‘I was shocked’: Con­tro­ver­sy brews at Emory af­ter promi­nent Chi­nese neu­ro­sci­en­tists are oust­ed over dis­clo­sure is­sues

It’s what Chi­nese sci­en­tists work­ing in the US have been dread­ing since MD An­der­son oust­ed three of its Asian fac­ul­ty mem­bers fol­low­ing NIH-di­rect­ed in­ves­ti­ga­tions: A sec­ond pres­ti­gious in­sti­tu­tion has closed down a promi­nent lab and ter­mi­nat­ed the two Chi­na-born re­searchers head­ing the lab.

The news, com­ing out of Emory Uni­ver­si­ty, is once again stir­ring up in­dig­na­tion, be­wil­der­ment and anx­i­ety among Chi­nese aca­d­e­mics and ne­ti­zens alike, not least be­cause the oust­ed pro­fes­sors have gone pub­lic with their side of the sto­ry, ques­tion­ing how the school han­dled the fir­ing, dis­put­ing ac­cu­sa­tions and ex­press­ing their wor­ry. As a con­se­quence, sev­er­al post­docs from Chi­na work­ing in their lab have al­so been asked to leave the coun­try.

Xi­ao­jiang Li Emory

Xi­ao­jiang Li and Shi­hua Li were 23-year vet­er­ans of Emory and not­ed neu­ro­sci­en­tists spe­cial­iz­ing in Hunt­ing­ton’s dis­ease. The mar­ried cou­ple, who are now US cit­i­zens, joint­ly ran a lab at Emory that re­cent­ly cre­at­ed a pig mod­el for the ge­net­ic ail­ment that they say rep­re­sents bet­ter test­ing grounds for new treat­ments. Last April, they pub­lished this find­ing in Cell in col­lab­o­ra­tion with Ji­nan Uni­ver­si­ty and the Chi­nese Acad­e­my of Sci­ences in Guangzhou.

Xi­ao­jiang Li was giv­ing a speech at Ji­nan, where he is a part-time pro­fes­sor, when The At­lanta Jour­nal-Con­sti­tu­tion re­port­ed on May 23 that Emory has fired two re­searchers for fail­ing to dis­close fund­ing from and re­search ties with Chi­nese en­ti­ties.

The no­ti­fi­ca­tion ar­rived one week ear­li­er, he told the Chi­nese blog Zhishifen­zi, and on the same day, his lab was shut down. The grad­u­ate stu­dents and post­docs at the scene were de­mand­ed to stop their ex­per­i­ments, va­cate the lab and at­tend in­ter­views with “strangers in suits,” Zhishifen­zi re­port­ed based on con­ver­sa­tions with wit­ness­es.

On May 24, Xi­ao­jiang Li bat back at Emory through a state­ment to Sci­ence, in which he claimed to have dis­closed his Chi­nese re­search ac­tiv­i­ty to the uni­ver­si­ty since 2012 when he be­gan work­ing on non-hu­man pri­mate re­search in Chi­na and co­op­er­at­ed with its in­ves­ti­ga­tion dat­ing back to No­vem­ber 2018.

Shi­hua Li Emory

“I was shocked that Emory Uni­ver­si­ty would ter­mi­nate a tenured pro­fes­sor in such an un­usu­al and abrupt fash­ion and close our com­bined lab con­sist­ing of a num­ber of grad­u­ates and post­doc­tor­al trainees with­out giv­ing me spe­cif­ic de­tails for the rea­sons be­hind my ter­mi­na­tion,” he said, adding he’s re­quest­ed a copy of the in­ves­ti­ga­tion.

As in the case with MD An­der­son, Emory said it ini­ti­at­ed its own in­ves­ti­ga­tions af­ter the NIH brought sus­pi­cion of mis­con­duct to their at­ten­tion.

The probe at the pres­ti­gious Hous­ton re­search hos­pi­tal in­volved a to­tal of five re­searchers, with con­cerns span­ning vi­o­la­tions of peer re­view con­fi­den­tial­i­ty as well as fail­ure to dis­close for­eign sources of fund­ing and po­ten­tial con­flicts of in­ter­est. Au­thor­i­ties made the call to purge three of them, cleared an­oth­er of sanc­tions, and are still look­ing in­to the last.

Amid a trade war with Chi­na and in­creased na­tion­al vig­i­lance re­gard­ing aca­d­e­m­ic es­pi­onage, the NIH be­gan warn­ing grantee in­sti­tu­tions about sci­en­tists with for­eign ties in 2018, prompt­ing at least 55 to launch their own probes.

“(W)e re­mind uni­ver­si­ties to look close­ly at their or­ga­ni­za­tions to mit­i­gate un­scrupu­lous prac­tices by for­eign en­ti­ties that aim to cap­i­tal­ize on the col­lab­o­ra­tive na­ture of the U.S. bio­med­ical en­ter­prise,” an NIH spokesper­son told End­points News in the wake of MD An­der­son’s ac­tions, which marked the pub­lic in­stance of a US bio­med­ical in­sti­tu­tion sanc­tion­ing its own re­searchers for al­leged threats of for­eign in­flu­ence.

The fate of Xi­ao­jiang Li’s six NIH-fund­ed projects re­mains un­known, as does those of his post­doc re­searchers be­ing force­ful­ly repa­tri­at­ed (one of whom is preg­nant), Xi­ao­jiang Li said to Sci­ence. The pres­i­dent of Ji­nan has pub­licly pledged to host the Li’s en­tire team and pro­vide them with the fa­cil­i­ties and equip­ment to con­tin­ue their work.


Im­age: Emory Uni­ver­si­ty. Shut­ter­stock

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

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Trump ad­min­is­tra­tion re­vives bid to get drug list prices on TV ads

The Trump administration is not giving up just yet. On Wednesday, the HHS filed an appeal against a judge’s decision in July to overturn a ruling obligating drug manufacturers to disclose the list price of their therapies in television adverts — hours before it was stipulated to go into effect.

In May, the HHS published a final ruling requiring drugmakers to divulge the wholesale acquisition cost— of a 30-day supply of the drug — in tv ads in a bid to enhance price transparency in the United States. The pharmaceutical industry has vehemently opposed the rule, asserting that list prices are not what a typical patient in the United States pays for treatment — that number is typically determined by the type of (or lack thereof) insurance coverage, deductibles and out-of-pocket costs. Although there is truth to that claim, the move was considered symbolic in the Trump administration’s healthcare agenda to hold drugmakers accountable in a climate where skyrocketing drug prices have incensed Americans on both sides of the aisle.

We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Mer­ck Serono’s Se­nior Vice Pres­i­dent and Glob­al Head of On­col­o­gy
EL­LIOTT LEVY — Am­gen’s Se­nior Vice Pres­i­dent of Glob­al De­vel­op­ment
CHRIS BOSHOFF — Pfiz­er On­col­o­gy’s Chief De­vel­op­ment Of­fi­cer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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Ver­sant-backed Chi­nook gets a $65M launch round for its dis­cov­ery quest in a resur­gent kid­ney field

Versant is once again stepping off the beaten track in biotech to see if they can blaze a trail of their own in a field that has looked too thorny to many investors for years.

The venture group and their partners at Apple Tree are bringing their latest creation out of stealth mode today. Born in Versant’s Inception Sciences’ Chinook Therapeutics is betting that its preclinical take on kidney disease can get an early lead among the companies starting up in the field.

Sir An­drew Dil­lon, NICE's first — and on­ly — chief ex­ec­u­tive to step down next year

Using a laptop borrowed from his former employer, South London’s St George’s Hospital, Sir Andrew Dillon set about establishing NICE — launched by the then health secretary Frank Dobson — in 1999.  On Thursday, the UK cost-effectiveness watchdog said its first and only chief executive — Dillon — is stepping down in March 2020.

Back in the day, decisions about which drugs and interventions were funded by the National Health Service (NHS) were made at the local level, but this ‘postcode prescribing’ system was fraught with skewed healthcare deployment making the structure unsustainable. A national system was deemed necessary — and NICE was formed to bridge that gap.

Eight weeks be­tween each HIV treat­ment? GSK notch­es PhI­II win as it chas­es OK for long-act­ing reg­i­men

GSK has cleared another test in its grand plan to topple Gilead’s HIV dominance by offering alternative treatments that consist of fewer drugs and last longer. A year after scoring positive Phase III data on a four-week course of cabotegravir and rilpivirine, its ViiV subsidiary now says that an eight-week regimen seem to work just as well.

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Finch grabs a $53M round de­signed to take their ‘break­through’ mi­cro­bio­me treat­ment through a po­ten­tial­ly piv­otal tri­al

With a breakthrough designation in one hand and a fresh $53 million in venture backing in the other, Somerville, MA-based Finch Therapeutics is taking a shot at a one-trial pathway to a possible FDA OK for their new treatment for preventing recurrent C. difficile infections.

The funding brings their total raise for the microbiome company to $130 million, CEO Mark Smith tells me — enough money to pave a runway past the FDA approval they’ve sketched into the most optimistic version for their near-term future.