"A patient who is offered a treatment with serious implications," he says, "needs time and encouragement to think, and to talk to other people, before making a decision."
Mr Herxheimer also points out that reliable information about the potential dangers of drugs is hard to come by. "Companies do not want to do more work than regulators require, and once they have marketed a drug they hesitate to pay for more research," he says, "especially if the results might be inconvenient."
Critics say that even the studies that are published can not be trusted. On April 10, 2004, the British Medical Journal, citing Jurendi et al, criticized the authors of studies on SSRIs for exaggerating benefits and downplaying the harm the drugs caused. As one example, Jurendi pointed to a clinical trial of 93 children on Paxil which produced eleven serious adverse events in children taking the drug compared with only two in children in the placebo group.
Yet, despite this significant difference in adverse events, and the fact that seven of the Paxil children were admitted to the hospital, when the study was published the authors stated that Paxil "was generally well tolerated in this adolescent population, and most adverse effects were not serious."
Less than 3 months after the article appeared in the BMJ, Paxil maker, GlaxoSmithKline was charged with fraud by New York State Attorney General, Eliot Spitzer, for hiding studies that "not only failed to show any benefit for the drug in children but demonstrated that children taking Paxil were more likely to become suicidal than those taking a placebo."
According to Mr Spitzer, the company had in fact conducted at least 5 studies on the use of Paxil with children, but only published one, and even that study showed mixed results. In the end, Paxil paid more than $2 million to the state of New York to settle the charges and agreed to publish all clinical trials online.
That same summer, Forest Labs barely weaseled out of a similar fraud case. On June 29, 2004, the company received a request from Mr Spitzer asking in part, for information about how the company tested and promoted drugs like Celexa for off-label uses.
Because the FDA has not approved the use of SSRIs for pediatric depression, Forest was barred from promoting the drugs for such uses. However, doctors are allowed to prescribe the drugs off-label, and in 2004, Celexa happened to be the fourth most prescribed drug for children diagnosed with depression.
At the time, a representative of Mr. Spitzer's office, quoted in the June 30, 2004, New York Times, said Mr. Spitzer was particularly interested in how Forest tested and promoted Celexa and Lexapro for the off-label treatment of pediatric depression.
In another similarity to the Paxil case, Mr. Spitzer's investigation was announced a week after the Times reported that Forest did not tell a medical journal about a failed clinical trial of Celexa use in children when it published an article about a positive trial on Celexa with pediatric patients for which some of the article's authors were Forest employees.
The basic finding of the failed study was that Celexa showed no more effectiveness than a placebo when used to treat depression in pediatric patients.
On September 7, 2004, Mr. Spitzer announced that a settlement had been reached with Forest to resolve the inquiry into whether the company concealed information about the safety and effectiveness of Celexa and Lexapro. As part of the settlement, Forest agreed to post all studies on the drugs online, but somehow got away without having to pay any fines.
A month later in October 2004, the FDA finally ordered a black box label for all SSRIs, the strongest warning available, describing the increased risk of suicidal thoughts and behavior among children, and in July 2005, the agency issued a pubic health advisory that stated: "Several recent scientific publications suggest the possibility of an increased risk for suicidal behavior in adults who are being treated with antidepressant medication."
In 2000, Gwen Olsen, the author of "Confessions of an Rx Drug Pusher," walked away from the pharmaceutical industry, after spending 15 years selling drugs that she now admits are deadly. She states that there is "rampant economic incentive to over-prescribe drugs."
Ms Olsen left her job when her bosses wanted her to sell Celexa. In clinical studies, she says, the drug had been shown to increase the risk of suicidal thinking and behavior in children and adolescents who had depression.
She notes that other side effects of SSRIs are also more harmful to children because of their developing organs. "They are three times as likely to react to these drugs as an adult is," she says.
Mr Herxheimer also points out that reliable information about the potential dangers of drugs is hard to come by. "Companies do not want to do more work than regulators require, and once they have marketed a drug they hesitate to pay for more research," he says, "especially if the results might be inconvenient."
Critics say that even the studies that are published can not be trusted. On April 10, 2004, the British Medical Journal, citing Jurendi et al, criticized the authors of studies on SSRIs for exaggerating benefits and downplaying the harm the drugs caused. As one example, Jurendi pointed to a clinical trial of 93 children on Paxil which produced eleven serious adverse events in children taking the drug compared with only two in children in the placebo group.
Yet, despite this significant difference in adverse events, and the fact that seven of the Paxil children were admitted to the hospital, when the study was published the authors stated that Paxil "was generally well tolerated in this adolescent population, and most adverse effects were not serious."
According to Mr Spitzer, the company had in fact conducted at least 5 studies on the use of Paxil with children, but only published one, and even that study showed mixed results. In the end, Paxil paid more than $2 million to the state of New York to settle the charges and agreed to publish all clinical trials online.
That same summer, Forest Labs barely weaseled out of a similar fraud case. On June 29, 2004, the company received a request from Mr Spitzer asking in part, for information about how the company tested and promoted drugs like Celexa for off-label uses.
Because the FDA has not approved the use of SSRIs for pediatric depression, Forest was barred from promoting the drugs for such uses. However, doctors are allowed to prescribe the drugs off-label, and in 2004, Celexa happened to be the fourth most prescribed drug for children diagnosed with depression.
At the time, a representative of Mr. Spitzer's office, quoted in the June 30, 2004, New York Times, said Mr. Spitzer was particularly interested in how Forest tested and promoted Celexa and Lexapro for the off-label treatment of pediatric depression.
In another similarity to the Paxil case, Mr. Spitzer's investigation was announced a week after the Times reported that Forest did not tell a medical journal about a failed clinical trial of Celexa use in children when it published an article about a positive trial on Celexa with pediatric patients for which some of the article's authors were Forest employees.
The basic finding of the failed study was that Celexa showed no more effectiveness than a placebo when used to treat depression in pediatric patients.
On September 7, 2004, Mr. Spitzer announced that a settlement had been reached with Forest to resolve the inquiry into whether the company concealed information about the safety and effectiveness of Celexa and Lexapro. As part of the settlement, Forest agreed to post all studies on the drugs online, but somehow got away without having to pay any fines.
A month later in October 2004, the FDA finally ordered a black box label for all SSRIs, the strongest warning available, describing the increased risk of suicidal thoughts and behavior among children, and in July 2005, the agency issued a pubic health advisory that stated: "Several recent scientific publications suggest the possibility of an increased risk for suicidal behavior in adults who are being treated with antidepressant medication."
In 2000, Gwen Olsen, the author of "Confessions of an Rx Drug Pusher," walked away from the pharmaceutical industry, after spending 15 years selling drugs that she now admits are deadly. She states that there is "rampant economic incentive to over-prescribe drugs."
Ms Olsen left her job when her bosses wanted her to sell Celexa. In clinical studies, she says, the drug had been shown to increase the risk of suicidal thinking and behavior in children and adolescents who had depression.
She notes that other side effects of SSRIs are also more harmful to children because of their developing organs. "They are three times as likely to react to these drugs as an adult is," she says.
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