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When Should We Start Making H5N1 Vaccine, and Who Will Make That Decision? In Short, It’s Complicated
If the H5N1 bird flu virus ever acquires the ability to transmit easily to and among people — keep your fingers crossed that it doesn’t — the world is going to need serious amounts of vaccine. Like, lakes of the stuff.
Some manufacturers have been working with H5N1 viruses for years, producing small batches of doses that have undergone preliminary human testing. Some millions of doses — in the low double digits — have even been stockpiled by the U.S. government.
But deciding when to start producing the H5N1 vaccine at scale, in the quantities needed to vaccinate the world, is no easy feat. It’s a high-cost, high-risk endeavor. Get it right and you save lives. Hesitate, and lives will be lost. But making the call if the vaccine turns out not to be needed is not a cost-free decision either.
A number of the mRNA manufacturers, Pfizer and Moderna among them, have been working on, but have not yet licensed seasonal flu vaccines. Without a seasonal product line to disrupt, it would be easier for those players to make pandemic vaccines — should they choose to enter the market. But there would need to be the promise of sales.
GSK Whistleblower Claims Drugmaker Cheated U.S. Government Over Zantac Cancer Risk
GSK (GSK.L) has been sued by an independent Connecticut laboratory that accused the drugmaker of defrauding the U.S. government and taxpayers by concealing cancer risks in Zantac, once a blockbuster heartburn drug. In a whistleblower complaint filed on Monday, Valisure said GSK violated the federal False Claims Act by hiding the risks for nearly four decades while Medicare, Medicaid and other health programs covered billions of dollars of prescriptions.
The New Haven-based lab said its testing in 2019 revealed that Zantac, also known as ranitidine, could form a cancer-causing carcinogen known as NMDA and was therefore “unfit for human consumption.” It said GSK concealed the same result from the U.S. Food and Drug Administration, which approved Zantac in 1983.
Valisure is seeking billions of dollars in damages from GSK, including civil fines of up to $11,000 per violation, in a complaint filed in Philadelphia, where some of the British drugmaker’s operations are based.
More than 70,000 private lawsuits over Zantac remained pending this month in U.S. courts. Most are in a Delaware state court, where a judge is weighing whether the cases can proceed. The first trial over Zantac’s link to cancer began this month in Chicago and may end this week.
Ombudsman: Health Ministry Didn’t Check 82% of Reports on COVID Vaccine Side Effects
State Comptroller Matanyahu Englman’s office released a report Tuesday criticizing the Health Ministry’s conduct during the COVID-19 pandemic, revealing that the ministry didn’t process or analyze thousands of reports it had received about various vaccine side effects.
In 2021, the Health Ministry received some 345,200 reports on side effects caused by the coronavirus vaccine, sent by hospitals and Health Maintenance Organizations, the Comptroller’s Office said, but just 18% of reports were accurately recorded in the ministry’s database. The other 82% of reports were lost due to technical errors and system malfunctions.
The Health Ministry also failed to process an additional 33,000 reports filed by the public regarding side effects due to limited ability to analyze reports filed anonymously. Adding to that, a lack of manpower in the ministry’s Department of Epidemiology meant that reports that contained identifying details were also unable to be reviewed and investigated.
As a result of the missing data, the Health Ministry based its findings on the safety of the COVID-19 vaccine on just 55,000 reports.
In Pharma Tax Probe, Wyden Puts Pfizer in Hot Seat With CEO Letter
Three years into a Senate Finance Committee investigation into Big Pharma’s tax strategies, committee Chair Ron Wyden, D-Oregon, has set his sights on Pfizer.
By sending a letter to Pfizer CEO Albert Bourla, Ph.D., Wyden hopes to learn more about the tax payments made by the pharma giant in recent years. The senator noted that the company’s 9.6% tax rate in 2022 — and its negative tax rate last year — were “substantially lower” than the U.S. corporate tax rate of 21%.
“Despite generating over $364 billion in sales over the last six years, Pfizer incomprehensibly pays a lower tax rate than millions of working American families,” Wyden wrote in the letter. While Pfizer generated 42% of its global sales in the U.S. in 2022, the company only booked 16% of its profits in the U.S. that year, according to Wyden.
In his letter, Wyden asked the company to provide detailed documents showing information about its taxes and earnings, specifically those that could shine light on tax incentive agreements in Puerto Rico, Singapore and potentially Ireland.
FDA Sued by Scientist Urging Sexual Side Effects Warning for Widely Used Depression Drugs
A Howard University scientist on Monday sued the U.S. Food and Drug Administration for failing to act on his six-year-old petition seeking a warning label for two classes of common antidepressant drugs about the potential for persistent sexual side effects. In a complaint filed in Washington, D.C. federal court, Antonei Csoka said the FDA has “unreasonably delayed issuing a decision in light of the nature and extent of the public health interests addressed in the petition.”
Csoka was one of 22 scientists who filed the so-called citizen petition with the FDA in May 2018, urging the agency to require an update to warning labels of selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs).
Current warning labels for the drugs — which include Eli Lilly‘s Prozac, Viatris’s Effexor and generic versions of them — warn of sexual side effects during use. The petition said research has shown that these side effects, including loss of sexual function and pleasure, can persist after the drugs are discontinued.
Csoka’s lawsuit said that the FDA ran afoul of its own regulations, which generally require a response to citizen petitions within 180 days. It said that the agency issued an interim response in November 2018 saying the petition required further review but has since not made a decision or taken any actions requested in the petition.
Moderna and Novavax Hope for Early Launch of This Year’s COVID Shots, Despite FDA Delay
U.S. vaccine makers say that the Food and Drug Administration’s delay in designing this fall’s COVID-19 vaccines shouldn’t push back the rollout of the shots, amid rapid shifts in the genetic makeup of the virus.
Vaccine makers Moderna and Novavax are hoping for an August rollout this year, earlier than last year’s late September debut of updated shots. Moderna CEO Stéphane Bancel recently told Barron’s that launching the shots in August instead of September could add three million doses to the market.
Uptake of Flu, Whooping Cough, and COVID Vaccines Remains Low Among Pregnant Women
A study conducted by researchers at the University of Warwick has unveiled crucial insights into the complex factors shaping vaccination decisions among pregnant women, particularly in the wake of the COVID-19 pandemic.
Despite the availability of free vaccinations for pregnant women in the U.K., of those who gave birth in England in October 2021, 29.4% had received two doses of the COVID-19 vaccine, compared to approximately 60.4% of the general population.
The study, titled “What factors influence the uptake of vaccinations amongst pregnant women following the Covid-19 pandemic: A qualitative study,” published in Midwifery, interviewed pregnant women aged between 19 and 41 exploring their perceptions, experiences, and the factors influencing their decisions regarding vaccinations.
Dr. Jo Parsons from the University of Warwick who led the research said, “This research demonstrates the influence that the COVID-19 pandemic has had on pregnant women’s views and uptake of recommended vaccinations and is further evident by the continuing decline in uptake since the pandemic.”
Hawaii Court Orders Drug Companies to Pay $916 Million in Plavix Blood Thinner Lawsuit
A Hawaii court has ordered the manufacturers and distributors of the blood thinner Plavix to pay the state a combined $916 million after finding the companies failed to disclose the efficacy and safety of the medication, the state attorney general said Tuesday.
The judgement was issued against Bristol Myers Squibb Company and three U.S.-based subsidiaries of French pharmaceutical company Sanofi.
“As Judge Ashford found following a trial, these pharmaceutical defendants acted in bad faith and marketed a product that could potentially have devastating effects on Hawaii patients, when they knew that the medicine would lack efficacy for a substantial portion of the population,” Attorney General Anne Lopez said in a statement.
Hawaii was the fifth state to file a lawsuit claiming unfair and deceptive marketing of Plavix, after Louisiana, Mississippi, West Virginia and California.
FTC Oversight of Pharmaceutical Sector ‘Minimal’ Over Last 20-Plus Years — the Agency Pursued a Handful of Actions per Year, Allowed 61 of 62 Mergers It Challenged
The Federal Trade Commission (FTC) pursued about one merger action and three enforcement actions per year in the pharmaceutical industry over the last two decades, accounting for only a sliver of the alleged misconduct in the sector, a study of publicly available documents showed.
From 2000 to 2022, the FTC initiated or completed a total of 85 actions in the pharmaceutical sector, including 62 challenges of mergers, 22 enforcement actions against allegedly unlawful business practices, and one rule related to pharmaceuticals, reported Aaron Kesselheim, MD, JD, MPH, of Brigham and Women’s Hospital and Harvard Medical School in Boston, and colleagues.
Of the 62 mergers the FTC challenged, 61 were given the green light after settlements, and one was abandoned. The 22 enforcement actions led primarily to settlements, as well as one FTC order and one judgment in the agency’s favor, they noted in JAMA.
A review of the breadth and type of actions taken by the agency suggests it hasn’t exercised its full potential in this sector, Kesselheim told MedPage Today, noting that it’s “remarkable” how few mergers the agency challenged, given their numbers.
