A California prison inmate locked up on a gang-related murder conviction led a scheme that defrauded the U.S. government out of more than $550 million in Covid-era federal tax credits, prosecutors said.

The inmate, Kristopher Thomas, was also charged with running a drug trafficking operation from his cell at Kern Valley State Prison that shipped large amounts of methamphetamine to several states and smuggled fentanyl into that prison, court filings show.

Thomas’ mother, 55-year-old Kettisha Thompson-Dozier, and her spouse, Charmane Dozier, 44, who both live in Waldorf, Maryland, were charged with him in the tax credit scheme, along with Sharon Vance, 36, of Hawthorne, California, according to prosecutors.

All four defendants are charged in that case with conspiracy to defraud the government with respect to claims.

Five other people were charged with Thomas in the alleged drug trafficking scheme.

Thomas, 36, has been in prison since December 2010 following a murder conviction. He was sentenced to 50-years-to-life behind bars for the August 2009 killing in Los Angeles of Dequawn Allen, whom he shot after asking where Allen was from.

Thomas is a member of the Main Street Mafia Crips, a Los Angeles street gang, according to the U.S. Attorney’s Office for the Eastern District of California, which is prosecuting him for both alleged schemes.

A criminal complaint accuses Thomas and his co-conspirators of filing, from early 2022 through July 2023, more than 400 payroll tax returns that claimed the employer retention credits in the names of fake businesses, and in the names of real companies that overstated the wages and numbers of workers they had.

The employee retention credits became a refundable federal tax credit for employers during the Covid-19 pandemic to encourage businesses to retain workers. The credit maximum was $5,000 per employee in 2020 and was increased to $7,000 per employee per quarter in 2021.

“Thomas provided instructions to co-conspirators about how to file payroll tax returns, how to respond to correspondences to the IRS, how to deposit the tax refund checks received, and more,” a criminal complaint said.

Thomas and the other conspirators used the money from the scam for personal expenses, which included Thomas paying for his family and friends “to be driven to Las Vegas from Los Angeles, party for the night at a luxury penthouse, and then fly back to Los Angeles on a private jet” to celebrate his birthday, the U.S. Attorney’s Office said.

“It is remarkable that a prison inmate coordinated with others on the outside to distribute over 100 pounds of methamphetamine into the community,” said U.S. Attorney Philip Talbert.

“But that apparently was not enough: he also conspired to pursue over half a billion dollars in federal tax credits that were meant to help struggling businesses during the COVID-19 pandemic,” Talbert said.

Both the tax scheme and the drug trafficking operation came to light after August 2022, when the Drug Enforcement Administration began an investigation into Thomas at his prison in Delano, California, after identifying him as the source of methamphetamine in Hawaii, Talbert’s office said.

Thomas used a prison-issued electronic tablet to call “numerous romantic partners, family members, and other individuals believed to be involved in drug trafficking,” the U.S. Attorney’s Office said.

DEA agents intercepted those calls and also intercepted text messages showing Thomas communicating about the tax fraud scheme, prosecutors said.

Agents seized more than 90 pounds of meth linked to Thomas in Oahu, Hawaii, more than 94 pounds of the same drug in Alabama, New Jersey and Oklahoma, and elsewhere, prosecutors said.

Agents also seized 14 pounds of fentanyl, 9.5 pounds of heroin, and 8.5 pounds of cocaine as a result of the DEA’s wiretaps on Thomas, according to prosecutors.

And “a half a pound of fentanyl was seized after it was smuggled into [Kern Valley State Prison] at Thomas’s direction,” the U.S. Attorney’s Office said.

Charged with Thomas in the drug scheme were Justin Damonte Mitchell, 31, of Los Angeles; former Kern Valley State Prison inmate Derrick Charles, 41; Natasha Michelle Bailey, 44, of Bakersfield, California; Antrell Maeshack Sr., 41, of Santa Clarita, California; and 29-year-old Marie Joo-Yeon Choi of Los Angeles.

Former President Donald Trump is set to deliver a pair of headline speeches Friday night at two socially conservative Christian groups’ gatherings in Washington, D.C., his first trip to the nation’s capital since his criminal arraignment last month.

Trump’s top Republican rival, Florida Gov. Ron DeSantis, is also scheduled to speak at the two summits hosted by the Concerned Women for America Legislative Action Committee and the Family Research Council.

At the concerned women’s conference, DeSantis leaned into his gubernatorial record as an eager instigator of high-profile fights against progressive social policies that he grouped under the banner of “woke ideology.”

The left is trying to “use our schools to indoctrinate our kids” and engage in “social experimentation, like trying to jam men into women’s sports,” he said, pulling a murmur of agreement from the crowd of roughly 270 group members.

The women’s group, which espouses staunch opposition to abortion, gay marriage and a progressive view of transgender rights, bills itself as the nation’s largest public policy women’s organization. The Family Research Council takes a similarly hard-line tack on social issues.

Republican Sens. Ted Cruz of Texas, Marco Rubio of Florida and Tommy Tuberville of Alabama also spoke to the women’s group, among others including a “pro-life activist” and a “detransition activist.”

Three other GOP primary candidates — former Vice President Mike Pence, Sen. Tim Scott of South Carolina and entrepreneur Vivek Ramaswamy — were invited but have not been confirmed to speak, according to the group’s event website.

Pence and Ramaswamy were both slated to speak at the Family Research Council’s “Pray Vote Stand” summit, however.

Pence, an evangelical Christian who often invokes his faith in his political speech, unveiled what he called a “plan to rebuild the American family.”

He laid out a four-pronged strategy that aims to “encourage marriage” — Pence is an opponent of same-sex marriage — end “transgender ideology,” give parents more options for schooling their children and further challenge abortion rights.

“Save the babies and we’ll save America,” he said.

In a different political moment, Trump’s personal baggage on women’s issues might be a liability for him in the GOP primary.

One of his four active criminal cases is focused on hush money paid to a porn star who alleges she had an extramarital affair with Trump, which he denies.

In May, he was found liable for sexually abusing the writer E. Jean Carroll and ordered to pay $5 million in her civil rape and defamation case. Trump has also been found liable for defaming Carroll in a similar separate case, which is nevertheless set to head to trial in January.

More than a dozen women have accused Trump of sexual misconduct.

Meanwhile, former first lady Melania Trump has been absent from the campaign trail — a stark contrast with Casey DeSantis, who is regularly by her husband’s side as he crisscrosses key primary states.

Casey DeSantis is also taking a lead role in “Mamas for DeSantis,” a campaign initiative aimed at mothers. Trump’s campaign has no clear matching platform: searches for “women, “woman” or “mother” on his “Agenda47” campaign policy page yield no results.

And yet, national polls of the Republican primary field give Trump a commanding lead among both men and women.

A Quinnipiac University survey released Wednesday, for instance, showed 58% of Republican or Republican-leaning women backing Trump in the presidential primary, compared with 64% of their male counterparts.

Just 14% of women in the same group picked DeSantis, while 5% chose former United Nations Ambassador Nikki Haley, the only woman in the running for the GOP nomination.

The poll also showed that while Trump and President Joe Biden are in a dead heat overall, the Democratic incumbent holds a double-digit edge over Trump among women registered voters: 56% said they would pick Biden in an election against Trump, who was chosen by 37% of respondents.

Part of that split may be attributable to Trump’s role in last year’s hugely consequential Supreme Court decision striking down the constitutional right to an abortion that had been upheld by Roe v. Wade for nearly a half-century.

The three conservative justices appointed by Trump all voted to strike down Roe. The ruling instantly became a rallying cry for Democrats, who went on to outperform expectations in the 2022 midterm elections.

A large majority of U.S. adults still say they disapprove of the highly unpopular court’s decision, recent surveys have shown.

But the women’s group Trump is addressing Friday has strongly cheered the decision, with Penny Nance, the organization’s president, calling it a “huge victory for human rights and life.”

Trump was last in D.C. in early August for his arraignment on federal charges stemming from special counsel Jack Smith’s probe of the former president’s efforts to overturn his loss in the 2020 election.

Trump pleaded not guilty to a four-count indictment accusing him and several co-conspirators of illegally perpetrating three criminal conspiracies to try to subvert the election results. He was arraigned at a federal courthouse just a few minutes’ walk from the U.S. Capitol, the scene of the Jan. 6, 2021, riot by thousands of Trump’s supporters who temporarily halted the peaceful transfer of presidential power.

One of Trump’s alleged conspiracies involved an effort to impede Congress from confirming Biden’s victory at the Capitol on Jan. 6. As the scene devolved into a violent riot, Trump and his allies “exploited the disruption” to further their conspiracy, Smith alleged in the indictment.

The case is set for trial next March.

Trump’s latest appearance in D.C. will take place at a hotel ballroom a few blocks from the White House Ellipse. Shortly before the riot kicked off on Jan. 6, Trump held a “Stop the Steal” rally at that site, urging his followers to march to the Capitol and pressure GOP lawmakers to reject key electoral votes.

The D.C. indictment was the first of two separate criminal cases charging Trump with trying to reverse his election loss. The other, a sweeping state-level case in Georgia, has yet to set a trial date for Trump and many of his co-defendants.

Medicare plans to expand its coverage of PET scans that are used to help diagnose Alzheimer’s disease, a major policy shift that could make it easier for patients to access new treatments entering the US market.

The proposal would abolish the current Medicare policy nationwide. Currently, the Seniors Program will cover one PET scan per age for patients participating in clinical trials.

Medicare’s proposal would allow regional organizations, called Medicare Administrative Contractors, to decide whether to cover the diagnostic tool. These regional contractors make coverage decisions based on whether the service is “reasonable and necessary” for a diagnosis.

Chiquita Brooks-LaSure, president of the Centers for Medicare and Medicaid Services, said in a statement Monday that the proposed policy “fulfills CMS’s commitment to allow broader coverage of this diagnostic test.” A CMS spokesperson said a final decision could come within 90 days.

Positron emission tomography scans are an important diagnostic tool that detects the presence of a protein amyloid in the brain associated with Alzheimer’s disease. Screenings are the most common way to help diagnose patients.

People on Medicare generally pay 20% of the cost of a PET scan after the deductible is met. The cost of a one-time scan would be about $313 per patient, according to one estimate in a study published in the medical journal JAMA Internal Medicine.

doctor. It’s possible for regional contractors to come to different coverage decisions for PET scans, said Sean Tunis, CMS’ former chief medical officer. But these organizations generally work together on key issues and there’s no reason to think their policies on PET scans will differ widely across the United States, said Tunis, now a consultant at Rubix Health.

Medicare’s coverage of PET scans should make it easier for patients to access new treatments like Leqembi, which was approved by the Food and Drug Administration earlier this month.

Medicare agreed to cover Leqembi’s treatment for Eisai and Biogen’s Alzheimer’s, but requires patients diagnosed with mild cognitive impairment or mild Alzheimer’s disease with documented evidence of amyloid on the brain.

Most patients choose positron emission tomography to confirm the presence of amyloid because imaging is less invasive than alternative diagnostic tools such as spinal taps. Blood tests are also in development, and some are already in use, but not yet widely deployed.

Medicare said it would also cover other antibody therapies for Alzheimer’s with the same terms if they receive approval from the Food and Drug Administration. Eli Lilly The US Food and Drug Administration (FDA) expects to make a decision on its treatment, donanimab, by the end of the year.

The Alzheimer’s Association, a pressure group that advocates for people living with the disease, said the new policy proposed by Medicare would remove unnecessary barriers for patients. Maria Carrillo, the consortium’s chief scientific officer, called the decision “a huge step forward”.

Uninsured Americans pay an average of nearly $98 for a bottle Eli Lillygeneric insulin, even after the company pledged to lower the product’s list price to $25 per vial, according to a report released Thursday by the senator. Elizabeth Warren.

Eli Lilly pledged earlier this year to lower the list price of the generic insulin, Lispro, from $82.42 per vial starting May 1. The Indianapolis-based pharmaceutical company is one of the largest insulin manufacturers in the world.

The Massachusetts senator’s report surveyed more than 300 pharmacy chains and independents in the United States between June 9 and 28 to determine whether the price reduction announced by Eli Lilly “translated into real patient relief.”

The survey found that a third of pharmacies charge uninsured patients $164 or more for a bottle of Eli Lilly’s Lispro.

Seven pharmacies charged $200 per bottle or more, and two sold the product for more than $300.

Chain pharmacies charged uninsured customers an average of $123 per vial for generic insulin, compared to an average of $63 at independent pharmacies.

Eli Lilly did not immediately respond to CNBC’s request for comment on the poll.

The study findings indicate that “Eli Lilly’s promises of affordable insulin have not been delivered to uninsured patients across the country,” Warren said in a statement.

She said the data also shows that Congress needs to take more steps to rein in excessive pricing, such as capping insulin fees at $35 per month for all patients, regardless of their insurance status.

President Joe Biden’s Inflation Reduction Act currently sets co-insulin amounts at $35 per month for people covered by Medicare.

“My new report confirms that far too many uninsured Americans do not have access or cannot afford to pay astronomical prices for life-saving universal insulin — lawmakers need to step up and take action,” Warren said in a press release.

Insured Americans usually pay a fraction of the list price of insulin. But uninsured people often have to pay the full cost, which could force them to ration or stop taking a life-saving diabetes treatment.

Nearly 30% of uninsured diabetics reported skipping insulin doses, taking less than prescribed or delaying purchases within the past year, Warren said, citing a 2022 study conducted by researchers from Harvard University and other institutions.

“No American should ever be forced to choose between life-saving medications, such as insulin, and their ability to pay for food, shelter, and their daily needs,” Warren said.

Earlier this year, Eli Lilly, Sanofi And Novo Nordisk is committed to reducing the list prices of the most commonly prescribed types of insulin by at least 70% later in 2023.

Eli Lilly and Sanofi also set monthly insulin costs at $35 for people with private insurance.

The three companies together control 90% of the global insulin market.

Their commitments were met with praise from lawmakers and Biden, who was pleased that the companies were finally heeding the calls to help make diabetes care more affordable in the United States.

But the Warren poll raises questions about the effectiveness of cost-cutting efforts.

About 37 million people in the United States, or 11.3% of the country’s population, have diabetes, according to the Centers for Disease Control and Prevention.

The American Diabetes Association said nearly 8.4 million people with diabetes are insulin dependent.

Medicare has agreed to pay for Leqembi’s treatment for Alzheimer’s disease, a major turning point for patients diagnosed with the early stages of the disease.

Leqembi is the only drug on the market now that has been shown to slow the progression of early-stage Alzheimer’s disease in a clinical trial. The monoclonal antibody, given twice monthly through an IV, slowed cognitive decline by 27% over the course of 18 months in the trial.

Leqembi is made by the Japanese pharmaceutical company Eisai and its partner Biogenheadquartered in Cambridge, Massachusetts.

Medicare’s decision to cover Leqembi, which came moments after the US Food and Drug Administration approved the drug Thursday, promises to make treatment more accessible to patients.

Medicare coverage is critical for most patients to have any hope of being able to afford Leqembi. Eisai priced Leqembi at $26,500 a year before insurance coverage, which is too expensive for Medicare patients, whose average income is about $30,000.

Medicare foots the majority of the bill, though many patients will still face several thousand dollars out of their own pockets.

Patients on traditional Medicare will pay 20% of Leqembi’s bill, according to the federal Centers for Medicare and Medicaid Services. That means those patients could see an annual bill of more than $5,000, according to an estimate from KFF, a nonprofit group that researches healthcare issues.

People with Medicare Advantage plans typically pay 20% more for drugs like Leqembi, up to the out-of-pocket limit, which was about $5,000 on average for in-network services, according to the KFF.

Patients with supplemental insurance such as Medigap or Medicaid may pay less, according to the KFF.

People with modest means may not be able to afford an out-of-pocket Leqembi even with Medicare coverage, said Tricia Newman, a Medicare expert at KFF.

Newman said this is particularly worrisome because blacks and Hispanics are more likely to develop Alzheimer’s disease but are likely to have lower incomes.

If demand for Leqembi is high, there are also concerns that patients could face long waiting times to see specialists and receive injections.

Medicare has certain conditions that must be met for patients to be eligible for Leqembi coverage.

To be diagnosed with Alzheimer’s disease or mild cognitive impairment, patients should undergo a cognitive assessment and undergo a positron emission tomography scan or a spinal tap to detect the amyloid protein associated with the disease. PET scans are the most common way to detect amyloid because they are less invasive.

Medicare currently covers one PET scan per age for amyloid detection. A spokesperson for the agency said CMS is reconsidering this policy and plans to release a proposed rule soon.

The requirement for clinicians to enter patient information into the registration system is controversial. The Alzheimer’s Association and some members of Congress are concerned that the requirement to collect data creates unnecessary red tape for patients to receive treatment.

The federal Centers for Medicare and Medicaid Services has created a nationwide portal that is supposed to make it easier for doctors to enter required information about their patients. CMS has released a video showing clinicians how to navigate the system:

Doctors can access free registration on this website.

doctor. The record is simple and unlikely to be burdensome for patients and doctors, said David Knopman, a neurologist who specializes in Alzheimer’s disease at the Mayo Clinic in Minnesota.

Patients diagnosed with mild cognitive impairment or mild Alzheimer’s disease need to talk to their doctor about whether Leqembi’s benefits outweigh the risks, according to CMS.

Although Leqembi slightly slowed cognitive decline in clinical trials, the treatment also carries serious risks of brain swelling and bleeding. In the trial, 13% of patients given Leqembi had swelling and 14% had bleeding.

Swelling and bleeding were usually mild, with no obvious symptoms, but these episodes can be fatal, according to an independent Food and Drug Administration review of clinical trial data. When symptoms do appear, they include headache, confusion, dizziness, vision changes, and nausea.

People who have two copies of a gene mutation called APOE4 are at increased risk of swelling and bleeding and patients should be tested to confirm if they have the mutation before taking Leqembi, according to the US Food and Drug Administration. A CMS spokesperson said Medicare covers testing for the APOE4 mutation.

And according to the Food and Drug Administration, patients who take anticoagulants appear to be more likely to have bleeding in the brain.

Three patients who received Leqembi died in the trial, although the Food and Drug Administration could not determine if these deaths were related to the treatment.

Patients who have been appropriately diagnosed and informed should be able to decide for themselves whether they want to take Leqembi after weighing the benefits of the treatment against the risks of potentially serious side effects, Knopman said.

The Food and Drug Administration on Thursday fully approved the Alzheimer’s treatment Leqembi, a pivotal decision that would expand access to the expensive drug for older Americans.

Medicare announced shortly after the US Food and Drug Administration (FDA) approval that it now covers antibody treatment for patients enrolled in the insurance program for seniors, though several conditions apply.

Leqembi is the first antibody treatment for Alzheimer’s disease to receive full approval from the Food and Drug Administration. It is also the first such drug to gain broad coverage through Medicare.

Leqembi is not a cure. The treatment slowed cognitive decline from early-onset Alzheimer’s disease by 27% over the course of 18 months during the Eisai clinical trial. The antibody, which is given twice a month by intravenous infusion, targets a protein called amyloid that is associated with Alzheimer’s disease.

Medicare coverage is a critical step in helping older Americans with early-onset Alzheimer’s disease pay for treatment. With a median income of about $30,000, most people on Medicare can’t afford Leqembi’s $26,500 annual rate set by Eisai without insurance coverage.

Medicare had previously agreed to cover Leqembi only for patients participating in clinical trials after the treatment received urgent approval in January. This policy has severely restricted access to the drug.

To be eligible for coverage, patients must be enrolled in Medicare, be diagnosed with mild cognitive impairment or mild Alzheimer’s disease, and have a physician participate in a data collection system set up by the federal government to monitor treatment benefits and risks.

Joanna Pike, president of the Alzheimer’s Association, a lobby group that advocates for people living with the disease, said that while Leqembi is not a cure, it will help patients in the early stages of the disease maintain their independence, manage their daily lives and spend more time with their families.

“This gives people months to get to know their spouses, children and grandchildren,” Paik said in a statement Thursday. “It also means more time for the person to drive safely, accurately, and quickly to take care of family finances and to participate fully in hobbies and interests.”

But the treatment carries serious risks of brain swelling and bleeding. Three patients who participated in the Esay study died. FDA scientists said it’s unclear if Leqembi played a role in these deaths.

Alzheimer’s disease is the most common cause of dementia among older adults and the sixth leading cause of death in the United States, according to the Food and Drug Administration.

doctor. David Knopman, a neurologist who specializes in Alzheimer’s disease at the Mayo Clinic in Minnesota, said Leqembi clearly showed a benefit for patients in the Eisai trial, though he cautioned that the treatment’s efficacy was modest.

Adequately diagnosed and informed patients should be able to decide for themselves whether they want to take Leqembi after weighing the benefits and risks of treatment as well as the potential logistical challenges of finding a place to receive the twice-monthly injections, Knopman said.

To receive coverage, Medicare requires patients to find a healthcare provider who participates in a scoring system that collects factual data about the drug’s benefits and risks. The system is controversial. The Alzheimer’s Association and some members of Congress worry that this requirement will create barriers to treatment.

There are concerns that the number of healthcare providers participating in such registries will be limited, and that people in rural towns and other disadvantaged communities will have to travel many hours to find such a provider.

The Centers for Medicare and Medicaid Services has created a nationwide portal to make it easier for healthcare providers to provide required data on patients receiving Leqembi. The free-to-use portal went into effect moments after the FDA’s decision on Thursday.

representative. Anna Echo of California, ranking Democrat on the House Subcommittee on Health, and Rep. Nanette Bargan, D-Calif., raised concerns in a letter to CMS last month that patients might struggle to find a physician involved in the system.

Alzheimer’s disease is usually diagnosed with the help of a positron emission tomography (PET) scan to detect the amyloid protein associated with the disease or in some cases with a spinal tap. Medicare currently covers one PET scan per age for dementia. It is not clear if the program plans to change that policy.

There is also concern that there may be too few specialist doctors and sites to administer the injection if Leqembi is widely adopted as a treatment and patient demand for the antibody is high.

Some studies have estimated that wait times for antibody treatments like Leqembi could range from months to years over the next decade depending on demand.

Thomas Phillipson, who advised the FDA commissioner and CMS official during the second Bush administration, said registration is an unnecessary hurdle and Medicare should drop it, but he doesn’t think the requirement will create an insurmountable barrier for patients arriving at Lekembe.

If Leqembi is in high demand, said Phillipson, an expert in health care economics at the University of Chicago, doctors will have an incentive to participate in the enrollment and drug companies will want to help.

He said how high the demand for Leqembi would be was uncertain. He said families concerned about serious side effects may choose not to take the treatment, while others will decide the benefits outweigh those risks.

Leqembi’s price and treatment benefit-risk profile are controversial.

Medicare patients treated with Leqembi will pay 20% of the medical bill after they meet the Part B deductible, according to CMS. Costs may vary depending on whether the patient has supplemental medical coverage or other secondary insurance, depending on the agency.

Patients can face up to $6,600 in annual costs for Leqembi even with Medicare coverage, according to a study published in JAMA Internal Medicine. The study estimated that the treatment could cost Medicare up to $5 billion a year depending on how many people get the injections.

senator. Bernie Sanders, chairman of the Senate Health Committee, called Leqembi’s price “unreasonable” and in a letter last month asked Health and Human Services Secretary Xavier Becerra to take action to reduce the cost.

Sanders said the patient’s out-of-pocket costs for Leqembi would amount to one-sixth of seniors’ total annual income, and he noted that the higher cost of treatment could increase premiums for everyone on Medicare.

Leqembi’s annual list price of $26,500 is lower than the company’s estimate of $37,600 for the total value of the treatment per patient, Eisai says. The Institute for Clinical and Economic Review, a nonprofit organization that analyzes healthcare costs, estimated in April that it should be between $8,900 and $21,500 a year.

Although Leqembi could be costly for Medicare, Philipson said delaying treatment coverage would dramatically increase health care spending as people with mild Alzheimer’s disease, which can be managed at home, progress to more serious illness requiring nursing home care. Expensive.

Phillipson and his colleagues at the University of Chicago estimated that delaying Medicare coverage of antibody therapies for Alzheimer’s disease by a year would lead to $6.8 billion in spending increases. By 2040, healthcare spending will increase by $248 billion.

Thursday’s full FDA approval comes after a panel of six outside advisors voted unanimously in June to support the drug’s clinical benefit for patients. The committee was unusually small because some members had recused themselves due to conflicts of interest.

The American Academy of Neurology said in a February letter to CMS that there is a consensus among its experts that Eisai’s clinical trial for Leqembi was well designed and that the results were “clinically and statistically significant.”

Some nonprofit groups such as Public Citizen, a consumer advocacy organization, have strongly opposed FDA approval of Leqembi. A representative from Public Citizen told the advisory committee that the evidence of the drug’s benefit did not outweigh the significant risks of brain swelling and bleeding.

Representatives from the National Center for Health Research and Physicians of America, also nonprofits, told the panel that the Eisai clinical trial did not include enough black patients, who are at a higher risk of developing Alzheimer’s disease.

Leqembi has been technically approved for the US market since January, when the US Food and Drug Administration (FDA) cleared the treatment under an accelerated course. The US Food and Drug Administration (FDA) uses accelerated approvals to save time and get drugs to critically ill patients faster.

But Medicare refused to cover Leqembi at the time, asking for more evidence that the expensive treatment had real clinical benefit for patients who outweigh the risks.

The program’s cautious coverage policy stems from the controversial Food and Drug Administration (FDA) approval in 2021 of another antibody treatment for Alzheimer’s disease called Aduhelm, which was also introduced by Eisai and Biogen.

An advisory committee for the US Food and Drug Administration (FDA) declined to approve Aduhelm because the data did not support a clinical benefit for patients. Three counselors resigned after the agency decided to approve the treatment anyway.

Knopman is one of the advisors who resigned because of the FDA’s decision on Adholm. He said that a date for Kimbe is different. Knopman said Esay ran a clean trial that showed the antibody had modest clinical benefit for patients.

A congressional investigation later found that the FDA’s approval of Adholm was “riddled with irregularities.”

In his letter to Becerra, Sanders said the FDA “has a special responsibility to restore the public’s trust following its inappropriate relationship with Biogen during the agency’s review of a previous Alzheimer’s disease drug, Aduhelm.”

An advisory panel for the Centers for Disease Control and Prevention recommended Wednesday that adults 60 and older, after consultation with their physicians, receive a single dose of RSV vaccines from Pfizer And GSK.

The panel said older people should use “joint clinical decision making,” which involves working with their healthcare provider to determine how much they can benefit from a shot.

Outgoing CDC Director Rochelle Walensky will decide whether to finalize the recommendation.

The committee’s decision brings one step closer to making punches against respiratory syncytial virus available to the public this fall, when the disease usually begins to spread at higher levels.

The recommendation also comes weeks after the Food and Drug Administration approved both vaccines, making them the world’s first authorized shots against respiratory syncytial virus.

The virus is a common respiratory infection that usually causes mild cold-like symptoms, but causes more severe cases in the elderly and children. Each year, RSV kills between 6,000 and 10,000 older adults and a few hundred children under 5 years old, according to the CDC.

Pfizer and GSK on Wednesday submitted new clinical trial data to the panel, which provided the first glimpse of the picks’ durability after one season of RSV. The season usually lasts from October to March in the northern hemisphere.

A single dose of Pfizer’s shot was 78.6% effective in preventing lower respiratory tract infections with three or more symptoms during the middle of the second RSV season, according to new clinical trial results presented Wednesday. This is down from over 85% at the end of the first season in seniors.

Pfizer said efficacy dropped to 48.9% in the “mid-season 2” for less severe forms of the disease in that age group, down from about 66%.

The company said Wednesday that a single dose of the GSK shot was 78.8% effective against severe RSV disease after two seasons, compared to 94% after one season. Severe illness refers to conditions that prevent normal daily activities.

For less severe RSV disease, efficacy decreased to 67.2% during two seasons from 82% after one season.

doctor. Michael Melgar, the CDC medical officer who evaluated the data on both shots, noted during a public meeting that both Pfizer and GSK still lacked efficacy data for subgroups of the elderly population at high risk for RSV infection.

Melgar said adults age 75 and older with an underlying medical condition are underrepresented in Phase 3 clinical trials from both companies. He said that elderly people with weakened immune systems were excluded from the trials altogether.

Both companies said studies on this population are ongoing.

It’s still not clear how much the footage will cost. GSK said it would price its vaccine between $200 and $295. Pfizer said it will price it between $180 and $270.

The companies refused to guarantee pricing.

The picks will help the US battle the RSV season coming into the fall after an unusually intense RSV season last year.

Hospitals across the country have been overwhelmed by cases of the virus in children and the elderly, in large part because the public has stopped practicing Covid-sanitary measures that have helped keep the spread of RSV down.

A panel of independent advisers to the Food and Drug Administration on Friday unanimously approved the Alzheimer’s drug Leqembi, made by Eisai and Biogenpaving the way for full treatment approval this summer.

The councilors voted 6-0 that Eisai’s data showed clinical benefit for patients. The FDA is not required to follow the advisers’ recommendation, but the panel’s vote for Leqembi will weigh heavily in favor of full approval.

The FDA is expected to make a final decision on Leqembi on July 6. The agency’s decision will determine whether Medicare broadly covers the treatment. The adult program severely limits Leqembi’s coverage at this time, as it was previously approved through an expedited process.

Eisai has set Leqembi’s annual list price at $26,500 per year, meaning most patients cannot afford the treatment without Medicare coverage.

The Leqembi Advisory Committee on Friday was unusually small, with only six voting members.

Dr. Teresa Buracchio, acting head of the FDA’s office of neuroscience, said the smaller-than-usual committee was the result of a number of experts withdrawing from Friday’s meeting because of conflicts of interest.

“Although this group is small, it contains the appropriate expertise needed to have a robust discussion on the topic at hand today,” Buraccio said.

Leqembi is the second Alzheimer’s treatment from Eisai and Biogen to come under FDA review, following the controversial approval of the drug Aduhelm in the summer of 2021.

The drug regulator granted accelerated approval to Aduhelm, developed by the two companies, despite 10 of 11 advisory committee members concluding that the treatment did not demonstrate clinical benefit. A congressional investigation subsequently found that Aduhelm’s approval was “riddled with irregularities.”

Sen. Bernie Sanders, chairman of the Senate Health Committee, told the Department of Health and Human Services in a letter Wednesday that “FDA has a special responsibility to restore public trust after the inappropriate relationship with Biogen during the agency’s review of a previous illness of Alzheimer’s drug, Aduhelm.”

Eisai’s study of Leqembi found that the drug slowed cognitive decline in early Alzheimer’s patients by 27%. The antibody is administered twice a month by intravenous infusion. It targets a protein called amyloid, often called plaque, that builds up in the brain and is associated with the disease.

Buracchio told the group that the agency views these results as clinically relevant to patients. Several families whose loved ones have been diagnosed with Alzheimer’s disease told the panel during the public comment section that Leqembi has given them hope.

Joan Bridges told the panel that Lekemby had helped her husband Jerome continue his daily activities, which had improved their lives: “Going from hopelessness to hope for our future was made possible by Lekemby – a new life,” Bridges told the panel

“Alzheimer’s disease is a terrible, crippling disease for patients and their caregivers,” Bridges said. “The fact that Leqembi can slow the process is a huge step in fighting the disease and making life more rewarding for those diagnosed with Alzheimer’s.”

But Leqembi also carries serious risks of brain swelling and bleeding. During the study, 13% of patients receiving Leqembi experienced swelling and 14% experienced bleeding.

Swelling and bleeding are usually mild with no obvious symptoms, but these episodes can be life-threatening, according to the FDA.

There were three deaths in the study that were possibly related to Leqembi, although the FDA was unable to draw definitive conclusions in its review.

Two patients who died had cerebral hemorrhages after the infusion. They were given blood thinners. A third patient who died had an underlying condition called cerebral amyloid angiopathy, in which the blood vessels in the brain are weak, which can lead to bleeding.

Dr. Deniz Erten-Lyons, an FDA official, told the group that taking blood thinners during treatment with Leqembi may increase the risk of brain bleeds.

Several groups voiced strong opposition to the FDA’s approval of Leqembi during the public comment section of Friday’s meeting.

Nina Zeldes of Public Citizen’s Health Research Group said the FDA has not clearly presented convincing evidence that Leqembi has clinical benefit. Zeldes said the serious safety concerns associated with the treatment outweigh the benefit based on the current data.

Dr. Donna Kim Murphy, a neuroscientist with Doctors for America, said the Eisai study was flawed because black Americans, who are at higher risk for Alzheimer’s disease, were severely underrepresented in the trial. Black Americans accounted for 2.3% of participants who received Leqembi during the trial.

“With the racial incidence of Alzheimer’s and cerebral hemorrhage in black patients and their significant underrepresentation in this study, I as a neurologist cannot advise this group with data on lecanemab,” Murphy said.

Buraccio said the panel was smaller than usual due to the withdrawal of experts due to conflicts of interest.

The FDA’s decision on who to include in Friday’s meeting was influenced by a letter from the Alzheimer’s Association, which advocated for full approval of Leqembi, Burrachio said. At least one FDA advisory committee member, Dr. David Weissman, signed this letter.

Weisman was initially granted permission to participate in Friday’s meeting despite serving as principal investigator for Biogen and Eisai clinical trials of Leqembi and Aduhelm at Abington Neurological Associates.

Weissman subsequently withdrew from the meeting and did not participate.

Incumbent Dr. Robert Alexander was cleared to chair the panel on Friday, despite owning up to $150,000 worth of stock in companies that compete with Eisai and Biogen. The FDA disclosure did not name the companies.

Alexander is the Chief Scientific Officer of the Alzheimer’s Prevention Initiative at the Banner Alzheimer’s Institute. Banner is conducting an Alzheimer’s clinical trial for a competing firm, and Alexander receives a $50,000 to $100,000 salary a year from funding supporting the trial.

Brian Marshall, who heads the office that manages the FDA’s advisory committees, asked the agency to grant Alexander a waiver because he has unique experience that is “invaluable” to Friday’s meeting.

Leqembi is technically already on the US market after receiving fast-track approval in January, but very few seniors have access to the expensive treatment because Medicare limits coverage to people who participate in clinical trials. No clinical trials are conducted.

As a result, most older people only have access to Leqembi if they can afford to pay for the drug out of pocket. Leqembi has a list price of $26,500 per year.

Medicare promised to broadly cover Leqembi the same day the FDA fully approved the drug. The Veterans Health Administration already covers treatment for veterans.

Sen. Sanders said Leqembi’s price was “reckless” and urged HHS Secretary Xavier Becerra to take action to lower the price in a letter ahead of this week’s meeting.

Sanders said seniors would face significant out-of-pocket costs even if Medicare covered Leqembi. The cost of the drug would also put a significant financial burden on the seniors program, raising premiums even for people who don’t use the drug, he said.

The US Food and Drug Administration has authorized the temporary import of an unapproved chemotherapy drug from China in an effort to ease an acute shortage of cancer drugs in the United States, according to an update posted on the agency’s website on Friday.

A document showed that Qilu Pharmaceutical, which manufactures and markets cisplatin injections in China, obtained the Food and Drug Administration’s permission to export the drug to the US market weeks ago.

A letter dated May 24 from Qilu’s deputy general manager notified healthcare professionals of the approval.

Qilu is coordinating with Toronto-based Apotex to distribute 50-milligram vials of cisplatin in the United States

Health care providers can start ordering the drug Tuesday through wholesalers.

Cisplatin is a generic drug that has been available for decades in the United States and is distributed by several approved manufacturers. These manufacturers could not keep up with demand. The Qilu version of cisplatin is not approved in the United States

Headquartered in Jinan, Shandong Province, Qilu says it is one of the top 10 pharmaceutical manufacturers in China.

The FDA told CNBC this week that the agency is considering importing unapproved chemotherapy drugs, but did not disclose at the time the names of any manufacturers that might supply the drug.

A spokesperson for the US Food and Drug Administration said the agency evaluates the quality of imports of unapproved drugs to ensure they are safe for American patients.

Doctors say some cancer patients could die if a national shortage of drugs like cisplatin is not resolved soon. There are shortages of at least 13 other cancer medications across the United States

Cancer drug shortages have forced some hospitals to ration drugs by reducing dosage to expand supply and prioritize patients with the best chance of recovery.

Cisplatin is widely used to treat cancers of the testicle, lung, bladder, cervix, and ovary, among other conditions. Up to 20% of cancer patients are treated with cisplatin and other platinum-based chemotherapy drugs, according to the National Cancer Institute.

The World Health Organization says medicine is an essential part of basic healthcare.

A national shortage of cisplatin began in February after a pharmaceutical company based in India temporarily halted production for the US market.

Intas Pharmaceuticals decided to pause production after last year the US Food and Drug Administration found a “chain of failures” in its quality control unit.

An Intas spokesperson told CNBC this week that the company is working with the Food and Drug Administration to bring the production back to the United States, but no date has been set yet.