The Bay Area Reporter - July 18, 1995
G'Dali Braverman ACT UP/Golden Gate Writers Pool

After months of negotiations with activists around the country, Merck flew in four corporate representatives to San Francisco for July 13 meetings with a handful of AIDS activists. The company was hopeful that the community would be pleased with its proposal for broadening access of Crixivan to people at later stages of HIV disease. Indeed, few complaints were voiced.

Earlier this year Merck had announced that it would provide drug to only 300 patients, outside of studies, nationally. The company had cited production limitations as the primary problem. After much pressure from ACT UP/Golden Gate (definitely not to be confused with ACT UP/San Francisco) and The Living Well Project (formerly known as GAPA Community HIV Project), Merck set up west coast meetings to discuss community concerns. At those meetings the two organizations made sure that Merck dealt directly with people with HIV/AIDS. "It was the first time I could ever remember meeting with a pharmaceutical company where everyone in the room, except the drug company reps, was HIV-positive." said Jeff Getty of ACT UP/Golden Gate.

Activists focused on the need for broader access, as well as targeted outreach to underserved populations. Hearing extensive input directly from people with fewer than 50 CDs and those depending upon the public healthcare system proved to be crucial to altering Merck's vision of an expanded access program. Between March and June of this year the company began considering the creation of a program that would enroll up to 1,400 patients through approximately a dozen "HUB sites" around the country. The HUB sites were to include existing research sites slated to conduct Phase III studies.

While initial screening would happen through these sites, subsequent access to drug would have been made available through a patient's primary care physician. Although activists were not wholly in favor of this proposal, they continued to work with Merck in identifying the limitations of this approach, as well as the benefits of pursuing other options. Many activists felt that it would be unreasonable for patients with very low T-cell counts to have to travel long distances for initial screenings. Concerns that such a program would discriminate against sicker patients may have eventually contributed to the scrapping of the HUB site expanded access idea.

The program that Merck announced this week may be one of the best thought-out limited expanded access programs the community has seen to date.

Constructive pressure

"It is because of constructive pressure from the activist and advocacy community that we are offering this program," says John Doorley, Merck's Executive director of Corporate Communications. While the program offers only 1,400 people the opportunity to get the Merck protease inhibitor this year, accessing the lottery is very user-friendly for patients, caregivers, and doctors. One simply calls 1-800-497-8383 to register, between July 17 and August 11. The call is both free and confidential. Merck has also assured the community that they have contracted with a company that will provide over 100 operators to accept calls; so busy signals and voice mail music limbo is not anticipated.

By using a lottery system Merck has dealt with community concerns over patients who depend upon public healthcare. Because public healthcare doctors have limited support staff it was felt that they are less likely to quickly access an expanded access program. First-come-first-serve programs for drug allocation have resulted in greater access to those with private care. It is critical that industry get a truer snapshot of the effects of treatments in a wider spectrum of the AIDS community. Data on drugs should not be biased or restricted by one type or level of HIV care.

On August 15, l,100 names will be randomly picked. These individuals and their doctors will have until September 8 to complete and send in a Patient Qualification Form. Merck will then request that blood samples from this prospective pool of participants be sent off to a central lab. Of importance to all applicants is the fact that a wait list will be created for all patients who fall outside the first l,100 names picked. Therefore, if for any reason slots become available from amongst the first group, wait-listed patients will become eligible.

By now you may have asked yourself, why are there 1,400 slots but only 1,100 names being picked through the lottery? The remaining 300 slots will be divided evenly amongst research sites conducting a controlled study of people with less than 50 T4 cells. Patients who have made a good-faith effort to enter that study, but do not qualify or screen out, will be re-routed into the 300 remaining expanded access slots.

Locally, that study is taking place at San Francisco General Hospital. "Our greatest priority is to enroll and complete our Phase III trials, so that we can make Crixivan more available," says Linda Disterlath, Merck's Executive Director of Public Affairs.

While no one seems confident as to guessing how many jelly beans are in the jar (i.e., how many people will apply for Crixivan) everyone expects that applicants will far outnumber slots. Some activists are asking that Merck take this opportunity to collect the most basic data on all patients applying for Crixivan. Activists have proposed that all applicants be asked (but not required) to consent to having a third party access the National Death Registry at some future time. This might help the community at large at some future point. Merely being able to look at differences in survival between those who did or did not receive drug would be an invaluable piece of information. Of course, many other factors could come into play in explaining survival differences; but a large enough group might allow for a wash-out of those variables. Weighing information on survival against the risks or toxicities of taking a new drug is probably more important to people at later stages of disease than fluctuations in T-cells.

There are a few other issues that People with AIDS might consider in applying for Crixivan. If you have less than 50 CD4s and entered the Hoffman La Roche lottery for the Saquinavir protease inhibitor, you can still apply for Crixivan. This may be a good strategy, since there is no guarantee that you'll get a slot in either program. However, while neither program restricts use of other antiretrovirals (such as 3TC), both programs will not allow patients to be on another protease inhibitor.

Finally, it's important to note that the Crixivan 800 number will have Spanish speaking operators. However, monolingual non-English speaking patients will either need to rely upon a provider or physician in order to apply. The Living Well Project is offering multilingual support to Asians and Pacific Islanders seeking additional information regarding the Crixivan Program; merely call 415-575-3939 (Extension 305 for English only). Remember, anyone can call the Crixivan 1-800-497-8383 for information regardless of whether one intends to apply or not. While this seems like an inconsequential fact, it's important to recognize that activists have helped to create this line of direct communication between patients and industry. Today our doctors are busier than ever. As patients we need to be able to bring information and options to them. After all, that is how standard of care in HIV has continued to evolve.

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