Growing up in Lahore — Pakistan’s cultural capital — fall used to be the perfect time for Mariam to enjoy outdoor activities after months of scorching summer heat. Now, she cannot imagine the same for her young daughters as Lahore’s air, ranked the most polluted globally, becomes unusually toxic in cooler months.

“You can just smell, sometimes you can taste it, and feel it as well,” said the mother of two describing what it is like to breathe the polluted air.

With an AQI reading of 345 early in the day, Lahore ranked second worst city in the world for air pollution on Tuesday, according to the Air Quality Index or AQI run by IQAir, a Swiss air purifier manufacturer.

An AQI above 151 is unhealthy, while above 301 the air is hazardous for breathing.

IQAir’s index ranked Lahore the most polluted city of 2022.

Smog emergency

The city, along with several other in Pakistan’s biggest province Punjab,is under a month-long smog emergency since early November.

Smog – a combination of smoke and fog – is a specific phenomenon that occurs when certain pollution particles mix with cold, moist air and hang close to the ground, reducing visibility.

In a bid to reduce traffic congestion and exposure to toxic air, the top court in Punjab on Monday ordered the closure of government-run educational institutions on Saturdays until the end of January 2024. The court also asked the provincial government to come up with a work-from-home plan for the private sector.

A year-long emergency

For a few weeks in fall, smoke in Punjab’s air increases as Pakistani and Indian farmers on both sides of the divided state burn agricultural residue to prepare fields for planting the next crop. Environmentalists, however, say the government is in denial about the extent of Pakistan’s pollution problem, which is primarily driven by low quality, high-Sulphur fuel.

“Air pollution has always been an issue in Pakistani cities, going back the better part of 15 odd years,” Ahmad Rafay Alam, a Lahore-based environmental lawyer told VOA. “We have a year-long regional air pollution emergency and we tend to think of it as a Lahore smog issue.”

According to the Air Quality Life Index developed by the Energy Policy Institute at the University of Chicago, 98.3 of Pakistanis breathe air that is below the country’s own national air quality standard.

In 2017 the provincial Environmental Protection Department came up with an 11-point policy, on court orders, focusing on controlling emissions from vehicles and factories.

The court was, however, dissatisfied and constituted a smog commission for detailed analysis and recommendations on improving air quality.

Speaking to VOA, Naseem-ur-Rehman Shah, secretary of the provincial Environment Commission claimed that 80% of factories were now monitoring their emissions while 70-percent of brick kilns had moved to an environmentally friendly design

Still, data paints a terrifying picture.

“Every figure is telling you that the air pollution in Lahore is about, on the lower end, like 30, 40 times higher than the WHO safe limits,” said Abid Omar, founder of Air Quality Pakistan Initiative, a network of volunteers who monitor air quality using IQAir monitors.

Omar is based in Karachi which routinely competes with Lahore and Delhi for the worst air quality in the world.

Monitoring

For the city of nearly 15 million people, Punjab’s environmental agency gathers data from only five air quality monitors in Lahore.

Omar’s Pakistan Air Quality Initiative has 50 monitors feeding into IQAir’s Air Quality Index.

Shah’s department does not use PAQI’s data over standardization concerns but it is planning to add several monitors of its own.

In 2019, the provincial environmental regulator was forced to revise its air quality standards after it emerged officials were underreporting pollution by using low standards.

Alam represented the complainants in taking the regulator to court.

Knee jerk reaction

With air quality declining dramatically this month, the provincial and city administration have ramped up crackdown on smoke-emitting factories, brick kilns, and vehicles.

Citing city administration, local media reported that more than 16,000 vehicles were ticketed and over $100,000 dollars in fines imposed since the beginning of the emergency.

Omar calls such administrative measures a knee jerk reaction lacking long-term impact.

“Because it’s very random and ad hoc implementation, it’s not going to be an effective policy,” Omar said.

Shah called such criticism unfair. “We are working to eliminate sources of pollution,” he said.

Policy shift

“What we need to do is improve the quality of our refineries, which don’t produce high quality fuels … you have to transition to renewable energies, which is expensive and time consuming,” said Alam, pointing to studies that show fuel and energy sector are among the primary polluters in the country.

In May this year, Pakistan’s Ministry of Climate Change introduced the National Clean Air Policy. It aims to reduce harmful emissions in the next 10 years by introducing interventions in transport, industry, agriculture, waste and household sectors.

Such an overhaul will take time, money, and political will.

For Mariam, who runs three air purifiers in her home, the only option at the moment is to keep her daughters indoors as much as possible.

“It actually feels like … you’re being deprived of something very basic … not being able to breathe in fresh air.”

According to the Air Quality Life Index at the University of Chicago, Pakistanis are losing 3.9 years of life expectancy because of breathing toxic air. In Lahore and the rest of Punjab, residents are on track to lose between 3.7 to 4.6 years of life expectancy.
…

Innovations in food production could alleviate hunger for millions of people, according to Britain, which hosted a global summit on food insecurity Monday, but critics say the focus on technology ignores the growing inequality of wealth.

The summit was a joint initiative between Britain, Somalia, the United Arab Emirates, the Children’s Investment Fund Foundation and the Bill and Melinda Gates Foundation, aimed at boosting food security through science and innovation.

Innovation hub

British Prime Minister Rishi Sunak said a renewed focus was needed to alleviate hunger.

“It can’t be right that today in 2023, almost 1 billion people across the world regularly do not have enough to eat, that millions face hunger and starvation, and over 45 million children under five are suffering acute malnutrition. In a world of abundance, no one should die from lack of food and no parent should ever have to watch their child starve,” Sunak told delegates in London.

He outlined Britain’s plans to host a “virtual hub” for innovation in food production, known as CGIAR (Consultative Group on International Agricultural Research), aimed at making global food systems more resilient to future shocks in a changing climate.

“We’ve already helped develop crops that are drought-resistant and even richer in vitamins, now feeding 100 million people across Africa. And we’re going further, launching a new U.K. CGIAR science center to drive cutting-edge research on flood-tolerant rice, disease-resistant wheat and much more. These innovations will reach millions across the poorest countries, as well as improving U.K. crop yields and driving down food prices,” Sunak said.

Somalia emergency

Somali President Hassan Sheikh Mohamud also addressed the summit, telling delegates that the country’s stabilization program, developed in partnership with Britain, was working on tackling his country’s humanitarian crisis.

Somalia is among the countries worst-hit by climate change and food insecurity. The government recently declared a state of emergency after 113,000 people were forced to flee their homes following extreme rainfall and extensive flooding, which also caused widespread damage to crops and farmland. The floods come a year after Somalia suffered its worst drought in 40 years.

Technological solutions

Can new technology end global food insecurity, like that endured by Somalia and many other poorer nations? It’s one tool in the box, said analyst Steve Wiggins, a food security specialist at the ODI development think tank.

“The fundamentals of global hunger are the fundamentals of poverty, marginalization, and people being in situations of extraordinary vulnerability. Those are the fundamentals of hunger and that’s what we have to drive towards,” he told VOA.

“Of course, there are technical advances that we get that we’re very happy for, which make things a little bit easier,” Wiggins added, highlighting innovations like solar-powered irrigation in Mali. “So, if you want to pump water onto your fields, it’s becoming increasingly easy without having to spend money on diesel to do so.”

Inequalities

Critics say the focus on technology ignores the main driver of food insecurity.

“This summit is welcome. I think some of the solutions are welcome. But I think it’s not going to be enough to tackle that huge problem of hunger, which has been with us for decades and which we seem to be going backwards in many steps,” said Nick Nisbett of the Institute of Development Studies.

“Technological solutions tend to focus on the supply side, so new tech for agriculture and supply chains and so on. But what we actually need to do is to tackle the inequalities that lie behind that hunger.”

“Possibly the simplest thing to do is actually to give people food or to give people the money to [go] out and buy and purchase food in [the] markets themselves,” Nisbett told VOA.
…

A federal judge in Nevada has dealt another legal setback to Native American tribes trying to halt construction of one of the biggest lithium mines in the world.

U.S. District Judge Miranda Du granted the government’s motion to dismiss their claims the mine is being built illegally near the sacred site of an 1865 massacre along the Nevada-Oregon line.

But she said in last week’s order the three tribes suing the Bureau of Land Management deserve another chance to amend their complaint to try to prove the agency failed to adequately consult with them as required by the National Historic Preservation Act.

“Given that the court has now twice agreed with federal defendants (and) plaintiffs did not vary their argument … the court is skeptical that plaintiffs could successfully amend it. But skeptical does not mean futile,” Du wrote Nov. 9.

She also noted part of their case is still pending on appeal at the 9th U.S Circuit Court of Appeals, which indicated last month it likely will hear oral arguments in February as construction continues at Lithium Nevada’s mine at Thacker Pass about 370 kilometers northeast of Reno.

Du said in an earlier ruling the tribes had failed to prove the project site is where more than two dozen of their ancestors were killed by the U.S. Cavalry Sept. 12, 1865.

Her new ruling is the latest in a series that have turned back legal challenges to the mine on a variety of fronts, including environmentalists’ claims it would violate the 1872 Mining Law and destroy key habitat for sage grouse, cutthroat trout and pronghorn antelope.

All have argued the bureau violated numerous laws in a rush to approve the mine to help meet sky-rocketing demand for lithium used in the manufacture of batteries for electric vehicles.

Lithium Nevada officials said the $2.3 billion project remains on schedule to begin production in late 2026. They say it’s essential to carrying out President Joe Biden’s clean energy agenda aimed at combating climate change by reducing dependence on fossil fuels.

“We’ve dedicated more than a decade to community engagement and hard work in order to get this project right, and the courts have again validated the efforts by Lithium Americas and the administrative agencies,” company spokesperson Tim Crowley said in an email to The Associated Press.

Du agreed with the government’s argument that the consultation is ongoing and therefore not ripe for legal challenge.

The tribes argued it had to be completed before construction began.

“If agencies are left to define when consultation is ongoing and when consultation is finished … then agencies will hold consultation open forever — even as construction destroys the very objects of consultation — so that agencies can never be sued,” the tribal lawyers wrote in recent briefs filed with the 9th Circuit.

Will Falk, representing the Reno-Sparks Indian Colony and Summit Lake Paiute Tribe, said they’re still considering whether to amend the complaint by the Dec. 9 deadline Du set, or focus on the appeal.

“Despite this project being billed as `green,’ it perpetrates the same harm to Native peoples that mines always have,” Falk told AP. “While climate change is a very real, existential threat, if government agencies are allowed to rush through permitting processes to fast-track destructing mining projects like the one at Thacker Pass, more of the natural world and more Native American culture will be destroyed.”

The Paiutes call Thacker Pass “Pee hee mu’huh,” which means “rotten moon.” They describe in oral histories how Paiute hunters returned home in 1865 to find the “elders, women, and children” slain and “unburied and rotting.”

The Oregon-based Burns Paiute Tribe joined the Nevada tribes in the appeal. They say BLM’s consultation efforts with the tribes “were rife with withheld information, misrepresentations, and downright lies.”
…

Oregon’s first-in-the-nation law that decriminalized the possession of small amounts of heroin, cocaine and other illicit drugs in favor of an emphasis on addiction treatment is facing strong headwinds in the progressive state after an explosion of public drug use fueled by the proliferation of fentanyl and a surge in deaths from opioids, including those of children.

“The inability for people to live their day-to-day life without encountering open-air drug use is so pressing on urban folks’ minds,” said John Horvick, vice president of polling firm DHM Research. “That has very much changed people’s perspective about what they think Measure 110 is.”

When the law was approved by 58% of Oregon voters three years ago, supporters championed Measure 110 as a revolutionary approach that would transform addiction by minimizing penalties for drug use and investing instead in recovery.

But even top Democratic lawmakers who backed the law, which will likely dominate the upcoming legislative session, say they’re now open to revisiting it after the biggest increase in synthetic opioid deaths among states that have reported their numbers.

The cycle of addiction and homelessness spurred by fentanyl is most visible in Portland, where it’s not unusual to see people using it in broad daylight on busy city streets.

“Everything’s on the table,” said Democratic state Sen. Kate Lieber, co-chair of a new joint legislative committee created to tackle addiction. “We have got to do something to make sure that we have safer streets and that we’re saving lives.”

Measure 110 directed the state’s cannabis tax revenue toward drug addiction treatment services while decriminalizing the possession of so-called “personal use” amounts of illicit drugs. Possession of under a gram of heroin, for example, is only subject to a ticket and a maximum fine of $100.

Those caught with small amounts of drugs can have the citation dismissed by calling a 24-hour hotline to complete an addiction screening within 45 days, but those who don’t do a screening are not penalized for failing to pay the fine. In the first year after the law took effect in February 2021, only 1% of people who received citations for possession sought help via the hotline, state auditors found.

Critics of the law say this doesn’t create an incentive to seek treatment.

Republican lawmakers have urged Democratic Gov. Tina Kotek to call a special session to address the issue before the Legislature reconvenes in February. They have proposed harsher sanctions for possession and other drug-related offenses, such as mandatory treatment and easing restrictions on placing people under the influence on holds in facilities such as hospitals if they pose a danger to themselves or others.

“Treatment should be a requirement, not a suggestion,” a group of Republican state representatives said in a letter to Kotek.

Law enforcement officials who have testified before the new legislative committee on addiction have proposed reestablishing drug possession as a class A misdemeanor, which is punishable by up to a year in jail or a $6,250 fine.

“We don’t believe a return to incarceration is the answer, but restoring a (class A) misdemeanor for possession with diversion opportunities is critically important,” Jason Edmiston, chief of police in the small, rural city of Hermiston in northeast Oregon, told the committee.

However, data shows decades of criminalizing possession hasn’t deterred people from using drugs. In 2022, nearly 25 million Americans, roughly 8% of the population, reported using illicit drugs other than marijuana in the previous year, according to the annual National Survey on Drug Use and Health.

Some lawmakers have suggested focusing on criminalizing public drug use rather than possession. Alex Kreit, assistant professor of law at Northern Kentucky University and director of its Center on Addiction Law and Policy, said such an approach could help curb visible drug use on city streets but wouldn’t address what’s largely seen as the root cause: homelessness.

“There are states that don’t have decriminalization that have these same difficult problems with public health and public order and just quality-of-life issues related to large-scale homeless populations in downtown areas,” he said, mentioning California as an example.

Backers of Oregon’s approach say decriminalization isn’t necessarily to blame, as many other states with stricter drug laws have also reported increases in fentanyl deaths.

But estimates from the U.S. Centers for Disease Control and Prevention show, among the states reporting data, Oregon had the highest increase in synthetic opioid overdose fatalities when comparing 2019 and the 12-month period ending June 30, a 13-fold surge from 84 deaths to more than 1,100.

Among the next highest was neighboring Washington state, which saw its estimated synthetic opioid overdose deaths increase seven-fold when comparing those same time periods, CDC data shows.

Nationally, overdose deaths involving synthetic opioids such as fentanyl roughly doubled over that time span. Roughly two-thirds of all deadly overdoses in the U.S. in the 12 months ending June 30 involved synthetic opioids, federal data shows.

Supporters of Oregon’s law say it was confronted by a perfect storm of broader forces, including the COVID-19 pandemic, a mental health workforce shortage and the fentanyl crisis, which didn’t reach fever pitch until after the law took effect in early 2021.

A group of Oregon lawmakers recently traveled to Portugal, which decriminalized the personal possession of drugs in 2001, to learn more about its policy. State Rep. Lily Morgan, the only Republican legislator on the trip, said Portugal’s approach was interesting but couldn’t necessarily be applied to Oregon.

“The biggest glaring difference is they’re still not dealing with fentanyl and meth,” she said, noting the country also has universal health care.

Despite public perception, the law has made some progress by directing $265 million dollars of cannabis tax revenue toward standing up the state’s new addiction treatment infrastructure.

The law also created what are known as Behavioral Health Resource Networks in every county, which provide care regardless of the ability to pay. The networks have ensured about 7,000 people entered treatment from January to March of this year, doubling from nearly 3,500 people from July through September 2022, state data shows.

The law’s funding also has been key for providers of mental health and addiction services because it has “created a sustainable, predictable funding home for services that never had that before,” said Heather Jefferis, executive director of Oregon Council for Behavioral Health, which represents such providers.

Horvick, the pollster, said public support for expanding treatment remains high despite pushback against the law.

“It would be a mistake to overturn 110 right now because I think that would make us go backwards,” Lieber, the Democratic state senator, said. “Just repealing it will not solve our problem. Even if we didn’t have 110, we would still be having significant issues.” 
…

SpaceX’s uncrewed spacecraft Starship, developed to carry astronauts to the moon and beyond, failed in space shortly after lifting off Saturday, cutting short its second test but making it further than an earlier attempt that ended in an explosion. 

The two-stage rocket ship blasted off from the Elon Musk-owned company’s Starbase launch site near Boca Chica in Texas, helping boost the Starship spacecraft as high as 90 miles (148 kilometers) above ground on a planned 90-minute test mission to space and back. 

But the rocket’s Super Heavy first stage booster, though it achieved a crucial maneuver to separate with its core Starship stage, exploded over the Gulf of Mexico shortly after detaching, a SpaceX webcast showed. 

Meanwhile, the core Starship stage boosted farther toward space, but a few minutes later a company broadcaster said that SpaceX mission control suddenly lost contact with the vehicle. 

“We have lost the data from the second stage… we think we may have lost the second stage,” SpaceX engineer and livestream host John Insprucker said. He added that engineers believe an automated flight termination command was triggered to destroy the rocket, though the reason was unclear. 

About eight minutes into the test mission, a camera view tracking the Starship booster appeared to show an explosion that suggested the vehicle failed at that time. The rocket’s altitude was 91 miles (148 kilometers). 

FAA will oversee investigation

The launch was the second attempt to fly Starship mounted atop its towering Super Heavy rocket booster, following an April attempt that ended in explosive failure about four minutes after lift-off. 

The U.S. Federal Aviation Administration, which oversees commercial launch sites, confirmed a mishap occurred that “resulted in a loss of the vehicle,” adding no injuries or property damage have been reported. 

The agency said it will oversee a SpaceX-led investigation into the testing failure and will need to approve SpaceX’s plan to prevent it from happening again. 

The mission’s objective was to get Starship off the ground in Texas and into space just shy of reaching orbit, then plunge through Earth’s atmosphere for a splashdown off Hawaii’s coast. The launch had been scheduled for Friday but was pushed back by a day for a last-minute swap of flight-control hardware. 

Testing failures 

Starship’s failure to meet all its test objectives could pose a setback for SpaceX. The FAA will need to review the company’s failure investigation and review its application for a new launch license. SpaceX officials have complained that such regulatory reviews take too long. 

On the other hand, the failure in a program for which SpaceX plans to spend roughly $2 billion this year was in line with the company’s risk-tolerant culture that embraces fast-paced testing and re-testing of prototypes to hasten design and engineering improvements. 

“More things were successful than in the previous test, including some new capabilities that were significant,” said Carissa Christensen, CEO of space analytics firm BryceTech. 

“There’s not money and patience for unlimited tests, but for a vehicle that is so different and so big, two, three, four, five tests — is not excessive,” Christensen said. 

At roughly 43 miles (70 kilometers) in altitude, the rocket system executed the crucial maneuver to separate the two stages — something it failed to do in the last test — with the Super Heavy booster intended to plunge into Gulf of Mexico waters while the core Starship booster blasts farther to space using its own engines. 

But the Super Heavy booster blew up moments later, followed by the Starship stage’s own explosion. SpaceX in a post on social media platform X said, “success comes from what we learn,” adding that the core Starship stage’s engines “fired for several minutes on its way to space.” 

A fully successful test would have marked a key step toward achieving SpaceX’s ambition producing a large, multi-purpose, spacecraft capable of sending people and cargo back to the moon later this decade for NASA, and to Mars. 

SpaceX’s worker safety culture underpinning its speedy development ethos is facing scrutiny by lawmakers after a Reuters investigation documented hundreds of injuries at the rocket company’s U.S. manufacturing and launch sites. 

Clock is ticking 

NASA, SpaceX’s primary customer, has a considerable stake in the success of Starship, which the U.S. space agency is counting on to play a central role of landing humans on the moon within the next few years under its human spaceflight program, Artemis, successor to the Apollo missions. 

NASA chief Bill Nelson, who has made competition with China a core need for speed in Artemis, said Saturday’s Starship test was an “opportunity to learn — then fly again.” 

Musk — SpaceX’s founder, chief executive and chief engineer — sees Starship as eventually replacing the company’s workhorse Falcon 9 rocket as the centerpiece of its launch business that already lifts most of the world’s satellites and other commercial payloads into space. 

“The clock is ticking,” said Chad Anderson, a SpaceX investor and managing partner of venture capital firm Space Capital. “NASA has a timeline where they’re trying to get to the moon, and this is their primary vehicle to do it. So, SpaceX needs to deliver on a timeline.” 

Jaret Matthews, CEO of lunar rover startup Astrolab that has booked space on a future Starship flight, toured SpaceX’s Starbase site this year and said he expects the company to resume tests after the Saturday flight, though such a pace is expected to be driven largely by the FAA’s review and the extent of Starship’s technical failures. 

“They have the next number of vehicles already lined up in the factory ready to go,” he said. “I think people will be shocked by the cadence that emerges next year.” 
…

U.S. President Joe Biden and Chinese President Xi Jinping agreed earlier this week that Beijing will crack down on companies in China that produce precursor chemicals for fentanyl, an agreement that Biden said would “save lives.”

In exchange, the Biden administration agreed to lift sanctions on China’s Physical Evidence Identification Center of the Ministry of Public Security and the National Drug Laboratory. In May 2020, the U.S. Department of Commerce sanctioned the lab for allegedly participating in human rights violations against Uyghurs and other ethnic minorities in Xinjiang.

China, which is the source of most fentanyl precursors used in the U.S., argued that U.S. export controls have “severely affected” China’s inspection and testing of fentanyl-related substances and impaired its “goodwill to help the U.S. in drug control,” according to the spokesperson of the Chinese Embassy in the United States.

Although a cooperative effort to curb the supply of fentanyl brought some results over the years, enthusiasm dampened as tensions grew between China and the U.S. On Aug. 5, 2022 — after then-House Speaker Nancy Pelosi visited Taiwan, a self-governing island Beijing considers its own — China officially announced the suspension of anti-drug cooperation with the U.S.

Here is some background to the Biden-Xi deal.

What is fentanyl?

According to the U.S. Centers for Disease Control and Prevention (CDC), fentanyl is 50 times more potent than heroin and 100 times more potent than morphine. It is a prescription drug in the United States used for treating severe pain.

Illegally manufactured fentanyl “is often added to other drugs because of its extreme potency, which makes drugs cheaper, more powerful, more addictive, and more dangerous,” according to the CDC.

Fentanyl sold on the black market is often mixed with heroin and/or cocaine to increase a user’s sense of euphoria, according to the CDC.

Why does the United States care about the fentanyl issue?

Fentanyl is now the leading cause of death among Americans ages 18 to 49, according to U.S. Department of Justice data.

What does the fentanyl problem in the United States have to do with China?

According to a report by the Congressional Research Service: “Prior to 2019, China was the primary source of U.S.-bound illicit fentanyl, fentanyl-related substances, and production equipment.” It said Chinese traffickers supplied fentanyl and fentanyl-related substances to the U.S. via international mail and express consignment operations.

Xi promised then-U.S. President Donald Trump to tighten regulation of fentanyl and related substances when the two met in 2018 on the sidelines of the G20 Summit in Buenos Aires, Argentina. This was seen as a move taken by China to ease trade disputes.

China then passed new laws that took effect on May 1, 2019, to put all fentanyl-related substances under national control.

In July 2022 testimony, a senior adviser to the Office of National Drug Control Policy stated that as a result, “the direct shipment of fentanyl and fentanyl-related substances from China to the United States went down to almost zero.”

What role does China play?

After China regulated fentanyl-related substances, Mexican transnational criminal organizations became the main operators in the production and distribution of illegal fentanyl in the U.S., according to data from the U.S. Drug Enforcement Administration (DEA).

“The cartels are buying precursor chemicals in the People’s Republic of China (PRC); transporting the precursor chemicals from the PRC to Mexico; using the precursor chemicals to mass produce fentanyl; pressing the fentanyl into fake prescription pills; and using cars, trucks, and other routes to transport the drugs from Mexico into the United States for distribution,” said Anne Milgram, administrator of DEA, at a Senate hearing in February.

Why does the US accuse China of lax cooperation?

Certain precursors used in the production of fentanyl are internationally classified as unscheduled chemicals and legal to produce in China and export. Beijing argues that it cannot restrict the export of precursors that are not illegal.

The U.S. has repeatedly called on China to adopt a “know-your-customer” approach such as identifying and verifying customer identities to ensure that these chemicals are not sold to likely drug traffickers and to alert authorities about such buyers.

However, in an interview with Newsweek in September 2022, Qin Gang, the then-Chinese ambassador to the U.S., said that approach “goes far beyond the obligations of countries under the United Nations Convention on Drug Control.”
…

Britain’s medicines regulator has authorized the world’s first gene therapy treatment for sickle cell disease, in a move that could offer relief to thousands of people with the crippling disease in the U.K.

In a statement Thursday, the Medicines and Healthcare Regulatory Agency said it approved Casgevy, the first medicine licensed using the gene editing tool CRISPR, which won its makers a Nobel prize in 2020.

The agency approved the treatment for patients with sickle cell disease and thalassemia who are 12 years old and older. Casgevy is made by Vertex Pharmaceuticals (Europe) Ltd. and CRISPR Therapeutics. To date, bone marrow transplants, extremely arduous procedures that come with very unpleasant side effects, have been the only long-lasting treatment.

“The future of life-changing cures resides in CRISPR based (gene-editing) technology,” said Dr. Helen O’Neill of University College London.

“The use of the word ‘cure’ in relation to sickle cell disease or thalassemia has, up until now, been incompatible,” she said in a statement, calling the MHRA’s approval of gene therapy “a positive moment in history.”

Both sickle cell disease and thalassemia are caused by mistakes in the genes that carry hemoglobin, the protein in red blood cells that carry oxygen. 

In people with sickle cell — which is particularly common in people with African or Caribbean backgrounds — a genetic mutation causes the cells to become crescent-shaped, which can block blood flow and cause excruciating pain, organ damage, stroke and other problems.

In people with thalassemia, the genetic mutation can cause severe anemia. Patients typically require blood transfusions every few weeks, and injections and medicines for their entire life. Thalassemia predominantly affects people of South Asian, Southeast Asian and Middle Eastern heritage.

The new medicine, Casgevy, works by targeting the problematic gene in a patient’s bone marrow stem cells so that the body can make properly functioning hemoglobin.

Patients first receive a course of chemotherapy, before doctors take stem cells from the patient’s bone marrow and use genetic editing techniques in a laboratory to fix the gene. The cells are then infused back into the patient for a permanent treatment. Patients must be hospitalized at least twice — once for the collection of the stem cells and then to receive the altered cells.

“This is so exciting. It’s a new wave of treatments that we can utilize for patients with sickle cell disease,” said Dr. James LaBelle, director of the pediatric stem cell and cellular therapy program at the University of Chicago. He said Britain’s approval suggested the U.S. authorization was likely “imminent.”

Casgevy is currently being reviewed by the U.S. Food and Drug Administration; the agency is expected to make a decision early next month, before considering another sickle cell gene therapy.

LaBelle said officials at the University of Chicago are “already moving forward to build not only the clinical infrastructure but also the reimbursement infrastructure to get these patients this treatment.”

Britain’s regulator said its decision to authorize the gene therapy for sickle cell disease was based on a study done on 29 patients, of whom 28 reported having no severe pain problems for at least one year after being treated. In the study for thalassemia, 39 out of 42 patients who got the therapy did not need a red blood cell transfusion for at least a year afterwards.

Gene therapy treatments can cost millions of dollars and experts have previously raised concerns that they could remain out of reach for the people who would benefit most.

Last year, Britain approved a gene therapy for a fatal genetic disorder that had a list price of £2.8 million ($3.5 million). England’s National Health Service negotiated a significant confidential discount to make it available to eligible patients.

Vertex Pharmaceuticals said it had not yet established a price for the treatment in Britain and was working with health authorities “to secure reimbursement and access for eligible patients as quickly as possible.”

In the U.S., Vertex has not released a potential price for the therapy, but a report by the nonprofit Institute for Clinical and Economic Review said prices up to around $2 million would be cost-effective. By comparison, research earlier this year showed medical expenses for current sickle cell treatments, from birth to age 65, add up to about $1.6 million for women and $1.7 million for men.

Medicines and treatments in Britain must be recommended by a government watchdog before they are made freely available to patients in the national health care system.

Millions of people around the world, including about 100,000 in the U.S., have sickle cell disease. It occurs more often among people from places where malaria is or was common, like Africa and India, and is also more common in certain ethnic groups, such as people of African, Middle Eastern and Indian descent. Scientists believe being a carrier of the sickle cell trait helps protect against severe malaria.
…

The U.S. flu season is under way, with at least seven states reporting high levels of illnesses and cases rising in other parts of the country, health officials say.

The Centers for Disease Control and Prevention posted new flu data Friday, showing very high activity last week in Louisiana, and high activity in Alabama, Florida, Georgia, Mississippi, New Mexico and South Carolina. It was also high in the District of Columbia and Puerto Rico, the U.S. territory where health officials declared an influenza epidemic earlier this month.

“We’re off to the races,” said Dr. William Schaffner, a Vanderbilt University infectious diseases expert.

Traditionally, the winter flu season ramps up in December or January. But it took off in October last year, and is making a November entrance this year.

Flu activity was moderate but rising in New York City, Arkansas, California, Maryland, New Jersey, North Carolina, Tennessee and Texas. And while flu activity has been high in Alaska for weeks, the state did not report data last week, so it wasn’t part of the latest count.

Tracking during flu season relies in part on reports of people with flu-like symptoms who go to doctor’s offices or hospitals; many people with the flu are not tested, so their infections aren’t lab-confirmed. COVID-19 and other respiratory viruses can sometimes muddy the picture.

Alicia Budd, who leads the CDC’s flu surveillance team, said several indicators are showing “continued increases” in flu.

There are different kinds of flu viruses, and the version that’s been spreading the most so far this year usually leads to a lesser amount of hospitalizations and deaths in the elderly — the group on whom flu tends to take the largest toll.

So far this fall, the CDC estimates at least 780,000 flu illnesses, at least 8,000 hospitalizations and at least 490 flu-related deaths — including at least one child.

Budd said that it’s not yet clear exactly how effective the current flu vaccines are, but the shots are well-matched to the flu strains that are showing up. In the U.S., about 35% of U.S. adults and 33% of children have been vaccinated against flu, current CDC data indicates. That’s down compared to last year in both categories.

Flu vaccination rates are better than rates for the other two main respiratory viruses — COVID-19 and RSV. About 14% of adults and 5% of children have gotten the currently recommended COVID-19 shot, and about 13.5% of adults 60 and older have gotten one of the RSV shots that became available earlier this year.
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