NOTES FROM THE UNDERGROUND; PWA Health Group - July, 1997

Thanks to people with AIDS, this changed. PWAs organized: learned the regulations, met with industry and government officials, and drew up proposals. By 1988, FDA Commissioner Frank Young and company CEOs alike agreed there was a problem, but nothing changed until PWAs started demonstrating in the streets. New FDA regulations allowed companies to open programs as soon as there was minimal safety data. Big company programs opened (see chart):

• 1989-91: DDI reaches 23,000 people, based on data from 100 people [Bristol-Myers]
• 1990-91: DDC reaches 5,186 people in the first "parallel track" program [Roche]
• 1992-94: D4T reaches 12,477 people [Bristol-Myers]
• 1995: 3TC reaches over 32,000 people, the largest program ever [Glaxo Wellcome]

In 1996, expanded access all but disappeared. Why? AIDS hadn't changed, lots of drugs were in the pipeline, and company profits were climbing. In fact, the more money drug companies made, the smaller and shorter the programs got (see chart). In 1996, marketing replaced compassion for PWAs with no other options. Companies designed programs as public relations stunts, getting their brand name out, not the drug. How could they offer lotteries for life-saving drugs?

• 1995 (July): Roche's Saquinavir lottery (lottery!) offers 2,000 slots, but starts drug delivery in September; 2,000 new slots open in October, but the program closes at the end of October with FDA approval.
• 1995 (Aug): Abbott's Norvir lottery has 2,000 slots, reaches 1,480 PWAs in Dec-Jan, and closes two months later in March with FDA approval.
• 1995 (Aug): Merck's Crixivan lottery has 1,500 slots, reaches 1,100 PWAs by the end of January, and closes three months later in April with FDA approval.
• 1996: Viramune "expanded access" reaches 325 people, because almost all PWAs are excluded [Boehringer-Ingelheim].
• 1996-97: Upjohn's Delavirdine reaches 1,527 people.
• 1996-97: Agouron's Viracept program reaches a few hundred PWAs until just before approval, when the entry rules are relaxed. Agouron claims 3,100 people got the drug before the program closed two months later. Their well-publicized pediatric program reaches only 33 kids.
• 1997: Glaxo Wellcome plans to offer 1592 to 2,500 people worldwide by July. It's July, and neither this nor the spring program for kids is anywhere to be seen.

Drug companies are the most profitable sector of the American economy. Yet the better their AIDS drugs get, the stingier they get. Especially with resistance to their early drugs, early access is as critical as ever.

Like it or not, drug companies are not the same as other corporations. They are part of our health care system. They make products that can save lives. They have a responsibility to society, not just their investors. All over the world, drug prices are regulated, preserving both profit and access. But not in the US, where government officials support corporate health over public health. Expanded access is a real way for companies to honor their community role, offering hope and collecting critical safety data. Expanded access programs are not required. They cost money. In 1989, the urgency of PWAs pushed companies to be generous. AIDS in 1997 is just as urgent. Once again, we need to organize, get noisy and push for fair, early access for all of us who need this chance.
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Copyright © 1997 - NOTES FROM THE UNDERGROUND - The PWA Health Group Newsletter. All rights reserved. No part of this publication may be copied or reproduced in any form or by any means without the written permission from the PWA Health Group. NOTE: The PWA Health Group is no longer in existence, as per notification in 2003. An organization called Visionary Health Concepts has succeded them. VHConcepts is a HIV/Hepatitis+ owned and operated health education company specializing in providing free HIV & Hepatitis treatment programs For more information please contact Email: edu@vhconcepts.com. .