The European Medicines Agency (EMA) on Friday recommended scrapping approval for a drug used to prolong gestation, citing a "possible but unconfirmed" risk of cancer.
The EU health regulator's Pharmacovigilance Risk Assessment Committee (PRAC), which monitors drug-related side effects, considered new studies in its review that showed the treatment, 17-hydroxyprogesterone caproate (17-OHPC), was not effective in preventing premature birth.
It also reviewed results from a study which looked at the risk of cancer in people who had been exposed to 17-OHPC in the womb. PRAC considered data on the effectiveness of the medicines in their authorised uses and decided to recommend withdrawing approval for the drug.
In some EU countries, 17-OHPC medicines are authorised as injections to prevent pregnancy loss or premature birth in pregnant women, according to the regulator. They are also authorised for treating various gynaecological and fertility disorders, including those caused by the lack of a hormone called progesterone.
Last year, the U.S. Food and Drug Administration (FDA) withdrew its approval for Covis Pharma's preterm birth prevention drug, Makena, saying that the drug was not effective in treating the complication.
Cases of bird flu have been confirmed among wild fowl in western China, the agriculture ministry said on Saturday, as concerns grow over a U.S. outbreak infecting cattle herds.
Two counties in Qinghai province confirmed 275 cases of H5 influenza among dead Pallas's gull and other wild birds, China's Ministry of Agriculture and Rural Affairs said in a notice on its website.
The ministry received a report on the cases from the China Animal Disease Control Center, and the national Avian Influenza Reference Laboratory confirmed the finding, the notice said.
The H5N1 outbreak among dairy cattle in at least nine U.S. states since late March has raised questions over whether it could spread to humans. No such cases have been reported.
The U.S. announced on May 11 that it would spend close to $200 million to fight the outbreak.
News of the China cases came as the nation's anti-graft watchdog announced a corruption probe of the agriculture minister on Saturday.
Hundreds of protesters in Peru's capital marched on Friday to demand the scrapping of a new law that describes transgender people, among others, as having a mental illness so they can access health benefits.
Around 500 demonstrators peacefully walked the streets of downtown Lima, hoisting banners with slogans that read "No more stigmas" and "My identity is not a disease."
The law, which was approved administratively last week by the government of President Dina Boluarte, specifies that those who identify as transgender, along with "cross dressers" and "others with gender identity disorders," are considered to be diagnosed with "illnesses" that are eligible for mental health services via both public and private providers.
The protesters reached the health ministry offices, but no clashes were reported.
"Gender identities are no longer considered pathologies," said activist Gahela Cari Contreras, who accused Boluarte's government of trying to trample on the LGBTQ+ community's rights. "We're not going to let them."
Critics of the law have argued that its update of the country's PEAS health regulations was unnecessary, since existing rules already allowed for universal access to mental health services.
Government officials have sought to chalk up the controversy as a misunderstanding.
In a statement released shortly after the law was promulgated, the health ministry insisted that it rejects the stigmatization of LGBTQ+ people and that the legal language simply seeks to ensure more complete health coverage.
The ministry "categorically reaffirms respect for the dignity of the person and their free actions within the framework of human rights, providing health services for their benefit," according to the statement.
Despite the ministry's argument, the protesters were not persuaded and some medical experts advocated for the law to be corrected via an amendment.
"We don't see any need to incorporate diagnoses or pathologies that no longer exist into health insurance plans," said Pedro Riega Lopez, dean of Peru's CMP medical college and himself a doctor.
General Motors and South Korea's LG Energy Solution, LG Electronics reached a settlement to establish a $150 million fund to provide relief to Chevrolet Bolt EV owners affected by defective batteries, documents filed in a U.S. court on Thursday showed.
General Motors first launched Chevrolet Bolt EVs in 2015, and used batteries made by LG entities as part of a business arrangement with the car manufacturer. GM started recalls in 2020 after it faced numerous complaints about fires in some vehicles.
"GM, LG Energy Solution and LG Electronics have agreed to a settlement with plaintiffs to resolve class action litigation related to the Bolt EV battery recall," GM said in an emailed statement to Reuters.
"As a result, Bolt owners who received a battery replacement or who have installed the latest advanced diagnostic software may qualify for compensation," the company said.
Owners of the recalled Bolt EVs who installed the final software remedy at a GM-authorized dealership before Dec. 31, 2023 may receive up to $1,400, according to documents filed with Michigan eastern district court.
Owners who sold or terminated the lease of their vehicle before the software remedy became available and those who already received a battery replacement will receive a minimum $700 payment, according to the filing.
Last year, GM ended production of the Bolt EV to make room for new electric vehicles.
In 2021, the company had announced a billion dollar recall campaign to cover thousands of Bolts over battery fire risks. The recall prompted GM to halt Bolt production and sales for more than six months at that time.
Shanghai has compiled a list of data that can be transferred overseas without security assessments, according to a government document seen by Reuters, a much anticipated move as China tries to lure foreign investment to boost a sluggish economy.
Foreign firms including financials and automakers such as Elon Musk's Tesla have been lobbying the Chinese authorities to allow cross-border sharing of information after Beijing tightened control of data generated domestically in a national security drive.
The 2022 rules require all "important" offshore transfer of data related to operations within the country to clear security reviews by the Cyberspace Administration of China. This has caused indefinite delays in data transfers, confusion and concern among foreign firms.
The government of Shanghai, China's market and business capital, has compiled a first batch of "ordinary data" in three sectors - intelligent and connected vehicles, mutual funds and biomedicine. These require the least regulation for data transfers, the government document says.
Under a one-year pilot project, companies registered in the city's free-trade Lingang Area, where Tesla's Shanghai factory is located, may transfer data on the list overseas without needing further security assessments, according to the document，which was shared with companies attending an event announcing the white list in Shanghai.
The document details broader plans for Lingang to become a hub for cross-border data, as well as specific scenarios for each of the three sectors that would be classified as "ordinary data".
Details first reported by Reuters based on the document were later confirmed by Lingang authorities, which announced the scheme on its website late Friday afternoon.
According to the Lingang website, the newly announced data transfer rules take effect immediately.
For the auto sector, the data includes information involving manufacturing such as procurement and stockpile, research and development including auto design and tests, after-sales services and used car sales.
The Shanghai government's event on Friday about the new scheme with foreign companies included Tesla, Ford and BMW, said a person with direct knowledge of the matter.
The city government and the three companies did not immediately reply to Reuters requests for comments.
MORE CLARITY
Shanghai's pilot project follows company demands for more clarity around cross-border data transfers. Data transfer permission was a topic when Musk met last month with top Chinese government officials.
The United Auto Workers failed in its effort to organize a Mercedes-Benz plant in Alabama, but the loss on Friday was a good result for a first effort in a historically anti-union state, labor professors and analysts said.
Employees at the Vance, Alabama, plant voted 56% against joining the union. Until the UAW won overwhelmingly last month at a Volkswagen plant in Tennessee, the union had repeatedly failed to organize a foreign-owned automaker in the region for its nearly 90-year existence.
However, the defeat at Mercedes does not preclude the UAW from trying to organize other plants in the South, or eventually trying again at Mercedes, said Peter Bible, a former General Motors executive who was involved in labor talks with the UAW.
"They'll be back," he said, adding that the UAW actually attracted more votes than he expected given the plant's location in the South.
Worker uncertainty over the auto industry's transition to electric vehicles will only provide more opportunities for the union, Bible added.
The UAW earlier this year committed $40 million to organizing more than a dozen non-union automakers, including Toyota and Tesla. Widening its reach beyond the Detroit automakers is critical for the UAW to maintain its influence within the industry.
At Mercedes, a strong anti-union campaign from the German automaker and southern politicians swayed some to vote against the UAW, workers said. Six U.S. governors, including Alabama's Kay Ivey, signed a letter asking workers to reject the UAW. They said unionization would stunt the auto industry's growth across the South.
However, Harley Shaiken, a labor professor at the University of California, Berkeley, pointed out that the UAW lost twice at VW in Tennessee before finally winning handily. The result at Mercedes was similar to an earlier loss at VW in 2014, when 53% voted against the union.
UAW President Shawn Fain, speaking after the loss, did not outline the union's next steps, but signaled it's not the end of its efforts. The union and its representatives previously cited organizing progress at a Hyundai plant in Alabama, and Toyota plants in Missouri and Georgetown, Kentucky.
OVER-ESTIMATING SUPPORT
"We left nothing on the table," Fain said at a UAW union hall near Vance. "There's no regrets in this fight."
"This is a David and Goliath fight," he added. "Sometimes Goliath wins a battle. But David wins the war."
The UAW called for the election after it said a supermajority of workers signed cards supporting the union, but it clearly lost support in the run-up to the vote.
This is a lightly edited excerpt from Simon Hankinson’s testimony before the House Homeland Security Subcommittee on Oversight, Investigations, and Accountability at a hearing on “Security Risk: The Unprecedented Surge in Chinese Illegal Immigration,” on Thursday, May 16.
I served as a Foreign Service officer in seven countries. I have adjudicated thousands of visa applications to facilitate lawful visits, commerce, and immigration to the United States while excluding aliens who were legally inadmissible. The visa process I worked with overseas stands in total contrast to what happens at the U.S. border today.
Over the past two years, I have visited the border in Arizona, California, New York, and Texas. On those visits, I saw nationals of many countries apprehended by the Border Patrol. In San Diego last March, I watched Border Patrol dropping off dozens of aliens, including Chinese, at a bus stop to release them into the country.
Mass release of people who entered the country illegally happens nearly every day, multiple times, at multiple locations. At best, this is a mockery of U.S. immigration law and sovereignty. At worst, it is a huge national security and community safety risk. In addition to many Chinese aliens with connections to the Chinese Communist Party (CCP), People’s Liberation Army (PLA), and other state entities, it is statistically probable that the Department of Homeland Security (DHS) is releasing people with serious criminal records.
According to U.S. law, DHS is supposed to detain aliens who enter the country illegally. But the Biden administration has replaced border control with mass processing, parole, and release. DHS has also abused immigration parole at an unprecedented scale.
In January 2021, which included the first 11 days of the new Biden administration, the Border Patrol encountered 17 Chinese aliens between ports of entry. By January 2024, it was 3,700 in that one month alone. As of April 30 this year, DHS had already encountered 48,501 inadmissible Chinese aliens in fiscal year 2024 (which began Oct. 1, 2023); 27,583 of them between ports of entry.
Nearly all are being released into an asylum process that will take years to conclude. At the end of that process, those ordered removed are extremely unlikely to be deported, because the Chinese government does not cooperate in accepting their nationals back.
In fiscal year 2023, Immigration and Customs Enforcement (ICE) removed only 288 Chinese aliens, leaving up to 100,000 still in the United States, despite final orders of removal.
Most Chinese entering illegally are seeking employment. They use asylum claims to enter, remain, and work in the United States. Illegal immigration ebbs and flows corresponding to a risk-reward calculation. Today, Chinese are coming in great numbers simply because they can. Worldwide awareness of our open border, spread by social media, shows them how.
For example, Chinese citizens do not need a visa to fly to Ecuador, after which they can continue by land north to the United States. And starting on May 17, Air China will begin direct flights from Beijing to Havana. If Chinese aliens are willing to take the dangerous trek by land from Ecuador to the United States via the Darien Gap, why wouldn’t they also be willing to traverse the 90 miles by water to Florida?
Overseas, an in-person interview by a U.S. consular officer is the first line of “vetting” for foreign visa applicants wanting to come to the United States. This is buttressed by consular staff who know local languages, customs, and news. Larger embassies host other federal agencies that can assist with vetting investigations.
The second line of vetting is through automatic checks of U.S. government databases. Applicants are frequently refused entry based on adverse information that would not have been discovered had the person arrived illegally with no identity documents at the border.
Meanwhile, at the border today, most “national security decisions” of who gets into our country are no longer made by American officers. Under President Joe Biden’s policies, what was once a privilege for aliens has become a right.
Despite what the Biden administration wishes the public to believe, there is no real “vetting” of those released at the border, nor of those allowed in under parole programs, much less of the “gotaways” who enter covertly between ports of entry without inspection. The official visa “front door” competes with a wide-open back door at the border, where there are no routine criminal background checks using records from the person’s home country. Unless a foreign national has a record held by U.S. agencies, DHS is flying blind.
Concerning China specifically, Customs and Border Protection (CBP) agents have reportedly reduced the number of standard questions asked of inadmissible Chinese aliens at the border from 40 to five.
But, however many questions, the process relies on an alien telling the truth and agents taking them at their word. Even if CBP requests additional information on an individual, China routinely ignores U.S. requests for verification of nationality, and they reportedly hide records of criminal and corruption cases.
DHS releases most aliens caught at the border with a Notice to Appear in immigration court—at a date far into the future. Aliens are then free to go wherever they want, with no way for ICE to easily find them.
There are more than 6 million aliens on ICE’s Non-Detained Docket, of whom only about 184,000 are tracked using what’s called Alternatives to Detention, which uses passive methods to track them, such as having the alien check in with ICE by phone every day. Only 2 percent of aliens tracked using Alternatives to Detention have actual GPS monitors.
To close this dangerous loophole, the United States needs to re-implement agreements with Mexico and Northern Triangle countries of Central America so that inadmissible aliens are not released into the interior of the United States pending the decision in their asylum cases, but instead remain in those countries as they await their determinations (the vast majority of which will result in their asylum applications being rejected).
Given the population, economy, and politics of China, the United States can never meet the demand for those seeking to enter our country illegally. The United States will at some point have to remove those who are ineligible to enter or remain, or else abandon the rule of law that made this country so attractive for so many immigrants in the first place.
