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Tag: pharmaceutical industry

  • FDA advisers vote unanimously in support of over-the-counter birth-control pill | CNN

    FDA advisers vote unanimously in support of over-the-counter birth-control pill | CNN

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    CNN
     — 

    Advisers for the US Food and Drug Administration voted unanimously on Wednesday in support of making the birth-control pill Opill available over-the-counter, saying the benefits outweigh the risks.

    Two FDA advisory panels agreed that people would use Opill safely and effectively and said groups such as adolescents and those with limited literacy would be able to take the pill at the same time every day without help from a health care worker.

    The advisers were asked to vote on whether people were likely to use the tablet properly so that the benefits would exceed the risks. Seventeen voted yes. Zero voted no or abstained.

    Opill manufacturer Perrigo hailed the vote as a “groundbreaking” move for women’s health.

    “Perrigo is proud to lead the way in making contraception more accessible to women in the U.S.,” Murray Kessler, Perrigo’s president and CEO, said in a statement. “We are motivated by the millions of people who need easy access to safe and effective contraception.”

    The FDA doesn’t have to follow its advisers’ advice, but it often does. It is expected to decide whether to approve the over-the-counter pill this summer.

    If it’s approved, this will be the first birth-control pill available over the counter in the United States. Opill is a “mini-pill” that uses only the hormone progestin.

    At Wednesday’s meeting, Dr. Margery Gass of the University of Cincinnati College of Medicine thanked the FDA for its consideration of switching Opill to an over-the-counter product.

    “I think this represents a landmark in our history of women’s health. Unwanted pregnancies can really derail a woman’s life, and especially an adolescent’s life,” she said.

    The FDA has faced pressure to allow Opill to go over-the-counter from lawmakers as well as health care providers.

    Unwanted pregnancies are a public health issue in the US, where almost half of all pregnancies are unintended, and rates are especially high among lower-income women, Black women and those who haven’t completed high school.

    In March 2022, 59 members of Congress wrote a letter to FDA Commissioner Dr. Robert Califf about OTC contraception.

    “This is a critical issue for reproductive health, rights, and justice. Despite decades of proven safety and effectiveness, people still face immense barriers to getting birth control due to systemic inequities in our healthcare system,” the lawmakers wrote.

    A recent study showed that it’s become harder for women to access reproductive health care services more broadly – such as routine screenings and birth control – in recent years.

    About 45% of women experienced at least one barrier to reproductive health care services in 2021, up 10% from 2017. Nearly 19% reported at least three barriers in 2021, up from 16% in 2017.

    Increasing reproductive access for women and adolescents was a resounding theme among the FDA advisers.

    “We can take this opportunity to increase access, reduce disparities and, most importantly, increase the reproductive autonomy of the women of our nation,” said Dr. Jolie Haun of the James A. Haley Veterans’ Hospital and the University of Utah.

    Dr. Karen Murray, deputy director of the FDA’s Office of Nonprescription Drugs, said the agency understands the importance of “increased access to effective contraception” but hinted that the FDA would need more data from the manufacturer.

    Some of the advisers and FDA scientists expressed concern that some of Perrigo’s data was unreliable due to overreporting of “improbable dosing.”

    Murray said the lack of sufficient information from the study poses challenges for approval.

    “It would have been a much easier time for the agency if the applicant had submitted a development program and an actual use study that was very easy to interpret and did not have so many challenges. But that was not what happened for us. And so the FDA has been put in a very difficult position of trying to determine whether it is likely that women will use this product safely and effectively in the nonprescription setting,” she said. “But I wanted to again emphasize that FDA does realize how very important women’s health is and how important it is to try to increase access to effective contraception for US women.”

    Ultimately, the advisers said, they don’t want further studies of Opill to delay the availability of the product in an over-the-counter setting.

    “I just wanted to say that the improbable dosing issue is important, and I don’t think it’s been adequately addressed and certainly leads to some uncertainty in the findings. But despite this, I would not recommend another actual use study this time, and I think we can make a decision on the totality of the evidence,” said Kate Curtis of the US Centers for Disease Control and Prevention.

    Curtis said she voted yes because “Opill has the potential to have a huge positive public health impact.”

    Earlier in the discussion, Dr. Leslie Walker-Harding of the University of Washington and Seattle Children’s Hospital said the pill is just as safe as many other medications available on store shelves.

    “The safety profile is so good that we would need to take every other medicine off the market like Benadryl, ibuprofen, Tylenol, which causes deaths and people can get any amount of that without any oversight. And this is extremely safe, much safer than all three of those medications, and incorrect use still doesn’t appear to have problematic issues,” she said.

    Dr. Katalin Roth of the George Washington University School of Medicine and Health Sciences also emphasized the safety of the pill over the 50 years it has been approved as a prescription drug in the US.

    “The risks to women of an unintended pregnancy are much greater than any of the things we were discussing as risks of putting this pill out out over-the-counter,” she said. “The history of women’s contraception is a struggle for women’s control over their reproduction, and we need to trust women.”

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  • A 13-year-old died in Ohio after participating in a Benadryl TikTok ‘challenge’ | CNN

    A 13-year-old died in Ohio after participating in a Benadryl TikTok ‘challenge’ | CNN

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    CNN
     — 

    A 13-year-old in Ohio has died after “he took a bunch of Benadryl,” trying a dangerous TikTok challenge that’s circulating online, according to a CNN affiliate and a GoFundMe account from his family.

    Jacob Stevens was participating in a TikTok challenge with some friends at home when he ingested the antihistamine, the family donation account states. Jacob was on a ventilator for almost a week before he died, according to WSYX.

    CNN has not independently confirmed his cause of death.

    Overdosing on Benadryl can result in “serious heart problems, seizures, coma, or even death,” the US Food and Drug Administration said in a 2020 warning to the public about the deadly “Benadryl Challenge” on TikTok.

    Here’s what your teen could see on TikTok

    Jacob’s grandmother is doing anything she can “to make sure another child doesn’t go through” with the challenge, she told CNN affiliate WSYX.

    In a statement to CNN, TikTok said, “Our deepest sympathies go out to the family. At TikTok, we strictly prohibit and remove content that promotes dangerous behavior with the safety of our community as a priority. We have never seen this type of content trend on our platform and have blocked searches for years to help discourage copycat behavior. Our team of 40,000 safety professionals works to remove violations of our Community Guidelines and we encourage our community to report any content or accounts they’re concerned about.”

    The maker of Benadryl, Johnson & Johnson, has called the challenge “dangerous.”

    “We understand that consumers may have heard about an online ‘challenge’ involving the misuse or abuse of diphenhydramine,” the undated online statement reads.

    “The challenge, which involves ingestion of excessive quantities of diphenhydramine, is a dangerous trend and should be stopped immediately. BENADRYL® products and other diphenhydramine products should only be used as directed by the label.”

    “We are working with TikTok and other social platforms to remove content that showcases this behavior,” the statement added. “We will look to partner across industry and with key stakeholders to address this dangerous behavior.”

    CNN has reached out to the Stevens family and Columbus Public Health for comment.

    The FDA’s 2020 warning said the agency had “contacted TikTok and strongly urged them to remove the videos from their platform and to be vigilant to remove additional videos that may be posted.”

    Benadryl is an antihistamine used to treat symptoms such as a runny nose or sneezing from upper respiratory allergies, hay fever or the common cold. It’s safe and effective when used as recommended, the FDA said.

    “Diphenhydramine is marketed under the brand-name Benadryl, store brands, and generics. It is also available in combination with pain relievers, fever reducers, and decongestants,” the agency said.

    Consumers and parents should store Benadryl and other over-the-counter medications and prescription medicines out of the reach of children, the FDA said.

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  • ADHD medication abuse in schools is a ‘wake-up call’ | CNN

    ADHD medication abuse in schools is a ‘wake-up call’ | CNN

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    CNN
     — 

    At some middle and high schools in the United States, 1 in 4 teens report they’ve abused prescription stimulants for attention deficit hyperactivity disorder during the year prior, a new study found.

    “This is the first national study to look at the nonmedical use of prescription stimulants by students in middle and high school, and we found a tremendous, wide range of misuse,” said lead author Sean Esteban McCabe, director of the Center for the Study of Drugs, Alcohol, Smoking and Health at the University of Michigan in Ann Arbor.

    “In some schools there was little to no misuse of stimulants, while in other schools more than 25% of students had used stimulants in nonmedical ways,” said McCabe, who is also a professor of nursing at the University of Michigan School of Nursing. “This study is a major wake-up call.”

    Nonmedical uses of stimulants can include taking more than a normal dose to get high, or taking the medication with alcohol or other drugs to boost a high, prior studies have found.

    Students also overuse medications or “use a pill that someone gave them due to a sense of stress around academics — they are trying to stay up late and study or finish papers,” said pediatrician Dr. Deepa Camenga, associate director of pediatric programs at the Yale Program in Addiction Medicine in New Haven, Connecticut.

    “We know this is happening in colleges. A major takeaway of the new study is that misuse and sharing of stimulant prescription medications is happening in middle and high schools, not just college,” said Camenga, who was not involved with the study.

    Published Tuesday in the journal JAMA Network Open, the study analyzed data collected between 2005 and 2020 by Monitoring the Future, a federal survey that has measured drug and alcohol use among secondary school students nationwide each year since 1975.

    In the data set used for this study, questionnaires were given to more than 230,000 teens in eighth, 10th and 12th grades in a nationally representative sample of 3,284 secondary schools.

    Schools with the highest rates of teens using prescribed ADHD medications were about 36% more likely to have students misusing prescription stimulants during the past year, the study found. Schools with few to no students currently using such treatments had much less of an issue, but it didn’t disappear, McCabe said.

    “We know that the two biggest sources are leftover medications, perhaps from family members such as siblings, and asking peers, who may attend other schools,” he said.

    Schools in the suburbs in all regions of the United States except the Northeast had higher rates of teen misuse of ADHD medications, as did schools where typically one or more parent had a college degree, according to the study.

    Schools with more White students and those who had medium levels of student binge drinking were also more likely to see teen abuse of stimulants.

    On an individual level, students who said they had used marijuana in the past 30 days were four times as likely to abuse ADHD medications than teens who did not use weed, according to the analysis.

    In addition, adolescents who said they used ADHD medications currently or in the past were about 2.5% more likely to have misused the stimulants when compared with peers who had never used stimulants, the study found.

    “But these findings were not being driven solely by teens with ADHD misusing their medications,” McCabe said. “We still found a significant association, even when we excluded students who were never prescribed ADHD therapy.”

    Data collection for the study was through 2020. Since then, new statistics show prescriptions for stimulants surged 10% during 2021 across most age groups. At the same time, there has been a nationwide shortage of Adderall, one of the most popular ADHD drugs, leaving many patients unable to fill or refill their prescriptions.

    The stakes are high: Taking stimulant medications improperly over time can result in stimulant use disorder, which can lead to anxiety, depression, psychosis and seizures, experts say.

    If overused or combined with alcohol or other drugs, there can be sudden health consequences. Side effects can include “paranoia, dangerously high body temperatures, and an irregular heartbeat, especially if stimulants are taken in large doses or in ways other than swallowing a pill,” according to the Substance Abuse and Mental Health Services Administration.

    Research has also shown people who misuse ADHD medications are highly likely to have multiple substance use disorders.

    Abuse of stimulant drugs has grown over the past two decades, experts say, as more adolescents are diagnosed and prescribed those medications — studies have shown 1 in every 9 high school seniors report taking stimulant therapy for ADHD, McCabe said.

    For children with ADHD who use their medications appropriately, stimulants can be effective treatment. They are “protective for the health of a child,” Camenga said. “Those adolescents diagnosed and treated correctly and monitored do very well — they have a lower risk of new mental health problems or new substance use disorders.”

    The solution to the problem of stimulant misuse among middle and high school teens isn’t to limit use of the medications for the children who really need them, McCabe stressed.

    “Instead, we need to look very long and hard at school strategies that are more or less effective in curbing stimulant medication misuse,” he said. “Parents can make sure the schools their kids attend have safe storage for medication and strict dispensing policies. And ask about prevalence of misuse — that data is available for every school.”

    Families can also help by talking to their children about how to handle peers who approach them wanting a pill or two to party or pull an all-night study session, he added.

    “You’d be surprised how many kids do not know what to say,” McCabe said. “Parents can role-play with their kids to give them options on what to say so they are ready when it happens.”

    Parents and guardians should always store controlled medications in a lockbox, and should not be afraid to count pills and stay on top of early refills, he added.

    “Finally, if parents suspect any type of misuse, they should contact their child’s prescriber right away,” McCabe said. “That child should be screened and assessed immediately.”

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  • Opinion: Mifepristone saved my life | CNN

    Opinion: Mifepristone saved my life | CNN

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    Editor’s Note: Roxanne Jones, a founding editor of ESPN The Magazine and former vice president at ESPN, has been a producer, reporter and editor at the New York Daily News and The Philadelphia Inquirer. Jones is co-author of “Say it Loud: An Illustrated History of the Black Athlete.” She talks politics, sports and culture weekly on Philadelphia’s 900AM WURD. The views expressed here are solely hers. Read more opinion on CNN.



    CNN
     — 

    The ruling earlier this month by a Texas federal judge to suspend the US Food and Drug Administration’s approval of a drug that is used frequently for medication abortions, is very personal for me.

    That’s because I took mifepristone years ago during a miscarriage, and it saved my life.

    When I was prescribed mifepristone, it had not yet taken center stage in America’s abortion wars. I did not have to make a rushed road trip across state lines to get my medicine, unlike many women who need the drug but live in one of the many states that have restricted access to medication abortion or passed near-total bans on abortion.

    I was not forced to set up a secret meet-up with a stranger in order to buy my medicine on the black market, as several women I spoke to recently said they planned to do. Nor did I have to order mifepristone online and find myself navigating the many scammers taking advantage of the current patchwork of state abortion laws in the US.

    Mifepristone is one of two drugs used in a medication abortion and the other, misoprostol, was not subject to the ruling by the Texas judge. The two drugs can be administered to someone having a miscarriage, allowing them to terminate the pregnancy when the fetus is not viable.

    It happened some years ago: After experiencing more than a day of hemorrhaging during the first trimester of my pregnancy, I visited my ob-gyn, who explained after examining me that my blood pressure was dropping rapidly and the heavy bleeding I was experiencing was an unmistakable sign of a miscarriage.

    For many women, being prescribed mifepristone is part of their routine medical care. Not so in my case: As my doctor explained, I was facing a dire medical emergency. I was grateful for the medication that saved my life.

    My miscarriage took me by surprise. I had loved being pregnant the first time around, about a decade earlier. And as a healthy woman, I had no reason for fear when I became pregnant again. By the time I was administered mifepristone, I was losing a life that I had already begun to love. And like many other women, despite my level of education or economic status, I could not outrun the statistics that put Black women at higher risk.

    Up to one in four known pregnancies will end in a miscarriage. And for Black women, the numbers are alarmingly higher. According to an analysis of 4.6 million pregnancies in seven countries, the risk of a miscarriage for Black women is 43% higher than for White women.

    In the Black community, women have traditionally been taught to bear their burdens silently — keep your business to yourself — even after something as devastating as pregnancy loss. We are conditioned to do as I did back then, and keep it moving as we try to outrun the long list of statistics that tell us our lives are in danger from every direction, whether it be from health care risks to societal injustices or other stressors.

    During my miscarriage, I was a woman who was afraid, hemorrhaging and in excruciating pain, in desperate need of safe, emergency medical care. Thanks to the administration of mifepristone, I was allowed dignity during my miscarriage. It’s what every woman deserves — whether it be facing a potentially life-threatening miscarriage or seeking an abortion.

    I learned from my experience that every miscarriage matters. Women must have access to whatever medicines and counseling we need to help us heal and that includes mifepristone. What we don’t need is to be criminalized by politicians and punitive reproductive laws that have long been out of step with public opinion. Despite the continuing political attacks on women’s reproductive rights, more than 61% of US adults say abortion should be legal in all or most cases, according to Pew Research Center.

    After the US Justice Department asked the Supreme Court to intervene, Justice Samuel Alito issued a temporary order to preserve the status quo, ensuring access to the drug while giving the justices more time to study the issue.

    I am hoping the justices can put politics aside and focus on the science surrounding the safety of mifepristone, a drug that, thankfully, I had access to when my life was in danger. Mifepristone, a synthetic steroid, is even safer than common prescription drugs including penicillin and Viagra.

    Following the science demands that, regardless of where you stand on the issue of abortion, consideration must be made for cases like mine and the millions of other women who for years have safely used this medication for complications surrounding miscarriages.

    We do not know how the legal fight over medication abortion will unfold. But women across the nation – in blue and red states alike – are watching. Punitive laws like the one signed last week by Florida Gov. Ron DeSantis seek to criminalize reproductive care providers. And worse, they are stripping us of rights that men take for granted – it’s unlikely they will be prohibited by the law from making health care decisions about their own bodies.

    It must end. And I’m betting that whether it be with our voice or our votes, women will have the last word.

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  • Biden administration declares fentanyl laced with xylazine ‘an emerging threat’ in the US | CNN

    Biden administration declares fentanyl laced with xylazine ‘an emerging threat’ in the US | CNN

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    CNN
     — 

    The White House has declared that the powerful synthetic opioid fentanyl combined with xylazine – an animal tranquilizer that’s increasingly being used in illicit drugs – is an “emerging threat” facing the United States due to its role in the ongoing opioid crisis.

    Administration officials call the threat FAAX, for fentanyl-adulterated or -associated xylazine.

    The move, announced Wednesday, marks the first time in history that any administration has declared a substance to be an emerging threat to the country, said Dr. Rahul Gupta, director of the Office of National Drug Control Policy. The SUPPORT Act of 2018 established that the office has authority to declare such “emerging threats,” and no administration has used it until now. Last year, Congress declared methamphetamine an emerging drug threat but none have been declared by an administration previously. Under other agencies or in separate circumstances, concerns such as bioterrorism, infectious diseases or climate change may be identified as “emerging threats.”

    “This drug, which is an animal sedative, is being mixed with fentanyl and is being found in almost all 50 states now,” Gupta said Tuesday. “It’s become an important part for us to make sure that we’re declaring it an emerging threat.”

    Now that the administration has declared fentanyl combined with xylazine an emerging threat, it has 90 days to coordinate a national response. “We are working quickly to develop and implement a whole of government nationwide plan, with real deliverable action, that will save lives and will be published within 90 days of this designation,” Gupta said.

    Xylazine, also known as tranq or tranq dope, has been linked to an increasing number of overdose deaths in the United States due to its rising illicit use. Between 2020 and 2021, overdose deaths involving xylazine increased more than 1,000% in the South, 750% in the West and about 500% in the Midwest, according to an intelligence report released last year by the US Drug Enforcement Administration.

    And in some cases, people might not even know that xylazine was in the drug they used.

    Just last month, authorities at the DEA issued a public safety alert about the “widespread threat” of fentanyl mixed with xylazine, reporting that in 2022 approximately 23% of fentanyl powder and 7% of fentanyl pills seized by the DEA contained xylazine.

    Fentanyl, which has been driving the opioid crisis, is a fast-acting opioid, and people who use it illicitly say that adding xylazine can extend the duration of the high the drug provides.

    Xylazine is not an opioid. It is approved by the US Food and Drug Administration for use as a tranquilizer in veterinary medicine, typically in horses, but it is not approved for use in humans. And xylazine can do major damage to the human body, including leaving drug users with severe skin ulcers, soft-tissue wounds and necrosis – sometimes described as rotting skin – that can lead to amputation.

    “Xylazine is one of the contaminants in fentanyl, but there could be others,” Gupta said. “So, I think with the declaration of an emerging threat, we’re sending a clear message to producers and traffickers of illicit xylazine and illicit fentanyl that we’re going to respond quicker, we’re going to match the challenge of evolution of these drugs supply, and that we’re going to protect lives first and foremost.”

    Now that xylazine has been declared an emerging threat, some of President Biden’s $46 billion drug budget request to Congress can be used to respond.

    This year, the Biden administration announced that the President has called on Congress to invest $46.1 billion for agencies overseen by the Office of National Drug Control Policy to tackle the nation’s illicit drug crisis.

    If the budget request is not approved, there could be the option to reallocate money within the Office of National Drug Control Policy, but “we don’t want to be in a position where moneys that are being utilized for some other important aspect of saving lives has to be moved away for this purpose,” Gupta said Tuesday. “That is the reason we are asking Congress to act.”

    Such funds could be used to test drugs on the street for xylazine, collect data on FAAX, invest in care for people exposed to FAAX and develop potential treatments for a xylazine-related overdose.

    The medication naloxone, also known as Narcan, is an antidote for an opioid overdose, but people who have overdosed on a combination of opioids and xylazine may not immediately wake up after taking naloxone, as it may not reverse the effects of xylazine in the same way it does opioids.

    “We need to recognize, first of all, that there is a shift that is occurring from organic compounds and substances like heroin and cocaine to more synthetics,” Gupta said of the state of the nation’s illicit drug crisis.

    “Both the types of drugs have changed – from predominantly organic to predominantly synthetics – but the way drugs are bought and sold have also changed,” he said. “Now, all you need is a phone in the palm of your hand and a social media app to order and buy some of the most dangerous substances on planet Earth.”

    Xylazine is just one of the many adulterants – or substances that are typically added to others – found in the nation’s illicit drug supply.

    “All of a sudden, you can synthesize hundreds of compounds and kind of mix them together and see what does the best in the market,” Joseph Friedman, a researcher at the University of California, Los Angeles, told CNN in March. “People are synthesizing new benzodiazepines, new stimulants, new cannabinoids constantly and adding them into the drug supply. So people have no idea what they’re buying and what they’re consuming.”

    Some of these adulterants may be as simple as sugar or artificial sweeteners added for taste or additives or fillers that bulk up the drug. Sometimes, they may be contaminants left over from the manufacturing process.

    But all of these things can carry real-life health harms, says Naburan Dasgupta, an epidemiologist and senior scientist at the Gillings School of Global Public Health at the University of North Carolina, Chapel Hill.

    Like an opioid, xylazine can depress the respiratory system, so the risk of overdose multiplies when it’s combined with heroin or fentanyl.

    Also, “in the veterinary literature, we know that it causes a really bad severe form of anemia. And so when people are injecting heroin that’s contaminated with xylazine, they can end up with a near-fatal form of blood iron deficiency,” Dasgupta said in March. “We had one person here who ended up going to the hospital needing multiple blood transfusions. And it was all because of the xylazine.”

    US lawmakers are moving to classify xylazine as a controlled substance.

    In March, bipartisan legislation – the Combating Illicit Xylazine Act – was introduced in the House and Senate. It describes illicit xylazine as an “urgent threat to public health and safety” and calls for it to be a Schedule III drug under the Controlled Substances Act, a category on the five-level system for substances with moderate to low potential for physical or psychological dependence. Xylazine would be one level below opioids like fentanyl.

    “Our bipartisan bill would take important steps to combat the abuse of xylazine by giving law enforcement more authority to crack down on the illicit distribution of this drug, including by putting stiffer penalties on criminals who are spreading this drug to our communities,” Sen. Maggie Hassan, D-N.H., said in a statement in March.

    The bill would also require manufacturers to send reports on production and distribution to the DEA so the agency can ensure that the product is not being diverted to the black market.

    “This bill recognizes the dangers posed by the increasing abuse of animal tranquilizers by drug traffickers, and provides new tools to combat this deadly trend,” Sen. Chuck Grassley, R-Iowa, said in the statement.

    “It also ensures that folks like veterinarians, ranchers and cattlemen can continue to access these drugs for bona fide animal treatment.”

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  • Rival rulings on medication abortion hypercharge the post-Roe legal war | CNN Politics

    Rival rulings on medication abortion hypercharge the post-Roe legal war | CNN Politics

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    CNN
     — 

    A pair of conflicting federal court rulings on Friday created arguably the most contentious and chaotic legal flashpoint over abortion access since the Supreme Court’s ruling last summer that overturned Roe v. Wade and ended the right to an abortion nationwide.

    Within less than an hour, two major rulings came down in separate, closely watched cases concerning medication abortion – in lawsuits that are completely at odds with each other.

    In one case, filed by anti-abortion activists in Texas, a judge said the FDA’s 2000 approval of mifepristone – one of the drugs used to terminate a pregnancy – should be halted. But the court paused its ruling for a week so that it can be appealed, and that appeal is already under way.

    In the second case, where Democratic-led states had sued in Washington to expand access to abortion pills, a judge ordered the federal government to keep the drug available in the 17 states, plus the District of Columbia, that brought the lawsuit.

    On their face, both cases deal with the administrative law that controls how the US Food and Drug Administration goes about regulating mifepristone. The disputes did not rely directly on the question of whether there is a right to an abortion – the question that was at the center of the Supreme Court’s ruling last June. But tucked in the Texas ruling, by US District Judge Matthew Kacsmaryk, was the idea that embryos could have individual rights that courts can consider in their rulings.

    Both cases emerge from a political environment that was unleashed by the Supreme Court’s Roe v. Wade reversal and a willingness to push the legal envelope that the Supreme Court ruling created. The abortion issue is now on a path back to the Supreme Court, as higher courts are asked to sort out the contradictory commands of Friday night’s decisions.

    Because the Texas judge has paused his ruling, it has no immediate impact on the availability of medication abortion drugs. But the next several days stand to be a dramatic and combustible legal fight over the order – a fight ratcheted up by the rival ruling in Washington.

    Besides pausing his ruling for one week, Kacsmaryk – an appointee of former President Donald Trump who sits in Amarillo, Texas – seemed to hold nothing back as he ripped apart the FDA’s approval of mifepristone and embraced wholeheartedly the challengers’ arguments the drug’s risks weren’t adequately considered.

    Kacsmaryk, whose anti-abortion advocacy before joining the federal bench was documented by a recent Washington Post profile, showed a striking hostility to medication abortion, which is the method used in a majority of the abortions in the United States.

    Leading medical organizations have already condemned his opinion and pushed back at the judge’s analysis of the safety of medication abortion.

    The judge said that the FDA failed to consider “the intense psychological trauma and post-traumatic stress women often experience from chemical abortion,” in what was a repeated invocation of “chemical abortion,” the term preferred by abortion opponents. Kacsmaryk suggested that the FDA’s data was downplaying the frequency with which the drug being mistakenly administered to someone who had an ectopic pregnancy, i.e. a pregnancy outside the cavity of the uterus. He repeated the challengers’ accusations that the FDA’s approval process had been the subject of improper political pressure.

    He said the FDA’s refusal to impose certain restrictions on the drug’s use “resulted in many deaths and many more severe or life-threatening adverse reactions.”

    “Whatever the numbers are, they likely would be considerably lower had FDA not acquiesced to the pressure to increase access to chemical abortion at the expense of women’s safety,” he said.

    Jack Resneck Jr., the president of the American Medical Association, said in a statement that Kacsmaryk’s ruling “flies in the face of science and evidence and threatens to upend access to a safe and effective drug.”

    “The court’s disregard for well-established scientific facts in favor of speculative allegations and ideological assertions will cause harm to our patients and undermines the health of the nation,” the AMA president said.

    Kacsmaryk’s opinion paid no heed to the argument made by the FDA’s defenders that cutting off access to medication abortion would put the health of pregnant people at risk and that it would force abortion seekers to terminate their pregnancies through a surgical procedure instead.

    Instead, the judge wrote that a ruling in the challengers’ favor would ensure “that women and girls are protected from unnecessary harm and that Defendants do not disregard federal law.”

    As he explained why the preliminary injunction – which was being handed down before the case could proceed to a trial – was justified, he said that embryos had their own rights that could be part of the analysis. That assertion goes farther than what the Supreme Court said in its June ruling, known as Dobbs v. Jackson Women’s Health.

    “Parenthetically, said ‘individual justice’ and ‘irreparable injury’ analysis also arguably applies to the unborn humans extinguished by mifepristone — especially in the post-Dobbs era,” Kacsmaryk said Friday.

    Whereas Kacsmaryk had been asked by the challengers in Texas to block medication abortion, US District Judge Thomas Owen Rice, who sits in Spokane, Washington, was considering whether abortion pills should be easier to obtain.

    Rice, an Obama appointee, granted the Democratic attorneys general who brought the lawsuit a partial win.

    They had asked Rice to remove certain restrictions – known as REMS or Risk Evaluation and Mitigation Strategy – the FDA has imposed on mifepristone, with the blue states arguing the drug was safe and effective enough to make those restrictions unnecessary.

    While Rice is rejecting that bid for now, he granted a request the states also made that the FDA be ordered to keep the drugs on the market. But Rice’s ruling only applies in the 17 plaintiff states and the District of Columbia.

    His decision maintains the status quo for the availability of abortion pills in those places and he specifically is blocking the agency from “altering the status quo and rights as it relates to the availability of Mifepristone under the current operative January 2023 Risk Evaluation and Mitigation Strategy.”

    Rice’s opinion was a striking split screen to Kacmsaryk’s. While the Texas judge said the FDA did not adequately take into account the drug risks, Rice showed sympathy to the arguments that the rules for mifepristone’s use were too strict and that the agency should be taking a more lenient approach to how the abortion pill is regulated.

    Ultimately, he said he would not grant the Democratic states’ request that he remove some of the drug restrictions at this preliminary stage in the proceedings, because that would go well beyond maintaining the status quo while the case advances. He noted that if he had granted that request, it would also undo a new FDA rule that allows pharmacies to dispense abortion pills. That would reduce its availability and would run “directly counter to Plaintiffs’ request.”

    If Kacsmaryk’s ruling halting mifepristone’s approval is allowed to go into effect, it will run headlong into Rice’s order that mifepristone remain available in several states. Kacsmaryk’s ruling is a nationwide injunction.

    The Justice Department and Danco, a mifepristone manufacturer that intervened in the case to defend the approval, both filed notices of appeal. Both Attorney General Merrick Garland and Danco said in statements that in addition to the appeals, they will seek “stays” of the ruling, meaning emergency requests that the decision is frozen while the appeal moves forward.

    They’re appealing to the US 5th Circuit Court of Appeals, which is sometimes said to be the country’s most conservative appeals court. Yet some legal scholars were skeptical that the 5th Circuit, as conservative as it is, would let Kacmsaryk’s order take effect.

    Washington, where the blue states’ lawsuit was filed, is covered under the 9th Circuit, a liberal appellate court. But it’s unclear if the ruling from Rice will be appealed. Garland said the Justice Department was still reviewing the decision out of Washington. A so-called circuit split would increase the odds that the Supreme Court would intervene. But given how the practical impact of the two district court rulings contradict each other, the Supreme Court may have no choice but to get involved.

    The lawyer for the challengers in the Texas case, anti-abortion medication associations and doctors, said Friday evening that he had not reviewed the Washington decision, so he could not weigh in on how it impacted Kacsmaryk’s order that the drug’s approval be halted.

    “I’m not sure whether there’s a direct conflict yet and with the Washington state decision just because I haven’t read it yet, but there may not be a direct conflict,” Erik Baptist, who is an attorney with Alliance Defending Freedom, said. “But if there is a direct conflict then there may be – it may be inevitably going to the Supreme Court, but I’m not convinced that it’s necessary at this point to make that conclusion.”

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  • Ozempic Is About to Be Old News

    Ozempic Is About to Be Old News

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    All of a sudden, Ozempic is everywhere. The weight-loss drug that it contains, semaglutide, is a potent treatment for obesity, and Hollywood and TikTok celebrities have turned it into a sensation. In just a few months, the medication has been branded as “revolutionary” and “game-changing,” with the power to permanently alter society’s conceptions of fatness and thinness. Certainly, a drug like semaglutide could be all of those things: Never in the history of medicine has one so safely led to such dramatic weight loss in so many people.

    But let’s not get ahead of ourselves. As weight-loss medications go, Ozempic is far from perfect. Though the drug has profound impacts, it requires weekly injections, a tolerance for uncomfortable side effects, and the stamina—not to mention the budget—for long-term treatment. (Ozempic has somehow become a catchall term for semaglutide but technically that product has gotten FDA sign-off only as a diabetes medication. A larger dose of semaglutide, marketed as Wegovy, has been approved for weight loss.)

    Made by the Danish drugmaker Novo Nordisk, semaglutide dominates the U.S. weight-loss market right now, but its reign might be short-lived. The colossal demand for these drugs has spurred a competition in the pharmaceutical industry to develop even more potent and powerful medications. The first of them could become available as soon as this summer. For all its hype, semaglutide is the stepping stone and not the final destination of a new class of obesity drugs. Just how good they get, and how quickly, will go a long way in determining whether this pharmaceutical revolution actually meets its full promise.

    In a sense, semaglutide hardly represents a major step forward in science. Diet drugs are nothing new, and even the category of pharmaceuticals that these new products belong to, called “GLP-1 agonists,” has been around for several years. These drugs mimic the hormone GLP-1 (glucagon-like peptide one) and bind to its receptor in the body. This triggers a sense of fullness associated with having just eaten, and also slows the release of food from the stomach. (It also increases insulin secretion, keeping blood sugar in check, which is why Ozempic is still intended as a diabetes drug.) Already, these pharmaceuticals have gotten better over time: A daily injection called liraglutide and sold as Saxenda, which was approved by the FDA in 2014 for obesity, leads to the loss of 5 to 10 percent of a person’s body weight in most cases. But one reason semaglutide took off in a way that liraglutide didn’t is that it can lead to weight loss of up to 20 percent. “Now you have a shot that’s once a week instead of every day, you’re making dramatic improvements, and people notice more,” Angela Fitch, the president of the Obesity Medicine Association and the chief medical officer of the obesity-care start-up Knownwell, told me.

    But not everyone who takes these drugs can achieve that level of weight loss. More than 60 percent of those on Wegovy experience smaller changes, in part because the drug can’t account for the complex drivers of obesity that aren’t related to food. The next generation of drugs is reaching for more. The first leap forward is Mounjaro, known generically as tirzepatide, a diabetes drug from Eli Lilly that the FDA is expected to approve for weight loss this year. In one study, it led to 20 percent or more weight loss in up to 57 percent of people who took the highest dose; The Wall Street Journal recently called it the “King Kong” of weight-loss drugs. People on Mounjaro tend to lose more weight more quickly and generally have a “better experience” than those on Wegovy, Keith Tapper, a biotech analyst at BMO Capital Markets, told me. It’s also cheaper, though by no means cheap, at roughly $980 for the highest-dose option, he said; a dose of Wegovy costs about $1,350.

    These leaps in potency are happening on the molecular level. Like semaglutide, Mounjaro mimics the effects of GLP-1, but it also hits receptors for another hormone—GIP. That leads to even more weight loss by further attenuating focus on food and potentially also increasing the activity of a fat-burning enzyme, said Tapper. So-called dual-agonist drugs “offer a step change” in both weight loss and blood-sugar control, he added.

    And why stop at two receptors when so many others are involved in regulating hunger? “This area is exploding in terms of research and testing different combinations of hormones,” which are still poorly understood, Shauna Levy, a professor specializing in bariatric surgery at Tulane University School of Medicine, told me. Eli Lilly has another drug in the works that targets three receptors; one from the drugmaker Amgen works by “putting the brakes” on the GIP receptor and “putting the gas” on GLP-1’s, a company spokesperson told me. Several other companies have already joined what some have dubbed a “race” to develop the next great obesity drug, in which Lilly, Pfizer, Amgen, Structure Therapeutics, and Viking Therapeutics are expected to be the front-runners, said Tapper.

    The potency of weight-less drugs is not the only factor that will determine the shape of their future trajectory. Wegovy and Mounjaro injections are tolerable for most people, but they are less convenient than a pill. Making oral versions of these drugs isn’t as easy as packing everything into a capsule, though. Semaglutide is a molecule that gets chewed up in the stomach. For this reason, the semaglutide pill Rybelsus, which is already approved for diabetes, leads to far less dramatic weight loss than its injectable kin. But drugmakers are undeterred by this complication, because a pill even more powerful than semaglutide would no doubt have many customers. In January, Pfizer’s CEO Albert Bourla said that an oral weight-loss drug “unlocks the market,” which he estimated could eventually be worth $90 billion. Pfizer doesn’t have any weight-loss drugs yet but is developing a twice-daily GLP-1 agonist pill; Eli Lilly also has an oral version in the works. Tapper expects those drugs to become available in 2026, and a similar offering from Structure Therapeutics is likely to follow the next year.

    Drugmakers will also likely vie to create drugs with fewer side effects. Novo Nordisk notes that gastrointestinal issues are common with semaglutide; accounts of horrible nausea, constipation, and vomiting have proliferated online. As one actor put it to New York Magazine, people on Ozempic are “shitting their brains out.” With Wegovy, more serious issues, such as pancreatitis, thyroid cancer, and kidney failure, are also possible but are considered rare. Although nothing to scoff at, side effects tend to subside with prolonged treatment and can usually be managed with help from a doctor, said both Fitch and Levy, who regularly prescribe semaglutide to patients with obesity. It’s possible, Levy added, that people experiencing really terrible effects may be getting their drugs from shady compounding pharmacies or even from other countries.

    The fact that people are turning to sketchy outlets to get weight-loss drugs underscores the biggest issue with them: access. Medicare and most private insurance companies don’t cover anti-obesity drugs. (Such drugs are classified as “cosmetic” by the Centers for Medicare and Medicaid Services, and thus don’t qualify for coverage.) “I am hopeful that the price will come down with more competition,” Fitch told me. But there’s no guarantee that will happen: Competition typically makes a product cheaper over time, but research suggests that isn’t always the case in pharmaceuticals. Even if the drugs do become cheaper, they may not become cheap enough. The oral forms of these drugs, some of which could be available by 2026, are expected to cost about $500 a month, Tapper said. By 2030, the cost of obesity drugs could come down to about $350 a month, according to a recent Morgan Stanley analysis, which would still be out of reach for many Americans.

    Levy estimates that the next five years will bring about a “huge explosion” of next-gen obesity drugs. In that case, the market will likely expand to accommodate a variety of drugs with different price points and efficacies. Some people may aim to lose 20 or more percent of their body weight; some may be content with less. The market is so diverse that it will likely “support a broad range of options,” said Tapper, such as cheaper, lower-dose oral drugs for people who have milder medical issues, and more expensive injectables for those with more severe medical concerns. That opens up the possibility that medically mediated weight loss could soon be an option for a far greater proportion of people.

    Regardless of how much these drugs’ costs may decrease, they will always add up if people are paying out of pocket for them. They are meant to be taken long term: Once a person stops taking Wegovy, the weight tends to come right back. The current crop of weight-loss medications are essentially maintenance drugs, much like the cholesterol-busting drug Lipitor, which is taken daily to treat long-term disease. But Lipitor, unlike obesity drugs, is generally covered by insurance. Unless obesity drugs receive the same kind of coverage, no level of improvement will lead them to deliver on what Ozempic is promising us now.

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  • WHO advisers to consider whether obesity medication should be added to Essential Medicines List | CNN

    WHO advisers to consider whether obesity medication should be added to Essential Medicines List | CNN

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    CNN
     — 

    Advisers to the World Health Organization will consider next month whether to add liraglutide, the active ingredient in certain diabetes and obesity medications, to its list of essential medicines.

    The list, which is updated every two years, includes medicines “that satisfy the priority health needs of the population,” WHO says. “They are intended to be available within the context of function health systems at all times, in adequate amounts in the appropriate dosage forms, of assured quality and at prices that individuals and the community can afford.”

    The list is “a guide for the development and updating of national and institutional essential medicine lists to support the procurement and supply of medicines in the public sector, medicines reimbursement schemes, medicine donations, and local medicine production.”

    The WHO Expert Committee on the Selection and Use of Essential Medicines is scheduled to meet April 24-28 to discuss revisions and updates involving dozens of medications. The request to add GLP-1 receptor agonists such as liraglutide came from four researchers at US institutions including Yale University and Brigham and Women’s Hospital.

    These drugs mimic the effects of an appetite-regulating hormone, GLP-1, and stimulate the release of insulin. This helps lower blood sugar and slows the passage of food through the gut. Liraglutide was developed to treat diabetes but approved in the US as a weight-loss treatment in 2014; its more potent cousin, semaglutide, has been approved for diabetes since 2017 and as an obesity treatment in 2021.

    The latter use has become well-known thanks to promotions from celebrities and on social media. It’s sold under the name Ozempic for diabetes and Wegovy for weight loss. Studies suggest that semaglutide may help people lose an average of 10% to 15% of their starting weight – significantly more than with other medications. But because of this high demand, some versions of the medication have been in shortage in the US since the middle of last year.

    The US patent on liraglutide is set to expire this year, and drugmaker Novo Nordisk says generic versions could be available in June 2024.

    The company has not been involved in the application to WHO, it said in a statement, but “we welcome the WHO review and look forward to the readout and decision.”

    “At present, there are no medications included in the [Essential Medicines List] that specifically target weight loss for the global burden of obesity,” the researchers wrote in their request to WHO. “At this time, the EML includes mineral supplements for nutritional deficiencies yet it is also described that most of the population live in ‘countries where overweight and obesity kills more people than underweight.’ “

    WHO’s advisers will make recommendations on which drugs should be included in this year’s list, expected to come in September.

    “This particular drug has a certain history, but the use of it probably has not been long enough to be able to see it on the Essential Medicines List,” Dr. Francesco Blanca, WHO director for nutrition and food safety, said at a briefing Wednesday. “There’s also issues related to the cost of the treatment. At the same time, WHO is looking at the use of drugs to reduce weight excess in the context of a systematic review for guidelines for children and adolescents. So we believe that it is a work in progress, but we’ll see what the Essential Medicines List committee is going to conclude.”

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  • The US sanctioned Chinese companies to fight illicit fentanyl. But the drug’s ingredients keep coming | CNN

    The US sanctioned Chinese companies to fight illicit fentanyl. But the drug’s ingredients keep coming | CNN

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    CNN
     — 

    The seller, who went by the name Linda Wang, was curt when asked if she sold a chemical often used to create fentanyl.

    “That’s banned,” Wang replied, before quickly providing an alternative: “CAS79099 powder is best. U can have a try.” 

    After more than a week of back and forth, she seemed impatient. “Ok. 79099 powder in USA warehouse now…if you need. Pls order asap,” she wrote in a text message exchange.

    The interaction is part of a CNN investigation that explored whether US-sanctioned chemical companies in China are evading Washington DC’s crackdown on illicitly made fentanyl – finding at least one China-based company that had links to a sanctioned entity, and a seller eager to ship potential ingredients for the lethal drug.

    More than 100,000 Americans died from drug overdoses in 2021, and two-thirds of the fatalities involved synthetic opioids – much of it believed from illicitly made fentanyl, according to the Centers for Disease Control.

    The drug can be 50 times stronger than heroin and 100 times stronger than morphine – and pharmaceutical grade versions of it can be prescribed by doctors for severe pain. But illegally manufactured fentanyl has turbocharged the US’s opioid overdose crisis in the last decade, according to data from the CDC.

    Controlling the illegal trade of the drug has turned into a geopolitical headache for the Biden administration, as China’s vast chemicals market – which supplies the world with raw materials for everything from perfume to explosives– is also a major pipeline of the building blocks of fentanyl, known as fentanyl precursors, according to US officials. 

    Further complicating the fight against fentanyl is the sheer variety of precursors that can be used to make fentanyl and other illicit drugs. Most such precursors also have legitimate uses – including for medical research – and are perfectly legal to sell, making up part of the booming transnational trade.

    China has strict anti-drug policies domestically, but critics in the US say it is not doing enough to help monitor or regulate purchases from buyers aiming to use Chinese-made ingredients to manufacture illegal drugs overseas.

    In 2019, Beijing stepped up its crack down on the production and sale of finished fentanyl and its variants, but US-China anti-drug cooperation has since stalled amid disagreements on trade, human rights, the Covid-19 outbreak and Taiwan. Hopes that US Secretary of State Antony Blinken would bring up fentanyl during a planned visit to Beijing died in early February, when Blinken postponed his trip after a surveillance balloon from China floated over the continental US. 

    As the opioid crisis topped the domestic agenda in 2021, the US sanctioned four companies in China accused of exporting fentanyl or fentanyl precursor chemicals. Online commercial records suggest ties between one of those sanctioned companies, Hebei Atun Trading Co., Ltd., and another China-based company called Shanxi Naipu Import and Export Co., Ltd., that continues to sell fentanyl precursors legally.

    According to official public records in China, Hebei Atun Trading Co., Ltd., began liquidating in June 2021 and was formally dissolved in August that year. Shanxi Naipu Import and Export Co., Ltd. was registered in the same period, according to official records, and it shares a number of key things in common with Hebei Atun.

    For example, Hebei Atun’s still-active Facebook page once linked to a now-defunct website of Shanxi Naipu – which is where CNN found Wang’s phone number.

    The two companies’ websites are registered to the same email address, and at one time appeared to share an IP address. Today, Shanxi Naipu’s websites appear to be carbon copies of Hebei Atun’s since-deleted page – with the same navigation tabs, email address and stock photo of a pipette dropping amber-colored liquid into a cell tray. The Russian and Portuguese versions of the site list “Hebei Atun Trading Co. Ltd.” as their copyright holder.

    One post on a Shanxi Naipu website was titled, “Hebei ATUN Trading Co., Ltd. Wishes you a Happy New Year!” (sic). It has since been deleted. 

    When presented with CNN’s findings, Shanxi Naipu denied ties to Hebei Atun, saying, “we are not related at all.” In statements emailed to CNN, Shanxi Naipu said it had purchased the sanctioned company’s Facebook account, email and cell phone number in order to “attract internet traffic.”

    Shanxi Naipu also denied selling the fentanyl precursor that Wang offered by text, and stressed that everything they sell is legal, and said that they were taking steps to stop the repercussions from the apparent links to Hebei Atun.

    “To prevent further impact from Hebei Atun, we have immediately removed relevant promotional websites and platforms,” the company said in an emailed statement.”

    Logan Pauley, a China analyst who tracks criminal and drug networks, told CNN, “It’s easy on the Chinese side to start a new company to copy and paste the same text that you’re posting on social media or you’re posting on a trade website, and then just to recreate the same operation over and over again.”

    And Gary Hufbauer, trade expert at the Peterson Institute for International Economics and former US treasury official, likens it to a game of cat-and-mouse. While the US government can add an entity to its sanctions list “overnight,” said Hufbauer, there may not be the resources in the US Treasury’s Office of Foreign Assets Control, which enforces sanctions, to keep tabs on new companies that may leverage sanctioned companies’ branding or operations. 

    In a statement to CNN, a spokesperson for the US Treasury said it “had not hesitated” to go after “bad actors” – citing the four sanctioned Chinese companies – and would continue to sanction companies and individuals involved in the drug trade.

    “Treasury continues to monitor the effects of our designations,” they said. “If additional information becomes available that can assist sanctions compliance efforts, when appropriate, we provide that information to industry and/or the public.”

    Asked if Beijing was knowingly lax in its efforts to stem the flow of precursor chemicals from its country, the Chinese Foreign Ministry pointed out that most were not controlled substances, in a lengthy statement that also questioned US efforts to treat addiction and demand for opioids.

    “China has always strictly controlled precursor chemicals in accordance with international conventions and domestic laws. The US side’s so-called ‘fentanyl precursors,’ a small number of them are listed substances by the United Nations, and China has always been resolute in implementing the listed measures. But most of the rest are common chemicals that are not listed by the United Nations, China or even the United States itself,” it said in a written statement to CNN.

    “Government departments do not have the right or the possibility to regulate non-listed chemicals and common commodities,” it added.

    The ministry statement went on to highlight China’s harsh domestic penalties on drug trade and consumption. “The Chinese people deeply resent drugs. the Opium War was the beginning of China’s modern history of humiliation. The Chinese government has always cracked down on drug crime, and China is a no-go area for international drug dealers.”

     Such unregulated precursors, like the one offered by Wang, are not illegal to sell but can be used in the manufacture of illicit substances like fentanyl, methamphetamine, and cocaine.

    Several precursors used to create fentanyl have been put under international control since 2017, but a savvy chemical engineer can combine legal precursors further up the synthesis chain to make similar compounds.

    “What we have seen illicit chemists doing now is that certain components of the synthesis are now … harder for them to purchase, so what they’re doing now is they’re buying compounds that are structurally very, very similar,” Alexandra Evans, a forensic chemist with the D.C. Department of Forensic Sciences, told CNN from her lab in the US capital.

    Or they can create fentanyl analogues, substitutes that are chemically similar to fentanyl and which has made the crisis more deadly in recent years. One fentanyl analogue was found to be 10,000 times stronger than morphine, according to a 2021 US government report.

    Controlling the stream of chemicals has turned into a deadly game of whack-a-mole – where manufacturers are able to use a variety of precursors to synthesize fentanyl and its analogues faster than either can be identified, banned, or regulated. 

    Many of the building blocks to fentanyl have benign purposes and are legal to buy, but a menu Wang sent of Shanxi Naipu’s chemical products for sale appeared designed to support illegal drug manufacture, according to a synthetic chemist who analyzed the list for CNN. 

    It was “obviously a list curated to help people create illicit drugs,” Lyle Isaacs, a professor in the Department of Chemistry and Biochemistry at the University of Maryland, told CNN of the more than 25 chemical compounds on the menu. 

    At least three compounds on the list could be made into fentanyl, he said. One of the compounds, CAS 79099-07-3, also known as 1-Boc-4-piperidone, was what Wang offered to sell CNN; the other two compounds also have legitimate uses and can be found, for example, in academic laboratories researching future medicines, Isaacs said. 

    Still more compounds on the list appeared to be building blocks for meth, ecstasy, ketamine, and the cutting of cocaine, as well as over-the-counter drugs like paracetamol, a common pain medication that can also be used to cut heroin and other narcotics, he added. 

    Asked about the list, Shanxi Naipu reiterated in its statement to CNN that all products on it are legal in China, stating: “We are not professional chemists but just a trading company. Even though we don’t have an intimate knowledge of the composition and use of thousands of chemicals, we have always strictly ensured the legality of our products!”

    Attempts to contact Wang through the company for comment were not successful, and the company said in its statement that she no longer works for them.

    There are measures that responsible chemical sellers can take to avoid their products being used for illegal drugs.

    Identity checks are a hallmark of reputable sellers, said a former Drug Enforcement Administration (DEA) official. The source spoke to CNN on the condition of anonymity because they were not authorized to speak to the media. To sell non-listed chemicals, a good-faith seller would normally ask a buyer about the intended use of the compound, and whether the buyer had the backing of a company or institution, such as a research organization or university.  

    American buyers of regulated chemicals require licenses from the DEA, depending on how hazardous they are. Reputable sellers may also ask for tax identifications even for chemicals that are not controlled, like precursor materials, the source said.

    At no point in the conversation was Wang aware, nor did she ask for the identities of the CNN reporters speaking to her or what CNN planned on using it for. She even offered a “door to door” precursor delivery service via warehouses in the US or Mexico – locations that CNN has been unable to verify.

    In its statement to CNN, Shanxi Naipu denied that it had warehouses in either country.

    The small quantity of precursor needed to manufacture fentanyl ultimately makes shipments destined for illicit ends hard to catch at the border, points out Martin Raithelhuber, an illicit synthetic drugs expert at the United Nations Office on Drugs and Crime.

    “You have hundreds of thousands of tonnes (of chemicals in a shipment), and you are looking for a few kilograms, which are sufficient to produce a supply of millions of doses (of fentanyl),” he said. 

    Since China banned the production of fentanyl and related substances in 2019, Mexican criminal organizations have largely taken control of the drug’s production and sale, smuggling finished fentanyl to consumers in the US, according to a 2022 report from the Congressional Research Service.

    Mexico is now the source of “the vast majority” of meth, heroin and illicit fentanyl seized in the US, according to the US International Narcotics Control Strategy Report (INCSR) released in March 2023. “In 2022, the United States identified Mexico as the sole significant source of illicit fentanyl and fentanyl analogues significantly affecting the United States,” it reads.

    “Criminal elements, mostly in the People’s Republic of China, ship precursor chemicals to Mexico, where they are used to produce illicit fentanyl,” Dr. Rahul Gupta, director of the White House’s Office of National Drug Control Policy, told the Senate Foreign Relations Committee earlier this year. 

    “The only limit on how much fentanyl they can make is the amount of precursor chemicals they can get,” DEA Administrator Anne Milgram told CNN in early March.

    The Biden administration has taken aim at these groups and in February sanctioned a network of Sinaloa Cartel members and associated entities for their involvement in the fentanyl and methamphetamine trade. 

    Mexico’s law enforcement has also fought the trade, seizing and impounding hundreds of kilos of fentanyl precursors and pills – including a cache of over a million potential fentanyl pills in the Mexican border city of Tijuana on March 13.

    Ultimately, tackling fentanyl requires close coordination between the US, Mexico, and China. Even if countries like Mexico had the best national control measures, international cooperation is needed to understand “which flows are the ones we need to watch or [be] worried about,” Raithelhuber said.

    Former DEA official Matthew Donahue told CNN he would like to see Mexico do more, including cracking down on properties and other assets of those involved in the drug trade.

    But as the US pressures other governments to help slow the flow of illicit fentanyl, relations between the three countries have turned into a three-way blame game.

    Following the kidnapping of four Americans in a Mexican border town by cartel members in early March, US Republicans called for the US military to be allowed to fight cartels and destroy drug labs in Mexico – something Mexican President Andrés Manuel López Obrador called “an offense to the people of Mexico.” 

    “We are not a protectorate of the United States or a colony of the United States. Mexico is a free, independent, sovereign country. We don’t take orders from anyone,” López Obrador said at a news conference on March 9. 

    Washington has also called on Beijing to do more, with the latest US INCSR report describing China’s oversight functions as “poorly staffed and under-resourced to oversee its massive chemical industry.” Though it acknowledges Beijing’s harsh penalties for drug trafficking, the report laments ineffective controls on shipment labeling, customer vetting and pill-making equipment.

    The Ministry of Foreign Affairs’ statement to CNN emphasizes its “stringent” control of listed chemicals that could be used for drug-making and argues that Beijing has “improved” several “regulatory mechanisms such as end-user verification, leakage monitoring, and source backtracking, and has strengthened management of more than 200,000 chemical companies.”

    Both China and Mexico have called on the US to do some soul-searching about demand for illicit fentanyl.

    “US legislators and the authorities there are not doing their job because they are not addressing the causes (of addiction); there are no care programs for young people in the US,” López-Obrador said last week.

    “Using China as a scapegoat will not solve the drug crisis in the United States … ,” the Chinese Foreign Ministry’s statement to CNN read. “We advise the US side to reflect on itself, stop shifting blame, strengthen domestic prescription drug control, enhance publicity on the dangers of drugs, and take practical measures to reduce domestic drug demand.”

    Prescription opioids like oxycodone and hydrocodone – which have a similar chemical structure to heroin and fentanyl – were major contributors to the early opioid crisis in the US. Pharmaceutical giants, notably Purdue Pharma, downplayed the potentially addictive properties of the drugs and incentivized US doctors to prescribe the painkillers. But prescribing was curtailed as overdoses from prescription opioids climbed and now waves of heroin and illicit fentanyl took over, making the crisis far more deadly. 

    Amid the recriminations, fentanyl products continue to pour through US borders and Americans continue to die. 

    To raise awareness of the human toll, the US Drug Enforcement Administration last year created “The Faces of Fentanyl” exhibit at its headquarters in Arlington, Virginia where families can submit a photo of a loved one lost to the fentanyl crisis. So far more than 5,000 photos have been submitted.

    “We can’t be desensitized” to the number of lives lost to drug overdoses,” Donahue, the former DEA official, said. “The pain and suffering that these families are going through. That has got to mean something.” 

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  • 19th century chastity law endangers 21st century abortion medicine | CNN Politics

    19th century chastity law endangers 21st century abortion medicine | CNN Politics

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    A version of this story appears in CNN’s What Matters newsletter. To get it in your inbox, sign up for free here.



    CNN
     — 

    The Wild West of the post-Roe v. Wade legal landscape is focused on a lone federal judge in Amarillo, Texas, who could use a 19th century law to limit access to abortion medication for every American woman.

    The judge, 45-year-old Matthew Kacsmaryk, held a hearing Wednesday about whether he should impose a preliminary injunction that would require the US Food and Drug Administration to withdraw or suspend its approval of the drug, mifepristone, while a larger case progresses.

    Mifepristone is taken along with another drug, misoprostol, as part of the two-step medication abortion process. Misoprostol can be prescribed on its own, but it is considered less effective.

    Kacsmaryk, who sounded open to the idea of restricting access to mifepristone, will have to agree with some or all of these general points raised if he decides to issue an injunction:

    • That doctors who don’t perform abortions and live in Texas, where abortions are already banned, are harmed by abortions conducted elsewhere.
    • That an FDA approval conducted over the course of four years and finalized 23 years ago was so flawed that it should be rescinded.
    • That a single federal judge in Amarillo should do what no federal judge has ever done and unilaterally rescind an FDA approval.
    • That a drug, which studies suggest is on par with ibuprofen in terms of safety, is actually so harmful it should be reconsidered by the FDA.

    CNN’s Tierney Sneed wrote a longer list of takeaways from the hearing, where anti-abortion rights doctors and activist groups teed up their lawsuit in Kacsmaryk’s courtroom to further limit access to abortion care in the US.

    It’s important to note that no matter what Kacsmaryk does, it will be appealed up through the 5th US Circuit Court of Appeals and potentially to the Supreme Court.

    But perhaps the most incredible question Kacsmaryk faces is whether an 1870s chastity law named for an anti-vice crusader, Anthony Comstock, should be resuscitated and applied to the medicine that now accounts for a majority of US abortions.

    Comstock operated the New York Society for the Suppression of Vice and was a special agent of the US Postal Service. He was known for seizing contraband like contraceptives and condoms in the name of rooting out obscenity, according to the New York Historical Society.

    Mary Ziegler, a law professor at the University of California, Davis who has written about the Comstock Act for CNN Opinion, described Comstock as being “obsessed by what he saw as the decaying morals of a country preoccupied with sex.”

    Ziegler writes:

    The law he inspired barred not just the mailing of “obscene books” but also birth control and abortion drugs and devices. In the 19th and early 20th centuries, the Comstock Act was used to prohibit the mailing of many literary classics, from Geoffrey Chaucer’s “The Canterbury Tales” to works by James Joyce and Walt Whitman.

    Comstock himself proudly carried a gun and scoured the mail for cases involving information about abortion or contraception, even if a doctor provided it. By Comstock’s standard, the law was a great success: he claimed to have destroyed 15 tons of books, arrested more than 4,000 people and driven at least 15 people to suicide.

    While Congress has acted to relax elements of the Comstock Act, including to allow the mailing of contraceptives, it is still technically on the books with regard to the mailing of anything that could be used for an abortion.

    During the Covid-19 pandemic, the FDA dropped its requirement that a person obtain mifepristone in person. A prescription is still required.

    In December, the Department of Justice notified the US Postal Service that the Comstock Act did not apply as long as “the sender lacks the intent that the recipient of the drugs will use them unlawfully.”

    The FDA permanently removed the in-person requirement in January, hoping to guarantee more access to the medication after the Supreme Court ended Roe v. Wade last June.

    The group that brought the Texas lawsuit, the Alliance for Hippocratic Medicine, wants to reapply the Comstock Act and restrict the mailing of abortion medication.

    The FDA’s already exhaustive and detailed drug approval process was especially scrutinized for mifepristone, which was more commonly known as part of the RU-486 regimen when it became available to American women at the turn of the century.

    It had been available in Europe for a dozen years before that. Here’s CNN’s report from September 2000.

    That the drug works safely as a means of abortion is not really up for dispute as a medical matter after all that time, according to CNN’s Jen Christensen, who explains more about the medication in this article about mifepristone.

    Another CNN data analysis suggests mifepristone is safer than penicillin and Viagra.

    Mifepristone has a death rate of 0.0005% – five deaths for every 1 million people in the US who used it. Penicillin’s death rate is four times greater. Viagra’s is 10 times greater, according to the analysis by CNN’s Annette Choi and Will Mullery.

    Kacsmaryk had a long history of challenging laws providing greater access to reproductive rights before he became a federal judge. While he has promised to be an impartial judge, every Democrat and one Republican, Sen. Susan Collins of Maine, opposed his nomination in 2019.

    Now Kacsmaryk is the only federal judge at the courthouse in Amarillo, which almost guarantees he hears cases filed there.

    So it may be no coincidence that the group challenging use of mifepristone set up an outpost months before filing its lawsuit. The group is based in Tennessee, but one of the doctors named as a plaintiff in the lawsuit practices near Amarillo.

    However one feels about judicial shopping and whether that happened in this case, the word appears to be out that a conservative judge is alone in Amarillo and open for business.

    According to a CNN profile, Kacsmaryk has also put on hold Biden administration policies related to immigration and overseen cases related to vaccine requirements and gender identity. Last December, he halted a federal program in Texas that allowed minors to get birth control without their parents’ consent.

    That suit regarding the birth control program established in 1970 was brought by a Texas father “raising each of his daughters in accordance with Christian teaching on matters of sexuality,” which he said forbids premarital sex.

    Kacsmaryk agreed, even citing the Catechism of the Catholic Church in his decision to say “contraception (just like abortion) violates traditional tenets of many faiths, including the Christian faith Plaintiff practices.”

    His sister described him to The Washington Post as an anti-abortion rights activist and detailed her own decision to give a child up for adoption rather than seek an abortion.

    “He’s very passionate about the fact that you can’t preach pro-life and do nothing,” Jennifer Griffith told the Post. “We both hold the stance of you have to do something. You can’t not.”

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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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