A star can­cer sci­en­tist failed to dis­close in­dus­try pay­ments over the years — does that mat­ter so much?

Dur­ing the big AS­CO con­fer­ence at the be­gin­ning of last June, promi­nent Memo­r­i­al Sloan Ket­ter­ing sci­en­tist José Basel­ga had this to say about the da­ta he had col­lect­ed for an ex­per­i­men­tal PI3K drug at Roche called taselis­ib:

This is proof that tar­get­ing the PI3K path­way has an ef­fect in breast can­cer and that there are pa­tients who will ben­e­fit. To me that is in­cred­i­bly ex­cit­ing.

Roche, how­ev­er, was not near­ly so en­thu­si­as­tic.

Soon af­ter, the phar­ma gi­ant would dump the whole thing, writ­ing off an­oth­er drug in a se­vere­ly dis­ap­point­ing class that couldn’t muster a strong enough ef­fect to make it worth­while to push it to the mar­ket.

What may not have been well known at the time was that Basel­ga’s en­thu­si­as­tic en­dorse­ment ar­rived af­ter he had col­lect­ed $50,000 in con­sult­ing fees from Roche over the pre­vi­ous four years, and had al­so bagged a $3 mil­lion pay­ment for his share of the sale of Ser­agon, a high-pro­file can­cer biotech that went to Roche for $725 mil­lion.

There isn’t any­thing un­usu­al about those pay­ments. Basel­ga is a high­ly sought af­ter in­ves­ti­ga­tor, board mem­ber and sci­en­tif­ic ad­vis­er and has long been known as one of the top ex­perts in the field — the kind any bio­phar­ma would like to have in its cor­ner. What stands out, though, is that ac­cord­ing to a piece pub­lished by The New York Times and ProP­ub­li­ca over the week­end, Basel­ga has rou­tine­ly failed to dis­close his in­come from a ros­ter of biotech and phar­ma com­pa­nies that he had done work for over the years, both among the jour­nals which ea­ger­ly pub­lished his work as well as or­ga­ni­za­tions like AS­CO, where he head­lined ma­jor pre­sen­ta­tions. 

Basel­ga didn’t de­ny it. He went on to amend his work on 17 pa­pers, but shrugged off nu­mer­ous oth­er in­stances where he hadn’t cit­ed his po­ten­tial con­flicts of in­ter­est, say­ing it was nev­er nec­es­sary. As for the times he had failed to make a nec­es­sary dis­clo­sure about his fi­nan­cial ties, well, he said, his work­ing ties with bio­phar­ma are well known and any such cas­es were sim­ple in­con­sis­ten­cies.

Oth­ers, though, weren’t quite ready to let him off the hook. If some­one of Basel­ga’s stature won’t take these dis­clo­sures se­ri­ous­ly, why would any­one?

“If lead­ers don’t fol­low the rules, then we don’t re­al­ly have rules,” Walid Gel­lad, di­rec­tor of the Cen­ter for Phar­ma­ceu­ti­cal Pol­i­cy and Pre­scrib­ing at the Uni­ver­si­ty of Pitts­burgh, told the au­thors of the re­port. “It says that the rules don’t mat­ter.”

The ab­sence of Basel­ga’s ros­ter of in­dus­try con­flicts al­so eras­es some im­por­tant con­text for his en­dorse­ments of ex­per­i­men­tal drugs, like taselis­ib.

The re­port trig­gered some in­ter­est­ing chat­ter on Twit­ter over the last two days. And we have a snap poll on the is­sue we’d like you to par­tic­i­pate in, which you can see be­low the Twit­ter ex­change.


 


Snap poll for End­points read­ers


Im­age: José Basel­ga. AU­RA BIO­SCIENCES

Aerial view of Genentech's campus in South San Francisco [Credit: Getty]

Genen­tech sub­mits a big plan to ex­pand its South San Fran­cis­co foot­print

The sign is still there, a quaint reminder of whitewashed concrete not 5 miles from Genentech’s sprawling, chrome-and-glass campus: South Francisco The Industrial City. 

The city keeps the old sign, first erected in 1923, as a tourist site and a kind of civic memento to the days it packed meat, milled lumber and burned enough steel to earn the moniker “Smokestack of the Peninsula.” But the real indication of where you are and how much has changed both in San Francisco and in the global economy since a couple researchers and investors rented out an empty warehouse 40 years ago comes in a far smaller blue sign, resembling a Rotary Club post, off the highway: South San Francisco, The Birthplace of Biotech.

Here comes the oral GLP-1 drug for di­a­betes — but No­vo Nordisk is­n't dis­clos­ing Ry­bel­sus price just yet

Novo Nordisk’s priority review voucher on oral semaglutide has paid off. The FDA approval for the GLP-1 drug hit late Friday morning, around six months after the NDA filing.

Rybelsus will be the first GLP-1 pill to enter the type 2 diabetes market — a compelling offering that analysts have pegged as a blockbuster drug with sales estimates ranging from $2 billion to $5 billion.

Ozempic, the once-weekly injectable formulation of semaglutide, brought in around $552 million (DKK 3.75 billion) in the first half of 2019.

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

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Oxitec biologist releases genetically modified mosquitoes in Piracicaba, Brazil in 2016 [credit: Getty Images]

In­trex­on unit push­es back against claims its GM mos­qui­toes are mak­ing dis­ease-friend­ly mu­tants

When the hysteria of Zika transmission sprang into the American zeitgeist a few years ago, UK-based Oxitec was already field-testing its male Aedes aegypti mosquito, crafted to possess a gene engineered to obliterate its progeny long before maturation.

But when a group of independent scientists evaluated the impact of the release of these genetically-modified mosquitoes in a trial conducted by Oxitec in Brazil between 2013 and 2015, they found that some of the offspring had managed to survive — prompting them to speculate what impact the survivors could have on disease transmission and/or insecticide resistance.

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Pur­due threat­ens to walk away from set­tle­ment, asks to pay em­ploy­ees mil­lions in bonus­es

There are two updates on the lawsuit against Purdue Pharma over its role in fueling the opioid epidemic, as the Sackler family threatens to walk away from their pledge to pay out $3 billion if a bankruptcy judge does not stop outstanding state lawsuits against them. At the same time, the company has asked permission to pay millions in bonuses to select employees.

Purdue filed for chapter 11 bankruptcy this week as part of its signed resolution to over 2,000 lawsuits. The deal would see the Sackler family that owns Purdue give $3 billion from their personal wealth and the company turned into a trust committed to curbing and reversing overdoses.

While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA. 

Jason Kelly. Mike Blake/Reuters via Adobe

Eye­ing big ther­a­peu­tic push, Gink­go bags $290M to build a cell pro­gram­ming em­pire

Ginkgo Bioworks is on a roll. Days after publicizing a plan to nurture new startups via partnerships with accelerators Y Combinator and Petri, the Boston biotech says it has raised another $290 million for its cell programming platform to reach further and wider.

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UP­DAT­ED: Speak­er Nan­cy Pelosi to un­veil bill for fed­er­al­ly ne­go­ti­at­ed drug prices

After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.

David Grainger [file photo]

'Dis­con­nect the bas­tard­s' — one biotech's plan to break can­cer cell­s' uni­fied de­fens­es

Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

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