MSK's José Basel­ga steps off Bris­tol-My­er­s' board as the in­dus­try de­bates the con­tro­ver­sy over in­dus­try ties

The dam­age re­port from the con­tro­ver­sy sur­round­ing Memo­r­i­al Sloan Ket­ter­ing’s chief physi­cian José Basel­ga keeps mount­ing.

Late on Fri­day came word from Bris­tol-My­ers Squibb that Basel­ga had re­signed from the big biotech’s board of di­rec­tors.

“Bris­tol-My­ers Squibb $BMY is com­mit­ted to the high­est stan­dards of ethics, com­pli­ance and in­tegri­ty,” not­ed the com­pa­ny in a brief state­ment. “These prin­ci­ples are cen­tral to the Com­pa­ny’s mis­sion and our abil­i­ty to de­liv­er in­no­v­a­tive med­i­cines to pa­tients with se­ri­ous dis­ease.”

Basel­ga had on­ly joined the board 5 months ago.

That res­ig­na­tion came sev­er­al days af­ter The New York Times and ProP­ub­li­ca re­port­ed that the renowned can­cer re­searcher had rou­tine­ly failed to fol­low the rules and cite his many fi­nan­cial ties with bio­phar­ma com­pa­nies in jour­nal ar­ti­cles and at con­fer­ences, forc­ing his ouster at Memo­r­i­al Sloan Ket­ter­ing.

Late Thurs­day word spread that the ar­ti­cle had set off a storm of con­tro­ver­sy, trig­ger­ing a chain re­ac­tion of alarm at MSK that prompt­ed the sci­en­tist to turn in his let­ter of res­ig­na­tion. In it, he wrote:

I fear my con­tin­ued role lead­ing clin­i­cal care and re­search will be­come too much of a dis­trac­tion to the hos­pi­tal and its re­mark­able team of physi­cians, re­searchers and staff.

Basel­ga, the once high­ly sought af­ter physi­cian-in-chief at MSK, al­so ac­cept­ed re­spon­si­bil­i­ty for his fail­ures to dis­close his many ties to phar­ma and biotech com­pa­nies, adding that those links were al­so well known and care­ful­ly re­port­ed to MSK it­self.

The news trig­gered a fren­zy of com­ments on Twit­ter, with a mix of views on the sud­den down­fall of a wide­ly cel­e­brat­ed re­searcher. If noth­ing else, it will put a spot­light on the grow­ing fi­nan­cial con­nec­tions be­tween re­searchers and the in­dus­try — and like­ly trig­ger a rush to fill in any gaps on dis­clo­sures in the com­ing weeks.

Quite a few peo­ple felt that forc­ing Basel­ga out at MSK was ex­ces­sive. But it’s al­so clear that prop­er­ly re­port­ing these ties is a se­ri­ous con­cern for the in­dus­try. We put up a poll for peo­ple at the be­gin­ning of the week, and drew more than a few harsh re­bukes for what he had failed to do.

Out of 447 re­spons­es, 330 — 74% — felt his fail­ure to re­port fi­nan­cial ties was a sig­nif­i­cant is­sue. On­ly 26% felt it was not. Sig­nif­i­cant, though, meant dif­fer­ent things to dif­fer­ent peo­ple. 

Here’s a sam­pling of the com­ments we heard:

It’s un­ac­cept­able and un­eth­i­cal. It hurts a lot the al­ready bad rep­u­ta­tion of phar­ma in­dus­try and of all the hon­est peo­ple and ex­cel­lent pro­fes­sion­als who work in clin­i­cal de­vel­op­ment. I am spe­cial­ly touched by his un­eth­i­cal be­hav­ior as I work in phar­ma/CROs and try to do my job as best as pos­si­ble with the high­est eth­i­cal stan­dards I can and have.
Not dis­clos­ing un­der­mines the goal of the en­tire process. The in­for­ma­tion should be pro­vid­ed and avail­able. Whether it in­flu­ences a stake­hold­er’s de­ci­sion one way or an­oth­er is sec­ondary to the fun­da­men­tal dis­clo­sure process. – John Cial­lel­la, Charles Riv­er Labs
Sig­nif­i­cant enough to call him out and have the dis­clo­sures cor­rect­ed but not wor­thy of a ma­jor ex­pose or alarm. He’s not the first or last re­searcher who didn’t dis­close some­thing. Don’t con­done it but lets not over­re­act ei­ther. Just set clear guide­lines and en­force them.
I’d de­fine sig­nif­i­cance as ris­ing to a crim­i­nal, civ­il or eth­i­cal breach. And that breach de­pends on in­tent. It is fair­ly clear that his in­tent was not to de­ceive and this was an over­sight. He made an er­ror. What is much more sig­nif­i­cant was the shod­dy ‘gotcha’ jour­nal­ism that im­plied ma­lign in­tent with­out prov­ing it. – David Weis­man, MD
I don’t think this par­tic­u­lar fail­ure to dis­close con­flicts was sig­nif­i­cant since Basel­ga’s con­sult­ing agree­ments/ad board mem­ber­ships are pret­ty much pub­lic knowl­edge. How­ev­er, this should be a sign to jour­nals, con­fer­ences and oth­er pub­lish­ing en­ti­ties to im­prove their process­es to al­ways en­sure au­thors ad­here to their dis­clo­sure agree­ments. For piv­otal stud­ies, FDA col­lects fi­nan­cial dis­clo­sure forms for all pri­ma­ry in­ves­ti­ga­tors *and* subin­ves­ti­ga­tors, which is sub­mit­ted with the clin­i­cal da­ta.
The re­la­tion­ship of trust be­tween pa­tients and doc­tors is fun­da­men­tal to our med­ical sys­tem. This sys­tem­at­ic fail­ure to com­ply with wide­ly-ac­cept­ed stan­dards of con­flict dis­clo­sure un­der­mines that foun­da­tion, while al­so pro­vid­ing a bad ex­am­ple to younger re­searchers and a good cov­er to un­scrupu­lous re­searchers. Why should any­one dis­close their con­flicts when some­one as ac­claimed as Dr. Basel­ga does not?

Im­age: José Basel­ga. AS­CO

BY­OD Best Prac­tices: How Mo­bile De­vice Strat­e­gy Leads to More Pa­tient-Cen­tric Clin­i­cal Tri­als

Some of the most time- and cost-consuming components of clinical research center on gathering, analyzing, and reporting data. To improve efficiency, many clinical trial sponsors have shifted to electronic clinical outcome assessments (eCOA), including electronic patient-reported outcome (ePRO) tools.

In most cases, patients enter data using apps installed on provisioned devices. At a time when 81% of Americans own a smartphone, why not use the device they rely on every day?

Chris Gibson (Photo By Vaughn Ridley/Sportsfile for Web Summit via Getty Images)

Re­cur­sion founders gin for­tunes as IPO back­ers show­er $436M on one of the biggest boasts in AI -- based on some very small deals

In the AI drug development world, boasting often comes with the territory. Yet few can rival Recursion when it comes to claiming the lead role in what company execs like to call the industrialization of drug development, with promises of continued exponential growth in the number of drugs it has in the pipeline.

On Friday, the Salt Lake City-based biotech translated its unicorn-sized boasts into a killer IPO, pricing more than 24 million shares at the high end of its range and bringing in $436 million — with a large chunk of that promised by some deep-pocket backers.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Covid-19 vac­cine halt drags on, an FDA ap­point­ment at long last, the great CRO con­sol­i­da­tion, and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Conference season is upon us, and while we’d much prefer to be wandering down the hallways and presentation rooms in person, the team is ready to cover the most consequential data coming out of these scientific meetings. Get in touch early if you have news to share.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 107,000+ biopharma pros reading Endpoints daily — and it's free.

Image: Shutterstock

Eli Lil­ly asks FDA to re­voke EUA for Covid-19 treat­ment

Eli Lilly on Friday requested that the FDA revoke the emergency authorization for its Covid-19 drug bamlanivimab, which is no longer as effective as a combo therapy because of a rise in coronavirus variants across the US.

“With the growing prevalence of variants in the U.S. that bamlanivimab alone may not fully neutralize, and with sufficient supply of etesevimab, we believe now is the right time to complete our planned transition and focus on the administration of these two neutralizing antibodies together,” Daniel Skovronsky, Lilly’s CSO, said in a statement.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 107,000+ biopharma pros reading Endpoints daily — and it's free.

Ex­clu­sive in­ter­view: Pe­ter Marks on why full Covid-19 vac­cine ap­provals could be just months away

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, took time out of his busy schedule last Friday to discuss with Endpoints News all things related to his work regulating vaccines and the pandemic.

Marks, who quietly coined the name “Operation Warp Speed” before deciding to stick with his work regulating vaccines at the FDA rather than join the Trump-era program, has been the face of vaccine regulation for the FDA throughout the pandemic, and is usually spotted in Zoom meetings seated in front of his wife’s paintings.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Near­ly a year af­ter Au­den­tes' gene ther­a­py deaths, the tri­al con­tin­ues. What hap­pened re­mains a mys­tery

Natalie Holles was five months into her tenure as Audentes CEO and working to smooth out a $3 billion merger when the world crashed in.

Holles and her team received word on the morning of May 5 that, hours before, a patient died in a trial for their lead gene therapy. They went into triage mode, alerting the FDA, calling trial investigators to begin to understand what happened, and, the next day, writing a letter to alert the patient community so they would be the first to know. “We wanted to be as forthright and transparent as possible,” Holles told me late last month.

The brief letter noted two other patients also suffered severe reactions after receiving a high dose of the therapy and were undergoing treatment. One died a month and a half later, at which point news of the deaths became public, jolting an emergent gene therapy field and raising questions about the safety of the high doses Audentes and others were now using. The third patient died in August.

“It was deeply saddening,” Holles said. “But I was — we were — resolute and determined to understand what happened and learn from it and get back on track.”

Eleven months have now passed since the first death and the therapy, a potential cure for a rare and fatal muscle-wasting disease called X-linked myotubular myopathy, is back on track, the FDA having cleared the company to resume dosing at a lower level. Audentes itself is no more; last month, Japanese pharma giant Astellas announced it had completed working out the kinks of the $3 billion merger and had restructured and rebranded the subsidiary as Astellas Gene Therapies. Holles, having successfully steered both efforts, departed.

Still, questions about precisely what led to the deaths of the 3 boys still linger. Trial investigators released key details about the case last August and December, pointing to a biological landmine that Audentes could not have seen coming — a moment of profound medical misfortune. In an emerging field that’s promised cures for devastating diseases but also seen its share of safety setbacks, the cases provided a cautionary tale.

Audentes “contributed in a positive way by giving a painful but important example for others to look at and learn from,” Terry Flotte, dean of the UMass School of Medicine and editor of the journal Human Gene Therapy, told me. “I can’t see anything they did wrong.”

Yet some researchers say they’re still waiting on Astellas to release more data. The company has yet to publish a full paper detailing what happened, nor have they indicated that they will. In the meantime, it remains unclear what triggered the events and how to prevent them in the future.

“Since Audentes was the first one and we don’t have additional information, we’re kind of in a holding pattern, flying around, waiting to figure out how to land our vehicles,” said Jude Samulski, professor of pharmacology at UNC’s Gene Therapy Center and CSO of the gene therapy biotech AskBio, now a subsidiary of Bayer.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

J&J faces CDC ad­vi­so­ry com­mit­tee again next week to weigh Covid-19 vac­cine risks

The CDC’s Advisory Committee on Immunization Practices punted earlier this week on deciding whether or not to recommend lifting a pause on the administration of J&J’s Covid-19 vaccine, but the committee will meet again in an emergency session next Friday to discuss the safety issues further.

The timing of the meeting likely means that the J&J vaccine will not return to the US market before the end of next week as the FDA looks to work hand-in-hand with the CDC to ensure the benefits of the vaccine still outweigh the risks for all age groups.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 107,000+ biopharma pros reading Endpoints daily — and it's free.

Osman Kibar (Samumed, now Biosplice)

Os­man Kibar lays down his hand at Sa­mumed, step­ping away from CEO role as his once-her­ald­ed an­ti-ag­ing biotech re­brands

Samumed made quite the entrance back in 2016, when it launched with some anti-aging programs and a whopping $12 billion valuation. That level of fanfare was nowhere to be found on Thursday, when the company added another $120 million to its coffers and quietly changed its name to Biosplice Therapeutics.

Why the sudden rebrand?

“We did that for obvious reasons,” CFO and CBO Erich Horsley told Endpoints News. “The name Biosplice echoes our science much more than Samumed does.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 107,000+ biopharma pros reading Endpoints daily — and it's free.

Alan List, new Precision BioSciences CMO, in 2019 (Diane Bondareff/AP Images for Moffitt Cancer Center)

Eli Lil­ly-part­nered biotech taps star in­ves­ti­ga­tor Alan List as CMO — a year af­ter he re­signed from Mof­fitt over Chi­na scan­dal

After laying low for more than a year following a scandal that led to his ouster, former Moffitt Cancer Center CEO Alan List has emerged in the frontlines of biotech.

An expert in hematology and oncology drug development known as a lead investigator for Celgene’s blockbuster Revlimid, List is swapping “clinical trials consultant” for the chief medical officer title at Precision BioSciences — a Eli Lilly-partnered biotech boasting a new gene editing approach to cell and gene correction therapies.