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Gardasil Side Effects Caused Neuropathic Injuries, Skin Reactions, HPV Vaccine Lawsuit Claims
While most Gardasil HPV vaccine lawsuits have been filed by teens and young adults, a recently filed claim alleges that a 42-year-old woman developed severe skin reactions and neuropathic injuries from Gardasil side effects.
The complaint was filed by Michele Damiano in the Supreme Court of New York on January 13, claiming that Merck & Co. failed to disclose information to users and the medical community about the potential risks associated with the widely marketed vaccine for the prevention of HPV infections.
Following a growing number of reports linking Gardasil side effects to serious and disabling injuries, including postural orthostatic tachycardia syndrome (POTS), premature ovarian failure, premature menopause, neuropathic injuries and other autoimmune disorders, hundreds of lawsuits are now being filed against Merck throughout the U.S.
The lawsuit claims Merck knew or should have known about the health risks and purposefully deceived the public about the safety and effectiveness of the Gardasil vaccine.
U.S. Court Rejects J&J Bankruptcy Strategy for Thousands of Talc Lawsuits
A U.S. appeals court on Monday shot down Johnson & Johnson‘s (JNJ.N) attempt to offload tens of thousands of lawsuits over its talc products into bankruptcy court. The ruling marked the first major repudiation of an emerging legal strategy with the potential to upend U.S. corporate liability law.
J&J is among four major companies that have filed so-called Texas two-step bankruptcies to avoid potentially massive lawsuit exposure. The tactic involves creating a subsidiary to absorb the liabilities and immediately file for Chapter 11.
The court ruled the healthcare conglomerate improperly placed its subsidiary into bankruptcy even though it faced no financial distress. J&J’s two-step sought to halt more than 38,000 lawsuits from plaintiffs alleging the company’s baby powder and other talc products caused cancer. The appeals court ruling revives those lawsuits.
Monday’s decision by the U.S. 3rd Circuit Court of Appeals in Philadelphia dismissed the bankruptcy filed by the J&J subsidiary in 2021. Before the filing, J&J had faced costs of $3.5 billion in verdicts and settlements.
Moderna’s RSV Shot Nabs FDA Breakthrough Tag, Boosting Position in Race With Pfizer, GSK
Moderna’s respiratory syncytial virus (RSV) vaccine for older adults has scored breakthrough designation from the FDA as the three-way race with Pfizer and GSK nears the finish.
The Cambridge, Massachusetts-based company’s announcement Monday comes two weeks after it posted competitive phase 3 data of the vaccine, mRNA-1345. The shot was found to be 83.7% effective against RSV-associated lower respiratory tract disease defined by two or more symptoms, with the majority of side effects rated as mild or moderate. Moderna says the phase 3 data was used to gain U.S. regulators’ breakthrough nod.
The designation for Moderna has practical application to expedite the FDA’s review of the company’s vaccine, but it’s also symbolic, showing that the drugmaker is hot on the heels of Pfizer and GSK. The latter two pharmas have received priority review status and Moderna planning to use a priority review voucher — in all cases trimming the FDA review period by four months.
Moderna is a few months behind GSK and Pfizer in the RSV regulatory sprint, however, and plans to apply for approval in the first half of 2023. GSK had its application accepted by the FDA in early November 2022 with Pfizer’s accepted a month later. Sanofi is taking a different approach, developing nirsevimab as a protective antibody for infants; the FDA accepted Sanofi’s approval application earlier this month.
Why Drugmakers Have Raised Prices on Nearly 1,000 Drugs so Far This Year
With pharmaceutical companies hiking prices on nearly 1,000 drugs in January, some consumers might experience sticker shock the next time they pick up prescriptions.
The price increases come as a new federal law requires companies to pay Medicare a rebate if they increase prices above the rate of inflation. Other Inflation Reduction Act provisions — such as capping Medicare recipients’ out-of-pocket expenses at $2,000 and allowing Medicare to negotiate the costliest drugs — haven’t kicked in yet.
Major drug companies such as AbbVie, Pfizer and Bristol-Myers Squibb have raised prices so far this month, according to data provided by 46brooklyn Research, a nonprofit that researches drug pricing. The amount consumers pay depends on their insurance coverage and complex rebates are often hidden from public view.
Through the first three weeks of January, drugmakers raised prices on 985 products.
Pharma Companies: A Conglomerate of Monopolies
When it comes to claiming market control, pharmaceutical companies stand apart from healthcare’s other monopolies. Whereas hospitals and health systems rely primarily on mergers and acquisitions, drug companies employ a slew of powerful tactics: from legislative protections and legal loopholes to stonewalling would-be competitors and more.
But there is one thing that unites all healthcare monopolies: As their powers expand, they become complacent. And when that happens, innovation dies and Americans pay the price, both with their wallets and their health.
The rising price of prescription drugs has sparked outrage for more than a decade. That’s largely because medications aren’t like other expensive products.
Monopolistic pricing in healthcare is both excessive and unfair, leaving millions of patients with only one choice: pay up or suffer. Drug companies know that’s not really a choice, and they take full advantage. Last year, Americans paid $460 billion for prescription drugs, accounting for 16.7% of all healthcare expenditures.
I Wrote About High-Priced Drugs for Years. Then My Toddler Needed One.
When a salmon-colored rash flared on my 3-year-old son’s tummy one afternoon in August, I shrugged it off. The next time I asked Evan to lift up his shirt to take a photo, it was gone. When he stopped sleeping through the night, I thought it was a dreadful new developmental phase. But then on a Saturday, he stopped walking and spiked a 104-degree fever. A nurse gave me clear directions: “Get in your car, and start driving to the ER.”
After days in the hospital, the doctors had ruled out a long list of infections, as well as scary conditions like leukemia. That left them circling around a rare type of childhood arthritis called systemic onset juvenile idiopathic arthritis, or sJIA, in which the innate immune system, the body’s first line of defense against pathogens, goes haywire. Young children are tormented by daily spiking fevers, a fleeting rash and arthritis. Some develop a life-threatening immune activation syndrome. Untreated, destructive joint damage can occur. We were in shock.
But the doctors mentioned a drug that they’d probably want to try — anakinra, a biologic drug that blocks a key prong of the immune system and quells inflammation. Like most rare disease drugs, anakinra (also known by the trade name Kineret) was obscure, but I’m a health and science reporter and I’d heard of it. In 2020, I interviewed a pediatric rheumatologist, Randy Cron at the University of Alabama at Birmingham, who wanted to test whether anakinra could help people with severe COVID-19.
Anakinra is expensive — on average, private health plans pay about $4,000 a month for it — so we needed to get approval before it would be covered. In early September, Aetna denied the request, requiring an additional test. Our doctors ordered the test and appealed.
In October, after another emergency room visit, daily spiking fevers, $2,000 of bloodwork and a growing feeling of despair about whether our son would ever be able to walk or play normally again, I received a letter from Aetna. It was a decision to “uphold the denial” to cover the drug, and it came from a team led by a urologist, a medical specialty that would not typically treat sJIA.
Valley Fever, Historically Found Only in the Southwest, Is Spreading. It Can Have Devastating Consequences.
Devin Buckley was home in Chicago for spring break when the previously healthy 18-year-old wound up in the intensive care unit, struggling to breathe. It was there that he was finally diagnosed with Valley fever after a family friend suggested the doctors test for it.
Valley fever is an infection caused by breathing in spores of the fungus coccidioides. The spores can survive through heat and drought, lingering in the soil. When the dirt is disturbed — through construction, wind or even walking — the spores can be lofted into the air. The fungus is endemic to the hot, dry soils of the Southwest; 97% of all U.S. cases of Valley fever are reported in Arizona and California, according to the California Department of Public Health.
But that could change: Fungal infections, including Valley fever, are increasingly being diagnosed outside of their usual ranges. One study in the journal GeoHealth projected that, due to climate change, the range of Valley fever could spread east, through the Great Plains and north, to the Canadian border, before the end of the century.
Scientists have been trying to develop a vaccine for Valley fever since the 1960s, according to the CDC. In the 1980s, one candidate was eventually tested in humans, but it didn’t work well. But in recent years, researchers at the University of Arizona College of Medicine in Tucson have developed a vaccine that’s highly effective in dogs. Dogs, like humans, are susceptible to Valley fever. The vaccine could be approved by the U.S. Department of Agriculture for use in dogs by early 2024. If so, it would be the first time the U.S. has approved a vaccine to protect against a fungal infection in animals or humans.
AbbVie’s Humira Gets a U.S. Rival, but Costs Could Stay High
U.S. patients will finally get access to cheaper versions of AbbVie Inc’s (ABBV.N) blockbuster arthritis drug Humira this year, but the cost savings are expected to be limited.
Rival drugmaker Amgen Inc (AMGN.O) on Tuesday launched Amjevita, the first biosimilar version of AbbVie’s 20-year-old drug, with two tiers of pricing. One sets a 5% discount to Humira’s monthly price of $6,922. The other will be about half price but may not be widely available.
At least another seven Humira biosimilars are expected this summer and could debut with discounted list prices. Even then, patient groups, pharmacists, doctors and academics said they will be obscured by the U.S. private insurance system of middlemen negotiation and after-market discounts called rebates.
Indonesia Finds Local Trader Forged Ingredient Label in Probe of Cough Syrup Deaths
Indonesian police said on Monday a local trader of industrial-grade chemicals sold them as pharmaceutical-grade, leading to their use in medicated syrups that authorities suspect may have caused the deaths of more than 200 children across the country.
Authorities have said two ingredients, ethylene glycol (EG) and diethylene glycol (DEG), found in some syrup-based paracetamol medications are linked to acute kidney injury, which many of the children suffered.
The two ingredients are used in antifreeze, brake fluids and other industrial applications, but also as a cheaper alternative in some pharmaceutical products to glycerine, which is a solvent or thickening agent in many cough syrups. They can be toxic and can lead to acute kidney injury.
Pipit Rismanto, a senior police official, told reporters authorities have found that CV Samudera Chemical sold “industrial-grade” EG and DEG as pharmaceutical-grade propylene glycol manufactured by Dow Chemical Thailand and supplied them to distributors of local drug-makers. Police have arrested and charged officials at Samudera and its distributor CV Anugrah Perdana Gemilang. More suspects may be named as the investigation continues, Pipit said.
