PI Action alerts & updates ... 1997

Glaxo Wellcome Continues to Limit Access to 1592

In the last year, activists have worked to demand wide access to Glaxo Wellcome’s 1592, a promising new antiviral which may be needed by people failing other therapies. After months of advocacy and negotiations, Glaxo has finally announced that it will shortly launch a compassionate use program for the drug. However, the first stage of the program will only allow for 5,000 slots worldwide over the next six months, registering only 200 new people per week. 1592 is the only new drug likely to become available in the near future for those who have failed available combinations with protease inhibitors. In preliminary testing, 1592 appears to be reasonably safe and highly potent. A second larger program of expanded access is under development for the first half of 1998, but this may come too late to help those with the most immediate need.

The 1592 Access Coalition, a group of treatment advocates nationwide, has announced a 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 for the drug no later than March, 1998. Please join this effort to make 1592 available to those who have run out of options!

Action Needed:
Write and call Robert Ingram, CEO of Glaxo Wellcome. Urge Glaxo to increase its compassionate use program for 1592 to meet the need of all who are qualified, and to accelerate their plans for submitting data for an FDA approval. Also ask Glaxo to file for accelerated approval for 1592 no later than March, 1998.

Write your physician and ask him/her to communicate the same message to their Glaxo Wellcome sales representatives. Enclosed are sample letters to help craft your message. Please remember to send us copies of your letters and any responses you may receive.

Copy this Alert and distribute widely to family, friends, co-workers and other advocates.

Many activists are calling for a boycott of some Glaxo products For more information about the boycott, contact Jeff Getty at 510-653-6099.

Contact information:
Robert Ingram, CEO
Glaxo Wellcome
5 Moore Dr.
Research Triangle Park, NC 27709
919-248-2100

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 ddI. 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 can not 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 only have 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’s currently plans to file for FDA approval in 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, refer to the fact sheet enclosed in this mailing. You can also call Project Inform’s National HIV/AIDS Treatment Hotline at 1-800-822-7422.

Sample Letter to Glaxo Wellcome

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

RE: Development of 1592Dear 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 need 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 for 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 need 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 shows 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 to know the size of the need for immediate access to this drug, there is every reason to believe it may exceed the 5000 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 now. This is where we need 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 is unacceptable. With your help, we can turn this situation around.

Thank you for your time and consideration.

Sincerely,
Your name