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FDA Defends COVID Vaccine Against Smoking Gun Claims
Anti-vaccine advocates have recently made allegations against the Pfizer COVID-19 vaccine in hopes that the charges may hurt the drug manufacturer. In a series of posts on X (formerly Twitter), Steve Kirsch expressed concern over reports that Pfizer‘s vaccine was contaminated, saying that the Food and Drug Administration (FDA) “is now at a crossroads.”
“Either they admit that they knew about the plasma contamination and failed to disclose that to the public and to the outside committees, or they can claim that they didn’t know about it in which case Pfizer is liable. But we have the Pfizer documents that were given to the FDA so we know what the FDA got,” Kirsch wrote.
He went on: “And I seriously doubt there’s any disclosure of SV40 contamination. That means we have an adulterated vaccine and the FDA has to remove it from the market until the adulteration is fixed. If the FDA doesn’t do that, they should face criminal prosecution for endangering the public, and not following the law.” (SV40 refers to simian virus 40.)
Newsweek reached out to Pfizer via email for comment.
An FDA spokesperson told Newsweek: “With over a billion doses of the mRNA vaccines administered, no safety concerns related to the sequence of, or amount of, residual DNA have been identified.”
Health Misinformation and Lack of Confidence in Vaccines Continue to Grow, Years After the COVID Pandemic, Survey Shows
Vaccine misinformation, which first began spiraling during the COVID-19 pandemic, has grown in the United States in the years since, according to a new survey from the Annenberg Public Policy Center of the University of Pennsylvania.
More than 1,500 adults responded to the survey between October 5 -12 and according to the results, the share of people who viewed vaccines as less safe and effective has increased since April 2021, when the group was first included on a panel for the survey.
Americans are less likely to consider it safe to get the measles, mumps and rubella (MMR), pneumonia and COVID-19 vaccines than they were in April 2021. While still a small group, people with views about the vaccines causing autism, cancer and illnesses such as the flu or COVID-19 also ticked up.
The percentage of Americans who believe that vaccines are approved for use in the U.S. are safe dropped 6 percentage points since April 2021 to 71%, while the share of adults who don’t think the approved vaccines are safe nearly doubled in the same time frame — increasing from 9% to 16%.
One H.S. in Virginia Had 8 Opioid Overdoses in 3 Weeks in Unprecedented Outbreak
Authorities are investigating an unprecedented outbreak of opioid overdoses at a single high school in Sterling, Virginia. Eight students at Park View High School have overdosed in the last three weeks, according to the Loudoun County Sheriff’s Office.
In total, the sheriff’s office is investigating nine opioid overdoses at Park View this year among male and female students. None of the overdoses were fatal, but each required some sort of medical intervention such as treatment, CPR or transport to a hospital.
Before the outbreak at Park View, the sheriff’s office had investigated nine opioid overdoses among young people in Loudoun County this year, bringing the annual total to 18 so far. In 2022, there were 19 such reports.
Thomas Julia, the communications director for the sheriff’s office, said all nine cases at Park View are believed to involve fentanyl since the students took round blue pills marked “M30” — one of the most common appearances of fentanyl that mimics oxycodone sold at pharmacies. Nevertheless, the sheriff’s office is sending the pills to laboratories to confirm that fentanyl was present, Julia said.
Big Pharma’s Shocking Move to Medicate Kids Without Parental Consent
Big Pharma is getting more aggressive with its tactics to gain control. Why? Because it’s threatened by the increasing number of people who are becoming more aware of their ploys. Not everyone trusts their doctors quite like they did before. COVID led to the collapse of the medical mirage, so people have questions. And people want answers. We are prodding the narrative: What exactly are its intentions with our children? What is going on with the number of vaccines? What is going on with pharmaceutical care?
Big Pharma is answering by passing legislation as to whether you should — or should not — have access to your children’s medical records, decisions, and medicines. CarolinaCARE is the first of what I’m sure will be many instances to come of medical professionals deeming children as adults so parents lose access to their children’s medical records.
CarolinaCARE is a home-delivery pharmacy service owned by Atrium Health and based out of North Carolina. But CarolinaCARE serves multiple states that have different laws pertaining to access to health information, which includes prescriptions, so they have sent out a notice to their clients because they are making a change “to remain compliant with laws in all the states CarolinaCARE services to ensure continued privacy of your child’s prescription records.”
Privacy from whom? From you, the parent. Starting November 1, children who are 12- to 17-year-olds must create new accounts on their website so they have access to their prescriptions and medications because their parents will no longer have access.
Moderna Takes Hefty $1.3 Billion COVID Write-Off, Scales Back Manufacturing as Sales Shrink
The days of booming COVID-19 vaccine sales, which sent Moderna into the ranks of pharma’s top companies, have passed. Now, the company is coping with low demand and taking inventory write-downs for “excess and obsolete” stock of its only marketed product.
Moderna’s third-quarter earnings report featured an array of financial losses and various charges. In total, the company recorded a net loss of $3.6 billion, $3.1 billion of which was tied to “resizing and tax allowances.” The drugmaker pulled down quarterly sales of $1.8 billion, which beat analysts’ consensus expectation of $1.45 billion.
But Moderna’s costs were a crucial hindrance for the quarterly performance. For example, the company took a $1.3 billion inventory write-down attributed to “excess and obsolete” COVID vaccine stock.
Moderna isn’t alone in taking sizable write-downs thanks to COVID vaccine overstock. Fellow mRNA player Pfizer reported $5.6 billion in charges during its third quarter, $900 million of which was attributed to its vaccine Comirnaty and $4.7 billion of which stemmed from antiviral Paxlovid.
Pfizer also took a revenue hit from a lack of COVID sales, reporting a 42% decrease to $13.23 billion for the third quarter.
Bayer Ordered to Pay $332 Million in Roundup Cancer Trial
A California jury on Tuesday found Bayer (BAYGn.DE) liable in a case brought by a man who claimed his cancer was due to exposure to the company’s Roundup weed killer, and ordered it to pay $332 million in damages.
The verdict includes $7 million in compensatory damages and $325 million in punitive damages awarded to plaintiff Mike Dennis, who was diagnosed at age 51 with a form of non-Hodgkin lymphoma, according to a spokesperson for the company.
The punitive damage award is almost certain to be reduced sharply, as the U.S. Supreme Court has found that punitive damages should be less than 10 times the compensatory damages in virtually all cases.
This marks the third trial loss for Bayer this month, after being hit by a $175 million verdict and a $1.25 million verdict in two separate Roundup trials. Before that, it had won nine consecutive trials over similar claims.
‘We Are Really Keen to Join Forces With Seagen’: Pfizer CEO on Plans to Acquire Cancer Drugmaker
Pfizer CEO Albert Bourla discussed his company’s plans to acquire cancer drugmaker Seagen in a Tuesday interview with CNBC’s Jim Cramer. “We are really keen to join forces with Seagen,” Bourla said. “We are going to kill cancer.”
The company plans to acquire Seagen in a $43 billion deal, and Bourla said he is “optimistic” it will close by year-end or early next year. He said Pfizer is in discussion with the Federal Trade Commission to approve the deal, and that the European Commission approved it earlier in October.
Pfizer’s Tuesday quarterly report failed to meet Wall Street’s expectations, citing inventory write-offs due to lower-than-expected use of its COVID products like Paxlovid and the vaccine. Bourla also said the company’s U.S. vaccination projections are lower than expected for a variety of reasons, including “COVID fatigue.”
“We are far away from the COVID fear,” he said. “Now, we are in the middle of the COVID fatigue. Nobody wants to speak about COVID, and we have also a lot of anti-vaxxers’ rhetoric.”
Do Celebrity Vaccine Endorsements Like Travis Kelce’s Actually Change Behavior?
Once the domain of aging TV stars, hawking health products from vitamins to diabetes supplies to a geriatric demographic, A-list celebrity endorsements of healthcare products are positively trendy. Migraine sufferer Lady Gaga has a deal with Nurtec ODT, a prescription drug that treats migraines from pharma company Pfizer. “This Is Us” actor Mandy Moore is contracted by Incyte to promote Opzelura, an eczema treatment.
Now Kansas City Chiefs tight end Travis Kelce, who is making headlines as Taylor Swift’s current paramour, is the latest — and buzziest — pharma spokesperson. In a campaign promoted by Pfizer, he encourages people to get a “twofer”— a COVID shot and flu shot at the same time.
But there’s a problem here for Kelce and Pfizer (and it’s not Jets QB and anti-vaxxer Aaron Rodgers’ trash talking): Celebrity endorsements to promote health behavior change don’t work, at least not in the way you might think.
“Selling” health is not the same as selling shoes. Classic research in health campaign design shows that tactics used to effectively promote health behaviors are not the same as ones used to sell us on the “newest and greatest” consumer goods.
Novo Nordisk Flags Big 2024 Sales Boost Despite Wegovy Curbs
Novo Nordisk forecast another year of double-digit sales growth for its two most popular drugs on Thursday and said it will boost U.S. supplies of Wegovy next year, as it battles to meet soaring demand for the weight-loss drug.
Danish drugmaker Novo (NOVOb.CO), which overtook LVMH (LVMH.PA) as Europe’s most valuable listed company this year, posted record operating profit and sales for the third quarter, underscoring Wegovy’s phenomenal success.
“Specifically on the U.S. market, we’ll be supplying significantly more in 2024 compared to what we are in 2023,” Novo CFO Karsten Munk Knudsen told Reuters in an interview. It is also facing competition from U.S. rival Eli Lilly’s diabetes drug Mounjaro, which is expected to get U.S. approval for weight loss by the end of 2023.
It is also facing competition from U.S. rival Eli Lilly‘s diabetes drug Mounjaro, which is expected to get U.S. approval for weight loss by the end of 2023.
Eli Lilly ‘Aggressively Planning’ Manufacturing Expansions, CEO Says, as Mounjaro Soars
Supply problems for Eli Lilly’s diabetes med Mounjaro were no secret. But strong demand continues to push sales of the GLP-1/GIP agonist to new highs ahead of an FDA decision on weight loss.
Global revenue from Mounjaro reached $1.4 billion in the third quarter, up 44% from the three months that ended in June, Lilly said Thursday. Wall Street analysts knew that Mounjaro has been flying off the shelf, but they still underestimated the drug’s quarterly performance by 15%.
Mounjaro’s sales would have been even higher, but “intermittent delays” in filling orders dragged down the volume, Lilly said.
Supply of different doses of Mounjaro has become somewhat unpredictable as significant demand outstripped Lilly’s output from time to time. During a call with investors Thursday, Lilly’s CFO Anat Ashkenazi acknowledged that the company experienced a “tight supply” of Mounjaro throughout most of the third quarter.
Lilly recently invested $450 million in its Research Triangle Park facility in North Carolina with additional drug filling, device assembly and packaging capacity for the company’s incretin products, including Mounjaro.
