Ann Tracy for Shirley Jarrott — (FDA Psychopharmacologic Drugs Advisory Hearings)

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Department Of Health And Human Services Public Health Service Food And Drug Administration

FDA Psychopharmacologic Drugs Advisory Hearings

Friday, September 20, 1991

DR. CASEY: Thank you. Shirley Jarrott?

MS. TRACY: Hello. I am speaking for Shirley Jarrott.  She had an emergency in her family and could not make it from Oregon. My name is Ann Tracy from Salt Lake  City, Utah.

DR. CASEY: Excuse me, please. Mr. Bernstein, do we have any record of the representation?

MR. BERNSTEIN: No, we do not.

DR. CASEY: Ma’am, do you know if Miss Jarrott contacted the agency?

MS. TRACY: As far as I know, she completed all the forms that she faxed to the agency.

Dr. Casey: Could you submit that to the agency after your presentation?

MS. TRACY : Certainly. I’m the Utah Director for the Prozac Survivors Support Group and have been in constant contact with Shirley and know of her case and the problems that she has had and, I am representing her, I that she has had in directly related to would like to discuss the severe problems her health in the use of Prozac which was severe liver damage.

The suicidal tendencies, of course, were there as well, but her concern is the damage to her liver that she has to live with constantly. This is something that I have been extremely concerned with. I’m alarmed at the high incidence of liver impairment that seems to be being reported to you, and the biggest reason I am concerned directly what regulates the amount of is because that is Prozac within the body.

If we have the Prozac rising to higher levels, of course, we’re going to have some very severe problems, and I think that that might be one reason why we’re seeing what we’re seeing. Prozac has directly affected my life. I was engaged last year to a young man who was on Prozac. He was put on Prozac in early 1989, prescribed for stress and some depression related to business failure. The personality changes came quickly.

I couldn’t even begin to describe the horror that happened to him for the next two-and-a-half years of his life. He looks back now, after being off three months – he would have come, but he’s too sick — after three months of being off, he looks back at the last two-and-a-half years and cannot remember much. He doesn’t know what was dream and what was real. There’s no detection there of reality.

I would like to encourage your committee to start looking at brain-wave patterns in the use of antidepressants. When you look at brain-wave patterns of somebody on Prozac I see a total anesthetic sleep state with eyes open. That, to me, is frightening. I think that is why so many families are describing their loved ones as being gone, just completely gone. They’re no longer there. There’s really no other way to describe someone that you’ve loved so much who’s changed so  much.

I believe that this is also one reason why the patients are unaware of what is happening to them and unaware of the effects, and that is why families tend to be the ones that notice the effects rather than the patients themselves.

Prozac works on the mood center of the brain to remove depression, but in doing so I believe that it also removes other feelings that are extremely vital to life. So   many people are saying that they cannot feel guilt, they have no conscience, they cannot love, they cannot feel empathy or compassion. To me, that’s alarming. To have individuals walking around that cannot feel guilt?  Of course, we would have more violent behavior.

Another thing that really alarms me in what I have seen with so many patients — and Utah has got some very severe problems with this particular drug, it’s very widely used – is the fact that so many people that tend to have a tendency toward alcoholism are reverting to alcoholism with the use of Prozac. I would like that investigated. I would like to know why people who have worked for years to overcome this particular addiction in their lives are reverting to this. Dr. Teicher noted that in one of his cases. To me,  that is really frightening.

I would like you please to take another look at Prozac. Consider all the shattered lives and shattered families that are out there and, believe me, they are everywhere. All you have to do is start asking. Thank you.