首支HIV家庭自检器上市背后的“丑闻”

    一桩24年前的丑闻上周静悄悄地浮出了水面。7月3日，美国食品和药物管理局（FDA）批准了全球首支HIV病毒“家用快速自检器”的发售。人们可以通过该自检器在家中私密地测试自己是否感染上了艾滋病病毒。

    这支名为OraQuick的自检器获批发售无疑是件好事——你也肯定会这么想。只需一滴唾液，就可快速检测一个人是否感染了HIV病毒。它由美国的OraSure科技公司生产，每支只卖不到60美元，每次检测只需20分钟时间。根据FDA今年五月在一次听证会上提交的统计数据显示，这支自检器在上市发售的第一年里就可能有效阻止4,000多起新的HIV感染。目前美国每年新增HIV感染者约5万人，也就是它至少可以阻止其中8%的人被感染。【据美国疾病防治中心（the Centers for Disease Control and Prevention）介绍，现在美国约有120万名HIV携带者，其中约有20%的人并不知道自己感染了HIV。自从艾滋病在上世纪80年代被发现以来，大概已经有110万人被确诊患有艾滋病，死于艾滋病的患者已经超过619,000人。】

    那么为什么说这是一桩“丑闻”呢？事实上，虽然这样一支HIV快速自检器上周才获批，但是早在24年前，FDA就接到了第一份请求批准销售HIV自检器的申请。

    与传统的临床检查相比，家庭自检最大的优势就是它的保密性。在美国说起艾滋病，人们总会下意识地把它与同性恋和注射毒品联系在一起。如果去门诊或诊所做HIV测试，病人的隐私就存在很大风险。由于艾滋病一开始就是致命的，而且无法治愈，因此人们一旦确诊感染了这种“同性恋瘟疫”——也就是HIV，往往就会陷入歇斯底里的境地。得了HIV的人有理由担心会在就业上受到歧视，在社交上也会被其他人避之而唯恐不及。

    但同时，艾滋病高危人群必须接受测试，这样他们才能采取措施，避免疾病的传播。家庭快速自检为他们提供了一种谨慎、经济而方便的检测方式。

    1987年末，一家名为“大学医院实验室”（University Hospital Laboratories）的公司向FDA提交了一份请求批准销售家用HIV快速血液自检器的申请。这家公司的老板名叫艾略特•米勒森。意想不到的是，FDA在1988年3月拒绝接受该公司提交申请文件——一般来说，只有先接受了申请文件，随后才能开始漫长的监管审批过程。不仅如此，FDA还出台了一系列条条框框来约束未来任何HIV检测产品的申请，这相当于先发制人地否决了HIV快速家庭自测。唯一有可能或得审批资格的只有那些在临床环境下进行的检测产品。

    不难看出，FDA出台这样的规定，背后也有着合理的公共卫生动机。首先，FDA担心的是，患者在测试前后都要获得适当的心理辅导。患者要意识到检测结果有可能出现假阳性，以免如果真的出现假阳性时造成不必要的恐慌。同时他们也要意识到，检测结果也有可能呈假阴性，这样他们就不会自以为逃过一劫，再去危害他们的性伴侣。另外他们也要知道，如果他们真的感染了HIV，有哪些方案可以选择，有哪些“病友会”可以参加。（许多艾滋病维权人士当时几乎反对任何形式的HIV测试，因为他们担心测试结果会被滥用，造成HIV阳性患者遭到排挤和迫害——当然，我们还是希望FDA之所以出台这些规定，主要是出于公共卫生的考虑，而不是出于政治压力，或是担心“恐艾症”什么的。）

    A 24-year scandal was quietly acknowledged last week. On July 3 the U.S. Food and Drug Administration approved the first "rapid home" test for HIV—a test that people can take in the privacy of their own homes to determine whether they have the virus that causes AIDS.

    The approval is an unambiguously good thing—or so you would think. The saliva test in question, made by OraSure Technologies and known as OraQuick, costs less than $60 and takes just 20 minutes to self-administer. According to statistics an FDA advisory committee presented at a hearing in May, it holds the potential to prevent the transmission of more than 4,000 new HIV infections in its first year of use alone. That would be about 8 percent of the roughly 50,000 new infections we currently see annually in the United States. (About 1.2 million people in the U.S. are now living with HIV, according to the Centers for Disease Control and Prevention, of whom about 20 percent don't realize they have it. Since the epidemic began in the early 1980s, about 1.1 million people have been diagnosed with AIDS, and more than 619,000 have died from it.)

    The scandal is that the approval of a rapid home test for HIV did not occur until last week—about 24 years after the FDA received its first application seeking permission to market one.

    The big advantage of a home test over a clinical test is confidentiality. HIV infection in this country has historically been associated with homosexuality and intravenous drug use, among other causes. By going to a clinic or family doctor's office and asking for an HIV test, the patient placed his privacy at great risk. And since AIDS was initially fatal and untreatable—the "gay plague"—there was hysteria about contracting it. People with HIV had reason to fear employment discrimination and social shunning of all kinds.

    At the same time, it was crucial that people at risk get tested so that they could take steps to avoid spreading the disease. The rapid home test seemed to offer a discreet, inexpensive, convenient option.

    In late 1987, a company called University Hospital Laboratories, run by businessman Elliott Millenson, submitted an application seeking approval of a rapid home blood test for HIV. In March 1988, however, the FDA declined to accept it for filing—the ministerial act that ordinarily initiates the long regulatory process that leads to approval. Instead, it published a series of prerequisites for future applications seeking approval for any HIV diagnostic test which preemptively forbade rapid home tests. The only test applications that would be allowed to even enter the approval pipeline would be those that would be performed in a clinical setting.

    It's easy to see the legitimate, public-health motivations behind such a rule. There was great concern that the patient receive proper counseling, both before and after the test. The patient needed to appreciate the possibility of false positives, so he wouldn't panic unnecessarily if he got one. He needed to appreciate the danger of false negatives, so he wouldn't become reckless, endangering sexual partners. And he needed to understand the options and support groups available in the event he received a true positive. (On top of all these concerns, many AIDS activists at the time were opposed to almost any form of HIV testing out of fear that results could be used to ostracize and persecute HIV-positive people—though one hopes that public health concerns were paramount to the FDA, rather than political pressure and hysteria.)