Are you thinking of the Ebola outbreak as a flash in the pan, a problem we’ve outdistanced? Think again: Ebola virus and other emerging infectious diseases for which we don’t have effective treatments are the reality in public health. And they’re expected to keep on coming.
“This is the new normal,” says Luciana Borio, the Food and Drug Administration’s Assistant Commissioner for Counter-terrorism Policy. “It’s not going to go away. We keep seeing now one infectious disease emerge after another.”
I sat down with Borio, Ed Cox, director of the FDA’s Office of Microbial Products, and more than 100 entrepreneurs, researchers, and business people last night at the Forbes Healthcare Summit to talk about the key question for combating all these germs: how do we test drugs to kill them, and vaccines to prevent them from ever entering our bodies?
It’s a thorny question, but that’s not the only reason we’re shouting in the video I’ve embedded in this post. The din of the cocktail party was deafening. Luckily, the microphones picked up our conversation with perfect clarity, and you can hear us better than the people in the room could.
Last night, Borio and Cox published an article in the New England Journal of Medicine arguing that despite the hopes of some public health experts, both vaccines and drugs will need to be tested against control groups that include a placebo. It’s key guidance for vaccine makers like Johnson & Johnson JNJ +0.88%, GlaxoSmithkline, and Inovio, and for the many companies looking to test Ebola treatments including Mapp Pharmaceutical and Chimerix.
I challenged the regulators: if Ebola virus disease is so very deadly, why do we need control groups?
One reason, Cox said, is that what’s called supportive care – fluid replacement, electrolytes, support with blood products when that’s possible – seems to be very effective, effective enough to make it hard to tell whether it’s the drug or the supportive care that is helping. And ethically, patients in a study would get that. “It’s really not placebo per se, but it’s the best available standard of care that patients would receive in a clinical trial,” Cox said.
With vaccines, the need to have a control group is even greater, Borio said. In Liberia, the number of Ebola cases is going down. If vaccines had been widely distributed a few months ago without employing a control group, we’d be attributing that decrease to those vaccines.
“It’s really imperative to be able to use those limited supplies of vaccine doses in a way that will allow us to learn if they’re safe and effective for this outbreak and for generations to come – because future outbreaks will occur,” she said.
But if supportive care is so great, why not get that to the people suffering and dying in West Africa, instead of making this a research project? That’s what Jonathan Bush, the co-founder and chief executive of electronic records firm AthenaHealth, wanted to know.
“Guys, it seems to me that when we give people the standard of care they actually mostly live,” Bush said. “You give somebody the six liters of fluid that they’re blasting out of themselves for long enough then we win and Ebola loses.”
Borio responded: “I think it is something that’s on the President’s agenda for global health security. But the reality is that delivering care to patients in those settings is extraordinarily challenging.”
It’s one of those scary, heart-rending health care facts: the best chance for some patients in West Africa to get the care that we know works could be to end up in a clinical trial being run by multinational drug companies.