24. Profits-Before-People Delays Release New AIDS Drug

Sources: SAN FRANCISCO BAY TIMES Title: "The Fight For 1592: AIDS Activists Battle Glaxo Over Access To Anxiously Awaited New Drug," Date: May 15, 1997 Author: Bruce Mirken; SAN FRANCISCO BAY GUARDIAN Title: "OTC Drugs to be Boycotted: AIDS Activists Announce Boycott of Drug Company," Date: July 2, 1997 Author: Nina Siegal

Major media coverage: The Wall Street Journal, November 12, 1996, section B, page 1, column 3

SSU Censored Researchers: Kecia Kaiser, Deborah Udal, and Bryan Way
Community Evaluator: Mary King, M.D.

A decade after the high price of AZT caused AIDS activists to declare a war on Burroughs Wellcome pharmaceutical company, the AIDS community is again gearing up for battle with drug giant Glaxo-Wellcome over access to what San Francisco AIDS Foundation Director of Treatment Education and Advocacy Ron Baker calls "the most important AIDS drug in the research pipeline."

That drug, known as 1592U89, or 1592, belongs to the class of drugs called nucleoside analogs, (a.k.a. "nukes") the same category as AZT, 3TC, ddC, ddl, and d4T. For full effectiveness, nukes must be, "cocktailed," or combined with other protease and non-protease inhibitor drugs. Many AIDS patients have already used the older nukes and have HIV strains that have become resistant to these drugs. For them, 1592, which in earlier tests demonstrated far more anti-HIV punch and appears to be less toxic, represents the only hope for building a drug cocktail that can keep them alive.

Realizing the need for 1592, advocates began meeting with Glaxo-Wellcome last summer to persuade the company to offer the drug immediately on a "compassionate use" basis. Glaxo said they would consider it, but unveiled a plan with only three minuscule programs -- one for children, one for those suffering from severe dementia, and a third for adults without dementia -- which would enroll a total of 2,500 patients. Equally alarming is the fact that access will be restricted to only 30 to 50 sites worldwide. Adults will have to enroll at unspecified "geographically dispersed centers" -- which is also unusual.

The company doesn't expect to file for FDA approval until mid-1998 because of concerns that there is a serious lack of general information on its effects, and because studies have included so few people. Glaxo claims that it is a lack of knowledge around the specifics of how viral resistance works that is holding up their filing for FDA approval.

AIDS activists aren't buying Glaxo's assertions. The 1592 Access Coalition says Glaxo-Wellcome has been stalling development of the drug for nine years because it already manufactures most of the current AIDS medications available. Since these provide a large share of Glaxo's profits, 1592 may make the older drugs become very unpopular, even extinct. Many believe Glaxo is stalling to maximize profits from current AIDS drugs. In other words, profits stand in the way of millions of desperate and dying people.

UPDATE BY AUTHOR BRUCE MIRKEN: "This article was written after nearly a year of glowing media stories that all but declared AIDS over as a result of new anti-HIV drugs that became widely available in 1996. Doctors, researchers, and AIDS activists knew that the drugs weren't working for everyone and that access to promising new compounds was becoming a critical issue for thousands who were running out of options, but little of this was being reported. This story is significant because it represented the tip of a much larger iceberg: That the much-heralded protease inhibitors, though important, were not a miracle cure and that the pharmaceutical industry's responsibilities to people with AIDS had not ended.

"I must add that Project Censored's decision to recognize this piece is significant in another, equally important way. Project Censored has had a long and unhappy history of paying little attention to the gay and lesbian press, for which it has been taken to task repeatedly. I fervently hope this means we're finally on the radar screen for good.

"The campaign for access to 1592 continued through the summer, with a series of protests staged by ACT UP/New York, ACT UP/Golden Gate (based in San Francisco), and others. Over a dozen organizations united to call for an international boycott on Zantac, Glaxo's top-selling product. For months there was little progress, but in October 1997, the company agreed to make the drug available on a larger scale in early 1998, in a program with fewer restrictions, and some activists considered the company's offer good enough to allow them to call off the boycott.

"I am not aware of any mainstream press response to my story, but the protests organized by ACT UP did attract some mainstream media attention beginning in June and July. In San Francisco both daily papers and some radio and TV stations did stories on 1592 and the boycott of Glaxo."

For more information on this and related AIDS-treatment access and research issues, some good places to start are:

ACT UP/Golden Gate, Tel: 415/252-2900;
Web site: http://www.actupgg.org;

ACT UP/East Bay, Tel: 510/568-1680;

ACT UP/New York, Tel: 212/966-4813;
Web site: http://www.actupny.org;

Project Inform, Tel: 415/558-8669; AIDS Treatment News, Tel: 800/ TREAT12 (for subscription information).

UPDATE BY AUTHOR NINA SIEGAL: "In addition to the boycott of Glaxo-Wellcome by the San Francisco chapter of AIDS activist group ACT UP/Golden Gate, Mothers' Voices, a group of mothers of people with AIDS or otherwise related to people who had died from AIDS, then urged the heads of two New York State public employee retirement systems to divest from Glaxo-Wellcome. The two investment funds sent letters to Glaxo threatening to pull out a million shares, worth more than $50 million, if the company did not expand its compassionate use program.

"As a result of the pressure exerted by a four-month boycott, on October 13, the company met with ACT UP to discuss the group's demands, and on October 31, the company agreed to implement an expanded drug access program with no limits. The only criteria would be that the patient be unable to put together a triple combination therapy program.

"The announcement of the boycott was covered in San Francisco by the local gay newspapers and was later picked up by the Associated Press. But according to John Iversen, co-founder of ACT UP/East Bay, the AP story only ran in the San Francisco Examiner. The threat of divestment was covered by The New York Post on August 8, but that story received no other press attention, according to Iverson. To publicize the boycott, ACT UP brought advertisements in The Nation and In These Times, but neither of those publications ran a story on the boycott."