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Group of 16 Gardasil Lawsuits to Be Selected for Bellwether Pool in HPV Vaccine MDL
A federal judge is calling for a group of 16 Gardasil lawsuits to be prepared for a series of early bellwether trials, which will help the parties determine how juries are likely to respond to expert testimony and evidence that will be repeated throughout a growing number of claims brought by individuals who experienced complications after receiving the HPV vaccine.
Gardasil is a widely used vaccine that is typically administered to teens and young adults before they are sexually active, to protect against HPV infections, which can lead to the development of cervical cancer later in life. However, despite being marketed as safe and effective, Merck & Co. now faces lawsuits alleging that the HPV vaccine caused debilitating autoimmune complications, including postural orthostatic tachycardia syndrome (POTS), neurological problems, premature ovarian failure and other side effects.
There are currently about 80 complaints pending in the federal court system, which have been centralized before U.S. District Judge Robert J. Conrad in the Western District of North Carolina since they each involve common questions of fact and law.
However, over the coming months and years, it is widely expected that the litigation will continue to expand, and hundreds of individual cases will ultimately be filed in the HPV vaccine MDL (multidistrict litigation).
Infant Formula Crisis Exposed FDA and Industry Failings, Lawmakers Say — Experts at House Oversight Subcommittee Hearing Say U.S. Is Vulnerable to Another Crisis
Lawmakers drilled into the FDA’s handling of the infant formula crisis and proposed solutions at a House Committee on Oversight and Accountability subcommittee hearing Tuesday, underscoring the still-precarious position that the U.S. finds itself in.
Questions at the hearing highlighted the missteps by the FDA that led to the crisis but also pointed to an industry chokehold on the formula market that formed its backdrop — and could set the stage for another.
Proposed solutions were a more unified FDA approach to food safety, more regulation and authority for the FDA to hold formula companies accountable, and diversification of the infant formula market.
The reckoning comes a month after a second infant formula recall from Reckitt, which — though smaller than 2022’s Abbott recall — revealed lingering weaknesses in the FDA’s performance. The agency was again slow to respond, with a 5-month gap between Reckitt’s positive test and a recall, according to Politico.
J&J Bows Out of RSV Vaccine Race After Scrapping Trial
Johnson & Johnson (JNJ.N) said it will discontinue the late-stage study of its experimental respiratory syncytial virus (RSV) adult vaccine, weeks after rivals Pfizer and GSK gained a lead in the race for the first vaccine against the virus.
The drugmaker, which started the global study in September 2021 in about 23,000 adults aged 60 years and older, did not provide any further details about the trial.
Pfizer (PFE.N) and GSK’s (GSK.L) RSV vaccines gained the backing of a panel of U.S. Food and Drug Administration advisers in late February and early March, bringing them a step closer to approval in the United States. The health regulator is expected to decide on the two vaccines by May.
Pfizer and GSK are running a tight race to tap into the RSV vaccine market, which is estimated to be more than $5 billion and could exceed $10 billion by 2030, according to analysts.
FDA Approves Narcan — an Opioid Antidote — for Over-the-Counter Use Amid Overdose Epidemic
The U.S. Food and Drug Administration approved Narcan for over-the-counter use Wednesday, marking the first time a drug used to reverse the effects of an opioid overdose is available without a prescription, in an effort to combat the ongoing epidemic plaguing the country.
The FDA approved a four-milligram nasal spray dose of Narcan, or naloxone hydrochloride, for over-the-counter use, in a move that’s expected to take months.
The FDA said it will be up to manufacturers to determine the price and availability of the drug, but it expects the medication to be available in convenience stores, drug stores, gas stations and grocery stores.
Single-Drug and Combo Birth Control Pills Both Carry Increased Breast Cancer Risk: Study
Although progesterone-only birth control pills have long been recommended as a safer alternative to combination hormone pills, the findings of a new study suggest that both versions may increase the risk of breast cancer.
Researchers from the University of Oxford in the United Kingdom have released new data, which appear to refute decades of research pointing to single-hormone birth control as less likely to cause breast cancer when compared to dual-hormone birth control pills, like estrogen and progesterone combination pills. The findings were published on March 21 in the journal PLoS Medicine.
The study indicates the risk of breast cancer for current or former users of combination birth control pills that contain both synthetic versions of estrogen and progesterone face a small increased risk of developing breast cancer. A similar risk was also seen for users of progesterone-only contraception.
Does Direct-to-Consumer Advertising Directly Harm Patients?
Researchers from Johns Hopkins University recently published an article in JAMA that highlights rising concern around the effects of direct-to-consumer advertising (DTC) on healthcare. Their work shows that DTC advertising might have direct harm to patients.
They studied drug characteristics and total advertising expenditures for the 150 top-selling branded prescription drugs in the United States, finding that total promotional spending by the manufacturer was associated with a significantly lower added clinical benefit for the drug.
In fact, companies spent nearly 15% more on DTC advertising for drugs that had demonstrated lower added benefits. Even more troubling, each 1.5% increase in spending was associated with a 10% increase in sales.
Simply put, pharmaceutical companies spent more money on DTC advertising when medical research found that the drug was less effective, and this spending directly led to more sales for those inferior drugs.
Exclusive: WHO to Consider Adding Obesity Drugs to ‘Essential’ Medicines List
Drugs that combat obesity are under consideration for the first time for the World Health Organization’s “essential medicines list,” used to guide government purchasing decisions in low- and middle-income countries, the U.N. agency told Reuters.
The request to consider obesity drugs was submitted by three doctors and a researcher in the United States. It covers the active ingredient liraglutide in Novo Nordisk’s (NOVOb.CO) obesity drug Saxenda, which will come off patent soon, allowing for cheaper generic versions.
The panel could reject the request or wait for more evidence. A decision by the WHO to include Saxenda and eventual generics on the list for adults would mark a new approach to global obesity by the health agency.
It could also pave the way for a newer, more powerful treatment from Novo Nordisk called Wegovy to be recommended for low- and middle-income countries in the future. For both Saxenda and Wegovy, there is a lack of long-term safety and effectiveness data for obesity. Studies suggest people will likely have to take the drugs for the rest of their lives to keep the weight off.
Information About Each Tylenol Autism, ADHD Injury Claim to Be Provided on Plaintiff Fact Sheets
With Johnson & Johnson and major retailers like Walmart and CVS facing a growing number of Tylenol injury claims brought by families of children diagnosed with autism and ADHD, the federal judge presiding over litigation has approved the use of a standardized Plaintiff Fact Sheet to gather information about the problems experienced by each of the children following exposure to acetaminophen during pregnancy.
More than 100 families of children with ADHD or autism from Tylenol are already pursuing lawsuits, and the size of the litigation is expected to increase dramatically over the coming months and years.
Each of the complaints raises similar allegations, indicating that drug makers have known for decades about the link between autism and Tylenol, as well as attention deficit hyperactivity disorder (ADHD) and other developmental problems. However, rather than warning about the acetaminophen risks for unborn children, plaintiffs claim that the drug has been promoted as safe for use by pregnant women.
‘We Have Arrived in the Post-Antibiotic Era’: WHO Warns of Too Few New Drugs for Deadly Superbugs
Late last year, one of Dr. Vance Fowler’s patients — a man in his 60s who’d returned to North Carolina from visiting his family in Nepal — died of a bacterial infection. He’d been treated at a top U.S. hospital with access to the strongest antibiotics. But the infection, a drug-resistant strain of E. coli, surged on.
Health officials have warned the public about antibiotic resistance for decades. That’s become more urgent in light of an upcoming World Health Organization report tallying only a handful of new antibiotics in development.
Preliminary data from the report, released by the WHO this month, paint a dire picture: Just 27 new antibiotics for the most threatening infections are in the clinical trial stage of drug development. In contrast, there were more than 1,300 cancer drugs in clinical trials in 2020, according to a report from the trade organization Pharmaceutical Research and Manufacturers of America.
Of the antibiotics in trials, the WHO considers only six of them innovative enough to overcome antibiotic resistance, and just two capable of targeting the most resistant bacteria. Agency officials will present the full report during the European Congress of Clinical Microbiology and Infectious Diseases next month.
Ohio Sues Prescription Drug Middlemen Over Business Practices
The Columbus Dispatch reported:
Calling them “modern gangsters,” Ohio Attorney General Dave Yost on Monday accused pharmacy benefit managers of illegally driving up drug prices for patients who rely on insulin and other key medications.
“Medications shouldn’t cost an arm and a leg, metaphorically or literally,” Yost said in a written statement. “Insulin is just a symptom of the problem; PBMs are the disease.”
Yost filed a lawsuit in Delaware County Common Pleas Court against Express Scripts, Prime Therapeutics, Ascent, Humana Pharmacy Solutions and two parent companies.
He alleges the companies collude to control drug prices and have failed to live up to promises to negotiate lower drug prices from manufacturers and deliver those savings to patients. Instead, Express Scripts created a complex ‘pay to play’ rebate scheme that pushes manufacturers to boost drug prices in order to get their medications on preferred lists.
