Psychiatric Drug Facts via :

“Most psychiatric drugs can cause withdrawal reactions, sometimes including life-threatening emotional and physical withdrawal problems… Withdrawal from psychiatric drugs should be done carefully under experienced clinical supervision.” Dr. Peter Breggin

Jan 27, 2012

"a reasonable expectation of safety"

Via Med Page Today:

FDA Supplement Guidance Not Strict Enough, MD Says 
By Emily P. Walker, Washington Correspondent, MedPage Today
Published: January 26, 2012

"An FDA proposal to require dietary supplement manufacturers to submit data proving their product is safe doesn't go far enough, according to a physician writing in the New England Journal of Medicine.

More than 100 million Americans spend more than $28 billion on vitamins, minerals, herbal ingredients, amino acids and other natural products in the form of dietary supplements each year, "assuming they are both safe and effective," wrote Pieter A. Cohen, MD, of Harvard Medical School and the Cambridge Health Alliance.

But they have no assurance that the products are safe because FDA regulation of supplements is too weak, Cohen wrote in a Perspective piece.

By law, ingredients that were used and sold in supplements prior to 1994 can be marketed without any proof that they are safe or effective. But under a law called the Dietary Supplement Health and Education Act (DSHEA), manufacturers of any ingredient introduced after 1994 must provide the FDA with evidence supporting "a reasonable expectation of safety."Cohen said that part of the law "has thus far not been enforced.""

This is the statement that set off my bs amplifier detector:
"Cohen also said that under the guidance, manufacturers would not be required to submit both favorable and unfavorable data to the FDA, so they could cherry-pick only positive data to submit." read here

The good Doctor, Pieter A. Cohen, MD, of Harvard Medical School and the Cambridge Health Alliance is concerned that people assume supplements are safe; which is definitely a valid concern. However, people also assume that FDA approved drugs are safe; and many are in fact approved on cherry picked data. Many drugs have been approved using biased research that is conducted unethically---some of this marketing research has been done at Harvard---Even worse, some drugs were approved based on falsified data; the FDA proclaimed the drugs 'safe,' without requiring that new drug trials be conducted.

I would hope that addressing the safety of FDA approved drugs, known to be fatal would be prioritized. I suspect that the regulatory focus is purposely being put on nutritional supplements, and labeling of food in an effort to divert the public's attention from the Adverse Events Reported for FDA-approved drugs...

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