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August 24 DC Protest Against the FDA- What's Everybody Mad About?

By       Message Evelyn Pringle     Permalink
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This conduct is not due to mistakes, it is representative of by now an all too familiar pattern of criminal behavior by top officials within the nation's top regulatory agencies and the pharmaceutical industry.

This year Eli Lilly, was made to pay nearly $700 million to settle charges that it did not warn consumers that the drug, Zyprexa, could cause diabetes, which resulted in grave injuries and death to 100s of people, but nobody was charged with a crime.

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Ellen Liversidge will be at the DC rally. She lost her son due to Lilly's crimes and she's none to happy about the fact that as part of the settlement, the plaintiff's attorneys agreed not let the public know about the extent of Lilly's wrongdoing.

In February, 2004, people may have become a bit angry when they read in the San Francisco Chronicle that top FDA officials had ordered one of its own researchers, who reviewed more than 20 trials, involving 4000 children, not to disclose his findings that confirmed that SSRIs increased the risk of suicide in kids.

Another protest supporter, Vera Hassner Sharav, president of the Alliance for Human Research Protection, explains how a Harvard review of children's charts, found that within 3 months of treatment on an SSRI antidepressants, 22% of the children suffered drug-induced adverse psychiatric effects, and overall, 74% suffered adverse events during the course of treatment.

"The FDA has known for years," she said, "but failed to reveal that antidepressants consistently fail to demonstrate a benefit in children. At least 12 of 15 trials failed."

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The FDA has also known that SSRIs increase the risk of suicide and hostility in children. As far back as 1996, an FDA review showed a "7-fold greater incidence of suicidality in children treated with Zoloft than adults," Vera reports. She has accused the FDA of "foot dragging, equivocating, and tinkering with definitions while children are dying."

Dr Donald Marks, MD, Ph D is a prescribing physician, a father, and a former associate director and director for clinical research for two multinational pharmaceutical companies. He says, "SSRI manufacturing and sales is serious business with tens of millions of patients in the U.S. and a market in the tens of billions of dollars."

He contends, "that any attempt to decrease sales by increasing warnings will be met with severe organized resistance."

According to Dr Marks, "SSRI manufacturers, such as Glaxo and Pfizer, have conducted clinical trials in depressed children, many of which show no efficacy against placebo."

"The seriousness and severe adverse event effects of SSRI drugs make their use hardly justified in the majority of cases," he added.

"My own prescribing experience with SSRI drugs," Dr Marks said, "has revealed significant agitation and aggression, akathisia, activation of mania and hypomania, increased depression, serious dependency and withdrawal difficulties, suicidal ideation, and toxic interactions with other drugs."

The symptoms of SSRI toxicity can also be mistaken for the progression of the underlying mental state, "leading to use of more of the same and other offending SSRI drugs rather than to withdrawal of the causative SSRI agent," he warns.

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While discussing the dangers of SSRIs, Rosie Carr Meysenburg, produced 3 handouts. The first was a personal letter from Dr Peter S Jensen, who at the time, was the head of Child & Adolescent Disorders Research Branch of the National Institute of Mental Health, which said that research indicates that antidepressants for adolescents are not very effective.

The second document was a personal letter from Dr Larry S Goldman, Director the American Medical Association, in which he wrote that physicians have known for many years the dangers of giving any antidepressants to patients with certain disorders and there is a substantial risk of precipitating mania or psychosis.

The third was an article from the Journal of Clinical Psychiatry researched at Yale University which stated that 11% of all psychiatric hospital admissions were from antidepressant-induced mania and psychosis. It also noted another area of research showing that Prozac and other SSRIs can simulate the effects of LSD.

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Evelyn Pringle is an investigative journalist focused on exposing corruption in government and corporate America.

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