Exclusive: Wegovy Fuels Sharp Rise in Use of Weight-Loss Drugs for U.S. Youth
A small but rapidly growing number of U.S. adolescents began treatment with Novo Nordisk‘s weight-loss drug Wegovy last year, a powerful new tool to address record rates of pediatric obesity, according to data shared exclusively with Reuters.
In the first 10 months of 2023, 1,268 children ages 12 to 17 with an obesity diagnosis started taking Wegovy, according to U.S. insurance claims data compiled by health technology company Komodo Health.
In 2022, only 25 children were prescribed the drug, which did not receive U.S. approval for adolescent use until December of that year. A month later, the influential American Academy of Pediatrics recommended that weight-loss drugs be offered to children with obesity starting at age 12.
The data indicate an increasing willingness among families to embrace Wegovy, the first highly effective treatment for obesity, short of surgery. Use of the weekly injection can involve great cost, with limited data on long-term risks and benefits.
Risk of Carditis Among Adolescents After Extending the Interdose Intervals of BNT162b2
Previous studies indicate an increased carditis risk among adolescents following the two-dose messenger RNA COVID-19 vaccine. Several jurisdictions have extended the interdose interval between the first and second doses to reduce the risk. However, the effectiveness of such an extension policy remains inconclusive.
Using the territory-wide vaccine record-linked electronic health records in Hong Kong, we conducted a nested case-control study from February 23, 2021, to August 15, 2022. Adolescents aged between 12 and 17 who received two-dose BNT162b2 were included for comparing risks between standard interdose interval (21–27 days) versus extended interdose interval ( ≥ 56 days).
The carditis cumulative incidence within 28 days following the second dose was calculated. The adjusted odds ratio was estimated from multivariable conditional logistic regression. We identified 49 adolescents with newly diagnosed carditis within 28 days following the second dose.
Compared to the standard interdose interval group, adolescents with an extended interval had a significantly lower risk of carditis [adjusted odds ratio (aOR) 0.34 (95% CI: 0.16–0.73)]. Sensitivity analysis of carditis occurring within 14 days following the second dose yielded a similar estimate [aOR 0.30 (95% CI: 0.13–0.73)]. Extending the interdose interval of the BNT162b2 vaccine from 21 to 27 days to 56 days or longer is associated with 66% lower risk of incident carditis among adolescents.
CDC: Just 39% of Children Have at Least One Dose of HPV Vaccine
A new Centers for Disease Control and Prevention (CDC) report today notes that 38.6% of children aged 9 to 17 had received at least one dose of the human papillomavirus (HPV) vaccine in 2022, with rates rising with age from 7% in the youngest kids to 57% in the oldest.
HPV vaccination has been recommended in the United States since 2006 for girls and 2011 for boys. The multiple-dose vaccine, targeted to be initiated for children ages 11 to 12 years, may be started as young as age 9 and prevents against the most common cancer-causing HPV strains.
Overall, girls (42.9%) were more likely than boys (34.6%) to have received one or more HPV vaccine doses.
POTS Lawsuit Alleges Gardasil HPV Vaccine Manufacturer Failed to Disclose Autoimmune Side Effects
The parents of a young girl who suffered severe side effects from Gardasil HPV vaccine injections have filed a lawsuit against Merck, indicating that the drug maker failed to warn about the risk of devastating autoimmune problems, including postural orthostatic tachycardia syndrome (POTS).
The complaint was filed earlier this month on behalf of a minor child, identified only with the initials C.A.B., in the U.S. District Court for the Western District of North Carolina, indicating that Merck has continued to sell a vaccine that is known to create a dangerous and unreasonable risk of injury for users.
This case now joins a growing number of Gardasil lawsuits being pursued against the manufacturer, alleging that Merck has withheld information about permanent and life-changing autoimmune side effects linked to the HPV vaccination from users, families and the medical community for years.
According to a docket report issued on February 1, there are currently at least 140 complaints involving Gardasil POTS injuries and other autoimmune side effects pending in the federal court system. There are also a substantial number of additional claims pending in the U.S. Vaccine Court, where families must initially bring a petition seeking compensation under the National Vaccine Injury Compensation Program before they are able to bring a civil lawsuit if the claim is not resolved within eight months.
Case Dismissed: Appeals Court Slams Expert Witness in Diabetes Drug Lawsuits
Multi-district litigation over the diabetes drug saxagliptin, a case that combined more than 80 suits from around the country, has failed because the plaintiffs’ sole expert witness was unreliable and did not show a causal link between the medication and heart failure, a federal appeals court said this week.
A three-judge panel of the 6th U.S. Circuit Court of Appeals upheld the Federal District Court for Eastern Kentucky, which in 2022 had dismissed the lawsuits brought by Leatha Taylor and dozens of others against Bristol-Myers Squibb Co., AstraZeneca Pharmaceuticals and two more firms.
The decision could have long-term implications for litigation that relies on expert witnesses, including medical malpractice and product liability insurance claims. It reinforces court decisions through the years that have made it clear that juries cannot decide matters of causation in complex medical matters without expert testimony.
Pfizer Quells 12 Years of Lipitor Antitrust Litigation With $93 Million Settlement
With a $93 million settlement, Pfizer can wash its hands of more than a decade’s worth of antitrust litigation over the once-lucrative cholesterol med Lipitor. For years, Pfizer and Sun Pharma’s Ranbaxy Laboratories have been engaged in litigation from drug purchasers accusing the companies of conspiring to delay Lipitor generics through an unlawful “reverse payment” agreement.
Now, the deal just needs a judge’s stamp of approval to go through. If cleared, the settlement would offer plaintiffs “immediate economic relief,” through a cash payment, the lawyers added.
After its approval in the 1990s, Lipitor eventually became one of the world’s best-selling drugs. From 1992 to 2017, the statin pulled a whopping $94.67 billion in U.S. sales.
Even though sales have slowed these days due to generic competition, the med is expected to come in third on the list of highest lifetime drug sales by 2028, behind Humira and Merck’s Keytruda, statistics platform Statista reports.
Drug Offers ‘Wonderful’ Breakthrough in Treatment of Asbestos-Linked Cancer
Scientists have developed a drug to treat mesothelioma, a notoriously hard-to-treat cancer linked to asbestos, in the biggest breakthrough in two decades.
Thousands of people are diagnosed with the disease globally every year, which tends to develop in the lungs and is mainly caused by exposure to asbestos at work. It is aggressive and deadly and has one of the world’s worst cancer survival rates.
In an international trial spanning five countries, led by Queen Mary University of London, a new drug that cuts off the tumor’s food supply quadrupled three-year survival rates. The results were published in the journal JAMA Oncology.
Amazon Artificial Tears Lawsuit Filed Over Bacterial Keratitis Infection From Contaminated Eye Drops
After using Artificial Tears eye drops from Amazon.com, a Louisiana woman indicates she developed permanent injuries to her eyes and vision loss, due to toxic bacteria that was in the eye drops.
Jessica Herndon filed a complaint on February 13 in the U.S. District Court for the District of New Jersey, presenting claims not only against the manufacturers of the Artificial Tears, EzriCare LLC, Ezrirx LLC, Global Pharma Healthcare Private LTD., and Aru Pharma, Inc., but also against Amazon.com, Inc., which is where she purchased the contaminated eye drops.
The eye drops were part of a massive EzriCare Artificial Tears recall first announced by the U.S. Food and Drug Administration (FDA) in February 2023, after at least 55 reports were confirmed involving users who had suffered eye infections after exposure to bacteria in eye drops.
Herndon now joins a growing number of consumers who are pursuing Artificial Tears lawsuits, alleging that bacteria in the eye drops caused a wide range of health problems, including vision loss, eye infections, bloodstream infections and other injuries. At least four deaths have now been linked to the eye drops, as well as a number of users who required surgical removal of their eyes.
Putin Says Russia Is Close to Creating Cancer Vaccines
President Vladimir Putin said on Wednesday that Russian scientists were close to creating vaccines for cancer that could soon be available to patients. Putin did not specify which types of cancer the proposed vaccines would target, nor how.
A number of countries and companies are working on cancer vaccines. Last year the U.K. government signed an agreement with Germany-based BioNTech to launch clinical trials providing “personalised cancer treatments”, aiming to reach 10,000 patients by 2030.
Pharmaceutical companies Moderna and Merck & Co are developing an experimental cancer vaccine that a mid-stage study showed cut the chance of recurrence or death from melanoma — the most deadly skin cancer — by half after three years of treatment.