Bris­tol My­ers launch­es pro­gram to make clin­i­cal tri­als more ac­ces­si­ble for peo­ple with dis­abil­i­ties

About a fourth of US adults live with some type of dis­abil­i­ty, ac­cord­ing to the CDC. On Wednes­day, Bris­tol My­ers Squibb launched a new ini­tia­tive to en­sure those pa­tients get ac­cess to clin­i­cal tri­als.

The phar­ma gi­ant is team­ing up with the non­prof­it Dis­abil­i­ty So­lu­tions to cre­ate the Dis­abil­i­ty Di­ver­si­ty in Clin­i­cal Tri­als (DDiCT) Ini­tia­tive, a pro­gram that’s ini­tial­ly fo­cus­ing on com­ing up with a set of rec­om­men­da­tions for im­prov­ing ac­cess, speed of en­roll­ment and par­tic­i­pa­tion of peo­ple with dis­abil­i­ties in tri­als.

“We col­lect da­ta around oth­er un­der­rep­re­sent­ed groups in clin­i­cal tri­als,” Julie Sowash, ex­ec­u­tive di­rec­tor of Dis­abil­i­ty So­lu­tions, told End­points News. “Peo­ple with dis­abil­i­ties are al­most al­ways ex­clud­ed from that de­mo­graph­ic col­lec­tion.”

The news comes as phar­ma com­pa­nies face mount­ing pres­sure to make clin­i­cal tri­als more in­clu­sive. A slate of phar­ma com­pa­nies has set eq­ui­ty goals, in­clud­ing Gilead, which to­day an­nounced an $85 mil­lion con­tri­bu­tion to the Gilead Foun­da­tion to sup­port health eq­ui­ty.

A re­cent re­view of stud­ies in the UK’s Na­tion­al In­sti­tute for Health and Care Re­search port­fo­lio found that 60% ex­clud­ed learn­ing dis­abil­i­ty groups — and re­searchers have not­ed sim­i­lar ex­clu­sion in the US. Ac­cord­ing to a JA­MA re­view of Phase III and IV stud­ies, ex­plic­it ex­clu­sion cri­te­ria pre­vent­ed a sig­nif­i­cant num­ber of peo­ple with in­tel­lec­tu­al, de­vel­op­men­tal or phys­i­cal dis­abil­i­ties from par­tic­i­pat­ing in tri­als.

Oth­er bar­ri­ers to par­tic­i­pa­tion in­clude in­ac­ces­si­ble tri­al sites, med­ical equip­ment and “ableist bi­as­es which de­ter this com­mu­ni­ty from re­ceiv­ing po­ten­tial­ly life-sav­ing treat­ments,” BMS said in a state­ment. Sowash cit­ed in­formed con­sent as one spe­cif­ic ex­am­ple of this.

“There are a lot of reg­u­la­tions around can a per­son with a dis­abil­i­ty con­sent, who can con­sent for them?” she said. “And we need to just see, are those med­ical­ly nec­es­sary? Are they med­ical­ly rel­e­vant to the re­search process?”

Samit Hi­rawat

The ini­tia­tive aligns with BMS’ broad­er di­ver­si­ty goals, in­clud­ing a com­mit­ment to lo­cate a quar­ter of its clin­i­cal tri­al sites in “high­ly di­verse com­mu­ni­ties” this year. It was ini­ti­at­ed by BMS’ Dis­abil­i­ty Ad­vance­ment Work­place Net­work (DAWN), and will be co-led by the com­pa­ny’s glob­al drug de­vel­op­ment team.

While Sowash hopes the ini­tia­tive will even­tu­al­ly help set a new in­dus­try stan­dard for clin­i­cal tri­al pro­to­cols, she ac­knowl­edged that they’re still in the “knowl­edge-gath­er­ing stage,” which in­volves col­lect­ing da­ta, iden­ti­fy­ing bar­ri­ers and un­der­stand­ing how to make tri­als more ac­ces­si­ble.

“We’re go­ing to start to see what those gaps and op­por­tu­ni­ties are to make what could be dra­mat­ic im­prove­ments to ac­cess for health­care for peo­ple with dis­abil­i­ties,” she said.

“Through this work, Bris­tol My­ers Squibb can set the stan­dard and stage for ac­cess to life-chang­ing and life-sav­ing med­i­cines for peo­ple with dis­abil­i­ties,” BMS CMO Samit Hi­rawat said in a state­ment. “The long-term goal of our DDiCT pro­gram is to de­vel­op and pi­lot tri­als that are ac­ces­si­ble to the widest va­ri­ety of pa­tients.”

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

No­vo Nordisk re­mains un­der UK scruti­ny as MHRA con­ducts its own re­view in 'in­cred­i­bly rare' case

The UK’s Medicines and Healthcare products Regulatory Agency is now reviewing Novo Nordisk’s marketing violation that resulted in its loss of UK trade group membership last week. Novo Nordisk was suspended on Thursday from the Association of the British Pharmaceutical Industry (ABPI) for two years after an investigation by its regulatory arm found the pharma broke its conduct rules.

MHRA said on Tuesday that its review of the Prescription Medicines Code of Practice Authority (PMCPA) investigation is standard practice. An MHRA spokesperson emphasized in an email to Endpoints News that the situation with Novo Nordisk is “incredibly rare” while also noting ABPI took “swift and proportionate action.”

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FTC says patent bat­tle over Parkin­son's drug could have 'sig­nif­i­cant im­pli­ca­tion­s' for pa­tients

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.

Growth hor­mone from No­vo Nordisk is in short­age over man­u­fac­tur­ing de­lays

Novo Nordisk’s growth hormone Norditropin is in shortage because of manufacturing delays, according to an FDA site that tracks drug shortages as well as the American Society of Health-System Pharmacists’ shortages list.

The FDA has shortages of the drug listed for its 5, 10, 15 and 30 mg doses, while the pharmacists’ group, also known as ASHP, reported shortages of the same doses, except for the 15 mg version.

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PhRMA calls for more di­verse in­fra­struc­ture up­grades to US emer­gency tri­als frame­work

The White House’s Office of Science and Technology Policy (OSTP) last year sought to find ways to better coordinate large-scale clinical trials in the US — as the UK lead by example during the pandemic — especially for these emergency clinical trials.

The lobbying group PhRMA Tuesday called for more clinical trial diversity in underserved areas, including by making participation less of a burden, and expanding eligibility criteria when appropriate.

Mar­ket­ingRx roundup: What could a US Tik­Tok ban mean for phar­ma? Pfiz­er, Lil­ly lead phar­ma March Mad­ness ad­ver­tis­ers

Just as pharma marketers finally make moves into TikTok, the threat of a US ban on the social media channel is now looming. Already banned on federal employee phones by an initial Congressional act, more bills and maybe bans are on the way. With rare bipartisan agreement, lawmakers have introduced legislation that would give the US president the power to ban TikTok (although not mentioned by name) and other foreign-owned technology platforms that represent a security threat to the US.

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Chat­G­PT with phar­ma da­ta de­buts for med­ical meet­ings, be­gin­ning with AACR

What do you get when you combine ChatGPT generative AI technology with specific pharma and clinical datasets? A time-saving tool that can answer questions about medical conference abstracts and clinical findings in seconds in one new application from ZoomRx called FermaGPT.

ZoomRx is debuting a public version of its generative AI product specifically for medical conferences beginning this week for the upcoming American Association for Cancer Research (AACR) annual meeting that runs April 14-19.

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Andy Plump, Takeda R&D chief (Jeff Rumans for Endpoints News)

What kind of PhI­Ib da­ta is worth $4B cash? Take­da’s Andy Plump has some thoughts on that

A few months back, when Takeda caused jaws to drop with its eye-watering $4 billion cash upfront for a mid-stage TYK2 drug from Nimbus, it had already taken a deep dive on the solid Phase IIb data Nimbus had assembled from its dose-ranging study in psoriasis.

Now, it’s rolling that data out, eager to demonstrate what inspired the global biopharma to go long in a neighboring, but new, disease arena for the pipeline. And the most avid students of the numbers will likely be at Bristol Myers Squibb, who will have a multi-year head start on pioneering the TYK2 space with Sotyktu (deucravacitinib) as Takeda makes its lunge for best-in-class status.

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FDA warns Proc­ter & Gam­ble over NyQuil la­bel's in­gre­di­ent list­ings

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.