In Ebola Outbreak, Doctors Appear to Ignore FDA on Experimental Drugs

I stopped watching movies for a couple years after seeing Outbreak (1995) in the theatres. What did it was a scene of a character infected with an airborne Ebola-like disease coughing away in a movie theatre – the filmmakers zooming in on the germs as they spread among the audience. Even though Ebola is not airborne, that scene still freaked me out considerably and kept me from movie theatres for years. (However, I do still enjoy the J.T. Walsh scene where he insists that even infected Americans deserve due process.)

Ebola freaks us all out, as a horrific and highly infectious disease with an 80 percent mortality should. The current outbreak in Guinea, Liberia, and Sierra Leone has killed 887 people so far, and wide coverage has been given to stories about an infected woman breaking quarantine, an infected man collapsing at the Lagos Airport before flying to Minneapolis, and an uninfected woman collapsing in London after a flight from Africa. Donald Trump wormed his way into the news cycle by denouncing the decision to bring two infected Americans home for treatment here.

We learned yesterday that the treatment worked – Dr. Kent Brantly is now walking around and Nancy Writebol has seen “significant improvement.” The treatment is a serum called ZMapp, derived from injecting mice with Ebola protein coding and harvesting the resultant antibodies. ZMapp had shown success with monkeys, but it has not gone through the Food and Drug Administration’s laborious three-phase approval process and is therefore not approved for use on humans.

The FDA has put human trials on a different Ebola drug by rival pharmaceutical company Tekmira on hold, demanding more paperwork on how the drug works. (Their stock is down on the ZMapp news.) All told, under normal circumstances it takes a pharmaceutical company around twelve years to navigate the FDA process from application to market. The FDA’s goal is to avoid negative publicity about a dangerous drug killing Americans, so it tests and tests and tests.

Anyone who watched last fall’s Oscar-winning movie Dallas Buyers’ Club knows that a decade of scrupulous FDA testing while people die isn’t always popular. In that movie, AIDS patients in the 1980s unsuccessfully battle the FDA for the right to access drugs still trapped in the FDA approval process. The episode bruised the FDA and led them to adopt a “compassionate use” regulation, allowing patients to access life-saving but unapproved drugs after a laborious application process (albeit less laborious than the drug approval process). About 1,200 people a year take drugs under the regulation.

And yet that’s doesn’t seem to be what happened here. News accounts suggest that the National Institutes for Health (NIH), the Centers for Disease Control (CDC), and/or the manufacturer simply ignored the FDA. Dr. Sanjay Gupta at CNN marvels how fast it all happened:

Getting approval for compassionate use is often long and laborious, but in the case of Brantly and Writebol, they received the medication within seven to 10 days of their exposure to the Ebola virus.

The NIH explained the process of how the serum was given to the two Americans, without one mention of FDA approval:

Samaritan’s Purse contacted CDC officials in Liberia to discuss the status of various experimental treatments that they had identified via a search from the literature. CDC officials referred them to an NIH scientist who was on the ground in West Africa assisting with outbreak response efforts and broadly familiar with the various experimental treatment candidates.

The scientist was able to informally answer some questions and referred them to appropriate company contacts to pursue their interest in obtaining experimental product.  She was not officially representing NIH and NIH did not have an official role in procuring, transporting, approving, or administering the experimental products administered to the two U.S. patients.

No one is willing to say that they just ignored the FDA, for obvious reasons. A pharmaceutical company that earns the ire of the FDA for even a trivial reason might as well close its doors. But if doctors who know the disease, perhaps with the silent approval of NIH and the CDC, acted to save lives by defying FDA rules, kudos to them. This case is probably too high-profile for the FDA to march in, confiscate the drugs, and arrest everyone involved (as they do on an almost weekly basis).

This case is exceptional. It should be less so.