Original URL: http://www.theregister.co.uk/2007/12/07/bioterror_gold_rush/

It's not too late to join the bioterror gold rush

Follow the money

By George Smith, Dick Destiny

Posted in Science, 7th December 2007 12:07 GMT

Analysis "If ramping up fear among American's about the threat of biological warfare was intended, in part, to drum up support for biodefense spending - as some conspiracy buffs theorize - then the downside is that accidents may result in an overreaction in the public and the media," reported The Fort Worth Star Telegram in a business story a couple months back.

The piece in question was eminently pro-business, written from the point of view that all bioterror research was good. Anyone who questioned the scope of it was a bit misinformed. The only critic was Edward Hammond of the Sunshine Project, based in Texas.

Hammond had obtained documentation from Texas A&M University's biodefense research facility and published it. This work revealed accidents in the labs: the release of Brucella bacteria, which caused illness in one research assistant, and exposure to the agent which causes Q fever, causing immune responses, but no illness, in three others. As a result, the Centers for Disease Control moved in, investigated, and then suspended biodefense research at the school.

What was left out of the article was that Hammond's Sunshine Project mailing list had been reporting for some time prior to the Texas A&M incidents - entrenched secrecy and general unwillingness to submit to oversight on the part of the growing number of US university laboratories involved in biodefense research.

The newspaper asked whether Hammond's point - "that the greatest threat is not going to be a guy in a turban but in our own biochemical lab" - was valid or if he was "an overzealous self-appointed whistleblower..."

The rest of the article furnished statements only from scientists with vested interests in promoting biodefense research. They offered flavors of the famous excuse from Dr Strangelove in which Buck Turgidson defensively responds to the president's denunciation of the Air Force's failure to screen out psychotics: "I don't think it's fair to condemn a whole program for a single slip-up, sir."

Ronald Kendall, a scientist at Texas Tech, was corralled by the Ft Worth paper to say the Texas A&M incidents were "unfortunate" and that it was "a barometer of society that when an organization or university makes a mistake, we're all lumped together".

Support for such a view hinged on everyone accepting the accidents at Texas A&M as isolated occurrences. That was tossed into the wastebin by news a month later, in early October, that lab accidents in the academic biodefense research community were more commonplace.

According to AP, there were 36 secret accidents and lost shipments in 2007, 100 accidents and missing shipments with more being investigated in total, since 2003.

The news of routine mishaps and lack of accountability was clustered around an investigative hearing into such matters before the Subcommittee on Oversight and Investigations/Committee on Energy and Commerce in the House of Representatives.

For its part at the hearing, the biodefense research academy contributed only pro forma mouthpieces: Eddie Davis, the interim president of Texas A&M, the school in the hot seat; and Gigi Kwik Gronvall from the University of Pittsburgh's Center for Biosecurity.

The most pressing observations from the session did not emanate from them.

Instead it was left to Keith Rhodes of the Government Accounting Office and others, including Hammond, to show that biodefense in academia was going through a large and unmonitored boom, with high-containment labs being added across the country in anticipation of future work. And the expansion has not yet peaked.

"No single agency has the mission to track and determine the risk associated with the expansion of [high containment] labs in the United States and no single federal agency knows how many such labs there are," wrote Rhodes in a GAO report offered as print testimony. "[No] one is responsible for the aggregate risks associated with the expansion of these high-containment labs."

If you follow press releases from universities and the private sector, much of the boom is built upon the simple pursuit of grants - free money. It is a biotech gold rush in the war on terror.

The promoters of the boom, like Kendall at Texas Tech, brush aside criticisms that it is an overreaction in the war on terror or a bald-faced money grab. "[The] consensus of 16 intelligence agencies is that there is a high level of threat from an attack," he told the Ft Worth newspaper.

One rebuttal is that the "16 national intelligence agencies" have not had an especially good track record in threat assessment from the war on terror.

Another conclusion drawn from the anti-terror gold rush is that the pure expansion in number of labs handling agents of interest to bioterrorists will (1), expose more lab workers to their potential for serious infection, and: (2) increase the profile and number of repositories from which the agents can be diverted by insiders. The additional risk of a boffin within the biodefense academy going to the dark side cannot be estimated with any certainty, although it is not a zero chance.

One aspect of the biodefense boom not often discussed is that some of the investments are simply poor ones or the bankrolling of junky science.

For one example, George Mason University's federally funded National Center of Biodefense, one equipped with a high-containment Biosafety Level 4 lab, cracked up in 2006-2007.

Founded by Ken Alibek, the world famous defector from the old Soviet Union's biowarfare program, Alibek resigned in late 2006, after internal acrimony over teaching responsibilities and research.

Although little has come from George Mason's research in biodefense, the school did appear to turn into a diploma mill of sorts, one for biodefense, awarding 13 PhDs on the subject. It also became a recycler for two high profile scientists formerly embroiled in a conflict-of-interest scandal at the National Institutes of Health and Food and Drug Adminstration, now fallen to minor biodefense research.

Since the biodefense boom is seen to be where the money is, following resuscitation of orphan drugs, formerly thrown out after testing in peer-reviewed studies, becomes interesting.

One such case recent is that of IM862, a dipetide compound of two amino acids, which was briefly a cause for excitement around the turn of the century because it was thought to have anti-cancer potential. IM862 inhibited the formation of new blood vessels from pre-existing ones, known as angiogenesis, a necessity for growth of tumors. Many were interested in its potential for treating things like ovarian cancer.

A company called Cytran banked on the compound and clinical trials were started. The scientific literature subsequently shows IM862 was ineffective as an anti-cancer agent, doing nothing in tests against renal cell carcinoma and even hastening progression of disease in one study of its use in Kaposi's Sarcoma afflicted AIDS patients. Cytran had spent 11 years and $50m on IM862, declaring bankruptcy almost immediately upon result of the bad news. Its intellectual property was sold off in a fire sale held for creditors.

However, in the defense establishment it sometimes appears convenient to throw out negative results in search of slim reeds for biodefense.

Im862 has been reborn as glufanide disodium (or oglufanide disodium), potential bioterror defender. The Defense Threat Reduction Agency (DTRA), as part of the free money-dispensing machinery in the boom, awarded an Australian firm, Implicit Biosciences, $18.2m to look into the drug as a cure-all, specifically against the microbe which causes melioidosis, a disease similar to glanders. The eyebrow-raiser is the sudden morphing of a compound found ineffective against cancer in peer-reviewed clinical studies to one funded, in the seeming absence of good scientific rationale, for use as a bioterror silver bullet. The testing of IM862 is to be carried out jointly in Seattle with animals infected with various biowarfare agents.

So you think Aunt Minnie's special hangover remedy might have potential against bioterror? Uncle Sam wants to hear from you. ®

George Smith is a senior fellow at GlobalSecurity.org, a defense affairs think tank and public information group. At Dick Destiny, he blogs his way through chemical, biological, and nuclear terror hysteria, often by way of the contents of neighbourhood hardware stores.