Fornits
Treatment Abuse, Behavior Modification, Thought Reform => Facility Question and Answers => Psych Hospitals => Topic started by: Ursus on November 10, 2009, 04:47:17 PM
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This is an oldish piece, and hopelessly anemic, given that it's from the New York Times. It bears noting, however, how much earlier the rest of the world is waking up to the need for more careful consideration of prescribing decisions, when it comes to the use of this group of drugs in children...
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The New York Times
British Warning on Antidepressant Use for Youth (http://http://www.nytimes.com/2003/12/11/world/british-warning-on-antidepressant-use-for-youth.html?fta=y)
By ERICA GOODE; Heather Timmons contributed reporting from London for this article.
Published: December 11, 2003
(Correction Appended)
British drug regulators yesterday recommended against the use of all but one of a new generation of antidepressants in the treatment of depressed children under 18.
In a letter sent to doctors and other health professionals, the government regulators said a review of data on the safety and effectiveness of the drugs, known as S.S.R.I.'s, indicated that their benefits did not outweigh their potential risks.
Their effectiveness in treating depression in children, they said, has not been sufficiently demonstrated, and some drugs have been linked with suicidal thoughts and self-harm in children and adolescents. A summary of the findings was published on the Web site of the British Medicines and Healthcare Products Regulatory Agency (http://www.mhra.gov.uk (http://www.mhra.gov.uk)).
The agency, the equivalent of the Food and Drug Administration in the United States, said it was issuing a strong signal to doctors but was not barring the drugs completely because there were cases when their use might still be warranted.
The agency exempted Prozac, from Eli Lilly, but recommended against the use of six drugs: Paxil, from GlaxoSmithKline; Zoloft, from Pfizer; Effexor, from Wyeth; Celexa and Lexapro, from Forest Laboratories Inc., and Luvox, from Solvay.
The F.D.A. is investigating whether the data support a link between suicide and the S.S.R.I.'s -- selective serotonin reuptake inhibitors --in children and adolescents. On Feb. 2, an advisory committee for the agency will hold public hearings on the issue. But Dr. Russell Katz, director of the division of neuropharmacological drug products, said that for many reasons, finding whether such a link exists was no easy task. ''Our view at the moment is that the risk is not particularly well-understood or defined,'' Dr. Katz said. ''It is not at all a straightforward matter to figure this out.''
He said there was no indication that the British regulators had access to any studies beyond those already under review by the F.D.A.
In June, the American agency warned doctors that they should not prescribe Paxil for depressed children and adolescents until it had sorted out the issue. In October it issued a health advisory noting that doctors should use caution in prescribing S.S.R.I.'s to young patients and should closely monitor those taking the drugs.
Only a few of the drugs -- including Prozac, Paxil and Zoloft -- have been tested in large trials as a treatment for depression in young people.
One big problem for outside researchers, and for the public, is that the data that seems to show a link between the drugs and suicide is privately held by drug companies, though it has been provided to the government agencies.
Even for those who have the data, determining if a link exists is complicated, Dr. Katz and other experts said, because it is not always clear that the patients described as suicidal actually are. For example, experts say, some teenagers may cut or harm themselves but do not intend to commit suicide.
There are no reliable estimates of how many American children and teenagers are on antidepressants, but studies indicate the number has risen sharply over the past decade. Experts on the British agency's advisory committee estimated that 40,000 Britons under 18 were taking such drugs, with about half taking Prozac.
The British agency exempted Prozac, the regulators said, because studies have shown it to be effective for treating depression in children and adolescents.
Some experts said the British action was extreme.
''I think they're really overreacting,'' said Dr. Jeffrey A. Lieberman, a professor of psychiatry and pharmacology at the University of North Carolina. ''This is really going way too far, and in the process doing more harm than good.''
Dr. David Shaffer, a professor of psychiatry and pediatrics at Columbia University who sent a letter on the issue at Pfizer's request to the British drug agency, said he had concluded that there was insufficient data to restrict the use of the drugs in adolescents. ''The bottom line is that suicidal ideation and suicide attempts are very common in depressed kids,'' he said.
Dr. David Healy, of the University of Wales College of Medicine, who has been outspoken about the need for more unbiased testing of antidepressants, said the British agency had not addressed larger questions about the drugs.
''The issue isn't necessarily that these drugs should be banned for children,'' he said. ''The question is, 'What is the safest way they can be used?' ''
Other researchers said the British action was helpful in calling attention to the unanswered questions about the effectiveness and safety of antidepressants for children.
''Right now there is a large question of whether the standard of treatment for children diagnosed with depression'' should be the inhibitors, said Dr. Julie Magno Zito, associate professor of pharmacy and medicine at the University of Maryland.
Alison Langley, a spokeswoman for the British agency, said the recommendation was issued because the drugs ''don't work in the majority of cases for children under 18 with depressive illnesses.''
Although the regulators cautioned doctors that the S.S.R.I.'s should not be prescribed ''as new therapy,'' they added that if a child was already taking one of the drugs and doing well, ''the normal completion of the planned treatment course should be considered as an option in the management of the illness.''
They also said that the drugs might still be appropriate for some children -- those who cannot tolerate Prozac, for example -- and cautioned only that in such cases the medication should be prescribed and supervised by a specialist rather than by a general practitioner.
In addition, the regulators noted that their recommendation did not apply to the use of Luvox and Zoloft for children and adolescents who suffered from obsessive-compulsive disorder, citing research that demonstrated the effectiveness of the two drugs for the condition.
Children and adolescents who are currently taking the drugs, the regulators cautioned, should not stop taking them abruptly or change their treatment without medical supervision.
Correction: December 17, 2003, Wednesday A front-page article on Thursday about British regulators' warnings against prescribing certain antidepressants for children misstated the class of chemical compound to which one drug belonged. Effexor, made by Wyeth, is a selective serotonin and norepinephrine reuptake inhibitor, or S.N.R.I. (not a selective serotonin reuptake inhibitor, or S.S.R.I.).
Copyright 2010 The New York Times Company
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More recent news, from about a year ago:
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The New York Times
Drug Maker Is Accused of Fraud (http://http://www.nytimes.com/2009/02/26/business/26drug.html?fta=y)
By BARRY MEIER and BENEDICT CAREY
Published: February 25, 2009
The Justice Department charged the drug maker Forest Laboratories on Wednesday with defrauding the government of millions of dollars by illegally marketing the popular antidepressants Celexa and Lexapro for unapproved uses in children and teenagers.
In a civil complaint filed by the United States attorney's office in Boston, federal prosecutors alleged that former top executives at Forest concealed for several years a clinical study that showed that the drugs were not effective in children and might even pose risks to them, including causing some to become suicidal.
From 2001 to 2004, Forest heavily promoted results from another clinical trial it had financed that showed that the drugs were effective, without disclosing the negative study to those researchers, its own medical advisers or its sales representatives, the complaint said.
An official of Forest, which is based in Manhattan, said the company's lawyers were reviewing the complaint and did not have an immediate comment. Celexa and Lexapro are two versions of the same drug, citalopram. The drugs are currently approved by the Food and Drug Administration only for adults.
By failing to disclose the negative trial results, prosecutors said in the complaint, "Forest told prescribing physicians a half-truth and thereby prevented them and the public from having all potentially available information when making decisions about how to treat a serious medical condition in pediatric patients."
Doctors are free to prescribe drugs to patients, including children, for whom those drugs are not approved by federal regulators. But it is illegal for companies to actively promote such uses.
The filing follows a long-running federal investigation that began with complaints filed by two former company officials. Under the civil charges brought against Forest, the government is seeking to recover up to three times the amount of money spent by federal programs to pay for pediatric prescriptions of Celexa and Lexapro, but did not specify a figure.
Prosecutors also charged that Forest paid kickbacks, in the form of baseball tickets and gift certificates to expensive restaurants, to doctors who prescribed its drugs, and provided some doctors with paid vacations. The complaint also charges that the company separately ran so-called seeding studies, or trials that were really marketing efforts to promote the drugs' use by doctors.
Forest's stock fell in late afternoon trading, after news of the lawsuit began to circulate, ending down more than 5 percent, at $23.14.
Currently, drug makers are required to disclose the results of all their clinical trials. But the issues surrounding Forest's marketing of Celexa and Lexapro date to before those rules were in place.
Lexapro is Forest's biggest product, with total sales of $2.3 billion in 2008. Last year, the company submitted new clinical data to the F.D.A. seeking approval for the drug's use in the treatment of depression in adolescents.
According to court papers, Forest was aware of two studies started in the late 1990s to help win F.D.A. approval for the use of Celexa to treat depression in children.
One study was conducted by Dr. Karen D. Wagner, a child psychiatrist at the University of Texas Medical Branch at Galveston. The other study was conducted by H. Lundbeck, the Danish drug company that developed citalopram, Celexa's active ingredient.
In 2002, Forest submitted results from Dr. Wagner's study, which were positive, and those from the Lundbeck study, which were negative, to the F.D.A.
Based on the Lundbeck findings, regulators rejected pediatric approval for Celexa, finding that the report was "a clearly negative study that provides no support for the efficacy of citalopram" in children. The agency, however, did not disclose the study's results because Forest had submitted them confidentially.
But by 2001, several top Forest executives, including the company's current president, Dr. Lawrence Olanoff, were aware of Lundbeck's negative results, prosecutors stated. For the next three years, those executives did not disclose those results within the company or to outside researchers like Dr. Wagner, who worked closely with it, the complaint stated.
In 2002, as Celexa faced generic competition, Forest began to market Lexapro, another version of citalopram.
In court papers, prosecutors said that the existence of the Lundbeck study first came to public light when The New York Times published an article about it. Three days after that article was published in June 2004, Forest acknowledged the study as well as an another, earlier trial that also failed to show any benefits of Lexapro as a depression treatment for children.
Antidepressants approved for adults continue to be widely used by doctors to treat children. But those drugs, including Celexa and Lexapro, all now carry a prominent "black box" warning that the drugs could cause suicidal thinking or behavior in some children.
In an analysis last year, Dr. Erick H. Turner, a senior scholar at the Center for Ethics in Health Care at Oregon Health and Science University, found that most antidepressant makers had in the past failed to report negative findings, or tried to cast a positive light on their findings, to make their drugs appear more effective in adults.
Copyright 2009 The New York Times Company