Brazil tries to control drug registration

Study shows flaws

also

in end-of-life treatment in USA

provided written instructions on wishes, including pain control

treatment

Medical professionals need to do a much better job of discussing treatment options with patients facing the end of life to make sure that what patients want matches what they get. In the largest US study of its kind, researchers found that too many patients are dying in pain and tethered to machines because doctors routinely ignore or fail to discuss end-oflife treatment wishes. The study, funded by the Robert Wood Johnson Foundation, was conducted in five major medical centres. In the first 2 years, researchers looked at patterns of care for 4301 patients not expected to live more than 6 months and having at least one of nine fatal conditions. The study showed that: about half the time doctors were unaware

California’s anti-immigrant law is unconstitutional

: whether patients did not want cardio: pulmonary resuscitation; 46% of do-not: resuscitate (DNR) orders were not

written until 2 days before death, reveallittle advance planning; nearly 40% of patients spent at least 10 days in the intensive-care unit, where they received aggressive, costly, and futile treatment; . and half the patients spent their last 3 : days in moderate to severe pain. In the second phase of the study, 4804 similar patients were divided into a control group and an experimental group. In the experimental group nurses were assigned to talk to patients and families about right-to-die concerns and to keep the communication lines open between doctors and patients; patients and families Janet Firshein

: ing : : : : : : : : : : .

and heroic measures; and computer reports were given to doctors that estimated survival probability within 6 months. Despite the interventions, there was little change in how doctors treated patients nearing death. "The tools that experts thought would work didn’t", says study leader Prof William Knaus, intensive-care specialist at the University of West Virginia, adding that the interventions did not affect the time patients spent in the intensive-care unit or on a ventilator, the prevalence or timing of documentation of DNR orders, the cost of care, or the duration or intensity of pain. ’

Brazil tries to control

drug

:

registration

requests, 2122 of them related to drugs. Another reason for raising the fee is to deter rogue requests for registrations. Last year a technical commission found more than 800 irregularities (see Lancet 1994; 343: 50). Applications to register new drugs are often disguised as requests for minor changes to an existing product, such as changing the labelling or packing. Of the 2122 applications made in September, 61% are for product modification. "Fake" drugs are another problem. The move to raise fees is, however, politically delicate. Brazil is immersed in an anti-inflation battle, and any attempt to raise public fees can be used by opponents as an argument that it is inflationary.

A federal judge has ruled that major Brazil’s National Health Surveillance Secportions of California’s controversial antiretariat plans to raise fees for handling immigration law are unconstitutional registrations of drugs, food, cosmetics, because they supersede federal authority and other products. Currently the highest over immigration. Passed by the electorate fee is about 900 reais (around US$900), by a 59 to 41% majority and known as which is for the registration of a new drug. Proposition 187, the statewide measure NHSS head Elisaldo Carlini said the fees seeks to deny illegal immigrants nonmight increase at least tenfold. With the emergency medical treatment, nursingnew fees, he hopes to finance at least part home care for the elderly and disabled, of the agency’s activities. "These registrawelfare benefits, and elementary and sections, after all, are a service we provide to ondary education. Physicians, teachers, : private organisations", said Carlini. The and others were directed to report alleged agency receives many more registration offenders. But Judge Mariana R Pfaelzer requests than it can process. In Septemruled that the state is pre-empted from Cláudio Csillag ber, for example, there were 5511 barring illegal immigrants from federally funded health-care and social welfare services, to which they are entitled under Finland’s way of health-care : federal law. State Attorney General Dan Finland’s National Research and Devel- : basic principles in making choices are whose office defended 187, vowed toopment Centre for Welfare and Health : human rights, self-determination, equalappeal the case to the US Supreme Court (STAKES) has published an English ver- : ity, and justice. On health benefits, first if necessary. "We are in the first round of a sion of its report on prioritisation in : priority should be given to cases where 10-round heavyweight fight, and at this health care. From Values to Choices is availintervention is needed to preserve or point we are about even on the score", he able from STAKES, PO Box 220, 00531 : restore age-specific functional capacity. declared. But legal authorities say that it : Helsinki. Norway and Sweden, too, had : The patient’s own evaluation of benefit may be years before a final ruling is made. set bodies to look into health-care and wills : deserves

priorities

setting

Lungren,

Meanwhile,

a

Republican-dominated

up

pri-

special attention,

orities. The English version of Sweden’s : Congress is considering several immigrafinal report was also published this year. tion laws inspired by 187 and public Both the Swedish and Finnish reports : uneasiness over illegal immigrants. stress the definition of basic concepts : When 187 passed in November 1994, such as health, health care, need, quality : health authorities feared that illegal immiof life, and health benefit. Since the bulk grants would be reluctant to seek care of health care in the Nordic countries is : because of deportation possibilities publicly funded, wide lay participation in :: despite lawsuits that block health workers prioritisation decisions is essential. Hence : from implementing the law until its legalthe Finnish report stresses the principle of : ity has been established. But health "transparent" or public decision making. officials at most non-county clinics in Los Both reports avoid Oregon-type priority Angeles, where most illegal immigrants lists. Instead, the prioritisation process is : live, say that while some clinics experldivided into political/administrative and enced an initial drop, attendance is now clinical levels. On the latter, life-threatennear normal with the exception of preing diseases get highest priority. Patients natal care and some other facilities. : with impaired autonomy need special consideration. : Nelson to the Finnish the Harry According report,

;

!

1480

living

should be encouraged. Prolongation of life by all possible means is not the only or most important goal of health care. The working party recommended that a national centre for evaluation of healthcare technology be set up to aid evidencebased medicine. This centre, FinOHTA, was recently established. Since in rapidly ageing societies the only way to avoid painful choices between patients is success on the political and administrative levels of prioritisation, the Finnish, Norwegian, and Swedish Ministries of Health and Social Affairs will, with WHO, be holding an international congress on priorities in health care in Stockholm from Oct 13-16, 1996. Jorma Palo