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zoom RSS 薬剤開発のための新しいナショナルセンター立ち上げへ/米国医療事情 NIH

<<   作成日時 : 2010/12/10 20:07   >>

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画像 米国政府は、NIHの諮問委員の推奨により薬剤開発のための新しいセンターを立ち上げる方針だという。見込みがあっても不確定の科学的知見を探ることを製薬会社ができなかったりしようとしないことを、新たなナショナルセンターでおこなう。NIHは今までこうしたことは行ってこなかった。
 製薬会社は5,000の化合物から250を動物に使用してそのうちやっと1つを探し当ててFDAから認可を得ている状況だという。開発には15年の歳月と8億ドル以上の資金が必要である。
 NIHでも新薬開発の手助けはしてきた。樹皮から作られた制癌剤タクソールは国立がん研究所試験室で発見された。
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新たな抗生物質の開発を促進する/米国医療事情 多剤耐性菌
http://kurie.at.webry.info/201011/article_6.html
患者参加不足で臨床試験の遅れ/米国医療事情
http://kurie.at.webry.info/200903/article_20.html

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U.S. takes step to government drug development center
http://www.reuters.com/article/idUSTRE6B66ZG20101207

By Maggie Fox, Health and Science Editor

WASHINGTON | Tue Dec 7, 2010 5:42pm EST

WASHINGTON (Reuters) - The U.S. government took a big step toward getting more involved in developing drugs on Tuesday, when advisers to the National Institutes of Health recommending setting up a new center to do it.

The new National Center for Advancing Translational Sciences would do some of the dirty work that pharmaceutical companies cannot or will not do, by taking promising but uncertain basic scientific findings out of the test tube and finding ways to use them to treat people, NIH Director Dr. Francis Collins said.

"NIH has never done anything quite like this," Collins said in a telephone interview.

"We are asking how can we improve the success of getting the ideas from an early stage to a successful clinical trial, because there is a terrible failure rate right now."

The pharmaceutical company lobbying group PhRMA estimates that out of every 5,000 compounds screened for their potential to become drugs, only 250 make it out of the lab and into animals and only one finally gets approved by the U.S. Food and Drug Administration.

PhRMA says it can take as long as 15 years and cost more than $800 million to get there.

NIH has long helped develop new drugs -- Taxol, a cancer drug made from tree bark, started development in a National Cancer Institute lab. Collins said the new institute would not interfere with these efforts but would instead be a place to coordinate them better.

NIH's Scientific Management Review Board voted on Tuesday to recommend establishment of the new center -- something Collins immediately embraced, as it was an idea he has been pushing since he took over in 2009.

PARTNERSHIP WITH INDUSTRY

"This is a great opportunity for NIH to tighten up our partnership with industry in terms of development of therapeutics," Collins said.

"It solves a problem for them, too. As you know, the success of getting new drugs approved by FDA has been pretty spotty over the past few years in spite of investment. Pharmaceutical companies are pretty frustrated," he added.

"They love this idea because it is a way of filling their pipeline."

But Collins denies any suggestion that the new approach would amount to taxpayers subsidizing for-profit companies.

"There will be royalties," he said. "Those in part will feed back into NIH so that the taxpayers' investment will be repaid."

The center would likely focus on rare diseases, as well as diseases common in the developing world, where drug companies cannot hope to turn big profits.

"Clearly we don't want to compete with projects industry would be all over," Collins said. "If there is an obvious target for a common disease, that is probably something we would not go after."

But one early project may involve asking drug companies to give NIH access to failed compounds to see if they could be "re-purposed" for other diseases, he said.

Collins must report to his bosses at the Health and Human Services Department and Congress, but he estimates the new center could be up and running by next year. There is little new money so the $700 million cost would come from the existing NIH budget.

Much of the work will come in the form of grants to academic centers, in much the way NIH works now, he added.

(Editing by Mohammad Zargham)

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