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She Thought It Was Xanax. She Died of Fentanyl Poisoning. Just One Fake Pill Can Kill.
U.S. deaths from drug overdose remain historically high with more than 105,000 estimated fatalities in 2022. The crisis continues to be largely fueled by fentanyl, a highly addictive synthetic opioid that is deadly in the tiniest dose. And now a new type of drug is pushing overdose deaths higher: fake or counterfeit pills. Not the kind of illicit drug you buy from a dealer on a dark street corner.
These are marketed as real prescription drugs for patients being treated for ailments like cancer, diabetes or depression. But they are largely unregulated and sold online, through social media, or in foreign pharmacies at a cheaper price than at your neighborhood pharmacy.
At best, these fake pills don’t work. At worst, they can kill you.
According to a recent report by the Centers for Disease Control and Prevention, overdose deaths involving counterfeit pills more than doubled between the summer of 2019 and late 2021.
Public health and law enforcement officials warn that the fake pills are made to look like legitimate pharmaceutical pills like Percocet, Vicodin, Viagra and Adderall.
COVID Inquiry Postpones Vaccine Investigation
The COVID inquiry will not start hearing evidence about the development of vaccines and other drugs this summer, as originally planned.
Witness hearings will be postponed until a later date, likely to be after the next general election. Baroness Hallett, who is chairing the inquiry, recognized the decision would be “disappointing for some.” But she said more time was needed to prepare for a separate investigation into the impact of COVID on the NHS.
The module investigating vaccines and therapeutics was originally expected to start in the summer of 2024, but that has now been postponed.
The investigation into vaccines was meant to look in detail at the rollout of jabs across the U.K., including the setting up of the U.K. vaccines taskforce and the role of the Joint Committee on Vaccination and Immunisation.
It will also cover concerns around vaccine safety, including any suggested link between the jabs and heart issues, and whether reforms are needed to the scheme which is meant to pay out if an individual’s health is damaged after taking the jabs.
FDA Pushes Back on Calls for Safety Tests of Generic Drugs
For decades, FDA has used paperwork reviews and occasional plant inspections to ensure that companies make safe products. Because the agency believes that quality and safety are the manufacturer’s responsibility, it does not routinely test the medicines themselves.
Pharmaceutical companies spend huge sums of money to create new drugs and secure the FDA’s approval for sale, so they can’t afford to slip up. But when a drug’s patent expires and competitors start offering low-cost generic copies, the FDA’s “honor system” can break down. In the cutthroat world of generic drug manufacture, the cheapest producer usually wins — whether they follow the rules or not.
Intense global competition pushed most generic drug and ingredient production overseas to countries with low labor costs and weak regulatory controls. Once that happened, reports of contaminated or understrength drugs grew. Rather than recognize and respond to the threat, the FDA kept assuring the public that “You can take a generic medicine as an equal substitute for its brand-name counterpart.” This statement implies that all generic drugs sold in the U.S. are equally safe and effective.
Although most meet minimum quality standards, not all of them do. Currently, American patients, doctors and hospitals have no way to differentiate high-quality generic drugs, and the companies that make them, from the manufacturers that cut corners. The FDA’s approach to monitoring can take years to spot a problem. The only way to strengthen the process is to independently evaluate the quality of our generic medicines in accredited labs before they are sold.
There’s only one problem. The FDA hates the idea.
Weight-Loss Products Should Not Be Sold to Under-18s, Experts Warn
The study, published on Thursday in the Journal of the American Medical Association, finds nearly one in 10 adolescents have used a medically unapproved weight-loss product. It finds the prevalence of 12- to 18-year-olds using diuretics, laxatives and diet pills without a prescription from a doctor was 2% in the past week, 4% in the past month, 6% in the past year and 9% in their lifetime.
Unprescribed weight-loss products are not medically recommended for children because they do not work, are dangerous for both their physical and psychological health, are associated with unhealthy weight gain in adulthood, and increase the risk of developing an eating disorder, the researchers say.
Bryn Austin, a professor at the Harvard School of Public Health and co-author of the paper, says the public health issue is commercially driven, with manufacturers aggressively marketing these products to young people through advertising and influencers on social media.
“These products have been linked with stroke, heart attack, liver injury, kidney injury, and death, and this has happened around the world. So this global study … is such an important contribution here to be able to see this is not just happening in Australia, or the United States or the U.K. This is happening in many places around the world.”
FDA’s Califf Calls for More Plain-Language Scientific Evidence to Dilute Vaccine Misinformation
FDA commissioner Robert Califf has urged the clinical and biomedical community to step up efforts to counter vaccine misinformation with “accurate plain-language information” about the benefits and risks of vaccination.
Califf and Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, finger “the large volume of vaccine misinformation” as a driver of hesitancy. With some people preferring “social media narratives over evidence-based vaccine information” from clinicians, the FDA leaders are urging “the clinical and biomedical community to redouble its efforts to provide accurate plain-language information regarding the individual and collective benefits and risks of vaccination.”
Califf and Marks’ request reflects a belief that the best way to counter misinformation is “to dilute it with large amounts of truthful, accessible scientific evidence.” One challenge is that statistics and facts can fail to move people in the same way as narrative tactics employed by people who are opposed to vaccines.
Novo Nordisk Supports Consolidation of Wegovy, Ozempic Stomach Paralysis Lawsuits in MDL
In response to a growing number of Wegovy and Ozempic stomach paralysis lawsuits being filed in U.S. District Courts nationwide, Novo Nordisk has joined with plaintiffs in asking a panel of federal judge to consolidate and centralize the claims before one judge for coordinated discovery and pretrial proceedings.
More than 40 complaints have been brought throughout the federal court system against Novo Nordisk and the manufacturers of similar weight loss and diabetes drugs, known as glucagon-like peptide-1 (GLP-1) receptor agonists, each raising similar allegations that users and the medical community were not adequately warned about the risk that side effects may cause permanent and debilitating stomach problems, known as gastroparesis or stomach paralysis.
In addition to the filed lawsuits, Ozempic stomach paralysis lawyers have reported that thousands of additional claims are under active investigation, and the size and scope of the litigation is expected to increase dramatically in the coming months and years. As a result, a group of plaintiffs filed a motion with the U.S. Judicial Panel on Multidistrict Litigation (JPML) last month, calling for the centralization of all stomach paralysis lawsuits against GLP-1 manufacturers as part of one federal MDL, or multidistrict litigation.
JPM24: Pfizer CEO Promises ‘Year of Execution’ After Recent Struggles, Seagen Buyout
Pfizer knows it had a bad year in 2023. Speaking to reporters at the 2024 J.P. Morgan Healthcare Conference on Monday, the company’s CEO, Albert Bourla, spoke bluntly about the hits the company took, and he acknowledged the underperformance of certain key launches.
But 2024 represents a fresh opportunity for the pharma giant, Bourla said. “In essence, you should expect 2024 — after all the changes in the setup that we did in year ’23 — to be a year of execution,” he told the JPM audience.
Pfizer will attempt to execute, in part, by leveraging its recent $43 billion buyout of antibody-drug conjugate specialist Seagen, Bourla explained. Further, the company hopes to advance its presence in respiratory syncytial virus (RSV), where Pfizer recently launched its vaccine Abrysvo.
Despite the struggles, Bourla maintains that several Pfizer successes last year have been “lost in translation.” Among those wins, Pfizer scored a “record” number of FDA approvals in 2023, the CEO added, pointing to green lights for nine new molecules.
