INVESTIGATION OF THE INSTITUTIONAL RESPONSE TO THE HIV BLOOD TEST PATENT DISPUTE AND RELATED MATTERS

Staff Report
Subcommittee on Oversight and Investigations
Committee on Energy and Commerce

Highlights of the Executive Summary

I. Use of the Institut Pasteur Virus by Gallo et al.

• "There is no longer any doubt that the IP [Institut Pasteur] scientists were first to isolate the AIDS virus. The LTCB [Laboratory of Tumor Cell Biology] scientists eventually did isolate and grow their own AIDS viruses; however, they did not discover the AIDS virus isolate with which they performed all of their seminal experiments. Instead, they performed all of these experiments with the IP virus, first under its own original name ('LAV'), then under two different names -- 'MOV' and 'HTLV-IIIb'" (ref).
• "A substantial body of circumstantial evidence assembled and reviewed during the Subcommitee's investigation shows that at the very inception of their seminal experiments, the LTCB scientists knew or had reason to know that the virus they were working with and claimed as their own was the IP virus. The evidence also shows that within weeks of the announcement of their putative 'discoveries,' the LTCB scientists had additional, compelling evidence that their virus was the IP virus" (ref).
• "... the evidence shows that in the critical closing days of 1983 into early 1984, Gallo/Popovic had one useable virus isolate ... [the IP isolate] which was successively renamed according to the then-existing exigencies, and ultimatedly was patented and claimed as the LTCB's own" (ref).
• "Drs. Gallo and Popovic claim that IIIb, like MOV, was a genuine LTCB isolate, independent of ... [the IP virus]. But the Subcommittee's investigation found that aside from Gallo/Popovic's assertions, there is no evidence to support this claim and there is ample evidence to question it" (ref).
• "... in the first paper in which 'IIIb' did appear, the experiments said to have been performed with IIIb were discovered by Subcommittee staff to have been performed with 'MOV,' i.e., the name of the virus was simply changed" (ref).
• "... when the genetic identity of the IP and LTCB isolates began to emerge as a focus of concern at NCI, public health concerns were subjugated to 'scientific' intrigues, and the public and scientific community were misled about the nature of HIV" (ref).
• "... it is the LTCB scientists' own actions, both at the time they performed their seminal experiments, and even more, within a few weeks of the announcement of those experiments, that make compelling the case that there was something to hide, that the LTCB scientists knew there was something to hide, and that they made every effort to do exactly that" (ref).

II. Gallo's "Other Isolates"

• "Another element of Dr. Gallo's campaign to counter charges of misappropriation of the IP virus was his claim that because he had numerous other HIV isolates, particularly isolates obtained long before the receipt of the IP virus at the LTCB, he had no motive nor need to use the IP virus. Dr. Gallo particularly singled out 'RF' as one isolate that in and of itself eliminated any motive for misappropriation ... There was just one problem: the claims were not true, as Gallo himself admitted to Subcommittee staff" (ref).
• "... there were two major problems with the possible use of RF for the LTCB blood test. First, contrary to Dr. Gallo's repeated assertions, RF was not ready to be used, and there could be no certainty about when it would be ready and (2) there was no time for delay" (ref).

III. Patent Applications of Gallo et al.

• "... HHS [the U.S. Department of Health and Human Services] submitted applications for U.S. patents on an HIV antibody blood test and a method of producing the virus. These patent applications contained the seeds of the French/American dispute. They contained fundamental assertions that could not be substantiated" (ref).
• "The real inventors of the HIV blood test were the IP scientists, who had developed and begun to use their blood test the previous Summer (1983) ... Dr. Gallo and his colleagues did not disclose to PTO [the U.S. Patent and Trademark Office] their knowledge and use of the IP blood test, nor did they disclose the IP scientists' considerable body of scientific work on their virus and blood test ..." (ref).
• "... no later than the Summer of 1984, Gallo et al. knew that IIIb and LAV were -- at least -- functionally identical and were the cause of AIDS ... No disclosure of any of these results was made by Gallo et al. to PTO ... where the Gallo et al. blood test patent application was being examined" (ref).
• "Both the attorneys and the PTO examiner told Subcommittee staff that numerous aspects of the IP and LTCB work [with the IP virus] were material to the claims of Gallo et al. and should have been disclosed" (ref).
• "The Gallo et al. patent was issued in record time ... At the time the Gallo et al. patent issued, the IP patent application, submittted over four months prior to the submission of the Gallo et al. patent application, had not been touched ... The differential handling of two applications for the same invention has never been satisfactorily explained ..." (ref).
• "According to the examiner, when she first saw the IP application, within two weeks of issuing Gallo et al., she recognized immediately that PTO had 'screwed up' in issuing the Gallo et al. patent" (ref).

IV. Cover-up in the 1980s

• "The HHS response to the IP challenge ... was immediate and reflexive. The response was to defend -- at all costs and irrespective of the evidence -- the claims of Gallo et al. The Subcommittee investigation showed that HHS officials and attorneys conducted a paraody of an investigation; they did not seek the truth, but rather sought to create an official record to support the claims of Gallo et al." (ref).
• "HHS officials accepted uncritically everything they were told by Dr. Gallo and his colleagues, incorporating the LTCB scientists' information unqualifiedly and without confirmation into official reports of the Department. When these officials encountered hard evidence that contradicted the NCI/HHS claims, the evidence was ignored, discarded, and/or suppressed" (ref).
• "DOJ [Department of Justice] attorneys, in turn, took the 'facts' they were given by NCI/HHS and incorporated them, often nearly verbatim, into U.S. Government pleadings in the Claims Court and before the PTO. At the same time, HHS and DOJ sought by every means at their disposal to thwart IP's discovery of evidence that would reveal the truth about the LTCB claims" (ref).
• "... despite top HHS officials' awareness that many of the claims of Gallo et al. were, at best, highly questionable and without substantiation, HHS determined to 'play out' the U.S. defense as long as possible, and 'roll over' only when defeat became inevitable" (ref).
• "The U.S. Government pleadings ... contain numerous misleading claims. They also reflect numerous material omissions. The misinformation and material omissions are traceable directly to documents and statements prepared by Dr. Gallo and his LTCB colleagues ... " (ref).

V. Continuing Cover-up at HHS/NIH

• "... Dr. Bernadine Healy told Chairman Dingell, concerning Dr. Gallo, that she felt she had to 'save Bob' ... Dr. Healy attempted, by every means possible, to fulfill her pledge and at the same time, to save the blood test patent for NIH" (ref).
• "... although the HHS Office of Inspector General (OIG), the United States Attorney, and the Subcommittee had by this time amassed a substantial body of evidence demonstrating probable misconduct, Dr. Varmus, who was advised throughout by HHS General Counsel Harriett Rabb, refused to forward that evidence to a Surgeon General's Board of Inquiry ..." (ref).
• "... Subcommittee staff briefed the HHS General Counsel about the Subcommittee investigation's findings indicating the strong likelihood of misconduct on the part of HHS scientists, officials, and attorneys. The General Counsel ... told Subcommittee staff she kept Dr. Varmus fully informed about the information provided to her by the staff. Thus, it is difficult to comprehend how Dr. Varmus could have made his strong denials of official misconduct" (ref).
• "... it remains unclear whether Dr. Varmus will support or obstruct Dr. Broder's long-range plans for dealing with the fitness questions raised by the several investigations of Gallo et al." (ref).

Executive Summary