Studies highlight costs, risks with direct-to-consumer men’s health products

A group of studies presented at the 2021 American Urological Association annual meeting illustrate the costs and risks inherent to seeking care for men’s health-related conditions online and/or from non-urologists.

The studies were presented in a press briefing moderated by Petar Bajic, MD, of the Center for Men’s Health at the Glickman Urological and Kidney Institute in Cleveland, Ohio.

Shock Wave therapy

In the first study, James Weinberger, MD, MBA, reported on results of a study evaluating shock wave therapy for erectile dysfunction in 7 major US cities.¹

“Shock wave therapy has emerged as a restorative therapy for referrals for erectile dysfunction in the second-line setting. The shock wave therapy market segment has largely been dominated by GAINSWAVE, a practitioner database and direct-to-consumer advertising platform that has promoted the efficacy of shock wave therapy for erectile dysfunction, despite limited evidence supporting its claim,” explained Weinberger, a urology resident at the David Geffen School of Medicine at the University of California, Los Angeles, working with Sriram Eleswarapu, MD, PhD, and colleagues.

For their study, the investigators used Google search to identify shock wave therapy providers across 7 major metropolitan areas (Atlanta, Georgia; Boston, Massachusetts; Dallas, Texas; Los Angeles, California; New York, New York; Philadelphia, Pennsylvania; and Washington DC). Search terms used included “Shockwave therapy for erectile dysfunction in [city],” “Shockwave therapy for ED in [city],” and “GAINSWAVE in [city].” Clinics had to explicitly advertise shock wave therapy and be located within the boundaries of 1 of the metropolitan areas to be included in the analysis. The investigators obtained information via phone, specifically inquiring about providers administering treatment as well as pricing and duration of treatment. Clinics were excluded from the analysis after 3 failed attempts at contact.

Sixty clinics that offered shock wave therapy for erectile dysfunction were identified, out of which 60% offered comprehensive information about providers, pricing, and duration.

The average price was $3559 per treatment course (range, $650-$10,800). Across the 7 metropolitan areas, an average of 10% of providers were trained in urology, and 13% were non-physician providers.

“Level 1 data on shock wave therapy for ED is still pending. It should not be marketed as having such. Importantly, erectile dysfunction can portend significant morbidities. If patients are exploring treatment in the second-line setting, they should really be evaluated by [a] urologist, who can perform a formal men’s health evaluation,” Weinberger said.

Prescription costs for PDEis

A second study sought to compare costs of prescriptions for phosphodiesterase inhibitors (PDEi) when obtained from online direct-to-consumer (DTC) companies vs a traditional physician visit.²

For the study, the investigators evaluated pricing for 90-day supplies of sildenafil (Viagra), 20 mg and 100 mg, and tadalafil (Cialis), 5 mg and 20 mg. Two DTC companies, 2 compounding pharmacies, 3 Canadian pharmacies, and 16 local American pharmacy chains in 5 zip codes were included in the analysis. Direct communication was used to obtain DTC and compounding and Canadian pharmacies pricing, whereas pricing for local pharmacies was obtained through GoodRx with an online coupon. The price for a physician visit was determined based on 2020 Centers for Medicare & Medicaid Services reimbursement.

“We found that physician visit with a local pharmacy prescription with the coupon consistently produced the lowest available prices. Online direct-to-consumer consistently provided the most expensive option for fulfilling PDEi prescriptions. These effects were most pronounced at higher doses and with tadalafil compared with sildenafil,” said first author Dennis Schneider, BS, a fourth-year medical student at the University of California, Irvine, working with Faysal A. Yafi, MD, FRCSC, and colleagues.

The price difference between online DTC and physician visit with a local pharmacy was $54.55 for sildenafil 20 mg, $762.84 for sildenafil 100 mg, $594.20 for tadalafil 5 mg, and $2719.00 for tadalafil 20 mg.

Male infertility supplements

In the third study presented during the briefing, investigators evaluated supplements related to male infertility.³

The investigators queried the online marketplaces Amazon, Google Shopping, and Walmart for currently available male infertility supplements. They collected customer reviews and data regarding costs, ingredients, and advertised claims. They then compared the active ingredients to the current literature of randomized controlled trials of supplements.

The investigators analyzed 30 distinct supplements, from which 73 total ingredients were found. Zinc (57%), folic acid (53%), L-Carnitine (50%), and selenium (50%) were the most common active ingredients identified.

“The majority of these ingredients—almost 60% of them—were not studied in human trials. I thought that was 1 of our most important findings,” said first author Igor Inoyatov, MD, urology resident at Renaissance School of Medicine at Stony Brook University, Stony Brook, New York, working with Yefim R. Sheynkin, MD, FACS, and colleagues.

Additionally, only zinc and vitamin E have been shown to improve fertility rates, Inoyatov said.

Analyzing the products’ claims, 70% claimed to improve sperm motility, 63% claimed to increase sperm count, and 12% claimed to increase chance of conception. Average 30-day cost per product was $35.10.

“While they’re relatively less expensive than artificial reproductive technology, these ingredients are not backed up by proven clinical efficacy,” Inoyatov said.

References

1.Weinberger J, Shahinyan R, Yang SC, et al. Trends in marketing, pricing, AND deployment of shock wave therapy for erectile dysfunction in U.S. major metropolitan cities. Paper presented during the 2021 American Urological Association annual meeting. September 10-13; virtual. Abstract MP36-13

2. Schneider D, El-Khatib F, Jenkins L, Yafi F. Contemporary cost-analysis comparison of direct-to-consumer vs. traditional prescriptions of PDE5 inhibitors. Paper presented during the 2021 American Urological Association annual meeting. September 10-13; virtual. Abstract MP36-05

3. Inoyatov I, Mossack S, Hung M, et al. Online male infertility supplements: a growing market without growing evidence. Paper presented during the 2021 American Urological Association annual meeting. September 10-13; virtual. Abstract MP31-18