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这是一篇刊登在最新一期“ 哈佛商业评论” Harvard Business Review 上颇引人注目的文章,披露了大制药公司背后隐藏的秘密,也是一篇为MBA在读生提供的案例。现试着将其翻成中文,以便读者对照阅读。由于时间仓促,加之本人水平有限和对相关的背景无暇深入了解,所以错译,漏译之处在所难免,还望诸位多多谅解。

Big Pharma’s Hidden Business Model and How Your Company Funds It

大型药厂背后隐藏的经营模式以及假如你有类似的制药公司应该如何出手花钱。

by Donald W. Light  |   8:00 AM September 12, 2012

Business executives may not know it, but they are wasting billions of their gross profits on ineffective, even harmful drugs in their health plans. That’s one implication of the study Joel Lexchin and I just published in the BMJ (formerly British Medical Journal).

负责经营的总裁们或许没有意识到这种背后隐藏的经营模式,而他们却把数十亿毛利润浪费在了所谓康复计划中疗效不大,甚至有害的药品开发上。我同乔尔莱客辛曾在以前的名为“英国医学杂志”上发表了有关的研究论文,其中就涉及了该问题。

 

The study assembles considerable evidence about the hidden business model of major pharmaceutical companies: to devote most of their research budget to developing hundreds of drugs that provide few if any advantages over existing drugs and then market them heavily to doctors and patients. As a result, about 80 percent of increased expenditures for drugs goes to paying for these minor variations.

我们的那篇研究论文收集了很多的相关证据,阐述了有关大制药公司背后隐藏的经营模式:他们几乎把大部分的研究经费投入到了开发数百种新药中去,最终研究成的也就那么屈指可数的几种,而这几种药的优势比起市面儿上正销售的药所拥有的特性也强不了哪里去,而市场却给这些所谓新药强制定位硬塞给医生和病人使用。结果就是为研制这些药增加的开支中80%都用来支付这些药性的微小变化上了。

 

Even worse, testing for harmful side effects is minimal when new drugs are approved by the FDA as “safe.” And only 10-15 percent are clinically superior, according to independent review bodies. So employers and employees end up paying for treating the side effects as well as overpaying for new drugs with few advantages to offset risks of harms. The chances that a newly approved drug will get a severe, black box warning or be withdrawn for serious side effects is about 20 percent over its lifetime.

还有更糟糕的, 根据一些独立评审机构统计厂家很少去对新药有害副作用做试验,尤其是当美国食品药品管理局批准这些新药为所谓“安全”时,做药性副作用测试就更是微乎其微的了,而在这些新药中只有10-15%疗效卓著。为此雇主和雇员们会为很少特性的新药多付钱以弥补这些新药具有的危害所带来的危险,同时会停止应对药品副作用所支付的费用。 有此会产生多种可能性就是刚刚批准的新药会被强制要求在药品包装上须向病人强调说明药品的副作用,否则就会因为副作用严重被强行下架,这种药品在整个药品生存周期中差不多占20%

 

Drug companies also develop clinically superior new drugs, which enlarge the medicine chest of effective drugs that greatly benefit millions of people. But while they are waiting for the next big breakthrough, companies have to fill their product line with clinically similar drugs to market as “better” than their competitors’ similar drugs. Even new molecules are usually not clinically superior. Equating “innovative” with new molecules misses the point: to develop clinically superior new medicines.

这些药公司也为临床研发效果显著的新药,而这些新药确给那些使数百万人受益的有效药品清单中扩充了品种,可在他们期待着下一个突破时,公司就不得不把临床所需类似的药同他们的新产品混在一起充数推向市场,号称比他们的竞争对手研制的类似药品标榜成“更好”甚至新药的化学分子结构通常在诊所试用效果并不出色。而还偏要将新研制的化学分子同所谓“创新”相提并论以搅乱视听,对外就宣称为研发的新药卓越,的到了临床的验证。

 

The apparent business model of Big Pharma emphasizes the billions spent at great risk to find “innovative” and “breakthrough” new molecules that must be priced high to recover research costs that have become “unsustainable.” However, revenues have increased six times more than their increased costs for research—hardly “unsustainable.” This handsome return comes from the hidden business model that generates billions in costs for employers and employees.

显而易见大制药公司的经营模式强调的是冒巨大风险花数十亿去开发所谓“创新”和“具有突破性” 的新型化学分子结构的药物。而必须将价格提高以支付研究成本,实际上这些成本已经无法支撑了。然而,利润却比投入到很难支撑的研究增长的开销上涨了6倍。这一可观的回报就来自这个背后隐含的经营模式,而正是这种隐含的经营模式为雇主们和员工们增加了数十亿的成本。

 

The FDA approves new drugs as “safe” and “effective” with little evidence that they are either in regular medical practice. In fact, industry-friendly regulations prohibit the FDA from using comparative effectiveness to approve new drugs. That would be un-American because it would jeopardize “innovation” and high-tech research jobs. Of course, the opposite is true: requiring new drugs to be clinically superior would foster true innovation and stop rewarding pseudo-innovation.

美国国家食品药品管理局批准的所谓“ 安全” 和“有效”的新药依据不足,可以说根本就没有经过常规的医疗实践。事实上来说,工业规则是不允许美国食品药物管理局采用相对比较性效果来批准新药的。那不是美国人的做事方式因为这种方式会扼杀“创新”和所从事的高科技研究工作。

 

Since companies test their own products—an obvious conflict of interest—they naturally design clinical trials to maximize evidence that they are beneficial and minimize evidence they are harmful. For example, they randomly sample from a pool that excludes people most likely to have adverse reactions, like patients with two or more health problems, women, children, and minorities. Many trials run for only a few months, long enough to gather evidence of a drug’s main effects but too short to pick up evidence of many harmful reactions.

假设这些公司试验自己产的新药显然就会同他们的利益发生冲突,所以他们自然会精心设计采用临床做试验以最大程度地验证这些新药是对病人有益,而将药的危害程度最小化。例如他们会在一组参与试验的人群中将可能会对新药产生恶劣反应的人排除掉,然后再随机抽选参与试验人员,像有两种以上健康问题的病人,妇女,儿童和少数族裔都会被排斥在外。许多试验也就只进行几个月而已,这几个月对汇集主要药性效果所需的证据应该是足够了,可对获得更多因新药引发有害反应的证据就会显得时间太短。

 

Then drug companies retain teams of science writers and editors to shape the published medical literature in order to persuade doctors that new drugs are more effective and safer than they are. Systematic reviews find that sponsored scientific articles almost always conclude the company’s drug is better. Negative results are usually not published at all. Employees and their physicians thus get biased information about biased trials. At Harvard’s Edmond J. Safra Center for Ethics, some fellows study how these institutional practices corrupt medical science and clinical practice.

这些制药公司还雇了几个班子的科技写手和编辑让他们撰写医学著作发表为的是让医生们信服新药更有效果,更安全。据系统性审评发现那些通过资助写出的科学文章得出的结论几乎总能证明这些制药公司的新药更好。负面的结果通常是绝然不会被公开发表的。由于试验本身偏激所以雇员们和为他们工作的医务人员们所的到信息也是偏激的。最近在哈佛爱得蒙撒发拉专门研究道德标准所设立的中心,一些同行在研究这些机构是如何不择手段地败坏医药科学以及临床实践的。

 

The bottom line is that prescription drugs have become the 4th leading cause of death and a leading cause of hospitalizations, accidents, and falls. See The Risks of Prescription Drugs (Columbia 2010). These cost employers even more in hidden ways. Most of the estimated 50 million adverse side effects suffered by Americans each year are minor: nausea, headaches, muscle and joint pain, itchiness and rashes, dizziness, depression, and feeling tired. But these decrease productivity and compromise good judgment on the job and off.

底线是处方药在导致住院治疗,各种意外事故以及跌倒和最终导致死亡方面被列为第4位。而这些花费以隐含的方式会让雇主付得更多。美国人每年因为严重药物副作用引发的小毛病就有大约5千万之多,大部分是恶心,头痛,肌肉和关节痛,发痒和皮疹,头晕,抑郁以及过渡疲劳。正是因为这些病导致生产力下降以及使员工就上班还是休假所做的合理判断大大折扣。

 

Driving all this are employers paying top dollar for new drugs that are little or no better than much cheaper, well-established drugs. Employers hold the key to sending clear market signals to Big Pharma—pay no more than generics for no better clinical value, a bit more for a bit more value, and only a lot more for significantly more value. The point is not to cut prices but to price to reward better patient outcomes.

导致这一切的起因都是雇主为新药支付昂贵的价钱,而这些新药比起那些已证明疗效好且更便宜的已有名声的药来说并不见得好到哪儿去,或根本就不会更好。雇主掌控着给大制药公司发送清晰的市场信号的优势,-不会给那些连非专利注册都不如的没有临床价值的药物多付一分钱,一分钱一分货,所以只会给有更多显著价值的药付大价钱。问题是不减价而要给那些对病人更有效果的药肯花钱,并给予奖励。

 

It’s so obvious, and employers think they are managing drug costs through their pharmacy benefit managers (PBMs) and insurers. But PBMs and insurers profit from costs increasing, even as they talk a good game of holding down costs. And they do not draw on international review bodies to inform employers about the many new drugs with little added value.

这是很显然的事,且雇主认为通过他们的药品福利管理师和保险公司就控制着药成本。可药品福利管理师和保险公司却随着成本的上涨从中获利,甚至还花言巧语的讲会降低成本。他们不会利用国际性评审机构去告知雇主很多新药并没有增加任何价值。

 

No PBM (a uniquely American middleman who takes his cut) is doing what the Germans are doing for their employers—assessing the marginal gain of new drugs and paying only for greater value. The European trade association for pharmaceutical companies cries foul: how dare the new German agency for better value compare new patented drugs with older generics! But why not? Isn’t the point to see if the new ones are better than the old ones in the same class that cost a fraction as much?—How dare the new Germany agency undermine innovative research! But paying more only for better products is good business practice and rewards true innovation instead of pseudo-innovation.

药品福利管理师(是唯一能砍价的美国中间人) 正在从事的是德国人为他们雇主作的事。-评估新药的利润收获以及只付价值更高的新药。专门负责制药公司的欧洲贸易协会大肆叫嚣: 新德国机构怎么敢用非专利的老药同注册专利的新药相媲美呢?可问题是为什么不能呢? 难道不是在同一等级里新药若比旧药更好那新药的成本就一定要多增加一块?这家新德国机构怎么敢如此破坏创造性研究!可是只有为更好的产品多付才是好的经营举措而且应该奖励创新,摒弃虚假创新。

 

Senator Bernie Sanders of Vermont has another proposal: reward research teams or companies with a large sum directly and quickly if they develop superior drugs for unmet needs and buy out the IP rights so that all drugs can be available at low generic prices from the start. It speeds up the innovation cycle (which otherwise has to wait for sales at patent-protected high prices), and it keeps health care costs down. Lower costs, more true innovation.

美国佛猛特州参议院伯尼桑德斯却另有倡议: 他认为假设研究队伍或有大笔资金的制药公司能不为既得利益开发性能卓越的新药以及买断相应的知识产权,就应该直接和迅速地给予他们奖励,以便能让所有新药从开始就都能像非注册专利药物一样保持低价位。这将加速创新周期(否则不得不在专利保护的状态下高价出售)这样也可以将医保费降下来。成本越低,创新相对就越真实。

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