How McK­in­sey used its FDA con­nec­tions to help opi­oid man­u­fac­tur­ers: New con­gres­sion­al re­port

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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Alaa Halawaa, executive director at Mubadala’s US venture group

The ven­ture crew at Mubadala are up­ping their biotech cre­ation game, tak­ing care­ful aim at a new fron­tier in drug de­vel­op­ment

It started with a cup of coffee and a slow burning desire to go early and long in the biotech creation business.

Wrapping up a 15-year discovery stint at Genentech back in the summer of 2021, Rami Hannoush was treated to a caffeine-fueled review of the latest work UCSF’s Jim Wells had been doing on protein degradation — one of the hottest fields in drug development.

“Jim and I have known each other for the past 15 years through Genentech collaborations. We met over coffee, and he was telling me about this concept of the company that he was thinking of,” says Hannoush. “And I got immediately intrigued by it because I knew that this could open up a big space in terms of adding a new modality in drug discovery that is desperately needed in pharma.”

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'Band­ing to­geth­er': 50 fe­male biotech ex­ec­u­tives lay out plans for board di­ver­si­ty, new com­pa­nies and men­tor­ing founders

Earlier this month, during the Silicon Valley Bank meltdown, Angie You recalled the speed with which female biotech CEOs were helping each other connect with bankers, get their wires through and assuage concerns during a financial implosion.

This past weekend, 50 of about 125 women who are part of that Slack group and a broader coalition self-dubbed the Biotech Sisterhood met in person in Cancun for the second rendition of an annual summit connecting female biotech CEOs. The attendance list doubled that of the inaugural gathering in Arizona 12 months ago.

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FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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No­var­tis touts sev­en years of dura­bil­i­ty da­ta for Zol­gens­ma

The same day that Roche touted positive durability and safety data for its spinal muscular atrophy drug Evrysdi, Novartis also made a splash with its multi-million dollar gene therapy for the disease.

Novartis rolled out interim data from two long-term follow-up studies Monday at the 2023 Muscular Dystrophy Association (MDA) Clinical and Scientific Conference. In the first study, LT-001, all children in the trial that were treated after showing symptoms of SMA “maintained all previously achieved motor milestones” up to 7.5 years after being dosed. The average time since Zolgensma was given was 6.86 years.

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Rohan Palekar, 89bio CEO

89bio’s PhII da­ta add to quick suc­ces­sion of NASH read­outs as field seeks turn­around

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.

Francesco Marincola, newly-appointed Sonata Therapeutics CSO

Kite's head of re­search leaves for Flag­ship start­up Sonata

Another leader is departing Kite Pharma, and will to spend the “last part” of his career exploring how cancer evades the immune system.

Kite’s senior VP and global head of cell therapy research Francesco Marincola left the Gilead CAR-T unit last week for Sonata Therapeutics. Flagship last May unveiled the startup, which was pieced together from two fledgling biotechs Inzen and Cygnal Therapeutics. As CSO, Marincola will lead Sonata’s push to reprogram cancer cells to make them more immunogenic.

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Flare Therapeutics biochemists Yong Li (L) and Valerie Vivat

A $123M Flare will get Third Rock on­col­o­gy biotech in­to the clin­ic this year

Flare Therapeutics will start its first human trial this year with an investigational urothelial cancer drug after pulling together a $123 million Series B from Big Pharmas, VCs and its incubator, Third Rock Ventures.

Launched in 2021 on the idea that a biotech could finally succeed at drugging the much-sought-after but stubborn transcription factor, Flare Therapeutics said Wednesday it is now primed for the clinic after closing its large financing haul earlier this year. The raise is a relatively stark figure in a tough startup financing environment but further buoys the upbeat signals coming out of other Third Rock biotechs in recent weeks, including the $200 million CARGO Therapeutics and $100 million Rapport Therapeutics rounds.

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Roche and Lil­ly team up to de­vel­op blood test to de­tect ear­ly signs of Alzheimer's

Eli Lilly is teaming up with Roche to help develop a blood test to detect early signs of Alzheimer’s disease and determine whether a patient should go for further confirmatory testing.

Roche’s Elecsys Amyloid Plasma Panel (EAPP) measures pTau 181 protein assay and APOE E4 assay in human blood plasma – elevations in pTau 181 are present in the early stages of Alzheimer’s, while the presence of APO E4 is the most common genetic risk factor for the disease.

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