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.

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Scoop: Roche scraps one of two schiz­o­phre­nia PhII tri­als af­ter fail­ing the pri­ma­ry end­point

Roche has terminated one of two Phase II trials testing its drug ralmitaront in patients with schizophrenia, the Big Pharma confirmed to Endpoints News.

The study was terminated last month, according to a June 22 update to the registry on clinicaltrials.gov. Begun in September 2020, the trial was looking at ralmitaront in patients with acute schizophrenia. The trial enrolled 286 patients out of an originally planned 308.

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Merdad Parsey, Gilead CMO

Four months af­ter CRL due to con­t­a­m­i­nant wor­ries, Gilead re­turns to FDA for next-gen HIV drug

Just shy of four months ago, Gilead’s next-gen HIV drug candidate lenacapavir got hit with a CRL over CMC issues involving the type of vials planned for use. Now, the pharma is headed back to the FDA for round two.

Gilead announced Monday afternoon that it had refiled its NDA submission filled with new CMC data after the FDA essentially balked at borosilicate glass vials, originally used for the non-oral form of lenacapavir. The drug candidate, which recently won a positive opinion from Europe’s CHMP, is being developed for HIV-1 infection “in heavily treatment-experienced (HTE) people with multi-drug resistant (MDR) HIV-1 infection.”

Years af­ter link­ing arms with Bris­tol My­ers and both Mer­cks, Sutro finds its lat­est part­ner in Tokyo

Astellas and Sutro Biopharma are linking arms on a new field of antibody-drug conjugates that they hope will improve upon existing cancer immunotherapies.

The Tokyo pharma will dole out $90 million in cash for the collaboration, the companies said Monday afternoon. That upfront payment will extend the South San Francisco biotech’s runway from late 2023 into the first half of 2024, Cowen analysts noted.

Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Matt Gline, Roivant CEO (John Sciulli/Getty Images for GLG)

Roivant chops sick­le cell gene ther­a­py, der­ma­tol­ogy drugs to fo­cus on 'high­er val­ue pro­ject­s'

Roivant is sweeping a suite of drugs, including a gene therapy for sickle cell disease already in the clinic, out of its pipeline.

Six programs from four of its “vants” are being wound down as part of “a company-wide cost optimization and pipeline reprioritization initiative to reduce our expected operating expenses and prioritize our capital resources.”

When reached by Endpoints News, a spokesperson said, “We don’t anticipate a material reduction in headcount but we will likely reassign some folks to higher value projects as part of winding down specific programs.”

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