Drug dis­trib­u­tor, for­mer ex­ecs charged for fu­el­ing opi­oid cri­sis as le­gal cam­paign widens its scope

As fed­er­al and state at­tor­neys in­ten­si­fy their ef­forts to hold a whole net­work of phar­ma­ceu­ti­cal ac­tors ac­count­able for fu­el­ing the opi­oid epi­dem­ic, for the first time a drug dis­trib­u­tor is fac­ing crim­i­nal charges re­lat­ed to their sales tac­tics and com­pli­ance fail­ures.

Rochester Drug Co­op­er­a­tive, the sixth largest drug whole­saler in the US, has been ac­cused of dis­trib­ut­ing nar­cotics that it knew “were be­ing sold and used il­lic­it­ly” and fail­ing to re­port these im­prop­er us­es to au­thor­i­ties. Sep­a­rate­ly, the in­ves­ti­ga­tion has al­so charged RDC’s for­mer CEO Lau­rence Doud III and chief of com­pli­ance William Pietruszews­ki for crim­i­nal of­fens­es.

The in­dict­ment fol­lows a 2015 civ­il law­suit that RDC ul­ti­mate­ly set­tled, in which the com­pa­ny ad­mit­ted it failed to re­port thou­sands of nar­cotics pur­chase or­ders to the DEA as they were re­quired.

Ge­of­frey Berman

“This pros­e­cu­tion is the first of its kind: Ex­ec­u­tives of a phar­ma­ceu­ti­cal dis­trib­u­tor and the dis­trib­u­tor it­self have been charged with drug traf­fick­ing — traf­fick­ing the same drugs that are fu­el­ing the opi­oid epi­dem­ic that is rav­aging this coun­try,” said Ge­of­frey Berman, US At­tor­ney for the South­ern Dis­trict of New York, in a state­ment.

Crim­i­nal in­ves­ti­ga­tions be­gan in 2017, ac­cord­ing to the Rochester De­mo­c­rat and Chron­i­cle. RDC said it agreed to a $20 mil­lion set­tle­ment over five years to part­ly re­solve the ac­cu­sa­tions in ad­di­tion to a strict mon­i­tor­ing pro­gram, lead­ing to a de­ferred pros­e­cu­tion.

But the ex­ecs re­main en­meshed in crim­i­nal pro­ceed­ings, with Pietruszews­ki plead­ing guilty to three counts of con­spir­a­cy and ex-CEO Doud — who claims RDC oust­ed him with the in­tent of pin­ning him as the scape­goat — con­test­ing the charges.

Pros­e­cu­tors in New York said RDC prof­it­ed from the sky­rock­et­ing sales of opi­oids from 2012 to 2016, with their oxy­codone tablets soar­ing more than 800% and fen­tanyl dosages ris­ing 2000%. While the com­pa­ny iden­ti­fied about 8,300 po­ten­tial­ly sus­pi­cious “or­ders of in­ter­est” — in­clud­ing for oxy­codone — it re­port­ed just four to the DEA. In that pe­ri­od, Doud’s pay more than dou­bled to $1.5 mil­lion, they stat­ed.

William Pietruszews­ki

What­ev­er comes of the case will like­ly set im­por­tant prece­dents. Just a day be­fore the crim­i­nal charges were filed, the New York Times re­port­ed that at­tor­ney gen­er­als in New York, Ver­mont and Wash­ing­ton State have al­so ini­ti­at­ed new civ­il suits against gi­ant dis­trib­u­tors like McKesson, Car­di­nal Health and Amerisource­Ber­gen. The ac­cu­sa­tions cen­ter around these com­pa­nies’ brazen neg­li­gence in their gate­keep­ing role in the sup­ply of opi­oids.

Opi­oid over­dos­es kill an av­er­age of 130 Amer­i­cans per day. As health­care of­fi­cials scram­ble to con­tain its con­se­quences, the na­tion­wide le­gal cam­paign is still ex­plor­ing new tac­tics to hold re­spon­si­ble all the ac­tors that played a part in the cri­sis — from the drug­mak­ers mar­ket­ing opi­oids to the doc­tors pre­scrib­ing them.

Im­age: Lau­rence Doud. AP IM­AGES

Mer­ck is tak­ing the ax to its US op­er­a­tions, cut­ting 500 jobs in its lat­est re­or­ga­ni­za­tion

Merck is cutting 500 jobs in its US sales and headquarters commercial teams in its latest effort to find new ways to streamline the operation.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 62,500+ biopharma pros reading Endpoints daily — and it's free.

Alice Shaw, Lung Cancer Foundation of America

Top ALK ex­pert and can­cer drug re­searcher Al­ice Shaw bids adieu to acad­e­mia, hel­lo to No­var­tis

Jay Bradner has recruited a marquee oncology drug researcher into the ranks of the Novartis Institutes for BioMedical Research. Alice Shaw is jumping from prestigious posts intertwined through Mass General, Harvard and Dana-Farber to take the lead of NIBR’s translational clinical oncology group.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 62,500+ biopharma pros reading Endpoints daily — and it's free.

Mi­rati preps its first look at their KRAS G12C con­tender, and they have to clear a high bar for suc­cess

If you’re a big KRAS G12C fan, mark your calendars for October 28 at 4:20 pm EDT.

That’s when Mirati $MRTX will unveil its first peek at the early clinical data available on MRTX849 in presentations at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston.

Mirati has been experiencing the full effect of a rival’s initial success at targeting the G12C pocket found on KRAS, offering the biotech some support on the concept they’re after — and biotech fans a race to the top. Amgen made a big splash with its first positive snapshot on lung cancer, but deflated sky-high expectations as it proved harder to find similar benefits in other types of cancers.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 62,500+ biopharma pros reading Endpoints daily — and it's free.

The FDA will hus­tle up an ex­pe­dit­ed re­view for As­traZeneca’s next shot at a block­buster can­cer drug fran­chise

AstraZeneca paid a hefty price to partner with Daiichi Sankyo on their experimental antibody drug conjugate for HER2 positive breast cancer. And they’ve been rewarded with a fast ride through the FDA, with a straight shot at creating another blockbuster oncology franchise.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 62,500+ biopharma pros reading Endpoints daily — and it's free.

Sean Parker, AP

Sean Park­er helps cre­ate a CRISPRed cell ther­a­py 2.0 play — and he’s got a high-pro­file set of lead­ers on the team

You can rack up one more high-profile debut effort in the wave of activity forming around cell therapy 2.0. It’s another appealing Bay Area group that’s attracted some of the top hands in the business to a multi-year effort to create a breakthrough. And they have $85 million in hand to make that first big step to the clinic.

Today it’s Ken Drazan and the team at South San Francisco-based ArsenalBio that are coming from behind the curtain for a public bow, backed by billionaire Sean Parker and a collection of investors that includes Beth Seidenberg’s new venture investment operation based in LA.
Drazan — a J&J Innovation vet with a long record of entrepreneurial endeavors — exited the stage in 2018 when his last mission ended as he stepped aside as president of Grail. It wasn’t long, though, before he was helping out with a business plan for ArsenalBio that revolved around the work of a large group of interconnected scientists supported by the Parker Institute for Cancer Immunology.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 62,500+ biopharma pros reading Endpoints daily — and it's free.

Med­ical an­i­ma­tion: Mak­ing it eas­i­er for the site and the pa­tient to un­der­stand

Medical animation has in recent years become an increasingly important tool for conveying niche information to a varied audience, particularly to those audiences without expertise in the specialist area. Science programmes today, for example, have moved from the piece-to-camera of the university professor explaining how a complex disease mechanism works, to actually showing the viewer first-hand what it might look like to shrink ourselves down to the size of an ant’s foot, and travel inside the human body to witness these processes in action. Effectively communicating a complex disease pathophysiology, or the novel mechanism of action of a new drug, can be complex. This is especially difficult when the audience domain knowledge is limited or non-existent. Medical animation can help with this communication challenge in several ways.
Improved accessibility to visualisation
Visualisation is a core component of our ability to understand a concept. Ask 10 people to visualise an apple, and each will come up with a slightly different image, some apples smaller than others, some more round, some with bites taken. Acceptable, you say, we can move on to the next part of the story. Now ask 10 people to visualise how HIV’s capsid protein gets arranged into the hexamers and pentamers that form the viral capsid that holds HIV’s genetic material. This request may pose a challenge even to someone with some virology knowledge, and it is that inability to effectively visualise what is going on that holds us back from fully understanding the rest of the story. So how does medical animation help us to overcome this visualisation challenge?

Hal Barron, GSK's president of R&D and CSO, speaks to Endpoints News founder and editor John Carroll in London at Endpoints' #UKBIO19 summit on October 8, 2019

[Video] Cel­e­brat­ing tri­al fail­ures, chang­ing the cul­ture and al­ly­ing with Cal­i­for­nia dream­ers: R&D chief Hal Bar­ron talks about a new era at GSK

Last week I had a chance to sit down with Hal Barron at Endpoints’ #UKBIO19 summit to discuss his views on R&D at GSK, a topic that has been central to his life since he took the top research post close to 2 years ago. During the conversation, Barron talked about changing the culture at GSK, a move that involves several new approaches — one of which involves celebrating their setbacks as they shift resources to the most promising programs in the pipeline. Barron also discussed his new alliances in the Bay Area — including his collaboration pact with Lyell, which we covered here — frankly assesses the pluses and minuses of the UK drug development scene, and talks about his plans for making GSK a much more effective drug developer.

This is one discussion you won’t want to miss. Insider and Enterprise subscribers can log-in to watch the video.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Flu Virus (Source: CDC)

FDA ex­pands Xofluza ap­proval as Roche strug­gles to catch loom­ing flu mar­ket

As a potentially powerful flu season looms, so does a big test for Roche and its new flu drug, Xofluza. The Swiss giant just got a small boost in advance of that test as the FDA expanded Xofluza’s indication to include patients at high risk of developing flu-related complications.

Xofluza (baloxavir marboxil) was approved last October in the US, the first landmark flu drug approval in 20 years and a much-needed green light for a company that had watched its leading flu drug Tamiflu get eaten alive by generics. Like its predecessor, the pill offered a reduction in flu symptoms but not a cure.

EMA backs sev­en ther­a­pies, in­clud­ing Mer­ck­'s Ebo­la vac­cine

The first-ever Ebola vaccine is on the precipice of approval after the European Medicine’s Agency (EMA) backed the Merck product in this week’s roster of recommendations.

The drugmaker $MRK began developing the vaccine, christened Ervebo, during the West African outbreak that occurred between 2014 and 2016, killing more than 11,000.

The current outbreak in the Democratic Republic of Congo (DRC) has shown case fatality rates of approximately 67%, the agency estimated. Earlier this year, the WHO declared the outbreak — which so far has infected more than 3,000 people — a public health emergency of international concern.