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US arrests El Chapo’s wife, accusing her of helping her run the drug empire

Emma Coronel Aispuro, the wife of Mexico’s most notorious drug dealer, better known as El Chapo, was arrested on Monday and charged with helping her husband run his multibillion dollar criminal empire and d ‘plotting to get him out of prison after his capture in 2014.

Ms. Coronel, a former beauty queen, had been under investigation for at least two years by US federal authorities for complicity with her husband, Joaquín Guzmán Loera, convicted in 2019 during a trial in Brooklyn for orchestrating a huge drug plot. and was subsequently sentenced to life imprisonment.

Court documents filed in Ms Coronel’s case say she relayed messages for Mr Guzmán that helped him carry out drug shipments from 2012 to 2014 and escape capture by legions of US authorities and Mexican women who had pursued him for years. During Mr Guzmán’s trial, evidence showed Ms Coronel was also one of the main conspirators in a sophisticated plot to get him out of the Altiplano prison in Mexico by digging a close tunnel a mile long in the shower of his cell.

Ms. Coronel, 31, is a dual Mexican-American citizen with roots in both Southern California and the city of Culiacán in the Mexican state of Sinaloa, which has long served as the base of operations for Mr. Guzmán’s anti-drug organization, the Sinaloa cartel. She was taken into custody at Dulles International Airport, near Washington, and is scheduled to appear for the first time in U.S. District Court for the District of Columbia on Tuesday. His lawyer, Jeffrey Lichtman, who also represented Mr Guzmán, declined to comment on the arrest.

While it is unusual for law enforcement to prey on the wives of prominent drug figures, prosecutors in Mr. Guzmán’s trial have presented substantial evidence that Ms. Coronel, unlike other wives drug trafficker, was deeply involved in her husband’s criminal affairs.

They presented BlackBerry messages clearly stating that she had helped Mr. Guzmán run his operations – sometimes with his own father. Other posts indicated that she was intimately involved not only in Mr. Guzmán’s notorious tunnel escape from the Altiplano in 2015, but also in helping him escape capture by US and Mexican authorities after a raid. botched in 2012 in the Mexican resort of Cabo San Lucas.

During Mr Guzmán’s trial, his former chief of staff, Dámaso López Núñez, told the jury that Ms Coronel had sought to help her husband escape once again after his takeover in 2016 and his return to the Altiplano. According to Mr. López’s testimony, Ms. Coronel devised a plot to bribe the top Mexican prison official, but before the plan could be carried out, Mr. Guzmán was extradited to the United States for to be judged there.

Ms Coronel, who is Mr Guzmán’s third – if not fourth – wife and mother of two of his many children, grew up in the drug business. Documents filed by the court indicate that his father, Inés Coronel Barreras, who was detained in 2013 in Mexico, was one of Mr. Guzmán’s main lieutenants.

Prosecutors have filed charges against several members of Mr. Guzmán’s nuclear family. His two eldest sons, Jesús Alfredo Guzmán Salazar and Ivan Archivaldo Guzmán Salazar, still at large in Mexico, have been charged in the United States for years. Two of his youngest sons, Joaquín Guzmán López and Ovidio Guzmán López, were indicted in Washington just days after their father’s conviction and also remain fugitives.

The FBI said Ms Coronel married Mr Guzmán around 2007. The marriage – in the rugged mountainous region of Culiacán – took place when Ms Coronel was 17 and Mr Guzmán was more than double his age.

In an interview with the New York Times during Mr Guzmán’s trial, Ms Coronel defended her husband, saying she did not recognize him as the drug lord prosecutors described him. “I admire him as the human being that I have met,” she says, “and the one that I married.”

She was a constant presence in the New York courtroom during the three-month trial, often showing up in the latest fashion trends. Fiercely loyal to her husband – despite her serial diligence – Ms Coronel orchestrated one of the trial’s most dramatic non-legal moments, sending a message to one of Mr Guzmán’s mistresses, Lucero Guadalupe Sánchez López, who one day appeared as a witness.

After Ms Sánchez López proclaimed her love for Mr Guzmán from the podium, Ms Coronel arranged for her husband to arrive in court the next day with a burgundy velvet smoking jacket, identical to the one she was wearing. It was a sign that Ms Coronel was Mr Guzmán’s wife and that Ms Sánchez López, in her blue prison uniform, was just the other woman.

On Monday evening, it was not clear why federal authorities arrested Ms Coronel after implicating her in her husband’s crime more than two years ago.

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Drug prevents coronavirus infection in nursing homes, manufacturer claims

An unusual experiment to keep staff and residents of nursing homes from being infected with the coronavirus has been successful, drugmaker Eli Lilly said Thursday.

A drug containing monoclonal antibodies – virus fighters grown in the lab – has avoided symptomatic infections in residents exposed to the virus, even the most vulnerable frail elderly, according to preliminary results of a study conducted in partnership with the National Institutes of Health.

The researchers found an 80% reduction in infections among residents who received the drug, compared to those who received a placebo, and a 60% reduction among staff, both statistically very powerful results. said Eli Lilly.

The data has not yet been peer reviewed or published. The company plans to present the results at an upcoming medical meeting and publish them in a peer-reviewed journal, but did not say when.

The study included 965 participants in nursing homes: 666 staff and 299 residents. (The company hoped more residents would participate, but it proved difficult to register them; many suffered from dementia and others were concerned about being given an intravenous drug.)

There were four deaths from Covid-19 among study participants. All of them were residents of the nursing homes who received a placebo, not the drug.

The drug, bamlanivimab, already has Emergency Use Clearance from the Food and Drug Administration which allows Eli Lilly to provide it to symptomatic patients at the onset of their infection.

But this study asked if the drug could stop infections before they started. It was an unusual experience: in trucks equipped with mobile laboratories, medical staff traveled to nursing homes as soon as a single infection was detected. Upon arrival, the workers set up temporary infusion centers to administer the drug.

The research ended this weekend with an emergency meeting of the Security and Data Oversight Council, an independent group monitoring the incoming results. The data was strong and compelling enough to put an end to placebos.

Vaccines against covid19>

Answers to your questions about vaccines

While the exact order of vaccinees can vary by state, most will likely prioritize medical workers and residents of long-term care facilities. If you want to understand how this decision is made, this article will help you.

Life will only return to normal when society as a whole is sufficiently protected against the coronavirus. Once countries authorize a vaccine, they will only be able to immunize a few percent of their citizens at most in the first two months. The unvaccinated majority will always remain vulnerable to infection. A growing number of coronavirus vaccines show strong protection against the disease. But it is also possible for people to spread the virus without even knowing they are infected, as they have only mild symptoms, if any. Scientists do not yet know if the vaccines also block the transmission of the coronavirus. So for now, even vaccinated people will have to wear masks, avoid crowds inside, etc. Once enough people are vaccinated, it will become very difficult for the coronavirus to find vulnerable people to infect. Depending on how quickly we as a society reach this goal, life may start to move closer to something normal by fall 2021.

Yes, but not forever. The two vaccines that will potentially be authorized this month clearly protect people against Covid-19 disease. But the clinical trials that delivered these results were not designed to determine whether vaccinated people could still spread the coronavirus without developing symptoms. It remains a possibility. We know that people naturally infected with the coronavirus can spread it without experiencing a cough or other symptoms. Researchers will study this question intensely as the vaccines roll out. In the meantime, even vaccinated people will have to consider themselves as possible spreaders.

The Pfizer and BioNTech vaccine is given by injection into the arm, like other typical vaccines. The injection will be no different from any you received before. Tens of thousands of people have already received the vaccines and none of them have reported serious health problems. But some of them experienced short-lived discomfort, including aches and pains and flu-like symptoms that usually last for a day. People may need to plan a day off or school after the second shot. While these experiences are not pleasant, they are a good sign: they are the result of your own immune system encountering the vaccine and building a powerful response that will provide long-lasting immunity.

No. Moderna and Pfizer vaccines use a genetic molecule to stimulate the immune system. This molecule, known as mRNA, is ultimately destroyed by the body. The mRNA is packaged in an oily bubble that can fuse with a cell, allowing the molecule to slip inside. The cell uses mRNA to make proteins from the coronavirus, which can stimulate the immune system. At any given time, each of our cells can contain hundreds of thousands of mRNA molecules, which they produce to make their own proteins. Once these proteins are made, our cells then shred the mRNA with special enzymes. The mRNA molecules made by our cells can only survive for a few minutes. The mRNA in vaccines is designed to resist the enzymes in the cell for a bit longer, so that the cells can produce additional viral proteins and elicit a stronger immune response. But mRNA can only last a few days at most before being destroyed.

“My jaw dropped when I saw the results chart,” said Dr. Myron Cohen, professor of medicine at the University of North Carolina at Chapel Hill and a senior researcher who helped design and implement study.

Although the study is complete, Dr. Daniel Skovronsky, scientific director of Eli Lilly, said the company will continue to rush to nursing homes in its study network when an outbreak is detected. “Everyone will get the medicine,” he says.

Experts who were not part of the study were enthusiastic, but stressed that they had not yet seen full data. “I only see positive aspects here,” said Dr. Ofer Levy, director of the precision vaccination program at Boston Children’s Hospital. “It’s a victory.”

Dr Kathleen Neuzil, director of the Center for Vaccine Development and Global Health at the University of Maryland, was also encouraged.

“The mortality effect is remarkable,” she said, adding that the drug should be used more widely to prevent and treat Covid-19, “especially in populations such as residents of nursing homes, who have high mortality and may have suboptimal responses to vaccines. “

Vaccines, of course, also protect people from infection with the virus, and nursing home staff and residents were among the first priority groups for vaccines. But supplies are insufficient and many nursing home workers frightened by vaccines have refused to obtain them.

And after vaccination, it can take six weeks for the body to produce enough antibodies for maximum protection, said Dr. Srilatha Edupuganti, a vaccine researcher at Emory University in Atlanta and researcher in the study.

Treatment with monoclonal antibodies, she said, can give almost equivalent protection immediately, although it will not last as long as the protection offered by a vaccine.

Eli Lilly plans to approach FDA about emergency use authorization for use of drug to prevent infections in frail elderly populations, especially those in nursing homes or long-care facilities duration, said Dr Skovronsky.

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Alzheimer’s drug shows promise in small trial

In a small clinical trial, an investigational Alzheimer’s drug slowed the rate at which patients lost the ability to think and take care of themselves, drugmaker Eli Lilly said on Monday.

The results have not been published in any form and have not been widely reviewed by other researchers. If that’s correct, this is the first time that a positive result has been found in a so-called Phase 2 study, said Dr Lon S. Schneider, professor of psychiatry, neurology and gerontology at the University of Southern California.

Other investigational drugs for Alzheimer’s disease have never been tested in phase 2 trials, moving directly to larger phase 3 trials, or have not produced positive results. The Phase 3 studies themselves have repeatedly had disappointing results.

The two-year study involved 272 patients with brain scans indicating Alzheimer’s disease. Their symptoms ranged from mild to moderate.

The drug, donanemab, a monoclonal antibody, binds to a small part of the hard plaques in the brain made up of a protein, amyloid, which are hallmarks of Alzheimer’s disease. Patients received the drug by infusion every four weeks.

Participants who received the drug had a 32 percent deceleration in rate of decline, compared to those who received a placebo. In six to twelve months, the plaques were gone and remained missing, said Dr Daniel Skovronsky, the company’s scientific director. At that point, the patients stopped taking the drug – they were given a placebo instead – for the duration of the study.

The small study needs to be replicated, noted Dr. Michael Weiner, a leading Alzheimer’s disease researcher at the University of California, San Francisco. Yet “this is great news,” he said. “This gives hope to patients and their families.”

Eli Lilly has not released the kind of relevant data needed for in-depth analysis, Dr Schneider said. For example, the company only provided percentages describing job declines among participants, not actual numbers.

The company will provide this data at a later meeting and in an article in a medical journal, Dr Skovronsky said. Eli Lilly got the results on Friday and was required to report them immediately, he said, as the results may affect Lilly’s action.

Dr Schneider, who served on an independent data safety and oversight committee for the study, said he was not allowed to reveal more data than the company provided.

The trial served as a test of the so-called amyloid hypothesis. The idea is that Alzheimer’s disease is intimately linked to the accumulation of amyloid in the brain; if amyloid buildup can be prevented or reversed, the disease can be prevented or cured.

Pharmaceutical companies have spent billions of dollars testing anti-amyloid drugs to no avail, leading many experts to believe the hypothesis is wrong – or that the only way to treat Alzheimer’s is to start. very early, before there are clinical signs of disease.

The Eli Lilly trial recruited patients not on the basis of symptoms but on scans showing significant accumulations of amyloid in their brains. The researchers also performed analyzes for a protein, tau, which forms spaghetti-like tangles in the brain after the onset of the disease.

“We needed mild to moderate entanglement pathology, but not so many tangles that the disease may be beyond hope,” said Dr Skovronsky.

The primary endpoint, or objective of the trial, was a measure that combined performance on mental reasoning and memory tests with assessments of participants’ performance in activities of daily living, such as dressing and prepare meals.

The main side effect has been seen consistently in patients receiving experimental monoclonal antibodies to treat Alzheimer’s disease: fluid buildup in the brain. It happened in nearly 30% of patients, said Dr Skovronsky, but most had no symptoms. The effect was seen on brain scans.

While the trial was ongoing, Eli Lilly began a second Phase 2 trial, Trailblazer 2, in hopes that the initial effort would produce results. These results are expected in 2023.

Dr Skovronsky said Eli Lilly will speak to the Food and Drug Administration and regulatory authorities in other countries to help patients access the drug.

“The data is certainly interesting,” he said. “But we’ll have to see what the regulators say.”

He has been hoping for 25 years for definitive proof that the amyloid hypothesis is correct.

“This is what we expected,” said Dr Skovronsky.

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Suspected drug network in Duke, UNC Chapel Hill and Appalachian state

The cooperating defendant said he felt safe selling to fraternity member Charles Poindexter as most of the sales took place in the fraternity house, behind closed doors. Drugs have been sold for frat parties – larger parties needing more drugs, prosecutors said.

Mr Poindexter, 23, told investigators he purchased cocaine, marijuana and MDMA, known as Molly, from the cooperating defendant. And he said the 22 members of his Fellowship Pledge class “came in” to buy an ounce of cocaine for spring break in his sophomore year, Mr. Martin’s office said.

Mr. Poindexter has been charged with conspiracy to distribute cocaine, using a communications device to facilitate a drug-related crime, and distributing a controlled substance within 1,000 feet of a college or public or private university. A graduate of the UNC, he has not yet pleaded but has “a lot of remorse for his actions”, according to his lawyer, David B. Freedman.

“Sir. Poindexter comes from a big family,” Mr. Freedman said. “He’s been very cooperative with the process. Unfortunately when kids go to college they live in a bubble and don’t realize that their actions have real consequences. ”

Kevin M. Guskiewicz, Chancellor of UNC Chapel Hill, said the university was “extremely disappointed to learn of these alleged actions on our campus.”

“The university is committed to working with law enforcement to fully understand the involvement of any person or academic organization so that disciplinary action can be taken,” he said in a statement. “While none of the people named today are currently registered students, we will remain vigilant and continue to work with our law enforcement partners to identify and address any illegal drug use on our campus. “

Phi Gamma Delta said in a statement that it was “disheartening to learn of the allegations involving our chapter and members of the University of North Carolina.”

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Drug makers withdraw from needy aid program

WASHINGTON – Some of the country’s largest pharmaceutical companies have stopped giving federally-mandated drug discounts to hospitals and clinics that care for poorer Americans, a move that prompts the Secretary of Health, Alex M. Azar II, to demand the restoration of the broken prices or to punish the companies.

The companies – including two that are partnering with the Trump administration on coronavirus vaccines – began cutting their participation in the federal drug pricing program over the summer, saying some hospitals and clinics were operating it to improve their own results. They say that the individual patients are not injured.

But hospitals, clinics and pharmacies serving the poor say the change violates federal law and has been devastating – both to patients and to their own budgets – amid an economic recession brought on by the worst pandemic in 100 years. They say the cuts are illegal and now is not the time to cut discounts that help them better serve the poor.

On Monday, a bipartisan group of state attorneys general, including Xavier Becerra of California, who is President-elect Joseph R. Biden Jr.’s choice for health secretary, wrote a clearly worded letter to Mr. Azar, l ‘calling either to demand rebates or impose fines on drug manufacturers. Twenty-eight states and the District of Columbia signed.

“The health secretary needs to step in here and make sure prescription drugs are provided to people who need them right now amid a pandemic,” said Attorney General William Tong of Connecticut, who heads the effort with Mr. Becerra. . “It really amazes me that companies don’t seem to understand that people need access to healthcare and prescription drugs, literally, to live.

A spokeswoman for Mr Azar declined to comment, citing an ongoing dispute. Several associations representing hospitals and clinics have sued the Trump administration, seeking to force Mr. Azar to act.

The problem is the future of the so-called 340B drug pricing program created by Congress in 1992. It forces pharmaceutical manufacturers to offer deep discounts on drugs to certain health centers and hospitals that depend on support from the drug industry. taxpayers – including Ryan White and federal HIV / AIDS clinics. qualified health centers – to have their medications covered by Medicaid.

These hospitals, clinics and their affiliated pharmacies pass the discounts on to consumers who do not have insurance or adequate insurance to pay for their drugs. But for insured patients, hospitals, clinics and pharmacies are reimbursed by insurance programs at higher levels and are supposed to use the savings to expand services to the poor.

The goal is “to stretch scarce federal resources as much as possible, reach more eligible patients, and provide more comprehensive services,” the Health Resources and Services Administration, which manages the program, says on its website.

William von Oehsen, a lawyer representing a Ryan White clinic association in a lawsuit against the government, described the 340B program as a “vital fundraising tool” and said drug companies “must do their part to reduce costs for those providers who are heavily dependent on taxpayer support. “

The pharmaceutical industry, however, never liked the program. A statement on the website of PhRMA, the industry trade group, says the program “needs to be fixed.”

Drugmakers say 340B has grown significantly larger than Congress anticipated, costing them tens of billions of dollars each year in part because of a health resource agency decision about 10 years ago extend discounts to pharmacies that enter into contracts with eligible hospitals and health services. centers.

A report by the Government Accountability Office released in 2018 found that about a third of the 12,000 clinics and hospitals covered use contract pharmacies. The number of pharmacies under contract has grown rapidly, according to the report, from around 1,300 in 2010 to nearly 20,000 in 2017.

“The law does not provide for contract pharmacies,” said Derek Asay, senior government strategy adviser at Eli Lilly, who notified the health resources agency in July that it would reduce its participation in the program, starting with the prescriptions for the drug Cialis, which treats erectile dysfunction.

Mr Asay, who said the program had been “plagued by abuse and integrity issues,” said Lilly decided to cut discounts for nearly all contracted pharmacies. In the case of hospitals or clinics that don’t have in-house pharmacies, he said, the company will make an exception to allow a contracted pharmacy to benefit from discounts.

But Mr Becerra – on whose knees the matter will fall if the Senate confirms him as secretary of health – said in a statement that the drugmakers were acting “illegally” by changing the program without Congress’ consent. Hospital and clinic executives, as well as their lawyers, agree.

Sue Veer, president and CEO of Carolina Health Centers, a network of federally supported clinics, said removing contract pharmacies “would reduce the savings my health centers can keep and reinvest in primary care. , things like behavioral health and addiction programs ”or programs for people with HIV

Lilly’s decision prompted a reprimand from Robert P. Charrow, general counsel for the federal Department of Health and Human Services. Mr. Azar, who heads the department, was President of Eli Lilly from 2012 to 2017.

In a letter sent in September, Mr Charrow noted that the company’s share price had jumped 11% since January, while “most healthcare providers, many of whom are covered entities. ‘Section 340B, were in financial difficulty and needed assistance’ from the federal government. government. He said the timing of Lilly’s price changes was “at the very least insensitive to the recent state of the economy.”

Other pharmaceutical companies – including AstraZeneca and Sanofi, both of which are working in partnership with the government on coronavirus vaccines – have followed Lilly’s lead, each imposing their own set of restrictions.

Sanofi spokeswoman Ashleigh Koss said that while the company “supports the 340B program and its primary goal of improving access to outpatient medicines for uninsured and vulnerable populations,” it refuses to grant discounts. pharmacies that do not wish to provide data ”. necessary to identify and prevent waste and abuse. “

AstraZeneca said in a statement that the company “has changed our approach to help mitigate significant compliance issues that have been well documented in audits” performed by the Government Accountability Office, which audits government programs for Congress.

The companies claim that patients are not harmed. But health officials and the lawyers who represent them say that’s not true.

In an affidavit filed in federal court in connection with Mr. von Oehsen’s lawsuit on behalf of Ryan White Clinics for Access 340B, Daniel Duck, the owner of the Corner Drug Store in Springhill, Louisiana, described a patient who was paying $ 17.30 per month. for insulin as part of the store’s “money-savings program” for customers who qualified for the 340B awards.

But the cost rose to more than $ 1,300 after the drug’s maker, Sanofi, “no longer allowed the drug to be purchased with discounts of $ 340 billion.” Eventually, the patient found a way to get insulin through Medicare for a co-payment of $ 300, which she said she would not be able to afford the following month.

An attorney for Equitas Health, which serves as a contracted pharmacy for a federally qualified health center in Columbus, Ohio, described a similar experience involving four patients who would normally pay four cents for an insulin drug made by Sanofi.

“The retail price of the prescription is $ 400,” lawyer Trent Stechschulte wrote in an email. Combined with a $ 15 preparation fee, he said, it’s a cost patients cannot afford and a level that hurts the finances of hospitals serving the poor.

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Covid study shows arthritis drug can help patients recover

Adding an arthritis drug called baricitinib to Covid treatment regimens including remdesivir, an antiviral drug, could reduce recovery times by a day or more, especially for people with severe severity, according to a study published Friday. sick.

The results of a government-sponsored clinical trial were made public more than three weeks after the Food and Drug Administration issued an emergency use authorization for the dual treatment. Earlier this month, some experts said they were uncomfortable rolling out drugs without the ability to verify the underlying data supporting their performance. Last month, the World Health Organization also recommended against using remdesivir as a treatment for patients with Covid, as evidence to support its use was lacking.

Limited results were announced earlier in press releases, showing that hospitalized Covid patients treated with baricitinib and remdesivir recovered a day faster than those who received remdesivir alone.

Some questioned the adoption of the combination treatment given the high price of baricitinib – which could be around $ 1,500 per patient – and also cited side effects such as blood clots. Several doctors have also questioned whether adding baricitinib was worth it because steroids like dexamethasone were cheap and widely available. Baricitinib and dexamethasone are thought to work by reducing excessive inflammation, which leads to many severe cases of Covid.

The new article, published in the New England Journal of Medicine, adds some granularity to the results, showing that some patient subgroups benefited from the addition of baricitinib much more than others. The trial recruited more than 1,000 hospitalized patients with Covid, all of whom received remdesivir. People who were sick enough to require a high dose of supplemental oxygen or a non-invasive form of ventilation recovered eight days faster when baricitinib was included in their drug regimen.

In these groups, “I think the data clearly support the role of baricitinib,” said Dr Boghuma Kabisen Titanji, an infectious disease physician at Emory University who pioneered the first studies of baricitinib against coronavirus.

Dr Titanji also noted that the data suggested that some patients may be less likely to die or need a ventilator if they take baricitinib in addition to remdesivir. But these results, like the results that showed faster recovery times, were not consistent among trial participants.

Dr Lauren Henderson, a pediatric rheumatologist at Boston Children’s Hospital, said she was encouraged by the results and the prospect of having another option in the coronavirus treatment arsenal.

But she and several other experts added that they may still be inclined to abandon dexamethasone as a treatment for critically ill Covid-19 patients who need respiratory assistance.

Dexamethasone, unlike baricitinib, has been shown in studies to reduce mortality in critically ill Covid patients. It is also inexpensive and easy to obtain, while baricitinib is seen more as a specialty drug, which could pose supply chain barriers, said Dr Erin McCreary, infectious disease pharmacist at the ‘University of Pittsburgh.

Several experts pointed to another National Institutes of Health trial that will conduct a direct comparison of two combined treatment regimens: one that puts hospital patients on remdesivir and baricitinib, and another that combines remdesivir with dexamethasone. Dr. McCreary also stressed the importance of studying patients who receive both baricitinib and dexamethasone “to determine if there is an additional benefit”.

Dr Andre Kalil, an infectious disease physician at the University of Nebraska Medical Center and principal investigator of the new document, noted that while dexamethasone had already become a widely accepted treatment for Covid-19, the steroid still needed study. further. He cited “a host of serious safety concerns” with the drug that deserved careful consideration.

Like other steroids, dexamethasone, which largely eases inflammation, can cause a host of unwanted side effects, including aggravating conditions like diabetes or osteoporosis.

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McKinsey has offered to pay drug companies rebates for OxyContin overdoses

When Purdue Pharma agreed last month to plead guilty to criminal charges involving OxyContin, the Justice Department noted the role an unidentified consulting firm had played in boosting sales of the addictive pain reliever even as public outrage was increasing because of the widespread overdoses.

Documents released last week in federal bankruptcy court in New York City show the adviser was McKinsey & Company, the world’s most prestigious consultancy. 160 pages include emails and slides revealing new details about McKinsey’s advice to the Sackler family, billionaire Purdue owners, and the company’s now notorious plan to ‘boost’ OxyContin sales at some point. where opioid abuse had already killed hundreds of thousands of Americans.

In a 2017 presentation, according to the records, which were filed in court on behalf of several state attorneys general, McKinsey presented several options to boost sales. One was to give Purdue distributors a discount for each overdose of OxyContin attributable to the pills they sold.

The presentation estimated how many corporate customers, including CVS and Anthem, could overdose. He predicted that in 2019, for example, 2,484 CVS clients would either have an overdose or an opioid use disorder. A rebate of $ 14,810 per “event” meant that Purdue would pay CVS $ 36.8 million that year.

CVS and Anthem were recently some of McKinsey’s biggest clients. Press officers for both companies said they never received a rebate from Purdue for customers who overdosed on OxyContin.

Although McKinsey was neither charged by the federal government nor prosecuted, he began to worry about the legal repercussions in 2018, according to the documents. After Massachusetts filed a lawsuit against Purdue, Martin Elling, an executive at McKinsey’s North American pharmaceutical practice, wrote to another senior partner, Arnab Ghatak: “It probably makes sense to have a quick conversation. with the risk committee to see if we should do anything “other than” eliminate all of our documents and emails. No suspicion, but as the going gets tough someone might turn to us.

Mr Ghatak, who also advised Purdue, responded, “Thanks for the warning. It will be fine. “

It is not known whether the company’s consultants destroyed any documents.

The two men were among McKinsey’s top consultants. Five years earlier, the documents show, they emailed colleagues about a meeting where McKinsey persuaded the Sacklers to aggressively market OxyContin.

The meeting “went very well – the room was only filled with family members, including senior statesman Dr Raymond,” Ghatak wrote, referring to Purdue co-founder, the doctor Raymond Sackler, who would die in 2017.

Mr. Elling agreed. “At the end of the meeting,” he wrote, “the results were perfectly clear to everyone and they gave resounding approval to move quickly.”

McKinsey’s plan was accepted, although Russell Gasdia, then Vice President of Sales and Marketing at Purdue, questioned the company’s approach, writing to Mr. Ghatak the day before the meeting to say that ‘he had real concerns “about the need to boost sales” of OxyContin.

Another Purdue executive, David Lundie, agreed with the strategy, however. Mr Lundie said the proposal would attract the attention of the Sackler family, according to the documents. It made.

In 2017, Purdue CEO Craig Landau wrote that the crisis was caused by “too many Rx written” at “too high a dose” and “for too long”. The drugs, he said, were prescribed “for conditions which often do not require them” by doctors who lacked “the required training in how to use them appropriately.”

When McKinsey was next called upon to “take down” the aggressive sales campaign, according to court documents, Mr Landau allegedly said it was something “we should have done five years ago.”

A McKinsey press secretary said on Wednesday the company “is cooperating fully with opioid investigations” and announced in 2019 that it “will not advise any clients in the world on specific opioid cases.”

In a statement last month, the Sacklers said family members “who have served on the Purdue board of directors have acted ethically and legally.”

McKinsey’s involvement in the opioid crisis came to light early last year, with the release of documents from Massachusetts, which is among states suing Purdue. These recordings show McKinsey was helping Purdue find a way to “counter the emotional messages of mothers of overdosed teens” of OxyContin.

On Tuesday, Purdue pleaded guilty to criminal charges, including fraud against federal health agencies and paying illegal bribes to doctors. The company also faces penalties of approximately $ 8.3 billion. As part of the settlement, members of the Sackler family will pay $ 225 million in civil penalties.

In a statement released after the settlement was announced in October, Purdue said it “deeply regrets and accepts responsibility” for misconduct involving its marketing of OxyContin.

The federal settlement with Purdue comes as states and municipalities demand compensation from opioid makers for helping fuel a health crisis that has killed more than 450,000 Americans since 1999. Purdue is now seeking bankruptcy protection , just like other manufacturers.

“It’s the banality of evil, MBA edition,” said Anand Giridharadas, a former McKinsey consultant who reviewed the documents, of the company’s work with Purdue. “They knew what was going on. And they found a way to look beyond, through him, around him, in order to answer the only questions that were close to their hearts: how to make the customer money and, when the walls close, how. protect.

Mr Giridharadas is a New York Times contributor who wrote a 2018 book that examined the power of elites, including those at McKinsey, to find out how they escape responsibility for social harm.

In recent years, McKinsey has drawn criticism and unwanted attention for its dealings around the world, including in authoritarian countries such as China, Russia and Saudi Arabia. Its business in South Africa was decimated after McKinsey worked with companies linked to a corruption scandal that led to the country’s president being ousted. In the United States, McKinsey has worked with Immigration and Customs Enforcement under President Trump’s leadership, suggesting ways to reduce spending on food and accommodation for detainees.

Documents released last week detail McKinsey’s work with Purdue dating back to 2008, the year after the drugmaker pleaded guilty to deceptive regulators. The Food and Drug Administration previously told Purdue that OxyContin would face sales restrictions and that doctors who prescribe it would require specialized training.

The Sackler family saw the rules as a threat and, joining McKinsey, hatched a plan to “band together” with other opioid makers to push back on them, according to an email. McKinsey prepared Purdue executives for a vital meeting ahead of an FDA advisory panel reviewing its proposed reformulation of OxyContin to make it less prone to abuse. The reformulation was put on the market in 2010.

McKinsey put together backgrounders that anticipated the questions Purdue would receive. A possible question: “Who at Purdue is personally responsible for these deaths?”

The proposed response: “We all feel responsible.”

Dr Richard Sackler, now patriarch of the family, was pleased with the preparations, writing to his daughter in an email from January 2009: “Marianna, I am writing to tell you how impressed I was with the preparation for the meeting. from the FDA. The method and process as well as the content were excellent and represented a major change from efforts like this in the past. “

Purdue’s FDA meeting appeared at least partially successful. Even to this day, the FDA has never required specialized training for prescribers of OxyContin, wrote state attorneys who filed the documents last week.

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Pharmacist and drug dealer sentenced to jail in Firebomb Rival pharmacy conspiracy

The illicit drug transaction between a Nebraska pharmacist and a Maryland Dark Web dealer was going so well that the couple were running out of drugs to sell, according to federal prosecutors.

They said pharmacist Hyrum T. Wilson, 41, of Auburn, New Brunswick, sent over 19,000 doses of prescription drugs from Hyrum’s Family Value pharmacy in Auburn to William Anderson Burgamy IV, 33 , Hanover, MD, from August 2019. to April 2020.

But when Mr Wilson hit limits set by a distributor, capping the amount of medicine he could get and send to Mr Burgamy, the two hatched a plan.

The gains were said to have been twofold, prosecutors said: Mr Wilson and Mr Burgamy were planning to raid a rival drugstore, scavenging a stock of drugs to sell. Then, after torching the pharmacy, business would explode at Hyrum, increasing the amount of drugs Mr. Wilson could send to Mr. Burgamy to sell on his dark web site, NeverPressedRx.

On Friday in U.S. District Court in Alexandria, Virginia, Mr. Burgamy was sentenced to 14 years in prison and Mr. Wilson to nine years. Mr. Burgamy had previously pleaded guilty to four counts of conspiracy to distribute controlled substances, money laundering and conspiracy to use firearms and conspiracy to use explosives. Mr. Wilson had pleaded guilty to three counts, similar to Mr. Burgamy’s, but without the firearms count.

The plot, which the pair had dubbed “Operation Firewood,” involved skull masks, duffel bags, Molotov cocktails and a rental car, with the list of supplies written in a black leather notebook. Mr Wilson designed an “getaway” map with escape routes for Mr Burgamy to use after the attack, the Justice Department said.

But the plot was never realized. It began to unfold in December, when the FBI, along with agents from the United States Postal Inspection Service, Food and Drug Administration, and Drug Enforcement Administration, began investigating NeverPressedRx, the site of Mr. Burgamy, in connection with an international investigation into trafficking. on the dark web, according to the Justice Department.

As of January, investigators made and received nine undercover purchases of Oxycodone and Adderall from NeverPressedRx. During the investigation, the police identified Mr. Burgamy as the operator of the site; Mr Burgamy was monitored “on several occasions as he was placing packages” of NeverPressedRx in the mail, according to court documents.

The site, which proclaimed that “all of our stock comes directly from a US pharmacy,” had an excellent reputation: 99.95% of its reviews were positive, investigators found in April.

On April 9, federal law enforcement arrested Mr. Burgamy at his home before raiding it. They found eight firearms, all loaded, including two AR-15 assault rifles, as well as “thousands of prescription opioid pills,” according to court documents.

Federal law enforcement officers executed search warrants at Mr. Wilson’s home and pharmacy the same day. He was arrested a week later.

The Justice Department said Mr Burgamy gave Mr Wilson reduced profits from drug sales through Bitcoin payments, wire transfers and mailed money packets. Mr Burgamy said he made almost $ 1 million from the operation.

Credit…Alexandria Sheriff’s Office, via Associated Press

As the couple waited for the coronavirus restrictions to be lifted before implementing the rival pharmacy’s bombing plan, the virus presented another opportunity, the ministry said: Mr Wilson and Mr Burgamy discussed the sale of hydroxychloroquine and chloroquine to take advantage of the pandemic. .

Mr Wilson’s attorney, Joseph Howard, said in a telephone interview on Friday night that his client was persuaded into drug trafficking and the firebomb plot by Mr Burgamy after the two met online by playing the “War Dragons” video game.

Mr. Wilson is autistic, said Mr. Howard, and “just can’t function socially.” He was happy to have found a friend in Mr Burgamy, Mr Howard said. When he realized he was “trapped,” Mr. Wilson tried to sell the pharmacy in an attempt to evade the operation, Mr. Howard said.

Mr Burgamy’s lawyer Elizabeth Ann Mullin, a public defender, declined to comment on Friday evening.

Hyrum’s Family Value Pharmacy was one of three pharmacies in Nebraska selected in December for a state health department pilot program to distribute free naloxone nasal spray kits to prevent opioid overdoses.

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WHO rejects antiviral drug remdesivir as Covid treatment

The World Health Organization on Thursday recommended not to use the antiviral remdesivir, a drug that had generated great interest as a treatment for Covid-19.

An expert group “concluded that remdesivir had no significant effect on mortality or on other important patient outcomes, such as the need for mechanical ventilation or the time needed for clinical improvement” , announced the WHO. The committee published its review in The BMJ. The report does not completely rule out the drug’s use as a Covid treatment, but said evidence was lacking to recommend its use.

Gilead Sciences, maker of remdesivir, whose trade name is Veklury, said in a statement that its drug “is recognized as a standard of care for the treatment of hospital patients with Covid-19 in the guidelines of many credible national organizations,” including the US National Institutes of Health and Infectious Diseases Society of America, Japan, UK and Germany. He added that there are “several randomized, controlled studies published in peer-reviewed journals that demonstrate the clinical benefits of Veklury.”

The potential usefulness of remdesivir had been the subject of debate and skepticism for months, and particularly in recent weeks, after the Food and Drug Administration approved it as the first treatment for Covid-19 in late October. A large study, sponsored by the National Institutes of Health, found that the drug reduced the recovery time of hospital patients by 15 to 11 days. Two other trials reviewed by the agency, sponsored by Gilead, did not include placebo controls, which are considered essential for judging effectiveness.

President Trump received remdesivir along with other treatments last month when he was hospitalized with Covid.

Since at least March, when the pandemic began to spread from China to Europe via the United States, pharmaceutical companies and researchers have been working on the fly, and practicing doctors have experimented with any treatment that shows promise. , including steroids. In September, the WHO expert group strongly recommended the use of steroids for critically ill patients.

For the new analysis, the panel looked at evidence from four trials, including one conducted by the NIH and one sponsored by the WHO and recently posted to a pre-print server, which included around 5,000 patients, the largest in this day. The article has not been peer reviewed or published in a scientific journal.

The results of this trial “called into question some of the benefits that were seen earlier in the NIH study,” said Dr. Bram Rochwerg, associate professor of medicine at McMaster University in Hamilton, Ont. and co-chair of the WHO panel.

Dr Rochwerg said the expert panel “made it clear in the document that trials with remdesivir should continue and some populations could benefit.” But the drug is expensive and administered intravenously, he noted. Its use could divert resources that could be deployed more efficiently, Dr Rochwerg said.

Remdesivir has been cleared for emergency use since the spring in the United States, and in October Gilead reported that it had generated $ 873 million in revenue so far this year.

The widely adopted use of the drug for Covid symptoms had baffled some experts long before FDA approval.

“This is a completely appropriate decision by the WHO,” wrote Dr Peter Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center, in an email. “Remdesivir costs thousands of dollars, the largest randomized trial examining its use in Covid suggests that it may have no benefit of any kind, and the only positive study dates back to an era prior to the use of the dexamethasone for serious illness, ”he added. to a steroid now commonly used in hospitals.

Dexamethasone is a treatment that helps patients with Covid-19 at certain stages of the disease.

The WHO expert group report, called the “Living Guideline,” is an initiative to continuously inform physicians and patients when new evidence emerges that is changing current medical practice.

“It’s a little troubling that we haven’t found much that works yet,” said Dr Rochwerg. “But I hope that ongoing research will identify other drugs that improve survival and symptoms.”

[Like the Science Times page on Facebook. | Sign up for the Science Times newsletter.]

Categories
Travel News

WHO rejects antiviral drug remdesivir as Covid treatment

The World Health Organization on Thursday recommended not to use the antiviral remdesivir, a drug that had generated great interest as a treatment for Covid-19.

An expert group “concluded that remdesivir had no significant effect on mortality or on other important patient outcomes, such as the need for mechanical ventilation or the time needed for clinical improvement” , said WHO. The committee published its review in The BMJ. The report does not completely rule out the drug’s use as a Covid treatment, but said evidence was lacking to recommend its use.

Gilead Sciences, maker of remdesivir, whose trade name is Veklury, said in a statement that its drug “is recognized as a standard of care for the treatment of hospital patients with Covid-19 in the guidelines of many credible national organizations,” including the US National Institutes of Health and Infectious Diseases Society of America, Japan, UK and Germany. He added that there are “several randomized, controlled studies published in peer-reviewed journals that demonstrate the clinical benefits of Veklury.”

The potential usefulness of remdesivir had been the subject of debate and skepticism for months, and particularly in recent weeks, after the Food and Drug Administration approved it as the first treatment for Covid-19 in late October. A large study, sponsored by the National Institutes of Health, found that the drug reduced the recovery time of hospital patients by 15 to 11 days. Two other trials reviewed by the agency, sponsored by Gilead, did not include placebo controls, which are considered essential for judging effectiveness.

President Trump received remdesivir along with other treatments last month when he was hospitalized with Covid.

Since at least March, when the pandemic began to spread from China to Europe via the United States, pharmaceutical companies and researchers have been working on the fly, and practicing doctors have experimented with any treatment that shows promise. including steroids. In September, the WHO expert group strongly recommended the use of steroids for critically ill patients.

For the new analysis, the panel looked at evidence from four trials, including one conducted by the NIH and one sponsored by the WHO and recently posted to a pre-print server, which included around 5,000 patients, the largest in this day. The article has not been peer reviewed or published in a scientific journal.

The results of this trial “called into question some of the benefits that were seen earlier in the NIH study,” said Dr. Bram Rochwerg, associate professor of medicine at McMaster University in Hamilton, Ont. and co-chair of the WHO panel.

Dr Rochwerg said the expert panel “made it clear in the document that trials with remdesivir should continue and some populations could benefit.” But the drug is expensive and administered intravenously, he noted. Its use could divert resources that could be deployed more efficiently, Dr Rochwerg said.

Remdesivir has been cleared for emergency use since the spring in the United States, and in October Gilead reported that it had generated $ 873 million in revenue so far this year.

The widely adopted use of the drug for Covid symptoms had baffled some experts long before FDA approval.

“This is a completely appropriate decision by the WHO,” wrote Dr Peter Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center, in an email. “Remdesivir costs thousands of dollars, the largest randomized trial examining its use in Covid suggests that it may have no benefit of any kind, and the only positive study dates back to an era prior to the use of the dexamethasone for serious illness, ”he added. to a steroid now commonly used in hospitals.

Dexamethasone is a treatment that helps patients with Covid-19 at certain stages of the disease.

The WHO expert group report, called the “Living Guideline,” is an initiative to continuously inform physicians and patients when new evidence emerges that is changing current medical practice.

“It’s a little troubling that we haven’t found much that works yet,” said Dr Rochwerg. “But I hope that ongoing research will identify other drugs that improve survival and symptoms.”

[Like the Science Times page on Facebook. | Sign up for the Science Times newsletter.]