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U.S. Panel Backs GSK Vaccine, Heating up RSV Vaccine Race
A panel of outside advisers to the U.S. health regulator on Wednesday backed GSK Plc’s (GSK.L) respiratory syncytial virus (RSV) vaccine, setting it up for a race with rival Pfizer to become the first approved U.S. shot against the disease.
The Food and Drug Administration’s (FDA) advisory committee voted unanimously in favor of the vaccine’s effectiveness in preventing lower respiratory tract disease caused by RSV in adults aged 60 and above and voted 10 to 2 for its safety.
The panelists seemed significantly more confident about the demographic profile used during the GSK study in comparison to Pfizer‘s (PFE.N) RSV vaccine, which was recommended by the FDA panel on Tuesday.
Pfizer and GSK are running a tight race to tap into the RSV vaccine market, which is estimated to be over $5 billion and could exceed $10 billion by 2030, according to analysts.
‘This Is My Last Responsibility’: Indonesia’s Parents Seek Justice Over Child Cough Syrup Deaths
The Indonesian language has words for children who have lost their mothers or fathers, but none for parents who lose their children. Some say that is because the pain is inexplicable, something 42-year-old Safitri Puspa Rani can attest to.
Safitri’s eight-year-old son Panghegar died in October 2022, one month after his birthday. Panghegar had spent weeks in a pediatric intensive care unit, fighting acute kidney injury caused by syrup medicines that had been contaminated with toxic chemicals commonly found in industrial solvents and antifreeze.
More than 200 Indonesian children have died after taking the syrups. Some who survived have been left debilitated. Authorities confirmed contaminated syrups as the cause only in November last year. At least 116 medicines from six companies have been banned for containing high levels of toxic chemicals diethylene glycol and ethylene glycol.
Still grappling with grief, Safitri and 24 other parents are now joining a class action to sue Indonesia’s health ministry, food and drug agency and eight pharma companies, including some suppliers of the raw materials, over the death and suffering of their children. Parents want the government and the companies involved to take responsibility and improve manufacturing processes and disease management standards.
U.S. CDC Concludes Cough Syrups Likely to Blame for Children’s Deaths in Gambia — Report
Contaminated cough and paracetamol syrups imported into Gambia almost certainly caused the deaths of 66 children due to acute kidney injury, according to an investigation led by the United States Centers for Disease Control and Prevention and Gambian scientists.
The links between the children’s deaths and contaminated medicines first came to light in October, when the World Health Organization sent out an alert saying four cough syrups made by India’s Maiden Pharmaceuticals Ltd contained toxic levels of diethylene and ethylene glycol and should be withdrawn.
The new investigation “strongly suggests” that medicines contaminated with the toxins, imported into Gambia, led to the cluster of acute kidney injuries among 78 children. Most were aged under 2, and 66 died between June and September 2022. Four more children have since died, bringing the official toll up to 70.
Maiden has denied its drugs were at fault for the deaths in Gambia, and the Indian government has said the syrups showed no contamination when it tested them. Production at the factory was stopped in October, but the company is now seeking to restart work.
Vaccine Makers Are Preparing for Bird Flu
Minks in Spain, seals in Scotland, sea lions and dolphins in South America: a number of mammal species have recently been found to be infected with H5N1, a highly pathogenic strain of avian influenza. Avian flu is not new; epidemiologists have been studying it for decades. But the detection of the virus in mammals has many concerned about the potential that it could spill over to humans and cause a larger outbreak.
The U.S. is somewhat equipped to handle avian flu: there is a stockpile of egg-based flu vaccines for the H5N1 strain. Eggs are one of the most common ways to make a flu vaccine. To create it, manufacturers inject an inactivated or weakened virus into a fertilized chicken egg, incubate the egg for a few days while the virus multiplies and then harvest the virus to use for the vaccine. The country has a secret chicken stockpile in undisclosed locations across the U.S. just in case we need to make egg-based vaccines quickly — such as during a flu pandemic.
There are also efforts to apply messenger RNA (mRNA) technology — such as that used for some of the COVID vaccines — to flu vaccines. According to University of Washington microbiologist Deborah Fuller, these efforts range from developing a universal flu vaccine to creating a “multivalent” vaccine that targets only a few subtypes — or versions of the virus (like a typical seasonal flu vaccine does). One advantage of mRNA technology is its speed of production. And because of the COVID pandemic, there is now more infrastructure to mass-produce doses.
Scott Hensley, a professor of microbiology at the University of Pennsylvania, is also investigating mRNA flu vaccines. He’s part of a research team developing a 20-subtype mRNA flu vaccine that includes an H5N1 strain (although not the one currently circulating in birds). The team recently published its findings in Science. Hensley’s lab is now developing a single-strain vaccine tailored to the current bird flu strain — and is already testing it in laboratory animals. He emphasizes that, as with the COVID vaccines, his vaccines are meant to prevent serious illness and death, not infection.
Merck Study Calls for HPV Vaccination at Earlier Ages, Despite Gardasil Side Effects Concerns
A new study conducted by the drug maker Merck calls for increased use of its Gardasil HPV vaccine, beginning treatments among children as young as 9 years old, even as a growing number of individuals are now pursuing lawsuits alleging Merck failed to adequately disclose long-term health side effects.
In a study published in the medical journal Pediatrics on February 27, Merck researchers recommend that doctors and parents should begin the process of vaccinating children against human papillomavirus (HPV) vaccine treatment around ages 9 or 10, in order to guarantee they complete the vaccination process before sexual activity.
Although it has been promoted as safe, teens and young adults have reported experiencing a variety of problems caused by the HPV vaccine Gardasil, including postural orthostatic tachycardia syndrome (POTS), premature ovarian failure, premature menopause, seizures and other autoimmune disorders, which emerged shortly after receiving the injection.
In recent months, Merck has faced a growing number of Gardasil lawsuits brought in the federal court system, each involving similar allegations that the drug maker placed its desire for profits before the health and safety of consumers, by failing to disclose known risk information to parents or the medical community.
Futuristic Vaccine to Prevent Alzheimer’s Starts Southern California Trial
A futuristic vaccine to prevent Alzheimer’s disease is in the works right here in Southern California. And it won’t even involve needles.
Researcher Michael Agadjanyan at the Institute for Molecular Medicine in Huntington Beach, along with David Sultzer from UCI MIND and Lon Schneider from USC, received a $12 million grant from the National Institute on Aging to support clinical trials aiming to keep “the long goodbye” at bay.
Six sites across the nation are hosting the Phase 1 trial that they designed, including the Hoag Memorial Hospital Presbyterian’s Pickup Family Neurosciences Institute in Newport Beach. The vaccine and its monthly booster will be administered to people early in the disease not by needle injection, but by pressure pushing it into the skin. The hope is to spur the immune system to action to block the buildup of harmful material in the brain, and/or to clean it up.
Forty-eight volunteers aged 60 to 85 with mild cognitive impairment due to Alzheimer’s disease are sought for the trial, which is also underway in Arizona, Florida, Georgia and New Jersey.
U.S. FDA Panel to Review Expanded Use of Merck-AstraZeneca’s Cancer Drug
Merck & Co Inc (MRK.N) and British drugmaker AstraZeneca PLC (AZN.L) said on Thursday that an independent committee of advisers to the U.S. health regulator will review the companies’ application for the expanded use of their drug Lynparza to treat an advanced form of prostate cancer.
The U.S. Food and Drug Administration’s (FDA) committee is scheduled to meet on April 28. The companies are seeking approval for the drug Lynparza in combination with other medications — abiraterone and prednisone or prednisolone — for the treatment of a type of treatment-resistant prostate cancer in adult patients.
Here’s How the Other Major Insulin Makers Are Responding After Eli Lilly’s Price Cap
Facing pressure to curb diabetes-treatment costs, Eli Lilly & Co. announced on March 1 that it is slashing insulin prices and immediately capping the out-of-pocket cost of all of its insulins at $35 a month. President Joe Biden, who made insulin costs a focus of his State of the Union speech last month, praised the move by Lilly and called on other drugmakers to also lower insulin prices.
The price cuts by the Indianapolis-based Lilly, one of the world’s top three insulin producers, are expected to provide critical relief to the millions of Americans who rely on the medicine to control their blood sugar levels. So far, none of the other major insulin manufacturers have announced new price caps in light of Lilly’s announcement, but health policy experts say its competitors are now facing increasing pressure to respond.
Aside from Eli Lilly, other top insulin makers include French drugmaker Sanofi and Danish pharmaceutical company Novo Nordisk. The three companies control about 90% of the U.S. insulin market. Representatives for Sanofi, which makes Apidra and Lantus insulin, and Novo Nordisk, which makes NovoLog and Levemir insulin, each told TIME that they offer programs that limit costs for people with and without coverage, but would not say whether they plan to follow Lilly’s move.
This Dental Device Was Sold to Fix Patients’ Jaws. Lawsuits Claim It Wrecked Their Teeth.
More than 10,000 dental patients have been fitted with an Anterior Growth Guidance Appliance, or “AGGA,” according to court records. But the unproven and unregulated dental device, often costing patients about $7,000, has not been evaluated by the FDA, according to a months-long joint investigation by KHN and CBS News. The FDA relies on device companies to submit new products for evaluation, and because the AGGA was never submitted, it has been sold to patients without that government review.
Dentists across the country promote the AGGA on their websites, often claiming it can “grow,” “remodel,” or “expand” an adult’s jaw without surgery, sometimes saying it has the potential to make patients more attractive and treat common ailments like sleep apnea and TMJ.
However, after reviewing dental scans that the AGGA inventor submitted in court to prove the device works, eight experts told KHN and CBS News the scans show signs of the AGGA displacing teeth instead of expanding the jaw. Some experts said, based on their experience with former AGGA patients, the device caused tens of thousands of dollars in damage to the patient’s mouths.
Pfizer, Viatris and More Must Face ‘Overarching Conspiracy’ Claims in Generic Price-Fixing Suit
Pfizer and several other drugmakers must face an antitrust lawsuit alleging they colluded to manipulate the prices of dozens of drugs for skin conditions.
Tuesday, Pennsylvania federal judge Cynthia Rufe denied almost all motions by the companies — and some of their former executives — to dismiss the price-fixing allegations.
Pfizer, Viatris, Bausch Health, Sun Pharma, Amneal and more together face price-fixing allegations brought by almost all U.S. states and other healthcare stakeholders. The lawsuit, originally filed in 2016, first centered on the heart rhythm drug digoxin and skin infection antibiotic doxycycline. It’s since grown to incorporate allegations around about 80 products.
The plaintiffs allege that the companies used trade shows, industry dinners, golf outings and other events to collude and carve out each manufacturer’s “fair share” of the market for topical drugs. The practices suppressed competition and led to artificially high prices, the plaintiffs have argued.
