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.
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."
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.
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.