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.

Peter Marks appeared before a virtual SVB Leerink audience yesterday and said that his staff at FDA’s CBER is on the verge of working around the clock. Manufacturing inspections, policy work and sponsor communications have all been pushed down the to-do list so that they can be responsive to Covid-related interactions. And the agency’s objective right now? “To save as many lives as we can,” Marks said, likening the mortality on the current outbreak as equivalent to “a nuclear bomb on a small city.”

It’s another day of hauling cash in the biopharma world as four more IPOs priced Friday and a fifth filed its initial paperwork.

The biggest offering comes from PMV Pharma, an oncology biotech focusing on p53 mutations, which raised $211.8 million after pricing shares at $18 apiece. Prelude Therapeutics, developing PRMT5 inhibitors for rare cancers, was next with a $158 million raise, pricing shares at $19 each. Graybug Vision raised $90 million after pricing at $16 per share for its wet AMD candidates, and breast cancer biotech Greenwich Lifesciences brought up the rear with a small, $7 million raise after pricing shares at $5.75.

Days after J&J dosed the first participants of its Phase III ENSEMBLE trial, the pharma giant has detailed the early-stage data that gave them confidence in a single-dose regimen.

Testing two dose levels either as a single dose or in a two-dose schedule spaced by 56 days in, the scientists from Janssen, the J&J subsidiary developing its vaccine, reported that the low dose induced a similar immune response as the high dose. The interim Phase I/IIa results were posted in a preprint on medRxiv.

Sitting atop the executive branch, President Donald Trump is the ultimate authority at the FDA. He can fast track any vaccine to approval himself. If it came to that, of course.

What he can’t do is unilaterally order the legislative branch to loosen the Treasury’s coffers for $6.6 billion. Nor can he command pharmaceutical companies to pay for $200 vouchers sent to 33 million Medicare beneficiaries for prescription drugs before the election.

The concerns keep mounting over President Donald Trump’s politicization of the FDA and other federal agencies guiding the development of a safe and effective vaccine. And today, the telegenic New York governor Andrew Cuomo appeared to introduce even more politics into the matter — latest in an ongoing series of incidents that have cast the proudly independent FDA in starkly political terms.

During his daily press conference Cuomo said that the state will review any coronavirus vaccines approved by the federal government, citing a lack of trust in the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.

In the latest incident where Alex Azar has steadfastly taken the side of President Donald Trump over that of the FDA, the HHS secretary was noncommittal this morning when asked if he supports the attempt by his subordinates at the FDA to strengthen guidelines for a vaccine EUA.

Appearing on NBC’s Today Show, the HHS secretary muddied the waters, stating that the guidance that matters is the one that is “actually already out there.”