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Fentanyl Plus Stimulants Drives ‘Fourth Wave’ of Overdose Epidemic in the U.S.
The U.S. is in the throes of what researchers have deemed a “fourth wave” of the opioid crisis, a phase characterized by overdose deaths caused by the combination of stimulants and the powerful synthetic opioid fentanyl.
Overdose deaths in the U.S. surpassed 100,000 for the first time in 2021, fueled by the rise of synthetic opioids, which accounted for 75% of those deaths. Once propelled by prescription opioids and then heroin, the decades-long crisis was overwhelmed by synthetic opioids in the mid-2010s.
The proportion of overdoses involving fentanyl and a stimulant — most commonly cocaine and methamphetamine — increased more than fiftyfold from 2010 to 2021, a study published Thursday in the journal Addiction found.
DeSantis’ Administration Advises Against Updated COVID Shots for People Under 65
Florida Gov. Ron DeSantis’ administration on Wednesday advised against the updated COVID-19 shots for people under the age of 65 — a rebuke to federal agencies, which greenlit the shots for anyone 6 months and older earlier this week.
“I will not stand by and let the FDA and CDC use healthy Floridians as guinea pigs for new booster shots that have not been proven to be safe or effective,” the governor said in a statement Wednesday. “Once again, Florida is the first state in the nation to stand up and provide guidance based on truth, not Washington edicts.”
State Surgeon General Dr. Joseph Ladapo has espoused vaccine-skeptical ideas and landed in hot water earlier this year for allegedly altering data to suggest vaccines pose a higher health risk for young men than they really do. At the time, Ladapo released a statement to Politico reading: “To say that I ‘removed an analysis’ for a particular outcome is an implicit denial of the fact that the public has been the recipient of biased data and interpretations since the beginning of the mRNA COVID-19 vaccine campaign.”
Florida is defending its position because the updated shots “recommendation was based on the fact that the newly FDA approved COVID boosters lack a human clinical trial and evidence of benefit or efficacy,” according to the Florida news release.
Is America Going Too Far on COVID Vaccines?
With cases of COVID-19 in the U.S. once again on the rise, despite government officials finally declaring the end of the health emergency earlier this year, the Centers for Disease Control and Prevention (CDC) recommended on Tuesday that all Americans aged 6 months and older receive at least a booster shot of the latest COVID-19 vaccine.
A day before the announcement, the Food and Drug Administration approved a new formula for the Pfizer-BioNTech and Moderna vaccine that takes new variants into account.
Many governments around the world are recommending booster shots for the most vulnerable categories in their population. But American authorities are recommending it for just about everyone to protect them against serious illness.
But is America going too far — or are other countries not going far enough?
Pharmacies’ Appeal of $650 Million Opioid Judgment Heads to Ohio Top Court
A federal appeals court weighing whether to uphold a $650 million judgment against pharmacy operators CVS (CVS.N), Walmart (WMT.N) and Walgreens (WBA.O) for fueling the opioid epidemic in parts of Ohio has asked the state’s highest court to weigh in first.
The Cincinnati-based 6th U.S. Circuit Court of Appeals on Monday said that the pharmacies’ appeal of the judgment won by two Ohio counties raised “novel and unresolved questions” of whether state law permits the public nuisance claim the case was centered on.
The 6th Circuit canceled the Oct. 20 oral arguments that had been set in the case. U.S. Circuit Judge Richard Griffin cited a lack of “controlling precedent from the Ohio Supreme Court to guide us” in asking that court to weigh in first.
The case brought by Ohio’s Lake and Trumbull counties was the first the three companies had faced at the trial of the thousands of lawsuits filed by states and local governments against drug makers, distributors and pharmacies over the deadly U.S. opioid addiction crisis.
In New Regeneron Deal for COVID Drug, White House Imposes Price Limits for First Time
A groundbreaking clause in a new deal between the Department of Health and Human Services and the pharmaceutical company Regeneron marks the first time the Biden administration has directly used its leverage to challenge drugmakers’ list prices, experts told STAT.
The contract between Regeneron and the government requires that the list price for a future monoclonal antibody drug to prevent COVID-19 is the same or lower in the United States as in other high-income countries. The release doesn’t explain which countries the government will be comparing prices with, or how pricing data will be determined.
The deal was part of the White House’s Project NextGen initiative, which includes $5 billion in new vaccines and therapies. HHS announced that it is spending $326 million to help Regeneron develop a new monoclonal antibody to prevent COVID-19. Regeneron in January announced plans to start testing a potentially variant-proof antibody, which is set to go into clinical trials later this year.
Popular OTC Medicines for Colds and Allergies Don’t Work, FDA Panel Says
Phenylephrine, a popular ingredient in many over-the-counter allergy and cold medicines, is ineffective in tablet form, an independent advisory committee to the U.S. Food and Drug Administration agreed Tuesday.
Phenylephrine is the main ingredient used in products like Benadryl Allergy Plus Congestion, Sudafed PE and Vicks Sinex.
The ingredient is considered safe to use; that was not up for debate. But many doctors have questioned phenylephrine’s effectiveness for years. These products generated nearly $1.8 billion in sales last year alone, according to data from the FDA that was presented to the Nonprescription Drugs Advisory Committee on Monday during the committee’s two-day meeting.
Cough Syrup Killed Scores of Children. Why No One Has Been Held to Account
Irfan was one of at least 16 children whom authorities in India’s northern region of Jammu and Kashmir found had been poisoned. Twelve died after their kidneys and other organs failed, a police charge sheet showed; four others were left with severe disabilities.
Investigations by police and state drug inspectors pointed to medicines made by one manufacturer, Digital Vision Pharma. The family-owned business is based in the neighboring state of Himachal Pradesh, a center for India’s pharmaceutical industry and one of Asia’s biggest drug manufacturing hubs.
Government analyses of the syrups made by Digital Vision that the children took — as well as samples taken from the company’s factory and its distributor in early 2020 — found they contained a 34% concentration of the toxin diethylene glycol (DEG), according to the charge sheet for an ongoing criminal case against Digital Vision’s owners and an investigative report by Jammu and Kashmir’s drugs regulator, both seen by Reuters.
The rash of poisonings has led to criminal probes, lawsuits and a surge in regulatory scrutiny in India and abroad. Indian regulators have conducted a wave of inspections this year that found possible violations in nearly nine in 10 of some 160 factories targeted. Still, despite intense lobbying on behalf of the families of the children in Jammu, no one has yet been found guilty in a court of law for the cough syrup deaths.
Proposed $35 Price Cap on Insulin Heads to Gov. Gavin Newsom’s Desk
A proposal by a Bay Area lawmaker that would cap the cost of insulin to $35 is heading to Gov. Gavin Newsom’s desk after being unanimously approved by state legislators.
Senate Bill 90 by State Sen. Scott Wiener (D-San Francisco) passed the Assembly with a 63-0 vote and the State Senate on a 39-0 vote. The measure would ban co-pays over $35 for a 30-day supply of insulin and prohibit health plans from imposing a deductible on insulin prescriptions.
The measure comes as the price of insulin has risen substantially in the past decade. As a result, many people with diabetes have incurred thousands of dollars in credit card debt to pay for the medication or have rationed their insulin to save money.
Moderna Says Flu Vaccine Showed Promising Results in Phase Three Trial, Paving Path to Approval
Moderna on Wednesday said its experimental mRNA-based flu vaccine produced a stronger immune response against four strains of the virus than a currently available flu vaccine in a late-stage trial, clearing the way for a path to approval in the U.S.
The results come as Moderna tries to beef up its pipeline and become a company known for more than its blockbuster mRNA COVID vaccine, which won more approvals from U.S. regulators this week. Moderna expects its COVID shot — its only commercially available product — along with its flu jab, and other experimental respiratory vaccines to make up to $15 billion in sales by 2027.
An interim analysis of the trial found that mRNA-1010 produced higher antibody levels for all four influenza strains recommended by the World Health Organization — two each for influenza A and B — compared to Fluarix. Moderna’s flu shot also generated higher seroconversion rates, which refers to the development of specific antibodies against a virus.
Moderna said the safety findings were similar in the trial to previous ones, which found muscle pain, headache, fatigue, pain and swelling as the most common side effects of mRNA-1010.
In Warning Letters, FDA Tells 8 Companies to Stop Selling Illicit Eye Drugs
Eight companies are finding themselves in hot water for allegedly churning out illicit eye drugs, the FDA said Tuesday.
The drugs are unapproved and illegally marketed, the FDA said, which is especially risky considering that medications administered through the eye bypass some of the body’s natural defenses. The illegal therapies are purportedly used to treat diseases such as pink eye, cataracts, glaucoma and more, according to the agency’s release.
The companies in the warning letter sweep are Boiron, CVS Health, DR Vitamin Solutions, Natural Ophthalmics, OcluMed, Similasan, TRP Company and Walgreens Boots Alliance.
