FDA Approves Antidepressants for Children After Bribery Reve

[Yammitor]

FDA Approves Antidepressants for Children, Even After Revelations of Bribery
Saturday, June 13, 2009 by: David Gutierrez
http://www.naturalnews.com/026444_antidepressants_the_FDA_corruption.html

The FDA has approved Forest Laboratories' antidepressant Lexapro (escitalopram) for use in children and adolescents, even as the federal government and 11 states have filed a lawsuit against the company for illegally pushing the drug on kids.

The federal government has accused Forest of bribing pediatricians to prescribe Lexapro and a related drug, Celexa (citalopram), to treat depression in children, even though such use had not been approved by the FDA at the time. The government also claims that Forest concealed the results of studies showing the drugs to be no more effective than a placebo.

"By knowingly and actively promoting these antidepressants for off-label pediatric use without disclosing the results of the negative pediatric study and by paying kickbacks, Forest caused false claims to be submitted to federal health care programs in violation of the False Claims Act," said the federal complaint, issued on Feb. 25.

Lexapro was introduced in 2001 as a successor to Forest's blockbuster Celexa, which lost patent protection and became available for generic replication in 2003. Both drugs are antidepressants in the selective serotonin reuptake inhibitor (SSRI) class, and like other SSRIs have been shown to significantly increase the risk of suicidal thoughts and behaviors in children, adolescents and young adults after even short-term use.

Lexapro is the 15th biggest selling drug in the United States.

On March 20, the FDA approved Lexapro for the treatment of major depressive disorder in children between the ages of 12 and 17, based on the findings of only one clinical study. Another study showed the drug to have no more effect than a placebo.

"A lot of these kinds of trials are not successful because it's very difficult to do depression studies," said Forest spokesman Frank Murdolo. "But we have two studies that were successful."

The second study referenced by Murdolo was conducted on Celexa, which the FDA declined to approve for use in children. A second Celexa study found no evidence that the drug was effective.

The FDA also approved Lexapro as a way to maintain control of depression symptoms, even though Forest admits there is no clinical evidence for that benefit in children. The FDA argued that it was possible to extrapolate the effectiveness of the drug from adult studies.

Lexapro is only the second antidepressant to receive US approval for use in children.

According to a federal complaint however, Forest has been marketing Lexapro and Celexa to children illegally for at least nine years.

In 1999, the FDA asked the company to conduct two independent clinical trials into Celexa's effectiveness in children, offering as incentive a six-month patent extension. Forest commissioned two studies -- one by the Danish company Lundbeck, which initially developed the drug, and another by U.S. researcher Karen Dineen Wagner. While the Wagner study found "a statistically ... significant reduction in depressive symptoms in children and adolescents" and "no serious adverse events" from the drug's use, the Lundbeck study found that Celexa provided no benefits over the placebo. In addition, out of a total participant population of 244 in the Lundbeck study, nine more Celexa patients attempted or considered suicide compared with those taking a placebo.

For the next three years, however, Forest widely publicized the Wagner study but did not disclose the results of the Lundbeck study.

[scorpio]

FDA – Now headed by a freckle-faced Jewess, Margaret A. Hamburg


She was sworn in as Commissioner on May 22, 2009, less than one month before it was announced that Forest Labratories' Principle product line, Lexapro would be approved for children, according to the article you site.  
Forest Labratories...They have been busy lately.

"On July 10, 2009, Forest Laboratories, Inc. entered into a Settlement Agreement with Lundbeck, Forest's licensor of the patent at issue, Sun Pharmaceuticals and Caraco Pharmaceutical, regarding pending patent infringement disputes regarding U.S. Patents, which were licensed by Forest from Lundbeck on an exclusive basis in the United States.  These patents are listed in the U.S. Food and Drug Administration's Orange Book for Forest's LEXAPRO® brand escitalopram oxalate tablet products."  This is an excerpt from their own SEC filing that you can find on their website... http://www.frx.com/

Between June 10 –July 14, there have been several SEC filings titled "Statement of Changes in Beneficial Ownership."  3 different  filing on 6/10, one on 6/11 and one on 6/17 and one on 7/14...
On June 10, 2009,  26,725 shares of common stock in Forest Labs were dumped by 3 high ranking officials:

Elaine Hockberg, SVP Marketing Dumped only 5185 shares for $23,435
Lawrence Olanoff, President & COO Dumped 9096 shares for $23,435
Howard Solomon,, Chairman & CEO Dumped 12,444 shares for $23,435

On June 11, 2009 George Cohan, Director Acquired 8,000 shares for $12,289,
Then on July 14, 2009, Solomon Dumps another 3560 shares for $0.00

What gives?  I am by no means an SEC filing analyst, nor am I an expert on trading common stock, but just from a general accounting standpoint, this looks fishy! Who else acquired the dumped shares besides the lowly paid director Cohan?
Just as a side note, I thought it might be of interest to see just how much these people make...

Elaine Hockberg: Total compensation for 2009 Is over $2.6 million, not including over &115 million in "unexercised options."

Howard Solomon: His total compensation for 2009 Is over $5.1. million, not including over &7 million in "unexercised options."

Lawrence Olanoff, His total compensation for 2009 Is over $4.1. million, not including over &8.3 million in "unexercised options."

There are other note worthy Jews on the board of this company.  This just scratches the surface of more corrupt insider trading and dealing!!  http://people.forbes.com/search