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Thursday, June 23, 2022

Blame Regulatory State For Healthcare Burnout Crisis

 The surgeon general just came out with an ominous new warning—but it doesn't involve tobacco, alcohol, or any other substance.

Instead, Dr. Vivek Murthy raised the alarm about the growing burnout crisis among America's healthcare workforce. His report details the problem at length and even proposes a long list of solutions that state and federal policymakers could pursue.

Unfortunately, the report mostly downplays one of the best solutions — reducing the thicket of unnecessary regulations that so frustrates doctors, nurses, and administrators.

Job burnout—defined by the Mayo Clinic as "a special type of work-related stress" that leads to "a state of physical or emotional exhaustion that also involves a sense of reduced accomplishment and loss of personal identity"—is rampant among healthcare professionals. The surgeon general cites a National Academy of Medicine study that found that up to 54% of nurses and physicians and up to 60% of medical students and residents report symptoms of burnout.

In fairness, Dr. Murthy's report does note that administrative burdens are a cause of the problem. But it understates the role of ill-conceived regulations, which are perhaps the single biggest driver of the burnout crisis.

In a 2018 poll sponsored by the Physician's Foundation, 40% of doctors identified regulatory burdens as one of the least satisfying aspects of their job. In another survey that same year, 79% of doctors named administrative hassle—a common side-effect of overregulation—as the top factor ruining the practice of medicine.

Doctors spend a significant amount of time on "indirect patient care"—paperwork, in layman's terms. According to a recent study published in the journal JAMA Internal Medicine, first-year residents collectively spend more than 10 hours a day interacting with a patient's medical record or documenting what they're doing.

Or consider the onerous scope-of-practice restrictions in many states. These rules prohibit nurse practitioners and physician assistants from providing certain types of routine care without the supervision of a doctor, even though studies have shown that patients treated by these professionals experience health outcomes that are just as good, or even better, than the outcomes reported by patients treated by physicians. Fortunately, 26 states and the District of Columbia now allow nurse practitioners and physician assistants to practice independently, without the supervision of a physician.

These restrictions increase the workload on doctors and can demoralize nurses and physician assistants. And that can cause people to leave the medical field. Almost 22% of doctors are contemplating an early retirement because they feel overworked, according to a December 2021 survey by Doximity. Another 12% are considering a career change.

As this burnout crisis grows more acute, even more healthcare professionals will quit their jobs. The remaining workers will find themselves stretched even thinner than they are today. That will create a negative feedback loop that leads to yet more exhaustion and early retirements.

The Association of American Medical Colleges estimates that the country will be short as many as 124,000 physicians by 2034. The undersupply of nurses is already so severe that more than one in six hospitals reported "critical nursing shortages" this winter. Some states had to request assistance from the National Guard to staff hospitals.

Ironically, all of this regulation, which is intended to keep people safe, actually endangers patients by fostering burnout. Doctors who report symptoms of burnout are 2.2 times more likely to make medical errors.

The sheer number of regulatory and administrative requirements placed on doctors and other healthcare workers has made these professions far more stressful, tedious, and exhausting than they need to be. Reducing this regulatory burden, and thus combating burnout, is quite literally a matter of life and death for patients.

Sally C. Pipes is president, CEO, and the Thomas W. Smith fellow in healthcare policy at the Pacific Research

.

https://www.forbes.com/sites/sallypipes/2022/06/20/blame-the-regulatory-state-for-the-healthcare-burnout-crisis/

EMA recommends Novavax COVID vaccine for adolescents

 The advisory committee to the European Union's drug regulator on Thursday recommended expanding the use of Novavax Inc's COVID-19 vaccine for adolescents aged 12 to 17 years. 

https://finance.yahoo.com/news/ema-recommends-novavax-covid-vaccine-141808151.html

Harris meets Dem AGs as White House gears up for abortion ruling

 U.S. Vice President Kamala Harris will meet a group of seven Democratic attorneys general on Thursday, a White House official said, to discuss the defense to a major ruling that could dramatically curtail abortion rights in the country.

The conservative-majority U.S. Supreme Court is expected to issue a decision in the coming days to overturn Roe v. Wade, which guaranteed the right to an abortion - potentially paving the way to about half of the 50 U.S. states banning or heavily restricting the procedure.

The White House meeting offers a peek into the preparations underway before the ruling comes out and ahead of the state-level abortion battles that are widely expected to play out. The meeting will be attended by the attorneys general of Wisconsin, Nevada, Illinois, California, Delaware, New York and Washington state, the official, who did not wish to be identified told Reuters.

State attorneys general have considerable influence over rules in their state and Democratic attorneys general have pledged to hold the line if Roe falls. They are expected to have unprecedented influence over the future of abortion access and will form the first line of defense for the Biden administration fighting to preserve abortion rights at the state level.

"She (Harris) will amplify actions they are taking as models for other states," the official said.

For example, in Washington state, attorney general Bob Ferguson has called on the state's medical licensing authorities to publicly state that they will not disqualify health care providers from practicing in the state solely because they have performed abortions in states where it has become illegal.

In Delaware, attorney general Kathleen Jennings sued to block a town from requiring an abortion clinic to hold burials for fetal remains at the patient's expense.

The Democratic Attorneys General Association (DAGA) is preparing to spend millions to elect candidates who support abortion rights, including in Republican-led states that are likely to ban almost all abortions if Roe is overturned.

In May, a draft opinion indicating the court is set to overturn the landmark 1973 Roe v. Wade ruling was leaked. https://reut.rs/39NTwlQ

As the court gets closer to issuing a final ruling on the case, expected in late June, Harris has leaned into the topic aggressively. She has been among the most outspoken abortion rights voices in the Biden administration - a topic that remains a complicated one for President Biden.

Biden, a lifelong Catholic, was opposed to Roe in the early days of his career and has only later come to embrace abortion rights. He made forceful comments after the draft opinion was revealed but up to that point he had never said the word "abortion" aloud as president.

On Wednesday, Harris convened a meeting with a diverse group of stakeholders on the issue of abortion rights that included patients and health care providers, reproductive rights advocates, faith leaders, constitutional and privacy experts.

"We must be ready to stand as an united front when this decision comes down," Harris said. "Part of what we will do as a coalition is make clear ... how Roe will impact privacy rights across the board."

https://www.yahoo.com/news/exclusive-harris-meets-democratic-attorneys-040350543.html

Valneva: Positive CHMP Opinion for Marketing Inactivated COVID-19 Vaccine in Europe

 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization in Europe for Valneva’s inactivated whole-virus COVID-19 vaccine candidate, VLA2001, for use as primary vaccination in people from 18 to 50 years of age.

The European Commission (EC) will review the CHMP recommendation, and a decision on the marketing authorization application for VLA2001 is expected shortly. If granted, this will be the first COVID-19 vaccine to receive a standard marketing authorization in Europe.

The CHMP concluded by consensus after a thorough evaluation that, “the data on the vaccine were robust and met the EU criteria for efficacy, safety and quality.”

https://finance.yahoo.com/news/valneva-receives-positive-chmp-opinion-131600656.html

US PMIs Plunge To 2-Year Lows Amid 'Remarkable Drop In Demand'

 With European PMIs plunging in June, and US Macro Surprise data collapsing, it was perhaps somewhat surprising that analysts only expected a marginal drop in preliminary June US PMIs. And we were right to be surprised as the data printed dramatically below expectations.

  • US Manufacturing dropped from 57.0 to 52.4 (below 56.0 expectations)

  • US Services dropped from 53.4 to 51.6 (below 53.3 expectations)

Source: Bloomberg

The manufacturing print is the weakest since June 2020, and Services at 5-month lows (but very close to two-year lows too).

This dragged the US Composite PMI tumbled to 51.2 - a 5-month low - signaling notable weakness in Q2 GDP (and Q3 GDP)...

Commenting on the flash PMI data, Chris Williamson, Chief Business Economist at S&P Global Market Intelligence said:

“The pace of US economic growth has slowed sharply in June, with deteriorating forward-looking indicators setting the scene for an economic contraction in the third quarter. The survey data are consistent with the economy expanding at an annualized rate of less than 1% in June, with the goods-producing sector already in decline and the vast service sector slowing sharply.

“Having enjoyed a mini-boom from consumers returning after the relaxation of pandemic restrictions, many services firms are now seeing households increasingly struggle with the rising cost of living, with producers of non-essential goods seeing a similar drop in orders.

“There has consequently been a remarkable drop in demand for goods and services during June compared to prior months.

“Businesses have become much more concerned about the outlook as a result of the rising cost of living and drop in demand, as well as the increasingly aggressive interest rate path outlined by the Federal Reserve and the concomitant deterioration in broader financial conditions.

Business confidence is now at a level which would typically herald an economic downturn, adding to the risk of recession.

“A corollary of the drop in demand was less pressure on prices, with the survey’s inflation gauges for firms’ costs and their selling prices falling sharply in June to suggest that, although still elevated, price pressures have peaked.”

So it seems Powell is getting his wish as the US plunges into recession... and that tanks inflation.

Suck it up, buttercup!

Galapagos starts spending Gilead’s cash

 The first strategic move from Galapagos’s new chief executive was a long way from what investors wanted to see from the troubled biotech: to bring in a project with good hopes of near term revenues. Instead they have been delivered a move into the Car-T space.

This technology might be a scientific triumph, but the products that have made it to market have been a commercial disaster in terms of both sales and profits. The move just about makes sense considering that Gilead has opt in rights and is one of the big Car-T players. But this is a crowded field and delivering on what is being claimed for the two deals unveiled today will be tough.

Yesterday Galapagos bought Cellpoint for €125m ($132m) cash up front, and Aboundbio for $14m. Galapagos is on the hook for an additional €100m in milestone payments, but these are small enough sums for a group with a cash balance of €4.6bn. 

Cellpoint’s technology ought to speed up the manufacturing time for Car-T cells, Galapagos says, with cells ready in around a week.

While Car-T has delivered some remarkable remissions, the time the whole process takes remains a big problem. Screening patients can take months, but these patients have very advanced cancers and many die before infusions can start. And this is before the manufacturing stage that Galapagos is aiming at here.

The first two programmes using Cellpoint’s production platform with CD19 Car-Ts are in phase 1/2a in relapsed-refractory non-Hodgkin and chronic lymphocytic leukaemia; data are due in a year or so. Galapagos will oversee early development. Should Gilead opt in, the two groups would co-develop the therapies, and Gilead would have rights outside Europe. 

Faster still

In future, the vein-to-vein time could be cut further, to four or five days, management said on a call today. But it will wait until phase 1 data come out before deciding whether to pursue this. Novartis claims to be even faster, having told Evaluate Vantage last year that its T-Charge technology can get vein-to-vein time down to two days

For comparison, vein-to-vein times for approved Car-Ts are around two to six weeks. Perhaps today's deals are Gilead's way of chasing Novartis to faster manufacturing. None of this fixes another huge issue, however: the time it can take from screening to infusion, an underappreciated issue with this technology. With reports of this taking up to six months in some cases, it means advanced cancer patients are having to be bridged with chemo, and some die while waiting. 

Another less-than-thrilling aspect of the deal is the choice of CD19, a well served space, as the first project's target. Beyond that, the plan is to use Aboundbio’s fully human antibody-based library along with Cellpoint’s platform to bring three more Car-T candidates to the clinic over the next three years.

Underwhelming

Galapagos’s relationship with Gilead began in 2019 as the result of a substantial deal that effectively gave the US developer rights over the Belgian firm’s pipeline, in return for a huge $5bn cash injection. But a series of calamities has left that pipeline threadbare, and Gilead’s business development with another black mark.

Since early 2020, Galapagos’s stock has seen 80% of its value erased. A 4% drop in its shares today suggests investors are underwhelmed by this new direction.

The new strategy is being overseen by Johnson & Johnson’s former chief scientific officer Paul Stoffels, who was brought in earlier this year to right the ship. He has made no secret of his desire to strike deals, and has previously said that Galapagos’s healthy cash balance was prompting numerous small developers to knock on the door, offering their wares.

Galapagos has been trading at or below cash for months and this deal is unlikely to change that. The hope has to be that further transactions are in the works, more in line with what shareholders are waiting for. 

https://www.evaluate.com/vantage/articles/news/deals/galapagos-starts-spending-gileads-cash

Albireo: New Data in Pediatric and Adult Liver Diseases

 

  • New analyses of PEDFIC Phase 3 trials show that patients whose pruritus improves on Bylvay® (odevixibat) also experience improvements in sleep, quality of life, serum bile acids and hepatic parameters
  • Long-term data from PEDFIC trials of Bylvay show dramatic quality of life deficits in patients and families affected by PFIC
  • Studies show consistent and sustained efficacy for Bylvay across all PFIC types
  • Announces new SPARK Grants Program, accepting applications for projects to improve care for rare liver diseases, starting with PFIC