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zoom RSS 医療産業との不透明な関係 医学論文と医学雑誌/米国医療事情

<<   作成日時 : 2010/09/28 20:09   >>

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 月曜日に発表された研究によると、2007年に医療用品会社から高額のコンサルタント料を受け取った32人中25人は発表雑誌論文で会社との金銭的な関係を明らかにしていない。
 2007年に100万ドル以上の支払いを受け、翌年1つ以上の雑誌論文を発表した32人の医師や研究者についての調査研究による。
 医学雑誌編集者の国際委員会は、批判に対して最近2年でより良い公開方針を提案している。各雑誌はその方針にはまだほど遠い段階にある。
 この研究で取り上げられた Journal of Arthroplasty では24論文中17で公開されていない。Journal of Bone and Joint Surgery では10記事中7つが金銭的関係を公開していたが、来年からはさらに厳しい方針とする計画であったという。
 政府調査により公表を余儀なくされた5つの医療用品会社の公開資料に基づいている。2007年にコンサルタントにロイヤリティを含めて約2億5000万ドルを支払っている。Zimmer社は8700万ドル、DePuy Orthopaedicsが6300万ドル、Stryker社が4500万ドル、Bio met社が2700万ドル、Smith & Nephewが2400万ドルだった。そのうち1億1400万ドルが41人に支払われ、そのうちの32人が翌年に整形外科雑誌の著者や共著者となった。調査した95論文の54%にあたる51が会社との金銭的関係を公表していない。32人のうち25人の公表が不十分だった。
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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
http://kurie.at.webry.info/201003/article_19.html
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http://kurie.at.webry.info/201001/article_13.html
ハーバード・メディカル・スクールの倫理的苦境/米国医療事情
http://kurie.at.webry.info/200903/article_8.html
二大製薬企業が医師への金銭提供について公表/米国
http://kurie.at.webry.info/200810/article_10.html
小児向精神薬治療研究での問題/米国
http://kurie.at.webry.info/200806/article_17.html
医学論文ゴーストライターのさらなる規制を/米国医療事情
http://kurie.at.webry.info/201006/article_22.html
エルゼビアが医学論文ゴーストライター問題について調査を表明
http://kurie.at.webry.info/200812/article_36.html
バイオックス研究のゴーストライター
http://kurie.at.webry.info/200804/article_30.html
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Medical Industry Ties Often Undisclosed in Journals
By DUFF WILSON
Published: September 13, 2010
http://www.nytimes.com/2010/09/14/business/14devices.html

画像Twenty-five out of 32 highly paid consultants to medical device companies in 2007, or their publishers, failed to reveal the financial connections in journal articles the following year, according to a study released on Monday.
Multimedia

The study compared major payments to consultants by orthopedic device companies with financial disclosures the consultants later made in medical journal articles, and found them lacking in public transparency.

“We found a massive, dramatic system failure,” said David J. Rothman, a professor and president of the Institute on Medicine as a Profession at Columbia University, who wrote the study with two other Columbia researchers, Susan Chimonas and Zachary Frosch.

The study, published on the Web site of The Archives of Internal Medicine, focused on 32 medical doctors and doctoral researchers who were each paid at least $1 million in 2007 and published one or more journal articles the next year.

Most of the doctors and most of the orthopedic journal articles did not disclose their financial relationships with companies, the study found.

Professor Rothman called for stricter disclosure policies, including precise amounts of consulting payments. He said journal readers needed the information to consider the potential for bias.

Dr. Marcia Angell, a former editor of The New England Journal of Medicine, who was not involved with the study, called it “an ingenious study, with unsurprising results.” She added, “It is one more indication of the widespread corruption of the medical profession by industry money.”

“The journals’ lax enforcement of disclosure policies probably reflects the fact that journals, too, are dependent on industry support,” Dr. Angell said in an e-mail to a reporter after reviewing the study.

The International Committee of Medical Journal Editors, responding to criticism, has proposed better disclosure policies in the last two years. But each journal sets its own policy, and critics say many of them have still not gone far enough.

The Journal of Arthroplasty lacked disclosures in 17 of 24 articles in the study. Glen Campbell, head of health sciences journals for the publisher Elsevier, said it required disclosure. “We’re impressed with the quality of research here which clearly shows a collective need for greater adherence by authors and encouragement by publishers to comply,” he wrote in an e-mail.

The Journal of Bone and Joint Surgery, which disclosed the financial ties in seven of 10 articles in the study, said in a statement on Monday that it agreed on the need for improvement and planned to announce tighter policies next year.

“It is important to us that the readers of our research work are fully aware of the sources of support for this innovative research,” the journal editor, Dr. Vernon T. Tolo, director of the orthopedic center at Children’s Hospital Los Angeles, wrote.

The study was based on disclosures by five medical device companies, mostly forced by government investigations. The companies paid about $250 million to consultants in 2007, including royalties, the study says. Zimmer paid $87 million; DePuy Orthopaedics, $63 million; Stryker, $45 million; Biomet, $27 million; and Smith & Nephew, $24 million.

Of that total, $114 million went to 41 doctors, the study said, of whom 32 wrote or were co-authors on orthopedic journal articles the next year. The study focused on a representative sample of 95 of those articles. It said 51 of them, or 54 percent, did not mention the financial relationship with a company. It showed that 25 of the 32 authors did not disclose some or all of the time.

The study does not identify individual doctors or their journal articles. Professor Rothman said he did not know how often the journals required disclosures in 2008, but he said the lack of results showed “a broken system” regardless of who was to blame.

Representatives from Stryker, Zimmer and DePuy had no immediate comment on Monday.

The research focused on doctors paid more than $1 million because that seemed a significant conflict-of-interest that should have been disclosed the next year, Professor Rothman said.

In a further criticism, he said none of the medical journals required authors to disclose exactly how much they had received, making it impossible to distinguish between payments ranging from $10,000 to $8.8 million.

“We’ve got accurate data out there,” he said. “Why aren’t we using it?”

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From Disclosure to Transparency

The Use of Company Payment Data

Susan Chimonas, PhD; Zachary Frosch, BA; David J. Rothman, PhD

Arch Intern Med. Published online September 13, 2010. doi:10.1001/archinternmed.2010.341

Background It has become standard practice in medical journals to require authors to disclose their relationships with industry. However, these requirements vary among journals and often lack specificity. As a result, disclosures may not consistently reveal author-industry ties.

Methods We examined the 2007 physician payment information from 5 orthopedic device companies to evaluate the current journal disclosure system. We compared company payment information for recipients of $1 million or more with disclosures in the recipients' journal articles. Payment data were obtained from Biomet, DePuy, Smith & Nephew, Stryker, and Zimmer. Disclosures were obtained in the acknowledgments section, conflict of interest statements, and financial disclosures of recipients' published articles. We also assessed variations in disclosure by authorship position, payment-article relatedness, and journal disclosure policies.

Results Of the 41 individuals who received $1 million or more in 2007, 32 had published articles relating to orthopedics between January 1, 2008, and January 15, 2009. Disclosures of company payments varied considerably. Prominent authorship position and article-payment relatedness were associated with greater disclosure, although nondisclosure rates remained high (46% among first-, sole-, and senior-authored articles and 50% among articles directly or indirectly related to payments). The accuracy of disclosures did not vary with the strength of journals' disclosure policies.

Conclusions Current journal disclosure practices do not yield complete or consistent information regarding authors' industry ties. Medical journals, along with other medical institutions, should consider new strategies to facilitate accurate and complete transparency.


Author Affiliations: Center on Medicine as a Profession, College of Physicians and Surgeons, Columbia University, New York, New York.

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