Singh Ajai, Singh Shakuntala
Mens Sana Monogr. 2005 Mar;3(1):41-80. doi: 10.4103/0973-1229.27878.
As things stand today, whether we like it or not, industry funding is on the upswing. The whole enterprise of medicine in booming, and it makes sense for industry to invest more and more of one's millions into it. The pharmaceutical industry has become the single largest direct funding agency of medical research in countries like Canada, the United Kingdom and the United States.Since the goals of industry and academia differ, it seems that conflicts of interest are inevitable at times. The crucial decision is whether the public welfare agenda of academia, or the corporate research agenda of industry, should occupy center stage when they conflict.There is enough evidence to show that funding by industry is very systematic, and results that are supportive of the safety and efficacy of sponsor's products alone get the funds. It is no surprise, therefore, that one finds very few negative drug trials reports published, and whatever are, are likely to be by rival companies to serve their commercial interests.Renewed and continued funding by industry decides the future prospects of many academic researchers. At the same time there is now evidence that pharmaceutical companies attempt suppression of research findings, may be selective in publishing results, and may delay or stymie publication of unfavourable results. This is a major area of concern for all conscientious researchers and industry watchers.Industry commonly decides which clinical research/trial gets done, not academia, much though the latter may wish to believe otherwise. It finds willing researchers to carry this out. This can be one area of concern. Another area of pressing concern is when industry decides to both design and control publication of research.It makes sense for researchers to refuse to allow commercial interests to rule research reporting. Research having been reported, the commercial implications of such reporting is industry's concern. But, doctoring of findings to suit commerce is to be resisted at all costs. In this even pliant researchers need have no fear, for if they indeed publish what will work, the concerned sponsor will benefit in the long run. The only decision academia has to make is refuse to comply with predestined conclusions of sponsors for the 'thirty pieces of silver'. Instead do genuine research and make sixty for themselves.The useful rule of thumb is: Keep the critical antenna on, especially with regard to drug trials, and more especially their methodology, and study closely the conflict of interest disclosed, and if possible undisclosed, before you jump on the band wagon to herald the next great wonder drug.There are three important lessons to be learnt by academia in all academia-industry relationships:i)LESSON NUMBER ONE: incorporate the right to publish contrary findings in the research contract itself. Which means, it makes great sense for academia to concentrate on the language and contractual provisions of sponsored research, to read the fine print very closely, and protect their research interests in case of conflict.ii)LESSON NUMBER TWO: a number of lawsuits successfully brought up against industry recently reflect earnest attempts by patient welfare bodies and others to remedy the tilt. It will result in a newfound confidence in academia that augurs well for academia industry relationship in the long run. Hence the second lesson for academia: do not get browbeaten by threats of legal actioniii)LESSON NUMBER THREE: Academia should keep itself involved right from inception of the clinical trial through to ultimate publication. And this must be an integral part of the written contract.The time to repeat cliches about the exciting future of the academia-industry connect is past. A concerted effort to lay a strong foundation of the relationship on practical ethical grounds has become mandatory.
就目前的情况而言,无论我们是否喜欢,行业资助都在呈上升趋势。整个医学事业蓬勃发展,企业将越来越多的资金投入其中是有道理的。在加拿大、英国和美国等国家,制药行业已成为医学研究的最大单一直接资助机构。
由于企业和学术界的目标不同,利益冲突似乎有时不可避免。关键的决定是,当两者发生冲突时,学术界的公共福利议程还是企业的商业研究议程应占据核心地位。
有足够的证据表明,企业资助非常系统,只有支持赞助商产品安全性和有效性的结果才能获得资金。因此,毫不奇怪,很少有负面药物试验报告发表,而发表的那些报告很可能是竞争对手公司为了商业利益而发布的。
企业持续的资助决定了许多学术研究人员的未来前景。与此同时,现在有证据表明,制药公司试图压制研究结果,可能会有选择地公布结果,并且可能会延迟或阻碍不利结果的发表。这是所有有良知的研究人员和行业观察家主要关注的领域。
通常是企业决定进行哪些临床研究/试验,而不是学术界,尽管后者可能希望情况并非如此。企业会找到愿意进行研究的人员来实施。这可能是一个令人担忧的领域。另一个紧迫的担忧领域是企业决定研究的设计和报告的发布。
研究人员拒绝让商业利益主导研究报告是有道理的。研究报告之后,此类报告的商业影响是企业的事情。但是,为迎合商业而篡改研究结果必须不惜一切代价加以抵制。在这种情况下,即使是顺从的研究人员也无需担心,因为如果他们确实发表了有效的成果,相关赞助商从长远来看会受益。学术界唯一要做的决定就是拒绝为了“三十块银币”而遵从赞助商预先设定的结论。相反,要进行真正的研究,为自己赚取六十块银币。
保持敏锐的批判性思维,尤其是在药物试验方面,更特别是其方法,并在你跟风宣扬下一种神奇药物之前,仔细研究已披露和可能未披露的利益冲突。
在所有学术界与企业的关系中,学术界需要吸取三个重要教训:
一、教训一:在研究合同本身中纳入发表相反研究结果的权利。这意味着,学术界专注于受资助研究的语言和合同条款,仔细研读细则,并在发生冲突时保护自己的研究利益是非常有意义的。
二、教训二:最近针对企业成功提起的一些诉讼反映了患者福利机构和其他方面为纠正这种失衡所做的认真努力。这将给学术界带来新的信心,从长远来看对学术界与企业的关系是个好兆头。因此,学术界的第二个教训是:不要被法律诉讼的威胁吓倒。
三、教训三:学术界应该从临床试验开始到最终发表全程参与。这必须是书面合同的一个组成部分。
重复关于学术界与企业合作令人兴奋的未来这类陈词滥调的时代已经过去。必须齐心协力在实际道德基础上为这种关系奠定坚实基础。