仮福真琴の精神科医はうそだらけトップへ統合失調症治療薬、ジプレキサ・・・

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mixiの中で『現代の精神医療』の問題点を取り上げた 市民の人権擁護の会サイクバスターさんの日記を、本人から許可を頂き転載しています。

統合失調症治療薬、ジプレキサ・・・2008年02月16日22:35
(mixiのサイクバスターさんの日記から転載)

2006/Dec/17 New York Times 誌より・・・
Eli Lilly Said to Play Down Risk of Top Pill

もう、一年以上前のことになってしまいますが、ジプレキサ・・・というイーライリリー社が製造している統合失調症治療薬に関して、ニューヨークタイムズ紙が報じたものです。紙面の冒頭部分をざっと要約すると・・・このように書かれています。

 イーライリリー社の内部文書と、重役たちの間でやりとりされた電子メールによれば、同社でもっとも売れいている製品である向精神病薬「ジプレキサ」の安全性について、過去10年間もみ消しを図ってきたことが判明した。ジプレキサは昨年42億ドル(約4,620億円)を売り上げたリリー社のトップ商品で、全世界で200万人もの人々が服用している。
 精神障害者の代理人を努めるアラスカ州の弁護士から提供されたこれらの文書は、糖尿病のリスクファクターである肥満や血糖上昇とジプレキサとの関係を、イーライリリー社の重役が医師たちに隠してきたことを示している。
 イーライリリー社は、ジプレキサの服用によってコントロールできない体重増加や糖尿病が起こりうるというデータを持っていたが、このことが売り上げに及ぼす影響を懸念し、同社のMRに対して、顧客である医師たちとの会話においてはこのことを控えめに伝えるよう指示していた。
 ジプレキサの服用した30%以上の患者に22ポンド(10kg)かそれ以上の体重増加がみられ、患者の中には100ポンド(45kg)を上回る体重増加に見舞われた例もあった。。。

(すみません、全文訳すことはできませんので、以降原文を掲載しておきます・・・)
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Eli Lilly Said to Play Down Risk of Top Pill

The drug maker Eli Lilly has engaged in a decade-long effort to play down the health risks of Zyprexa, its best-selling medication for schizophrenia, according to hundreds of internal Lilly documents and e-mail messages among top company managers.

Darron Cummings/Associated Press
Zyprexa is Lilly’s top-selling drug, with sales of $4.2 billion last year.

Joshua Borough for The New York Times
James B. Gottstein, a lawyer who represents the mentally ill, said the documents about Zyprexa’s side effects raised public health issues.
The documents, given to The Times by a lawyer representing mentally ill patients, show that Lilly executives kept important information from doctors about Zyprexa’s links to obesity and its tendency to raise blood sugar — both known risk factors for diabetes.

Lilly’s own published data, which it told its sales representatives to play down in conversations with doctors, has shown that 30 percent of patients taking Zyprexa gain 22 pounds or more after a year on the drug, and some patients have reported gaining 100 pounds or more. But Lilly was concerned that Zyprexa’s sales would be hurt if the company was more forthright about the fact that the drug might cause unmanageable weight gain or diabetes, according to the documents, which cover the period 1995 to 2004.

Zyprexa has become by far Lilly’s best-selling product, with sales of $4.2 billion last year, when about two million people worldwide took the drug.

Critics, including the American Diabetes Association, have argued that Zyprexa, introduced in 1996, is more likely to cause diabetes than other widely used schizophrenia drugs. Lilly has consistently denied such a link, and did so again on Friday in a written response to questions about the documents. The company defended Zyprexa’s safety, and said the documents had been taken out of context.

But as early as 1999, the documents show that Lilly worried that side effects from Zyprexa, whose chemical name is olanzapine, would hurt sales.

“Olanzapine-associated weight gain and possible hyperglycemia is a major threat to the long-term success of this critically important molecule,” Dr. Alan Breier wrote in a November 1999 e-mail message to two-dozen Lilly employees that announced the formation of an “executive steering committee for olanzapine-associated weight changes and hyperglycemia.” Hyperglycemia is high blood sugar.

At the time Dr. Breier, who is now Lilly’s chief medical officer, was the chief scientist on the Zyprexa program.

In 2000, a group of diabetes doctors that Lilly had retained to consider potential links between Zyprexa and diabetes warned the company that “unless we come clean on this, it could get much more serious than we might anticipate,” according to an e-mail message from one Lilly manager to another.

And in that year and 2001, the documents show, Lilly’s own marketing research found that psychiatrists were consistently saying that many more of their patients developed high blood sugar or diabetes while taking Zyprexa than other antipsychotic drugs.

The documents were collected as part of lawsuits on behalf of mentally ill patients against the company. Last year, Lilly agreed to pay $750 million to settle suits by 8,000 people who claimed they developed diabetes or other medical problems after taking Zyprexa. Thousands more suits against the company are pending.

On Friday, in its written response, Lilly said that it believed that Zyprexa remained an important treatment for patients with schizophrenia and bipolar disorder. The company said it had given the Food and Drug Administration all its data from clinical trials and reports of adverse events, as it is legally required to do. Lilly also said it shared data from literature reviews and large studies of Zyprexa’s real-world use.

“In summary, there is no scientific evidence establishing that Zyprexa causes diabetes,” the company said.

Lilly also said the documents should not have been made public because they might “cause unwarranted fear among patients that will cause them to stop taking their medication.”

As did similar documents disclosed by the drug maker Merck last year in response to lawsuits over its painkiller Vioxx, the Lilly documents offer an inside look at how a company marketed a drug while seeking to play down its side effects. Lilly, based in Indianapolis, is the sixth-largest American drug maker, with $14 billion in revenue last year.

The documents — which include e-mail, marketing material, sales projections and scientific reports — are replete with references to Zyprexa’s importance to Lilly’s future and the need to keep concerns about diabetes and obesity from hurting sales. But that effort became increasingly difficult as doctors saw Zyprexa’s side effects, the documents show.

In 2002, for example, Lilly rejected plans to give psychiatrists guidance about how to treat diabetes, worrying that doing so would tarnish Zyprexa’s reputation. “Although M.D.’s like objective, educational materials, having our reps provide some with diabetes would further build its association to Zyprexa,” a Lilly manager wrote in a March 2002 e-mail message.

But Lilly did expand its marketing to primary care physicians, who its internal studies showed were less aware of Zyprexa’s side effects. Lilly sales material encouraged representatives to promote Zyprexa as a “safe, gentle psychotropic” suitable for people with mild mental illness.
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さて、ことの本質はこうです。
製薬メーカーは重大な副作用が治験段階で発生し得ることを知りながら、それを公表してこなかった。そんな中で、この薬は42億ドルもの売上げをあげる薬となった。。。

で、問題は・・・ 体重増加に見舞われている患者を目の前にしながら、精神科医はそれを副作用とも認識せず、患者に投与し続けていたわけです。製薬会社によって副作用が隠蔽されていたとはいえ、目の前の患者の異変にさえ気がつかない医師に医師としての適正を感じません。

もはや製薬会社と精神科医は一蓮托生の関係にあるわけで、チェック機能など働くはずもありません。これが、今精神医療で起きていることの事実のほんの一部です。そして、この後、リリー社は多くの訴訟を抱えることとなるのです。

他の日記

精神医療の問題点(サイクバスターさんの日記から転載)

Amazon.co.jpアソシエイト:薬 副作用 精神

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:%E8%96%AC%E3%80%80%E5%89%AF%E4%BD%9C%E7%94%A8%E3%80%80%E7%B2%BE%E7%A5%9E :yakugai_  :3

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精神科セカンドオピニオン2―発達障害への気づきが診断と治療を変える (精神科セカンドオピニオン) は、セカンドオピニオンに相談に来た誤診誤治療のほとんどの人が発達障害だったという事例を、適正診断を目指す医療関係者の方々が執筆しています。

精神科セカンドオピニオン―正しい診断と処方を求めて は、誤診・誤治療・誤処方でひどい目にあった方たちの実録集です。精神科での誤診・誤治療は、一部ではなく大部分です。精神科に通っても症状が悪化している人は必見です。

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