RELATED RESOURCES:
PDF: "Voluntary Compliance" - Original Letters from the Biotech Industry
Chart: 90% of Top Biotech Companies Don't ComplyThe Sunshine Project
News Release
18 April 2007
(info added, 19 April)
Earth Calling NSABB: Voluntary Compliance Won't Work
The record of voluntary compliance with NIH biotech guidelines is dismal.
18 of the top 20 US biotech companies don't comply with existing guidelines.
Sunshine Project backs contention with original letters from companies.
Biosecurity review of bioweapons agent and related research must be mandatory.
18 April 2007 -- Tomorrow, a working group of the National Science Advisory Board on Biosecurity (NSABB) will table critically flawed recommendations on managing the risks of dual-use research with biological weapons implications. The recommendations will have the result, which is entirely predictable, of not reigning in the biosecurity problems they purport to address.
A main reason? They are voluntary. Original documents from leading biotechnology companies are a devastating indictment of NSABB's proposed reliance on voluntary compliance to ensure that new federal dual-use research guidelines are actually followed.
Experience with the NIH Guidelines on genetic engineering research demonstrates that NSABB's recommendations for guidelines on dual-use research are doomed to fail because voluntary compliance typically means noncompliance. In fact, many institutions that are obligated to follow NIH's existing guidelines do not do so, a problem that the Sunshine Project has systematically documented since 2004. (For more information on general problems of noncompliance with the NIH Guidelines, please see the publications cited below.)
"One especially clear proof that NSABB's bioweapons recommendations are half-baked," says Sunshine Project Director Edward Hammond, "is the dismal rate of compliance with NIH's genetic engineering guidelines by the private sector." Since 2004, two unprecedented national surveys of compliance with the NIH Guidelines have revealed that so-called voluntary compliance is typically nothing but a ruse.
From the biggest biotech multinationals down to start-up gene boutiques, the vast majority of companies, as well as many non-profits and public institutions, do not comply with the NIH Guidelines (see chart). Important examples are summarized here, and this news release is accompanied online with link to a file (click here) that contains letters from some of the biggest names in biotechnology, all expressly stating that they do not obey the NIH Guidelines or view compliance with them as an on-again, off-again cherry picking exercise.
A system that half or more of its target members ignore is pointless. "NSABB is divorced from reality if its members believe that another set of voluntary NIH guidelines is sufficient, and would be remotely effective, at preventing dual-use disasters," says Hammond, "Effective federal management of dual-use risks requires making safety and security oversight truly mandatory and subject to the sobering light of public scrutiny. We shouldn't wait for a bioweapons disaster to protect ourselves from ourselves."
Examples: "Voluntary Compliance" with NIH Guidelines by the Biotech Industry
The DuPont Corporation, one of the world's largest biotechnology companies, has "deactivated our voluntary compliance with the NIH Guidelines," according to a letter it sent to the Sunshine Project on 26 October 2006.
Bristol-Myers Squibb, a major pharmaceutical multinational, does not comply with the NIH Guidelines, even though NIH says that it does. In a letter sent from its lawyer on 15 November 2006, the company emphatically demanded that the Sunshine Project delete from its website "any suggestion that Bristol Myers Squibb Company or its affiliated companies are subject to the NIH Guidelines" despite the fact that the "suggestion" was actually a list of allegedly NIH guidelines-compliant institutions provided by NIH itself.
Eli Lilly Corporation says that it voluntarily complies with the NIH Guidelines; but according to a letter it sent the Sunshine Project on 31 May 2006, voluntary compliance means that it can pick and choose when and where it wishes to comply, or not comply and, in the instant case, it chose not to comply.
According to NIH records, Genencor Corporation complies with the NIH Guidelines at sites in California and Iowa. We asked Genencor, and on 25 July 2006, it denied following the NIH Guidelines in Iowa and said that while its California operation "complies voluntarily," in actual fact, it was not complying with NIH rules at that time.
According to NIH, the Merck Corporation complies with its biotechnology guidelines at some but not all of its locations. The Sunshine Project has repeatedly asked the allegedly compliant Merck sites for minutes of the safety committees that compliance with the NIH Guidelines mandate; but Merck refuses to reply.
Biogen IDEC, one of the world's largest biopharmaceutical companies, does not comply with the NIH guidelines. Formerly independent companies, according to records obtained by the Sunshine Project under the Freedom of Information Act, IDEC ditched the NIH Guidelines in September 2001, and Biogen followed suit in October 2002 (before merging).
Syngenta Corporation, a Swiss giant and one of the world's largest agricultural biotechnology companies, does not comply with the NIH Guidelines. At one time, one of its subsidiaries, Rogers Seed, did; but when Syngenta assumed control, compliance ended.
Hoffman - La Roche Corporation, the well-known pharmaceutical company, only voluntarily complies with the NIH Guidelines at its Palo Alto, California facility and not elsewhere.
18 Out of the Top 20 US Biotech Companies do not Comply with NIH Biotech Guidelines
About 85% of over 52,000 biotech employees do not work at a compliant company.
Both Companies that Claim Compliance are in
Cambridge, MA where local law requires compliance.
Top 20 US Biotech Companies ('04) 2004 Revenue (US$ millions)* Employees* NIH Says Compliant with Guidelines? (i.e., is safety committee NIH-registered)** States to Sunshine Project that it actually complies? (i.e. will it respond to requests as required by NIH Guidelines)*** Amgen 10550 14,400 Genentech 4621 7,646 Biogen IDEC 2212 4,266 Genzyme 2201 7,000 Chiron 1723 5,400 Gilead Biosciences 1325 1,654 MedImmune 1141 1,823 Cephalon 1015 2,173 Millennium Pharma 448 1,477 Genencor 470 1,271 ImClone Systems 389 866 Celgene 378 766 MGI Pharma 196 282 Nabi Biopharma 180 727 Regeneron Pharma 174 730 Enzon Pharma 170 n/a Ligand Pharma 169 359 Acambis (US/UK) 157 270 InterMune 151 326 Vertex 103 736 Of 52,000+ workers, only 8,500 work at a compliant company NIH data: 75% (15) of the Top 20 firms don't comply. Even NIH's Dismal Data is Exaggerated: Only 2 out of 5 companies that NIH says comply state that they actually comply. * Source: Wikipedia/MedAdNews. This list is of "pure" US biotech companies, and excludes larger conglomerates, e.g. DuPont, that have biotech operations as part of larger enterprise.
** Source: List of NIH Registered Biosafety Committees provided by NIH (FOIA Case 32063, reply of 27 February 2006).
*** Source: Replies to survey letters sent by the Sunshine Project in 2006.
**** In order to be compliant, a committee must be registered.
Supporting files (1.9mb, PDF format) (updated 19 April):
http://www.sunshine-project.org/publications/pr/support/deregistries.pdf
For More Information on General Noncompliance with NIH Guidelines, please see:
Biosafety Bites 2006-2007
http://www.sunshine-project.org/ibc/bb2006.htmlMandate for Failure: The State of IBCs in an Age of Bioweapons Research
http://www.sunshine-project.org/biodefense/ibcreport.htmlBiosafety Bites 2004
http://www.sunshine-project.org/biodefense/bb.html.