Biotech Firms Seek Legal Shield for AIDS Work
Last week, researchers from Genentech Inc. told an international conference on AIDS in Paris of a major breakthrough in the quest for a vaccine to halt the spread of the fatal syndrome.
The scientists disclosed that they had produced a protein that, when injected into test animals, generated antibodies that protected human cells from infection with the AIDS virus.
But Genentech says its laboratory triumph over the dreaded microbe may not yield a commercial vaccine unless the company wins another victory, this time in the less orderly world of politics.
Fearing lawsuits if inocculations against AIDS have unintended side effects, Genentech of South San Francisco, Chiron Corp. of Emeryville and other biotechnology companies are seeking passage of a bill in the state Assembly that would limit the liability of manufacturers of an AIDS vaccine. (The drug companies would still be liable in cases involving negligence.)
Given the current state of liability law, a decision to manufacture and distribute an AIDS vaccine “could be a bet-your-company proposition,” says Brian Cunningham, Genentech’s general counsel.
As a result, Cunningham says, “even if we had an efficacious vaccine and Food and Drug Administration approval today, I do not believe we would market the product.”
The bill, introduced by John Vasconcellos (D-Santa Clara), also would provide incentives for vaccine research. It would earmark $6 million for testing a vaccine in humans. And it would guarantee a market by allocating $20 million for the state to purchase 1 million doses once industry comes up with a successful preventive agent.
“There have been glimmers of success, but the project ahead (to develop a vaccine) remains tremendous,” says Dr. Marcus Conant, a San Francisco physician who is chairman of the state Department of Health’s task force on AIDS.
Between $10 million and $30 million will be required to develop a vaccine, and clinical trials could cost an additional $20 million, according to the bill’s sponsors. By skewing the economics in favor of a vaccine, “this bill would show the companies and the venture capitalists who back them that there’s a reasonable prospect for profit,” Conant says.
But behind-the-scenes opposition from the powerful California Trial Lawyers Assn., whose members bring personal injury lawsuits, has slowed the progress of the bill. Assembly Speaker Willie Brown (D-San Francisco) has scheduled a meeting in his office this morning in an attempt to forge a compromise.
The bill has garnered an impressive group of supporters. Dr. Jonas E. Salk, who in 1952 developed the first vaccine against polio, sent a telegram urging “favorable consideration.” Salk’s telegram will be read at a hearing on the bill by the Assembly Judiciary Committee on Tuesday morning.
Dr. Donald Francis, a Centers for Disease Control epidemiologist who played a key role in the worldwide eradication of smallpox, will testify in favor of the bill. Francis has called the reluctance of companies to undertake vaccine production “a scandal for our society.”
The key provision of the bill would exempt makers of federally approved AIDS vaccines from the so-called doctrine of strict liability. Under that doctrine, manufacturers, whether negligent or not, can be held responsible for damages caused by their products.
The exemption would be enacted by declaring that an AIDS vaccine is an “unavoidably dangerous” product. The term comes from a 1985 California Court of Appeal decision that exempted makers of an oral polio vaccine from strict liability.
The bill “wouldn’t absolve a manufacturer of all liability,” explains Genentech lobbyist David Nagler. “If a batch of vaccine is defective in its manufacture, the full force of the liability law will still apply.” The state also would assume some of the liability arising from an AIDS vaccine, with claims payable from a compensation fund.
Wayne McClean, executive vice president for the trial lawyers association, insists that his group isn’t trying to kill the bill. “We just want to make sure somebody is accountable and responsible and will use the right amount of safety and care,” he says.
“It’s hard to find the right balance, but I feel confident we can reach a solution,” he says. He declined to elaborate.
“On Monday, we’re going to find out whether we and the California Trial Lawyers Assn. can find common ground,” says Genentech general counsel Cunningham, who plans to attend the meeting in Speaker Brown’s office.
Genentech fears that changes sought by the lawyers’ group may water down the provision for protection from liability so much that the company will be unable to produce a vaccine. “What California does will be a precedent, both for other states and at the federal level,” Cunningham says.
Any further delay will effectively kill the bill for this session, says Michael P. Twombly, a senior consultant to Vasconcellos. It could also cost thousands of lives. By some estimates, 1,000 people--many of them outside the traditional risk groups of homosexual men and intravenous drug abusers--are being infected with the AIDS virus every day.
“We are very close,” Twombly says. “We are striving for a compromise that will produce a vaccine. We aren’t interested in a compromise that won’t produce a vaccine.”
Adds Conant, the San Francisco physician who has been diagnosing an average of two new cases of AIDS every week and counts 100 people with AIDS among his patients: “Maybe people who’ve been spared the daily hands-on experience don’t understand the urgency of this.”
“Education isn’t enough,” Conant continues. “A vaccine will be the only effective way of stopping the disease in this country.”
