Direct-to-consumer platforms are on the rise for weight loss drugs, testosterone treatments, hair loss treatments, libido concerns, supplements, and antidepressants.
Sales are skyrocketing as customers benefit from anonymity and lower fees.
Patient safety and patient access should both be prioritized in the same capacity.
What are the benefits of ordering a cost-saving medication with the tap of your finger, and more importantly, what are the risks?
After four different at-home sleep tests, one incorrect diagnosis of sleep apnea, a $790 visit to the emergency room, two urgent care visits, four EKGs, and two chest exams, I ended up having a B12 vitamin deficiency.
Before discovering the deficiency due to incorrect lab results and my doctor being booked for four weeks, I was desperate to find a solution.
I decided to sign up for a popular platform that I was continuously getting advertisements for that prescribes medications that range from libido gummies to general vitamins. After a ten-minute questionnaire on an iPhone messaging app, the company charged my card for a prescription. And just like that, I was sent a bottle of the antidepressant Zoloft.
While, yes, I was given a prescription, I felt uneasy about the process. It was too quick, too easy to lie. Moreover, I was expecting something like a beta blocker, more of a chill pill rather than a drug known for emotional blunting. Did I really need Zoloft? Was my anxiety that bad? What if I didn't even have anxiety? Can just anyone get prescriptions like this?
Online prescription shopping is on the rise
When Amazon Pharmacy opened its browser in 2020, people were able to purchase their medications alongside their toilet paper and cleaning supplies. With the company owning 52% of America's online retail market, suddenly, picking up your pills wasn't that difficult anymore.
Some companies like Teladoc, Amwell, and MDLIve take prescriptions and offer urgent care services, psychiatry, and primary care. Other companies like Him&Hers, Apostrophe (a brand of Him&Hers), and Roman focus on a variety of conditions ranging from dermatology to weight loss to mental health. And they don't take insurance. Patients only pay a small amount, and their order is secured.
These types of companies are bringing in big money, too. Nurx, a telehealth company that delivers birth control, HIV medication, and PrEP to people in need in rural areas, raised $41 million dollars before it was acquired by Thirty Madison in 2022. Now, it's raised $210 million. Hims&Hers and Ro both raised $100 million dollars each.
Until the COVID-19 pandemic, telemedicine and telehealth were largely underused. But now, telemedicine is thriving as patients see cost-saving benefits, as well as less travel time and less wait time. Moreover, it benefits doctors, too.
"You don't have to have a clinic; you have an app. One doctor could prescribe hundreds of medications in a day as opposed to, say, 20 visits," explains Dr. Ateev Mehrotra, M.D., M.P.H., an associate professor of health care policy and medicine at Harvard Medical School and a staff physician at Beth Israel Deaconess Medical Center.
Hims had 1.4 million subscribers in 2023, and they expect to make 1.2 billion in sales by 2025. The growth in demand and popularity is surging with investor money, as well as physician and customer interest. Clearly, this type of subscription-based telemedicine isn't going away anytime soon.
In an email interview, a spokesperson from the General Pharmaceutical Council in the UK says that online health services are growing in part because of the pandemic and also because there are changes in how people are accessing medical information, advice, and services.
"There can be significant benefits for patients using online services to get medicines and treatment, but there are also significant risks that need to be managed to protect patient safety," they said.
The dangers of securing online medications
The promise of fuller hair, better libido, stronger erections, or a smaller waistline can all be satisfied by signing up for one of the several services available in today's digital world. But there's a long list of dangerous incidents that have involved improper drug purchases in the past few years. In 2022, an Australian woman became septic after ordering medication online for a urinary tract infection. In late 2023, Austrians were hospitalized for taking counterfeit Ozempic ordered online. And there have been several recent deaths in the United Kingdom traced back to fake online pharmacies.
Many websites offering harder drugs like morphine and painkillers are popping up on the black market. These types of websites are more sinister, offering a "no prescription, no problem" marketing ploy. By shipping medications from India and Pakistan, the websites serve as drug mills, violating regulations with the United States and the U.K.
Another concern is self-diagnosing, like in my case, where the customer may not even be sure they know what they have but decide to seek help on their own. A 2023 Tebra survey found that 25% of their 1,000 participants used social media to diagnose themselves. Others may do so out of the need for privacy.
In a paper by Northern University Illinois Law Review from 2021, the author mentions how medical practitioners are able to take vital signs in person, like blood pressure and heart rate. Online websites, apps, and telehealth services can't take your vitals through the phone.
However, some clinics blur the lines when it comes to accurate vitals that the patients supply.
Dr. Justin Dubin, M.D., a urologist and men's health specialist in South Florida, conducted research where he went undercover as a secret shopper for direct-to-consumer testosterone replacement clinics for his 2022 findings published in JAMA Internal Medicine. He followed a script, where he identified himself as a 34-year-old man with symptoms of low testosterone, like low libido and low energy. He explained that he desired future fertility as well.
In order to be diagnosed with low testosterone per urology guidelines, a person must have low testosterone, which is less than 300, as well as symptoms such as decreased sex drive, erectile dysfunction, focusing issues, or obesity.
After providing blood work, Dubin joined telehealth calls for initial consults where, despite having a normal testosterone level of 650 — nowhere near the low amount of 300 — he says that six of the seven companies offered him testosterone and only half discussed fertility with him.
"One of the biggest things that guys don't know is that taking testosterone causes infertility. In fact, it's about 65% of men with normal sperm become sterile within just four months of using testosterone therapy," explains Dubin to Healthnews.
While infertility isn't permanent, testosterone levels can sometimes take upwards of a year to return back to normal.
Dubin says men's health is a hot topic in his area. "They just show up, they're given an injection, they don't know what's going on," he explains. "We want to make sure that access to medicine is great and access to care is good. We want to make sure that people are getting the appropriate care they need."
Mehrotra says that these platforms are "totally flipping the clinical model." He says that when he went to medical school, their job was to figure out what the patient's story was, their history, a physical exam, and then a diagnosis and treatment would follow.
With these platforms, that progression is reversed. When a patient comes to them saying what particular treatment they would prefer, be it birth control, Ozempic, an SSRI, or testosterone, only then does the company decide if the medication is correct or not.
However, on the flip side, Mehrotra also says, "In some cases, who are we to tell patients that if they want birth control, that they can't have birth control?"
Yes, online services are convenient and easy for women to gain access to birth control, "And that's awesome," he says. "But on the one hand, was it also discouraging women from getting an IUD or other long-acting reversible contraceptive, which was actually probably more effective for them?"
The benefit of anonymity
Dubin says many people feel embarrassed or shy about attending a real-life clinic, so seeking an online clinic offers a more private experience. With prescriptions for testosterone growing increasingly in the U.S., Dubin wanted to make sure these companies were providing appropriate guideline-based care in his research.
"Testosterone levels are on the decline. There's a lot of data suggesting that. We know that testosterone declines as you get older. But I think that we're starting to understand, first off, that testosterone should not be a stigmatized medicine. It is a good medicine. I treat people with low testosterone all the time. It's about treating them appropriately," says Dubin.
As a doctor dealing largely with men's health, he says that it makes sense for guys to look online for resources.
"First off, there's a huge stigma on men's health. Guys don't want to talk about their health problems, and they're embarrassed. If you have signs and symptoms of low testosterone, things like low energy, low libido, decreased erections, a lot of guys don't want to talk about this," he explains.
He says that if a patient comes in and sits down in a waiting room, "it feels like an announcement that they have a problem."
Telemedicine can give them the anonymity they desire.
I am very pro-telemedicine. Telemedicine does absolutely have benefits.Dubin
Customers get access to care
Mehrotra says, "A lot of people struggle to access the care they need, and these kinds of companies could improve access to care across two dimensions."
One is the low out-of-pocket fee as well as accessibility for those who don't have insurance or who are underinsured. Secondly, Mehrota points out, is the "logistics of life." People are busy; we don't have time to take off work or spend our Saturdays in a waiting room.
Mehrotra did his own secret shopper study, which was published in the New England Journal of Medicine in 2019, where women from all over the country looked at apps for birth control. The women were told to mention contraindications to the pharmacies. The team found that this method was very effective as the pharmacies would consider and ask questions about these contraindications.
He says, "There's a lot of areas of the country where it's very hard for a woman to get birth control because of a lack of clinicians. And so people are having to come in regularly for their birth control pills, and that leads to lapses and unintended pregnancies."
Michelle Carnahan, the President at Thirty Madison, a family of specialized healthcare brands which Nurx falls under, tells Healthnews that they are focused on increasing access to birth control, emergency contraception, and reproductive healthcare.
Nearly 500,000 women depend on Nurx for access to their healthcare so that they can make important healthcare decisions for themselves. We are focused on providing the best-in-class treatment to every single individual as we continue in our work to broaden access to reproductive care for women.Carnahan
She explains that improving access to women's healthcare is an ongoing and long process. Today, she says, Nurx is staying in the conversation for the "long game."
As a result, patients are able to access medication at a low, easy cost with the privacy and accessibility they deserve.
Regulations for online medicine
The American Urological Association guidelines state that if you have erectile dysfunction, a physical exam is necessary. So, how can these direct-to-consumer platforms send out ED medication without a physical? Without diagnostic testing and physical exams, how are the contracted physicians able to accurately examine the individual? The answers to the questions are grey, which is troublesome, but it isn't stopping customers.
Some states do uphold certain laws. Washington prohibits treatment to anyone who answers an online questionnaire, and Ohio state regulators say that patients must meet on a video or in-person call.
In theory, the U.S. Food and Drug Administration (FDA) is responsible for following up on advertisements online, helping to ensure the accuracy of websites and promotions. However, this doesn't always happen. Advertisements fall through the cracks, and websites don't always ensure that patients will receive the proper black box label warnings and side effects.
For pharmaceutical companies, the FDA prohibits any marketing material that advertises a medicine for an unapproved usage. For example, beta-blockers like propranolol should not be marketed as anxiety medication or for other unintended and unapproved use. Pfizer and Johnson & Johnson have been guilty of this, each paying more than $2 billion dollars for off-label marketing.
For many direct-to-consumer platforms, the company contracts health professionals to work as dermatologists or psychiatrists. Then, these pharmacies or doctors are able to prescribe off-label medication to interested customers.
Another loophole is that some of these platforms call themselves tech services, not health providers, blurring the lines between what is allowed and what isn't. In short, there aren't any clear-cut regulations for direct-to-consumer services. Drug manufacturers and drug distributors get the brunt of the federal drug marketing laws. Consumer sites have still yet to be regulated.
For now, many of these companies are staying within those blurred lines, raising concerns regarding off-label prescriptions. Nevertheless, they keep to a short list of concerns that they can treat. Once they extend their list of treatable conditions, it may lead to more regulation and FDA interference.
Mehrotra finds that primary care relationships should be well established, and the reality is that most people don't have that. If you have diabetes, heart failure, are post-transplant, have rheumatoid arthritis, or lupus, Mehrota says this type of treatment option isn't right for you. Complex care requires a relationship with a doctor.
Dubin suggests that patients should chat with their primary care doctor, who can point them in the direction of care. "Because at the end of the day, you're not going to be able to solve this problem most likely on your own," he says.
The FDA says there are red flags on websites to look out for. An online pharmacy offering a prescription drug at a discounted price, with no prescription, typically sells unapproved or fraudulent medicines.
The bottom line is that most direct-to-consumer services are looking to provide positive benefits for their customers. And right now, it's even tough to weigh the pros and cons.
The smartest choice you can make for yourself is to be vigilant, especially when ordering medication from a rogue website. Check-in with your primary physician first, do your research in terms of the telehealth company and outcome you hope to receive, and don't rely entirely on an online service for all of your health needs.
Healthnews reached out to other direct-to-consumer companies like Him&Hims, Roman, and Apostrophe for comment but did not hear back.
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- Crunchbase News. U.S. Telehealth Startups Offer Cures To Healthcare Challenges.
- Northern Illinois University Law Review. Online and Off Label: Closing the Regulatory Gap in Online Direct-to-Consumer Drug Promotion and Prescribing.
- Urology Care Foundation. What Is Low Testosterone?
- American Health and Drug Benefits. Negative Consequences of the Widespread and Inappropriate Easy Access to Purchasing Prescription Medications on the Internet.
- JAMA. Prescriptions on Demand: The Growth of Direct-to-Consumer Telemedicine Companies.
- Journal of General Internal Medicine. Direct-to-Consumer Drug Advertisement and Prescribing Practices: Evidence Review and Practical Guidance for Clinicians.