Vanity Fair published an article for January, 2011, titled "Deadly Medicine" in which the reader will most definitely begin to question any FDA approved psychiatric medication. "The authors investigate the globalization of the pharmaceutical industry, and the U.S. Government's failure to rein in a lethal profit machine".1
Seroquel is an antipsychotic drug that carries FDA warnings such as abnormal dreams, dyskinesia, thinking abnormally, tardive dyskinesia, vertigo, involuntary movements, anorexia and hypothyroidism.
What is even more troubling about the FDA approval is that per the Vanity Fair report,
"To secure the F.D.A.’s approval for Seroquel, which ultimately would go to treat schizophrenia, bipolar disorders, and manic episodes associated with bipolar disorder, AstraZeneca, the fifth-largest pharmaceutical company, conducted clinical trials across Asia, Europe, and the United States. Among the sites: Shenyang and more than a dozen other cities in China, and multiple cities in Bulgaria, Estonia, Hungary, Latvia, Lithuania, Croatia, Indonesia, Malaysia, Poland, the Russian Federation, Serbia, Ukraine, and Taiwan."
This drug was originally approved for schizoprhenic patients, but off-label uses have become rampant.
The articles states, "Up to 70 percent of the prescriptions for Seroquel were written for a purpose other than the one for which it had been approved, and sales rose to more than $4 billion a year."
Reportedly, AstraZeneca was not completely open about the side effects of this drug. Many pediatric and adult patients have developed diabetes since its release on the market. This, then, prompts the use of another round of drugs used to treat the diabetes.
The article continues,
"In an internal e-mail from 1997 discussing a study comparing Seroquel with an older anti-psychotic drug, Haldol, a company executive praised the work of the project physician, saying she had done a great “smoke-and-mirrors job,” which “should minimize (and dare I venture to suggest) could put a positive spin (in terms of safety) on this cursed study.” After the e-mail was disclosed, in February 2009, the company said that the document cannot “obscure the fact that AstraZeneca acted responsibly and appropriately as it developed and marketed” the drug. In April, AstraZeneca reached a half-billion-dollar settlement with the federal government over its marketing of Seroquel. The U.S. attorney in Philadelphia, where the settlement was filed, declared that the company had “turned patients into guinea pigs in an unsupervised drug test.” Meanwhile, the company was facing more than 25,000 product-liability lawsuits filed by people who contended the drug had caused their diabetes."
The primary message in the Vanity Fair investigations is that the drug trials are occuring outside the U.S. and say that there are many U.S. medical investigators that perfer it that way because the regulations are much more lax.
"A study of 174 trials under the Pediatric Exclusivity Provision found that 9 percent of them did not report the location or number of sites of the clinical trials. Of those that did, two-thirds had been conducted in at least one country outside the United States, and 11 percent were conducted entirely outside the United States. Of the 79 trials with more than 100 subjects participating, 87 percent enrolled patients outside the United States. As is the case with adult studies, many children’s trials conducted abroad are neither reported nor catalogued on any publicly accessible government database. There is no public record of their existence or their results."
Consumers beware and ensure, minimally, that you do safeguard your basic human right of full informed consent. Take a look at the listed FDA warnings and side effects of all psychiatric prescriptions.