Congressman Calls on FDA to Investigate Prozac Documents ASAP

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atracyphd2

 

Fri, 7 Jan 2005 12:34:20 EST

 

 

[drugawareness] Congressman Calls on FDA to Investigate

Prozac Documents ASAP

 

Congressman Maurice Hinchey of New York has had the documents turned

over to

the British Medical Journal for about a week now. He has grave

concerns about

what he has found in these documents and has just sent a letter to the FDA

asking some very pointed questions.

 

Because he raises in this letter many of the same questions I have raised

over the years, I will leave his remarks for you to view below.

 

THANK YOU!!! To Congressman Hinchey for having the courage to stand

firm in

this situation. Ted Weiss of NY would have done the same had he had

the chance

before he died.

 

Ann Blake Tracy, Ph.D.,

Executive Director, International Coalition For Drug Awareness

Website: www.drugawareness.org

Author: Prozac: Panacea or Pandora? - Our Serotonin Nightmare

& audio tape on safe withdrawal: " Help! I Can't Get

Off My Antidepressant! "

 

Order Number: 800-280-0730

 

 

 

http://www.house.gov/apps/list/press/ny22_hinchey/morenews/010605fdaprozac.html

 

For Immediate Release

 

January 6, 2005

 

 

Hinchey Calls On FDA To Immediately Investigate Prozac Documents

 

Washington, D.C. - Deeply concerned over documents he was given by the

British Medical Journal (BMJ) indicating that Eli Lilly & Company has

long known of

a potential link between its anti-depressant medication, Prozac, and

increased

rates of suicide and violence, Congressman Maurice Hinchey (NY-22)

yesterday

called on the FDA to launch an immediate investigation. Hinchey said

that the

recent revelations raise serious concerns as to when Eli Lilly and the FDA

knew of these increased risks and why no action has been taken to

alert the

public.

 

Following, is the text of Hinchey's letter to FDA Acting Commissioner

Lester

Crawford:

 

January 5, 2005

 

Dr. Lester Crawford

Acting Commissioner

Food and Drug Administration

5600 Fishers Lane

Rockville, Maryland 20857

 

Dear Commissioner Crawford:

 

During the past week, there have been several news reports about Eli Lilly

and Co. documents, dating back to the mid-1980s, that discuss a

possible link

between Prozac and increased suicidality. The British Medical Journal

sent me

copies of these documents and it is my understanding that BMJ sent

copies to FDA

as well. There are conflicting reports as to whether all of these

documents,

and the information they contained, were previously available to FDA.

 

Before going further, it is important to note that the documents in

question

were uncovered during the discovery process of product liability

lawsuits like

those your former Chief Counsel, Daniel Troy, had sought to shut down.

Your

agency has been criticized lately for being too close to the drug

industry and

I have shared in that criticism. There is no better example of these

allegations than the actions of Mr. Troy, who filed unsolicited court

briefs on behalf

of pharmaceutical companies being sued by injured patients. This would

eviscerate the public's, as well as FDA's, ability to access

previously undisclosed

information that may be vital to the public interest. We are fortunate

that

this was not FDA's policy at the time of the Fentress trial and others.

 

In September, FDA " directed manufacturers of all antidepressant drugs to

revise the labeling for their products to include a boxed warning and

expanded

warning statements that alert health care providers to an increased

risk of

suicidality (suicidal thinking and behavior) in children and

adolescents being

treated with these agents, and to include additional information about

the results

of pediatric studies. " This decision, while welcomed by many, was long

delayed.

 

The documents I have received raise several critical questions about

what FDA

and Eli Lilly may have known about a potential relationship between Prozac

and increased suicidality thirteen or more years ago. They include

adverse event

reports that indicate Prozac may have had a far higher rate of suicide and

violent acts than those for four other commonly used antidepressants

in the

1980s and early 1990s. For example, according to one adverse event

report chart,

3.7 percent of fluoxetine (Prozac) reports, which totaled 14,198, were

suicide

attempts. This rate is nearly five times higher than that of

Amtriptuline,

which had the next highest suicide rate, as well as more than 12 and

18 times

the rates of Desipramine and Trazodone respectively. One Eli Lilly

document,

entitled " Activation and Sedation in Fluoxetine Clinical Trials "

describes how

fluoxetine (Prozac) had an activation rate (38 percent) twice that of

a placebo

(19 percent).

 

Given this information and the fact that increased activation has recently

been considered as a cause for increased suicidality, I call on you to

initiate

immediately an investigation into this matter to determine the following:

 

1. Did FDA have every single one of the Eli Lilly documents regarding

Prozac

that BMJ provided recently to your agency and was it aware of all the

issues

raised in those documents?

 

2. If yes, what was FDA's response to the information contained in

these Eli

Lilly documents, in particular the 38 percent activation rate I

referred to

earlier?

 

3. If no, why do you believe that Mr. Troy's attempts to shut down product

liability cases, which may bring to light undisclosed, yet critically

important

health information, to be in the best interests of FDA and the public

health?

 

4. Was FDA aware of the adverse event reports denoting significantly

higher

suicide and violent act rates for Prozac than those of other commonly used

antidepressants in the mid 1980s and early1990s?

 

5. If yes, what was FDA's response to this information?

 

6. Do these documents reveal any new information that requires a response

from FDA or Eli Lilly?

 

Thank you for your attention to these concerns. I look forward to

receiving

your prompt response.

 

 

Sincerely,

 

Maurice D. Hinchey