Rigel's Phase 2 Data Of Fostamatinib In COVID-19 Patients Published

 Rigel Pharmaceuticals Inc. (RIGL) said that data from NIH/NHLBI-Sponsored phase 2 trial of fostamatinib in hospitalized COVID-19 patients were published in clinical infectious diseases, an official publication of the Infectious Disease Society of America.

The company noted that the results from the 59 patient Phase 2 trial demonstrated that the addition of fostamatinib to standard of care, which included the antiviral remdesivir and the steroid dexamethasone, was well tolerated and associated with clinically meaningful improvement in clinical outcomes in hospitalized COVID-19 patients who required supplemental oxygen. Patients treated with fostamatinib had less severe adverse events.

The company noted that the study was not powered to test clinical efficacy, but numerous prespecified secondary endpoints consistently favored fostamatinib, including mortality, time to sustained recovery, change in ordinal scale assessment, number of days on oxygen, and number of days in the ICU. The study date suggested that fostamatinib may provide an additional therapeutic benefit compared to current standard of care alone.

"Additional studies are needed to confirm the efficacy findings and show how fostamatinib may address the dysregulated immune response observed in COVID-19 patients," said Jeffrey Strich, principal investigator of the study and a physician at the NIH Clinical Center.

The study met the primary endpoint showing fostamatinib did not increase the incidence of serious adverse events compared with placebo.

The overall incidence of serious adverse events by Day 29 was approximately 50% less in the fostamatinib group compared with the placebo group. The most frequent serious adverse event reported by Day 29 was hypoxia, occurring in 1 patient receiving fostamatinib and 3 patients receiving placebo.

At Day 29, in the overall population there were zero deaths in the fostamatinib group compared to 3 in the placebo group.

There were 4 intubated patients in the trial on mechanical ventilation upon enrollment with 2 patients randomized to each treatment group. Both patients in the fostamatinib group were extubated and discharged from the hospital, while both patients in the placebo group deceased.

The company noted that its phase 3 clinical trial in COVID-19, which it expects to complete later this year, will provide the company with further understanding of the safety and efficacy of fostamatinib and its potential as a new therapy for these patients.

In Mid-August, Rigel Pharmaceuticals said that the U.S. Food and Drug Administration did not issue emergency use authorization for fostamatinib for the treatment of COVID-19 in hospitalized adults, due to insufficient clinical data.

https://www.nasdaq.com/articles/rigels-phase-2-data-of-fostamatinib-in-covid-19-patients-published-in-clinical-infectious

Apple plans new sleep tracking, blood pressure, more tech for future Watch

 Amid reports that the Apple Watch Series 7 is facing production delays and won’t feature any new health sensor technology, a new report today reiterates that the Apple Watch is still “at the center of Apple’s health ambitions.” Apple is exploring a variety of new health features for the Apple Watch for the coming years, the Wall Street Journal says today.

Blood pressure tech

While a report yesterday erroneously suggested the Apple Watch Series 7 could feature blood pressure monitoring capabilities, Bloomberg’s Mark Gurman refuted that possibility in a post on Twitter. As such, the Apple Watch Series 7 is not expected to feature any new health sensors, with the focus instead being on a new design and faster processor.

The Wall Street Journal reports today, however, that Apple still has long-term health ambitions for the wearable, including blood pressure monitoring — but without specific numbers. Again, this feature is not expected to make the cut for the Apple Watch Series 7 this year.

The version of the feature under discussion at Apple would try to show users how their blood pressure is trending, but without providing a baseline measure of systolic and diastolic blood pressure, according to people familiar with these plans. Some employees have raised questions to managers about how useful such a feature would be, the people said, though they cautioned that the feature is still in development and could change.

Long term, Apple is also reportedly studying a “cuffless blood-pressure device, which is theorized as a device that could give a blood-pressure reading without inflating.”

More advanced sleep tracking

For the Apple Watch Series 8, Apple is said to be investing new sleep tracking features, including the ability to detect advanced sleep patterns and sleep apnea. These features would help the Apple Watch better compete with the latest wearables from companies like Fitbit.

One challenge for Apple in terms of expanding sleep tracking capabilities, however, is battery life. Apple is said to be investigating ways to read data from sensors overnight with as big of an effect on battery life.

Blood glucose

Apple is also studying a watch feature that might detect diabetes, the report says. The company is said to be “struggling” with this process, however, and has not made much progress on the efforts over recent years.

This isn’t the first time it has been reported that Apple is studying ways to monitor blood glucose with Apple Watch. Various reports over the years have suggested that Apple is developing a non-invasive glucose monitoring technology, with one report in 2017 indicating that Tim Cook has been seen actively wearing a glucose tracker prototype on his body around Apple’s campus.

Today’s report also adds that Apple is working with the National University of Singapore on a research project to offer “lifestyle coaching for pre-diabetics who wear more invasive blood-glucose monitoring devices from other companies.”

Body temperature

As previously reported by Bloomberg, the Apple Watch Series 8 could feature support for taking a person’s temperature. This would require a new sensor to be added to the Apple Watch. “A planned use for the sensor in 2022 would be for fertility planning, the people said, giving women clues about where they are in their ovulation cycle,” the WSJ report explains.

In the future, Apple reportedly hopes that this. feature could be used to detect fevers, but it’s unclear if that would be available from the start.

Updates to existing features

Finally, the Wall Street Journal reports that Apple is pushing the FDA to approve updates to existing capabilities of the Apple Watch.

Separately, Apple wants the FDA to sign off on updates to existing watch features. One such update would allow people diagnosed with the irregular heart rhythm known as atrial fibrillation, or AFib, to use the watch feature designed to track that condition, according to the documents and people familiar with the plans. Another would allow the company to alert users if their blood-oxygen level drops, people familiar with the issue said. Today the blood-oxygen sensor provides a reading, but doesn’t alert users, and the AFib feature can only be used by people who say they don’t have that condition.

https://9to5mac.com/2021/09/01/apple-watch-blood-pressure-temperature-more/ 

Merck begins late-stage trial of experimental COVID-19 drug

 Merck & Co Inc MRK.N and partner Ridgeback Biotherapeutics said on Wednesday they had begun enrolling patients in a late-stage trial of their experimental drug molnupiravir for prevention of COVID-19 infection.

The oral antiviral drug will be studied in over 1,300 volunteers to see if it can prevent the spread of the coronavirus.

Merck said in June the U.S. government has agreed to pay about $1.2 billion for 1.7 million courses of its experimental COVID-19 treatment, if it is proven to work in a separate, ongoing large trial and authorized by U.S. regulators.

The new late-stage study is enrolling participants who are at least 18 years of age and stay in the same household as someone infected with symptomatic COVID-19.

https://www.nasdaq.com/articles/merck-begins-late-stage-trial-of-experimental-covid-19-drug-2021-09-01-0

Amid Sanctions, Taliban Expected To Double Down On Drug Trafficking

 By Emel Akan of The Epoch Times

As the world watches events in Afghanistan unfold, many have started to wonder what the Taliban rule means for the future of the country’s opium production.

Afghanistan is the world’s largest producer of the opium poppy, which is the raw material for heroin, one of the world’s deadliest drugs. The country accounted for nearly 83 percent of global opium production between 2015 and 2020, according to estimates of the U.N. Office on Drugs and Crime (UNODC). And it’s a key supplier for heroin markets across Europe and Asia.

The U.S. military presence failed to curtail opium production throughout the Afghan countryside. For two decades, opiate economy, which includes cultivation of the poppy, processing into heroin, and trafficking, has been a major source of cash for Afghanistan.

Despite its anti-heroin rhetoric, the Taliban has benefited greatly from this opium poppy economy and become a major player in the world’s drug trade.

In its first official press conference in Kabul, the Taliban pledged to end opium cultivation in Afghanistan, in an effort to gain acceptance from the international community.

“Today, when we entered Kabul, we saw a large number of our youth who was sitting under the bridges or next to the walls and they were using narcotics. This was so unfortunate,” Taliban spokesman Zabihullah Mujahid told reporters on Aug. 17.

“From now on, Afghanistan will be a narcotics-free country, but it needs international assistance,” he said, adding that foreign aid is needed to help Afghan farmers switch to alternative crops.

Afghanistan is noted for its high-quality fruits including pomegranates, grapes, and melons. Various international organizations in the past have helped Afghan families grow pomegranates, for example, as an important alternative to opium.

Despite its agriculture sector and rich mineral resources, the country has been critically dependent on foreign aid, which has dried up with the Taliban takeover.

International donors had been providing 75 percent of the Afghan government’s operating budget, Vanda Felbab-Brown, director of the Initiative on Nonstate Armed Actors at the Brookings Institution, wrote in a Chatham House report.

The Biden administration froze nearly $9 billion in Afghan government reserves that were held in the United States. The International Monetary Fund also blocked Afghanistan from receiving nearly $440 million in funds that were scheduled to be sent earlier. And the German government announced a suspension of $300 million in development aid budgeted for this year.

Financial sanctions will also make it difficult for international organizations to provide humanitarian aid to Afghan families.

Hence, the country is expected to drift into a humanitarian and financial crisis soon, according to experts, which may lead the new regime to increase illicit activities, including drug trafficking.

“The immediate effects of the financial squeeze in place is that cash liquidity in Afghanistan may drop, which will drive up inflation—including food prices—while disadvantaging Afghanistan’s poorest and the hundreds of thousands of internally displaced people,” Felbab-Brown wrote.

As in the past, she noted, those who attempt to ban poppy cultivation in rural areas can “find themselves facing significant losses of political capital and violent opposition.”

Gretchen Peters, executive director at the Center on Illicit Networks and Transnational Organized Crime, believes the Taliban shouldn’t be trusted when it comes to its promises to eradicate the poppy trade.

“They pulled a maneuver like that back in the ’90s. They did actually succeed in banning farmers from growing poppy for a year,” she told NPR.

“But the secret was the Taliban were actually sitting on these huge, vast stores of opium. The price of opium went through the roof, and they sold it and made a lot more money than they had the year previous.”

According to Peters, the Taliban will now have full access to the capacities and institutions of state, including its banking system, airlines, and border crossings, which would make its drug trafficking a lot easier.

Recently, poppy cultivation has expanded in most regions of the country, soaring 37 percent in the past year alone, according to UNODC.

https://www.zerohedge.com/markets/amid-sanctions-taliban-expected-double-down-drug-trafficking

Philips starts repair, replacement of millions of respiratory devices

  Royal Philips (NYSE: PHG; AEX: PHIA) today announced an update in connection with the June 14, 2021 recall notification* for specific Philips sleep and respiratory care devices that was issued to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices. More than half of the affected devices in use globally are in the US. The vast majority (>80%) of the registered affected devices in the US to date are in the first-generation DreamStation product family.

Philips received authorization from the US Food and Drug Administration (FDA) for the rework of the affected first-generation DreamStation devices [1], which consists of replacement of the PE-PUR sound abatement foam with a new material. Philips anticipates rework to commence in the course of September 2021. In addition to the rework, the company has already started replacing certain affected first-generation DreamStation CPAP devices in the US with DreamStation 2 CPAP devices. Philips remains in dialogue with the FDA with respect to other aspects of the recall notification and mitigation plan in the US [2].

Philips is initiating the repair and replacement programs in other countries as well and expects to have these underway in the majority of its markets by the end of September 2021. The company intends to complete the repair and replacement programs within approximately 12 months.

https://www.biospace.com/article/releases/philips-starts-repair-and-replacement-program-of-first-generation-dreamstation-devices-in-the-us-in-relation-to-earlier-announced-recall-notification-/

COVID recession pushed Social Security insolvency up a year

 The sharp shock of the coronavirus recession pushed Social Security a year closer to insolvency but left Medicare’s exhaustion date unchanged, the government reported Tuesday in a counterintuitive assessment that deepens the uncertainty around the nation’s bedrock retirement programs.

The new projections in the annual Social Security and Medicare trustees reports indicate that Social Security’s massive trust fund will be unable to pay full benefits in 2034 instead of last year’s estimated exhaustion date of 2035. For the first time in 39 years the cost of delivering benefits will exceed the program’s total income from payroll tax collections and interest during this year. From here on, Social Security will be tapping its savings to pay full benefits.

The depletion date for Medicare’s trust fund for inpatient care remained unchanged from last year, estimated in 2026.

In the 1980s, financial warnings about Social Security prompted then-President Ronald Reagan and lawmakers of both parties in Congress to collaborate on a long-term solvency plan, but such action is unlikely in today’s bitter political climate. Democrats who control the White House and Congress offered assurances they would protect both programs.

“The Biden-Harris administration is committed to safeguarding these programs and ensuring they continue to deliver economic security and health care to older Americans,” Treasury Secretary Janet Yellen said in a statement.

The latest estimates reflected the push and pull of many factors flowing from the pandemic, and the full impact may take years to sort out. The deep but relatively short recession slashed revenue from payroll taxes. But the death toll from COVID-19, concentrated among older people, reduced future Social Security benefit payouts. Hospitals were stressed by the influx of COVID patients, but Medicare didn’t have to pay for as many knee surgeries, colonoscopies and other more routine procedures. Birth rates and immigration, which tend to bolster the two programs, both fell.

For Social Security, the loss of payroll tax revenue outweighed any savings from what the program would have paid out to people whose lives were lost in the pandemic. The report noted that employment, earnings, interest rates and economic growth plummeted in the second quarter of 2020 after the pandemic hit the United States.

“The finances of both programs have been significantly affected by the pandemic and the recession of 2020,” the trustees said. But “given the unprecedented level of uncertainty” there was no consensus on what the long-lasting effects of the pandemic would be. A looming question for Medicare: Will the population of beneficiaries who survived the pandemic be healthier on the whole, or will a high number suffer from new conditions like long COVID?

Social Security pays benefits to more than 65 million Americans, mainly retirees but also disabled people and survivors of deceased workers. Medicare covers more than 60 million older and disabled people. Together, both programs account for more than 40% of the federal budget, and act as stabilizer not only for families, but for the national economy.

While long-term projections are sobering, in the short run there was some good news for Social Security recipients.

Government economic experts who prepared the Social Security report estimated recent increases in inflation mean the cost-of-living adjustment for 2022 will approach 6%, a whopping jump from the 1.3% COLA awarded for this year.

Some of that may go for higher Medicare costs. The Medicare “Part B” premium for outpatient coverage was projected to rise by $10 a month in 2022, to $158.50 under the report’s intermediate assumptions. The official number won’t be released until later this year.

Social Security and Medicare remain under intense financial pressure with the retirement of millions of baby boomers, who are living longer than previous generations.

When the Social Security trust fund is depleted the government will be able to pay 78% of scheduled benefits, the report said. When Medicare’s trust fund for inpatient care runs short, it will be able to pay only 91% of expected costs, mainly hospital bills.

Because reductions of that magnitude would cause a political uproar, it is likely that a future Congress would find ways to recover the lost benefits, either by hiking the payroll taxes paid by current workers or by increasing government borrowing to cover the shortfall. With Medicare, lawmakers could also raise premiums paid by beneficiaries.

It’s unclear how the Medicare projections will affect the debate on Capitol Hill about authorizing the program to negotiate prescription drug prices and then using projected savings to provide new Medicare coverage for dental, vision and hearing services. Republicans have argued that any savings should go to shore up the underlying program, not expand benefits.

The Medicare report steered clear of making any projections about the new Alzheimer’s drug, Aduhelm, which has a list price of $55,000. Most of the 6 million Americans dealing with Alzheimer’s are covered by the program, though not all would be candidates for the medication.

The trustees’ reports, which have been delayed for months, represent the government’s effort to assess the impact of last year’s pandemic and recession on Social Security and Medicare.

The U.S. economy lost a staggering 22.4 million jobs in March and April 2020 as the pandemic forced businesses to close or cut their hours and the economy went into recession.

But the recession turned out to be brief and hiring has bounced back as economic growth has resumed. Employers have brought back 16.7 million jobs since April 2020 but that gain still leaves the labor force 5.7 million jobs below where it was before the pandemic hit.

The trustees of Social Security and Medicare include the secretaries of Treasury, Health and Human Services, and Labor, as well as the Social Security commissioner. They are supposed to be joined by two “public trustees,” knowledgeable private citizens who act as the eyes and ears of taxpayers and beneficiaries. But those posts have been vacant since July 2015 — before the end of the Obama administration. And this year there’s no Social Security commissioner either, since President Joe Biden fired Andrew Saul, a holdover appointee from the Trump administration.

https://apnews.com/article/business-medicare-6d527d62acb9a6ee09361d81ccacd36f

State mask bans face federal civil rights inquiries

 The Education Department on Monday opened civil rights investigations into five Republican-led states that have banned or limited mask requirements in schools, saying the policies could amount to discrimination against students with disabilities or health conditions.

The department’s Office for Civil Rights announced the investigations in letters to education chiefs in Iowa, Oklahoma, South Carolina, Tennessee and Utah. Those states have issued varying prohibitions on mask requirements, which the office says could prevent some students from safely attending school.

Education Secretary Miguel Cardona accused the states of “putting politics over the health and education of the students they took an oath to serve.”

“The department will fight to protect every student’s right to access in-person learning safely,” Cardona said in a statement.

It marks a sharp escalation in the Biden administration’s battle with Republican states that say mask-wearing should be a personal choice. President Joe Biden last week asked Cardona to explore possible legal action, prompting the department to examine whether the policies could amount to civil rights violations.

The states under investigation have adopted a range of policies that outlaw or curb mask mandates. A state law in Iowa forbids school boards from mandating mask wearing. In Tennessee, school mask mandates are permitted, but a recent executive order from Gov. Bill Lee allows families to opt out of them.

Those policies conflict with guidance from the Centers for Disease Control and Prevention, which recommends universal mask wearing for students and teachers in the classroom. The CDC issued the guidance in light of the rapid spread of the highly contagious delta variant of COVID-19.

In announcing the investigations, the department said it will examine whether the policies violate a federal law protecting students with disabilities. Under that law, students with disabilities must be given access to a “free appropriate public education” alongside their peers without disabilities.

But states that outlaw mask mandates could be preventing schools from taking necessary steps to protect students with disabilities or medical conditions, the department said.

In its letters, the department said it’s concerned that the states “may be preventing schools from making individualized assessments about mask use so that students with disabilities can attend school and participate in school activities in person.”

Education Department investigations often end with voluntary agreements that remedy alleged violations. But if the agency concludes that states violated civil rights laws, it could issue sanctions as severe as a loss of federal education funding.

The inquiries were launched at the department’s discretion and not in response to complaints from parents. But Cardona said he has heard from families who are concerned that state mask policies could put their children at risk.

Some Republicans quickly denounced the investigations. Iowa Gov. Kim Reynolds said individuals should be trusted to make the best decisions for themselves.

“Iowa was able to reopen schools safely and responsibly over a year ago. President Biden and his team know this, yet they’ve decided to pick a political fight with a handful of governors to distract from his own failures,” Reynolds said in a statement.

A spokesperson for Oklahoma Gov. Kevin Stitt said that, “until every American citizen is safely out of Afghanistan, President Biden shouldn’t spend a single second harassing states like Oklahoma for protecting parents’ rights to make health decisions for their kids.”

But Oklahoma’s education chief, who has said mask mandates should be an option, appeared to share the Education Department’s concerns. In a statement, State Superintendent Joy Hofmeister said the state “is preventing schools from fulfilling their legal duty to protect and provide all students the opportunity to learn more safely in-person.”

In South Carolina, the state’s top education official has similarly clashed with the governor over mask policies. A statement from the state education agency said Superintendent Molly Spearman has “repeatedly implored” lawmakers to reconsider their ban on mask mandates.

South Carolina education officials said they are sensitive to the law’s effect on vulnerable students, and are “acutely aware of the difficult decisions many families are facing concerning a return to in-person instruction.”

Some other states previously outlawed mask mandates, but the policies were overturned by courts or are not being enforced, including in Florida, Texas, Arkansas and Arizona. The Education Department has not opened investigations in those states but said it is watching closely and is prepared to take action.

Masks have emerged as a major source of contention as the nation’s schools start a new school year during a surge in COVID-19 cases. Although most states let schools decide their own policies, some have taken firm stances for or against mandates.

States including California, New York and Louisiana have issued statewide mask requirements inside schools, while Texas, Florida and others moved to prevent schools from requiring masks.

In Florida, which had taken one of the toughest stances against mask mandates, a judge ruled Friday that schools are legally allowed to require masks. The judge overturned an order from Gov. Ron DeSantis that had barred such mandates, ruling that it was unconstitutional and cannot be enforced.

Other states opposing mask mandates face similar legal challenges. In South Carolina, the American Civil Liberties Union last week filed a federal lawsuit over the state’s policy forbidding mask mandates. The suit, filed on behalf of parents and disability rights groups, argues that the ban excludes vulnerable students from public schools.

In Iowa, a mother of twin boys recently sued the state over its ban on school mask requirements. In her suit, Frances Parr said her children were set to start first grade this year, but she is now teaching them at home over fears about their safety.

In the Des Moines school district, which has opposed the state’s policy against mask mandates, officials were encouraged by the support from the federal government. The district is encouraging mask-wearing but is forbidden from requiring it.

“If our state government doesn’t change its position as the pandemic continues then hopefully the federal government will find a legal path that allows us to do more to keep our students and staff safe,” district spokesperson Phil Roeder said in a statement.

https://apnews.com/article/health-education-coronavirus-pandemic-75626804dd993775d292a6b450e13d01