I. INTRODUCTION

I. INTRODUCTION

A. Background

In April 1984, the United States Government announced with great fanfare that government scientists had discovered the virus that was the cause of AIDS, had discovered a method for growing the virus, and had invented a blood test to detect antibodies to the virus. Officials and scientists of the Department of Health and Human Services (HHS) described these claimed accomplishments as "a triumph of science" and "another miracle" added to "the long honor roll of American medicine and science."

On April 23, 1984, the same day HHS held a major press conference for the international media, the HHS scientists who claimed these accomplishments (Dr. Robert C. Gallo and his colleagues at the National Cancer Institute's [NCI] Laboratory of Tumor Cell Biology [LTCB]) applied for United States patents on an HIV antibody blood test and a method for propagating the AIDS virus. In the patent applications, Dr. Gallo and his colleagues affirmed, under penalty of criminal prosecution for making false statements, that they were,

"... the original, first and joint inventors... of the subject matter which is claimed and for which a patent is sought ..."

Gallo et al. also affirmed, under penalty for making false statements, their duty

"... to disclose information which is material to the examination of this application ..."

Dr. Gallo and his colleagues likewise all signed the declaration at the conclusion of the patent application that contained this affirmation:

"... all statements made herein of my own knowledge are true and ... all statements made on information and belief are believed to be true ... with the knowledge that willful false statements and the like ... are punishable by fine or imprisonment, or both, ... and such willful false statements may jeopardize the validity of the application or any patent issued thereon."

Announcement of the HHS scientists' claimed discoveries also was made via numerous scientific papers and presentations. But the announcements were no sooner made than suspicions about the claims, followed by overt concerns, began to be voiced. The concerns included the following:

• the U.S. Government scientists' supposed discovery of the AIDS virus was not a bona fide discovery; the U.S. Government scientists in reality had "discovered" another scientist's virus (that of Dr. Luc Montagnier of France's Institut Pasteur [IP]) and used the IP virus for their putative breakthroughs;

• the U.S. Government scientists had not appropriately credited the prior work of the IP scientists in discovering the AIDS virus and inventing the HIV antibody blood test; neither had the U.S. scientists acknowledged and appropriately credited the contribution of the IP scientists' virus samples to the LTCB's "discoveries";

• the U.S. Government had engaged in "inequitable conduct" before the United States Patent and Trademark Office (USPTO), having failed in its duty of candor and disclosure to that office.

In 1985-86, following a breakdown in informal negotiations between HHS and IP, the issues were joined in four formal legal proceedings (a lawsuit for breach of contract, a patent interference proceeding, a tort claim, and a lawsuit under the Freedom of Information Act [FOIA]). The legal battles continued for nearly two years, ending only when a political settlement was negotiated by the President and Prime Minister of the United States and France, respectively. Under the terms of the settlement, the United States Government has received an average of $2,000,000 annually, while Dr. Gallo and his two "coinventors" each have received $100,000 annually, since 1987.

During the 1985-87 legal proceedings, United States representatives from the Department of Justice (DOJ) submitted numerous briefs and other pleadings on behalf of the research of Gallo et al. Many of the claims made by the United States representatives mirrored claims made by Dr. Gallo himself, in statements to the media, to colleagues and associates in official correspondence, and to HHS officials and HHS/DOJ attorneys, in memoranda and related documents generated in response to the French/American dispute. The U.S. representatives' and Dr. Gallo's claims have been examined in detail during the Subcommittee's investigation; the Subcommittee has documented numerous instances in which these claims cannot be substantiated and, in fact, are contradicted by the available evidence.

The Subcommittee's investigation also has produced evidence that during the 1985-87 legal proceedings, the United States Government significantly disadvantaged the IP by systematically denying its representatives access to key information about the work of Gallo et al., particularly information contained in laboratory records and related documents withheld from the IP. The Subcommittee's investigation has identified a number of key documents and items of information whose very existence was withheld from the IP. IP representatives have told Subcommittee staff that their willingness to agree to the 1987 settlement with the United States was attributable in large part to their lack of awareness of these documents and key items of information, particularly those relating to the LTCB scientists' use of the IP virus, LAI/LAV.

The settlement that supposedly ended the French/American dispute once and for all began to unravel almost as soon as it was consummated in March 1987. The unravelling of the settlement was due in significant part to the inherent weaknesses of the U.S. position, plus the work of investigative journalists who documented compelling evidence that profound deceits had been officially perpetuated by representatives of the U.S. Government. Yet it was not until 1991, in the midst of a three-year series of HHS investigations that Dr. Gallo finally acknowledged publicly what for years he had denied was even physically possible: the virus the LTCB scientists used to make their HIV blood test -- the virus claimed by the LTCB as its "prototype" HIV isolate -- was in fact the IP HIV isolate LAI/LAV.

Two years earlier, Dr. Gallo acknowledged publicly that the cell line he used to grow the AIDS virus, like the virus itself, was not his own laboratory's discovery, but the discovery of a scientist in another NCI laboratory, Dr. Adi Gazdar. Dr. Gazdar originally pressed NCI officials for inclusion as an inventor on the Gallo et al. patents. Eventually, however, Dr. Gazdar accepted a $10,000 NCI award, and he left off his inventorship claims.)

Even with these admissions, and notwithstanding the HHS investigations, many significant questions remained, both about the LTCB's HIV research and about the claims made by the United States Government concerning that research. In fact, from 1987 on, even as several HHS components initiated investigations of Dr. Gallo's claims, other HHS components continued to propound the questionable claims and to suppress evidence that demonstrated their dubious nature.

The investigation touches on matters of scientific truth, of institutional integrity, and of national honor. The fact that these issues had their origins a decade ago in no way diminishes their contemporary significance, particularly considering that in some quarters, a cover-up of apparent misconduct has persisted to the present day. The very persistence of the questions concerning the U.S. Government's claims, as well as the actions of U.S. Government officials in defending those claims, demonstrate compellingly that until the Subcommittee investigation, major questions remained unresolved. This report addresses those questions.

B. HHS/NIH's Sorry History of Misconduct Investigations

The 2 1/2-year investigation by the Subcommittee on Oversight and Investigations focused on the following issues:

1. Possible scientific fraud associated with the putative discovery of the AIDS virus and development of an HIV antibody blood test at the LTCB, NCI, National Institutes of Health, (NIH). At all times during the events examined in the Subcommittee investigation, Dr. Gallo was Chief of the LTCB.

2. Possible patent fraud and inequitable conduct associated with the United States' application for an HIV blood test patent (as well as several associated patents);

3. Apparent inequitable handling of patent applications at the USPTO;

4. A cover-up by senior government officials of the original scientific and patent fraud and inequitable conduct, in the context of several legal proceedings, including the PTO interference and a lawsuit in the United States Court of Claims. As part of the cover-up, these officials and U.S. Government attorneys asserted on behalf of the United States claims that they knew or had reason to know were false, claims that could not be substantiated.

The investigation included interviews with several dozen witnesses, along with review and analysis of ten of thousands of pages of documentary evidence. The investigation was significantly delayed by the obstructionism of key officials, past and present, particularly at HHS. In one instance, the Subcommittee held a hearing in Executive session, due to the refusal of a potential witness to appear voluntarily for an interview by Subcommittee staff. In the case of other witnesses who did appear for a voluntary interview, their memories seemed to have been selectively obliterated concerning matters in which they were substantially involved.

Agency obstructionism was particularly pronounced vis-a-vis documentary evidence. Because of the passage of time since many key events, because of deliberate as well as genuine forgetfulness concerning these events, documentary evidence was a particularly important element in the investigation. Yet very significant delays, as well as several incidents of actual withholding and destruction of documents responsive to the Subcommittee's requests, took place.