Mark Siljander and Stanley Lewis call themselves entrepreneurs providing a valuable service. Their critics accuse the two local businessmen of attempting to cash in on the public anxieties over the AIDS epidemic.
Over the next few months, the Food and Drug Administration will decide which side is right.
At issue are the separate plans of Siljander, a onetime congressman from Michigan who is now based in Reston, and Lewis, a Baltimore psychologist, to sell home AIDS test kits in drug stores that will allow consumers to test themselves for AIDS without going to a clinic.
The two are part of a national trend that has seen private firms increasingly attempt to move into the AIDS-testing business, adding a for-profit dimension to a service that until now has been dominated almost entirely by publicly funded, nonprofit health clinics.
But the proposals also have raised a host of ethical and regulatory questions, and sparked vehement opposition from many public health officials who question whether private firms -- especially those offering home testing kits -- will provide adequate service, safety and, in particular, counseling to clients.
While both Siljander and Lewis predict they will be selling the home testing kits by the end of this year, the final decision rests with the FDA, which has jurisdiction over all medical testing devices and services. The agency is now considering the matter, and has given no indication of when it will decide.
Siljander, who had the backing of the Moral Majority when he ran for Congress and a taste of controversy during his three terms in Congress, formed the American Institute for the Detection of AIDS last year with two Chicago doctors. Buyers of Proteck, as his kit will be known, get a lancet to draw their own blood, a special box to send the sample through the mail to an licensed lab, and a 900 number to call a week later to get the result.
"We're looking for people who have been promiscuous but who are embarrassed to go to a doctor," Siljander said. "There are millions of people out there who don't want to go to a clinic."
The government has estimated the number of Americans potentially at risk for AIDS who haven't yet been tested at between 30 million and 40 million.
Lewis, meanwhile, bought Peace of Mind Inc., a Nevada-based manufacturer of rubber "bumpers" for ladders, last summer and has turned it into a multifaceted high-tech research outfit with an eye to AIDS "marketing strategies." The company plans to market a similar home blood-collection and testing kit, saying that it has lined up "upscale retail locations" to sell its product. "We want to market this test to middle America," Lewis said.
Siljander's and Lewis' companies are two of several firms that have asked the FDA for permission to enter the AIDS home testing market. But there are other local entrepreneurs in other facets of the AIDS-testing business. Two Maryland businessmen, Wayne Simmons and Mark Regan, for example, opened a clinic in Greenbelt last summer offering confidential AIDS testing for a flat fee of $55, and have just completed a private placement that could see their company, Blood Check Inc., open seven additional facilities in and around Washington and Baltimore over the next few months.
Blood-Check and services like it, however, are essentially expanded commercial versions of the private testing that many doctors have offered in their offices since the beginning of the AIDS epidemic. Home collection kits, on the other hand, place AIDS testing for the first time outside the medical community, a fact that has made them the most controversial of the for-profit testing alternatives being put forth by private companies.
"This is a brand new field. There's a chance to make enormous sums of money, but we've got essentially no regulation," said Rep. Ron Wyden (D-Ore.), a member of the House health and environment subcommittee. "It's an area that's ripe for fraud and manipulation. Home kits go right to the heart of people's fear."
Wyden and two other congressmen wrote to FDA Commissioner Frank Young last October asking the agency to "take proper precautions to insure the safety and efficacy of the test kits." The letter focused not so much on the question of accuracy -- the testing procedures and laboratories to be used by home kit manufacturers are the same as those used by health clinics -- but rather on the safety of sending possibly infected blood samples through the mail, as well as the question that, for many, is the critical issue surrounding home testing: whether face-to-face counseling services are made available to consumers who test positive for the disease.
At present, publicly funded AIDS clinics are required by health officials to provide counseling before and after testing to explain the test and to help clients prepare emotionally for the results.
"Everyone recognizes that the value of testing is directly related to the quality of the counseling associated with it," said Jeff Levy, executive director of the National Gay and Lesbian Task Force, one of a number of groups that have strongly endorsed the government's counseling requirement.
Because the proposed home testing services rely so heavily on mail and phone contact with kit buyers, critics have questioned whether they can provide an adequate level of counseling. Few suggest that the FDA will go so far as to ban home kits on these grounds -- indeed, many experts believe that home testing, in one form or another, is probably inevitable.
What the FDA is trying to do, however, is to decide what restrictions and conditions to place on the sale of the kits: how to balance the convenience and accessibility offered by home collection against the dangers inherent in a test environment that is outside of a medical setting.
The entrepreneurs hoping to sell the kits said they plan to offer counseling to their customers. Siljander said his Proteck kit, for example, will have counseling instructions inside the package, trained counselors staffing the 900-number phone lines "with answers to the 18 or 20 most often asked questions," plus a list of counseling services around the country to which testees can be referred.
Is that enough? Siljander thinks so, but many public health officials disagree. "Testing by itself is a waste of time without high-quality education," said Peter Hawley, medical director at the Whitman-Walker Clinic in Washington, which handles much of the region's AIDS testing. "It's not good enough to hand people a lot of brochures. Some people won't read them. Some people have mixed emotions about AIDS, some of which has to do with denial. We have people who come out of these sessions thinking that if they test negative they must be immune to AIDS. All sorts of misinformation gets communicated."
"If you ask anyone who has done this kind of work in testing centers, you will find out that people are in need of direct hands-on counseling," Levy said. "Calling hot lines doesn't do the trick."
Peace of Mind's proposal goes a step further, asking test applicants to pick up their results from special offices the firm hopes to open in 150 cities. Rather than have trained counselors on staff, the company plans to offer clients who test positively for the AIDS virus an interactive computerized video counseling session.
"Our concern was that the people currently doing counseling are doing a poor job," Lewis said. "We wanted a system set up in an entirely standardized fashion by us."
Lewis said many existing counseling efforts fail because recipients don't understand what they are told. So Lewis' computerized system requires viewers to answer questions at each stage of the five-part session.
"They've got to understand what's going on," Lewis said. "Otherwise they can't get into the next section."
But counseling by video and computer doesn't satisfy some health officials. "The post-test counseling has to be done one-to-one. It can't be done any other way," Hawley said. "Interactive video is not capable of judging the emotional state of the patient. ... I'd hate to have a patient find out they're positive, and then walk out and kill themselves."
The AIDS-testing entrepreneurs respond to these charges by stressing what they see as the failure of publicly funded testing efforts to reach people outside the highest risk groups.
"A lot of people don't want to go to these clinics. They're often not in the best parts of town. They don't offer much privacy," said David Pivar, president of California's Discrete Medical Testing Inc., another firm hoping to enter the home collection business. "The easier the accessibility of the testing, the more people who think they are at risk will take it."
Blood-Check's Wayne Simmons believes that pre- and post-test counseling required by public clinics may be a big reason why many Americans decline to be tested for AIDS.
"We never send anyone out of the facility if they need help," he said. "But the choice is left to the individual. We see anything mandatory about AIDS testing as a deterrent." Simmons said market research by his firm shows that 77 percent of respondents indicated that they wanted counseling to be available but not compulsory.
By doing away with counseling requirements and putting a kit in neighborhood drug stores, testing firms think they can attract the broadest possible market.
"We happen to believe the major marketplace for this kind of product is the millions of businessmen, government employees who travel, who have committed an indiscretion and are not about to tell their wives or to go anywhere and have a test," Peace of Mind's Lewis told an FDA advisory committee meeting in December. "We have not done any market surveys. Perhaps we could start with this building and survey the government employees to see how many of them are really worried about that."
Siljander hopes to enlist celebrities and public figures for an extensive "It's Best to Know" campaign to encourage Americans to be tested.
Home testers also intend to price their services aggressively. The charge for a preliminary AIDS test conducted by a private physician can run in excess of $75 -- a reflection of the high prices private laboratories charge for processing the samples. Siljander expects to sell his kit in drug stores for $9.95, plus a $20 or $25 surcharge to get the test processed. Lewis told the FDA he could go even lower: to $18. "I promise you, at $18 there is a very healthy margin," he said.
But few believe that competitive pricing alone will end the controversy over home testing.
"Let's talk candidly for a moment. This type of disease brings out every kook from the woodwork," said Siljander. "Some of these guys have little or no credibility."
"I can't tell anybody not to deal with these people," Reed Tuckson, D.C. commissioner of public health, said of the private AIDS testers. "But I would above all hope that any person involving themselves with a private firm would make very sure that their anxiety is not being exploited by unscrupulous persons. Citizens ought to be prepared and aware that there are people who may try to exploit them."