He said that the Clinical Efficacy Trials subsection of the drug labeling should not only describe the clinical trials that showed Celexa's adequate effects, but should also mention the "well controlled clinical studies that failed to do so."
"I believe it is useful for the prescriber, patient, and 3rd party payer to know," Dr Leber wrote, "without having to gain access to official FDA review documents, the citalopram's antidepressants effects were not detected in every controlled clinical trial intended to demonstrate those effects."
"I am aware," he said, "that clinical studies often fail to document the efficacy of effective drugs, but I doubt the public, or even the majority of medical community, are aware of this fact."
"Moreover," Dr Leber concluded, "I believe that labeling that selectively describes positive studies and excludes mention of negative ones can be viewed as being potentially "false and misleading."
Many studies have shown the various SSRIs to be ineffective. In April 2002, a study in the Journal of American Medical Association compared the effectiveness of the SSRI, Zoloft, the herb St. John's Wort, and a placebo and found the placebo treated patients had a 31.9% rate of remission of symptoms, while Zoloft's rate was only 24.8%, which barely beat out St. John's Wort rate of 23.9%.
In what should have served as the final nail in the coffin for the dishonest myth about the great success of SSRIs for treating depression, in June 2005, the Washington Post, citing a study primarily funded by the National Institute of Mental Health, that reported: "Despite a dramatic increase in treatment of psychiatric disorders during the past 10 years, there has been no decrease in the rate of suicidal thoughts and behavior among adults."
According to Attorney Kwok, "Women are prescribed psychotropic drugs at twice the rate of men."
"You'd think that would mean something like twice the science went into how these drugs affect women's health," he notes.
"But that isn't the case," he says, "because new moms are finding out too late that the Celexa they took was putting their unborn baby in grave danger."
Andrew Herxheimer, from the Cochrane Centre, is a clinical pharmacologist and the author of, "Communicating with Patients about Harms and Risks." He refers to Celexa as just another me-too drug. "I don't know what there is that makes it different from other SSRIs or special in any way," he states.
He notes that before a decision is made to prescribe a drug, its benefits and harms must be weighed, ideally by the clinician and the patient together, he says. And the clinician is expected to know or find out about the nature and probability of each benefit and harm, and how to maximize benefits and minimize harms.
According to Mr Herxheimer, three major areas that should be covered by doctors when helping patients decide whether to take a drug are: (1) obtaining reliable information about benefits and harms; (2) effectively communicating probabilities to the patient; and (3) determining what to do to reverse or mitigate harmful effects when they occur.
Too often he says, information on specific populations like pregnant women is not provided. "Because controlled trials compare treatments they usually report only group means and test their significance," he explains. "This gives clinicians no help in treating people who are more or less sensitive to the drug than average."
"Clinicians should identify how much the benefits matter to their patient," he advises, "and
whether a specific harm is particularly threatening or would be intolerable to that particular patient."
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