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Who should get experimental Ebola medications? And are they safe?

By Tony Pugh
McClatchy Washington Bureau / (MCT)

WASHINGTON – As Ebola continues to devastate West Africa and new patients slowly bring the disease to other countries, experts fear the growing crisis could one day create an ugly scrum for the limited supply of experimental treatments and vaccines.

Deciding which patients should be at the head of the line to get these medications could become the next ethical dilemma for caregivers, drug companies, humanitarian groups and government officials.

The scarce supply could pit front-line health care workers in Africa against the masses of Ebola patients there – even U.S. soldiers, if infections occur among the military forces deployed there.

The benefit of treating older patients would have to be weighed against trying to save younger ones. And experimental treatments for newly diagnosed patients would have to be evaluated against the needs of those with more advanced infections.

The resulting triage would spark immense public debate about privilege, ethics and risk; issues that have only been hinted at in the limited use of experimental medications thus far in the current outbreak.

But if infections begin jumping borders more frequently, questions about the “distributive justice” of experimental medications could potentially erode public confidence in the fairness of the patient selection process.

“So it’s important to talk about this beforehand so we can be prepared to make fair decisions and good decisions when we need to make them,” said Dr. Marion Danis, who heads the section on ethics and health policy in the department of bioethics at the National Institutes of Health.

The U.S. government, through the NIH, the Department of Health and Human Services and the Food and Drug Administration, is working to accelerate the approval, testing, production and distribution of potential Ebola treatments and vaccines.

Two vaccine candidates are in Phase 1 clinical trials being tested for safety in humans. One, developed by GlaxoSmithKline and the NIH, uses a chimpanzee virus to introduce Ebola virus genes into the body and stimulate an immune response. It has shown promising results in animals against the Zaire Ebola species wreaking havoc in West Africa.

Safety testing is also underway on another experimental vaccine, developed by the Public Health Agency of Canada.

The most promising of several medications to treat Ebola is ZMapp, developed by Mapp Biopharmaceutical Inc. The San Diego company is working with a host of federal agencies to speed development and testing of the drug.
But that’s a slow and costly process, and manufacturers don’t expect meaningful amounts of promising Ebola vaccines and treatments for months, even years. Officials at GlaxoSmithKline have said their Ebola vaccine candidate won’t be ready in time to provide any significant relief for the current outbreak.

That didn’t sit well with Manica Balasegaram, executive director of Doctors Without Borders’ access campaign.

“Nobody knows how long this outbreak will last; our patients, front-line workers, and people across West Africa can’t afford to hear ‘it’s too late,’ ” Balasegaram said in a statement last week.

“The situation on the ground is disastrous; this is a crisis. A vaccine could be the tipping point, but we need (Glaxo) to show leadership by making a bold decision now and (taking) on some risk in driving through a process of accelerating development in parallel with the scale-up of supply.”

That dire need for pharmaceutical intervention prompted a World Health Organization panel to determine in August that it’s ethically permissible to offer patients in West Africa experimental Ebola drugs whose effectiveness, safety and potential for adverse reactions have not been fully vetted in humans.

“But I personally think there are a lot of pitfalls to that,” said Holly Taylor, a core faculty member of the Johns Hopkins Berman Institute of Bioethics.

Citing the use of ZMapp in the treatment of Dr. Kent Brantly and Nancy Writebol, the American medical workers in Liberia who survived their Ebola infections, Taylor said doctors don’t know whether the drug aided both patients’ recovery or not, because ZMapp’s effectiveness hasn’t been clinically proven in humans.

“If they haven’t shown that it’s safe and effective in humans, I don’t think it would be a good idea at all to give it to anybody,” Taylor said.

While Brantly and Writebol’s recoveries may appear to validate ZMapp’s effectiveness, Taylor noted that both patients received superb supportive care at a top-flight medical facility, Emory University Hospital in Atlanta, a benefit that also contributed to their recovery.

“So if we play this out and say we don’t know it’s safe or effective, but we’re going to give it to people in a sort of unsystematic way of just sort of saying, ‘We think this might work, you can take it,’ we won’t learn anything about it,” Taylor said.

“We won’t know if they’re better off or worse off. And the worst-case scenario is they’re worse off, but we don’t know it because they die of the disease . . . and we can’t really measure whether or not that particular compound was effective,” she said.

For that reason, the WHO panel advised that “there’s a moral obligation to collect and share” all clinical data obtained from the use of experimental Ebola drugs.
“If at all possible, you should be able to collect scientific information while you’re giving it to people, so that was really the effort we made to resolve that conflict,” said the NIH’s Danis, who was a member of the WHO panel.

“When people are facing death, you would want them to be fully informed that we don’t know that (the medications) are proven, but it would certainly be ethically acceptable to give it to them,” Danis said. “And I think some people might even feel like it’s more than acceptable. It’s really something we ought to do.”

In deciding who should get the drugs, “I think there’s a principal and we should say it, that we take care of our own nationals first,” said Dr. Arthur Caplan, director of the Division of Medical Ethics at New York University.

Case in point: U.S. soldiers in Africa.

“No one should doubt that anybody who gets exposed among those troops, they’re going to get special care,” he said. “I can tell you now there won’t be any tossing of coins or debates behind closed doors.”

But most ethicists, even Caplan, seem to agree that health care workers in West Africa should be at the front of the line, even before patients.

“Just for this outbreak,” said Dr. Robert Garry Jr., a professor of microbiology and immunology at the Tulane University School of Medicine. “Because you need to break this outbreak transmission chain, so you need to be able to protect the health care workers so they can get in there and do their jobs.”

Caplan said that health care workers would be more likely to volunteer in West Africa if they knew they’d be prioritized for experimental medicines should they become infected.

But Danis said putting health care workers first “could be perceived as unfair by the public.”

“Others would say non-health care workers got sick through no fault of their own, so why should they be penalized and have to go second?” she asked rhetorically.

In the case of younger patients vs. older ones, Garry said the medicines should go to the patients who had the best chance to survive.

“Unfortunately, with this disease, the older you are, the less your chance of surviving, so there’s definitely an age bias,” Garry said. “The younger person would have the better chance of surviving.”

Caplan and Garry agreed that newly infected patients should get experimental medications ahead of those with more advanced infections, since the medications are likely to be more effective against a new infection.
But Danis said some may assert that people more likely to identify their infections early are those with the most family support and money, “so you will end up giving it to people who are, to start with, more advantaged,” she said.

These issues, Danis said, point out the importance of having a fair and transparent strategy for deciding such questions, “meaning you should have input from all stakeholder groups” in deciding how experimental medications are distributed.

Equally important, Caplan said, is sharing with the public the rationale behind those decisions, because apparent disparities distributing the medication could create even more problems.

“If you want to keep public trust, you’d better be explaining why things might be different from case to case,” Caplan said. “In an epidemic, or when you have fears of one coming, you’ve really got to keep public trust, and the only way to do that, I think, is to give out more information than usual.”
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(c)2014 McClatchy Washington Bureau

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