The sites promise easy and embarrassment-free access to erectile dysfunction and libido pills. “E.D. meds prescribed online, delivered to your door,” one said recently. “Starting at $2 per dose.”
“Low sex drive? That can be optional,” another one said. “Try today — $99.”
The sites, Roman and Hers, as well as others now make obtaining lifestyle drugs for sexual health, hair loss and anxiety nearly as easy as ordering dinner online.
On the sites, people self-diagnose and select the drug they want, then enter some personal health and credit card information. A doctor then assesses their choice, with no in-person consultation. If approved, the medicine arrives in the mail days or weeks later.
The sites invert the usual practice of medicine by turning the act of prescribing drugs into a service. Instead of doctors making diagnoses and then suggesting treatments, patients request drugs and physicians serve largely as gatekeepers.
Some of these companies operate in a regulatory vacuum that could increase public health risks, according to interviews with physicians, former federal health regulators and legal experts. And federal and state health laws, written to ensure competent medical care and drug safety, have not kept pace with online services, they say.
“It’s restaurant-menu medicine,” said Arthur L. Caplan, a medical ethics professor at New York University School of Medicine.
After answering questions online, two reporters for The New York Times in California gained approval for generic Viagra prescriptions through Roman and Hims, a site run by the same start-up that owns the Hers site. A third Times reporter ordered Addyi, the libido drug, through Hers.
Whether the sites’ screening processes are sufficient is open to interpretation. This year, a doctor in California, who had prescribed Viagra online through a site called KwikMed.com, surrendered his medical license after the state’s medical board accused him of failing to provide standard medical care like examining the patient and taking vital signs.
Some start-ups, like Kick Health, sell blood pressure pills or other prescription drugs for unapproved uses like calming the symptoms of performance anxiety.
One drug, Addyi, which can cause fainting if taken with alcohol, arrived without the necessary safety warning protocols created by the drug’s manufacturer.
Much like Uber, which argues that it is not a transportation company even as it connects drivers and passengers, the drug sites argue that they are tech platforms, not health providers. The sites connect consumers — and often process their payments — to doctors who may prescribe drugs and pharmacies that can ship the medications.
To comply with state laws, the doctors work for separate companies that cater to the sites. The doctors are typically paid for each health consultation, or by the hour, not the number of prescriptions written. The sites generate revenue for themselves by charging service or processing fees to consumers, the doctors or both.
Kick, Roman and Hims each said they complied with laws and did not influence the doctors’ prescribing decisions.
Zachariah Reitano, the chief executive of Ro, the owner of Roman, said his site encouraged people to tend to their health who might not otherwise have done so.
“It provides more convenient, higher-quality, more affordable care for certain conditions and saves people a lot of time and energy,” Mr. Reitano said.
Zachariah Reitano, the chief executive of Ro, says the Roman site encourages people to tend to their health by making it easier for them to connect with doctors.CreditSean Pressley for The New York Times
Justin Ip, the chief executive of Kick, said his company was “trying to be careful and cautious” about complying with health laws. He added that federal marketing restrictions on drug makers did not apply to his company.
Federal drug marketing rules apply to drug manufacturers, drug distributors, packers and their representatives. Whether the consumer drug sites fall into any of those categories is an unsettled question. And there is no single federal or state agency in charge of overseeing online prescription drug services.
“Where are the regulatory agencies in this?” asked Dr. C. Neill Epperson, a women’s behavioral health expert at the University of Colorado School of Medicine. “How can this just be O.K.?”
Prescribing Algorithms
The new wave of sites that market drugs directly to consumers began popping up several years ago, promising to streamline medical care with software.
Several gained traction with cheeky TV commercials, billboard ads and social media feeds featuring sexual imagery like cactuses. They use slick packaging, wrapping doses of Viagra in condom-size envelopes or sending chocolate along with birth control pills.
The premise is so attractive to investors that Hims and Ro have raised nearly $100 million each. They have also tapped experts for advice, including Dr. Joycelyn Elders, a former surgeon general who is a medical adviser to Ro, and men’s health specialists at leading hospitals.
Dr. Elders said she had signed on to advise Ro to promote accurate information about sexual health.
Nurx, a San Francisco start-up that markets contraceptives for women, has raised more than $41 million. Keeps, a hair loss treatment site for men, is based in New York and has raised nearly $23 million.
“We believe this is a radical new way of providing care — by changing unstructured interactions into structured care, by shifting work from M.D.s to algorithms where possible,” Andy Weissman, a managing partner at Union Square Ventures, wrote in a blog post in 2016 after his firm led an investment round in Nurx.
Limited Doctor Interaction
For people who get nervous before public speaking, there is Kick, a San Francisco start-up that operates in 12 states. The site offers consumers a blood pressure drug, propranolol, to calm a racing heart and shaking hands.
But the site’s home page did not disclose that the medication was not federally approved to treat anxiety. In fact, it suggested the opposite: “FDA approved prescriptions tailored to you,” the home page said.
After queries from a reporter, the site added a sentence on a drug information page noting that prescribing propranolol for anxiety was “off-label” — or not federally approved.
The Food and Drug Administration generally prohibits pharmaceutical companies from marketing medicines for unapproved uses, as they have not been federally vetted for safety and effectiveness. Over the last decade, Pfizer and Johnson & Johnson have each paid fines of more than $2 billion to settle government charges of illegally marketing unapproved drug uses.
Doctors are permitted to practice medicine as they see fit, including prescribing drugs for unapproved uses. Mr. Ip of Kick noted that doctors regularly prescribed propranolol to treat anxiety.
But state and professional ethical standards typically require doctors to establish relationships with new patients, and examine them, before prescribing a drug. The interactions with physicians through the sites can be quite limited.
After submitting the information to Hims and being charged, a reporter received a message from a doctor saying he was a good candidate for erectile dysfunction treatment and asking if he had any questions. The reporter had no questions and ordered the drug.
Roman, Hims and Kick each said they designed their systems to ask the questions doctors would ask of new patients. The companies said the questions changed based on a person’s previous answers, allowing for individualized diagnoses. The companies use algorithms to flag or weed out people with medical conditions, like high blood pressure, that could make certain prescriptions inappropriate.
Some states specifically prohibit doctors from relying solely on online questionnaires to prescribe drugs to new patients. Hims, Kick and Roman said their processes were interactive and should not be considered questionnaires.
In Ohio, state regulators said doctors must — at a minimum — communicate with patients in real time, through audio or video, to meet their standards.
But Spence Bailey of Columbus, Ohio, said he had never spoken to a doctor by phone or on video when ordering hair loss medication from Hims, communicating only through the site’s messaging system.
He said he was satisfied, but canceled his monthly subscription because it was too expensive.
Hims said it complied with state medical board rules.
On some sites, it can be unclear who is reviewing consumers’ health data and prescribing the drugs.
A reporter in California who requested generic Viagra through Roman received a message from a doctor, including his name and a link to a page listing his medical school, qualifications and state licenses.
But a different reporter in California, who requested generic Viagra through Hims, received a message without a doctor’s name.
After being asked about the interaction by a Times reporter, the company said it had changed its software to require doctors to include their medical credentials on such messages.
Incomplete Warnings
A week or two after reporters were approved for prescriptions, the medications arrived in discreet packages.
A shipment of the Addyi libido pills, from Postmeds, a pharmacy based in Hayward, Calif., came with a colorful “usage guide.” “It’s time to get busy,” the guide said.
The Hers questionnaire, as well as an online message from the doctor, had explicitly warned about fainting risks that can arise from taking the drugs with alcohol. But the usage guide made no mention of it. That potential danger was included only in the required F.D.A. information insert printed in a tiny typeface.
Pharmacists dispensing Addyi “must counsel all patients on the need to avoid alcohol” with every prescription, according to protocols created by Sprout Pharmaceuticals, the drug’s manufacturer.
Instead, the pills came with a card providing a phone number for a “drug consultation” with Postmeds.
“The idea here is that there must be an added layer of professional counseling,” said Ned Milenkovich, a pharmacist and lawyer with the firm Much Shelist in Chicago.
Cindy Eckert, Sprout’s chief executive, referred questions to Hers and the pharmacies it uses. Hers referred questions to Postmeds. Umar Afridi, Postmeds’ chief executive, said the required medical insert contained the alcohol warning, satisfying the counseling requirements.
Blurred Lines
The start-ups have stayed under the regulatory radar partly by arguing that they are not health providers. But the lines between the companies and the entities handling the prescribing can blur.
Ro’s terms of use policy says that another company, Roman Pennsylvania Medical, provides the sites’ doctors. And Mr. Reitano, Ro’s chief executive, said the start-up’s clinical directors and the owners of the physician company did not hold equity in Ro.
But Roman Pennsylvania has the same address in New York as Ro, according to business registration documents. Its president, Dr. Tzvi Doron, is a Ro clinical director.
Keeps, the hair-loss site, also has links to a physician corporation, KMG Medical Group, that supplies doctors to its users. Steven Gutentag, Keeps’s chief executive, said that KMG was an independent corporation and that Keeps did not control the doctors’ decisions.
But the two entities are closely related. Keeps’s customers pay KMG Medical Group for their doctor consultations, and KMG pays Keeps’s parent company, Thirty Madison, for the patient software it uses and other business services.
Then there is Dr. Michael Demetrius Karagas, a Texas physician who is KMG Medical Group’s owner. He, too, has close ties to Keeps: He is the father of one of its co-founders, Demetri Michael Karagas. Dr. Karagas did not respond to requests for comment.
