The FDA is restricting the use of 2 drugs first authorized to treat COVID

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The FDA is restricting the use of 2 drugs first authorized¹ to treat COVID

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The FDA curbed³ the use of two out of three monoclonal antibody treatments. Studies show they're highly unlikely to work against the omicron variant⁴, which is overwhelming hospitals.

STEVE INSKEEP, HOST:

Hospitals in much of this country are under extreme stress. They're caring for more COVID patients than in any other time in the pandemic. And we have news today of one reason why so many people are in the hospital. Medicine that can keep high-risk COVID patients out of hospitals is in short supply. Also, this week the FDA announced it's restricting the use of two of the first drugs authorized to treat COVID. NPR's Pien Huang joins us now. Good morning.

PIEN HUANG, BYLINE⁵: Good morning, Steve.

INSKEEP: Why is the FDA restricting two COVID drugs?

HUANG: Well, so on Monday, the FDA curbed the use of two out of three monoclonal antibody treatments. And these two drugs, made by Regeneron and Eli Lilly, worked well earlier in the pandemic. But recent lab studies show that they're highly unlikely to work against the omicron variant. And remember, omicron now accounts for around 99% of U.S. cases.

INSKEEP: Yeah.

HUANG: Erin Fox, a pharmacy⁶ director at University of Utah Health, says the FDA is following the science.

ERIN FOX: Honestly, I'm shocked that it took them this long to do it because things are bad enough without wasting valuable health care provider time infusing a medicine that is not going to be effective.

HUANG: Omicron has dominated since Christmas, but every state has continued to get these two treatments. Now the Department of Health and Human Services, which distributes these drugs, has stopped sending them out.

INSKEEP: I can feel the politics coming into this because people who have stressed vaccine⁷ choice, choice to avoid vaccines⁸, have instead stressed treatments like the monoclonal antibodies. And you're telling me that some of them have now been disallowed⁹. What are some state officials saying about this?

HUANG: Well, as you mentioned, state officials are not necessarily happy about this in some states. The FDA's move prompted Florida's health department to shut down all of its state-run antibody treatment sites. Governor Ron DeSantis called for the Biden administration to reverse this decision - accused the president of, quote-unquote, "medical authoritarianism¹⁰." But even the makers¹¹ of the drugs acknowledge that they don't work well against omicron.

Now, there is one antibody drug left called sotrovimab that does work against omicron, but it's in very short supply. Each week, there are only around 50,000 doses available for the whole country, and that's not nearly enough to go around.

INSKEEP: Hasn't the FDA recently expanded the use of another drug, though?

HUANG: That's right. So the drug is called remdesivir. It was the first antiviral drug to get FDA approval back in 2020. But at the time, it was only for very sick patients in the hospital. Now, recently, the FDA broadened that approval to include patients not sick enough to be hospitalized. Dr. Raymund Razonable at Mayo Clinic in Minnesota says recent research shows that for high-risk patients, remdesivir reduced the risk of getting hospitalized by 87%.

RAYMUND RAZONABLE: And it confirms what people - what I, as an infectious disease provider - have assumed from the very beginning, that for antivirals to work, it has to be given early.

HUANG: Now, Razonable calls it a blessing¹² that the evidence for remdesivir came out right as omicron was coming in. And there's plenty of this drug available, but it's also not very easy to administer. A patient has to go to a clinic and get IV infusions¹³ over three consecutive¹⁴ days.

INSKEEP: Which sounds like a lot. Aren't there pills you could take at home?

HUANG: Yeah, there are two pills - Paxlovid from Pfizer and molnupiravir from Merck. And out of these two pills, doctors are more inclined to prescribe Paxlovid. It works twice as well as molnupiravir in keeping patients out of the hospital. But these pills are also not easy to get. For the past two weeks, 500,000 courses of both drugs went out at a time when 10 million people tested positive. Carl Dieffenbach with NIH says the situation with treatments is starting to get better.

CARL DIEFFENBACH: So as the omicron surge wanes¹⁵, demand will go down. At the same time, supply is going up.

HUANG: Dieffenbach says that drug companies are also whipping up new monoclonal antibodies, which could be available soon.

INSKEEP: NPR health reporter Pien Huang, thanks so much.

HUANG: Thanks for having me.

1 authorized   

a.委任的，许可的

参考例句：

• An administrative order is valid if authorized by a statute.如果一个行政命令得到一个法规的认可那么这个命令就是有效的。

2 transcript   

n.抄本，誊本，副本，肄业证书

参考例句：

• A transcript of the tapes was presented as evidence in court.一份录音带的文字本作为证据被呈交法庭。
• They wouldn't let me have a transcript of the interview.他们拒绝给我一份采访的文字整理稿。

3 curbed   

v.限制，克制，抑制( curb的过去式和过去分词 )

参考例句：

• Advertising aimed at children should be curbed. 针对儿童的广告应受到限制。 来自辞典例句
• Inflation needs to be curbed in Russia. 俄罗斯需要抑制通货膨胀。 来自辞典例句

4 variant   

adj.不同的，变异的；n.变体，异体

参考例句：

• We give professional suggestions according to variant tanning stages for each customer.我们针对每位顾客不同的日晒阶段，提供强度适合的晒黑建议。
• In a variant of this approach,the tests are data- driven.这个方法的一个变种，是数据驱动的测试。

5 byline   

n.署名；v.署名

参考例句：

• His byline was absent as well.他的署名也不见了。
• We wish to thank the author of this article which carries no byline.我们要感谢这篇文章的那位没有署名的作者。

6 pharmacy   

n.药房，药剂学，制药业，配药业，一批备用药品

参考例句：

• She works at the pharmacy.她在药房工作。
• Modern pharmacy has solved the problem of sleeplessness.现代制药学已经解决了失眠问题。

7 vaccine   

n.牛痘苗，疫苗；adj.牛痘的，疫苗的

参考例句：

• The polio vaccine has saved millions of lives.脊髓灰质炎疫苗挽救了数以百万计的生命。
• She takes a vaccine against influenza every fall.她每年秋季接种流感疫苗。

8 vaccines   

疫苗，痘苗( vaccine的名词复数 )

参考例句：

• His team are at the forefront of scientific research into vaccines. 他的小组处于疫苗科研的最前沿。
• The vaccines were kept cool in refrigerators. 疫苗放在冰箱中冷藏。

9 disallowed   

v.不承认（某事物）有效( disallow的过去式和过去分词 )；不接受；不准；驳回

参考例句：

• The judge disallowed that evidence. 法官驳回那项证据。 来自辞典例句
• Her claim was disallowed on the ground(s) that she had not paid her premium. 她要求赔款遭到拒绝，原因是她事先没有交纳保险费。 来自辞典例句

10 authoritarianism   

权力主义，独裁主义

参考例句：

• Modern authoritarianism is a vestige of traditional personal rule. 现代独裁主义则是传统的个人统治的残余。
• In its latter days it was a byword for authoritarianism, incompetence, and corruption. 在后期，它是独裁、无能和腐化的代号。

11 makers   

n.制造者，制造商（maker的复数形式）

参考例句：

• The makers of the product assured us that there had been no sacrifice of quality. 这一产品的制造商向我们保证说他们没有牺牲质量。
• The makers are about to launch out a new product. 制造商们马上要生产一种新产品。 来自《简明英汉词典》

12 blessing   

n.祈神赐福；祷告；祝福，祝愿

参考例句：

• The blessing was said in Hebrew.祷告用了希伯来语。
• A double blessing has descended upon the house.双喜临门。

13 infusions   

n.沏或泡成的浸液（如茶等）( infusion的名词复数 )；注入，注入物

参考例句：

• Intravenous infusions are also used to administer medications. 静脉输液也可作为一种给药方法。 来自辞典例句
• INTERPRETATION: GKI infusions significantly reduced plasma glucose concentrations and blood pressure. 结论：静脉滴注GKI显著降低血压和血糖浓度。 来自互联网

14 consecutive   

adj.连续的，联贯的，始终一贯的

参考例句：

• It has rained for four consecutive days.已连续下了四天雨。
• The policy of our Party is consecutive.我党的政策始终如一。

15 wanes   

v.衰落( wane的第三人称单数 )；（月）亏；变小；变暗淡

参考例句：

• The moon waxes till it becomes full, and then wanes. 月亮渐盈，直到正圆，然后消亏。 来自《现代汉英综合大词典》
• The moon waxes and wanes every month. 月亮每个月都有圆缺。 来自《简明英汉词典》