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达拉斯买家俱乐部、波士顿法律与FDA的故事

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   这部片子改编自真实事件。但正如它的港译名“续命枭雄”,真实事件在被改编为影片的过程中被多少带上了点美国式的个人英雄主义色彩。现实中的达拉斯买家俱乐部暴利以及药物滥用的一面则在电影中做了暧昧的淡化处理(直至结尾列队鼓掌的一段简直是得到了美化升华)。当然,以“艺术加工”之名所做的改编无可厚非。但相比动人的情节以及男主角和男配角精湛的演技,FDA药物审批制度这个近几十年来争议不断的议题倒也值得拿出来讲一讲。
   美国的食品药品监督管理局(Food and Drug Administration,FDA)是直属美国健康及人类服务部管辖的联邦政府机构,其主要职能为负责对美国国内生产及进口的食品和药品进行监督管理。在联邦法律的授权之下,FDA实施多项安全监管职能,其中就包括处方药的药品测试、制造、广告、市场营销和药品安全等方面的监管。诸多职权中,药品审批制度赋予了FDA对新药的生杀大权,而这也直接关乎到了制药公司的商业利益。巨额药物研发成本在曾经极为严苛且冗长的审批程序面前都可能落得竹篮打水一场空,可以想见制药公司当时对于FDA的敌对态度。
   而正如影片中所展现的,20世纪80年代艾滋病的蔓延之势曾一度失控制。相比爆发的疫病,药物的研发终归不可避免地滞后一步,但此时关于艾滋病的医学研究亦非毫无进展。然而,横亘在新药与患者之间仍是可能长达数年的漫长临床试验和审批。于是,FDA的药物审批制度成了绝望的患者以及艾滋病活动人士们当然的靶子。制药公司与民众的呼声愈高,政治力量的介入亦变得无可避免。终于,在重重压力之下,FDA做出妥协,并在国会授权下制订了 “快速审批方案”,以加速批准那些治疗“严重或致死性疾病” (serious or life-threatening disease or condition)的药物。这些加快审批程序的规定在1992年都被进行了扩大适用并被编入相关法案之中。随着2012年7月9日,《FDA安全与创新法案》(Food and Drug Administration Safety and Innovation Act)正式实施,如今FDA已经有了四条特别审批通道,即快速通道(Fast Track)、优先审评(Priority Review)、加速批准(Accelerated Approval)和突破性药物(Breakthrough Therapies)。进入特别审批通道的药物,最快数月甚至数周就能完成审批周期。
   但事实上,有的时候恰恰只有时间才能够检验出真正的药物危害。快速通道大门开启后,经FDA快速批准的药物发生安全问题的事件屡见不鲜,大量药物都在投放市场后才被发现严重的副作用。《美国医学会杂志》曾报道指出,通过FDA快速审查的药物只是在一个相对狭窄的受众群里经过小规模的试验即可通过审批。快速审批制度导致对药物的研究测试过少,而快速批准后药品的后续研究、检测报告等重要信息往往不能及时跟进。至于FDA的快速审批制度又是否有被制药公司滥用之嫌,也是屡遭质疑。
   这里想提到另外一部美剧。波士顿最后一季的最后一集,Denny因为需要同样未经FDA批准但能治疗老年痴呆的药物而挑战了FDA的审批制度,还把这个案子上诉到了最高法院。尽管有Alan的全力辩护,但结果却并未能如其所愿。值得一提的是,在现实中,关于患者是否拥有使用未经批准药物的权利的案件亦真实存在。2006年的“Abigail Alliance Citizen Petition to FDA”案中,Abigail Alliance认为FDA应该允许被诊断患有严重或致死性疾病(serious or immediately life-threatening disease)的患者使用已经完成了临床实验Ⅰ期的药物。该主张虽然在2006年5月得到了第一上诉法庭的支持,但是2008年3月经过重审被推翻,美国最高法院并未接受此案的上诉申请。
   在此,想引述波士顿法律中为FDA药物审批制度辩护的律师的一段总结陈词作为结尾。这段精彩的陈词可以说是点出了药物审批制度,甚至这个制度看似不合情理的冗长,所真正蕴含的合理性。这段台词亦代表了本文所想要表达的一些思索,与大家分享,算是提供一个不同的视角。
  
   “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.”

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