????一樁24年前的丑聞上周靜悄悄地浮出了水面。7月3日，美國(guó)食品和藥物管理局（FDA）批準(zhǔn)了全球首支HIV病毒“家用快速自檢器”的發(fā)售。人們可以通過(guò)該自檢器在家中私密地測(cè)試自己是否感染上了艾滋病病毒。

????這支名為OraQuick的自檢器獲批發(fā)售無(wú)疑是件好事——你也肯定會(huì)這么想。只需一滴唾液，就可快速檢測(cè)一個(gè)人是否感染了HIV病毒。它由美國(guó)的OraSure科技公司生產(chǎn)，每支只賣(mài)不到60美元，每次檢測(cè)只需20分鐘時(shí)間。根據(jù)FDA今年五月在一次聽(tīng)證會(huì)上提交的統(tǒng)計(jì)數(shù)據(jù)顯示，這支自檢器在上市發(fā)售的第一年里就可能有效阻止4,000多起新的HIV感染。目前美國(guó)每年新增HIV感染者約5萬(wàn)人，也就是它至少可以阻止其中8%的人被感染。【據(jù)美國(guó)疾病防治中心（the Centers for Disease Control and Prevention）介紹，現(xiàn)在美國(guó)約有120萬(wàn)名HIV攜帶者，其中約有20%的人并不知道自己感染了HIV。自從艾滋病在上世紀(jì)80年代被發(fā)現(xiàn)以來(lái)，大概已經(jīng)有110萬(wàn)人被確診患有艾滋病，死于艾滋病的患者已經(jīng)超過(guò)619,000人?！?/p>

????那么為什么說(shuō)這是一樁“丑聞”呢？事實(shí)上，雖然這樣一支HIV快速自檢器上周才獲批，但是早在24年前，F(xiàn)DA就接到了第一份請(qǐng)求批準(zhǔn)銷(xiāo)售HIV自檢器的申請(qǐng)。

????與傳統(tǒng)的臨床檢查相比，家庭自檢最大的優(yōu)勢(shì)就是它的保密性。在美國(guó)說(shuō)起艾滋病，人們總會(huì)下意識(shí)地把它與同性戀和注射毒品聯(lián)系在一起。如果去門(mén)診或診所做HIV測(cè)試，病人的隱私就存在很大風(fēng)險(xiǎn)。由于艾滋病一開(kāi)始就是致命的，而且無(wú)法治愈，因此人們一旦確診感染了這種“同性戀瘟疫”——也就是HIV，往往就會(huì)陷入歇斯底里的境地。得了HIV的人有理由擔(dān)心會(huì)在就業(yè)上受到歧視，在社交上也會(huì)被其他人避之而唯恐不及。

????但同時(shí)，艾滋病高危人群必須接受測(cè)試，這樣他們才能采取措施，避免疾病的傳播。家庭快速自檢為他們提供了一種謹(jǐn)慎、經(jīng)濟(jì)而方便的檢測(cè)方式。

????1987年末，一家名為“大學(xué)醫(yī)院實(shí)驗(yàn)室”（University Hospital Laboratories）的公司向FDA提交了一份請(qǐng)求批準(zhǔn)銷(xiāo)售家用HIV快速血液自檢器的申請(qǐng)。這家公司的老板名叫艾略特?米勒森。意想不到的是，F(xiàn)DA在1988年3月拒絕接受該公司提交申請(qǐng)文件——一般來(lái)說(shuō)，只有先接受了申請(qǐng)文件，隨后才能開(kāi)始漫長(zhǎng)的監(jiān)管審批過(guò)程。不僅如此，F(xiàn)DA還出臺(tái)了一系列條條框框來(lái)約束未來(lái)任何HIV檢測(cè)產(chǎn)品的申請(qǐng)，這相當(dāng)于先發(fā)制人地否決了HIV快速家庭自測(cè)。唯一有可能或得審批資格的只有那些在臨床環(huán)境下進(jìn)行的檢測(cè)產(chǎn)品。

????不難看出，F(xiàn)DA出臺(tái)這樣的規(guī)定，背后也有著合理的公共衛(wèi)生動(dòng)機(jī)。首先，F(xiàn)DA擔(dān)心的是，患者在測(cè)試前后都要獲得適當(dāng)?shù)男睦磔o導(dǎo)。患者要意識(shí)到檢測(cè)結(jié)果有可能出現(xiàn)假陽(yáng)性，以免如果真的出現(xiàn)假陽(yáng)性時(shí)造成不必要的恐慌。同時(shí)他們也要意識(shí)到，檢測(cè)結(jié)果也有可能呈假陰性，這樣他們就不會(huì)自以為逃過(guò)一劫，再去危害他們的性伴侶。另外他們也要知道，如果他們真的感染了HIV，有哪些方案可以選擇，有哪些“病友會(huì)”可以參加。（許多艾滋病維權(quán)人士當(dāng)時(shí)幾乎反對(duì)任何形式的HIV測(cè)試，因?yàn)樗麄儞?dān)心測(cè)試結(jié)果會(huì)被濫用，造成HIV陽(yáng)性患者遭到排擠和迫害——當(dāng)然，我們還是希望FDA之所以出臺(tái)這些規(guī)定，主要是出于公共衛(wèi)生的考慮，而不是出于政治壓力，或是擔(dān)心“恐艾癥”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.)