九月7,2019

#TPonMB:健康课。杜克,让’s respect FDA’s independence


卫生部(DOH)秘书Francisco Duque最近宣布他’ll consult with the UP-PGH 登瓦夏 Task Force regarding the possible reintroduction of the controversial anti-dengue vaccine 登瓦夏, saying he wants a decision on 登瓦夏’所有部门之间的共识决定命运“因为许多团体对此有不同的立场。”

但是在我们继续之前,这里’s some context.
[注意:这是 首次发表在《马尼拉公报》上 在2019年8月10日]。

The 2017 登瓦夏 scandal stemmed from the haphazard DOH-led mass vaccination program affecting almost a million school-age children. Despite Sanofi’自己的研究承认这种药物可能会对没有登革热的接受者产生严重的不良影响,DOH还在2016年和2017年在吕宋岛中部,马尼拉大都会和卡拉巴松的四年级学生中进行了大规模疫苗接种。

The Scandal erupted in November, 2017, when Sanofi through a press release admitted that 登瓦夏 worsens dengue symptoms in recipients who have no prior history of dengue, thereby confirming Sanofi’是大规模疫苗接种计划之前的声明,赛诺菲于2015年在同行评审杂志上发表了该声明。

到目前为止,据称有数百名疫苗接种者死亡,公共检察官’Office(PAO)的尸检报告显示,大多数孩子的内脏都有肿胀和出血,最终导致多器官衰竭。受影响的家庭,与PAO’的帮助下,已对DOH,制造商赛诺菲(Sanofi)和当地经销商Zuellig Pharma提起诉讼。

The cases are still pending in various courts and Sanofi has consistently denied liability over these deaths. After Sanofi failed to submit mandatory post-marketing surveillance reports, the Food and Drug Administration (FDA) permanently revoked 登瓦夏’的产品注册证书(CPR)于今年2月,在该国是非法的。

因此,我不明白为什么卫生部长如此积极地参与甚至不属于菲律宾国家处方药的合法药物的非法毒品,菲律宾国家处方药是合法允许DOH采购的官方药物清单。

对于大规模疫苗接种计划,DOH,Sanofi和Zuellig的刑事责任已经由法院处理,’s allow them to decide on it. The issue at, is the propriety of the reinstatement of 登瓦夏’CPR以及随后的问题是谁是恢复其参与的合适人选。

Manufacturer Sanofi by nature wants 登瓦夏’恢复了CPR,但是’同样清楚的是,国会授权FDA,没有其他人可以审查此类提交… and Sec. Duque isn’t in FDA.

As a side note, this writer also finds it odd that 登瓦夏 advocate and former Health Secretary Esperanza Cabral has been doing media rounds lately without disclosing in any of those interviews that she is a trustee of the Zuellig Family Foundation, the philanthropic arm of 登瓦夏 local distributor Zuellig Pharmaceuticals.

Former Philippine College of Physicians president Dr. Tony Leachon is right when he recently asked whether Sanofi has already submitted the post-marketing surveillance reports, as those missing reports are what made the FDA revoke 登瓦夏’首先是CPR。

如果还避风港’提交这些报告后,辩论结束了。否则’s up to the FDA and FDA alone to independently review these reports, check for compliance, and decide whether to reinstate 登瓦夏’是否注册。话虽如此,这位作家可以’但是,对于现在承受着极端和不必要压力的UP-PGH专业人士,他们表示同情。

如果秒杜克(Duque)坚持要全力以赴,然后至少必须公开赛诺菲(Sanofi)’丢失了它必须最近提交的监视后报告。秘书应让公众看到赛诺菲对参议员理查德·戈登(Richard Gordon)所说的数十万孩子的评价,“被当作​​豚鼠一样对待。 ”

登瓦夏’s proponents argue that the drug may be sufficiently safe for those who have had dengue, and this writer agrees with them. However, if 登瓦夏 must be reinstated, then it must be reinstated with clear guidelines on how it should administered, taking into account data collected over the past three years that it was available in the market, the same data that can be found only in Sanofi’的上市后监督报告,显然仍然缺少这些报告。

Sec. Duque is strongly encouraged to let the FDA do its job without undue external interference. FDA officer-in-charge Usec. Eric Domingo is more than capable of accomplishing that, especially since he hails from Pampanga, one of the provinces covered by the botched 2017 登瓦夏 mass vaccination Program.

秒杜克必须只专注于法律允许他执行的任务,而这不会’t include FDA’的工作。说实话,第二节。杜克’甚至可以将其最新举动解释为从事超出其职权范围的行为,使他可以接受FDA甚至可能认为该秘书的任何公民提起的诉讼。’的行为正在危害公共安全。

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