1592 Access: Larger Program Planned
Plans for a larger 1592 expanded access program, projected to start early in 1998, were discussed at an October 13 meeting attended by several treatment advocates and Glaxo Wellcome representatives. After the meeting, some community groups called off a boycott of Glaxo Wellcome products, which had been organized to protest serious difficulties in gaining access to the drug.Community representatives proposed the following design for the 1998 program:
No Arbitrary Limitation on Program Size. As neither the company nor community representatives could estimate the actual need for the drug, it was agreed from the outset that there should be no pre-established numeric limit on the total number of patients served by the program. Every effort should be made to allocate all available drug, not used for clinical trials, to the program.
Principle of Expanded Access/Eligibility Criteria. The underlying principle of the expanded access program should be to allow patients to construct a viable treatment regimen based on the current treatment guidelines. Unless required by the FDA, community representatives felt this definition eliminated the need to set arbitrary entry criteria such as viral load, CD4+ counts, or failure of specific drugs. (See "Expanded Access to Experimental Drugs: Activist Seek More Open Programs" in our last issue, AIDS Treatment News #282.)
Initiation of Program. Glaxo agreed to make every effort to initiate a broader expanded access program as soon as possible in the 1st Quarter of 1998--without committing to a date certain.
Traditional Distribution. The new program should not be restricted to a small number of centers or physician practices, but should be a more traditional expanded access which would permit registration through a patient's primary care physician.
Flexibility. The program should be designed with enough flexibility that patients who need the drug as a treatment option will have access.
Community Meetings. Glaxo representatives should continue to meet with community treatment advocates and with physicians by holding future meetings in various cities to solicit feedback on the proposed framework for a wider program in 1998.
Glaxo recently reported a total of 615 patients enrolled in the 1592 adult program, but as of October 10 only two children had been enrolled in the pediatric program. At the meeting concerns were raised about the pediatric viral load criteria being too restrictive. It was agreed this limit should be lowered, subject to FDA approval.
Much of the current delay in access to 1592 and other experimental drugs is primarily due to local IRBs (institutional review boards), which often meet only monthly and do not understand the disease or the drug; they may make vital access programs wait in line behind more routine research projects. Glaxo set up a national IRB for the 1592 open label program, but when hospitals have their own IRB, they often require their physicians to use it instead of a national one. As of the October meeting ten sites had not enrolled any patients, as their own IRB approvals were still pending.
Community representatives in attendance were encouraged by the general tenor of the meeting; they felt that a more constructive dialogue and spirit of working in cooperation had begun. They remain hopeful that Glaxo will use best efforts in its 1998 program to adequately address access for all patients who need the drug.
