GOP lawmakers worry vaccine mandate will impact defense supply chain

 Nearly a dozen GOP members of the House Armed Services Committee on Friday pressed the Biden administration over the Pentagon’s looming COVID-19 vaccination deadline for defense contractors, claiming the mandate should be reconsidered or it might compromise supply chains. 

“We strongly urge you to reconsider the manner in which you are seeking to address this issue so as not to harm the livelihood of civilian contractors, industry partners, and strategic goals of our armed services,” the 11 lawmakers wrote to President Biden and Defense Secretary Lloyd Austin.

“Those who adamantly refuse the vaccine will accept termination. We will lose critical experience in skilled labor. We will lose opportunities for mentorship and on-the-job training from veteran craftsmen. In the long-term, we will miss quality control standards. We will face endemic cost overruns and rework as decades of lessons are not passed to the next generation,” they wrote.

Lawmakers who signed the letter were committee ranking member Mike Rogers (R-Ala.) as well as Republican Reps. Rob Wittman (Va.), Vicky Hartzler (Mo.), Elise Stefanik (N.Y.), Joe Wilson (S.C.), Blake Moore (Utah), Doug Lamborn (Colo.), Jack Bergman (Mich.), Scott DesJarlais (Tenn.), Bill Posey (Fla.) and Jerry Carl (Ala.).

Austin in late August ordered all service members and defense personnel to “immediately begin” getting the coronavirus vaccine, leaving it to the individual military services to decide when to set deadlines for the inoculation.

Defense Department contractors need to be fully vaccinated by Dec. 8 or risk being fired, as laid out under guidance the Biden administration released for federal contractors and subcontractors in September.

In their letter, the lawmakers do not specifically ask the Pentagon to pause its mandate, rather, they ask the department to consider the economic negatives of such a rule.

“We have, from day one, promulgated [Centers for Disease Control and Prevention] and DoD guidance. We have championed the vaccine rollout and battled the surrounding misinformation. But we cannot stand idly by while the DoD makes a mistake that will inevitably compromise national security for decades,” they wrote.

The letter follows a more pointed message sent earlier this week by Senate Armed Services Committee ranking member James Inhofe (R-Okla.), who asked Austin to suspend the mandate altogether, claiming a “lack of clarity and consistency” among the military services in implementing the order.

https://thehill.com/policy/defense/578109-gop-lawmakers-worry-vaccine-mandate-will-impact-defense-supply-chain

Southwest Airlines Says It Won't Fire Workers Who Don't Get COVID Vaccine

 By Jack Phillips of Epoch Times,

Southwest Airlines’ CEO said the company will not fire employees who do not get the COVID-19 vaccine by Dec. 9 following a Biden administration mandate that was announced last month for federal contractors.

In a statement to news outlets Friday, the Dallas-based carrier confirmed to Fox News it does not want to “lose any employee” over President Joe Biden’s mandate, adding that firing a worker over the vaccine “makes no sense.” It came a day after Southwest CEO Gary Kelly made a similar announcement during an earnings call.

“This is an evolving process working with the government in terms of what they expect, and very clearly, we wanted our employees to know that nobody is going to lose their job on December the 9th if we’re not perfectly in compliance,” Kelly said, according to news reports. The Epoch Times has contacted Southwest for comment.

“It is a work in progress, and we’re going to continue working in good faith to meet the requirements of the executive order. But I’ve already said, and I’m sure you’ve heard, we’re not going to fire anybody who doesn’t get vaccinated,” he continued.

Biden’s mandate will start on Dec. 8, requiring federal contractors to make sure their workers are vaccinated. Employees can be granted a medical or religious exemption.

But Kelly’s and Southwest’s announcements this week mark a reversal in the carrier’s vaccination stance. Earlier this month, Southwest stated that workers would have to be fully vaccinated or receive an exemption to “continue employment with the airline” after it conducted a “thorough review of President Biden’s COVID Action Plan and determined that the carrier’s contracts with the U.S. government require full compliance with the federal vaccination directive.”

Also on Thursday, Southwest said in its quarterly results that it lost some $75 million after thousands of flights were canceled and delayed earlier this month. The firm blamed the weather and unspecified staffing issues, although there was widespread speculation that pilots and other employees walked out over the vaccine requirement.

“I’m not going to fire anybody,” Kelly told CNBC Thursday after the quarterly results were released.

Hundreds of workers and others also demonstrated outside Southwest’s Dallas headquarters on Monday, demanding an end to the vaccination requirement.

Earlier in October, Southwest’s pilot’s union filed a lawsuit against the company, arguing that the COVID-19 shot could trigger potential career-ending side-effects for pilots.  In court filings over the weekend, Southwest asked a judge to dismiss the lawsuit and said an injunction against its vaccine mandate could potentially harm its business.

American Airlines CEO Doug Parker said this week that unvaccinated workers also will not be fired by the Dec. 9 mandate, saying the company will “work with” those who haven’t got the shot.

https://www.zerohedge.com/markets/makes-no-sense-southwest-airlines-says-it-wont-fire-workers-who-dont-get-covid-vaccine

Hundreds of NY GE workers walk off the job over vaccine mandate

 A few hundred General Electric employees walked off the job at a company facility in Schenectady, New York, on Friday, in protest of the firm mandating that all U.S. employees must get vaccinated for COVID-19 or face termination, according to new reports.

The demonstration is the latest of several protests held by GE employees in multiple states since the firm announced the vaccination requirement.

GE announced the mandate last week, joining other large employers in forcing the vaccines for workers to be in compliance with the Biden administration's deadline for all federal contractors to have fully vaccinated workforces by Dec. 8.

On Wednesday, dozens of people – including GE employees – protested outside one of the company's facilities in in Lafayette, Indiana, according to The Center Square. 

Then on Thursday, roughly 100 GE workers walked out of a plant in Greenville, South Carolina, over the vaccine requirement. There have also been reports of demonstrations by GE employees in Ohio.

So far, the New York protest is estimated to be the largest.

WTEN-TV's Mikhaela Singleton reported that the number of Schenectady workers totaled 200-plus, and provided a picture of the group marching around the sign donning GE logo outside the plant.

Footage shared by WNYT-TV's Jonathan Hunter showed the protesting employees carrying "Don't Tread on Me" flags.

GE has not yet responded to FOX Business' request for comment on the demonstrations.

https://www.foxbusiness.com/economy/hundreds-ge-workers-new-york-walk-off-job-vaccine-mandate

Theranos devices ran 'null protocol' to skip actual demo for investors

 There is a saying in the startup world that many companies try to fake it till they make it. From yesterday’s testimony in the criminal trial of Theranos founder Elizabeth Holmes, it sounds like her company took that saying to heart.

Prosecutors questioned Daniel Edlin, a former product manager, about Theranos’ investor pitches and other relationships, trying to build the case that the blood-testing startup knowingly misled investors about the capabilities of its technology. 

Edlin was recruited to work at Theranos through his friend Christian, Holmes’ brother—the two had attended Duke University together. At the startup, he was involved in a range of investor-related activities, including giving tours. Each tour was scripted—that’s not surprising—but the path was approved by Holmes herself, Edlin said, which adds to evidence that she had the final say on many investor-related matters. Before one tour, he recalled, Theranos’ proprietary testing devices were set up in a room to look like they were in active use.

In demos of the company’s technology, investors would have their fingers pricked for testing alongside one of Theranos’ proprietary devices, but the actual test would be run in a lab away from prying eyes. Machines that were shown to investors often ran a “demo app” that would prevent error messages from displaying on the device’s screen or a “null protocol” that wouldn’t analyze the sample. Edlin testified that these ruses were used within a month of Theranos offering testing services for patients.

In one notable demo given to an unnamed person in New York in June 2013, Theranos tested the person’s blood twice—once in New York and again at the company’s lab at its California headquarters. The two different runs gave different results. “The discrepancy will be a problem. We need to see if we can correct for it,” Holmes wrote in a group email. In response, Daniel Young, a Theranos executive, told Edlin to change the reference ranges, which would cause the results to appear to fall within the normal range.

In another instance, Edlin emailed Holmes and COO Ramesh “Sunny” Balwani to alert them that a device was “stuck on 99%” for eight minutes during a 2013 demo.

Investor binders

Meanwhile, investors were given binders that made hyperbolic claims about Theranos’ diagnostic technology. One binder sent to media tycoon Rupert Murdoch, who invested $125 million, said, “Theranos offers tests with the highest level of accuracy.” The company’s technology, it also said, “generates significantly higher integrity data than currently possible.”

But when Theranos was putting together a website in advance of its rollout with Walgreens, it was told by a specialty law firm focusing on food and drug law to dial back many similar claims. An email shown to the court from the firm told Theranos to provide evidence for claims that the company’s technology had “unprecedented speed and accuracy,” that its nanotainers and tests required “1/1,000 the size of” a typical blood draw, and that the company could provide “results to you and your doctor faster than previously possible.” The law firm also cautioned that Theranos should temper several passages, including ones that said the company's testing technology was “more precise,” “faster and easier,” and had the “highest levels of accuracy.”

Pentagon relationship

In addition to giving tours and demos for investors, Edlin was involved in Theranos’ relationship with the Department of Defense. Jim Mattis, who met Holmes while he was a US Marine Corps general, was intrigued by the idea of using the company’s testing technology on the battlefield. Over the years, Theranos’ relationship with the Pentagon had become part of its pitch; Wade Miquelon, a former Walgreens CFO, testified earlier that he was told the technology was being used in Afghanistan in medical evacuation helicopters.

Yet Edlin told the court that Theranos devices had never been used to test soldiers’ blood in the field and that the devices needed to run at 72–82˚ F, which likely precluded them from working in regions like Africa, where the Pentagon was considering their use. He said that Theranos devices had been sent to a warehouse in Kentucky for the military to evaluate, but nothing further came of it.

Holmes was deeply involved in talks with the Pentagon, Edlin said. “I’d say any substantive communication I had with the military, I either discussed with her ahead of time... or email drafts were reviewed and approved before I sent them back out,” he said.

Balwani backstory

The prosecution also used Edlin’s testimony to bolster its case that Holmes was in charge of the company. Holmes’ defense is expected to rely on claims that Balwani, with whom she was in a relationship, was psychologically, emotionally, and sexually abusing her. The implication is that she was under his control and that he was actually the one running Theranos.

Edlin said he first heard of Holmes and Balwani’s relationship when he was at Duke. When he worked at Theranos, he said he knew that Holmes and Balwani were still in a relationship and that the two lived together, despite the fact that their relationship hadn’t been disclosed to investors.

“During those interactions, was there anything that stood out in your mind about the way Ms. Holmes and Mr. Balwani acted together?” assistant US attorney John Bostic asked him.

“It was always more of a relaxed setting outside of work,” Edlin said. “Didn’t really discuss work. It was much more relaxed, social.”

Edlin also said that when he was in work meetings with Holmes and Balwani, Holmes always appeared in charge. “I was in meetings where Sunny said that he would defer to Elizabeth on certain things, and generally Elizabeth was the CEO,” he said. “She had kind of the final decision-making authority.”

https://arstechnica.com/tech-policy/2021/10/theranos-devices-ran-demo-apps-that-blocked-error-messages-during-investor-pitches/

Roche implant for chronic eye disorder wins FDA approval

 The U.S. Food and Drug Administration on Friday approved Swiss drugmaker Roche Holding AG's eye implant for a chronic disorder causing blurred vision, most patients of whom currently have to receive monthly eye injections.

Roche's Susvimo, previously called port delivery system (PDS), is a surgically implantable device designed to continuously deliver a customized version of the company's drug ranibizumab, branded as Lucentis, over several months.

It removes the need for patients to receive injections of Lucentis, which is a standard of care for wet age-related macular degeneration (AMD) and is required at least every month to improve sight or prevent vision loss.

"This device will be a first-of-its-kind alternative to the current standard of care injections for patients with wet AMD," chief medical officer Levi Garraway said in an interview with Reuters before the approval.

More than 98% of patients treated with the device were able to go six months before needing a refill in the company's late-stage study last year.

Wet AMD occurs when abnormal blood vessels leak fluid or blood into an area at the center of the retina called the macula, and the risk of the disorder rises with age.

The number of people with AMD in the United States is expected to reach 5.44 million by 2050, according to the National Eye Institute https://www.nei.nih.gov/learn-about-eye-health/outreach-campaigns-and-resources/eye-health-data-and-statistics/age-related-macular-degeneration-amd-data-and-statistics.

https://www.marketscreener.com/quote/stock/ROCHE-HOLDING-AG-9364975/news/Roche-implant-for-chronic-eye-disorder-wins-FDA-approval-36757938/

Arizona AG asks restraining order to block federal vaccine mandate

 Arizona Attorney General Mark Brnovich (R) filed an amended lawsuit against the Biden administration Friday, seeking a temporary restraining order and nationwide preliminary injunction to block the White House's new vaccine requirements.

Brnovich was the first GOP official in the country to file a lawsuit against the mandates last month just after Biden announced them. His amended complaint adds new claims to address the rules in place for federal employees and contractors, as well as expected rules for private businesses.

Brnovich, who is running for Senate in 2022 against Democratic Sen. Mark Kelly, is one of many Republicans who have opposed the administration over vaccine rules in recent weeks, including Florida Gov. Ron DeSantis, Texas Gov. Greg Abbott and a host of congressional Republicans.

Brnovich accused the White House of abridging personal freedoms and of overreach. His lawsuit also alleges that the mandates violate individuals’ statutory right to refuse vaccines available under Emergency Use Authorizations (EUA) from the Food and Drug Administration, because he claims Pfizer's approved version of the vaccine is not being distributed.

The lawsuit's original complaint was focused on what he claimed was the difference in treatment of U.S. citizens and those caught crossing the border illegally, who are not required to accept a vaccine.

Currently, all federal employees and contractors must be fully vaccinated against COVID-19 by Nov. 22, unless they are granted a specific exception due to a medical condition, disability or because of a sincerely held religious belief. 

There is no option for COVID-19 testing as an alternative. People who are granted exemptions will need regular testing, but details have yet to be released. 

President Biden also announced a new rule to be issued through the Labor Department rule that will require companies with at least 100 employees to implement coronavirus vaccination or testing protocols for their workers. However, the rule has not yet been issued, so it can't be challenged in court.

Anticipating the rule, many companies have already put their own requirements into place.

Health experts have praised mandates as an effective way to get people vaccinated, and the White House has fully leaned into them as a way to turn the tide of the pandemic after initially steering clear of federal intervention.

https://thehill.com/homenews/state-watch/578058-arizona-attorney-general-asks-for-restraining-order-to-block-federal

With Merck blocking its path, Agenus reroutes, to investors' dismay

 

• Shares of Agenus, a Massachusetts-based biotechnology company, fell around 22% Friday morning after the company announced plans to withdraw an application that could have gotten one of its most closely watched drugs approved in the U.S.
• Agenus' drug is designed to fight cancer by alerting the immune system to the presence of malignant cells. Specifically, it blocks the activity of PD-1, a protein that stifles the body's immune response and that has been a prominent target for cancer drugmakers. To date, the Food and Drug Administration has approved seven medicines targeting PD-1 or the related PD-L1, including Bristol Myers Squibb's Opdivo, Roche's Tecentriq and Merck & Co.'s Keytruda.
• Agenus aimed to get its drug approved for cervical cancer that had returned or spread after chemotherapy. The FDA had agreed to speedy review — a regulatory advantage typically offered when a drug is developed for a disease with insufficient treatment options. But according to Agenus, the agency has since recommended the company withdraw its application in light of the recent approval of Keytruda for the same indication.

Keytruda ranks as one of the world's most profitable drugs. In just the three months from July to September, it brought in more than $4 billion for Merck — a commercial success that reflects just how many types of cancer Keytruda treats. Since first coming to market in 2014, the drug has won more than two dozen FDA approvals.

On Oct. 13, Keytruda received yet another approval, this time in combination with chemotherapy and potentially Avastin for patients with hard-to-treat cervical cancer whose tumors test positive for the PD-1 protein. Cervical is the fourth most commonly diagnosed cancer in women in the U.S.

The decision allowed Keytruda to be used as an initial, "first-line" treatment and, importantly, upgraded to full approval an accelerated OK from 2018 that had cleared the drug for cervical cancer patients whose disease had progressed following chemotherapy. Keytruda is currently the only PD-1 drug approved in cervical cancer.

Agenus had hoped its drug, known as balstilimab, could provide another, potentially better option in the "second-line" setting. While comparing clinical trial results can be tricky, the company notes how, among 140 evaluable patients in a single-arm study evaluating balstilimab as a second-line treatment, tumors shrunk in 20% of patients who were positive for the PD-1 protein and 8% of those who were negative.

Conversely, the study that led to Keytruda's initial approval as a second-line cervical cancer treatment found that tumors shrank in 14% of patients with the PD-1 protein and 0% of those without it.

"Balstilimab has demonstrated meaningful clinical activity and an excellent safety profile in second-line cervical cancer, including in PD-L1 negative patients, who are ineligible to receive standard of care anti-PD-1 therapy, which makes the decision to withdraw so difficult for us," said Steven O'Day, chief medical officer at Agenus, in an Oct. 22 statement.

Agenus noted that the decision does not change its plans to develop balstilimab in combination with other drugs. The company is sponsoring studies that pair balstilimab with experimental Agenus medicines targeting other proteins of interest to cancer research, including CTLA-4 and CD137.

Yet, the withdrawal does mean Agenus will discontinue an ongoing confirmatory trial testing balstilimab in patients with cervical cancer that has spread or returned after chemotherapy. The company expects ending that trial will reduce research and development expenses by more than $100 million. Last year, Agenus spent $143 million on R&D.

However, Agenus intends to launch an expanded access programs so patients and doctors can access balstilimab in the U.S. and several other countries.

https://www.biopharmadive.com/news/agenus-withdraw-application-fda-cancer-keytruda/608757/