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Volume 90 No. 2 February 2007 Volume 90 No. 2 February 2007 UNDER THE JOINT VOLUME 90 NO. 2 February 2007 EDITORIAL SPONSORSHIP OF: Medicine Health Brown Medical School Eli Y. Adashi, MD, Dean of Medicine HODE SLAND & Biological Science R I Rhode Island Department of Health PUBLICATION OF THE RHODE ISLAND MEDICAL SOCIETY David R. Gifford, MD, MPH, Director Quality Partners of Rhode Island COMMENTARIES Richard W. Besdine, MD, Chief Medical Officer 38 Ethical Guidelines and Guidelines On Ethics Are Not the Same Rhode Island Medical Society Joseph H. Friedman, MD Barry W. Wall, MD, President 39 Blessed Are the Pure of Heart EDITORIAL STAFF Stanley M. Aronson, MD Joseph H. Friedman, MD Editor-in-Chief Joan M. Retsinas, PhD CONTRIBUTIONS Managing Editor Stanley M. Aronson, MD, MPH 40 Spotlight on Claudication: An Important Disease Gets Attention Editor Emeritus Timothy P. Murphy, MD, Gregory Dubel, MD, James Bass, MD, Sun Ho Ahn, MD, Gregory M. Soares, MD, and Joselyn Cerezo, MD EDITORIAL BOARD Stanley M. Aronson, MD, MPH 43 Update on Idiopathic Pulmonary Fibrosis: The Role of Gamma Interferon Jay S. Buechner, PhD and Cytokines John J. Cronan, MD Napoleon A. Puente, MD, Jason M. Aliotta, MD, and Michael A. Passero, MD James P. Crowley, MD Edward R. Feller, MD 46 On Heachache Tablets: Headache Incantations From Ur III (2113–2038 BC) John P. Fulton, PhD Vlad Zayas, MD Peter A. Hollmann, MD Sharon L. Marable, MD, MPH 48 Disruptive Physician Behaviors Anthony E. Mega, MD Marguerite A. Neill, MD Robert S. Crausman, MD, MMS, Alberto Savoretti, MD, and Jeven Conroy Frank J. Schaberg, Jr., MD Lawrence W. Vernaglia, JD, MPH Newell E. Warde, PhD COLUMNS OFFICERS 50 THE CREATIVE CLINICIAN – Giant Cell Mycarditis Presenting As Isolated Right Barry W. Wall, MD Ventricular Dysfunction President Richard Regnante, MD, and Athena Poppas, MD, FACC K. Nicholas Tsiongas, MD, MPH President-Elect 55 GERIATRICS FOR THE PRACTICING PHYSICIAN – Managing the Medication Portfolio & Diane R. Siedlecki, MD Avoiding Polypharmacy in the Older Adult Vice President Ana C. Tuya, MD Margaret A. Sun, MD Secretary 57 HEALTH BY NUMBERS – Hospital Community Benefits, 2005 Mark S. Ridlen, MD Bruce Cryan, MBA, MS Treasurer Kathleen Fitzgerald, MD 59 PUBLIC HEALTH BRIEFING – Taking a Social Marketing Approach To Implementing Immediate Past President Clinical Best Practices: A Pilot Project DISTRICT & COUNTY PRESIDENTS Robert Marshall, PhD, Arthur Frazzano, MD, MMS, Deidre Gifford, MD, MPH, Geoffrey R. Hamilton, MD Marcia Petrillo, MA, Shannon Sansonetti, MA, and Jeffrey Stumpff, MA Bristol County Medical Society Herbert J. Brennan, DO 62 HEALTH INSURANCE UPDATE – National Provider Identifiers – Implications for the Kent County Medical Society Local Provider Community Rafael E. Padilla, MD Patricia E. Huschle, MS Pawtucket Medical Association Patrick J. Sweeney, MD, MPH, PhD 63 ADVANCES IN PHARMACOLOGY – Off-Label Drug Use Providence Medical Association Andrea G. Dooley, PharmD Nitin S. Damle, MD Washington County Medical Society 66 PHYSICIAN’S LEXICON – A Plethora of Pertinent Prefixes Jacques L. Bonnet-Eymard, MD Woonsocket District Medical Society Stanley M. Aronson, MD 66 Vital Statistics Cover: “Summer Love” 18"x18" Oil On Canvas by Bill Chisholm, a Rhode Island art- 68 February Heritage ist who recently received “2006 Best In Show For Fine Art” at Providence Fine Furnishings Show. He exhibits in galleries throughout New England. www.billchisholm.com; Medicine and Health/Rhode Island (USPS 464-820), a monthly publication, is owned and published by the Rhode Island Medical Society, 235 [email protected] Promenade St., Suite 500, Providence, RI 02908, Phone: (401) 331-3207. Single copies $5.00, individual subscriptions $50.00 per year, and $100 per year for institutional subscriptions. Published articles represent opinions of the authors and do not necessarily reflect the official policy of the Rhode Island Medical Society, unless clearly specified. Advertisements do not imply sponsorship or endorsement by the Rhode Island Medical Society. Periodicals postage paid at Providence, Rhode Island. ISSN 1086-5462. POSTMASTER: Send address changes to Medicine and Health/Rhode Island, 235 Promenade St., Suite 500, Providence, RI 02908. Classified Information: RI Medical Journal Marketing Department, P.O. Box 91055, Johnston, RI 02919, phone: (401) 383-4711, fax: (401) 383-4477, e-mail: [email protected]. Production/Layout Design: John Teehan, e-mail: [email protected]. 37 VOLUME 90 NO. 2 FEBRUARY 2007 patients with Parkinson’s disease if they had Commentaries a problem with a runny nose. If they did I then asked if it developed before, with or after the PD. If the patient was accompa- nied by anyone over the age of 50 I asked that person too if they had a runny nose. Ethical Guidelines and Guidelines To be “ethical” I prefaced my first question with the statement that I was doing a sur- On Ethics Are Not the Same vey, which was a research study to deter- mine if a runny nose was more common in PD than in people without PD. Of course I recently saw a patient who had abused I was annoyed but not dismayed. This I had a strong suspicion that this was the a drug which was not included on the usual came later. I became a site investigator for a case but it’s never been a published obser- toxicology “screen” sent from the emer- pharmaceutical company’s study of a vation, although an ENT colleague told gency departments (ED) of most Ameri- prodrug of gabapentin, to be used to treat them that it’s a well known observation in can hospitals. What made this case impor- restless legs syndrome. This drug has a dif- his field. This isn’t the idiotic question you tant to me was that one of the parents, a ferent kinetic profile, making it possibly su- may think it is. For one thing it turns out physician, told the ED doctor what drug perior, possibly not, but at least different from that it may be very embarrassing. For an- to look for; and when the tox screen came a patent viewpoint. More of a “me too” sort other patients and families are generally very up negative, the patient was then thought of drug than a breakthrough. But I was sur- pleased to know when some oddball symp- to have a neurological disorder and re- prised when I read the protocol. The FDA tom is “part” of the disease and that they ferred to me. had required safety testing that was far more are not being hypochondriacal or “weird” The doctor hadn’t thought to check complex than what was needed to demon- in some way. In this case it turned out to be what drugs the tox screen tests for and what strate that the drug was effective. What is about ten times more common in PD pa- drugs are missed. As it happens, the tar- bizarre is that the safety data required had tients than the controls. This probably has geted drug, dextromethorphan, which is no justifiable basis. In fact, one could argue some clinical importance in that this is most the single most abused drug by children in convincingly that the extensive data on likely the result of early sympathetic dys- the United States, does not appear on the gabapentin should have made it easier rather function that may, in fact, precede the usual tox screen so that an “extended” or than harder to demonstrate safety in the case motor signs of the disease. If true, this would “complete” tox screen must be requested. I of this newer drug. Maybe to compensate provide another “pre-symptom” of the dis- thought this mistake so important that I for their weak post-marketing work they are ease that will be helpful when we find a published a report in a neurology journal doing as much as they can pre-approval? drug that slows the disease progression. The to call attention to the ED oversight. What From an investigator’s standpoint, the only result was submitted as a letter to the editor happened next is what’s bizarre. outcome of the mandated testing will be a of a prestigious journal. The journal was As a result of this report I was con- higher price for the drug when it comes to very interested, asked a number of ques- tacted by two major drug companies that market. tions, but refused to consider a revision market cough medicines containing This caused me then to reflect on a when they learned that I had not obtained dextromethorphan. I was to report to the study I designed for my own center. It re- Institutional Review Board approval. I was Food and Drug Administration an adverse quired FDA approval for testing an old drug not surprised, but had decided a priori to effect of the drug! Now, who in their right on a new patient population. To test low “test” whether common sense was a con- mind would consider an intentional over- doses of extended-release ropinerol, doses sideration in contemporary academic medi- dose for the effect of getting high a side ef- which we routinely give to PD patients in cine. I then consulted the IRB about the fect? And didn’t I already exceed my civic their 60’s or 70’s, in a schizophrenic popu- study. The response was, “You don’t need duty by publishing the case so that anyone lation, of physically healthy people decades IRB approval for a study of this sort, unless at the FDA and anyone who can read En- younger than the PD patients, the FDA you want to publish it. Many journals re- glish would be able to find the effects of asked us to give the dose in the office and quire IRB approval for any study.” When I this drug with a computer search? What monitor the subject for eight hours.
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