????盡管如此，FDA拒絕一切HIV自檢設備的研究、甚至不允許研究HIV自檢的可行性的做法依然十分不妥。為什么就不能允許研究人員做些測試，看看圍繞著家庭自檢的那些疑慮是否合理呢？為什么連醫療器械公司只是研究一下這個問題、想減輕艾滋病的風險也不允許呢？說得好聽些，這條禁令屬于“家長式作風”。只是因為擔心有些人會對家庭自檢的檢測結果做出不理智的極端情緒反應就剝奪了所有人選擇家庭自檢的權力，強迫大家都去醫院做檢測。（有些門診既不夠私密，收費也高，也不方便，而且很多去了門診檢測的人要么沒有獲得任何心理輔導，要么也只是被馬馬虎虎地敷衍幾句，沒有多大價值。）

????雖然FDA的禁令在1988年看起來似乎還有些道理，但隨著時間的推移卻變得越來越站不住腳。隨著治療艾滋病的藥物不斷涌現，人們對艾滋病的恐慌也不再那么歇斯底里，政治上的阻力也日漸減輕，在很多情況下甚至傾向于支持HIV自檢。因此在17年后，也就是2005年，FDA終于取消了禁令，開始考慮接受HIV家用測試器械的申請。又過了7年，OraQuick自檢器終于走完了漫長的審批流程，在上周獲批上市發售。

????需要指出的是，雖然統計數據表明，OraQuick在上市后的第一年就可能阻止4,000多起HIV傳播，這個數據實際上很模糊。實際可能更少，也可能更多。不過不管真實數據如何，我們都需要記住，由于FDA長期以來對家庭快速自檢的反對，導致了OraQuick自檢器仍然不是最先進的檢測方法。這種方法已經被醫療專業人士使用了8年了。FDA表示OraQuick的“窗口期”是90天，也就是說患者在感染90天內，檢測結果可能不會呈陽性。按今天的標準，這個窗口開得有些大。今天還有其它快速的檢測方法——它們也已經獲得了FDA的批準——不過也只能用于臨床測試。它們的窗口期只有12到26天左右。

????窗口期對于HIV傳播非常重要，因為人們在首次感染HIV病毒之后的傳染性是最強的。據信，超過一半的HIV傳播都是由患者在被感染的60到90天內傳播給下一個受害者的。

????所以如果OraQuick真的能在今年阻止4,000起新增HIV感染的話，不妨想象一下，如果上周獲批的是一種目前最先進的檢測技術，會有多少人因此從HIV的魔爪下逃過一劫。

????再想象一下，如果在五年前，有任何一種HIV快速家庭檢測方法獲批的話，又有多少人會幸免于難。

????那么10年前呢？

????或是15年前。

????或是20年前。

????或是24年前。

????這就是我所說的“丑聞”。

????譯者：樸成奎

????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.