Experimental Drugs Poised for Use in Ebola Outbreak International Health Groups Are in Discussions with the Democratic Republic of the Congo

NEWS IN FOCUS INDONESIA Government plan HAWAIIAN VOLCANO Scientists PUBLISHING Open-access CANCER Researchers explore to clamp down on foreign scramble to analyse data drive escalates as stand-offs using the microbiome scientists draws protest p.476 from Kilauea eruption p.477 spread across Europe p.479 against tumours p.482 KENNY KATOMBE/REUTERS

Health Ministry officials carry the first batch of experimental Ebola vaccines in Kinshasa, Democratic Republic of the Congo, on 16 May 2018.

PUBLIC HEALTH Experimental drugs poised for use in Ebola outbreak International health groups are in discussions with the Democratic Republic of the Congo.

BY ERIKA CHECK HAYDEN are detected to save lives. That’s a change from now has more than 7,500 doses on hand. The the past, when doing research during an out- vaccine was given to health-care workers id workers responding to the Ebola break was seen as a distraction. beginning on 21 May, and could be adminis- virus outbreak in the Democratic The switch has been driven by the availability tered this week to patients and their contacts. Republic of the Congo (DRC) are of new vaccines and drugs — and by memories Public-health experts hope that the experi- Aseeking approval to treat patients with experi- of the 2014–16 epidemic. Officials were so slow mental vaccine, called rVSV-ZEBOV, will mental drugs. These include three potential to deploy potential vaccines and drugs that the help to control the outbreak. Forty-six peo- treatments — ZMapp, favipiravir and GS-5734 epidemic had waned before clinical trials could ple have been infected and 26 have died, the — that were given to patients during the 2014– start. Now, “there’s an acceptance that research World Health Organization (WHO) said on 16 Ebola epidemic in West Africa. during an outbreak is something we need to do”, 21 May. The virus has spread over a wide area The drugs are being considered in addition says Daniel Bausch, director of the UK Public and infected at least one person in a major city, to the use of an experimental vaccine; none of Health Rapid Support Team in London. Mbandaka — home to 1.2 million people. the treatments has been definitively proved to The DRC allowed the use of an experimen- The rVSV-ZEBOV vaccine, manufactured lower the risk of death from Ebola. tal Ebola vaccine during the country’s last by Merck, was shown to protect against Ebola The move to test experimental drugs and outbreak, in May 2017, although the outbreak in a trial run during the West African epi- vaccines early in the outbreak, which was ended before the vaccine was shipped. Earlier demic. None of the 5,837 volunteers who took confirmed on 8 May, is part of a push to start this month, the government approved the the vaccine in that trial became infected. research as soon as possible after Ebola cases first shipments of the vaccine and the country Officials in the DRC have quashed eight

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previous outbreaks through conventional POLICY public-health measures, such as tracking down people with Ebola and their contacts to under- stand the disease’s path. But they worry about how far the virus has already travelled this time Indonesia plans strict and about the possibility that it could spread even farther — as it did in the West African epidemic, which took root in 3 countries and foreign research laws claimed more than 11,000 lives. “We think the outbreak could become complicated, as it did in West Africa, so we must do everything to Regulations could hamper international collaborations. stop it,” says Jean-Jacques Muyembe-Tamfum, director-general of the National Institute for BY DYNA ROCHMYANINGSIH “beneficial output for Indonesia”. Biomedical Research in Kinshasa. Erik Meijaard, a conservation scientist Whether that will include deploying exper- cientists in Indonesia fear that a govern- at the University of Queensland in St Lucia, imental drugs is now under discussion. The ment plan to introduce stringent rules for Australia, who studies orangutans in Borneo, WHO is consulting experts to consider the foreign researchers will scare off potential says the proposal is “unworkable” for evidence for such treatments, and the medi- Scollaborators and hamper experiments. The foreigners: “You could do a few years’ research, cal humanitarian organization Médecins Sans proposals also suggest tough new penalties, find out that the outcomes do not benefit Frontières (MSF) is talking to DRC officials including prison sentences, for foreign scien- Indonesia, and then you cannot publish.” about using them, says Annick Antierens, who tists who break some existing rules, such as the Meijaard adds that, overall, the draft law coordinates Ebola clinical trials for MSF. requirement to have a research permit. seems vague and is “certain to turn away Although the rVSV-ZEBOV vaccine could Next month, representatives from two foreign researchers and stop people from help prevent new infections, Antierens says, science academies will meet with politicians studying in Indonesia if there is an unclear experimental drugs might still be needed in the hope of convincing them to reconsider risk of being fined or sent to jail”. because officials lack a good understanding of the proposals. The ministry’s director-general for research where Ebola first emerged during this outbreak “The new regulations will only repel and development reinforcement, Muhammad or how it is spreading. So there are likely to be foreign scientists to do research in Indonesia, Dimyati, doesn’t think the rules will stop col- very many people who are already infected. and this is not good for Indonesia’s science,” laboration. “We encourage foreign scientists Using experimental vaccines and drugs in says Berry Juliandi, a member of the Young to publish their research conducted in Indo- an outbreak raises logistical and ethical com- Academy of Sciences and a biologist at Bogor nesia. But they should not write alone and they plexities, such as delivering them to remote Agricultural University. The contribution of have to involve Indonesian scientists. This will settings by aeroplane or motorbike and design- international scientists is crucial for Indo- certainly give benefits to Indonesia’s science.” ing humane and rigorous clinical trials. The nesian research because foreign science Dimyati says every country has a right to 2014–16 Ebola outbreak saw controversy over agencies have larger budgets and more protect its natural resources for the welfare whether potential drugs and vaccines should sophisticated technology, he says. of its people. “The sanctions are intended to be tested in trials that randomly assign patients Government documents state that the remind scientists to receive either the experimental treatment or proposed regulations for international “We encourage about their role in standard care. MSF and officials at the WHO science are meant to protect Indonesia’s foreign society, which is argued that withholding the medicines from natural resources and to increase local science scientists to to find innovation desperate patients would be unethical. capacity. The proposals are among several out- publish research that is beneficial for Some of the treatments MSF is now lined in a draft law submitted to the House of conducted in mankind without considering were given to varying numbers of Representatives in August 2017. Indonesia. But violating regula- people in the 2014–16 epidemic. ZMapp, an If the law is approved by the house, interna- they should not tions of a country,” antibody treatment made by Mapp Biophar- tional scientists will have to submit their raw write alone.” he says. maceutical in San Diego, California, was tested data to the research ministry; involve Indone- Not all research- in a 72-person trial; 22% of the 36 people who sian colleagues as equal partners in research ers think the penalties are a bad idea. Laksana received the drug died, compared with 37% projects; and name all Indonesian researchers Handoko, a physicist at the Indonesian of the 35 who did not receive it. Favipiravir, involved in a project on every peer-reviewed Institute of Sciences in Jakarta, supports an antiviral drug from the Japanese company paper that arises from the work. criminal punishments for researchers who Toyama Chemical, was given to 126 patients The draft law also imposes harsh penalties take specimens out of the country without a in the West African outbreak, and a few dozen on foreign researchers who break existing transfer agreement. It’s stealing, he says. in other trials. The antiviral drug GS-5734 was regulations. Foreign scientists will still need a Jason von Meding of the University of New- given to three people. government permit to do research, and a spe- castle in Australia, who studies disaster risk- The Congolese Ministry of Health and a cial transfer agreement to remove specimens, reduction in southeast Asia, says that scientists national ethics review board would need to but breaking these rules would be upgraded in developing countries need protection for approve new drug trials. Observers say that to a criminal offence. Researchers could face their work — and that international scientists studies must proceed more equitably than they a prison sentence of up to 2 years, or hefty should not be afraid of the draft law if they’ve did in the 2014–16 outbreak, when experimen- fines of as much as 2 billion Indonesian done nothing wrong. But he thinks that less- tal treatments were given first to international rupiah (US$143,000). The current penalty severe sanctions would be more appropriate doctors and aid workers. for a researcher who violates a permit can than the proposed criminal penalties. “We were pretty tone deaf,” says Lawrence vary from a verbal warning to the permit The research ministry’s director of Gostin, director of the WHO Collaborating being revoked. There has been no national intellectual property, Sadjuga, says it could Center on Public Health Law and Human policy or penalty for scientists who remove be some time before the proposals become Rights at Georgetown University in Wash- specimens without an agreement. law, because members of the house have to ington DC. “We need to do that completely The draft law would also require that inter- debate the draft, and they are preparing for differently this time.” ■ national scientists do research that produces an election in 2019. ■