New York Times columnist, Nicholas Kristof, relates the story of Andrew Francesco, a boy who began taking Ritalin at age five and died from complications with Seroquel when he was fifteen. His father, a former pharmaceutical industry executive, reveals the industry’s greed in his memoir “Overmedicated and Undertreated.” Now the industry is pushing for a first-amendment right to market its drugs for off-label uses.
《紐約時報》專欄作家尼古拉斯·克里斯托夫(Nicholas Kristof)講述了安德魯·弗朗切斯科(Andrew Francesco)的故事。安德魯是一個從五歲開始服用利他林(Ritalin)的男孩,並於十五歲時因為使用思瑞康(Seroquel)引發的併發症去世。他的父親是一位前製藥行業高管,在他的回憶錄《過度用藥與治療不足》(”Overmedicated and Undertreated”)中揭露了這個行業的貪婪。現在,該行業正在推動第一修正案的權利,以便將其藥物用於非標籤用途進行市場推廣。

Andrew Francesco was a rambunctious, athletic and joyful child, but also a handful. When he was 5 years old, a psychiatrist prescribed Ritalin. As he grew older, he disrupted classes and was given a growing number of potent antipsychotic and other medications.

These didn’t work, so he was prescribed more. Pushed out of one school after another, Andrew grew frustrated, unhappy and sometimes alarming. His parents hid the kitchen knives. Then his mother died at 54; the family believes that the stress of raising Andrew was a factor.

When Andrew was 15, the medications caught up with him and he suffered a rare complication from one of them, Seroquel. One Friday he was well enough to go to school; on Sunday he was brain-dead.


《紐約時報》專欄作家尼古拉斯·克里斯托夫(Nicholas Kristof)講述了安德魯·弗朗切斯科(Andrew Francesco)的故事。安德魯是一個從五歲開始服用利他林(Ritalin)的男孩,並於十五歲時因為使用思瑞康(Seroquel)引發的併發症去世。他的父親是一位前製藥行業高管,在他的回憶錄《過度用藥與治療不足》(”Overmedicated and Undertreated”)中揭露了這個行業的貪婪。現在,該行業正在推動第一修正案的權利,以便將其藥物用於非標籤用途進行市場推廣。

安德魯·弗朗切斯科(Andrew Francesco)曾是個活潑、運動能力強且充滿快樂的孩子,但他也相當難以管教。5歲時,一名精神科醫生為他開了利他林(Ritalin)。隨著年齡的增長,他在課堂上搗亂,隨後被開了越來越多的強效抗精神病藥物和其他藥物。

這些藥物沒有起效,因此他又被開了更多的藥。安德魯被一所又一所學校退學,變得越來越沮喪、不快樂,有時甚至令人感到不安。他的父母不得不把廚房裡的刀具藏起來。後來,他的母親在54歲時去世,家人相信撫養安德魯的壓力是導致她早逝的一個因素。

當安德魯15歲時,這些藥物對他產生了影響,他因為其中一種藥物——思瑞康(Seroquel)而出現了罕見的併發症。某個星期五,他的身體狀況還足以去上學;但到了星期天,他已經腦死亡。

That’s the story that Steven Francesco, a longtime pharmaceutical industry executive and consultant, tells in “Overmedicated and Undertreated,” his harrowing memoir of raising Andrew, his son. He makes clear that the larger problem — even from his view as an industry insider — is a sector that sometimes puts profits above public well-being.
這就是史蒂芬·弗朗切斯科(Steven Francesco)在他的回憶錄《過度用藥與治療不足》(“Overmedicated and Undertreated”)中講述的故事,他是一名長期在製藥行業擔任高管和顧問的人,記述了撫養他的兒子安德魯的艱難歷程。他在書中明確指出,即使從他作為行業內部人的角度來看,問題的根源在於這個行業有時將利潤置於公眾福祉之上。

Here’s the central issue: Children with emotional or mental disorders have become a gold mine for the drug industry. Psychiatric medicines for children account for billions of dollars in sales annually, and the market has boomed.
Between the mid-1990s and the late 2000s, prescriptions of antipsychotics for children rose about sevenfold.

And now the industry is getting even greedier. It is pushing for a First Amendment right to market its drugs for off-label uses, a path that would leave children like Andrew with mental health issues particularly vulnerable. You may think of free speech as a citizen’s right to dissent; pharmaceutical executives see it as a tool to market drugs for unapproved uses.

Two courts have ruled for the drug companies. That’s the triumph of an ideology that sees corporations as virtuous players endowed with individual freedoms, and regulators as untrustworthy Luddites.

這裡的核心問題是:患有情緒或心理障礙的兒童已經成為製藥行業的金礦。兒童用精神科藥物每年創造了數十億美元的銷售額,這一市場蓬勃發展。

從1990年代中期到2000年代後期,兒童抗精神病藥物的處方量增加了大約七倍。

如今,這個行業變得更加貪婪。它正在推動其藥物的“第一修正案”權利,即將藥物用於未經批准的用途進行市場推廣,這條道路將使像安德魯這樣有心理健康問題的兒童特別容易受到傷害。你可能認為言論自由是公民反對意見的權利,而製藥公司的高管則將其視為推銷未經批准用途藥物的工具。

兩家法院已經對製藥公司作出了有利判決。這是將公司視為擁有個人自由權利的美德角色,並將監管者視為不可信的反技術派的意識形態的勝利。

“The recent court decisions could erode the F.D.A. approval process — put in place to protect the public — and threaten public health and patient safety,” warns Dr. Margaret Hamburg, until recently the Food and Drug Administration’s commissioner.

Experts on mental health fear that these rulings could lead to “terrible trouble by confounding science with marketing,” says Dr. Steven E. Hyman, a Harvard expert on psychiatry and former director of the National Institute of Mental Health.

Already, 80 percent of the psychiatric medicine administered to children is “off label,” Francesco estimates, meaning that the F.D.A. hasn’t approved its use for that purpose. Sometimes, off-label use makes sense, but it must be done with care, not just as a result of aggressive marketing by pharmaceutical companies simply aiming to boost quarterly profits.

“Children, because their brains are still developing, are not just small adults,” Hyman notes.

The pharmaceutical industry repeatedly has shown why “regulation” shouldn’t be a dirty word in American politics:

“最近的法院判決可能會削弱食品藥品監督管理局(F.D.A.)的批准程序——這一程序是為了保護公眾設立的——並威脅公共健康和病患安全,”直到最近仍擔任食品藥品監督管理局局長的瑪格麗特·漢堡(Dr. Margaret Hamburg)警告說。

哈佛大學精神病學專家、前國家精神衛生研究所所長史蒂文·E·海曼博士(Dr. Steven E. Hyman)表示,精神健康專家擔心這些裁決可能會導致“將科學與市場推廣混為一談,從而引發可怕的問題。”

弗朗切斯科(Francesco)估計,目前有80%的兒童精神藥物是“非標籤”使用,這意味著 F.D.A. 並未批准這些藥物用於該用途。有時,非標籤使用是合理的,但必須謹慎操作,而不是僅僅因製藥公司為提升季度利潤而進行的激進推廣。

“兒童的大腦仍在發育,因此他們不僅僅是縮小版的成年人,”海曼指出。

製藥行業一再表明為什麼“監管”不應該在美國政治中成為一個污名化的詞彙:

■ In the early 1960s, many countries allowed the “wonder drug” thalidomide to treat morning sickness in pregnant women. A heroic female doctor at the F.D.A., Frances Kelsey, resisted industry pressure to approve thalidomide in the United States, thus averting thousands of horrific birth defects like those it caused abroad.
■ 1960 年代初期,許多國家允許使用“神奇藥物”沙利度胺(thalidomide)來治療孕婦的妊娠反應。然而,當時在美國食品藥品監督管理局(F.D.A.)工作的女醫生弗朗西絲·凱爾西(Frances Kelsey)堅持抵制製藥業的壓力,拒絕批准沙利度胺在美國上市,從而避免了數千例像沙利度胺在其他國家所引發的可怕出生缺陷。

■ In the mid-1990s, pharmaceutical companies argued that doctors systematically under-treated pain, and as a solution the manufacturers aggressively marketed opioids. The companies’ behavior was sometimes criminal (executives of the company that made OxyContin pleaded guilty to criminal charges), but also hugely profitable. This helped lead to a crisis of addiction to prescription painkillers and heroin; today, drug overdoses kill more Americans than guns or cars do.
■ 1990 年代中期,製藥公司宣稱醫生系統性地低估了對疼痛的治療,作為解決方案,這些製藥商大力推廣鴉片類藥物。這些公司的行為有時是犯罪的(生產 OxyContin 的公司高管對刑事指控認罪),但同時也帶來了巨大的利潤。這種行為促成了處方止痛藥和海洛因成癮的危機;如今,藥物過量導致的死亡人數已超過了槍支和車禍導致的死亡人數。



■ In a recent column, I recounted how Johnson & Johnson deceptively marketed an antipsychotic medicine called Risperdal, concealing for example the fact that it can cause boys to grow large, pendulous breasts (one boy developed a 46DD bust). J&J got caught, pleaded guilty and paid more than $2 billion in penalties and settlements — but also registered $30 billion in Risperdal sales. The executive who oversaw this illegal marketing effort was Alex Gorsky, who then was promoted to chief executive of J&J. If you’re a pharmaceutical company, crime sometimes pays.

It’s true of course that pharmaceuticals are, literally, lifesavers; indeed, they may have saved my life from malaria. Steven Francesco says that while one drug killed Andrew, another seemed to help him, although he also says that animal therapy, in the form of a dog, seemed to help him more. Children’s mental health in particular is complicated, with difficult trade-offs, requiring oversight.

Think of cars: They, too, offer a huge benefit but still require careful regulation.

So if you agree with today’s politicians thundering against regulation, or if you think that pharmaceutical companies should enjoy a free speech right to peddle drugs, then talk to a family fighting opiate addiction. Or a parent of a thalidomide child. Or consult the grieving family of Andrew Francesco.

■ 在最近的一篇專欄中,我講述了強生公司(Johnson & Johnson)如何欺騙性地推銷一種名為 Risperdal 的抗精神病藥物,例如隱瞞了該藥物會導致男孩長出大而下垂的胸部這一事實(一個男孩發展出46DD的胸部)。強生被抓包,認罪,並支付了超過 20 億美元的罰款和和解金——但同時也從 Risperdal 的銷售中獲得了 300 億美元的收益。負責這次非法營銷活動的高管是亞歷克斯·戈爾斯基(Alex Gorsky),他後來被提拔為強生的首席執行官。如果你是一家製藥公司,犯罪有時是有利可圖的。

當然,製藥業的確是救命的;事實上,藥物可能救了我免於瘧疾的死亡。史蒂芬·弗朗切斯科(Steven Francesco)表示,雖然一種藥物殺死了安德魯,但另一種藥物似乎幫助了他,儘管他也指出,動物療法——例如一隻狗——似乎對他幫助更大。特別是兒童的心理健康問題十分複雜,存在艱難的取捨,需要謹慎的監管。

想想汽車:它們也提供了巨大的好處,但仍然需要謹慎的監管。

所以,如果你同意今天那些反對監管的政治家的言論,或者認為製藥公司應該享有自由言論的權利來推銷藥物,那麼請與一個與鴉片成癮鬥爭的家庭交談,或者與一位沙利度胺患兒的父母交談,或者向安德魯·弗朗切斯科的悲痛家屬詢問意見。

“Drugs, Greed and a Dead Boy”
《藥物、貪婪和一個死亡的男孩》

“Drugs, Greed and a Dead Boy” is an investigative article written by Alan Schwarz and published in The New York Times in February 2013.
《藥物、貪婪和一個死亡的男孩》是由艾倫·施瓦茲(Alan Schwarz)撰寫,並於 2013 年 2 月發表在《紐約時報》上的一篇調查報導。

The article tells the tragic story of Richard Fee, a 24-year-old college graduate who became addicted to ADHD medications like Adderall.
這篇文章講述了理查德·費伊(Richard Fee)的悲劇故事,他是一位 24 歲的大學畢業生,對 Adderall 等 ADHD 藥物產生了癮癖。

Despite not having a clear diagnosis of ADHD, Richard was able to obtain prescriptions for increasing doses of stimulant medications from various doctors.
儘管沒有明確的 ADHD 診斷,理查德仍能從多位醫生那裡獲得不斷增加劑量的興奮劑藥物處方。

His misuse of these medications led to severe mental health issues, including paranoia, hallucinations, and depression.
他對這些藥物的濫用導致了嚴重的精神健康問題,包括偏執、幻覺和抑鬱。

Tragically, Richard Fee took his own life in 2011.
不幸的是,理查德·費伊於 2011 年自殺身亡。

The article highlights the potential dangers of overprescribing stimulant medications, the ease with which individuals can obtain these drugs, and the lack of proper oversight in diagnosing ADHD.
這篇報導強調了過度處方興奮劑藥物的潛在危險、人們獲取這些藥物的容易程度,以及在診斷 ADHD 時缺乏適當的監管。

It also discusses the role of pharmaceutical companies in promoting these medications and questions the practices of some healthcare providers.
同時,文章還討論了製藥公司在推廣這些藥物中的作用,並對某些醫療提供者的做法提出了質疑。

By bangqu

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