1592: Protests on Small Access Program

1592 (generic name abacavir), an important experimental HIVtreatment being developed by Glaxo Wellcome, has been in development for about nine years but has so far only been given to 200-300 people (it was first tested in people in 1995). Glaxo has announced a small "compassionate use" program, scheduled to start in July, to make 1592 available to 2500 adults and children worldwide (in countries where the drug is already in clinical trials). In this program, 1592 will be distributed at only about 50 sites in the U.S.; according to Glaxo, these sites will accept patients referred to them. The company also plans to start a larger "expanded access" program, hopefully by early 1998, although no date has been set. [For more information on 1592, see
AIDS TREATMENT NEWS #271 (May 16, 1997), #261 (December 20, 1996), #259 (November 15, 1996), and #253 (August 23, 1996).]

AIDS advocates are concerned that thousands of people with no other treatment option may be unable to obtain this new drug for at least the next six months, due to the small size of the initial program.

Glaxo has given two reasons for the limitations of the compassionate use program: production difficulties in scaling up the manufacturing process, and limited human experience with the drug. The company points out that it plans to increase human use of 1592 from about 250 now, to about 4500 in six months: 2000 in phase III trials, plus 2500 in open-label compassionate use. Most advocates expect that 2500 slots will be far too few for persons who have no other options; they acknowledge that there are production difficulties but suspect that capacity is largely determined by decisions on how much money and other resources are made available, especially with a drug like 1592 which does not appear to be particularly difficult to manufacture. Also, they believe that persons with no other satisfactory options should be allowed to take the risk of using a drug early in human testing, pointing out that ddI was made available before approval to almost ten times as many people as planned for 1592, based on about the same human experience as 1592 has now.

Programs for pre-approval expanded access to AIDS treatments have become far more restrictive in the last year and a half. The PWA Health Group researched this history, and noted the contrast between the large expanded access programs for ddI, ddC, d4T, and 3TC (the largest expanded access program of all, by Glaxo Wellcome), compared to far smaller programs for the protease inhibitors saquinavir, ritonavir, and indinavir -- and for the initial "compassionate use" program for 1592 (with a larger "expanded access" program announced for later, but with no specifics given).

Some of the protests are:

* The 1592 Access Coalition, a group of over 20 activists, are circulating a sign-on letter to AIDS organizations (see below). The letter will be sent to the CEO of Glaxo Wellcome.

The 1592 Access Coalition is also working with the White House, through the Office of National AIDS Policy director Sandra Thurman.

* Activists are planning a national boycott of Glaxo's over-the-counter product Zantac. For more information, contact ACT UP/Golden Gate, 415/252-9200, fax 415/252-9277, email actup@actupgg.org

* On May 31, 300 AIDS activists from New York, Philadelphia, and Cleveland conducted a die-in at the POZ Life Expo in New York, protesting lack of access to experimental AIDS medications by persons who need them. After learning of the planned demonstration, Glaxo Wellcome withdrew from the Expo.

At this time no information has been released on exactly when the July access program will start, nor what number physicians or patients should call to register. More information may be available within a week or two.

1592 Access Coalition Consensus Letter

The following letter, addressed to Robert Ingram, Chief Executive Officer of Glaxo Wellcome, is being circulated to AIDS organizations for sign-on. Organizations can sign the letter by faxing their endorsement to Linda Grinberg at FAIR, 310/471-4565. If you have any questions or need more information about 1592 or the proposed access program, contact Ron Baker at 415/487-8065. If you want to join the Coalition or be more involved in the protests, leave a message for Jeff Getty at ACT UP/Golden Gate, 415/252-9200.

"Re: Development of Abacavir (1592)

"Community treatment advocacy groups and activists watch with growing concern as the major pharmaceutical companies continue to reduce the size of compassionate use and expanded access programs for promising new AIDS drugs. The limited 1592 compassionate use program proposed by Glaxo Wellcome provides the most recent example of the industry's misguided policy on early access.

"The individuals and organizations listed below call on Glaxo Wellcome to take the following actions regarding 1592:

"I. Compassionate Use Program.

"A. Commit to significantly increase the size of the compassionate use program scheduled to begin in July 1997. (It is anticipated that more than 10,000 patients worldwide may need 1592);

"B. Triage patients to ensure those in most critical need are given highest priority;

"C. Provide monthly progress reports to designated community representative(s) regarding production capacity and patient enrollment;

"D. Describe procedures to ensure equity of access and avoidance of preferential treatment to patients at selected sites;

"E. Provide the drug to patients who cannot access the medical sites designated by Glaxo. (Traditionally, compassionate use programs reach patients through their healthcare providers.)

"II. Expanded Access Program

"A. Initiate an expanded access program at the earliest possible date in 1997;

"B. Provide details regarding inclusion/exclusion criteria, size and scope of program, distribution plans, and other pertinent information as soon as possible.

"III. Protocols and Clinical Trial Sites - Provide information on 1592 protocols and identify clinical study sites, as promised, immediately.

"IV. Accelerated Approval

"A. File for accelerated approval of 1592 no later than March 1998;

"B. Initiate rolling data submissions to FDA as soon as possible.

"Promising new therapies such as 1592 must become available as soon as possible to people without treatment options who face disease progression or death. Community advocates and activists call upon Glaxo Wellcome and all AIDS drug manufacturers to recognize that people with advanced disease have a basic right to speedy access to new experimental therapies when all other treatment options have failed.

"We look forward to receiving your response to our concerns regarding 1592."

Sincerely,

1592 Access Coalition

Ron Baker, Bill Bahlman, Peter Cashman, Sally Cooper, Paul Davis, Martin Delaney, Jeff Getty, David Gilden, Linda Grinberg, John Iverson, Cleve Jones, Kate Krauss, James Learned, Jules Levin, Andrew Lipschitz, M.D., Joel Martinez, Eileen Mitzman, Leigh Paidolfino-Danas, Lili Rundback, Matthew Sharp, and Theo Smart

The letter has only been available for a few days before this article went to press. The following AIDS organizations have endorsed it so far:
ACT UP/East Bay
ACT UP/Golden Gate
ACT UP/Los Angeles
ACT UP/New York
AIDS Action Now (Toronto)
AIDS Service Center, Pasadena
APLA (AIDS Project Los Angeles)
Center for AIDS: Hope and Remembrance Project
CRIA (Community Research Initiative on AIDS)
FAIR (Foundation for AIDS and Immune Research, formerly the
Linda Grinberg Foundation)
GMHC (Gay Men's Health Crisis)
Healing Alternatives Foundation
Log Cabin Republicans
Mothers' Voices
NATAP (National AIDS Treatment Advocacy Project)
Project Inform
San Francisco AIDS Foundation
TAG (Treatment Action Group)

Comment

Whatever happens with access to 1592, what is most important is to use all antiretrovirals well. It is widely agreed that a single drug should not be used by itself, and should not be added by itself to a regimen which is failing to control the virus. Otherwise the virus is likely to develop resistance to the new medication, and the patient will lose most or all future benefit of using that drug, or other treatments to which the virus may be cross resistant. To help prevent this, at least two new drugs should be added at the same time.

One reason for the importance of 1592 is that many people have already used up most of their antiretroviral options, as a result of the way these drugs were used in the past, when less was known about HIV treatment. 1592 may be a potential addition to the one or two treatments they have left.

Those who cannot get access to a combination which is promising for them might choose to wait to change treatments, if possible, until a better regimen is available -- rather than adding new drugs one by one when they become accessible.

None of this justifies any delay in making a new treatment available to patients and physicians (such as the idea of holding back a drug until it can be provided with other drugs). Each person is different -- and many now have one or more approved treatments which they could use, but also need something else, such as 1592, to put together a promising antiretroviral regimen for themselves.