WHO Al­leges Fraud in Lab, Clin­i­cal Prac­tices of Sem­ler

Ma­nip­u­la­tion of at least 5 stud­ies in­di­cates that vi­o­la­tions are a com­mon prac­tice, it says in a re­port on the clin­i­cal re­search out­fit Ben­galuru-based con­tract re­search firm was pulled up by US FDA over data in­tegrity last week

The Economic Times - - Companies: Pursuit Of Profit - Vikas.Dan­dekar@ times­group.com

Mum­bai: The World Health Or­ga­ni­za­tion (WHO) has al­leged ‘fraud’ and pointed to vi­o­la­tions of good lab­o­ra­tory and clin­i­cal prac­tices at Sem­ler Re­search, a Ben­galuru-based con­tract re­search or­gan­i­sa­tion, which was pulled up last week by the US FDA for data in­tegrity is­sues.

“Ma­nip­u­la­tion of at least five stud­ies over an ex­tended pe­riod of time in­di­cates this is a com­mon prac­tice,” the world health body wrote in its ‘no­tice of con­cern’ re­port on April 12 on the clin­i­cal re­search out­fit. The WHO said upon in­ves­ti­ga­tions of the study doc­u­men­ta­tions for prod­ucts like atazanavir, ac­eta­zo­lamide, cele­coxib and saquinavir, in­spec­tors iden­ti­fied ev­i­dence of such ma­nip­u­la­tions by com­par­ing con­cen­tra­tion-time curves for spe­cific pairs of study sub­jects.

“It is of the im­pres­sion that to ex­e­cute this type of ma­nip­u­la­tion, sev­eral staff mem­bers on var­i­ous lev­els within the or­ga­ni­za­tion have to be col­lab­o­rat­ing and co­or­di­nat­ing. The is­sue is thus not con­fined to a sin­gle per­son op­er­at­ing out­side of the qual­ity man­age­ment sys­tem,” WHO said. The WHO team cited its in­spec­tions be­tween Jan­uary 27 and 31, 2015, and a fol­low-up be­tween De­cem­ber 2 and 5, 2015, and high­lighted is­sues such as ma­nip­u­la­tion of study sam­ples.

The WHO said its find­ings bring into ques­tion the va­lid­ity of stud­ies (per­formed for 12 prod­ucts) that are un­der as­sess­ment, but not pre­qual­i­fied.

Those prod­ucts in­clude fixed dose com­bi­na­tions of HIV prod­uct efavirenz, la- mivu­dine and teno­fovir, an­other com­bi­na­tion of lamivu­dine, zi­dovu­dine and nevrap­ine, an­tibi­otic drug azithromycin, an­ti­malar­ial com­bi­na­tion of artemether and lume­fantrine, anti-TB drug com­bi­na­tion ri­fampicin, iso­ni­azid and pyraz­i­namide.

It also brought into ques­tion nearly a dozen other prod­ucts that are al­ready pre­qual­i­fied and be­long to com­pa­nies such as My­lan, Mi­cro Labs, Lupin and Strides.

In its let­ter, the WHO noted Sem­ler had ac­knowl­edged that “four FDA stud­ies and one WHO study have ques­tion­able data”, that th­ese trends “can­not be phys­i­o­log­i­cally ex­plained” and that there were “sys­tem gaps iden­ti­fied dur­ing the ret­ro­spec­tive in­ves­tiga­tive au­dit in the sys­tem due to which we are not able to iden­tify who and why this hap­pened”.

“This im­plies that Sem­ler ac­knowl­edges ex­is­tence of th­ese un­nat­u­ral trends in their data, the root cause has not been iden­ti­fied and the sys­tem can­not sup­port ad­e­quate root cause anal­y­sis for th­ese is­sues of con­cern,” WHO said.

For prod­ucts that pre­qual­i­fied, the WHO has di­rected ap­pli­cants that the risk as­sess­ments with pro­posed cor­rec­tive and pre­ven­tive ac­tion be sub­mit­ted for all the stud­ies within 30 days and for those that are not pre­qual­i­fied, it has re­quested for bio-waivers where ap­pli­ca­ble, and sub­mis­sions of fresh stud­ies which may be ex­tended to 12 months.

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