Send a Tweet
Most Popular Choices
Share on Facebook 9 Share on Twitter Printer Friendly Page More Sharing
General News    H4'ed 3/3/10

Cold Case Files - Paxil Birth Defects

By       (Page 5 of 19 pages) Become a premium member to see this article and all articles as one long page. (View How Many People Read This)   No comments
Author 38068
Message Evelyn Pringle

Although Paxil was not approved in Japan until 2000, a couple years after it was approved in the US in 1992, Glaxo began looking into marketing the drug in Japan and meeting the requirements for approval by the Minister of Health and Welfare (MHW), the Japanese equivalent to the FDA.


"And the Japanese, they suspected, were not going to accept their dead rat pup studies," Tracey told the jury in his opening statement on September 15, 2009.


"And so GSK began discussions internally," he said. "Internally among themselves they said: What are we ... going to do if Japan makes us do the studies to find out why the rat pups died?"


While Healy was testifying, Tracey introduced a February 9, 1994 memo to Glaxo employee Charlie Fake, and copied to others, from Jenny Greenhorn titled, "Paroxetine Japanese reprotox requirements," and asked Healy to explain the meaning of "reprotox."


Any "agency in the world has a requirement from the pharmaceutical companies to look at the reproductive toxicities of a drug," Healy said. "This includes the impact of the drug on fertility, as well as the potential for the drug to cause birth defects."


The first sentence of the memo stated, "we have reviewed the three plans for meeting the Japanese reprotox requirements for their regulatory implications elsewhere, should a valid, significant positive i.e., adverse, result be obtained."


The next two sentences in the memo stated: "The conclusions reached within regulatory are summarized below."


"It should be noted that there is little or no regulatory information in this area, and we know of no precedents, neither have we consulted with experts outside of the company due to sensitivity of the issue," they wrote.


Next Page  1  |  2  |  3  |  4  |  5  |  6  |  7  |  8  |  9  |  10  |  11  |  12  |  13  |  14  |  15  |  16  |  17  |  18  |  19

 

Rate It | View Ratings

Evelyn Pringle Social Media Pages: Facebook page url on login Profile not filled in       Twitter page url on login Profile not filled in       Linkedin page url on login Profile not filled in       Instagram page url on login Profile not filled in

Evelyn Pringle is an investigative journalist and researcher focused on exposing corruption in government and corporate America.
Go To Commenting
The views expressed herein are the sole responsibility of the author and do not necessarily reflect those of this website or its editors.
Writers Guidelines
Contact AuthorContact Author Contact EditorContact Editor Author PageView Authors' Articles
Support OpEdNews

OpEdNews depends upon can't survive without your help.

If you value this article and the work of OpEdNews, please either Donate or Purchase a premium membership.

STAY IN THE KNOW
If you've enjoyed this, sign up for our daily or weekly newsletter to get lots of great progressive content.
Daily Weekly     OpEdNews Newsletter
Name
Email
   (Opens new browser window)
 

Most Popular Articles by this Author:     (View All Most Popular Articles by this Author)

Tracking the American Epidemic of Mental Illness - Part II

Tracking the American Epidemic of Mental Illness - Part I

The Rise and Fall of Provigil -" Part I

The Rise and Fall of Provigil - Part II

Psychiatric Drugging of Infants and Toddlers in the US - Part I

Tracking the American Epidemic of Mental Illness - Part III

To View Comments or Join the Conversation: