FDA Safety Warnings and Trends in Testosterone Marketing to Physicians

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The American Journal of Managed Care, March 2022, Volume 28, Issue 3

This article presents an evaluation of testosterone marketing practices around the period of the testosterone label warning by physician specialty and rural vs urban primary care service area.

ABSTRACT

In response to study findings showing the risk of cardiovascular adverse events associated with testosterone therapy, the FDA issued safety warnings in 2014 and modified testosterone labeling in March 2015 to indicate the increased risk of stroke and heart attack. It is unknown whether there were changes in testosterone marketing practices by pharmaceutical companies following the FDA label warning. Both primary care physicians (PCPs) and non-PCPs prescribe testosterone and are targeted by pharmaceutical marketing representatives to encourage testosterone prescribing. Likewise, pharmaceutical marketing occurs in both urban and rural areas. Our study is the first to examine testosterone marketing practices around the period of the testosterone label warning by physician specialty and rural vs urban primary care service area.

In this study, we found that testosterone marketing efforts such as marketing spending per encounter, quarterly marketing spending per physician, and quarterly number of encounters per physician increased among non-PCPs and urban physicians for 4 quarters following an FDA boxed warning in 2015 on testosterone prescriptions. After the black box warning, off-label testosterone advertisements stopped. This reduction in advertising could have made it more attractive for pharmaceutical companies to increase their marketing spending targeting non-PCPs and physicians in urban areas. Understanding responses of pharmaceutical companies to FDA guidelines is important and can help inform future guideline initiatives.

Am J Manag Care. 2022;28(3):e78-e79. https://doi.org/10.37765/ajmc.2022.88841

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In response to study findings showing the risk of cardiovascular adverse events associated with testosterone therapy, the FDA issued safety warnings in 2014 and modified testosterone labeling in March 2015 to indicate the increased risk of stroke and heart attack.1 It is unknown whether testosterone marketing practices by pharmaceutical companies changed after the label warning. Both primary care physicians (PCPs) and non-PCPs prescribe testosterone and are targeted by pharmaceutical marketing representatives to encourage prescribing. Likewise, such marketing occurs in both urban and rural areas. Our study is the first to examine testosterone marketing practices around the time of the label warning by physician specialty and rural vs urban primary care service area (PCSA).

METHODS

We identified physicians who received testosterone marketing spending from the CMS Open Payment Database between August 2013 and December 2017 and constructed 3 outcome measures for testosterone marketing for each physician–quarter-year observation: number of marketing encounters, marketing spending per encounter, and total marketing spending per physician.

We estimated linear regressions for each of the outcome variables, adjusting for indicators of quarter-year, physician Census region, physician location in a rural PCSA (vs urban), and physician specialty (PCP or not). To examine whether the marketing outcome variables were different by PCPs vs non-PCPs in any given quarter-year, we also included interactions of the PCP indicator with each quarter-year. In separate models, to examine differential adjusted outcomes by physician rural/urban status, we included interactions of the physician rural location indicator with each quarter-year. We then presented adjusted outcome variables by physician specialty and rural/urban status with CI bands over each quarter in the study period.

RESULTS

The open payment sample contained 54,365 unique physicians, of whom 38.97% were PCPs and 90.32% were located in urban PCSAs. By Census region, 43.03% were from the South; 19.44%, Midwest; 18.95%, Northeast; and 18.58%, West.

Throughout the study period, non-PCPs received more marketing encounters per physician than PCPs, as did urban physicians compared with rural physicians (eAppendix Figures 1 and 2 [eAppendix available at ajmc.com]). For non-PCPs and urban physicians, all marketing outcome variables increased following the FDA warning in quarter 1 of 2015 and stayed higher for an additional 3 quarters before returning to levels similar to those prior to the FDA warning (Figure and eAppendix Figures 1-5). For example, in quarter 1 of 2015—the quarter of the FDA warning—total marketing spending per non-PCP was $278.26 more than per PCP (95% CI, $240.88-$315.65; P < .001) (Figure), marketing spending per encounter was $40.36 more than per PCP (95% CI, $29.41-$51.30; P < .001) (eAppendix Figure 3), and number of encounters per non-PCP was 0.15 more than per PCP (95% CI, 0.08-0.22; P < .001) (eAppendix Figure 1). For periods outside the immediate 4 quarters following the FDA label warning, total marketing spending per physician and spending per encounter for non-PCPs were not significantly different from those for PCPs (Figure and eAppendix Figure 1).

DISCUSSION

Pharmaceutical companies spend money on marketing to influence and increase physician drug prescriptions and boost sales.2 In this study, we found that testosterone marketing efforts such as marketing spending per encounter, quarterly marketing spending per physician, and quarterly number of encounters per physician increased among non-PCPs and urban physicians for 4 quarters following an FDA boxed warning in 2015 on testosterone prescriptions. After the black box warning, off-label testosterone advertisements stopped.3 This reduction in advertising could have made it more attractive for pharmaceutical companies to increase their marketing spending4 targeting non-PCPs and physicians in urban areas. Other studies’ findings have showed that non-PCPs prescribe testosterone more than PCPs5 and that men in urban areas are more likely to choose testosterone replacement therapy than their counterparts in rural areas,6 making non-PCPs and urban areas a more suitable target for pharmaceutical marketing.

Author Affiliations: Division of Health Policy and Management, University of Minnesota School of Public Health (AT), Minneapolis, MN; Department of Finance, Medical Industry Leadership Institute, University of Minnesota Carlson School of Management (AS, PK-M), Minneapolis, MN.

Source of Funding: This research was supported by funding from the Agency for Healthcare Research and Quality (R01 HS025164, PI: Karaca-Mandic).

Author Disclosures: Dr Karaca-Mandic reports funding from the Agency for Healthcare Research and Quality (R01 HS025164) during the conduct of the study; personal fees from Tactile Medical, Precision Health Economics, and Sempre Health; and grants from American Cancer Society, National Institute for Health Care Management, National Institute on Drug Abuse, and National Institutes of Health outside the submitted work. The remaining authors report no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this article.

Authorship Information: Concept and design (AT, AS, PK-M); acquisition of data (PK-M); analysis and interpretation of data (AT, AS, PK-M); drafting of the manuscript (AT, AS, PK-M); critical revision of the manuscript for important intellectual content (AT, AS, PK-M); statistical analysis (AT, AS, PK-M); provision of patients or study materials (AT, AS); obtaining funding (PK-M); and supervision (AT, AS, PK-M).

Address Correspondence to: Pinar Karaca-Mandic, PhD, University of Minnesota Carlson School of Management, 321 19th Ave S, Minneapolis, MN 55455. Email: pkmandic@umn.edu.

REFERENCES

1. FDA Drug Safety Communication: FDA cautions about using testosterone products for low testosterone due to aging; requires labeling change to inform of possible increased risk of heart attack and stroke with use. FDA. Updated February 26, 2018. Accessed March 19, 2021. https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-cautions-about-using-testosterone-products-low-testosterone-due

2. Fickweiler F, Fickweiler W, Urbach E. Interactions between physicians and the pharmaceutical industry generally and sales representatives specifically and their association with physicians’ attitudes and prescribing habits: a systematic review. BMJ Open. 2017;7(9):e016408. doi:10.1136/bmjopen-2017-016408

3. Morden NE, Woloshin S, Brooks CG, Schwartz LM. Trends in testosterone prescribing for age-related hypogonadism in men with and without heart disease. JAMA Intern Med. 2019;179(3):446-448.
doi:10.1001/jamainternmed.2018.6505

4. Bandari J, Ayyash OM, Emery SL, Wessel CB, Davies BJ. Marketing and testosterone treatment in the USA: a systematic review. Eur Urol Focus. 2017;3(4-5):395-402. doi:10.1016/j.euf.2017.10.016

5. Jasuja GK, Bhasin S, Rose AJ, et al. Provider and site-level determinants of testosterone prescribing in the Veterans Healthcare System. J Clin Endocrinol Metab. 2017;102(9):3226-3233. doi:10.1210/jc.2017-00468

6. Rosen RC, Seftel AD, Ruff DD, Muram D. A pilot study using a web survey to identify characteristics that influence hypogonadal men to initiate testosterone replacement therapy. Am J Mens Health. 2018;12(3):567-574. doi:10.1177/1557988315625773