Fol­low­ing re­ports that McK­in­sey en­gaged in abu­sive and de­cep­tive busi­ness prac­tices to stoke the flames of the opi­oid epi­dem­ic, the House Over­sight Com­mit­tee on Wednes­day re­leased a new re­port doc­u­ment­ing how the con­sult­ing com­pa­ny lever­aged its work with the FDA to dri­ve new busi­ness with opi­oid man­u­fac­tur­ers.

Doc­u­ments un­cov­ered by the com­mit­tee al­so show how opi­oid jug­ger­naut Pur­due Phar­ma ex­plic­it­ly tasked McK­in­sey with pro­vid­ing ad­vice on how to in­flu­ence the FDA’s de­ci­sions.

“In 2011, at least four McK­in­sey con­sul­tants work­ing on a $1.8 mil­lion FDA con­tract to en­hance drug safe­ty and ad­dress ‘the ad­verse im­pact of drugs on health in the US’ were si­mul­ta­ne­ous­ly work­ing for Pur­due — in­clud­ing on projects de­signed to per­suade FDA of the safe­ty of Pur­due’s opi­oid prod­ucts. One project in­volved writ­ing ‘scripts’ for Pur­due to use in a meet­ing with FDA on the safe­ty of pe­di­atric Oxy­Con­tin,” the 53-page re­port says.

The com­mit­tee’s in­ves­ti­ga­tion al­so un­cov­ered 37 FDA con­tracts that were staffed by at least one McK­in­sey con­sul­tant who si­mul­ta­ne­ous­ly or pre­vi­ous­ly worked for Pur­due, and McK­in­sey failed to dis­close its re­la­tion­ships with opi­oid man­u­fac­tur­ers to FDA.

Many of the de­tails re­gard­ing these un­usu­al re­la­tion­ships be­tween McK­in­sey, FDA and opi­oid man­u­fac­tur­ers are just be­ing un­earthed now, even as they were forged a decade ago.

And while the FDA does not have any cur­rent con­tracts with McK­in­sey, and the con­sult­ing com­pa­ny agreed in Feb­ru­ary to pay $573 mil­lion to 53 at­tor­neys gen­er­al to re­solve al­le­ga­tions that it ag­gres­sive­ly pro­mot­ed the sale of high­er dos­es of opi­oids, the con­gres­sion­al re­port sheds new light on what McK­in­sey did and how it used FDA.

From 2008 to to­day, McK­in­sey worked on 76 con­tracts for the FDA, and the agency has paid McK­in­sey more than $140 mil­lion since 2008, the con­gres­sion­al in­ves­ti­ga­tors found.

At the same time, three se­nior McK­in­sey con­sul­tants — Navjot Singh, Jeff Smith, and Sas­try Chilukuri — worked on mul­ti­ple projects for both Pur­due and FDA.

In the case of Smith, who was “fre­quent­ly cross-staffed” on FDA and Pur­due projects, “One project in­volved the ef­fec­tive­ness of Pur­due’s REMS for Oxy­Con­tin, which was at the time be­ing im­ple­ment­ed by the FDA of­fice Mr. Smith was ad­vis­ing on drug safe­ty,” the re­port says.

Smith lat­er com­plained to Chilukuri that Chilukuri had over­rep­re­sent­ed the ca­pa­bil­i­ties of the FDA’s drug safe­ty track­ing sys­tem, known as Sen­tinel, and that the false claim that Sen­tinel can be “used to as­sess the ef­fi­ca­cy of opi­oids” end­ed up in a speech by for­mer FDA com­mis­sion­er Scott Got­tlieb.

In 2017, Smith al­so be­gan serv­ing as one of the lead McK­in­sey part­ners on a new FDA con­tract, but two days ear­li­er, Smith had start­ed an­oth­er en­gage­ment at Pur­due, at the spe­cif­ic re­quest of Pur­due’s VP of busi­ness, ac­cord­ing to the re­port.

In a state­ment on Wednes­day, McK­in­sey de­fend­ed its pri­or work, not­ing that it stopped ad­vis­ing clients on opi­oid-re­lat­ed busi­ness in 2019:

McK­in­sey’s work for the FDA has fo­cused on ad­min­is­tra­tive and op­er­a­tional top­ics, in­clud­ing im­prove­ments to or­ga­ni­za­tion­al struc­tures, busi­ness process­es and tech­nol­o­gy. We have not ad­vised the FDA on reg­u­la­to­ry de­ci­sions or on spe­cif­ic phar­ma­ceu­ti­cal prod­ucts.

89bio said its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH, in two of three dose groups.

The San Francisco biotech said it thinks the Phase IIb data pave the way for a potential Phase III, following in the footsteps of another biotech in its drug class, Akero Therapeutics. To fund a late-stage study, CEO Rohan Palekar told Endpoints News 89bio “would need to raise additional capital,” with the company having about $188 million at the end of last year.