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Thursday, September 21, 2023

U.S. revives Cold War submarine spy program to counter China

 On a windswept island 50 miles north of Seattle sits a U.S. Navy monitoring station. For years, it was kept busy tracking whale movements and measuring rising sea temperatures. Last October, the Navy gave the unit a new name that better reflects its current mission: Theater Undersea Surveillance Command.

The renaming of the spy station at the Whidbey Island facility is a nod to a much larger U.S. military project, according to three people with direct knowledge of the plans: conducting the biggest reconstruction of America’s anti-submarine spy program since the end of the Cold War.

The revival of the multibillion-dollar effort, known as the Integrated Undersea Surveillance System (IUSS), comes as China has ramped up military exercises around Taiwan, heightening concerns about a potential conflict over the democratically ruled territory, which Beijing wants brought under its control.

The IUSS revamp project has not previously been reported. It involves modernizing America’s existing network of underwater acoustic spy cables and retrofitting a fleet of surveillance ships with cutting-edge sensors and subsea microphones, moves aimed at boosting the military’s ability to spy on its foes. The United States has agreed to sell Australia similar technology to help bolster allied defenses in the Pacific region.

The most innovative change in the Navy’s ocean reconnaissance system is an investment in new technologies to miniaturize and globalize traditional maritime surveillance tools. The original network of fixed spy cables, which lie in secret locations on the ocean floor, was designed to spy on Soviet submarines seven decades ago, the three people said.

The Navy’s plan includes deploying a fleet of unmanned sea drones to listen for enemy craft; placing portable “underwater satellite” sensors on the seafloor to scan for submarines; using satellites to locate ships by tracking their radio frequencies; and utilizing artificial intelligence software to analyze maritime spy data in a fraction of the time human analysts would usually take.

The Chinese navy's nuclear-powered submarine Long March 11 takes part in a naval parade off the eastern port city of Qingdao on April 23, 2019.  The Pentagon says China is building advanced nuclear-powered subs that are quieter and harder to detect than previous models. REUTERS/Jason Lee

The existence of the IUSS was only made public in 1991 at the end of the Cold War, and the details of its operations remain top secret, the three people said. The three spoke about the classified program on condition of anonymity.

Reuters was able to piece together details of the unit’s plans through interviews with more than a dozen people involved in the effort, including two current Navy staffers working on maritime surveillance, advisors to the Navy and defense contractors involved in the projects.

The news agency also reviewed hundreds of Navy contracts. That examination identified at least 30 deals linked to the surveillance program signed over the last three years with defense giants as well as a string of startups working on unmanned sea drones and AI processing. A Reuters review of ship-tracking data and satellite imagery also revealed new details about the Navy’s secretive underwater cable laying.

The IUSS is led by Captain Stephany Moore, a veteran Navy intelligence officer. The program operates under the command of the Submarine Force U.S. Pacific Fleet, headed by Rear Admiral Richard Seif.

Richard Seif, now a rear admiral and commander of Submarine Force U.S. Pacific Fleet, speaks at a 2017 event in Hawaii. The force is leading a U.S. effort to modernize America’s network of underwater acoustic spy cables as tensions with China rise in the Pacific Theater. U.S. Navy/Handout via REUTERS

Moore and Seif declined interview requests. In response to questions from Reuters, a spokesperson for the Submarine Force U.S. Pacific Fleet said the Navy could not discuss specifics related to its undersea surveillance system for “operational security reasons.”

“The systems have and will experience growth and recapitalization as subsea technologies are developed and as defense priorities are updated,” the spokesperson said in a statement.

Tim Hawkins, a spokesperson for the U.S. 5th Fleet, which is based in the Middle East and has led U.S. sea drone trials, told Reuters the Navy is improving surveillance from “space to seabed” with the aim of painting the clearest-ever picture of global activity at sea.

China, meanwhile, is working on its own maritime spy program, known as the Great Underwater Wall, two U.S. Navy sources told Reuters.

That system, already under construction, consists of cables fitted with sonar listening sensors laid along the seafloor in the South China Sea, a tense arena due to territorial disputes between Beijing and its neighbors. China is also building a fleet of underwater and surface sea drones to scour for enemy submarines, the two people said.

The Chinese push extends far into the Pacific. The state-run China Academy of Sciences said in 2018 it was operating two underwater sensors: one in Challenger Deep in the Mariana Trench, the deepest known point on earth; the other near Yap, an island in the Federated States of Micronesia. Though China says these sensors are used for scientific purposes, they could detect submarine movements near the U.S. naval base on Guam, a Pacific island territory, the Navy sources said.

China’s Ministry of Defense did not respond to requests for comment about any aspect of this story. China’s Foreign Ministry declined to comment.

U.S.-China Naval Competition

The Indo-Pacific has become the main arena for military competition between the United States and China. Beijing’s increased aggression towards U.S. ally Taiwan, its territorial disputes with neighbors, and its opposition to the long-standing American naval presence in the region, which China views as provocative, have increased friction between the two superpowers.

Sources: Natural Earth; Military.com; U.S. Naval Forces Korea; GlobalSecurity.org; Reuters reporting

The U.S. Navy’s surveillance push is driven by three main factors, according to the three people with direct knowledge of the plans. First is the meteoric rise of China as a sea power and the potential for its vessels to attack Taiwan or sabotage critical undersea infrastructure, including oil pipelines and fiber-optic internet cables.

Second is Ukraine’s success in employing new maritime warfare tactics in its counteroffensive against invading Russian forces; Ukraine has used relatively cheap unmanned sea vehicles to strike enemy ships and bridges. This development has exposed the vulnerability of large surface vessels to drone attacks, and the need for the U.S. Navy to master this technology for its own offensive operations, as well as learn ways to defend against it. That, in turn, could heighten the importance of submarine warfare in any conflict with China, the three people said.

Finally, rapid technological change, including more sensitive underwater sensors, artificial intelligence and sea drones, is fueling a surveillance arms race between Beijing and Washington.

U.S. upgrades are long overdue and moving too slowly because the Pentagon remains focused on building huge warships and submarines, Brent Sadler, a former U.S. Navy submarine officer, told Reuters.

“We have to invest faster in next-generation capabilities. We're losing the lead, and the Chinese are rapidly catching up,” said Sadler, now a naval warfare fellow at The Heritage Foundation, a Washington-based think tank.

The U.S. Navy and Department of Defense did not respond to requests for comment about the pace at which the Navy is adopting new technologies.


Sense of urgency

America’s underwater espionage program was launched in the 1950s with a submarine detection system known as the Sound Surveillance System. That consisted of so-called hydrophone cables – a type of subsea microphone – laid on the seabed. The name changed to the IUSS in 1985. That’s when the fixed cables were supplemented with technology known as the Surveillance Towed Array Sensor System (SURTASS), long vertical sonar arrays dragged below Navy ships to listen for enemy submarines lingering in the depths.

At its peak in the 1980s, the IUSS comprised thousands of Navy sailors and analyzed data from ships and undersea cables at 31 different processing facilities. Tracking Soviet vessels was central to the original mission, according to declassified Navy documents.

With the breakup of the Soviet Union in the 1990s, the IUSS was scaled back. Increasingly its analysts were tasked with monitoring marine life and offshore earthquakes.

Today, just two surveillance sites remain: the facility located within the Naval Air Station Whidbey Island in Washington State, and another at the Dam Neck naval station in Virginia Beach, Virginia.

The 2022 renaming of a U.S. Navy listening post on Whidbey Island near Seattle signals a larger Pentagon effort to upgrade America’s undersea surveillance capabilities as China’s naval power grows. U.S. Navy/Handout via REUTERS

Once dubbed Naval Ocean Processing Facilities, they were rechristened Theater Undersea Surveillance Commands last year. The new name is “more fitting of the expansive coverage of our mission,” Jon Nelson, commanding officer at the Whidbey Island unit, said at a name-changing ceremony in October 2022.

China’s rise as a naval rival, and Ukraine’s effective harassment of Russia's Black Sea fleet with drones, have renewed the U.S. military’s focus on ocean surveillance in a fast-changing maritime environment, according to Phillip Sawyer, a retired U.S. Navy vice admiral and former head of the submarine forces in the Pacific.

“It has given us a sense of urgency that perhaps was lacking in the ’90s and the early 2000s,” said Sawyer, now the Undersea Warfare Chair at the Naval Postgraduate School in Monterey, California.

Adding to that urgency: the need to protect subsea internet cables crisscrossing the ocean floor, a global network that carries 99% of transcontinental internet traffic. These cables are the heart of an intensifying competition between the United States and China to control advanced technologies, Reuters reported in March.

In February, two undersea internet cables were cut that connected Taiwan with the Matsu Islands, a cluster of isles governed by Taiwan that sit close to the Chinese mainland. It took weeks to restore internet service fully to some 14,000 island residents. Taiwanese authorities said at the time they suspected two Chinese vessels were to blame, but provided no direct evidence and stopped short of calling it a deliberate act.

China did not comment on the incident at the time. China’s defense and foreign ministries did not respond to fresh requests for comment about it.

Washington is betting that unmanned surveillance vessels can reduce the likelihood of potentially explosive confrontations such as this run-in with China on March 8, 2009. A U.S. surveillance ship, the USNS Impeccable, was harassed by five Chinese vessels as it conducted routine operations in international waters in the South China Sea, according to the Pentagon. This photo, shot from the USNS Impeccable, shows two Chinese trawlers blocking its way. U.S. Navy/Handout via Reuters

In May, the Quad – an alliance between Australia, Japan, India and the United States – said the four countries would partner to protect and build undersea high-speed fiber-optic cables in the Indo-Pacific.

Both the Chinese and U.S. navies regularly carry out military exercises around American ally Taiwan as military analysts study how any potential conflict over the island could play out.

Although U.S. warships and submarines are widely considered technically superior, China has the largest navy in the world, comprising around 340 ships and submarines, according to the Pentagon’s 2022 report on China’s military. China is building more advanced nuclear-powered submarines that are quieter and harder to detect, the report said.


Ships going dark

The jewel of the U.S. subsea surveillance operations remains the global network of listening cables first laid during the Cold War, still the best subsea spying infrastructure in the world, according to two Navy sources with direct knowledge of the system.

Those cables were instrumental in solving the mystery surrounding the privately-owned Titan submersible that imploded in June, killing five people on a voyage to view the century-old wreckage of the Titanic, the sources said.

The U.S. Navy said in a statement that it had assisted in the search for the Titan after an analysis of acoustic data detected “an anomaly consistent with an implosion.” The Navy did not respond to questions from Reuters about how it had obtained the acoustic data.

Over the last three years, some of this cable network has been expanded and replaced with advanced cables fitted with state-of-the-art hydrophones and sensors to more accurately pinpoint the location of enemy vessels, the two people said.

The U.S. Navy’s Undersea Surveillance System

The United States is expanding and upgrading its anti-submarine surveillance capabilities as tensions rise with China. The listening network, shown here in a 2017 U.S. Navy document, began with the Sound Surveillance System (SOSUS): long cables fitted with underwater microphones laid on the ocean floor in the 1950s to listen for Soviet submarines. SOSUS has since been supplemented with additional listening cables, known as the Fixed Distributed System (FDS). Data collected by underwater sensors placed in secret locations is routed to onshore processing centers, where it is analyzed to pinpoint enemy vessels.

Source: U.S. Navy

Much of this work has been carried out by the 40-year-old USNS Zeus, the first and only operational cable ship specifically built for the U.S. Navy, the people said. Assisting are the CS Dependable and CS Decisive, two cable ships owned by the private U.S. firm SubCom, they said. SubCom has become a key player in the tech war with China, Reuters reported in July.

To keep the locations of U.S. underwater spy cables secret, these three ships have been masking their locations, known in the shipping industry as “going dark,” according to the two Navy sources and a Reuters analysis of ship tracking data.

Commercial ships are required under international law to keep their identification transponders switched on to prevent collisions and help authorities fight maritime crimes. But nations can secure exemptions for some private vessels, particularly those working on national security projects, according to London-based maritime lawyer Stephen Askins.

Between Jan. 1, 2022, and August 22 of this year, the CS Dependable and the CS Decisive were not transmitting identification signals for 60% and 57% of the days they spent at sea, respectively, according to data on LSEG’s Eikon terminal.

SubCom and the U.S. Department of Defense did not respond to requests for comment about any exemption for SubCom vessels.

The second element of the original U.S. subsea spy program is a fleet of five large catamaran-style ships equipped with the SURTASS system, the cables fitted with sonar listening gear and dragged through the ocean.

The ocean surveillance ship USNS Able is shown in Yokosuka, Japan, in 2016. Some military analysts say the U.S. Navy is not moving fast enough to deploy next-generation spy technologies such as sea drones, AI and mobile listening sensors. U.S. Navy/Handout via REUTERS

In February 2020, the Navy awarded Lockheed Martin a $287 million contract to produce new advanced towed sonar arrays for these ships. The first of these new cables was delivered last year, according to two Navy sources.

Lockheed Martin did not respond to a request for comment.

Now the Navy is building new miniaturized, mobile versions that can be deployed undetected, the sources said. These modules, known as Expeditionary SURTASS, or SURTASS-E, can be placed in cargo containers loaded onto any flat-decked vessel, allowing commercial ships to carry out surveillance for the Navy, two sources with knowledge of the project said.

Over the last three years, the Navy has been testing the system from an offshore supply vessel in the Atlantic, and it has since been used in active operations in secret locations, the sources said.

In May, the U.S. State Department said in a statement that it had approved the sale of a $207 million SURTASS-E system to the government of Australia.

An Australian Defense spokesperson told Reuters it was investing in new undersea surveillance capabilities to protect critical infrastructure and monitor evolving subsea threats.

Japan also operates a fleet of three ocean surveillance ships, fitted with U.S. SURTASS cables, the two U.S. Navy sources said.

Japan’s navy, known as the Maritime Self-Defense Force, said in a statement that it was coordinating with its allies to counter China’s increased naval threat; it declined to comment specifically on surveillance operations.


Sea drones with sharp ears

The Navy is experimenting with new ways to listen for subs in areas where its warships are closely monitored by China, including the Taiwan Strait and South China Sea, two sources with knowledge of those efforts said.

This means using stealthier methods such as sending out small, unmanned sea drones fitted with infrared cameras and underwater microphones, and dropping portable listening devices from commercial ships, the people said.

One of the first successful attempts to make an autonomous subsea surveillance unit was the Transformational Reliable Acoustic Path System (TRAPS), developed by Leidos, a Virginia-based Fortune 500 defense firm, the people said. The Navy awarded Leidos a $73 million contract to develop the system in 2019.

TRAPS consists of a processing box attached to deep ocean sensors. It is designed to sit on the seafloor and listen for submarines overhead, like an underwater satellite.

The U.S. Navy has purchased a submarine detection system known as TRAPS. Made by Virginia-based Leidos, these mobile units can be surreptitiously dropped to strategic locations on the ocean floor, where they listen for enemy subs moving above. Data from these units is relayed to military facilities via surface vessels and satellites. Leidos/Handout via REUTERS.

These underwater spy units could be surreptitiously dropped off the side of a fishing vessel or tugboat in enemy territory, Chuck Fralick, Leidos’ chief technology officer and a retired Navy officer, told Reuters.

“You can get listening or surveillance capability pretty much anywhere in the world you want,” Fralick said.

The Navy has also been experimenting with small sea drones, including uncrewed sailboats and autonomous miniature submarines that cost $800,000 to $3 million to build – relatively small change in the world of defense systems.

These craft don’t yet carry weapons. But they can be fitted with high-definition cameras, underwater microphones, satellite uplinks and other spy gear, giving the Navy a low-cost means to expand its surveillance dramatically, Navy spokesman Hawkins said.

In the future, these vessels could be used to fire submarine-sinking torpedoes, drop underwater mines or set off decoy devices that make loud noises beneath the surface to confuse the enemy, two Navy sources said.

The Navy did not respond to questions about arming sea drones.

Saildrone Voyager

The U.S. Navy has begun purchasing a fleet of small, uncrewed vessels that can carry out maritime reconnaissance work, both on and below the surface. Saildrone, a San Francisco-based firm, says it has already supplied the Navy with 22 of its solar-powered autonomous boats, including the Voyager model.

Source: Saildrone

Saildrone, a San Francisco-based firm founded in 2012 by British engineer Richard Jenkins, for years has been collecting data from its unmanned sailboats to track marine life movements and measure impacts of climate change.

Now military customers are calling. In the past two years, Saildrone says it has supplied the U.S. Navy with 22 of its solar-powered boats, including the 33-foot Voyager, which can be equipped with a smart camera and a variety of sensors. The Navy confirmed that it has purchased Saildrones.

Though the Navy has yet to place large orders, Saildrone and other drone startups say they are each ready to supply hundreds of vessels a year.

Navy spokesperson Hawkins declined to say how many more uncrewed vessels the military might procure. But he said the sea drone industry was “on the cusp of a technological revolution.”

Krystal Application for KB408 for Type 1 Alpha-1 Antitrypsin Deficiency OKd

Orphan Drug Designation Granted to KB408

Krystal Biotech Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company focused on the discovery, development, and commercialization of genetic medicines to treat diseases with high unmet medical needs, announced today that the U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug Application (IND) for KB408 for the treatment of alpha-1 antitrypsin deficiency (AATD).

KB408 is a modified, replication-defective, non-integrating HSV-1-derived vector carrying two full-length copies of the serpin family A member 1 (SERPINA1) gene to enable expression of alpha-1 antitrypsin (AAT). KB408 is formulated for inhaled delivery to the respiratory cells of the lungs via nebulization

https://www.biospace.com/article/releases/krystal-biotech-announces-fda-clearance-of-investigational-new-drug-application-for-kb408-for-the-treatment-of-type-1-alpha-1-antitrypsin-deficiency/

Crime Trend Nobody Wants to Talk About

 Hate crimes — violent actions motivated by prejudice on the basis of race, religion or sexual orientation — are all over the news, all the time. But these reprehensible assaults tell only a part of the crime story plaguing our nation’s cities. Media pundits and public officials fail to ring alarm bells over crimes fueled by the opposite of hate: those fueled by apathy.


Brazen, unprovoked and seemingly random violent attacks targeting strangers have been on the rise in many urban areas. The problem has gotten worse since anti-police activists gained the upper hand in public discourse.

Earlier this month in New York City, an assailant struck a 60-year-old woman in the subway 50 times with her cane during a shocking caught-on-video beating. The woman did not know her attacker. Last year, a commuter was pushed into a subway track and left for dead. In other random attacks, an elderly lady was punched in the head, a woman was struck with a brick and a man was attacked by strangers while coming home from work, all in formerly-safe neighborhoods.

A recent poll found 41% of New Yorkers think crime in the city is worse than ever. Finding the cause of such violence is not always easy, but city statistics appear to bear out the idea that a disproportionate amount of violence in New York is committed against strangers. In 2022, more than 170,000 felonies were reported in the city, the highest level on record. In particular, crimes that are more likely to involve random targeting, such as robberies, car theft, burglary and felony assault, all increased sharply. Auto theft alone was up almost a third.

What is going on? 

A significant portion of this wave of random attacks and robberies is likely related to society’s direction. Our nation has become spiritually unmoored in several ways, with belief in God at an all-time low and escapism through crime or drugs distracting people from depression or purposelessness. The traditional family unit has broken down. Children raised by biological, married parents do better by almost every measure — and yet roughly 24 million, or one-third of all American children, currently live with a single parent. Of those children, 81 percent are living without a father in the home. Some communities suffer from broken families at even higher rates. For example,  57% of Black children are living absent their fathers. We’ve known for years that having two parents is one of the best ways to prevent juvenile crime.

Along with these factors, rapidly changing society has made us more cynical. Social media (especially TikTok) have shortened attention spans and dulled serotonin receptors to the point that people often crave something real and instantaneous, whether it is positive or negative.

At the policy level, lawless behavior has become increasingly tolerated in many cities since the riots in 2020 following George Floyd’s death. These jurisdictions are experiencing a vicious cycle in which criminals victimize innocent people, get arrested, and then are released back onto the streets to victimize more people. Those looking to do harm realize they will not get in serious trouble for their actions. In New York City, District Attorney Alvin Bragg’s office has become a revolving door for career criminals who shamelessly brutalize people in daylight. Some are arrested more than 100 times, just to be released to commit more crimes. In August, New York City Mayor Eric Adams revealed that 10 criminals alone committed nearly 500 crimes in the city. Six of them were free on the streets at the time of his announcement. 

Furthermore, our apparent societal decision to treat nearly all police as criminals has provided fertile ground for crimes of apathy. Morale among officers hit record lows in 2021, and many departments still cannot fill vacancies. The situation is so bad in some parts of the country that entire police departments are simply shutting down altogether. Instead of being commended for choosing an honorable career that requires courage and strength, police officers are sneered at by much of the country who were told by liberals, celebrities and mainstream media that cops are racist pigs. Why would a young person today choose what has become such a thankless and dangerous job?

Not only is police intervention less likely, but public action is even less so. Major cities often have fewer legal gun carriers — that is, if their right to carry isn’t suspended — while any action by a passerby could be interpreted as racist, even if it’s recorded. Just think of the response to the death of Jordan Neely on a Manhattan subway earlier this year. So, instead of helping a person who is being brutalized, many witnesses simply stand there and watch, with their phones recording what happens.


The only crimes most media seem interested in talking about are hate crimes. We’re told by federal authorities, including the president, that “white supremacy is the biggest threat facing our nation.” Putting aside that such statements are not supported by statistics, public perception is key. A 2021 poll asked the public to estimate the number of unarmed Black men killed by police. A majority of self-described “very liberal” respondents estimated the number at 1,000 or more. More than 7% thought it was 10,000 or more. The actual number was 27. The FBI reported more than 7,000 hate crimes in 2021, compared to 1.3 million overall violent crimes nationwide.           

Democrats have allowed an important, but relatively infrequent, concern to overshadow the overwhelming increase in other violent crime that has emerged over the past three years.

Sadly, it often takes anti-police leftists being brutalized themselves to realize how destructive their ideology has been on communities. Recently, the second vice chair of Minnesota’s Democratic Party was physically harmed in a carjacking in Minneapolis. The event left her with a broken leg, cuts and bruises. The former backer of defunding the police wrote a social media post in which she said to remember her “when you are thinking about supporting letting juveniles and young people out of custody to roam our streets.”

There are solutions to these society-wide problems, as much as some politicians may not want to acknowledge them. From the government side, proper funding and respect for the nation’s police would go a long way toward reducing our current issues. We’ve seen the effects of the left’s partially-successful effort to criminalize the police. There would be two major social solutions that are less likely. First is the rebuilding of the traditional family, gutted from Lyndon Johnson’s Great Society programs onward. Second would be the rejection of the nihilism and moral relativism that gave us our current environment. 

Perhaps we as a nation will not solve our problems with crime and societal breakdown. However, remember that even in the darkest days of New York City’s past, there was a solution to growing street crime and disorder in the early 1990s. It can be done. It is possible to at least turn the tide of the battle, but it requires something that major cities and the nation are sorely lacking: true leadership.

Kristin Tate (@KristinBTate) is a writer based in Texas focused on government spending, federal regulation and digital currencies. She is an on-air contributor for Sky News and routinely provides political commentary for U.S.-based cable networks. Her latest book is, “The Liberal Invasion of Red State America.”

https://themessenger.com/opinion/the-shocking-crime-trend-nobody-wants-to-talk-about

Medicare Restricts Coverage for Vital Transplant Tests

 The road to an organ transplant can be a long and painful process, from getting on the transplant waiting list to finally receiving a new organ. But the difficult journey doesn’t stop there. Once someone is given a second chance at life through organ donation, the focus of their care pivots toward ensuring the ongoing health of the transplant to avoid rejection.

Patients require anti-rejection medication and must undergo frequent testing and invasive biopsies to monitor for organ injury. However, these decades-old methods may detect organ rejection after it’s too late to intervene. It is estimated that within the first year post-transplant, one in three lung transplants will fail. Within five years, one in three hearts and one in five kidneys will fail.

As a pediatric nephrologist and two-time kidney transplant recipient myself, I know this perilous journey firsthand. I had my first kidney transplant at age 24, a gift from my father. Unfortunately, my first transplant ultimately failed, and I had to go on grueling dialysis for several years. However, a revolutionary advancement in post-transplant care that became available in 2017 could have potentially saved my first kidney.

Non-invasive diagnostic testing, performed through a simple blood test, has offered a much-needed tool for transplant patients to detect organ injury or rejection earlier – so that doctors can intervene at the earliest stages of damage to the organ. These molecular tests, including gene expression profiling (GEP) and donor-derived cell-free DNA (dd-cfDNA), can also help avoid traditional biopsies, a process that can be physically painful, harmful to the organ, and disruptive to patients’ daily lives.

In my case, routine screening with less invasive and earlier indicators of damage might have allowed for earlier detection of rejection before there was a persistent decline in my kidney health, and allowed for intervention sooner. With my second transplant, I am grateful to have these tests as a part of my routine care. They give me peace of mind that my doctors have the real-time information they need to intervene and ensure the long-term health of my kidney.

That is why I am deeply concerned about a new policy change that has already impacted access to these tests for Medicare patients.

In March 2023, MolDX, a program administered by Medicare contractors to determine coverage for molecular transplant diagnostic tests, issued a billing article (Medicare’s coverage guidance) that makes significant changes to how tests like dd-cfDNA are covered. In accordance with federal legislation, any significant coverage changes should be put through public comment where patient advocates, clinicians, and other experts can weigh in on the potential impact of proposed policy changes. However, in this case, clinicians and patients like me were not able to voice our concerns.

One of the changes imposed includes a new restriction on the use of molecular tests for monitoring the health of transplants or for surveillance purposes, a move that will greatly reduce the ability to detect subclinical or early signs of rejection.

Additionally, the billing article limits Medicare reimbursement to one molecular test per visit. This is especially troublesome for heart transplant patients where the combination of GEP and dd-cfDNA molecular tests most effectively monitors for potential rejection. For kidney patients, dual testing was just starting to gain traction, but now that progress has been halted, with one company removing their dual test product from the market immediately following the effective date of the billing article.

These restrictions are already hindering innovation in the transplant field and will impact all patients, but especially those in rural, marginalized, and under-resourced communities, who confront significant barriers to healthcare access and are disproportionately impacted by chronic conditions like kidney disease.

For example, patients being treated by providers in their local community where resources for biopsies may not be available will no longer have access to molecular diagnostics for surveillance because the new restrictions require tests to be used in lieu of a biopsy. This means they’ll need to travel to the nearest transplant center more frequently – a center that may be hours away.

Restricting access to technology that can save people from going through organ rejection is unacceptable. That is why the transplant community is mobilizing to protect healthcare coverage for those lucky enough to be given the gift of life. Several medical societies have written letters to MolDX raising concerns, including the American Society of Transplant Surgeons and the International Society for Heart and Lung Transplantation. Additionally, a coalition of more than a dozen patient advocacy groups has banded together to fight for access and coverage for post-transplant care. This Honor the Gift coalition was originally established in 2019 and successfully advocated to extend Medicare’s immunosuppressive medication coverage for kidney transplants.

The transplant community is resilient and will continue to fight for equitable and optimal care for all patients. To start, we must urge policymakers to take a closer look at the misuse of the MolDX billing article to restrict access to critical and innovative care.

Dr. Ken Sutha is a pediatric nephrologist at Stanford Medicine Children’s Health and a two-time recipient of a kidney transplant.

https://www.realclearpolitics.com/articles/2023/09/21/medicare_restricts_coverage_for_vital_transplant_tests_149784.html

American Pandemic ‘Samizdat’

 On May 15, 1970, the New York Times published an article by esteemed Russia scholar Albert Parry detailing how Soviet dissident intellectuals were covertly passing forbidden ideas around to each other on handcrafted, typewritten documents called samizdat. Here is the beginning of that seminal story:

Censorship existed even before literature, say the Russians. And, we may add, censorship being older, literature has to be craftier. Hence, the new and remarkably viable underground press in the Soviet Union called samizdat.

Samizdat – translates as: “We publish ourselves” – that is, not the state, but we, the people.

Unlike the underground of Czarist times, today’s samizdat has no printing presses (with rare exceptions): The K.G.B., the secret police, is too efficient. It is the typewriter, each page produced with four to eight carbon copies, that does the job. By the thousands and tens of thousands of frail, smudged onionskin sheets, samizdat spreads across the land a mass of protests and petitions, secret court minutes, Alexander Solzhenitsyn’s banned novels, George Orwell’s “Animal Farm” and “1984,” Nicholas Berdyayev’s philosophical essays, all sorts of sharp political discourses and angry poetry.

Though it is hard to hear, the sad fact is that we are living in a time and in a society where there is once again a need for scientists to pass around their ideas secretly to one another so as to avoid censorship, smearing, and defamation by government authorities in the name of science.

I say this from first-hand experience. During the pandemic, the U.S. government violated my free speech rights and those of my scientist colleagues for questioning the federal government’s COVID policies.

American government officials, working in concert with big tech companies, defamed and suppressed me and my colleagues for criticizing official pandemic policies – criticism that has been proven prescient. While this may sound like a conspiracy theory, it is a documented fact, and one recently confirmed by a federal circuit court.

In August 2022, the Missouri and Louisiana attorneys general asked me to join as a plaintiff in a lawsuit, represented by the New Civil Liberties Alliance, against the Biden administration. The suit aims to end the government’s role in this censorship and restore the free speech rights of all Americans in the digital town square.

Lawyers in the Missouri v. Biden case took sworn depositions from many federal officials involved in the censorship efforts, including Anthony Fauci. During the hours-long deposition, Fauci showed a striking inability to answer basic questions about his pandemic management, replying “I don’t recall” over 170 times.

Legal discovery unearthed email exchanges between the government and social media companies showing an administration willing to threaten the use of its regulatory power to harm social media companies that did not comply with censorship demands.

The case revealed that a dozen federal agencies pressured social media companies Google, Facebook, and Twitter to censor and suppress speech contradicting federal pandemic priorities. In the name of slowing the spread of harmful misinformation, the administration forced the censorship of scientific facts that didn’t fit its narrative de jour. This included facts relating to the evidence for immunity after COVID recovery, the inefficacy of mask mandates, and the inability of the vaccine to stop disease transmission. True or false, if speech interfered with the government’s priorities, it had to go.

On July 4, U.S. Federal District Court Judge Terry Doughty issued a preliminary injunction in the case, ordering the government to immediately stop coercing social media companies to censor protected free speech. In his decision, Doughty called the administration’s censorship infrastructure an Orwellian “Ministry of Truth.”

In my November 2021 testimony in the House of Representatives, I used this exact phrase to describe the government’s censorship efforts. For this heresy, I faced slanderous accusations by Rep. Jamie Raskin, who accused me of wanting to let the virus “rip.” Raskin was joined by fellow Democrat Rep. Raja Krishnamoorthi, who tried to smear my reputation on the grounds that I spoke with a Chinese journalist in April 2020.

Judge Doughty’s ruling decried the vast federal censorship enterprise dictating to social media companies who and what to censor, and ordered it to end. But the Biden administration immediately appealed the decision, claiming that they needed to be able to censor scientists or else public health would be endangered and people would die. The U.S. 5th Circuit Court of Appeals granted them an administrative stay that lasted until mid-September, permitting the Biden administration to continue violating the First Amendment.

After a long month, the 5th Circuit Court of Appeals ruled that that pandemic policy critics were not imagining these violations. The Biden administration did indeed strong-arm social media companies into doing its bidding. The court found that the Biden White House, the CDC, the U.S. surgeon general’s office, and the FBI have “engaged in a years-long pressure campaign [on social media outlets] designed to ensure that the censorship aligned with the government’s preferred viewpoints.”

The appellate judges described a pattern of government officials making “threats of ‘fundamental reforms’ like regulatory changes and increased enforcement actions that would ensure the platforms were ‘held accountable.’” But, beyond express threats, there was always an “unspoken ‘or else.’” The implication was clear. If social media companies did not comply, the administration would work to harm the economic interests of the companies. Paraphrasing Al Capone, “Well that’s a nice company you have there. Shame if something were to happen to it,” the government insinuated.

“The officials’ campaign succeeded. The platforms, in capitulation to state-sponsored pressure, changed their moderation policies,” the 5th Circuit judges wrote, and they renewed the injunction against the government’s violation of free speech rights. Here is the full order, filled with many glorious adverbs:

Defendants, and their employees and agents, shall take no actions, formal or informal, directly or indirectly, to coerce or significantly encourage social-media companies to remove, delete, suppress, or reduce, including through altering their algorithms, posted social-media content containing protected free speech. That includes, but is not limited to, compelling the platforms to act, such as by intimating that some form of punishment will follow a failure to comply with any request, or supervising, directing, or otherwise meaningfully controlling the social media companies’ decision-making processes.

The federal government can no longer threaten social media companies with destruction if they don’t censor scientists on behalf of the government. The ruling is a victory for every American since it is a victory for free speech rights.

Although I am thrilled by it, the decision isn’t perfect. Some entities at the heart of the government’s censorship enterprise can still organize to suppress speech. For instance, the Cybersecurity and Infrastructure Security Agency (CISA) within the Department of Homeland Security can still work with academics to develop a hit list for government censorship. And the National Institutes of Health, Tony Fauci’s old organization, can still coordinate devastating takedowns of outside scientists critical of government policy.

So, what did the government want censored?

The trouble began on Oct. 4, 2020, when my colleagues and I – Dr. Martin Kulldorff, a professor of medicine at Harvard University, and Dr. Sunetra Gupta, an epidemiologist at the University of Oxford – published the Great Barrington Declaration. It called for an end to economic lockdowns, school shutdowns, and similar restrictive policies because they disproportionately harm the young and economically disadvantaged while conferring limited benefits.

The Declaration endorsed a “focused protection” approach that called for strong measures to protect high-risk populations while allowing lower-risk individuals to return to normal life with reasonable precautions. Tens of thousands of doctors and public health scientists signed on to our statement.

With hindsight, it is clear that this strategy was the right one. Sweden, which in large part eschewed lockdown and, after early problems, embraced focused protection of older populations, had among the lowest age-adjusted all-cause excess deaths of nearly every other country in Europe and suffered none of the learning loss for its elementary school children. Similarly, Florida has lower cumulative age-adjusted all-cause excess deaths than lockdown-crazy California since the start of the pandemic.

In the poorest parts of the world, the lockdowns were an even greater disaster. By spring 2020, the United Nations was already warning that the economic disruptions caused by the lockdowns would lead to 130 million or more people starving. The World Bank warned the lockdowns would throw 100 million people into dire poverty.

Some version of those predictions came true – millions of the world’s poorest suffered from the West’s lockdowns. Over the past 40 years, the world’s economies globalized, becoming more interdependent. At a stroke, the lockdowns broke the promise the world’s rich nations had implicitly made to poor nations. The rich nations had told the poor: Reorganize your economies, connect yourself to the world, and you will become more prosperous. This worked, with 1 billion people lifted out of dire poverty over the last half-century.

But the lockdowns violated that promise. The supply chain disruptions that predictably followed them meant millions of poor people in sub-Saharan Africa, Bangladesh, and elsewhere lost their jobs and could no longer feed their families.

In California, where I live, the government closed public schools and disrupted our children’s education for two straight academic years. The educational disruption was very unevenly distributed, with the poorest students and minority students suffering the greatest educational losses. By contrast, Sweden kept its schools open for students under 16 throughout the pandemic. The Swedes let their children live near-normal lives with no masks, no social distancing, and no forced isolation. As a result, Swedish kids suffered no educational loss.

The lockdowns, then, were a form of trickle-down epidemiology. The idea seemed to be that we should protect the well-to-do from the virus and that protection would somehow trickle down to protect the poor and the vulnerable. The strategy failed, as a large fraction of the deaths attributable to COVID hit the vulnerable elderly.

The government wanted to suppress the fact that there were prominent scientists who opposed the lockdowns and had alternate ideas – like the Great Barrington Declaration – that might have worked better. They wanted to maintain an illusion of total consensus in favor of Tony Fauci’s ideas, as if he were indeed the high pope of science. When he told an interviewer, “Everyone knows I represent science. If you criticize me, you are not simply criticizing a man, you are criticizing science itself,” he meant it unironically.

Federal officials immediately targeted the Great Barrington Declaration for suppression. Four days after the declaration’s publication, National Institutes of Health Director Francis Collins emailed Fauci to organize a “devastating takedown” of the document. Almost immediately, social media companies such as Google/YouTube, Reddit, and Facebook censored mentions of the declaration.

In 2021, Twitter blacklisted me for posting a link to the Great Barrington Declaration. YouTube censored a video of a public policy roundtable of me with Florida Gov. Ron DeSantis for the “crime” of telling him the scientific evidence for masking children is weak. 

At the height of the pandemic, I found myself smeared for my supposed political views, and my views about COVID policy and epidemiology were removed from the public square on all manner of social networks.

It is impossible for me not to speculate about what might have happened had our proposal been met with a more typical scientific spirit rather than censorship and vitriol. For anyone with an open mind, the GBD represented a return to the old pandemic management strategy that had served the world well for a century – identify and protect the vulnerable, develop treatments and countermeasures as rapidly as possible, and disrupt the lives of the rest of society as little as possible since such disruption is likely to cause more harm than good.

Without censorship, we might have won that debate, and if so, the world could have moved along a different and better path in the last three and a half years, with less death and less suffering.

Since I started with a story about how dissidents skirted the Soviet censorship regime, I will close with a story about Trofim Lysenko, the famous Russian biologist. Stalin’s favorite scientist was a biologist who did not believe in Mendelian genetics – one of the most important ideas in biology. He thought it was all hokum, inconsistent with communist ideology, which emphasized the importance of nurture over nature. Lysenko developed a theory that if you expose seeds to cold before you plant them, they will be more resistant to cold, and thereby, crop output could be increased dramatically.

I hope it is not a surprise to readers to learn that Lysenko was wrong about the science. Nevertheless, Lysenko convinced Stalin that his ideas were right, and Stalin rewarded him by making him the director of the USSR’s Institute for Genetics for more than 20 years. Stalin gave him the Order of Lenin eight times.

Lysenko used his power to destroy any biologist who disagreed with him. He smeared and demoted the reputations of rival scientists who thought Mendelian genetics was true. Stalin sent some of these disfavored scientists to Siberia, where they died. Lysenko censored the scientific discussion in the Soviet Union so no one dared question his theories.

The result was mass starvation. Soviet agriculture stalled, and millions died in famines caused by Lysenko’s ideas put into practice. Some sources say that Ukraine and China under Mao Tse-tung also followed Lysenko’s ideas, causing millions more to starve there.

Censorship is the death of science and inevitably leads to the death of people. America should be a bulwark against it, but it was not during the pandemic. Though the tide is turning with the Missouri v. Biden case, we must reform our scientific institutions so what happened during the pandemic never happens again.

Dr. Jay Bhattacharya is the inaugural recipient of RealClear’s Samizdat Prize. This article was adapted from the speech he delivered at the award ceremony on September 12 in Palo Alto, California.

https://www.realclearpolitics.com/articles/2023/09/21/american_pandemic_samizdat_149787.html

WTO Posts Ukraine Trade Dispute Case Versus Its EU Neighbors

 

  • Kiev alleges EU nations imposed an illegal ban on farm imports
  • The four nations now have 60 days to enter into consultations

The World Trade Organization on Thursday published Ukraine’s request for dispute settlement proceedings after Poland, Hungary and the Slovak Republic banned imports of a range of Ukrainian agricultural goods.

Ukraine’s request for consultations marks the first formal step of the WTO’s lengthy dispute resolution process and could escalate into Ukraine’s first WTO dispute case as a plaintiff against a European Union member. Ukraine is simultaneously working to join the 27-nation bloc.

https://www.bloomberg.com/news/articles/2023-09-21/wto-posts-ukraine-trade-dispute-case-versus-its-eu-neighbors

Roche inks pipeline deals with Orionis, PeptiDream

 Roche has bolstered its R&D pipeline in oncology and neuroscience with a pair of partnerships with Orionis Biosciences and PeptiDream, parting with upfront cash of $87 million for projects in the hot areas of molecular glues and radiotherapy-delivering drugs.

The deal with Orionis has a top-line value of $2 billion, with $47 million of that paid upfront, and is focused on the development of monovalent molecular glues for cancer and neurodegenerative disorders. It updates an earlier alliance between the companies signed in 2020.

Orionis’ Allo-Glue platform is designed to find small-molecule compounds that can bind to a specific intracellular protein and change its form and function, for example, marking it as defective and a candidate for breakdown and disposal by the cell’s housekeeping processes.

Orionis’ approach can also generate drugs that encourage the binding of a protein with another protein with which it would not normally interact, effectively sticking them together.

Protein degraders are attracting a lot of attention in the pharma sector at the moment as a possible way to address hitherto “undruggable” targets, and have sparked a series of big-ticket licensing deals between their developers and big pharma partners.

Molecular glues come into that category but are also attracting attention in their own right, as seen by Bristol-Myers Squibb’s alliances with Evotec and SyntheX and recent partnerships between MSD and Proxygen, as well as Incyte and BioTheryx.

Orionis will design molecular glues for targets chosen by Roche’s Genentech unit, with the latter responsible for taking over responsibility for any resulting candidates from the late preclinical stage.

“Molecular glue degraders are an exciting modality to target disease-related proteins that have proven challenging with more traditional treatment modalities,” said James Sabry, global head at Roche Pharma Partnering.

“For patients with unmet needs, this offers a new therapeutic approach to modulate major disease drivers.”

Peptide-radioisotope alliance

In its PeptiDream partnership, Genentech is paying $40 million upfront, with another $1 billion in potential milestone payments, for access to the biotech’s peptide drug discovery platform, continuing a progressive buy-in to the technology that started back in 2015.

PeptiDream’s macrocyclic peptides can either act as medicines in their own right or can serve as targeting mechanisms for another therapeutic payload. In this case, the partners will work on macrocyclic peptide-radioisotope drug conjugates that can deliver radiotherapy to specific tissues, such as tumours, and reduce off-target effects elsewhere.

The Japanese biotech will undertake preclinical development of the candidates before handing them over to Genentech for further development. It also has billion-dollar-plus collaborations in place with Astellas, MSD, and Eli Lilly.

https://pharmaphorum.com/news/roche-inks-pipeline-deals-orionis-peptidream