Bioethicists call for stronger oversight of direct-to-consumer neurotechnologies

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Bioethi­cists call for over­sight of poor­ly reg­u­lat­ed, con­sumer-grade neu­rotech­nol­o­gy prod­ucts (Med­ical News):

“The mar­ket­ing of direct-to-con­sumer “neu­rotech­nolo­gies” can be entic­ing: apps that diag­nose a men­tal state, and brain devices that improve cog­ni­tion or “read” one’s emo­tion­al state. How­ev­er, many of these increas­ing­ly pop­u­lar prod­ucts aren’t ful­ly sup­port­ed by sci­ence and have lit­tle to no reg­u­la­to­ry over­sight, which pos­es poten­tial health risks to the pub­lic. In a new piece pub­lished in the jour­nal Sci­ence this week, two bioethi­cists from Penn Med­i­cine and the Uni­ver­si­ty of British Colum­bia sug­gest the cre­ation of a work­ing group that would fur­ther study, mon­i­tor, and pro­vide guid­ance for this grow­ing indus­try — which is expect­ed to top $3 bil­lion by 2020.

“There’s a real thirst for knowl­edge about the effi­ca­cy of these prod­ucts from the pub­lic, which remains unclear because of this lack of over­sight and gap in knowl­edge,” said lead author Anna Wexler, PhD, an instruc­tor in the depart­ment of Med­ical Ethics and Health Pol­i­cy at the Perel­man School of Med­i­cine at the Uni­ver­si­ty of Penn­syl­va­nia. “We believe a diverse, ded­i­cat­ed group would help back up or refute claims made by com­pa­nies, deter­mine what’s safe, bet­ter under­stand their use among con­sumers, and address pos­si­ble eth­i­cal concerns.” 

The Paper

Over­sight of direct-to-con­sumer neu­rotech­nolo­gies (Sci­ence):

Sum­ma­ry: Mar­ket­ed for the pur­pose of mod­u­lat­ing cog­ni­tion or a vari­ety of affec­tive and men­tal states, a grow­ing ecosys­tem of neu­rotech­nol­o­gy prod­ucts is being sold direct to con­sumers (DTC) with­out neces­si­tat­ing the physi­cian as inter­me­di­ary. Offer­ing indi­vid­u­als the prospect of mon­i­tor­ing and manip­u­lat­ing a range of brain func­tions from mem­o­ry to men­tal health, the major prod­uct cat­e­gories are neu­romon­i­tor­ing devices, cog­ni­tive train­ing appli­ca­tions, neu­rostim­u­la­tion devices, and men­tal health apps. The mar­ket for these prod­ucts is pre­dict­ed to top $3 bil­lion by 2020 (1). Yet there are good rea­sons to con­clude that reg­u­la­to­ry over­sight of DTC neu­rotech­nolo­gies is insuf­fi­cient. We sug­gest ways to pro­vide sys­tem­at­ic sup­port for reg­u­la­to­ry agen­cies, fund­ing bod­ies, and a pub­lic that is thirsty for knowl­edge about the effi­ca­cy of DTC neu­rotech­nol­o­gy products. 

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