首支HIV家庭自检器上市背后的“丑闻”

    尽管如此，FDA拒绝一切HIV自检设备的研究、甚至不允许研究HIV自检的可行性的做法依然十分不妥。为什么就不能允许研究人员做些测试，看看围绕着家庭自检的那些疑虑是否合理呢？为什么连医疗器械公司只是研究一下这个问题、想减轻艾滋病的风险也不允许呢？说得好听些，这条禁令属于“家长式作风”。只是因为担心有些人会对家庭自检的检测结果做出不理智的极端情绪反应就剥夺了所有人选择家庭自检的权力，强迫大家都去医院做检测。（有些门诊既不够私密，收费也高，也不方便，而且很多去了门诊检测的人要么没有获得任何心理辅导，要么也只是被马马虎虎地敷衍几句，没有多大价值。）

    虽然FDA的禁令在1988年看起来似乎还有些道理，但随着时间的推移却变得越来越站不住脚。随着治疗艾滋病的药物不断涌现，人们对艾滋病的恐慌也不再那么歇斯底里，政治上的阻力也日渐减轻，在很多情况下甚至倾向于支持HIV自检。因此在17年后，也就是2005年，FDA终于取消了禁令，开始考虑接受HIV家用测试器械的申请。又过了7年，OraQuick自检器终于走完了漫长的审批流程，在上周获批上市发售。

    需要指出的是，虽然统计数据表明，OraQuick在上市后的第一年就可能阻止4,000多起HIV传播，这个数据实际上很模糊。实际可能更少，也可能更多。不过不管真实数据如何，我们都需要记住，由于FDA长期以来对家庭快速自检的反对，导致了OraQuick自检器仍然不是最先进的检测方法。这种方法已经被医疗专业人士使用了8年了。FDA表示OraQuick的“窗口期”是90天，也就是说患者在感染90天内，检测结果可能不会呈阳性。按今天的标准，这个窗口开得有些大。今天还有其它快速的检测方法——它们也已经获得了FDA的批准——不过也只能用于临床测试。它们的窗口期只有12到26天左右。

    窗口期对于HIV传播非常重要，因为人们在首次感染HIV病毒之后的传染性是最强的。据信，超过一半的HIV传播都是由患者在被感染的60到90天内传播给下一个受害者的。

    所以如果OraQuick真的能在今年阻止4,000起新增HIV感染的话，不妨想象一下，如果上周获批的是一种目前最先进的检测技术，会有多少人因此从HIV的魔爪下逃过一劫。

    再想象一下，如果在五年前，有任何一种HIV快速家庭检测方法获批的话，又有多少人会幸免于难。

    那么10年前呢？

    或是15年前。

    或是20年前。

    或是24年前。

    这就是我所说的“丑闻”。

    译者：朴成奎

    Still, the approach the FDA took—to reject out of hand all research into even the feasibility of rapid home testing—was ill-advised. Why not allow researchers to do trials to see if the apprehensions surrounding home testing were empirically justified? Why discourage medical device companies from even exploring the question and trying to mitigate the dangers? At best, the ban was paternalistic. Out of concern that some people might respond emotionally and irrationally to the extremely valuable information a home test could provide, everyone was deprived of that option and forced to go to a clinic instead. (This was so even though clinics were not private, more expensive, less convenient, and plenty of people who went to them ended up receiving no counseling or perfunctory counseling of uncertain value.)

    And even if the FDA's ban on considering home testing kits might have been defensible in 1988, it became less so as each year passed—as drugs become available to treat AIDS, as fears became less hysterical, and as political opposition abated and, in many cases, morphed into support. Yet the years did pass—17 of them—before the FDA in 2005 effectively lifted its ban and started considering applications for HIV home testing kits. It then took another seven years for the OraQuick test to wend its way to the approval finish line—the journey it completed last week.

    To be sure, the statistics suggesting that OraQuick might avert more than 4,000 HIV infections in its first year are squishy. It could be less. It might be more. But whatever the true figure turns out to be, we need to remember that even the OraQuick test, because of the FDA's long opposition to home rapid tests, is not a state-of-the-art procedure. It's been in use by healthcare professionals for eight years already. The FDA says that OraQuick's "window period" is 90 days, meaning that infected people should not expect to see a positive result if they were infected less than 90 days before they give themselves that test. By today's standards, that's a wide window. There are other rapid tests available today—which have already won FDA approval, though, again, only for use at clinics—which have window periods as short as 12-26 days.

    Window periods are important, since people are most infectious right after they are first exposed to the HIV virus. More than half of HIV transmissions are believed to pass from an infected person to a new victim during the infected person's first 60 to 90 days of exposure.

    So if OraQuick might avert 4,000 new infections this year, imagine the number that could have been prevented if a state-of-the-art test had been approved last week.

    And now imagine the number that could have been averted if a rapid home test of any description had been approved five years ago.

    Or ten.

    Or 15.

    Or 20.

    Or 24.

    That's the scandal.