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新英格兰杂志评论:FDA 应该拯救而不是抛弃

(2008-04-30 12:08:22)
标签:

gcp

fda

杂谈

分类: 临床试验
Playing "Kick the FDA" — Risk-free to Players but Hazardous to Public Health
让FDA出局——对玩者没有风险却严重危害公众健康
The Food and Drug Administration (FDA) is responsible for regulating $1 trillion worth of consumer products, or 25% of the U.S. consumer economy — the food we eat, the cosmetics we use, the medical devices implanted in our bodies or used in our care, and the drugs we take. It is of grave concern when an agency with such pervasive effects on our lives loses the public's confidence.
FDA负责监管价值近1万亿美元的消费品或者25%的美国消费经济——吃的食物,用的化妆品,植入体内或者健康相关的医疗器械以及服用的药物。当一个对我们生活产生如此巨大影响的部门失去公信力时,自然会引起极大地关注。
Public opinion polls show that confidence in the FDA fell from 80% in the 1970s to 36% in 2006 — ratings usually reserved for tobacco companies and used-car dealers. Much of this deterioration in confidence can be attributed to some high-profile events, ranging from the withdrawal of Vioxx (rofecoxib) to the apparent adulteration of the heparin supply, which many observers have laid largely at the FDA's door — while ignoring the responsibilities of others and the fact that the agency's federal funding is grossly inadequate. Kicking the FDA has become a popular sport for the press and legislators, but by failing to hold others accountable, it puts the public health at serious risk while carrying no personal risk for those who play it.
民意投票显示,FDA的支持率从70年代的80%降至2006年的36%——只有烟草公司和二手车行依然保留好感。信任度的大幅下降归因于几件引人瞩目的事件——从万络(罗非昔布)召回到明显的肝素供应掺假,许多观察家把矛头直指FDA而忽略了其他人的责任和当局经费严重不足这一事实。媒体和国会议员试图让FDA出局,由于忽略了其他原因,因而将使公众健康置于更加危险的境地,但对当局者不会带来任何个人风险。
How did we arrive at this crisis, and what can be done to resolve it? I submit that it is time to demand that the critics assume their own share of responsibility for the recent problems. We need to acknowledge that ensuring the safety and integrity of our food, drugs, cosmetics, and medical devices is primarily the responsibility of manufacturers, with the FDA providing a regulatory framework and oversight. It is also critical that legislators recognize their responsibility to provide the agency with funding that is adequate for it to perform its important functions.
危机是如何造成的,我们如何处理解决?我以为,要求评论家们认为自己对近期的问题也应负一份责任的时机到了。我们需要承认,确保食品、药品、化妆品和医疗器械的安全性和真实性主要是生产厂家的责任,而FDA只不过是监管体系。国会议员应认识到其职责是为药监部门提供充足的经费使其正常运转,这一点很重要。
The fundamental problem is that legislators have heaped more and more responsibility on the FDA without appropriately increasing its budget. Between 1988 and 2007, additional FDA responsibilities were imposed by 137 specific statutes, 18 statutes of general applicability, and 14 executive orders.At the same time, the FDA received a 2007 federal appropriation of only $1.57 billion — less than 75% of the budget for the school district in its home county in Maryland, and about the same as the projected cost of the infamous Alaskan "bridge to nowhere." The number of federally appropriated personnel authorized for the FDA has decreased from 9167 in 1994 to 7856 in 2007. And the remaining personnel must work with inadequate information technology: 80% of the FDA's computer servers are more than 5 years old; critical clinical trial records are stored on paper in warehouses, largely inaccessible for analysis; and the information technology budget is about 40% of that for the Centers for Disease Control and Prevention.
一个主要的问题是国会议员们给FDA增加了越来越多的职责而预算没有适当的增加。在1988年和2007年间,有137部特别法,18部一般适用法以及14条总统命令为FDA强加了额外的职责。与此同时,FDA2007年的联邦财政拨款仅为15.7亿美元,比其所在马里兰州的学区预算的75%还要少,与声名狼藉的阿拉斯加的“无止桥”的计划投资相当。FDA认可的权威的联邦人员人数也由1994年的9167下降至2007年的7856。保留下来的人员必须使用不充分的信息技术进行工作:80%的FDA的计算机服务器运行超过5年;重要的临床试验记录由于以纸质形式保存在仓库中,因而大都很难用来分析;并且用于信息技术的预算只有用于疾病预防和控制中心(CDCP)的40%。
Moreover, the agency's work has become vastly more complex, thanks to new science and substantial change in the business environment. Today, industry sources its products from all over the world, seeking the best price wherever it can be obtained. Astonishingly, an estimated 80% of the active pharmaceutical ingredients in U.S. prescription drugs are manufactured overseas, with India and China being the two largest providers. Although the desire to obtain the lowest-cost supplies is understandable, this shift comes with additional responsibilities for manufacturers, who must ensure the quality, chain of custody, and integrity of their supply chain, especially by supervising the manufacturing process in countries whose regulatory environments are more lax than ours.
还有,由于商业环境中新技术的引用和实质性的改变,当局的工作变得异常繁琐复杂。目前,工厂为它们的产品在世界各地寻找来源,以期获得价格最优惠的原料。令人吃惊的是,美国处方药中的原料药(API)80%来自国外,其中印度和中国是两家最大的供应商。尽管追求低成本供应的愿望是可以理解的,但是转变的同时生产企业应承担额外的责任即确保质量、监管链和供应链的完整性,尤其是在那些政策环境比我们松散的国家生产的工艺过程的监督管理。
After a number of deaths and serious adverse reactions occurred in the United States and Germany in association with the administration of heparin, investigators discovered in March that some batches of what should have been pure heparin contained as much as 50% of oversulfated chondroitin sulfate. Since this substance does not occur naturally and mimics heparin in assays, it may have been introduced deliberately, as a cheaper substitute. This incident recalls a 2007 episode in which melamine introduced into pet food resulted in the deaths of a number of animals. Melamine contains a high proportion of nitrogen and was added to livestock feed from China to produce misleading results in assays for protein content, increasing the feed's value. Clearly, manufacturers need to take much stronger steps to ensure the integrity of their supply chain. Such responsibilities go far beyond "meeting regulatory requirements." Neither adulteration of drugs and food products nor the use of lead in toys can be prevented solely by regulators; prevention requires intense supervision by responsible manufacturers.
在美国和德国发生许多起与肝素监管相关的患者死亡和严重不良反应事件后,研究者在3月份发现,本应含有纯肝素的一些批次产品中竟然含高达50%的多硫酸软骨素。既然该物质不能自然产生,并且分析中不能替代肝素,那么很可能是以廉价物的身份人为添加的。该事件不禁让人回忆起2007年的三聚氰胺加入到宠物食品中导致许多动物死亡的事件。三聚氰胺含氮量很高,被加入至源于中国的动物饲料中从而改变蛋白质含量的结果,提升饲料的价值。显而易见,生产企业需要采取更强有力的措施保证其供应链的完整。这样的职责已经超出了“符合政府规定”的范畴。食品药品中的掺假和玩具中铅的存在不能仅靠政府预防;预防同样需要有责任心的企业的强力监督。
Unfortunately, the heparin incident has played out in the press and Congress as a failure of the FDA to inspect the Chinese facility, and the agency was quickly condemned for having inspected only 15 facilities in China in 2006. But it is inappropriate and unrealistic to expect the FDA to ensure the integrity of every manufacturer's entire supply chain. If a manufacturer chooses to save money by purchasing raw material from China, then it must bear the additional costs of zealous quality control and oversight in a country with a very limited regulatory system and a fluid commercial structure. U.S. taxpayers should not have to pay to send inspectors to every factory in China to allow industry to obtain cheaper and largely unregulated products there.
很不幸,肝素门事件被媒体和国会渲染为FDA检查中国企业的失败,监管部门由于在2006年仅对中国的16家企业进行了检查而备受责难。然而,希望FDA确保每一个企业的供应链的完整是不适当也是不现实的。如果某企业出于省钱的目的购买中国的原料,那么它必须承担因积极的质量控制以及该国监管能力薄弱和贸易流动时的监管而发生的额外费用。US纳税人不必要求检查员到每一个提供廉价的和大宗不受管制的产品的中国工厂。
It is easier to attack the FDA than to assume one's own share of responsibility. The press, for its part, frequently reports legislators' criticisms of the agency without providing any analysis of their voting records on FDA appropriations. But the bigger scandal is Congress's grossly inadequate funding of the agency, which demands swift and decisive action. No longer should our legislators be able to publicly excoriate FDA employees while ignoring their own complicity. No longer should any of us berate the FDA while failing to acknowledge that we are asking it to do more and more work with fewer and fewer resources. No longer should manufacturers be able to imply that inadequate FDA inspection is an excuse for adulteration of their product during manufacture. We must stop allowing the game of "kick the FDA" to be risk-free to participants. The public's health is at stake, and the time for adequate federal funding of the FDA is now.
攻击FDA远比考虑自己的职责容易得多。媒体频繁报道国会议员对于FDA的批评之词,而不要求其提供任何FDA拨款时的投票记录的分析。但更大的公愤是国会对要求监管局迅速行动,而经费支持严重不足。国会议员们不应再当众批评FDA雇员时而忽略了自己恰恰是同谋犯。我们也不应再斥责FDA时而不承认我们正要求他们以很少的资源做很多的事。生产企业不应再以FDA检查不到位为借口而产品生产过程中掺假。我们必须停止让FDA出局让参与者没有风险的游戏。公众健康正处在生死攸关的境地, 给予FDA充足的经费的时候到了。

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