A Cure For Ebola? Ctd

Brian Till objects to the disparity between the treatment American Ebola patients Nancy Writebol and Kent Brantly are receiving, including an experimental antibody therapy called ZMapp, and the little to no care afforded African patients:

The inequality in care couldn’t be starker. When a doctor and aid worker from the United States are stricken with a horrific disease, an erstwhile unknown cure is sent from freezers at the National Institutes of Health in suburban Washington, D.C., to a hospital on the other side of the world, and a Gulfstream jet outfitted for medevac is arranged to deliver them to one of the world’s premier medical centers. But when two Liberian nurses working at the same hospital are stricken with the same disease, they are treated with the standard of care that other affected Africansthose lucky enough to receive any medical attention at allhave been afforded for the past seven months: saline infusions and electrolytes to keep them hydrated. …

The Obama administration has not said whether it will allow ZMapp to go into production. Mapp Biopharmaceuticals published a statement to their website late Monday stating that the company is working “with appropriate government agencies to increase production as quickly as possible.” (An executive at BioProcessing, a Kentucky firm that produces at least one component of ZMapp, told an industry publication last August that his company can produce the proteins for ZMapp in two weeks.)

A TPM reader with a background in bioethics speculates about why the experimental drug was given to these two aid workers, and no, it’s probably not because they’re white:

It’s hard to overstate how unusual it is for a drug at this stage of development to be given to humans.

This CNN piece suggests that they’ve only tried it on eight macaques so far. That’s a small number; they’d normally do significantly more testing in primates (or some other good animal model) before moving on to humans. Then when they did move to humans, they’d begin by testing for safety, then do various complicated further tests on larger numbers of people, and only then, if it had proved to be safe and effective, would they be able to apply for FDA approval.

This means, first, that this probably wouldn’t have been considered a “treatment” yet, just a promising lead. But second: trying a drug at this stage on humans has serious ethical risks. You’d want to be really, really sure that the people in question had given informed consent, and that that informed consent included their being absolutely clear that this drug not only might not work, but that it might actually be harmful to them. You’d want to be sure that they understood what it means for a drug to be at this preliminary stage of testing, and that they fully appreciated the fact that they were taking a huge gamble. … I think that this (along with the fact that the drug seems to require careful handling of the sort that would best be provided in a serious hospital, and the fact that there seems to have been only a limited amount of the drug available) would argue strongly in favor of trying the drug first on doctors, and specifically doctors who understand how much of the normal testing process was being bypassed, and what that meant.

Julia Belluz deflates the ZMapp hype, pointing out that just because the two Americans who received the drug appear to be doing well so far, that doesn’t prove anything about its efficacy:

[T]his drug has never undergone testing in people, only monkeys. The data on the efficacy of ZMapp in monkeys has never even been published. Studies on similar drugs are not entirely confidence inducing, either. In this study, two of the four monkeys given monoclonal antibodies 48 hours after exposure to Ebola survived. In this second study, the animals had a 43 percent survival rate when given the drug cocktail after the onset of symptoms. So even though the treatment of monoclonal antibodies decreased the mortality rate — if given close to exposure of the illness —  scientists haven’t moved past these tiny animal studies to testing in actual people.

Mapp Biopharmaceuticals is also just one of some 25 labs in seven countries working on these antibody cocktails for Ebola, and none of them have entered a phase one trial in humans, according to the journal Science. For this reason Dr. Martin Hirsch, a Harvard virologist, told Vox, “It’s too premature to say that the patients being treated miraculously improved.”

Olga Khazan explains why scientists are looking for an ebola treatment rather than a vaccine:

Vaccines don’t work that well in fast-moving epidemics. There are a few things you can do with a vaccine once an outbreak starts. One is immunizing healthcare workers and the families of infected patients. Sometimes doctors try “ring vaccination,” or targeting residents of villages on the perimeter of the outbreak in an attempt to isolate and quash it.

But most vaccines take a few weeks to provide immunity, and even then, they don’t always control the disease’s spread. Donald Allegra, chair of infection control at Newton Medical Center in New Jersey, remembers trying to halt the advance of measles in a Cambodian refugee camp in the 1970s. “We vaccinated 10,000 kids, but didn’t have an effect on the outbreak,” he said. “Vaccines and acute outbreaks don’t work very well together.”