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美国境内的沙利度胺幸存者数量比政府承认的要多The U.S. has more thalidomide survivors than the government admits

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1962年10月15日,时任美国食品药品监督管理局(FDA)药理学家弗朗西斯·奥尔达姆·凯尔西博士手持三盒“康泰曼”(Contergan),这是沙利度胺的德国品牌名称。凯尔西阻止了FDA批准该药物在美国通用。

Dr. Frances Oldham Kelsey, then-pharmacologist at the Food and Drug Administration, holds three packages of Contergan, the German brand name for thalidomide, on Oct. 15, 1962. Kelsey prevented the FDA from approving the drug for general use in the United States.

威廉·J·史密斯/美联社 当总部位于辛辛那提的制药公司威廉·S·默尔(William S. Merrell)于1960年末申请FDA批准一种德国生产的镇静剂时,他们预计该申请将顺利通过审批流程,并赶在圣诞节前上架销售。

William J. Smith/AP When Cincinnati-based pharmaceutical company William S. Merrell applied for Food and Drug Administration approval for a German-made sedative in late 1960, it expected the application to sail through the process and be on store shelves in time for Christmas.

沙利度胺在那一年及次年均未获得批准。FDA内一位坚持不懈的医学审查员阻止了该药物获得通用批准。弗朗西斯·奥尔达姆·凯尔西博士的行动从根本上改变了该机构的测试和审批流程,促成了如今健全法规的建立。

The drug, thalidomide, was not approved that year or the next. A persistent medical reviewer at the FDA kept the drug from being approved for general use. Dr. Frances Oldham Kelsey's actions fundamentally changed the agency's testing and approval process, leading to the robust regulations that exist today.

约翰·F·肯尼迪总统公开赞扬凯尔西,称她使“我们免于遭受降临在德国家庭身上的这场可怕的人间悲剧”。但事实并非完全如此。

President John F. Kennedy publicly praised Kelsey for sparing "us this terrible human tragedy which has been visited on families in Germany." Except that wasn't entirely true.

医生们当时已经向包括孕妇在内的数千名美国患者开具了沙利度胺。一些母亲在孕期服用该药物的孩子出生时肢体严重畸形。这些孩子如今已成年,他们希望联邦政府正式承认他们的存在。

Doctors were already giving thalidomide to thousands of U.S. patients including pregnant women. Some children whose mothers were given the drug during pregnancy were born with severely deformed limbs. Those children are now adults, and they want the federal government to formally acknowledge their existence.

“我们今天去看医生,他们说这在美国没有发生过。哦,确实发生了,”格温·赖希曼说。她出生时患有海豹肢症,这是沙利度胺导致的标志性肢体短缩畸形。

"We go to doctors today who say it didn't happen here in the United States. Oh yeah, it did," said Gwen Riechmann who was born with phocomelia, the signature shortened limb deformity caused by thalidomide.

海豹肢症较为罕见,但在沙利度胺销售更广泛的英国和德国等国家,其发病率略高于美国。

Phocomelia is rare, but slightly more common outside the United States in countries such as Britain and Germany, where thalidomide was more widely sold.

20世纪60年代初,赖希曼的母亲怀孕时,医生给她开了一种新的镇静剂以缓解恶心。她不知不觉地成为了美国一项未经监管的沙利度胺临床试验的一部分。

When Riechmann's mother was pregnant with her in the early 1960s, the doctor gave her a new sedative to help with her nausea. She was unwittingly part of an unregulated U.S. clinical trial for thalidomide.

据詹妮弗·范德贝斯(Jennifer Vanderbes)所著、详细记录了沙利度胺历史的《神奇药物》(Wonder Drug)一书所述,梅里尔公司(Merrell)分发了数千剂未贴标签的药物,并告诉医生该药在治疗从失眠到孕吐等一系列问题上是绝对安全的。她说,该公司并未要求医生追踪药物使用情况或反馈副作用。

Merrell handed out thousands of unlabeled doses, telling doctors it was perfectly safe for treating a range of issues from insomnia to morning sickness, according to Jennifer Vanderbes, whose book Wonder Drug details the history of thalidomide. She said the company didn't require the doctors to track the medication or report back on side effects. "This was such a sloppy investigation," said John Swann, retired FDA senior historian.

“这是一项极其草率的调查,”美国食品药品监督管理局(FDA)退休高级历史学家约翰·斯旺(John Swann)表示。

As the FDA drilled into Merrell's records, Swann said, the amount of thalidomide that couldn't be accounted for was striking.

斯旺说,当FDA深入调查梅里尔公司的记录时,无法追踪去向的沙利度胺数量之多令人震惊。

"When you have a problematical product, you trace back to where it's been distributed," Swann said. When the FDA did that, it found, "and certainly the company had admitted, that there was just a great deal that was unaccounted for."

“当你面对一种有问题的产品时,你会追溯它的分发去向,”斯旺说。当FDA这样做时,它发现,“而且公司也确实承认,有大量的药物去向不明。”

"It's probably the most iconic toxic drug of all time because of its signature injuries," Vanderbes said. "It transformed the FDA because it made it clear that more significant and serious drug testing had to take place before drugs were released on the market."

“由于其标志性的伤害,它可能是史上最具代表性的毒药,”范德贝斯说。“它改变了FDA,因为它明确了在药物投放市场之前,必须进行更重要、更严格的药物测试。”

"It's probably the most iconic toxic drug of all time because of its signature injuries," Vanderbes said. "It transformed the FDA because it made it clear that more significant and serious drug testing had to take place before drugs were released on the market."

范德贝斯说,医生们没有告诉女性她们服用的是沙利度胺,也没有在医疗记录中进行记载。这些女性“没有任何显示处方的纸条。她们也没有贴标签的药瓶。”但许多人却生下了肢体残缺的孩子。

The doctors didn't tell the women they were taking thalidomide or document it in their medical records, Vanderbes said. The women "had no slips of paper that showed their prescription. They had no bottles with a label." What many did have were children born with truncated limbs.

范德贝斯说,即便在这些婴儿出生后,甚至在科学界已经了解沙利度胺的危害之后,医生们仍未透露他们曾给患者服用过这种药物。一些女性甚至被明确告知她们并未服用过该药。

But even after these babies were born, and even after the scientific community understood the dangers of thalidomide, doctors did not reveal that they had given their patients the drug, Vanderbes said. Some women were specifically told they had not taken it.

多年后,许多女性的孩子也被告知他们不可能是沙利度胺的受害者,因为他们的医生认为美国躲过了那场沙利度胺丑闻。范德贝斯估计,美国可能还有大约一百名幸存者。

Years later, many of the women's children were also told they couldn't be thalidomide survivors because their doctors believed the United States had escaped the thalidomide scandal. Vanderbes estimates there could be around a hundred U.S. survivors.

美国食品药品监督管理局(FDA)前历史学家斯旺表示,很难确切知道有多少美国出生的婴儿的母亲曾服用过该药物,但肯定不止FDA正式承认的17例。

Swann, the former FDA historian, said it's hard to know an exact number of American-born babies whose mothers took the drug, but it was certainly more than the 17 formally acknowledged by the FDA.

2018年,里希曼共同创立了倡导组织“美国反应停幸存者”。该组织约有100人,包括盟友和幸存者,正推动国会通过一项法案,以正式承认美国反应停幸存者的存在,并向每人提供15万美元,未来还可能追加资金。

In 2018, Riechmann co-founded the advocacy group USA Thalidomide Survivors. The group of roughly 100 people, which includes allies as well as survivors, is pushing Congress to pass a bill that would officially acknowledge American thalidomide survivors and give each $150,000, with the possibility of additional money in the future.

她说:“美国是唯一没有为反应停幸存者提供任何形式的支持,甚至没有承认其存在的国家。”“我们首先寻求的是承认,是的,我们确实存在。其次,是支持。”里希曼表示,幸存者们正在变老,健康状况也在恶化,但他们不能放弃——即使他们也无法再等待太久。

"The U.S. is the only country that has not provided any kind of support or even recognition that they have thalidomide survivors," she said. "We are looking for, first, recognition that, yes, we do exist. And then, secondly, support." Survivors are aging, and their health is deteriorating, Riechmann said, but they can't give up — even if they also can't wait long.