From: Thomas Pretlow [tgpretlow@earthlink.net] Sent: Saturday, September 14, 2002 10:16 PM To: fdadockets@oc.fda.gov; gary@commercialalert.org Subject: adds for drugs & tobacco Dear Sir or Madam: I am writing to express my strong belief that our country has gone way beyond acceptable limits in permitting advertisements of tobacco and pharmaceuticals to the public. As a physician-patient, I have had a long-standing rule that I will not take a pharmaceutical until it has been widely marketed for at least ten years. As one who has witnessed many complications of drugs, I want drugs test-flown on a wide scale before I use them. While I do not take care of patients directly, I advise my friends that new drugs should be used only for very significant conditions that do not respond effectively to older drugs. I am continuously amazed at the side effects that are not observed and entered into the Physicians Desk Reference until long after the drug has been marketed widely. The public is not sufficiently sophisticated to interpret the adds that now appear routinely on TV, and patients should not be encouraging physicians to consider changing therapies because they, the patients, have been led to erroneous judgements based on TV adds. As one who has given a lecture entitled "The Pathology of Tobacco Users" every year since 1969 in the three different medical schools where I have taught, I cannot conceive how any decent politician, regardless of the inappropriately received political contributions, could permit the kinds of tobacco adds that are current. Corporations are not citizens or individuals. They should not be permitted to advertise misleading claims that inflict harm on a public many parts of which are not highly sophisticated in their understanding and relevant knowledge. This letter represents only my opinion as a citizen, not the opinion of my employer. I identify my employer only to make you aware that I have some knowledge of the effects of pharmaceuticals and tobacco. Thomas G. Pretlow, M.D. Professor of Pathology, Urology, Oncology, and Environmental Health Sciences Case Western Reserve University School of Medicine (telephone: 216-368-8700; e-mail: tgp3@po.cwru.edu)