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Ten Doctors on FDA Panel Reviewing Abbott Heart Device Had Financial Ties With Company
When the FDA recently convened a committee of advisers to assess a cardiac device made by Abbott, the agency didn’t disclose that most of them had received payments from the company or conducted research it had funded — information readily available in a federal database.
One member of the FDA advisory committee was linked to hundreds of payments from Abbott totaling almost $200,000, according to a database maintained by the Department of Health and Human Services. Another was connected to 100 payments totaling about $100,000 and conducted research supported by about $50,000 from Abbott. A third member of the committee worked on research supported by more than $180,000 from the company.
The government database, called “Open Payments,” records financial relationships between doctors and certain other healthcare providers and the makers of drugs and medical devices. KFF Health News found records of Abbott payments associated with 10 of the 14 voting members of the FDA advisory panel, which was weighing clinical evidence for a heart device called TriClip G4 System. The money, paid from 2016 through 2022 — the most recent year for which the database shows payments — adds up to about $650,000.
The Abbott payments illustrate the reach of medical industry money and the limits of transparency at the FDA. They also shed light on how the agency weighs relationships between people who serve on its advisory panels and the makers of drugs and medical devices that those committees review as part of the regulatory approval process.
EU Regulator to Review Reports of Suicidal Thoughts and Weight Loss Drugs
A European Medicines Agency committee will this week hold a meeting related to its probe into reports of suicidal thoughts after taking diabetes and weight loss drugs such as Novo Nordisk‘s (NOVOb.CO) Ozempic, an agenda showed on Monday.
The agency began its review into the class of weight loss and diabetes drugs, known as GLP-1 receptor agonists, last July after Iceland’s health regulator flagged three cases of patients thinking about suicide or self-harm after using Novo’s drugs — diabetes drug Ozempic and weight-loss treatment Saxenda.
The list of drugs the EU regulator was looking into includes Novo’s Rybelsus, Saxenda and Victoza and Xultophy, apart from Ozempic and Wegovy.
A preliminary review by the U.S. Food and Drug Administration in January this year found no such link. Still, it warned it could not definitively rule out a small risk due to limited data.
Recovery From Antibody-Mediated Biliary Ductopenia and Multiorgan Inflammation After COVID Vaccination
The coronavirus disease 2019 (COVID-19) pandemic has caused significant morbidity and mortality. Spike messenger RNA (mRNA)-based vaccines against severe acute respiratory syndrome coronavirus may contribute to immune-mediated injuries.
Here we present a case of a previously healthy 47-year-old man, who developed progressive jaundice 2 weeks after receiving his 3rd COVID-19 vaccination (1st mRNA-based vaccine). Apart from elevated serum total bilirubin levels (peaked at >70 mg/dL), deteriorating renal (blood urea nitrogen: peak, 108.5 mg/dL; creatinine: peak, 6 mg/dL) and exocrine pancreas (amylase: peak, 1717 U/L; lipase: peak, 5784 U/L) profiles were also seen.
While these mRNA-based vaccines have demonstrated good safety and efficacy overall, they have been used worldwide for the first time in human history, and rare adverse events have been reported, such as myocarditis, rhabdomyolysis, vaccine-induced immune thrombotic thrombocytopenia, and autoimmune diseases.
While cases of autoimmune hepatitis and kidney diseases have been reported individually, there is limited information regarding multiorgan injuries post-vaccination, and the underlying mechanisms remain poorly understood. Here we present a case involving severe cholangiopathy and multiorgan injury (liver, kidney, and pancreas) following COVID vaccination and explore the potential underlying mechanisms.
Many Cancer Drugs Still Unproven 5 Years After Accelerated Approval
U.S. News & World Report reported:
New research questions the effectiveness of the U.S. Food and Drug Administration‘s accelerated drug approval program after finding that many cancer drugs remain unproven five years later.
The study, published Sunday in the Journal of the American Medical Association and presented simultaneously at the American Association of Cancer Research’s annual meeting in San Diego, found that 46 cancer drugs were granted accelerated approval between 2013 and 2017.
Of those, 41% showed no benefit after five years of follow-up. And of the 63% that were converted to regular approval, less than half (43%) demonstrated any clinical benefit in confirmatory trials.
Judge Slashes Bayer $1.56 Billion Roundup Verdict to $611 Million
A Missouri judge slashed a $1.56 billion verdict against Bayer (BAYGn.DE) to $611 million for three people who claimed its Roundup weed killer caused their cancer, by reducing punitive damages. Bayer said on Friday it is appealing.
The German company’s Monsanto unit had been found liable in November by a Cole County, Missouri, jury to Valorie Gunther of New York, Jimmy Draeger of Missouri and Daniel Anderson of California, who blamed their non-Hodgkin’s lymphoma on their exposure to Roundup.
The German company’s Monsanto unit had been found liable in November by a Cole County, Missouri, jury to Valorie Gunther of New York, Jimmy Draeger of Missouri and Daniel Anderson of California, who blamed their non-Hodgkin’s lymphoma on their exposure to Roundup.
House Committee to Press FDA Commissioner Robert Califf on Shortage Oversight, Other Issues
Amid ongoing drug shortages and other headline-grabbing issues that fall under the FDA’s purview, the House Committee on Oversight and Accountability is putting the agency’s commissioner Robert Califf, M.D., on the hot seat.
In what could be a heated culmination of multiple concurrent House investigations, the committee is set to press Califf in an April 11 public hearing that will seek to “hold the commissioner accountable for what the FDA is doing to address ongoing crises,” committee Chairman James Comer, R-Kentucky, said in a press release.
Outside of the drug shortage probe, the hearing is set to explore the FDA’s response to the nationwide infant formula crisis, its regulation of tobacco and nicotine products as well as hemp and CBD-derived products, plus efficacy concerns surrounding certain over-the-counter decongestants.
Scientists Develop Vaccine Against Lethal Xylazine, Often Mixed With Street Drugs
U.S. News & World Report reported:
A new vaccine might be able to block the toxic effects of the animal tranquilizer xylazine, which is being added to illicit drugs and increasing overdose risk. The vaccine trains the immune system to attack the drug, and has been effective in animal trials, researchers said.
Researchers sought to create a targeted vaccine that would initiate an immune response to xylazine, protecting the body against the drug’s effects.
The team tested three vaccine formulations in which a xylazine molecule was paired with different protein types, in hopes of prompting an immune response that would create anti-xylazine antibodies.
Vaccine-by-Mouth Could Replace Antibiotics in Fighting UTIs
U.S. News & World Report reported:
A new oral vaccine could prove a potential alternative to antibiotics for people with recurring urinary tract infections, a new study says.
Developed by the Spanish pharmaceutical company Immunotek, the MV140 vaccine contains four bacterial species in a pineapple-flavored suspension of water, researchers said. These bacteria prompt the body to produce infection-fighting antibodies. The vaccine is administered with two spritzes under the tongue every day for three months.
“Further research into more complex UTIs is needed, as well as research looking at different groups of patients, so we can better optimize how to use this vaccine,” added Dr. Gernot Bonkat, a professor at the Alta Uro Medical Centre for Urology in Switzerland, who was not involved in the research. “While we need to be pragmatic, this vaccine is a potential breakthrough in preventing UTIs and could offer a safe and effective alternative to conventional treatments.”
Researchers presented these findings Sunday at a meeting of the European Association of Urology in Paris. Results presented at medical meetings should be considered preliminary until published in a peer-reviewed journal.
Examining High Drug Costs in America. What You Need to Know
Soaring drug prices in America have left many Americans unable to pay for medications and treatments that could otherwise improve their health and well-being. 58 million Americans have experienced medication insecurity, or the inability to pay for a medication in the last 12 months, according to a Gallup report published by Senator Chuck Grassley.
So why are medications astronomically higher in America than essentially every other country on the globe? The answer is not straightforward and there are a multitude of factors that contribute to high drug costs in America. A major reason lies in the lack of government regulation on pharmaceutical costs. In many countries, the federal government regulates and negotiates the final price of a drug with drug makers.
In the United States, with very few exceptions, drug companies can set their own prices on different drugs based on market demand. Pharmaceutical companies argue prices need to be high to drive innovation and fund research necessary to develop cures and cutting-edge therapies for an array of diseases. The average cost to bring a drug through clinical trials is $2 billion, according to a statement published in MedPage Today.
Although high drug prices may be necessary to drive research and innovation, Senator Bernie Sanders points out the greed in big pharma. In the recent hearing on high drug costs, he explained that Bristol Myers Squibb spent $3.2 billion more on stock buybacks and dividends than research, and Johnson & Johnson spent $46 billion more on stock buybacks and dividends than research since 2012.
