County Did Not OK AIDS Vaccine Study, Report Says

In a confidential report to be finalized today, investigators for the Los Angeles County Department of Health Services allege that the county’s top epidemiologist failed to obtain the permission of--or even notify--his superiors before committing public resources to a federal research project designed to lay the groundwork for testing future AIDS vaccines.

The investigators also say that Dr. Peter Kerndt’s application for the contract to conduct the so-called HIVNET study for the National Institutes of Health (NIH) implied that the research would be done under the auspices of the county health department. In fact, Kerndt was acting on behalf of a nonprofit consortium of doctors affiliated with County-USC Medical Center, where he also teaches.

But the health department investigators also have concluded that the study does not single out poor African Americans for tests from which they might contract AIDS. Fears that it might do so first were voiced last week by County Supervisor Yvonne Brathwaite Burke. The study’s purpose, county investigators and NIH officials say, is to identify potential participants in some future vaccine trial, if and when the federal government determines that human test subjects are needed in Los Angeles.

The issue was first raised in an uncharacteristically heated statement by Burke. At the end of a business-as-usual board meeting, the supervisor vented at length her suspicion that county health officials were involved in a conspiracy that might subject poor African Americans in her district to medical atrocities under the guise of scientific research.

Addressing a suddenly attentive audience, Burke said she believed her constituents at two public housing projects were at risk of being unwittingly drawn into a secretive, federally financed program to test AIDS vaccines--a prospect she compared to one of the most notorious racial injustices in American history.

“The residents at Jordan Downs and Nickerson Gardens do not now need to be intentionally infected with components of HIV and treated as human guinea pigs in order to benefit pharmaceutical companies,” Burke told her colleagues, urging that they approve an investigation.

“These government-sponsored human testing activities,” she added, “bring back haunting memories in the African American community of the great injustices that were committed in Tuskegee” beginning in the early 1930s.

In that now-infamous incident, doctors covertly allowed Southern blacks to develop end-stage syphilis so they could study the progression of the disease.

The county Health Services Department launched an immediate investigation of Burke’s concerns about the study, which had been brought to her attention by fearful community activists in Watts the week before.

And, while health officials say there is no reason to be concerned that anyone may contract AIDS in the course of such a study, investigators have raised what they regard as serious questions about Kerndt’s conduct of the research project.

*

For example, investigators say, the application for federal funds to conduct the project was submitted under a cover sheet bearing the county health department letterhead. On that sheet, Kerndt describes himself only as the director of the county’s HIV Epidemiology Program. Investigators also are concerned about a business card that was handed out to community activists by a HIVNET researcher that clearly said he worked for the county health department.

But such a research project should have been cleared by both Health Services Director Mark Finucane and the Board of Supervisors, Burke said late Thursday.

“I think this kind of a study, that has the potential for liability for the county as well as a commitment of resources, not to mention identifying Los Angeles County with the study, should have been a policy decision voted on by the Board of Supervisors,” she said.

“What I gather is that the county was not told what its participation would be,” Burke said.

The supervisor also said that the county’s top health officials “didn’t even know this [study] was happening, that this proposal involved [potential use of] a vaccine.”

In a lengthy interview last week, Kerndt vehemently denied any irregularities in his handling of the contract for the study, which is part of a nationwide effort to prepare for tests of vaccines to immunize people against AIDS.

Kerndt could not be reached for further comment Thursday. But in the earlier interview he said no one in county government or the South Los Angeles community was misled concerning the project’s nature.

Kerndt’s group is responsible for finding 600 gay men who are black, Latino or Asian/Pacific Islander, as well as 200 heterosexual women, all of whom are at high risk of acquiring the AIDS virus through sexual or other habits.

The study requires that they be counseled, monitored and tested over a period of years, and those who acquire the AIDS virus will be compared with those who didn’t, to see how their lifestyles differed.

In the future, those 800 people could be asked to participate in testing of any vaccines approved for human trials, a procedure that is already underway in other cities around the nation.

Dr. Zeda Rosenberg, who is heading the entire HIVNET project for the AIDS Division of the NIH’s National Institute of Allergy and Infectious Diseases, said Thursday that she wasn’t troubled by any commingling of Kerndt’s county responsibilities and those of the nonprofit group to which he also belongs because most local public health agencies traditionally set up such organizations to conduct research studies for NIH.

*

But John Schunhoff, the county’s acting public health director, said Kerndt’s actions raise “a whole series of questions, including whether [the county and its residents] are being adequately informed and involved in designing the programs” to ensure that the tests are safe.

“I think there is a community problem,” Schunhoff said, “particularly in the African American community where there is a great amount of distrust about humans being used as subjects. Sufficient groundwork was not done in the community, or the Latino or the Pacific Islanders who would also be [study participants], to let them know what the study would be about.”

Kerndt, however, said he has taken great pains to involve the community in all phases of the project since he got the go-ahead to begin looking for participants last October.

Minutes of the Nov. 25 “HIVNET Community Advisory Board Meeting” bear that out, indicating that the volunteers Kerndt had recruited planned to set up a series of town halls and forums to involve the community.

In response to questions from the advisory board members at that meeting, Kerndt pledged that “if the community felt that this project was inappropriate or harmful, then he would stop it.”

Scientists here and at the NIH say none of the potential vaccines likely to be approved for testing on humans contain the actual AIDS virus, and that all test subjects would have to be fully informed of any risks they might incur.

Nevertheless, the NIH is sending an emissary out next week to allay the South Los Angeles community’s concerns about the study.