The Bay Area Reporter - May 2, 1995
G'Dali Braverman ACT UP Writers Pool

In an unexpected last-minute turn of events, Glaxo contacted the GAPA Community HIV Project (GCHP) on Wednesday, April 26 with a preliminary announcement stating the criteria for the 3TC Expanded Access Program would be drastically changed.

Glaxo had announced on March 30 that, due to drug supply problems, the expanded access program for 3TC would only enroll 350 applicants per week. Current applications have been upwards of 800 per week. Community activists agreed that drug should be prioritized for people with lowest CD4s (t-cells), but also stipulated that the primary criteria for accessing drug, 300 CD4s or less, must not be changed; now Glaxo is poised to inform doctors of an amendment to the program, allowing only patients with less than 100 CD4s to apply! Suddenly it appears us though Glaxo is attempting to reduce the total number of patients receiving free 3TC prior to their projected autumn '95 application to the FDA for drug approval.

Community activists feel strongly that people having between 100 and 300 CD4s should not be excluded from applying/accessing 3TC. Many of those patients have failed on, or are unable to tolerate AZT, ddI, ddC, and d4T.

While Glaxo has not yet produced hard data, the company guesstimates that the average CD4 count amongst patients who are currently receiving drug is approximately 90. By using 100 CD4 as the cut-off for eligibility, the company has suggested that few patients will be excluded. However, activists note that 90 is the average - not the top end of the range - of CD4 for those receiving/seeking drug. Even if all 350 slots per week were to be filled by people with fewer than 100 CD4s, the community feels that applications for those with higher T-cells should be accepted and processed, and patients should be wait-listed.

"While Glaxo has acknowledged community concern around the needs of patients at later stage of disease, the company is clearly making a policy decision which is independent of drug supply issues," says Jeff Getty of ACT UP/Golden Gate.

At an April 10 meeting in San Francisco, Glaxo representative Dr. Mark Rubin repeatedly assured activists that time, and not cost, was the issue in supplying 3TC for the expanded access program. Dr. Rubin pointed out that the company had been willing to build, remodel, or subcontract manufacturing facilities in order to increase drug production. Glaxo chose to remodel existing facilities, allowing 3TC to be manufactured faster by eliminating several steps in production.

Subcontract contact

Glaxo claims that 100% manufacturing capacity will be achieved by September of this year. Given this projection, it seems that at very least patients should not have to wait until September to apply and then endure the three to six weeks necessary for processing applications and shipping drug.

Like Bristol Myers's ddI and d4T, and Hoffman-LaRoche's ddC, Glaxo's 3TC expanded access program is managed through an independent contractor. That means that when your doctor calls an 800 number to request the drug for you s/he is not calling Glaxo. The contracted agency is responsible for accepting orders, processing documentation, and making sure that drug is shipped in a timely fashion each month for each patient.

Traditionally, drugs which have been dispensed through an expanded access program are continually provided post-approval until such time as patients can actually acquire drug through pharmacies. That could mean a two- or three-month period of time, from September, during which Glaxo would be providing additional drug to several thousand patients.

Assuming that September will see continued demand at the rate of the present 800 applicants per weeks, three months could mean 5,400 (800-350 x 12 weeks) additional patients requesting/receiving 3TC. Since cost is not a consideration for Glaxo (the largest pharmaceutical in the world, which is incidentally buying-out Burroughs Wellcome), the company should be easily able to afford the expense of additional personnel for administration of the program.

Glaxo representative Jennifer McMillan has said that, in the event that requests drop below 350 per week for patients with CD4<100, the company will "consider" applications from patients with more than 100 CD4s. However, this would once again require amending the study protocol, a time consuming process. Moreover, activists fear that busy doctors will simply discourage patients with higher CD4s from requesting drug. Regardless of fluctuations in demand (above or below 350 per week) a wait list would allow ongoing accrual now and faster access come September.

To this end activists are even amenable toward placing other earlier demands, made upon Glaxo, on a back burner at this time. "However, we are still committed to working with Glaxo to develop a more targeted process for outreach and drug access for people with HIV/AIDS who are dependent upon the public health clinics," said GCHP's Executive Director Steve Lew.

If you or anyone you know would be disqualified from accessing 3TC, given Glaxo's latest proposal, please clip any part of this article and simply write your CD4 count, first name, or any other information in bold print directly over the newsprint. Then fax it to (415) 206-9549 (9:00 a.m. to 5:00 p.m. western standard time). This is not a Glaxo Fax number! It is the fax number of a person living with HIV who has consented to collect community response.

These responses will be presented to Glaxo by GAPA Community HIV Project, ACT UP/Golden Gate, and a collection of other agencies providing AIDS treatment advocacy to the affected community. Remember, Glaxo has not yet instituted their current proposal. Your responses are critical to keeping the present less-restrictive eligibility criteria of less than 300 T-cells. Thanks. ACT UP! FIGHT BACK! FAX BACK!

ACT UP Golden Gate meets every Tuesday at 7:30 p.m. at 592 Castro Street, upstairs.
950502
BR950501

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