Waivers? China Pharmaceuticals Killing Americans

Primer:

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In part from Reuters: “My friend President Xi said that he would stop the sale of fentanyl to the United States – this never happened and many Americans continue to die,” Trump said in a tweet.

“We’re losing thousands of people to fentanyl,” he later told reporters.

The Chinese embassy did not immediately respond to a request for comment.

Fentanyl is an opioid painkiller 50 times more potent than heroin, and has a central role in the devastating U.S. opioid crisis. In the United States, fentanyl and all of its analogues are controlled substances subject to strict regulation.

More than 28,000 synthetic opioid-related overdose deaths, mostly from fentanyl related substances, were recorded in 2017, according to the U.S. Centers for Disease Control and Prevention.

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Added from Bloomberg:

China has become the world’s largest supplier of active pharmaceutical ingredients, or API, providing key components to drugmakers worldwide. But a yearlong recall of tainted heart drugs taken by millions of Americans is prompting U.S. national security officials to ask whether China’s growing role in the pharmaceutical supply chain could pose a threat to the health of military personnel.

“The national security risks of increased Chinese dominance of the global API market cannot be overstated,” Christopher Priest, the acting deputy assistant director for health care operations and Tricare for the Defense Health Agency, told a U.S.-China advisory panel last week in Washington.

The Defense Health Agency manages much of the health care of military members, including prescription drugs.

Concerns about the safety and efficacy of Chinese-made drugs are rising at a time of heightened trade tensions between Washington and Beijing. Last week, Trump unveiled plans for new tariffs on Chinese goods; China plans to halt imports of U.S. crops in response. The yuan sank on Monday against the dollar.

The National Security Council is looking into Chinese drug manufacturing and trying to identify the most at-risk medications, Priest told the U.S.-China Economic and Security Review Commission in Washington, without elaborating. The National Security Council declined to comment.

The Defense Health Agency is supposed to use drugs that comply with the Trade Agreements Act, a 1979 law that requires many federal purchases to be made in the U.S. or another compliant country. China isn’t on the approved list, but the agency has waivers for almost 150 drugs they otherwise wouldn’t be able to procure, Priest said. The TAA covers only finished products, not their components.

Many drugs taken by military members and civilians have active ingredients made in China. While drugmakers typically don’t disclose where every molecule in a pill comes from, the recall of contaminated blood-pressure drugs has shown that many of their active components originated in Chinese factories.

Rocket Fuel

Larry Wortzel, a member of the U.S.-China commission and a military retiree, said four of his blood-pressure medications were recalled in three months. Wortzel’s pills, versions of a drug called valsartan, were manufactured in India but had active ingredients from China.

“They were contaminated with rocket fuel,” Wortzel said. “I imagine active people have the same problem. This affects the readiness of our troops.”

The recalled valsartan contained a probable carcinogen known as NDMA, a manufacturing byproduct once used to make rocket fuel and also found in grilled and cured meats.

Priest called the recalls “a never-ending saga” and a “wake-up call.”

The recalls began in July 2018 with valsartan made by China’s Zhejiang Huahai Pharmaceutical Co. The U.S. Food and Drug Administration has largely blamed the company’s manufacturing process for creating the NDMA, which went undetected for as long as four years. Drugmakers in other countries who used similar processes have also had to recall blood-pressure pills.

Some valsartan purchased by the Defense Logistics Agency and later recalled was TAA-compliant, said Patrick Mackin, a spokesman for the DLA. The agency manages the supply chain for the U.S. military, including ensuring pharmaceuticals make their way to military treatment facilities. With valsartan in shortage, according to the FDA, the agency sought a TAA waiver for valsartan on July 15, Mackin said.

A Bloomberg investigation this year detailed doubts among U.S. health officials about the data generic-drug companies, including Zhejiang Huahai and others involved in the valsartan recalls, use to prove their products are safe and effective.

“We wouldn’t have our aircraft carriers and nuclear submarines built in China, and for very important medications, we really should look at what it takes to purchase based on value not just price,” Rosemary Gibson, the author of the book “China Rx,” told the commission. “We want cheap, we can buy cheap. But what’s missing from the whole equation is quality.”

Shortage Fears

Quality isn’t the only concern. Shortages could also arise from attempts by the Chinese to cut off supply, particularly amid the U.S.-China trade standoff.

“If China shut the door on exports, our hospitals would cease to function, so this has tremendous urgency,” Gibson said.

Priest said pharmaceutical companies should be compelled, using the buying power of the entire federal government, to maintain the infrastructure to make drugs without relying on countries like China.

The House Energy and Commerce Committee is investigating the FDA’s ability to police foreign manufacturing. The committee’s leaders asked the agency for more information on the valsartan recall in June, including about a dispute between senior officials and an agency inspector who raised red flags at Zhejiang Huahai more than a year before the NDMA was detected. The panel also asked the Government Accountability Office to look at the FDA’s oversight of foreign drug manufacturing.

“Shame on us for not paying attention to something so critical and assuming, which has been the orthodoxy for a long time, that the industry would regulate itself,” Benjamin Shobert, senior associate for international health at The National Bureau of Asian Research, told the commission.

 

Defamation Laws v. President Trump

The El Paso shooter left a 4 page manifesto laying out his political and society position(s) on several topics including the Hispanic invasion. He also addressed fake news and that Trump did not have anything to do with his evil decisions to go on a killing rampage. So, Cloudflare fired one of it’s customers, 8Chan. The shooter’s manifesto was posted on 8Chan. A cyber site known as ZDNet among others reporting the termination of 8Chan had it the subtitle the following: “8Chan has harbored a community of hate” (in part). No argument there.

Okay, yet consider the words ‘harbored a community of hate’. In a review of media and politicians, it is beyond dispute that they too have harbored a community of hate.

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Senator and presidential candidate Kamala Harris often has called President Trump a ‘predator‘.

Senator Cory Booker declared on Meet the Press that Trump is responsible for El Paso shooting.

Mayor Pete Buttigeig along with Elizabeth Warren and Julian Castro and others have said the same thing.  These politicians created the phrase ‘white nationalism’ to describe Trump and Trump supporters.

Bernie Sanders too? Yes.

While being one of the moderators of the Democrat debate, Don Lemon of CNN twice called Trump a racist. Not to be left out is the New York Times and for sure the Washington Post.

So we have yet another ‘community of hate’ and is anyone challenging these politicians or media to look inward and ask if they are complicit is all this?

So, what about defamation laws? Glad you asked. Consider the following:

What is Defamation?

Defamation is a common law tort, governed by state law, in which an individual makes a “publication” of a defamatory statement of and concerning the plaintiff that damages the reputation of the plaintiff. Defamation comes in two forms: slander and libel. Slander involves the oral “publication” of a defamatory remark that is heard by another, which injures the subject’s reputation or character. Libel is the written “publication” of a defamatory remark that has the tendency to injure another’s reputation or character.

What are the elements of a cause of action for defamation?

The elements of a defamation suit; whether slander or libel, are:

1. A defamatory statement;

2. Published to a third party;

3. Which the speaker knew or should have known was false;

4. That causes injury to the subject of the communication

So, just how many are really creating more hate and division and the manifestation of this into the full landscape of domestic tranquility or the that matter even when it comes to global relations between the United States and countries across the world?

Active shooters and deadly ambushes on soft targets where very innocent people die is the result of all this high octane rhetoric by some many. Evil pulled the trigger(s). Evil is a form of mental defect. See something say something? Okay, that does often work when it comes to public safety and nabbing criminals. Great. Yet here is another suggestion for a layered approach. How about the cyber wing of our government, suggesting the NSA create a search algorithm that searches online sites including dark parts of the web like that of 8Chan to flush out evil as spelled out in the El Paso shooter’s manifesto? Google, Facebook and Twitter all created and apply these kinds of software tactics. Suggesting the NRA is to blame is without basis, suggesting Trump is to blame is without basis, suggesting that white nationalism is to blame is without basis.

There is no single cure to this community of hate. There must be a layered approach, so having a cogent summit and plan is suggested. After the Parkland shooting, the Trump White House did host a summit and several approaches were suggested including a state by state Red Flag law system to keep schools safe.

How do you legislate away hate that may turn deadly? You don’t but politicians and media must become introspective in this community of hate.

For more consideration is the recent item published by the LA Times. In part:

For two years, we’ve been studying the life histories of mass shooters in the United States for a project funded by the National Institute of Justice, the research arm of the U.S. Department of Justice. We’ve built a database dating back to 1966 of every mass shooter who shot and killed four or more people in a public place, and every shooting incident at schools, workplaces, and places of worship since 1999. We’ve interviewed incarcerated perpetrators and their families, shooting survivors and first responders. We’ve read media and social media, manifestos, suicide notes, trial transcripts and medical records.

Our goal has been to find new, data-driven pathways for preventing such shootings. Although we haven’t found that mass shooters are all alike, our data do reveal four commonalities among the perpetrators of nearly all the mass shootings we studied.

First, the vast majority of mass shooters in our study experienced early childhood trauma and exposure to violence at a young age. The nature of their exposure included parental suicide, physical or sexual abuse, neglect, domestic violence, and/or severe bullying. The trauma was often a precursor to mental health concerns, including depression, anxiety, thought disorders or suicidality.

Second, practically every mass shooter we studied had reached an identifiable crisis point in the weeks or months leading up to the shooting. They often had become angry and despondent because of a specific grievance. For workplace shooters, a change in job status was frequently the trigger. For shooters in other contexts, relationship rejection or loss often played a role. Such crises were, in many cases, communicated to others through a marked change in behavior, an expression of suicidal thoughts or plans, or specific threats of violence.

Third, most of the shooters had studied the actions of other shooters and sought validation for their motives. People in crisis have always existed. But in the age of 24-hour rolling news and social media, there are scripts to follow that promise notoriety in death. Societal fear and fascination with mass shootings partly drives the motivation to commit them. Hence, as we have seen in the last week, mass shootings tend to come in clusters. They are socially contagious. Perpetrators study other perpetrators and model their acts after previous shootings. Many are radicalized online in their search for validation from others that their will to murder is justified.

Fourth, the shooters all had the means to carry out their plans. Once someone decides life is no longer worth living and that murdering others would be a proper revenge, only means and opportunity stand in the way of another mass shooting. Is an appropriate shooting site accessible? Can the would-be shooter obtain firearms? In 80% of school shootings, perpetrators got their weapons from family members, according to our data. Workplace shooters tended to use handguns they legally owned. Other public shooters were more likely to acquire them illegally. Go here for the full article.

When Russia Helps N Korea Cheat on Sanctions, What to Do

Primer: Do you wonder what Russia’s votes on the UNSC really do to help North Korea? Do you wonder about the 40,000+ North Korean slave laborers in Russia add to the North Korean economy each year? About $200 million. How about the Russian oil pipeline that goes through North Korea? What about the rail system between the two countries and how that helps North Korea skirt sanctions with illicit goods transportation? Then there is the alleged legitimate navy and fishing fleets between Russia and North Korea. Money? Or the weekly air flight service from Vladivostok to Pyongyang. Or how Russia provides internet service to North Korea in addition to China, known as SatGate and the fiber optic lines that run along the rail system. Check front companies in China, Singapore and the banking system known as Dalcombank or just flying cash twice a week.

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FDD: The Treasury Department on Monday sanctioned a North Korean trading company official for helping Pyongyang evade U.S. and UN sanctions through illicit activity in Vietnam. The designation, which arrived in the brief interval between two North Korean missile tests in less than a week, suggests that Washington understands the importance of investigating and disrupting North Korea’s extensive overseas illicit networks.

Treasury’s latest target is Kim Su Il, who works for a Vietnam-based trading company on behalf of North Korea’s Munitions Industry Department, which the U.S. and UN have both sanctioned. According to Treasury, Kim helped export UN-sanctioned goods such as anthracite coal, titanium ore concentrate, and other raw materials from North Korea to Vietnam. Both anthracite coal and titanium ore are among the top exports that fund the regime’s illicit activities. Treasury also found that Kim Su Il helped charter ships and export Vietnamese products to North Korea, as well as to China and other undisclosed countries.

Kim Su Il’s designation is a reminder that North Korea’s overseas networks continue to thrive despite sanctions. In January, The Wall Street Journalreported that up to six Chinese-owned vessels transported North Korean coal between North Korea and Vietnam throughout 2018. In March 2018, the UN Panel of Experts also found that North Korean coal shipments to Vietnam go as far back as January 2017 – eight months before the UN Security Council’s comprehensive coal ban on North Korea went into effect. This persistent trade affirms Assistant Secretary of the Treasury Marshall Billingslea’s assessment in 2017 that coal “has been the center of North Korea’s revenue generation” for many years.

In March 2019, the same UN Panel of Experts exposed North Korea’s numerous overseas illicit money-making schemes, which employ networks of front companies, North Korean government workers, and local banks. For example, in Malaysia, North Korea’s intelligence agency, the Reconnaissance General Bureau, operated two companies that provided revenue to Pyongyang: the Malaysia-Korea Partners Group and Global Communications.

The UN Panel also found that foreign governments were applying “insufficient scrutiny” on the activities of North Korea’s overseas banking and government representatives, thereby enabling these company networks to thrive. The lax monitoring has ultimately allowed Pyongyang’s representatives to conduct financial transactions across numerous borders. Chinese banks in particular have been key enablers of North Korea’s actions.

Treasury provided robust evidence of this lax oversight last month when it sanctioned the Russian Financial Society (RFS) for helping North Korea evade sanctions. This designation revealed how a U.S.-sanctioned North Korean banking representative in Moscow exploited local financial service providers, specifically RFS, to conduct business for sanctioned North Korean companies. The incident showed that designating only the North Korean nationals working abroad is not enough. Rather, Washington also should target the banks and financial institutions that allow North Korean government officials based overseas to thrive.

Treasury’s next steps therefore should focus on investigating Kim Su Il’s local network of companies, individuals, and banks. Closing these gaps in enforcement is an indispensable step for maximizing the impact of U.S. sanctions on North Korea.

bin Ladin’s Son Hamza is Dead

U.S. has intel that Osama bin Laden’s son and heir, Hamza, is dead, officials say

The officials would not provide details of how Hamza bin Laden died or if the U.S. played a role. It is unclear if Washington has confirmed his death.

WASHINGTON — The United States has obtained intelligence that the son and potential successor of al Qaeda leader Osama bin Laden, Hamza bin Laden, is dead, according to three U.S. officials.

The officials would not provide details of where or when Hamza bin Laden died or if the U.S. played a role in his death. It is unclear if the U.S. has confirmed his death.

Hamza bin Laden’s last known public statement was released by al Qaeda’s media arm in 2018. In that, he threatened Saudi Arabia and called on the people of the Arabian peninsula to revolt.

Hamza bin Laden is believed to have been born around 1989. His father moved to Afghanistan in 1996 and declared war against the U.S. Hamza went with him and appeared in al Qaeda propaganda videos. As leader of al Qaeda, Osama bin Laden oversaw operations against Western targets that culminated in the Sept. 11, 2001, attacks on New York’s World Trade Center and on the Pentagon.

Navy SEALS killed Osama bin Laden in 2011 during a raid on his Abbottabad, Pakistan, compound. Hamza was not found at the compound. Letters seized from the compound suggested the elder bin Laden wanted his son to join him in Abbottabad and was grooming him as a leader.

Hamza is one of 11 sons of Osama bin Ladin. Hamza bin Laden, the son of the late al-Qaida leader, has married the daughter of Mohammed Atta, the lead hijacker in the 9/11 terror attacks, according to his family. Bin Laden’s wives and surviving children have returned to Saudi Arabia, where they were given refuge by the former crown prince Mohammed bin Nayef. The women and children remain in close contact with Bin Laden’s mother, Alia Ghanem, who told the Guardian in an interview that she remained in regular touch with surviving family members.

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In part from CTC in 2017:

Despite al-Qa`ida’s generally dim view of women, it appears that Usama bin Ladin respected and valued each of his wives. But he was surely familiar with the Qur’an’s warning that, “Try as you may, you cannot treat all your wives impartially.” It was well known that bin Ladin had a favorite. This was Hamza bin Ladin’s mother, Khairia Sabar, a child psychologist from the respected al-Hindi family of Saudi Arabia. The pair had been introduced when Saad, one of bin Ladin’s sons by his first wife, Najwa al-Ghanem, had attended Khairia’s clinic to receive therapy for a mental disorder.3 Khairia was single, in her mid-30s, and in fragile health—an unpropitious situation for a woman in a conservative kingdom where teenage brides are far from uncommon. Bin Ladin, by contrast, was seven years younger, the son of a billionaire, and already making a name for himself as a fundraiser for the mujahideen struggle against the Soviets in Afghanistan. Moreover, by this time, bin Ladin already had two wives. But Najwa, the first of them, encouraged him to pursue Khairia, believing that having someone with her training permanently on hand would help her son Saad and his brothers and sisters, some of whom also suffered from developmental disorders.4

Not surprisingly given Khairia’s age and state of health, she and bin Ladin struggled to conceive. Over the first three years of their marriage, as bin Ladin moved back and forth between Saudi Arabia and the theater of war in Afghanistan, she endured miscarriage after miscarriage. During this time, bin Ladin added a fourth wife to the family—another highly educated Saudi woman, Siham Sabar.5 Then, in 1989, both Siham and Khairia bore him sons. Siham’s was called Khalid, a name that in Arabic means “eternal.” Khairia’s boy was named Hamza, meaning “steadfast.” Thenceforward, in accordance with ancient Arab custom, Khairia became known by the honorific Umm Hamza, the Mother of Hamza. The boy would remain her only child by bin Ladin, but that fact has by no means diminished either Hamza’s importance or Khairia’s.

How About Consulting FBI and SOCOM on Immigration

Homeland Security and Homeland Defense cannot be divided, one relies on the other.

For starters, the FBI has had a long term operation in Central America. The FBI declares the gang operations for instance in El Salvador does affect public safety in America.

“Many of the gang members committing these homicides are 13-, 14-, and 15-year-olds,” he explained, “and every day there are new members coming in.”

“We aren’t facing a group of youths who are rebelling, but a very structured organization conducting criminal activities,” said Luis Martinez, El Salvador’s attorney general and the country’s highest ranking law enforcement officer. “They are using military-grade weapons, and they are using them against the police, military, and prosecutors.”

MS-13 and 18th Street gang members have gained a foothold in numerous U.S. cities, including Los Angeles, Boston, Houston, Charlotte, Newark, and the Northern Virginia suburbs of Washington, D.C. They commit a variety of crimes—mainly trafficking drugs and extorting individuals and business owners—and they maintain strong ties to Central America.

The program is called Central American Law Enforcement Exchange (CALEE).

The success of the Central American Law Enforcement Exchange (CALEE) program hinges on bringing together U.S. and Central American law enforcement officers who share a common cause in the fight against violent transnational gangs. During the most recent CALEE, an important new partner was added to the group—prosecutors.

“We have seen that when prosecutors and investigators work together from the outset, cases tend to have more successful outcomes,” said Special Agent Grant Mann, who helped plan and administer CALEE 2015, the sixth session since the program began in 2009.

In the U.S, it is typical for FBI agents and prosecutors to sit down at the beginning of an investigation to discuss possible charges and investigative strategies. Historically, that collaborative process is less common in Central America—but thanks to programs such as CALEE, it is gaining acceptance.

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At Joint Task Force-Bravo which is located at Soto Cano Air Base, Hondura, the task force supports training engagements, counterdrug missions and humanitarian and disaster relief efforts in Central America.

Southern Command continues support for Guatemala’s counter trafficking efforts, human rights efforts and future U.S. military engagement activities. Guatemalan police unit and an interagency task force – both focused on countering illicit traffickers in the nation in cooperation with the U.S. military.

Additionally, in El Salvador we have partnerships that provides key support to regional counter illicit trafficking efforts. The U.S. military has a Cooperative Security Location hosted at Comalapa International Airport where U.S. aircraft fly missions to detect, monitor and track aircraft or vessels engaged in illicit drug trafficking in the region.

File photo of the Curacao/Aruba Cooperative Security Location. (U.S. Air Force photo)

The CSLs are not bases.  They are tenant activities on existing airfields whose purpose is to support CTOC missions (see more on SOUTHCOM’s role in Countering Transnational Criminal Organizations).

U.S. Southern Command oversees the operations from the CSLs.  The Key West, Fla.-based Joint Interagency Task Force South coordinates U.S. aircraft usage and operations.

From these locations, U.S. detection and monitoring aircraft fly missions to detect, monitor and track aircraft or vessels engaged in illicit drug trafficking. The unarmed aircraft offer unique surveillance capabilities that support and compliment the counter-drug efforts of partner nation law enforcement agencies. (Note: Host nation officials are responsible for decisions to interdict suspected traffickers within their borders/airspace, and U.S. law enforcement agencies lead interdiction efforts in international waters.)

U.S. military, Drug Enforcement Agency, U.S. Coast Guard and U.S Customs personnel operate from the CSLs to support the U.S. aircraft and to coordinate communications and information.   More here.

The House Armed Services Committee is chaired by Democrat Adam Smith. Back in May of 2019, Chairman Smith admitted several crisis conditions in Central America, the Southern border and Latin America. This included the flow of migrants and the flaws of the asylum laws. However, Congressman Adam Smith still blames the Trump White House for the cause of the crisis.

There continues to be particular focus and resource attention on Venezuela which does affect other neighboring countries. Southern Command leader Adm. Faller declares that Iran, China and Russia exacerbate the problems not only in Venezuela but also in Central America. This rogue foreign actor declaration was also validated by other national security experts in the hearing, noting Kathryn Wheelbarger, acting assistant defense secretary for international security affairs and Kenneth Rapuano, assistant secretary for homeland defense and global security.