By Bob Roehr
WASHINGTON – The Food and Drug Administration (FDA) began consideration of the process to approve a home test for HIV at a meeting outside of Washington, DC Nov. 3. The process is likely to take many years and may never overcome the barriers that some would like to maintain for such a product.
"Let me be clear, this is a multi-step process…we are not going to be evaluating an HIV test for approval today," Elliot P. Cowan told the Blood Products Advisory Committee. He is the FDA official who would be responsible for such a review. He said the meeting was to help establish the criteria by which to evaluate such tests.
The FDA has approved 817 different home tests, for everything from pregnancy to glucose monitoring for diabetes. Cowan said none have been approved for infectious diseases; tests for strep and flu have been submitted but rejected. He called counseling "a central issue" in the discussion around HIV testing.
Current interest in the subject was stimulated when OraSure Technologies approached the agency about seeking approval to sell its HIV test over the counter to consumers. The test uses an oral swab to collect secretions from around the gum line and looks for anti-HIV antibodies in those secretions.
The twenty-minute test was approved for use by clinics and health care workers in March 2004 and has become widely used to screen for HIV. A second confirmatory test is required to validate an HIV diagnosis, as is common practice for all HIV tests.
Cowan said conditions have changed since the FDA last addressed this issue. Perhaps most important is the introduction of HAART, combination therapy that has dramatically changed the course of HIV infection so that for many it has become a chronic, manageable disease.
The technology to detect HIV infection also has improved. Detection no longer need be based upon drawing blood, reducing the biohazards of residual blood and needles that might transmit infection.
Bernard Branson, who heads up HIV diagnostics at the CDC, said roughly 20 million HIV tests are conducted each year in the US. But at publicly funded sites in 2000, an average of 31 percent of those who took a conventional HIV test did not return for the results.
He pointed to survey data that "many people prefer to receive positive test results in their home situation where they are comfortable, rather than in a clinic with a stranger." He suggested that this attitude might also apply to taking the test. The CDC supports wider access to testing and sees a home test as contributing to that end.
Joseph Inungu reviewed psychological and social data associated with HIV testing. He said that while testing positive for HIV can be a life-changing experience, there is no evidence that it leads to an increased risk of suicide. Persons with AIDS who commit suicide are likely to be in the very advanced end of life stage of disease and/or suffer from severe depression or other major psychological problems.
He further noted that virtually all of these studies were conducted during the worst days of the epidemic, prior to the introduction of HAART. One might assume that the prospect of successful therapy would reduce social and psychological pressures associated with testing positive, though additional study is necessary "to see how people really react."
Public comment
The public comment section opened with the charge by Elliott Millenson that politics was behind the FDA's resistance to a home test kit. He developed such a product in the 1980s, but "it was clear the FDA would not approve such a test, so we developed a blood collection kit instead."
He sought approval in 1987 and only after waging a nine-year administrative and legal battle did he gain approval to market the "Confide" system. Customers would put a drop of blood on special filter paper, mail it to the company, and call in a week later for the results. He no longer is affiliated with the company.
"FDA was pressured by AIDS activists who feared the social consequences of making AIDS tests too easily accessible, and clinics that fear the financial consequences — reduced government funding if home AIDS testing caught on," Millenson said.
"Senior executives at major health care companies believe the FDA has had a strong bias against home AIDS testing for two decades." He urged the Committee to "recommend that the FDA send a clear, credible, decisive message to industry that it is not just accepting applications [for home tests], it's aggressively encouraging them."
Wesley Rodriguez, testifying for the Latino Commission on AIDS, said almost half of Latinos who are HIV positive do not know their status. "The stigma associated now with testing is that only bad people get HIV/AIDS — men and women who use drugs, homosexuals, and/or people who are promiscuous — so just taking the test is seen as admission of this bad behavior." Making a test available over the counter would help to "routinize and destigmatize" HIV testing.
Many community-based organizations "have made a sizable real estate and personnel investment in the testing process." He said, "The possibility of a home test threatens the revenue and grants of these organizations."
Freyna Spielberg, an HIV prevention researcher at the University of Washington, compared use of a home test to screen for HIV to self-examination for breast cancer. "We wouldn't say don't do that because if you find something, it might make you anxious." She sees a home test "as one of the few tools that we have to change the curse of the epidemic, right now. I'm hoping that it is fast-tracked."
"We support the idea of making over the counter testing available," said Terje Anderson, executive director of the National Association of People With AIDS. "But it is unlikely to revolutionize testing." He believes the people most likely to use it are already aware of their risk for HIV and are repeat testers, but for a small number of people, "it does increase the likelihood that they will get tested."
He related how he learned his own HIV status by testing with a home collection kit. "If that hadn't been available, I may have waited several more years before I visited a clinic or talked to my physician about getting tested. And I am somebody who has been working in this field for an awfully long time."
"Quality counseling and referrals are essential," Anderson said. "We want people to know their HIV status so they can take advantage of the advances in care and treatment."
"We need to stop being paternalistic to people, telling them that we understand solely how they should get tested…We believe that people have the right to make choices."
