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<<   作成日時 : 2008/06/10 00:06   >>

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 小児への向精神薬使用に火を付けた世界的に有名なハーバードの児童精神科医は2000-2007年に製薬企業から少なくとも160万ドルを得ていたが、多くは大学事務への届け出をしていなかったと、議会の調査でわかった。
画像 Dr. Joseph Biederman と同僚の Dr. Timothy E. Wilens が、連邦と大学の研究規則に違反する可能性がある。Dr. Wilensは2000年から2007年に少なくとも160万ドルを得たのを遅れて報告し、同じ同僚の Dr. Thomas Spencer も100万ドルを得たことを報告した。しかし、修正された申告でさえ、研究者の収入は控えめなものであると、アイオワ共和党 Grassley上院議員は言う。
 1例として、大学に提出された公開報告で、Dr. Biederman は2001年にJohnson & Johnsonからの収入を全然報告していなかった。再チェックにより、3,500ドルを受け取ったとしたが、Johnson & Johnsonは 58,169ドルを支払ったと言った。
 NIHとしては、研究規律違反があれば、受入しがたく許容できないという。
 Drs Biederman and Wilens が連邦政府から得た研究資金はMGHが管理していて、2005年に2億8700万ドルであった。
 Dr. Biederman は児童精神医学において最も有力な研究者のひとりであり、最も問題の多い若年患者の研究で広く賞賛されている。1994-2003年に40倍に増加した小児の双極性障害の診断と向精神薬の爆発的な使用に火を付けたことに役立つものであった。議員による調査では研究の質には言及されていない。
 向精神薬の小児への効果は明瞭であると何年もの間医師たちは知ってはいるが、体重増加や代謝への影響が引きおこされやすく、最終的な生活の改善(improve children’s lives over time)には程遠いものである。
 最近25年間は、製薬と医療機器のメーカーは研究資金調達の主要なソースとして連邦政府に取って代わり、医療産業のサポートは多くの大学研究計画に不可欠である。企業の研究統括部が優秀な科学者を募集する時、営業部はかれらの中にすごい大道商人がいると気づいた。
 NIHは連邦資金提供された研究では、年に1万ドル以上の製薬企業からの資金提供は大学に報告するよう研究者に求めている。昨年、3000以上の大学、325,000人に230億ドル以上の政府研究資金が提供された。個々の研究者の潜在的な矛盾を監査することは不可能だろうと政府は主張し、大学を信頼している。
 いくつかの州では製薬メーカーに医師への供与を公開義務づける法律があるが、Grassley議員らは連邦法を求めている。ハーバード大には3人の研究者の資産公開を要求し、いくつかの製薬企業には彼らへの支出リストを依頼した。この7年で数十万ドル受け取っているように見えると言う。
 2000年にDr. Biedermanは、小児のADHDに対するEli Lilly の薬 Strattera についてNIHの研究費を受けて研究し、ハーバード大にはLilly からの資金は10,000ドル未満であったと報告したが、Lilly は14,000ドル以上支払ったという。
画像

 ここ10年でDr. Biederman らは、小児の双極性障害の積極的な診断と薬物治療を促進、子どもの診断が見過ごされており向精神薬で治療可能であると主張、結果として診断治療が急速に拡大した。2007年時点で、約50万人が小児とティーンエイジャーが少なくとも1回の治療を受け、この中には6才未満の20,500人も含まれる。
 今では10代の初めに双極性障害が発症し、多くの子どもがこの病気で苦しんでいることを疑う精神科医は殆どいない。
 しかし、その影響を批判的に見ているグループもある。子どもへの商業的実験にハーバードの承認を与えたとする。多くの研究者に小児の双極性障害がどういうものかということに強い異論があり、ハーバードグループによる不必要な定義の拡張にいくらか不安をいだいている。2001-2006年の薬物試験は規模も小さく、ルースで、多くが断定的ではない結果を発表している。現在殆どの研究者が50%の低下を躁評価尺度としているが、いくつかの研究では30%以上の低下で定義している。
 児童精神医学領域では特に、企業の影響を受けない研究が絶対的に必要である。
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DSMと製薬会社の関係
http://kurie.at.webry.info/200805/article_57.html
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Researchers Fail to Reveal Full Drug Pay

By GARDINER HARRIS and BENEDICT CAREY
Published: June 8, 2008

A world-renowned Harvard child psychiatrist whose work has helped fuel an explosion in the use of powerful antipsychotic medicines in children earned at least $1.6 million in consulting fees from drug makers from 2000 to 2007 but for years did not report much of this income to university officials, according to information given Congressional investigators.
J. Scott Applewhite/Associated Press

Senator Charles E. Grassley pushed three experts in child psychiatry at Harvard to expose their income from consulting fees.

Dr. Joseph Biederman belatedly reported at least $1.6 million in consulting fees.

By failing to report income, the psychiatrist, Dr. Joseph Biederman, and a colleague in the psychiatry department at Harvard Medical School, Dr. Timothy E. Wilens, may have violated federal and university research rules designed to police potential conflicts of interest, according to Senator Charles E. Grassley, Republican of Iowa. Some of their research is financed by government grants.

Like Dr. Biederman, Dr. Wilens belatedly reported earning at least $1.6 million from 2000 to 2007, and another Harvard colleague, Dr. Thomas Spencer, reported earning at least $1 million after being pressed by Mr. Grassley’s investigators. But even these amended disclosures may understate the researchers’ outside income because some entries contradict payment information from drug makers, Mr. Grassley found.

In one example, Dr. Biederman reported no income from Johnson & Johnson for 2001 in a disclosure report filed with the university. When asked to check again, he said he received $3,500. But Johnson & Johnson told Mr. Grassley that it paid him $58,169 in 2001, Mr. Grassley found.

The Harvard group’s consulting arrangements with drug makers were already controversial because of the researchers’ advocacy of unapproved uses of psychiatric medicines in children.

In an e-mailed statement, Dr. Biederman said, “My interests are solely in the advancement of medical treatment through rigorous and objective study,” and he said he took conflict-of-interest policies “very seriously.” Drs. Wilens and Spencer said in e-mailed statements that they thought they had complied with conflict-of-interest rules.

John Burklow, a spokesman for the National Institutes of Health, said: “If there have been violations of N.I.H. policy ― and if research integrity has been compromised ― we will take all the appropriate action within our power to hold those responsible accountable. This would be completely unacceptable behavior, and N.I.H. will not tolerate it.”

The federal grants received by Drs. Biederman and Wilens were administered by Massachusetts General Hospital, which in 2005 won $287 million in such grants. The health institutes could place restrictions on the hospital’s grants or even suspend them altogether.

Alyssa Kneller, a Harvard spokeswoman, said in an e-mailed statement: “The information released by Senator Grassley suggests that, in certain instances, each doctor may have failed to disclose outside income from pharmaceutical companies and other entities that should have been disclosed.”

Ms. Kneller said the doctors had been referred to a university conflict committee for review.

Mr. Grassley sent letters on Wednesday to Harvard and the health institutes outlining his investigators’ findings, and he placed the letters along with his comments in The Congressional Record.

Dr. Biederman is one of the most influential researchers in child psychiatry and is widely admired for focusing the field’s attention on its most troubled young patients. Although many of his studies are small and often financed by drug makers, his work helped to fuel a controversial 40-fold increase from 1994 to 2003 in the diagnosis of pediatric bipolar disorder, which is characterized by severe mood swings, and a rapid rise in the use of antipsychotic medicines in children. The Grassley investigation did not address research quality.

Doctors have known for years that antipsychotic drugs, sometimes called major tranquilizers, can quickly subdue children. But youngsters appear to be especially susceptible to the weight gain and metabolic problems caused by the drugs, and it is far from clear that the medications improve children’s lives over time, experts say.

In the last 25 years, drug and device makers have displaced the federal government as the primary source of research financing, and industry support is vital to many university research programs. But as corporate research executives recruit the brightest scientists, their brethren in marketing departments have discovered that some of these same scientists can be terrific pitchmen.

To protect research integrity, the National Institutes of Health require researchers to report to universities earnings of $10,000 or more per year, for instance, in consulting money from makers of drugs also studied by the researchers in federally financed trials. Universities manage financial conflicts by requiring that the money be disclosed to research subjects, among other measures.

The health institutes last year awarded more than $23 billion in grants to more than 325,000 researchers at over 3,000 universities, and auditing the potential conflicts of each grantee would be impossible, health institutes officials have long insisted. So the government relies on universities.
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A Doctor’s Underreported Transactions

Universities ask professors to report their conflicts but do almost nothing to verify the accuracy of these voluntary disclosures.

“It’s really been an honor system thing,” said Dr. Robert Alpern, dean of Yale School of Medicine. “If somebody tells us that a pharmaceutical company pays them $80,000 a year, I don’t even know how to check on that.”

Some states have laws requiring drug makers to disclose payments made to doctors, and Mr. Grassley and others have sponsored legislation to create a national registry.

Lawmakers have been concerned in recent years about the use of unapproved medications in children and the influence of industry money.

Mr. Grassley asked Harvard for the three researchers’ financial disclosure reports from 2000 through 2007 and asked some drug makers to list payments made to them.

“Basically, these forms were a mess,” Mr. Grassley said in comments he entered into The Congressional Record on Wednesday. “Over the last seven years, it looked like they had taken a couple hundred thousand dollars.”

Prompted by Mr. Grassley’s interest, Harvard asked the researchers to re-examine their disclosure reports.

In the new disclosures, the trio’s outside consulting income jumped but was still contradicted by reports sent to Mr. Grassley from some of the companies. In some cases, the income seems to have put the researchers in violation of university and federal rules.

In 2000, for instance, Dr. Biederman received a grant from the National Institutes of Health to study in children Strattera, an Eli Lilly drug for attention deficit disorder. Dr. Biederman reported to Harvard that he received less than $10,000 from Lilly that year, but the company told Mr. Grassley that it paid Dr. Biederman more than $14,000 in 2000, Mr. Grassley’s letter stated.

At the time, Harvard forbade professors from conducting clinical trials if they received payments over $10,000 from the company whose product was being studied, and federal rules required such conflicts to be managed.

Mr. Grassley said these discrepancies demonstrated profound flaws in the oversight of researchers’ financial conflicts and the need for a national registry. But the disclosures may also cloud the work of one of the most prominent group of child psychiatrists in the world.

In the past decade, Dr. Biederman and his colleagues have promoted the aggressive diagnosis and drug treatment of childhood bipolar disorder, a mood problem once thought confined to adults. They have maintained that the disorder was underdiagnosed in children and could be treated with antipsychotic drugs, medications invented to treat schizophrenia.

Other researchers have made similar assertions. As a result, pediatric bipolar diagnoses and antipsychotic drug use in children have soared. Some 500,000 children and teenagers were given at least one prescription for an antipsychotic in 2007, including 20,500 under 6 years of age, according to Medco Health Solutions, a pharmacy benefit manager.

Few psychiatrists today doubt that bipolar disorder can strike in the early teenage years, or that many of the children being given the diagnosis are deeply distressed.

“I consider Dr. Biederman a true visionary in recognizing this illness in children,” said Susan Resko, director of the Child and Adolescent Bipolar Foundation, “and he’s not only saved many lives but restored hope to thousands of families across the country.”

Longtime critics of the group see its influence differently. “They have given the Harvard imprimatur to this commercial experimentation on children,” said Vera Sharav, president and founder of the Alliance for Human Research Protection, a patient advocacy group.

Many researchers strongly disagree over what bipolar looks like in youngsters, and some now fear the definition has been expanded unnecessarily, due in part to the Harvard group.

The group published the results of a string of drug trials from 2001 to 2006, but the studies were so small and loosely designed that they were largely inconclusive, experts say. In some studies testing antipsychotic drugs, the group defined improvement as a decline of 30 percent or more on a scale called the Young Mania Rating Scale ― well below the 50 percent change that most researchers now use as the standard.

Controlling for bias is especially important in such work, given that the scale is subjective, and raters often depend on reports from parents and children, several top psychiatrists said.

More broadly, they said, revelations of undisclosed payments from drug makers to leading researchers are especially damaging for psychiatry.

“The price we pay for these kinds of revelations is credibility, and we just can’t afford to lose any more of that in this field,” said Dr. E. Fuller Torrey, executive director of the Stanley Medical Research Institute, which finances psychiatric studies. “In the area of child psychiatry in particular, we know much less than we should, and we desperately need research that is not influenced by industry money.”


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