Forsham v. Califano

• Court: U.S. Court of Appeals — District of Columbia Circuit
• Writing for the Court: Before BAZELON, LEVENTHAL and MacKINNON; LEVENTHAL; MacKINNON; BAZELON; PER CURIAM; BAZELON; Statement of BAZELON
• Citation: Forsham v. Califano, 587 F.2d 1128, 190 U.S.App.D.C. 231 (D.C. Cir. 1978)
• Decision Date: 17 October 1978
• Docket Number: No. 76-1308,76-1308
• Parties: , 4 Media L. Rep. 1122 Peter H. FORSHAM et al., Appellants, v. Joseph A. CALIFANO, Jr., Secretary of the Department of Health, Education and Welfare, et al.

Page 1128

587 F.2d 1128

190 U.S.App.D.C. 231, 4 Media L. Rep. 1122

Peter H. FORSHAM et al., Appellants, v. Joseph A. CALIFANO, Jr., Secretary of the Department of Health, Education and Welfare, et al.

No. 76-1308.

United States Court of Appeals District of Columbia Circuit.

Argued Dec. 2, 1976.

Decided July 11, 1978.

As Amended July 19, 1978.

On Rehearing Oct. 17, 1978.

Harvey W. Freishtat, Boston, Mass., with whom Anthony J. Roccograndi, Chayet & Sonnenreich, Boston, Mass., was on the brief, for appellants.

Michael Kimmel, Atty., Dept. of Justice, Washington, D. C., with whom Rex E. Lee, Asst. Atty. Gen., Earl J. Silbert, U. S. Atty. and Leonard Schaitman, Atty., Dept. of Justice, Washington, D. C., were on the brief, for Federal appellees.

Mary Elizabeth Kurz, Asst. Atty. Gen. of the State of Md., Baltimore, Md., with whom David H. Feldman, Asst. Atty. Gen., of the State of Md., Baltimore, Md., was on the brief, for appellee, Klimt.

Before BAZELON, LEVENTHAL and MacKINNON, Circuit Judges.

Opinion for the Court filed by Circuit Judge LEVENTHAL.

Concurring opinion filed by Circuit Judge MacKINNON.

Dissenting opinion filed by Circuit Judge BAZELON.

LEVENTHAL, Circuit Judge:

In its broad aspect this appeal presents the question whether and under what conditions data compiled by a private group that is receiving money under a federal grant-in-aid program are or become "agency records" by virtue of the fact that the agency has funded the program and has the authority to demand those records.

An action was brought by specialists in the treatment of diabetes, as individuals and a committee, ¹ to obtain raw research data of the University Group Diabetes Program (UGDP). The program is a privately conducted and federally funded long-term clinical study of the treatment of diabetes, that has reported certain harmful consequences attendant upon the long-term use of oral hypoglycemic agents. Plaintiffs question the validity of the study, and are concerned lest a useful therapeutic tool be unnecessarily removed from the market. They seek access to the raw data in order to implement their challenge to the study's validity.

The action was brought under the Freedom of Information Act (FOIA), 5 U.S.C. § 552. That Act is addressed to each "agency" of the Federal Government as defined. ² Broadly speaking, and subject to exceptions, it directs each agency to make available to the public certain information, and also "agency records." It establishes the District Court's "jurisdiction to enjoin the agency from withholding agency records and to order the production of any agency records improperly withheld from the complainant." 5 U.S.C. § 552(a) (4)(B).

A. BACKGROUND

1. The UGDP Study and the Sponsoring Institute

The UGDP is a study funded by 13 federal grants administered by the National Institute of Arthritis, Metabolism and Digestive Diseases (hereafter sometimes Institute or NIAMDD). That institute is an "agency" under the Act, being part of the National Institutes of Health, which in turn is an organization within the Public Health Service, in the Department of Health, Education and Welfare. The grants were made under the statutory grant-in-aid authority of the Public Health Service Act, 42 U.S.C. § 241(c). The grants were made to each of 12 participating university medical centers on the basis of their applications, and a grant was made to the UGDP Coordinating Center at the University of Maryland. ³

The pertinent background facts are presented in the affidavit of Dr. G. Donald Whedon, Director of NIAMDD:

4. The inspiration for the UGDP study came from private non-government physicians and scientists in mid-1959. Between 1959 and 1961, before the study actually began with the entry of the first patients, the design, methods, and objectives of the study were evaluated by persons associated with the UGDP and representatives of NIAMDD. The Food and Drug Administration was not involved in the planning, inception, or design of the UGDP study. The study was funded by NIAMDD as part of its responsibility to support research in the field of diabetes and not with any specific regulatory objective in mind.

9. The UGDP raw data (e. g., patient charts and forms) are the property of the individual investigators and the Coordinating Center and are not owned by NIAMDD. Furthermore, it is not the normal practice of NIH or this Institute to require grantees to submit their raw data for review and, in fact, submission of raw data to the institute is extremely rare. Management of the day-to-day operations of grant-supported activities is the responsibility of the grantee. Supervision of the grantee's funded activities by this Institute is generally limited to review of periodic reports submitted by the grantee. (45 CFR §§ 74.80, 74.82). Due to the large number of research grants outstanding currently approximately 1800 it would not be physically possible for the Institute to subject raw data, if submitted, to critical review, and to require submission of the raw data of the UGDP study would have been an extraordinary requirement. It is the practice to evaluate applications for renewal grants on the basis of progress reports and final reports submitted to NIH. This practice was followed with respect to the UGDP grants. No specific provisions of the UGDP grants required submission of raw data to the Department of Health, Education and Welfare. Pursuant to 45 CFR § 74.23, officers or employees of the Department could obtain access to the raw data for purposes of audit inspection and copying if access is deemed pertinent to the grant. The raw data which are the subject of this case have never been seen by, or been in the possession of, any officer or employee of the National Institutes of Health. * * *

The particular documents sought by the plaintiffs in this case are observations on over 1000 diabetic patients, who were monitored from 5 to 8 years. It is estimated that there are some 55 million such documents.

In June, 1970, the UGDP investigators made a presentation of the methods and initial results of their study at the annual meeting of the American Diabetes Association. The results indicated that the administration of tolbutamide (an oral hypoglycemic drug) to mild adult-onset diabetics led to a death rate from cardiovascular disease higher than that of groups treated with diet alone, with a fixed dosage of insulin, or with a variable dosage of insulin. The findings were published in the December 1970 Journal of the American Diabetes Association. During 1970 and 1971, over a dozen articles were published in medical journals concerning the study, some supportive and some critical. ⁴

The NIAMDD contracted in 1972 with the Biometric Society, a private international professional society of biostatisticians, for an in-depth assessment of the quality of the UGDP study. The Society made a report to the Institute in 1974 that apparently found some merit on both sides of the controversy. It concluded that while some of the criticisms of the UGDP study were valid most were unpersuasive, and the evidence of harmfulness adduced in the UGDP study was "moderately strong." This was made public in the American Medical Association Journal for February 1975. ⁵

2. Food and Drug Administration

The Food and Drug Administration of HEW, on being apprised of the UGDP results, issued in its October, 1970, Bulletin to the medical community a recommendation that tolbutamide should be used only in cases of adult-onset, stable diabetes that could not be controlled by diet and could not be treated with insulin. A June, 1971, FDA bulletin proposed changes in labeling of oral hypoglycemic drugs to warn of cardiovascular hazards. Plaintiff committee sued to enjoin the proposed labeling on ground of deficiencies in the UGDP study, and the First Circuit remanded to the FDA for exhaustion of administrative remedies. ⁶

The FDA deferred further action on the labeling pending the review of the UGDP study by the Biometric Society. As already noted, the 1974 report of the Biometric Society was mixed, but overall found "moderately strong" evidence of harmfulness in the UGDP study. Its contract with NIAMDD did not require the Society to seek access to the UGDP raw data, but it apparently did examine some of the raw data. ⁷ The contract did not require the Society to submit any raw data to the Institute, and none was submitted.

3. FOIA requests and District Court proceedings

Stressing that the raw data had been made available to the Biometric Society, plaintiffs' committee began a series of FOIA requests in 1974 and 1975 for access to the raw data and a copy of the draft report of the Biometric Society. Plaintiffs were given preliminary galley proofs of the report later published in the AMAJ. HEW notified plaintiffs on August 7, 1975, that the raw data were the property of those engaged in the UGDP study and had not been reviewed or even seen by either the UGDP sponsor (NIAMDD) or FDA.

This FOIA action was begun on September 30, 1975. The complaint sought the production of the raw data, defined as consisting of the forms transmitted to the Coordinating Center and the computer tapes and/or programs on the basis of which the data were analyzed. The complaint also sought a draft report of the Biometric Society. ⁸

On Feb. 5, 1976, the district court granted the motion of the HEW officials to dismiss the complaint, on the ground that no official or employee of HEW is now or has ever been in possession of the raw data relating to UGDP, that these raw data are the property of the individual investigators and UGDP study coordinating center, and in the Center's possession, custody and control; that neither the investigators nor the Coordinating Center is an "agency" within 5 U.S.C. § 552, and that the raw data are not "agency records" subject to the disclosure provisions of FOIA. ⁹

4. Developments pending appeal

On July 25, 1977, while the appeal to this court...