Tobacco Documents Online

B336 LM435 P322 GOLD JAMA-J AM MED ASSOC broadcast antismoking commercials, smoking restrictions in restaurants and private workplaces, the radio and television ad ban, and the tar/nicotine listing requirement 3 The 1971 radio and television ad ban resulted in about a 27.8% savings in real ad spending for cigarette companies with no detectable reduction in demand.3 To be prudent, a total ad ban should be accompanied by controls on the introduction of new cigarette brands/varieties and by antismoking policies known to reduce consumption. Such effective measures include excise tax increases, res- taurant smoking restrictions, and broadcasting antismoking commercials. For each 10% increase in real cigarette price, a demand decrease of approximately 3.7% results 3 For each 10% increase in the smoking-age population covered by gov- ernment smoking restrictions, a drop in demand of around 6.5% is seen.3 An optimal antismoking agenda would give highest priority to these efficacious policies. William L. Simonich, PhD Cancer Treatment Centers of America Zion, Ill 1. Gostin LO, Brandt AM. Criteria for evaluating a ban on the advertisement of cig- arettes: balancing public health benefits with constitutional burdens. JAMA. 1993; 269:904-909. 2. Bergler R. Advertising and Cigarette Smoking: A Paychodogicad Study. Bern, Switzerland: Hans Huber Publishers; 1981. 3. Simonich WL. Government Antiamking Policies. New York, NY: Peter Lang Publishing Inc; 1991. In Reply.-Smoking is a highly complex and insufficiently understood behavior. Consequently, effective reductions in smoking behavior are likely to be achieved through a com- prehensive public health strategy based on the best available data. At the same time, antismoking policies must be re- spectful of human rights and avoid promoting intolerance of socially unacceptable behaviors. Dr Simonich is correct to warn that a ban on advertising could sharply reduce the cost of doing business for cigarette manufacturers. Since the cigarette market exhibits some price elasticity, significant increases in taxes may be necessary to maintain or increase the price of cigarettes. We support a multidimensional public health approach to cigarette smoking, including tax increases, health education, smoking prevention, and cessation programs. We urge some caution regarding the remaining two suggestions made by Simonich-government-imposed smoking restrictions and a ban on the introduction of new brands of cigarettes. Government-imposed smoking restrictions can represent a broad spectrum of policies with widely varying impacts on public health. While we support the restrictions on smoking in public areas that many states and municipalities have enacted, more aggressive government-imposed smoking re- strictions could be perceived as punitive and unduly invasive. Most data on secondhand smoke are based on studies involv- ing long-term exposure rather than casual transient exposure to smoke.' For this reason, any government ban on smoking would require careful assessment of both its public health benefits as well as its potential intrusiveness. Policies, such as an ad ban, that focus attention and responsibility squarely on the tobacco industry for the risks of their product may have certain benefits over policies directed at individual smokers. The proposal to ban the introduction of new cigarette brands is also problematic. While government could constitutionally ban the manufacture of cigarettes, it has chosen not to do so. If government continued to allow the manufacture of cigarettes but prohibited the introduction of new brands, it probably would be regarded as arbitrary and capricious. In order for such a law to pass constitutional muster, advocates would have to show why new brands pose a serious and special danger to pub- lic health over and above currently existing brands. It is true that the empirical data to support a ban on cigarette advertising are equivocal. However, given the vast complexity of designing studies that show a causal relation- ship between advertising and smoking, any evaluation of a ban must rest on a careful assessment of many factors. The profound harms of smoking, the history of unsuccessful reg- ulation of the industry, the unique characteristics of ciga- rettes in American life, and the minimum burdens on First Amendment values lead us to reiterate our conclusion that a ban on cigarette advertising would be an important part of a comprehensive public health strategy. Lawrence O. Gostin, JD American Society of Law, Medicine, and Ethics Boston, Mass Allan M. Brandt, PhD Harvard Medical School Boston, Mass 1. Respivutory Health Effects of Paaaive Smoking: Lung Cancer and Other Disor- dera. US Environmental Protection Agency, Office for Research and Development, Office of Health and Environmental Assessment; 1992. Nicotine Inhaler for Smoking Cessation To the Editor.-In a recent article, Tonnesen et al' suggest that a nicotine inhaler in smoking cessation could be imple- mented in general practitioner offices with high success rates and that it would be "acceptable" to patients. In addition, the program is described as "low intervention." Results from their study do not support such statements. Their study involved volunteers who were recruited through newspaper advertisements and who were motivated to quit smoking. Furthermore, subjects came to the clinic for a total of eight visits within 1 year, with each visit lasting `Yrom 30 to 60 minutes." Subjects saw videotapes on smoking cessa- tion, had group instructions about the use of the nicotine inhaler, had assessments with fiscal and biological parame- ters, and received individual counseling. Such broad and ex- pensive interventions are admirable, but in my practice as well as that of most primary care physicians, I don't think they would be classified as low-intervention efforts. More- over, I am surprised that despite such efforts, the placebo group had only a 5% successful smoking cessation rate at 1 year. In a prior study by Tonnesen et a1,2 23% of participants in a smoking cessation trial who were randomized to placebo were abstinent at 1 year. The claim that nicotine inhalers will be acceptable to pa- tients also seems premature given experiences with the use of the nicotine patch, the cost of which has been unacceptable for many of my patients. Will the nicotine inhaler, when it reaches the market (as I'm sure it will) cost as much or more than the patch when used at a per-unit dose? Furthermore, did the patients in the study receive their inhalers free of charge? If both answers are yes, then I expect that the inhaler will be less acceptable than envisioned, thus making success rates less than reported. Effectiveness trials with other nicotine replacement strategies have shown them to be less successful than that reported in controlled research reports.3 Finally, did patients truly use an average of 3.8 inhalers per day, with each inhaler on average good for 300 puffs, as reported? If true, then the average patient puffed 1.2 per minute every hour for 16 hours a day. Again, I am not sure my patients would find this acceptable. Adam Goldstein, MD University of North Carolina Chapel Hill 322 JAMA,July21,1993-vol 27o,No.3 Q~ERRM~OICAL ASSDC3 IL 2031367504 Letters

who sells equipment related to laparoscopic cholecystectomy. A more systematic and fair means of hearing all sides of the controversy and more time for public debate is clearly need- ed. We would advocate that panel deliberations, normally held in executive session, be held at least in part in the public forum and allow for open exchange with members of the audience. Fourth, decision theoretic models could help define the consensus questions more sharply and aid in synthesizing the literature.a At the conference, some panelists expressed fras- tration at the difficulty of weighing the evidence without these approaches. Finally, changes should be made to enforce panel closure on the difficult issues, so that consensus development can provide patients and practitioners the guidance they need to make more effective health care decisions. Itzhak Jacoby, PhD Uniformed Services University of the Health Sciences Bethesda, Md Thomas E. Scott, MD, MPH US Air Force Biloxi, Miss 1. NIH Consensus Development Panel on Gallstones and Laparoecopic Cholecys- tectomy. Gallstones and laparoscopic cholecystectomy. JAMA 1993;269:1018- 1024. 2 Rennie D. Consensus statements. N Engl J Med. 1981;304:68b666. 3. Jacoby I. Evidence and consensus. JAMA 1988;259:3089. In Reply.-We regret that Drs Jacoby and Scott thought we were skirting controversy in the NIH Consensus Conference on laparoscopic cholecystectomy. These conferences are based on specific questions posed by a planning committee to ad- dress controversies for which there are data to form unbi- ased, scientifically based recommendations. The issue of cer- tification and training was not one of these questions. Pre- scribing training guidelines has been, and remains, inappro- priate for NIH consensus conferences. Comments about training were invited, and Charles K. McSherry, MD, expe- rienced in laparoscopic training, provided useful information. Learning laparoscopic cholecystectomy depends on the skills and aptitudes of the trainee surgeon; no definitive number of procedures determines when a surgeon is qualified. From the panel's statement: "[I)t is imperative that detailed guidelines be established for surgeon training, determination of com- petence, certification, and continuous monitoring of quality." The panel did not try to dictate whether the common bile duct should be evaluated intraoperatively in all or only highly suspect cases. Data are still inadequate on this issue and the cholangiographic technique of choice. Forcing a consensus with incomplete data, multiple coexisting factors, and major cost implications is not warranted. The question of when to schedule a consensus conference is debatable. We saw the rapid-fire spread of laparoscopic cholecystectomy without attempts to survey the new ap- proach and decided the medical and lay communities should be made aware of the pros and cons of the procedure quickly. The planning committee considered that the number of pa- tients treated to date was adequate for evaluation. The NIH staff did not select the presenters alone but relied on the assistance of a planning committee of practicing and academic specialists knowledgeable in the field. Of the 28 presenters, none were intramural NIH scientists, and only eight held NIH grants. Their means of support were never considered during selection. We welcome suggestions on how to obtain greater public and clinician participation in planning consensus conferences. The meeting was widely advertised and several presenta- tions were added to the original program. We permitted only one 3-minute video from a discussant. No 15-minute presen- JAMA, July 21, 1993-Vol 270, No. 3 tations were added. Jacoby and Scott provided written ma- terial at the conference, which was promptly distributed to the panel and presented by them orally with slides. We could not accommodate more presentations because of time con- straints. Attendees with additional comments were encour- aged to submit them in writing. In contrast to many others, Jacoby and Scott submitted none. More discussion time would be helpful. However, the panel should not deliberate in public. Dr Jacoby is a former acting director of the NIH consensus program. We prefer the procedure used during his tenure, namely, ardent debate among panelists in executive session. This, most importantly, minimizes intellectual bias introduced by outside advocates. Audience input is solicited during final public review. Decision theoretic models, used in previous conferences, are certainly valuable in many situations. Thus, Jacoby and Scott's material was included for presentation and distrib- uted to the panel. They were offered, but declined the op- portunity to add written material to the published proceed- ings of the conference.' John Gollan, MD Brigham and Women's Hospital Boston, Mass Saran Kalser, PhD Jay Hoofnagle, MD John Ferguson, MD William Hall Elsa Bray National Institutes of Health Bethesda, Md 1. Gollan JL, Kaiser SC, Pitt HA, Straaberg SM. Proceedings of the NIH Consen- sus Development Conference on Gallstones and Laparoscopic Cholecystectomy. Am J Surg. 1993;166:387548. Banning Tobacco Advertising: Boon to the industry? To the Editor.-Companies try to influence consumers by advertising and by product differentiation. In a recent article, Gostin and Brandt' present a case for banning all cigarette ads to eliminate this prosmoking influence. Allowing advertising conveys social approval of smoking. However, the precise way advertising affects cigarette con- sumption is controversial. Individuals may be led to begin smoking by the example of family members, by peer pres- sure, and/or by advertising.' Does advertising induce people to smoke who would not otherwise do so or does it mainly shift consumption among people who have already decided to smoke? If the former, a total cigarette ad ban will reduce aggregate demand. If the latter, a total ad ban will not reduce demand. Instead, it will add billions of dollars to cigarette company profits from foregone ad spending and probably allow companies to reduce cigarette prices and add more new product lines, which would boost consumption. Because of the grave consequences of being wrong, anti- smokers should try to judge advertising bans based on careful consideration of relevant data. The econometric literature shows 14 studies where advertising is found to be associated with increased aggregate cigarette demand and 11 studies where it is not e More to the point, radio and television cig- arette ad bans are found to be effective in lowering demand in four studies but ineffective in 10 studies a The efficacy of ad bans must be considered unproven. New product introductions may be the major way cigarette companies increase demand. For every 10 new brands/vari- eties introduced nationally, a demand increase of about 4% is seen, controlling for real price, real income, real advertising stock, the average nicotine yield of cigarettes, and eight gov- ernment antismoking initiatives, including warning labels, Letters 321 203i367505

1. Tonnesen P, Nmregaard J, Milckeleen K, Jergensen S, Nilsson F. A double-blind trial of a nicotine inhaler for smoking cessation. JAMA 19913;269:1268-1271. 2 Tonnesen P, Fryd V, Hansen M, Helated J, Gunneraen AB, Forchammer H. Ef- fect of nicotine chewing gum in combination with group counseling on the cessation of smoking. N Engl J Med. 1988;318:613-518. 3. Hughes JR, Gast SW, Keenan RM, Fenwick dW, Healy ML. Nicotine vs placebo gum in general practice. JAMA 1989;261:130a1306. In Reply.-Our enrollment in the nicotine inhaler study was al- most supersonic: all 286 smokers were enrolled in 5 days in the afternoon after working hours. Many subjects felt that the ses- sions were unsatisfactory due to the hurry and lack of personal contact. The subjects saw a 7-minute videotape at entry only. This could also be arranged in a primary care setting. We believe that the primary care physician could take advantage of his or her knowledge of, and partnership with, the smoker, and so the consultation time need not be more than 5 to 10 minutes. The low success rate in the placebo group in our study is a reflection of the minimal psychological support provided, combined with a relatively low degree of motivation to quit in moderately nicotine-dependent subjects. In contrast, we have attained high- er success rates when we used nicotine gum in combination with group meetings.' The inhaler was delivered free of charge, which might have enhanced compliance with the device. As the cost of the inhaler might influence optimal usage, reimbursement for the cost of the inhaler as well for other nicotine products would be desirable. The subjects using the active nicotine inhaler attained a nicotine substitution that was 24% to 43% of their smoking levels. They used from one to 14 inhalers daily. It is not possible to see when the nicotine inhaler is empty. However, the subjects were told to replace the inhaler when they felt it had no more effect. It is our impression that they used the inhaler almost as often during the day as when smoking cigarettes but had to puff harder and more often compared with when using cigarettes. Using the inhaler does not seem to be more difficult than using the nicotine gum. Last, we should optimize the implementation of smoking cessation in general practice since the efficacy of this treat- ment in its current state is as cost-effective as other pre- ventive measures.2 Lack of time is not a legitimate excuse for not "treating" the smoking behavior. Philip Tgnnesen, MD, Jesper NOrregaard, MD Kim Mikkelsen, MD Stig JOrgensen, MD Bispebjerg Hospital Copenhagen, Denmark 1. Tonnesen P, Fryd V, Hansen M, Helsted J, Gunnersen AB, Forchammer H. Ef- fect of nicotine chewing gum in combination with group counseling on the cessation of smoking. N Engl J Med. 1988;318:513-618. 2. Fowler G. Educating doctors in smoking cessation. Tobacco Control. 1993;2b~'z Persistent Ear Discomfort and Neck Pain To the Editor.-We read with interest the excellent synopsis of otorhinolaryngologic causes of persistent ear discomfort and neck pain by LeLiever.' In our experience, in addition to eustachian tube dysfunction, an often overlooked cause of the symptoms described is activation of myofascial trigger points in the clavicular division of the sternocleidomastoid muscle (although some have questioned the basic concept2~3). As characterized by Travell and Simons,° when activated sternocleidomastoid trigger points are present and produce characteristic referred ear and neck pain on one side in the pattern described in the question posed to LeLiever,' such points are usually found on the opposite side as well. This would account for the bilateral distribution of the patient's pain, as well as her increased pain on flexion of her neck. Travell and Simons note that persons with such trigger points also often experience referred frontal headaches and referred autonomic phenomena, especially postural dizziness and equi- librium disturbances.' Though some dispute the validity of the method,O we have had considerable success demonstrating such activated trig- ger points with liquid crystal thermography, validated by thorough physical palpation of the clavicular division(s) of the involved sternocleidomastoid muscle(s) and by disappear- ance of referred ear pain after treatment of the trigger point(s). Occasionally, chronic ear pain can result from acti- vation of trigger points in the upper part of the deep layer of the ipsilateral masseter muscle; an activated trigger point in the medial pterygoid muscle can also produce chronic ear pain on the same side, but this is often accompanied by more jaw pain than was described in the case presented to LeLiever.° David E. Conwill, MD, MPH B. H. Cook, MD, PhD University of Mississippi Medical Center Jackson L LeLiever WC. Eustachian tube dysfunction. JAMA. 1993Z9:809. 2. Deyo PA. Back pain: the history and physical examination. JAMA 1993;269:356. 3. Deyo PA. TENS for chronic low back pain. N Engl J Med 1990;323:1425. 4. Travell JG, Simons DG. Myofaacial Pain and Dyafunction: The Trigger Point ManuaL Baltimore, Md: Williame & Wilkins; 198310?,235, 249-259. 5. Cotton P. AMA's Council on Scientific Affairs takes a fresh look at thermography. JAMA 1992;267:1885-1887. 6. Swerdlow B, Dieter JNI. An evaluation of the sensitivity and specificity of med- ical thermography for the documentation of myofascial trigger points. Pain. 1992;48205-213. Suicide Attempts and the Nicotine Patch To the Editor.-Within recent months, four pharmaceutical manufacturers have brought nicotine replacement patches onto the US market for the treatment of nicotine dependence. The package inserts for these nicotine patches warn physi- cians that the risks of nicotine replacement therapy in pa- tients with known cardiovascular or peripheral vascular dis- ease should be weighed carefully against the benefits of smok- ing cessation. We write to report the case of a patient with known coronary artery disease who attempted suicide by means of nicotine overdose using nicotine patches. Report of a Case.-Our patient was a 44-year-old man who presented in October 1992 with a single episode of major depression and recurrent suicidal ideation. Diagnos- tic evaluation resulted in additional diagnoses of patholog- ical gambling, alcohol dependence syndrome, and nicotine dependence. The patient had undergone coronary angio- plasty in August 1992 for coronary artery disease. Two weeks prior to his October hospital admission, he at- tempted suicide by means of nicotine overdose. He placed seven 21-mg nicotine patches on his chest and began smoking cigarettes, two at a time. Prior to applying the patches, he had flushed the patch enclosures down the toilet. It was his intent to precipitate myocardial infarc- tion, and he had planned to hurriedly remove the patches and similarly dispose of them once he developed chest pain. He also brewed and consumed a pot of double- strength coffee. Approximately 2 hours into this attempt, having experienced no chest pain or other untoward symp- toms, he became anxious that he might actually succeed in his suicide attempt and abruptly removed all the patches and discontinued smoking. Comment.-We contacted Marion Merrell Dow Inc (oral communication with Elizabeth McManamy, RPH, Global Prod- uct Safety Specialist, February 1993), the producer of Nico- derm, regarding other reports of overdose or attempted over- dose with Nicoderm. The pharmaceutical company had four reports of overdose on record, one of which was intentional JAMA, July 21, 1993-Vol 270, No. 3 Letters 323 203-13G'7506

, 0 and none of which resulted in death. Among those who at- tempt suicide, drug overdose is the most common method. The use of the nicotine patch appears to be a new variety of drug overdose. Given the large numbers of patients who are seeking the help of physicians in the form of prescriptions for the nicotine patch, we suggest that the prescribing physician screen each patient's affective status just as one would before prescribing other powerful psychoactive substances. Charles J. Engel, MD A. Hilton Parmentier, MD Milwaukee Psychiatric Hospital Wauwatosa, Wis Screening for Gestational Diabetes To the Editor.-Magee et all recommend wider use of the modified criteria of Carpenter and Coustan2 for the diagnosis and treatment of gestational diabetes mellitus (GDM). Ab- normalities of carbohydrate metabolism are likely a contin- uum, however, requiring treatment of some patients with lesser degrees of intolerance at the expense of others not requiring therapy. Langer et al3 recommend therapy for those with one abnormal value on the 3-hour glucose toler- ance test (GTT) using the National Diabetes Data Group (NDDG) values, since this group had an adverse perinatal outcome if left untreated. In comparison with those with a normal 1-hour glucose screen, Leiken et al' noted a signifi- cantly higher frequency of macrosomia in those with an ab- normal 1-hour glucose screening test though their 3-hour tests were "normal" by the modified criteria. Included in this normal group and not analyzed separately, however, were 16.8% of the study patients with one abnormal value on the 3-hour test. Was there an adverse outcome in the study by Magee et al in those with one abnormality on the 3-hour GTT by the modified criteria, or do these more conservative values pre- clude the need for treating these patients? Bruce L. Ring, MD Brockton, Mass 1. Magee MS, Walden CE, Benedetti TJ, Knopp RH. Influence of diagnostic criteria on the incidence of gestational diabetes and perinatal morbidity. JAMA. 1993;269: 609-615. 2. Carpenter WM, Coustan DR. Criteria for screening tests for gestational diabe- tea. Am J Obatet Gynecod. 1982;144:768-773. 3. Langer 0, Brustman L, Anyaegbunam A, Mazze R. The significance of one abnormal glucose tolerance test value on adverse outcome in pregnancy. Am J Ob- stet Gynecol. 1987;157:758-763. 4. Leikin EL, Jenkins JH, Pomerantz GA, Klein L. Abnormal glucose screening tests in pregnancy: a risk factor for fetal macrosomia. Ob8tet Gynecot. 1987;69:670-573. In Reply.-Dr Ring asks about perinatal morbidity in pregnancies with one rather than the usual two abnormal GTT values that are diagnostic for GDM. Previous studies show that a single GTT abnormality by NDDG criteria is associated with increased perinatal morbidity.', To inves- tigate this question in our own data set, we first deter- mined if individuals with one abnormal value by the NDDG criteria had increased perinatal morbidity. We pre- viously found that 65 (3.2%) of the women screened had two elevated GTT values by NDDG criteria, the classical definition of GDM. An additiona160 women (3.0%) of those screened had one elevated GTT value by NDDG criteria. The macrosomia rate (birth weight, >4000 g) was 29% in the GDM group and 25% in the group with one abnormal value, consistent with previous reports.12 We then deter- mined how many of the 60 individuals with one elevated NDDG value had two elevated values by the modified criteria, ie, had GDM by this criterion. Twenty-eight of these 60 women were abnormal by two modified criteria values and the remaining 32 were normal. The macrosomia 324 JAMA, July 21, 1993-Vol 270, No. 3 rate was 35.0% in the abnormal group and 15.6% in the normal group. For comparison, the rate of macrosomia was 20% in negative screenees and 19% in subjects with a negative GTT. The majority of perinatal morbidities were also greater in the abnormal vs the normal group by the modified criteria. In conclusion, the modified criteria (us- ing two values) capture the subjects with one abnormal NDDG value at increased risk for macrosomia and peri- natal morbidity. Over half of individuals with a single abnormal GTT value by NDDG criteria are not at risk for GDM morbidity. To select individuals with one abnormal value by the lower modified criteria would inappropriately label an even larger majority of subjects as being at risk for GDM and could prompt inappropriate therapy. M. Scott Magee, MD Carolyn E. Walden, MS Thomas J. Benedetti, MD Robert H. Knopp, MD University of Washington Seattle 1. Leikin EL, Jenkins JH, Pomerantz GA, Klein L. Abnormal glucose screening tests in pregnancy: a risk factor for fetal macrosomia. Obstet Gynecol. 1987;69:570-573. 2. Langer 0, Brustman L, An,yaegbunam A, Mazze R. The significance of one abnormal glucose tolerance test value on adverse outcome in pregnancy. Am J Ob- atet Gynecol. 1987;157:758-763. Unusual Cause for Baldness Inspires the Muse To the Editor.-It appears that one of the effects of direct consumer advertising of prescription drugs is the intem- perate demand for therapy by a presold and pressing patient. A 29-year-old man was annoyed that I actually wished to ex-_ amine him and order laboratory tests. Responding to the Ro- gaine (minoxidil) television advertisements, he simply wanted a prescription so he could get along with growing hair. Clinically, there was diffuse thinning, with many long hairs with depig- mented bulbs (telogen hairs) easily dislodged with gentle trac- tion. The remainder of the physical examination was unremark- able. He denied recent illness, sores, or rashes. His serological test for syphilis was reactive at a 1•.3`L0 dilution. The hair loss was his only clinical manifestation of secondary syphilis. The limerick muse inspires the following cautionary rhyme: A young man on Rogaine rub bent, Desired to Docs circumvent, His hairs, tho' they're willin', Really need penicillin, So instead of all coming, they went! Christopher M. Papa, MD University of Medicine and Dentistry of New Jersey New Brunswick CORRECTION Omission in Figure Legend.-An error occurred in the Preliminary Communication entitled "Preliminary Study of the Efficacy of In- sulin Aerosol Delivered by Oral Inhalation in Diabetic Patients," published in the April 28, 1993, issue of THE JOURNAL (1993;269: 2106-2109). The legend to Fig 2 on page 2108 should have included the statement, "The insulin values shown in black circles have been logarithmically transformed (base log,o)." - Letters 20a136'750"1

L Tonnesen P, Ngrregaard J, Mikkelsen K, Jgrgensen S, Nilason F. A double-blind trial of a nicotine inhaler for smoking cessation. JAMA 1993;269:1268-1271. 2 Tonnesen P, Fryd V, Hansen M, Helsted J, Gunnersen AB, Forchammer H. Ef- fect of nicotine chewing gum in combination with group counseling on the cessation of smoking. N Engl J Med. 1988;318:513-518. 3. Hughes JR, Gast SW, Keenan RM, Fenwick JW, Healy ML. Nicotine vs placebo gum in general practice. JAMA 1989;261:1300-1305. In Reply.--Ollr enrollment in the nicotine inhaler study was al- most supersonic: all 286 smokers were enrolled in 5 days in the afternoon after working hours. Many subjects felt that the ses- sions were unsatisfactory due to the hurry and lack of personal contact. The subjects saw a 7-minute videotape at entry only. This could also be arranged in a primary care setting. We believe that the primary care physician could take advantage of his or her knowledge of, and partnership with, the smoker, and so the consultation time need not be more than 5 to 10 minutes. The low success rate in the placebo group in our study is a reflection of the minimal psychological support provided, combined with a relatively low degree of motivation to quit in moderately nicotine-dependent subjects. In contrast, we have attained high- er success rates when we used nicotine gum in combination with group meetings.' The inhaler was delivered free of charge, which might have enhanced compliance with the device. As the cost of the inhaler might influence optimal usage, reimbursement for the cost of the inhaler as well for other nicotine products would be desirable. The subjects using the active nicotine inhaler attained a nicotine substitution that was 24% to 43% of their smoking levels. They used from one to 14 inhalers daily. It is not possible to see when the nicotine inhaler is empty. However, the subjects were told to replace the inhaler when they felt it had no more effect. It is our impression that they used the inhaler almost as often during the day as when smoking cigarettes but had to puff harder and more often compared with when using cigarettes. Using the inhaler does not seem to be more difficult than using the nicotine gum. Last, we should optimize the implementation of smoking cessation in general practice since the efficacy of this treat- ment in its current state is as cost-effective as other pre- ventive measures? Lack of time is not a legitimate excuse for not "treating" the smoking behavior. Philip Tgnnesen, MD, Jesper Narregaard, MD Kim Mikkelsen, MD Stig JOrgensen, MD Bispebjerg Hospital Copenhagen, Denmark 1. Tonnesen P, Fryd V, Hansen M, Helated J, Gunnersen AB, Forchammer H. Ef- fect of nicotine chewing gum in combination with group counseling on the cessation of smoking. N Engl J Med. 1988;318:513-518. 2. Fowler G. Educating doctors in smoking cessation. Tobacco Control. 1993;2:5-6. Persistent Ear Discomfort and Neck Pain To the Editor.-We read with interest the excellent synopsis of otorhinolaryngologic causes of persistent ear discomfort and neck pain by LeLiever.' In our experience, in addition to eustachian tube dysfunction, an often overlooked cause of the symptoms described is activation of myofascial trigger points in the clavicular division of the sternocleidomastoid muscle (although some have questioned the basic concept'^I). As characterized by Travell and Simons,4 when activated sternocleidomastoid trigger points are present and produce characteristic referred ear and neck pain on one side in the pattern described in the question posed to LeLiever,' such points are usually found on the opposite side as well. This would account for the bilateral distribution of the patient's pain, as well as her increased pain on flexion of her neck. JAMA, July 21, 1993-Vol 270, No. 3 B336 LM435 P323 T ONN JAMA-J AM MED ASSOC Travell and Simons note that persons with such trigger points also often experience referred frontal headaches and referred autonomic phenomena, especially postural dizziness and equi- librium disturbances ° Though some dispute the validity of the method,5,s we have had considerable success demonstrating such activated trig- ger points with liquid crystal thermography, validated by thorough physical palpation of the clavicular division(s) of the involved sternocleidomastoid muscle(s) and by disappear- ance of referred ear pain after treatment of the trigger point(s). Occasionally, chronic ear pain can result from acti- vation of trigger points in the upper part of the deep layer of the ipsilateral masseter muscle; an activated trigger point in the medial pterygoid muscle can also produce chronic ear pain on the same side, but this is often accompanied by more jaw pain than was described in the case presented to LeLiever.4 David E. Conwill, MD, MPH B. H. Cook, MD, PhD University of Mississippi Medical Center Jackson 1. LeLiever WC. Eustachian tube dysfunction. JAMA 1993269:809. 2. Deyo PA. Back pain: the history and physical examination. JAMA 1993;269:356. 3. Deyo PA. TENS for chronic low back pain. N Engl J Med. 1990;323:1425. 4. Travell JG, Simons DG. Myofaacia.l Pain and Dyafunetion: The Trtgger Point Manual. Baltimore, Md: Williams & Wilkins; 1983:202-235, 249-259. 5. Cotton P. AMA's Council on Scientific Affairs takes a fresh look at thermography. JAMA 1992;267:1885-1887. 6. Swerdlow B, Dieter JNI. An evaluation of the sensitivity and specificity of med- ical thermography for the documentation of myofascial trigger points. Pain. 1992;48205-213. Suicide Attempts and the Nicotine Patch To the Editor.-Within recent months, four pharmaceutical manufacturers have brought nicotine replacement patches onto the US market for the treatment of nicotine dependence. The package inserts for these nicotine patches warn physi- cians that the risks of nicotine replacement therapy in pa- tients with known cardiovascular or peripheral vascular dis- ease should be weighed carefully against the benefits of smok- ing cessation. We write to report the case of a patient with known coronary artery disease who attempted suicide by means of nicotine overdose using nicotine patches. Report of a Case.-Our patient was a 44-year-old man who presented in October 1992 with a single episode of major depression and recurrent suicidal ideation. Diagnos- tic evaluation resulted in additional diagnoses of patholog- ical gambling, alcohol dependence syndrome, and nicotine dependence. The patient had undergone coronary angio- plasty in August 1992 for coronary artery disease. Two weeks prior to his October hospital admission, he at- tempted suicide by means of nicotine overdose. He placed seven 21-mg nicotine patches on his chest and began smoking cigarettes, two at a time. Prior to applying the patches, he had flushed the patch enclosures down the toilet. It was his intent to precipitate myocardial infarc- tion, and he had planned to hurriedly remove the patches and similarly dispose of them once he developed chest pain. He also brewed and consumed a pot of double- strength coffee. Approximately 2 hours into this attempt, having experienced no chest pain or other untoward symp- toms, he became anxious that he might actually succeed in his suicide attempt and abruptly removed all the patches and discontinued smoking. Comment.-We contacted Marion Merrell Dow Inc (oral communication with Elizabeth McManamy, RPH, Global Prod- uct Safety Specialist, February 1993), the producer of Nico- derm, regarding other reports of overdose or attempted over- dose with Nicoderm. The pharmaceutical company had four reports of overdose on record, one of which was intentional COPYRIGHT AMER MEDICAL ASSOC3 IL Letters 323 203136'7508

and none of which resulted in death. Among those who at- tempt suicide, drug overdose is the most common method. The use of the nicotine patch appears to be a new variety of drug overdose. Given the large numbers of patients who are seeking the help of physicians in the form of prescriptions for the nicotine patch, we suggest that the prescribing physician screen each patient's affective status just as one would before prescribing other powerful psychoactive substances. Charles J. Engel, MD A. Hilton Parmentier, MD Milwaukee Psychiatric Hospital Wauwatosa, Wis Screening for Gestational Diabetes To the Editor.-Magee et al' recommend wider use of the modified criteria of Carpenter and Coustan2 for the diagnosis and treatment of gestational diabetes mellitus (GDM). Ab- normalities of carbohydrate metabolism are likely a contin- uum, however, requiring treatment of some patients with lesser degrees of intolerance at the expense of others not requiring therapy. Langer et al3 recommend therapy for those with one abnormal value on the 3-hour glucose toler- ance test (GTT) using the National Diabetes Data Group (NDDG) values, since this group had an adverse perinatal outcome if left untreated. In comparison with those with a normal 1-hour glucose screen, Leiken et al4 noted a signifi- cantly higher frequency of macrosomia in those with an ab- normal 1-hour glucose screening test though their 3-hour tests were "normal" by the modified criteria. Included in this normal group and not analyzed separately, however, were 16.8% of the study patients with one abnormal value on the 3-hour test. Was there an adverse outcome in the study by Magee et al in those with one abnormality on the 3-hour GTT by the modified criteria, or do these more conservative values pre- clude the need for treating these patients? Bruce L. Ring, MD Brockton, Mass 1. Magee MS, Walden CE, Benedetti TJ, Knopp RH. Influence of diagnostic criteria on the incidence of gestational diabetes and perinatal morbidity. JAMA. 1993;269: 609-615. 2. Carpenter WM, Coustan DR. Criteria for screening tests for gestational diabe- tes. Am J Obstet f'sgneeol. 1982;144:768-773. 3. Langer 0, Brustman L, Anyaegbunam A, Mazze R. The significance of one abnormal glucose tolerance test value on adverse outcome in pregnancy. Am J Ob- stet Gynecol. 1987;157:758-7&3. 4. Leilon EL,Jenkins JH, Pomerantz GA, Klein L. Abnormal glucose screening tests in pregnancy: a risk factor for fetal macrosonria. Obatet Gynecol. 1987;69:570-573. In Reply.-Dr Ring asks about perinatal morbidity in pregnancies with one rather than the usual two abnormal GTT values that are diagnostic for GDM. Previous studies show that a single GTT abnormality by NDDG criteria is associated with increased perinatal morbidity.12 To inves- tigate this question in our own data set, we first deter- mined if individuals with one abnormal value by the NDDG criteria had increased perinatal morbidity. We pre- viously found that 65 (3.2%) of the women screened had two elevated GTT values by NDDG criteria, the classical definition of GDM. An additiona160 women (3.0%) of those screened had one elevated GTT value by NDDG criteria. The macrosomia rate (birth weight, >4000 g) was 29% in the GDM group and 25% in the group with one abnormal value, consistent with previous reports.',' We then deter- mined how many of the 60 individuals with one elevated NDDG value had two elevated values by the modified criteria, ie, had GDM by this criterion. Twenty-eight of these 60 women were abnormal by two modified criteria values and the remaining 32 were normal. The macrosomia 324 JAMA, July 21, 1993-Vol 270, No. 3 rate was 35.0% in the abnormal group and 15.6% in the normal group. For comparison, the rate of macrosomia was 20% in negative screenees and 19% in subjects with a negative GTT. The majority of perinatal morbidities were also greater in the abnormal vs the normal group by the modified criteria. In conclusion, the modified criteria (us- ing two values) capture the subjects with one abnormal NDDG value at increased risk for macrosomia and peri- natal morbidity. Over half of individuals with a single abnormal GTT value by NDDG criteria are not at risk for GDM morbidity. To select individuals with one abnormal value by the lower modified criteria would inappropriately label an even larger majority of subjects as being at risk for GDM and could prompt inappropriate therapy. M. Scott Magee, MD Carolyn E. Walden, MS Thomas J. Benedetti, MD Robert H. Knopp, MD University of Washington Seattle L Leikin EL, Jenkins JH, Pomerantz GA, Klein L. Abnormal glucose screening tests in pregnancy: a risk factor for fetal macrosomia Obatet Gynecol. 1987;69:570573. 2. Langer 0, Brustman L, Anyaegbunam A, Mazze R. The significance of one abnormal glucose tolerance test value on adverse outcome in pregnancy. Am J Ob- stet Grynecol. 1987;157:758-763. Unusual Cause for Baldness Inspires the Muse To the Editor.-It appears that one of the effects of direct consumer advertising of prescription drugs is the intem- perate demand for therapy by a presold and pressing patient. A 29-year-old man was annoyed that I actually wished to ex-. amine him and order laboratory tests. Responding to the Ro- gaine (minoxidil) television advertisements, he simply wanted a prescription so he could get along with growing hair. Clinically, there was diffuse thinning, with many long hairs with depig- mented bulbs (telogen hairs) easily dislodged with gentle trac- tion. The remainder of the physical examination was unremark- able. He denied recent illness, sores, or rashes. His serological test for syphilis was reactive at a 1:320 dilution. The hair loss was his only clinical manifestation of secondary syphilis. The limerick muse inspires the following cautionary rhyme: A young man on Rogaine rub bent, Desired to Does circumvent, His hairs, tho' they're willin', Really need penicillin, " So instead of all coming, they went! Christopher M. Papa, MD University of Medicine and Dentistry of New Jersey New Brunswick CORRECTION Omission in Figure Legend.-An error occurred in the Preliminary Communication entitled "Preliminary Study of the Efficacy of In- sulin Aerosol Delivered by Oral Inhalation in Diabetic Patients," published in the April 28, 1993, issue of THE JOURNAL (1993;269: 2106-2109). The legend to Fig 2 on page 2108 should have included the statement, "The insulin values shown in black circles have been logarithmically transformed (base logio).° Letters 2031367509