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

Staff Report
of the Subcommittee on Oversight and Investigations
Committee on Energy and Commerce
United States House of Representatives

TABLE OF CONTENTS

I. INTRODUCTION

A. Background

B. Focus and Process of the Investigation

II. EARLY ATTEMPTS TO ISOLATE AND GROW HIV

A. The LTCB's Misplaced Focus

B. Subversion of the Barre-Sinoussi et al. Paper

C. Paradoxical Claims

D. Consequences of the LTCB's Misplaced Focus

III. CLAIMS AND REALITY CONCERNING THE LTCB'S HIV RESEARCH

A. Claims about the LTCB's "Early Isolates"

1. Claims in the Scientific Literature

2. Claims in Legal Proceedings

3. Dr. Gallo's Statements to OSI and Subcommittee Staff

B. How the LTCB Scientists Benefitted from their Knowledge and Use of LAV

1. Knowledge of the IP Work with LAV

2. Use of LAV at the LTCB

(a) Dr. Popovic's Notes

(b) What the LTCB Records Show

(c) The "Host Range" Experiment

3. What Gallo and Popovic Said About their Use of the IP Virus

(a) What Gallo/Popovic Said to Montagnier et al.

(b) What Gallo/Popovic Said in 1985-86

(c) What Dr. Gallo Told OSI and Subcommittee Staff

C. LAI/LAV by Another Name

1. LAI as "MOV"

(a) The Transformation of LAI to "MOV"

(b) Gallo/Popovic's Explanations

2. LAI as "HTLV-IIIb"

3. The HUT-78/HT/H9 "Breakthrough"

(a) Claims that HT/H9 was "New"

(b) Claims of a November 1983 "Breakthrough"

(c) H9's Hidden Defect

IV. EVENTS LEADING TO THE APRIL 1984 HHS ANNOUNCEMENT

A. Further Work with LAI/MOV

B. Work Reportedly Done with "HTLV-IIIb"

1. Origins of H9/IIIb

2. Chaos in LTCB "IIIb" Records

C. Subsequent Claims by Gallo/Popovic About Their "Breakthrough" Discoveries

D. The CDC Data

E. Functional Identity of LAV and "HTLV-III"

F. The Popovic et al. Science Paper

G. Selection of the Isolate for the LTCB HIV Antibody Blood Test

1. The Gallo/Popovic Debate

2. Other Isolates and the LTCB HIVBlood Test -- There Was No Choice

3. There Was No Time for Delay

V. COMPARING THE VIRUSES

A. The HHS Press Conference

B. Comparisons in the Spring/Summer of 1984

1. Serological Comparisons

2. Immunological (Proteins) Comparisons

3. Molecular (Genetic) Comparisons

C. Accusation

D. Stonewalling the Assistant Secretary

E. Aftermath of the Comparisons

F. The Sabotaging of Bryant et al.

G. Fate of the Comparison Papers

H. Dr. Gallo's Explanations

VI. GALLO/HHS ON LTCB MATERIALS TRANSFERS

A. Practices at the LTCB

B. Practices at NCI, NIH, and PHS

C. The Unique Role of Dr. Lowell Harmison

VII. THE FRENCH/AMERICAN DISPUTE: FIRST PHASE

A. Scientific Events Leading to the Dispute

1. Scientific Papers: HIV is Not an "HTLV"

2. Scientific Papers: Too Alike to be Different

B. Issuance of the Gallo et al. Blood Test Patent

C. The Initial Challenge

VIII. HHS' INITIAL RESPONSE

A. The HHS Mindset

B. Gallo and Popovic Respond

C. The "Fischinger Report"

D. Beyond the Fischinger Report

1. The Grinstead Response

2. Malcolm Martin's Information

3. CDC's Information

4. "Major Areas of Oversight"

5. Disposition of the Martin and CDC Information

6. Dr. Gallo's Response

7. Dr. Gallo's Explanations

E. Key Players at HHS

1. C. McLain Haddow

2. Dr. James Mason

3. Darrel Grinstead

4. Dr. Lowell Harmison

F. The Negotiations

1. Bad News From the HHS Attorneys

2. IP's Quest for Information

IX. THE FRENCH/AMERICAN DISPUTE: LITIGATION

A. Overview of the Proceedings

1. Lawsuit in the Court of Claims

2. Interference Before the USPTO

3. Tort Claim

4. Lawsuit Under the Freedom of Information Act (FOIA)

B. THE U.S. GOVERNMENT STRATEGY

1. Major Players

2. Litigation Strategy

3. Government Attorneys in Action

C. DEFINING EVENTS

1. The LAI/LAV EM "Mix-Up"

2. The Counter-Offensive to the EM "Mix-Up"

(a) Counteroffensive: "CC"

(b) Counteroffensive: The "Early Isolates" Nature Letter

3. Potential Disaster at PTO

X. THE SETTLEMENT (AND THEREAFTER)

A. Terms of the Settlement

B. Unravelling of the Settlement