The FDA Is on the Verge of Approving the First Drug Treatment for Radiation Poisoning

On Friday, the FDA will discuss whether it is comfortable recommending a blood-boosting drug to treat people who survive a nuclear meltdown or atomic war.

The National Institutes of Health thinks it may have found a "medical countermeasure" to radiation poisoning and an FDA advisory committee is reviewing its claims. It's the first time a committee has considered stamping the FDA seal of approval on a possible cure for radiation exposure, according to a briefing on the upcoming meeting.

"The FDA-approval of a product for use in a radiological/nuclear setting will facilitate access to this product in the event of such an emergency," the advisory committee says in the briefing. That's agency speak for "We might be onto something."

The agency's interest stems from a recent NIH report on filgrastim, a drug used to boost white blood cells in cancer patients receiving chemotherapy. The report showed that 19 of 24 monkeys injected with filgrastim survived radiation exposure for 60 days, compared to nine who survived without the drug.

We all experience that moment walking through the body scanners at the airport or undergoing X-rays at the hospital, where our knowledge of the perils of radiation exposure triggers an imaginary sensation in our skin, intimating that we're being beamed with poison rays down to our marrow. There's a fear that standing close to the microwave, laying in a tanning bed, or using cell phones will leave us with brain tumors, translucent skin, or warped sperm or eggs.

But the radiation we absorb in those circumstances is relatively harmless—or at least it's not enough to cause radiation sickness—according to the Mayo Clinic. The bigger worries right now are either exposure from a post-proliferation dirty bomb—or, you know, Iran or North Korea could lose their marbles and go nuclear.

On a more positive note, there appears to be a new groundswell in interest in nuclear power, with China and India heavily invested in new technologies, and with researchers now saying that nuclear power has saved 1.8 million lives due to its negligible effect on climate change. Meltdowns are exceedingly rare, but having a new class of radiation-fighting drug could help ease the stigma of nuclear power her in the US.

At the moment, our best bet for surviving radiation poisoning involves a combination of antibiotics and blood transfusions. It's essentially the broad therapy approach we apply to a lot of the nastiest biological diseases we don't quite have a handle on. With radiation sickness, treatment is even more vital, since symptoms typically start presenting within 24 hours of exposure.

DARPA is developing a treatment based on a bactericidal/permeability-increasing protein to reinforce antibiotics. So we should be excited at the possibility of being able to deploy a well stocked drug to treat the nightmares that accompany radiation exposure. (Neulasta, a version of filgrastim marketed by Amgen and the company's 2nd best-selling drug, and Neupogen combined for $5.4 billion in sales in 2012.)

With most drugs or therapies the FDA is priming for use in humans, the next step in the process—after primates—is a round of clinical trials involving real people. The problem with filgrastim is that you would have to submit people to toxic and potentially deadly amounts of radiation before testing a treatment, and the agency isn't willing to go quite that far.

In these situations, the FDA relies on what it appropriately calls "the Animal Rule," which refers to a regulation that prohibits human testing in cases that are not "ethical or feasible." But we're not just relying on the monkeys. The availability of a potentially life-saving remedy could hinge on the advisory committee members and their discussion.