On­line drug sites up­end doctor-pa­tient pre­scrip­tion model

The Buffalo News - - FRONT PAGE - By Natasha Singer and Katie Thomas

The sites prom­ise easy and em­bar­rass­ment-free ac­cess to erec­tile dys­func­tion and li­bido pills. “ED 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 startup 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 star­tups, 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 ar­gues that it is not a trans­porta­tion com­pany even as it con­nects driv­ers and pas­sen­gers, the drug sites ar­gue that they are not health providers but tech plat­forms. 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, high­erqual­ity, more af­ford­able care for cer­tain con­di­tions and saves peo­ple a lot of time and en­ergy,” Rei­tano said.

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 drug­mak­ers 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?” said Dr. C. Neill Ep­per­son, a women’s be­hav­ioral health ex­pert at Univer­sity of Colorado School of Medicine. “How can this just be OK?”

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.

El­ders said she signed on to ad­vise Ro to pro­mote ac­cu­rate in­for­ma­tion about sex­ual health.

Nurx, a San Fran­cisco startup 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 MDs 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 startup 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 home­page 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. Dur­ing 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. Ip of Kick noted that doc­tors regularly pre­scribe 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.

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 was sat­is­fied, but can­celed his monthly sub­scrip­tion be­cause it was too ex­pen­sive.

Hims said it com­plied with state med­i­cal board rules.

Blurred lines

The star­tups 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 Rei­tano, Ro’s chief ex­ec­u­tive, said the startup’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’ 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’ cus­tomers pay KMG Med­i­cal Group for their doctor con­sul­ta­tions, and KMG pays Keeps’ 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. Michael Kara­gas did not re­spond to re­quests for com­ment.

New York Times

Zachariah Rei­tano, CEO of Ro, which markets life­style drugs on­line, says his site en­cour­ages peo­ple to tend to their health who might not oth­er­wise have done so.

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