Lurie v. Department of Army
| Decision Date | 15 July 1997 |
| Docket Number | Civil Action No. 95-1085(JHG). |
| Citation | 970 F.Supp. 19 |
| Parties | Peter LURIE, et al., Plaintiffs, v. DEPARTMENT OF THE ARMY, Defendant. |
| Court | U.S. District Court — District of Columbia |
Eric Robert Glitzenstein, Meyer & Glitzenstein, Washington, DC, for plaintiffs.
Lisa Sheri Goldfluss, U.S. Attorney's Office, Robert Lawrence Shapiro, Spriggs & Hollingsworth, Washington, DC, for defendant.
Presently pending is the defendant's Motion for Summary Judgment. Upon consideration of this motion, the plaintiffs' opposition, the defendant's reply, the plaintiffs' Notice of Recent authorities and the defendant's response thereto, and after reviewing the withheld documents which were submitted for in camera review pursuant to this Court's Orders of September 27 and November 12, 1996, the motion will be denied in part and granted in part. Disclosure will be ordered as set out in this opinion.
This FOIA suit stems from research that the Department of the Army conducted into a potential vaccine for the HIV virus, which causes AIDS. In 1991 and early 1992, researchers at the Walter Reed Army Institute of Research ("WRAIR"), led by Lieutenant Colonel ("Lt.Col.") Robert Redfield, M.D., Chief of the Department of Retroviral Research, reported to Congress and published in well-known medical publications that, based on certain clinical trials, a vaccine known as gp160 appeared to have salutary effects on persons infected with HIV. See Ten Years of AIDS: Hearing before the Subcomm. on Health and the Environment, Comm. on Energy and Commerce ("Ten Years of AIDS Hearing"), 102d Cong., 1st Sess. 96 (June 6, 1991) (testimony of Lt.Col. Redfield) ("the individuals that have been immunized appear not to have a fall in their CD4 cells as opposed to historical controls"); AIDS Research Opportunities: Hearing before the Subcomm. on Health and the Environment of the Comm. on Energy and Commerce ("AIDS Research Opportunities Hearing"), 102d Cong., 2d Sess. 95 (testimony of Lt.Col. Redfield) ("I am part of the research team that may, in fact, provide a treatment for all people with early HIV infection."); Robert R. Redfield, et al., A Phase I Evaluation of the Safety and Immunogenicity of Vaccination with Recombinant gp160 in Patients with Early Human Immunodeficiency Virus Infection, New England J. of Med. (June 13, 1991), reprinted in AIDS Research Opportunities Hearing, supra, at 83-90; see also AIDS Research Opportunities Hearing, supra, at 81 (Feb. 24, 1992) (testimony of Colonel ("Col.") Donald Burke, M.D., Director, Division of Retrovirology, WRAIR) ("we showed unequivocally that vaccine therapy with gp160 was safe and that it did indeed boost the natural levels of antibodies and cellular immunity").
Dr. Redfield described the imitative at the Defense Department's Walter Reed Army Medical Center:
Well, the long-term goals of the Defense Department have been trying to develop a vaccine for treatment and prevention, and for a great — actually, about a century ago the concept of using vaccines as therapeutic was actually originated.
What we attempted to do at Walter Reed over the last several years was to see if you could modify the immune response of patients that are chronically infected to boost it so maybe they can control it better by actually using an AIDS vaccine to treat. And next week, there is also that original Phase I feasibility trial that will be published, and, in fact, it is feasible. You can actually use a vaccine in an individual with a chronic infection and change the entire immune response and defense that they have against that virus, and it is safe. At present, it is intriguing because the individuals that have been immunized appear not to have a fall in their CD4 cells as opposed to historical controls.
Ten Years of Aids Hearing, supra, at 96.
Lt.Col. Redfield's prediction of a potential breakthrough in the war on AIDS aroused extraordinary interest in Congress, in the news media and in the medical community. See, e.g., AIDS Conference to Unleash Research Covering Vaccines and Gene Therapy, Wall St. J., at B4 (July 15, 1992) ( ); Multiple Mutating HIV Strains Stymie Researchers Seeking a Vaccine for AIDS, Wall St. J., at B6 (May 26, 1992) ( ); Bernie Ankey, U.S. Medicine Interviews Robert R. Redfield, U.S. Medicine, at 8 (April 1992) (); 137 Cong.Rec. S17663 (Nov. 22, 1991) (statement of Sen. Dodd) ( ).
In July 1992, Lt. Col. Redfield made a presentation to the Eighth International AIDS Conference in Amsterdam which was widely interpreted as a bold assertion that there had been statistically significant decreases in the amount of HIV in the blood of those patients who received the gp 160 vaccine as opposed to those in a control group. As were his previous public statements, Redfield's Amsterdam presentation was widely covered by the media. See, e.g., At AIDS Talks, Hope is Weighed Down by the Hard Reality, N.Y. Times, at 1, 15 (July 26, 1992) (); Richard A. Knox, New Problems, New Hopes at AIDS Parley, Bost. Globe (July 26, 1992) ( ); 257 Science, at 605 (July 31, 1992) (). In the same article, the Boston Globe reported on the Army's program and the pressure for its expansion:
The U.S. Army is spending $15 million on a trial in progress of GP-160 compared with a dummy vaccine in 600 H.I.V.-infected patients. Studies so far, which indicate GP-160 is apparently harmless are generating pressure by AIDS activists and doctors to let the experimental vaccine be tried in a bigger group, perhaps 2,000 HIV-infected volunteers while waiting for definitive evidence.
"Can we let the next three years go by without some kind of wider acceptance to GP-160?" said Dr. Calvin Cohen of Boston, research director of the Community Research Initiative of New England. "Clinical researchers like me need to meet with the Food and Drug Administration and try to make it happen."
Knox, New Problems, New Hopes at AIDS Parley, supra.
On September 18, 1992, Senator Sam Nunn introduced Amendment No. 3094 to the bill that became the 1993 National Defense Authorization Act. This amendment provided $20 million for further testing of gp160:
Mr. President, I offer this amendment that would add $20 million for AIDS and research at the Department of Defense medical research facilities.
This amendment would provide for the third phase of testing for a new vaccine which has shown great promise as a way of delaying the onset of the deadly implications of the AIDS virus. This advantage is now seen in stage 2 testing in Walter Reed Medical Center. According to Army medical experts, phase 2 has shown that the vaccine should go to phase 3 as soon as possible.
This research and other fine medical work at Walter Reed are excellent examples of our military research facilities which can and are helping to solve the problems that are important and crucial to civilian society.
Mr. President, I urge adoption of the amendment on behalf of myself and Senator Warner, and I also say former Senator Russell Long has brought this matter to our attention.
* * *
Mr. President, in the case of this kind of research, time literally means saving the lives of people now sick with this deadly disease. The sooner we get these tests completed, the better off so many people in our Nation will be.
138 Cong.Rec. S14156, S14159-60 (Sept. 18, 1992), reprinted at 1992 WL 229956 (Cong. Rec.).
The $20 million rider to the Defense authorization act set off a firestorm of debate in the scientific research community because it circumvented the normal process for federal funding of scientific and medical research. See Jon Cohen, Did Political Clout Win Vaccine Trial for MicroGeneSys?, 258 Science, at 211 (Oct. 9, 1992). Bernadine Healy, the director of the National Institutes of Health (NIH), commented that it was unprecedented for Congress to direct research to a specific experiment. Id. And, as it had before, this development in...
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