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Top FDA vaccine regulator abruptly exits post
Top FDA vaccine regulator abruptly exits post

Politico

time30-07-2025

  • Health
  • Politico

Top FDA vaccine regulator abruptly exits post

With help from Lauren Gardner Driving the Day A SURPRISE VACANCY — Dr. Vinay Prasad, the FDA's chief vaccine regulator, departed unexpectedly from his position on Tuesday, POLITICO's David Lim reports. His departure follows recent accusations from conservative activist Laura Loomer that he was a progressive and not aligned with President Donald Trump's agenda. It also comes amid a dispute between the FDA and biopharmaceutical company Sarepta Therapeutics centering around Elevidys, a Duchenne muscular dystrophy treatment that Prasad had publicly criticized before his government service. 'Dr. Prasad did not want to be a distraction to the great work of the FDA in the Trump administration and has decided to return to California and spend more time with his family,' HHS spokesperson Andrew Nixon said in a statement. 'We thank him for his service and the many important reforms he was able to achieve in his time at FDA.' While at the agency, Prasad served as FDA Commissioner Marty Makary's right-hand, playing a prominent role in developing the Trump administration's approach to Covid-19 vaccine policy. He was the director of the Center for Biologics Evaluation and Research and also worked as the FDA's chief medical and scientific officer. Prasad could not be reached for comment Tuesday night. Endpoints News and STAT previously reported the news of Prasad's departure. Prasad, a frequent guest on Makary's FDA podcast, was scheduled to participate in another round of meetings with pharmaceutical and biotech chief executives in New York, Raleigh and Atlanta in the coming weeks with Makary and top drug regulator George Tidmarsh. WELCOME TO WEDNESDAY PULSE. At least 85 people got sick last year after a pizza restaurant mistakenly used THC-infused oil to prepare dough, according to a recent CDC report. Send your tips, scoops and feedback to khooper@ and sgardner@ and follow along @kelhoops and @sophie_gardnerj. At the Agencies DIRECTING A CHANGING CDC — The Senate voted to confirm Susan Monarez as the next CDC director Tuesday, marking an end to the agency's four-month stint without a director or acting head and setting her up to helm an agency that's undergoing a rapid transformation. Over the past several months, the Trump administration has rapidly changed the CDC, terminating thousands of its employees and upending some of its key functions, like the way the agency recommends vaccines. Here are the biggest challenges Monarez will have to navigate over the coming months. — The impact of the reduction in force: In April, around 2,400 CDC employees were told they would be terminated, including scientists, communications officials and entire offices — though a few hundred of those employees have since been rehired. The administration is refocusing the CDC on infectious disease as it sheds much of its personnel working on chronic disease, occupational safety and health equity. The agency also absorbed some other agencies' work, including the Administration for Strategic Preparedness and Response. Implementing those changes — many of which are still up in the air — will now fall to Monarez. — Vaccine choices: In June, HHS Secretary Robert F. Kennedy Jr. overhauled the CDC's vaccine advisory panel, which votes on the immunizations that should be included in the agency's childhood and adult vaccine schedules. Kennedy fired the panel's 17 members and replaced them with eight new picks, with one withdrawing soon after their appointment. Several of Kennedy's choices have histories in the anti-vaccine movement, and the new panel has indicated it plans to revisit the childhood vaccine schedule. Monarez will likely have to approve any changes made by the committee before they become official policy. It's customary for the CDC director to approve such changes, but Kennedy himself could continue to do so. At her confirmation hearing in June, Monarez said she hasn't seen a causal link between vaccines and autism, though she dodged questions about whether she disagrees with any of Kennedy's moves. — Communication challenges: Over her tenure, Monarez will need to find a way to effectively communicate with various sectors of the public who say they have lost trust in the CDC. That could prove especially challenging, as public health experts question Kennedy's influence over the agency and post-pandemic distrust lingers. And some of the agency's key tools for communicating information to the public have also been impacted over the past few months — including the Morbidity and Mortality Weekly Report, the agency's flagship journal. An analysis of the journal's recent publications by MedPage Today found that MMWR has published fewer articles over the past three months compared with the output over the same period in past years. Eye on Insurers A NEW ALZHEIMER'S APPROACH — Nonprofit health insurer EmblemHealth launched a first-of-its-kind lifestyle medicine program Tuesday for patients with early-stage Alzheimer's disease, Kelly reports. The New York-based insurer announced it would cover the program, designed by preventive medicine researcher Dr. Dean Ornish and aimed at enhancing brain health and slowing disease progression through lifestyle modifications. Eligible enrollees who have mild cognitive impairment or early-stage dementia associated with Alzheimer's disease can enroll in the program for free. Why it matters: The new initiative aligns with the Make America Healthy Again agenda that HHS Secretary Robert F. Kennedy Jr. has spearheaded, focusing on targeting the nation's chronic disease crisis through lifestyle habits like healthy eating and regular exercise. It also comes as promising new Alzheimer's drugs have come to the market over the past few years, but some insurers have been reluctant to cover the treatments, given their steep price tag. Background: The program offers biweekly online or in-person classes to provide patients with clinical, emotional and food support, according to a news release from EmblemHealth, which serves more than 2 million people in the New York tristate area and is one of the nation's largest not-for-profit insurers. The services offered include access to 'nutritious, whole food, plant-based meals and snacks' and guidance on preparing the foods at home, getting daily exercise and mitigating stress. On Tuesday, Ornish announced results of a study he conducted on the program, where 26 people participated for 40 weeks and showed 46 percent improvement in 3 in 4 standardized tests — including measures of memory, judgment, problem-solving and in-home functionality. About 38 percent of the participants showed no decline, and 83 percent overall improved or maintained cognition. 'Partnering with a leading insurer such as EmblemHealth provides access to invaluable resources,' said Ornish, founder and president of the nonprofit Preventive Medicine Research Institute in Sausalito, California, in a news release. 'Bringing this program to seniors through a leading physician group and a mature community support system makes it possible to achieve groundbreaking results.' In the courts ALIGNING BEHIND PLANNED PARENTHOOD — Nearly two dozen Democratic-led states filed a lawsuit Tuesday challenging the GOP megabill's provision blocking Medicaid payments to Planned Parenthood affiliates, arguing that lawmakers are trying to force states to violate constitutional protections for free speech, Lauren reports. The suit, filed in federal district court in Massachusetts and led by California Attorney General Rob Bonta, echoes the constitutional arguments Planned Parenthood made in its own challenge to the law, for which a federal judge granted an injunction Monday. The states say the statute — and Congress' and the Trump administration's records of disparaging the nonprofit's abortion-rights advocacy — violates the First Amendment and the Fourteenth Amendment's equal-protection guarantees against government retaliation. The states also argue the provision violates the Constitution's prohibition of bills of attainder, a constitutional concept that blocks legislators from singling out entities for punishment without a trial. 'The President and Congress are implementing a cruel, backdoor abortion ban through this provision, putting their political agendas over people's lives,' Bonta said in a statement. State-specific arguments: The Democratic states' lawyers contend that lawmakers 'conscripted' states into unconstitutionally targeting Planned Parenthood clinics. The law also saddles states with determining which entities with operations across state lines would have to be excluded from Medicaid payments, they said. Why now? Judge Indira Talwani, an Obama appointee to the U.S. District Court in Massachusetts, granted Planned Parenthood's motion for a preliminary injunction Monday, putting the defunding provision on hold as the case moves through the courts. The states acknowledged that development in their Tuesday statement but said they 'remain committed to ensuring full relief.' Some Planned Parenthood clinics lost their Medicaid funding last week after a temporary restraining order expired on July 21, the same day Talwani granted a partial injunction that applied only to the few affiliates that wouldn't be subjected to the defunding provision because they don't provide abortions. At the White House PATIENT DATA PLEDGES — The White House and CMS are expected to announce today that roughly 60 entities in the health care sector will pledge to make patient data more accessible and speed its delivery among patients, clinicians and payers, according to an HHS employee granted anonymity to discuss the sensitive plans, POLITICO's Ruth Reader reports. The agency hopes the commitments will stoke companies to make it easier for patients to import their data into an app of their choice, where they can manage their day-to-day health and easily share their history with doctors. Pledges, not rules: The Trump administration has sought such commitments to compel the industry to make changes without having to engage in a lengthy rulemaking or guidance process. But the federal government has tried similar tactics in the past. In 2016, the then-secretary of the Department of Health and Human Services, Sylvia Burwell, under President Barack Obama announced at a health IT conference that dozens of health industry organizations would commit to easing the flow of health information to patients. Nearly 10 years later, those voluntary commitments haven't materialized into better data access. Still, the Trump administration thinks it can appeal to the private sector more effectively. Names in the News Andi Lipstein Fristedt is now executive vice president, chief strategy and policy officer at the Parkinson's Foundation. She previously was deputy director and chief strategy officer at the CDC. WHAT WE'RE READING STAT's Chelsea Cirruzzo reports that HHS is vetting potential new members for the U.S. Preventive Services Task Force, the federal advisory panel that recommends which preventive services insurers must cover.

CDC confirms at least 85 people experienced THC sickness from pizza place in Wisconsin
CDC confirms at least 85 people experienced THC sickness from pizza place in Wisconsin

The Hill

time26-07-2025

  • Health
  • The Hill

CDC confirms at least 85 people experienced THC sickness from pizza place in Wisconsin

STOUGHTON, Wis. (WFRV) – The Centers for Disease Control and Prevention (CDC) released a report about nine months after an incident at a Wisconsin pizza parlor where THC-infused oil was used to prepare dough. According to the report, at least 85 individuals, ranging from 1 to 91 years old, consumed food from the pizza shop in Stoughton, Wisconsin, between Oct. 22 and 24. The CDC said that the restaurant was in a building with a shared kitchen utilized by a state-licensed edible THC vendor. Initial reports came as emergency medical services in the area reported to Public Health Madison and Dane County (PHMDC) that seven people had been taken to local hospitals for symptoms such as dizziness, sleepiness and anxiety. Each individual reported eating from the same local restaurant. The seven individuals were treated at a Stoughton hospital with THC intoxication symptoms. One person who had eaten pizza from the same place reported that they had a positive THC test result without knowingly consuming any, prompting an outbreak investigation. The restaurant closed immediately on Oct. 24, confirming to PHMDC about the THC vendor in the shared kitchen. According to the CDC report, the restaurant owner confirmed that they ran out of cooking oil on Oct. 22, using some from the shared kitchen to prepare dough. Further investigation revealed that the oil used tested positive for THC, as the restaurant mistakenly used THC-infused oil from the cooperative kitchen to prepare dough. No criminal charges were filed as police deemed the contamination to be unintentional. The restaurant reopened on Oct. 26 after deep cleaning and sanitation procedures approved by the Wisconsin Food Code. The CDC report stated the following, '85 persons who responded to a health department questionnaire reported symptoms consistent with THC intoxication that occurred within 5 hours after eating food from a pizza restaurant.' The restaurant apologized for the incident after initial reports from October 2024.

Popular eatery unintentionally drugged patrons with THC-laced pizza
Popular eatery unintentionally drugged patrons with THC-laced pizza

Arab Times

time26-07-2025

  • Health
  • Arab Times

Popular eatery unintentionally drugged patrons with THC-laced pizza

NEW YORK, July 26: Health officials have revealed that a popular Wisconsin eatery, Famous Yeti's Pizza, accidentally served pizzas laced with THC, the psychoactive compound in marijuana, leading to the intoxication of 85 customers over a two-day period last October. According to a newly released report from the Centers for Disease Control and Prevention (CDC), the incident occurred between October 22 and 24, 2024, when the restaurant in Stoughton unknowingly used cooking oil contaminated with hemp-derived THC. The oil had been borrowed from a shared kitchen space within the same building after the restaurant ran out of its own supply. Emergency medical services alerted the local public health department after transporting seven individuals to the hospital exhibiting symptoms of THC intoxication, including dizziness, anxiety, hallucinations, and paranoia. Patients, aged between 1 and 91, reported having eaten at Famous Yeti's Pizza prior to falling ill. One patient likened their experience to consuming a THC-infused edible. All later tested positive for the drug. Further investigation revealed that the contaminated oil was originally used by another vendor in the shared kitchen to produce edible cannabis products. The only indication that the oil contained THC was a label on the cap, which the restaurant's operator acknowledged seeing, according to health officials. In addition to the hospitalized individuals, 78 other patrons responded to a health department questionnaire, reporting at least one symptom of THC exposure within five hours of dining at the establishment. Complaints ranged from dizziness and nausea to elevated heart rate, vomiting, sleepiness, and panic attacks. Fortunately, all 85 affected individuals made full recoveries without complications. The restaurant, which has been a staple in the community for over 12 years, publicly addressed the incident via a Facebook post. Owner Cale Ryan expressed deep remorse, writing, 'We made a horrendous mistake… We put people and families at risk and frightened and confused children and parents.' Stoughton police conducted a thorough investigation and concluded that the contamination was unintentional. As a result, no criminal charges were filed. Famous Yeti's Pizza reopened on October 26 after undergoing cleaning and sanitization in accordance with the Wisconsin Food Code. More than six months later, the restaurant remains open and continues to be a popular dining destination in the area. In response to the incident, the CDC issued a reminder urging restaurants to ensure that ingredients containing THC are clearly labeled and securely stored to prevent similar accidents in the future.

Trulieve Announces Expanded Distribution of Onward and Launch of THC-Infused Energy Drink Upward
Trulieve Announces Expanded Distribution of Onward and Launch of THC-Infused Energy Drink Upward

Cision Canada

time23-07-2025

  • Business
  • Cision Canada

Trulieve Announces Expanded Distribution of Onward and Launch of THC-Infused Energy Drink Upward

Onward and Upward premium beverages are available for consumers over 21 years old TALLAHASSEE, Fla., July 23, 2025 /CNW/ -- Trulieve Cannabis Corp. (CSE: TRUL) (OTCQX: TCNNF) ("Trulieve" or "the Company"), a leading and top-performing cannabis company in the U.S., today announced expanded distribution of premium Onward beverages and the launch of Upward, a premium THC-infused energy drink. Onward and Upward Farm Bill-compliant beverages are available online and at retail locations in Florida and Illinois. "We are thrilled by the overwhelmingly positive customer response to Onward and are excited to announce expanded distribution of Onward in Florida and Illinois," said Trulieve's Chief Executive Officer Kim Rivers. "Building on the positive momentum in the beverage category, we are launching Upward, a new THC-infused energy drink designed to support active and wellness-focused lifestyles." Onward and Upward beverages are available at all ABC Fine Wine & Spirits and Total Wine & More locations in Florida. We recently entered into new distribution partnerships with Romano Beverage covering Illinois and Anheuser-Busch covering Northern Florida. With these new and expanded arrangements, Onward and Upward beverages can be found at hundreds of stores in Florida and Illinois. New premium Upward beverages come in a variety of delicious flavors including 5 milligram Lemonade, Peach Nectarine, and Strawberry Tea and 10 milligram Pink Lemonade. These low-calorie energy drinks are crafted in the USA using the harmonious balance of THC and CBD found in Onward, plus a boost of energy derived from green coffee beans and black tea leaves. To place an online order, locate a store near you, or check product test results online, please visit Follow us on Facebook, Instagram, X, and TikTok at @DrinkOnward. About Trulieve Trulieve is an industry leading, vertically integrated cannabis company and multi-state operator in the U.S., with leading market positions in Arizona, Florida, and Pennsylvania. Trulieve is poised for accelerated growth and expansion, building scale in retail and distribution in new and existing markets through its hub strategy. By providing innovative, high-quality products across its brand portfolio, Trulieve delivers optimal customer experiences and increases access to cannabis, helping patients and customers to live without limits. Trulieve is listed on the CSE under the symbol TRUL and trades on the OTCQX market under the symbol TCNNF. For more information, please visit Investor Contact Christine Hersey, Vice President of Investor Relations +1 (424) 202-0210 [email protected] Media Contact Phil Buck, APR, Corporate Communications Manager +1 (406) 370-6226 [email protected] SOURCE Trulieve Cannabis Corp.

Texas governor vetoes bill that would ban all THC products
Texas governor vetoes bill that would ban all THC products

San Francisco Chronicle​

time23-06-2025

  • Business
  • San Francisco Chronicle​

Texas governor vetoes bill that would ban all THC products

AUSTIN, Texas (AP) — Texas Gov. Greg Abbott vetoed a bill Sunday to ban all THC consumables, allowing the booming market flush with THC-infused vapes, gummies and other products to continue to be sold across the state. Abbott, a Republican, waited until the final moment to veto the bill in what would have been one of the most restrictive THC bans in the country and a significant blow to the state's billion-dollar industry. The law would have made it a misdemeanor to own, manufacture or sell consumable THC, or tetrahydrocannabinol, products and was the latest push by states to regulate THC after a 2018 federal law allowed states to regulate hemp, a similar plant to marijuana that can be synthetically processed to produce THC, the compound giving marijuana its psychoactive properties. Loopholes in existing law have allowed many THC-infused goods to enter the market across the country, including states with strict marijuana laws. Texas has some of the strictest marijuana laws in the country, prohibiting all recreational use and providing a limited medical marijuana program. The consumables market has allowed residents to legally access goods giving a similar high to marijuana. Republican lawmakers have criticized the products as dangerous due to a lack of federal oversight in how the goods are manufactured. Texas' ban is one of the more far-reaching among states that have taken similar steps. Several states, including California, have imposed age limits and restrictions on the potency of THC products. Critics of the Texas bill say it allows people who cannot access marijuana through the state's medical marijuana program to acquire goods that can provide a similar relief. Many retailers across the state also pointed to the thousands of jobs and millions in revenue the industry brings each year. ___

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