One More Screwup

by hilzoy

From the Washington Post:

"Federal health officials yesterday scuttled the largest piece of the Bush administration's two-year program to counter bioterrorism, canceling an $877.5 million contract with VaxGen to develop an anthrax vaccine after the company missed a deadline to begin human testing.

The decision, delivered in a one-page letter, ends a troubled effort by the small California firm that has come to symbolize the failures of the government's ambitious $5.6 billion Project BioShield. The termination occurred on the same day President Bush signed legislation attempting to salvage the program by reorganizing its management and pumping more money into firms doing the work. (...)

VaxGen was picked for the project in 2004 despite having never successfully produced a drug. It was known for a failed attempt at an AIDS vaccine, and the company has had accounting and management problems, which caused it be delisted from the Nasdaq Stock Market.

In signing on to develop an anthrax vaccine, the company agreed to meet the government's aggressive timetable, producing a drug in five years, half the industry standard for such a product. VaxGen was to be paid as it began delivering the 75 million doses to the government, enough for 25 million people, roughly the equivalent of the population in the New York and Washington areas combined.

But VaxGen struggled from the beginning. The product's expected delivery was delayed two years as the company attempted to improve the vaccine's potency and reliability. In November, the company suffered another blow when the Food and Drug Administration refused to allow the firm to begin human testing because of those long-standing concerns."

When you pick a company that has never successfully produced a drug and has serious accounting and management problems and then throw hundreds of millions of dollars at it, it shouldn't be surprising that bad things happen. That our government has been doing this sort of thing is just one more reason why we need Congressional oversight.

It's also worth noting that there were several approaches that the government could have taken to deal with the threat of bioterrorism. One would have been to really try to beef up our public health infrastructure, which has been underfunded for decades. Another would have been to try to develop vaccines or treatments to deal with specific agents that might be used in bioterrorist attacks. The first has a number of real advantages over the second. It puts us in a better position to respond to any bioterrorist attack, not just an attack using specific pathogens. Moreover, it has significant ancillary benefits, like allowing us to respond more effectively to outbreaks of disease that are not caused by bioterrorist attacks. Finally, it involves a lot less risk of pinning our hopes on one big project that ultimately fails, both because improving our public health system involves a lot of smallish projects, not a few big ones, and because, for the most part, those projects involve doing things we already know how to do.

Ideally, the government ought to pursue both approaches. It should strengthen our public health system while developing and stockpiling treatments and vaccines for pathogens that seem likely to be used by bioterrorists, if those treatments exist and are cost-effective. But if it has to pick one to concentrate on, I'd go with the first every time. Our government, naturally, chose the second, and while it may or may not have been foreseeable that this particular project would fail, the risk of big expensive projects failing is a completely foreseeable consequence of this strategy.

Comments

[Model 62]

Ehh, so why was VaxGen picked in the first place?

[Model 62]

Not much of an explanation (a suggestion of cronyism), but here's a little more from Harpers.

[Ugh]

Failure? What are you talking about? The gov't returned millions and millions of dollars to the private sector, it's like a tax cut only you don't have to mess with the tax code.

[cleek]

i blame the media. by not telling us all the good things the Bush administration has done, they allowed us to ignore the failures... and now it's too late, and VaxGen's owners are rich!

[Slartibartfast]

Wow. Nearly a billion dollars to develop an anthrax vaccine. I just have to get myself into the biotech market.

[idlemind]

Just as improving the public health system to handle epidemics better also improves our ability to handle bioterrorism, improving our response to natural disasters also improves our ability to handle non-biological terrorism. We all know how well that has gone.

[Sebastian Holsclaw]

Isn't this story really about the wisdom of letting the government try to nose its way too far into the creation of pharmaceuticals?

:)

Just kidding. Sort of.

[cleek]

Isn't this story really about the wisdom of letting the government try to nose its way too far into the creation of pharmaceuticals?

no, it's about putting a stake through the heart of one of the right-wing's cherished zombie myths.

not kidding. mostly.

:)

[cleek]

heh. oops. pretend mine and Sebastian's comments were both on the thread below. mine makes more sense that way :)

[Ugh]

heh. oops. pretend mine and Sebastian's comments were both on the thread below. mine makes more sense that way :)

I blame that "typepad" fellow.

[Urinated State of America]

"When you pick a company that has never successfully produced a drug"

Actually, most biotech companies have never produced a drug.

Vaxgen was originally a spin-out of Genentech, and mostly staffed by ex-Genentech and Amgen employees. Most vaccine production is based on 1950s technology, with little- to no- purification of the product. Vaxgen's process was going to produce 95% pure vaccine, as opposed to the 30% pure current vaccine: less crud to cause side effects. Why FDA were beating them up over stability when the alternative vaccine was so poor I don't know.

"and has serious accounting and management problems and then throw hundreds of millions of dollars at it, it shouldn't be surprising that bad things happen."

Well, DHHS set an almost ludicrous schedule for development - 5 years for delivery versus the ~8-10 years for a typical biotherapeutic. But when Vaxgen went for the contract it was right after their HIV vaccine failed, and they were hungry.

I think the subtext of this is the rivalry between the producer of the previous, non-recombinant vaccine, Bioport, and Vaxgen.

"One would have been to really try to beef up our public health infrastructure, which has been underfunded for decades. Another would have been to try to develop vaccines or treatments to deal with specific agents that might be used in bioterrorist attacks."

I'm curious what exactly you expect the public health infrastructure to respond with if it doesn't have specific treatments or prophylactics against a biologic attack.