The Sunshine Project
Biosafety Bites (v.2) #14 (6 June 2006)

 

Cowboy BSL-4 in Texas Thumbs its Nose at the NIH Guidelines and the NIH Office of Biotechnology Activities

The Southwest Foundation for Biomedical Research (SFBR) in San Antonio, Texas (http://www.sfbr.org) has BSL-4 containment, thousands of primates, and some of the world's most dangerous viruses, such as Ebola and Lassa (1). Founded in 1941 by a Yale-educated oil tycoon whose other scientific endeavors included a search for the Abominable Snowman (a.k.a. Bigfoot) (2), SFBR is something of a receptacle for biomedical research that can't find a place at other institutions, especially those more squarely in the public eye. This is especially true of SFBR's relationship with the University of Texas System.

SFBR does dirty work for other labs, including dangerous experiments challenging animals with anthrax spores (3) and controversial projects such as sequencing indigenous peoples' DNA (4), testing their medicinal plants (5), and making genetically engineered monkeys (6).

If SFBR's official agenda wasn't controversial enough, it also conducts secret government biological projects that the public will never learn about. SFBR's biolabs are ringed with razor wire and have government clearance for classified research. "Many of the staff possess security clearances and have considerable experience in classified research and collaborations with national defense agencies." wrote its President in 2002 (7). SFBR also wants the Department of Homeland Security's proposed National Bio and Agro-Defense Facility (NBAF), a gigantic new 30 acre (12 ha) biodefense BSL-4 complex.

SFBR employs 400 and receives millions of dollars in federal biomedical grants every year, including participation in a National Institutes of Health (NIH) biodefense "Center of Excellence". It keeps the Bigfoot tradition alive with over 6,000 penned chimpanzees, baboons, macaques, and other primates, who alone receive about $6 million in NIH funding each year for their upkeep.

Despite its BSL-4 lab and extensive research involving biological weapons agents, SFBR refuses to comply with the NIH Guidelines on Research Involving Recombinant DNA Molecules, the allegedly obligatory federal system that requires the establishment and operation of Institutional Biosafety Committees (IBC) to ensure the safety of biotechnology research. In fact, SFBR cannot - or will not - produce any real evidence that its IBC exists and fulfills its obligations.

The Sunshine Project first requested SFBR's IBC minutes, which it is required to make available to the public, in January 2004. SFBR did not reply. We requested SFBR's minutes again in May 2004. It replied by saying that it had none and that its IBC could be inactive for years between meetings.

Initially incredulous that SFBR could be so nonchalant about its IBC, the Sunshine Project sought clarification in letters sent in June and July 2004, which requested IBC minutes of all meetings since the end of 1999. In July 2004, SFBR replied with what it says is the entirety of its IBC "minutes", including discussions, for a period of four and a half years. It consists of a list of project titles that fit on a single page of paper. SFBR could not name any date on which its IBC had met. The entirety of its correspondence with the NIH Office of Biotechnology Activities (OBA) in this 4 1/2 year period was one letter consisting of two sentences (and no substance).

Having determined that SFBR's IBC was not exercising its responsibilities and was obviously noncompliant with the NIH Guidelines, on 29 July 2004, the Sunshine Project filed a complaint against SFBR with the NIH Office of Biotechnology Activities. Nearly a year later, on 1 July 2005, the Sunshine Project was assured by the Director of NIH OBA that the complaint had been acted upon.(8)

In March 2006, the Sunshine Project requested the SFBR IBC minutes again. In reply, SFBR sent another page of paper, containing the titles of four projects and the names of eight persons on its IBC. This allegedly reflected all IBC activity from 8 July 2004 through 13 April 2006. As with its 2004 reply, there is no significant reflection of any actual IBC meeting(s), protocol review, laboratory safety review, discussion of safety incidents and response, consideration of dual-use aspects of research, or any other biosafety business.

In sum, one of the only BSL-4 laboratories in the US, a player in biodefense studies, and a magnet for research that walks safety and ethical tightropes simply does not care about compliance with the NIH Guidelines. The Sunshine Project has once complained about this situation to NIH OBA and has been assured that the complaint was acted upon. Yet follow-up revealed no improvement in disclosure by SFBR and no indication that its IBC is anything more than a paper committee - a signature mill designed to generate a false impression of compliance with the NIH Guidelines.

The sad state of SFBR's IBC and the apparent inability (or disinterest) on the part of NIH in bringing about its compliance with the NIH Guidelines is more evidence of the failure of the Asilomar system and that scientific self-regulation is a dangerous approach to address the risks of dual-use biological research.

Before publishing this article, the Sunshine Project was contacted by the SFBR President, Anthony Infante. While Dr. Infante told the Sunshine Project that SFBR is seeking the NBAF facility; he said "Before I tell you more I need to know who you are and how you may be able to help us." (9) The Sunshine Project was not interested in helping SFBR, however, we offered the President the opportunity to improve upon his IBC Chair's response to our requests for minutes. No further correspondence was received from Dr. Infante or his staff.

NOTES AND SOURCES

(1) SFBR. NIH Establishes Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research (4 Sep 2003), URL: http://www.sfbr.org/pages/news_release_detail.php?id=40

(2) Bigfoot, or the Abominable Snowman (also known as Yeti), is said to be a kind of 3 meter tall hairy humanoid that inhabits remote
regions of the world. The SFBR founder also spent time chasing the Loch Ness Monster in Scotland.

(3) Interestingly, this anthrax work - which seeks treatments for antibiotic resistant anthrax - is conducted at BSL-4, rather than BSL-3, the containment level at which anthrax is normally handled. This suggests that SFBR's anthrax has unusual properties. Source: Cost-Reimbursable Consortium Agreement #UTA03-545 Between The University of Texas at Austin And Southwest Foundation for Biomedical Research, dated April 2003 with April 2004 addendum, URL: http://www.cbwtransparency.org/archive/sfbrbsl4anthrax.pdf

(4) SFBR works in several studies involving indigenous peoples' DNA, including the NIH-funded Strong Heart Family Study (Arizona, Oklahoma, and the Dakotas) and studies at Zuni Pueblo, New Mexico. A comprehensive search would likely reveal other projects.

(5) Through a connection with the Soejarto lab at the University of Illinois - Chicago, SFBR obtained access to large collection of indigenous peoples' medicinal plants, which it has proposed to screen as potential sources of biodefense drugs.

(6) SFBR operates an NIH-funded primate gene therapy core in collaboration with the Baylor School of Medicine. Another researcher working at SFBR, with an appointment at the University of Texas Health Science Center in San Antonio, is seeking to manipulate sperm and eggs to genetically-engineer baboons.

(7) Ledford, F (former SFBR President). Letter of Commitment from Southwest Foundation for Biomedical Research (re: Regional Center of Excellence in Biodefense and Emerging Infectious Diseases), 13 Nov 2002, URL: http://www.cbwtransparency.org/archive/swfbrlet.pdf

(8) Personal communication with Dr. Amy Patterson, Director, NIH OBA, 1 Jul 2005.

(9) E-mails with Dr. Anthony Infante, President, SFBR, 1 May and 8 May 2006.

Letters from Robert Lanford, Chair, SFBR IBC, and purported IBC minutes provided, letters dated 4 Jun 2004, 8 July 2004, and 13 Apr 2006.