UP­DAT­ED: Feds charge an­oth­er CRO staffer with fak­ing da­ta in a Glax­o­SmithK­line pe­di­atric asth­ma study

A Flori­da woman has been in­dict­ed as part of a clin­i­cal tri­al fraud scheme over a Glax­o­SmithK­line pe­di­atric asth­ma study, the Jus­tice De­part­ment an­nounced Tues­day, the lat­est de­vel­op­ment in a case where three in­di­vid­u­als have al­ready plead­ed guilty.

Jes­si­ca Pala­cio was charged with par­tic­i­pat­ing in a plot to fal­si­fy med­ical records, giv­ing off the ap­pear­ance that tri­al par­tic­i­pants were mak­ing their sched­uled vis­its to a Mi­a­mi CRO and tak­ing an ex­per­i­men­tal asth­ma med­ica­tion as re­quired. Pala­cio was al­so charged with ly­ing to FDA in­ves­ti­ga­tors about her con­duct.

The FDA Of­fice of Crim­i­nal In­ves­ti­ga­tions is con­tin­u­ing to in­ves­ti­gate the case, which was launched last Au­gust.

“Re­li­able and ac­cu­rate da­ta from clin­i­cal tri­als is the cor­ner­stone of FDA’s eval­u­a­tion of a new drug,” said Justin Field­er, spe­cial agent at the Mi­a­mi branch of the FDA’s Of­fice of Crim­i­nal In­ves­ti­ga­tions, in a state­ment. “We will con­tin­ue to mon­i­tor, in­ves­ti­gate and bring to jus­tice those whose ac­tions may sub­vert the FDA ap­proval process and en­dan­ger the pub­lic health.”

Pala­cio and three oth­ers work­ing for the CRO known as Un­lim­it­ed Med­ical Re­search fab­ri­cat­ed par­tic­i­pa­tion of pa­tients in the study be­tween 2013 and 2016, the DOJ said. The pur­port­ed mas­ter­mind of the scheme, a woman named Yvelice Vil­la­man-Ben­cosme, plead­ed guilty to con­spir­a­cy to com­mit wire fraud in Jan­u­ary and was sen­tenced to 63 months in prison. As part of her plea agree­ment, Vil­la­man-Ben­cosme was or­dered to for­feit $174,000.

In that agree­ment, Vil­la­man-Ben­cosme ad­mit­ted that she at­tempt­ed to de­fraud GSK by us­ing pa­tients’ per­son­al in­for­ma­tion from her pri­vate med­ical prac­tice to cre­ate false in­for­ma­tion to be en­tered in­to case his­to­ries. The four made it ap­pear as though pa­tients sat­is­fied el­i­gi­bil­i­ty cri­te­ria, re­ceived phys­i­cal ex­ams, took the study drug and re­ceived pay­ment for clin­i­cal tri­al vis­its.

The plea deal list­ed one ex­am­ple of a pa­tient known on­ly as D.H., who Vil­la­man-Ben­cosme had said was “do­ing well” and rec­om­mend­ed the con­tin­ued use of med­ica­tion af­ter a vis­it in April 2015. None of Vil­la­man-Ben­cosme’s record­ed state­ments in the check­up were true, as D.H. was not par­tic­i­pat­ing in the study.

Vil­la­man-Ben­cosme fal­si­fied case his­to­ries for at least 11 in­di­vid­u­als and ad­mit­ted to par­tic­i­pat­ing in the scheme be­tween around Sep­tem­ber 2013 and June 2016.

The clin­i­cal tri­al in ques­tion was the GSK-spon­sored study dubbed VESTRI, ac­cord­ing to court doc­u­ments from last Au­gust. Re­searchers had aimed to mea­sure the long-term safe­ty of Ad­vair Diskus, an in­haled asth­ma med­ica­tion, in pa­tients aged 4 to 11 years old. Re­sults from the study were re­port­ed in March 2016 and pub­lished in the New Eng­land Jour­nal of Med­i­cine that Sep­tem­ber.

Asked for com­ment, GSK said it com­mis­sioned Un­lim­it­ed Med­ical Re­search as one of the sites to con­duct the VESTRI study and ful­ly co­op­er­at­ed with the DoJ probe, a spokesper­son con­firmed to End­points News.

“As soon as we be­came aware of pos­si­ble clin­i­cal tri­al fraud we con­duct­ed an in­ter­nal in­ves­ti­ga­tion; ex­clud­ed the da­ta from the stud­ies and re­ports; and re­port­ed the po­ten­tial fraud to the FDA and the In­sti­tu­tion­al Re­view Boards,” the spokesper­son told End­points in an email.

Phone calls to Un­lim­it­ed Med­ical Re­search went unan­swered. The CRO gi­ant Parex­el was al­so list­ed as a study col­lab­o­ra­tor on the gov­ern­ment’s clin­i­cal tri­als web­site, and Parex­el told End­points ear­ly Thurs­day that the com­pa­ny has “no af­fil­i­a­tion” with Un­lim­it­ed Med­ical Re­search.

Two oth­er in­di­vid­u­als in the case have plead­ed guilty to con­spir­a­cy to com­mit wire fraud. Lisett Raven­tos was sen­tenced to 30 months in prison in March, and May­tee Lle­do was sched­uled to be sen­tenced in April. Pala­cio was the on­ly mem­ber of the group to al­so be charged with mak­ing false state­ments on a signed af­fi­davit.

This sto­ry has been up­dat­ed with com­ment from Glax­o­SmithK­line and Parex­el.

Un­pack­ing the Aduhelm de­ci­sion, Ver­tex's half full glass, a $525M J&J breakup, 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.

By now you have surely read about the FDA’s controversial approval of Biogen’s Alzheimer’s drug and all its reverberations. But I’d still recommend checking out the meaty recap below to make sure you didn’t miss all the angles that the Endpoints team has covered. If you’d rather look ahead, look no further than our three-day virtual panels next week at BIO, where we will discuss what the new normal means for every part of the industry.

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Aaron Kesselheim (Scott Eisen/AP Images for AIDS Healthcare Foundation)

Har­vard’s Aaron Kessel­heim re­signs from ex­pert pan­el in wake of ad­u­canum­ab OK, blast­ing FDA for ‘worst drug ap­proval de­ci­sion in re­cent U.S. his­to­ry'

A third member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has resigned in the wake of Biogen’s controversial Aduhelm approval, slamming the agency as he left and further deepening the controversy surrounding the decision.

Harvard University professor Aaron Kesselheim quit in protest Thursday afternoon, calling the Aduhelm OK “probably the worst drug approval decision in recent U.S. history.” Kesselheim follows both Joel Perlmutter, a neurologist from Washington University in St. Louis, and David Knopman, a neurologist from the Mayo Clinic, out the door.

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David Knopman (Mayo Clinic via YouTube)

A sec­ond ad­comm mem­ber aban­dons his post in af­ter­math of con­tro­ver­sial ad­u­canum­ab de­ci­sion

As the fallout from the FDA’s approval of Alzheimer’s med aducanumab grows, a second member of the adcomm overseeing that drug’s review has walked away. But even with two experts now having resigned from that committee in protest, is there enough broad-level outrage to prevent another aducanumab from getting approved?

The FDA on Wednesday lost another member of its Peripheral and Central Nervous System Drugs Advisory Committee as Mayo Clinic neurologist David Knopman hit the exit over the agency’s decision to approve Biogen’s Alzheimer’s drug Aduhelm despite the committee’s near-unanimous vote against it.

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What does a clear ma­jor­i­ty of the bio­phar­ma in­dus­try think of the FDA ap­proval of ad­u­canum­ab? 'Hor­ri­fy­ing' 'Dan­ger­ous' 'Con­fus­ing' 'Dis­as­ter'

Over the years, we’ve become used to seeing a consensus emerge early in our industry polls at Endpoints News. And when we took the pulse of drug hunters on the heels of a controversial FDA approval for aducanumab this week, it became immediately apparent that the vast majority of our readers — heavily concentrated among biopharma staffers and execs — were incensed by what they had just witnessed.

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FDA au­tho­rizes about 10M J&J vac­cine dos­es, trash­es 60M more from trou­bled Emer­gent plant

The FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.

The agency said it’s not yet ready to allow the Emergent plant to be included in the J&J EUA, but that may occur soon. FDA came to the decision to authorize some of the doses after reviewing facility records and quality testing results.

FDA plans new stud­ies on ac­cel­er­at­ed ap­proval dis­clo­sures in bio­phar­ma ads

When people read biopharma companies’ websites about new drugs approved via the FDA’s accelerated pathway, like Biogen’s new Alzheimer’s drug, do they understand that these drugs may only be reasonably likely to predict clinical benefit and still require confirmatory studies?

That’s what the FDA’s Office of Prescription Drug Promotion wants to firm up as an agency analysis of direct-to-consumer websites for accelerated approval drugs previously found that only 21% of the disclosures used language directly from the label.

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An ex­pen­sive watch, shell com­pa­nies and fake in­voic­es: How two Is­raeli traders tapped in­to a $100M glob­al biotech in­sid­er trad­ing ring

It appears that we have reached the end of the saga about the global insider trading ring that collectively reaped $100 million from placing “timely, profitable” trades in biotech stocks like Ariad, Pharmacyclics and Receptos.

Tomer Feingold and Dov Malnik — Israeli traders living in Switzerland — were the last out of eight to be charged as the SEC unraveled the scheme, which ran from 2013 through 2017. Together, according to a statement in March, the pair had pocketed more than $4 million.

Janet Woodcock, acting FDA commissioner, at Thursday's Senate Appropriations hearing (Bill Clark/CQ Roll Call via AP Images)

Sen­a­tors lam­bast new Alzheimer’s drug’s price but give Janet Wood­cock a free pass on the ap­proval de­ci­sion

Senate Finance Democrats took aim at Biogen’s pricey new Alzheimer’s drug on Thursday, but members on both sides of the aisle at a separate appropriations hearing didn’t question acting FDA commissioner Janet Woodcock on the approval.

“I was appalled that Biogen priced their Alzheimer’s drug approved by the FDA at $56,000 per year — I’m not going to debate whether this is effective or not, but it’s double the household median income for Michiganders over the age of 65,” Sen. Debbie Stabenow (D-MI) said at the finance hearing.

Reshma Kewalramani, Vertex CEO (BIO via YouTube)

UP­DAT­ED: Ver­tex strikes out on its lat­est big shot at a rare ge­net­ic dis­ease. But they're go­ing to keep on swing­ing

It’s been several months since Vertex culled one of its small molecules for alpha-1 antitrypsin deficiency (AATD), taking a big hit after evidence of liver damage surfaced in a key Phase II trial. Now we learned that the company has whiffed on its second shot, and there’s nothing left in the clinic to treat the rare genetic disease — but that won’t stop it from trying.

Despite avoiding the safety issues that plagued the last candidate, Vertex $VRTX is taking the axe to VX-864 after Phase II results revealed the magnitude of the drug’s response is “unlikely to translate into substantial clinical benefit.” As a result of the news, the company’s stock fell 12.5% after hours.

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