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Monday, January 3, 2022

Mesoblast Updates After FDA Meeting on Graft Versus Host Disease Therapy

 

  • Meeting held with the US Food and Drug Administration’s (FDA) Office of Tissues and Advanced Therapies (OTAT) to address potency assay and chemistry, manufacturing and controls (CMC) items identified in the complete response letter (CRL) for remestemcel-L in the treatment of steroid-refractory acute graft versus host disease (SR-aGVHD) in children

  • OTAT indicated that Mesoblast’s approach to address the outstanding CMC items is reasonable

  • OTAT indicated that the in vitro immunomodulatory activity Mesoblast intends to measure for potency is a reasonable critical quality attribute (CQA) for the product, and the relevance of this activity to clinical outcomes should be established

  • Mesoblast has now generated substantial new data that it believes establish the relevance of the proposed in vitro immunomodulatory activity of remestemcel-L to the in vivo clinical effect of the product in the Phase 3 trial in children with SR-aGVHD, including survival and biomarkers of in vivo activity

  • Mesoblast will provide these new data to OTAT, and address other outstanding items as required for the Biologics License Application (BLA) resubmission

Planet Fitness Not Seeing an Omicron Variant Slowdown in Gym Visits

 The omicron variant of Covid-19 has led a lot of people to change travel plans, but it has apparently not had a major effect on people going to the gym to work out. At least that's what Planet Fitness (PLNT) - Get Planet Fitness, Inc. Class A Report CEO Chris Rondeau said during his appearance today (Jan. 3) on CNBC's "Squawk Box."

"In December of 2020, when we saw the spiking of the variant, the spiking of Covid back then before there was even a vaccine, we did see a pullback on workouts and cancellations spiking," he said. "During the delta variant and with omicron, we're not seeing that pullback."

Traffic Still Strong at Planet Fitness

The gym CEO said he has not seen traffic to his locations pull back nor has he seen an increase in cancellations during the latest surge of the virus.  

"I think they're feeling more comfortable with the protocols that we have out in place. I think they're realizing fitness is truly essential," he said. "The last thing we ever should have done is shut down gyms."

Planet Fitness has taken a number of steps to mitigate the transmission of Covid. These include:

  • Regular and thorough cleaning of all gym equipment
  • Sanitation stations on the gym floor
  • Touchless check-in.
Planet Fitness does not have a company-wide mask policy for its members. Instead, it follows whatever the local applicable laws are. The company has also added a "crowd meter" on its app that allows members to see how crowded their club is before electing to visit.

Planet Fitness Is Almost Back

While there was a concern during the pandemic that people would dump their gym membership for Peloton (PTON) - Get Peloton Interactive, Inc. Class A Report and other at-home connected fitness options, that does not appear to be the case.

Rondeau told Jim Cramer on an edition of CNBC's "Mad Money" that aired in November that his company has largely completed its comeback.

“Our height was 15.5 [million members]. We’re 97% all the way recaptured back to where we were pre-Covid,” Rondeau said.

“We saw the highest third-quarter net member growth in company history,” The CEO added. “People are choosing bricks and mortar. They’re coming back faster than we’ve ever seen. They’re rejoining our clubs faster than we’ve ever seen. The Gen Z’s are joining faster than we’ve ever seen. All the winds are blowing the right direction, and the sails are wide open.”

https://www.thestreet.com/investing/planet-fitness-not-seeing-omicron-variant-slowdown-in-gym-visits

The Collins And Fauci Attack On Traditional Public Health

 by Jayanta Bhattacharya and Martin Kulldorff via The Epoch Times,

On Oct. 4, 2020, with Prof. Sunetra Gupta of Oxford University, we wrote the Great Barrington Declaration (GBD). Our purpose was to express our grave concerns over the inadequate protection of the vulnerable and the devastating harms of the lockdown pandemic policy adopted by much of the world; We proposed an alternative strategy of focused protection.

The key scientific fact on which the GBD was based—a more than thousand-fold higher risk of death for the old compared to the young—meant that better protection of the old would minimize COVID deaths. At the same time, opening schools and lifting lockdowns would reduce the collateral harm to the rest of the population.

The Declaration received enormous support, ultimately attracting signatures from over 50,000 scientists and medical professionals and over 800,000 members of the public. Our hope in writing was two-fold.

  • First, we wanted to help the public understand that—contrary to the prevailing narrative—there was no scientific consensus in favor of lockdown. In this, we succeeded.

  • Second, we wanted to spur a discussion among public health scientists about how to better protect the vulnerable, both those living in nursing homes (where ~40 percent of all COVID deaths have occurred) and those living in the community. We provided specific proposals for focused protection in the GBD and supporting documents to spur the discussion. Though some in public health did engage civilly in productive discussions with us, in this aim we had limited success.

Unbeknownst to us, our call for a more focused pandemic strategy posed a political problem for Dr. Francis Collins and Dr. Anthony Fauci. The former is a geneticist who, until last week, was the director of the U.S. National Institutes of Health (NIH); the latter is an immunologist who directs the National Institute of Allergy and Infectious Diseases (NIAID). They are the biggest funders of medical and infectious disease research worldwide.

Collins and Fauci played critical roles in designing and advocating for the pandemic lockdown strategy adopted by the United States and many other countries. In emails written four days after the Great Barrington Declaration and disclosed recently after a FOIA request, it was revealed that the two conspired to undermine the Declaration. Rather than engaging in scientific discourse, they authorized “a quick and devastating published takedown” of this proposal, which they characterized as by “three fringe epidemiologists” from Harvard, Oxford, and Stanford.

Across the pond, they were joined by their close colleague, Dr. Jeremy Farrar, the head of the Wellcome Trust, one of the world’s biggest non-governmental funders of medical research. He worked with Dominic Cummings, the political strategist of UK prime minister Boris Johnson. Together, they orchestrated “an aggressive press campaign against those behind the Great Barrington Declaration and others opposed to blanket COVID-19 restrictions.”

Ignoring the call for focused protection of the vulnerable, Collins and Fauci purposely mischaracterized the GBDl as a “let-it-rip” “herd immunity strategy,” even though focused protection is the very opposite of a let-it-rip strategy. It is more appropriate to call the lockdown strategy that has been followed a “let-it-rip” strategy. Without focused protection, every age group will eventually be exposed in equal proportion, albeit at a prolonged “let-it-drip” pace compared to a do-nothing strategy.

When journalists started asking us why we wanted to “let the virus rip,” we were puzzled. Those words are not in the GBD, and they are contrary to the central idea of focused protection. It is unclear whether Collins and Fauci ever read the GBD, whether they deliberately mischaracterized it, or whether their understanding of epidemiology and public health is more limited than we had thought. In any case, it was a lie.

We were also puzzled by the mischaracterization of the GBD as a “herd immunity strategy.” Herd immunity is a scientifically proven phenomenon, as fundamental in infectious disease epidemiology as gravity is in physics. Every COVID strategy leads to herd immunity, and the pandemic ends when a sufficient number of people have immunity through either COVID-recovery or a vaccine. It makes as much sense to claim that an epidemiologist is advocating for a “herd immunity strategy” as it does to claim that a pilot is advocating a “gravity strategy” when landing an airplane. The issue is how to land the plane safely, and whatever strategy the pilot uses, gravity ensures that the plane will eventually return to earth.

The fundamental goal of the GBD is to get through this terrible pandemic with the least harm to the public’s health. Health, of course, is broader than just COVID. Any reasonable evaluation of lockdowns should consider their collateral damage to patients with cancer, cardiovascular disease, diabetes, other infectious diseases, as well as mental health, and much else. Based on long-standing principles of public health, the GBD and focused protection of the high-risk population is a middle ground between devastating lockdowns and a do-nothing let-it rip strategy.

Collins and Fauci surprisingly claimed that focused protection of the old is impossible without a vaccine. Scientists have their own specialties, but not every scientist has deep expertise in public health. The natural approach would have been to engage with epidemiologists and public health scientists for whom this is their bread and butter. Had they done so, Collins and Fauci would have learned that public health is fundamentally about focused protection.

It is impossible to shut down society completely. Lockdowns protected young low-risk affluent work-from-home professionals, such as administrators, scientists, professors, journalists, and lawyers, while older high-risk members of the working class were exposed and died in necessarily high numbers. This failure to understand that lockdowns could not protect the vulnerable led to the tragically high death counts from COVID.

We do not know why Collins and Fauci decided to do a “take down” rather than use their esteemed positions to build and promote vigorous scientific discussions on these critical issues, engaging scientists with different expertise and perspectives. Part of the answer may lie in another puzzle—their blindness to the devastating effects of lockdowns on other public health outcomes.

Lockdown harms have affected everyone, with an extra heavy burden on the chronically ill; on children, for whom schools were closed; on the working class, especially those in the densely populated inner cities; and on the global poor, with tens of millions suffering from malnutrition and starvation. For example, Fauci was a major advocate for school closures. These are now widely recognized as an enormous mistake that harmed children without affecting disease spread. In the coming years, we must work hard to reverse the damage caused by our misguided pandemic strategy.

While tens of thousands of scientists and medical professionals signed the Great Barrington Declaration, why didn’t more speak up in the media? Some did, some tried but failed, while others were very cautious about doing so. When we wrote the Declaration, we knew that we were putting our professional careers at risk, as well as our ability to provide for our families. That was a conscious decision on our part, and we fully sympathize with people who instead decided to focus on maintaining their important research laboratories and activities.

Scientists will naturally hesitate before putting themselves in a situation where the NIH Director, with an annual scientific research budget of $42.9 billion, wants to take them down. It may also be unwise to upset the director of NIAID, with an annual budget of $6.1 billion for infectious disease research, or the director of the Wellcome Trust, with an annual budget of $1.5 billion. Sitting atop powerful funding agencies, Collins, Fauci, and Farrar channel research dollars to nearly every infectious disease epidemiologist, immunologist, and virologist of note in the United States and UK.

Collins, Fauci, and Farrar got the pandemic strategy they advocated for, and they own the results together with other lockdown proponents. The GBD was and is inconvenient for them because it stands as clear evidence that a better, less deadly alternative was available.

We now have over 800,000 COVID deaths in the United States, plus the collateral damage. Sweden and other Scandinavian countries—less focused on lockdowns and more focused on protecting the old—have had fewer COVID deaths per population than the United States, the UK, and most other European countries. Florida, which avoided much of the collateral lockdown harms, currently ranks 22nd best in the United States in age-adjusted COVID mortality.

In academic medicine, landing an NIH grant makes or breaks careers, so scientists have a strong incentive to stay on the right side of NIH and NIAID priorities. If we want scientists to speak freely in the future, we should avoid having the same people in charge of public health policy and medical research funding.

https://www.zerohedge.com/covid-19/collins-and-fauci-attack-traditional-public-health

Duke University accused of 'conspiring' to take over independent physician practice

 Duke University is facing a lawsuit alleging that it tried to absorb an affiliated independent, multispecialty physician practice through “unlawful, unfair and improper tactics.”

The suit claims that following prior unsuccessful attempts to purchase the group, the university and its health system “conspired” with department chairs to break off and assimilate five departments from the physician group into a new faculty practice, a move that would “cause irreparable harm” to the independent group and its members.

Speaking to North Carolina-based outlet The News & Observer, a representative of the university denied the lawsuit’s claims and said the organization will fight it in court. Fierce Healthcare has reached out to Duke for confirmation of these statements.

The complaint was filed Monday in Durham County Superior Court by Eugene Moretti, M.D., a Duke faculty member, on behalf of Private Diagnostic Clinic (PDC), of which he is a member.

The 80-year-old practice, which has roughly 1,850 physician members and about $1 billion in generated annual revenues, has participated in a formal partnership agreement with the university and its academic medical center for nearly 50 years, according to the suit. In October, the university delivered a notice of termination for the agreement effective at the end of 2021, according to the plaintiff.

Duke had twice looked to negotiate a merger between PDC and its health system since 2008 but could not reach terms and abandoned each attempt, per the complaint. Following these failures, the university then “devised a plan to take over the PDC without input from the PDC’s members and without paying fair compensation for the value of the enterprise,” according to the suit.

Moretti alleged “upon information and belief” that Duke University School of Medicine Dean Mary Klotman, M.D., met with five department chairs, each of whom are managers of PDC, to break off their departments from the independent group and into a new faculty practice (Duke Faculty Practice) (PDF) that would see their members become employees of Duke’s School of Medicine.

Additionally, the university announced a policy requiring physicians performing research at Duke to quit PDC and join the faculty practice by July 2022.

“At least 400 members of the PDC perform research at Duke,” the plaintiff wrote in the suit. “Duke’s mandate thus means that approximately 21% of PDC’s members have been forced to choose between, on the one hand, staying with the PDC and losing the research grants that they receive through Duke and, on the other, continuing their research but having to quit the PDC to become exclusively employed by Duke.”

The university and department chairs made these plans that threaten “hundreds of millions of dollars of revenue” without informing the “rank and file” members of PDC, Moretti alleged. The alleged plans are also a violation of the longstanding partnership agreement between the organizations, which includes language specifying that Duke would “not interfere in [PDC’s] organization and operations,” according to the suit.

Alongside the allegations against Duke, Moretti’s case also alleges that department heads including Anthony Joseph Viera, M.D., breached their fiduciary duties toward PDC. Moretti, on behalf of PDC, asked the court to award compensatory and treble damages to the physician group.

“After trying and failing for years to negotiate a purchase and merger with the PDC, Duke decided to interfere with the operations of the PDC in violation of its contractual agreements and to pressure and entice department chairs to breach their fiduciary duties to the PDC,” Erica Harris, a partner at Susman Godfrey representing Moretti, said in a statement. “Dr. Moretti has devoted the past 25 years of his career to the PDC and Duke. He is disappointed and saddened that some of Duke’s administrators have resorted to unlawful tactics to destroy what so many have worked so hard to build.”

https://www.fiercehealthcare.com/practices/duke-university-accused-conspiring-to-take-over-independent-physician-practice

CMS wants insurers to offer standardized plan options on the ACA exchanges

 The Biden administration is aiming to require insurers to offer standardized plan designs on the Affordable Care Act's (ACA's) exchanges.

As part of the Centers for Medicare & Medicaid Services' (CMS') 2022 Notice of Benefit and Payment Parameters rule, which was released late Tuesday, payers would have to offer standardized plan options for every product network type, plan tier type and plan classification.

CMS said the goal is to allow consumers to have an easier shopping experience. As standardized plans share a uniform cost-sharing structure, it's simpler to compare across plans.

“We are building a more competitive, transparent and affordable health care market," said Department of Health and Human Services Secretary Xavier Becerra. "At the end of the day, health care should be a right for everyone, not a privilege for some.”

In addition, CMS wants to reestablish mandated network adequacy reviews for plans on the federal exchange. 

"The standards used for these reviews would highlight key characteristics like time and distance to care, as well as appointment wait times," CMS said in a release.

The rule also aims to address health equity through several provisions. For one, insurers would be required to include 35% of essential community providers in each plan's service area. Ensuring access to those facilities would improve access to coverage for people in underserved and low-income areas, CMS said.

The rule would also bar insurers explicitly from discriminating against patients based on sexual orientation or gender identity. Protections for these covered services were removed in 2020 under the Trump administration.

The rule also proposes streamlining the essential health benefits non-discrimination policy by requiring insurers to rely on clinical evidence in their plan designs. For example, a plan could not force inordinately high prescription costs on people with chronic conditions without a clinical backing.

https://www.fiercehealthcare.com/payer/cms-wants-insurers-to-offer-standardized-plan-options-aca-exchanges

Theranos founder Elizabeth Holmes guilty on four counts

 A federal jury on Monday found Theranos founder Elizabeth Holmes guilty on four counts of wire fraud, more than two years after she was charged with misleading investors with fraudulent claims about the efficacy of her blood-testing technology.

The jury made up of eight men and four women found Holmes, 37, guilty after a four-month trial on three counts of wire fraud against Theranos investors and one count of conspiracy to commit wire fraud, as The Wall Street Journal reported.

The jury found Holmes not guilty on three counts of committing wire fraud against patients who had paid Theranos for blood test results. The jury was unable to reach a verdict on two other counts of wire fraud and one count of conspiracy to commit wire fraud.

CNBC reported that U.S. District Court Judge Edward Davila will sentence Holmes at a later date. Holmes potentially faces decades in prison, with the penalty for wire fraud being up to 20 years.

Her conviction is a bleak result for the Stanford University dropout, who was once hailed as the next Steve Jobs, after whom she modeled herself.

With her lofty claim of being able to conduct a multitude of diagnostic tests with only one drop of blood, Holmes was able to attract a bevy of eager investors, including the family of former Education Secretary Betsy DeVos, media mogul Rupert Murdoch and the pharmacy chain Walgreens.

Apart from investors, Holmes also had a slew of cultural and political luminaries who publicly supported her ambitions. Former Secretaries of State Henry Kissinger and George Schultz sat on Theranos's board of directors.

Holmes once participated in a panel with former President Clinton, who said he was "impressed" by her "dogged determination" to improve the quality of laboratory tests.

During the trial, prosecutors said that Holmes "chose fraud over business failure," having recognized that her company's flagship product had numerous defects, but still decided against informing her many investors.

“She chose to be dishonest. This choice was not only callous; it was criminal," assistant U.S. Attorney Jeff Schenk said in his closing arguments.

Holmes's defense sought to paint her as an entrepreneur who wished to improve health care. During her testimony, Holmes stated that any information she disseminated came from experts within her company.

“I wanted to convey the impact,” she said. "I wanted to talk about what this company could do a year from now, five years from now, 10 years from now. They weren’t interested in today or tomorrow or next month, they were interested in what kind of change we could make."

Holmes also claimed that Theranos COO Ramesh “Sunny” Balwani, with whom she was in an undisclosed relationship for 10 years, was physically and emotionally abusive towards her and controlled her daily life.

She has accused Balwani of rape, saying he would "force me to have sex with him when I didn’t want to because he would say that he wanted me to know he still loved me.”

Balwani's own trial is scheduled to begin later this year. He also faces charges of wire fraud and conspiracy to commit wire fraud.

https://thehill.com/regulation/court-battles/588094-jury-finds-theranos-founder-elizabeth-holmes-guilty-on-four-counts

Neurodegenerative disease biotech Vigil Neuroscience sets terms for $112 million IPO

 Vigil Neuroscience, a Phase 1 biotech developing antibody therapies for neurodegenerative diseases, announced terms for its IPO on Monday.


The Cambridge, MA-based company plans to raise $112 million by offering 7 million shares at a price range of $15 to $17. At the midpoint of the proposed range, Vigil Neuroscience would command a fully diluted market value of $491 million.

The company is utilizing a precision medicine approach to develop a pipeline of therapies, initially addressing genetically defined patient subpopulations, that it believes will activate and restore immune cell function within the brain. Its lead candidate, VGL101, is a fully human monoclonal antibody (mAb) that is initially being developed for adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP). In November 2021, the FDA cleared Vigil's IND for VGL101 in ALSP. The company initiated its first-in-human Phase 1 trial in December, and topline data is expected in the 2H22.

Vigil Neuroscience was founded in 2020 and plans to list on the Nasdaq under the symbol VIGL. Morgan Stanley, Jefferies, Stifel, and Guggenheim Securities are the joint bookrunners on the deal. It is expected to price during the week of January 3, 2022.