Ap­proved dig­i­tal pill stirs wor­ries of ‘Big Brother’

The Buffalo News - - NATIONAL NEWS - By Pam Bel­luck

PITTS­BURGH – For the first time, the Food and Drug Ad­min­is­tra­tion has ap­proved a dig­i­tal pill – a med­i­ca­tion em­bed­ded with a sen­sor that can tell doc­tors whether, and when, pa­tients take their medicine.

The ap­proval, an­nounced late Mon­day, marks a sig­nif­i­cant ad­vance in the grow­ing field of dig­i­tal de­vices de­signed to mon­i­tor medicine-tak­ing and to ad­dress the ex­pen­sive, long-stand­ing prob­lem that mil­lions of pa­tients do not take drugs as pre­scribed.

Ex­perts es­ti­mate that so-called non­ad­her­ence or non­com­pli­ance to med­i­ca­tion costs about $100 bil­lion a year, much of it be­cause pa­tients get sicker and need ad­di­tional treat­ment or hos­pi­tal­iza­tion. “When pa­tients don’t ad­here to life­style or med­i­ca­tions that are pre­scribed for them, there are re­ally sub­stan­tive con­se­quences that are bad for the pa­tient and very costly,” said Dr. Wil­liam Shrank, chief med­i­cal of­fi­cer of the health plan di­vi­sion at the Univer­sity of Pitts­burgh Med­i­cal Cen­ter.

Ameet Sarpat­wari, an in­struc­tor in medicine at Har­vard Med­i­cal School, said the dig­i­tal pill “has the po­ten­tial to im­prove pub­lic health,” es­pe­cially for pa­tients who want to take their med­i­ca­tion but for­get.

But, he added, “if used im­prop­erly, it could foster more mis­trust in­stead of trust.”

Pa­tients who agree to take the dig­i­tal med­i­ca­tion, a ver­sion of the an­tipsy­chotic Abil­ify, can sign con­sent forms al­low­ing their doc­tors and up to four other peo­ple, in­clud­ing fam­ily mem­bers, to re­ceive elec­tronic data show­ing the date and time pills are in­gested.

A smart­phone app will let them block re­cip­i­ents any­time they change their mind. Al­though vol­un­tary, the tech­nol­ogy is still likely to prompt ques­tions about pri­vacy and whether pa­tients might feel pres­sure to take med­i­ca­tion in a form their doc­tors can mon­i­tor.

Dr. Peter Kramer, a psy­chi­a­trist and the au­thor of “Lis­ten­ing to Prozac,” raised con­cerns about “pack­ag­ing a med­i­ca­tion with a tat­tle­tale.”

While eth­i­cal for “a fully com­pe­tent pa­tient who wants to lash him or her­self to the mast,” he said, “‘dig­i­tal drug’ sounds like a po­ten­tially co­er­cive tool.”

Other com­pa­nies are de­vel­op­ing dig­i­tal med­i­ca­tion tech­nolo­gies, in­clud­ing an­other ingestible sen­sor and vis­ual recog­ni­tion tech­nol­ogy ca­pa­ble of con­firm­ing whether a pa­tient has placed a pill on the tongue and has swal­lowed it.

Not all will need reg­u­la­tory clear­ance, and some are al­ready be­ing used or tested in pa­tients with heart prob­lems, stroke, HIV, di­a­betes and other con­di­tions.

Be­cause dig­i­tal tools re­quire ef­fort, like us­ing an app or wear­ing a patch, some ex­perts said they might be most wel­comed by older peo­ple who want help re­mem­ber­ing to take pills and by peo­ple tak­ing fi­nite cour­ses of med­i­ca­tion, es­pe­cially for ill­nesses like tu­ber­cu­lo­sis. The tech­nol­ogy could po­ten­tially be used to mon­i­tor whether post-sur­gi­cal pa­tients took too much opioid med­i­ca­tion or clin­i­cal trial par­tic­i­pants cor­rectly took drugs be­ing tested.

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