米ＦＤＡ長官、コロナ血漿療法でデータ誤用を謝罪

【ワシントンＡＦＰ＝時事】米食品医薬品局（FDA）のスティーブン・ハーン長官は24日、新型コロナウイルス感染症（COVID-19）からの回復者の血漿（けっしょう）を用いた治療を緊急許可すると発表した際に、その効果に関する主要データの引用が不正確だったとして謝罪した。（写真はスティーブン・ハーン長官〈右〉とドナルド・トランプ大統領）
　米国は２３日、実験的な治療法として、ＣＯＶＩＤ-１９から回復した人の血漿を使用することを緊急許可。しかしハーン長官や衛生当局高官らはその発表の際、回復者の血漿を用いることで、ＣＯＶＩＤ-１９の致死率が３５％減少するというドナルド・トランプ大統領の主張をそのまま繰り返し、他の専門家らから非難を浴びた。
　致死率がそれほど減少するならば、同感染症の世界的大流行との闘いにおいて形勢を一転させる治療法となるが、実はこの統計は誤っていた。
　当局は米総合病院メイヨー・クリニックの研究結果としてこのデータを発表したが、研究主任のスコット・ライト医師はＡＦＰに対し、データは同院独自のものではなく、メイヨーと他の研究結果からＦＤＡが総合分析したものだと思うと語った。
　ハーン長官は２４日夜、ツイッターへの投稿で「私は２３日夜の回復期血漿療法の効果に関する自らの発言で批判を受けている。この批判は全面的に正しい。データが示しているのは絶対リスク減少ではなく、相対リスク減少だと言うべきだった」と認めた。
　ただこれだけ大幅なトーンダウンをしたとはいえ、ＦＤＡがメイヨー・クリニックの研究結果のどの数値を引用したのかは依然不明。血漿療法が緊急許可に値するかどうかは、科学界で見解が分かれている。【翻訳編集ＡＦＰＢＢＮｅｗｓ】
〔ＡＦＰ＝時事〕（2020/08/26-13:10）

Dr Stephen Hahn, the commissioner of the US Food and Drug Administration, apologized Monday after misrepresenting a key statistic on how effective blood plasma is for treating COVID-19 when announcing an emergency approval measure.
The US on Sunday issued emergency approval for plasma taken from recovered coronavirus patients, so that more people can get access to the experimental treatment.
But Hahn and other senior health officials came under fire from experts after repeating a claim made by President Donald Trump that blood plasma from recovered COVID-19 patients reduced mortality rates by 35 percent.
What that means is -- and if the data continue to pan out -- 100 people who are sick with COVID-19, 35 would have been saved because of the administration of plasma, Hahn said Sunday, after Trump had called it a tremendous number.
Health secretary Alex Azar added: I just want to emphasize this point, because I don't want you to gloss over this number. We dream in drug development of something like a 35 percent mortality reduction. This is a major advance in the treatment of patients. This is a major advance.
Such a reduction would indeed be a game changer in the fight against the pandemic -- but the statistic is false.
The officials said these results came from a study of 35,000 patients conducted by Mayo Clinic, but Dr Scott Wright, the study's leader, told AFP it did not come from his institution's research. He said he believed it might be an integrated analysis the FDA had arrived at by looking at both Mayo's work and other studies.
FDA spokeswoman Emily Miller later tweeted that 35 percent referred to the relative difference in mortality risk between those patients in Mayo's study who received a high level of antibodies against those who received a low level of antibodies.
I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma, said Hahn in a tweet thread on Monday night. The criticism is entirely justified. What I should have said better is that the data show a relative risk reduction not an absolute risk reduction.
But it was not immediately clear which figures the FDA had used from the Mayo study to arrive even at this far more modest claim. The study has not yet been peer-reviewed and is available in preprint form on a medical research server, so it remains possible that more data will eventually be forthcoming.
The scientific community is divided on whether plasma should have received an emergency use approval.
Early research suggests it may be helpful and safe but no clinical trials -- considered the gold standard of medical research -- have yet found conclusively in its favor.
Political commentators have questioned the timing of the FDA's latest move as Trump lags in polls before the November election.