Fellow for 2012-2013 at the Edmond J. Safra Center for Ethics at Harvard University in Cambridge, MA. Teaching health policy for 12 years at York University in Toronto, ON. Research fellow at Harvard Medical School and a lecturer on law at Bentley University in Waltham, MA.
J Law Med Ethics. 2013 Fall;41(3):590-600. doi: 10.1111/jlme.12068.
Over the past 35 years, patients have suffered from a largely hidden epidemic of side effects from drugs that usually have few offsetting benefits. The pharmaceutical industry has corrupted the practice of medicine through its influence over what drugs are developed, how they are tested, and how medical knowledge is created. Since 1906, heavy commercial influence has compromised congressional legislation to protect the public from unsafe drugs. The authorization of user fees in 1992 has turned drug companies into the FDA's prime clients, deepening the regulatory and cultural capture of the agency. Industry has demanded shorter average review times and, with less time to thoroughly review evidence, increased hospitalizations and deaths have resulted. Meeting the needs of the drug companies has taken priority over meeting the needs of patients. Unless this corruption of regulatory intent is reversed, the situation will continue to deteriorate. We offer practical suggestions including: separating the funding of clinical trials from their conduct, analysis, and publication; independent FDA leadership; full public funding for all FDA activities; measures to discourage R&D on drugs with few, if any, new clinical benefits; and the creation of a National Drug Safety Board.
在过去的 35 年里，患者深受药物副作用的影响，但这些药物通常只有很少的益处。制药行业通过影响药物的研发、测试方式以及医学知识的产生，从而破坏了医学实践。自 1906 年以来，沉重的商业影响破坏了国会立法，无法保护公众免受不安全药物的侵害。1992 年授权用户收费制度，使制药公司成为 FDA 的主要客户，加深了该机构的监管和文化捕获。行业要求缩短平均审查时间，由于没有足够的时间彻底审查证据，导致住院和死亡人数增加。满足制药公司的需求已优先于满足患者的需求。除非扭转这种监管意图的腐败，否则情况将继续恶化。我们提供了一些实际建议，包括：将临床试验的资金与其进行、分析和发布分开；FDA 领导的独立性；为 FDA 的所有活动提供全额公共资金；采取措施鼓励研发那些几乎没有新临床效益的药物；以及创建一个国家药物安全委员会。
