Evidence submitted to the Royal Society Inquiry of Edinburgh by the Director Patent and Licensing Affairs United Biomedical Inc.

http://www.ma.hw.ac.uk/RSE/enquiries/footandmouth/EVIDEN22.PDF

 

Sir:

I would like to submit evidence to your enquiry bearing on the development of FMDV diagnostics and the non-cooperative practices of the FMD World Reference Centre, IAH-Pirbright.

My company, United Biomedical, Inc. (UBI) of Hauppauge, NY U.S.A., has been working to develop safe peptide-based immunoassays for detection of FMD infection since 1997. We began this work in response to the outbreak in Taiwan. We have since developed peptide-based assays to detect antibodies for the NS and VP1 proteins of FMDV. Part of this work has been published

(Shen et al. Vaccine, 1999;17:3039-3049).

We have been working with the United States Dept. of Agriculture Plum Island Animal Disease Center (USDA PIADC). When we first undertook this research, Dr. Fred Brown of the USDA Animal Research Service (ARS) and other investigators with the USDA Animal & Plant Health Inspection Service (APHIS), both located on Plum Island, agreed to allow us to use their containment facility and to share their sera from FMDV-infected and vaccinated animals.

Otherwise we had no way to work on this project. We also requested use of sera that is the property of IAH-Pirbright but was located at the USDA PIADC. Dr. Brown informed us that he would need permission from Pirbright to use these samples.

I have a copy of a letter to the Director of the USDA Plum Island Animal Disease Center in which Dr. David Mackay of IAH states that he cannot give permission to UBI, a company, to have access to sera originating from IAH-Pirbright because of an "unacceptable conflict of interest as we ourselves are in the process of developing tests for antibody to NS proteins which will ultimately be made available to National FMD Laboratories in a similar manner to the kits we currently provide." This letter is dated 5 November 1997 and pre-dates the UK outbreak. In another letter, to Dr. Brown also dated 5 November 1997, Dr. Mackay explains that "we have ultimately decided it is not in our interests to collaborate with a company which intends to develop a commercial diagnostic kit in direct competition to our own intentions." This refusal included the sera still owned by IAH that were already in the possession of the USDA lab on Plum Island. Their was no danger from distribution of this sera, or expense, since the sera collection was already on Plum Island. The USDA Plum Island facility is an internationally-recognized biocontainment laboratory, and all usage of FMD-infected serum by UBI would have been restricted to Plum Island. Clearly, safety and MAFF regulations were not the controlling factors here, but rather a desire to exploit their privileged position as the World Reference Centre to restrict competition. IAH-Pirbright is now involved with a competitor of UBI for the commercialization of their own NS test so it appears that their lack of cooperation may have been due to an economic conflict of interest. To put a kinder light on it, perhaps they simply decided to retain an intellectual exclusivity to FMD immunoassays.

Either motivation is equally unethical and retarded development of FMD immunoassays. Without access to the Pirbright World Reference Centre collection, we were unable to fully standardize the UBI tests at that time..We believe it is perfectly OK for them to profit from their own tests, but as the publicly funded OIE-designated World Reference Center, it is improper for them to reserve their resources to themselves or to use an arbitrary standard to exclude companies from the ranks of qualified FMD researchers. (Unfortunately, an anti-company attitude is more pervasive among FMD researchers than it is in most fields of the life sciences and in this age of biotechnology, this attitude needs to be seriously questioned.) Furthermore, it is important to keep this conflict of interest in mind when they, as the World Reference Center, evaluate competitive diagnostic tests. The status of the FMD World Reference Center at the IAH as a disinterested party for the evaluation of FMD products is problematic.

Dr. Brown can verify all of my statements. He is in the UK this week where he is participating in the FMD investigations. Dr. Brown and others at the USDA also have been working on a device to detect FMDV RNA by PCR, in real-time, in collaboration with Tetracore, Inc., another U.S. biotechnology company. This project is also worth your looking into, independently of IAH-Pirbright.

UBI has not been involved with that project.

UBI also has an FMD vaccine program. IAH-Pirbright has provided advice and has offered access to their facilities. The conflict of interest seems to be limited to diagnostics.

Sincerely,

Alan M. Walfield, Ph.D.

Director Patent and Licensing Affairs

United Biomedical Inc.

25 Davids Drive

Hauppauge, NY 11746 U.S.A.