No clear an­swers: Yes, re­cent ac­tions against Chi­nese Amer­i­can sci­en­tists do pose a threat — but maybe those of­fi­cial con­cerns about es­pi­onage are valid too

Ear­li­er this week we asked our read­ers to chime in on a con­ver­sa­tion in­spired by for­mer NIH di­rec­tor and Sanofi R&D chief Elias Zer­houni, who was con­cerned that re­cent purges of Chi­nese Amer­i­can sci­en­tists at top bio­med­ical in­sti­tu­tions could spell trou­ble for the sci­en­tif­ic com­mu­ni­ty. While ground­ed in na­tion­al se­cu­ri­ty rea­sons, he ar­gues, the US risks los­ing valu­able tal­ent and col­lab­o­ra­tions if it doesn’t han­dle the sit­u­a­tion prop­er­ly.

The re­sults to our snap poll, which gath­ered 220 re­spons­es, re­flects a lack of con­sen­sus on the three key ques­tions: How se­ri­ous is the prob­lem of aca­d­e­m­ic es­pi­onage? In try­ing to fix that is­sue, are we hurt­ing Chi­nese Amer­i­can sci­en­tists? And what, if any­thing, should be done about it?

More re­spon­dents be­lieve that wor­ries about aca­d­e­m­ic es­pi­onage are at least “some­what” well-found­ed, con­sti­tut­ing al­most 60%. On the oth­er side, 30% say “not re­al­ly” or “ab­solute­ly not,” with 10% stand­ing in the mid­dle.

“Ma­jor­i­ty of aca­d­e­m­ic find­ings are of no val­ue,” one read­er com­ments.

An­oth­er raised the con­cern that aca­d­e­mics don’t al­ways know where the line is be­tween friend­ly shar­ing of in­for­ma­tion and IP theft:

In­sti­tu­tions don’t al­ways train their fac­ul­ty and staff on ac­cept­able/un­ac­cept­able col­lab­o­ra­tion poli­cies, and there’s a fast-and-loose cul­ture in acad­e­mia on many top­ics (da­ta re­pro­ducibil­i­ty, HR, lab safe­ty, IP) that goes be­yond so-called aca­d­e­m­ic es­pi­onage.

But even for those con­cerned with some lev­el of es­pi­onage, there is a di­vide as to whether it’s a sys­temic ef­fort com­ing specif­i­cal­ly from Chi­na or bad ac­tors that are bound to pop up, re­gard­less of na­tion­al­i­ty.

A slight ma­jor­i­ty agrees that the dis­missals at MD An­der­son and Emory threat­en the en­tire Chi­nese Amer­i­can sci­en­tif­ic com­mu­ni­ty in the US — in par­tic­u­lar, the bio­med­ical re­search field, not least be­cause it shapes the pub­lic dis­course about sci­en­tists with roots in Chi­na.

Com­bine the cur­rent ad­min­is­tra­tion’s an­ti-im­mi­grant stance with these re­cent events and even Amer­i­can born Chi­nese sci­en­tists like me feel threat­ened. It adds to a cli­mate of fear – who’s look­ing over our shoul­ders and mis­in­ter­pret­ing our ac­tions?

Those who hold the op­po­site view, though, say iso­lat­ed cas­es — in which in­di­vid­u­als were al­leged­ly pun­ished for shar­ing con­fi­den­tial in­for­ma­tion and vi­o­lat­ing con­flict of in­ter­est poli­cies — don’t make a con­spir­a­cy against an en­tire eth­nic group.

Along the same lines, while 60% of re­spon­dents say they share an ur­gency to ad­dress the fears of Chi­nese Amer­i­can sci­en­tists, 20% do not and the rest are ei­ther neu­tral or haven’t formed an opin­ion.

Many in sup­port wor­ry about a re­verse brain drain, es­pe­cial­ly as they have had a pos­i­tive ex­pe­ri­ence work­ing with Chi­nese-born col­leagues: “In the ab­sence of pos­i­tive in­for­ma­tion, in­di­vid­u­als will make there own de­ci­sions, and well-fund­ed Chi­nese com­pa­nies are push­ing hard for tal­ent al­ready.”

Oth­ers main­tain the prob­lem is overblown.

“It should be clear to all that there is noth­ing to be con­cerned about if sci­en­tists are not par­tic­i­pat­ing in ques­tion­able part­ner­ships with for­eign gov­ern­men­tal agen­cies or com­pa­nies, etc. It seems crazy to sug­gest that sci­en­tists who work with­in the nor­mal con­fines of acad­e­mia or in­dus­try would be at risk with­out ad­di­tion­al ac­tion.”

What about Zer­houni’s pro­pos­al to set up a blue-rib­bon com­mit­tee to draft a new set of clear­ly de­fined rules to gov­ern for­eign sci­en­tif­ic en­gage­ment?

The idea is clear­ly still in its in­fan­cy, with more than half re­spond­ing “neu­tral” or “no opin­ion” and some pro­fess­ing lack of un­der­stand­ing as to what that en­tails. Sup­port and dis­agree­ment are split right down the mid­dle.

Go­ing back to the ex­pul­sions that trig­gered the con­ver­sa­tion, a re­spon­dent sug­gests the so­lu­tion will be more in­for­ma­tion.

The best way for­ward is for the gov­ern­ment to spell out ex­act­ly what the ev­i­dence against these in­di­vid­u­als was. If it is con­vinc­ing to sci­en­tists that their in­ten­tions re­al­ly were to hurt Amer­i­can sci­ence and ben­e­fit Chi­nese, the ac­tions will be ac­cept­ed and will serve as a warn­ing to oth­ers per­haps con­sid­er­ing sim­i­lar ad­ven­tures. On the oth­er hand, if the ev­i­dence is weak or they mis­in­ter­pret­ed the in­tent of the ac­tions of these peo­ple, then wide­spread pan­ic will en­sue, with or with­out a “blue rib­bon pan­el”.

So­cial im­age: Shut­ter­stock

No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; 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.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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Demis Hassabis, DeepMind CEO (Qianlong/Imaginechina via AP Images)

Google's Deep­Mind opens its pro­tein data­base to sci­ence — po­ten­tial­ly crack­ing drug R&D wide open

Nearly a year ago, Google’s AI outfit DeepMind announced they had cracked one of the oldest problems in biology: predicting a protein’s structure from its sequence alone. Now they’ve turned that software on nearly every human protein and hundreds of thousands of additional proteins from organisms important to medical research, such as fruit flies, mice and malaria parasite.

The new database of roughly 350,000 protein sequences and structures represents a potentially monumental achievement for the life sciences, one that could hasten new biological insights and the development of new drugs. DeepMind said it will be free and accessible to all researchers and companies.

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In­side Bio­gen's scram­ble to sell Aduhelm: Pro­ject 'Javelin' and pres­sure to ID as many pa­tients as pos­si­ble

In anticipation of Aduhelm’s approval for Alzheimer’s in June, Biogen employees were directed to identify and guarantee treatment centers would administer the drug through a program called “Javelin,” a senior Biogen employee told Endpoints News.

The program identified about 800 centers for use, he said, and Biogen now pays for the use of bioassays to identify beta amyloid in potential patients having undergone a lumbar puncture procedure, the employee said — and one center preparing to administer the drug confirmed its participation in the bioassay program.

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Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

No­var­tis dis­cards one of its ‘wild card’ drugs af­ter it flops in key study. But it takes one more for the hand

Always remember just how risky it is to gamble big on small studies.

A little more than 4 years ago, Novartis reportedly put up a package worth up to $1 billion for the dry eye drug ECF843 after a small biotech called Lubris put it through its paces in a tiny study of 40 moderate to severe patients, tracking some statistically significant markers of efficacy.

By last fall, the program had risen up to become one of CEO Vas Narasimhan’s top “wild card” programs in line for a potential breakthrough year in 2021. These drugs were all considered high-risk, high-reward efforts. And in this case, risk won.

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EMA re­jects FDA-ap­proved Parkin­son's drug, signs off on Mod­er­na vac­cine use in ado­les­cents ahead of FDA

The European Medicines Agency on Friday rejected Kyowa Kirin’s Parkinson’s disease drug Nouryant (istradefylline), which the US FDA approved in 2019 under the brand name Nourianz.

EMA said it considered that the results of the clinical studies used to support the application “were inconsistent and did not satisfactorily show that Nouryant was effective at reducing the ‘off’ time. Only four out of the eight studies showed a reduction in ‘off’ time, and the effect did not increase with an increased dose of Nouryant.”

6 top drug­mak­ers of­fer per­spec­tives on FDA's new co­vari­ates in RCTs guid­ance

Back in May, the FDA revised and expanded a 2019 draft guidance that spells out how to adjust for covariates in the statistical analysis of randomized controlled trials.

Building on the ICH’s E9 guideline on the statistical principles for clinical trials, the 3-page draft was transformed into an 8-page draft, with more detailed recommendations on linear and nonlinear models to analyze the efficacy endpoints in RCTs.

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Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

Ex-Mer­ck chief Ken Fra­zier takes a lead­ing role in a $600M 'Health As­sur­ance' ven­ture fund

Ken Frazier has opened up a new chapter in his storied career.

The ex-Merck CEO is joining a high-minded venture group with plans to carve a unique role for itself at the well-traveled juncture of tech and life sciences. And the new job comes through an old college buddy.

Officially, Frazier now becomes chairman of General Catalyst’s health assurance initiative. Their $600 million fund was unveiled back in early April, planning to invest in companies that could push the “evolution from a ‘sick care’ system to a resilient, proactive Health Assurance system designed to help people stay well, bend the cost curve, and make quality care more affordable and more accessible to all.”

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Mol­e­c­u­lar Di­ag­nos­tics Can Trans­form Can­cer Care. Let’s Make It Hap­pen.

Like so many people around the world, my life has been profoundly shaped by cancer. Those personal experiences, along with a deep love of clinical laboratory science and a passion to apply the power of genomics in medicine, motivated me to launch a company that would improve cancer care through better diagnostics. Thirteen years later, I am proud that we are delivering more accurate information at multiple points along the patient journey, with a focus on eight of the 10 cancers that are most commonly diagnosed in the United States.

Mod­er­na es­tab­lish­es pub­lic health-fo­cused char­i­ty; FDA ap­proves As­traZeneca di­a­betes drug for pe­di­atric use

To help promote public health and healthcare in underserved areas of the world, Moderna will establish a charity with a $50 million endowment.

The Cambridge, MA-based company announced the board of directors’ approval Thursday. The foundation will focus on “charitable, scientific and educational endeavors” with an emphasis on promoting public health and the access to healthcare, the press release said. The foundation will start operations once its status as a 501(c)(3) is approved.