How Aids Activists Challenged America And Saved The Fda From Itself

James Driscoll

Description

In this extraordinary history, James Driscoll reveals the untold story of how AIDS activists, by thwarting bureaucratic plans imposed by the U.S. Food and Drug Administration (FDA), both saved HIV patients and rescued the FDA itself from a self-inflicted public health catastrophe.
By 1996, accelerated approval of AIDS drug cocktails transformed AIDS from a death sentence to a manageable disease. That approval, however, came only after years of struggle pitting AIDS activists against the hidebound culture of the Food and Drug Administration, which wanted to run lengthy efficacy trials required for full approval and possibly delay the drugs at a cost of tens of thousands of lives.
Driscoll’s courageous efforts, which are an important personal part of the story, navigated conflicts among AIDS activist groups as they struggled with both major American political parties to be heard and respected. He examines the effect of AIDS activism on the LGBT community, its views of itself, and its place in modern American society. Additional materials analyze FDA mistakes, drug pricing, and other contemporary challenges for the LGBTs community.

Sujets

• LGBTQ+ Studies
• Public Health
• Social Science
• Sociologie, société et politique
• AIDS
• American studies
• Pharmaceutical drug
• Queer studies
• Medicine
• Activism
• Food and Drug Administration
• Syndrome d'immunodéficience acquise

Informations

• Publié par: Academica Press
• Date de parution: 01 février 2021
• Nombre de lectures: 0
• EAN13: 9781680539783
• Langue: English
• Poids de l'ouvrage: 2 Mo

Extrait

HOW AIDS ACTIVISTS CHALLENGED AMERICA
(And Saved FDA from Itself)
A History and Memoir
BY JAMES DRISCOLL, PH.D.
WHAT HAPPENED IN SAN FRANCISCO IS REVEALED IN THESE PAGES
HOW AIDS ACTIVISTS CHALLENGED AMERICA
(And Saved FDA from Itself)
A History and Memoir
BY JAMES DRISCOLL, PH.D.
WHAT HAPPENED IN SAN FRANCISCO IS REVEALED IN THESE PAGES
ACADEMICA PRESS
WASHINGTON~LONDON
Library of Congress Cataloging-in-Publication Data
Names: Driscoll, James P., 1946- author.
Title: How AIDS activists challenged America and saved FDA from itself / James P. Driscoll.
Description: Washington : Academica Press, 2020
Includes bibliographical references and index.
Identifiers: LCCN 2020935347 | ISBN 9781680531404 (hardcover) | ISBN 9781680531428 (paperback) | ISBN 9781680539783 (ebook)
LC record available at https://lccn.loc.gov/2020935347
Copyright 2020 James P. Driscoll
FOR DAVE, STEVE, JIM, DAVID, DUANE, AND ALL THOSE WHO SUFFERED, FOUGHT, AND DIED MUCH TOO SOON.
Contents
Prologue
AIDS: A Tsunami of Death
PART I: Plight
Chapter 1
Twice Aborted Lives
Chapter 2
Refugees Become Activists (1988: 20,967 AIDS deaths)
Chapter 3
A Tale of Two Cities
Chapter 4
The Politics of AIDS
Chapter 5
Trailblazers in Identity Demagoguery
Chapter 6
Paths to Nowhere and Byways of Denial (1991: 35,690 deaths from AIDS)
Chapter 7
A City Riddled with Denial
PART II: Struggles Conflicts
Chapter 1
The DDC-DDI Petition: A Fast Lane for AIDS Drugs
Chapter 2
The Real AIDS Drug Underground and its FDA Enablers
Chapter 3
Vigilante Activism
Chapter 4
Regulation without Representation
Chapter 5
Activists, Media, and Scientists
Chapter 6
Racing Against the Clock (1992: 38,333 deaths from AIDS)
Chapter 7
The Moral Challenges of Partisan Politics
Chapter 8
FDA Reform Gathers Steam (1993: 39,779 AIDS deaths)
Chapter 9
Log Cabin Republicans and other Republicans (1994: 42,645 AIDS deaths)
PART III: Climax
Chapter 1
Celebrity Deaths and Non-Gay AIDS Activists
Chapter 2
The Great Commissioner
Chapter 3
The Axis of Obstruction (1995: 48,979 AIDS Deaths)
Chapter 4
The Grand Patient Alliance of 1995
PART IV:
Outcomes
Chapter 1
1996 Persons of the Year
Chapter 2
Congress Passes an FDA Reform Bill, Finally
Chapter 3
New Era, Different Challenges (1999: 16,762 AIDS deaths)
Conclusion
What Can We Learn?
PART V: Loose Ends
APPENDIX I
A Counter to FDA s Thalidomide Mythos: FDA Delays of HIV Rapid Testing Cost Lives
APPENDIX II
Larry Kramer s Cyclopean Distraction: Corporate Greed
APPENDIX III
Politicians Sins of Omission
APPENDIX IV
High Ranking Purveyors of Stigma
ENDNOTES
Epilogue: FDA and COVID-19
Index
Prologue
Those who cannot remember the past are condemned to repeat it.
George Santayana, July 31, 1913
Americans want to forget the terrifying details of the AIDS epidemic that raged through the country killing vast numbers over the dozen years between 1984 and 1996. President Reagan exhibited the reticence of many when he declined to speak the word AIDS while tens of thousands of his fellow citizens suffered and died from the disease.
We will have epidemics in the future, perhaps more lethal than AIDS. Will our leaders again turn a blind eye to the new mortal threat? If they do, will we be so lucky as to face a rather slow moving epidemic confined to sequestered segments of our population? Will our chaotic, overburdened healthcare systems delay adapting to the challenges of a novel disease, as they did with AIDS? Drug and biotechnology research, development, and approval still are beset with the regulatory featherbedding and wrong-headed priorities that almost stalled the life-saving AIDS multi-drug cocktails three additional years. Will FDA, NIH, NIAID, CDC again prioritize guarding their turf over bold action to save lives?
The AIDS cocktails, were so named because, like mixed drinks, they combine two or more agents which, used together, prove more effective than single drugs, or monotherapies. The wily AIDS virus is extremely adaptive. HIV can develop resistance to a single drug in a short time, whereas multiple drugs retain their effectiveness much longer. FDA delayed approval of the earlier AIDS drugs and their use in combinations, and it tried to delay the cocktails by requiring time consuming efficacy trials before the new therapies could be approved for widespread use. Their delays triaged their fetish for pedantic accuracy above the patients life and death needs for treatment.
To understand why FDA delays outraged AIDS activists and sparked protests one must bear in mind a crucial point: FDA delayed approval by demanding additional proof of the efficacy of AIDS drugs and combinations even after sufficient safety was established. The agency claimed to be protecting patients and sometimes intimated, disingenuously, that safety was at issue, when their real objective was always more extensive measurement of efficacy. Their regulatory over-reach is particularly shocking considering that high level FDA personnel who made life and death decisions on access to AIDS drugs included almost no one from the effected population which was more than 85% either gay or African American men.
To the patients, it made little sense to delay approval of new AIDS drugs just to get more exact measures of efficacy since there were no effective alternative drugs, none whatsoever. Given that we faced a deadly epidemic without effective long term treatments, the pragmatic and humane approach would have been to approve the drugs on an accelerated or conditional basis once their safety was known and we had evidence for efficacy, and then further test their degrees of efficacy clinically in the field. That is what the patients and their doctors wanted, but a rigid, paternalistic FDA bureaucracy blocked the way and that is why we needed clamorous, obstinate, and resourceful AIDS activists.
The efficacy standard was and remains key to FDA s power over the drug companies, researchers, and desperate patients. Testing efficacy gives FDA ascendency over a drug s market share and profitability by allowing the agency to assess the relative value of competing products. Follow the money . Drugs that come to market first enjoy a major competitive advantage. FDA decides the when and how as well as the if of drug approval, and it determines the conditions of use in the drug s labeling. FDA s delays of approving AIDS drugs were all about defending these powers.
The problem of efficacy testing overkill delaying approvals remains very much alive in FDA today. By driving up research and development costs and inducing gratuitous caution, it creates an impediment to medical innovation that poses a threat to patients in future epidemics as well as to patients currently afflicted with rare or untreatable diseases and conditions.
FDA s mistakes in AIDS are evident in the chronicles and documents from the 1988-96 period and remain in the memories of the dwindling number of survivors, but they have not been collated in comprehensive narratives with their lessons forthrightly drawn. That s a problem with all history, we like to bury painful memories. We want to forget the horrors of the AIDS epidemic, just as we want to forget the ugly strife and violence of the Vietnam war or the latest terrorist act. We even want to forget the last time we got food poisoning. Still we need to remember to avoid the source of contamination.
The following accounts describe actions, events, and the emotions behind them that many, sometimes including myself, want to forget. It was often painful dredging them out of my memory and from the documents of the time. Indeed, I did not want to write this book, yet I knew if it were not written an essential part of the AIDS and LGBT story might be lost. A precept from author Toni Morrison set forth my task: If there is a book you want to read, but it hasn t been written yet, then you must write it. Doubting that any other surviving activists would tell the full story, I bit the bullet, pulled out my dusty files, and got to work.
The writing has often involved reliving the suffering, grief, injustice, and tragedy that so many, endured, myself among them. However, in 1988, I faced an even more painful and difficult task. While I did not have AIDS myself, I belonged to a community that was dying all around me. I chose to fight with the dying rather than abandon them, which many others did. Recalling decades later the heroic struggles and terrible suffering of friends who died, their lost brilliance, beauty, humor, and love, at times puts me in sadness bordering despair. How I long to see them again, in some cases to tell them in more ways than words what they meant to me. Yet time irreversible is a raven croaking nevermore, nevermore.
Like the rest of humanity, gay people are capable of awesome heroism, startling brilliance, great sacrifices, and of loving incandescently. Unlike the rest, our most passionate loves are toward members of our own sex. This is much easier for outsiders to comprehend on an intellectual level than it is to apprehend emotionally. The majority assume their shared views and experiences form the default setting of all humanity. Gays men and women partake in a difference that in important respects is as profound and consequential as race, religion, and culture. Gays often fail to appreciate the magnit