医師の一分

アクセスカウンタ

zoom RSS 治療ガイドライン作成医師の利益相反

<<   作成日時 : 2011/03/29 23:45   >>

なるほど(納得、参考になった、ヘー) ブログ気持玉 2 / トラックバック 0 / コメント 0

 最近の循環器疾患の指針をまとめた委員会にのいくつかが私的な金銭的利害相反を持つ医師らが優勢であったという研究発表がされた。
 ガイドライン諮問委員会は、独立して科学的に評価を下し実際の臨床をどう実施するかを一般医師に推奨するための方針を作成する選ばれた専門科グループである。作成されたガイドラインは医療行為や医療製品の選択、保険適応、政府の政策、誤診などに影響する。
 発表された研究によれば、2003-2008年に策定された American Heart Association and American College of Cardiology 米国心臓病学会の17のガイドラインを作った498人のうち56%で利益相反が報告された。こうしたグループのリーダーについて言えば、その81%という高率にガイドラインに関係する企業と私的な利益関係があった。
 心臓病学会の前会長でクリーブランドクリニックの循環器科部長スティーブンE.ニッセン博士は、公開というよりこうした関係は禁止すべきであると言う。
 2010年に循環器専門医学会は利益相反の制限を厳しくしたという。委員会の座長やメンバーの過半数は利益相反に関連しないことを求めた。実際、44%は金銭的利益を受けていなかったとジェームズN.カークパトリック博士は言う。
 指針を出そうとするなら、クリーンであるべきである。驚くべきは、それがまだ実行されていないとコロンビア大のデイビッドJ.ロスマンは言う。心臓病専門医は、精神科医や整形外科医とともに、企業からの贈り物、謝礼金、コンサルティング、講演を引き受けることがまた良く知られているという。
 その報告は「信頼できる診療実施指針を開発するための基準」と呼ばれるこれまでで最も厳しい規制を提案した。
 しかし、全米科学アカデミーの健康部門はさらに厳しい規制を提案した。メンバーの家族に対する贈与や関連企業の広報活動への関与も禁止とした。

---------------------------------------------------
Study Finds Conflicts Among Panels’ Doctors
By DUFF WILSON
Published: March 28, 2011
http://www.nytimes.com/2011/03/29/health/29ethics.html

画像Doctors with private financial conflicts of interest dominated some of the panels that wrote guidelines on cardiovascular health in recent years, according to a medical journal study released on Monday.

The guideline panels are the select groups of experts who are assigned to evaluate science independently and issue their advice to other doctors on what to do in clinical practice. The guidelines influence medical care, product choice, insurance coverage, government policy and malpractice cases.

The study, published in the Archives of Internal Medicine, found that conflicts of interest were reported by 56 percent of 498 people who helped write 17 guidelines for the American Heart Association and American College of Cardiology, from 2003 through 2008.

Of people who led those groups, an even higher rate ― 81 percent ― had personal financial interests in companies affected by their guidelines, the study found.

In a related commentary in the journal, Dr. Steven E. Nissen, chairman of cardiovascular medicine at the Cleveland Clinic and a former president of the American College of Cardiology, called for banning most of those conflicts rather than just disclosing them.

In a joint statement on Monday, the cardiology and heart associations said that they had tightened their conflict-of-interest controls in 2010 to align with recommendations from the Council of Medical Specialty Societies. They now require that the people leading the group and a majority of members of any guideline-writing group be free of conflicts of interest.

Dr. James N. Kirkpatrick, the study’s senior author, said its most important finding may be that 44 percent of guideline writers actually had no financial interests in the area they reviewed. That rebuts the argument that there are not enough experienced experts who are independent, he said.

“The conflicts are quite prevalent, but they’re by no means ubiquitous,” Dr. Kirkpatrick, an assistant professor of medicine at the Hospital of the University of Pennsylvania, said in an interview about the research, which was led by Dr. Todd B. Mendelson, now in residency at the University of Pittsburgh.

David J. Rothman, a professor and president of the Institute on Medicine as a Profession at Columbia University, said the study shows an overdue need for change.

“The guy who’s calling balls and strikes should not be a shareholder in one of the teams,” Dr. Rothman said. “It’s so self-evident that if you’re going to be doing guidelines, it should be clean. What’s amazing is that it hasn’t been accomplished yet.”

Dr. Kirkpatrick said the study focused on cardiology because of its many guidelines and thorough disclosure requirements. Dr. Rothman, who was not involved in the study, said that it was also known that cardiologists, along with psychiatrists and orthopedic physicians, have been well-known for taking industry gifts, honoraria, consulting and speaking engagements.

The American Heart Association and American College of Cardiology statement also said their new policies were “almost perfectly aligned” with an Institute of Medicine report last week. That report proposed the strictest rules yet for what it called “standards for developing trustworthy clinical practice guidelines.”

But the institute, the health arm of the National Academy of Sciences, went further than the heart groups.

It not only proposed banning conflicts by chairmen and a majority of members, but it said panelists and their family members should divest themselves of financial investments and never participate in marketing activity or advisory boards for affected companies.

Dr. Ralph L. Sacco, president of the American Heart Association, said his group applauded the journal’s study and institute’s recommendations. But he said requiring divestiture could limit the number of experts available to work on guidelines.

“What becomes difficult is some of the experts out there who are well regarded in their field have often conducted research, and some research on devices and drugs is sponsored by companies,” Dr. Sacco, chairman of neurology at the University of Miami medical school, said in an interview Monday.

That includes himself. Dr. Sacco said he ended his own role in a pharmaceutical company’s research project when he became president-elect of the heart association, a move required by its top officers.

-----------------------------------------------------
Doctors' Conflicting Interests Can Cost Money and Lives, and Hinder Medical Discoveries
Are Doctors' Industry Ties Influencing Your Care?
http://abcnews.go.com/Health/medical-conflicts-interest-disaster-patients/story?id=13060973
by STEFAN P. KRUSZEWSKI, M.D.
March 28, 2011

In recent months, the print media have once again outed another group of physicians who benefit from undisclosed financial renumeration from pharmaceutical companies, accompanied by serious conflicts of interest. One headline from The New York Times News Service read "California Docs Paid to Promote Drugs," while other news outlets carried similar stories.

The fact that doctors take money from pharmaceutical companies happens to be old news. But this time around, the docs in question come from Stanford University. Previous news stories reported that doctors receiving pharmaceutical funding hailed from Harvard, the University of Miami, the Medical College of Georgia and the University of Cincinnati College of Medicine.

More than a few of these doctors are psychiatrists who have received tax-supported, public National Institutes of Health and National Institute of Mental Health funding for clinical research, have participated in U.S. Food and Drug Administation advisory panels or have appeared on, or on behalf of, various not-for-profit psychiatric advocacy boards -- some of which are heavily supported by the manufacturers of psychiatric medications.

In 2006, my colleagues and I wrote a brief letter to the editor to the Journal of the American Medical Association, one of America's premier peer-reviewed medical journals. Our letter expressed concern about the lack of honest disclosure of conflicts by certain psychiatric authors in a previously published article.

Multiple authors had recommended specific antidepressant therapy but failed to reveal that they were being paid by multiple antidepressant manufacturers to speak, advocate and do research for the companies that sold the drugs.

During the review process, an associate editor at the journal asked the question (and inadvertently copied me on an email that had been sent to another associate editor), "What's the big deal? What's all this [expletive deleted] about conflicts of interest?"

Academic journals, heavily supported by advertising money, are biased and complicit in the conflict of interest fiasco.

Sometimes I wonder why I -- or anyone else for that matter -- should care about psychiatrists who pimp for drug companies. After all, physician spokespeople and drug manufacturers are capitalists, and capitalism is our economic cornerstone. Every day, any financial news consumer hears the refrain invoking the social advantages of free market capitalism. It is the mantra of a major financial television network. And even though I'm a psychiatrist, I'm also a capitalist, so why should I worry?

But I do worry, because drug promotion and clinical decision-making that are brokered on the backs of dollar bills have a greater chance of causing serious adverse outcomes, including illnesses and death. If a physician embellishes the effectiveness of a drug or minimizes its risk, that directly hurts you and me.

Physicians who are heavily supported by pharmaceutical companies and medical device makers are not forming independent, unbiased decisions. Instead, their brains have been lined with gifts, perks and money, which influences their rose-colored opinions.

My psychiatric colleagues are especially vulnerable here. The result is that your mother, your husband or my child can't make a reliable decision about the risks and benefits of particular drugs. How could they? The prescribing doctors often don't know the risks and benefits, so how could we be expected to learn what they don't know?

Conflicts of interest promoted by pharmaceutical manufacturers negatively affect decisions about current and future medical care. That is tragic, because those half-baked recommendations come with a price that no amount of capitalism can justify. It's simple and ugly: If you or your mom suddenly succumbs to an arrhythmia whose side effects were not appreciated by your doctor because your doctor was misinformed by another doctor serving as the manufacturer's spokesperson, that is tragic.

I see it virtually every day in my clinical practice: in young men who have breast lesions and abnormal breast development from atypical antipsychotics; in sudden unexpected deaths, or "suds," from psychiatric drugs in individuals who had no risk factors for sudden death; in tic and dyskinetic movement disorders in kids arbitrarily prescribed stimulants, and the huge weight gain and symptoms of type 2 diabetes in children and young adults who receive a sedative, such as quetiapine, for sleep.

The bad news doesn't stop with current care. Conflicted clinical research -- often done especially by and for a particular psychiatric pharmaceutical manufacturer -- whose design and analysis are biased and whose summary and conclusions are misleadingly positive, fracture the backbone of scientific research.

The legacy of fraudulent research lingers for years before it is recognized and repudiated. That effort impedes real progress, wastes time, money and human resources that could be focused on finding real cures to help all of us. And that's not good for anybody.

Dr. Stefan Kruszewski is an addiction psychiatrist and CEO of Kruszewski & Associates, a Harrisburg, Pa., company that focuses on health care and financial fraud.


---------------------------------------------------
Conflicts of Interest in Cardiovascular Clinical Practice Guidelines

Todd B. Mendelson, MD, MBE; Michele Meltzer, MD, MBE; Eric G. Campbell, PhD; Arthur L. Caplan, PhD; James N. Kirkpatrick, MD

Arch Intern Med. 2011;171(6):577-584. doi:10.1001/archinternmed.2011.96

Background Clinical practice guidelines (CPGs) serve as standards of care in practice, quality improvement, and reimbursement. The extent of conflicts of interest (COIs) in cardiology guideline production has not been well studied. Herein, we describe the scope of COIs in CPGs.

Methods We examined the 17 most recent American College of Cardiology/American Heart Association guidelines through 2008. Using disclosure lists, we cataloged COIs for each participant as receiving a research grant, being on a speaker's bureau and/or receiving honoraria, owning stock, or being a consultant or member of an advisory board. We also cataloged the companies and institutions reported in each disclosure. "Episode" describes 1 instance of participation in 1 guideline by 1 person. "Individual" describes 1 person who may be involved in multiple episodes. "Company" describes a commercial or industry affiliation reported by an individual in a single episode. Analysis involved descriptive statistics and correlation analyses (Pearson correlation coefficient, {chi}2 and R2).

Results Fifty-six percent of the 498 individuals reported a COI, corresponding to 56% of the 651 episodes. Being a consultant or member of an advisory board was the most common type. The percentage of episodes involving a COI varied between guidelines (range, 13%-87%). The number of episodes per individual was associated with both presence and number of disclosures (P < .001 for both comparisons). Of 478 companies, the number per guideline ranged from 2 to 242 companies (mean, 38 companies). One company was the most frequently reported company in 7 of 17 guidelines.

Conclusion Conflicts of interest are prevalent in cardiology guidelines, but there seems to be a significant number of experienced experts without COIs.

テーマ

関連テーマ 一覧


月別リンク

ブログ気持玉

クリックして気持ちを伝えよう!
ログインしてクリックすれば、自分のブログへのリンクが付きます。
→ログインへ
気持玉数 : 2
なるほど(納得、参考になった、ヘー) なるほど(納得、参考になった、ヘー)

トラックバック(0件)

タイトル (本文) ブログ名/日時

トラックバック用URL help


自分のブログにトラックバック記事作成(会員用) help

タイトル
本 文

コメント(0件)

内 容 ニックネーム/日時

コメントする help

ニックネーム
本 文
治療ガイドライン作成医師の利益相反 医師の一分/BIGLOBEウェブリブログ
文字サイズ:       閉じる