来源：《洛杉矶时报》
原文刊登日期：2022年2月24日
The U.S. Food and Drug Administration accelerated the approval of a drug called Makena meant to prevent premature births. Now there’s mounting evidence that the drug does not work. The FDA should use its authority to pull Makena from the market until and unless the company that makes it can prove that it is effective.
美国食品和药物管理局加速批准了一种名为Makena的药物，该药物旨在预防早产。现在有越来越多的证据表明这种药物无效。FDA应该使用其权力将Makena从市场上撤出，除非生产它的公司能够证明它是有效的。
The drug’s approval was based on a flawed government-sponsored study: The test subjects weren’t in the same situations. Women who received the placebo were at higher risk than those who received the drug, so naturally their rates of preterm births were higher. Nor did the study look at whether use of the drug reduced infant death and disability — which is the main point of preventing preterm births.
该药物的批准基于一项有缺陷的政府资助研究：测试对象并不处于相同的情况。服用安慰剂的女性比服用药物的女性面临更高的风险，因此她们的早产率自然更高。该研究也没有研究使用该药物是否能减少婴儿死亡和残疾率——这是预防早产的关键。
Despite this questionable data, the FDA approved the drug in 2011. But the agency, to its credit, called on the pharmaceutical company to conduct more research to show whether the drug prevented death or disability. The study, which took eight years to produce, found that it didn’t work, and in 2020, FDA staff recommended the medication be taken off the market. But it wasn’t. Makena is still being sold and administered to pregnant women.
尽管数据存在问题，FDA还是在2011年批准了该药物。但值得赞扬的是，FDA呼吁制药公司进行更多的研究，以证明该药物是否能防止婴儿死亡或残疾。这项历时八年的研究发现，该药物无效。2020年，FDA工作人员建议将该药物从市场上撤下。但事实并非如此。Makena仍在被出售，并给孕妇服用。
Clovis Pharma, the Luxembourg company that owns the rights to the drug, points out that the second study, conducted internationally, included relatively few nonwhite women. That’s relevant because in the United States, Black women are 50% more likely to be at high risk of preterm labor than white women.
拥有该药使用权的卢森堡公司克洛维斯制药(指出，在国际上进行的第二项研究中，非白人女性的受试者相对较少。这是相关的，因为在美国，黑人女性早产的风险比白人女性高50%。
At best, the efficacy of Makena isn’t clear. It is generally considered safe, but common side effects include high blood pressure and migraines. At worst, however, it could be harmful. Some researchers have expressed concern about the possibility of long-term effects on babies whose mothers took it.
往好了说，Makena的功效还不清楚。它通常被认为是安全的，但常见的副作用包括高血压和偏头痛。然而，在最坏的情况下，它可能是有害的。一些研究人员已经表达了对母亲服用该药物可能对婴儿产生长期影响的担忧。
The FDA says that it sorted the data in the study to determine whether any racial group had better success rates with the drug and found it wasn’t working for any of them. The default for a medication whose effectiveness is in considerable doubt should be to remove it from the market. It’s unclear why the FDA, which approved the drug under a speedier process than usual, isn’t moving with similar alacrity to reverse itself now that it has determined the drug doesn’t work.
FDA表示，他们对研究中的数据进行了整理，以确定是否有任何种族群体使用该药物的成功率更高，但发现该药物对任何一个种族都不起作用。对于疗效有相当大疑问的药物，其默认做法应该是将其从市场上撤下。目前尚不清楚FDA在以比以往更快的速度批准该药后，为何在确定该药无效后，不像以往那样迅速采取行动逆转自己的决定。
Clovis wants to conduct more research on Makena’s effectiveness. Good plan. But the drug should not remain on the market in the interim and should not be reapproved unless solid data show clearly that it works. The company has been granted an FDA hearing, but the hearing hasn’t even been scheduled. It’s been asked to stop selling the medication and refused, making the FDA’s prompt action imperative.
克洛维斯希望对Makena的有效性进行更多的研究。这是个不错的计划。但在此期间，该药物不应留在市场上，也不应重新批准，除非可靠数据明确表明它有效。该公司已经获准参加FDA的听证会，但听证会还没有安排。该公司被要求停止销售这种药物，但遭到拒绝，因此FDA必须立即采取行动。
The FDA also needs to take into account the public’s loss of faith in the accelerated-approval process if it doesn’t move swiftly to correct early errors. That process was meant to speed urgently needed treatments to those who would benefit, not to keep questionable medications on the market.
FDA还需要考虑到，如果它不迅速采取行动纠正早期错误，公众会对加速审批过程失去信心。这一过程的目的是将急需的治疗加快实施到那些将受益的人身上，而不是将有问题的药物留在市场上。