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Pharma Bro Shkreli Launched “Unmonitored Drug Trial” With No FDA Oversight: Prosecutors

Martin Shkreli

Embattled “Pharma bro” Martin Shkreli launched an “unmonitored drug trial in Cyprus” without FDA oversight for a treatment under development by his former company, Retrophin, according to federal prosecutors who are seeking a 15-year prison sentence on charges of securities fraud.

Shkreli was ordered to forfeit over $7.3 million in assets, including his one-of-a-kind Wu-Tang album he said he’d release if Trump won.

Along with the Wu-Tang Clan “Once Upon a Time in Shaolin” album that Shkreli has boasted he bought for $2 million, he would have to give up $5 million in cash in a brokerage account. He also would be forced to forfeit other valuables including a Picasso painting and another unreleased recording that he claims he owns, “Tha Carter V” by Lil Wayne. –ABCny7

The results of the drug trial conducted without FDA oversight were used to obtain “single-patient results that” were used in a Retrophin financial filing that was not disclosed during the company’s 2014 IPO, noted prosecutors.

The drug trial was mentioned by prosecutors to counteract what they said was a “highly misleading” portrayal by Shkreli’s defense team about his work on a drug to cure the condition known as PKAN.

Prosecutors said that because of that portrayal, among other things, Shkreli does not deserve a sentence lighter than the very stiff one being recommended by federal sentencing guidelines. –CNBC

PKAN is a childhood neurodegenerative genetic disease which ultimately leads to death. Shkreli and two other men, Andrew Vaino and Marek Biestek hold the patent on RE-024, a drug they hope can cure the condition, which only affects around 5,000 people worldwide.

“There are no approved treatment options for PKAN and current therapeutic strategies are limited to symptom management,” Retrophin says on its site.

During sentencing recommendations last week, Shkreli’s lawyers stated “With this patent, Retrophin was able to begin studies and clinical trials to drastically improve the lives of thousands of patients suffering from this terrible disease.”

Retrophin is currently enrolling patients in a “phase 3 clinical trial” of RE-024 according to their website, which is “being conducted under a Special Protocol Assessment (SPA) agreement, which indicates concurrence by the U.S. Food and Drug Administration (FDA) that the design of the pivotal trial can adequately support a New Drug Application (NDA) seeking U.S. approval of RE-024 for treatment of PKAN.”

Despite his name being on the patent, prosecutors said of Shkreli, “his insistence on taking shortcuts in order to get PKAN [drug] to market drastically delayed the development of the drug while he was the CEO of Retrophin.” Shkreli was ousted from Retrophin by its board in the fall of 2014.

“Because the Food and Drug Administration … has rigorous safety processes and procedures that must be followed before a new drug can be provided to patients, even on an experimental basis, Shkreli was unable to give the drug directly to patients … as he had promised,” prosecutors wrote.

“Instead, he — as with any other drug developer — needed to secure a series of approves from the FDA, a process that can be long and painstaking,” the filing said.

Instead of waiting for said approval, Shkreli instead launched “an unmonitored drug trial in Cyprus,” reads a court filing.

Prosecutors said that because the trial did not have FDA controls, and because “its operation was unacceptable to the FDA,” the trial was not, despite Shkreli’s claims to the contrary, “part of Retrophin’s ‘efforts to receive FDA approval.’ ”

The filing said it was “instead a way to get single-patient results that could be — and subsequently were — reported in Retrophin’s 8-K filings,” dated Aug. 11, 2014. –CNBC

Cowen biotech stock analyst Eric Schmidt, however, told CNBC that clinical trials are often run outside of the purview of the FDA – though he’s never heard of one in Cyprus.

“I can’t recall ever hearing about a study in [Cyprus] and it is possible there is something weird or strange about that territory that might make this instance particularly suspect,” Schmidt said. “But the simple fact that a company has gone outside of the FDA’s jurisdiction for the purpose of running a study according to foreign law is not news.”

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Nearly 200 Cases Of Sexual Abuse Reported At Stanford University

Stanford University revealed nearly 200 reports of sexual violence, unwanted contact or sexual harassment in a recently released report during the 2016-2017 academic year, including 29 allegations of sexual assault.

“The report we are issuing today shows that prohibited sexual conduct happens throughout our community at Stanford,” Provost Persis Drell wrote in a letter accompanying the report. “I believe the actual numbers of incidents of wrongful sexual conduct are probably larger than are being reported to us.”

Almost 60 of the incidents involved sexual harassment in the workplace or academic setting – mostly involving academic staff.


“We are encouraged to see Stanford releasing a report this like,” Jennifer Reisch, legal director at Equal Rights Advocates, a San Francisco-based civil rights organization that focuses on sexual harassment, said in an email. “However, the numbers of reported incidents, especially of sexual harassment and sexual assault, are alarmingly high for one school year.” –mercurynews.com

20 out of 30 formal investigations of sexual harassment in an academic setting were found to be in violation of policy – with five male staff members, one female staff member, and one male faculty member having been removed from the university.

33 reports of sexual harassment involving students resulted in two formal investigations, with one male graduate banned from campus for three years after graduation, and another male undergraduate told to stay away from the person who made the complaint.

The 29 reports of sexual assault, mostly involving students, led to 11 formal investigations, with one male undergraduate student being suspended for three academic quarters, which amounts to one school year. He was also ordered to stay away from the victim and to undergo counseling on alcohol use and respecting personal boundaries. Another male undergraduate received a similar punishment, and one visiting researcher was permanently banned from campus. The school did not immediately respond to a question about whether any of the cases were also prosecuted in court.


“The report is a great signal from the administration that they are taking our demands for transparency seriously,” said Stanford junior and student body candidate Shanta Katipamula, adding “This is one instance in a very, very large picture and I think there’s still a long ways to go.”

In a comment referencing the #MeToo movement of victims disclosing unwanted sexual harassment, Provost Persis Drell noted that “In recent months, there has been a moment of reckoning across our country and around the world —  bringing to light new stories every day and reminding us of the deep impacts of sexual harassment and violence on the lives of countless people in our world. This movement further underscores that at Stanford, we must confront these issues as community issues, not simply as student issues; we must confront them as our issues, not someone else’s issues.”

Stanford has come under fire for several high-profile sexual assault cases, including that of a young woman by then-student Brock Turner in 2015. The Mercury News noted at the time that the university continued to promote the legacy of a well-known professor despite quietly having suspended him for sexual misconduct with a young graduate student.


Stanford will be introducing a program in the spring to help sophomores focus on “healthy relationships,” while another group of students will participate in a program to help students avoid sexual assault by acquaintances.

“Ultimately,” Drell said, “I hope the report helps encourage members of our community to come forward with their concerns and to have conversations about conduct and the expectations we have for one another.”

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Saudis Cozying Up To Russia As US Influence In Middle East Wanes

What began as an opportunistic agreement between Russia and Saudi Arabia over oil production has blossomed into a broader relationship that has the potential to further erode the already waning influence the United States has in the Middle East.

Experts have pointed out that Russia now seems to have relationships with most major powers in the region – on both sides of several conflicts; including Iran, Syria, Israel, Hamas and Hezbollah. The U.S., meanwhile, has a tense relationship with Syria and is gearing up for conflict with Iran.

It was the United States, ironically, that drove Russia and Saudi Arabia together in the first place, with the surprising rise of an oil sector that is now producing record-high volumes, last seen in 1970.

With the cut in Saudi production, the United States’ still-growing output of 10 million barrels a day is now more than Saudi Arabia’s and catching up to No. 1 producer Russia. Even with this surge, the United States is still reliant on about 8 million barrels a day of imports, some of which come from Saudi Arabia. –CNBC

“What I think is brilliant about [Russian President Vladimir] Putin is, there was an immediate imperative to get this done because of U.S. production, but I think Putin understood the opportunity there was for Russia to take a role with OPEC,” said RBC global head of commodities strategy, Helima Croft. “He leveraged it to expand Russia’s regional influence.”

Saudi Arabia may believe that Russia could help them with Iran – a longtime ally of the Kremlin – over fears that the Islamic Republic which is already supporting the opposite side in a proxy war in Yemen, will develop nuclear weapons.

“I think the Saudis are in this for geopolitical reasons, and even though Trump went to Saudi Arabia and it’s supposed to be this great relationship, the Saudis are casting around and realizing Russia has taken up a lot of slack for the United States in the Middle East,” said Georgetown University Professor Angela Stent.

Saudis want Russia to shift alliances

RBC’s Croft says the United States has left a power vacuum with its shifting middle east policies. “I think our Iran policy, what happened in Syria, they did not think America was a stalwart. Then you have the Russians. They were willing to be more transactional with them”

Right now Russia and Saudi Arabia’s relationship is becoming thicker than oil,” Croft said, while in regards to the Saudis, “I think they see themselves as trying to show the Russians they have a better friend in the Middle East (than Iran).”

The seeds for discord in the Middle East were planted by the George W. Bush administration.

“We went into Iraq. It didn’t go the way we thought it was going to go. What it did was allow Iran to come in and increase its influence. For countries that consider Iran to be an existential threat, this was a big mistake because that was the outcome of the war,” Stent said.

Forging ahead

Saudi Arabia’s state-owned Aramco is reportedly making an investment in a Russian Arctic LNG project, while the Russian Direct Investment Fund is expected to invest in Aramco’s upcoming IPO, notes Croft.

“I think it is a strategic alliance when it comes to energy that could well extend to other things. They discussed in the past military matters, purchasing military goods. They talked about investing in Russia. It’s not just purely an energy relationship. It’s more of a strategic political relationship that started as energy reform,” said the director of economics research at the Gulf Research Center in Riyadh, John Sfakianakis.

Talking oil…

While an OPEC agreement led by Saudi Arabia and including Russia and other producders is expected to last into 2019, the topic of oil could be up for discussion during the June OPEC meeting. Saudi Energy Minister Khalid Al-Falih says the deal will be reviewed next year for potential changes – however Russian companies have reportedly been eager to increase production.

“Going forward, this arrangement has to hold. It needs to remain for quite some time so oil prices remain at this range of $60ish for some time. It suits everybody, especially the producing countries — $60/$65 is a good price from the $30 we had a couple of years ago. It helps everybody. It keeps the balance of payments in good order. My take is, this arrangement will hold, at least for the rest of the year, and then we’ll see what they do,” said Sfakianakis.

Russia’s warming relationship with the Saudis comes amid Crown Prince Mohammed bin Salman’s push for “Vision 2030,” a comprehensive set of reforms aimed at modernizing Saudi Arabia and diversifying away from the oil business. Bin Salman is making moves into technology, entertainment and tourism – with the upcoming Saudi Aramco IPO to be the cornerstone of the strategy.

Meanwhile US-Russian relations are at a new low – as Special Counsel Robert Mueller continues his investigation into allegations of Russian meddling in the 2016 election. Russia is also under sanctions from both Obama and Trump for its incursion into Ukraine. “[Relations] haven’t been this low since Gorbachev came to power,” said Georgetown’s Stent.

Saudi-US relations, on the other hand, remain warm – as the longtime ally of the United States joined a March 2017 coalition which includes Israel, Egypt and several other countries aimed at wiping out terrorist networks. Bin Salman will be visiting the United States later this month.

“Trump’s first visit and trip abroad was to Saudi Arabia. What he signaled was a strong relationship with Saudi Arabia, and a lot of that was about money,” noted Stent, who pointed out that the trip coincided with a big arms deal announcement.

“If there is a broader and more structured [Mideast] policy, I don’t know what it is,” said Stent, adding that “if the U.S. wants to be more of a player in the region, it has to talk to Iran.”

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Nor’Easter Death Toll Reaches 9; National Guard Deployed; Over 60 Dead In Europe

The death toll from the ongoing “monster nor’easter” has reached nine, while millions of customers across the East Coast have been plunged into darkness and over 1,400 flights were cancelled according to FlightAware.com.

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Several of the deaths were due to falling trees – estimated at over 750 in New York City alone, while police in Andover Township, New Jersey report that a 41-year-old man was killed after coming into contact downed power lines on Friday.


“Those two things create an environment of power outages — downed power lines and trees blocking roadways,” said Steve Bellone, county executive of Suffolk County in New York.


The storm officially known as Winter Storm Riley blanketed the East Coast on Saturday, as over a dozen utility companies have reported massive power failures in several states.

More than 235,000 customers were still without power in Massachusetts Saturday night, according to the state’s Emergency Management Agency, after initial reports of 450,000 without electricity. New Jersey power companies said Saturday that more than 164,000 customers were affected by outages, and Pennsylvania companies PECO, PPL and West Penn Power had more than 288,000 customers experience outages. Virginia power companies Dominion Energy and Novec Power said nearly 160,000 were affected by the storm. –NBC

Approximately 270,000 New Yorkers were without power on Saturday according to Gov. Andrew Cuomo.

We are deploying the National Guard and senior officials to ramp up recovery efforts and ensure the thousands of New Yorkers impacted by this storm are getting the help they need,” Cuomo said. “Some travel restrictions and advisories remain in effect, and I urge drivers to stay off the roads so that the National Guard, first responders and utility workers can assist those that need help.”

Eight people in Virginia, Maryland, New York, Pennsylvania, Massachusetts and Rhode Island have died due to the heavy winds and downed trees, according to authorities.

Early Friday morning, a tree fell onto a Virginia home and killed 6-year-old Anthony Hamilton while he was sleeping, Chesterfield County Police reported. Later in the day, Putnam County Sheriff Robert L. Langley Jr. in New York said that an unidentified 11-year-old boy died when a tree fell onto his home and trapped him underneath. His mother, who was at home with the child, was hospitalized. –NBC

In Rhode Island, Newport Police reported that a man in his 70’s died after being struck by a tree, while Baltimore Public Safety reported a 77-year-old woman had been killed by a large branch that dropped from a tree above her. Also killed by trees were Sean Gregory Walker, 44, a 57-year-old Pennsylvania man, 25-year-old Rodriguez Melendez and 36-year-old Ryan MacDonald.

60 dead across Europe

Meanwhile, Europe has been experiencing a deep freeze which has claimed some 60 lives in the past week – including 23 in Poland, seven in Slovakia, and six in the Czech Republic. More deaths were reported in Lithuania, France, Spain, Italy, Romania, Serbia, Slovenia, Britain, the Netherlands and Sweden.


As temperatures across Europe generally remained sub-zero, travel has been largely disrupted – with major delays on roads, railways and airports.

Switzerland has seen the mercury plummet to records of up to minus 40 degrees Celsius (minus 40 Fahrenheit) in the ongoing blizzard, which has also impacted air, road and train transport around Europe and even covered usually balmy Mediterranean beaches with a blanket of snow.

In France, 21 departments, mainly in the northwest, remained on alert for snow and black ice as the vicious cold snapwhich British media have dubbed “the Beast from the East,” the Dutch the “Siberian Bear” and Swedes the “snow cannon” — maintained its grip. Dailysabah.com

In Ireland, the Dublin airport has shut down, while some 24,000 people remain without electricity as temperatures hover just below freezing – with Britain’s Meteorological Office forecasting more snow.

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Why is this happening?

As ZeroHedge reported two weeks ago, the polar vortex has been split in two – causing warming over the arctic while two massive cold masses continue to hover over Europe and North America.


From the Weather Channel:

“Across the Arctic, where the polar vortex typically stays locked, the stratosphere has warmed. This typically kicks into motion a polar vortex disruption like we are seeing. The stratosphere is a layer of the upper atmosphere above which most of our weather occurs – known as the troposphere – and where most of the polar vortex resides.”

The vortex over Western Europe and much of Eurasia has sent the region into a dangerous deep freeze which may last into early March.

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Goldman: Trump Tariffs On Steel And Aluminum Likely Signal NAFTA Exit

Goldman Sachs thinks President Trump’s decision to impose tariffs on foreign steel and aluminum probably signals an exit from NAFTA.

The 25% tax on steel and 10% tax on alumium would be the most substantial trade restictions to date, notes the bank’s chief economist.

“Unlike routine antidumping and countervailing duty cases or less common safeguard cases, the Section 232 authority the President will apparently use is rarely used and more controversial,” wrote Jan Hatzius, chief economist at Goldman Sachs. “There is a good chance that this could eventually lead the President to announce he intends to withdraw from NAFTA, but such an announcement does not appear likely in the near term.”

The proposal “does not rely on any economic argument and instead proposes trade restrictions on national security grounds,” notes Hatzius – referring to the Commerce Department’s use of Section 232 of the 1962 Trade Expansion Act as a basis for the tariffs.

The Trump admin contends that China and other countries dumping cheap steel and aluminum puts U.S. competitors out of business, thus risking national security.

According to the U.S. Department of Commerce, Canada and Brazil – two key trading allies – were the top sources of foreign steel to the U.S. as of September 2017. China, frequently criticized politically for dumping cheap steel on trade partners, is not one of the top 10 sources of steel to the U.S. –CNBC

In January, Trump announced solar and washing machine tariffs – after he offered some clarification on comments which many thought to be to precede a NAFTA pullout.

“I happen to be of the opinion that if it doesn’t work out we’ll terminate it, but I think you’re doing pretty well, Bob,” Trump said, referring to U.S. Trade Representative Robert Lighthizer.

In January, Reuters noted that Trump does not expect a trade war to result from any new tariffs.

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YouTube Blames “Newer Members” Of Mod Team For Punishing Conservative Channels

YouTube has blamed “newer members” of it’s 10,000 person fleet of content moderators for a growing number of recent video takedowns, strikes, and account restrictions taking place across a large cross-section of conservative channels.

YouTube announced the mod team last December, which is tasked with spotting said fake news, along with misleading or extreme content in the wake of a raging debate over the effect of propaganda and inaccurate reporting after Hillary Clinton’s 2016 election loss.

Google issued the following statement in response to the crackdown:

As we work to hire rapidly and ramp up our policy enforcement teams throughout 2018, newer members may misapply some of our policies resulting in mistaken removals,” wrote a YouTube spokesman in an email. “We’re continuing to enforce our existing policies regarding harmful and dangerous content, they have not changed. We’ll reinstate any videos that were removed in error.”

Some of the banned accounts include:

Anti-School, Bombard’s Body LanguageCharltonCharles WaltonDefangoDustin NemosDavid SeamanDestroying The IllusionRon JohnsonRichie Allen, and Titus Frost.

Those who were issued strikes, partial bans, or temporary suspensions include According to Joe, Blackstone Intelligence, BakedAlaska, InfoWars, Jerome Corsi, Military Arms Channel, and MrLTavern, among many others. –The Outline

Over the last week, The Alex Jones channel was issued two strikes – however the second one was mysteriously removed hours later, maybe due to on overzealous “newer member” who disagreed with Infowars’ politics. And last August, politically incorrect University of Toronto professor Jordan B. Peterson found himself locked out of his YouTube account with no explanation before regaining access.


Meanwhile, the Daily Caller reveals that Google has also enlisted the left-wing nonprofit Southern Poverty Law Center (SPLC) to participate in its “trusted flaggers” program. The SPLC notoriously branded African American presidential candidate and neurosurgeon Dr. Ben Carson as an “extremist,” while gaining a reputation for finding creative ways to label conservatives as “hate groups” in general.

The Washington Examiner’s Emily Jashinsky noted last year that “the SPLC’s claim to objectivity is nothing less than fraudulent, a reality that informed observers of its practices from both the Left and Right accept.”

The routine of debunking their supposedly objective classifications occurs like clockwork each time a major outlet makes the mistake of turning to them when reporting on the many conservative thinkers and nonprofits the group absurdly designates as hateful.” –DC

YouTube says the trusted flaggers are equipped with digital tools which allow for the mass flagging of content for review by YouTube personnel. Moreover, the partner groups “act as guides to YouTube’s content monitors,” and engineers who develop algorithms to police more efficiently.

“We work with over 100 organizations as part of our Trusted Flagger program and we value the expertise these organizations bring to flagging content for review. All trusted flaggers attend a YouTube training to learn about our policies and enforcement processes. Videos flagged by trusted flaggers are reviewed by YouTube content moderators according to YouTube’s Community Guidelines. Content flagged by trusted flaggers is not automatically removed or subject to any differential policies than content flagged from other users,”-YouTube Spokesperson

Another “trusted flagger” partner we reported about last year is the Anti-Defamation League (ADL). Originally organized to combat anti-Semitism, the ADL – with it’s Soros-linked National director who last worked in the Obama admin, now spouts hyperbolic propaganda against conservatives, while failing to apply the same nebulous standards to the left.


Gun control

As ZeroHedge reports, YouTube’s mass censorship comes at yet another critical inflection point in the nation’s dialogue over gun control following the Parkland, FL shooting. While gun control advocates have been given a platform on major networks, gun rights activists have been muzzled  – primarily when their opinion has to do with 17-year-old Parkland survivor David Hogg along with several of his classmates who are anti Second Amendment.

Hogg went on CNN and was allowed to call the NRA “child murderers,” (a claim which CNN host Alisyn Camerota told spokeswoman Dana Loesch “I don’t believe you” when it was pointed out), while conservative accounts suggesting Hogg is an actor, or that he was given lines to read for post-shooting interviews, are being censored by left leaning social media platforms.

Many have noted that Parkland 16-year-old pro-gun Parkland shooting survivor Kyle Kashuv has yet to be verified by Twitter, while Hogg and several of his classmates who went on Ellen to advocate for gun control have all been given “blue checks” by the platform.

YouTube also came under fire last week for promoting a clip of Hogg which fueled the “crisis actor” debate, featuring an exchange between Hogg and a Redondo Beach, CA lifeguard from 2017, in which the High School student places his boogie board on a trash can before getting in an altercation with the lifeguard.

After the lifeguard scuffle briefly became YouTube’s No. 1 trending video, it was removed under their harassment and bullying policy and apologized for helping to fuel the “crisis actor” theory.

YouTube’s official policy states that “harmful or dangerous” and “hateful” content may violate its guidelines – and if video creators receive three strikes for violating the rules within three months, YouTube will terminate the account.

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