"But at least seven others have relationships that were not disclosed," it wrote. Among the most significant of the missing disclosures, the Journal said, are those of author, Lori Altshuler, director of the Mood Disorders Research Program at UCLA, who as it turns out is a speaker or consultant to at least five antidepressant makers.
"In total," the WSJ stated, "the authors failed to disclose more than 60 different financial relationships with drug companies."
"Dr. Cohen and some of his coauthors," the Journal wrote, "subsequently hit the lecture circuit, telling physicians about their findings while also spotlighting flaws in other recent studies that have found increased risks to babies born to mothers who use antidepressants."
The July 2006, FDA also advised of a second study published on February 9, 2006, in the New England Journal of Medicine, that focused on newborns with persistent pulmonary hypertension (PPHN), a serious and life-threatening lung condition.
According to the FDA, babies with PPHN have high pressure in their lung blood vessels and are not able to get enough oxygen into their bloods stream, and often need intensive medical care.
In the study, the FDA said, "PPHN was six times more common in babies whose mothers took an SSRI antidepressant after the 20th week of the pregnancy compared to babies whose mothers did not take an antidepressant."
Critics say the Cohen study was strategicly published in JAMA around the same time that the PPHN study appeared in the NEJM warning of the alarming breathing problem and that Dr Cohen and many of the other authors immediately set out to discount the findings of the PPHN study in lectures and seminars.
On July 19, 2006, the FDA also issued a new warning that said when SSRIs are taken together with triptans, drugs used to treat migraine headaches, a life-threatening condition called serotonin syndrome may occur.
According to the FDA, the condition causes serious changes in how the brain, muscles and digestive system work due to high levels of serotonin in the body.
In the Shore lawsuit, the complaint points out in language relevant here, that the defendants had a duty "to monitor epidemiological and pharmaco-vigilance data regarding their marketed drugs."
The lawsuit alleges that when the drug company defendants learned that there was a substantial risk of birth defects associated with Celexa, they had a duty to inform doctors, regulatory agencies, and the public whether they learned of the information through clinical trials, other outside sources, or pharmaco-vigilance activities.
According to experts, FDA regulations establish only "minimum safety standards" and they do not require that a company have proof of causality before a warning is added to a drug label. The regulations in fact, they say, mandate a warning whenever there is an "association" between a drug and a potentially lethal condition, pursuant to 21 C.F.R. ??201.57(e).
Experts predict that juries will view the failure to warn about the potential dangers of SSRIs to the unborn fetus as the most reprehensible. "This situation is even more devastating than what we saw with Vioxx," Mr Kwok says, "because the victims are so young."
"Their whole lives - if they survive," he states, "will be under threat of illness and additional surgery, with a very poor prognosis."
"The financial implications of a case like this," Mr Kwok says, "are huge for Forest Laboratories."
"They have convinced women to depend on Celexa the way a diabetic needs insulin," he states. "As a result, their profits have been huge."
"In total," the WSJ stated, "the authors failed to disclose more than 60 different financial relationships with drug companies."
"Dr. Cohen and some of his coauthors," the Journal wrote, "subsequently hit the lecture circuit, telling physicians about their findings while also spotlighting flaws in other recent studies that have found increased risks to babies born to mothers who use antidepressants."
The July 2006, FDA also advised of a second study published on February 9, 2006, in the New England Journal of Medicine, that focused on newborns with persistent pulmonary hypertension (PPHN), a serious and life-threatening lung condition.
In the study, the FDA said, "PPHN was six times more common in babies whose mothers took an SSRI antidepressant after the 20th week of the pregnancy compared to babies whose mothers did not take an antidepressant."
Critics say the Cohen study was strategicly published in JAMA around the same time that the PPHN study appeared in the NEJM warning of the alarming breathing problem and that Dr Cohen and many of the other authors immediately set out to discount the findings of the PPHN study in lectures and seminars.
On July 19, 2006, the FDA also issued a new warning that said when SSRIs are taken together with triptans, drugs used to treat migraine headaches, a life-threatening condition called serotonin syndrome may occur.
According to the FDA, the condition causes serious changes in how the brain, muscles and digestive system work due to high levels of serotonin in the body.
In the Shore lawsuit, the complaint points out in language relevant here, that the defendants had a duty "to monitor epidemiological and pharmaco-vigilance data regarding their marketed drugs."
The lawsuit alleges that when the drug company defendants learned that there was a substantial risk of birth defects associated with Celexa, they had a duty to inform doctors, regulatory agencies, and the public whether they learned of the information through clinical trials, other outside sources, or pharmaco-vigilance activities.
According to experts, FDA regulations establish only "minimum safety standards" and they do not require that a company have proof of causality before a warning is added to a drug label. The regulations in fact, they say, mandate a warning whenever there is an "association" between a drug and a potentially lethal condition, pursuant to 21 C.F.R. ??201.57(e).
Experts predict that juries will view the failure to warn about the potential dangers of SSRIs to the unborn fetus as the most reprehensible. "This situation is even more devastating than what we saw with Vioxx," Mr Kwok says, "because the victims are so young."
"Their whole lives - if they survive," he states, "will be under threat of illness and additional surgery, with a very poor prognosis."
"The financial implications of a case like this," Mr Kwok says, "are huge for Forest Laboratories."
"They have convinced women to depend on Celexa the way a diabetic needs insulin," he states. "As a result, their profits have been huge."
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