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Another HIV-1 trial loses placebo control
THE LANCET
POLICY AND PEOPLE
Insurance for long-term care planned in Japan patients’ impairment. Half of the egislation was passed on Dec 9 for funding will come from monthly prea new public long-term-care miums levied on people over 40. insurance scheme—Kaigo Hoken—to There will also be a 10% copayment be fully operational from 2000. This at the point of service provision. Rates makes Japan only the third country, will be altered for after Holland and those on low income. Germany, to provide The rest of the fundsuch insurance. ing will come from These proposals general taxation. are epoch making, Will this scheme be because they depart effective? There are radically from the two potential drawJapanese tradition backs. First, health that families are and social-services primarily responsible professionals in each for long-term care. municipal governEligibility criteria will Will you still care, when I’m 64? ment will have to no longer take into assess eligibility and decide on care account the extent of informal care plans—skills that have long been available to patients; and ultimate neglected in Japan. Second, the mechresponsibility for care will lie with the anism of quality assurance has not state rather than with families. been clearly defined. The scheme The scheme will pay for institumarks a new departure in Japanese tional and home-based care not only social policy, but these obstacles will for those aged 65 or more, but also for need to be overcome quickly if clients people over 40 years old with “ageand caregivers are to receive the related” diseases such as dementia. intended benefits. Each municipal government is deemed a provider, and the level of services will be decided by the Yumiko Arai
L
Anderson Wachira Kigotho
Dorothy Bonn
Sean Sprague, Panos Pictures
the US Centers for Disease Control and Prevention, which funded this and other similar placebocontrolled studies in developing countries. Sydney Wolfe of the Washington-based US lobby group, Public Citizen’s Research Group, said that moves to abandon placebo arms were a crucial acknowledgment that it was possible to conduct scientifically valid and useful studies without using placebo. Wolfe pointed out that Marc Lallemant of Harvard University School of Public Health (Boston, MA, USA) has planned similar trials in Thailand with no placebo group. According to Wolfe, the ethics review board involved had said that a placebo-controlled study would be unethical. Wolfe and research associate Peter Lurie said unpublished data from ACTG 076—the original study that established the efficacy of AZT in reducing maternal–infant HIV-1 transmission—indicate that shorter AZT courses are almost certainly more useful than placebo.
anning the distribution of cigarette promotional items (CPIs), such as T-shirts, lighters, backpacks, and electronic equipment, would help to dissuade American youths from smoking, say US researchers. The researchers, from DartmouthHitchcock Medical Center (Lebanon, NH, USA), interviewed more than 1200 students in five rural schools and found that one-third owned a CPI. After control for confounders, such as having family and friends who smoked, students who owned CPIs were more than four times as likely to be smokers as those who did not own CPIs (Arch Pediatr Adolesc Med 1997; 151: 1189–96). Never smokers and experimental smokers who owned CPIs were more likely than non-owners to start smoking in school grades 6–9, a period when children are most vulnerable to starting smoking. The sale of CPIs in the USA has risen massively, the authors note. Money spent by the tobacco industry on CPIs increased from 7·7% of its advertising budget in 1990 to 25·8% in 1994. “It is difficult to conceive of alternatives for limiting the impact of CPIs on children short of an outright ban”, say the authors, who support the inclusion of CPIs in US Food and Drug Administration restrictions on cigarette promotion to minors. The tobacco industry is challenging these restrictions in federal court. In the UK, smoking is increased in boys whose favourite television sport is motor racing (see Lancet Nov 15, p 1474). Conversely, countries such as Finland and New Zealand that have banned tobacco advertising have seen smoking rates fall substantially. Earlier this month, European Union health ministers agreed to phase in a total ban on tobacco advertising and sponsorship by 2006. Meanwhile, in Massachusetts, USA, where 78% of adults who frequent bars are non-smokers, bar owners could get more customers if smoking were banned. A team from Boston University found that, if bars were smoke-free, 20% of survey respondents said they would go to bars more often, and 10% of people who did not go to bars would start going (Am J Publ Hlth 1997; 87: 2042–44). This could mean 120 000 more customers for bars and clubs in Massachusetts, say the authors.
Another HIV-1 trial loses placebo control
R
esearchers from Johns Hopkins University School of Public Health (Baltimore, MD, USA) have abandoned the placebo group in a study that was to involve 900 HIV-1positive women in Ethiopia. Originally, the study was designed to have three groups, in order to identify alternatives to the standard zidovudine (AZT) regimen for preventing mother–infant HIV-1 transmission. The first group was to receive: 600 mg oral AZT daily for the last 6–9 weeks of pregnancy; then in labour, intravenous AZT 2 mg/kg over 1 hour; then 1 mg/kg per hour until delivery. Infants receive 2 mg/kg AZT orally every 6 hours for three days. The second group were to receive similar treatment except infants would not get AZT. Mothers and infants in the third group were to get placebo. Now the trial will proceed with the two AZT-treated groups only. The researchers said that it had been clear since 1994 that shorter AZT regimens might work as well as the standard US regimen. This contrasts with the opinion of the US National Institutes of Health and
Vol 350 • December 20/27, 1997
Tobacco-promotion bans will work
B
1831
POLICY AND PEOPLE
Insurance for long-term care planned in Japan patients’ impairment. Half of the egislation was passed on Dec 9 for funding will come from monthly prea new public long-term-care miums levied on people over 40. insurance scheme—Kaigo Hoken—to There will also be a 10% copayment be fully operational from 2000. This at the point of service provision. Rates makes Japan only the third country, will be altered for after Holland and those on low income. Germany, to provide The rest of the fundsuch insurance. ing will come from These proposals general taxation. are epoch making, Will this scheme be because they depart effective? There are radically from the two potential drawJapanese tradition backs. First, health that families are and social-services primarily responsible professionals in each for long-term care. municipal governEligibility criteria will Will you still care, when I’m 64? ment will have to no longer take into assess eligibility and decide on care account the extent of informal care plans—skills that have long been available to patients; and ultimate neglected in Japan. Second, the mechresponsibility for care will lie with the anism of quality assurance has not state rather than with families. been clearly defined. The scheme The scheme will pay for institumarks a new departure in Japanese tional and home-based care not only social policy, but these obstacles will for those aged 65 or more, but also for need to be overcome quickly if clients people over 40 years old with “ageand caregivers are to receive the related” diseases such as dementia. intended benefits. Each municipal government is deemed a provider, and the level of services will be decided by the Yumiko Arai
L
Anderson Wachira Kigotho
Dorothy Bonn
Sean Sprague, Panos Pictures
the US Centers for Disease Control and Prevention, which funded this and other similar placebocontrolled studies in developing countries. Sydney Wolfe of the Washington-based US lobby group, Public Citizen’s Research Group, said that moves to abandon placebo arms were a crucial acknowledgment that it was possible to conduct scientifically valid and useful studies without using placebo. Wolfe pointed out that Marc Lallemant of Harvard University School of Public Health (Boston, MA, USA) has planned similar trials in Thailand with no placebo group. According to Wolfe, the ethics review board involved had said that a placebo-controlled study would be unethical. Wolfe and research associate Peter Lurie said unpublished data from ACTG 076—the original study that established the efficacy of AZT in reducing maternal–infant HIV-1 transmission—indicate that shorter AZT courses are almost certainly more useful than placebo.
anning the distribution of cigarette promotional items (CPIs), such as T-shirts, lighters, backpacks, and electronic equipment, would help to dissuade American youths from smoking, say US researchers. The researchers, from DartmouthHitchcock Medical Center (Lebanon, NH, USA), interviewed more than 1200 students in five rural schools and found that one-third owned a CPI. After control for confounders, such as having family and friends who smoked, students who owned CPIs were more than four times as likely to be smokers as those who did not own CPIs (Arch Pediatr Adolesc Med 1997; 151: 1189–96). Never smokers and experimental smokers who owned CPIs were more likely than non-owners to start smoking in school grades 6–9, a period when children are most vulnerable to starting smoking. The sale of CPIs in the USA has risen massively, the authors note. Money spent by the tobacco industry on CPIs increased from 7·7% of its advertising budget in 1990 to 25·8% in 1994. “It is difficult to conceive of alternatives for limiting the impact of CPIs on children short of an outright ban”, say the authors, who support the inclusion of CPIs in US Food and Drug Administration restrictions on cigarette promotion to minors. The tobacco industry is challenging these restrictions in federal court. In the UK, smoking is increased in boys whose favourite television sport is motor racing (see Lancet Nov 15, p 1474). Conversely, countries such as Finland and New Zealand that have banned tobacco advertising have seen smoking rates fall substantially. Earlier this month, European Union health ministers agreed to phase in a total ban on tobacco advertising and sponsorship by 2006. Meanwhile, in Massachusetts, USA, where 78% of adults who frequent bars are non-smokers, bar owners could get more customers if smoking were banned. A team from Boston University found that, if bars were smoke-free, 20% of survey respondents said they would go to bars more often, and 10% of people who did not go to bars would start going (Am J Publ Hlth 1997; 87: 2042–44). This could mean 120 000 more customers for bars and clubs in Massachusetts, say the authors.
Another HIV-1 trial loses placebo control
R
esearchers from Johns Hopkins University School of Public Health (Baltimore, MD, USA) have abandoned the placebo group in a study that was to involve 900 HIV-1positive women in Ethiopia. Originally, the study was designed to have three groups, in order to identify alternatives to the standard zidovudine (AZT) regimen for preventing mother–infant HIV-1 transmission. The first group was to receive: 600 mg oral AZT daily for the last 6–9 weeks of pregnancy; then in labour, intravenous AZT 2 mg/kg over 1 hour; then 1 mg/kg per hour until delivery. Infants receive 2 mg/kg AZT orally every 6 hours for three days. The second group were to receive similar treatment except infants would not get AZT. Mothers and infants in the third group were to get placebo. Now the trial will proceed with the two AZT-treated groups only. The researchers said that it had been clear since 1994 that shorter AZT regimens might work as well as the standard US regimen. This contrasts with the opinion of the US National Institutes of Health and
Vol 350 • December 20/27, 1997
Tobacco-promotion bans will work
B
1831