医師の一分

アクセスカウンタ

zoom RSS リベートを受け取る医師の取り締まり/米国医療事情

<<   作成日時 : 2009/03/05 20:01   >>

ブログ気持玉 0 / トラックバック 0 / コメント 0

 製薬・医療機器会社から医師への違法なリベートを防げなかった連邦当局と検察は、製品を使うためにお金を受け取る医師を調査している。
 長い間、陪審員が尊敬する医師に同情するだろうと考えて検察はめったに医師を追跡してこなかった。しかし、数月以内に、製品を使うことと交換に、高収益なコンサルティング協定を機器メーカーに要求したと言う多くの外科医に対する文民と犯罪の告発を申し立てることを役員は計画している。
 医師に対する動きは、医師を豊かにはしても医療費を増大させ、時に患者を危険に曝すような産業のマーケティング戦術を制限するための多様なキャンペーンの一部である。
 こうした方法で新たな手段により医学と産業の間の関係を変換するかもしれない。
 過去1年、検察と違法なマーケティング戦術で告発された製薬・医療機器メーカーとの協定の一部として収集された罰金の額はかなり増大した。
 1月にイーライ・リリーは、向精神薬Zyprexaを違法にマーケティングしたという連邦犯罪の罪を停止させるために14億ドルもの罰金を支払うつもりだと発表した。 2週間後、ファイザーは、Bextra(市場からリコールされた鎮痛剤)を違法にマーケティングしたという非難で予想される罰金を支払うために23億ドルを取っておいたことを発表した。
 検察は記録的な数の会社から記録的な罰金を徴収したが、更にこうした機会を拡張する必要があると認識している。企業のみを見る戦略では完全とは言えず、政府としても医師による犯罪の証拠を探している。
 収監と罰金のほかに、有罪宣告された医師のライセンスの一時停止や連邦のメディケア・メディケイドプログラムからの排除を受ける可能性がある。
 医学倫理学会の会長Dr. Charles D. Rosenは、全体としての医師の職業を汚す恐れが予測され、少数者の公益信託の悪用が多数に被害を及ぼすと言う。
 連邦当局は司法取引の一部として、コンサルタントや講師として働く医師への全ての支払いを公表するように製薬・医療機器メーカーにますます強制するようになってきている。メーカーは、医師を説得して、不適当で非公認の方法で薬剤処方や医療機器使用させるという違法な陰謀で繰り返しコンサルタント料を支払っているという。検察は、これらの協定の詳細の公開が、犯罪の指導を、より実施しづらく、より見分けやすくするであろうし、メーカーから医師がお金や贈り物を受け取ることに消極的になることを望んでいる。
 かなりの割合の医師がメーカーからお金を受け取っているので、public postings はかなり効果がある。
 ミネソタ州では、ユニークな支払い公開と贈り物制限法は、メディカルセンターの多くを医療産業のマーケティング習慣に厳しい制限を課す気にさせた。州で最大規模のPark Nicollet Health Servicesは、贈り物とほとんど全ての無料薬剤サンプルを禁止し、医師へのコンサルタント支払いを公開した。
 アイオワの共和党Grassley上院議議員らによる法案では全ての医療産業の医師への支払いの公開を義務づけている。法案が通過する前に公表を発表した会社は賞賛された。イーライ・リリー、ファイザー、メルク、セファロン、グラクソ、メドトロニックが公表を表明している。
 コンサルト料支払いの明細が公表されることで汚名を着せられたと思う医師がいる。ミネソタの研究者 Dr. Richard Grimm は、いつ降圧剤処方をするかについてガイドラインを作成する政府後援の高血圧症審査員を2回努めた。しかし、州の記録から、彼が1997年から2005年までの製薬会社から798,000ドル以上を得たと明らかにされたことで、そのような審査員を務める勧誘は全く来なくなったと言う。Dr. Grimmは「製薬会社から金を受け取れば、堕落しているにちがいないという自動的な仮定がある」と言う。
 検察は、新しい手段が、最終的に、製薬・医療機器会社が繰り返し法律を犯すことを防ぐだろうと期待している。1985年に関節炎治療薬オラフレクスと関連して、2006年には骨粗鬆症薬Evistaと関連して、1月にはZyprexaと関連して、違法なマーケティングの告発に対してイーライ・リリーは有罪を認めた。ファイザーは2004年に、違法に抗てんかん薬Neurontinをマーケティングしたことでの告発に対して有罪を認め4億3000万ドルの罰金を支払い、今はBextraのマーケティングで同様な告発に直面している。
----------------------------------------------------
Crackdown On Doctors Who Take Kickbacks
By GARDINER HARRIS
Published: March 3, 2009
http://www.nytimes.com/2009/03/04/health/policy/04doctors.html

WASHINGTON ― Federal health officials and prosecutors, frustrated that they have been unable to stop illegal kickbacks to doctors from drug and device companies, are investigating doctors who take money for using these products.

画像Darron Cummings/Associated Press
In January, Eli Lilly agreed to pay a $1.4 billion fine to settle federal criminal charges that it illegally marketed Zyprexa.

For years, prosecutors rarely pursued doctors because they believed that juries would sympathize with respected clinicians. But within a few months, officials plan to file civil and criminal charges against a number of surgeons who they say demanded profitable consulting agreements from device makers in exchange for using their products.

“What we need to do is make examples of a couple of doctors so that their colleagues see that this isn’t worth it,” said Lewis Morris, chief counsel to the inspector general of the Department of Health and Human Services. “We want to send the message to the physician community ― particularly surgeons ― that you can’t do this.”

The move against doctors is part of a diverse campaign to curb industry marketing tactics that enrich doctors but increase health care costs and sometimes endanger patients. Taken together, the new measures are likely to transform the relationship between medicine and industry.

Over the past year, for instance, prosecutors have greatly increased fines that are collected as part of plea agreements with drug and device companies charged with illegal marketing tactics. In January, Eli Lilly announced it would pay a record fine of $1.4 billion to settle federal criminal charges that it illegally marketed Zyprexa, an antipsychotic medicine. Two weeks later, Pfizer announced that it had set aside $2.3 billion to pay an expected fine over charges that it illegally marketed Bextra, a painkiller that has been withdrawn from the market.

Michael J. Sullivan, the United States attorney for Massachusetts, said that prosecutors ― after winning record fines from a record number of companies ― realized that they needed to expand the scope of their targets.

“The strategy of looking at the companies alone was not completely successful in terms of our objective to deter health care fraud,” Mr. Sullivan said. “So it’s fair to say that the government is looking at evidence of criminal wrongdoing even by doctors.”

Besides jail time and fines, doctors convicted in the cases could lose their licenses for a time and be excluded from the federal Medicare and Medicaid programs, severely limiting their potential pool of patients.

Dr. Charles D. Rosen, an orthopedic surgeon and president of the Association for Medical Ethics, predicted that the pending cases would tarnish the entire profession. “The abuse of the public trust by the few will hurt the many,” Dr. Rosen said.

Also, as part of plea bargains, federal health officials are forcing a growing number of drug and device makers to post publicly all payments made to doctors who serve as consultants or speakers. Manufacturers have repeatedly used consulting payments in illegal schemes to persuade doctors to prescribe drugs or devices in inappropriate and unapproved ways, according to federal charges.

Prosecutors are hoping that public disclosures of the details of these agreements will make criminal conduct more difficult to conduct and easier to spot, and that they will discourage doctors from taking money and gifts from manufacturers at all.

“The rules of the game have changed,” said Dr. David Rothman, president of the Institute on Medicine as a Profession at Columbia University. “You’ve got to presume that anything you take from a drug or device company is going to be on a Web site. Your colleagues will know; your patients will know. That’s going to stop a lot of doctors from pocketing their gifts and funds.”

Since a substantial share of doctors accept money from drug or device makers, the public postings could have considerable effects.

In Minnesota, the state’s unique payment disclosure and gift limit law has led a growing number of academic and private medical centers to impose severe restrictions on industry marketing practices. Park Nicollet Health Services, one of the largest health systems in the state, banned all industry gifts and nearly all free drug samples and has made public all doctor consulting payments.

The Department of Health and Human Services inspector general’s power to require payment disclosures extends only to companies charged with wrongdoing. A bill sponsored by Senator Charles E. Grassley, Republican of Iowa, and Senator Herb Kohl, Democrat of Wisconsin, would mandate that all drug and device makers disclose such payments.

Companies that have announced their intentions to disclose payments to doctors even before the legislation is passed have won plaudits from ethicists and industry critics.

“Being more transparent by opening up our business to the public is an important step to building trust and confidence,” John C. Lechleiter, the chief executive of Eli Lilly, said in a speech in September to the Economic Club of Indiana.

On Feb. 9, the chief executive of Pfizer, Jeffrey B. Kindler, said the disclosures were part of the company’s commitment to increased transparency and would “earn the trust of patients and the public.”

Neither executive mentioned that prosecutors would soon require them to make such disclosures anyway. In addition to Eli Lilly and Pfizer, companies that have agreed to disclose payments to doctors include Merck, Cephalon, GlaxoSmithKline and Medtronic. Some executives contend that the disclosures will increase public support for the payments.

“Through greater transparency about the nature of these relationships, we will help people better understand how important they are to developing life-saving and enhancing products for patients who need them,” Bill Hawkins, the chairman and chief executive of Medtronic, said Tuesday.

But doctors who have seen details of their consulting deals made public say they have been tarred.

Dr. Richard Grimm, a Minnesota researcher, twice served on government-sponsored hypertension panels that create guidelines about when to prescribe blood pressure pills. But when state records revealed that he had earned more than $798,000 from drug companies from 1997 to 2005, invitations to serve on such panels dried up, he said.

“There’s this automatic assumption that if you make money from a drug company, you must be corrupt,” Dr. Grimm said.

Prosecutors are hoping the new measures will finally stop drug and device companies from repeatedly breaking the law.

Eli Lilly, for instance, pleaded guilty to illegal marketing charges in 1985 related to its arthritis drug Oraflex, in 2006 related to its osteoporosis drug Evista, and in January related to Zyprexa. In 2004, Pfizer paid a $430 million fine and pleaded guilty to criminal charges that it illegally marketed the epilepsy drug Neurontin, and it now faces similar charges over its marketing of Bextra.

A common problem in illegal drug and device marketing cases is doctors’ willingness to delude themselves into thinking that cash, lucrative trips and other kickbacks do not affect them, said Mr. Morris, the chief counsel.

“Somehow physicians think they’re different from the rest of us,” Mr. Morris said. “But money works on them just like everybody else.”

Mr. Sullivan, the United States attorney, said officials hoped to send a strong message to doctors. “I have been shocked at what appears to be willful blindness by folks in the physician community to the criminal conduct that corrupts the patient-physician relationship,” he said

Duff Wilson contributed reporting.

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

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
リベートを受け取る医師の取り締まり/米国医療事情 医師の一分/BIGLOBEウェブリブログ
文字サイズ:       閉じる