Hos­pi­tals re­port ‘se­vere short­ages’ of Covid-19 tests, HHS sur­vey finds

The US De­part­ment of Health and Hu­man Ser­vices’ (HHS) Of­fice of In­spec­tor Gen­er­al (OIG) on Mon­day re­leased the re­sults of tele­phone sur­vey of 323 hos­pi­tals across 46 states, the Dis­trict of Co­lum­bia and Puer­to Ri­co, find­ing “se­vere short­ages of test­ing sup­plies and ex­tend­ed waits for test re­sults.”

Hos­pi­tals re­port­ed that they were un­able to keep up with COVID-19 test­ing de­mands be­cause they lacked com­plete kits and/or the in­di­vid­ual com­po­nents and sup­plies need­ed to com­plete tests, in­clud­ing nasal swabs, vi­ral trans­fer me­dia and reagents used to de­tect the virus.

“One hos­pi­tal ad­min­is­tra­tor said that across the in­dus­try, ‘mil­lions [of tests] are need­ed, and we on­ly have hun­dreds.’ With­out ac­cess to need­ed test­ing ma­te­ri­als, some hos­pi­tals de­scribed di­vid­ing the me­dia in COVID-19 kits in half to dou­ble their ca­pac­i­ty and re­sort­ing to us­ing the trans­fer me­dia in flu and strep kits to pro­vide test­ing,” the re­port says.

The re­port comes as Pres­i­dent Don­ald Trump said last week, on a call with gov­er­nors: “I haven’t heard about test­ing be­ing a prob­lem.”

In ad­di­tion to the short­ages of the tests, hos­pi­tals re­port­ed fre­quent­ly wait­ing sev­en days or longer for test re­sults, and when pa­tient stays were ex­tend­ed while await­ing their re­sults, bed avail­abil­i­ty be­comes strained, as do per­son­al pro­tec­tive equip­ment (PPE) sup­plies and staffing.

“Hos­pi­tals’ re­liance on ex­ter­nal lab­o­ra­to­ries con­tributed to de­lays, par­tic­u­lar­ly as these lab­o­ra­to­ries be­came over­whelmed with tests to process from around the State or coun­try,” the re­port finds.

The sur­vey, con­duct­ed 23-27 March, al­so found hos­pi­tals re­port­ing “wide­spread short­ages” of PPE that put staff and pa­tients at risk. Oth­er sup­plies are in short­age too, such as in­tra­venous ther­a­py (IV) poles, med­ical gas, linens, toi­let pa­per and food, the re­port says. Oth­ers re­port­ed short­ages of no-touch in­frared ther­mome­ters, dis­in­fec­tants and clean­ing sup­plies.

As for ven­ti­la­tors, the sur­vey says that hos­pi­tals “re­port­ed an un­cer­tain sup­ply of stan­dard, full-fea­ture ven­ti­la­tors and in some cas­es used al­ter­na­tives to sup­port pa­tients, in­clud­ing adapt­ing anes­the­sia ma­chines and us­ing sin­gle-use emer­gency trans­port ven­ti­la­tors. Hos­pi­tals an­tic­i­pat­ed that ven­ti­la­tor short­ages would pose dif­fi­cult de­ci­sions about eth­i­cal al­lo­ca­tion and li­a­bil­i­ty, al­though at the time of our sur­vey no hos­pi­tal re­port­ed lim­it­ing ven­ti­la­tor use.”

RAPS: First pub­lished in Reg­u­la­to­ry Fo­cus™ by the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety, the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care prod­ucts. Click here for more in­for­ma­tion.

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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.

FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Alaa Halawa, executive director at Mubadala’s US venture group

The ven­ture crew at Mubadala are up­ping their biotech cre­ation game, tak­ing care­ful aim at a new fron­tier in drug de­vel­op­ment

It started with a cup of coffee and a slow burning desire to go early and long in the biotech creation business.

Wrapping up a 15-year discovery stint at Genentech back in the summer of 2021, Rami Hannoush was treated to a caffeine-fueled review of the latest work UCSF’s Jim Wells had been doing on protein degradation — one of the hottest fields in drug development.

“Jim and I have known each other for the past 15 years through Genentech collaborations. We met over coffee, and he was telling me about this concept of the company that he was thinking of,” says Hannoush. “And I got immediately intrigued by it because I knew that this could open up a big space in terms of adding a new modality in drug discovery that is desperately needed in pharma.”

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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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Senate health committee chair Bernie Sanders (D-VT) and Moderna CEO Stéphane Bancel (Tom Williams/CQ Roll Call via AP Images)

Mod­er­na CEO de­fends Covid-19 vac­cine price change at Sen­ate com­mit­tee grilling

Moderna CEO Stéphane Bancel faced a barrage of questions from the Senate health committee on Wednesday but emerged mostly unscathed as he defended the quadrupling of the price of the company’s blockbuster Covid-19 vaccine in the US, from about $26 per dose to $130 per dose.

What’s behind that rise in price, many senators on both sides of the aisle questioned, and Bancel offered a variety of reasons. First and foremost, the company is expecting a 90% reduction in demand for its vaccine next fall, when the FDA is likely to roll out another booster campaign to fight Covid-19.

Sanofi, Re­gen­eron boast PhI­II win with Dupix­ent in COPD, clear­ing first bar for ex­pan­sion

Dupixent, the blockbuster anti-inflammatory drug from Sanofi and Regeneron, has cleared a high-stakes Phase III study in chronic obstructive pulmonary disease, the companies announced Thursday morning.

If they hold up in a second, identical trial, the data pave the way for Dupixent to become the first biologic to treat patients whose COPD remains uncontrolled despite being on maximal standard-of-care inhaled therapy — the patient population studied in the pivotal program. The companies had spotlighted this as a key readout as they look to expand the Dupixent franchise and explore its full potential.

Genen­tech to stop com­mer­cial man­u­fac­tur­ing at Cal­i­for­nia head­quar­ters

Genentech is halting commercial manufacturing at its California headquarters — and laying off several hundred employees.

The move is the result of a decision Genentech made in 2007 to relocate manufacturing operations from its South San Francisco headquarters location to other facilities or move the work to CDMOs, said Andi Goddard, Genentech’s SVP of quality and compliance for pharmaceutical technical operations, in an interview with Endpoints News. Genentech has made changes in capabilities and invested more in technology, so it doesn’t need as many large-scale manufacturing facilities as it did in the past, she said.

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In­cyte wins ac­cel­er­at­ed ap­proval for PD-1 in rare skin can­cer

Incyte touted an accelerated approval for its PD-1 retifanlimab in a rare skin cancer on Wednesday, roughly a year and a half after the drug suffered a rejection in squamous cell carcinoma of the anal canal (SCAC).

Retifanlimab, marketed as Zynyz, was approved for metastatic or recurrent locally advanced Merkel cell carcinoma (MCC), a fast-growing skin cancer typically characterized by a single, painless nodule. It’s roughly 40 times rarer than melanoma, according to the nonprofit Skin Cancer Foundation — but incidence is growing, particularly among older adults, Incyte said in its announcement.

A new study finds that many patient influencers are sharing prescription drug experiences along with health information.

So­cial me­dia pa­tient in­flu­encers ‘danc­ing in the gray’ of phar­ma mar­ket­ing, more clar­i­ty need­ed, re­searcher says

It’s no surprise that patient influencers are talking about their health conditions on social media. However, what’s less clear is what role pharma companies are playing, how big the patient influencer industry is, and just how is information about prescription drugs from influencers relayed — and received — on social media.

While University of Colorado associate professor Erin Willis can’t answer all those questions, she’s been researching the issue for several years and recently published new research digging into the communication styles, strategies and thinking of patient influencers, many of whom partner with pharma companies.

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