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COVID Vaccine Death of Rory Nairn: Report Highlights Failures in Informing Consumers of Risks
The New Zealand Herald reported:
The death of a Dunedin man may have been prevented if he had been given more information before consenting to the COVID vaccination that later claimed his life. That’s according to findings released by Coroner Sue Johnson today following Rory Nairn’s death from myocarditis in 2021.
And, in a second report also released today, the pharmacy where he was given the vaccination has been found to have breached his right to information, but the Health and Disability Commissioner won’t be taking disciplinary action due to the unprecedented circumstances of a worldwide pandemic.
Health and Disability Commissioner Morag McDowell has released her report concerning Nairn’s death, which the Coroner had earlier determined was directly caused by the Comirnaty (Pfizer/BioNTech) COVID-19 vaccine.
Nairn experienced chest discomfort and heart flutters following his vaccination at a pharmacy in November 2021 but was unaware that myocarditis was a potentially serious side effect. The symptoms persisted for 12 days before he decided to go to the hospital but tragically, he collapsed and died before reaching medical help.
Sarasota Memorial Hospital Board Will Consider Adopting Ladapo’s Anti-Vaccine Guidance
Sarasota Herald-Tribune reported:
The Sarasota County Public Hospital Board will weigh a proposal by board member Vic Rohe that the hospital embrace assertions by Florida Surgeon General Dr. Joseph Ladapo that COVID–19 vaccinations are risky and inappropriate for human use when it meets at 2 p.m. Tuesday.
In January, Rohe asked for the proposal — a five-page motion that he said members of the community handed him — to be placed on a future agenda.
There may be a large turnout for the meeting scheduled for the auditorium of the Waldemere Tower at 1700 S. Tamiami Trail, Sarasota, since James Hoel, president of the far-right America First Southwest Florida Caucus, urged members at the organization’s May 8 meeting to attend the hospital board meeting and support Rohe’s motion.
In January, Ladapo questioned the safety of mRNA COVID-19 vaccines and ultimately recommended against their use. The CDC defines mRNA as genetic material that tells the body how to make proteins that work on the COVID-19 virus to prompt an immune response that helps people fight off the illness.
In a December 2023, letter to the FDA, he voiced concerns that the messenger RNA vaccine could impact an individual’s DNA.
Study Links Talc Use to Ovarian Cancer — a Potential Boon for Thousands Suing J&J
New research published this week lends credence to the more than 50,000 lawsuits against Johnson & Johnson that allege its talc-based baby powder caused ovarian cancer.
The analysis, released Wednesday in the Journal of Clinical Oncology, found that applying talc powder to the genitals was associated with ovarian cancer — and that the association was greater for people who used the powder frequently or for long periods of time.
The researchers are from the National Institutes of Health, and their findings were based on data from the Sister Study, which enrolled more than 50,000 women in the U.S. from 2003 to 2009. The participants joined when they were between 35 and 74 years old, and each had a sister who’d been diagnosed with breast cancer, which might put them at increased risk for breast or ovarian cancer.
Lawsuits related to J&J’s talc-based baby powder date back to 1999, when a woman alleged that a lifetime of using it led to her mesothelioma, a rare cancer usually caused by exposure to asbestos — a known carcinogen. In 2009, another woman sued the company, alleging that its talc-based products caused her ovarian cancer. Since then, many thousands of others have filed claims over cases of ovarian cancer or mesothelioma that they say were caused by asbestos in J&J baby powder.
People Using Popular Drugs for Weight Loss, Diabetes Are More Likely to Be Diagnosed With Stomach Paralysis, Studies Find
Injected medications that treat diabetes and obesity increase the risk of a rare but serious side effect: stomach paralysis, according to new data on the real-world use of the drugs. At least three new studies based on large collections of patient records show that the risk of being diagnosed with stomach paralysis, or gastroparesis, is higher for people who take GLP-1 agonists than for those who don’t.
The drugs curb hunger by slowing the passage of food through the stomach. They also help the body release more insulin and help send signals to the brain that turn down cravings. In some people, however, these medications can also cause unpleasant-to-severe bouts of vomiting, which may require medical attention. They can also slow the stomach so much that medical tests show a condition called gastroparesis.
Most of the time, doctors say, gastroparesis will improve after stopping the medication. But some people say that their condition did not get better even months after coming off the drug, with life-altering consequences.
In the new studies, the risk of gastroparesis appears to be rare, but it is consistent. Compared with similar people who didn’t take GLP-1 medications, those who did had about a 50% higher risk of being diagnosed with the condition.
Moderna Wins COVID Shot Patent Case Against Pfizer-BioNTech in Europe
Moderna (MRNA.O) said on Friday the European Patent Office had upheld the validity of one of the company’s key patents, a win in an ongoing COVID-19 vaccine dispute with Pfizer (PFE.N) and BioNTech (22UAy.DE). The company has been locked in a legal battle with Pfizer-BioNTech over their COVID shot Comirnaty after suing them in 2022 for allegedly copying its mRNA technology.
Pfizer and BioNTech have countersued, alleging that Moderna’s patent is invalid, after the companies’ rival vaccines generated billions in revenues during the pandemic. Pfizer said it was disappointed and would consider all legal options and may appeal the decision.
“Irrespective of the outcome of this legal matter, we will continue to manufacture and supply the Pfizer-BioNTech COVID-19 vaccine,” Pfizer said in a statement to Reuters.
Pfizer, BioNTech and Moderna are also involved in parallel proceedings related to their patents in Germany, the Netherlands, Belgium, England and the U.S. Last month, a Massachusetts federal court put a patent lawsuit on hold, while the U.S. Patent Office determined whether two of the three Moderna patents at issue are valid.
After Covis’ Makena Pull, EU Regulator Flags Safety and Efficacy Problems With Similar Preterm Birth Drugs
Following a controversy over Covis’ preterm birth drug Makena in the U.S. last year, the European Medicines Agency (EMA) is cracking down on hydroxyprogesterone caproate therapies across the pond. This time, the drugs’ questionable efficacy isn’t the only issue at stake.
The EMA’s safety arm, the Pharmacovigilance Risk Assessment Committee (PRAC), on Friday, called for the marketing suspension of drugs containing 17-hydroxyprogesterone caproate (17-OHPC) in Europe, citing both safety and efficacy concerns.
The drugs, which go by the names Lentogest and Proluton, among others, are authorized as injections in some European Union (EU) countries to help prevent pregnancy loss or premature birth in pregnant women. They’re also used to treat various gynecological and fertility disorders, including those caused by a lack of the hormone progesterone.
The problem is, aside from limited data on the drugs’ clinical worth in preventing premature birth and other indications, 17-OHPC-based medicines pose a “possible but unconfirmed risk of cancer” in unborn children, PRAC said.
But aside from the potential safety risk, PRAC also weighed efficacy data, which included results from a study of more than 1,700 women that found 17-OHPC is “no more effective than placebo” in preventing recurrent premature birth or medical complications due to prematurity in newborns.
Prescription Drug Ads Should Soon Start Looking Noticeably Different
A new chapter in drug advertising begins Monday when a federal transparency rule takes effect requiring commercials to clearly spell out potential side effects and when a person should avoid the medicine. Why it matters: The effort, more than a decade in the making, could demystify those rapid-fire disclaimers at the end of TV and radio ads through steps like simultaneous text that is displayed long enough to be read easily.
It marks a major update of a 2007 law that expanded the Food and Drug Administration‘s authority in areas including advertising — a multibillion-dollar business for U.S. prescription drugs. The agency proposed updating its standards in 2010 but didn’t finalize new guardrails until last November.
The “major statement” of an ad, where the known risks are enumerated, also has to be clear and conspicuous, by limiting distracting audio or visual elements, like a person dancing to an upbeat song.
Yes, but: The new rule doesn’t address the flood of potentially misleading social media content promoting prescription drugs, including new weight-loss treatments like Wegovy, that’s prompted calls in Congress for updated enforcement.
How COVID Vaccines Stand Up to New FLiRT Variants
Nicknamed FLiRT, the new class of COVID subvariants has quickly spread through the U.S., with one strain, KP.2, becoming the dominant strain of coronavirus in the U.S. as of May 11, according to the U.S. Centers for Disease Control and Prevention.
Their nickname, FLiRT, derives from the position of the mutations in their spike proteins — projections on the virus surface that allow them to enter our cells. These proteins are also used as a target by our immune system and vaccinations. So what do these mutations mean for our immunity against the new strains?
“Even though the FLiRT subvariants are now quite genetically distant from the XBB subvariants — the current vaccine is based on XBB.1.5 — the vaccine will still give some cross-immunity against them,” said Adrian Esterman, an epidemiologist and professor of biostatistics at the University of South Australia. “[However,] there will be a new vaccine available around September, based on either JN.1 or one of the FLiRT subvariants, that will give much better protection.”
From what we know so far, he added, most infected adults experience the new variants as a typical flu-like illness which they will get over in a couple of days. “Probably, the biggest concern is the potential for long COVID, especially after repeated infections,” Esterman said.
A New Test Predicts Who Will Benefit Most From Weight-Loss Drugs
As popular as the new group of weight-loss drugs like Wegovy and Zepbound are, not everyone responds to them in the same way.
In a new presentation at the Digestive Disease Week conference in Washington, Mayo Clinic associate professor of medicine Dr. Andres Acosta reported that a genetic test he developed can identify which people are most likely to respond to semaglutide (Wegovy) and which are not.
The test, called MyPhenome, from a company Acosta co-founded called Phenomix, relies on a combination of genetic and other factors to categorize people into different types of weight gain. Acosta identified about two dozen genes linked to obesity, and more than 6,000 variants of these genes, to sort people who struggle with weight gain into four categories.
In his latest presentation (the results of which have not yet been published in a journal), Acosta reports that the MyPhenome test for Hungry Gut predicts with 75% accuracy who will respond to semaglutide.
