FDA Reconsiders Ban on Home Kits for HIV Antibody Testing

FDA Reconsiders Ban on Home Kits for HIV Antibody Testing By William D. Appler and Gaile l. McMann n response to pressure from comIdustry, panies in the medical-device inthe Food and Drug Administration (FDA) this spring agreed to take a second look at its policy on blood-collection devices for HIV antibody testing, restricting their use to health care professionals. To date, the debate has focused primarily on the issue of specimen kits, rather than actual HIV antibodydetection tests, for lay use. Specimen kits would provide consumers with instructions and equipment (e.g., a lancet and filter-paper card) to obtain a blood sample. The coded filter-paper card would then be mailed to the clinical laboratory for testing, and the results communicated confidentially to the consumer. Currently, testing blood for the presence of mv antibodies is usually done with one of several commercial ELISA (enzyme-linked immunosorbent assay) in vitro diagnostic devices licensed by the FDA. Positive specimens are customarily tested again using a highly accurate confirmatory test such as the Western blot assay. Because of the complex procedures associated with these assays, there was never any question that these tests for HIV antibodies must be restricted to use by professionals.

HIV Testing Advances The technology for HIV antibody I assays, however, is advancing rapidly. Cambridge BioScience of Cambridge, Mass:, recently obWillwm D. Appler is a partner in the Washington office ofMcDermott, Will, & Emery. Gaile L. McMann is a licensed pharmacist and an assocwte in the law firm's Washington office. Received April 1989; accepted May 1989.

tained approval to market its latex agglutination test for detecting HIV antibodies in blood specimens. It is much easier to perform than commercial ELISA tests, and the results are available faster. Moreover, the sensitivity and specificity of the agglutination assay are reportedly comparable to the ELISA tests. Although Cambridge BioScience's in vitro diagnostic test is limited to professional use, it demonstrates the device industry's ongoing efforts to refine and simplify analytical technology. During a

'The ramifications from an incorrectly conducted diagnostic assay are obvious, and are particularly serious in the case of AIDS.' forum convened by the FDA in April to discuss home kits related to HIV antibody testing, representatives from two companies indicated they were currently developing assay systems that will detect mv antibodies in saliva. One company has already decided to seek approval to market its kit for home use; the second company has not yet defined its target market. Because it is only a matter of time before a company approaches the FDA with an application to market an HIV antibody test for lay use, the agency wisely decided to examine the issue of home testing, as well as specimen collection by consumers. Soon after the FDA announced that a public forum on HIV antibody tests and specimen kits for con-

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sumer use would be held in April, Rep. Ron Wyden (D-Ore.), chairman ofthe House Subcommittee on Regulation, Business Opportunities and Energy, convened a hearing in March to discuss these issues. At the outset, Wyden voiced his concern over the FDA's decision to reconsider its posture against home testing. Indeed, the opponents of home testing and sample collection, which included members ofthe psychiatry profession and spokespersons from AIDS organizations, far outnumbered the few representatives from the medical-device industry and from clinical laboratories who supported the concept. Concerns were raised that consumers could not accurately perform and interpret the test, or may not properly obtain a blood specimen for mailing to a testing laboratory. The ramifications from an incorrectly conducted diagnostic assay are obvious, and are particularly serious in the case of AIDS. Improperly handled specimens also will increase the likelihood of erroneous test results. In the context of HIV antibody testing, the consequences of false-negatives may be as serious as those stemming from false-positives. The potential for laypersons to misread directions or to inappropriately use a diagnostic or sampling device is supported to some extent by experience with home glucose monitors. Diabetic patients are educated by health-care personnel on how to obtain a specimen, operate the moniitor, and interpret the results. They also routinely use the monitor on a daily basis. Nevertheless, the FDA notes that a significant number of the Medical Device Reports received each year involve problems with glucose-monitoring devices. A majority of these reported problems are traced to user errors. 15

Thus, the question is, if laypersons who receive training on the proper operation of a diagnostic device are still prone to misusing the product, can consumers using an mv antibody test or sample-collection kit be expected to fare any better? Furthermore, the fact that laypersons are not likely to determine their HIV antibody status on a routine basis suggests that the incidence of antibody-test or sample-collection-kit misuse may be increased due to consumers' inexperience.

'Counseling that accompanies a negative test result is also an important component of the behavior modification that must occur to curtail the spread of AIDS.' It would also be extremely difficult for the FDA and even the manufacturers of home HIV tests and sample-collection kits to monitor problems and malfunctions. This is so since the confidential purpose of these products would likely deter consumers from voluntarily reporting inaccuracies or difficulties experienced. Accordingly, devices susceptible to serious misuse may unwittingly escape the FDKs regulatory measures.

Absence of Counseling learly, the most prominent obC jection home or mail-in testing involves the absence of, or into

adequacy of, counseling when the patient receives the results. With tests that are entirely self-administered, the user may not have any access to professional counseling. In light of the potentially devastating reactions that a person may experience upon learning that he is seropositive, many witnesses testified at the hearing that the dangers from self-determined HIV antibody status far exceed any perceived benefits. Opponents further noted that the counseling that accompanies a negative test result is also an important 16

component of the behavior modification that must occur in order to curtail the spread of AIDS. Negative results to an HIV antibody test have evoked a sense of invulnerability in some persons, who then continue their high-risk lifestyles. This response poses an obvious danger to the individual as well as others. Indeed, one spokeswoman from an AIDS organization cautioned the FDA and health professionals to avoid overemphasizing the importance of antibody test results. Behavior modification - not just the determination of HIV antibody status - must be the medical community's goal in order to control this disease. Based on the testimony during the congressional hearing and the public comments at the FDA's forum, it is readily apparent that home or mail-in testing without attendant counseling is unacceptable to the agency, members of healthcare professions, and AIDS organizations. Accordingly, proponents of sample-collection kits for lay use have shifted the debate to what type of counseling is necessary before and after a person learns of his antibody status. Representatives from AIDS clinics and psychiatrists maintain that face-to-face counseling, or at least the opportunity for personal contact with a trained counselor, is essential. They assert that this direct contact is necessary in order to determine at what point in a conversation, and in what manner, test results should be disclosed. Similarly, the personal approach offers the opportunity to assess the individual's reaction and determine what type of subsequent counseling is appropriate. Individuals supporting the concept of mail-in testing argue that while face-to-face counseling may be ideal, it is not the only acceptable means of informing individuals of their HIV antibody status. They suggest that the prospect of learning the results from another person in a one-on-one setting may in fact deter some persons from undergoing testing. (This hesitation about receiving test results in a face-toface confrontation may be validated to some extent by the figures reported by AIDS clinics on the num-

ber of persons who have the test run, but do not return for the results.) Supporters of mail-in testing products contend that counseling over the telephone by trained professionals is sufficient, and in some instances desirable. For instance, some persons may be more inclined to express their true emotions if absolute anonymity is maintained. Parallels have been drawn between suicide-prevention hotlines and the counseling that would be provided if mail~in testing is permitted. There are several other reasons offered in support of sample-collection kits for home use. For exam ple, an individual may be concerned about a breach in confidentiality or privacy when he must physically go to a clinic or physician's office to provide the specimen and receive the test results. Mail-in testing t heoretically offers absolute confidential-

APhA Opposes HIV Home Testing

T

he American Pharmaceutical Association is very concerned about the proper distribution and use of home-use in vitro test kits in general and the potential dangers of the HIV-l test kit specifically. In a May 8 letter to the FDA, APhA strongly supported the continuance of FDA's regulation prohibiting the sale of home-use collection kits or diagnostic devices designed to detect antibodies to human immunodeficiency virus type I (HIV-l). APhA also stated, "the use of an HIV test kit by untrained individuals: 1) is not a substitute for a diagnosis; 2) can lead to dange,r ous behavior in both false-negative and false-positive cases; 3) does not serve the interest of the individual who needs health care and psychological counseling; and .4 ) does not serve the public health in addressing the HIV epidemic. Therefore, APhA does not support direct sales to the public of home-use [in vitro diagnostics] for HIV-1 at this time." .i

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ity because the filter-paper card bearing the specimen is numerically coded, and the consumer initiates the contact with the clinicallaboratory for the results. Geographic inaccessibility of a clinic may be another reason some individuals forgo testing. Based upon the testimony offered during Wyden's hearing and the presentations made at the FDA's public forum, the issue of adequate counseling is pivotal to the acceptance of either home HIV tests or sample-collection kits. FUrthermore, it is fair to conclude that sentiment is currently running against the idea that telephone counseling is an appropriate substitute for face-toface contact. Several other factors have been raised in support of the position that

the FDA should continue to restrict the use of HIV antibody tests and sample-collection kits to professionals. Many states have enacted laws requiring that positive results be reported to health departments or similar public-health agencies. To the extent that individuals would elect to test themselves or use a mail-in service instead of going to a physician's office or clinic, efforts to monitor the spread of AIDS and keep accurate statistics would be thwarted. Finally, opponents of HIV antibody testing outside the professional health-care environment fear that home kits are a dangerous invitation to consumer deception and fraud. This concern appears well justified in light of the virtual onslaught of quack products in-

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tended to cure or prevent AIDS. Even more distressing is the fact that the FDA does not have the financial resources or the manpower to police all the dubious health-care products being sold. Thus, prudence might suggest that the door to the marketplace for home HIV testing and mail-in testing should remain closed.

No Decision Imminent DA is most unlikely to reach any resolution on the issue of home F testing or sample collection at any time in the near future. The director of the FDA's Center for Biologics Evaluation and Research intimated during the agency's public meeting in April that it may take a year before a final decision is made. While some may view this projection as yet another example of government inertia, others believe that a slow and deliberate decision is of critical importance. If the agency were to allow home test kits for HIV antibodies, it would be the first time that the FDA has ever permitted . laypersons access to a diagnostic product for an infectious disease. In the end, however, the FDA's announcement that it would reconsider its position restricting HIV antibody tests and sample-collection kits to professional use, and the meeting convened to hear public comments, may amount to nothing more than regulatory posturing. The agency can no longer be accused of unfairly refusing to accept applications for home sample-collection kits (and eventually HIV antibody tests for lay use) based upon an internal policy against these products. The medical-device industry has had its opportunity to comment, and to present evidence why the FDA should change its position. But from the authors' perspective, the agency will almost certainly construe the congressional hearing, the public forum, and the current sentiment against permitting HIV antibody testing outside the health-care environment as overwhelming support for its present policy against the use of these products by laypersons.® 17