Biodefense research in the United States – in terms of its funding and management – is a spider web of sorts, and it’s not easy for bidoefense drugs to get on the market.
“It’s very complicated because multiple government agencies are funding biodefense research with a variety of actors with labs, including corporations, non-profits, government-owned labs, universities, etc,” Project on Government Oversight spokesperson Joe Newman said in an e-mail. “Even getting a clear and accurate inventory of the number of labs with access to select agents is difficult.”
On its website, the Oversight group says the biodefense budget has increased some twenty-fold in the past decade. This raises a concern among members of that watchdog group.
“This biodefense response, if not overseen properly, may actually exacerbate the chances of accidental or intentional infection,” the group concludes.
That line of thinking – that more funding actually increases our chances of a bioterrorist strike – comes from Richard H. Ebright, a researcher at the Waksman Institute of Microbiology at Rutgers University in New Jersey. A Pro Publica article from December 2008 discussed Ebright’s concerns. He has publicly suggested that it would take just one post-graduate student with bad intentions working in a research lab to release a bioweapon.
Aside from safety issues in biosafety labs, a speech delivered several weeks ago by a prominent Biotechnology officer charges the government with a lack of cohesiveness among agencies with a hand in biodefense.
Speaking on behalf of the Biotechnology Industry Organization in front of the Congressional subcommittee responsible for emergency preparedness, Phyllis Arthur said:
“The lack of full integration across the Enterprise, especially as it pertains to the approval process for countermeasures, has, in several instances, led to significant delays and new regulatory actions by companies in order to achieve licensure for a product.”
It’s difficult for biotechnology companies to get a product approved, but it’s not necessarily because of government delay.
“For most drugs, the safety threshold is extremely high,” president of the International Security and Bio Policy Institute, Barry Kellman said. If there are side effects, the FDA won’t clear a drug and that’s for public safety reasons.
Two other reasons why it’s difficult to get medical countermeasures approved: There’s no market for biodefense drugs and thus little incentive for pharmaceutical companies to invest in them. Also, it’s considered unethical to test the drugs on a human population (imagine the bio-ethical concerns in releasing anthrax to test a medical countermeasure).
“You have to use alternative means of showing that a drug works,” Kellman said.
The FDA will approve a drug for the market if testing it on an animal is the only ethical way of doing so. However, as Managing Director of Health Care for the Government Accountability Office Cynthia Bascetta acknowledged in a recent testimony in front of Congress:
“Animals that manifest the disease in the same way as humans may not always exist.”
Think smallpox, a virus that only occurs in humans. Monkeypox is related to it, but not similar enough to make the case that a cure for monkeypox would work in the same way as a smallpox biodefense drug.
The Government Accountability Office acknowledges challenges exist in developing and acquiring medical countermeasures. That seems to be the underlying consensus among experts, which leaves public health and safety at a crossroads.
“It would help if there was a reduction in the number of agencies funding this kind of research, better accounting of the research going on, and if one agency was designated as the ‘biodefense executive’ with authority to coordinate biodefense efforts across the government,” said Newman, of the Project on Government Oversight.
