Hello!

I am writing you as a Minnesota taxpayer, a mother of three and a pediatrician who is very concerned about the dangers of the  SSRI antidepressants, especially for children. 

 

As you are aware, an FDA advisory panel held a hearing on Monday, February 2nd.  The many parents and children affected by these drugs gave brave and important testimony and independent researchers made an excellent effort to get important research on the public record.  Although I am pleased that the FDA wants to issue stronger warnings about the these drugs, I am not pleased with the way this hearing was handled.  It does not inspire confidence from me as either a professional or a consumer about the integrity of the scientific drug approval process.

 

I submitted the following questions to the Oversight and Investigations Subcommittee of the House Energy and Commerce Committee this morning after hearing that Mr. Greenwood asked the drug companies for more data on this issue (see story pasted below):

 

1) Why does the FDA allow a regulatory structure that allows the drug companies to hide serious adverse effects like suicide for years, in this case since 1996?

See http://www.guardian.co.uk/uk_news/story/0,3604,1103563,00.html

 

 

2) Why did the FDA stack the panel with people that have financial ties to those very drug companies?

 

3) Why didn't the FDA allow a world expert like Dr. David Healy, the Welsh psychopharmacologist whose analysis of the data in Britain prompted their ban on these drugs for children, to testify at all at this hearing?

See http://www.boston.com/news/globe/ideas/articles/2004/02/01/talking_back_to_prozac/

 

4) Why were other independent experts with no ties to the pharmaceutical companies given only two minutes to testify, making it effectively impossible to present their data?

 

5) Why didn't they allow their own medical officer, Dr. Andrew Mosholder, to present at the hearing when he had data that showed these drugs do increase the risk of suicide? http://www.sfgate.com/cgi-bin/article.cgi?file=/c/a/2004/02/01/MNGB64MJSP1.DTL

 

6) Why does the ACNP, a group with extensive ties to the pharmaceutical companies, get to have access to the unpublished data about these drugs so that they can declare them safe and effective, but independent researchers do not?

http://www.washingtonpost.com/ac2/wp-dyn/A58130-2004Jan28?language=printer

 

7) Why did the FDA exclude other negative studies about these drugs from the briefing papers given the panel?

 

The drug companies need to made to answer for their behavior in not making this information public, but the FDA does as well for allowing this to occur.  Mr. Kennedy has made a great start by writing a letter to the FDA asking them to hear both sides of this issue.  I hope that Minnesota citizens can rely on you to make sure that these types of questions are answered.

 

Below are two links to news stories on KSTP, Channel 5, that highlight how Minnesotans have been affected by these drugs and why we need Congress to be involved:

http://www.kstp.com/article/view/126677/

http://www.kstp.com/article/view/126692/

 

Please contact me with any questions.  Thank you for your consideration.

 

Sincerely,

Karen R. Effrem, MD

 

Karen R. Effrem, MD

International Center for the Study of Psychiatry and Psychology Advisory Board 

National Physicians Center for Family Resources Executive Board

EdWatch Board of Directors

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