Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -26

Accepted - Volume 1

Comment Record
Commentor Dr. Richard Ranheim Date/Time 2002-05-28 21:56:59
Organization Dr. Richard Ranheim
Category Health Professional

Comments for FDA General
2. Is FDA's current position regarding direct-to-consumer and other advertisements consistent with empirical research on the effects of those advertisements, as well as with relevant legal authority? What are the positive and negative effects, if any, of industry's promotion of prescription drugs, biologics, and/or devices? Does the current regulatory approach and its implementation by industry lead to over-prescription of drugs? Do they increase physician visits or patient compliance with medication regimes? Do they cause patient visits that lead to treatment for under-diagnosed diseases? Does FDA's current approach and its implementation by industry lead to adequate treatment for under-diagnosed diseases? Do they lead to adequate patient understanding of the potential risks associated with use of drugs? Does FDA's current approach and its implementation by industry create any impediments to the ability of doctors to give optimal medical advice or prescribe optimal treatment? I am to be 67 on my next birthday and have been in the General Practice of Medicine since my graduation from Baylor in Houston in 1961. I have the usual arthritic pains of any male of my age. However, additionally I have what my Gatroenterologist named Telangiectasia of the duodenum - proven by gastroscopy. {The closest that I can come to his diagnosis in the ICD-9 code book is Angiodysplasia of the duodenum : 537.82}. In the past 10 years I have sustained two (2) GI bleeds which have carried my hemaglobin down to the 4s!! Needless to say, following my second bleed earlier this year, I have strict orders to avoid aspirin in its many forms and ALL NSAIDs. For a time, I was in quite a bit of discomfort. However, I have found a combination of glucosamine and Lyprinol has made me just as comfortable - or more comfortable - than when I took aspirin and/or NSAIDs in the past. Most importantly, this combination does not cause my GI system to bleed. I would implore you to relax your autority over the area of Alternate Medicine/s. I don't believe that the FDA - or any international body - has studied these medications enough to make any well informed decision. And, certainly, the large pharmaceutical corporations will not make such studies unless they can turn a profit.

EC -26