Ebola fuels debate over speeding up trials for experimental drugs

One day after the U.S. announced a military-led approach to combating Ebola, lawmakers on Wednesday urged federal health officials to speed up its clinical response to the crisis.

Rep. Michael Burgess (R-Texas) demanded to know why the Food and Drug Administration (FDA) was not allowing clinical trials of certain experimental drugs, such as TKM-Ebola.

{mosads}“I’m still bewildered as to why TKM-Ebola has this hold,” Burgess said during a hearing of the House Foreign Relations subcommittee on Africa. “Instead of clinical holds, let’s talk about clinical trials. Let’s talk about making things available,” he added.

Burgess said while the success of the drugs remains inconclusive, some treatments had helped heal American doctor Kent Brantly, who sat just steps away from him at the hearing. “Even Mr. Brantly took a risk,” Burgess, who is a medical doctor, said.

But Rep. Betty McCollum (D-Minn.) warned against turning Africa into “a testing ground” with drugs that haven’t been properly vetted.

“I know there’s a lot of pressure, but I, for one, think we need to follow the science,” she said. She added that an untested vaccine could “discredit” U.S. efforts to combat the disease and make people more fearful across the affected areas.

Luciana Borio, director of the FDA’s office of counterterrorism and emerging threats, defended the agency’s “unprecedented” effort to handle new drug applications to fight Ebola. She said some were reviewed in just days, which had set agency records. 

“There’s no question in my mind that it’s all hands on deck and everybody is very aware of the gravity of the situation and very determined to do all that they can,” Borio said.

One experimental vaccine began human testing at the National Institutes of Health this month, and is now more than halfway through the trial.

Rep. Chris Smith (R-N.J.) said he was also “shocked” to learn the clinical trials were not allowed to proceed.

“With just two or three drugs in the pipeline, that’s not a large universe,” he said.

Smith also urged stronger action to care for the thousands of health workers who have fallen ill, which he called “one of the untold problems” of the epidemic. 

“A lack of faith in national or international systems has impeded many African health workers,” Smith said. “People on the frontline are dying, as well as their families.”