It's not just Charles Lieber: NI­H's on­go­ing in­ves­ti­ga­tion has swept up 54 sci­en­tists who vi­o­lat­ed rules about for­eign ties

Michael Lauer NIH

The NIH’s work­ing group for for­eign in­flu­ences on re­search in­tegri­ty has opened cas­es against 189 sci­en­tists sus­pect­ed of vi­o­la­tions re­lat­ed to over­seas ties since launch­ing an on­go­ing, sweep­ing in­ves­ti­ga­tion al­most two years ago, new­ly avail­able sta­tis­tics showed, lead­ing to the ter­mi­na­tions and res­ig­na­tions of 54 sci­en­tists.

Of those who have been in­ves­ti­gat­ed, 41% have al­so been re­moved from the NIH sys­tem, barred from seek­ing fur­ther grants. Michael Lauer, NIH’s head of ex­tra­mur­al re­search, pre­sent­ed a com­pre­hen­sive set of these and oth­er num­bers in a vir­tu­al up­date on Fri­day, just a day af­ter Charles Lieber — the for­mer head of Har­vard’s chem­istry de­part­ment — was in­dict­ed in fed­er­al court for ly­ing about his Chi­nese con­nec­tions.

While high-pro­file cas­es like Lieber’s, as well as those at MD An­der­son, Emory Uni­ver­si­ty and Mof­fitt be­fore him, have gripped the bio­med­ical field, they mere­ly rep­re­sent in­di­vid­ual snap­shots of when in­sti­tu­tions re­spond to the NIH’s warn­ings about hid­den for­eign ties. The of­fi­cial da­ta shine light on the broad­er pic­ture.

Fran­cis Collins NIH

For one, more could be com­ing. The NIH has iden­ti­fied 399 sci­en­tists of pos­si­ble con­cern in to­tal, 251 of whom screened “pos­i­tive,” with an­oth­er 72 “pend­ing.”

Agency di­rec­tor Fran­cis Collins called that pic­ture “sober­ing,” ac­cord­ing to Sci­ence, which first re­port­ed on Lauer’s re­marks.

At the heart of the is­sue, Lauer high­light­ed, isn’t that US re­searchers are col­lab­o­rat­ing with in­ves­ti­ga­tors in for­eign coun­tries. Rather, it’s of­ten about NIH-backed sci­en­tists’ fail­ure to dis­close sig­nif­i­cant re­sources from al­ter­na­tive sources, con­flicts of in­ter­est or patents. In cer­tain cas­es, there were even peer re­view vi­o­la­tions.

Over­all, Chi­na stood out as the top coun­try pro­vid­ing for­eign sup­port to sci­en­tists, ei­ther re­flect­ing or con­firm­ing the long­stand­ing rhetoric on aca­d­e­m­ic es­pi­onage. Pre­sum­ably through the Thou­sand Tal­ents Pro­gram, Chi­nese fund­ing was in­volved in 93% of the cas­es.

It may thus be un­sur­pris­ing that the vast ma­jor­i­ty of cas­es in­volve an Asian man in his 50s, al­though 14% of the in­ves­ti­ga­tions cen­tered around whites. On av­er­age, the NIH has is­sued $678,000 in grant sup­port to each of these sci­en­tists, who are spread across 27 states and 59 cities.

But there is hope that in­sti­tu­tions are grow­ing more aware of the prob­lems — which might not have pre­vi­ous­ly been con­sid­ered se­ri­ous un­til the FBI and the NIH cracked down on them — and tak­ing ac­tions against non-com­pli­ance. As part of their ef­forts, the NIH has con­tact­ed 87 uni­ver­si­ties or re­search cen­ters; slight­ly more than half men­tioned they are im­ple­ment­ing new mea­sures.

In a nod to con­cerns that the height­ened sen­ti­ments are stok­ing fears among sci­en­tists of Asian her­itage who fear they may be tar­get­ed, Lauer made sure to tuck this re­as­sur­ance to the end of his slides:

We re­it­er­ate the im­por­tance of the con­tri­bu­tion of for­eign sci­en­tists to bio­med­ical re­search; we must not cre­ate a cli­mate that is un­wel­com­ing to them.

Donald and Melania Trump watch the smoke of fireworks from the South Lawn of the White House on July 4, 2020 (via Getty)

Which drug de­vel­op­ers of­fer Trump a quick, game-chang­ing ‘so­lu­tion’ as the pan­dem­ic roars back? Eli Lil­ly and Ab­Cellera look to break out of the pack

We are unleashing our nation’s scientific brilliance and will likely have a therapeutic and/or vaccine solution long before the end of the year.

— Donald Trump, July 4

Next week administration officials plan to promote a new study they say shows promising results on therapeutics, the officials said. They wouldn’t describe the study in any further detail because, they said, its disclosure would be “market-moving.”

— NBC News, July 3

Something’s cooking. And it’s not just July 4 leftovers involving stale buns and uneaten hot dogs.

Over the long weekend observers picked up signs that the focus in the Trump administration may swiftly shift from the bright spotlight on vaccines being promised this fall, around the time of the election, to include drugs that could possibly keep patients out of the hospital and take the political sting out of the soaring Covid-19 numbers causing embarrassment in states that swiftly reopened — as Trump cheered along.

So far, Gilead has been the chief beneficiary of the drive on drugs, swiftly offering enough early data to get remdesivir an emergency authorization and into the hands of the US government. But their drug, while helpful in cutting stays, is known for a limited, modest effect. And that won’t tamp down on the hurricane of criticism that’s been tearing at the White House, and buffeting the president’s most stalwart core defenders as the economy suffers.

We’ve had positive early-stage vaccine data, most recently from Pfizer and BioNTech, playing catchup on an mRNA race led by Moderna — where every little sign of potential trouble is magnified into a lethal threat, just as every advance excites a frenzy of support. But that race still has months to play out, with more Phase I data due ahead of the mid-stage numbers looming ahead. A vaccine may not be available in large enough quantities until well into 2021, which is still wildly ambitious.

So what about a drug solution?

Trump’s initial support for a panacea focused on hydroxychloroquine. But that fizzled in the face of data underscoring its ineffectiveness — killing trials that aren’t likely to be restarted because of a recent population-based study offering some support. And there are a number of existing drugs being repurposed to see how they help hospitalized patients.

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George Yancopoulos (Regeneron)

UP­DAT­ED: Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others.

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

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Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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Look­ing for 'ex­ter­nal in­no­va­tion,' Boehringer In­gel­heim re­serves $500M+ for new Shang­hai hub

Now that Boehringer Ingelheim’s bet on contract manufacturing in China has paid off, the German drugmaker is anteing up more to get into the research game.

Boehringer has set aside $507.9 million (€451 million) for a new External Innovation Hub to be built in Shanghai over five years. The site will become one of its “strategic pillars” as the team strives to get 71 approvals — either for new products or indications — by 2030, said Felix Gutsche, president and CEO of Boehringer Ingelheim China.

Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”