Home 
by James Learned, PWA Health Group
One year ago, I thought Glaxo Wellcome's nucleoside analogue, 1592 (Abacavir), was one of the most exciting new drugs in the pipeline. Now, a year later, I'm much more wary of 1592's potential and have just turned down an invitation to a private meeting with Glaxo representatives at their United States headquarters in North Carolina. It's been a tough year, and my experience working to help get 1592 to people has raised a lot of confusing questions. I hope that this can help all of us talk to each other about where we are and where we're going with treatment activism.
Community Efforts
Last Fall, community folks began asking Glaxo for a 1592 compassionate use program. A Wall Street Journal article in early November, criticizing Glaxo for not having a program in place, was immediately followed by a community consensus statement (from the 1592 Access Coalition) demanding a two-phase expanded access program to begin "without delay." Three months later, in February, Glaxo released a brief reply: "The first compassionate use of 1592 will be a program for children which is scheduled to begin within the next three months." In fact, an extremely limited pediatric program opened nine months later (250 kids worldwide). From the beginning, the community made it clear that Glaxo's plan was far too small. But throughout this year, Glaxo has played an ugly numbers game. First they said they'd make 1592 available to 2,500 people worldwide as of July. Then the number grew to 5,000 people -- not that they were really making more drug available, they'd just give it out slower, allotting it to 200 new people a week from August through December. Meaning that the PWAs who would finally get drug the week of December 22nd were included in that 5,000 person number for 1997. The numbers game confused most of us while implying twice as large a program.In fact, since the compassionate use program design was "officially" announced in April, the amount of 1592 offered by Glaxo has remained completely unchanged. The design is the worst I've seen. The result today is that 1592 is available to 100 people a week through only 60 sites in the whole country! This means, in practice, that doctors at each site can choose one of their hundreds of patients each week -- leaving everyone else who needs 1592 out in the cold.
Production Problems, My Ass
Glaxo has cited "production problems" as the main reason for this tiny program. Production excuses have been used before, most notoriously by Merck, Abbott and Roche in last year's protease nightmare. I think too many of us have been willing to buy this excuse. Personally, I don't think it's the role of the community to validate a lousy company plan, whatever the company's excuses. I don't care about Glaxo's supposed production problems! Glaxo is the largest pharmaceutical company in the world, one of the largest companies of any kind in the world, a company intimately familiar with the idea of subcontracting and planning for demand. If they wanted to, they could subcontract 1592 today. 1592 is similar to 3TC -- it just ain't that hard to make. Furthermore, Glaxo could make more of it immediately available by using stock they're holding to determine shelflife, like other companies have in the past. If there is a real supply problem, it's simply because the company doesn't want to make enough drug to supply a real compassionate use program.Right now, they're deciding how much drug they'll make available for a second, larger expanded access program in 1998. They said this would open in January; now it's mysteriously moved to March). This summer, Glaxo projected being able to serve 8,000 - 9,000 people through this second program in '98, about 5,400 of them in the United States. This number is way below what everyone thinks is needed, even Glaxo.
Glaxo Feels Our Pain
Glaxo has shown no interest in hearing, let alone addressing community concerns. There have been protests and street actions in New York, San Francisco and Toronto. The New York City Council and San Francisco's Board of Supervisors have publicly demanded that Glaxo enlarge the programs. Articles in HIV newsletters have denounced Glaxo and the program design. Meanwhile, representatives from Glaxo's "Health Care Coalitions and Advocacy Relations Department" (named, I'm afraid, with no sense of irony) have had private conversations with individuals in which they avow their commitment to address community concerns, while at the same time giving each person conflicting information. On July 9, Glaxo reps participated in the only conference call the company has agreed to, largely in response to pressure from the Office of AIDS Policy in Washington. It was the most frustrating conversation I've had with a drug company. The reps were unable or unwilling to respond to any of the specific questions and ideas which had been sent to the company a month earlier and widely published in national newsletters. After hearing the anger, frustration and disappointment voiced by the many community people on the call, the company refused to meet with anyone "for the time being". Meanwhile, the tiny first program outlined by Glaxo in April finally opened in August, with press release fanfare and absolutely no changes in numbers or entry criteria.Following the July conference call, I spoke with Linda Grinberg, a good buddy who spearheaded much of the work of the 1592 Access Coalition. We discussed the likelihood that Glaxo would stall a couple of months and then invite a handpicked group of community people to meet in private, listen attentively, and rubber-stamp the 1998 expanded access plan, as has happened so often with past programs. I fantasized a scenario in which people would boycott the meeting, forcing the company to deal publicly with the very real, large and diverse community of PWAs who desperately need 1592, rather than only those who relish the proverbial place at the table. I felt very high and mighty, sure of my position as a model of integrity.
An Invitation!
During the last week of August, while many of the 60 compassionate use sites still weren't open, I and seven others who work on treatment access issues received an invitation to be flown down to Glaxo's offices in Research Triangle. The company wanted to discuss "development plans for 1592 and 141 (Glaxo's upcoming protease) and to initiate a dialogue between the company and the community as we begin to define the larger expanded access program." The "initiate a dialogue" phrase was particularly bizarre considering all the calling, writing and faxing that people had been doing all year to no avail.I was surprised since I'm not accustomed to being invited to the private meetings that are so common between treatment "activists" and pharmaceutical companies. In general, I don't like the concept of private meetings. The cruel lotteries and vastly diminished expanded access programs of the last few years are, I believe, the direct and sorry result of private meetings. Look at how few people received Saquinavir, Norvir or Crixivan from those hideous lotteries that community members helped devise. Community members involved in private meetings have the best intentions. But not even the brightest and most aggressive advocate can represent "the community" -- the true HIV/AIDS community is far more diverse, interesting and full of passion and ideas than a few seasoned treatment activists can ever be. And besides, the reality is that every time we meet with a company, it's used against us. The way community involvement is exploited is repulsive. In the case of 1592, after a year of hostile phone calls and meetings, Sir Richard Sykes, Glaxo's CEO in London, writes to investors and PWAs alike: "we are working with ... members of the HIV community around the world." He implies that we're satisfied -- an ugly distortion of our honest attempts to help create useful programs.
Rationalizations
So I received my invitation from Glaxo with a mixture of confusion and heightened responsibility. My immediate reaction was to refuse it. But when I talked with other people, advocates as well as individuals who really need 1592, my resolution wavered. I began to wander down the path taken by all of us -- including myself -- who have ever attended exclusive meetings. What if Glaxo is at last interested in listening to our concerns? What if I'm able to articulate those concerns in a way that's both aggressive and clear? If I decline the offer, Glaxo will say that they invited the community to "dialogue" and the community refused to talk. Damned if I do, and damned if I don't. After all, it's not as though they can buy me, compromise my integrity, or change my conviction that 1592, whatever its merits, must be available to whoever needs it. And besides, it's just one meeting. And in North Carolina! It's not like I'm heading off for a weekend in San Francisco or Paris!Time to Pull Back
For an entire year, Glaxo has refused to listen. They have refused to change their programs in any way. They've treated the community with contempt. This is the company whose price-gouging on AZT in 1987 will live forever in the memory of those of us who are still around. And the company that raised the prices of AZT and 3TC last year when the drugs began to be more widely used in combinations. And the company that conducted the largest expanded access program in history (3TC to 32,000 people in 1995) based on less data than we have for 1592. Glaxo has boycotted two POZ Expos (New York and Washington, DC) for fear of having to face non-violent demonstrations by PWAs demanding 1592. The company has circulated internal memos about death threats and urged private security for Glaxo employees traveling to New York, creating paranoia and distrust based on nothing. The only thing Glaxo has to fear is the honest demand that they create ethical access to possibly life-saving treatment.So I refused Glaxo's invitation. As did others. Whether the private meeting takes place or not will make no difference to how many PWAs get 1592 next year. After I declined the invitation, a Glaxo rep (sincerely or cleverly befuddled, who can tell?) called to ask me how the company could develop a good relationship with the community. The answer is simple: MAKE 1592 AVAILABLE TO THOSE WHO NEED IT. Glaxo has shown no good faith. Creating an ethical access program and releasing critical data would be a sign that the company understands its moral responsibility to people with AIDS. Until then, let the boycotts, the demonstrations, the letter-writing, telephoning and faxing increase in size, imagination and force.
Now What?
Community-corporate partnership doesn't work to our benefit -- ever. The pharmaceutical industry and people with HIV/AIDS have different goals -- sometimes overlapping, but different. The industry is about profit. We're about survival and health. We will always be adversaries who need each other. I'm almost overwhelmed with questions about the role of those of us who work on treatment access issues. As Martin Delaney of Project Inform has eloquently written, when do our attempts to get a new drug turn into more marketing for the companies? We've splashed 1592's name everywhere, creating enormous demand and unrealistic expectations. DMP266 (Sustiva), Dupont Merck's new NNRTI, has received very little play, even though it may be a far more useful anti-viral. And those of us who talk to the drug companies, who are we accountable to? When the resulting programs are lousy, doesn't our involvement in their design inevitably discourage community outrage? Doesn't today's model of treatment demand new standards of inclusion for compassionate use programs? Why aren't we demanding data from these programs so that we know early on how the drugs work? And, maybe most important, why aren't we openly discussing and examining the current process of who gets chosen to represent the communities of people with HIV and AIDS? Can we do this without trying to destroy each other in the process?Ethical and sound medical access to new treatments requires grassroots organizing, the polar opposite of private, elitist meetings where individuals represent "the community." We all have a part to play in this organizing work, and every voice needs to be heard.
1592: What Is It?
Glaxo Wellcome's new nucleoside analogue, 1592 (Abacavir), is now available to a few thousand people worldwide through the smallest, most abysmal "compassionate use" program ever. 1592 is no miracle drug; early trials have reported side-effects including up to 70% nausea. Test tube studies show that cross-resistance may exist between 1592 and ddI, 3TC and ddC, so it may not be useful to people who've already gone through these other nucleosides. Anecdotally, some folks with earlier exposure to these other nucleosides have had excellent if limited results with 1592, while others definitely haven't. But for someone who's anti-viral naive, 1592 may be the most potent nucleoside yet. But whatever its degree of treatment potential, 1592 must be made available to anyone who needs it. To apply for the compassionate use program, have your doctor call (800) 501-4672.
PWA Health Group
last modified: 10/10/97