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<<   作成日時 : 2009/05/09 23:55   >>

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 1991年にDr. Margaret A. Hamburgはニューヨーク市の保健局長に命じられて、貧弱な予算と団結せずやる気のない職員という遺産を引き継いだ。
 FDA食品医薬品局は彼女に親しみを感じている。オバマ政権が彼女に達成してほしいと望んでいるような問題を抱えるいわばUターン場所である。木曜日に上院委員会はDr. HamburgをFDA長官として承認するかどうかを検討する。 公聴会は豚インフルエンザ感染により1週間繰り上げられた。
 彼女は薬剤・食品の安全問題に深い経験があるわけではないが、感染症研究者でバイオテロと公的準備対策の専門家である。ニューヨークでの公衆衛生のリーダーシップは多くの支持を得ていた。
 全ての輸入品の1/3を占める食物と薬剤は消費財の1兆ドル以上になり、FDAが監督している。特に食品安全性の監督について大きな改革が必要とされている。医療機器での監督も内部告発により重大な欠陥があるとされた。
 母親である精神科医のDr. Beatrix Hamburgによれば、彼女はこうした問題に取り組むために生まれてきたと言う。2歳の時にはすでに非常に独立心が強く、周囲に影響されなかったと言う。父親は医学研究所の前所長である。
 ニューヨーク市では薬剤耐性結核の問題に財政危機の時に取り組んできた。Rikers島の刑務所での多発に対して、90日間の短期間での結核病院の建設と年に125,000人もの全ての囚人の結核検診を成し遂げた。
 前任の3人がしなかったことを実行し、結核流行は沈静化した。さらに、麻薬常習者の間でH.I.V.伝染の広がりを遅くするために針交換プログラムを成功させた。
 公聴会の前に、オバマ政権は、来年のFDA予算を19%増加させ、その増加の半分は食品安全に向けると発表した。
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Obama’s Choice to Lead F.D.A. Doesn’t Shy Away From Difficult Situations
http://www.nytimes.com/2009/05/07/health/policy/07fda.html
By GARDINER HARRIS
Published: May 6, 2009

WASHINGTON ― Appointed in 1991 to serve as acting health commissioner of New York City, Dr. Margaret A. Hamburg inherited urgent problems, a spare budget and a divided and demoralized staff.
Skip to next paragraph
Joseph Garnett Jr./St. Petersburg Times

画像Dr. Margaret A. Hamburg

The Food and Drug Administration could have a familiar feel for her.

The turnaround that she engineered is exactly what the Obama administration is hoping she will achieve at the drug agency, which is reeling from a host of similar problems.

On Thursday, the Senate Health, Education, Labor and Pensions Committee will consider whether to confirm Dr. Hamburg as F.D.A. commissioner. The hearing was moved up a week in the wake of the swine flu outbreak, which has given her nomination urgency. She is expected to be confirmed.

Although she lacks deep experience in drug- or food-safety issues, Dr. Hamburg was an infectious disease researcher and is an expert in bioterrorism and public preparedness, both of which seem keenly relevant. Her leadership in New York has won her admirers among public health advocates, many of whom said she would be a good leader to an agency a previous commissioner had likened to a cancer patient.

The Food and Drug Agency regulates more than $1 trillion worth of consumer goods, including a third of all imported goods. It is widely thought to need major reforms, particularly to its oversight of food safety. An unusual group of internal whistle-blowers has claimed that the agency’s oversight of medical devices is deeply flawed.

Dr. Hamburg was born to tackle such problems, said her mother, Dr. Beatrix Hamburg. Her father is a former president of the Institute of Medicine. Shortly after Margaret Hamburg’s second birthday, her mother learned that her daughter had a fiercely independent streak and “was just not going to be pushed around,” Dr. Beatrix Hamburg said.

So her mother, a psychiatrist, gave her daughter difficult tasks with significant obstacles. “She took to it like a duck to water,” Dr. Beatrix Hamburg said. Dr. Margaret Hamburg has been tackling difficult tasks ever since.

The toughest was a growing epidemic of drug-resistant tuberculosis in New York City during a fiscal crisis. H.I.V. infections, drug abuse and homelessness had caused tuberculosis to come roaring back from dormancy. Solving the problem seemed beyond the powers of the health department, divided and demoralized in the wake of the abrupt departure of her predecessor.

A key problem was that many of those infected failed to take their medicines until cured, leading to the creation of drug-resistant disease strains. Dr. Hamburg pushed for the power to civilly detain until cured tuberculosis patients, many with mental illnesses or drug addictions.

The request for such broad powers could have led to opposition from advocacy and other organizations, but Dr. Hamburg was quietly persuasive, said Mark Barnes, an associate health commissioner at the time.

She turned her attention to Rikers Island, where scores of the island’s huge jail population were infected with TB.

“A number of us became aware that we were sitting on a ticking time bomb at Rikers,” said Dr. Steven M. Safyer, who was then the medical director of the Montefiore Rikers Island Medical Center.

Despite the city’s financial problems, Dr. Hamburg got the city to construct in 90 days a top-notch tuberculosis hospital on the island and to screen all inmates for the disease ― as many as 125,000 people in a year. Dr. Safyer said Dr. Hamburg had managed, with calm and persuasive arguments, to get citywide backing for her TB efforts.

“It’s not rocket science, but three health commissioners before her had not done it,” Mr. Barnes said. The tuberculosis epidemic subsided.

Dr. Hamburg also persuaded Mayor David N. Dinkins to support a successful needle-exchange program to slow the spread of H.I.V. infections among drug addicts. When she first proposed the program, “I said, ‘You’ve got to be kidding,’ ” Mr. Dinkins remembered. “You’ve got to appreciate how extreme of an idea that was. But I listened to her. She’s got that ability.”

As a teenager, Dr. Hamburg spent a semester in Africa working with the renowned primatologist Jane Goodall. She has two children. She attended Harvard with her husband, Peter Brown, a mathematician and financial analyst.

Family, friends and coworkers all describe Dr. Hamburg as bright, funny and unusually calm. Dr. David Hamburg told of a speech his daughter was scheduled to give in New York City two years ago. Just before the talk, Dr. Hamburg’s husband called to tell her that their house had caught fire, although there were no injuries. She delivered the speech anyway.

“You would have never known that anything was wrong in her life,” Dr. David Hamburg said in an interview. “That’s vintage Peggy. She can carry on in a cool, organized way under heavy pressure.”

----------------------------------------------------
Senators Offer Their Support to F.D.A. Nominee
http://www.nytimes.com/2009/05/08/us/politics/08fda.html
By GARDINER HARRIS
Published: May 7, 2009

WASHINGTON ― The Obama administration’s choice to lead the Food and Drug Administration breezed through her Senate confirmation hearing on Thursday while the administration proposed a budget that would give the agency more money.

Dr. Margaret A. Hamburg’s confirmation was all but assured when Senator Orrin G. Hatch, Republican of Utah, strongly endorsed her. “I want you to know that I support you,” Mr. Hatch said, “and I intend to help you not only to get through this process but to do your job out there.”

Mr. Hatch’s endorsement was followed by those of Senator Richard M. Burr, Republican of North Carolina, as well as every Democrat at the hearing of the Senate Health, Education, Labor and Pensions Committee.

One reason for the enthusiasm for Dr. Hamburg may be the unease many conservatives have expressed about Dr. Joshua M. Sharfstein, the agency’s acting commissioner, who will become principal deputy commissioner when Dr. Hamburg is confirmed.

Dr. Sharfstein once worked at the advocacy organization Public Citizen and served on the staff of Representative Henry A. Waxman, a California Democrat who is a fierce critic of the drug industry.

Mr. Hatch, closely allied with drug makers, wondered aloud why the Obama administration had appointed Dr. Sharfstein and asked Dr. Hamburg how she would split her responsibilities with him. She said she would be the agency’s only commissioner.

“I believe that there were reports in the press that were quite misleading,” Dr. Hamburg said. The reports suggested “that I would focus on food and tobacco, should that become part of the F.D.A.’s mandate, and he would focus on drugs. That is simply untrue,” she added.

In her opening remarks, Dr. Hamburg said that she would take an active role in the government’s decision about what vaccine to make in response to the swine flu outbreak. She said she would make a priority of improving oversight of food safety.

The committee may vote as soon as next week to send the nomination to the full Senate.

Before Dr. Hamburg’s hearing, the Obama administration announced that it had proposed increasing the F.D.A.’s budget next year by 19 percent, including $295 million in allocated money and $215 million in additional industry user fees. Half of the increase would go to food safety efforts.

The administration proposed collecting $94 million in fees from food companies, a tax that would require Congressional approval.

The administration also proposed collecting $47 million in fees from makers of generic drugs to help finance the staff needed to reduce a backlog of years in generic drug applications. Kathleen Jaeger, president of the Generic Pharmaceutical Association, said her industry would support such fees “so long as there are guarantees that the fees would result in the timely review and approval of generic applications.”

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