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Letters to the Editor The Journal welcomes letters to the editor. If found suitable, they will be published as space allows. Letters she l.i Letters to the Editor behe typedtuned double-spaced,double-snared should not exceed 400 words, and arcare subiectsubject to abridementabridgment and other editorial chane”.1. ; 1 in accordance with Journal style. All letters that reference a recently published Journal article are sent to £ original authors for their reply. If no reply is published, the authors have not responded by date of publicatio' Send letters to Paul M. Fischer, Editor, The Journal o f Family Practice, 519 Pleasant Home Rd Suite A J Augusta, C,A 30907-3500, or Fax (706) 855-1107. ’ n TERAZOSIN FOR BPH prostatic hyperplasia: a primary care trial. J in treatment of symptomatic BPH. Iam Fam Pract 1994; 39:129-33. confident that the improvement seen To the Editor: 2. Kessler DA, Rose JL, Temple RJ, et al. which was more than twice the level of I read with dismay a recent article in Therapeutic-class wars— drug promotion placebo effect seen in Dr Lepor’s study is The Journal concerning treatment of hy­ in a competitive marketplace. N Engl J Med significant. 1 do think that the study is a 1994; 331:1350-3. pertension and symptomatic benign pros­ valuable addition to the double-blind tatic hyperplasia (BPH) with terazosin.1 3. Lepor H, Auerbach S, Purasbaez A, et al. A randomized, placebo-controlled multi­ data that have been accumulated by other In this study, over 700 primary care center study of the efficacy and safety of investigators in the use of terazosin and physicians throughout America were “ re­ terazosin in the treatment of benign pros­ other alpha[ blockers. cruited” to enroll patients, but we are not tatic hyperplasia. J Urol 1992; 148:1467- This was the first large-scale trial utiliz­ told how they were recruited. Since the 74. ing alpha blockers to treat symptomatic study was funded by the manufacturer of 4. Brawer MIC, Adams G, Epstein H. Terazo­ BPH in the primary care office setting. All terazosin, one wonders if financial incen­ sin in the treatment of benign prostatic hy­ the other trials have been conducted in I tives were involved that could have biased perplasia. Arch Fam Med 1993; 2:929-35. academic urological offices (medical j 5. Sackett DL. How to read clinical journals: the trial. Such studies, termed “ seeding schools), and one can question their rd- : trials,” are routinely employed by phar­ to distinguish useful from useless or even harmful therapy. Can Med Assoc J 1981; evance regarding how patients would re­ maceutical companies to gain exposure 124:1156-62.' spond in the typical primary care office. and increase the use of their product 6. Kaplan NM. Clinical hypertension. Balti­ Therefore I think that this type of trial is without producing any useful informa­ more, Md: Williams & Wilkins, 1990. extremely valuable in documenting that tion.2 these agents, which have clearly been Open-label enrollment was used: shown to be safe and effective in double­ there was no placebo control group, and blind trials in academic urological offices, , the study was not blinded. While this is The preceding letter was referred to Dr Guthrie, who responds as follows: were also safe and effective in the very not always inappropriate, the study of practice setting where they will be pre­ BPH demands a more scientific approach. Dr Jerant raises two specific points and dominantly used. While the open-label The lack of a placebo group is an espe­ a general philosophical question that I design is not perfect, I think this type of cially glaring problem in a BPH treatment will address. large community-based study provides le­ study. Previous investigators have dem­ First, the physicians who provided the gitimate supplementary data to the dou­ onstrated that patients with BPH who re­ research were recruited by the sales force ble-blind data accumulated in other in­ ceive placebo often show considerable for Abbott Laboratories in North Chi­ vestigations. improvements in symptom scores.3'4 cago, 111. This is a traditional mechanism Dr Jerant questions the definition of Thus, contrary to the author’s assertions, for recruitment of physicians in large- hypertension. The trial was originally de­ I do not find an asset of this study to be scale clinical trials such as this. However, veloped to look at a multitude of issues in the “ power of numbers.” Without a pla­ this was not a “ seeding trial” or “ demon­ patients who were either documented as cebo control group this amounts to noth­ stration project,” which have been used hypertensive in the office or currently ing more than a large case series,5 and by pharmaceutical companies in the past treated with antihypertensive medica­ conclusions regarding the safety and effi­ to encourage physicians to use newly de­ tions, with that being accepted as the def­ cacy of terazosin from the data presented veloped products. inition of hypertension. For a variety ot are unfounded. Terazosin had been on the market for reasons, I did not feel that the other data We are given no information on hypertension for a number of years, and they attempted to accumulate beyond the what defines “ hypertension,” and no de­ this project was developed as a large-scale BPH data were valuable, and those data lineation of the “ run-in” period required Phase IV project to investigate a variety of were therefore discarded. This report was to make the diagnosis. This is a pertinent questions about terazosin. The project developed to document the very positive concern because “ regression to the involved proper informed consent and effects on the subset of patients who had mean” in hypertension treatment trials is Institutional Review Board approval symptomatic BPH. The hypertensioi well recognized.6 consistent with all legitimate research data were presented not to document the Authors, publishers, and readers projects. The physicians were paid efficacy of alpha-blockers in treating hy­ must share responsibility for what appears $60.00 per patient, a modest amount pertension. The design did not allow f o r in the medical literature. considering the amount of work in­ that type of accurate documentation, and CPT Anthony F. Jerant, MD volved, which included the cumbersome that issue has been documented in a large Eisenhower Army Medical Center gathering of scores from the Boyarsky number of other studies in the past. It was Fort Gordon, Georgia scale, in use at that time to detect symp­ included simply to provide reassurance to tomatic BPH. practitioners that patients who had nor In a second point, Dr Jerant ques­ mal blood pressures and received alpha tioned the open-label design, an issue blockers as treatment for their BPH did References with which I thought I had dealt in the so without becoming significantly hypo manuscript, particularly since we both tensive. The hypertension data are there 1. Guthrie R. Terazosin in the treatment of referenced the same study by Dr Lepor, fore included fundamentally as a safety issue j hypertension and symptomatic benign which had provided data on placebo effect The issues raised by Dr Jerant appearto 222 The Journal of Family Practice, Vol. 40, No. 3(Mar), 19® Letters to the Editor ^ basically philosophical, concerning FAMILY PRACTICE reflect the value of the procedure as much ivhat should constitute family medicine PROCEDURES as it reflects unavailable role models, in­ research. In the early days of our specialty, adequate training, and political resis­ our research background was provided by To the Editor: tance. nonclinicians who were brought into our Eliason et al deserve credit for study­ In the area of obstetric (OB) ultra­ specialty from a variety of other research ing the diagnostic and therapeutic skills of sound, data by Wadland et al11 suggest backgrounds, such as social sciences and family practice.1 These data constitute a that among family physicians who prac­ statistics. This background has produced “ snapshot” of 325 Wisconsin family phy­ tice maternity care, 53% of OB-capable ivhat I think is an inappropriate concern sicians in the spring of 1993. The “ quit family physicians have unrestricted OB- ivith academic structure inside our re­ ratio” is defined as the number of physi­ ultrasound privileges in their hospital search community. System- or structure- cians who have quit the procedure di­ practice. The 4.3% described in the Elia­ oriented rather than clinically oriented re­ vided by the number still providing the son study is distinctly different. Connor et search projects are dominating family procedure. This concept is a real contri­ al12 found that over 60% of family practice medicine research. Rarely do we see land­ bution. However, additional perspective residency programs are teaching OB ul­ mark clinical research conducted by fam­ is available from other published stud­ trasound. ily physicians, and rarely do we see origi­ ies.2-3 Family physician investigators have Each year, the American Academy of nal research from our literature been tracking the gradual transfer of ter­ Family Physicians (AAFP) tracks the per­ referenced by specialists in other fields. tiary care technology into primary care centage of family physicians performing a variety of procedures. Prior to 1992, This has also meant that the evolution of specialties such as family practice for many years. For example, prior to 1980, EGD and colonoscopy were not tracked clinical knowledge that is relevant to fam­ flexible sigmoidoscopy training was not because they were not viewed as family ily physicians has, for the most part, been available. Unfamiliar with the diagnostic practice procedures. More family physi­ conducted by physicians in other special­ benefits of this procedure when per­ cians, however, are acquiring these skills ties and published in literature outside formed by family physicians, some even each year.13-15 family medicine.
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