FDA hears claims of Cox-2 pain drug risks
Heavy dosages of popular pain drugs such as Merck's Vioxx pose a greater risk of heart attack than do diabetes, smoking or high blood pressure, a US regula Ptory panel was told yesterday.
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The cardiovascular risk was present not just in Vioxx but also in the entire class of painkillers known as Cox-2 inhibitors, Dr David Graham, a safety researcher at the watchdog Food and Drug Administration said.
The testimony, at an FDA hearing to review the safety of the bestselling products, challenges the drugmakers' claims that Cox-2 inhibitors are safer than other pain relievers.
Separately, European drug regulators yesterday recommended curbs on Cox-2s but stopped short of recommending that they be taken off the market. The European Medicines Agency advised doctors to use the lowest effective dose for the shortest possible time.
Dr Graham said even low doses of Cox-2s probably carried a greater risk of heart trouble than did high blood pressure and only a little less than did diabetes or smoking.
Dr Graham emerged as a controversial critic of Cox-2s in November when he told a congressional hearing that the regulatory system in the US was “virtually defenceless”. He also claimed that the FDA sought to suppress his views and research on Cox-2 dangers.
Dr Graham's presentation yesterday included some unpublished data from a study using California patient records in Medicaid, the state/federal healthcare programme for the poor.
The FDA had queried whether these data should be presented because they had not been peer-reviewed and accepted for publication.
Dr Graham argued that the drugs' benefits were negligible, given some scientists' belief that older pain medicines could be combined with ulcer drugs to reduce potential stomach bleeding.
“COX-2止痛药引发心脏病风险大过吸烟”
大剂量服用默克公司(Merck)的万络(Vioxx)等止痛药会引起患心脏病的风险，这种风险比糖尿病、吸烟或高血压导致心脏病的风险更大，美国的一个官方小组昨天被告知。
导致心血管方面的风险不单出现在万络上，也表现在整个被称为Cox-2抑制剂的止痛药类别上，戴维?格雷厄姆博士(Dr David Graham)说，他是美国药品监管机构“食品与药品管理局”(FDA)的药物安全研究员。
上述证词来自食品与药品管理局的一个听证会，该听证会旨在审查此类畅销药品的安全性。这些证词对制药企业的说法提出挑战。制药企业称Cox-2抑制剂比其它止痛药更为安全。
此外，欧洲药品监管机构昨天建议对Cox-2抑制剂类药物实施限制，但没有建议将它们撤出市场。欧洲药品局(European Medicines Agency)建议医生们使用最低有效剂量的Cox-2药物，并尽量缩短服用时间。
格雷厄姆博士表示，即使是低剂量的Cox-2药物，对心脏带来的危害也比高血压更大，而比糖尿病或抽烟对心脏的危害仅略小一些。
格雷厄姆博士在去年11月成为批评Cox-2药物的争议人物，当时他在国会的一个听证会上说，美国的监管系统“几乎不设防”。他还宣称，美国食品与药品管理局试图压制他的观点以及他对Cox-2药物危害的研究。
格雷厄姆博士昨天的发言中有一些未公开发表过的一些数据，这些数据来自一项采用加州医疗补助(Medicaid)项目病人记录的研究。Medicaid是美国州和联邦针对穷人的保健计划。
美国食品和药品管理局曾质疑这些数据是否应当被提出，因为它们未经过同行评议，也未被科学刊物发表。
格雷厄姆博士辩称，Cox-2药品带来的好处可以忽略不计，因为某些科学家认为较早期的止痛药物可以结合溃疡药物使用，以减少可能出现的胃出血症状。
