American Journal of Law & Medicine

Home HIV testing and conflicts with state HIV testing regulations.

I. INTRODUCTION

Currently the number of AIDs-related deaths in the United States has reached 311,000(1) and at least one million more Americans are infected with HIV.(2) Of those one million or more infected, many spread the virus unknowingly as approximately forty percent of those infected have never been tested.(3) More than eighty-five percent of the U.S. population has never been tested for HIV.(4) No cure or vaccine for HIV currently exists.

The federal and state governments have set up a patchwork of free and confidential HIV testing at local clinics.(5) States have enacted a variety of legislation concerning HIV testing and test results.(6) Most States have enacted statutes that require informed consent for an HIV test to be conducted.(7) All states require the reporting of AIDS cases, and many also require the reporting of HIV-positive status to state public health departments.(8) Furthermore, many states mandate certain requirements for HIV counseling.(9)

The Food and Drug Administration (FDA) has yet to approve the sale of home HIV tests. In January 1986, the FDA received its first notification of a manufacturer's intent to market a home HIV test.(10) The FDA rejected home HIV tests in 1988.(11) Support for the test increased within the FDA(12) and in 1994, the FDA's Blood Products Advisory Panel suggested that manufacturers undertake premarket studies of the home test.(13) Finally, the FDA issued new guidelines in February 1995, asserting that home HIV tests may be approvable.(14)

The home test model the FDA is currently considering, called Confide, is made by Direct Access Diagnostics, a division of Johnson & Johnson.(15) The test kit includes instructions and a pamphlet with AIDS information in both English and Spanish, a lancet, special paper for the blood sample that is marked with an individual identification code, and a return envelope.(16)

The user of this test pricks his or her finger and places three drops of blood on the special paper.(17) The sample is then mailed to a laboratory.(18) In approximately one week, the user calls to receive the test results using the identification code.(19) If the results are negative, a recorded message provides the information along with general HIV prevention advice.(20) If the results are positive, a trained counselor comes on the phone and provides counseling and information concerning possible retesting, treatment, and the location of medical, legal, and counseling services.(21) Follow-up counseling is available for a specified number of sessions.(22)

Part II of this Note analyzes the arguments surrounding the approval of a home HIV test, and recommends approval of the test. Part III examines the scope of state law preemption under the Medical Device Amendments to the Food Drug and Cosmetic Act, and analyzes whether various state HIV testing laws are preempted. Part IV presents arguments that state laws cannot be applied to home HIV testing, even if preemption is not found or exemption from preemption is granted. Finally, Part V concludes that state HIV testing legislation should not hinder the opportunity home HIV testing presents to save lives and reduce the spread of AIDS.

II. ARGUMENTS SURROUNDING THE HOME HIV TEST

Initial opposition to the test has weakened, and currently there is strong general support for the home HIV test.(23) Approval of the home test appears probable according to FDA chairman David Kessler,(24) and as evidenced by the new guidelines.(25) However, despite this strong support, several arguments against and concerns regarding home HIV tests have been raised by many clinics and gay and lesbian rights groups, among others.

Some of the earlier concerns have faded away. For example, when the first home test was prepared for FDA consideration, the accuracy of the test was a concern.(26) The test now under consideration uses the same testing methods on the sample, and matches the accuracy of HIV tests performed by doctors or clinics.(27) After examining and analyzing the arguments, I believe that the home HIV test is worthy of FDA approval.

A. THE STATE OF HIV TESTING AND ITS IMPORTANCE

Proponents of the home HIV test argue that the accessibility and anonymity of the test will encourage more people to be tested.(28) Surveys reveal that twenty-nine percent of adults would likely use a home test(29)--three times the number of people who indicated they would use current options.(30) This number increases to forty-two percent when limited to those defined at risk for infection.(31)

Forty percent of those infected with HIV have not been tested.(32) Furthermore, information is currently the only tool available in the battle against AIDS. There is no cure or vaccine, nor does there appear to be hope for one in the near future.(33) We do know the behaviors that create risk of exposure to the virus.(34) Thus, people can avoid behavior that would put others at risk if they know they are HIV-positive. Hence, there is a need for additional testing in order to reduce risky behavior and therefore reduce the spread of HIV.

In addition to protecting others against infection, testing can help those who are infected begin intervention earlier. The use of drugs such as aziothymidine (AZT) and other treatments can lengthen and/or improve the quality of remaining life.(35) Early knowledge may help those infected accept their situation more easily, and enable them to live their remaining years to the fullest. Recently, studies have indicated another benefit of knowledge of HIV status: it has been found that AZT substantially reduces the rate of transmission of HIV from an infected mother to her child in utero.(36) Thus, for public health and personal reasons, greater testing is desirable.

Finally, home HIV tests would allow people not only to ascertain their own HIV status, but also allow them to significantly reduce their risk of exposure from a potentially infected partner. For instance, if two people enter into a long-term monogamous sexual relationship, each person could reduce their risk of exposure to HIV through their potential partner by up to 99.9% by having their partner use the home HIV test.(37) This reduction of risk is notably better than that afforded by condoms, which reduce the risk of exposure between seventy and ninety percent.(38)

Although existing clinics funded by state and federal government provide free AIDS testing, they are unable to handle the demand for such testing.(39) In 1994, it is estimated that over five million requests for testing were placed at these clinics.(40) There are often waits as long as two to six weeks to receive testing, and an additional one to four weeks for the results.(41) Not only is the supply of testing not keeping up with the demand, but in many areas, especially those that are less densely populated, there are few or no clinics at all.(42) The home HIV test would help the supply of available testing meet the existing demand.

B. COUNSELING ISSUES

The most criticized aspect of the home HIV test is the quality of the counseling the user receives on hearing the results of the test.(43) The American Psychological Association, although it supports the concept of home HIV testing, is concerned about the counseling aspect, and would like a careful study of the issue.(44) As there is no cure available, a person receiving a positive test result must face what some might consider to be a death sentence. Many argue that people receiving such devastating news need face-to-face counseling.(45) In fact, there has been at least one reported case of a person who committed suicide after receiving news that he was HIV-positive.(46) Those who hear of their status over the phone may hang up before receiving necessary counseling. A person, knowing that a counselor will give news of a positive test, may hang up if the phone wait is long, inferring that the wait stems from the unavailability of a counselor and therefore that he or she is HIV-positive.(47) Opponents of home testing argue that the use of face-to-face counseling can prevent such results, and better inform people what it means to be HIV-positive.(48)

Phone counseling resulting in suicide or suicide attempts represents a small yet serious risk.(49) Inadequate counseling may result in the less dramatic but still serious harm of people not fully understanding the implications of an HIV-positive test result. Inadequate counseling may result from a home HIV test taker hanging up before or during counseling, or the counselor's inability to note the reactions of the test user and whether the user is absorbing the information provided by the counselor.

As a result of inadequate counseling, the user may not know that false positives occur.(50) Subsequent testing may reveal that the test result was a false positive. Such a person might not learn that the dormancy period for HIV averages around ten years,(51) or that drugs such as AZT can lengthen life expectancy, or at least improve quality of life.(52) The availability of medical, psychological, and legal services may remain unknown to those with HIV who have not received adequate counseling.

Although opponents of the home test are critical of the counseling it provides, the demand on clinics providing HIV testing has lowered the quality of counseling at these clinics. A recent Centers for Disease Control (CDC) survey indicated that thirty-one percent of people who had been tested received their results by phone or mail,(53) and eighty-five percent of those tested received no post-test counseling at all.(54) Those using the home test will receive their results over the phone, like many already do, and will receive counseling from trained HIV counselors, which most people currently do not receive.

Additionally, phone counseling has proved to be effective in other areas. Suicide hot lines are an example of the effective use of phone counseling.(55) Over ten million people a year receive counseling on such hot lines.(56) Furthermore, AIDS hot lines have successfully provided counseling and information on services to HIV-positive individuals.(57) To ensure the best possible phone counseling, the counselors for the Direct Access Diagnostics home HIV test will be guided by a computer program developed by Thom Moseley, who managed the AIDS hot line in Los Angeles.(58) After studying the program, Martin Delaney, the director of the AIDS information group, Project Inform, declared it "bulletproof as any system."(59) According to psychologist Thomas Coates, director of the Center for AIDS Prevention Studies at the University of California at San Francisco, the available evidence does not support concerns that telephone notification causes severe psychological reactions in people when they are told of their HIV-positive status.(60)

Furthermore, some people may actually prefer dealing with a counselor anonymously and over the phone, as opposed to face-to-face.(61) The fact that approximately twenty-five percent of those tested at clinics do not return for their results(62) is evidence of many people's dislike of face-to-face counseling.(63) Additionally, thirty percent of those who did not return for their results said they would use a home HIV test.(64) Thus, it appears that phone counseling can provide a satisfactory alternative to face-to-face counseling that may be more attractive to many people than current counseling, and of better quality in many cases.

C. CONCERNS OF ABUSE BY BUSINESSES AND INSURERS

Opponents of the home HIV test are concerned about possible abuses of testing by businesses and insurers.(65) For example, an HIV-positive result might be used to deny a person employment or insurance. However, concerns about abuse by insurers are inflated. Insurers rarely engage in testing or underwriting for medical insurance.(66) Additionally, because there is little legislation against such testing by insurers,(67) the incentive to test without consent is not that great. If the insurer wants to determine a person's HIV status, it can request permission to test. If the person refuses, the insurer simply refuses to insure that person. If HIV testing by insurers were illegal, then a strong incentive to test without consent would exist.

Opponents of the home test claim it would create a greater incentive for HIV testing without consent by decreasing the cost of testing,(68) and removing the health care professional from the process. The financial incentive to discover a person's HIV status exists because the cost of medical treatment for a person with HIV can be expensive.(69) Those with access to a blood sample yielding the necessary three drops of blood could utilize the home test. Businesses often have access to such blood samples during pre-employment(70) or annual physicals. It is true that if a business has withdrawn blood for testing purposes it could also test without consent using the traditional method.(71) However, it would require a larger blood sample, cost more, and probably require at least the tacit consent of the health care professional who has drawn the blood. Whether these differences are enough to entice more businesses to test illegally remains to be seen. Nonetheless, home HIV tests provide the potential for businesses to illegally discriminate against people with HIV.

It would be difficult to discover an employer's improper testing without the business taking action based on the result. Under a normal testing procedure, there may be evidence of test samples being sent to a lab or test results being sent back to the business, such as a lab bill. With a home test, there is no method of determining who sent the sample in and who called for the results. Additionally, to provide such a method would reduce the desirability of the test, because anonymity would be lost. Nonconsensual testing through the use of a home test by a business must be shown through circumstantial evidence, which although more difficult, is possible.(72)

Despite these difficulties, the potential for such abuse is not great. The use of a home test without a person's consent would violate the informed consent statutes of many states.(73) Additionally, a federal district court has held that where an action based on an informed consent statute was not available, causes of action for battery, negligence, and negligent infliction of emotional harm were possible against an insurer who tested without consent.(74)

Additionally, the Americans with Disabilities Act of 1990 (ADA)(75) provides relief against the discriminatory use of HIV information. …

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