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  • Takeaways from the Texas hearing on medication abortion drugs | CNN Politics

    Takeaways from the Texas hearing on medication abortion drugs | CNN Politics

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    Amarillo, Texas
    CNN
     — 

    Over the course of about four hours of arguments, a federal judge in Texas asked questions that suggested he is seriously considering undoing the US Food and Drug Administration’s approval of a medication abortion drug and the agency’s moves to relax the rules around its use.

    But the judge, US District Judge Matthew Kacsmaryk, an appointee of former President Donald Trump, also indicated he was thinking through scenarios in which he could keep the drug’s 2000 approval intact while blocking other FDA rules.

    Anti-abortion doctors and medical associations are seeking a preliminary injunction that would require the FDA to withdraw or suspend its approval of the drug, mifepristone, and that would block the agency’s more recent regulatory changes making the pills more accessible.

    Here are takeaways from the hearing:

    Kacsmaryk showed a particular interest in the arguments by the abortion opponents that the FDA approved mifepristone in an unlawful way.

    He zeroed in on a claim by the abortion foes that the studies that the FDA looked at when deciding whether to approve the drug did not match the conditions under which the agency allows it to be administered.

    Erik Baptist, attorney for the challengers, alleged that those studies all featured patients who received ultrasounds before being treated with the drug, which is not among the FDA’s requirements for prescribing abortion pills. Baptist accused the FDA of “examining oranges and declaring apples to be safe.”

    Kacsmaryk returned to that “apples to oranges” argument several times throughout the hearing.

    Justice Department attorney Daniel Schwei defended the FDA’s approach, arguing that the relevant law gives the FDA discretion to determine what studies are adequate for approving a drug’s safety. He also said the challengers’ claims were factually flawed, because the FDA also was looking at studies where the patients did not receive an ultrasound.

    Kacsmaryk was similarly focused on a claim by the plaintiffs that the FDA violated the law in the special, accelerated process that it used to approve mifepristone in 2000.

    At one point the judge revealed in the hearing that he had downloaded a list of the other drugs the FDA had approved through the process. He ticked through the list of drugs, which were made up mostly of treatments for HIV and cancer, and he asked the Justice Department for its “best argument” for why mifepristone fit into the list.

    One of the sharpest questions from the judge was whether the anti-abortion activists could point to another analogous case when a court intervened in the way he is being asked to intervene here.

    Baptist conceded there was none and blamed FDA delays in addressing citizen petitions and challenges. Later in the hearing, Baptist raised other times the FDA had suspended or withdrawn drugs based on court cases in other contexts, arguing those cases showed that Kascmaryk had the authority to grant the plaintiffs’ request.

    Attorneys for the defendants – which include both the FDA and a drug company that manufactures mifepristone and intervened in the case – pushed back on those examples. They said that the plaintiffs were relying on patent cases, where the dispute was between a brand name drug and a generic counterpart, and those examples were not analogous here.

    The medication abortion lawsuit targets actions the FDA took around medication abortion pills before last summer’s Supreme Court reversal of Roe v. Wade’s abortion rights protections.

    While that decision, known as Dobbs v. Jackson Women’s Health Organization, didn’t play a major role in Wednesday’s arguments, the judge referenced it and suggested it could have an impact on his thinking about the case.

    He brought up Dobbs early on in the hearing and raised it specifically in connection with a friend of the court brief filed by 22 GOP-led states supporting the challengers.

    The judge noted that the red states’ brief argued that the FDA’s actions were infringing on their state laws concerning abortion pills.

    He asked Erin Hawley, an attorney for the challengers, whether Dobbs was an “intervening event” that has “changed the landscape” around the relationship between state and federal government concerning abortion policy.

    Hawley agreed, calling it a “sea change.”

    If Kacsmaryk has any sore feelings over the blow up around his efforts to keep Wednesday’s hearing plans quiet, he didn’t show them at the proceedings.

    When questioning both sides of the case, Kacsmaryk had a restrained, straight-forward tone. He had occasional follow-up questions for the plaintiffs, but did not aggressively push back on their arguments. The substance of his questions for the FDA’s defenders was more skeptical, but he kept with the measured approach in his questioning, and avoided any pushiness when grilling the government and the drug company about the approval process.

    At the end of the hearing, he thanked the parties, as well as those who filed dozens of friend of the courts briefs, for their “superb” briefing. He also acknowledged the logistical hurdles the lawyers at the hearing went through to get to his courthouse in Amarillo, which is a several hours’ drive from Texas’ biggest cities.

    Left unmentioned by the judge was the fact that he tried to delay the announcement of the hearing until the evening before, which would have made it difficult for members of the public and the media to attend Wednesday’s proceedings. When there was blowback to The Washington Post reporting about his plan – laid out in a private teleconference with attorneys where he pointed to death threats and harassment that had been directed to the courthouse staff – he announced the hearing on Monday.

    The courtroom was open to the public, but only with limited seating: 19 seats for reporters and 19 for members of the public. By 6 a.m. CT Wednesday there were already lines outside the courtroom to claim those seats. Those attendees were not allowed to bring electronics in with them, and if they left the courthouse, they were not allowed back in.

    Kacsmaryk warned at the beginning of the hearing that anyone who disrupted the proceedings would be immediately removed without warning. But there were no such disruptions.

    Kacsmaryk wrapped up the hearing without any explicit timeline for when he’ll rule, telling the parties he would issue an order and opinion “as soon as possible.”

    While he was arguing, Schwei, the DOJ attorney, requested that the judge – if he were to rule against the FDA – to immediately put that ruling on pause so it could be appealed. The judge stopped short of promising an automatic stay in the event of an adverse ruling, but he acknowledged he understood what DOJ was asking for.

    An appeal would first go to a panel of three judges of the 5th US Circuit Court of Appeals, arguably the most conservative appeals court in the country. The panel’s decision could then be appealed either to the full 5th Circuit or the US Supreme Court.

    Beyond these procedural questions, Kacsmaryk seemed to be grappling with the practical impact of a ruling in favor of the plaintiffs. He asked plaintiffs’ attorneys, the DOJ lawyers and the attorneys for the drug company Danco whether it would be possible for him to block some but not all of the FDA actions the challengers were targeting. He returned to the question again when the plaintiffs were back up for the rebuttal.

    He also pressed Baptist, the attorney for the abortion opponents, on whether the plaintiffs were seeking an order that the FDA begin the withdrawal of the drug – a process that would take months – or if they thought the judge could directly take if off the market.

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  • First on CNN: Kamala Harris to make first trip to Iowa since becoming vice president | CNN Politics

    First on CNN: Kamala Harris to make first trip to Iowa since becoming vice president | CNN Politics

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    CNN
     — 

    Vice President Kamala Harris on Thursday will make her first trip to Iowa since taking office for an abortion rights event, a White House official told CNN.

    Harris will travel to Des Moines to convene a roundtable with local leaders about the fight to protect reproductive rights.

    The last-minute, high-profile trip comes after flurry of activity from Republicans presidential hopefuls who’ve descended on the early caucus state, like former President and current candidate Donald Trump and potential 2024 GOP candidate Ron DeSantis. GOP politicians have begun to woo caucus-goers who favor personal politicking, as the state is set to play its traditional role in kicking off the party’s 2024 nominating contest.

    President Joe Biden, who is expected to launch a 2024 reelection bid, has been absent from the state after urging national Democrats to replace Iowa first-in-the-nation caucuses with South Carolina, a primary state where the majority of Democratic voters are Black, which propelled him to the nomination in 2020. The Democratic National Committee adopted the president’s changes last month but the vice president’s visit to Iowa underscores how Democrats do not intend to fully abandon the state, despite its Republican-leaning trends.

    Harris’ trip will also come a day after a federal judge overseeing a challenge to the federal government’s approval of a medication abortion drug will hold a hearing in the case. The vice president has become the Biden administration’s lead messenger on the issue after the Supreme Court overturned Roe v. Wade last summer, holding that there is no longer a federal constitutional right to an abortion.

    This week, she slammed attacks on medication abortion and warned that preventing doctors from prescribing mifepristone, the first drug in the medication abortion process, could have wider ramifications.

    “But if extremists and politicians can override FDA approval and remove one medication from the shelves – in this case, abortion medication – one must ask: What medication is next?” Harris said in a recent press call with local media and coalition outlets.

    Harris has held dozens of events on access to abortion care since last year, meeting with activists and state lawmakers about abortion rights in deep red and swing states.

    Recently, Iowa State House Republicans introduced a bill that would ban all abortions in the state, determining that life begins at conception. Iowa’s Supreme Court ruled last year that the state Constitution does not protect the right to an abortion, clearing the way for the state’s Republican legislative majority to potentially enact stricter abortion measures.

    This story has been updated with additional details.

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  • US sues Rite Aid for missing opioid red flags | CNN Business

    US sues Rite Aid for missing opioid red flags | CNN Business

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    CNN
     — 

    The Justice Department on Monday filed a lawsuit against Rite Aid for allegedly violating the Controlled Substances Act, alleging that the company “knowingly filled unlawful prescriptions for controlled substances.”

    In a statement, Attorney General Merrick Garland said the Department of Justice is “using every tool at our disposal” to hold Rite Aid accountable for contributing to the opioid epidemic.

    Associate Attorney General Vanita Gupta said “Rite Aid’s pharmacists repeatedly filled prescriptions for controlled substances with obvious red flags, and Rite Aid intentionally deleted internal notes about suspicious prescribers. These practices opened the floodgates for millions of opioid pills and other controlled substances to flow illegally out of Rite Aid’s stores.”

    In the complaint, The Justice department alleges that from May 2014 to June 2019, Rite Aid filled thousands of unlawful combinations of prescriptions known as “the trinity” which included prescriptions for “excessive quantities of opioids, such as oxycodone and fentanyl.”

    Rite Aid pharmacists were accused of ignoring obvious signs of misuse and intentionally deleting some pharmacists’ internal warnings about suspicious prescribers, such as “cash only pill mill???”

    “These practices opened the floodgates for millions of opioid pills and other controlled substances to flow illegally out of Rite Aid’s stores,” Associate Attorney General Vanita Gupta said.

    The Justice Department said the prescriptions, who were issued illegally, “lacked a legitimate medical purpose, were not for a medically accepted indication, or were not issued in the usual course of professional practice.”

    Rite Aid is one of the country’s largest pharmacy chains, with more than 2,330 stores in 17 US states. It did not immediately respond to requests for comment.

    The Justice Department accused Rite Aid of violating the federal False Claims Act by submitting false prescription claims to government health care programs such as Medicare and Medicaid.

    It joined a whistleblower lawsuit filed in 2019 by two pharmacists and a pharmacy technician from Rite Aid stores in Pennsylvania, North Carolina and West Virginia.

    The Justice Department occasionally joins whistleblower cases it considers stronger.

    It has also sued Walmart and drug distributor AmerisourceBergen Corp over their alleged roles in the nation’s opioid crisis.

    More than 500,000 people died from drug overdoses in the United States from 1999 to 2020, including more than 90,000 in 2020 alone, according to the US Centers for Disease Control and Prevention.

    Reuters contributed to this report.

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  • Chinese companies and founders rush to calm investors after SVB collapse | CNN Business

    Chinese companies and founders rush to calm investors after SVB collapse | CNN Business

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    Hong Kong
    CNN
     — 

    The collapse of Silicon Valley Bank (SVB), which courted Chinese start-ups, has caused widespread concern in China, where a string of founders and companies rushed to appease investors by saying their exposure was insignificant or nonexistent.

    SVB, which worked with nearly half of all venture-backed tech and healthcare companies in the United States before it was taken over by the government, has a Chinese joint venture, which was set up in 2012 and targeted the country’s tech elite.

    The SPD Silicon Valley Bank, which was owned 50-50 owned by SVB and local partner Shanghai Pudong Development Bank, said Saturday that its operations were “sound.”

    “The bank has a standardized corporate governance structure and an independent balance sheet,” it said in a statement. “As China’s first technology bank, SPD Silicon Valley Bank is committed to serving Chinese science and technology companies, and has always had sound operations in accordance with Chinese laws and regulations.”

    It’s unclear what will happen to SVB’s ownership of the joint venture.

    SVB Financial Group, the parent company of SVB, also has two business consulting firms and one financial services firm in mainland China, according to corporate database Tianyancha.

    Concerns about the failure of SVB have spread around the world, as investors fretted about the broader risks to the global banking sector and any potential spillover effect.

    In an extraordinary move to restore confidence in America’s banking system, the Biden administration on Sunday guaranteed that customers of SVB and Signature Bank, which was closed by regulators, will have access to all their money.

    That action appears to have appeased global markets, with US futures rallying in response and some Asian markets paring earlier losses.

    In China, at least a dozen firms have issued statements since SVB collapsed trying to pacify investors or clients, saying that their exposure to the lender was limited. Most were biotech companies.

    BeiGene, one of China’s largest cancer-focused drug companies, said Monday it had more than $175 million uninsured cash deposits at SVB, which represents approximately 3.9% of its cash, cash equivalents and short-term investments.

    “The company does not expect the recent developments with SVB to significantly impact its operations,” it said.

    Zai Lab, a pharmaceutical firm, announced that its cash deposits at SVB were “immaterial” at about $23 million.

    The closure of SVB “will not have an impact” on the company’s ability to meet its operating expenses and capital expenditure requirements, including payroll, it said.

    Other companies that publicly assured investors included Andon Health, Sirnaomics, Everest Medicines, Broncus Medical, Jacobio Pharmaceuticals, Brii Biosciences, CStone Pharmaceuticals, Genor Biopharma and CANbridge Pharmaceuticals.

    Mobile ad tech firm Mobvista and wealth management firm Noah Holdings said their cash holdings at SVB were “minimal” or “immaterial.”

    Popular selfie app Meitu said it hadn’t held any bank accounts at SVB since 2020. It issued a statement “to avoid any potential public misunderstanding.”

    Ascletis Pharma, MicroPort NeuroTech, Antengene Corp, and Suzhou Basecare Medical Corporation also denied they had any deposits or business dealings with SVB.

    Pan Shiyi, co-founder and former chairman of Soho China, a major Beijing-based property developer, denied he had any money at SVB after reports went viral on social media that he had lost billions of yuan.

    “We never opened an account with Silicon Valley Bank, nor placed a deposit,” he said late Sunday on his Weibo account.

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  • Media outlets urge judge to announce his plans for a hearing in blockbuster medication abortion case | CNN Politics

    Media outlets urge judge to announce his plans for a hearing in blockbuster medication abortion case | CNN Politics

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    CNN
     — 

    Several media organizations asked a federal judge on Monday to publicly announce his plans to hold a hearing Wednesday in a blockbuster medication abortion case after the judge reportedly moved to keep the hearing under wraps.

    “Across the ideological spectrum, the public is intensely interested in this case,” the organizations wrote in their letter to US District Judge Matthew Kacsmaryk.

    The case concerns a challenge brought by anti-abortion doctors and medical associations to the federal government’s 2000 approval of a drug used to terminate pregnancies. Medication abortion is the most common method of abortion in the United States.

    “The Court’s delayed docketing of notice of Wednesday’s hearing, and its request to the parties and their counsel not to disclose the hearing schedule publicly, harm everyone, including those who support the plaintiffs’ position and those who support the defendants’ position,” the media outlets added.

    At 7 weeks pregnant she wanted an abortion. Here’s why she turned to a doctor in Austria

    The letter pointed to reporting by The Washington Post on Saturday that said on Friday, Kacsmaryk held a private phone call with the lawyers in the case and told them he was scheduling a hearing for Wednesday but not announcing those plans on the case’s docket until Tuesday evening. The judge reportedly told the lawyers not to publicize the hearing plans in the meantime.

    Kacsmaryk is currently considering the plaintiffs’ request for a preliminary injunction that would “withdrawal or suspend” that approval while the lawsuit plays out.

    If the judge grants the request to block access to the drug nationwide, it could make the pills harder to obtain even in states where medication abortion is legal.

    The media outlets told Kacsmaryk that the “Court’s attempt to delay notice of and, therefore, limit the ability of members of the public, including the press, to attend Wednesday’s hearing is unconstitutional, and undermines the important values served by public access to judicial proceedings and court records.”

    Kacsmaryk’s courtroom is in Amarillo, Texas – a division in the northern Texas panhandle that is a several hours’ drive from Texas’ biggest cities and accessible only by a limited number of direct flights.

    According to the Post, Kacsmaryk told the case’s lawyers he was holding off until Tuesday to announce the Wednesday hearing to limit the potential for protests and disruptions to the proceedings.

    “The Court cannot constitutionally close the courtroom indirectly when it cannot constitutionally close the courtroom directly,” the media outlets wrote.

    “The United States Supreme Court has made clear that, because of our historical tradition of public access to judicial proceedings, and because of the structural necessity of such access to ensure government transparency and accountability, the circumstances in which a courtroom can be closed without violating the First Amendment and common law rights of access are rare.”

    The organizations signing onto the letter are the Reporters Committee for Freedom of the Press, The Washington Post, NBCUniversal News Group, ProPublica, Inc., Texas Press Association, The Freedom of Information Foundation of Texas, The Markup, and Gannett Co., Inc.

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  • Washington Post: Judge keeps plans for medication abortion hearing out of public view for now | CNN Politics

    Washington Post: Judge keeps plans for medication abortion hearing out of public view for now | CNN Politics

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    CNN
     — 

    A federal judge has set a hearing for next week in a blockbuster medication abortion case in Texas but took a series of highly unusual steps to delay making the public aware that such a hearing was being scheduled, The Washington Post reported.

    US District Judge Matthew Kacsmaryk, who is hearing the case, held a private call Friday with the case’s lawyers and scheduled the hearing for Wednesday, according to the Post. The call was not publicly noticed on the case’s docket, nor did the judge issue a public order announcing that Wednesday’s hearing had been scheduled. The case is not under seal.

    In the case, anti-abortion doctors are asking the judge – an appointee of former President Donald Trump – to undo the federal government’s 2000 approval of pills used to terminate a pregnancy. Such a move could cut off access nationwide to the most common method of abortion.

    Kacsmaryk told the lawyers on the call, according to the newspaper, that he would hold off on publicly announcing the Wednesday hearing until Tuesday evening, so as to limit disruptions and potential protests at the proceeding. He also asked that the attorneys on the call – which reportedly included the Justice Department’s lawyers who are defending the drug’s approval, lawyers for the anti-abortion activists who are challenging it, and lawyers for a company that distributes the drug and has intervened in the case – not to publicize the hearing plans before then.

    The judge’s efforts to limit transparency around Wednesday’s hearing comes in a case that has major implications for access to abortion and is arguably the biggest legal battle over the procedure since the Supreme Court overturned nationwide abortion protections in a ruling last June.

    Voicemails left by CNN on Sunday morning with the court’s clerk’s office and with Kacsmaryk’s chambers about the Post’s Saturday night report were not immediately returned.

    The case is unfolding in Amarillo – a far-flung court division in Texas’ northern panhandle that is a several hours’ drive from the state’s biggest cities and has only limited direct flight routes. Federal judicial proceedings typically play out in public.

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  • Bodies of 2 Mexico kidnapping victims expected to be returned to the US for further autopsies, source says | CNN

    Bodies of 2 Mexico kidnapping victims expected to be returned to the US for further autopsies, source says | CNN

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    CNN
     — 

    The bodies of two Americans killed in an armed kidnapping in Mexico are expected to be returned to the US on Thursday, a source from the Mexico Attorney General’s Office tells CNN, after two survivors of the attack returned to the US for treatment at a hospital.

    The remains of Shaeed Woodard and Zindell Brown likely will be transported to a funeral home in Brownsville, Texas, a US official familiar with the investigation said. The repatriation would come two days after the bodies were discovered alongside their two surviving friends in a house around the Mexican city of Matamoros.

    Autopsies were completed Wednesday morning in Mexico, an official from the Tamaulipas Prosecutor’s Office told CNN, though Mexican authorities have not released causes of death. Second autopsies will be performed in the US, the US official said.

    CNN has reached out to the US State Department about the repatriation of remains.

    The deceased were part of a group of four friends from South Carolina who had driven Friday into Matamoros so one of them, Latavia Washington McGee, could undergo a medical procedure, two family members told CNN. But their trip was violently interrupted when unidentified gunmen fired on their van, then loaded the Americans into a vehicle and drove them away, the FBI said.

    An innocent Mexican bystander was also killed by a stray bullet almost a block and a half from where the Americans were kidnapped, according to Tamaulipas Gov. Américo Villarreal.

    Survivor Eric Williams was shot three times in the legs, his wife Michele Williams told CNN. When he and McGee were discovered alive Tuesday, Williams was taken to a hospital in Texas for surgery, she said.

    Washington McGee was also taken to the hospital, her mother, Barbara Burgess, told CNN, though Mexican authorities said she was uninjured.

    “She watched them die,” Burgess said, recounting what Washington McGee told her about the kidnapping. “They were driving through and a van came up and hit them, and that’s when they started shooting at the car, shooting inside the van. … She said the others tried to run and they got shot at the same time.”

    Washington McGee and Brown are cousins who were raised together as closely as siblings, Burgess said.

    “He was a good person, and I miss him,” Burgess said of Brown. “I loved him. (There’s) nothing I wouldn’t do for him.”

    Investigators believe the group was targeted by a Mexican cartel who mistook them for Haitian drug smugglers, a US official familiar with the investigation told CNN on Monday, and the kidnapping has renewed attention to efforts by US and Mexican officials to combat organized crime in Mexico.

    During a Wednesday news briefing held by Mexican President Andrés Manuel López Obrador, a government-sponsored fact-checking agency claimed reports of the Americans being mistaken for Haitian drug traffickers are false. The president said “adversaries” in Mexico and the US are attempting to make a “scandal” of the case.

    CNN has reached out to investigators in the US and Mexico, as well as the fact-checking agency.

    Mexican authorities are still investigating the kidnapping. One person, identified as 24-year-old Jose “N,” was detained when the Americans were found Tuesday, according to Villarreal, though officials would not confirm whether he is connected to a criminal organization.

    The kidnapping of the four friends on Friday spurred a days-long investigation by local and federal Mexican officials, who say they were in almost-constant contact with US authorities until the two survivors and the victims’ bodies were finally discovered.

    The four friends had booked a hotel in Brownsville, Texas, and were planning to drive to a doctor’s office in Matamoros on Friday for Washington McGee to undergo a medical procedure, a close friend who did not want to be identified told CNN.

    matamoros mexico kidnapping scene

    Video shows Americans kidnapped in Mexico being loaded into pickup truck

    At about 9:18 a.m. Friday, the group crossed into Matamoros, Villarreal said. But on their way to the clinic, the group became lost and were struggling to contact the doctor’s office for directions due to a poor phone signal, the close friend said.

    Suddenly, another vehicle collided into the group’s van and gunmen began shooting at the group, sending some of the friends running, according to Burgess, who recounted her daughter’s experience. “They all got shot at the same time,” she said.

    A video obtained by CNN shows Washington McGee being shoved onto the bed of a white pickup truck by a group of armed men, who then begin dragging at least two other limp bodies into the truck. Burgess, when asked about the video, said her daughter was treated “like trash.”

    The Americans were then taken from the scene in the vehicle, according to an FBI account of the kidnapping.

    Over the next few days, the groups was moved to several different locations to “create confusion and avoid rescue efforts,” Villarreal said.

    Meanwhile, Mexican investigators were searching for the missing group, sifting through surveillance footage and processing the vehicles and ballistics found at the scene, officials said.

    After noticing the Americans’ van had North Carolina license plates, Mexican authorities reached out to US officials, who were able to run the plates, according to Tamaulipas Attorney General Irving Barrios Mojica. They were also able to identify the gunmen’s truck, he said.

    “Several searches” were then initiated across multiple agencies, and the group was ultimately found in a “wooden house” in or near Matamoros on Tuesday morning, Villarreal said.

    Though US law enforcement were not involved in the search on the ground, federal and local agencies in Mexico were cooperating in the effort and a joint task force was created to communicate with US officials, Barrios Mojica said.

    The fatal kidnapping – and the possibility it was carried out by a cartel – has brought increased attention to ongoing efforts by US and Mexican officials to curb cartel activity that is a primary driver of the fentanyl trade between the countries.

    A US delegation traveled to Mexico this week to “discuss our governments’ ongoing cooperation in combating illicit fentanyl,” a national security council spokesman told CNN Wednesday.

    The visit comes as fentanyl – a potent synthetic opioid – fuels a record number of overdose deaths in the US, with Mexico being the “dominant source” of the drug in the US, according to a government report released last year.

    The delegation plans to address the kidnapping and discuss a “fundamental strategy to attack the cartels,” Department of Homeland Security Secretary Alejandro Mayorkas said Wednesday.

    President Joe Biden promised “strong penalties to crack down on fentanyl trafficking” in his State of the Union address last month. His administration has since sanctioned several cartel members and associated groups for their participation in the drug trade.

    López Obrador said there was “good cooperation” underway between the two countries on anti-drug efforts, but resisted calls from some Republican lawmakers in the US to designate cartels as terrorist organizations, saying it would infringe on Mexican sovereignty.

    “We do not get involved in seeing what the gangs in the United States that distribute fentanyl are doing or how the drug is distributed in the United States,” López Obrador said at his daily news conference in Mexico City.

    Ongoing talks between the US and Mexico are “working in a coordinated manner with respect to sovereignty,” he said.

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  • Newsom to shut Walgreens out of California state business following abortion pill decision | CNN Politics

    Newsom to shut Walgreens out of California state business following abortion pill decision | CNN Politics

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    CNN
     — 

    California will cease all its business with Walgreens, the retail drugstore chain, Gov. Gavin Newsom said on Monday, days after the company announced it would not dispense abortion medication in 21 Republican-dominated states.

    “California won’t be doing business with @walgreens – or any company that cowers to the extremists and puts women’s lives at risk,” the Democratic governor tweeted. “We’re done.”

    Newsom’s pushback came at an already fraught time for the future of medication abortion, which is used in more than half of all procedures nationwide, as a Texas judge weighs issuing a ban on Mifepristone, the first pill in a two-drug abortion regimen. Walgreens had responded to legal pressure from Republican attorneys general in 21 states – including a handful where abortion remains legal – in deciding to partially halt its efforts to sell the drug.

    “We intend to be a certified pharmacy and will distribute Mifepristone only in those jurisdictions where it is legal and operationally feasible,” the company said last week in a statement.

    Walgreens declined to comment on Newsom’s tweet.

    The clash between Newsom and Walgreens, a massive chain with thousands of stores around the country, marks the latest round of fallout following the Supreme Court’s decision to overturn Roe v. Wade. The ruling, handed down in June of last year, shook up national politics ahead of the 2022 midterms – with many Democrats crediting the backlash for helping their candidates in tough, swing state and seat races – and complicated relationships between political and business leaders.

    The state is currently “reviewing all relationships between Walgreens and the state,” said Newsom spokesman Brandon Richards. He also accused the company of giving in to “right wing bullies.”

    Newsom’s office announced Wednesday that California would be “pulling back” a renewal of a $54 million contract with Walgreens that would have taken effect May 1, 2023.

    California’s Department of General Services holds a contract with the retailer “to procure specialty pharmacy prescription drugs,” mostly used by the state’s Department of Corrections and Rehabilitation and its correctional health care system, Newsom’s office said in a news release.

    The state will explore other options “for furnishing the same services,” his office said.

    CNN has reached out to Walgreens for comment on Wednesday’s announcement.

    Late last week, Democratic California state Attorney General Rob Bonta issued a statement slamming Walgreens for bowing to political pressure from GOP officials.

    “Medication abortion is safe, effective, and serves as a lifeline for people in need of critical care, especially those from vulnerable and underserved communities,” Bonta said on Friday. “I am disappointed that Walgreens has decided to give in to political pressure from anti-abortion states, and cut off access to these necessary and lifesaving medications.”

    The company on Monday sought to clarify its position, though their latest statement only added to the confusion.

    “Walgreens plans to dispense Mifepristone in any jurisdiction where it is legally permissible to do so,” the company said. Medication abortion is legal and accessible in states like Kansas and Iowa, among others, despite opposition from top Republicans, who have threatened legal action.

    In a letter addressed to Kansas Attorney General Kris Kobach, an anti-abortion Republican, from last month, Walgreens said it “does not intend to dispense Mifepristone within your state and does not intend to ship Mifepristone into your state from any of our pharmacies.”

    Abortion remains protected under Kansas state law. Last summer, the state voted overwhelmingly to block efforts by lawmakers to ban the procedure following the Supreme Court’s decision to overturn Roe v. Wade less than two months earlier.

    The US Food and Drug Administration said in early January that pharmacies certified to dispense Mifepristone can do so directly to someone who has a prescription from a prescriber.

    This story has been updated with additional information.

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  • Fact check: Republicans at CPAC make false claims about Biden, Zelensky, the FBI and children | CNN Politics

    Fact check: Republicans at CPAC make false claims about Biden, Zelensky, the FBI and children | CNN Politics

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    Washington
    CNN
     — 

    The Conservative Political Action Conference is underway in Maryland. And the members of Congress, former government officials and conservative personalities who spoke at the conference on Thursday and Friday made false claims about a variety of topics.

    Rep. Jim Jordan of Ohio uttered two false claims about President Joe Biden. Rep. Marjorie Taylor Greene of Georgia repeated a debunked claim about Ukrainian President Volodymyr Zelensky. Sen. Tommy Tuberville of Alabama used two inaccurate statistics as he lamented the state of the country. Former Trump White House official Steve Bannon repeated his regular lie about the 2020 election having been stolen from Trump, this time baselesly blaming Fox for Trump’s defeat.

    Rep. Kat Cammack of Florida incorrectly said a former Obama administration official had encouraged people to harass Supreme Court Justice Brett Kavanaugh. Rep. Ralph Norman of South Carolina inaccurately claimed Biden had laughed at a grieving mother and inaccurately insinuated that the FBI tipped off the media to its search of former President Donald Trump’s Florida residence. Two other speakers, Rep. Scott Perry of Pennsylvania and former Trump administration official Sebastian Gorka, inflated the number of deaths from fentanyl.

    And that’s not all. Here is a fact check of 13 false claims from the conference, which continues on Saturday.

    Marjorie Taylor Greene said the Republican Party has a duty to protect children. Listing supposed threats to children, she said, “Now whether it’s like Zelensky saying he wants our sons and daughters to go die in Ukraine…” Later in her speech, she said, “I will look at a camera and directly tell Zelensky: you’d better leave your hands off of our sons and daughters, because they’re not dying over there.”

    Facts First: Greene’s claim is false. Ukrainian President Volodymyr Zelensky didn’t say he wants American sons and daughters to fight or die for Ukraine. The false claim, which was debunked by CNN and others earlier in the week, is based on a viral video that clipped Zelensky’s comments out of context.

    19-second video of Zelensky goes viral. See what was edited out

    In reality, Zelensky predicted at a press conference in late February that if Ukraine loses the war against Russia because it does not receive sufficient support from elsewhere, Russia will proceed to enter North Atlantic Treaty Organization member countries in the Baltics (a region made up of Latvia, Lithuania and Estonia) that the US will be obligated to send troops to defend. Under the treaty that governs NATO, an attack on one member is considered an attack on all. Ukraine is not a NATO member, and Zelensky didn’t say Americans should fight there.

    Greene is one of the people who shared the out-of-context video on Twitter this week. You can read a full fact-check, with Zelensky’s complete quote, here.

    Right-wing commentator and former Trump White House chief strategist Steve Bannon criticized right-wing cable channel Fox at length for, he argued, being insufficiently supportive of Trump’s 2024 presidential campaign. Among other things, Bannon claimed that, on the night of the election in November 2020, “Fox News illegitimately called it for the opposition and not Donald J. Trump, of which our nation has never recovered.” Later, he said Trump is running again after “having it stolen, in broad daylight, of which they [Fox] participate in.”

    Facts First: This is nonsense. On election night in 2020, Fox accurately projected that Biden had won the state of Arizona. This projection did not change the outcome of the election; all of the votes are counted regardless of what media outlets have projected, and the counting showed that Biden won Arizona, and the election, fair and square. The 2020 election was not “stolen” from Trump.

    NATIONAL HARBOR, MARYLAND - MARCH 03: Former White House chief strategist for the Trump Administration Steve Bannon speaks during the annual Conservative Political Action Conference (CPAC) at the Gaylord National Resort Hotel And Convention Center on March 03, 2023 in National Harbor, Maryland. The annual conservative conference entered its second day of speakers including congressional members, media personalities and members of former President Donald Trump's administration. President Donald Trump will address the event on Saturday.  (Photo by Anna Moneymaker/Getty Images)

    Bannon has a harsh message for Fox News at CPAC

    Fox, like other major media outlets, did not project that Biden had won the presidency until four days later. Fox personalities went on to repeatedly promote lies that the election was stolen from Trump – even as they privately dismissed and mocked these false claims, according to court filings from a voting technology company that is suing Fox for defamation.

    Rep. Jim Jordan claimed that Biden, “on day one,” made “three key changes” to immigration policy. Jordan said one of those changes was this: “We’re not going to deport anyone who come.” He proceeded to argue that people knowing “we’re not going to get deported” was a reason they decided to migrate to the US under Biden.

    Facts First: Jordan inaccurately described the 100-day deportation pause that Biden attempted to impose immediately after he took office on January 20, 2021. The policy did not say the US wouldn’t deport “anyone who comes.” It explicitly did not apply to anyone who arrived in the country after the end of October 2020, meaning people who arrived under the Biden administration or in the last months of the Trump administration could still be deported.

    Biden did say during the 2020 Democratic primary that “no one, no one will be deported at all” in his first 100 days as president. But Jordan claimed that this was the policy Biden actually implemented on his first day in office; Biden’s actual first-day policy was considerably narrower.

    Biden’s attempted 100-day pause also did not apply to people who engaged in or were suspected of terrorism or espionage, were seen to pose a national security risk, had waived their right to remain in the US, or whom the acting director of Immigration and Customs Enforcement determined the law required to be removed.

    The pause was supposed to be in effect while the Department of Homeland Security conducted a review of immigration enforcement practices, but it was blocked by a federal judge shortly after it was announced.

    Rep. Ralph Norman strongly suggested the FBI had tipped off the media to its August search of Trump’s Mar-a-Lago home and resort in Florida for government documents in the former president’s possession – while concealing its subsequent document searches of properties connected to Biden.

    Norman said: “When I saw the raid at Mar-a-Lago – you know, the cameras, the FBI – and compare that to when they found Biden’s, all of the documents he had, where was the media, where was the FBI? They kept it quiet early on, didn’t let it out. The job of the next president is going to be getting rid of the insiders that are undermining this government, and you’ve gotta clean house.”

    Facts First: Norman’s narrative is false. The FBI did not tip off the media to its search of Mar-a-Lago; CNN reported the next day that the search “happened so quietly, so secretly, that it wasn’t caught on camera at all.” Rather, media outlets belatedly sent cameras to Mar-a-Lago because Peter Schorsch, publisher of the website Florida Politics, learned of the search from non-FBI sources and tweeted about it either after it was over or as it was just concluding, and because Trump himself made a public statement less than 20 minutes later confirming that a search had occurred. Schorsch told CNN on Thursday: “I can, unequivocally, state that the FBI was not one of my two sources which alerted me to the raid.”

    Brian Stelter, then CNN’s chief media correspondent, wrote in his article the day after the search: “By the time local TV news cameras showed up outside the club, there was almost nothing to see. Websites used file photos of the Florida resort since there were no dramatic shots of the search.”

    It’s true that the public didn’t find out until late January about the FBI’s November search of Biden’s former think tank office in Washington, which was conducted with the consent of Biden’s legal team. But the belated presence of journalists at Mar-a-Lago on the day of the Trump search in August is not evidence of a double standard.

    And it’s worth noting that media cameras were on the scene when Biden’s beach home in Delaware was searched by the FBI in February. News outlets had set up a media “pool” to make sure any search there was recorded.

    Sen. Tommy Tuberville, a former college and high school football coach, said, “Going into thousands of kids’ homes and talking to parents every year recruiting, half the kids in this country – I’m not talking about race, I’m just talking about – half the kids in this country have one or no parent. And it’s because of the attack on faith. People are losing faith because, for some reason, because the attack [on] God.”

    Facts First: Tuberville’s claim that half of American children don’t have two parents is incorrect. Official figures from the Census Bureau show that, in 2021, about 70% of US children under the age of 18 lived with two parents and about 65% lived with two married parents.

    About 22% of children lived with only a mother, about 5% with only a father, and about 3% with no parent. But the Census Bureau has explained that even children who are listed as living with only one parent may have a second parent; children are listed as living with only one parent if, for example, one parent is deployed overseas with the military or if their divorced parents share custody of them.

    It is true that the percentage of US children living in households with two parents has been declining for decades. Still, Tuberville’s statistic significantly exaggerated the current situation. His spokesperson told CNN on Thursday that the senator was speaking “anecdotally” from his personal experience meeting with families as a football coach.

    Tuberville claimed that today’s children are being “indoctrinated” in schools by “woke” ideology and critical race theory. He then said, “We don’t teach reading, writing and arithmetic anymore. You know, half the kids in this country, when they graduate – think about this: half the kids in this country, when they graduate, can’t read their diploma.”

    Facts First: This is false. While many Americans do struggle with reading, there is no basis for the claim that “half” of high school graduates can’t read a basic document like a diploma. “Mr. Tuberville does not know what he’s talking about at all,” said Patricia Edwards, a Michigan State University professor of language and literacy who is a past president of the International Literacy Association and the Literacy Research Association. Edwards said there is “no evidence” to support Tuberville’s claim. She also said that people who can’t read at all are highly unlikely to finish high school and that “sometimes politicians embellish information.”

    Tuberville could have accurately said that a significant number of American teenagers and adults have reading trouble, though there is no apparent basis for connecting these struggles with supposed “woke” indoctrination. The organization ProLiteracy pointed CNN to 2017 data that found 23% of Americans age 16 to 65 have “low” literacy skills in English. That’s not “half,” as ProLiteracy pointed out, and it includes people who didn’t graduate from high school and people who are able to read basic text but struggle with more complex literacy tasks.

    The Tuberville spokesperson said the senator was speaking informally after having been briefed on other statistics about Americans’ struggles with reading, like a report that half of adults can’t read a book written at an eighth-grade level.

    Rep. Jim Jordan claimed of Biden: “The president of the United States stood in front of Independence Hall, called half the country fascists.”

    Facts First: This is not true. Biden did not denounce even close to “half the country” in this 2022 speech at Independence Hall in Philadelphia. He made clear that he was speaking about a minority of Republicans.

    In the speech, in which he never used the word “fascists,” Biden warned that “MAGA Republicans” like Trump are “extreme,” “do not respect the Constitution” and “do not believe in the rule of law.” But he also emphasized that “not every Republican, not even the majority of Republicans, are MAGA Republicans.” In other words, he made clear that he was talking about far less than half of Americans.

    Trump earned fewer than 75 million votes in 2020 in a country of more than 258 million adults, so even a hypothetical criticism of every single Trump voter would not amount to criticism of “half the country.”

    Rep. Scott Perry claimed that “average citizens need to just at some point be willing to acknowledge and accept that every single facet of the federal government is weaponized against every single one of us.” Perry said moments later, “The government doesn’t have the right to tell you that you can’t buy a gas stove but that you must buy an electric vehicle.”

    Facts First: This is nonsense. The federal government has not told people that they can’t buy a gas stove or must buy an electric vehicle.

    The Biden administration has tried to encourage and incentivize the adoption of electric vehicles, but it has not tried to forbid the manufacture or purchase of traditional vehicles with internal combustion engines. Biden has set a goal of electric vehicles making up half of all new vehicles sold in the US by 2030.

    There was a January controversy about a Biden appointee to the United States Consumer Product Safety Commission, Richard Trumka Jr., saying that gas stoves pose a “hidden hazard,” as they emit air pollutants, and that “any option is on the table. Products that can’t be made safe can be banned.” But the commission as a whole has not shown support for a ban, and White House press secretary Karine Jean-Pierre said at a January press briefing: “The president does not support banning gas stoves. And the Consumer Product Safety Commission, which is independent, is not banning gas stoves.”

    Rep. Ralph Norman claimed that Biden had just laughed at a mother who lost two sons to fentanyl.

    “I don’t know whether y’all saw, I just saw it this morning: Biden laughing at the mother who had two sons – to die, and he’s basically laughing and saying the fentanyl came from the previous administration. Who cares where it came from? The fact is it’s here,” Norman said.

    Facts First: Norman’s claim is false. Biden did not laugh at the mother who lost her sons to fentanyl, the anti-abortion activist Rebecca Kiessling; in a somber tone, he called her “a poor mother who lost two kids to fentanyl.” Rather, he proceeded to laugh about how Republican Rep. Marjorie Taylor Greene had baselessly blamed the Biden administration for the young men’s deaths even though the tragedy happened in mid-2020, during the Trump administration. You can watch the video of Biden’s remarks here.

    Kiessling has demanded an apology from Biden. She is entitled to her criticism of Biden’s remarks and his chuckle – but the video clearly shows Norman was wrong when he claimed Biden was “laughing at the mother.”

    Rep. Kat Cammack told a story about the first hearing of the new Republican-led House select subcommittee on the supposed “weaponization” of the federal government. Cammack claimed she had asked a Democratic witness at this February hearing about his “incredibly vitriolic” Twitter feed in which, she claimed, he not only repeatedly criticized Supreme Court Justice Brett Kavanaugh but even went “so far as to encourage people to harass this Supreme Court justice.”

    Facts First: This story is false. The witness Cammack questioned in this February exchange at the subcommittee, former Obama administration deputy assistant attorney general Elliot Williams, did not encourage people to harass Kavanaugh. In fact, it’s not even true that Cammack accused him at the February hearing of having encouraged people to harass Kavanaugh. Rather, at the hearing, she merely claimed that Williams had tweeted numerous critical tweets about Kavanaugh but had been “unusually quiet” on Twitter after an alleged assassination attempt against the justice. Clearly, not tweeting about the incident is not the same thing as encouraging harassment.

    Williams, now a CNN legal analyst (he appeared at the subcommittee hearing in his personal capacity), said in a Thursday email that he had “no idea” what Cammack was looking at on his innocuous Twitter feed. He said: “I used to prosecute violent crimes, and clerked for two federal judges. Any suggestion that I’ve ever encouraged harassment of anyone – and particularly any official of the United States – is insulting and not based in reality.”

    Cammack’s spokesperson responded helpfully on Thursday to CNN’s initial queries about the story Cammack told at CPAC, explaining that she was referring to her February exchange with Williams. But the spokesperson stopped responding after CNN asked if Cammack was accurately describing this exchange with Williams and if they had any evidence of Williams actually having encouraged the harassment of Kavanaugh.

    Sen. John Kennedy of Louisiana boasted about the state of the country “when Republicans were in charge.” Among other claims about Trump’s tenure, he said that “in four years,” Republicans “delivered 3.5% unemployment” and “created 8 million new jobs.”

    Facts First: This is inaccurate in two ways. First, the economic numbers for the full “four years” of Trump’s tenure are much worse than these numbers Kennedy cited; Kennedy was actually referring to Trump’s first three years while ignoring the fourth, which was marred by the Covid-19 pandemic. Second, there weren’t “8 million new jobs” created even in Trump’s first three years.

    Kennedy could have correctly said there was a 3.5% unemployment rate after three years of the Trump administration, but not after four. The unemployment rate skyrocketed early in Trump’s fourth year, on account of the pandemic, before coming down again, and it was 6.3% when Trump left office in early 2021. (It fell to 3.4% this January under Biden, better than in any month under Trump.)

    And while the economy added about 6.7 million jobs under Trump before the pandemic-related crash of March and April 2020, that’s not the “8 million jobs” Kennedy claimed – and the economy ended up shedding millions of jobs in Trump’s fourth year. Over the full four years of Trump’s tenure, the economy netted a loss of about 2.7 million jobs.

    Lara Trump, Donald Trump’s daughter-in-law and an adviser to his 2020 campaign, claimed that the last time a CPAC crowd was gathered at this venue in Maryland, in February 2020, “We had the lowest unemployment in American history.” After making other boasts about Donald Trump’s presidency, she said, “But how quickly it all changed.” She added, “Under Joe Biden, America is crumbling.”

    Facts First: Lara Trump’s claim about February 2020 having “the lowest unemployment in American history” is false. The unemployment rate was 3.5% at the time – tied for the lowest since 1969, but not the all-time lowest on record, which was 2.5% in 1953. And while Lara Trump didn’t make an explicit claim about unemployment under Biden, it’s not true that things are worse today on this measure; again, the most recent unemployment rate, 3.4% for January 2023, is better than the rate at the time of CPAC’s 2020 conference or at any other time during Donald Trump’s presidency.

    Multiple speakers at CPAC decried the high number of fentanyl overdose deaths. But some of the speakers inflated that number while attacking Biden’s immigration policy.

    Sebastian Gorka, a former Trump administration official, claimed that “in the last 12 months in America, deaths by fentanyl poisoning totaled 110,000 Americans.” He blamed “Biden’s open border” for these deaths.

    Rep. Scott Perry claimed: “Meanwhile over on this side of the border, where there isn’t anybody, they’re running this fentanyl in; it’s killing 100,000 Americans – over 100,000 Americans – a year.”

    Facts First: It’s not true that there are more than 100,000 fentanyl deaths per year. That is the total number of deaths from all drug overdoses in the US; there were 106,699 such deaths in 2021. But the number of overdose deaths involving synthetic opioids other than methadone, primarily fentanyl, is smaller – 70,601 in 2021.

    Fentanyl-related overdoses are clearly a major problem for the country and by far the biggest single contributor to the broader overdose problem. Nonetheless, claims of “110,000” and “over 100,000” fentanyl deaths per year are significant exaggerations. And while the number of overdose deaths and fentanyl-related deaths increased under Biden in 2021, it was also troubling under Trump in 2020 – 91,799 total overdose deaths and 56,516 for synthetic opioids other than methadone.

    It’s also worth noting that fentanyl is largely smuggled in by US citizens through legal ports of entry rather than by migrants sneaking past other parts of the border. Contrary to frequent Republican claims, the border is not “open”; border officers have seized thousands of pounds of fentanyl under Biden.

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  • Bempedoic acid improved heart health in patients who can’t tolerate statins, study finds | CNN

    Bempedoic acid improved heart health in patients who can’t tolerate statins, study finds | CNN

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    CNN
     — 

    Bempedoic acid may be an alternative for people who need to lower their cholesterol but can’t or won’t take statins, according to a large study published Saturday in the New England Journal of Medicine.

    Statins are the most commonly prescribed cholesterol-lowering drugs that help lower what’s known as the “bad” cholesterol, or low-density lipoprotein (LDL) cholesterol in the blood; more than 90% of adults who take a cholesterol-lowering medicine use a statin, according to the US Centers for Disease Control and Prevention.

    Statins are considered safe and effective, but there are millions of people who cannot or will not take them. For some people it causes intense muscle pain. Past research has shown anywhere between 7% and 29% of patients who need to lower cholesterol do not tolerate statins, according Dr. Steven Nissen, a cardiologist and researcher at the Cleveland Clinic and co-author of the new study.

    “I see heart patients that come in with terrible histories, multiple myocardial infarction, sometimes bypass surgery, many stents and they say, ‘Doctor, I’ve tried multiple statins, but whenever I take a statin, my muscles hurt, or they’re weak. I can’t walk upstairs. I just can’t tolerate these drugs,’ ” Nissen said. “We do need alternatives for these patients.”

    Doctors have a few options, including ezetimibe and a monoclonal antibody called a proprotein convertase subtilisin/kexin type 9, or PCSK9 inhibitors for short.

    Bempedoic acid, sold under the name Nexletol, was designed specifically to treat statin-intolerant patients. The FDA approved it for this purpose in 2020, but the effects of the drug on heart health had not been fully assessed until this large trial. The new study was funded in part by Esperion Therapeutics, the maker of Nexletol.

    For the study, which was presented Saturday at the American College of Cardiology’s Annual Scientific Session with the World Congress of Cardiology, Nissen and his colleagues enrolled 13,970 patients from 32 countries.

    All of the patients were statin intolerant, typically due to musculoskeletal adverse effects. Patients had to sign an agreement that they couldn’t tolerate statins “even though I know they would reduce my risk of a heart attack or stroke or death,” and providers signed a similar statement.

    The patients were then randomized into two groups. One was treated with bempedoic acid, the other was given a placebo, which does nothing. Researchers then followed up with those patients for up to nearly five years. The number of men and women in the trial were mostly evenly divided, and most participants, some 91%, were White, and 17% were Hispanic or Latino.

    The drug works in a similar way that statins do, by drawing cholesterol out of a waxy substance called plaque that can build up in the walls of the arteries and interfere with the blood flow to the heart. If there is too much plaque buildup, it can lead to a heart attack or stroke.

    But bempedoic acid is only activated in the liver, unlike a statin, so it is unlikely to cause muscle aches, Nissen said.

    In the trial, investigators found that bempedoic acid was well-tolerated and the percent reduction in the “bad” cholesterol was greater with bempedoic acid than placebo by 21.7%.

    The risk of cardiovascular events – including death, stroke, heart attack and coronary revascularization, a procedure or surgery to improve blood flow to the heart – was 13% lower with bempedoic acid than with placebo over a median of 3.4 years.

    “The drug worked in primary and secondary prevention patients – that is, patients that had had event and patients who were very high risk for a first event. There were a lot of diabetics. These were very high risk people,” Nissen said. “So the drug met its expectations and probably did a lot better than a lot of people thought it would do.”

    In the group that took bempedoic acid, there were a few more cases of gout and gallstones, compared with people who took a placebo.

    “The number is small, and weighing that against a heart attack, I think most people would say, ‘OK I’d rather have a little gout attack,’ ” Nissen said.

    Bempedoic acid had no observed effect on mortality, but that may be because the observation period was too short to tell if it had that kind of impact. Earlier trials on statins showed the same; it was only after there were multiple studies on statins that scientists were able to show an impact on mortality.

    Dr. Howard Weintraub, a cardiologist at NYU Langone Health who did not work on this study, said that while he knows some people will not consider a medication successful unless it reduces mortality, he thinks that is short-sighted.

    “I think there’s more to doing medicine then counting body bags,” Weintraub said.”Preventing things that can be life changing, crippling, and certainly change your quality of life forever going forward, and your cost of doing things going forward, I think is a good thing.”

    He was pleased to see the results of this trial, especially since the people in this study are often what he called “forgotten individuals” – the millions who could benefit from lowering their cholesterol, but can’t take statins.

    “It’s not like their LDL was 180 or 190 or 230, their LDL was 139. This is about average in our country,” Weintraub said. He said often doctors will just tell those patients to watch their diet, but he thinks this suggests they would benefit from medication.

    “Both groups primary and secondary prevention got benefit, which I think is impressive with the modest amount of LDL reduction,” Weintraub said.

    There are some limitations to this trial. It was narrowly focused on patients with a known statin intolerance. Nissen said the trial was not designed to determine whether bempedoic acid could be an alternative to statins.

    “Statins are the gold standard. They are the cornerstone. The purpose of this study was not to replace statins, but to allow an alternative therapy for people who simply cannot take them,” Nissen said.

    Bempedoic acid is a much more expensive drug than a statin. There are generic versions of statins and some cost only a few dollars. Bempedoic acid, on the other hand, has no generic alternative and a 30-day supply can cost more than $400, according to GoodRx.

    “I think what insurance companies need to recognize that even though this drug is going to cost more than statins, having a heart attack or a stroke or needing a stent is expensive. A 23% reduction in (myocardial infarctions) is a considerable reduction,” Weintraub said.

    In an editorial in the New England Journal of Medicine that accompanied the study, Dr. John H. Alexander, who works in the division of cardiology at Duke Clinical Research Institute, Duke Health, Durham said that doctors should take these results into consideration when treating patients with high cholesterol who can’t take statins.

    “The benefits of bempedoic acid are now clearer, and it is now our responsibility to translate this information into better primary and secondary prevention for more at-risk patients, who will, as a result, benefit from fewer cardiovascular events,” Alexander wrote.

    Dr. Manesh Patel, a cardiologist and volunteer with the American Heart Association who was not a part of the study, said that providers are already prescribing bempedoic acid for some patients, but with this new research, he thinks they will quickly be used with more statin-intolerant patients.

    “We continue to see that if we can lower your LDL significantly, we improve people’s cardiovascular health. And so we need as many different arrows in our quiver to try to get that done,” Patel said.

    Heart disease is the No. 1 killer for men and women in the world. One person dies every 34 seconds in the US from cardiovascular disease, according to the CDC. About 697,000 people in the US died from heart disease in 2020 alone – about the same number as the population of Oklahoma City.

    “Given the number of people that are eligible for statins, which are tens of millions of patients already, the number of people who cannot tolerate statins is in the millions,” Nissen said. “This is a big public health problem and I think we’ve come up with something that directly addresses this.”

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  • More than 4.5 million fentanyl pills, 3,000 pounds of methamphetamine seized in Arizona investigation, DEA says | CNN

    More than 4.5 million fentanyl pills, 3,000 pounds of methamphetamine seized in Arizona investigation, DEA says | CNN

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    CNN
     — 

    Arizona authorities targeting the Sinaloa drug cartel have seized narcotics estimated to be worth more than $13 million, including more than 4.5 million fentanyl pills, 3,100 pounds of methamphetamine and large quantities of heroin, cocaine and fentanyl powder, according to the Drug Enforcement Administration.

    In a news release, the agency said the seizure was the culmination of a three-year-long investigation during which 150 people had so far been charged.

    “The fentanyl seized represents more than 30 million potentially lethal doses,” the DEA said, announcing the seizure in partnership with the Tempe Police Department and Arizona Attorney General Kris Mayes.

    Authorities displayed some of the recovered narcotics at a joint news conference Thursday, attended by CNN affiliate KNXV.

    “The sample you see here today is staggering. There are over 4.5 million fentanyl pills, over 140 pounds of fentanyl powder, over 135 kilos of cocaine, over 3,000 pounds of methamphetamine, 35 kilos of heroin, 49 firearms and over $2 million in cash,” Interim Tempe Police Chief Josie Montenegro told reporters.

    Montenegro said the substances recovered “would be poisoning members of our community, including our youth and vulnerable population,” had the seizures not been made.

    “In addition, the dangers and crimes associated with illegal drugs would be plaguing our community,” Montenegro added.

    According to authorities, “numerous” people were taken into custody in the bust. At this time, authorities do not plan on releasing the names of those involved because it is a continuing investigation, according to Montenegro.

    Phoenix DEA Special Agent in Charge Cheri Oz said investigators are “laser-focused” on the Sinaloa cartel.

    “I want to be crystal clear, the drugs in this room and the drugs that are flooding Arizona every single day are sourced primarily by one evil as the Sinaloa drug cartel,” she said at the news conference. “We are laser-focused on the Sinaloa drug cartel and we will defeat them. We will not stop.”

    Oz also praised the efforts of DEA agents and other officers over the last three years. “Their hard work and tenacity is responsible for removing these deadly drugs before they poisoned our family, our friends and our neighborhoods,” she said.

    The country is struggling with a decades-long opioid epidemic in which fentanyl has become the most commonly used drug involved in overdoses.

    Pharmaceutical fentanyl is a synthetic opioid intended to help patients manage severe pain. It is 50 to 100 times more potent than morphine, and typically prescribed in the form of skin patches or lozenges. But most recent cases of fentanyl-related harm, overdose, and death in the United States are linked to illegally made fentanyl, according to the US Centers for Disease Control and Prevention.

    Deaths involving synthetic opioids increased by 22% in 2021, according to CDC data, and in 2022, there were about 181,806 nonfatal opioid overdoses recorded in the United States.

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  • 12 blue states sue FDA, saying it’s too strict in limiting abortion drugs as legal battle over mifepristone heats up | CNN Politics

    12 blue states sue FDA, saying it’s too strict in limiting abortion drugs as legal battle over mifepristone heats up | CNN Politics

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    CNN
     — 

    Twelve states led by liberal attorneys general announced Friday that they had sued the Food and Drug Administration, saying its limits on mifepristone, one of the two drugs used for medication abortion, are too strict.

    The suit is a possible hedge by states waiting to see how a federal judge in Texas rules in a lawsuit brought by anti-abortion groups seeking to block the FDA’s approval of mifepristone altogether. Conflicting rulings could mean the Supreme Court is asked to sort out the issue.

    RELATED: How a medication abortion, also known as an ‘abortion pill,’ works

    “The federal government has known for years that mifepristone is safe and effective,” Washington state Attorney General Bob Ferguson said in a statement. “In the wake of the Supreme Court’s radical decision overturning Roe v. Wade, the FDA is now exposing doctors, pharmacists and patients to unnecessary risk. The FDA’s excessive restrictions on this important drug have no basis in medical science.”

    Mifepristone was first approved in 2000 and medication abortion accounts for more than half of the abortions in the US. It is the first drug, followed by misoprostol, in the medication abortion regimen. Patients and providers must sign agreements stating the drug will be used to end a pregnancy, and pharmacies must have special certification.

    The lawsuit was filed in federal court in the Eastern District of Washington state. The states in the lawsuit are: Washington, Oregon, Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island and Vermont.

    A lawsuit seeking to block the use of medication abortion nationwide could receive an initial decision at any moment, after the plaintiffs in the case submitted to the court on Friday their final brief on the challenge.

    The lawsuit, filed in November by anti-abortion advocates against FDA, challenges the two-decade-old approval of mifepristone, the first drug in the medication abortion process.

    A decision by US District Judge Matthew Kacsmaryk, an appointee of former President Donald Trump, in favor of the plaintiffs could have far-reaching consequences since medication abortion now makes up a majority of abortions obtained in the US.

    In the filing submitted Friday, the anti-abortion advocates rehashed many of the arguments they made in earlier briefs. Its submission means that Kacsmaryk could soon rule on a motion by the plaintiffs to temporarily block use of the medication. The judge had previously said that once the February 24 filing deadline ended, “briefing will then be closed on the matter, absent any ‘exceptional or extraordinary circumstances.’”

    Kacsmaryk, however, could also call for a hearing, or ask for additional responses.

    The defendants in the case – the FDA and Danco, which makes mifepristone – argued in separate briefs to the court that a decision against the drug’s approval would be unprecedented and would shutter the drugmaker’s business.

    Reproductive rights advocates have stressed that a ruling in favor of the plaintiffs would be devastating, with NARAL Pro-Choice America saying in a statement that if the drug is yanked from the market, “64.5 million women of reproductive age in the US would lose access to medication abortion care, an exponential increase in harm overnight.”

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  • After recent student fentanyl overdoses in Texas community, court documents reveal drug supplier lived blocks away from schools | CNN

    After recent student fentanyl overdoses in Texas community, court documents reveal drug supplier lived blocks away from schools | CNN

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    CNN
     — 

    Parents across the Carrollton-Farmers Branch Independent School District (CFBISD), located in a Dallas, Texas, suburb, are reeling following a string fentanyl overdoses by nine students who attend schools in the district.

    The students, who range in age from 13 to 17 and are not identified by name in court documents, overdosed between September 18, 2022 and February 1, 2023. Three of the students died, and one of the students, a 14-year-old girl, overdosed twice, according to a statement by the US Attorney’s Office, Northern District of Texas.

    Law enforcement officers traced the drugs the students overdosed on to a house within walking distance from a middle school and a high school, court documents say.

    “First with all the school shootings, now this with drugs,” Lupe Rebadan, who has two children, as well as nieces and nephews, attending schools in the district told CNN. “Our kids are not safe at school… When is this all going to stop?”

    Luis Eduardo Navarette and Magaly Mejia Cano have been charged with conspiracy to distribute fentanyl, according to the US Attorney’s Office.

    “To deal fentanyl is to knowingly imperil lives. To deal fentanyl to minors – naive middle and high school students – is to shatter futures. These defendants’ alleged actions are simply despicable,” US Attorney Leigha Simonton said in the statement.

    The complaint illuminates a network of drug dealers and users, most of them teenagers who attend R.L. Turner High School, Dan Long Middle School and Dewitt Perry Middle School, and traced the proliferation of fentanyl tainted “M30” pills to Navarette and Cano’s residence.

    International drug trafficking organizations often produce M30 pills by mixing highly addictive fentanyl with acetaminophen “and other binder type substances and pressed into various tablets/pills,” says an affidavit by a Drug Enforcement Administration task force officer included in the criminal complaint.

    Many fake pills are made to look like prescription opioids such as oxycodone (Oxycontin, Percocet), hydrocodone (Vicodin), and alprazolam (Xanax); or stimulants like amphetamines (Adderall),” according to the DEA’s “One Pill Can Kill” website.

    Criminal organizations, according to the DEA officer’s affidavit, sell M30 pills for $1 to $2 dollars per pill when the purchasers buy in bulk amounts. Those are later sold to “street level dealers” for $3 to $5 per pill, and later sold to consumers for $10 per pill.

    Law enforcement tracked multiple teenagers engaging in “hand-to-hand transactions” with Navarette and Cano outside of their house, which is approximately five blocks from R.L. Turner High School and two blocks from DeWitt Perry Middle School, the court documents reveal.

    On January 12, a Carrollton Street Crimes Unit detective observed a 16-year-old obtain M30 pills from Navarette and Cano’s residence.

    The teenager appeared to crush and snort a pill on their front porch, “possibly package” the drugs, then walk toward the high school, where he was enrolled, according to the complaint.

    The school was notified by law enforcement, and later that day a school resource officer located the teenager in a bathroom making a “snorting sound” and appearing intoxicated.

    Navarette and Cano made their initial appearances in court on Monday, Erin Dooley of the US Attorney’s Office in Northern Texas told CNN. Naverette waived his right to a detention hearing and was ordered detained pending trial, and Cano had her detention hearing on Friday, she added. Attorneys for Navarette and Cano haven’t responded to CNN’s requests for comment.

    Days after the complaint outlining the 10 overdoses became available to the public, CFBISD released a statement expressing sorrow and concern over “the loss of young lives.”

    The district explained how it has educated the community about the threat from fentanyl over the past several months.

    “We will continue to work cooperatively with local law enforcement agencies to address this issue and to maximize safety on our campuses in every way possible. We believe if we work together as a community, we can avoid these tragedies,” the district said.

    The district said Narcan, or naloxone, an emergency drug used to treat fentanyl overdoses, had been obtained for all district facilities in October and random canine searches were being conducted on secondary campuses.

    Drug awareness presentations for parents will also resume this year, according to the district.

    “The fentanyl crisis is claiming far too many young Texans,” Texas Governor Greg Abbott tweeted Wednesday. Abbott launched the #OnePillKills campaign in October 2022 to “combat the growing national fentanyl crisis plaguing Texas.”

    In the first week of school in 2022, four students died from “fentanyl poisoning, or suspected poisoning” in Hays County Independent School District (HCISD), located in a suburb of Austin. This prompted the district to create “Fighting Fentanyl,” an informational campaign warning students and faculty about the deadly drug.

    Tim Savoy, the chief communication officer at HCISD, noted that the district has spent tens of millions of dollars for preventative measures against school shootings and Covid-19, two issues that have affected schools nationwide. The fentanyl crisis on school campuses deserves the same level of concern and response, he said.

    “This is a threat. We’re losing students, too. And so we made the decision that we have to get this equal attention and resources and do what we can,” Savoy told CNN.

    Despite the district’s awareness-raising campaign, an email from the superintendent on January 9 informed parents of “three more suspected accidental fentanyl poisonings” and one death in which fentanyl may have been to blame.

    “Our students are dying from this, and we have to do what we can,” Savoy said. “This is not just something that you’re seeing elsewhere. This is really happening in our community.”

    According to the Centers for Disease Control and Prevention, median monthly overdose deaths among 10- to 19-year-olds across the United States involving illicitly manufactured fentanyl surged 182% from December 2019 to December 2021.

    Adolescents are particularly vulnerable to fentanyl exposure due to the “proliferation of counterfeit pills resembling prescription drugs containing IMFs (illicitly manufactured fentanyls), and the ease of purchasing pills through social media,” according to the CDC.

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  • What to know about the lawsuit aiming to ban medication abortion drug mifepristone | CNN Politics

    What to know about the lawsuit aiming to ban medication abortion drug mifepristone | CNN Politics

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    CNN
     — 

    A federal judge may rule later this month on a lawsuit seeking to block the use of medication abortion nationwide, in the biggest abortion-related case since the Supreme Court overturned Roe v. Wade last year.

    The lawsuit, filed in November by anti-abortion advocates against the US Food and Drug Administration, targets the agency’s 20-year-old approval of mifepristone, the first drug in the medication abortion process

    Medication abortion, which now makes up a majority of abortions obtained in the US, has become a particularly acute flashpoint in the fallout from the Supreme Court’s decision last year overturning Roe v. Wade.

    US District Judge Matthew Kacsmaryk, an appointee of former President Donald Trump, has extended the briefing deadline in the case until February 24.

    Reproductive rights advocates say that if Kacsmaryk sides with the plaintiffs, “it would eliminate the most commonly used method of abortion care,” according to NARAL Pro-Choice America.

    Here’s what to know about the lawsuit:

    The lawsuit, filed last year by a coalition of anti-abortion national medical associations under the umbrella of the “Alliance for Hippocratic Medicine” and several doctors, is seeking a number of actions by the court, chief among them a preliminary and permanent injunction ordering the FDA “to withdraw mifepristone and misoprostol as FDA-approved chemical abortion drugs and to withdraw defendants’ actions to deregulate these chemical abortion drugs.”

    “After two decades of engaging the FDA to no avail, plaintiffs now ask this court to do what the FDA was and is legally required to do: protect women and girls by holding unlawful, setting aside, and vacating the FDA’s actions to approve chemical abortion drugs and eviscerate crucial safeguards for those who undergo this dangerous drug regimen,” the complaint reads.

    The FDA responded to the lawsuit last month by asking the judge to deny the motion for a preliminary injunction, arguing that issuing one in the matter “would upend the status quo and the reliance interests of patients and doctors who depend on mifepristone, as well as businesses involved with mifepristone distribution.”

    The agency also says a ruling against it would set a dangerous precedent.

    “More generally, if longstanding FDA drug approvals were so easily enjoined, even decades after being issued, pharmaceutical companies would be unable to confidently rely on FDA approval decisions to develop the pharmaceutical-drug infrastructure that Americans depend on to treat a variety of health conditions,” the FDA wrote.

    “A preliminary injunction would interfere with Congress’s decision to entrust FDA with responsibility to ensure the safety and efficacy of drugs. In discharging this role, FDA applies its technical expertise to make complex scientific determinations about drugs’ safety and efficacy, and these determinations are entitled to substantial deference.”

    Danco, which makes mifepristone, also made a similar request to the FDA’s in a court filing, stressing that the lawsuit could decimate the company’s business.

    “Danco is a small pharmaceutical company. It sells one drug: Mifeprex,” lawyers for the company wrote in court papers. “Entering the mandatory preliminary injunction plaintiffs seek would force FDA to withdraw approval for Danco’s only product, effectively shuttering Danco’s business.”

    “Congress entrusts decision-making like this with the FDA. And they’re coming in trying to overrule that, saying this medication is unsafe because women bleed. Well, that’s part of having an abortion. It’s also part of having a pregnancy,” said Ryan Brown, an attorney representing Danco in the case. “The bottom line being that they just want to do away with abortion across the board and for any reason.”

    Kacsmaryk was appointed to the court in 2017 by then-President Trump and was confirmed by a 52-46 vote in 2019.

    Since then, he’s helped make Texas a legal graveyard for policies of President Joe Biden’s administration, presiding over 95% of the civil cases brought in Amarillo, Texas.

    In December, Kacsmaryk put on hold the Biden administration’s most recent attempt to end the so-called “Remain in Mexico” program. And he has overseen Texas cases challenging vaccine mandates, the gender identity guidance issued by the US Equal Employment Opportunity Commission and the administration’s limits on the use of Covid-19 relief funds for tax cuts.

    Before joining the court, Kacsmaryk served as deputy general counsel at the First Liberty Institute, a nonprofit religious liberty legal group, where he worked mainly on “religious liberty litigation in federal courts and amicus briefs in the US Supreme Court,” according to his White House biography.

    The case is being closely watched by a number of interested parties, including Republican and Democratic state attorneys general. On Friday, two different multi-state coalitions filed amicus briefs with the court urging them to act one way or another in the matter.

    A coalition of 22 Democratic attorneys general urged Kacsmaryk to deny the motion for a preliminary injunction, writing in court papers that “annulling – or even merely limiting – any of the FDA’s actions relating to medication abortion would result in an even more drastic reduction in abortion access across the entire nation, worsening already dire outcomes, deepening entrenched disparities in access to health care, and placing a potentially unbearable strain on the health care system as a whole.”

    And a coalition of 22 Republican attorneys general asked the court to issue the preliminary injunction, arguing the FDA exceeded its authority when it approved the medication.

    “State laws on chemical abortion thus account for the public interests at issue – and they do so with the benefit of democratic legitimacy (and legal authority). The FDA’s actions can make no such claim. By obstructing the judgments of elected representatives, the agency has undermined the public interest,” they wrote.

    Abortion rights advocates have sounded the alarm on the case, stressing that a ruling by Kacsmaryk in favor of the plaintiffs would affect every corner of the country since the lawsuit is targeting a federal agency.

    “If FDA approval of mifepristone is revoked, 64.5 million women of reproductive age in the US would lose access to medication abortion care, an exponential increase in harm overnight,” NARAL said in a statement on Friday, pointing to internal research.

    “This research reveals the high stakes of this lawsuit, and we can only expect the worst from this Trump-appointed federal judge. Americans want access to abortion, but anti-choice bad actors are dead set on restricting reproductive freedom by any means possible,” said Angela Vasquez-Giroux, the group’s vice president of communications and research.

    And activists are mobilizing in Texas around the issue, with the Women’s March planning to hold a rally at the federal courthouse in Amarillo, Texas, on Saturday.

    “We’ve said it before: the fight for reproductive rights now lies in the states, and legal challenges like these are just the latest example of how our fight is bigger than Roe,” said Rachel Carmona, the executive director of Women’s March.

    On Thursday, Kacsmaryk told the plaintiffs that they had until February 24 to respond to a recent filing by the Danco, writing in an order that following the deadline, “briefing will then be closed on the matter, absent any ‘exceptional or extraordinary circumstances.’”

    On Friday, the plaintiffs in the case submitted one response to the FDA’s filing. But the deadline extension means that after the plaintiffs submit a separate response to Danco, the case is ripe for judgment since all required briefings will have been filed.

    Kacsmaryk can rule at any time after that, though he could also call for a hearing, or ask for additional responses as well.

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  • Tracking the opioid crisis: Inside the DEA’s secret lab | CNN

    Tracking the opioid crisis: Inside the DEA’s secret lab | CNN

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    Watch CNN Films’ “American Pain” at 9 p.m. ET Sunday, February 5.



    CNN
     — 

    Sitting among the warehouses of Dulles, Virginia, is one of the US Drug Enforcement Administration’s forensic labs. It’s one of eight across the country where scientists analyze illegal drugs and try to stay ahead of what’s driving deadly overdoses.

    Starting in the late 1990s with overprescribing of prescription narcotics, the opioid epidemic has continued to plague the United States for decades. What has changed is the type of drugs that have killed more than half a million people during the past 20 years.

    CNN was granted rare access to the secret lab where the DEA tests seized illicit drugs to understand what’s coming next.

    “The market is constantly changing, so we are trying to do everything we can from a science base to keep up with that,” Scott Oulton, deputy assistant administrator of the DEA’s Office of Forensic Sciences, told CNN Chief Medical Correspondent Dr. Sanjay Gupta.

    Holding a white bag of fentanyl precursor powder – one of the chemicals used to make the opioid – Oulton explained that the illicitly made painkiller continues to be a dominant presence in the drugs officials are finding.

    “This kilogram can be converted into fentanyl to make approximately 800 grams,” he said. “So it doesn’t take that much material, it’s fairly cheap, it’s inexpensive to obtain.”

    Fentanyl is the deadliest drug in the United States, and it’s often found in combination with other illicit drugs, including cocaine and heroin. But increasingly, fentanyl is showing up in illicit pills disguised as common prescription drugs like oxycodone, hydrocodone, even Adderall.

    Users buying drugs on the street that look like prescription pills may end up with a highly potent, potentially deadly drug they never intended to take.

    “Over 99% of what we see are fake. They contain fentanyl,” Oulton says of the pills that the agency is seizing.

    The 800 grams of fentanyl that Oulton held could be turned into 400,000 to 500,000 potentially lethal pills.

    As more and more of these lethal pills circulate, the opioid epidemic is reaching more of the population.

    Deena Loudon of Olney, Maryland, is among those living with its effects.

    “I truly love sharing Matthew with the world,” Loudon says as she flips through pictures of her son.

    One of her favorite memories is Matthew playing hockey – what Loudon calls his happy place.

    Matthew Loudon's mom says he turned to drugs after struggling with anxiety.

    But she also recalls his struggles with anxiety, which led him to turn to drugs. He started dabbling in them in the 10th grade. By the following year, his grades began to fall, and he couldn’t keep them high enough to stay in hockey.

    “He was using Xanax to help self-medicate himself and I think to help get rid of some of that angst so he could live somewhat of a normal life,” Loudon said.

    Matthew was always honest, almost to a fault, Loudon says. “He told me he tried everything. Like everything. Heroin, meth, crack, you name it, cocaine, whatever – until I guess he found what made him feel the best, and it was Xanax.”

    And as much as a mother can worry, Loudon says, Matthew always tried to reassure her. “I know what I’m doing,” he would tell her.

    She had heard about fentanyl showing up in pills in their area.

    “But you don’t ever think it’s going to happen to you,” Loudon said.

    She said they even had a conversation about fentanyl the day before he died. “I was sort of naive, wanting to stick my head in the sand and thinking ‘I bet he does know what he’s doing.’ ”

    On November 3, 2020, she found 21-year-old Matthew on the floor of their basement.

    Matthew’s autopsy report lists his cause of death as fentanyl and despropionyl fentanyl intoxication.

    “I don’t say he overdosed. I say he died from fentanyl poisoning. … Truthfully, like, at the end of the day, to me, he was murdered, right? Because he asked for one thing. They gave him something different. And it took his life.”

    For a parent, she said, the hardest thing is burying their child. It’s a pain she speaks out about in hopes of keeping other families safe.

    “It’s Russian roulette,” she warns them. “You never know what you’re gonna get.”

    The number of pills the DEA has seized skyrocketed in just three years, from 2.2 million in 2019 to 50.6 million in 2022.

    The sheer volume of pills has been one of the biggest challenges for the DEA’s lab, Oulton says. As the fentanyl threat continues to grow, the Virginia facility is expanding to accommodate the analysis needed.

    The lab can test for something as simple as the presence of fentanyl, but something called the purity of the pill also offers important insight. This means how much fentanyl is actually in one of these illicit pills.

    “Lately, we’ve been seeing a purity increase over the last year, where we used to say roughly four out of the 10 seizures that we were receiving would contain a lethal dose of greater than 2 milligrams. As of October last year, we started reporting that we’ve seen an uptick. Now we’re saying that six out of 10 of the seizures that we’re receiving contain over 2 milligrams,” Oulton said.

    He says they’re finding an average of 2.3 milligrams of fentanyl in each pill.

    Two milligrams may be the cutoff for what is considered lethal, but Oulton says that doesn’t necessarily mean a pill with 1.99 milligrams of fentanyl can’t be deadly.

    “One pill can kill” is his warning.

    “The message I would like to send out is, don’t take it,” he said. “Don’t take the chance. It’s not worth your life.”

    Oulton says he and his team are constantly finding new and different drugs and substances in pills – things they’ve never seen before.

    One machine in the lab is almost the equivalent of an MRI in a medical office, showing the structure and detail of a pill.

    “We will do what we call structural elucidation to determine that this is a different version of a fentanyl that’s got a new compound and molecule that’s been added to it,” Oulton said.

    They’ve seen “hundreds and hundreds of unique combinations,” he said.

    “We’ll see one that contains fentanyl, one with fentanyl and xylazine, one with fentanyl and caffeine, one with fentanyl and acetaminophen, and you don’t know what you’re getting.”

    Xylazine, a veterinary tranquilizer, poses a unique problem. It’s not an opioid, so even when it’s mixed with fentanyl, drugs designed to reverse an opioid overdose may not work.

    Narcan or naloxone, one of the more common overdose-reversing drugs, has become increasingly necessary as the prevalence and potency of illicit drugs increases. About 1.2 million doses of naloxone were dispensed by retail pharmacies in 2021, according to data published by the American Medical Association – nearly nine times more than were dispensed five years earlier.

    Oulton wants to be clear: The problem Isn’t with pills prescribed by your doctor and dispensed by a pharmacy – it’s the pills on the illicit market.

    Those, Matthew’s mother warns, are easy to get.

    “The first pills [Matthew] got was in high school. And it was just flipping out, floating around, and it was easy for him to get his hands on,” she said.

    Loudon’s message for parents now: Keep your eyes open.

    “Just be mindful of what your children are doing. You just just have to keep your eyes open. And even sometimes, when you keep your eyes open, you can miss some of the warning signs, but I think a parent knows their child best, so just keep talking.”

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  • Blinken under pressure to push China on role in lethal fentanyl trade when he visits Beijing | CNN Politics

    Blinken under pressure to push China on role in lethal fentanyl trade when he visits Beijing | CNN Politics

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    CNN
     — 

    Members of Congress are urging Secretary of State Antony Blinken to pressure China to do more to curb the flow of fentanyl and synthetic opioids into the United States on his visit to the country which is expected to take place in the next few days.

    On Wednesday, a group of 14 Republican senators led by Marco Rubio of Florida wrote to Blinken ahead of his trip highlighting China’s role in the “fentanyl crisis” as one of many issues they wanted him to address.

    More than 100,000 Americans died of drug overdoses from July of 2021 to July of 2022 and two thirds of those deaths were fueled by synthetic opioids, primarily fentanyl, according to the CDC.

    An extremely powerful synthetic drug, fentanyl is 50 to 100 times more potent than morphine and 30 to 50 times more potent than heroin.

    The Chinese government cracked down on the manufacture and distribution of fentanyl in 2019, in a move that was hailed by the Trump administration. As a result, China it is no longer the primary source of fentanyl getting into the US. But it’s still the key source of precursor chemicals which are often shipped to Mexico and used by cartels to produce fentanyl which is brought over the border.

    “China is the leading producer of these precursor chemicals and is shipping and selling them to the two major Mexican cartels (Sinaloa and New Generation) producing fentanyl,” explained David Luckey, a senior international and defense researcher at RAND Corporation.

    “Virtually 98% of the precursor chemicals that are made used to make fentanyl are coming from China,” Democratic Rep. David Trone of Maryland told CNN. Getting China to engage on this crisis “has got to be Secretary Blinken’s number one mission when he gets there.”

    Experts and lawmakers say the production of precursor chemicals in China is a primary factor fueling the ongoing opioid crisis.

    “Synthetic opioid trafficking is an area where even a few meaningful steps from the PRC (People’s Republic of China) can play a significant role in combating this worsening epidemic and saving American lives,” Trone wrote in a letter to Blinken last month. He urged Blinken not to negotiate with Chinese officials on other topics until he has secured a commitment from Beijing to do more to stem the fentanyl crisis.

    Trone, whose nephew died of a fentanyl overdose, believes China should commit to adopting rules requiring drug companies to know who their customers are, put into place and enforce export regulations on the chemical sector, and cooperate with US agencies including the Drug Enforcement Administration and Office of National Drug Control Policy to crack down on the fentanyl trade.

    Blinken has directed his team at the State Department to work with interagency partners to do “everything possible” to address this deadly crisis which is the leading killer of Americans between the ages of 18 to 49, State Department spokesperson Ned Price said earlier this year.

    But it’s unclear what direct asks he will make of the Chinese government during his visit.

    “Though its past action has helped to counter illicit synthetic drugs, we continue to urge the PRC to take additional meaningful concrete action to curb the diversion of precursor chemicals and equipment used by criminals to manufacture fentanyl and other synthetic drugs,” Price said.

    Some lawmakers believe that Blinken should offer trade talks with China if it engages on efforts related to stemming the fentanyl crisis. Yet other congressional aides say that China will only respond to pressure and believe that the administration should consider steps including additional sanctions related to the dangerous substances – to force their engagement.

    Todd Robinson, the top State Department official for international narcotics and law enforcement affairs, said that the effective way to approach the challenge will be through “collaboration and cooperation.”

    “China has its own problems with narcotics. Mexico has problems has its problems with narcotics. Colombia also has a problem. And what we’ve been saying is, this is no longer an issue where you can solely use one or the other. Everybody’s got a problem.”

    But the need for Chinese engagement is clear: reducing the supply of precursor chemicals from China would have a “huge” impact on the crisis and would “mean a dramatic decrease” in US deaths resulting from drug overdoses, Robinson said.

    China is the largest producer of chemicals that are in everyday products such as cleaning supplies. Many Chinese companies have begun producing and selling the precursor chemicals in addition to the chemicals they have already been producing.

    Challenges to tackling the root of the problem persist when China and other countries often turn the tables on the US and blame Americans for the addiction problem which drives the demand.

    “It’s not as simple as saying, ‘China, stop producing and exporting these chemicals’. There are several sides to this issue. In response, China, for example, could counter with, ‘Americans, stop buying and using drugs,’” said Luckey.

    Many Americans with a direct connection to the crisis are watching Blinken’s trip closely.

    West Virginia – which had more than 1,300 deaths due to synthetic opioids from March of 2021 to March of 2022, according to the CDC – is an epicenter of the domestic crisis.

    Jordan Dennison lives in the state, grew up with parents who were drug addicts, and developed his own opioid addiction in his teens. A few years ago – after more than 10 overdoses – he finally got clean. The 30-year-old now works at an outreach program to get addicts into treatment.

    “Drugs led me to lose everything. Every relationship I ever had. I came to learn that what I was using was not heroine it was fentanyl. I was getting it off the street, I would go anywhere to get it,” he told CNN. “I never knew where it came from, but I always assumed it was coming from China.”

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  • First on CNN: Biden administration to strengthen Obamacare contraceptive mandate in proposed rule | CNN Politics

    First on CNN: Biden administration to strengthen Obamacare contraceptive mandate in proposed rule | CNN Politics

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    CNN
     — 

    The Biden administration wants to make it easier for women to access birth control at no cost under the Affordable Care Act, reversing Trump-era rules that weakened the law’s contraceptive mandate for employer-provided health insurance plans.

    The proposed rule, unveiled Monday by the departments of Health and Human Services, Labor and Treasury, would remove an exemption to the mandate that allows employers to opt out for moral convictions. It would also create an independent pathway for individuals enrolled in plans offered by employers with religious exemptions to access contraceptive services through a willing provider without charge.

    The proposed rule would leave in place the existing religious exemption for employers with objections, as well as the optional accommodation for contraceptive coverage.

    The administration crafted the proposed rule keeping in mind the concerns of employers with religious objections and the contraceptive needs of their workers, a senior HHS official told CNN.

    “We had to really think through how to do this in the right way to satisfy both sides, but we think we found that way,” the official said, stressing that there should be no effect on religiously affiliated employers.

    Students at religiously affiliated colleges would have access to the expanded accommodation, just like workers in group health plans where the employer has claimed the exemption.

    Now that the proposed rule has been announced, the public will have the opportunity to comment during the next few months. Officials expect there to be many thousands of public comments, and it will be “many months” before the rule could be finalized.

    HHS expects the proposal would affect more than 100 employers and 125,000 workers, mainly through providing the proposed independent pathway for employees to receive no-cost contraception.

    Women using that pathway would obtain their birth control from a participating provider, who would be reimbursed by an insurer on the Affordable Care Act exchanges. The insurer, in turn, would receive a credit on the user fee it pays the government.

    “If this rule is finalized, individuals who have health plans that would otherwise be subject to the ACA preventive services requirements but have not covered contraceptive services because of a moral or religious objection, and for which the sponsoring employer or college or university has not elected the optional accommodation, would now have access,” Centers for Medicare and Medicaid Services Administrator Chiquita Brooks-LaSure said in a news release.

    How many people benefit, however, would depend on whether women and their health care providers know the independent pathway exists and whether providers and insurers are willing to set it up.

    “We’ll just have to see how widely that information is spread and in what way to providers and individuals,” said Laurie Sobel, associate director for Women’s Health Policy at the Kaiser Family Foundation, noting that the proposed rule would not require data collection to show the pathway’s takeup.

    But the Planned Parenthood Federation of America cheered the initiative.

    “Employers and universities should not be able to dictate personal health care decisions and impose their views on their employees or students,” said Alexis McGill Johnson, the group’s CEO. “The ACA mandates that health insurance plans cover all forms of birth control without out-of-pocket costs. Now, more than ever, we must protect this fundamental freedom.”

    The requirement to provide no-cost contraception is not in the Affordable Care Act itself. Instead, HHS under former President Barack Obama included it as one of the women’s preventive services that all private insurance plans must offer without charge.

    The mandate was controversial from the start, sparking lawsuits from religiously affiliated employers and closely held companies that said it violated their beliefs. Exemptions and accommodations have been available for such employers.

    The Trump administration, however, weakened the mandate. Under the rules issued in 2018, entities that have “sincerely held religious beliefs” against providing contraceptives are not required to do so. That provision also extends to organizations and small businesses that have objections “on the basis of moral conviction which is not based in any particular religious belief.”

    The rules also include an optional accommodation that lets objecting employers and private universities remove themselves from providing birth control coverage while still allowing their workers and dependents access to contraception. But the employer or university has to voluntarily elect the accommodation, which risks leaving many without access.

    The Trump administration changes were temporarily blocked after a Pennsylvania district court judge issued a nationwide injunction in 2019. But the following year, the Supreme Court ruled that the administration could expand exemptions for employers who have religious or moral objections to covering contraception.

    At the time, the National Women’s Law Center estimated that the ruling would impact about 64.3 million women in the United States with insurance coverage that included birth control and other preventive services without out-of-pocket costs.

    Employers are not required to notify HHS if they have a moral objection. The agency estimates about 18 employers have claimed that exemption and around 15 employees are affected.

    Still, if the rule is finalized, senior HHS officials say it is “plausible” there could be potential lawsuits brought by religiously affiliated employers – similar to what has been seen in the past.

    “There’s no new obligation on them to participate in any sort of process. This is simply an additional channel for employees in those employer health plans to receive access to contraceptive services,” another senior HHS official said.

    The contraceptive mandate has taken on increased importance now that the Supreme Court has overturned Roe v. Wade, allowing many states to impose severe restrictions on abortion access.

    The Biden administration in turn has focused on continuing access to birth control at no cost. The Health, Labor and Treasury department secretaries last year met with health insurers and issued guidance underscoring Obamacare’s contraceptive coverage requirements for private insurance under the Affordable Care Act.

    “Now more than ever, access to and coverage of birth control is critical as the Biden-Harris Administration works to help ensure women everywhere can get the contraception they need, when they need it, and – thanks to the ACA – with no out-of-pocket cost,” HHS Secretary Xavier Becerra said in a news release.

    This story has been updated with additional information.

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  • FTC calls on federal court to hold ‘pharma bro’ Martin Shkreli in contempt | CNN Business

    FTC calls on federal court to hold ‘pharma bro’ Martin Shkreli in contempt | CNN Business

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    Washington
    CNN
     — 

    The Federal Trade Commission on Friday called for a federal court to hold “Pharma Bro” Martin Shkreli in contempt after Shkreli allegedly flouted a recent FTC investigation into his business dealings and failed to make a $64.6 million payment he owed for his prior wrongdoings.

    The FTC’s contempt motion follows what the agency described as its an unsuccessful attempt to verify whether Shkreli has violated a court order barring him from ever working in the pharmaceutical industry again.

    Brianne Murphy, an attorney for Shkreli, called the issue with the FTC a misunderstanding that “can get resolved relatively quickly once we get additional information and context to them.” Murphy added that Shkreli’s new business does not run afoul of the court order because the new company “is a software company, rather than a drug company.”

    Shkreli was released from federal prison last year after serving a shortened sentence. He was convicted of securities fraud in 2017 for mismanaging two investments funds.

    Shkreli also infamously raised prices for the life-saving medication Daraprim by 4,000% while he was head of Turing Pharmaceuticals. His conduct earned him the title of “most hated man in America” by multiple publications. More recently, he was the subject a 134-page ruling in 2022 by the US District Court for the Southern District of New York that banned him for life from participating in the pharmaceutical industry, as part of a separate FTC antitrust case against him.

    That legally binding order triggered a new investigation into Shkreli’s activities in October, when public reports indicated he had co-founded a new “Web3 drug discovery software platform” known as Druglike, Inc.

    When the FTC emailed Shkreli to get documents from him and to schedule an interview about the matter, Shkreli repeatedly missed deadlines and allegedly slow-walked his responses, according to an FTC court filing Friday.

    “Shkreli has not attempted—much less ‘diligently,’ as Second Circuit law requires—to comply with the Order in a reasonable manner,” the filing said.

    The FTC also said Shkreli had been ordered to make his multimillion-dollar payment — representing a refund of his ill-gotten Daraprim gains — by March 6, 2022. But in fact, the FTC said, “to date he has paid nothing toward the judgment, and has made no efforts to comply with this provision of the Order.”

    As far as his involvement with Druglike, the FTC added: “Shkreli’s noncompliance is also clear and unambiguous: Shkreli has not submitted a supplemental Compliance Report, provided access to relevant documents, or made himself available for an interview.”

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  • Walgreens removes online purchasing limits for children’s fever medications | CNN

    Walgreens removes online purchasing limits for children’s fever medications | CNN

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    CNN
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    After weeks of high demand that stretched supply, Walgreens removed its online purchasing limits for children’s pain- and fever-reducing medications on Monday morning, spokesperson Zoe Krey told CNN.

    Walgreens only had limits in place on medicines purchased online. It did not have limits on medication purchased in stores.

    “So currently, we have no purchase limits either in-store or online,” Krey said.

    The change comes after high demand for children’s pain and fever medications led some stores, including CVS and Rite Aid, to limit purchases. A brutal respiratory virus season fueled the sales of kids’ medications to treat pain and fever to 65% higher than what was typical the year before.

    CVS on Monday told CNN there is currently a two product limit on all children’s pain relief products at its stores and online. A spokesperson for the chain said the limits were in place “to ensure equitable access for all our customers,” and said CVS was working with its suppliers to ensure continued access to the items.

    CNN has also reached out to Rite Aid for comment.

    Last month, the Consumer Healthcare Products Association, which represents makers of over-the-counter medicines, said manufacturers were running 24/7 to supply more medications to stores, but there was no timeline for when supply could catch up to demand.

    Since then, flu and RSV activity have peaked in the US, according to data from the US Centers for Disease Control and Prevention. Covid-19 cases are still on the rise.

    Still, flu and other respiratory virus activity remains “high” or “very high” in about half of states, according to CDC data updated Friday, and the US continues to contend with multiple respiratory viruses that are circulating at high levels.

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  • Alabama attorney general says people who take abortion pills could be prosecuted | CNN Politics

    Alabama attorney general says people who take abortion pills could be prosecuted | CNN Politics

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    CNN
     — 

    Alabama’s Republican attorney general said this week that women in the state who use prescription medication to terminate their pregnancies could be prosecuted under a chemical-endangerment law, even though Alabama’s anti-abortion law does not intend to punish women who receive abortions.

    Steve Marshall made the comments in the wake of a decision earlier this month by the US Food and Drug Administration to allow certified pharmacies to dispense the abortion medication mifepristone to people who have a prescription.

    “The Human Life Protection Act targets abortion providers, exempting women ‘upon whom an abortion is performed or attempted to be performed’ from liability under the law,” Marshall said in a statement to AL.com on Tuesday. “It does not provide an across-the-board exemption from all criminal laws, including the chemical-endangerment law—which the Alabama Supreme Court has affirmed and reaffirmed protects unborn children.”

    The chemical endangerment law was passed in 2006 amid high drug usage in Alabama with aims of protecting children from chemicals in the home, but district attorneys have successfully applied the law to protect fetuses of women who used drugs during pregnancy.

    It’s unclear if there are any pending cases against women in Alabama in the wake of the FDA’s announcement. CNN has reached out to Marshall’s office for comment.

    At least one Democrat, Alabama state Rep. Chris England, argued on Twitter that the chemical endangerment law is “extremely clear” and under it, a woman could not be prosecuted for taking a lawfully prescribed medication.

    “Any prosecutor that tries this, or threatens it, is intentionally ignoring the law,” England wrote on Thursday morning.

    Emma Roth, an attorney with Pregnancy Justice, a nonprofit that provides legal representation for women charged with crimes related to pregnancy, said on Twitter that the effect of Marshall’s comments will be to create “a culture of fear among pregnant women.”

    The comments are “extremely concerning and clearly unlawful,” Roth elaborated in a statement to CNN. “The Alabama legislature made clear its opposition to any such prosecution when it explicitly exempted patients from criminal liability under its abortion ban.”

    The chemical endangerment law says it does not require reporting controlled substances that are prescription medications “if the responsible person was the mother of the unborn child, and she was, or there is a good faith belief that she was, taking that medication pursuant to a lawful prescription.”

    Mifepristone can be used along with another medication, misoprostol, to end a pregnancy. Previously, these pills could be ordered, prescribed and dispensed only by a certified health care provider. During the Covid-19 pandemic, the FDA allowed the pills to be sent through the mail and said it would no longer enforce a rule requiring people to get the first of the two drugs in person at a clinic or hospital.

    Marshall’s comments underscore the legal uncertainty wrought by the Supreme Court’s decision last year to end the federal right to an abortion. In the wake of the Dobbs decision, several Republican-led states passed strict anti-abortion laws, while several others, including Alabama, that had passed so-called trigger laws anticipating an eventual overturn of Roe v. Wade, saw their new restrictions go into effect.

    While the anti-abortion movement seeks to prevent abortions from taking place, it has often opposed criminalizing the women who undergo the procedure.

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