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zoom RSS ジプレキサの副作用問題 14億ドル支払いで合意/米国医療事情

<<   作成日時 : 2009/01/17 02:31   >>

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画像 製薬会社イーライ・リリーは、向精神薬ジプレキサZyprexaを危険な副作用を受けやすい患者に認証外の使用のために販売したことで、14億ドルを支払うことで合意するという。企業内部告発による連邦訴訟の交渉途中であった。
 子どもや高齢者に対して危険性が高いのに連邦の認可なしに医師に処方を薦めて使用量が増加したことで告発された。法廷文書によれば、「介護時間と労力」を減らすため、手に負えない老人ホーム患者に鎮静目的でZyprexaを使うことを老人病専門医に勧めた。Zyprexaは、痴呆症に関連した精神疾患を持つ高齢患者で突然死、心不全、および肺炎のような命にかかわる感染のリスクを増大させる。小児では特に高度の体重増加と代謝異常を起こす傾向があるにもかかわらず小児科医や家庭医に治療を薦め、過去10年で小児への使用量は急増した。
 Zyprexaの使用者は多くは低所得層や障害者のため費用は政府支出によっている。2007年に48億ドルの販売額であり収益が186億ドルのリリーのドル箱である。薬価は1日25ドルになる。
 医師が適していると考えれば処方する自由があるので、今回の決定が医師の薬剤使用法に影響があるかどうかはわからない。しかし、FDAはZyprexaの使用を統合失調症と双極性障害の躁状態や興奮に対してのみ認可しており、製薬企業がFDA認可なしで販売促進はできない。
 2001年にTAP Pharmaceuticalがガン治療薬リュプロンの価格と販売に関連した罪で8億7500万ドルを支払った。こうしたケースは認証外の薬剤使用コストの一部を回復したに過ぎない。Zyprexaは、1996年承認以来世界で390億ドル以上を販売し最も売れた薬の1つである。その使用の半分は認可外使用、「オフラベル」使用であり、罰金の14億ドルはオフラベル販売の1年未満の額に過ぎない。2008年の最初の9ヶ月売上は35億ドルで前年より2%多い。
 Zyprexaは極めて進歩した新世代の向精神薬とされたが、長期的な最近の研究では、少量しか売れない古い薬より優れているわけでないという疑いも出ている。
 9月に出された政府の研究でも子どもに対して古い薬より効果的というわけではなく、重大な副作用が出ている。体重増加が著明なため安全監視委員会から中止命令が出た。
 2006年12月に、ニューヨーク・タイムズは、未認可の使用法で重度な肥満や糖尿病といった代謝異常をきたす傾向を軽視するためにどのように会社が策を練ったかを示すリリー社上層部による数百の内部文書やメールを暴露した。2000年の電子メールで糖尿病専門医がZyprexaと糖尿病の間の潜在的なリンクを「予想より重大になる可能性がある」と会社に警告したことが記されていた。この記事の後、ブラウン大学のDr. David Egilmanに対してリリー社から告訴を臭わせた脅しがなされ、2007年9月に、100,000ドルをリリー社に支払うことに合意したという。
 10月にリリー社は、Zyprexaと関連した消費者保護訴訟を解決するために6200万ドルを32の州とコロンビア特別区に支払うことに合意した。別個の訴訟を解決するために1500万ドルをアラスカ州に支払い、12億ドルを31,000人ののZyprexa原告に支払うことにも合意した。いくつかの私的なZyprexaへの訴訟は未解決のままである。
--------------------
非定型向精神薬による心臓死リスク
http://kurie.at.webry.info/200901/article_27.html
小児への向精神薬使用に批判/米国医療事情
http://kurie.at.webry.info/200811/article_40.html
新世代向精神薬の小児に対する副作用/米国医療事情
http://kurie.at.webry.info/200809/article_30.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
小児への向精神薬使用量の増加
http://kurie.at.webry.info/200805/article_9.html
小児の双極性障害(躁うつ病)の爆発的な増加/米国医療事情
http://kurie.at.webry.info/200709/article_8.html
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Lilly Said to Be Near $1.4 Billion U.S. Settlement on Drug
By GARDINER HARRIS
Published: January 14, 2009
http://www.nytimes.com/2009/01/15/business/15drug.html

Eli Lilly, the drug company, is expected to agree as soon as Thursday to pay $1.4 billion to settle criminal and civil charges that it illegally marketed its blockbuster antipsychotic drug Zyprexa for unauthorized use in patients particularly vulnerable to its risky side effects.

The amount of the settlement is a record sum for so-called corporate whistle-blower cases, which are federal lawsuits prompted by tips from company employees or former employees. Details of the agreement were provided by people involved in the negotiations.

Among the charges, Lilly has been accused of a scheme stretching for years to persuade doctors to prescribe Zyprexa to two categories of patients ― children and the elderly ― for whom the drug was not federally approved and in whom its use was especially risky.

In one marketing effort, the company urged geriatricians to use Zyprexa to sedate unruly nursing home patients so as to reduce “nursing time and effort,” according to court documents. Like other antipsychotics, Zyprexa increases the risks of sudden death, heart failure and life-threatening infections like pneumonia in elderly patients with dementia-related psychosis.

The company also pressed pediatricians and family practice doctors to treat disruptive children with Zyprexa, court documents show, even though the medicine’s tendency to cause severe weight gain and metabolic disorders is particularly pronounced in children. Over the last decade, Zyprexa’s use in children has soared.

The case is being prosecuted by the United States attorney’s office for the Eastern District of Pennsylvania. Patricia Hartman, a spokeswoman for the office, declined to comment.

Angela Sekson, a Lilly spokeswoman, said she could not comment on the status of the Zyprexa negotiations. Last fall, the company, anticipating a settlement, had set aside $1.4 billion for that purpose.

Lilly executives have for years insisted that the company’s Zyprexa marketing efforts were legal and appropriate. When asked whether she could repeat those assurances, Ms. Sekson said, “It would be inappropriate for me to comment further right now.”

It could not be confirmed on Wednesday whether the company would acknowledge wrongdoing as part of the settlement. Without a settlement, Lilly risks being barred from participating in the federal Medicaid and Medicare programs ― a huge part of its business ― even though such bans are almost unheard of for big drug makers because their products are considered so essential.

In the United States, most of Zyprexa’s sales are paid for by government programs because so many of those taking Zyprexa are indigent or disabled. Zyprexa had sales of $4.8 billion in 2007, making it the biggest seller by far for Lilly, whose revenue that year was $18.6 billion. Depending on dosage, the drug can cost as much as $25 for a daily pill.

The settlement may have little impact on how doctors actually use Zyprexa, because physicians are free to prescribe drugs as they see fit. But drug makers are barred from promoting drugs for uses not specifically approved by the Food and Drug Administration.

Zyprexa has F.D.A. approval only for the treatment of schizophrenia and the mania and agitation associated with bipolar disorder.

Just about every major drug company in recent years has pleaded guilty or is under investigation for urging doctors to use medicines beyond their approved uses. The Zyprexa case and others were brought by former drug company employees using a Civil War-era whistle-blower law to assert that the companies defrauded government health programs. The former employees usually share in the recovery.

The Zyprexa settlement would be the largest such recovery in history, surpassing the $900 million fine that Tenet Healthcare paid in 2006 to resolve whistle-blower assertions that it improperly billed Medicare. In 2001, TAP Pharmaceutical agreed to pay $875 million to resolve criminal and civil charges related to pricing and marketing of its cancer drug Lupron.

But while the fines in such cases involving drug makers have been substantial, they generally recover only a fraction of the costs associated with unapproved drug uses.

Zyprexa, for instance, has generated more than $39 billion in sales since its approval in 1996, making it one of the biggest-selling drugs in the world. As much as half of Zyprexa’s use is estimated to be for unapproved or “off label” use, the $1.4 billion fine ― punishment for years of illegal marketing efforts ― represent less than one year of off-label sales of the drug.

And despite mounting concern about Zyprexa’s risks and the negative publicity surrounding the legal case, sales were $3.5 billion for the first nine months of 2008, 2 percent higher than in the first nine months of 2007.

Zyprexa was initially received as a significant advance over an earlier generation of antipsychotics. But a series of landmark studies in recent years have cast doubt on that long-held view and suggested that Zyprexa was no better than older drugs that sell for far less.

A government study published in September, for instance, found that Zyprexa was no more effective in children than an older medicine but caused more serious side effects. The children receiving Zyprexa gained so much weight during the study that a safety monitoring panel ordered that they be taken off the drug.

In December 2006, The New York Times published articles detailing hundreds of internal Lilly documents and e-mail messages among top company managers that showed how the company sought for years to play down Zyprexa’s tendency to cause severe weight gain and metabolic disorders, including diabetes, while promoting unapproved uses.

One 2000 e-mail message, for instance, described how a group of diabetes doctors that Lilly had retained to consider potential links between Zyprexa and diabetes had warned the company that “unless we come clean on this, it could get much more serious than we might anticipate.”

Eli Lilly, the drug company, is expected to agree as soon as Thursday to pay $1.4 billion to settle criminal and civil charges that it illegally marketed its blockbuster antipsychotic drug Zyprexa for unauthorized use in patients particularly vulnerable to its risky side effects.

Details of the agreement were provided by people involved in the negotiations.

Among the charges, Lilly has been accused of a scheme stretching for years to persuade doctors to prescribe Zyprexa to two categories of patients ― children and the elderly ― for whom the drug was not federally approved and in whom its use was especially risky.

In one marketing effort, the company urged geriatricians to use Zyprexa to sedate unruly nursing home patients so as to reduce “nursing time and effort,” according to court documents. Like other antipsychotic drugs, Zyprexa increases the risks of sudden death, heart failure and life-threatening infections like pneumonia in elderly patients with dementia-related psychosis.

The company also pressed doctors to treat disruptive children with Zyprexa, court documents show, even though the medicine’s tendency to cause severe weight gain and metabolic disorders is particularly pronounced in children. Over the last decade, Zyprexa’s use in children has soared.

The case is being prosecuted by the United States attorney’s office for the Eastern District of Pennsylvania. Patricia Hartman, a spokeswoman for the office, declined to comment.

Angela Sekson, a Lilly spokeswoman, said she could not comment on the status of the Zyprexa negotiations. Last fall, the company, anticipating a settlement, had set aside $1.4 billion for that purpose.

The amount of the settlement is a record sum for so-called corporate whistle-blower cases, which are federal lawsuits prompted by tips from company employees or former employees. In this case, the whistle-blowers have not been publicly identified.

Lilly executives have for years insisted that the company’s Zyprexa marketing efforts were legal and appropriate. When asked whether she could repeat those assurances, Ms. Sekson said, “It would be inappropriate for me to comment further right now.”

It could not be confirmed on Wednesday whether the company would acknowledge wrongdoing as part of the settlement. Without a settlement, Lilly risks being barred from participating in the federal Medicaid and Medicare programs ― a huge part of its business ― even though such bans are almost unheard of for big drug makers because their products are considered so essential.

In the United States, most of Zyprexa’s sales are paid for by government programs because so many of those taking Zyprexa are indigent or disabled. Zyprexa had sales of $4.8 billion in 2007, making it the biggest seller by far for Lilly, whose revenue that year was $18.6 billion. Depending on dosage, the drug can cost as much as $25 for a daily pill.

The settlement may have little impact on how doctors actually use Zyprexa, because physicians are free to prescribe drugs as they see fit. But drug makers are barred from promoting drugs for uses not specifically approved by the Food and Drug Administration.

Zyprexa has F.D.A. approval only for the treatment of schizophrenia and the mania and agitation associated with bipolar disorder.

Zyprexa has generated more than $39 billion in sales since its approval in 1996, making it one of the biggest-selling drugs in the world.

And despite mounting concern about Zyprexa’s risks and the negative publicity surrounding the legal case, sales were $3.5 billion for the first nine months of 2008, 2 percent higher than in the first nine months of 2007. Prescriptions for the drug actually declined, but Lilly raised prices on the drug enough to increase its revenues.

Zyprexa was initially received as a significant advance over an earlier generation of antipsychotic drugs. But a series of landmark studies in recent years have cast doubt on that long-held view and suggested that Zyprexa is no better than older drugs that sell for far less.

A government study published in September, for instance, found that Zyprexa was no more effective in children than an older medicine but caused more serious side effects. The children receiving Zyprexa gained so much weight during the study that a safety monitoring panel ordered that they be taken off the drug.

In December 2006 articles in The New York Times detailed hundreds of internal Lilly documents and e-mail messages among top company managers that showed how the company sought for years to play down Zyprexa’s tendency to cause weight gain and metabolic disorders, including diabetes, while promoting unapproved uses.

One 2000 e-mail message, for instance, described how a group of diabetes doctors that Lilly had retained to consider potential links between Zyprexa and diabetes had warned the company that “unless we come clean on this, it could get much more serious than we might anticipate.”

After those articles were published, Lilly threatened to seek criminal contempt charges against Dr. David Egilman, a Massachusetts physician and associate clinical professor at Brown University, who made the documents available to The Times. In September 2007, Dr. Egilman agreed to pay Lilly $100,000 in return for the company’s agreement to drop the threat of criminal sanctions.

On Wednesday, Dr. Egilman said he felt vindicated by the imminent settlement. “I’m glad Lilly is acknowledging their wrongdoing,” he said. “Patients and doctors now know more about the side effects of the drugs they take.”

The government’s case will remain sealed until at least Thursday, when a judge is expected to approve the settlement. People involved in the negotiations say that prosecutors pressed for a resolution in the waning days of the Bush administration to avoid having to get another set of approvals from new bosses at the Justice Department in Washington.

While the settlement is intended to resolve all pending government claims, it is unclear whether all states, which are parties to the case through the federal-state Medicaid program, have agreed to the terms.

Some of the claims and evidence in the government’s case are similar to those made in a pending California state whistle-blower lawsuit in which Jaydeen Vicente, a former Lilly sales representative, described years of what she said were illegal Zyprexa marketing efforts.

Ms. Vicente and other Lilly sales representatives distributed a Lilly study contending that elderly patients who were prescribed the drug “required fewer skilled nursing staff hours than patients prescribed other competing medications” and reduced “caregiver distress,” the lawsuit states. Zyprexa often induces sleep in patients.

“In truth, this was Lilly’s thinly veiled marketing of Zyprexa as an effective chemical restraint for demanding, vulnerable and needy patients,” the lawsuit states.

In October, Lilly agreed to pay $62 million to 32 states and the District of Columbia to settle consumer protection claims related to Zyprexa. It has also paid the state of Alaska $15 million to settle a separate suit and agreed to pay $1.2 billion to 31,000 Zyprexa plaintiffs. Some private Zyprexa claims remain unresolved.

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ジプレキサの副作用問題 14億ドル支払いで合意/米国医療事情 医師の一分/BIGLOBEウェブリブログ
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