U.S, reg­u­la­tors ap­prove first dig­i­tal pill to track pa­tients

The Morning Journal (Lorain, OH) - - OBITUARIES - By Matthew Per­rone

U.S. reg­u­la­tors have ap­proved the first drug with a sen­sor that alerts doc­tors when the med­i­ca­tion has been taken, of­fer­ing a new way of mon­i­tor­ing pa­tients but also rais­ing pri­vacy con­cerns.

The dig­i­tal pill ap­proved Mon­day com­bines two ex­ist­ing prod­ucts: the for­mer block­buster psy­chi­atric med­i­ca­tion Abil­ify — long used to treat schizophre­nia and bipolar dis­or­der — with a sen­sor track­ing sys­tem first ap­proved in 2012.

The tech­nol­ogy is in­tended to help pre­vent dan­ger­ous emer­gen­cies that can oc­cur when pa­tients skip their med­i­ca­tion, such as manic episodes ex­pe­ri­enced by those suf­fer­ing from bipolar dis­or­der.

But de­vel­op­ers Ot­suka Phar­ma­ceu­ti­cal Co. and Pro­teus Dig­i­tal Health are likely to face hur­dles. The pill has not yet been shown to ac­tu­ally im­prove pa­tients’ med­i­ca­tion com­pli­ance, a fea­ture in­sur­ers are likely to in­sist on be­fore pay­ing for the pill. Ad­di­tion­ally, pa­tients must be will­ing to al­low their doc­tors and care­givers to ac­cess the dig­i­tal in­for­ma­tion.

These pri­vacy is­sues are likely to crop up more of­ten as drug­mak­ers and med­i­cal de­vice com­pa­nies com­bine their prod­ucts with tech­nolo­gies de­vel­oped by Sil­i­con Val­ley.

Ex­perts say the tech­nol­ogy could be a use­ful tool, but it will also change how doc­tors re­late to their pa­tients as they’re able to see whether they are fol­low­ing in­struc­tions.

“It’s truth serum time,” said Arthur Ca­plan, a med­i­cal ethi­cist at NYU’s Lan­gone Med­i­cal Cen­ter. “Is the doc­tor go­ing to start yelling at me? Am I go­ing to get a big ac­cusatory speech? How will that in­ter­ac­tion be han­dled?”

The tech­nol­ogy car­ries risks for pa­tient pri­vacy too if there are breaches of med­i­cal data or unau­tho­rized use as a sur­veil­lance tool, said James Gior­dano, a pro­fes­sor of neu­rol­ogy at Ge­orge­town Univer­sity Med­i­cal Cen­ter.

“Could this type of de­vice be used for real-time sur­veil­lance? The an­swer is of course it could,” said Gior­dano.

The new pill, Abil­ify MyCite, is em­bed­ded with a dig­i­tal sen­sor that is ac­ti­vated by stom­ach flu­ids, send­ing a sig­nal to a patch worn by the pa­tient and no­ti­fy­ing a dig­i­tal smart­phone app that the med­i­ca­tion has been taken.

The FDA stressed how­ever that there are lim­i­ta­tions to mon­i­tor­ing pa­tients.

“Abil­ify MyCite should not be used to track drug in­ges­tion in ‘real-time’ or dur­ing an emer­gency,” the state­ment said, “be­cause de­tec­tion may be de­layed or may not oc­cur.”

Pa­tients can track their dosage on their smart­phone and al­low their doc­tors, fam­ily or care­givers to ac­cess the in­for­ma­tion through a web­site.

In a state­ment is­sued last May at the time the FDA ac­cepted sub­mis­sion of the prod­uct for re­view, the com­pa­nies said “with the pa­tient’s con­sent, this in­for­ma­tion could be shared with their health care pro­fes­sional team and se­lected fam­ily and friends, with the goal of al­low­ing physi­cians to be more in­formed in mak­ing treat­ment de­ci­sions that are spe­cific to the pa­tient’s needs.”

While it’s the first time the FDA has ap­proved such a pill, var­i­ous spe­cialty phar­ma­cies and hos­pi­tals in the U.S. have pre­vi­ously “pack­aged” var­i­ous drugs and sen­sors. But the fed­eral en­dorse­ment in­creases the like­li­hood that in­sur­ers will even­tu­ally pay for the tech­nol­ogy.

Drug­mak­ers fre­quently re­for­mu­late their drugs to ex­tend their patent life and to jus­tify rais­ing prices. For in­stance, Ot­suka al­ready sells a long-act­ing in­jectable ver­sion of Abil­ify in­tended to last for one month. The patent on the orig­i­nal Abil­ify pill ex­pired in 2015.

The Ja­panese drug­maker has not said how it will price the dig­i­tal pill. Pro­teus Dig­i­tal Health, based in Red­wood City Cal­i­for­nia, makes the sen­sor.


This file photo, shows the U.S. Food & Drug Ad­min­is­tra­tion cam­pus in Sil­ver Spring, Md. On Mon­day the FDA ap­proved the first drug in the United States with a dig­i­tal in­ges­tion track­ing sys­tem, in an un­prece­dented move to en­sure that pa­tients with...

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