The Sunshine Project
Biosafety Bites (v.2) #18 - 17 October 2006

AlphaVax IBC: It's Been Years Since We Met

Since 2002, AlphaVax (Research Triangle Park, North Carolina) has received approximately $42 million in National Institutes of Allergy and Infectious Disease research grants. All of them involve biotechnology, and much of the work requires BSL-3 containment due to its dangerous nature. But AlphaVax's Institutional Biosafety Committee (IBC) hasn't bothered to meet for almost three and a half years.

AlphaVax's noncompliant IBC practices are especially glaring considering that its core technology is to genetically modify Venezuelan Equine Encephalitis virus (VEE, a select agent) for use in vaccines. The modified VEE, which is typically produced at BSL-3, incorporates genetic bits and pieces of other biological weapons agents, including Ebola, Marburg, and smallpox viruses (1), as well as SARS and pandemic influenza. AlphaVax's virus "replicons" target the human immune system to elicit a response designed to protect against future exposure to such agents.

Privately held AlphaVax can't claim ignorance. Its President sits on the board of the Biotechnology Industry Organization (BIO). It is a promoter of the controversial BARDA bill, sponsored by Senator Richard Burr (R-NC). Pharmaceutical heavy-hitter Wyeth, which has vaccine operations in North Carolina, owns part of AlphaVax. So does University of North Carolina, as well as European investors. (2) Collaborators include defense contractor Southern Research Institute (SRI) (3) and the US Army's Ft. Detrick.

AlphaVax concedes that its IBC has not held a meeting since May 2003; (4) but the company maintains memoranda that state otherwise. Using a dubious practice that is not permitted by NIH, AlphaVax sends out (undisclosed) safety documents by e-mail and then writes a memo to the file that grants blanket IBC approval to projects that the committee does not meet to review. For example, on 12 July 2006, over three years after its last IBC meeting, AlphaVax recorded the following in a memo:

"On July 12th 2006, the AlphaVax Institutional Biosafety Committee met and reviewed your amendment to the recombinant DNA registration document entitled 'Registration Document for Recombinant DNA Studies' ... You may proceed with this work immediately." (5)

No meeting took place. Other memos were written in 2003 and 2004 for which no IBC meeting actually took place. (AlphaVax provided nothing dated 2005.)

Even when it did meet, the AlphaVax IBC was not a robust committee. At its first meeting, in February 2003, it reviewed what an IBC is and promptly approved all projects. At its only subsequent meeting in May 2003, it reviewed only one project, although two members were absent and some of the remaining 6 were conducting the research under review. At neither meeting is there any indication in the minutes that the IBC executed any other aspect of its biosafety responsibilities apart from approving protocols.

Despite a research agenda focused on genetic mélanges of select agents aimed at the immune system, in response to a question from the Sunshine Project, AlphaVax denied that there is a need for it to have policies to police dual-use biological research. In essence, AlphaVax says that because it is a vaccine company it is innately immune to dual-use concern (6), as if inserting the genes of hemorrhagic fever viruses into VEE and formulating the result for humans isn't worthy of biosecurity attention. AlphaVax's position fundamentally misunderstands or misconstrues arms control and federal concerns about dual-use research, including those of the National Academies.

Meanwhile at NIH

Over the past three and half years, did federal officials in charge of IBCs detect AlphaVax's noncompliant committee that has failed to properly oversee work involving genetic engineering of biological weapons agents? Of course not. NIH does not really monitor the activities of IBCs. In fact, when the Sunshine Project questioned the compliance of the AlphaVax IBC in e-mail correspondence, in its own defense AlphaVax sent a copy of a 4 August 2006 letter that it received from the NIH Office of Biotechnology Activities (OBA).

The letter exposes the charade that NIH oversight of IBCs really is. Although AlphaVax's IBC does not bother to meet, it sends an "annual report" to NIH. Such "annual reports" simply list the names of IBC members. In response, NIH issues a standard reply saying that the IBC is compliant with provisions of the NIH Guidelines and that NIH "appreciates our partnership in ensuring the safety of recombinant DNA research and invites you to contact us ... if we can be of assistance."

In other words, the federal government doesn't care what an IBC does, so long as there is a list of names.

What Else Lurks in the Private Sector?

Nobody knows. Despite the criticism of AlphaVax's noncompliant IBC in this Biosafety Bites, it should be noted that the company replies to inquiries, as required by the NIH Guidelines. There are many companies (and other institutions) that ignore requests for IBC records. These non-responsive companies could be hiding equally dysfunctional biosafety committees or even worse.

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(1) AlphaVax's smallpox vaccine research uses genetic material from Vaccinia virus that is very similar to sequences found in smallpox (Variola). Other work includes vaccines for VEE itself, as well as its encephalitis cousins WEE and EEE.

(2) Bayer, which manufactures human vaccines, is represented on AlphaVax's IBC (as a "community member"), suggesting that it may also have a stake in AlphaVax as the IBC may have access to research details that the company would not share with a potential competitor. The other "community member" on the IBC is a professor at North Carolina State University.

(3) SRI is the organization that failed to kill anthrax bacteria that it sent to California, resulting in a 2004 accident at an Oakland, CA children's research institute.

(4) "We have not had any meetings since 29 May 2003, therefore no new minutes are attached." (Letter from AlphaVax to the Sunshine Project, dated 18 April 2006; but receieved 12 October 2006.)

(5) Memo provided to the Sunshine Project by AlphaVax.

(6) The entire pertinent part of the AlphaVax response reads:

In response to your question: The AlphaVax IBC has not implemented written policies for the identification, review and oversight of research involving any of the seven categories of concern identified by the NAS in its report Biotechnology in an Age of Terrorism (the Fink Committee report). This is simply due to the fact that we do not engage in any of the types of experimentation that are listed of concern. AlphaVax is a vaccine company that is in business to develop and market effective vaccines against infectious disease agents and cancer, therefore experimentation conducted by the company's scientists would not fall under any of the seven categories listed in the report.