FDA Protects SSRI Makers With Misleading Suicide Warning - 3

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FDA Protects SSRI Makers With Misleading Suicide Warning - 3

Two recent studies conducted in the UK report that exercise in a green environment may be the best remedy for depression. In response to the high cost of drugs, the rise in prescriptions and the fact that 93 percent of GPs reported that "they have prescribed antidepressants against their better judgment owing to a lack of alternatives," the studies found that "participating in green exercise activities provides substantial benefits for health and wellbeing."

The "green activities" included gardening, walking, running and bicycling, particularly in a "green" environment.

Another of the world's leading experts on psychiatric drugs, Dr David Healy, author of, "The Creation of Pharmacology (Harvard 2002)," also a frequent visitor traveling from the UK to Washington to testify at FDA hearings, says, "The clinical trial data pointing to a risk was compelling 17 years ago."

"In between 1990 and now," he notes, "the FDA and drug companies have argued that their assessment of risk benefit ratios has not warranted issuing warnings."

"But if we look at the supposed benefits," he explains, "in milder depressions - the vast majority of people who get antidepressants - the FDA analysis in December 2006 showed that only 1 in 10 people who are given antidepressants in clinical trials respond to the drug."

"Four out of 10 respond to being seen and given sensible advice," he notes.

"Putting this 1 in 10 response rate against a 1 in 100 rate of suicidal acts might not seem a bad bet," Dr Healy says, "but suicidal acts are not the only risk of treatment - patients can become severely anxious, homicidal, are at increased risk of broken bones, strokes and bleeds into the gut and other organs, weight gain and its attendant risks."

He also notes that one in two patients on antidepressants experience sexual dysfunction and that it now seems that in a proportion of these people, the problem may be permanent.

"In the case of children," he says, "there are additional risks like failure to grow."

Another serious adverse event with SSRIs is a discontinuation syndrome. Psychiatrist Dr Grace Jackson, author of, "Rethinking Psychiatric Drugs: A Guide for Informed Consent," warns that some patients may not be able to return to living without the drugs, not because they develop a "craving," but because the withdrawal effects they experience during drug cessation are intolerable and are misinterpreted by doctors as "proof" of depressive relapse, for which "lifelong therapy" is mandated.

Over the past several years, many new adverse events related to SSRI use have emerged, including life-threatening birth defects in infants born to mother's taking SSRIs during pregnancy. But because SSRI makers have hidden negative studies for years, experts say patients and doctors were not informed of all the known risks associated with SSRIs.

"Informed consent cannot be obtained for antidepressants---or for any pharmaceutical---unless all of the drugs' risks are known to the prescribers," according to psychiatrist, Dr Stefan Kruszewski, Faculty, Eastern University, Department of Addictions.

"They cannot be known," he says, "if all of the data is not made available to review or made public - as was the case with Paxil."

According to Dr Healy, a bigger issue stems from company efforts to make billions of dollars out of these drugs by having them given to people who have little to gain from treatment and a lot to lose."

Dr Healy says most patients with milder depression would get well if seen by a sympathetic physician or therapist and describes three side effects that have resulted from the SSRI controversy:

(1) Physicians have lost confidence in their own ability to help patients without drugs.

(2) A great deal of the problem stems from the fact that close to all of the literature physicians now read is ghostwritten and the articles overemphasize the benefits of treatment and hide the risks.

(3) Antidepressants might be useful drugs, if primarily used for those with severe disorders, but at the moment the drugs probably pose a greater risk than the illness to the lives, careers and relationships of those to whom they are being given.

Clinical pharmacologist, Andrew Herxheimer, also says doctors should be advised not to prescribe drugs, especially SSRIs, to patients with only mild or moderate depression, and if prescribing is deemed necessary, to use the lowest dose that is effective for the individual.

According to Dr Levine, the SSRI makers are not as unhappy as some might think with the warnings and negative publicity. "Patents have run out or are soon to run on all their big sellers," he explains, "and they are preparing their next generation of worthless, dangerous but patented drugs to replace the SSRIs."

Ms Menzies reports that there is a big push to switch people over from taking antidepressants to antipsychotics under the guise that people aren't depressed after all, they actually have bipolar disorder. "It is a very cleverly orchestrated marketing scheme and it's a continuation of the manipulation of a vulnerable population," she says.

Vince Boehm, another persistent advocate for warnings on SSRIs agrees, "This is all about marketing, and not about safety."

"This latest ploy" regarding the expanded antidepressant warnings, Boehm explains, "is a delaying action on the part of the manufacturers with FDA complicity."

"The FDA just commissioned a series of three year studies to evaluate the adult suicide problem," he notes, "and by the time these studies are done and released, the bulk of the medications listed in this announcement will be either off or going off patent."

By Evelyn Pringle
evelyn.pringle@sbcglobal.net

www.a-paxil-lawyer-source.com/
www.antidepressantadversereactions.com/
www.paxilbirthdefect.com/

(Written as part of the Paxil Litigation Monthly Round-Up, Sponsored by Baum Hedlund's Pharmaceutical Antidepressant Litigation Department)

Evelyn Pringle is a columnist for OpEd News and investigative journalist focused on exposing corruption in government and corporate America.

FDA Protects SSRI Makers With Misleading Suicide Warning - 3

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