On 28 and 29 July, the Sunshine Project informed UTMB that:
"Serious discrepancies are apparent between UTMB's declarations to the Texas Attorney General and guidelines that UTMB is required to follow in order to maintain its eligibility for a number of federal funding opportunities..."
The Project "hope[s] that the specific problems generated by UTMB's position on IBC access can be resolved in a mutually acceptable manner that creates an adequate public window on the activities of the UTMB IBC and which simultaneously avoids a potentially embarrassing situation with implications for UTMB's NBL application...
[If compelled to file a legal brief in response to the UTMB filing of 25 July,] the Sunshine Project intends to issue a nationally-oriented press statement with respect to the UTMB IBC and its adherence to NIH guidelines. The Project will also examine the possibility of pursuing a complaint against UTMB with the National Institutes of Health."
On 31 July, Dr Stanley Lemon, UTMB Dean of Medicine, replied.
UTMB has not, to our knowledge, released Dr. Lemon's e-mail. We will refrain from posting and commenting on its full text because it is unclear if it was intended as a formal statement by the institution. However, because UTMB has on a previous occasion made false statements to a reporter by claiming to have replied to items to which it did not, we post a partial reply to Dr. Lemon here. If UTMB wishes Dr. Lemon's response to be taken as its institutional position, the Sunshine Project will post Dr. Lemon's e-mail and a full reply.
(quoting Lemon in part)
"My office does not manage requests made to UTMB under the Public Information Act. You should refer any concerns related to such requests to the University's Vice President for Business Administration, Mr. Richard Moore. I have been assured by University counsel that UTMB is fully compliant with all applicable disclosure laws and NIH Guidelines" ...
Reply: The e-mail was copied to Moore, who did not reply. UTMB's Dean of Medicine and PI of its NBL application takes no proactive repsonsibility for NIH Guideline compliance?
"The University takes pride in the open and forthright manner in which it has presented its proposed research and laboratory construction programs related to infectious diseases to both local and national communities, and welcomes dialogue that is both honest and reasonable." ...
Reply: UTMB has refused virtually all requests for information on its biodefense programs, generally only releasing information when compelled to do so by the Texas Public Information Act. UTMB has been asked no less than nine times for information on its IBC. It has refused to reply except with one single page document and aggressive legal briefs. No "honest and reasonable" dialog about UTMB's biodefense programs is possible so long as UTMB refuses to divulge information about them and seeks to further restrict information about its activities through rulings of the Texas Attorney General.
"Our faculty helped frame the NIAID's Agenda for Biodefense Research in response to that threat, and I refer you to that document for an extensive and detailed yet general description of the biodefense research we intend to pursue at UTMB." ...
Reply: Touting its connections to NIAID, UTMB first trots out some hollow rhetoric ("pride in the open and forthright manner in which it has presented its proposed research") and then betrays the truth of its unwillingness to grapple with the public responsibilities entailed in its biodefense ambitions. UTMB asserts it is wide open; but refers the Sunshine Project to information not responsive to the issue at hand (IBC materials) and which is neither specific to UTMB nor produced by UTMB. Rather, Lemon cites a NIAID document that purportedly contains a "general description of the biodefense research we intend to pursue".
"... we recognize that future legislation or regulations adopted in the interests of national security may limit the ability of the University or its faculty to publicly disseminate such information. As a responsible public agency, the University would of course require that its faculty and staff be fully compliant with any such future legislation."
Reply: This is an interesting and dubious legal assertion. Apparently UTMB feels that it must not comply with Texas law and Federal regulations because it thinks that future "legislation or regulations" may absolve it of disclosure requirements. This position is consistent with UTMB's attempts at the Texas Attorney General's office to create new rulings to exempt all IBC information from public disclosure. But UTMB's responsibility is to comply with the law, not to cite nonexistent regulations or to try to generate new ones in order to evade disclosure of its activities. If UTMB really wants to be open, why is it seeking additional secrecy rights and citing nonexistent rules to justify its behaviour?
"... return on investment demands proper protection of intellectual property, and the University will continue to act to protect the intellectual property of its scientists in the field of infectious diseases..."
Reply: So, back to money and researcher's patents again. UTMB's grounds to resist disclosure shift constantly from "national security" to "intellectual property" to "medical records". None of the claimed grounds exist as UTMB describes them and none of them justify UTMB's stance with its IBC records. There are serious inconsistencies between UTMB arguments, as pointed out in the FOIFT brief - "there is a striking discontinuity between UTMB’s claim that the information is confidential under the Health and Safety Code and could not even be obtained through subpoena and at the same time to argue that the information is capable of being sold."
The text of the Sunshine Project's e-mail reply is here.
Envelope-to: hammond@sunshine-project.org
Date: Thu, 31 Jul 2003 23:04:17 -0500
To: "Lemon, Stanley M." <smlemon@utmb.edu>
From: Edward Hammond <hammond@sunshine-project.org>
Subject: Re: Your enquiry
Dear Dr. Lemon,
I am sorry to have interrupted your vacation. I hope that Maine is comfortably mild in comparison to our home state this week.
In addition to the e-mail message to which you refer, please be aware that I also called your office the previous day. There was no indication of your vacation on your voicemail system, to which I was unfortunately reduced to explaining the urgency of the situation. I did not receive a requested callback from your secretary. The e-mail message was also copied to Dr. Peters and Mr. (Richard) Moore, neither of whom explained that you were not in Galveston or offered a reply at all.
As I clearly stated in the e-mail, the tight timeline was mainly due to the procedures of the Attorney General's office, which I [hope] you will appreciate are utterly beyond my control.
It is also at the AG's office where UTMB most obviously continues to demonstrate aggressive defiance of NIH Guidelines. While the failure of UTMB science leaders to respond substantively to our queries is inexcusable, I will say that, based on my present knowledge of your procedures, the group that has poured the most fuel on this conflict is the UTMB Legal Affairs Department. Your lawyers give no indication that they remotely comprehend the complicated set of interrelated legal and public responsibilities entailed in UTMB's biodefense activities and ambitions. The fact that you take no apparent responsibility for their actions reinforces my perception, although I do not believe that you may entirely abdicate responsibility given your position as Dean of Medicine and PI of the NBL application. After all, it is the IBC that we are primarily talking about at this point in time. And you are the Dean of Medicine of a major research and teaching institution.
What is most striking about your e-mail is its assumptions regarding the nature of our concern with UTMB's biodefense program. Most of them are incorrect. Perhaps you have been poorly briefed by your staff or colleagues. I think that any correspondence we might have would be much more productive if UTMB reached a more sophisticated understanding of our positions, which I have stated and restated in correspondence with UTMB and which are found in the publications on our website (http://www.sunshine-project.org), in this case particularly the open letter UTMB received in February.
Clarifying these three UTMB illusions right away might put any dialog on a sounder footing:
1) The Sunshine Project is not, and has never been, opposed to biodefense research, per se. In fact, we view public academic institutions as the most appropriate setting for biodefense research and have agreed that a limited expansion, at appropriate locations, of US BSL-3/4 facilities conducting research on select agents is warranted.
2) The Sunshine Project has sought to avoid taking a position against UTMB's biodefense proposals because we do not oppose them in principle. UTMB's refusal to establish and maintain an adequate public window on its activities, however are the reason why we have determined, only this week, that we must oppose UTMB's NBL and RCE applications, and any other new UTMB monies for biodefense research, until UTMB's policies are changed and demonstrated to be effectively implemented,
3) The Sunshine Project has never alleged that UTMB is or intends to conduct offensive BW research and would appreciate UTMB having the decency to acknowledge that simple fact in correspondence and public statements.
As I have repeatedly emphasized with Mr. Tom Curtis, Dr. C.J. Peters, and others, our concerns relate to transparency, public accountability, and ensuring that treaties against BW are not undermined by biodefense research. If their perception is that the Sunshine Project is "against UTMB" or "against biodefense" or "thinks UTMB is going offensive", it is because they did not listen carefully.
UTMB has not seriously addressed the Project's concerns despite being asked to do so more than a half dozen times since September 2002. For that reason, and because NIAID's timeline is drawing to a close, the Sunshine Project and its non-profit partners now have no choice but to request that NIH place UTMB's NBL, RCE, and other biodefense applications aside until such time as UTMB establishes and demonstrates compliance with NIH Guidelines and reforms its attitudes and procedures on public access to information about its biodefense activities.
My e-mail was a final attempt to resolve this problem directly with UTMB prior to contacting NIH. As I stated would be the case absent a reply from UTMB within the timeframe described in my e-mail, I have begun contacting the news media and have contacted NIH and NIAID regarding the UTMB IBC.
I have not yet lodged a formal complaint at NIH OBA. Following UTMB failure to respond to our final request, certain Texas and other media have been made aware of many details of what is transpiring, and our letter of inquiry to NIH OBA concerning complaint procedures has been distributed on biological weapons control and biotechnology-oriented listservers. The Sunshine Project will file a formal complaint at OBA shortly, will file a legal brief with the Texas OAG, and will contact NIAID to ensure it is fully aware of the situation.
I remain open to the possibility of at least delaying the NIH OBA complaint should you wish to engage in a dialog. Due to activities of your Legal Affairs Department, however, there are prerequisites that the Sunshine Project would insist upon for any dialog. These are:
1) Formal withdrawal of all UTMB legal briefs filed with the OAG in reference to Sunshine Project requests;
2) A signed statement by UTMB clarifying that it does not claim its IBC to be a "medical committee" in the sense of Section 161.032 of the Texas Health and Safety Code;
3) A letter from UTMB to the OAG requesting that the Attorney General vacate OAG ruling OR2003-3283 on the basis of the UT SYSTEM withdrawing its exemption claims related to Section 161.032.
If that can be accomplished, we may then set about establishing mutually acceptable terms of reference for a dialog. Upon the completion of such terms of reference, the Sunshine Project will suspend its preparation of the NIH OBA complaint.
Due to the procedures of the Attorney General and the decisions of the UTMB Legal Affairs Department, the latest possible time at which all of the above may be accomplished is 10:00 AM, Central Time, on Monday, August 4th.
Otherwise we have no choice but to proceed with the complaint and other steps I have previously mentioned.
I genuinely regret this situation, because I have tried hard to avoid it and have other issues - such as the so-called "non-lethal" weapons used in the Moscow Theater - on which I would prefer to focus my efforts. But UTMB's intransigence has left no other possibility. UTMB clearly has scientific firepower applicable to biodefense. If only its understanding and fulfillment of its public and legal responsibilities were commensurate with its biodefense ambition.
Sincerely,
Edward Hammond