Banana Boat sunscreen recalled due to cancer-causing chemical

 Banana Boat is recalling three batches of its “hair and scalp” sunscreen after tests found that the product contains trace amounts of cancer-causing chemical benzene, the manufacturer said in an announcement submitted to the Federal Drug Administration.

Exposure to benzene through skin contact, inhalation and by mouth has been linked to cancer such as leukemia, Fox Business reported.

The Shelton, Connecticut-based company claimed in the Friday release that it “has not received any adverse events related to this recall” and that “daily exposure to benzene in the recalled products would not be expected to cause adverse health consequences.”

The recalled products have expiration dates of December 2022, February 2023 and April 2024, the company said. Banana Boat said it will also offer reimbursement to consumers who bought the recalled products.

The FDA assured that the levels found in the defective sunscreen “would not be expected to cause adverse heath consequences.” 

Edgewell Personal Care/FDA

No other batches made before or after those expiration dates listed were affected, according to the FDA release, and no other Banana Boat sunscreen is subject to the recall. 

The FDA recommends that buyers of Banana Boat’s Hair and Scalp sunscreen should “stop using the affected product immediately and appropriately discard.”

Consumers with questions regarding the recall can contact Edgewell Personal Care at 1-888-686-3988 or visit www.bananaboat.com for more information. Banana Boat also announced that they are offering reimbursement for consumers who have purchased a product marked with one of the lot of codes, which is on the bottom of the cans. 

https://nypost.com/2022/07/30/banana-boat-sunscreen-recalled-due-to-cancer-causing-chemical/

'VA looking at abortion care options in states with new restrictions'

 Secretary of Veterans Affairs Denis McDonough on Sunday said his department is examining how to best protect abortion access to veterans after the Supreme Court struck down Roe v. Wade, but he declined to provide a specific path forward.

CNN “State of the Union” co-anchor Jake Tapper asked McDonough to respond to a letter from 24 Senate Democrats calling on the department to allow abortion services at veteran hospitals.

“We’re going to make sure that they have access to the full slate of that care, because that’s what we owe them,” McDonough said.

The letter, led by Sens. Elizabeth Warren (D-Mass.) and Mazie Hirono (D-Hawaii), argues that the VA has statutory authority to provide abortions. The senators said the department should immediately begin a rulemaking process to change current regulations, which prevent it from providing abortions and abortion counseling as part of its medical benefits package.

When asked on Sunday if the VA would pay for veterans living in states with abortion restrictions to fly to areas where they can receive an abortion, McDonough declined to say.

“We’re looking expressly at these questions about how we guarantee the life and the health of our veterans, our women veterans, those 300,000 who rely on us for their care,” McDonough said. 

“I don’t have any announcements to make on that this morning, Jake, but we’re looking very closely at that to ensure that there’s no diminution and no reduction of services to them,” he added.

The Supreme Court’s decision last month overturning the constitutional right to abortion has set off a flurry of so-called trigger laws and other bills in state legislatures that restrict abortion access, also fueling intense fury among Democrats.

“My preference is that they not face risk to their lives as a result of this decision from the court,” McDonough said on CNN “We’re going to make sure that we’re in a position to take care of them.”

https://thehill.com/homenews/sunday-talk-shows/3581503-mcdonough-says-va-looking-at-abortion-care-options-in-states-with-new-restrictions/

WTO: Don’t make bad situation worse with IP waivers for Covid meds, diagnostics

 The World Trade Organization recently agreed to suspend patent protections for Covid-19 vaccines. The trade body is now considering going one step further: extending the intellectual property waiver to Covid-19 therapeutics and diagnostics. That misguided idea would have disastrous consequences: further eroding intellectual property protections will discourage research and development and make it even harder to fight deadly diseases and future pandemics.

South Africa and India first proposed an intellectual property waiver nearly two years ago. They claimed that suspending patents would allow manufacturers in developing countries to produce generic versions of vaccines and therapeutics without paying royalties to the companies that developed them, which was necessary to curb the pandemic and vaccinate people around the world.

Even then the argument was a stretch. But now, at a time when the global vaccine market is glutted and drug companies have formed countless voluntary partnerships with manufacturers in developing countries, the original logic behind the waiver has proven patently false.

Consider Aspen, a South African manufacturer that inked a licensing deal to produce Johnson & Johnson’s vaccine late last year. As of mid-May, after two months of production, Aspen hadn’t received a single order for its version of the J&J shot. Other manufacturers are reporting similar stories. The Serum Institute of India, the world’s largest vaccine manufacturer, halted production of Covid-19 vaccines in April after accumulating 200 million unused shots. Hundreds of millions of the country’s excess doses are expected to expire in September.

Simply put, vaccine supply isn’t the problem. The true barriers to global vaccination have been, and remain, vaccine hesitancy, logistical problems, and trade barriers. No number of doses or licensing deals — either voluntary or coerced — can overcome those administrative and cultural hurdles.

That hasn’t stopped WTO members from latching onto the erroneous idea that patents are the culprit for lagging global vaccination efforts and the prolonged fight against Covid-19. The recently-agreed-upon vaccine waiver resulted from months of closed-door negotiations between South Africa, India, the EU, and the United States.

The WTO has pledged to consider expanding the waiver to Covid-19 therapeutics within six months — despite the fact that the manufacturers of those therapeutics, like vaccine manufacturers, have already made voluntary agreements to help get the medications to those who need them across the globe.

In May 2020, Gilead Sciences established a voluntary licensing program for remdesivir, an antiviral initially developed for hepatitis and Ebola that proved somewhat effective against Covid-19. The company reported in April 2021 that more than 2.3 million people in more than 60 low- and middle-income countries had access to the drug because of its licensing agreements with generics manufacturers.

In October 2021, Merck agreed to a deal with the United Nations’ Medicines Patent Pool that allows manufacturers in more than 100 countries to make molnupiravir, its Covid-19 antiviral medication. A few weeks later, Pfizer made a similar agreement with the UN organization for Paxlovid, its antiviral pill. As of March, 35 generics companies had signed up to begin manufacturing Pfizer’s pill.

In other words, patents aren’t preventing generics manufacturers in low-income countries from licensing and producing Covid-19 therapies, so waiving patent protections wouldn’t increase the availability of those drugs. It would simply force companies like Gilead, Merck, and Pfizer to give up their intellectual property without earning any royalties from it.

That would set a dangerous precedent, one that could have disastrous long-term consequences for future innovation — and people who are hoping for better treatments and cures.

It takes roughly $2 billion to bring a drug to market. Exclusive patent rights give biotech investors confidence that they’ll be able to generate adequate returns if they’re lucky enough to get their experimental medicines through the regulatory approval process and onto pharmacy shelves.

Knowing that the WTO could invalidate those patent protections would cause investors to hesitate backing the next groundbreaking treatments, both for Covid-19 and other future health crises.

That will make the development of drugs like Paxlovid — which reduces risk of Covid-19 hospitalization or death by 51% — increasingly unlikely. It will make it harder for companies like Gilead to ramp up manufacturing and delivery of stockpiled drugs to combat new threats. And it will cause drugmakers to think twice before researching and developing treatments for deadly diseases ranging from cancer to Alzheimer’s.

Anyone looking for future cures can only hope the WTO declines to further weaken protection for intellectual property.

Kenneth E. Thorpe is a professor of health policy at Emory University, chairman of the Partnership to Fight Chronic Disease, and former Deputy Assistant Secretary of the U.S. Department of Health and Human Services.

https://www.statnews.com/2022/07/31/wto-dont-make-a-bad-situation-worse-by-granting-intellectual-property-waivers-for-covid-19-therapeutics-and-diagnostics/

Dems destroying our economy, one sector at a time

 The Biden administration and its co-conspirators, congressional Democrats, have been busy wrecking America these last 18 months. 

They launched a war on American energy, shutting down the Keystone pipeline and blocking domestic oil and gas exploration — resulting in skyrocketing gas prices, less fuel to heat and cool homes and businesses, and the sorry spectacle of an American president going gas-can-in-hand to beg foreign despots and dictators to supply us with some energy.

They launched a war on our sovereignty and national security by inviting illegal immigrants (and smugglers) to “come on in.” Through our open borders has come a tidal wave of Fentanyl and other illegal drugs now killing Americans all over the country.

They launched a war on education — keeping schools closed while children suffered mentally and emotionally.

And they launched a war on our Constitution, using executive orders to expand a regulatory state that threatens to suffocate individual autonomy and business innovation. Their legislation-through-regulation schemes are an end run around the people’s representatives — and therefore, around the people.

Then there is their reckless spending, triggering the highest inflation we’ve seen since the 1970s and lowering living standards for all Americans, hitting hardest those least able to afford it.

And now, to distract us from the wreckage and in a last-ditch effort to save their jobs in 2022, Democrats want to do what they do best: spend more taxpayer money. To pay for a portion of this spending, they would command drug companies to “negotiate” with Medicare on prices for certain brand-name drugs. “Negotiation” is a misnomer, however; if drug companies don’t agree with the government’s price, they would lose most of the revenue from those drugs’ sales. Congressional Democrats and their allies in the White House are determined to wreck our best-in-the-world health care system in much the same fashion as they’ve wrecked American energy, national security, education and constitutional governance.

Pharmaceuticals cost billions to develop, and many never make it to market. Continued investment in developing new drugs happens only because research and development pays off from time to time in the form of a “blockbuster” drug that makes billions — and covers the R&D costs of the once-promising drugs that didn’t pan out. Even the tantalizing possibility of developing a best-selling drug will not be enough to attract investment when the government can step in, dictate the price, and take away the profit that would have covered R&D losses. Undercutting this potential for profit means that capital will go elsewhere. Government cannot stop that, unless, of course, we abandon the free market and adopt a socialist economic system, which many on the left are clamoring for and which would explain why they seem determined to wreck our country.

Lower investment in the pharma sector means, of course, that the promise of many potential drugs will never be explored. Who knows what cures will never be developed — Would it have been for Alzheimer’s? Or pancreatic cancer? Or Parkinson’s? 

There are problems in our health care system that need to be addressed. But destroying the sector that has given so many of our citizens life-saving treatments and cures — especially to pay for more government spending and bureaucratic programs — is most certainly not the answer.

Beverly McKittrick is the director of the Regulatory Action Center (RAC) at FreedomWorks. Previously, she served in the Trump administration at the Department of Labor, Office of the Secretary.

https://thehill.com/opinion/congress-blog/3580619-democrats-destroying-our-economy-one-sector-at-a-time/

Reinfection, severe outcome more common with Omicron BA.5 variant

Compared with the earlier Omicron BA.2 subvariant, currently dominant Omicron BA.5 is linked with higher odds of causing a second SARS-COV-2 infection regardless of vaccination status, a study from Portugal suggests.

From late April through early June, researchers there studied 15,396 adults infected with the BA.2 variant and 12,306 infected with BA.5.Vaccines and boosters were equally effective against both sublineages, according to a report posted on Monday on medRxiv ahead of peer review.

However, 10% of BA.5 cases were reinfections, compared to 5.6% of BA.2 cases, which suggests a reduction in protection conferred by previous infection against BA.5 compared to BA.2, the researchers said. Moreover, the vaccines appeared to be less effective in reducing the risk of severe outcomes for BA.5 compared with BA.2.

“Among those infected with BA.5, booster vaccination was associated with 77% and 88% reduction in risk of COVID-19 hospitalization and death, respectively, while higher risk reduction was found for BA.2 cases, with 93% and 94%, respectively,” the researchers wrote.

While “COVID-19 booster vaccination still offers substantial protection against severe outcomes following BA.5 infection,” they said, their findings provide “evidence to adjust public health measures during the BA.5 surge.”

“That means once the heart is infected with SARS-CoV-2, it will activate the TLR4 signaling,” Zhiqiang Lin of the Masonic Medical Research Institute in Utica, New York said in a statement.

“We provided direct evidence that spike protein is toxic to the heart muscle cells and narrowed down the underlying mechanism as spike protein directly inflames the heart muscle cells,” he told Reuters. “More work is being done in my lab to test whether and how spike protein kills heart muscle cells.”

https://newsinfo.inquirer.net/1637097/reinfection-severe-outcome-more-common-with-omicron-ba-5-variant-research

Inside the super-secure Swiss lab trying to stop the next pandemic

 The setting is straight from a spy thriller: Crystal waters below, snow-capped Swiss Alps above and in between, a super-secure facility researching the world's deadliest pathogens.

Spiez Laboratory, known for its detective work on chemical, biological and nuclear threats since World War Two, was tasked last year by the World Health Organization to be the first in a global network of high-security laboratories that will grow, store and share newly discovered microbes that could unleash the next pandemic.

The WHO's BioHub program was, in part, born of frustration over the hurdles researchers faced in getting samples of the SARS-CoV-2 virus, first detected in China, to understand its dangers and develop tools to fight it.

But just over a year later, scientists involved in the effort have encountered hurdles.

These include securing guarantees needed to accept coronavirus variant samples from several countries, the first phase of the project. Some of the world's biggest countries might not cooperate. And there is no mechanism yet to share samples for developing vaccines, treatments or tests without running afoul of intellectual property protections.

"If we have another pandemic like coronavirus, the goal would be it stays wherever it starts," Isabel Hunger-Glaser, head of the BioHub project at Spiez, told Reuters in a rare media interview at the lab. Hence the need to get samples to the hub so it can help scientists worldwide assess the risk.

"We have realised it's much more difficult" than we had thought, she said.

SAFETY IN THE MOUNTAINS

Spiez Lab's exterior provides no hint of the high-stakes work inside. Its angular architecture resembles European university buildings erected in the 1970s. At times, cows graze on the grassy central courtyard.

But the biosafety officer in charge keeps his blinds shut. Alarms go off if his door is open for more than a few seconds. He monitors several screens showing security camera views of the labs with the greatest Biosafety Level (BSL) precautions.

SARS-CoV-2, the virus causing COVID, is studied in BSL-3 labs, the second-highest security level. Samples of the virus used in the BioHub are stored in locked freezers, said Hunger-Glaser. A system of decreasing air pressure means clean air would flow into the most secure areas, rather than contaminated air flowing out, in a breach.

Scientists working with coronavirus and other pathogens wear protective suits, sometimes with their own air supply. They work with samples in a hermetically sealed containment unit. Waste leaving the lab is super-heated at up to 1,000 degrees Celsius (1,830 F) to kill pathogens clinging to it.

To date, Spiez has never had an accidental leak, the team say. That reputation is a key part of why they were chosen as the WHO's first BioHub, said Hunger-Glaser.

The proximity to WHO headquarters, two hours away in Geneva, helped too. The WHO and Swiss government are funding the annual 600,000 Swiss franc ($626,000) budget for its first phase.

Researchers have always shared pathogens, and there are some existing networks and regional repositories. But the process is ad hoc and often slow.

The sharing process has also been controversial, for instance when researchers in wealthy countries get credit for the work of less well-connected scientists in developing nations.

"Often you just exchanged material with your buddies," said Hunger-Glaser.

Marion Koopmans, head of the Erasmus MC Department of Viroscience in the Netherlands, said it took a month for her lab to get hold of SARS-CoV-2 after it emerged in the central Chinese city of Wuhan in December 2019.

Chinese researchers were quick to post a copy of the genetic sequence online, which helped researchers begin early work. But efforts to understand how a new virus transmits and how it responds to existing tools requires live samples, scientists said.

EARLY CHALLENGES

Luxembourg was the first country to share samples of new coronavirus variants with the BioHub, followed by South Africa and Britain.

Luxembourg sent in Alpha, Beta, Gamma and Delta variants, while the latter two countries shared Omicron, WHO said.

Luxembourg got Omicron samples from South Africa, via the hub, less than three weeks after it was identified, enabling its researchers to start assessing the risks of the now-dominant strain. Portugal and Germany also received Omicron samples.

But Peru, El Salvador, Thailand and Egypt, all of which signalled in early 2022 that they wanted to send in variants found domestically, are still waiting, chiefly because it is unclear which official in each country should provide the necessary legal guarantees, Hunger-Glaser said.

There is no international protocol for who should sign the forms providing safety details and usage agreements, she added. None of the four countries responded to requests for comment.

Both WHO and Hunger-Glaser stressed the project is a pilot, and they have already sped up certain processes.

Another challenge is how to share samples used in research that could lead to commercial gain, such as vaccine development. BioHub samples are shared for free to provide broad access. However this throws up potential problems if, for example, drugmakers reap profits from the discoveries of uncompensated researchers.

WHO plans to tackle this longer-term, and bring labs in each global region online, but it is not yet clear when or how this will be funded. The project's voluntary nature may also hold it back.

"Some countries will never ship viruses, or it can be extremely difficult – China, Indonesia, Brazil," said Koopmans, referring to their stance in recent outbreaks. None of the three responded to requests for comment.

The project also comes amid heightened attention on labs worldwide after unproven claims in some Western countries that a leak from a high-security Wuhan lab may have sparked the COVID-19 pandemic, an accusation China and most international scientists have dismissed.

Hunger-Glaser said the thinking around emerging threats must change post-COVID-19.

"If it is a real emergency, WHO should even get a plane" to transport the virus to scientists, she said.

"If you can prevent the spreading, it's worthwhile."

https://sg.news.yahoo.com/inside-super-secure-swiss-lab-061659442.html

After starting New Mexico fire, U.S. asks victims to pay

 After the U.S. government started the largest wildfire in New Mexico's recorded history in April, it is asking victims to share recovery costs on private land, jeopardizing relief efforts, according to residents and state officials.

The blaze was sparked by U.S. Forest Service (USFS) prescribed fires to reduce wildfire risk. The burns went out of control after a series of missteps, torching 432 residences and over 530 square miles (1373 square km) of mostly privately owned forests and meadows, much of it held by members of centuries-old Indo-Hispano ranching communities.

"Today I'm announcing the federal government's covering 100% of the cost," President Joe Biden said during a visit to New Mexico in June. Biden was announcing a disaster declaration that covered debris removal and emergency protective measures.

But federal cost-sharing statutes on other federal relief programs are limiting Biden's authority and exposing holes in the government safety net meant to help survivors and restore landscapes.

It is a system more Americans will turn to as extreme fires and flooding become the climate change norm.

"I DIDN'T CAUSE THIS DAMN FIRE"

Biden's measure was meant to bridge FEMA relief and a congressional bill that may pass in the fall to provide 100% federal compensation for losses from the so-called Hermit's Peak Calf Canyon fire.

Daniel Encinias was among survivors who met Biden and was told by U.S. Department of Agriculture (USDA) officials he would get timely support at little or no cost.

He, his wife Lori, three teenage children, four dogs and eight cats are living in a camping trailer next to the ashes of their home in Tierra Monte, 35 miles northeast of Santa Fe.

Encinias submitted an application to the USDA's Natural Resources Conservation Service (NRCS) https://www.nrcs.usda.gov/wps/portal/nrcs/detail/nm/newsroom/releases/?cid=NRCSEPRD1923027 to fix his well, but was told to share 25% of costs based on a federal statute that could not be waived as it did not fall under Biden's declaration.

Encinias said he was told by NRCS officials his application would be considered in September and recovery work would begin six to 12 months thereafter if he was accepted

So like many fire survivors in this low-income area who have no insurance, the rancher and retired electrician did the work himself.

"Why the hell am I going to pay anything when I didn't cause this damn fire?" said Encinias, 55, as he fed his cattle hay he was forced to buy after his baler was torched.

An official for the NRCS' local office in Las Vegas, New Mexico, where Encinias applied for support directed questions to the national office. Officials there did not respond to requests for comment.

The White House did not respond to a request for comment.

UNCERTAIN TIMELINE FOR RECOVERY RELIEF

Many fire-hit families cannot afford sharing at least 25% of costs on the USDA's Emergency Forest Restoration Program (EFRP) https://www.fsa.usda.gov/Assets/USDA-FSA-Public/usdafiles/FactSheets/emergency_forest_restoration_program-fact_sheet.pdfwhich offers relief such as stabilization of burn areas prone to flash flooding, according to New Mexico State Forester Laura McCarthy. Residents sometimes own large areas of land passed down from 1800s Spanish-Mexican land grants while working blue-collar jobs.

"They're really struggling," said McCarthy.

That has left locals, state officials and federal agencies counting on cost shares to be dropped and passage of the congressional bill.

Democratic Representative Teresa Leger Fernandez sponsored the legislation which passed the House and will probably need help from Republicans in the Senate. The office of Senate minority leader Mitch McConnell did not immediately respond to a request for comment

Leger Fernandez is in talks with the USDA and White House on dropping cost shares and helped negotiate a waiver with the NRCS for flood mitigation work on private lands.

"The federal government burns your house down so they are responsible in my mind to pay 100% of the cost of rebuilding," said Leger Fernandez

Support cannot get to the 45-mile-long disaster https://www.yahoo.com/video/mountains-gone-grief-sacred-mexico-004919599.html area fast enough.

The blaze burned around 170 acres (68.8 hectares) of rancher Kenny Zamora's forest. His pastures in El Turquillo are covered with up to 2 feet of sludge after monsoon rains triggered debris flows on hillsides that no longer absorb water. The torrents have twice knocked down fences.

A retired employee of the USDA's Rural Development agency, Zamora applied for support from the USDA's Farms Service Agency (FSA) to feed his livestock.

The FSA office in Las Vegas told him he was not eligible. USDA officials told him the EFRP for the area has yet to be funded. He is paying for recovery work himself.

"If you don't have insurance you're pretty much on your own," said Zamora, 59, who like Encinias is considering joining a massive civil case that may be filed against the USFS.

The FSA Las Vegas office directed questions to State Executive Director Jonas Moya, who did not respond to a request for comment. The FSA's national office did not respond to requests for comment.

Climate change is worsening wildfires as ecosystems no longer have natural protections such as cooler nights to slow their spread. The destroyed landscapes are also less able to handle other disasters, such as floods https://www.fema.gov/sites/default/files/documents/fema_flood-after-fire_factsheet_nov20.pdf.

Two women and a man died https://www.reuters.com/article/new-mexico-wildfire-idAFL1N2Z400C after a flash flood swept through the burn scar northeast of Las Vegas on July 21.

In Tierra Monte, ash flows sent boulders tumbling below Encinias' trailer and drowned livestock.

FEMA has so far granted $4.2 million to 1,164 fire survivors, marking an average payout of $3,600. New Mexico Governor Michelle Lujan Grisham on Thursday said FEMA granted her request to extend Biden's declaration to residents who have suffered damage from flooding and debris flows in wildfire burn scars.

For now, Encinias' family is getting by on a $37,000 maximum payout from FEMA for the loss of their 5-bedroom home. They also lost eight acres of forest, farm machinery and cars.

"I'm hoping that finally something works out where it helps the people," said Encinias.

https://www.saltwire.com/atlantic-canada/news/after-starting-new-mexico-fire-us-asks-victims-to-pay-100758772/