In 1985, Elliot J. Millenson, 30 years old and flush with cash after some successful telecommunications deals, was looking for a new venture. The idea he settled on seemed simple enough, and he thought it would advance public health: a home-based test kit for HIV.
Perhaps Millenson was just ahead of his time. As the first home test for a fatal disease, the idea was immediately controversial. AIDS activists opposed it. So did the American Medical Assn. Stonewalled by the Food & Drug Administration in his fight to get the test approved, a beleaguered Millenson eventually sold his company to Johnson & Johnson.
The controversy didn't end there. J&J's aggressive promotion of the test before its approval led to an FDA investigation. The test even got tangled up in the congressional inquiry of House Speaker Newt Gingrich's finances.
REVERSAL OF FORTUNE. Now, nearly a decade after the original test was submitted to the FDA, approval seems near--perhaps within three months. If approved, the test would be sold without prescription for under $50 in stores. Called Confide, users send a blood sample from a finger prick off to a lab. A week later, using a computer code, they can get results and counseling over the phone. Two other companies--Home Access Health Corp. in Hoffman Estates, Ill., and ChemTrak Inc. in Sunnyvale, Calif.--have submitted similar products for FDA approval. SmithKline Beecham expects to submit a home version of its oral HIV test to the FDA in a year or so.
This reversal of fortune for home HIV tests is the result of two factors. One is deep-pocketed lobbying by J&J. The other is dissatisfaction with the status quo in HIV testing and a belief that home tests will widen access to new advances in early treatment. Wider testing is critical in stemming the rate of HIV infection that continues to rise among women, minorities, and adolescents. "It's really important for people at risk to find out their status" says Jeff Stryker, a researcher at the Center for AIDS Prevention Studies at the University of California San Francisco. "There's more and more you can do."
When Millenson first submitted his company's test for FDA approval in late December, 1987, the epidemic was just a few years old. Efforts were focused on providing comprehensive, clinic-based HIV testing. Concerned about the lack of face-to-face counseling and the accuracy of home testing, the agency refused in March, 1988, to review any tests not used in a professional setting.
Millenson wasn't deterred. Between 1987 and 1991 he badgered the FDA to review his application. Eventually he filed a complaint in U.S. District Court that resulted in a settlement, and the FDA agreed to review the test. In August, 1990, an FDA advisory committee voted not to approve the product, reiterating their opposition to home tests. Millenson took his message to the media, even requesting FDA approval for television host Larry King to take the test on his show.
EXTRAVAGANZA. Those efforts didn't lead to FDA approval, but in 1993 they did interest J&J. When J&J bought Millenson's test, the product gained an advocate with deep pockets and huge political clout. Millenson was put in charge of Direct Access Diagnostics, and the home HIV test--now called Confide--was redesigned. Former Surgeon General C. Everett Koop was hired to write the educational literature to accompany the test. J&J began a public relations extravaganza. They lobbied members of Congress, met with gay activists, and worked to repeal laws in Florida and Texas that require face-to-face counseling for HIV tests.
AIDS activist Bruce Decker, now deceased, was hired to visit clinics and gay organizations to promote Confide, says Christopher J. Portelli, executive director of the National Lesbian & Gay Health Assn. They were offered a cut of the profits if they agreed to support the test, says Portelli, who opposes home testing because he's concerned about the psychological trauma of finding out HIV status over the phone. "When you pour millions and millions of dollars directly into a small activist group, you get results," he says.
The campaign worked quite well--especially when coupled with stark evidence that current testing procedures were failing. In a study released by the Centers for Disease Control in February, 1994, only 18% of adults said they had been tested for the AIDS virus. Despite the goal of face-to-face counseling, some 33% of those tested got their results by phone or mail. The study also found that 42% of people at risk for AIDS--many of them minorities--indicated they would use a home test. Some saw opposition to home testing as paternalistic: "To me it's like telling women not to do a breast self-exam," says Dr. Deborah Cotton, an AIDS specialist at Massachusetts General Hospital. "They may get suicidal."
In June of 1994, an FDA advisory committee conducted a marathon 17-hour meeting in which dozens of doctors, AIDS activists, and public health officials spoke in support of the home test. Some said their airfare and some travel expenses had been paid by J&J.
Alarmed by this support, the test's opponents responded. Portelli's group--which represents some 11 clinics that do HIV testing--asked the FDA to investigate whether J&J's payment of some participant's expenses constituted a payoff. They also charged that J&J improperly promoted a nonapproved product by allowing Koop to display Confide on the Today Show. The investigation ended with no finding of wrongdoing, but it caused a public-relations headache for the company. "They should have been approved a year ago," says Paul Kawata, executive director of the National Minority AIDS Council, "but Millenson ruffled some feathers."
J&J's lobbying went further. In August, 1994, Millenson met with Representative Newt Gingrich and told him about problems getting Confide approved. No fan of the FDA, Gingrich fired off a letter to White House Chief of Staff Leon E. Panetta saying that the FDA should "approve the home test without any qualifications." It turned out that J&J had contributed some $30,000 to Gingrich's Progress & Freedom Foundation. This incident became part of the investigation into Gingrich's use of the foundation's funds. A congressional committee later found no evidence of any "improper linkage" between his actions and the contributions.
In February, 1995, the FDA officially revised its guidelines to allow review of home HIV tests. That same month, Millenson was fired for reasons neither he nor J&J will discuss. In fact, J&J has stopped talking about Confide at all. The two other companies--ChemTrak and Home Access--have quietly submitted their products for approval and begun staffing their 24-hour phone lines.
It's a business with no real model, and thus some sticky questions to confront. If counselors don't know the identity of the caller, for example, will that protect the company from liability in the event of a suicide? And what if there's a lab mistake and the company can't track down callers to correct it?
"WORRIED WELL." Peter Barton Hutt, a former FDA counsel and partner at the Washington firm Covington & Burling, says "you could make a list of a hundred things" to worry about. Most issues can be handled with educational materials and a label indicating that the test is for screening only--a user should seek a doctor's confirmation. On the suicide issue, studies show that incidence rises late in the disease, not at diagnosis. In any case, Hutt says liability costs are "built into the price of the product."
The companies hoping to sell these tests don't seem concerned. CDC studies project that 30 million Americans might buy a home HIV test. The initial target group is young women who are sexually active and have experience with home pregnancy tests. Because the test is as accurate as one doctors might do, Alene A. Holzman, vice-president at ChemTrak, envisions new couples taking it together before consummating their relationship. ChemTrak has dubbed the idea "relationship wellness testing."
This marketing to the "worried well" has some critics feeling that the test won't address true public health needs. "This program is all about money," says Jim Graham, executive director of the Whitman Walker Clinic in Washington. But as many doctors and AIDS activists know, millions of those at risk simply won't get tested any other way. "We in AIDS, with all best intentions, have created many barriers to testing," says Cotton. The home HIV tests could clear the way for more people to seek help for a terrible disease.