An ethics committee of the World Health Organization (WHO ) gave the green light for the treatment of Ebola patients with experimental drugs for the deadly virus. There was "unanimous agreement among experts that in the particular circumstances of the Ebola outbreak, it is ethical to offer unregistered treatments," said Marie-Paule Kieny, Assistant Director General of the WHO, at a press conference today in Geneva, Switzerland.
"It is important that the committee has affirmed the moral compassionate use" writes Arthur Caplan, a bioethicist at New York University in New York, in an email. "But there are huge ethical problems that remain unaddressed and unanswered experimental interventions about." Caplan is not a member of the WHO committee.
The panel of 12 members was summoned by telephone Monday, as the largest Ebola outbreak in the file raging in West Africa. The virus has sickened 1,848 people and killed 1,013 of them in Guinea, Liberia, Nigeria and Sierra Leone, according to the latest figures released by WHO. There are no vaccines or treatments against Ebola in the market. But researchers are developing several drugs, most of them supported by funding from the US government and fueled by worries of bioterrorism.
Since the beginning of the epidemic, scientists discussed whether some of these drug candidates could be used in Africa West . They were concerned, however, that trying these drugs in Africa would be considered racist and could increase distrust of health workers, already a problem in the fight against the epidemic. But after two American health workers fell ill in Liberia and received zmapp, an experimental mixture of monoclonal antibodies, the discussion took a turn . Some people began arguing that the drug should be made available in Africa, where the majority of patients die.
The ethics committee, composed of researchers, ethicists, and advocates for patient safety, reached a consensus that in certain circumstances of this epidemic, "it is ethical offering unproven interventions with unknown efficacy and adverse effects, as a potential treatment or prevention. " They also concluded that "there is a moral obligation to collect and share all the data generated, including treatment provided for compassionate use" and "a moral duty to evaluate these interventions (for the treatment or prevention ) within the shortest possible clincial trials in the circumstances. "
conduct clinical trials in the middle of the Ebola outbreak will be" difficult, "writes Peter Smith, an epidemiologist at the London School of Hygiene & Tropical Medicine and the one member of the ethics committee. But they are the best evidence of effectiveness, he believes. "clear explanations for testing to those in the affected communities will be vital as obtaining informed consent patients or their immediate relatives, "he wrote in an email.
Many questions remain unanswered, said Caplan. For example: who should weigh the risks and benefits of a given therapy. "This can not and should not be left to potential subjects," he wrote. Other issues that will pay for unapproved drugs, which can give consent to use them, and how companies will be protected against liabilities if medications have harmful side effects.
Even more difficult is the question of how the limited amount of available experimental drugs should be distributed. According to several reports, the last deliveries of zmapp were sent to Liberia to treat two doctors there, and it will take months to produce more drugs. Other experimental drugs are also available in small quantities. When used, should health care workers are treated first, as some scientists have suggested? How supplies should be divided between countries?
"work ethics Many more must be done to create a solid infrastructure for compassionate use in humanitarian emergencies," Caplan writes. The Ethics Committee will meet in Geneva at the end of the month, Kieny said. Then they will have to address at least some of these difficult issues
* Ebola files :. Given the current epidemic of Ebola, unprecedented in terms of the number of people killed and the rapid geographic spread, science and Science Translational Medicine have a collection of articles research and news on the viral disease available for researchers and the general public.
0 Komentar