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WASHINGTON (AP) — How do you get men excited about decades-old pills for hair loss, erectile dysfunction and other potentially embarrassing health conditions?
Online startups including Hims and Roman are banking on a mix of convenience, viral marketing and glossy packaging to turn generic prescription drugs and other pharmacy staples into a profitable new business model. But some in the medical establishment are raising concerns about their marketing and the quality of care they provide.
"There are both opportunities to improve access to care, but also risks to patients, and I think regulators are having to address that," said Lisa Robin, an executive with the Federation of State Medical Boards, which represents the organizations that license and discipline physicians.
The group has been advising U.S. physicians to carefully consider "their professional and ethical duties" before signing up to work for the companies.
Hims and Roman each said in separate statements that their doctors are required to deliver the same standard of care on their platforms as they do in person.
Like other on-demand services, Hims and Roman promise consumers quick, convenient access to what they want. That means customers essentially self-diagnose, selecting the medication of their choice and — pending approval by a doctor — receive the prescription by mail or through a local pharmacy. In place of a traditional exam, patients answer a battery of questions about their symptoms, medical history, allergies and other details.
Similar companies specialize in contraceptives, sleep medications and pills for anxiety. Backing the trend are millions in venture dollars from investors searching for the next Warby Parker or Dollar Shave Club — blockbuster online brands that have upended the markets for eyeglasses and razors by cutting out traditional retailers.
Dr. Adriane Fugh-Berman, who studies pharmaceutical marketing, worries the companies are minimizing the role of health professionals in carefully diagnosing and treating patients.
"These are lifestyle drugs, and they have potentially serious adverse effects, and this seems like too casual a way to be obtaining them," said Fugh-Berman, a professor at Georgetown University.
Potential side effects of Viagra include dizziness, blurred vision, muscle pain and sudden hearing loss. The female libido drug Addyi, which is also available through the websites, can cause fainting when combined with alcohol.
In some cases, the websites promote prescription drugs for unapproved uses, such as blood pressure drugs to reduce anxiety.
Hims' website touts blood pressure-reducing beta blockers as a way to ease "performance anxiety during your big event — like a big presentation at work or interview."
While that kind of "off-label" prescribing is common for many physicians, drugmakers are barred from advertising such uses because they have not been federally approved. The online startups, echoing Uber and other Silicon Valley startups, say they are technology companies and are therefore not subject to those rules.
The FDA didn't comment on the websites but said in a statement that off-label drug use "should be a conversation between the consumer and the health care provider."
Prescription drugs sold by Hims and Roman — both founded in 2017 — are available at most pharmacies nationwide. And retail giants like Walmart and CVS Health also offer medical consultations through apps and websites. So what's new here?
Hims' 30-year-old founder, Andrew Dudum, says his company is revamping the process "so people can have an amazing experience" and get "extremely beautiful products."
Hims — which also sells shampoo, vitamins and other consumer items — puts its products in discrete, minimalist packaging stamped with the company name. Its female-focused site, Hers, similarly offers custom-wrapped medications for low-sex drive alongside hair and skin products.
Customers are invited to "Shop Sex" or "Shop Hair," alongside Instagram-ready photos of young models and messages like: "we're here to help reduce the stress and guesswork out of your sexy time."
Roman CEO Zachariah Reitano, 28, says his company offers customers a chance "to talk about these things that can be highly stigmatized."
But real-time communication between doctor and patient doesn't always happen.
Telemedicine laws vary by state, and in many cases physicians can write prescriptions after simply reviewing a patient's stored responses to online questionnaires. Sometimes doctors will need to seek extra details via text messages or a phone call. Roman's website gives an example of a typical transaction in which the patient spends 20 minutes providing information and the physician spends two minutes reviewing it.
That's about the same length as a traditional U.S. office visit, according to data published two years ago. And Roman and Hims say their model is more convenient, discrete and often cheaper than the traditional office visit.
But customers looking for savings might be disappointed. Hims, Roman and most of their counterparts don't take insurance, and instead charge a cash fee.
Most of the drugs they sell can be found for less using prescription discount apps like GoodRx, which identifies the best prices at local pharmacies and applies coupons.
For instance, Hims sells the generic form of the hair loss drug Propecia at $28.50 for a month's supply, versus $11 at many national chains like Walmart or CVS.
Hims said in a statemejpoernt it offers "enormous value" and convenience by eliminating trips to the doctor, pharmacy visits and insurance copay fees.
A spokesman for Roman declined to comment on its prices.
As consumers increasingly migrate to the web for health services, experts say telemedicine will become more common. But even proponents of the technology stress the importance of maintaining conventional standards of care.
Many large hospitals and insurers offer online consultations, while also giving physicians access to patients' full medical records.
In the case of someone seeking a beta blocker for anxiety, a physician might notice that the patient had an irregular heart reading at a previous checkup. That might signal a potential safety issue since beta blockers can sometimes cause a dangerously slow heart rate.
Dr. Jonah Feldman says that kind of detail might be missed by an online service relying solely on patient-provided information.
The new websites "are really moving backward to a more fragmented version of care," said Feldman, a medical technology specialist at New York University's Winthrop hospital in New York.
Follow Matthew Perrone on Twitter: @AP_FDAwriter
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