the number of women at risk from the new pills had risen from 1·5 to 3 per 10 000. Malcolm Dean
Evidence mounts over Japan’s tainted-blood allegations
I
n the past 2 weeks a rash of written evidence has implicated top drug industry and government officials in a tainted blood product scandal involving the infection of more than 1800 haemophiliacs and others in the early and mid 1980s. On Sept 19, the then president and two former presidents of Osaka-based Green Cross, one of five major drug firms involved in the scandal, were arrested on charges of professional negligence resulting in death from their company’s HIV-infected blood-clotting products. These officials and others have repeatedly claimed that, before the government’s approval of safer, heated blood products in July, 1985, they had no clear knowledge of the risk of unheated foreign blood products. Yet 2 years before this, a Green Cross internal document warned of HIV contamination
Vol 348 • October 5, 1996
of US-imported blood, which at the time made up more than 85% of the firm’s blood-product ingredients. Furthermore, a diary kept by a Green Cross board member details a meeting that took place just before July, 1985, in which the three former presidents and other executives discussed the dangers of use of unheated foreign blood products. Also, two Green Cross in-house magazines (September, 1985, and January, 1986) carried stories about the safety of the company’s new heated products. Despite its own articles, though, Green Cross continued marketing unheated products, several of which were later proved to be contaminated. Prosecutors argue that this evidence, collected during a raid on Green Cross on Aug 21, shows that officials recognised but continued to ignore the hazards.
The Health and Welfare Ministry has also been severely criticised for failing to notice warning signs as early as 1983, and a murder accusation, the first of its kind, was filed on Sept 18 against a former ministry official for not recalling the unheated products once heated products were approved. On Sept 26, 41 HIV-infected haemophiliacs filed lawsuits against the government and five drug companies, including Green Cross, bringing the total number of plaintiffs in such suits, which began in 1989, to 1000. A March 29 out-ofcourt settlement for a larger group of plaintiffs resulted in their each being awarded a lump sum of 45 million yen (US$405 400) and 150 000 yen monthly payments for life to cover medical expenses. Ed Gutierrez, Guy Netley
951
DISPATCHES
LONDON
Risk reports push up pregnancies in Britain
A
key Health of the Nation target—a 50% reduction in pregnancies among the under–16s in a decade—is looking unachievable. Official figures released last week show that pregnancies within this group have started to rise again: from 8·1 to 8·3 per 1000 women between 1993 and 1994. Britain had the highest rates in Europe when it set itself the target of reducing the 1989 figure of 9·6 to 4·8 by the year 2000. Family planners again pointed to Britain’s reluctance to accept teenage sexuality and sexual activity. The Brook Advisory Service, a leading family planning agency, called for more openness at home, more relaxed sex education at school, and easier access to confidential advice and contraception services. Ministers were keen to reduce the numbers but reluctant to introduce measures that would reduce pregnancies, even placing restrictions on sex education in schools. Of the 7754 pregnancies to girls under 16 in 1994 (up from 7243 in 1993), 52·8% ended in abortion. But it is not just the under–16s at risk of unwanted pregnancies. The latest in a series of national opinion poll surveys done for an oral-contraceptive manufacturer shows a drop in the proportion of sexually active women using any form of birth control. The survey of 1000 women aged 16 to 44 found 25% who were not
KYOTO
using any contraception; 32% of this group were sexually active. The pill remains the most popular form of contraception but the proportion of women aged 25 to 29 using the pill dropped from 45% to 35% between 1993 and 1996. A key reason for this drop was last year’s scare over the safety of third-generation oral contraceptives, billed as
“. . . a key difficulty for decision-makers is not when the evidence is clear, but when it is weak or incomplete” “killer pills” by the tabloid press, there was an immediate 14% fall in their use and this year’s figure is still 4% below last year’s. Yet, as the Chief Medical Officer, Kenneth Calman, noted in his annual report on public health last week, the increase in risk from venous thromboembolism posed by the new pills was merely raised from 15 to 30 per 100 000 women per year. Pregnancy posed a much bigger risk. All of which led Calman to seek new ways of improving the reporting of risk by health journalists. In his annual report he set out a possible classification that if adopted, would provide the public and patients with a clearer guide to the potential risks of particular conditions.
Calman conceded that a key difficulty for decision-makers is not when the evidence is clear, but when it is weak or incomplete. In these circumstances it is crucial that policy-makers are open about what they know—and do not know—so that they can establish trust with the public. Calman said that the public—and professionals—were confused by the range of words currently used to describe risk: negligible, minimal, remote, very small, small. The adjectives used to qualify these definitions made communication even more confusing: avoidable-unavoidable; justifiable-unjustifiable; acceptableunacceptable; serious-not serious. Pressed by reporters, Calman said eventually that an agreed classification system might be used for new drugs or new clinical procedures to give patients a better picture of the risks involved. Meanwhile, the problem for reporters remains their news desks. All news editors were agog last year to learn that the new contraceptive pills “had doubled the chance of a blood clot”. Hence the splash headlines and extensive radio and television reports. Not many would have been interested in a story that said the number of women at risk from the new pills had risen from 1·5 to 3 per 10 000. Malcolm Dean
Evidence mounts over Japan’s tainted-blood allegations
I
n the past 2 weeks a rash of written evidence has implicated top drug industry and government officials in a tainted blood product scandal involving the infection of more than 1800 haemophiliacs and others in the early and mid 1980s. On Sept 19, the then president and two former presidents of Osaka-based Green Cross, one of five major drug firms involved in the scandal, were arrested on charges of professional negligence resulting in death from their company’s HIV-infected blood-clotting products. These officials and others have repeatedly claimed that, before the government’s approval of safer, heated blood products in July, 1985, they had no clear knowledge of the risk of unheated foreign blood products. Yet 2 years before this, a Green Cross internal document warned of HIV contamination
Vol 348 • October 5, 1996
of US-imported blood, which at the time made up more than 85% of the firm’s blood-product ingredients. Furthermore, a diary kept by a Green Cross board member details a meeting that took place just before July, 1985, in which the three former presidents and other executives discussed the dangers of use of unheated foreign blood products. Also, two Green Cross in-house magazines (September, 1985, and January, 1986) carried stories about the safety of the company’s new heated products. Despite its own articles, though, Green Cross continued marketing unheated products, several of which were later proved to be contaminated. Prosecutors argue that this evidence, collected during a raid on Green Cross on Aug 21, shows that officials recognised but continued to ignore the hazards.
The Health and Welfare Ministry has also been severely criticised for failing to notice warning signs as early as 1983, and a murder accusation, the first of its kind, was filed on Sept 18 against a former ministry official for not recalling the unheated products once heated products were approved. On Sept 26, 41 HIV-infected haemophiliacs filed lawsuits against the government and five drug companies, including Green Cross, bringing the total number of plaintiffs in such suits, which began in 1989, to 1000. A March 29 out-ofcourt settlement for a larger group of plaintiffs resulted in their each being awarded a lump sum of 45 million yen (US$405 400) and 150 000 yen monthly payments for life to cover medical expenses. Ed Gutierrez, Guy Netley
951