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Suggested Citation:"CONFERENCE PROGRAM." Institute of Medicine. 1991. Expanding Access to Investigational Therapies for HIV Infection and AIDS. Washington, DC: The National Academies Press. doi: 10.17226/1778.
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Expanding Access to Investigational Therapies
March 12–13, 1990
Program

Monday, March 12

8:15

Welcome and Opening Remarks

 

- Harold Ginsberg, Eugene Higgins Professor of Medicine and Microbiology, College of Physicians & Surgeons, Columbia University, and Co-chair, AIDS Roundtable

8:20

Expanding Access to Investigational Therapies: The Challenges Ahead

 

- Samuel O. Thier, President, Institute of Medicine

8:30

A Lucid Explanation and Brief History of Food and Drug Administration Policy on Investigational Drugs for Treatment Purposes

 

- Peter Barton Hutt, Partner, Covington & Burling

9:00

The Promise of Treatment Investigational New Drug Regulations: Have They Done What They Were Supposed to Do?

 

Moderator:

J. Richard Crout, Vice President, Medical and Scientific Affairs, Boehringer Mannheim Pharmaceuticals

 

Panelists:

Robert Temple, Director, Office of Drug Evaluation I, Food and Drug Administration

Jay Lipner, Partner, Silverstein Langer Lipner & Newburgh

Stephen Sherwin, Vice President for Clinical Research, Genentech, Inc.

Suggested Citation:"CONFERENCE PROGRAM." Institute of Medicine. 1991. Expanding Access to Investigational Therapies for HIV Infection and AIDS. Washington, DC: The National Academies Press. doi: 10.17226/1778.
×

 

Lawrence Corey, Professor of Laboratory Medicine, Microbiology, and Medicine, University of Washington

 

Raphael Dolin, Head, Infectious Diseases Unit, University of Rochester School of Medicine and Dentistry

10:00

Discussion

10:45

The Philosophy of Drug Regulation in the United States: Is It Changing from Beneficence to Patient Autonomy?

 

Moderator:

Dan Brock, Professor of Philosophy, Brown University

 

Panelists:

Harold Edgar, Professor of Law, Columbia University School of Law

Bernard Lo, Director, Program in Medical Ethics, University of California

Daniel Wikler, Professor, Department of Philosophy, University of Wisconsin

Carol Levine, Executive Director, Citizens Commission on AIDS

12:00

Discussion

1:45

Issues of Cost and Coverage: How Will the Changes Affect the Drug Industry, Payers, and Patients?

 

Moderator:

Patrick Gage, Executive Vice President, Genetics Institute, Inc.

 

Panelists:

Jerome Birnbaum, Executive Vice President for Research, Bristol-Myers Squibb Company

Paul De Stefano, Chief Corporate Counsel, Genentech, Inc.

David Higbee, Branch Chief, Catastrophic Medical Services, Office of Coverage Policy, Health Care Financing Administration

Susan Gleeson, Executive Director, Technology Management, Blue Cross and Blue Shield Association

Steven Peskin, Vice President and Medical Director, CIGNA Healthplan of Texas, Inc.

Suggested Citation:"CONFERENCE PROGRAM." Institute of Medicine. 1991. Expanding Access to Investigational Therapies for HIV Infection and AIDS. Washington, DC: The National Academies Press. doi: 10.17226/1778.
×

 

Lee Mortenson, Executive Director, Association of Community Cancer Centers

3:00

Discussion

3:45

Expanding Access and Gathering and Analyzing Data: Can You Have Your Cake and Eat It Too?

 

Moderator:

Lincoln Moses, Professor of Statistics, Stanford University

 

Panelists:

Melanie Thompson, President, AIDS Research Consortium of Atlanta, Inc.

Marvin Zelen, Chair, Department of Biostatistics, Harvard School of Public Health

Floyd J. Fowler, Senior Research Fellow, Center for Survey Research, University of Massachusetts

Susan Ellenberg, Chief, Biostatistics Research Branch, Division of AIDS, National Institute of Allergy and Infectious Diseases

5:00

Discussion

5:30

Adjournment

Tuesday, March 13

8:15

Reaching the Disenfranchised: What Role for Clinical Trials?

 

Moderator:

Gerald Friedland, Professor of Medicine, Epidemiology, and Social Medicine, Albert Einstein College of Medicine

 

Panelists:

Lawrence Brown, Jr., Senior Vice President for Research and Medical Affairs, Addiction Research and Treatment Corporation

Mark Smith, Associate Director, AIDS Service, Johns Hopkins University School of Medicine

Deborah Cotton, Clinical Director for AIDS, Beth Israel Hospital

Suggested Citation:"CONFERENCE PROGRAM." Institute of Medicine. 1991. Expanding Access to Investigational Therapies for HIV Infection and AIDS. Washington, DC: The National Academies Press. doi: 10.17226/1778.
×

Philip Pizzo, Chief, Pediatric Branch, National Cancer Institute

9:30

Discussion

10:15

Parallel Track: An Update

 

—James Allen, Director, National AIDS Program Office, Public Health Service

10:30

Parallel Track: What Should It Achieve?

 

Moderator:

Anthony Fauci, Associate Director for AIDS Research, National Institutes of Health, and Director, National Institute of Allergy and Infectious Diseases

 

Panelists:

Louis Lasagna, Dean, Sackler School of Graduate Biomedical Sciences, Tufts University

James Eigo, Member, Treatment and Data Committee, AIDS Coalition to Unleash Power

Daniel Hoth, Director, Division of AIDS, National Institute of Allergy and Infectious Diseases

Ellen Cooper, Director, Division of Antiviral Drug Products, Food and Drug Administration

11:45

Discussion

12:15

Expanding Access and the Needs of the Traditional Primary Care Provider

 

—Harvey Makadon, Assistant Professor of Medicine, Harvard Medical School, and Executive Director, Boston AIDS Consortium

12:35

Discussion

12:50

Summation

 

—Sheldon Wolff, Endicott Professor and Chairman, Department of Medicine, Tufts University School of Medicine, and Co-chair, AIDS Roundtable

1:00

Adjournment

Suggested Citation:"CONFERENCE PROGRAM." Institute of Medicine. 1991. Expanding Access to Investigational Therapies for HIV Infection and AIDS. Washington, DC: The National Academies Press. doi: 10.17226/1778.
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Page 1
Suggested Citation:"CONFERENCE PROGRAM." Institute of Medicine. 1991. Expanding Access to Investigational Therapies for HIV Infection and AIDS. Washington, DC: The National Academies Press. doi: 10.17226/1778.
×
Page 2
Suggested Citation:"CONFERENCE PROGRAM." Institute of Medicine. 1991. Expanding Access to Investigational Therapies for HIV Infection and AIDS. Washington, DC: The National Academies Press. doi: 10.17226/1778.
×
Page 3
Suggested Citation:"CONFERENCE PROGRAM." Institute of Medicine. 1991. Expanding Access to Investigational Therapies for HIV Infection and AIDS. Washington, DC: The National Academies Press. doi: 10.17226/1778.
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Page 4
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Expanding Access to Investigational Therapies for HIV Infection and AIDS Get This Book
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The call for a "parallel track" for AIDS drug development—a proposal that would allow the early distribution of AIDS drugs to large numbers of patients in parallel with the conventional clinical trials that assess the drugs' safety and efficacy—has sparked controversy within the scientific community. Questions have arisen about the risks to patients of such a plan, about its potential effect on the successful completion of standard controlled trials, and about whether the parallel track will generate useful data.

Larger questions have also been raised about whether the parallel track heralds fundamental changes in the philosophy underlying drug regulation in the United States, about the costs and financing of investigational therapies and associated medical costs, and about the role of expanded access mechanisms for drugs in reaching those whose health care is generally inadequate. This volume summarizes a conference hosted by the Institute of Medicine that illuminated these issues.

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