Abraham John, Davis Courtney
Centre for Research in Health and Medicine (CRHaM), Department of Sociology, University of Sussex, Arts E Building, Falmer, Brighton BN1 9SN, England, UK.
Soc Sci Med. 2005 Sep;61(5):881-92. doi: 10.1016/j.socscimed.2005.01.004. Epub 2005 Mar 2.
By going beyond individual case studies and solely quantitative surveys, this paper systematically examines why there were over twice as many new prescription drugs withdrawn from the market on grounds of safety in the UK as there were in the US between 1971 and 1992. Drawing on interviews with regulators, industry scientists and others involved, and on regulatory data never before accessed outside governments and companies, five key hypotheses which might explain this difference in drug safety withdrawals are analysed. These are: (1) simply because the UK approved more new drugs than the US; (2) because of an industrial corporate strategy to seek approval of 'less safe' drugs in the UK earlier; (3) because British regulators were more vigilant at spotting post-marketing safety problems than their US counterparts; (4) because the slowness of the US in approving new drugs enabled regulators there to learn from, and avoid, safety problems that had already emerged in the UK or European market; and (5) because more stringent regulation in the US meant that they approved fewer unsafe drugs on to the market in the first place. It is concluded that the main explanation for fewer drug safety withdrawals in the US is that the regulatory agency there applied more stringent pre-market review and/or standards, which took longer than UK regulatory checks, but prevented unsafe drugs marketed in the UK from entering the US market. Contrary to the claims frequently made by the pharmaceutical industry and regulatory agencies on both sides of the Atlantic, these results imply that it is likely that acceleration of regulatory review times in the US and the UK since the early 1990s is compromising drug safety.
通过超越个别案例研究和单纯的定量调查，本文系统地研究了为何在1971年至1992年间，因安全原因在英国撤市的新处方药数量是美国的两倍多。基于对监管机构人员、行业科学家及其他相关人员的访谈，以及从未在政府和公司之外获取过的监管数据，分析了五个可能解释药品安全撤市差异的关键假设。这些假设是：（1）仅仅因为英国批准的新药比美国多；（2）由于一种产业公司战略，即在英国更早地寻求批准“安全性较低”的药物；（3）因为英国监管机构在发现上市后安全问题方面比美国同行更加警惕；（4）因为美国在批准新药方面的迟缓使那里的监管机构能够从英国或欧洲市场已经出现的安全问题中吸取教训并避免；（5）因为美国更严格的监管意味着他们一开始批准进入市场的不安全药物更少。得出的结论是，美国药品安全撤市较少的主要原因是那里的监管机构进行了更严格的上市前审查和/或采用了更高的标准，这比英国的监管检查耗时更长，但阻止了在英国上市的不安全药物进入美国市场。与大西洋两岸制药行业和监管机构经常提出的说法相反，这些结果表明，自20世纪90年代初以来，美国和英国监管审查时间的加快可能正在损害药品安全。
