Ethics debate on Ebola treatment muddied by contradictory statements

Questions remain over why an experimental Ebola treatment was made available to three Westerners while its distribution to residents of West African countries affected by the most recent outbreak of the deadly virus was stalled because of a debate over ethics.

More than 1,000 people have died from the latest outbreak of Ebola, which has no proven cure or vaccine, since it was reported in March in Liberia, Nigeria, Sierra Leone and Guinea.

Liberian officials confirmed Tuesday that limited doses of an experimental Ebola treatment will be sent to the country a week after two Americans received the serum — a move that contradicts previous statements by officials who said there were no doses left.

After Liberian President Ellen Johnson Sirleaf confirmed the transfer of limited doses of ZMapp — the experimental serum that was also flown to a Spanish priest who contracted the virus in Liberia and died Tuesday — the treatment’s manufacturer, San Diego-based Mapp Biopharmaceuticals, said its supply was now “exhausted,” the New York Times reported.

But the Centers for Disease Control and Prevention (CDC) said last Wednesday, after Liberia and Nigeria requested the treatment, that there were “virtually no doses available,” according to a CDC representative. Days after that statement, Mapp flew ZMapp to Spain for the priest infected with the disease. Both the transfer of ZMapp to the priest and the decision to send the drug to Liberia raised questions about how many doses the company has and why they weren’t offered to Africans earlier.

Mapp officials declined to comment on efforts to make the treatments available to combat the recent Ebola outbreak, or the number of treatments remaining. The CDC also did not respond to Al Jazeera’s request for comment.

It was reported that Samaritan’s Purse, the aid organization the Americans worked for, contacted the CDC about possible Ebola treatments and that the CDC then referred it to the National Institutes for Health. The NIH ultimately connected Samaritan’s Purse with Mapp, which agreed to send the treatments to West Africa. The CDC and NIH have said that they had no direct involvement in the transfer of the drug or treatment of the Americans. The transfer of ZMapp to the Spanish man was also reportedly arranged with Mapp, not the CDC or NIH.

The approval to give ZMapp to West Africans came on the heels of a ruling on Monday by a panel of medical ethicists from the World Health Organization (WHO) saying it would be ethical to offer unproven drugs to West African countries because of “the particular circumstances of this outbreak.”

But the fact that doses of the medication had already been given to three Westerners without the same debate over ethics has also raised controversy.

“If there is an equal respect for all human life, why do ethical issues stand as barriers for one population of people, but not for another?” a Washington Post blog post questioned.

The ethics conversation “conflates research ethics with treatment ethics,” sociologist Amy Kaler noted, responding to widely reported fears that giving untested medication to Africans could be interpreted as experimenting on a vulnerable population. The critique has resonated so strongly because of a history of unethical studies on persons of African origins.

“The situation in West Africa is not a research situation, it’s more analogous to an emergency ward or a disaster zone,” Kaler wrote in a comment on a Washington Post piece. “[It is] quite right that research ethics require participants to be capable of giving fully informed consent, but emergency medical procedures are often carried out on people who are not capable of informed consent. If the man in line ahead of me at Starbucks suddenly fell over and stopped breathing, his ability to consent to medical treatment would not be at issue in making the decision whether to start CPR.”

Residents of West African countries hit by the outbreak have also questioned why the treatment was given to Westerners first.

Anthony Kamara, a 27-year-old from Freetown, Sierra Leone, told CBS news, “Americans are very selfish. They only care about the lives of themselves and no one else.”

Besides the ethical question of giving out untested medication, officials have been wary of agreeing to supply what little doses remain because they don’t know if it is effective or even safe. U.S. President Barack Obama said last week that it was unclear if the treatment would work. “We’ve got to let the science guide us,” he said.

The conditions of two Americans who were given ZMapp are reportedly improving, but it is unclear whether that is due to the medication.

In the current Ebola outbreak, the virus has about a 60 percent mortality rate — other strains can be as high as 90 percent — so it could be a matter of chance that their conditions have improved. Also, the two did not receive the treatment until several days after they had been infected. And in tests on primates, ZMapp was found to be most effective when administered within 24 hours. In those tests, the efficacy of the drug dropped sharply after 48 hours. ZMapp had never before been tested on humans.

Work on the previously unheard of ZMapp serum began nearly a decade ago under a coalition of Mapp Biopharmaceuticals, San Diego–based LeafBio and Toronto-based Defyrus Inc., a biodefense company that works with the U.S. military.

The U.S. government financed most of Mapp’s work, the New York Times reported, and has stored a small amount of ZMapp as part of a contingency plan in case of accidental exposure to Ebola by one or two people at U.S. research facilities, a source familiar with the plan said.

Dr. Anthony Fauci, a leading immunologist and director of the NIH, said according to the manufacturer, it could take two to three months to make “a modest amount” of the drug.

Several alternative Ebola treatments exist, from Vancouver-based Tekmira Pharmaceuticals and New York–based Profectus BioSciences, but they are also still at early, experimental stages.

Dr. Marie-Paule Kieny, assistant director-general of the WHO, told The New York Times that another therapy — made from the blood of patients who survived the virus, containing natural antibodies — may be possible. She added that it could be ready for human testing by September.

But some experts argue that ZMapp and other experimental treatments are not the answer to the current crisis.

Instead, they said West African countries affected by the outbreak should deploy “more health care workers, face guards, moon suits, gloves and antiseptic, along with restrictions on travel and burying the dead,” Arthur L. Caplan, founding head of the Division of Bioethics at New York University Langone Medical Center, told NBC news.

Despite his opinion on ZMapp and other experimental treatments, ZMapp’s distribution to Westerners ahead of Africans was problematic, Caplan said.

“When all is said and done, we need more transparency about what the tiny company in San Diego is doing in rationing its small supply of drugs,” Caplan said. “There are lots of people on the front lines of the Ebola epidemic who are justifiably wondering what the moral basis is to date for treating the three people who have gotten access to a last-ditch experimental treatment.”

With wire services