抗胆固醇类药物遭到攻击

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Shock to the system
体系的震荡
Cholesterol drugs are under attack
抗胆固醇类药物遭到攻击
“I SEE profound consequences arising from this,” says Steven Nissen of the Cleveland Clinic, an American research hospital. Dr Nissen, a leading cardiologist, is up in arms over the way Merck and Schering-Plough, two American pharmaceutical giants, have handled a clinical trial of Vytorin, a blockbuster anticholesterol
drug produced jointly by the two firms. Could this controversy upend the $25 billion
cholesterol-fighting industry?
Cleveland 临床研究中心的Steven Nissen说:“这件事情所引起的后果将是非常深远的。” Nissen博士，这位美国知名的心脏病专家，激烈的反对两个美国大型制药公司默克和先灵葆雅对Vytorin（一种由这两家公司联合研制的重磅炸弹级别的抗胆固醇的处方药）的临床试验所采取的做法。这场正在进行的争论会使价值250亿美金的抗胆固醇市场走向崩溃吗？
For years, the drugs of choice in combating heart disease have been statins such as Pfizer's Lipitor and AstraZeneca's Crestor. Concerned that the patent for its own statin, Zocor, was due to expire in 2006。
多年以来，治疗心脏病的药物一般首选他汀类药物例如辉瑞的利普妥和阿斯利康的Crestor，而默克的他汀类药物Zocor的专利保护在2006年就已经到期。
Merck found a clever way to rejuvenate its franchise. It combined Zocor with Zetia, a cholesterol drug developed by Schering-Plough, to create Vytorin. (Statins reduce the formation of so-called “bad cholesterol”, or LDL, in the liver; Zetia reduces its absorption.) But the Vytorin study, completed nearly two years ago and released only in January, found that on one important measure, the pricey branded
drug was no more effective than the generic version of Zocor on its own, which costs one-third as much. Merck and Schering-Plough insist they have done nothing wrong, and are adamant that Vytorin remains an important drug.
默克想到了一个重新获得专利保护的好办法。它将Zocor和先灵葆雅的降胆固醇药物Zetia作成复方制剂Vytorin（他汀类药物可以降低所谓的“有害胆固醇”（即LDL低密度脂蛋白胆固醇）在肝脏内的含量；而Zetia则可以减少人体对胆固醇的吸收）但是对Vytorin的临床研究，在大约两年以前就已经完成了，研究结果却在今年一月份才公布，根据公布的研究结果来衡量：新药Vytorin的疗效一点也不比已经沦为普药的Zocor好，而普药Zocor的价格只有新药Vytorin的1/3。默克与先灵葆雅却坚持它们并没有做错什么，并且认为Vytorin依然是一种重要的降胆固醇类药物。
On January 25th America's Food and Drug Administration (FDA) said it would scrutinise the study's results over the next eight months. A committee of the House of Representatives is also reviewing the handling of the study.
1月25日美国食品与药品监督管理局（FDA）宣布它将在未来8个月中对有关的临床研究结果进行详细的审核。国会的一个委员会也对对此事进行调查。
Andrew Cuomo, New York's attorney-general, launched his own
investigation on January 26th. His office will examine whether senior executives engaged in insider trading after learning of the results of the study, and whether Vytorin's lavish marketing campaign, which continued to run after the study was completed, violated the state's laws on false advertising claims.
纽约的首席检察官Andrew Cuomo于1月26日开始对此事进行独立调查。他的办公室将调查这两家美国制药公司的高级管理人员是否存在在已经知道研究结果后蓄意隐瞒对Vytorin不利的研究结果并继续开展大规模的营销活动，如果两家公司果真存在这样的行为，它们将可能因为涉嫌发布虚假广告而受到指控。
Meanwhile, several class-action suits have been filed in New Jersey, the home state of both pharmaceutical firms.
与此同时，在这两家公司的总部所在地新泽西，已经有几件与此有关的集体诉讼案在等待着它们。
These legal and political troubles for Merck and Schering-Plough have been accompanied by a frenzy of negative media coverage and a public outcry over Vytorin, a popular drug which was prescribed 22m times in America last year, raising wider questions for the industry. Some are even challenging the
scientific orthodoxy underpinning anti-cholesterol drugs, which maintains that reducing the level of LDL cuts the risk of heart disease.
默克和先灵葆雅在应对这一系列政治上和法律上的麻烦的同时还要面对媒体铺天盖地的负面报道和公众对Vytorin的声讨，Vytorin，这种去年美国处方数量达到2200万次的畅销药品现在却给整个降胆固醇药物产业带来了麻烦。一些人甚至对降胆固醇药物存在的科学依据提出了挑战，即是否可以通过降低人体内的低密度脂蛋白胆固醇来达到降低心脏病发病风险的效果。
Viren Mehta, an industry expert, calculates that global sales of Vytorin and Zetia will fall by 10% in 2008 and remain flat until 2011, when a more detailed study of Vytorin will be completed. Sales of Lipitor and other statins unrelated to the Vytorin study have already been hit. But John Boris of Bear Sterns, an
investment bank, reckons this is just a temporary setback caused by irresponsible media reports, and that sales will pick up again before long.
一位叫Viren Mehta的业内专家计算08年全球Vytorin和Zetia这两种药物的销售量会下滑10%，2011年（这一年会有一项与Vytorin有关的更详细的临床研究出结果）之前都不会出现增长；贝尔斯登（知名投资银行）John Boris却认为这只是一场由某些媒体不负责任的报道而导致的短暂挫折，销售量会很快恢复到这之前的水平。
It is probably too soon to assess the damage to Vytorin. If doctors and patients grow skittish and stick with plain old statins instead, as they are now doing, that could deal a big blow to its prospects.
现在还很难评价这一事件对Vytorin所造的损害。如果医生和病人们转向其他他汀类的普通药物，这将对Vytorin的未来造成巨大打击。
Roger Blumenthal of Johns Hopkins University says Vytorin should not be tried as the first anti-cholesterol remedy for new patients: statins should.
约翰霍普金斯大学的Roger Blumenthal认为Vytorin将不会被当作降低胆固醇的首选药物，但是他汀类药物本身还应当是首选。
Only if patients reach the maximum tolerable dose of statins, or face unbearable side effects, should they try Vytorin. If that advice were really followed, however, it would wipe out much of the drug's future earnings, because some 40-45% of doctors, Mr Boris estimates, prescribe Vytorin right away as a “front line” therapy.
只有病人使用其他他汀类药物的剂量过大或者副作用让患者无法使用,他们才会选择Vytorin.若果真如此,那这种新药未来的销售量会大幅下滑,因为根据Boris先生的估计目前大约有40-45%左右的医生在开处方时将Vytorin作为首选药品.
Daniel Jones, head of the American Heart Association, blames the aggressive marketing tactics of drug companies for pushing doctors into prescribing Vytorin in the first instance. Vytorin may yet have a bright future as a targeted remedy for a much smaller population group, rather than as a blockbuster.
美国心脏病协会的主席Daniel Jones先生批评这些制药公司采取过度的市场营销策略导致医生将Vytorin作为首选处方. Vytorin如果作为一种针对少数人群的靶标药物而非重磅炸弹药物，那它的前景应当是光明的。
And even Dr Nissen, a leading critic of Vytorin, concedes that those claiming that
all cholesterol science is bunk are going too far; he thinks statins, at least, have a bright future. The lasting effect of the Vytorin saga, he suggests, may be to change the way that drug trials are conducted. At the moment the FDA very rarely asks companies to conduct large-scale follow-up trials of new drugs after launch, and even when it does, its requests are often ignored. In future, regulators are more likelyto insist on such trials—and on the timely disclosure of their results. As Merck and Schering-Plough are discovering, sunlight can be a powerful disinfectant.
即使是Vytorin的主要批评者Nissen博士也承认那些对所有降胆固醇药物统统否定的做法有些过分，他认为他汀类药物本身会有光明的未来。至于Vytorin事件的最终结果，他建议改变对临床试验的管理方法。而目前FDA很少要求制药企业报告对已经上市的新药进行的大规模的重复的临床试验的情况，即使它这样做了，它的要求也往往被忽视。将来，监管者一定会要求企业必须公布这些临床试验的结果。默克和先灵葆雅正在发现，阳光是最有效的消毒剂。


阳光是最有效的消毒剂!!!