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Buyer Beware: Direct-to-Consumer Marketing Not Backed by Science

BALTIMORE, Sept. 10, 2021 /PRNewswire/ -- With the immense digital shift over the past few decades, the number of direct-to-consumer online companies has skyrocketed. Today, online markets are saturated with products and claims yet to be studied scientifically or regulated by the FDA, but are positioned to entice consumers. Three studies highlighting the importance of buyers being aware of these false claims, specifically in the direct-to-consumer marketing of erectile dysfunction or male infertility supplements, were presented during the 2021 American Urological Association (AUA) Annual Meeting. This virtual press session, moderated by Dr. Petar Bajic, is now available for viewing.

Watch Briefing

Abstracts presented:

Publication # MP36-13
Trends in Marketing, Pricing and Deployment of Shockwave Therapy for Erectile Dysfunction in U.S. Major Metropolitan Cities

The authors of this study sought to evaluate trends in marketing and implementation of shockwave therapy as a restorative treatment for erectile dysfunction in large metropolitan areas by investigating cost to patients, provider credentials and treatment protocols. Due to the increasing prevalence of erectile dysfunction and pronounced distress for patients, the shockwave therapy market has been largely dominated by GainsWave, a practitioner database and marketing platform that promotes the efficacy of shockwave therapy, despite limited evidence to support its claim.

Key findings include:

  • Patients are frequently seeking care for erectile dysfunction from non-urologists and more non-physician providers offer shockwave therapy than providers who completed training in urology.
  • Direct-to-consumer marketing is used to target distressed men, often with contradicting claims about the mechanism of therapy and the rates of cure. This is a concerning trend in major metropolitan markets, given the substantial financial impact for patients and inconsistent credentials among providers.
  • Across 7 of the most populous cities in the United States, 60 clinics offered shockwave therapy as treatment for erectile dysfunction and only 60 percent of clinics provided comprehensive information.

Publication # MP36-05
Contemporary Cost-Analysis Comparison of Direct-to-Consumer vs. Traditional Prescriptions of PDE5 Inhibitors

Consumers are now purchasing PDE5 inhibitors from online direct-to-consumer healthcare companies. The authors of this study sought to quantify the cost of phosphodiesterase inhibitors from online direct-to-consumer healthcare companies compared to a traditional physician visits and local pharmacy prescription fulfillment.

Key findings include:

  • Local pharmacies, in conjunction with online coupons, consistently provide a markedly less expensive option for fulfillment of PDEI prescriptions than online direct-to-consumer companies.
  • Less expensive options are most pronounced if a patient has flexibility in where he fills his prescription and can use the available local price.
  • Even including the cost of a physician visit, the traditional pharmacy was still less expensive than direct-to-consumer companies.

Publication # MP31-18
Online Male Infertility Supplements: A Growing Market Without Growing Evidence

The authors of this study examined the current online market for male infertility supplements and evaluated the clinical evidence of their ingredients. Amazon, Google Shopping and Walmart search engines were queried for currently available male infertility supplements and customer reviews, supplement costs, claims and ingredient information were collected.

Key findings include:

  • Patients should be warned of the large number of male infertility products on the market that have little to no evidence of improving fertility and may increase the burden of cost on patients who may eventually require artificial reproductive technology.
  • Male infertility supplements include ingredients that have not been found to have the advertised effect or have never been tested in human trials.
  • 70% of products claimed to improve sperm motility; 63% claimed to increase sperm count; and 12% claimed to increase the chance of conceiving.

"Today's consumer is faced with an abundance of information and advertising that promotes a wide range of treatments, medicines and alternative therapies," Dr. Bajic said. "This information is not always easily navigable by patients and, in some cases, may be misleading. It's more important than ever to have conversations with your doctor about information found online." 

Full abstracts can be viewed:
https://www.auajournals.org/doi/10.1097/JU.0000000000002045.13 
https://www.auajournals.org/doi/10.1097/JU.0000000000002045.05 
https://www.auajournals.org/doi/10.1097/JU.0000000000002035.18

About the American Urological Association: Founded in 1902 and headquartered near Baltimore, Maryland, the American Urological Association (AUA) is a leading advocate for the specialty of urology, and has more than 22,000 members throughout the world. The AUA is a premier urologic association, providing invaluable support to the urologic community as it pursues its mission of fostering the highest standards of urologic care through education, research and the formulation of health policy.

MP36-13

Trends in Marketing, Pricing and Deployment of Shockwave Therapy for Erectile Dysfunction in U.S. Major Metropolitan Cities

James M. Weinberger*, Los Angeles, CA, Gary Shahinyan, Aurora, CO, Shangyang Christopher Yang, Robert Shahinyan, Jesse N. Mills, Sriram V. Eleswarapu, Los Angeles, CA

Introduction: Due to the increasing prevalence of erectile dysfunction (ED) and pronounced distress for patients, a market for shockwave therapy (SWT) has emerged. The shockwave market segment has largely been dominated by GainsWave, a practitioner database and marketing platform that has promoted the efficacy of shockwave for ED despite limited evidence supporting its claim. We sought to evaluate trends in marketing and implementation of SWT as a restorative treatment for ED in large metropolitan areas by investigating cost to patients, provider credentials, and treatment protocols.

Methods: SWT providers in seven of the most populous metropolitan areas were identified using google search. Search queries included: "Shockwave therapy for erectile dysfunction in [city]"; "Shockwave therapy for ED in [city]"; "GainsWave in [city]". All clinics advertising SWT for ED within the boundaries of the selected metropolitan area were included; clinics were contacted by telephone, with the goal of identifying the pricing, duration, and provider administering the treatment.

Results: Across 7 of the most populous cities in the U.S., 60 clinics offered SWT as a treatment for ED. Comprehensive information was available for 60% of clinics. Only 10% of providers offering SWT were urologists, while 13% were not physicians. Table 1 highlights cost of SWT and provider credentials across each metropolitan area. Treatment duration was highly variable and ranged from one to indefinite courses based on individual patient circumstance.

Conclusions: SWT, as a restorative therapy for ED, is performed primarily by non­urologists and is not standardized. More non-physician providers offer SWT for ED than providers who completed training in urology. Across all clinics, direct-to-consumer marketing is used to target distressed men, often with contradicting claims about the mechanism of therapy and the rates of cure. The AUA and SMSNA classify SWT as an experimental therapy, indicating that patients should not be charged for receiving it. This study highlights concerning trends in major metropolitan markets, given the substantial financial impact for patients and inconsistent credentials among providers. Further, these findings suggest that patients are frequently seeking care for ED from non-urologists

MP36-05

Contemporary Cost-Analysis Comparison of Direct-to-Consumer vs. Traditional Prescriptions of PDE5 inhibitors

Douglas Schneider*, Farouk El-Khatib, Orange, CA, Lawrence Jenkins, Tucson, AZ, Faysal Yafi, Orange, CA

Introduction: Online direct to consumer (DTC) healthcare companies have begun prescribing phosphodiesterase inhibitor (PDEi) therapy after a text screen and focused telehealth visit. Prescription of PDEis has unknown costs relative to the traditional office visit, especially with the availability of online discounts. To inform physicians on how best to advise their patients to economically fill their prescriptions, this study seeks to quantify the cost of OTC PDEi treatment compared to a traditional physician visit and local pharmacy prescription fulfillment.

Methods: Nine pharmacies were included, including two DTC companies and seven national pharmacy chains, representing all locally available chains. National pharmacies which are subsidiaries were grouped together. Prices for chains were determined using their publicly available price on GoodRx® with coupon in Orange County, CA. Cost of physician visit was determined using 2020 CMS reimbursement for a level 3 new patient visit. Prices for DTC companies were acquired from direct communication with the company. Where offerings did not align with 90 dose regimens, price per pill was determined and price for 90 doses was calculated.

Results: For a 90 dose supply of sildenafil 20mg, a physician visit and local prescription cost a mean of $198.19, with a low of $127.36, compared to a mean of $220 and a low of $180.00 for online DTC. For sildenafil 100mg, a physician visit and local prescription had a mean cost of $617.97 with a low cost of $137.16, compared to a mean and low cost of $900.00 for DTC. For tadalafil 5mg, a physician visit and local prescription cost a mean of $221.89, with a low of $126.61, compared to an average and low of $720.00 for DTC. Finally, for tadalafil 20mg, a physician visit and local prescription cost a mean of $763.17, with a low of $155.32, compared to a mean of $3420.00 and a low of $2880.00 for DTC (Table 1).

Conclusions: In addition to the established benefits of physician visits for screening, our investigation suggests that local pharmacies, in conjunction with online coupons, consistently provide a markedly less expensive option for fulfillment of PDEi prescriptions than online DTC services. This is most pronounced if a patient has flexibility in where he fills his prescription and can use the available local price.

MP31-18

Online Male Infertility Supplements: A Growing Market Without Growing Evidence

Igor Inoyatov, Spencer Mossack, Michael Hung*, Varun Talanki, James Rail, David Schulsinger, Yefim Sheynkin, Stony Brook, NY

Introduction: The current American Urological Association guidelines state no clear recommendation can be made for the treatment of male infertility using antioxidants. While many supplements have been shown in small, low quality studies to improve semen parameters, few, if any have been shown to actually improve natural conception rates or live birth rates. We aim to examine the current online market for male infertility supplements and evaluate the clinical evidence of their ingredients.

Methods: Amazon, Google Shopping and Walmart search engines were queried for currently available male infertility supplements. Customer reviews, supplement costs, claims and ingredient information were collected. The active ingredients were then compared with known supplements included in randomized controlled trials (RCTs) for subfertile men.

Results: A total of 243 products were reviewed across the 3 online marketplaces and 30 distinct supplements were analyzed containing a total of 73 ingredients. We found that 70% of the products claimed to improve sperm motility, 63% claimed to increase sperm count, and 12% claimed to increase the chance of conceiving. The average 30 day cost per product was $35.10 and 4 products made "money back guarantees." At least half the products contained Zinc (57%), Folic Acid (53%), L-Carnitine (50%) and Selenium (50%). The most reviewed product accumulated 1214 reviews with an average rating of 4.48/5 stars. Of the 73 ingredients reviewed, 58.9% of them have never been studied in human clinical trials on male infertility. In total, 12 of the 15 most common ingredients were cited in human clinical trials. Only 2/15 (13%) ingredients (Vitamin E and Zinc) have been shown to improve conception rates while 6/15 (40%) ingredients have been shown to increase semen parameters.

Conclusions: The online market for male infertility supplements is saturated with products claiming to improve semen parameters and the chance of conceiving. While comparatively less expensive than artificial reproductive technology (ART), many include ingredients that have either not been found to have the advertised effect or have never been tested in human trials. Patients should be warned of the large number of male infertility products on the market that have little to no evidence of improving fertility, and may increase the burden of cost on patients who may eventually require ART.

Contact:
Christine Frey, AUA
443-909-0839,
cfrey@AUAnet.org

SOURCE American Urological Association