Lancet：临床研究试验报告在医疗公关下扭曲

When doctors are deciding which drug to prescribe a patient, the idea behind evidence-based medicine is that they inform their thinking by consulting scientific literature. To a great extent, this means relying on medical journals.
医生给病人开药时，通常会参考一些科学文献所推荐的药物，而所谓的文献一般就是医学期刊。

The trouble is that pharmaceutical companies, who stand to win or lose large amounts of money depending on the content of journal articles, have taken a firm grip on what gets written about their drugs. That grip was strong way back in 2004, when The Lancet's chief editor Richard Horton lamented that "journals have devolved into information laundering operations for the pharmaceutical industry." It may be even tighter now.
于是问题也就出现了，制药公司的盈亏依赖于这些期刊文章，所以他们对文章内容有着很强的控制力。早在2004年，著名杂志《柳叶刀》的主编Horton就感叹道“科学期刊已经沦落为制药工业的信息过滤器”。如今，情势愈演愈烈。

Drug companies exert this hold on knowledge through publication planning agencies, an obscure subsection of the pharmaceutical industry that has ballooned in size in recent years, and is now a key lever in the commercial machinery that gets drugs sold.
医药公司靠选题策划代理来搞定文章，这个曾在制药业不起眼的小行业近些年经历了爆炸式的发展，现在已成为药物销售的重要支持。

The planning companies are paid to implement high-impact publication strategies for specific drugs. They target the most influential academics to act as authors, draft the articles, and ensure that these include clearly-defined branding messages and appear in the most prestigious journals.
策划公司受雇为特效药制定能产生高度影响力的发行策略。他们会找最有影响力的学者来挂名发文、起草文章、同时确保该文能出现在最有影响力的杂志上，旗帜鲜明的宣传其产品。

Over the past few months I've tried to find out as much about these companies as possible. I wanted to know how big this industry is, exactly how it operates, and how people in the business think about their work. It's a nervous, opaque industry, but I did find answers to some of my questions.
过去几个月我都忙于挖掘更多的内幕信息，他们到底有多庞大、如何运转以及内部人员的真实想法。尽管该行业谨慎隐秘，可我最终还是找到了答案。

There are now at least 250 different companies engaged in the business of planning clinical publications for the pharmaceutical industry, according to the International Society for Medical Publication Professionals, which said it has over 1000 individual members.
至少有250家公司身处此行，为制药工业提供临床报告出版策划的服务；而国际医疗出版学会（ISMPP，官网http://www.ismpp.org/index.html）有1000多名会员。

Many firms are based in the UK and the east coast of the United States in traditional "pharma" centres like Pennsylvania and New Jersey.
许多公司位于英国与美国东海岸的传统制药中心，如宾夕法尼亚、新泽西。

Precise figures are hard to pin down because publication planning is widely dispersed and is only beginning to be recognized as something like a discrete profession. These numbers are higher than any previous estimate, yet in truth the industry is likely to be bigger still.
由于选题策划人员分布广泛、离散性强，所以很难给出一个精确的在行从业数字。但数量肯定是要高于以往任何一次的估量，而且正不断发展壮大。

In selling their services to drug companies, the agencies' explain their work in frank language. Current Medical Directions, a medical communications company based in New York, promises to create "scientific content in support of our clients' messages". A rival firm from Macclesfield, Complete HealthVizion, describes what it does as "a fusion of evidence and inspiration."
为了把服务卖给医药公司，这些代理公司会很直白的诠释自我。纽约的一家医药通信公司Current Medical Directions承诺提供“支撑客户需求的科学内容”。另一家来自麦克斯菲尔德的竞争对手Complete Healthvizion标语则是“数据与灵感的完美融合”。

Having talked to over a dozen publication planners I found that the standard approach to article preparation is for planners to work hand-in-glove with drug companies to create a first draft. "Key messages" laid out by the drug companies are accommodated to the extent that they can be supported by available data.
在与数十位选题策划交流后，我发现发表论文的标准做法就是策划人和药物公司合伙先写下初稿。而公司拎出来的“重要信息”最终会有理有据的呈现在文中。

Planners combine scientific information about a drug with two kinds of message that help create a "drug narrative". "Environmental" messages are intended to forge the sense of a gap in available medicine within a specific clinical field, while "product" messages show how the new drug meets this need.
通常有两种信息有助于“描述”药物。首先是“环境”信息：伪造某临床领域的现有药物存在缺陷的假象；其次就吹一下文中的“产品”可以填补这个空缺。

But the issue that dominates industry discussions is authorship.
然而主导行业言论的要素是著述者（译注：即挂名作者）。

In a flow-chart drawn up by Eric Crown, publications manager at Merck (the company that sold the controversial painkiller Vioxx), the determination of authorship appears as the fourth stage of the article preparation procedure. That is, only after company employees have presented clinical study data, discussed the findings, finalised "tactical plans" and identified where the article should be published.
从Merck公司的发行经理Crown绘制的流程表中，可发现著述者处于论文发表程序的第四阶段。前三阶段分别是提供临床研究数据，制定“战术策略”，以及确定发文期刊。（该公司出售争议性止痛药Vioxx（万络，抗关节炎药））

Perhaps surprisingly to the casual observer, under guidelines tightened up in recent years by the International Committee of Journal Editors (ICMJE), Crown's approach, typical among pharmaceutical companies, does not constitute ghostwriting.
在制药公司里Crown所述的方法是非常典型的，也许旁观者会惊讶的认为，有国际期刊编委会（ICMJE）近些年来的强力约束，该流程中不存在“代笔”。

What publication planners understand by the term is precise but it is also quite distinct from the popular interpretation.
选题策划者对这个词的理解与大众的理解不同，那是相当的精确。

"We've never done ghostwriting, per se, as I'd define it", says John Romankiewicz, president of Scientific Therapeutics Information, the New Jersey firm that helped Merck promote Vioxx with a series of positive articles in medical journals. "We may have written a paper, but the people we work with have to have some input and approve it."
“确切的讲，我们从不代笔”，新泽西科学疗法信息公司的主席John说“也许我们写过一两篇文章，但写这些文章的人还是有点料的”。这家公司曾帮助Merck公司写了不少提升Vioxx声誉的文章。

The industry has grown despite its prominent involvement in a succession of medical ghostwriting scandals.
事实上，与该行业的茁壮成长不可分割的，就是其深陷代笔囹圄。

In the early 2000s, court documents released through litigation over controversial drugs - such as Vioxx and the hormone replacement therapy Prempro - showed pharmaceutical companies frequently hiring medical communication agencies to ghostwrite articles and place them in influential medical journals under the "authorship" of well-known academics paid thousands of pounds for their endorsement.
早在2000年初，诸如Vioxx与激素取代疗法Premo等争议药物的相关诉讼案公文就流之于世。其内容指出制药公司频繁的雇佣医药通信人员代笔论文，发表于颇有影响力的期刊，并向著名学者支付上千英镑的挂名费以获取挂名推荐权。

The ICMJE tweaks, plus a new willingness to disclose their involvement in the preparation of articles, has fostered a remarkable confidence among industry proponents.
ICMJE也有意向承认曾涉足于所谓的“流程表”中，这极大地加强了支持者对该行业的信心。

"I feel that we're doing something good for mankind in the long-run," said Kimberly Goldin, head of the International Society for Medical Publication Professionals (ISMPP). "We want to influence healthcare in a very positive, scientifically sound way."
“长久来看，我感觉我们正在做些有益人类的事情，”国际医疗出版学会ISMPP的主席Goldin说：“我们致力于在人类健康方面做出正面、科学有效的影响。”

"The profession grew out of a marketing umbrella, but has moved under the science umbrella," she said.
“这个行业成长在市场的保护伞下，却利用科学这把保护伞掩饰了自己的不当行径。”

But without the window of court documents to show how publication planning is being carried out today, the public simply cannot know if reforms the industry says it has made are genuine.
然而若没有诉讼文件的公之于世，公众很难了解到该行业是否真的实行了改革。

Dr Leemon McHenry, a medical ethicist at California State University, says nothing has changed. "They've just found more clever ways of concealing their activities. There's a whole army of hidden scribes. It's an epistemological morass where you can't trust anything."
加州大学的的医学伦理学教授Leemon却说一切都是扯淡。“他们只是找到了更好的途径。要知道代笔者是成千上万的。这是一个你无法信任的谎言。”

Alastair Matheson is a British medical writer who has worked extensively for medical communication agencies. He dismisses the planners' claims to having reformed as "bullshit".
Matheson是一名英国医学论文写手，已为医疗通信代理做了相当多的事情。他也认为这些所谓的改革简直就是“扯淡”。

"The new guidelines work very nicely to permit the current system to continue as it has been", he said. "The whole thing is a big lie. They are promoting a product."
“新规定对现行系统做了相当好的传承与发扬，”他说，“一切就是个大谎言。”

Matheson expects an article he wrote about a new cancer treatment to appear in print later this year, with an oncologist considered a "key opinion leader" (KOL) by planners listed as the author in his stead. "You'd do the same thing if you were selling cornflakes," Matheson told me. "It's no different."
Matheson希望他的新论文明年能够发表，是有关抗癌疗法的，而策划公司圈定的一名“关键意见领袖(KOL)”将会挂名其上。Matheson说“这跟买脆玉米片没什么不同，没什么不同！”

And with the industry business model that is all about facilitating the influence of business over science thriving as it is, it's hard to see when, if ever, we will again see the thick line one likes to imagine there once was between the sale of cornflakes and the analysis of medicine. It has all become rather blurry.
事实上，这种商业影响高于科技繁荣的行业经营模式已经固化，也许我们永远都看不到这种卖药手段和卖玉米有什么明显的界限了，这是一条越来越模糊的分界线。