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Wednesday, September 18, 2024

Billionaire Paulson says he’ll yank his money from market if Harris wins election

 Billionaire hedge fund manager John Paulson has threatened to remove his money from the US markets if Vice President Kamala Harris defeats former President Donald Trump in November’s presidential election.

The Paulson & Co. founder — also a Trump megadonor — made the shocking revelation during his appearance on Fox Business’ “The Claman Countdown,” on Tuesday.

“It depends on the policy, if Harris is elected I would pull my money from the market,” Paulson said. “I’d go into cash and I’d go into gold because I think the uncertainty regarding the plans they outlined would create a lot of uncertainty in the markets and likely lower markets.”

Paulson cited the policies Harris’ campaign laid out that would focus on more centralized price controls and new government spending programs.

Economists have estimated the plans to cost over $1.7 trillion.

The future of the American stock market and economy relies on the winner of the Nov. 5 general election, the 64-year-old investor insisted.

“It very much depends on who is in the White House and who controls Congress,” Paulson said. “I’d be very concerned if Harris is elected and pursues the tax plans and other economic plans that she articulated.”

“If they do implement a 25 percent tax on unrealized gains, that would cause mass selling of almost everything — stocks, bonds, homes, art. I think it would cause a crash in the markets and a pretty quick recession.

Paulson, known for his lucrative bet against the subprime mortgage in 2007, backed his threat by confirming he would sell his liquid equities if the current Veep wins the Nov. 5 election.

The hedge fund manager hosted a fundraiser for the Trump campaign in Palm Beach, Fl. in April that raised over $50 million, breaking the single-event fundraising record.

While GOP megadonors attended the record-breaking event, Paulson believes the 2024 Presidential election comes down to the middle class.

“I think the middle class is key for this election,” Paulson said. “And who’s gonna do better for the middle class. When you look at the facts, the Trump policy had come out better for the average American.”

The hedge fund manager hosted a fundraiser for the Trump campaign in Palm Beach, Fl. in April that raised over $50 million, breaking the single-event fundraising record.AP

“Under his administration of the four years, average real wages grew about 6.5%,” he claimed. “Under Biden, because of the high inflation, real wages have declined from where they were when he started.”

“That’s why so many middle[class] Americans are having so many difficulties with common expenses like rent and food.”

Paulson believes inflation is coming down, but there’s more that can be done to help it.

The future of the American stock market and economy relies on the winner of the Nov. 5 general election, the 64-year-old investor insisted.Getty Images

“The important thing is keeping it down and to do that you need to bring down the deficit, bring down inflation and bring down the interest rates.

House Speaker Mike Johnson knocked “Camrade Kamala’s” economic plan, saying it’s like “Oprah (Winfrey) is running for president.”

“Candidate ‘Comrade Kamala’ Harris — as President Trump is known to call her — now wants to take it to a whole different level,” the House speaker said.

During her first 100 days, Harris would provide $25,000 in federal down payment assistance for first-time homebuyers who pair their rent on time for at least two years and lower- and middle-income families having children, in addition to her controversial plan to fix prices on groceries.

House Speaker Mike Johnson knocked “Camrade Kamala’s” economic plan, saying it’s like “Oprah (Winfrey) is running for president.”REUTERS
“We’ll keep those cuts in place to support job creation, along with the doubled guaranteed deduction and a strong child tax credit,” Johnson said in response to Harris’ plan.AP

Johnson shot back at the vice president’s plans, laying out the Republican’s “very-aggressive” first 100 days agenda, if the GOP were to win back control of Congress and the White House.

“We’ll keep those cuts in place to support job creation, along with the doubled guaranteed deduction and a strong child tax credit,” he promised.

“But unlike the Democrats’ proposal, we will ensure that our tax policy respects the dignity of work and does not pay people more for staying out of the workforce.”

https://nypost.com/2024/09/18/us-news/billionaire-hedge-fund-manager-john-paulson-says-hell-pull-money-from-market-if-kamala-harris-wins-presidential-election/

FDA Approves Merck’s Keytruda for First-Line Treatment of Pleural Mesothelioma

 

The mesothelioma approval for the Keytruda combination regimen potentially unlocks a $12 billion market opportunity, according to a recent report from research firm IMARC Group.

The FDA on Wednesday approved a new indication for Merck’s blockbuster cancer therapy Keytruda (pembrolizumab), adding pleural mesothelioma to the already-extensive list of malignancies that the PD-1 inhibitor can be used for.

Wednesday’s label expansion covers the use of Keytruda with pemetrexed and platinum chemotherapy to treat adult patients with unresectable advanced or metastatic malignant pleural mesothelioma, a type of cancer that originates in the linings of the chest and the lungs. The Keytruda-based regimen can be used in the frontline setting in this indication.

“We’re pleased to offer a new first-line treatment option for adult patients with unresectable advanced or metastatic malignant pleural mesothelioma, a disease where prognoses are generally poor,” Gregory Lubiniecki, vice president of oncology clinical research at Merck Research Laboratories said in a statement.

The pharma’s application for Keytruda in this indication was backed by findings from the Phase II/III KEYNOTE-483 trial, which enrolled 440 patients for its late-stage phase, regardless of their PD-L1 expression levels. The Keytruda regimen was compared against pemetrexed and cisplatin or carboplatin. The FDA accepted Merck’s filing in May 2024 and granted in Priority Review.

Results from KEYNOTE-483 showed that Merck’s PD-1 blocker yielded significant survival benefit for patients, cutting the risk of death by 21%. Median overall survival (OS) was 17.3 months in patients who received the Keytruda combo, as compared to 16.1 months in patients treated with chemotherapy alone.

The Keytruda regimen also led to significantly better progression-free survival, reducing the likelihood death or disease progression by 20% versus chemotherapy alone. Overall response rate was likewise significantly better in the combo treatment arm.

In terms of safety, Keytruda’s side effects in KEYNOTE-483 were broadly consistent with what had been established in previous studies. However, Merck in its announcement emphasized that immune-mediated events can occur in any organ system during or after treatment with Keytruda. These episodes can be severe or fatal, according to the pharma.

Wednesday’s mesothelioma approval for Keytruda opens up a multibillion-dollar opportunity for Merck. According to an August 2024 report from research and consulting firm IMARC Group, the malignant mesothelioma market is expected to exceed $12 billion in value by 2034. From 2024 to 2034, the space is expected to hit a compound annual growth rate of 6.5%.

Another player in the mesothelioma space is Bristol Myers Squibb with its own PD-1 blocker Opdivo (nivolumab), which was approved as a first-line treatment for malignant pleural mesothelioma in August 2020, in combination with the anti-CTLA-4 therapy Yervoy (ipilimumab). According to the IMARC report, there is a “robust pipeline” of other developmental therapies for mesothelioma, and the space is expected to grow even more rapidly as the industry adopts a more personalized and targeted approach to treatment and increases its focus on early detection.

https://www.biospace.com/fda/fda-approves-mercks-keytruda-for-first-line-treatment-of-pleural-mesothelioma

'Sanders Says Generics Companies Can Make, Sell Ozempic for Less Than $100 a Month'

Ahead of a Senate health committee hearing next week with Novo Nordisk CEO Lars Jørgensen, Sen. Bernie Sanders claims he has secured assurances from generics developers that they will charge a significantly lower monthly price than the $969 Americans currently pay for the Danish drugmaker’s blockbuster.

Sen. Bernie Sanders (I-Vt.), chair of the Senate health committee, on Tuesday announced that generic versions of Novo Nordisk’s blockbuster type 2 diabetes medication Ozempic can be produced and sold profitably for less than $100 a month.

Speaking at his committee’s expert roundtable, Sanders revealed that CEOs of several major generics companies have confirmed to him that it is possible to sell Ozempic generics, “the exact same drug that Novo Nordisk is manufacturing,” according to the senator—at a dramatically lower price. Currently, the pharma charges patients in the U.S. nearly $1,000 per month for the drug, according to Sanders.

The roundtable comes ahead of a Senate health committee hearing next week, where Novo Nordisk CEO Lars Fruergaard Jørgensen is slated to testify about the pharma’s pricing practices for Ozempic and Wegovy.

Sanders recently ramped up his critique of what he calls the “outrageously high prices” of Novo’s diabetes drug Ozempic and its sister semaglutide brand Wegovy, which is indicated for chronic weight management. In April 2024, the senator launched a probe into Novo’s pricing scheme, blasting how disproportionately more expensive these drugs are in the U.S. compared to other countries.

While a monthly supply of Ozempic goes for $969 in the U.S., patients in Canada and Germany can access the medication for $155 and $59, according to Sanders. Wegovy, meanwhile, sells for $1,349 per month in the U.S. and only $92 in the U.K. At these prices, Ozempic and Wegovy could potentially “bankrupt Medicare, Medicaid, and our entire healthcare system,” Sanders contends.

“The result of this absurd reality is that while 10 top pharmaceutical companies made over $110 billion in profits last year, 1 out of 4 Americans cannot afford the medicine their doctors prescribe,” the senator said at Tuesday’s roundtable meeting.

Sanders highlighted a March 2024 study in the Journal of the American Medical Association which found that injectable semaglutide can be manufactured at a profit for lower than $5 per month. Other GLP-1 therapies can also be produced at much cheaper than their current prices, according to the study, which noted that biosimilar and generic competition could further reduce prices.

In July 2024, Sanders co-wrote an opinion piece with President Joe Biden—published in USA Today—taking aim at both Novo and rival GLP-1 leader Eli Lilly for their “unconscionably high prices” for their therapies.

Novo Nordisk has reaped large rewards from its status as a frontrunner in the lucrative obesity market. In 2023, the Danish drugmaker generated around $33.7 billion in sales, easily beating analyst expectations driven by a 38% jump in GLP-1 diabetes revenues and a massive 147% growth in its obesity portfolio. Meanwhile, Lilly’s 2023 revenue exceeded $34 billion, growing 20% year-over-year. Its tirzepatide brands Mounjaro and Zepbound made $5.1 billion and $176 million, respectively.

https://www.biospace.com/policy/sanders-says-generics-companies-can-make-sell-ozempic-for-less-than-100-a-month

HRSA Threatens J&J With Sanctions Over Planned 340B Rebate Scheme

 

If Johnson & Johnson refuses to scrap its proposed changes to the 340B drug pricing for hospitals, it risks the termination of participation in the program and monetary fines, the Health Resources and Services Administration warned.

The U.S. Health Resources and Services Administration on Tuesday wrote a letter to Johnson & Johnson CEO Joaquin Duato, insisting that the pharma cease implementation of proposed modifications to its 340B drug discount policy.

If J&J refuses to comply, it will be in violation of its original obligations under the federal discount program for hospitals and will be open to “potential consequences,” according to the agency. These include the termination of J&J’s participation in the 340B program and other “civil monetary penalties.”

The pharma has until the end of the month to inform the Health Resources and Services Administration (HRSA) of its decision.

Tuesday’s warning from HRSA follows a previous announcement from J&J that it will implement sweeping changes to how it lowers drug costs under 340B. Instead of offering upfront discounts, the pharma plans to require participating hospitals to first purchase drugs at full price and then offer rebates later, subject to “validation.”

The 340B changes are slated to cover J&J’s blood thinner Xarelto (rivaroxaban) and blockbuster antibody Stelara (ustekinumab) and will go into effect on Oct. 15, 2024.

To qualify for rebates, hospitals should file their requests within 45 days of dispense and submit data related to the use and purchase of Xarelto and Stelara, according to the company. Rebates will be handed out “once the number of validated dispensed units equals the number of units in the purchased package size,” J&J noted at the time.

In its letter on Tuesday, HRSA slammed J&J’s “unapproved rebate proposal” noting that it “violates J&J’s obligations under the 340B statute.” The 340B program indicates that drugmakers enter into an agreement with the Secretary of the Department of Health and Human Services and arrive at a specific amount to be paid to the manufacturer, “taking into account any rebate or discount, as provided by the Secretary,” HRSA pointed out.

“The Secretary has not ‘provided’ that the rebates described in J&J’s notice” should be considered when determining the amount to be paid for Stelara and Xarelto, according to the agency.

J&J in a statement to STAT News said that it will continue to work “constructively” with HRSA to identify ways to “modernize” the 340B program “for a more sustainable future.”

Implemented in 1992, the 340B program establishes drug discounts for certain hospitals who in turn prescribe these medicines to patients that fall below the federal poverty level. The industry has in recent months tried to impose restrictions on the program, limiting the discounts available for hospitals that dispense the drugs through third-party pharmacies.

https://www.biospace.com/policy/hrsa-threatens-j-j-with-sanctions-over-planned-340b-rebate-scheme

Biden's Department Of Energy Short On Cash To Refill SPR At Low Prices

 By Charles Kennedy of OilPrice.com

The price of the U.S. WTI crude oil has finally stayed in the low $70s per barrel for a sustainable period of time, allowing the Biden Administration to ramp up the refill of the Strategic Petroleum Reserve (SPR), which it had said would do at prices of $79 a barrel or below.

WTI Crude is now at $70 per barrel as of Tuesday morning, after spending days below that threshold.

But the Energy Department has just $841 million left to buy crude for the SPR, Bloomberg reported on Tuesday, citing an estimate by ClearView Energy Partners, a consulting firm. That money would be enough to buy only around 12 million barrels of crude at today’s prices, per Bloomberg’s calculations.

This would be a drop in the ocean, considering that the SPR is only just over half full compared to its capacity of 700 million barrels.

DOE's Office of Petroleum Reserves has recently announced a call for bids to supply up to 1.5 million barrels of oil to the Bayou Choctaw site in January 2025. An additional solicitation will follow on August 12, 2024, for another 2 million barrels destined for the Bryan Mound site, also for delivery in January 2025.

The replenishment strategy comes in the wake of the SPR's critical role in stabilizing the market during global supply disruptions, notably the release of more than 180 million barrels of oil from the SPR starting in 2021, as gasoline prices remained high. The Department of Treasury claims that these releases, along with coordinated international efforts, helped reduce gasoline prices by up to 40 cents per gallon in 2022.

The SPR currently houses 375 million barrels of crude—a figure that is 263 million barrels less than oil in the SPR at the beginning of President Joe Biden’s term in office. The SPR, capable of storing as many as 714 million barrels of crude oil, is kept in underground salt caverns at four sites in Texas and Louisiana and was designed to protect the economy and American livelihoods during oil shortages.

https://www.zerohedge.com/energy/bidens-department-energy-short-cash-refill-spr-low-prices

Taiwan Firm Gold Apollo Says Didn't Make Exploding Beepers From Hell Used By Hezbollah

 Taiwanese pager manufacturer Gold Apollo Co., at the center of the exploding pagers incident used by Hezbollah fighters in Lebanon—resulting in nine deaths and nearly 3,000 injuries—shifted the blame onto Budapest-based BAC Consulting Kft. 

The Washington Post cites Hsu Kuang, the founder of Gold Apollo, who told reporters that BAC Consulting "entirely handled" the AR-924 pager manufacturing process. 

On Wednesday, Kuang told reporters at the company's headquarters in New Taipei City that BAC has been selling Gold Apollo's pager brand for less than two years. He was completely stumped by how a pager could be weaponized into an explosive device. 

"I'm just doing my business, why am I getting involved in a terrorist attack?" he told reporters, adding, "The product was not ours. It was only that it had our brand on it."


A statement from Gold Apollo noted that it authorized "BAC to use our brand trademark for product sales in specific regions, but the design and manufacturing of the products are entirely handled by BAC." 

On Tuesday, at around 330 local time across Lebanon, the pagers from hell exploded. Sources told Reuters that Hezbollah fighters began recently using pagers to evade Israeli tracking of their locations. 

Here's more about the exploding pagers from Bloomberg

One of the outstanding questions is how the blasts were planned and then triggered with such coordination. Small amounts of explosive were planted in beepers that Hezbollah had ordered, the New York Times reported, citing US and other officials briefed on the operation. Just one or two ounces of the material was added next to the battery of each pager, and a switch was embeded to trigger the detonation, the newspaper reported. Devices exploded simultaneously around the country at about 3:30 p.m.

Meanwhile, the Lebanese government has identified "Israeli aggression" as being behind the attack, while Hezbollah also says it holds Israel "fully responsible." Israel has yet to issue an official comment, but there are several reports from the region that war preparations are underway.

According to a report prepared by the American Center for Levant Studies (ACLS), early estimates suggest 4,000 Hezbollah fighters were injured in yesterday's attack, affecting about a quarter of leadership. 

Around 4,000 Hezbollah operatives in Lebanon were injured after their communication pagers exploded. Eleven members of Hezbollah, including leaders, were confirmed dead in today's attack with 400 in critical condition and 500 losing their sight. This significant blow left 10% to 25% of the party's leadership out of service, marking a major disruption in Hezbollah's command structure. Experts in the region are calling the incident a "checkmate" for Hezbollah. Explosions spread into Syria as devices detonated in a car in Damascus, injuring 18 fighters.

ACLS noted that pentaerythritol tetranitrate explosives were embedded into each of the pagers:

The pagers, acquired as part of a technological upgrade, were brought to Lebanon five months ago from the Taiwanese company Gold Apollo. The explosive material was inserted before the devices arrived in Lebanon. Initial reports indicate they contained PETN, a powerful explosive material. Each device had no more than 20 grams of PETN, known for its strength and sensitivity. While PETN doesn't explode on impact or ignition, it can be triggered by continuous vibrations. For reference, 1 kilogram of PETN equals 1.25 kilograms of TNT. Repeated, continuous messages sent to the pagers caused prolonged vibrations, leading to the explosion.

Now, everyone is checking their electronic devices for explosives.

https://www.zerohedge.com/geopolitical/taiwanese-firm-gold-apollo-says-it-didnt-make-exploding-pagers-hell-used-hezbollah

US Secures Convictions, Guilty Pleas As CCP-Directed Spying Exposed

 by Eva Fu, Catherine Yang via The Epoch Times (emphasis ours),

For years, Beijing has been deepening its hold on America, drawing intelligence from the U.S. government while silencing critics with the help of agents embedded in U.S. society.

The United States is now hitting back—and seeing results.

In early September, prosecutors arrested Linda Sun, former aide to New York Gov. Kathy Hochul, accusing her of acting on behalf of Beijing in exchange for gifts and payouts valued in millions of dollars to her family.

There has also been a marked increase in the rate of convictions or pleas in recent months. The Justice Department has brought forth dozens of CCP-directed espionage and foreign agent cases in the past four years, resulting in at least 13 convictions or pleas, with more than half of those taking place this year—including three in the past month. an Epoch Times review of the court records show.

On Aug. 6, a Chinese American scholar posing as a pro-democracy activist was convicted by a jury for spying on dissidents for the CCP.

On Aug. 13, a U.S. army intelligence analyst from Texas pleaded guilty to selling military secrets to the CCP.

On Aug. 23, a software engineer who worked two decades at Verizon pleaded guilty to gathering intelligence on countless dissidents and organizations targeted by the CCP since 2012.

Case documents reveal a broad range of criminal actions taken by agents, often different from what most may imagine to be spying. Beyond industrial espionage and covert influence campaigns, the regime has directed hacker rings, including a group that was charged and sanctioned this year for waging a 14-year campaign on the United States.

“I feel that our nation must take every opportunity to stop these threats,” Rep. Don Bacon (R-Neb.), chair of the cybersecurity subcommittee for the House Armed Services Committee, told The Epoch Times, noting that the U.S. intelligence community has identified Beijing as the number one threat to the United States.

Bacon has experienced Chinese espionage attempts firsthand. Last year, he was hacked by CCP-linked hackers who also broke into email systems of State and Commerce department officials and dozens of other groups.

Can we ever say that whatever actions we are taking are enough? I don’t believe so as the threats are increasing in frequency, sophistication, and national security impact,” Bacon said.

Who Are the Spies?

The CCP has long targeted people of Chinese descent—of whom there are more than 60 million people outside China—as potential assets in its intelligence operations.

Among those charged by the DOJ in the foreign agent cases are officials of the CCP’s top intelligence gathering agency Ministry of State Security (MSS), Chinese citizens traveling to the United States under false pretenses, hackers residing in Asian countries; as well as asylees, permanent residents, and U.S. citizens of Chinese descent.

Some reside in the United States while dozens of others charged are known to reside in China, and will now face arrest if they ever set foot on American soil.

There are also many who are U.S. citizens that aren’t of Chinese descent. They include active military members, former law enforcement, and experts in competitive fields.

Linda Sun, a former aide to New York Gov. Kathy Hochul, and her husband, Chris Hu, exit the federal court in Brooklyn after Sun was charged with acting on behalf of the Chinese Communist Party, in New York City on Sept. 3, 2024. Kent J. Edwards/Reuters

The CCP engages in what experts such as Casey Fleming, chair and CEO of risk consultancy BlackOps Partners, describe as “unrestricted warfare,” meaning there are no legal, ethical, or moral lines it will not cross to pursue its objectives. It capitalizes on one’s baser instincts—greed, pride, lust, shame—to recruit assets.

“Number one, it’s money. Number two, it’s ego. Number three, it’s blackmail,” Fleming, who advises the DOJ, FBI, and Congress on the CCP threat, told The Epoch Times.

In May, two New Yorkers pleaded guilty in an indictment that charged seven, including MSS officials in China, for trying to coerce an American family to go back to China to be imprisoned by the CCP.

The defendant had harassed the Chinese man with bogus lawsuits and told the victim it “really is a drop in the bucket for a country to spend $1 billion” to achieve what the CCP ordered, promising “endless misery” for the victim, he said. “It is definitely true that all of your relatives will be involved.”

In January, a former U.S. Navy sailor was sentenced to 27 months for giving sensitive military information to the CCP over the course of almost two years, in return for about $14,000.

“I mean, he’s paying me so I was like, okay, I’ll just do whatever he says,” the sailor told the FBI in an interview, describing the job as “easy money.”

Several other cases involving former military members include an indicted Navy sailor and army soldier, and a former U.S. army helicopter pilot who pleaded guilty.

Last month, Sgt. Korbein Schultz, an army intelligence analyst with the First Battalion of the 506th Infantry Regiment at Fort Campbell, pleaded guilty to sending military secrets to a CCP agent, receiving $42,000 in return.

Beginning around June 2022, Schultz began sending sensitive military files to an unnamed conspirator working for the CCP.  Schultz received payment up to $1,000 per document in return.

A month into the partnership, Schultz told the conspirator he would like to turn the relationship into a long term one, according to the indictment. He provided materials including details about U.S. precision rockets, their performance, and how they would be used. He also shared manuals and technical data of several US aircraft, documents referencing the Chinese military, and documents related to the U.S. military forces in the Indo-Pacific.

(left) Zhu Yong returns to Brooklyn Federal Court for a trial in New York City on May 31, 2023. America's first federal trial got underway over China's alleged attempts to forcibly repatriate its citizens under a campaign known as Operation Fox Hunt. (right) Congying Zhen leaves Brooklyn Federal Court in New York City on May 31, 2023. Yuki Iwamura/AFP via Getty Images

The conspirator asked for information of higher levels of classification as the partnership progressed and promised higher payments for more exclusive information.

“I hope so! I need to get my other BMW back!” Schultz wrote in response to the promise of higher pay. He told the conspirator he wished he could be “Jason Bourne,” and brought up the idea of moving to Hong Kong so he could work for the conspirator in person.

Four months into the partnership, the conspirator raised the suggestion of recruiting another service member who had access to higher classified information, and Schultz set out to do so over the next few months.

In another case, two men who pleaded guilty in July to acting as CCP agents had tried to bribe an IRS agent to target Falun Gong practitioners. Falun Gong, also known as Falun Dafa, is a spiritual practice with five meditative exercises and teaches the principles truth, compassion, and tolerance. Since 1999, the CCP has sought to “eradicate” the practice in a whole-of-state approach.

Unbeknownst to the two men, the IRS agent was an undercover FBI agent, who took the $5,000 bribe and offer of $50,000 total as evidence in their case. In a recorded call, one of the two men, John Chen, said the money came from Chinese authorities, who were “very generous” when it came to their goal to “topple” Falun Gong.

Insider Threat

Fleming says some “insider threats” were planted in companies and the military decades ago, pointing to the former Verizon software engineer who had been sending the CCP data on Chinese dissidents in America since at least 2012 as an example, and companies are now beginning to recognize the long term effort with these high profile cases.

Some recruits are attracted by the money, others prestige. “They’ve done that to Harvard professors and so on: ‘We’re going to let you set up a sister lab in China ... and you’ll be the head of the lab,‘” Fleming said as an example. “’You’re so smart and accomplished. We‘d like you to do a white paper.’”

Fleming said he receives a few of these offers a year himself. The most recent one, from Hong Kong, came just months ago. He promptly deleted it. “I know what’s going on, but many people don’t, and they take $7,500 to do a white paper,” Fleming said.

https://www.zerohedge.com/political/us-secures-convictions-guilty-pleas-ccp-directed-spying-exposed