FDA reg­u­la­tors OK first dig­i­tal pill to track pa­tients

Manteca Bulletin - - Dollars & Sense -

WASHINGTON (AP) — 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.

Newspapers in English

Newspapers from USA

© PressReader. All rights reserved.