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U.S. Could Vaccinate a Fifth of Americans in a Bird Flu Emergency
If the virus currently causing an outbreak of avian influenza among U.S. dairy cattle were to begin spreading widely among humans, the federal government says it could distribute enough vaccines within four months to inoculate a fifth of the U.S. population.
How effective that vaccine would be, and whether those doses would do enough to blunt the impact of a human pandemic, isn’t clear. Two clinical trials of the vaccine likely to be used, under way since last year, have yet to produce data.
The strain of avian flu known as H5N1 has been circulating among birds in the U.S. since late 2021, and is known only to have infected two people in the country, including a Texas dairy worker last month. U.S. officials aren’t near pulling the trigger on plans to roll out emergency vaccinations.
They are, however, watching closely. H5N1 has long been feared for its potential to cause a human pandemic, and the U.S. government has spent billions of dollars preparing for the threat of a pandemic influenza outbreak since the early 2000s, working with GSK, CSL subsidiary CSL Seqirus, and Sanofi to develop vaccines, build up a stockpile, and line up manufacturing capacity that could be switched on in an emergency.
Federal officials have referred in recent weeks to human vaccines that could be made available to the public, but details have been scant. After putting dozens of questions to federal officials and company representatives, Barron’s can offer a clearer picture of how the federal government says it would roll out emergency vaccines in a human H5N1 pandemic.
Adderall Abuse Risks Becoming Another Opioid Crisis, DEA Says
The fast rise of prescriptions for Adderall and other stimulants, along with rampant online treatment and advertising, suggest the start of another drug crisis like the opioid epidemic, a senior Drug Enforcement Administration official said Thursday. The warning is the most urgent public message yet on these types of drugs by the agency.
“I’m not trying to be a doomsday-er here,” Matthew Strait, deputy assistant administrator in the diversion control division said in an online seminar. But he compared the current situation with stimulants to the beginning of the opioid crisis and said “It makes me feel like we’re at the precipice of our next drug crisis in the United States.”
The DEA’s position on stimulants will have a direct effect on how many are manufactured, pharmacies’ access to them and how patients get prescriptions.
There are no standard guidelines for the diagnosis and treatment of ADHD in adults, which is “most concerning” for the DEA, Strait said. Specialists in the field have been working on creating such standards over the past two years.
Strait identified three similarities between the beginning of the opioid epidemic and the current situation: a public health concern, exploitation over the internet and an increased number of drugmakers manufacturing the drug.
Report: Less Than Half of Nursing Home Residents up to Date on COVID Vaccines
In this week’s Morbidity and Mortality Weekly Report, researchers review COVID-19 activity and vaccination in U.S. nursing homes from October 2023 through February 2024 and find up to 26% of nursing homes reported at least one case of COVID-19 during each week of the study period.
The study was based on information gathered as part of the Centers for Disease Control and Prevention’s (CDC) National Healthcare Safety Network.
Nursing homes were the first epicenters of the pandemic in the United States in 2020, as those 85 years and older are the most likely to die from infections with the novel coronavirus. Despite the risk of severe infection from COVID-19, the study authors found that only 40.5% of residents were up to date with COVID vaccination by the end of the study period. Residents in the South had the lowest rate (32.4%), compared to residents in the Northeast, who had the highest (47.3%).
In February, the CDC recommended that all adults aged older than 65 years receive one additional dose of an updated 2023–2024 COVID-19 vaccine at least 4 months after the previous updated dose.
How a Scientific Slip-Up Caused a Pregnant Woman to Get an Untested Treatment for Preterm Birth
Makena, once the only available treatment to prevent preterm birth, has had its share of controversy. A yearslong debate over the drug’s effectiveness led the Food and Drug Administration to withdraw its approval of the product and demand it be pulled from the market after a confirmatory trial couldn’t replicate the results of a key study.
But while the story of Makena’s rise and fall may be well known, one aspect of the drug’s legacy has gone untold. A widely cited study that supported Makena’s approval mixed up the names of two distinct molecules: 17P and progesterone. That error, which reverberated through dozens of papers, caused some women to mistakenly be given injections of high doses of progesterone to reduce their risk of preterm birth — an untested treatment — though it’s unclear precisely how many people were affected.
It wasn’t a prominent professor, a clinician, or a scientific watchdog who has driven the push to get the issue corrected — it was a lab manager,Tara Skopelitis, who was determined to leave no stone unturned in trying to solve the puzzle of her daughter’s illness.
Walgreens to Pay $110 Million to End Philadelphia Opioid Litigation
The city of Philadelphia has reached a $110 million settlement of its 2021 lawsuit against Walgreens pharmacy for the company’s role in supplying and perpetuating the opioid addiction crisis in Philadelphia.
Under the terms of the agreement, Walgreens admits no liability but will pay the city $110 million in compensation over five years. The first $20 million payment from Walgreens will be paid to the city in September. Thereafter in 2025, 2026 and 2027, the city will receive $23.3 million and, in 2028, $20 million
In 2023, the city announced its plans on how it will utilize and distribute $200 million in settlement funds from several opioid-related lawsuits over the next 18 years. The plan calls for the funds to be used for substance use education, treatment, prevention, and community engagement efforts in the neighborhoods most affected by the opioid crisis.
Walgreens continues to deny each and all of the claims and allegations of wrongdoing made by the city. The parties said they reached the settlement to avoid the expense and uncertainty of litigation.
Lawsuits Over Ozempic, Wegovy, Mounjaro and Other GLP1-RA Drugs May Hinge on Label Warnings
In position papers recently submitted, lawyers involved in lawsuits over Ozempic, Wegovy, Mounjaro and other similar medications detailed their stances on whether manufacturers provided adequate label warnings about the potential stomach paralysis side effects some users are experiencing, and how the growing litigation should be managed during pretrial proceedings.
Millions of Americans have used Ozempic, Wegovy, Mounjaro or other glucagon-like peptide-1 receptor agonists (GLP-1 RA) drugs in recent years, amid aggressive promotions by the drug makers that indicated the medications were safe and effective for weight loss.
However, former users are now pursuing Ozempic lawsuits, Wegovy lawsuits and Mounjaro lawsuits against the manufacturers, after developing painful and debilitating injuries, including intestinal blockages and a form of stomach paralysis known as gastroparesis.
Given common questions of fact and law raised in the litigation, the U.S. Judicial Panel on Multidistrict Litigation decided earlier this year to centralize all GLP-1 lawsuits before U.S. District Judge Gene E.K. Pratter in the U.S. District Court for the Eastern District of Pennsylvania, and it is widely expected that tens of thousands of lawsuits may ultimately be included in the federal MDL (multidistrict litigation).
COVID Vaccine Makers to Clash in London Over mRNA Patent Dispute
Moderna will clash with Pfizer and BioNTech in a pivotal London patent trial over the development of COVID-19 jabs that will help determine who pioneered the technology behind the coronavirus vaccines that saved millions of lives in the pandemic. The High Court is due on Tuesday to hear a legal complaint brought by Moderna, which alleges that its competitors infringed two of its patents in their use of the mRNA platform that was key to their vaccines. BioNTech and Pfizer have said the patents are invalid.
The High Court is due on Tuesday to hear a legal complaint brought by Moderna, which alleges that its competitors infringed two of its patents in their use of the mRNA platform that was key to their vaccines. BioNTech and Pfizer have said the patents are invalid.
The case is the latest in a series of intellectual property battles that companies are fighting around the world over mRNA technology, which has helped generate billions in revenues for the pharmaceuticals industry.
If successful, Moderna would be in line for a share of the profits Pfizer and BioNTech generated from their joint vaccine, Comirnaty. Legal experts said the London ruling could also influence litigation in other jurisdictions — and boost the reputations of the winners.
Easier-to-Make Cholera Vaccine Approved by WHO Amid Shortage
An oral vaccine for cholera that is simpler to make than existing versions has been approved by the World Health Organization in a move that is expected to rapidly increase production capacity amid global shortages.
The inactivated oral inoculation, Euvichol-S, has similar efficacy to the two WHO-approved vaccines, the WHO said in a statement Friday. It’s made by Seoul-based EuBiologics Co., the same company that makes the older versions.
While most people can be successfully treated for the waterborne disease, which causes severe dehydration from vomiting and diarrhea, through prompt administration of oral rehydration solution, it’s harder in communities that have little pre-existing immunity due to low vaccination rates and poor general health.
