Day: January 14, 2022

Martin Shkreli must return $64.6 million in profits he and his former company reaped from jacking up the price and monopolizing the market for a lifesaving drug, a federal judge ruled Friday while also barring the provocative, imprisoned ex-CEO from the pharmaceutical industry for the rest of his life. 

U.S. District Judge Denise Cote’s ruling came several weeks after a seven-day bench trial in December that featured recordings of conversations that Cote said showed Shkreli continuing to exert control over the company, Vyera Pharmaceuticals LLC, from behind bars and discussing ways to thwart generic versions of its lucrative drug, Daraprim. 

“Shkreli was no side player in, or a ‘remote, unrelated’ beneficiary of Vyera’s scheme,” Cote wrote in a 135-page opinion. “He was the mastermind of its illegal conduct and the person principally responsible for it throughout the years.” 

The Federal Trade Commission and seven states brought the case in 2020 against the man known in the media as “Pharma Bro,” about two years after he was sentenced to prison in an unrelated securities fraud scheme. 

“‘Envy, greed, lust, and hate,’ don’t just ‘separate,’ but they obviously motivated Mr. Shkreli and his partner to illegally jack up the price of a life-saving drug as Americans’ lives hung in the balance,” New York Attorney General Letitia James said, peppering the written statement with references to the Wu-Tang Clan, whose one-of-a-kind album Shkreli had to fork over to satisfy court debt. 

“But Americans can rest easy because Martin Shkreli is a pharma bro no more.” 

Messages seeking comment were left with Shkreli’s lawyers. 

Shkreli was CEO of Turing Pharmaceuticals — later Vyera — when it raised the price of Daraprim from $13.50 to $750 per pill after obtaining exclusive rights to the decades-old drug in 2015. It treats a rare parasitic disease that strikes pregnant women, cancer patients and AIDS patients. 

Shkreli defended the decision as capitalism at work and said insurance and other programs ensured that people who need Daraprim would ultimately get it. 

Shkreli eventually offered hospitals half off — still amounting to a 2,500% increase. But patients normally take most of the weekslong treatment after returning home, so they and their insurers still faced the $750-a-pill price. 

Shkreli resigned as Turing’s CEO in 2015, a day after he was arrested on securities fraud charges related to two failed hedge funds he ran before getting into the pharmaceutical industry. He was convicted of lying to investors and cheating them out of millions and is serving a seven-year sentence at a federal prison in Allenwood, Pennsylvania, and is scheduled to be released in November. 

The FTC and seven states — New York, California, Illinois, North Carolina, Ohio, Pennsylvania and Virginia — alleged in their case that Vyera hiked the price of Daraprim and illegally created “a web of anticompetitive restrictions” to prevent other companies from creating cheaper generic versions. Among other things, they alleged, Vyera blocked access to a key ingredient for the medication and to data the companies would want to evaluate the drug’s market potential. 

Vyera and its parent company, Phoenixus AG, settled last month, agreeing to provide up to $40 million in relief over 10 years to consumers and to make Daraprim available to any potential generic competitor at the cost of producing the drug. Former Vyera CEO Kevin Mulleady agreed to pay $250,000 if he violates the settlement, which barred him from working for a pharmaceutical company” for seven years. 

Shkreli proceeded to trial but opted not to attend the proceedings, instead submitting a written affidavit that served as his testimony. 

The trial record included evidence showing Shkreli kept in regular contact with company executives, even after he went to prison. A spreadsheet kept by one executive showed more than 1,500 contacts with Shkreli between December 2019 and July 2020. 

The record also included recordings of conversations Shkreli had from prison in which he discussed his control of Vyera, saying he had “no problem firing everybody,” boasting how he controlled the board, and comparing himself to Facebook founder Mark Zuckerberg and the pharmaceutical company to the social media behemoth. 

 
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The World Health Organization is recommending two new drugs for the treatment of COVID-19, adding to a growing list of therapeutic remedies for the deadly disease.

Baricitinib is an oral medication recommended for patients with severe or critical COVID-19.It is part of a class of drugs that suppresses the overstimulation of the immune system and is used in the treatment of rheumatoid arthritis.

WHO team lead for clinical care, Janet Diaz, says the drug should be given along with corticosteroids, a type of anti-inflammatory treatment. She notes three clinical trials of 2,600 people showed a drop in the mortality of patients with coronavirus infections once they received baricitinib.

She says WHO has also conditionally recommended the use of a monoclonal antibody drug called sotrovimab for treating patients with COVID-19 who have mild or moderate disease. 

“Conditional for those patients that are of the highest risk for complications,” Diaz said. “This would include patients who are older age, unvaccinated or have underlying conditions. This recommendation is based upon one trial, a well-done trial with just over 1,000 patients. And this trial showed a reduction for the need for hospitalization.”

Studies are ongoing on the effectiveness of monoclonal antibodies against the omicron variant. While Diaz says early laboratory studies show that sotrovimab continues to be effective against the new coronavirus strain, she says she would not call the drug a game changer.

“I think we have multiple therapeutic options right now for COVID-19 and more are on the way,” she said. “Unfortunately, viruses are known to develop resistance to certain drugs. So, SARS COVID-2 is not different in that respect … and if something happens where the resistance does develop, we try to hopefully reduce the chances that happens.”

The WHO official says other therapeutics are in the pipeline.

She says WHO is committed to equitable and affordable access for all member-states to COVID-19 drugs, and the agency and partners are meeting with pharmaceutical companies to negotiate fair prices and access for low- and middle-income countries to life-saving treatments. 

 
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Ukraine was hit by a massive cyberattack warning its citizens to “be afraid and expect the worst”, and Russia, which has massed more than 100,000 troops on its neighbor’s frontier, released TV pictures on Friday of more forces deploying in a drill.

The developments came after no breakthrough was reached at meetings between Russia and Western states, which fear Moscow could launch a new attack on a country it invaded in 2014.

“The drumbeat of war is sounding loud,” said a senior U.S. Diplomat.

Russia denies plans to attack Ukraine but says it could take unspecified military action unless demands are met, including a promise by the NATO alliance never to admit Kyiv.

Russia said troops in its far east would practice deploying to far-away military sites for exercises as part of an inspection. Defense Ministry footage released by RIA news agency showed numerous armored vehicles and other military hardware being loaded onto trains in the Eastern Military District.

“This is likely cover for the units being moved towards Ukraine,” said Rob Lee, a military analyst and a fellow at the U.S.-based Foreign Policy Research Institute.

The movements indicated Russia has no intention of dialing down tensions over Ukraine, having used its troop build-up to force the West to the negotiating table and press sweeping demands for “security guarantees” – key elements of which have been described by the United States as non-starters.

Ukrainian authorities were investigating a huge cyberattack, which hit government bodies including the ministry of foreign affairs, cabinet of ministers, and security and defense council.

“Ukrainian! All your personal data was uploaded to the public network. All data on the computer is destroyed, it is impossible to restore it,” said a message visible on hacked

government websites, written in Ukrainian, Russian and Polish.

“All information about you has become public, be afraid and expect the worst. This is for your past, present and future.”

Ukraine’s foreign ministry spokesperson told Reuters it was too early to say who could be behind the attack but said Russia had been behind similar strikes in the past. Russia did not immediately comment but has previously denied being behind cyberattacks on Ukraine.

The Ukrainian government said it had restored most of the affected sites and that no personal data had been stolen. Several other government websites had been suspended to prevent the attack from spreading.

The European Union’s top diplomat, Josep Borrell, condemned the attack and said the EU’s political and security committee and cyber units would meet to see how to help Kyiv: “I can’t blame anybody as I have no proof, but we can imagine.”

The message left by the cyberattack was peppered with references that echoed long-running Russian state allegations, rejected by Kyiv, that Ukraine is in the thrall of far-right nationalist groups. It referenced Volhynia and Eastern Galicia, the site of killings carried out in Nazi German-occupied Poland by Ukrainian insurgents, a point of contention between Poland and Ukraine.

The United States warned on Thursday that the threat of a Russian military invasion was high. Russia has consistently denied that. 

Moscow said dialogue was continuing but was hitting a dead end as it tried to persuade the West to bar Ukraine from joining NATO and roll back decades of alliance expansion in Europe.

The United States and NATO have rejected those demands but said they are willing to talk about arms control, missile deployments, confidence-building measures and limits on military exercises.

Russian Foreign Minister Sergei Lavrov said on Friday that Moscow was awaiting a point-by-point written response to its proposals.
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To mask or not to mask is a question Italy settled early in the COVID-19 outbreak with a vigorous “yes.” Now the onetime epicenter of the pandemic in Europe hopes even stricter mask rules will help it beat the latest infection surge.

Other countries are taking similar action as the more transmissible — yet, apparently, less virulent — omicron variant spreads through the continent.

With Italy’s hospital ICUs rapidly filling with mostly unvaccinated COVID-19 patients, the government announced on Christmas Eve that FFP2 masks — which offer users more protection than cloth or surgical masks — must be worn on public transport, including planes, trains, ferries and subways.

That’s even though all passengers in Italy, as of this week, must be vaccinated or recently recovered from COVID-19. FFP2s also must now be worn at theaters, cinemas and sports events, indoors or out, and can’t be removed even for their wearers to eat or drink.

Italy re-introduced an outdoor mask mandate. It had never lifted its indoor mandate — even when infections sharply dropped in the summer.

On a chilly morning in Rome this week, Lillo D’Amico, 84, sported a wool cap and white FFP2 as he bought a newspaper at his neighborhood newsstand.

“(Masks) cost little money, they cost you a small sacrifice,” he said. “When you do the math, it costs far less than hospitalization.”

When he sees someone from the unmasked minority walking by, he keeps a distance. “They see (masks) as an affront to their freedom,” D’Amico said, shrugging.

Spain reinstated its outdoor mask rule on Christmas Eve. After the 14-day contagion rate soared to 2,722 new infections per 100,000 people by the end of last week — from 40 per 100,000 in mid-October — Prime Minister Pedro Sanchez was asked whether the outdoor mask mandate was helping.

“Of course, it is. It’s not me saying it. It’s science itself saying it because (it’s) a virus that is contracted when one exhales,” Sanchez said.

Portugal brought masks back at the end of November, after having largely dropped the requirement when it hit its goal of vaccinating 86% of the population.

Greece has also restored its outdoor mask mandate, while requiring an FFP2 or double surgical mask on public transport and in indoor public spaces.

This week the Dutch government’s outbreak management team recommended a mask mandate for people over 13 in busy public indoor areas such as restaurants, museums and theaters, and for spectators at indoor sports events. Those places are currently closed under a lockdown until at least Friday.

In France, the outdoor mask mandate was partially re-instated in December in many cities, including Paris. The age for children to start wearing masks in public places was lowered to 6 from 11.

Austrian Chancellor Karl Nehammer announced last week that people must wear FFP2 masks outdoors if they can’t keep at least 2 meters apart.

In Italy, with more than 2 million people currently positive for the virus in a nation of 60 million and workplace absences curtailing train and bus runs, the government also sees masks as a way to let society more fully function.

People with booster shots or recent second vaccine doses can now avoid quarantine after coming into contact with an infected person if they wear a FFP2 mask for 10 days.

The government has ordered shops to make FFP masks available for 85 U.S. cents. In the pandemic’s first year, FFP2s cost up to $11.50 — whenever they could be found.

Italians wear them in a palette of colors. The father of a baby baptized this week by Pope Francis in the Sistine Chapel wore one in burgundy, with matching tie and jacket pocket square. But the pontiff, who has practically shunned a mask in public, was maskless.

On Monday, Vatican City State mandated FFP2s in all indoor places. The tiny, walled independent state across the Tiber from the heart of Rome also stipulated that Vatican employees can go to work without quarantining after coming into contact with someone testing positive if, in addition to being fully vaccinated or having received a booster shot, they wear FFP2s.

Francis did appear to be wearing a FFP2 when, startling shoppers in Rome on Tuesday evening, he emerged from a music store near the Pantheon before being driven back to the Vatican.

In Britain, where Prime Minister Boris Johnson has focused on vaccination, masks have never been required outdoors.

This month, though, the government said secondary school students should wear face coverings in class. But Education Secretary Nadhim Zahawi said that rule wouldn’t apply “for a day longer than necessary.”

When the British government lifted pandemic restrictions in July 2021, turning mask-wearing from a requirement to a suggestion, mask use fell markedly.

Nino Cartabellotta, president of the Bologna-based GIMBE foundation, which monitors health care in Italy, says Britain points to what can happen when measures like mask-wearing aren’t valued.

“The situation in the U.K, showed that use of vaccination alone wasn’t enough” to get ahead of the pandemic, even though Britain was one of the first countries to begin vaccination, he said in a video interview. 

 
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Drones sprayed holy water from the Ganges on thousands of Hindu pilgrims on Friday to reduce crowding during a massive festival being held despite soaring COVID-19 cases in India.

The Gangasagar Mela in the east of the country has drawn comparisons with another “superspreader” Hindu gathering last year that the Hindu nationalist government refused to ban. It was blamed in part for a devastating COVID surge.

Officials had said they expected around 3 million people — including ash-smeared, dreadlocked ascetics — to attend the festival’s climax on Sagar Island, where the Ganges meets the Bay of Bengal.

“At the crack of dawn, there was a sea of people,” local official Bankim Hazra told AFP by telephone.

“Holy water from the river Ganges was sprayed from drones on pilgrims … to prevent crowding,” he said.

“But the saints and a large number of people were bent on taking the dip… Pilgrims, most of them without masks, outnumbered the security personnel.”

An AFP photographer said that there were fewer people than in recent years and that rain put off some pilgrims from making the journey.

But there were still huge crowds, mostly without masks, taking a holy dip in the river.

A police official on duty at the event said that it was “impossible” to enforce COVID restrictions.

“Most pilgrims are bent on defying the rules,” he said.

“They believe that God will save them and bathing at the confluence will cleanse all their sins and even the virus if they are infected.”

No lockdown

Fatalities from India’s current wave of infections remain a fraction of what they were during the surge in April and May last year, with 315 deaths recorded Thursday compared with as many as 4,000 per day at the peak.

Infections are rising fast, however, with almost 265,000 new cases Thursday. Some models predict India could experience as many as 800,000 cases per day in a few weeks, twice the rate seen nine months ago.

Keen to avoid another painful lockdown for millions of workers reliant on a few dollars in daily wages, authorities in different parts of India have sought to restrict gatherings.

In New Delhi, all bars, restaurants and private offices are shut, and the capital is set to go into its second weekend curfew on Friday night.

In the financial capital of Mumbai, gatherings of more than four people are banned.

But in West Bengal state, the Calcutta High Court on Friday allowed the Gangasagar Mela to proceed.

As with 2021’s Kumbh Mela, it has attracted people from across northern India who, after cramming onto trains, buses and boats to reach the island, will then go home — potentially taking the highly transmissible omicron virus variant with them.

Amitava Nandy, a virologist from the School of Tropical Medicines in Kolkata, said the government “has neither the facilities nor the manpower” to test everyone attending or impose social distancing.

“A stampede-like situation could happen if the police try to enforce social distancing on the riverbank,” Nandy told AFP.

Devotee Sarbananda Mishra, a 56-year-old schoolteacher from the neighboring state of Bihar, told AFP: “Faith in God will overcome the fear of COVID. The bathing will cleanse them of all their sins and bring salvation.

“Death is the ultimate truth. What is the point of living with fear?” 

 
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Australia rejected the visa of Serbian tennis star Novak Djokovic for a second time Friday, something that could keep the world’s top-ranked men’s tennis player from the Australian Open and likely prompt a second trip to court.

Immigration Minister Alex Hawke said in a statement that he canceled Djokovic’s visa “on health and good order grounds, on the basis that it was in the public interest to do so.”

Prime Minister Scott Morrison said in a statement, “This pandemic has been incredibly difficult for every Australian but we have stuck together and saved lives and livelihoods. … Australians have made many sacrifices during this pandemic, and they rightly expect the result of those sacrifices to be protected.”

Finance Minister Simon Birmingham said Friday the policy settings of the government overall were “crystal clear.” He said on Channel 9’s Today show, “That is that people who enter Australia who are not Australian citizens should be double dose vaccinated unless they have a clear and valid medical exemption against that.”

About 90% of Australian adults are vaccinated after enduring long lockdowns to stop the spread of the coronavirus. Djokovic’s vaccine skepticism has met with widespread anger.

Hawke canceled Djokovic’s visa over concerns about the Serbian’s medical exemption from Australia’s COVID-19 vaccination rules. Djokovic’s visa was first canceled upon arrival in Melbourne last week when his vaccination exemption was rejected.

After being held with other asylum-seekers at an immigration detention hotel for several days, Djokovic won a legal dispute on procedural grounds that allowed him to remain in the country.

Djokovic acknowledged earlier this week that errors were made on his entry documents about his activities in the weeks before traveling to Australia.

The Serbian star issued a statement Wednesday saying his assistants had incorrectly declared that he had not traveled anywhere in the 14 days before departing for Melbourne last week. Reports have surfaced showing he traveled to Serbia and Spain.

Djokovic also said he did not know he tested positive for COVID-19 on Dec. 16 until the next day, after he appeared at a tennis event in Belgrade to present awards to children.

He also acknowledged that he should have canceled a planned magazine interview and photoshoot the day after learning of his status.

The defending champion was included Thursday in the Australian Open draw as the top seed for the tournament that opens Monday.

Djokovic drew unseeded fellow Serb Miomir Kecmanovic for his opening match that is expected to take place Monday or Tuesday.

Some information in this report came from The Associated Press and Reuters.

 
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A 4-billion-year-old meteorite from Mars that caused a splash here on Earth decades ago contains no evidence of ancient, primitive Martian life after all, scientists reported Thursday. 

In 1996, a NASA-led team announced that organic compounds in the rock appeared to have been left by living creatures. Other scientists were skeptical, and researchers chipped away at that premise over the decades, most recently by a team led by the Carnegie Institution for Science’s Andrew Steele. 

Tiny samples from the meteorite show the carbon-rich compounds are actually the result of water — most likely salty, or briny, water — flowing over the rock for a prolonged period, Steele said. The findings appear in the journal Science. 

During Mars’ wet and early past, at least two impacts occurred near the rock, heating the planet’s surrounding surface, before a third impact bounced it off the red planet and into space millions of years ago. The 2-kilogram (4-pound) rock was found in Antarctica in 1984. 

Groundwater moving through the cracks in the rock, while it was still on Mars, formed the tiny globs of carbon that are present, according to the researchers. The same thing can happen on Earth and could help explain the presence of methane in Mars’ atmosphere, they said. 

But two scientists who took part in the original study took issue with these latest findings, calling them disappointing. In a shared email, they said they stand by their 1996 observations. 

“While the data presented incrementally adds to our knowledge of (the meteorite), the interpretation is hardly novel, nor is it supported by the research,” wrote Kathie Thomas-Keprta and Simon Clemett, astromaterial researchers at NASA’s Johnson Space Center in Houston. 

“Unsupported speculation does nothing to resolve the conundrum surrounding the origin of organic matter” in the meteorite, they added. 

According to Steele, advances in technology made his team’s new findings possible. 

He commended the measurements by the original researchers and noted that their life-claiming hypothesis “was a reasonable interpretation” at the time. He said he and his team, which includes NASA, German and British scientists, took care to present their results “for what they are, which is a very exciting discovery about Mars and not a study to disprove” the original premise. 

This finding “is huge for our understanding of how life started on this planet and helps refine the techniques we need to find life elsewhere on Mars, or Enceladus and Europa,” Steele said in an email, referring to Saturn and Jupiter’s moons with subsurface oceans. 

The only way to prove whether Mars ever had or still has microbial life, according to Steele, is to bring samples to Earth for analysis. NASA’s Perseverance Mars rover has collected six samples for return to Earth in a decade or so; three dozen samples are desired. 

Millions of years after drifting through space, the meteorite landed on an icefield in Antarctica thousands of years ago. The small gray-green fragment got its name — Allan Hills 84001 — from the hills where it was found. 

 
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