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zoom RSS スタンフォード大医学部 製薬・医療機器メーカー紐付講演禁止 厳格化

<<   作成日時 : 2010/03/24 18:43   >>

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 スタンフォード大医学部は、adjunct faculty と呼ばれるvolunteer teaching staff による製薬・医療機器メーカー紐付きの講演を禁止する規則を実施する。
 スタンフォードは既に学部と医療産業との関係を制御する最も包括的なポリシーを持っている。2006年に制定された方針では、日常的な臨床研修と医学教育への潜在的な産業の影響を制限することを意図している。
 その方針は、製薬・医療機器メーカーが医師に報酬を払って製品について会社で準備されたスピーチを医師にさせる企業スピーカー部門に参加することを教職員に禁止する。患者のための無料サンプルも含めた無料の贈与物の収受を禁止する。
 月曜日から、660人のボランティア教師に対してもスタンフォードの名を冠しての同様の行為を禁止する。フルタイムかパートタイムかで区別するのは良くないという。
 製薬企業イーライ・リリーのためのスピーカーとして昨年6ヶ月で約75,000ドルを得た付属教職員について、ニューヨーク・タイムズが記事にしたため、スタンフォード大は昨年11月にその方針を考え直すと決めた。イーライ・リリーは現在、会社を代表して仕事をした医師に支払われた報酬のリストを毎季に公表している。(2010/03/21)

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 2009年前半、製薬巨人イーライ・リリーは3,971人の医師や医学専門家に平均11,230ドルを支払った。平均で12回の講演やコンサルタントであるという。
 トップ5の1人 Manoj V.Waikar博士の場合、51のイベントで74,850ドルを受け取った。会社としての上限は年に75,000ドルであるという。
 Waikar博士はカリフォルニア・パロアルトの精神科医で、スタンフォード大医学校の精神医学と行動科学の部門の adjunct clinical instructor付属臨床インストラクターである。統合失調症やうつ病について医療専門家に話をして報酬を受け取ったという。こうした病気はリリー社のZyprexaやCymbaltaで治療することができる。彼のウェブサイトによれば、AstraZeneca、Bristol-Myers Squibb、ファイザーを含めて他の会社のために話したり、コンサルティングの仕事をしたことが示されている。
 多くのメディカルセンターは、連邦規定に従い、製薬メーカーが話の内容を準備しコントロールするような企業後援のスピーチをすることを医師に禁止した。
 スタンフォード大は、正規教職員が製薬会社のスピーカーに関与することを禁止したが、Waikar博士のような無給のadjunct instructors付属インストラクターは、スタンフォードの名前を使っていない限り許可されている。(2009/11/04)

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Stanford Medical School to Expand Ethics Rules
By NATASHA SINGER
Published: March 21, 2010
http://www.nytimes.com/2010/03/22/health/policy/22docs.html

The Stanford University School of Medicine plans on Monday to introduce rules that would prohibit its volunteer teaching staff ― called adjunct faculty ― from giving paid speeches drafted by the makers of drugs or medical devices.

Stanford already has one of the most comprehensive policies in the country governing the interactions between academic faculty and the medical industry. The policy, enacted in 2006, is intended to limit potential industry influence on day-to-day clinical practice and medical education, according to a Stanford press release.

The policy prohibits faculty members from participating in industry speakers’ bureaus in which drug and medical device makers pay a physician to give company-prepared speeches to doctors about company medical products. It also prohibits Stanford faculty members from accepting free gifts, including drug samples for patients.

And as of Monday, the 660 community physicians who volunteer their time to teach at Stanford will also have to abide by the same policy ― or give up their Stanford titles.

“We welcome interactions with industry that are positive and collaborative,” Dr. Philip A. Pizzo, the dean of Stanford medical school, said Saturday in a phone interview. “But where I think the line should not be crossed and where we are not going to allow our full-time or part-time faculty to engage is in marketing.”

Until now, the policy has primarily governed full-time faculty members, who represent the day-to-day face of the medical school. That is because Stanford did not want to restrict the practice or income of unpaid adjunct faculty members, Dr. Pizzo said.

But Stanford decided to rethink its policy last November, he said, after The New York Times published an article about an adjunct faculty member who had earned almost $75,000 in six months last year as a speaker for the drug maker Eli Lilly. Lilly now publishes a quarterly database that lists the fees paid to individual physicians for speaking and consulting work on behalf of the company.

“I never imagined that someone in community practice would be earning as much from an industrial source,” Dr. Pizzo said.

Stanford grew concerned that the school’s reputation might be tarnished because of confusion over academic titles, he said. Members of the public, for example, might not understand the difference between a full professor, who was required to abide by the school policy, and an adjunct professor, who was not required to follow the policy but still carried a Stanford title, he said.

Now, those adjunct faculty members who want to enjoy the benefit of a Stanford title will have to adhere to the same policy on conflicts of interest as regular faculty members do.

Dr. Pizzo predicted that some adjunct faculty who earn substantial sums as industry speakers or who use free drug samples in their practices might choose to separate from Stanford instead.

“I think this is going to be a difficult debate going forward,” he said. “I think this is an individual choice.”

Stanford is not the only university reconsidering how it interacts with the pharmaceutical and health care industries.

In January, after teaching hospitals associated with the Harvard Medical School began prohibiting their staff physicians from participating in drug company speakers’ bureaus, a prominent allergy and asthma specialist named Dr. Lawrence M. DuBuske resigned from his job at the Brigham and Women’s Hospital in Boston, The Boston Globe reported.

Even so, Dr. Pizzo of Stanford said, the leading academic medical centers must set a new standard for engaging the public trust in medicine.

“Witness the gradual deterioration in how physicians have been perceived,” Dr. Pizzo said. “We have to get back on the high road and avoid the negative interactions in which industry engages physicians in marketing products.”

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Sought-After Speaker, With Script Outlines From Eli Lilly
http://www.nytimes.com/2009/11/04/health/policy/04sunshineside.html
By NATASHA SINGER
Published: November 4, 2009

In the first half of this year, the drug giant Eli Lilly paid 3,971 doctors and other medical professionals an average of about $11,230 each. The payments were for participating in an average of 12 speaking or consulting engagements during those six months, according to a company spokeswoman.

画像Dr. Manoj V. Waikar was among the top five earners of payments from Eli Lilly this year.

Dr. Manoj V. Waikar, for example, a physician among the top five earners this year, received $74,850 for consulting and speaking at 51 events, according to Lilly’s on-line faculty registry. The company caps payments at $75,000 for each health care provider in any calendar year.

Who is Dr. Waikar and what makes him such a sought-after speaker for Eli Lilly? Which of the company’s drugs did he cover? The Lilly database does not answer those questions.

An Internet search turned up Dr. Waikar’s Web site. Dr. Waikar, a psychiatrist in Palo Alto, Calif., is also an adjunct clinical instructor in the department of psychiatry and behavioral sciences at the Stanford University School of Medicine.

In response to queries from a reporter, Dr. Waikar wrote in an e-mail message that he received fees for speaking to other health care professionals about disorders like schizophrenia and depression, which can be treated with the Lilly drugs Zyprexa and Cymbalta respectively.

His Web site also indicates he has done speaking, consulting or advisory work for other companies, including AstraZeneca, Bristol-Myers Squibb and Pfizer.

Many academic medical centers have barred their doctors from giving such industry-sponsored speeches because drug makers prepare and control the content of the talks to ensure that they comply with federal regulations on drug marketing.

As some medical ethicists see it, the doctors essentially are giving canned speeches written by the drug companies; after all, the med schools would not allow students to present somebody else’s work. And so Stanford prohibits full faculty members from participating in drug company speakers’ bureaus. But unpaid adjunct instructors, like Dr. Waikar, are allowed to, as long as they are not using their Stanford titles.

In an e-mail message to a reporter, Dr. Waikar wrote that although drug company presentations were standardized to comply with drug marketing regulations, he and other speakers did provide suggestions on the content. And he said that there was room for spontaneity at such events, because he was allowed to answer questions from doctors in the audience, drawing from his own practice experience or opinions, as long as he explained the basis of his answers.

In an another e-mail message, Dr. Waikar wrote that talks like his could be helpful to primary care providers having to treat complex psychiatric problems. He added that doctors had contacted him after the talks to consult about difficult cases.

But Dr. Bernard Lo, the director of the medical ethics program at the medical school of the University of California, San Francisco, said that because drug companies controlled the content of such speeches, they should have their own employees give such talks. “Anyone who teaches medical students or residents should be bound by the same regulations,” Dr. Lo said. “Your own work has to be your own work.”

Stanford is reviewing its policy to determine if any clarifications or changes are needed, a spokesman for the medical school wrote in an e-mail message.

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スタンフォード大医学部 製薬・医療機器メーカー紐付講演禁止 厳格化 医師の一分/BIGLOBEウェブリブログ
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