Tag Archives: FDA

False peace of mind – Antidepressant Placebos

Beginning in 1998, a series of studies have repeatedly questioned the difference in efficacies between antidepressant drugs and placebos. Pioneering analysis work done by University of Connecticut researchers Irving Kirsch and Guy Sapirstein confirmed the effectiveness of antidepressants – but also their inert counterparts. In 38 studies conducted with over 3,000 depressed patients, placebos improved symptoms 75 per cent as much as legitimate medications.

“We wondered, what’s going on?” said Kirsch in a 2010 interview with Newsweek. The medical community, skeptical of his analysis, asked him to instigate a more comprehensive study with the results of all clinical trials conducted by antidepressant manufacturers, including those unpublished – 47 studies in total.

Over half of the studies showed no significant difference in the depression-alleviating effects of a medicated versus non-medicated pill. With this more thorough analysis, which now included strategically unpublished studies from pharmaceutical companies, placebos were shown to improve symptoms 82 per cent as much as the real pill.

FDA Issues Label Changes for Antipsychotic Drugs—Outlining risks for newborns whose mothers took drug

The U.S. Food and Drug Administration has notified health care providers that the Pregnancy section of drug labels for the entire class of antipsychotic drugs has been updated. The new drug labels include additional and consistent information regarding the potential risk for abnormal muscle movements (extrapyramidal signs [EPS]) and withdrawal symptoms among newborns whose mothers received the drugs in the third trimester of pregnancy.

After surviving war in Iraq, U.S. troops now being killed by Big Pharma

They survived live fire, explosive devices, terror attacks and grueling desert conditions. But upon returning home to seek treatment for the mental anguish that too often accompanies war, U.S. soldiers are now being killed by the pharmaceutical industry in record numbers.

A recent example is found with the late Senior Airman Anthony Mena, who returned home from Baghdad only to be killed by a toxic cocktail of prescription medications in his apartment in the USA. As the New York Times reports, a toxicologist found eight prescription medications in his blood

FDA Advisory Panel Recommends Electroshock Machine Too Risky For Reclassification to Less Dangerous Device

The Neurological Devices Advisory Panel of the U.S. Food and Drug Administration (F.D.A.), recommended Friday that devices used to deliver shock treatment, also known as electroconvulsive therapy (ECT) remain in the most high-risk category (Class III), reserved for the most dangerous medical devices and not be downgraded to a lower risk category. In so doing, it recommended that the companies which manufacture ECT devices be required to prove that ECT is both effective and safe in order to remain in use. ECT has long been known to cause serious harm to patients, including extremely severe and permanent memory loss, inability to learn and remember new events, depression, suicide, cardiovascular complications, prolonged and dangerous seizures and even death.