Genentech Shows Compassion, with a Catch
It was clear drugmaker Genentech had a potential public relations mess on its hands. AIDS patients who had participated in a government-sponsored trial to test Genentech’s experimental recombinant human nerve growth factor (rhNGF) were angry that the company had abruptly halted the study in April and cut off their supply of rhNGF. This despite claims by patients that the treatment eased the pain and dysfunction caused by a degenerative nerve disorder, HIV peripheral neuropathy. Prominent neurologists who had administered the trial were outraged as well that the company said it had no interest in pursuing further studies.
AIDS activists demanded Genentech explain itself. Patients and their supporters sent irate letters to the company and the media. Two small California newspapers ran stories on the company’s actions, and a Mother Jones reporter was working on another.
Then, suddenly, Genentech invited a handful of key activists and patients to “discuss rhNGF” and “options for next steps.”
After the July 2 meeting, Genentech made a surprising announcement: It would dispense its remaining supply of rhNGF to trial patients who wanted the drug, and it would be willing to discuss providing the drug to a third party for a new study (two things the company had previously said it had no interest in doing). The drugmaker’s move even earned it some positive coverage from the Associated Press.
How does Genentech explain its change of heart? “This was really the first time it had been clear to us that there was a constituency of patients that … felt they were benefiting from the drug and really wanted to stay on it,” says Dr. Stephen Dilly, vice president of medical affairs at Genentech.
Patients and physicians, however, dispute Genentech’s claim. Activist and patient liaison Mike Donnelly says he has benefited from rhNGF since he entered the trial in 1996 — and Genentech knew it. “NGF made a big difference in my life; I could be mobile again,” says Donnelly, who couldn’t walk more than a few blocks before the trial. “[Genentech] has known all along that people wanted to stay on this drug.”
Tom McElroy, another trial patient, made his feelings known loudly. In April and May he made frantic calls and sent letters to tell the company about how the treatment had helped him. “Before rhNGF I had lost the ability to walk a block or climb a flight of stairs,” McElroy wrote in May. “Since rhNGF, I am mobile, independent, and even went camping and did some very light hiking.” McElroy asked Genentech to continue supplying rhNGF to trial participants. Genentech replied simply that the drug “will not be available.”
AIDS groups and doctors say it was only because of their pressure that the drug was ever available to HIV patients. Genentech had developed rhNGF for a different — and potentially much more profitable — market: the more than 4 million Americans who suffer from diabetic neuropathy. Only about 200,000 AIDS patients have peripheral neuropathy, caused by HIV or certain HIV drugs, with some 25,000 new cases a year. But in 1996, while it funded a large-scale Phase III trial on rhNGF for diabetes patients, Genentech did agree to provide the drug for a smaller trial sponsored by the AIDS Clinical Trials Group (ACTG), funded by the National Institutes of Health.
Doctors who conducted the HIV trials saw very positive results: rhNGF didn’t make patients sick or interact with other drugs (some AIDS drugs can bring on additional illness by interacting with other medicines), patients got great relief from pain, and there was evidence of modest neurological improvement. Genentech disputes the validity of the results. The neurologists agree the results were not conclusive, but they determined that rhNGF showed enough promise to warrant further testing. “Some patients who responded were people who had responded to nothing else,” says Dr. Elyse Singer, who directed the HIV study at the University of California, Los Angeles.
Last April, though, Genentech pulled the plug on further rhNGF studies when the drug proved ineffective in the diabetes trial. With their supply cut off, AIDS patients eventually exhausted their remaining doses and began to regress physically. McElroy says he felt the effects within days. “Just the weight of the comforter bearing down on one foot was unbearable,” he says.
Genentech also showed an unwillingness to supply the drug for other studies. In November 1998, Dr. Justin McArthur, the principal investigator for the HIV trial and deputy director of neurology at Johns Hopkins University, sent Genentech a proposal for a follow-up study. He didn’t want funds — there was enough money from a running NIH grant to back another study of several hundred patients; all he needed was for the company to supply the rhNGF. According to McArthur, he was sent a reply saying that Genentech would not provide rhNGF for future studies.
Even now, with the company’s apparent reversal, McArthur is cautiously optimistic at best. “No one’s breaking open the champagne,” he says. Genentech says it will start distributing rhNGF to trial participants who want it. There is enough of the drug, company officials say, to last one to two years, though no one can say precisely how much or when patients will actually receive it — a critical point since some supplies will reach their expiration dates by year’s end.
Beyond the issues of dispensing the drug, there are questions surrounding Genentech’s support of future testing. The company says it is willing to provide rhNGF for future study but that it would do so only for a yearlong, pivotal Phase III study with at least 1,000 patients. And, according to Genentech spokesman Geoff Teeter, the company — which had revenues of $1.2 billion in 1998 — will not fund such a study. But without corporate backing, doctors say, a large-scale trial is unlikely to happen. “The ACTG has taken the position that pivotal studies should be sponsored by pharmaceutical companies, not tax dollars,” says McArthur.
Doctors hope that trial patients will resume getting the drug, but they remain skeptical of Genentech’s sudden compassion. “It doesn’t explain the capricious and cynical nature that’s been displayed here — that you can turn off a study and turn it back on months later,” says McArthur. “It’s not the proper way to treat patients, particularly those who are suffering.” —Leora Broydo
Russia Wants Your Nuclear Waste
Russia is the most radioactively contaminated country in the world: Its nuclear industry is in collapse and its current economic crisis is so severe that it can barely manage waste from its own nuclear reactors. Given these circumstances, it seems unlikely — not to mention ill- advised — that Russia would position itself to become the world’s nuclear waste dump. But Minatom, the Russian atomic ministry, is proposing just that — offering the bright, circular logic that revenue from such ventures would help solve the country’s existing nuclear crisis.
To cash in on a projected $150 billion market, Minatom wants to import thousands of tons of spent reactor fuel from Europe and Asia for both storage and reprocessing — the recovery of fissile plutonium from used fuel. A Minatom document leaked in January outlines negotiations with Swiss utilities to import 2,000 tons of spent Swiss nuclear fuel. Another memo indicates that Minatom has its eye on “final disposal” of 10,000 tons of spent fuel “from Switzerland, Germany, Spain, South Korea, Taiwan, and possibly Japan.”
Spokesman Yuri Bespalko says Minatom expects to make up to $10 billion over the next seven years from these deals, revenue that will pump up Russia’s faltering economy. Bespalko adds that funds will also be set aside for “upgrading the nuclear industry” and “solving the ecological problems.” Specifically, he mentions the task of cleaning up Lake Karachay in the Ural Mountains. (A person standing by the shore of Lake Karachay would receive a lethal dose of radiation in only half an hour, says Harvard nuclear expert Matthew Bunn.)
Minatom’s proposal has drawn fire from environmental groups. “Minatom has never spent [its profits] cleaning contaminated areas,” says Vladimir Slivyak of the Russian Socio- Ecological Union. “It does not care about safety of the population or environmental protection. But it cares about money — a lot.” Tobias Muenchmeyer of Greenpeace International pulls no punches, saying nuclear waste export to Russia “would be a criminal act of negligence by wealthy nations.”
Minatom calls the dire depictions of Russia’s nuclear industry overstated and emphasizes the use of reprocessed fuel in meeting the nation’s energy needs. But Oleg Bukharin, Russian energy specialist at Princeton, cautions that reprocessing creates additional radioactive waste and that, done incorrectly, “it could be disastrous.”
Although importing spent fuel for storage is currently illegal in Russia, this has not stopped Minatom from exploring potential deals:
- In December 1998, Minatom chief Evgeny Adamov wrote Energy Secretary Bill Richardson proposing the “transferÉof spent fuel from U.S. nuclear power plants to Russia for its long-term storage and subsequent reprocessing.” The Department of Energy refuses to comment on the Russian proposal, except to say that any plan that envisions reprocessing — illegal in the United States — would not be considered.
- And in July, Minatom and a U.S. nonprofit called the Non-Proliferation Trust — a group including an ex-CIA director and former Cold Warriors, and advised by the Natural Resources Defense Council — agreed to jointly pursue a 10,000-ton Russian waste-storage facility.
“There has been an effort to set up international storage facilities for a long time,” says Princeton’s Bukharin. “None of them has been successful.” Critics maintain that Russia is simply the wrong place to start: “Minatom has no idea about what to do with [our] own waste,” says Slivyak. — Julian Brookes and Jen Soriano
Go to your Web browser — type in Nigger.com. Go ahead. Try it.
Didn’t find anything? The NAACP — which owns the domain — prefers it that way. How about Kike.com? Nothing there either — the Anti-Defamation League is sitting on the domain. These non-Web sites are just two high-profile examples of a growing, if scattered, movement to preemptively register offensive domain names, thus keeping them out of the hands of Internet-savvy bigots.
“With the wonders of the Web comes this dark side, and it’s very, very dark,” says ADL civil rights director Elizabeth Coleman. With the goal of stemming hate speech, the ADL registered “Kike” and “K-i-k-e” in their common suffixes — .com, .org, and .net — in January 1998. “We didn’t want them to be used by people in an anti-Semitic way,” says Coleman.
The NAACP saw the merits of owning the N-word — and purchased the three common permutations of both “Nigger” and “N-i-g-g-e-r” a few weeks later. “You might say it’s a self-defense mechanism,” says spokesman John C. White. “We’d like to avoid having hate mongers use the sites for that purpose.”
NAACP webmaster James Smith, for one, advocates creating an educational site at Nigger.com. “It’s there. It’s a resource,” he says.
Employing similar logic, software engineer Jack Lakey is building a site for gay men at his Faggot.org domain, and Texan Sue Beckwith is doing the same for lesbians at Dyke.com. “I felt like I was doing the lesbian community a disservice by just sitting on the domain,” she says.
Given the Internet’s unregulated marketplace of ideas, it’s questionable what effect, if any, preemptive domain buying has. “Anything you do is small because the Web is so vast,” concedes the ADL’s Coleman. “It’s like chasing cockroaches.” — Michael Mechanic
Sixth Annual Roundup of Campus Activism
Top 10 Student Actions
From Madison to Mexico City, the students in our survey didn’t just accept that Chancellor knows best. Contrary to the image of the apathetic Gen Xer, students at these and other campuses mobilized and fought for change in civic and campus affairs ranging from homelessness and workers’ rights to diversity and fair tuition. — Jennifer Barrios
Arizona State University, Tempe (33,300*) After the Tempe City Council banned sitting on public sidewalks — a response to businesses distressed by “transient, homeless, runaway, and slacker” youth — some 40 students from Project SIT (Sidewalk Initiative Team) staged four downtown sit-ins and a peace vigil last December. Two SIT members also won a preliminary injunction, based on First Amendment rights, barring the city from enforcing the ordinance.
California State University, Northridge (21,000) Despite CSUN’s having one of the premier collegiate programs for the hearing-impaired, deaf students there still face communication barriers. They’ve had trouble getting interpreters for classes and for required out-of-class activities. Last February, more than 50 students, faculty, and interpreters protested, forcing the creation of a committee to study implementation of the Americans with Disabilities Act.
Fairfield University, Fairfield, Conn. (3,100) When this Jesuit university outsourced its janitorial staff to a private contractor, 40 students occupied the administration building to decry the move. The largely Hispanic janitors had earned $15 to $20 per hour working for Fairfield; under the new boss they made $6 to $10 hourly. After students threatened a hunger strike, the university agreed to cancel its agreement with the contractor and appointed a task force to revise its policy on using private contractors.
Massachusetts Institute of Technology, Cambridge (4,400) Members of GaMIT, a 30-year-old gay and lesbian student group, called for MIT to ban ROTC from campus, citing the school’s nondiscrimination policy (ROTC does not accept openly gay and lesbian students). As it grapples with the conflicting policies, MIT faces a pricey dilemma: Under a 1997 law, any school that bans ROTC will lose federal funding — in MIT’s case, $270 million.
National Autonomous University of Mexico (150,000) Mexico’s constitution guarantees its citizens the right to free higher education. So it came as a shock to students at this 448-year-old university when the administration voted to raise student fees from the equivalent of 4 cents (U.S.) a year to $145. Outraged, students and their supporters shut down the school in April. In a partial concession seven weeks later, the administration made the fees optional, but at press time the shutdown was still in effect.
Ohio State University, Columbus (36,300) When students voted to impose a flat fee on themselves for unlimited rides on COTA, the city’s bus system, disabled students protested that they were paying the same fee but not getting the same service. Night and weekend van service for disabled students had been cut back months before, and not all the city buses were accessible. After two sit-ins in front of administrative offices, the university agreed to expand van service and work with COTA to resolve transportation issues on and off campus.
University of California, Berkeley (22,400) Six students went on a hunger strike and hundreds camped out to protest cuts in UC-Berkeley’s Ethnic Studies Department. Eight days, 83 arrests, and one hospitalization later, the chancellor met with students and supportive faculty and agreed to all demands, including the establishment of a new multicultural center and a research facility.
University of California, Los Angeles (24,100) When Proposition 209 prohibited affirmative action in admissions at state schools, UCLA students sought other means to preserve diversity. With student input, the Academic Senate eventually voted to revise admission standards, decreasing the percentage of students admitted solely on the basis of grades.
University of Texas, Austin (36,900) The landmark 1996 Hopwood decision specifically barred affirmative action at UT-Austin’s law school — but state administrators applied it to all schools systemwide. In protest, students occupied the president’s office, demanding an official explanation. After 19 hours, the president agreed to hold a series of town hall meetings on the issue.
University of Wisconsin, Madison (27,800) Students took over the administration building in February, demanding the university strengthen the anti-sweatshop provisions of its apparel-licensing contract. After the sit-in grew to 300 students in four days, the chancellor met with students and acceded to all demands, including the disclosure of all factory locations and UW funding for research into what constitutes a living wage for workers in various countries.
(*) Figures show full-time undergraduate enrollment
Sources: American Civil Liberties Union, Anti-Defamation League, Campus Outreach Opportunity League, Center for Campus Organizing, Center for Commercial-Free Public Education, Feminist Majority Foundation, Habitat for Humanity, National Organization for Women, National Student Campaign Against Hunger and Homelessness, Oxfam America, Peace Corps, People for the Ethical Treatment of Animals, Planned Parenthood, SCALE, Sierra Student Coalition, USPIRG, United States Student Association.
Hellraiser James Gilmore
One cop’s community-first ethic has pitted him against a formidable opponent — his own department.
When the New York City Police Department decided to barricade a crime-infested block of West 159th Street in Washington Heights and saturate the area with officers this spring, local residents weren’t the only ones up in arms. Boldly breaking ranks with his own department, Detective James Gilmore decided to stand in protest with the community he has served for more than 13 years.
A critic of NYPD tactics under Mayor Rudolph Giuliani, Gilmore worried that the police presence would lead to an undue number of misdemeanor arrests and rob residents of their civil rights.
Gilmore and other community leaders sent petitions to City Hall demanding the plan be dropped, and organized community meetings, a neighborhood watch, and youth leadership activities as an alternative way of fighting crime. “Sometimes you have a problem where a gang of five people are disrupting a whole block,” says Gilmore. “Those five people are organized, the other 100 are not.”
In response to the community’s organizing, the Police Department has, thus far, held off on implementing its plans for 159th Street.
This is not the first time Gilmore has broken ranks with the department. Since 1986, he has led workshops teaching youth how to behave during a stop-and-search, what proper police procedure is, and how to report police misconduct. His approach speaks to the experiences of the primarily minority participants who live in heavily policed areas.
Gilmore’s after-work efforts are often in direct conflict with his department, and this has at times put his career in jeopardy. He was transferred out of his precinct in early 1997 — returning only after the community staged three protests on the steps of City Hall.
Despite his having to toe a difficult line, Gilmore remains committed to community-based policing: “The police can be a liberating or an oppressive force,” he says. “We each have a responsibility to act [in ways] advantageous to the communities we serve.” — Jessica Shattuck
“We have more ethical regulations for testing chimpanzees than we do for testing humans.”
— Alex Capron, co-director of the Pacific Center for Health Policy and Ethics at the University of Southern California
Capron was commenting on the government shutdown of all human clinical research trials at the West Los Angeles Veterans Affairs medical center last March due to violations of the research approval process. Human trials are governed by the principle of “informed consent,” which stipulates that participants get full knowledge of the potential risks and benefits. But, says Capron, people are often ill-equipped to judge the risks involved — particularly when they are ill. “Patients may feel pressured into [participating] directly or indirectly because their researcher is also their doctor.” — Speed Weed
Lauren Belvin, counsel to the Senate Communications Subcommittee, and Fox lobbyist Maureen O’Connell ended their partnership as co-owners of an antiques shop after an article in Mother Jones’ July/August issue raised questions about a conflict of interest, the Washington Post reported. Belvin is the architect of a proposal that would allow the Fox network to expand station ownership beyond current limits — a change that O’Connell has long promoted. Belvin told the Post that O’Connell never lobbied her, but says, “It is better to put this matter to rest rather than give it further time and attention it does not deserve.” — Peter Flax