From: Bechtel, Christine
Sent: Wednesday, May 15, 2002 7:36 AM
To: Butler, Jennie C
Subject: FW: Regarding the May 22nd Hearing

These are comments for the docket of the Part 15 hearing on Risk Management, May 22, 2002.  
Docket # 02N-0115

-----Original Message-----
From: Donna77642@aol.com [mailto:Donna77642@aol.com]
Sent: Tuesday, May 14, 2002 10:55 PM
To: bechtelc@cder.fda.gov
Subject: Regarding the May 22nd Hearing


I cannot attend, but I would VERY much like someone to pass on the following questions/concerns:


#1
Why is it that if a manufacturer of a car provides you with a car that ends up having a defective part (e.g., tires, etc.), they send you a letter warning you and advising you what you need to do, but if a doctor prescribes you some medicine that is found to be unsafe and THEY are send the med-watch letter warning them, that the patient who has taken the medication is not advised.

I think it is outrageous that with all our technology that patients do not get the same courtesy and protection as car owners, etc.  Our lives are in their hands.  It is my belief that doctors should be required to enter RX prescribed into a database so that when a med-watch letter comes warning of a problem, then the database could be serached for patients it affects AND they should be required to advise the patient.

#2
Why do TV ads warn people of RX problems and only give the main name a drug is called...I had taken the Phen-Fen combination and did not realize it because I did not realize Ionamin, when taken in combination with Pondimin, created the Phen-Fen problem.  It would be a great help to people if people (law firms) "concerned" about our health (and the money they would make off the problems, excuse me but you know it's true) would PLEASE let the public know all the names of the RX in question.  I do not begrudge the lawyers making the money, they deserve it after going to battle for us, but IF our health is really the main issue, then please, PLEASE tell them to mention ALL the name in their hundreds of ads.  I have no doubt that hundreds of people are walking around with damaged heart valves that have no idea they took a dangerous combination of RX.

I am so grateful that I found out about sites on the internet that you could subscribe to in order to get this helpful information, but what about the poor people who cannot afford computers?  What about them?

If you could please pass on these concerns, I would deeply appreciate it.

God bless you.

Donna Guidry