Wednesday, November 16, 2005

Faith-based vaccines

Given the completely incompetent handling of the yearly flu vaccine supply by the FDA and CDC, the idea of a single federal agency responsible for developing potential vaccines (oh, yes, and also countermeasures for use in case of a bioterrorist attack; sigh) sounds like a good idea. Pushed by Republican Senator Richard Burr of North Carolina in a bill for a Biomedical Advanced Research and Development Agency (BARDA), the proposed new agency is problematic. We think. If it happens, we doubt we'll know. Because its operations will be under wraps:
"I am not aware of any agency that has the full FOIA (Freedom of Information Act) exemption, even the CIA," said Mark Tapscott, the director of the Center for Media and Public Policy at the Heritage Foundation.

"What do they think they will be doing that will not be covered by the exemptions that the CIA has in place?" he said. "There needs to be a detailed explanation for why."

The agency would report directly to the Secretary of Health and Human Services, would receive a full exemption from the Freedom of Information Act, and would offer limited liability to companies that manufacture drugs that could be used in the event of an attack. (Winston-Salem Journal)
Why? National security? Nope.
Drug companies say they need to be free of public scrutiny to protect their research.

"The confidentiality is not meant to hide untoward results," said George Painter, the president and CEO of Chimerix Inc., a biotechnology company, based in Research Triangle Park, that is working on a smallpox vaccine, among others.

"To immediately have that information available would be harmful to a company because their competition could immediately get ahold of the work that's been done," he said.

Painter added that investors would be reluctant to pay for the work if they were not assured it would be protected from other companies usurping the results for free.
So if there is an emergency, we'll just have to "take our medicine," informed or not. Not to worry:
Doug Heye, a spokesman for Burr, said that the FOIA exemption was not automatic. It would only be used in limited circumstances, and the people making the decision would all be public officials.

"The exemption is for limited situations for proprietary use or national-security concerns that would make it necessary," Heye said.
Oh, they'll all be public officials. Why didn't you say so? Until they go to work for the pharmaceutical industry, anyway.

And there will also be immunity from liability if the drugs are made following FDA guidelines and in "good faith." Bad actors need not apply. But without oversight, how will be know if guidelines are being followed and good faith pursued? We'll just have to trust everyone concerned: the drug companies, the public officials, the drug company execs who are former public officials, the public officials who are used to be drug company execs.

That sounds fair.