達拉斯買傢俱樂部、波士頓法律與FDA的故事

       這部片子改編自真實事件。但正如它的港譯名「續命梟雄」，真實事件在被改編為影片的過程中被多少帶上了點美國式的個人英雄主義色彩。現實中的達拉斯買傢俱樂部暴利以及藥物濫用的一面則在電影中做了曖昧的淡化處理（直至結尾列隊鼓掌的一段簡直是得到了美化昇華）。當然，以「藝術加工」之名所做的改編無可厚非。但相比動人的情節以及男主角和男配角精湛的演技，FDA藥物審批制度這個近幾十年來爭議不斷的議題倒也值得拿出來講一講。
       美國的食品藥品監督管理局（Food and Drug Administration，FDA）是直屬美國健康及人類服務部管轄的聯邦政府機構，其主要職能為負責對美國國內生產及進口的食品和藥品進行監督管理。在聯邦法律的授權之下，FDA實施多項安全監管職能，其中就包括處方藥的藥品測試、製造、廣告、市場營銷和藥品安全等方面的監管。諸多職權中，藥品審批制度賦予了FDA對新藥的生殺大權，而這也直接關乎到了製藥公司的商業利益。巨額藥物研發成本在曾經極為嚴苛且冗長的審批程序面前都可能落得竹籃打水一場空，可以想見製藥公司當時對於FDA的敵對態度。
       而正如影片中所展現的，20世紀80年代愛滋病的蔓延之勢曾一度失去控制。相比爆發的疫病，藥物的研發終歸不可避免地滯後一步，但此時關於愛滋病的醫學研究亦非毫無進展。然而，橫亘在新藥與患者之間仍是可能長達數年的漫長臨床試驗和審批。於是，FDA的藥物審批制度成了絕望的患者以及愛滋病活動人士們當然的靶子。製藥公司與民眾的呼聲愈高，政治力量的介入亦變得無可避免。終於，在重重壓力之下，FDA做出妥協，並在國會授權下制訂了 「快速審批方案」，以加速批准那些治療「嚴重或致死性疾病」 （serious or life-threatening disease or condition）的藥物。這些加快審批程序的規定在1992年都被進行了擴大適用並被編入相關法案之中。隨著2012年7月9日，《FDA安全與創新法案》（Food and Drug Administration Safety and Innovation Act）正式實施，如今FDA已經有了四條特別審批通道，即快速通道（Fast Track）、優先審評（Priority Review）、加速批准（Accelerated Approval）和突破性藥物（Breakthrough Therapies）。進入特別審批通道的藥物，最快數月甚至數周就能完成審批週期。
       但事實上，有的時候恰恰只有時間才能夠檢驗出真正的藥物危害。快速通道大門開啟後，經FDA快速批准的藥物發生安全問題的事件屢見不鮮，大量藥物都在投放市場後才被發現嚴重的副作用。《美國醫學會雜誌》曾報導指出，通過FDA快速審查的藥物只是在一個相對狹窄的受眾群里經過小規模的試驗即可通過審批。快速審批制度導致對藥物的研究測試過少，而快速批准後藥品的後續研究、檢測報告等重要資訊往往不能及時跟進。至於FDA的快速審批制度又是否有被製藥公司濫用之嫌，也是屢遭質疑。
       這裡想提到另外一部美劇。波士頓最後一季的最後一集，丹尼因為需要同樣未經FDA批准但能治療老年痴呆的藥物而挑戰了FDA的審批制度，還把這個案子上訴到了最高法院。儘管有Alan的全力辯護，但結果卻並未能如其所願。值得一提的是，在現實中，關於患者是否擁有使用未經批准藥物的權利的案件亦真實存在。2006年的「Abigail Alliance Citizen Petition to FDA」案中，Abigail Alliance認為FDA應該允許被診斷患有嚴重或致死性疾病（serious or immediately life-threatening disease）的患者使用已經完成了臨床實驗Ⅰ期的藥物。該主張雖然在2006年5月得到了第一上訴法庭的支持，但是2008年3月經過重審被推翻，美國最高法院並未接受此案的上訴申請。
       在此，想引述波士頓法律中為FDA藥物審批制度辯護的律師的一段總結陳詞作為結尾。這段精彩的陳詞可以說是點出了藥物審批制度，甚至這個制度看似不合情理的冗長，所真正蘊含的合理性。這段台詞亦代表了本文所想要表達的一些思索，與大家分享，算是提供一個不同的視角。

 「If this man is dying of an incurable disease, why not give him the unapproved drug? Who does it hurt?
First of all, Mr. Crane is not necessarily terminal. I know the disease can take unpredictable courses, particularly when it comes to progression, and all with the same ending. The F.D.A. bans experimental drug use with good reason, because this does not just involve the individual patient. If untested drugs are suddenly made available, people will forgo entering into clinical drug trials. Promising drugs might not be studied, and therefore, never reach the market. That hurts over five million people have Alzheimer's. Something tells me we'd have plenty of subjects for clinical trials. With all due respect, Justice Scalia, if people can simply buy the drug, they won't choose to enter into a clinical study where they could risk getting a placebo.
Why shouldn't a person have a right to medical self-defense? This court rejected that right in marijuana cases where there were other treatments available. We let women abort viable fetuses to protect their own lives. A person may shoot and attack dead in self-defense. Shouldn't this man be able to take a drug to save himself, uh, especially, if, uh, it's his only hope? No. First of all, dying people are willing to assume any risk, including taking dangerous, untested drugs, which could kill them sooner. But again, what's the downside-the downside is clinical trials get shortchanged, interfered with. The safety and efficacy of these drugs is at stake, not to mention millions of lives.
My grandmother has Alzheimer's. She's one of those five million people. She sits at home waiting for a cure, desperate for F.D.A. approval, which could very well be delayed by letting... we've seen how pharmaceutical companies work. It's not about finding cures so much as it is finding markets, selling. If they get to peddle promising but untested drugs, we all know they'll do it. Drugs that engender false hopes, ones with higher profit margins if they get to skip the testing. Investors will pump their money into snake oils that dress up well. This is not a scrupulous industry, your honor. They most certainly don't deserve a pass on clinical trails, and that is what will effectively happen if untested drugs are okayed by this court.
We already have a problem in this country of rushing unsafe drugs to the market-it's epidemic. And as soon as we allow patients, especially the desperate ones, to exempt drugs from testing, it is going to get exponentially worse. Fewer people will be saved.
Rather, more will die.」