A Drug to Relieve the Pain

There is currently a letter writing campaign involving a 
promising new drug for the treatment of AIDS.  The drug is known 
as 1592  and was developed by the pharmaceutical company Glaxo 
Wellcome.  It is similar to AZT but is supposed to be more 
effective and have less side effects.

1592 has been in small clinical studies since 1995.  It has not 
been approved by the FDA (and Glaxo Wellcome has not applied for 
FDA approval), and so it is not available by prescription.  1592 
was supposed to have been released on July 1st for compassionate 
use by people with AIDS who have failed all other available drug 
treatments.  (A compassionate use program is a means of providing 
treatment, prior to FDA approval, to people who meet certain 
eligibility requirements.)  A person with AIDS in San Francisco 
told us that as of the end of August, his doctor - one of the 3 
in San Francisco who will distribute the drug - still had not 
received it and wasn’t aware of anyone who had.

The compassionate use program that Glaxo Wellcome does plan will 
have only 5,000 slots worldwide, registering only 200 new people 
per week, and by all accounts the numbers far exceed that.  We 
have heard one estimate of 10,000.  There will only be 65 doctors 
nationwide distributing the drug to only 2 patients per week.

The 1592 Access Coalition, a group of treatment advocates 
nationwide, organized the campaign to demand that Glaxo Wellcome 
increase the size of its compassionate use program to meet the 
actual demand for the drug and file for accelerated FDA approval 
no later than March, 1998.  They are asking everyone to join them 
in the effort to make 1592 available for those in need.  They are 
asking you to write or call Robert Ingram, CEO of Glaxo Wellcome, 
and to also write to your physician and ask him or her to 
communicate the same message to their Glaxo Wellcome sales 
representative.   

We understand that there is currently a boycott against Zantac, 
an over-the-counter drug which is a huge money-maker for Glaxo 
Welcome.  The boycott alleges that the reason Glaxo Wellcome has 
limited the number of participants in its compassionate use 
program and is taking its time to get FDA approval is that it 
wants to maximize its profits on already existing drugs, such as 
AZT.  For information about the boycott, you can contact Jeff 
Getty at 510/653-6099.

Following are background information and sample letters we 
received from Project Inform, an AIDS information and advocacy 
organization in San Francisco.  For more information, Project 
Inform is located at http://www.projinf.org (1965 Market Street, 
Suite 220, San Francisco, CA  94103; telephone 415/558-8669; fax 
415/558-0684).


Background Information

Glaxo Wellcome’s 1592 is a nucleoside analogue drug (similar to 
AZT) that has recently raised great interest in the AIDS 
community.  Initial study results demonstrate that this treatment 
has significant potential as a replacement for the current drugs 
of the same class, like AZT and ddl.  1592 has been shown to 
cross the blood-brain barrier, suggesting that the drug may play 
a role in the prevention and treatment of HIV-related dementia.

The most important feature of 1592 is that it is new and 
therefore may be needed by people who cannot find two new drugs 
when changing to a new combination.  Two new drugs are necessary 
for optimal results.  Many others simply have no drugs left which 
work for them.

Advocates are pressuring Glaxo Wellcome and the FDA to allow the 
earliest possible access to this drug for those who have no other 
therapy options or who lack new drugs to begin combination 
therapy.  Glaxo Wellcome is planning to launch a compassionate 
use program (a mechanism to provide treatment in development free 
of charge to people who meet certain eligibility requirements).  
However, this program will have only 5,000 slots to meet the 
demand worldwide.  While no one knows what the size of the real 
need is, it may easily exceed this number.

Glaxo Wellcome currently plans to file for FDA approval in 
mid-1998.  This may be too late for many people.  It is critical 
that they do everything possible to hasten this timetable and be 
prepared to supply the drug for a large scale expanded access 
program in the first half of 1998 to cover the gap while awaiting 
FDA approval.  The message to Glaxo Wellcome must be loud and 
clear:  Make this drug available, as soon as possible, for those 
people who have exhausted current therapies and lack sufficient 
elements for an effective combination therapy strategy.  Glaxo 
Wellcome should know that cooperation with the community is 
essential in the drug development process.

For more information about 1592, you can call Project Inform’s 
National HIV/AIDS Treatment Hotline at 800/822-7422.  



	Sample Letter to Glaxo Wellcome

Mr. Robert Ingram
Chief Executive Officer
5 Moore Drive
Research Triangle, NC   27709

Re:	Development of 1592

Dear Mr. Ingram:

I am writing to urge you to do everything in your power to 
provide immediate access to 1592 for all those in need.  Glaxo 
Wellcome’s 1592 compassionate use program, even for 5,000 people, 
may prove to be inadequate.

[Insert personal story here.  If you or someone you know may need 
access to 1592, discuss that here.]

In addition to increasing the size of your compassionate use 
program, I am also asking you to make sure that the larger 
expanded access program for 1592 start at the earliest possible 
date in 1997 and that you file for accelerated approval of 1592 
as soon as this is feasible, ideally no later than March, 1998.

As you well know, 1592 provides hope for many people living with 
HIV/AIDS who have failed on all available combination therapies 
or who lack an unused companion drug needed to make an effective 
combination therapy.  It would be inhumane  for Glaxo to limit 
access to this treatment.

I look forward to receiving your response to my concerns.

Sincerely,

Your name


	Sample Letter to Physicians

Dear Physician,

I believe that Glaxo Wellcome is not doing all it can to provide 
access to a promising new HIV antiviral, 1592, and I am asking 
for your help to change this situation and increase access to 
effective therapies for people with HIV and AIDS.

1592 has been in small clinical trials since 1995.  Data obtained 
so far show that the drug is many times more active than 
currently approved NRTI drugs, with fewer side effects.  Some 
trial participants have shown turnarounds every bit as dramatic 
as seen with protease inhibitors.

In spite of this promising data, Glaxo has repeatedly delayed 
further trials and is not planning to apply for FDA approval 
until mid-1998.  After much delay, Glaxo has offered a 
compassionate use program for only 5,000 people worldwide.  While 
we cannot pretend t o know the size of the need for immediate 
access to this drug, there is every reason to believe it may 
exceed the 5,000 slots announced worldwide.

I believe Glaxo Wellcome should implement a compassionate use 
program which truly meets the needs of people with HIV/AIDS and 
do whatever it takes to make 1592 available to all who need it.  
This is where I am asking for your help.  

I am asking you to let the Glaxo Wellcome sales representatives 
know that you believe the delay in making 1592 available and the 
inadequate compassionate use program are unacceptable.

With your help, we can turn this situation around.  Thank you for 
your time and consideration.

Sincerely,

Your name
____________________________________________________________
If you wish further information on this drug and it's
possible effects on our friends who are HIV/AIDS infected
please send me an EMAIL.