By David C. Holzman
A controversial congressional appropriation of $20 million to test an AIDS vaccine hasfound its way back to the Army, which will proceed with a single-vaccine Phase III trialof MicroGeneSys Inc.'s VaxSyn, the company said.
In an unorthodox action last year, Congress appropriated $20 million to the Departmentof Defense (DOD) for a Phase III trial of MicroGeneSys' gp160 HIV vaccine, following heavylobbying spearheaded by the Meriden, Conn., company.
Shudders reverberated through the biomedical community at the notion of Congress makingdecisions that should be left to scientists. The National Institutes of Health (NIH)conducted hearings last November at which a panel convened by Bernadine Healy, who wasthen director of NIH, concluded that a trial testing multiple recombinant HIV-subunitvaccines would be preferable to a single-vaccine trial.
Last April it looked like the $20 million would be transferred to NIH to contribute tothe cost of the multivaccine trial; in fact, DOD formally announced that it intended totransfer the funds. But this apparently never happened.
Now the company has achieved its original goal. On Wednesday, MicroGeneSys announcedthat the single-vaccine trial would be conducted as originally mandated by Congress by theWalter Reed Army Institute of Research (WRAIR).
Cost of Vaccine a Stumbling Block
For MicroGeneSys, a stumbling block for the multiple vaccine trials (which would haveenrolled from 6,000 to 12,000 HIV-infected people) had been the cost of enough gp160,Franklin Volvovitz, the company's chairman and president, told BioWorld onThursday. But American Home Products Corp. division Wyeth-Ayerst Laboratories, which hadhelped MicroGeneSys develop VaxSyn, agreed to reimburse MicroGeneSys for the vaccine to beused in the upcoming trial.
However, the trial to be conducted at WRAIR will involve nearly as many patients --5,000 to 10,000 -- as the proposed multivaccine trial.
Volvovitz said he hopes that patients will be enrolled for the study by the end of theyear and that the trial will start in early 1994.
The story of how the $20 million landed back in the lap of the Army is the subject ofmuch disagreement. “I guess we had to send the money over to NIH, where they thoughtthey could do a multivaccine trial,“ Marvin Rogul, associate director for researchmarketing and policy development at WRAIR, told BioWorld. “I think forwhatever reasons, they did not accept the money. So it came back to the military to do thetrial.“
Victor Zonana, a spokesman for NIH's parent, the Department of Health and HumanServices, told BioWorld that the money was “never transferred because wewere never able to persuade MicroGeneSys to donate its gp160 product for a multicandidatetrial.
“NIH never pays for the drugs it tests, and there was no reason to establish aprecedent here, especially when establishing a precedent would have drained funds from thedesign and implementation of a scientifically appropriate trial,“ Zonana said.
Nonsense, Volvovitz told BioWorld. “NIH has routinely purchasedexperimental drugs for Phase I, II and III studies.“ As proof, he faxed BioWorlddocumentation of several examples, including the May 24 issue of Portfolio Letter, whichalluded to “... the fact (that Immuno AG, a Swiss pharmaceutical company) received agrant to participate in the Phase II trials (of AIDS vaccines).“
Volvovitz added that his company offered its vaccine to NIH at cost.
He claimed that NIH had failed to answer his letter stating that “we'd be happy toparticipate in comparative studies,“ but was unable to provide a copy or tell BioWorldwith certainty to whom the letter had been addressed.
'Confidence with the Army'
He also implied that the Army was more fit to study the vaccine since it had alreadytested “over 600 patients, some with as much as four-year follow-up,“ while NIH,having tested the vaccine on only 70 patients, “is relatively new at this. Clearly,our confidence would be with the Army at this point.“
The FDA has final say over the protocols and could actually require a multivaccinestudy or simply scuttle the study, Mark Stern, NIH's news bureau chief, told BioWorld.FDA Chief David Kessler had opposed a single-vaccine trial at the NIH hearings lastwinter.
But Stern added, “It is still possible that the NIH will study the other threevaccine candidates (made by Genentech Inc.; Biocine, a joint venture between Chiron Corp.and Ciba-Geigy; and Immuno AG) in another fiscal year.“ Fiscal year 1993 ends in sixweeks.