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.

Is the U.S. Prepared for Foreign Interference of 2020 Elections

The Democrats continue to declare the Russians helped Donald Trump win the presidency and that now President Trump has done nothing to prevent Russian interference of the 2020 elections.

DHS is worried about our elections, and it's asking ...

But we need to look at some real facts.

  1. DHS launched several programs to aid the U.S. security of the nation’s elections systems. Beginning in 2017, a National Infrastructure Protection Plan was launched which began the real partnership with Federal, State and local governments including private sector entities. The sharing of timely and actionable threats, cybersecurity assistance including sensors all at no charge to election officials. Scanning, risk assessment and analysis along with training are all part of the Protection Plan, including conference calls scheduled as needed. What is most interesting is this program was initiated by a Presidential Policy Directive #21 signed by then President Obama in 2013.
  2. As ODNI Dan Coats has tendered his resignation effective in mid-August, many have said he has no accomplishment. This agency is merely an intelligence coordinator of many agencies and is bureaucratic but Coats did create a position that is dedicated to election security efforts and is headed by Shelby Pierson who has a deep resume in intelligence and was a crisis manager for election security in the 2018 elections. He has briefed the House Oversight and Government Reform Committee several times so for any Democrat to declare that the Trump administration has done nothing is false.
  3. DHS has a resource library including a checklist that is available for free for any election officials that can be accessed as new threats or conditions arise. This library includes HTTPS encryption techniques, incident response, ransomware best practices and securing voter registration data. Additionally, email authentication techniques are available, layering credentialed access logins, security baselines, monitoring intrusions and brute force attack attempts are shared with all participating partners.

All of these efforts are positive steps against foreign interference, however fake news and rogue actors are crafty, resourceful and well financed. The United States is not the only country that is a victim of foreign intrusions.

Foreign spy services that are utilizing information operations in order to influence US elections reportedly include —aside from Russia— Israel, Saudi Arabia, the United Arab Emirates, Venezuela and China.

The majority of foreign information operations take place on social-media platforms such as YouTube, Twitter, Instagram and Facebook. But there are also campaigns to influence more traditional American media, for instance by tricking newspapers into publishing letters to the editor that are in fact authored by foreign intelligence operatives. Analysts from FireEye, Graphika and other cybersecurity and network-analysis firms told The Postthat some information operations are difficult to detect, because the presence of a state security service is not always apparent. However, the messages that are communicated in tweets, Facebook postings, online videos, etc., tend to echo —often word for word— the rhetoric of foreign governments, and promote their geopolitical objectives. As can be expected, these objectives vary. Thus, Russian, Israeli and Saudi information operations tend to express strong political support for US President Donald Trump, arguably because these governments see his potential re-election as a development that would further their national interest. In contrast, Iranian information operations tend to lambast Trump for his negative stance on the Iranian nuclear deal and for his support for Saudi Arabia’s intervention in the Yemeni Civil War.

Stanley McChrystal has called for a nonpartisan, non-governmental Fair Digital Election Commission to protect the integrity of our elections by detecting, exposing, evaluating and remediating the impact of disinformation. Well we already have one where non-government cyber experts are collaborating with government officials and issuing attributions to the cyber actors as well as recommendations.

Fake news and false news influence voter’s attitudes. So one must ask where in Silicon Valley and the tech giants? We already know that Instagram, Facebook, Google, YouTube and Twitter are censoring so voters must be diligent in research and cautious themselves regarding the spread of fake news and validating stories beyond just reading the headlines.

Last year, 2018:

A new study by three MIT scholars has found that false news spreads more rapidly on the social network Twitter than real news does — and by a substantial margin.

“We found that falsehood diffuses significantly farther, faster, deeper, and more broadly than the truth, in all categories of information, and in many cases by an order of magnitude,” says Sinan Aral, a professor at the MIT Sloan School of Management and co-author of a new paper detailing the findings.

“These findings shed new light on fundamental aspects of our online communication ecosystem,” says Deb Roy, an associate professor of media arts and sciences at the MIT Media Lab and director of the Media Lab’s Laboratory for Social Machines (LSM), who is also a co-author of the study. Roy adds that the researchers were “somewhere between surprised and stunned” at the different trajectories of true and false news on Twitter.

Moreover, the scholars found, the spread of false information is essentially not due to bots that are programmed to disseminate inaccurate stories. Instead, false news speeds faster around Twitter due to people retweeting inaccurate news items.

“When we removed all of the bots in our dataset, [the] differences between the spread of false and true news stood,”says Soroush Vosoughi, a co-author of the new paper and a postdoc at LSM whose PhD research helped give rise to the current study.

The study provides a variety of ways of quantifying this phenomenon: For instance,  false news stories are 70 percent more likely to be retweeted than true stories are. It also takes true stories about six times as long to reach 1,500 people as it does for false stories to reach the same number of people. When it comes to Twitter’s “cascades,” or unbroken retweet chains, falsehoods reach a cascade depth of 10 about 20 times faster than facts. And falsehoods are retweeted by unique users more broadly than true statements at every depth of cascade.

The paper, “The Spread of True and False News Online,” is published today in Science.

 

 

Meet the United Front Work Department

The U.S. should perhaps scrapping any trade deal with China. Why?

Just this week, the United States Navy and Taiwanese authorities sailed through the Taiwan Strait. China threatened use of force to thwart any U.S. move over the partnership with Taiwan. So, the U.S. just tested that.

As an aside, the United States just approved a major sale of weapons requested by Taiwan totaling $2.2 billion. This is actually in compliance with U.S. law where we are to provide Taiwan with sufficient equipment and services for self-defense.

As part of the U.S. 7th Fleet, a guided missile cruiser transited the route continuing efforts to keep free and open the Indo-Pacific. President Trump is defying China and should actually as we dont respond to threats of war all while the White House National Security advisor John Bolton is in S. Korea. China continues to push the One China principle so as not to harm relations. Meanwhile, China has a robust active measures operation going on in Washington DC. So read on.

China’s Communist Party is intensifying covert influence operations in the United States that include funding Washington think tanks and coercing Chinese Americans, according to a congressional commission report.

The influence operations are conducted by the United Front Work Department, a Central Committee organ that employs tens of thousands of operatives who seek to use both overt and covert operations to promote Communist Party policies.

Johns Hopkins School of Advance International Studies, a major foreign policy education and analysis institute, has received funding from Tung Chee-hwa, a vice chairman of the Chinese People’s Political Consultative Conference, the party group that directs the United Front Work Department and includes a member of the Politburo Standing Committee, the collective dictatorship that rules China.

The funding for Johns Hopkins came from Tung’s non-profit group in Hong Kong, the China-U.S. Exchange Foundation, which is a registered Chinese agent.

In addition to Johns Hopkins, other think tanks linked to China and influential in American policy circles include the Brookings Institution, Atlantic Council, Center for American Progress, EastWest Institute, Carter Center, and the Carnegie Endowment for International Peace.

The Exchange Foundation is tied to Chinese government influence operations and uses the same public relations firm as the Chinese embassy. More here.

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President Xi views United Front work as an important tool to strengthen support for the CCP both inside and outside China by exploiting individuals’ emotional and ideological sympathies for China and providing financial support to key groups and individuals.24 Although the importance of United Front work declined after the founding of the People’s Republic of China,* a number of Western analysts agree it has regained its prominence since then, and especially since the rise of Xi Jinping, as Beijing has embraced a much more assertive approach to foreign policy.25In his address to the 19th National Congress of the CCP† in October 2017, President Xi called United Front work“an important way to ensure the success of the [Chinese Communist] Party’s cause” and urged the CCP to form the “broadest possible patriotic United Front.”26 President Xi has also called United Front work a “magic weapon” that is important for bringing about “the great rejuvenation of the Chinese nation.”

Several pieces of U.S. legislation in 2018 have included important provisions for countering CCP and other malign foreign influence.‡ Representative Joe Wilson (R-SC) and Senators Rubio and Tom Cotton (R-AK) introduced legislation in March 2018, titled the Foreign Influence Transparency Act, which would require organizations that promote the political agendas of foreign governments to register as foreign agents§ and would require universities to disclose certain donations and gifts from foreign sources.127 Senator Ted Cruz (R-TX) introduced the Stop Higher U.S.-China Economic and Security Review Commission 15Education Espionage and Theft Act in May 2018, which is intended to strengthen the U.S. government’s ability to counter foreign intelligence organizations working inside the U.S. educational system.128 Senator Rubio and his Congressional-Executive Commission on China co-chair Representative Chris Smith (R-NJ), along with co-sponsors, introduced companion bills in the Senate and House in June 2018 calling for the establishment of an interagency task force to compile an unclassified report on CCP influence operations targeting the United States and certain U.S. allies.129 Most significantly, the National Defense Authorization Act for 2019 contains important provisions to coordinate the U.S. government response to malign foreign influence operations and campaigns—including specifically by China.* Read in full here.