ALEXANDRIA, Va. -- Huge numbers of people worldwide couldbenefit from an AIDS vaccine. But "the likelihood ofreimbursement (for a vaccine) remains uncertain" from morethan 90 percent of those who live in developing countries, JackObijeski, senior director of product development at GenentechInc. said at the Conference on Advances in AIDS VaccineDevelopment:1993 here on Thursday.
Consequently, companies are targeting HIV strain B, prevalentin the industrialized world, to the exclusion of strains thatplague developing nations, said Peggy Johnson, acting deputydirector of the Division of AIDS of the NIH's National Instituteof Allergy and Infectious Diseases (NIAID), in her concludingremarks at the conference.
Nonetheless, HIV is everyone's problem, Obijeski implied, sincethe disease might ultimately cause political and economicinstability, and geographically distinct strains could spreadworldwide.
The big question, then, is how to make this market attractive.Several representatives of biotechnology companies offeredideas. The Third World market has not tempted Genentech, saidObijeski, and proposed pharmaceutical price controls under theClinton health-care plan would make it even less attractive.
But if every high-risk nation kicked in one-half of 1 percent ofits military budget, $10 billion would become available, whichwould be enough to attract more funds, said Obijeski.
One company has already jumped into that market. BesidesHIV, Cambridge Biotech Corp. of Worcester, Mass., is workingon malaria, schistosomiasis and tuberculosis, said PatrickLeonard, the company's chief executive officer. "These are hugeproblems for the developing world. I believe strongly that ifwe can find effective therapies, a way will be found to pay."
However, the high cost of clinical trials in the U.S. is a grossdisincentive, Leonard said. Why, he asked, should a productthat has no role in the U.S. be tested here?
Lance Bronnenkaut, president of Finishing Enterprises, offereda way around the problem based on the experience of hiscompany, which was set up as a non-profit to distributeintrauterine devices in developing countries.
To avoid having to wait to sell the product for FDA approval,the company first manufactured in Canada, which allowsexports to other countries as long as the recipient companyapproves of the device. "Following FDA approval, weconsolidated back to the U.S.," said Bronnenkaut.
But the key to success for his company was an agreement bydonor agencies to buy certain product volumes at specificprices to remove the uncertainties of start-up. And as forliability, he said, "we are a shallow pocket."
Liability was clearly a major concern among companies. Peopleparticipating in trials have been threatened with loss ofemployment and worse due to development of antibodies toHIV, and they have sometimes threatened to suemanufacturers. Robert Stein of the Washington law firmBlicker, Futterman & Stein recommended clear, informedconsent to deal with this issue.
As for bad reactions, he recommended that the industryprovide appropriate compensation and care for injured partiesto mollify a public perception that it lacks concern.
As the conference closed the mood was gloomy, since currentavenues of research have led to dead ends, and it is unclear asto where to go from here.
"You heard that Phase I sera have shown some breadth ofreactivity against lab isolates," said Johnson. But in vivo, withone small exception, "we have achieved nothing."
Nonetheless, a few advances stood out, particularly mucosalimmune response, she said, citing "oral polio vectors, which canexpress longer antigenic sequences, lipid links, syntheticpeptides, as well as recombinant proteins.
"There is evidence that cytotoxic T lymphocyte gag epitopesmight be important in disease progression," said Johnson. "Weneed information as to what these CTLs actually recognize."
And referring to Charles Arntzen's project at Texas A&M toexpress genes encoding candidate vaccines in transgenic plants,she said, "We can dream about a vaccine which gets distributedas seeds which people in lesser-developed countries can plantand feed to their children as mashed bananas."
-- David C. Holzman Washington Editor
(c) 1997 American Health Consultants. All rights reserved.