Reichert Janice M, Milne Christopher-Paul
Tufts Center for the Study of Drug Development, Tufts University, Boston, Massachusetts 02111, USA.
Am J Ther. 2002 Nov-Dec;9(6):543-55. doi: 10.1097/00045391-200211000-00016.
Recently, well-publicized reports by Public Citizen and the Joint Economic Committee (JEC) of the US Congress questioned the role of the drug industry in the discovery and development of therapeutically important drugs. To gain a better understanding of the relative roles of the public and private sectors in pharmaceutic innovation, the Tufts Center for the Study of Drug Development evaluated the underlying National Institutes of Health (NIH) and academic research cited in the Public Citizen and JEC reports and performed its own assessment of the relationship between the private and public sectors in drug discovery and development of 21 "impact" drugs. We found that, ultimately, any attempt to measure the relative contribution of the public and private sectors to the research and development (R&D) of therapeutically important drugs by output alone, such as counting publications or even product approvals, is flawed. Several key factors (eg, degree of uncertainty, expected market value, potential social benefit) affect investment decisions and determine whether public or private sector funds, or both, are most appropriate. Because of the competitiveness and complexity of today's R&D environment, both sectors are increasingly challenged to show returns on their investment and the traditional boundaries separating the roles of the private and public research spheres have become increasingly blurred. What remains clear, however, is that the process still starts with good science and ends with good medicine.
最近,公民健康研究组织(Public Citizen)和美国国会联合经济委员会(JEC)公布的报告对制药行业在治疗性重要药物的发现与开发中所起的作用提出了质疑。为了更好地理解公共部门和私营部门在药物创新中的相对作用,塔夫茨药物开发研究中心评估了公民健康研究组织和联合经济委员会报告中所引用的美国国立卫生研究院(NIH)及学术研究的基础内容,并对私营部门与公共部门在21种“有影响力”药物的发现与开发中的关系进行了自身评估。我们发现,最终,仅通过产出(如计算出版物数量甚至产品批准数量)来衡量公共部门和私营部门对治疗性重要药物研发的相对贡献的任何尝试都是有缺陷的。几个关键因素(如不确定性程度、预期市场价值、潜在社会效益)会影响投资决策,并决定公共部门资金、私营部门资金或两者资金是否最为合适。由于当今研发环境的竞争性和复杂性,两个部门在展示其投资回报方面都面临着越来越大的挑战,而且划分私营和公共研究领域作用的传统界限已变得越来越模糊。然而,仍然清晰的是,这个过程仍然始于优秀的科学,并以优质的药物告终。