Lurie v. Department of Army

970 F. Supp. 19, 1997 U.S. Dist. LEXIS 10370, 1997 WL 405111
CourtDistrict Court, District of Columbia
DecidedJuly 15, 1997
DocketCivil Action 95-1085(JHG)
StatusPublished
Cited by13 cases

This text of 970 F. Supp. 19 (Lurie v. Department of Army) is published on Counsel Stack Legal Research, covering District Court, District of Columbia primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Lurie v. Department of Army, 970 F. Supp. 19, 1997 U.S. Dist. LEXIS 10370, 1997 WL 405111 (D.D.C. 1997).

Opinion

MEMORANDUM OPINION AND ORDER

JOYCE HENS GREEN, District Judge.

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.

I. Background

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 Sub-com/m. 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) (“Dr. Redfield has been testing vaccines as a type of immune therapy in people who are infected with the AIDS virus. This spring he forecast that his data will show the treat *27 ments lower virus levels and stabilize infection-fighting immune cells.”); Multiple Mutating HIV Strains Stymie Researchers Seeking a Vaccine for AIDS, Wall St. J., at B6 (May 26, 1992) (“Robert Redfield, a researcher at Walter Reed Army Medical Center in Washington will soon have 600 volunteers enrolled in his studies of AIDS vaccines as immune-boosters. He is testing such vaccines not for purposes of prevention but as treatment for people who are already HIV-infected.”); Bernie Ankey, U.S. Medicine Interviews Robert R. Redfield, U.S. Medicine, at 8 (April 1992) (Dr. Redfield: “I personally believe it holds the key to converting HIV infection to a prolonged, subclinical disease within my lifetime.”); 137 Cong.Ree. S17663 (Nov. 22, 1991) (statement of Sen. Dodd) (“Last summer, the distinguished New England Journal of Medicine published the first results of a study conducted by Dr. Robert Redfield of Walter Reed.... [These interim test results] give us some reason for hope that we can develop a way to effectively help HIV infected people maintain their immune system function and stay healthy or at least stay healthy for a longer period of time.”).

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, Red-field’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) (“Dr. Robert R. Redfield, of Walter Reed Army Medical Center in Washington, said patients receiving the vaccine had lower amounts of H.I.V. and a reduced rate of decline of one of the monitoring tests of the immune system.”); Richard A. Knox, New Problems, New Hopes at AIDS Parley, Bost. Globe (July 26, 1992) (“ ‘There is no doubt in my mind that next year we will be on first base in terms of showing that human HIV infection can ultimately be a self-limited disease that never proceeds to immune system collapse,’ Dr. Robert Redfield of the Walter Reed Army Institute for Research in Maryland said in an interview. T think AZT was a bunt down the foul line.’ ”); 257 Science, at 605 (July 31, 1992) (“Robert Redfield of the Walter Reed Army Institute of Research claimed that he’s reduced the amount of HIV in the blood cells of infected people who have been treated for two years with a vaccine made from the HIV surface protein gp160.”). 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.

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