December 2016 Pulmonary Case of the Month

Lewis J. Wesselius, MD

Department of Pulmonary Medicine

Mayo Clinic Arizona

Scottsdale, AZ

Pulmonary Case of the Month CME Information

Members of the Arizona, New Mexico, Colorado and California Thoracic Societies and the Mayo Clinic are able to receive 0.25 AMA PRA Category 1 Credits™ for each case they complete. Completion of an evaluation form is required to receive credit and a link is provided on the last panel of the activity. 

0.25 AMA PRA Category 1 Credit(s)™

Estimated time to complete this activity: 0.25 hours

Lead Author(s): Lewis J. Wesselius, MD.  All Faculty, CME Planning Committee Members, and the CME Office Reviewers have disclosed that they do not have any relevant financial relationships with commercial interests that would constitute a conflict of interest concerning this CME activity.

Learning Objectives:
As a result of this activity I will be better able to:

1. Correctly interpret and identify clinical practices supported by the highest quality available evidence.
2. Will be better able to establsh the optimal evaluation leading to a correct diagnosis for patients with pulmonary, critical care and sleep disorders.
3. Will improve the translation of the most current clinical information into the delivery of high quality care for patients.
4. Will integrate new treatment options in discussing available treatment alternatives for patients with pulmonary, critical care and sleep related disorders.

Learning Format: Case-based, interactive online course, including mandatory assessment questions (number of questions varies by case). Please also read the Technical Requirements.

CME Sponsor: University of Arizona College of Medicine at Banner University Medical Center Tucson

Current Approval Period: January 1, 2015-December 31, 2016

Financial Support Received: None

History of Present Illness

The patient is a 29-year-old man who presented to the emergency room with right-sided pleuritic chest pain, fever, cough, and progressive dyspnea over 2 weeks.

Past Medical History, Social History and Family History

He had no prior significant medical issues and had been well until 2 weeks ago. A native of India, he has been in the US for about 5 months and works at American Express. He is a nonsmoker. Family history is noncontributory.

Physical Examination

• Vitals signs: Temperature 38.0^◦ C, Blood Pressure 155/85 mm Hg, Heart Rate 140 beats/min, Respirations 24 breaths/min
• General: Appears to be in moderate pain and respiratory distress
• Lungs: Decreased breath sounds on the right
• Heart: regular rhythm with a tachycardia
• Abdomen: unremarkable
• Extremities: unremarkable
• Neurologic: unremarkable

Radiography

His initial chest x-ray is shown in Figure 1.

Figure 1. Initial chest radiograph.

Which of the following best describes the chest x-ray? (Click on the correct answer to proceed to the second of seven pages)

1. Elevated right hemidiaphragm
2. Large right pleural effusion
3. Right lower lobe and middle lobe consolidation
4. Right lung atelectasis
5. None of the above

Cite as: Wesselius LJ. December 2016 pulmonary case of the month. Southwest J Pulm Crit Care. 2016;13(6):268-75. doi: https://doi.org/10.13175/swjpcc122-16 PDF

Inhaler Device Preferences in Older Adults with Chronic Lung Disease

Laith Ghazala, MD¹

Christian Bime, MD MSc^1,2

Felipe Cortopassi, PT RPFT MBA³

Todd Golden, MS¹

Cristine E. Berry, MD MHS^1,2

¹Department of Medicine and the ²Asthma and Airway Disease Research Center

University of Arizona College of Medicine

Tucson, AZ USA

³ Pulmonary Department

State University of Rio de Janeiro

Rio de Janeiro, RJ, Brazil

Abstract

Introduction: Patient preferences are important for medication adherence and patient satisfaction, but little is known about older adult preferences for inhaler devices.

Methods: We developed a 25-item written self-administered questionnaire assessing experience with inhalers, prior inhaler education, and preferences with respect to inhaler device features and inhaler device teaching. We then conducted a cross-sectional survey of patients at least 65 years of age with chronic lung disease who had experience using inhaler devices for at least six months in the ambulatory setting.

Results: Fifty participants completed the questionnaire. The majority of participants (80%) reported prior experience with a metered dose inhaler (MDI), but only 26% used an MDI with a spacer. Most patients (76%) had received formal instruction regarding proper use of the inhaler, but only 34% had ever been asked to demonstrate their inhaler technique. Physician recommendation for an inhaler, cost of the inhaler device, and inhaler features related to convenience were important with respect to patient preferences. With regard to inhaler education, participants prefer verbal instruction and/or hands-on demonstration at the time a new inhaler is prescribed in the setting of the prescribing provider’s office.

Conclusion:  Patient preferences for inhaler devices and inhaler education among older adults indicate physician recommendation, cost, and convenience are important. The impact of patient preferences on inhaler adherence and clinical outcomes remains unknown.

Introduction

Inhalers represent the mainstay of treatment for most patients with chronic lung disease, especially obstructive lung diseases  (1,2). There are several different inhaler devices, including pressurized metered-dose inhalers, dry powder inhalers, soft mist inhalers, and nebulizers. Evidence suggests that different inhaler devices are equivalent with respect to drug delivery when the technique for appropriate utilization has been mastered (3,4). However, several factors may influence the ability to use an inhaler device properly, such as cognitive function, inspiratory flow rate, or hand strength and dexterity. These issues are particularly relevant to consider when prescribing inhaler devices for older adults (5-7).

The multitude of inhaler devices on the market is growing every day, and while this may allow providers to better tailor therapy to individual patient needs, it also increases the complexity of selecting an inhaler device (3,5). For prescribing providers, it is ever more challenging to consider all the potential factors that may influence both proper use of and adherence to inhaler therapy. Ideally, a provider would assess patient-level factors that impact proper device use and cost of the device to an individual patient, as well as patient preferences. Individual preferences may be shaped by prior experience with inhalers, exposure to advertising, advice from family and friends, lifestyle factors, comorbidities, recommendations from other healthcare providers, and a variety of other factors. Therefore, in selecting an inhaler device for a patient, it is important that providers consider factors beyond those that influence proper inhaler use, as patient preferences may impact adherence to therapy (3,5).

After providers identify an appropriate inhaler device that their patient is capable of using properly (considering physical and/or cognitive limitations) and that is selected based on patient preferences, the next obstacle to achieving maximal inhaler efficacy is ensuring the patient has been properly instructed on the multiple steps required for optimal medication administration from their inhaler device. While the importance of teaching patients about proper inhaler technique has been emphasized in international guidelines for the care of patients with asthma and chronic obstructive pulmonary disease (COPD) (1,2), there is limited information available about patient preferences for device instruction, especially in older adults, including timing, setting, and format of education.

The elderly represent an important population in which inhalers are frequently prescribed but the challenges of inhaler device selection are magnified (6-8). Accordingly, we conducted a single-center cross-sectional study to identify patient preferences for inhaler device features and inhaler device education among older adults in the ambulatory setting. The results of this study have been previously reported in the form of an abstract (9).

Methods

In order to assess patient preferences regarding inhalers, we developed a 25-item written questionnaire survey (see online supplement). In addition to patient preferences about inhaler device features and inhaler device education, the survey also assessed demographic information, medical history, patient experience with inhaler devices and prior device education, and perceived challenges to proper device use.

Participants were recruited from the ambulatory clinics (pulmonary and internal medicine) and pulmonary function laboratory at Banner University Medical Center in Tucson, Arizona between May 2014 and February 2015. Individuals were included if they were at least 65 years of age and had a history of chronic lung disease for which they were prescribed an inhaler device for at least six months. Those who were hospitalized, who did not speak English, or who were unable to read or write were excluded. Surveys were self-administered.

All participants provided written informed consent. This study was approved by the local institutional review board and was conducted according to the ethical principals of the Declaration of Helsinki.

Survey responses were subsequently recorded and tabulated in REDCap (https://projectredcap.org/). Categorical data was described using proportions (N(%)) and continuous data was described using mean with standard deviation (SD) or median with interquartile ratio (IQR).

Results

Fifty participants of mean age 74 (range 65-89) years completed the survey, including 22 men and 28 women (Table 1).

Table 1. Study Participant Demographic and Clinical Characteristics

N=50; continuous variables are described using mean (standard deviation) and categorical variables are described as n (%). *Physician diagnosis of respiratory disease; categories are not mutually exclusive and patients may report multiple diagnoses. COPD=chronic obstructive pulmonary disease.

The vast majority (96%) of participants were living at home, and most participants (78%) reported being independent with respect to activities of daily living. The participants were mostly well-educated, with 26% having completed college and 38% with a graduate degree. Comorbid conditions were common, including factors that may influence inhaler use and education, such as visual impairment (37%), hearing impairment (33%), and hand arthritis (22%). Almost all participants reported a physician diagnosis of chronic obstructive pulmonary disease (COPD) or asthma. In addition five patients also reported a history of interstitial lung disease; two of those had mixed history of asthma and ILD.

The majority of participants (80%) reported prior experience with a metered dose inhaler (MDI), but only 26% used an MDI with a spacer (Table 2).

Table 2. Prior Inhaler Devices Used and Prior Education Regarding Inhalers

N=50; categorical variables are described as n (%). *Categories are not mutually exclusive as patients may have been prescribed multiple inhaler devices by multiple providers and received formal instruction from multiple providers using multiple educational formats. MDI=metered dose inhaler, DPI=dry powder inhaler, Neb=nebulizer.

Most patients (76%) had received formal instruction regarding proper use of the inhaler, but only 34% had ever been asked to demonstrate their inhaler technique (Table 2). The majority of participants (66%) also reported no challenges to using their prescribed inhaler device properly (Table 3).

Table 3. Perceived Challenges Influencing Proper Use of Prescribed Inhaler

N=50; survey respondents could select more than one answer.

When asked to rate how well they understood the purpose of their inhaled medication (1=no understanding, 10=complete understanding), participants reported good understanding with a median rating of 8 (IQR 6-9). When asked to rate their confidence regarding how well they understood the proper use and handling of their inhaler device (1=no confidence, 10=very confident), participants reported a high level of confidence with a median rating of 9 (IQR 8-10).

When asked about the importance of various inhaler features with respect to their own individual preferences, participants provided a rating score ranging from 1 (not important) to 10 (very important) (Table 4).

Table 4. Patient Preferences Regarding Inhaler Features

N= 50; patient ratings are presented as median (IQR) scores and are based on a scale from 1 (not important) to 10 (very important).

Nearly all patients identified physician recommendation of an inhaler device as being very important with a median rating of 10 (IQR 10-10). Other inhaler features that were deemed important by most patients include device portability and short medication administration time. Some factors, such as whether or not an inhaler device required regular cleaning, afforded multiple doses, or was used once daily, received high median scores but demonstrated broader variability in overall response range. Cost of the inhaler was important to many patients as well with a median rating of 10 (IQR 4-10) (Table 4). Although the survey did not ask participants to compare devices, no significant difference was noted in the analysis regarding preferences between those taking nebulizers and those using DPI or MDI.

When asked about their preference for inhaler education format, participants indicated that they preferred hands-on demonstration and/or verbal instructions (Table 5).

Table 5. Patient Preferences Regarding Inhaler Device Education

*Some participants did not respond to all questions and thus denominator reflects total n that responded. Preferences are not mutually exclusive because participants could select multiple options.

The majority (70%) would like to receive this teaching at their prescribing doctor’s office, and most (71%) indicated they would like the education to occur at the time a new inhaler is prescribed (Table 5).

Discussion

In our cross-sectional survey of patient preferences in older adults with respiratory disease and prior inhaler experience, we determined that physician recommendation for a given inhaler and the cost of the inhaler were very important to patients. Moreover, patient preferences for inhaler features related to convenience were common, including device portability, once daily dosing, short medication administration time, and multiple-dose devices. The majority of patients also preferred an inhaler device that did not require routine cleaning, such as a nebulizer device. Providers may need to educate patients beyond the purpose of an inhaler by taking time to describe the reasons for selection of a particular inhaler, especially in cases where patient preferences are not aligned with provider objectives in selecting an appropriate inhaler device when there are patient-specific limitations to proper inhaler technique.

This is particularly important for older adults, as we demonstrated in our study that comorbidities that influence proper inhaler use are common among elder patients who have been prescribed inhalers (e.g. hand arthritis, sensory impairment, and stroke). However, in spite of this, we found in our study that spacers remain underutilized, with only a minority of patients who had experience with MDI also reporting prior use with a spacer. Using a spacer in conjunction with a MDI has been recommended for all patients because it minimizes the need for hand-breath coordination and facilitates better drug delivery ², but spacers are thought to be especially important for older adults who may experience additional challenges to proper inhaler technique (7,10). Arthritis that limits flexibility and coordination in the absence of weakness could also impact proper device administration.

Overall, study participants reported being quite confident that they understood how to properly use their inhaler, yet only a minority of patients had ever been asked to demonstrate how they use their inhaler. This is in contrast to international guidelines for obstructive lung disease that recommend checking inhaler technique at each visit. ^{1, 2} Participants also reported very few perceived challenges to proper inhaler use, and several individuals reported no challenges at all, even when they were permitted to provide their own free response in the survey. These findings suggest that patients may underestimate the complexity of inhaler delivery systems and may therefore underappreciate the importance of inhaler education. There are limited data to compare different devices in patients with chronic lung diseases and this was not addressed in our study; however, Komase et al. (11) found that DPI is a preferred device due to its ease of use and association with fewer errors.

Of note, study participants strongly preferred to receive inhaler education at the time a new inhaler is prescribed in the prescribing provider’s office. However, this may be challenging to implement in practice, given the vast number of inhaler devices on the market. Not all clinic staff may be familiar with the features of the different classes of inhaler devices, comparing MDI to DPI to nebulizer, much less feel comfortable teaching about the various features of different DPI devices that are now available. Moreover, placebo devices for patient teaching are not always readily available for each device, which makes it difficult to teach proper use at the time a new device is prescribed. Our study findings indicate participants preferred an educational format of verbal instruction and/or hands-on demonstration, but it may be more feasible for clinic staff to use a web-based video format for initial instruction while patients are still in the office setting and can ask questions as needed and they can then watch the video again at home. This should be followed by another clinic visit to assess proper inhaler technique using the patient’s own device shortly after the prescription is filled. Of course, this is particularly important for older adults because they are more likely to demonstrate errors in inhaler technique than younger patients (12).

To date, there is little evidence that taking into account patient preferences regarding inhaler devices results in improved clinical outcomes. However, preferences may influence multiple factors that are important for disease impact, including inhaler device adherence, health-related quality of life, and patient satisfaction with the selected device (13,14). Further research is needed to establish the relationship between patient preferences with inhaler devices and clinical outcomes in patients with obstructive lung disease. The limited evidence to date regarding patient preferences for inhalers suggests that patients find factors related to convenience very important, similar to our findings. For example, Molimard and colleagues (15) showed that dose recording, multiple-dose carrying, and daily dosing were important to patients with COPD and that delivery device features were more critical to patients than the medication compound that was delivered. Ease of use and ability to use the inhaler device during episodes of dyspnea were also found to be important DPI features in a European study of patients with asthma and COPD (16).

The major strengths of this study include that it is patient-centered with an emphasis on patient preferences for inhaler devices and inhaler education. Moreover, we focused on older adults because this special subpopulation often receives inadequate attention, especially in the study of patient preferences, and the physical and cognitive factors that influence proper inhaler use are particularly relevant among elders. We acknowledge that this study is limited in that we did not directly assess proper inhaler use among the participants but instead queried their understanding of proper inhaler use, and therefore we cannot definitively conclude if participants were overly confident or appropriately confident. It is also important to note that our study participants were predominantly Caucasian and also well educated, and therefore the patient preferences we observed may not be representative of all adults with chronic lung disease. Of note, we did not assess use of soft-mist inhalers (SMI) or preferences related to SMI in our survey because they were not widely available in our region at the start of this study.

Conclusion

In summary, patient preferences for inhaler devices and inhaler education among older adults indicate physician recommendation, cost, and convenience are important. Prescribing providers should explain their rationale for inhaler device selection and the importance of inhaler education because patient preferences may not always align with provider priorities or the individual patient-level physical and cognitive factors a provider may consider when selecting an inhaler device.

References

1. Global Initiative for Obstructive Lung Disease (GOLD). The Global Strategy for Diagnosis, Management and Prevention of COPD (updated 2016). Accessed July 18, 2016 at www.goldcopd.org.
2. Global Initiative for Asthma (GINA). The Global Strategy for Asthma Management and Prevention (updated 2016). Accessed July 19, 2016 at www.ginasthma.org.
3. Yawn BP, Colice GL, Hodder R. Practical aspects of inhaler use in the management of chronic obstructive pulmonary disease in the primary care setting. Int J Chron Obstruct Pulmon Dis. 2012;7:495-502. [CrossRef] [PubMed]
4. Dolovich MB, Ahrens RC, Hess DR, et al. Device selection and outcomes of aerosol therapy: Evidence-based guidelines: American College of Chest Physicians/American College of Asthma, Allergy, and Immunology. Chest. 2005 Jan;127(1):335-71. [CrossRef] [PubMed]
5. Geller DE. Comparing clinical features of the nebulizer, metered-dose inhaler, and dry powder inhaler. Respir Care. 2005 Oct;50(10):1313-21; discussion 1321-2. [PubMed]
6. Taffet GE, Donohue JF, Altman PR. Considerations for managing chronic obstructive pulmonary disease in the elderly. Clin Interv Aging. 2014;9:23-30. [CrossRef] [PubMed]
7. Barrons R, Pegram A, Borries A. Inhaler device selection: special considerations in elderly patients with chronic obstructive pulmonary disease. Am J Health Syst Pharm. 2011 Jul 1;68(13):1221-32. [CrossRef] [PubMed]
8. Jarvis S, Ind PW, Shiner RJ. Inhaled therapy in elderly COPD patients; time for re-evaluation? Age Ageing. 2007 Mar;36(2):213-8. [CrossRef] [PubMed]
9. Ghazala L, Bime C, Cortopassi F, Baalachandran R, Oren E, Berry CE. Inhaler device preferences in older adults with chronic lung disease. Am J Resp Crit Care Med. 2015;191(A5797) [Abstract].
10. Lavorini F, Mannini C, Chellini E, Fontana GA. Optimising Inhaled Pharmacotherapy for Elderly Patients with Chronic Obstructive Pulmonary Disease: The Importance of Delivery Devices. Drugs Aging. 2016 Jul;33(7):461-73. [CrossRef] [PubMed]
11. Komase Y, Asako A, Kobayashi A, Sharma R. Ease-of-use preference for the ELLIPTA® dry powder inhaler over a commonly used single-dose capsule dry powder inhaler by inhalation device-naïve Japanese volunteers aged 40 years or older. Int J Chron Obstruct Pulmon Dis. 2014 Dec 11;9:1365-75. [CrossRef] [PubMed]
12. Chorao P, Pereira AM, Fonseca JA. Inhaler devices in asthma and COPD--an assessment of inhaler technique and patient preferences. Respir Med. 2014 Jul;108(7):968-75. [CrossRef] [PubMed]
13. Anderson P. Patient preference for and satisfaction with inhaler devices. Eur Respir Rev. 2005;14(96):109-116. [CrossRef]
14. Shikiar R, Rentz AM. Satisfaction with medication: an overview of conceptual, methodologic, and regulatory issues. Value Health. 2004 Mar-Apr;7(2):204-15. [CrossRef] [PubMed]
15. Molimard M, Colthorpe P. Inhaler devices for chronic obstructive pulmonary disease: insights from patients and healthcare practitioners. J Aerosol Med Pulm Drug Deliv. 2015 Jun;28(3):219-28. [CrossRef] [PubMed]
16. Hawken NA, Amri I, Elmoctar Neine M, Aballea S, Torvinen S, Plich A. Preferences for Dry Powder Inhaler Attributes Among Patients With Asthma and Chronic Obstructive Pulmonary Disease From Five European Countries. Value Health. 2015 Nov;18(7):A364. [CrossRef] [PubMed]

Quick Look

Current Knowledge:

Inhalers are the mainstay of therapy for obstructive lung disease, but selection of a particular inhaler for an individual can be challenging, particularly in the elderly because of factors related to aging that may influence proper inhaler technique. Providers should also consider patient preferences, but little is known about preferences for inhaler devices among older adults.

What this paper contributes to our knowledge:

Patient preferences for inhaler devices and inhaler education among older adults indicate physician recommendation, cost, and convenience are important. Providers should consider individual patient factors that influence proper inhaler use along with patient preferences when selecting an inhaler.

Cite as: Ghazala L, Bime C, Cortopassi F, Golden T, Berry CE. Inhaler device preferences in older adults with chronic lung disease. Southwest J Pulm Crit Care. 2016;13(5):225-34. doi: https://doi.org/10.13175/swjpcc097-16 PDF

November 2016 Pulmonary Case of the Month

November 2016 Pulmonary Case of the Month

Anjuli M. Brighton, MB, BCh, BAO

Tania Jain, MBBS

Alan H. Bryce, MD

Ramachandra R. Sista, MD

Robert W. Viggiano, MD

Lewis J. Wesselius, MD

Pulmonary and Hematology/Oncology Departments

Mayo Clinic Arizona

Scottsdale, AZ USA

Pulmonary Case of the Month CME Information

Members of the Arizona, New Mexico, Colorado and California Thoracic Societies and the Mayo Clinic are able to receive 0.25 AMA PRA Category 1 Credits™ for each case they complete. Completion of an evaluation form is required to receive credit and a link is provided on the last panel of the activity. 

0.25 AMA PRA Category 1 Credit(s)™

Estimated time to complete this activity: 0.25 hours

Lead Author(s): Anjuli M. Brighton, MB.  All Faculty, CME Planning Committee Members, and the CME Office Reviewers have disclosed that they do not have any relevant financial relationships with commercial interests that would constitute a conflict of interest concerning this CME activity.

Learning Objectives:
As a result of this activity I will be better able to:

1. Correctly interpret and identify clinical practices supported by the highest quality available evidence.
2. Will be better able to establsh the optimal evaluation leading to a correct diagnosis for patients with pulmonary, critical care and sleep disorders.
3. Will improve the translation of the most current clinical information into the delivery of high quality care for patients.
4. Will integrate new treatment options in discussing available treatment alternatives for patients with pulmonary, critical care and sleep related disorders.

Learning Format: Case-based, interactive online course, including mandatory assessment questions (number of questions varies by case). Please also read the Technical Requirements.

CME Sponsor: University of Arizona College of Medicine at Banner University Medical Center Tucson

Current Approval Period: January 1, 2015-December 31, 2016

Financial Support Received: None

History of Present Illness

Our patient is a 76-year-old gentleman  who was referred based on an abnormal CT scan. He has a history of metastatic melanoma and had begun immunotherapy with pembrolizumab 10 months prior to admission. He had low grade fevers and chills and some dyspnea on exertion and dry cough. He also had a 6-8 pound weight loss over 4 weeks.

PMH, SH and FH

He has a history of hairy cell leukemia since 2009; squamous and basal cell cancers; and diabetes on insulin. He is a retired commercial banker and has a 15 pack-year smoking history.

Physical Examination

Physical examination showed and SpO2 of 90% on room air. His lungs were clear. He had numerous depigmented lesions on his skin.

Radiography

A thoracic CT scan was performed (Figure 1) and compared to a scan done 3 months prior which was considered unremarkable.

Figure 1. Video of representative images of contrast-enhanced thoracic CT scan in lung windows.

Which of the following best describe the CT scan? (Click on the correct answer to proceed to the second of four pages)

1. Normal
2. Mosaic pattern of lung attenuation
3. Numerous bronchial-associated ground glass opacities
4. Numerous pulmonary nodules
5. Numerous pulmonary nodules with a halo sign

Cite as: Brighton AM, Jain T, Bryce AH, Sista RR, Viggiano RW, Wesselius LJ. November 2016 pulmonary case of the month. Southwest J Pulm Crit Care. 2016:13(5):191-5. doi: http://dx.doi.org/10.13175/swjpcc098-16 PDF

Tobacco Company Campaign Contributions and Congressional Support of the Cigar Bill

Richard A. Robbins, MD

Phoenix Pulmonary and Critical Care Research and Education Foundation

Gilbert, AZ USA

Abstract

Although it is widely held that campaign contributions influence support for legislation, the impact of contributions is unclear. Despite lack of a tobacco growing or manufacturing constituency, many members of Congress (MOC) in the Southwest support the pro-tobacco Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2015 (HR 662/S 441), aka the "Cigar Bill". The association between campaign contributions from tobacco companies (2006-16) with cosponsor for the Cigar Bill were examined. There was a highly significant correlation with 92% of Southwest MOC who cosponsored the Cigar Bill having received campaign contributions. In contrast, 31% of those who did not cosponsoring the bill had received tobacco company campaign contributions (p<0.001 by Fisher's Exact Test). These data demonstrates a highly significant correlation between campaign contributions and legislative support for the "Cigar Bill".

Introduction

It is generally accepted that campaign donations buy influence from elected legislators. However, a review by Powell (1) states that "political scientists have had great difficulty determining whether and how much influence contributions have on the legislative process". Studies have been inconsistent with some demonstrating a linkage between campaign contributions and influence while others do not, suggesting that there are other influences in addition to contributions. Powell (1) has pointed out that the influence of donations is likely to occur early in the legislative process such as during cosponsorship for legislation or earmarks.

The Traditional Cigars Manufacturing and Small Business Jobs Preservation Act of 2015 (HR 662/S 441, aka the "Cigar Bill"), would permanently exempt hand-rolled and certain machine-rolled cigars from any sort of FDA regulation. This legislation is opposed by at least 20 medial and public health organizations including the American Thoracic Society (ATS), the parent organization of the state thoracic societies including those in the Southwest US (2). The ATS states that  “HR 662 would undermine the science-based process created by the Tobacco Control Act for determining the appropriate level of oversight of tobacco products. The bill would prohibit FDA from promulgating any public health protections related to 'traditional large and premium cigars'. The bill would specifically exempt from FDA oversight some machine made cigars, including those which can cost as little as $1.00. It also could allow some flavored cigars to qualify for an exemption. Inexpensive and flavored cigars such as strawberry, grape, cherry, and chocolate, are exactly the type of cigars attractive to young people.” Furthermore, the bill would create a giant regulatory loophole for the cigar industry to exploit, including advertising to children, growing the candy-flavored cigar market and returning to false advertising tactics such as "light" or "low tar", and allowing certain machine rolled cigars to be widely distributed.

The Southwest US is not a major center for tobacco growing or manufacturing (3). Furthermore, tobacco consumption tends to be low in Southwest US (4). Therefore, the Southwest is a good area to study the influence of campaign contributions on legislative behavior because of the lack of the confounding influence of a constituency that makes a living by tobacco growing or manufacturing and even has a low prevalence of smokers. In this context, we examined the correlation between prior campaign contributions to MOC and their cosponsorship of the "Cigar Bill".

Methods

Campaign Contributions

Tobacco company political action committee (PAC) contributions to Congressional candidates was obtained from the Campaign for Tobacco-Free Kids website (5). Contributions from the years listed (2006-14) were summed and no effort was made to separate recent from more past contributions. The data was examined for Southwest US Congressmen from Arizona, New Mexico, Colorado, California, Nevada and Hawaii. Appendix A shows contributions to individual Congressmen.

Cosponsorship of the "Cigar Bill"

HR 662 and S 441 were introduced in the 2015 Congress by Rep. Bill Posey (R-FL-8) and Sen. Bill Nelson (D-FL) respectively. Cosponsorship was obtained from Congress.gov (6,7). The bill was cosponsored by 165 members of the US House and 20 members of the US Senate. MOC who did or did not the "Cigar Bill" from Arizona, New Mexico, Colorado, California, Nevada and Hawaii are identified in Appendix B.

Statistics

The relationship between cosponsorship for the "Cigar Bill" and tobacco campaign contributions was done by Fisher's exact test using a 2X2 contingency table. Amounts of campaign contributions were expressed as mean + SD. The Mann-Whitney U test was used to calculate comparisons of the amounts of campaign contributions.

Results

Eighty-four percent of Southwest MOC who cosponsored the "Cigar Bill" had received tobacco campaign contributions. In contrast, only 31% of Southwest MOC not cosponsoring the "Cigar Bill" had received tobacco company campaign contributions (p<0.001 by Fisher's Exact Test). Furthermore, the amount of contributions was larger for those cosponsoring the bill $14024 + $18384 compared to those who did not $4165 + $11240 (p<0.01 by Mann-Whitney U test).

Discussion

This manuscript shows a relationship between tobacco campaign contributions and cosponsorship of the pro-tobacco "Cigar Bill". Furthermore, the campaign amounts tended to be larger to those supporting the legislation compared to those who did no cosponsor the bill. Taken together these data suggest an influence of campaign contributions on legislation.

There is no doubt that cigarette smoking is harmful. Cigarette use among adults and high school students is decreasing compelling US tobacco companies to search for new markets (8). The cigar market, especially the flavored cigar market, represents one strategy to increase tobacco consumption and profits. Flavored cigar and cigarette use is increasing in US middle and high school students (9). Tobacco manufacturers have a history of modifying their products to avoid public health protections or attain lower tax rates (2). Therefore, tobacco companies supporting the "Cigar Bill" is not surprising. By removing regulation the tobacco companies can increase advertising to children and grow the candy-flavored cigar market. Furthermore, it seems likely that cigar manufacturers will modify their products or change their manufacturing processes to qualify for the exemptions provided by the "Cigar Bill" thus increasing the number of cigars on the market.

The title of the HR 662/S 441 is deceiving. The Traditional Cigar Manufacturing and Small Business Jobs Preservation Act is titled to conjure up images of small businesses hand-rolling premium cigars. However, many of the cigars being manufactured would not appear to be the large, thick, and expensive cigars manufactured with fine tobacco but rather small, thin, cheap cigars that are often flavored. There is little tobacco growing or manufacturing in the Southwest US making it difficult for the Congressmen to claim that they are supporting local small business. The lack of a constituency raises the question of why Southwest Congressmen are supporting this bill.  

This manuscript has several limitations. First, it seems likely that more recent campaign contributions might have greater legislative influence. However, we do not have campaign contributions after 2014 and made no effort to separate more recent from past tobacco company campaign contributions. Second, receiving tobacco company campaign contributions and cosponsoring the "Cigar Bill" does not necessarily represent cause and effect. It seems likely that tobacco companies would be more likely to support legislators that they perceive are sympathetic. Third, as pointed out by Powell (1), the issue of buying influence is likely more complex. For example, at least 2 of the legislators in Arizona object to smoking on religious grounds but have taken tobacco company contributions.  

Political support for any candidate is a complex issue. However, during this election year voters might wish to examine the behavior of their elected representatives and factor in support of pro-tobacco legislation when casting their ballot.

References

1. Powell LW. The influence of campaign contributions on legislative policy. The Forum: A Journal of Applied Research in Contemporary Politics 2013;11(3):339-55. [CrossRef]
2. American Thoracic Society. ATS opposes cigar bill in Congress. ATS Perspectives. Available at: https://www.thoracic.org/about/ats-perspectives/ats-opposes-cigar-bill-in-congress.php (accessed 8/9/16).
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Cite as: Robbins RA. Tobacco company campaign contributions and congressional support of the cigar bill. Southwest J Pulm Crit Care. 2016;13(4):187-90. doi: http://dx.doi.org/10.13175/swjpcc076-16 PDF

October 2016 Pulmonary Case of the Month

Coya T Lindberg, BS¹

Ryan R Nahapetian, MD²

F Zahra Aly, MD, PhD, FRCPath³

¹University of Arizona College of Medicine Tucson, Tucson, AZ

²Division of Pulmonary, Allergy, Critical Care, and Sleep Medicine, University of Arizona, Tucson, AZ

³Brody School of Medicine at East Carolina University, NC

Pulmonary Case of the Month CME Information

Members of the Arizona, New Mexico, Colorado and California Thoracic Societies and the Mayo Clinic are able to receive 0.25 AMA PRA Category 1 Credits™ for each case they complete. Completion of an evaluation form is required to receive credit and a link is provided on the last panel of the activity. 

0.25 AMA PRA Category 1 Credit(s)™

Estimated time to complete this activity: 0.25 hours

Lead Author(s): Coya Lindberg, BS.  All Faculty, CME Planning Committee Members, and the CME Office Reviewers have disclosed that they do not have any relevant financial relationships with commercial interests that would constitute a conflict of interest concerning this CME activity.

Learning Objectives:
As a result of this activity I will be better able to:

1. Correctly interpret and identify clinical practices supported by the highest quality available evidence.
2. Will be better able to establsh the optimal evaluation leading to a correct diagnosis for patients with pulmonary, critical care and sleep disorders.
3. Will improve the translation of the most current clinical information into the delivery of high quality care for patients.
4. Will integrate new treatment options in discussing available treatment alternatives for patients with pulmonary, critical care and sleep related disorders.

Learning Format: Case-based, interactive online course, including mandatory assessment questions (number of questions varies by case). Please also read the Technical Requirements.

CME Sponsor: University of Arizona College of Medicine at Banner University Medical Center Tucson

Current Approval Period: January 1, 2015-December 31, 2016

Financial Support Received: None

A 49-year-old man presented with chest discomfort to an outside medical facility in Arizona. He was previously healthy and had no chronic medical diseases. Physical examination was unremarkable and he was afebrile. A chest X-ray was performed (Figure  1).

Figure 1. Initial chest x-ray

Which of the following is most likely? (Click on the correct answer to proceed to the second of five panels)

1. There is a large right chest mass
2. There is a loculated pleural effusion in the minor fissure
3. There is a right ventricular aneurysm
4. There is right lower lobe consolidation
5. There is right middle lobe consolidation

Cite as: Lindberg CT, Nahapetian RR, Aly FZ. October 2016 pulmonary case of the month. Southwest J Pulm Crit Care. 2016;13(4):152-8. doi: http://dx.doi.org/10.13175/swjpcc096-16 PDF