Docket Management
Docket: 00N-1256 - Over-the-Counter Products
Comment Number: EC -72

Accepted - Volume 6

Comment Record
Commentor Dr. Stefan Kertesz Date/Time 2000-06-29 02:12:08
Organization Boston University School of Medicine
Category Health Professional

Comments for FDA General
1. General Comments 6/28/2000 I am a practicing general internist, working with Boston Health Care for the Homeless Program, and on faculty at Boston University School of Medicine. I also have interests in deriving evidence-based guidelines for clinical care and the care of underserved populations. I had the opportunity to observe (on C-SPAN) a portion of the June 28, 2000 FDA public hearing on Over the Counter Drug Products, and I thought I would relay some portion of my thoughts to you in the hope that it might have some influence on the kind of questions asked during the hearings tomorrow, and on the kind of discussion that takes place over the next few months. I do not know who is scheduled to present tomorrow, but in addition to my own comments, I offer the suggestion that you incorporate feedback from leaders in the realm of evidence-based General Internal Medicine. ----new paragraph------ What I observed today was a portion of the presentation by staff members from the Consumer Health Care Products Association. They said nothing particularly irresponsible, but I was concerned that the type of discussion encouraged these types of presenters, couched largely in terms of responsible pharmaceutical marketing is likely to miss the types of larger public health and clinical concerns that should concern most doctors and most patients. -----new paragraph------ My concern is this: how do we ensure that the use of pharmaceutical agents largely serves the overall health of the patients who consume them and does not primarily result in misallocation of attention and resources? The representatives from CHCPA would argue that good labelling will largely achieve this goal, and I think their argument, particularly its focus on the protections afforded by good labelling, is ignorant of the current way that practicing evidence-based clinicians are learning to think about health care. I believe Dr. Temple hinted at this very issue when he questioned about the types of labelling that might be used for cholesterol-reducing agents. ----new paragraph----- To return to my basic question, I perceive threats to good health that fall into three categories, and proper OTC pharmaceutical labelling only addresses one category of concern, while current pharmaceutical marketing strategies actually are neutral or directly harmful in relation to the other areas of concern. ----new paragraph----- a)threat #1: Toxicity. Good, clear labelling will --partially-- offset this problem, and I believe the FDA and pharmaceutical industry are more likely to handle this issue well than the other issues that follow. However, I would underscore what I suspect you know well, that labelling offers minimal safety protection to patients who are not functionally literate at the 12th grade level, and minimal protection to patients who are unaware of underlying personal health factors predisposing to drug toxicity. In regard to the former, I can state from experience as a physician at a major public city hospital, that very few patients in my patient base (homeless and non-homeless alike) are readily able to digest the contents of currently available OTC labelling. In regard to the latter, I offer the simple example of hepatitis C. My last impression from the public health literature is that most people with hepatitis C do not know they have it, and medical guidelines regarding population screening for hepatitis C are themselves in evolution. Patients will be put at risk if they are targeted with advertising for statin-type drugs. Drug labelling along the lines of do not take this medicine if you have liver disease will not substantially reduce the risk incurred by these patients. ------new paragraph----- b)threat #2: OTC pharmaceutical use may delay diagnosis of important medical conditions: This risk, while acknowledged by one of the presenters from the Consumer Health Care Products Association, is rather complicated. I am not familiar with the specialized research members of the FDA panel may have seen, but I would be concerned that we truly lack the data necessary to document its dimensions. A simple example is the existing availability of over-the-counter vaginal clotrimazole. How many women have not had pap smears (and now face a higher risk of cervical cancer), or now live with undiagnosed chlamydia (and are now at longterm risk for infertility) because they did not present for medical attention when they had symptoms of vaginitis? I am unaware of data concerning this question, and yet it seems like an outcome that should be of interest to the FDA. An analagous issue will arise with hypercholesterolemia. I co-authored the evidence-based cholesterol guideline for Beth Israel Hospital in Boston, and we emphasized the importance of screening for secondary causes of hypercholesterolemia. Will patients be expected, based on an elaborate drug label, to determine if they should order a TSH to screen for primary, asymptomatic hypothyroidism? If the patient is a woman over 60, many board-certified internists would simply order a TSH. How carefully is that issue going to be elucidated by drug company marketeers? Similar concerns might be raised in relation to the OTC availability of H2-blockers. Patients obtaining OTC H2-blockers may be at risk for undiagnosed Barrett's esophagus and the attendant risk of esophageal adenocarcinoma, although I think we need data to document that concern. How well have we documented this concern, and should it make a difference in OTC drug availabilty? Evidence-based clinically-minded physicians need to ask these questions, because I don't believe the pharmaceutical industry actually understands these questions in their true complexity. Certainly nothing in the portion of presentation from CHCPA appeared cognizant of this issue. ----new paragraph----- c)threat #3: OTC pharmaceutical use for primary preventative care issues (including blood pressure and cholesterol) encourages market-driven misallocation of resources and attention, as opposed to evidence-based medical care. In contrast to primary symptom management, where I think a plausible argument for OTC use exists, primary preventative risk reduction for many patients could be jeopardized by OTC availability. It is in the explicit interest of the pharmaceutical industry to inculcate target audiences with concern regarding any primary preventative care issue for which a drug appears to offer a fix. But in the patient with multiple risk factors, or in a patient with minimal absolute risk, things could go quite badly. A smoking 35 year old may well be induced to spend money, time and attention on pharmaceutical cholesterol reduction, when no trial whatsoever exists to support either the efficacy or the safety of longterm pharmaceutical cholesterol reduction in this population. Any such patient wanting to talk with me (as their physician) about cholesterol reduction would first have a chance to prioritize cigarette cessation, versus cholesterol reduction, versus other issues that may actually represent higher immediate risk to that patient such as seatbelt safety, HIV risk, or perhaps diagnosis of hepatitis C. I worry that well-funded pharmaceutical marketing drives for a drug like pravastatin will inappropriately take primary risk reduction out of the clinical realm where it should be handled, with little ultimate health benefit to anyone. -----new paragraph----- If I could offer a few suggestions for your consideration, they would include the following: ----new paragraph---- a)Seek the input and advice of experts in evidence-based General Internal Medicine. Organizations such as the American College of Physicians and the Society of General Internal Medicine represent a repository of expertise concerning evidence-based medicine and primary preventative care. They have experts with better knowledge of the data relevant to the ongoing hearings. -----new paragraph---- b)Please push the kinds of questions outlined above in your discussions at the FDA hearings. ----new paragraph----- c)Find ways to ensure that proper data concerning health care outcomes are collected, no matter what decision is made as a result of the current hearings. I would caution that the kinds of general health outcomes related to OTC drug availability are not at all the same as typical drug company post-marketing reports concerning drug toxicity. The question of interest is the overall impact of OTC drug availability on the health and health care-seeking behavior of patients and defined populations, whether the outcomes are drug interactions, delayed diagnoses, or perhaps beneficial outcomes as patients attempt to take control of their primary preventative care with the guidance of drug company marketing efforts. With increasing concern from both the medical professions and the managed care payers to make sure that patient health care is evidence-based, I see no reason that we should exempt OTC pharmaceutical sales from questions of this nature. -----new paragraph------ Sincerely yours, Stefan Kertesz, MD Assistant Clinical Professor, Boston University School of Medicine and Boston Medical Center Staff Physician, Boston Health Care for the Homeless Program Diplomate, American Board of Internal Medicine, 1996 address: 54 Harvard Ave. #1, Brookline MA 02446 e-mail:

EC -72