Betrayal of Confidence
It's been three months since the first home HIV/AIDS test hit the market nationwide. Already, despite all of the hoopla over its arrival, it has acquired a seemingly permanent spot on the shelf behind the counter at local pharmacies. But as easily as the home HIV/AIDS test seems to have assimilated into public life, that was the not the case when it came to getting one brand, Confide, to the market.Indeed, Confide's arrival on your pharmacy shelves came only after several years of sometimes bitter and acrimonious relations between the creator of the test and the company that markets it.Elliott Millenson is the creator of Confide and the former CEO of Direct Access Diagnostics, a subsidiary of Johnson & Johnson. But just two years after selling the rights to his home HIV/AIDS test to Johnson & Johnson, Millenson found himself out in the cold. Now he has sued the nation's largest health care products company for the rights to Confide and the company that produces it on the grounds that he was terminated without just cause."This is a pretty tragic story," says Millenson. "I sold Johnson & Johnson my company in 1993. One of the conditions of the three-year contract was that I assume the position as CEO of Direct Access Diagnostics. The contract also stated that my company would be returned to me if I was fired without cause, and there was no reason for me to be fired." Millenson first expressed interest in developing and marketing a home-use blood collection kit for HIV testing in 1986. But there was one catch: The Food and Drug Administration was not convinced that a home HIV/AIDS test would be the most efficient and effective way to test people for the virus, according to an FDA report.The FDA consulted with other public health agencies about home test kits for HIV, and in March 1988, the agency notified manufacturers and other interested parties by letter that it believed that HIV specimen collection should be limited to "professional use only."Millenson didn't give up. He says he believed in the product, so he continued to urge the FDA to accept the application for his home test. Finally, after numerous rejections, he sued the FDA for not considering his application. In April 1989, the FDA held an open public meeting to further discuss home testing, according to Lenore Gelb, spokesperson for FDA. And after considering the data and comments from that meeting, the agency published a notice in the July 30, 1990, Federal Register reiterating its position that HIV specimen collection kits should remain for professional use only. The agency did, however, also state in the report a willingness to work with manufacturers on requirements for a pre-market approval application and to review data for home collection kits.Millenson's lawsuit against the FDA prevailed, and his company (then called University Hospital Laboratories) submitted a pre-market approval application for its home collection system.But in July 1990, the FDA's Blood Products Advisory Committee recommended against approval because the application lacked sufficient data. Questions remained regarding possible problems with such issues as dealing with samples that test positive, adequacy of telephone counseling, and compliance with state notification requirements while maintaining patient confidentiality.While awaiting approval from the FDA, Millenson sold the company (which was renamed Direct Access Diagnostics) to Johnson & Johnson under the condition he remain CEO for three years and that the company -- and therefore rights to the Confide home HIV/AIDS test -- would be returned to him if he was fired "without cause." He would soon realize how important it was to include that detail.In June 1994, FDA reconvened its Blood Products Advisory Committee for a comprehensive examination of HIV testing data, including a discussion of home-use systems. The committee concluded that the benefit of having an alternative means of reaching previously unreachable populations for HIV testing outweighed potential risks.But home testing wasn't a done deal yet. Members expressed concerns about how accessible -- both economically and physically -- a home-use kit would be to target groups and about the effectiveness of education and follow-up services. The committee recommended pilot studies to evaluate these issues.In 1995, just two years into his contract, Millenson was fired by Johnson & Johnson from his position as CEO of Direct Access Diagnostics. He says the reason he was given for being fired was for allegedly "violating a directive from my superiors about making contributions."According to Millenson, the firing was without cause and a violation of his contract. So he sued Johnson & Johnson for the return of his company, as well as back pay.Not long after Millenson was fired, the FDA published a revised guidance stating that over-the-counter home specimen collection kit systems for HIV testing may be approvable."In July, I finished a hearing, and the judge found there was no basis for my termination, and I was awarded my company back and also back pay," says Millenson.Johnson & Johnson, a $21 billion a year health-care company, petitioned to have the arbitration overturned, but a judge ruled against that action also. Not willing to give up, Johnson & Johnson recently filed a motion of reconsideration. A ruling has not been made yet, and a Johnson & Johnson spokesperson refused to comment since the case was still pending. Should Johnson & Johnson win the case, it is doubtful that consumers will notice a difference in the product. But Millenson says once the legal tug-of-war is over and he is back in control of his company, there will be definite changes to the product.Since he was fired before the home test was approved by the FDA and the product was marketed by Direct Access Diagnostics, Millenson says there were decisions made that he does not agree with."I think the product should be marketed more aggressively than they do," says Millenson. "And there are inside-the-package things that I wouldn't have done, like two lancets when only one is necessary. I believe the two lancets create anxiety. And the sample mailer is too large and intimidating. Those are some of the packaging changes I would probably make."Millenson also says he would more than likely lower the price of the test. Millenson's changes seem to be broadly related to improving the user-friendliness of the home HIV test -- changes which Millenson claims could have been avoided had Johnson & Johnson retained the company's advisory board. Johnson & Johnson dismantled the group after his departure, according to Millenson.The advisory board had a major impact on Direct Access Diagnostics' marketing plans to reach diverse groups of people at risk for HIV/AIDS. The committee also convinced the company to distribute test kits to some of the people at risk who might not be able to afford them."We wanted a feedback loop for the product and that's why the advisory board was there," says Millenson. "You can't put a product out there and say that's it...that's the best we can be. No. You can always improve upon that product, and, many times, input from members from different communities brought together as a committee can help continue its improvement."Millenson says he believes the battle is almost over, and he feels confident he will reclaim the company he created."There's been a lot involved with getting this product on the market," says Millenson, "but it's worth it. It's not a product for everyone, but for people that choose to use it, it's great."