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Medicare Officially Limits Coverage of Aduhelm to Patients in Clinical Trials

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For the previous few months, Medicare officers have been inundated with impassioned pleas about how you can deal with protection of the controversial new Alzheimer’s drug Aduhelm.

Advocacy teams for sufferers have stated the federal insurance coverage program for individuals 65 and over should pay for a drug accepted by the Meals and Drug Administration. Many Alzheimer’s medical doctors and specialists cautioned towards broadly overlaying a therapy that scientific proof exhibits has unsure profit and critical security dangers. Particular person sufferers and households weighed in on either side with emotional statements.

On Thursday, Medicare officers introduced their closing determination. This system will cowl Aduhelm provided that individuals obtain it as individuals in a medical trial, probably a small proportion of the estimated 1.5 million individuals in america who’ve gentle Alzheimer’s-related cognitive decline, the situation Aduhelm was accepted to deal with.

Chiquita Brooks-LaSure, the administrator of the Facilities for Medicare and Medicaid Companies stated the choice was meant to guard sufferers whereas gathering knowledge to point whether or not Aduhelm, an costly monoclonal antibody given as a month-to-month infusion, might really assist them by slowing the tempo of their cognitive decline.

“It’s our obligation at C.M.S. to essentially ensure it’s affordable and obligatory,” Ms. Brooks-LaSure stated in an interview Thursday. “The overwhelming majority” of the roughly 10,000 feedback the company obtained on its web site, she stated, have been in favor of “actually limiting protection of Aduhelm to a extremely managed house the place we might proceed to judge its appropriateness for the Medicare inhabitants.”

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A serious situation for Medicare had been how you can take care of different comparable medicine for Alzheimer’s, a number of of that are prone to be thought of for F.D.A. approval quickly. In a proposal in January, C.M.S. had stated it might cowl them in the identical method as Aduhelm as a result of it sometimes made protection selections for a whole class of medication.

However after each specialists and advocacy teams raised issues, Medicare officers stated Thursday that they might not robotically apply the identical restrictions to every new drug. If, not like with Aduhelm, the F.D.A. finds that there’s clear proof {that a} drug may help sufferers, Medicare would cowl it for all eligible sufferers and would solely impose a requirement that the sufferers’ expertise be tracked.

Dr. Lee Fleisher, the chief medical officer at C.M.S., stated the two-track method of coping with the fast-developing area of Alzheimer’s therapies, a program known as Protection with Proof Growth, “is supposed to be nimble and actually reply to any new medicine on this class which might be within the pipeline, and do show medical profit.”

The choice is extraordinarily uncommon for Medicare, which just about all the time robotically pays for medicine that the F.D.A. has accepted, a minimum of for the medical situations designated on labels.

However Aduhelm’s path has been very uncommon, too. The F.D.A. itself acknowledged that it was unclear if the drug was useful when it accepted Aduhelm final June. It greenlighted the drug underneath a program known as “accelerated approval,” which permits authorization of medication which have unsure profit if they’re for critical illnesses with few therapies and if the drug impacts a organic mechanism in a method thought of fairly probably to assist sufferers.

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The medical trial proof reviewed by the F.D.A. confirmed that sufferers in a single trial appeared to expertise slight slowing of cognitive decline, whereas sufferers in an almost an identical trial didn’t seem to learn in any respect. About 40 p.c of sufferers on the dosage later accepted skilled mind swelling or mind bleeding, typically gentle, however generally critical. Each a council of senior F.D.A. officers and the company’s impartial advisory committee had stated there wasn’t sufficient proof for approval.

Questions in regards to the approval, and whether or not the F.D.A. labored too intently with Biogen, Aduhelm’s producer, have prompted investigations by congressional committees, the Well being and Human Companies division’s inspector common, the Federal Commerce Fee and the Securities and Change Fee. Main medical facilities, together with the Cleveland Clinic, have declined to supply Aduhelm.

Because of issues raised by Alzheimer’s specialists and a few teams, Medicare officers introduced a number of different adjustments to their earlier proposal. As an alternative of requiring randomized managed trials accepted by C.M.S., Medicare will cowl individuals in any trial accepted by the F.D.A. or the Nationwide Institutes of Well being. It’ll enable these trials to be carried out in a broader array of places, not simply hospital settings, and to incorporate individuals with different neurological situations like Down syndrome, lots of whom develop Alzheimer’s however had been excluded from the sooner proposed plan.

The trials will nonetheless must adjust to a Medicare requirement to recruit a racially and ethnically various group of individuals, contrasting with the earlier trials of Aduhelm, during which most individuals have been white.

Within the trials, “the producers should come to us with how are they going to incorporate all sufferers that characterize the Medicare inhabitants, and the way are they going to make sure that all of those sufferers are getting applicable medical therapy and monitoring of their therapy whereas they’re in every of those research,” Tamara Syrek Jensen, the director of protection and evaluation for C.M.S.’s Middle for Medical Requirements and High quality, stated in an interview.

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The F.D.A. has additionally required Biogen to conduct one other medical trial to find out if the drug offered any proof of profit, but it surely stated that within the years it is going to take for that trial to be accomplished, Aduhelm could be out there to sufferers. Beneath Thursday’s determination, Medicare would cowl the prices for individuals in Biogen’s trial.

Medicare’s protection analysis crew makes selections with out contemplating the price of a drug, however the Aduhelm determination might ease some issues about how overlaying the drug may have an effect on the pocketbooks of the nation’s thousands and thousands of Medicare beneficiaries.

Final yr, Medicare’s actuarial division, appearing with out realizing what the protection determination could be, imposed one of many biggest-ever will increase in Medicare Half B premiums for 2022, partly pushed by the potential of protection for Aduhelm, which on the time was priced by its producer at $56,000 a yr.

Since then, Biogen, dealing with weak gross sales of the drug after many hospitals and medical doctors wouldn’t prescribe it, lowered the worth to $28,800 a yr, nonetheless a lot greater than many analysts have stated is warranted.

Xavier Becerra, secretary of well being and human providers, had stated that he would contemplate reducing premiums after the ultimate protection determination for Aduhelm was made, including that “We’re going to ensure that seniors don’t pay greater than they need to.”

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Within the interview Thursday, Ms. Brooks-LaSure, the C.M.S. administrator, stated “The secretary advised us to take a look at it, and we’re going to interact within the technique of reviewing the Half B premium.”

Advocacy teams, a number of of which obtain some funding from Biogen and different pharmaceutical corporations, had campaigned vigorously for broad Medicare protection. These teams stated sufferers ought to be capable to resolve with their medical doctors whether or not to strive an F.D.A.-approved drug and claimed it was discriminatory to solely reimburse participation in medical trials that is probably not simply accessible to many sufferers.

“We simply can’t let it stand as it’s,” Harry Johns, the chief government of the Alzheimer’s Affiliation, advised the group’s workers, in response to a recording of the assembly obtained by The New York Instances.

In an interview earlier than the Medicare announcement, Mr. Johns indicated that the affiliation wouldn’t be glad if Medicare’s restrictions utilized solely to Aduhelm, saying, “We completely imagine there may be ample proof to offer protection for the primary accepted therapy.”

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Column: Ex-'pharma bro' Martin Shkreli claims he launched a crypto coin with Barron Trump. Where's the evidence?

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Column: Ex-'pharma bro' Martin Shkreli claims he launched a crypto coin with Barron Trump. Where's the evidence?

Some people just have a knack, even a skill, for placing themselves at the center of obnoxious public business deals.

But few have proved as adroit at the practice as Martin Shkreli.

Remember him? Shkreli’s first foray into public notice came in 2015, when he jacked up the price of a 60-year-old drug to a point where it was virtually out of reach of patients for whom it was a lifesaving treatment.

Barron gave me the order to launch the coin.

— Martin Shkreli, claiming a business relationship with Barron Trump

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At this moment, he is back in the spotlight for claiming that he launched a crypto token dubbed DJT on behalf of Donald Trump’s son Barron. More on that in a moment.

To begin at or near the beginning, in 2015, Shkreli’s company, Turing Pharmaceuticals, acquired the rights to a drug named Daraprim.

The drug was a crucial treatment for the parasite-borne disease toxoplasmosis, which in its worst manifestations can cause blindness, neurological problems or death. The disease remedy is a six-week, two-pill-a-day course of Daraprim; at the standard price of $13.50 per pill, that brought the cost of a full course of treatment to about $1,130.

Shkreli raised the price of Daraprim to $750 per pill, or $63,000. For those needing more protracted treatment such as HIV patients, the cost could exceed $630,000.

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That made Shkreli the poster boy for the dysfunction in America’s pharmaceutical market, especially since Turing hadn’t developed Daraprim itself; the drug had been on the market since 1953. He seemed to bask in his renown, turning in a smirking performance before a congressional committee in 2016 that got him labeled the “pharma bro” in the popular press.

Shkreli kept making news. In 2015 he had been charged by the Securities and Exchange Commission and federal prosecutors with fraud, based on allegations that he had cheated investors in two hedge funds he founded. A federal court jury convicted him on three felony counts in 2017. A federal judge sentenced him to seven years in prison; he was released in 2022.

Also in 2022, the Federal Trade Commission banned Shkreli for life from participating in the pharmaceutical industry, due to his actions involving Daraprim.

That brings us up to date, more or less. At this moment, Shkreli is embroiled in two controversies.

We’ll start with the Barron Trump affair. About a week ago, a crypto blogger stated on X (formerly Twitter) that Donald Trump “is launching an official token” dubbed DJT, Trump’s initials, on the Solana trading platform. “Barron spearheading,” he wrote.

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Unlikely as that might sound, it fit into what appears to be a trend of third parties trying to associate Barron, 18, with Trumpian enterprises. In May, the Florida Republican Party selected him as a delegate to the Republican National Convention.

Barron’s mother, Melania, put the kibosh on that, stating that Barron couldn’t attend due to “prior commitments” — even though the selection had been endorsed by Donald Trump.

The tweet referring to DJT sent the new token soaring in the crypto market from a price of less than a penny to nearly three cents on June 17 and 18. On Tuesday it was trading between about 1.6 cents and 1.8 cents.

The initial tweet launched a frenzied effort among crypto followers to find out who really was behind DJT. On June 18 the crypto data firm Arkham Intelligence offered a $150,000 “bounty” to anyone who could identify the real creator of DJT. A day later it awarded the prize to ZachXBT, a self-identified “detective” on X, who established to Arkham’s satisfaction that it was Shkreli.

Since then, Shkreli has offered to produce evidence that he and Barron collaborated on the launch, including logs of Zoom meetings in which he and someone identified as “bt” participated.

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Shkreli wouldn’t comment to me on the record. Neither the Trump Organization nor the Trump presidential campaign replied to my queries about whether Barron worked with or even knew Shkreli or was involved with the coin.

During a lengthy webcast June 19 on the Spaces live-audio feature of X, however, Shkreli maintained that he had been brought together with Barron by one of Barron’s high school friends and that the coin was developed and launched at Barron’s initiative, and that Barron was determined to launch a Trump coin before Donald Trump Jr., whom he supposedly detests.

“I was approached, not the other way around,” Shkreli said. “Barron gave me the order to launch the coin…. He was adamant that Don Jr. was going to launch a coin.”

Shkreli said that Barron was also worried that Trump’s presidential campaign would launch its own token. “We kept this from the campaign. We don’t trust the campaign. We don’t like the campaign people — I viewed them and Barron viewed them as bloodsuckers, as political consultants who know nothing and are just trying to drain as much money as they can out of the situation.”

He said Barron pulled out of the deal after the publicity wave arrived.

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There isn’t much anyone can do to verify a word of that, until and unless Barron Trump surfaces with his own version, if he even has a version and Shkreli hasn’t concocted the whole yarn.

Shkreli’s record doesn’t inspire confidence. Consider the convoluted history of the album “Once Upon a Time in Shaolin” by the hip-hop group Wu-Tang Clan. The musicians recorded the album with the intention of creating just a single copy that could be played only at listening parties but not commercially exploited until 2103.

At a 2015 auction Shkreli bought it for $2 million. After his conviction for fraud, it was among the $7.36 million in assets the federal government seized to satisfy judgments against Shkreli. The arts collective PleasrDAO bought it from the government for $4.75 million, only to discover, according to a lawsuit filed earlier this month, that Shkreli had copied the album and was streaming songs from it online.

PleasrDAO has obtained a temporary restraining order prohibiting Shkreli from streaming or issuing copies of the unique album, pending a hearing scheduled for next month.

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Meat processing plant fined nearly $400,000 over child labor violations

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Meat processing plant fined nearly $400,000 over child labor violations

A federal court has ordered a meat processor in the City of Industry and a staffing agency in Downey to turn over $327,484 in illegal profits associated with child labor, and fined the companies an additional $62,516 in penalties.

The U.S. Department of Labor obtained the court order last week after it investigated A&J Meats and The Right Hire, which helps companies find employees. Investigators concluded that children as young as 15 were working in the processing plant, where they were required to use sharp knives as well as work inside freezers and coolers, in violation of federal child labor regulations.

The two companies also scheduled the children to work at times not permitted by law. Children worked at the facility more than three hours a day on school days, past 7 p.m. and more than 18 hours a week while school was in session, according to a news release from the Department of Labor.

Marc Pilotin, western regional solicitor at the Department of Labor, said the meat processor and staffing agency “knowingly endangered these children’s safety and put their companies’ profits before the well-being of these minors,” according to the news release.

“These employers egregiously violated federal law and now, both have learned about the serious consequences for those who so callously expose children to harm,” he said.

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Federal law prevents companies from employing minors in dangerous occupations, including most jobs in meat and poultry slaughtering, processing, rendering and packing factories.

The judgment obtained in the U.S. District Court for the Central District of California is part of a settlement the Labor Department reached with the companies. It also forbids A&J Meats, its owner Priscilla Helen Castillo and The Right Hire staffing agency from trying to trade goods connected to “oppressive child labor.”

As part of the settlement agreement, Castillo and the two companies will be required to provide annual training to employees on federal labor law for at least four years and submit to monitoring by an independent third party for three years.

Yesenia Dominguez, owner of The Right Hire, denied the claims made by the Department of Labor, saying her company did not hire any minors. She said her employees are trained to ask for documentation from workers’ home countries that lists their ages, since often they are migrants and might be undocumented.

“Those allegations aren’t true,” she said. “We do business by the book.”

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Dominguez said she felt the government “gave us no choice but to settle.”

A&J Meats did not immediately respond to a request for comment.

The Labor Department has investigated other meat processing plants in California in the last year connected to Castillo’s father, Tony Elvis Bran.

In December, federal investigators found grueling working conditions at two poultry plants in City of Industry and La Puente operated by Exclusive Poultry Inc., as well as other “front companies” owned by Bran.

Children as young as 14 stood for long hours cutting and deboning poultry and operating heavy machinery, the labor department said. The workers came primarily from Indigenous communities in Guatemala.

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The poultry processor, which supplies grocery stores including Ralphs and Aldi, was ordered to pay nearly $3.8 million in fines and back wages.

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Smart & Final workers strike amid accusations of retaliation

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Smart & Final workers strike amid accusations of retaliation

Hundreds of employees at two Smart & Final warehouses went on strike last week amid accusations the retail chain’s parent company retaliated against them for unionizing and is planning mass layoffs.

About 600 workers at the facilities in the City of Commerce and Riverside walked off the job Thursday.

The work stoppage comes after a year of increasing tensions between the workers and Grupo Chedraui, the Mexican company that owns Smart & Final.

At a meeting with employees in May last year, a Smart & Final executive announced that the company planned to close five Southern California distribution centers. The executive told employees at the warehouses they would be terminated and have to reapply for their jobs for lower pay when a new 1.4-million-square-foot facility in Rancho Cucamonga opened, according to several workers who attended the meeting.

The announcement came shortly after workers at the City of Commerce facility had voted to unionize and days before a union election was scheduled to be held at the Riverside distribution center, leading to claims by employees and union officials that the move was in retaliation for the unionization push.

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Teamsters Local 630, which represents the workers, has filed more than 30 unfair labor practice charges with the National Labor Relations Board, alleging the company is interfering with workers’ right to organize, among other claims.

Chedraui denies that its actions were retaliatory, saying the planned warehouse closures are part of a plan to integrate “five outdated and capacity-strained facilities that are spread across 2,000 square miles.”

“The Teamsters’ claims are simply not true,” the company said in an emailed statement. “Our new facility will employ nearly 1000 people, creating hundreds more American jobs than exist today. This will substantially reduce our carbon footprint and enable us to continue providing affordable food to communities in California that need it the most.”

Chedraui said the strike, which began Thursday, hasn’t caused any major disruptions in its operation of distribution centers.

Grupo Chedraui acquired Smart & Final in 2021 for $620 million through its American subsidiary, Chedraui USA. Along with Smart & Final it operates two other chains in the U.S., El Super and Fiesta Mart, making it the fourth-largest grocery retailer in California, according to company news releases. It also operates stores in Arizona, Texas, New Mexico and Nevada.

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Many of the Smart & Final warehouse workers have been with the company for more than 20 or 30 years and make about $32 per hour, union organizers and workers said in interviews. At job fairs for prospective hires at the new distribution center, Chedraui is advertising pay at $20 an hour, the organizers and employees claim.

“Things are very uncertain for us,” said Daniel Delgado, who has worked for more than 19 years at Smart & Final’s distribution center in Riverside. With the strike, “we are trying to send the company a message — a message that we are tired of being looked at as a faceless number.”

“We know this company has made billions of dollars off our backs,” he said.

Chedraui USA had $7.5 billion in domestic sales in 2022, a 137% increase over its 2021 revenue, according to an analysis of the nation’s top 100 retailers by the National Retail Federation.

In April, state Assemblymember Chris Holden (D-Pasadena) wrote to Chedraui , warning that the company’s plan to force warehouse workers to reapply for jobs appeared to violate a law he authored last year. The measure, Assembly Bill 647, aims to protect jobs of grocery employees, including warehouse workers, in the event of mergers or reorganizations of companies.

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And Daniel Yu, assistant chief of the California Labor Commissioner’s Office, sent a letter in May to Chedraui, urging the company to suspend its plans to relocate its facility and delay hiring in order for his office to collect evidence to determine whether the company’s actions violate labor law.

The decision to strike this month came after a three-week work stoppage last year and other protests by employees. Maurice Thomas was among hundreds of workers who rallied outside a Smart & Final in Burbank in August. He joined the company about three years ago, leaving his job at a Frito-Lay plant in Texas to take care of his parents in California.

“It’s been real, real tough,” Thomas said. “The company has no interest in bargaining with us, they are delaying until either we give up or they move to this new facility without us. But we are not going down without a fight,” he said.

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