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June 29th, 2023 
Awake Goy 06/14/23
The Defender’s Big Pharma Watch delivers the latest headlines related to pharmaceutical companies and their products, including vaccines, drugs, and medical devices and treatments. The views expressed in the below excerpts from other news sources do not necessarily reflect the views of The Defender. Our goal is to provide readers with breaking news that affects human health and the environment.
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Super-Engineered Vaccines Created to Help End Polio
Scientists have “super-engineered” polio vaccines to prevent them from mutating into a dangerous form that can cause outbreaks and paralysis.
The oral vaccines contain weakened live polioviruses and the genetic redesign locks them into that weakened state. The U.S. and U.K. teams have now created upgraded vaccines against all three types of polio.
It takes only one mutation to turn the safe polio vaccine back into a virus that can move out of a child’s stomach, invade their nervous system and cause paralysis. And if those viruses spread from an immunized child — through their contaminated feces — there is a risk of infecting the unvaccinated and triggering an outbreak.
There are now more cases of “vaccine-derived polio” than of the wild poliovirus and the polio detected in London’s sewers last year was connected to the oral vaccine. So the researchers have genetically altered the weakened virus even further to make it much harder for it to start causing paralysis again.
Ozempic Side Effects Could Lead to Hospitalization — and Doctors Warn That Long-Term Impacts Remain Unknown
Drugs like Ozempic, Mounjaro and Wegovy are extremely effective for weight loss. But shedding pounds isn’t the only change patients might experience.
These drugs were originally prescribed to patients with Type 2 diabetes as they produce insulin and lower blood sugar. They also release a hormone that slows down digestion and keeps food in a patient’s stomach longer. This process suppresses hunger and leads to weight loss — but that can take a toll on the body.
The most common side effects of Ozempic, according to the drug’s website, are nausea, stomach pain, constipation, diarrhea and vomiting.
Other serious side effects of Ozempic include thyroid tumors, pancreatitis, changes in vision, hypoglycemia, gallbladder issues, kidney failure and cancer. The most severe complications Shah sees in her patients are pancreatitis and gallbladder issues — either can lead to hospitalization.
It’s unclear how these drugs when prescribed for weight loss, affect the body after years of use.
Antibiotics Losing Power Against Bloodstream Infections That Kill Newborns
U.S. News & World Report reported:
Babies around the world are dying because the antibiotics used to treat sepsis infections in hospitals are losing their effectiveness, a new report warns. A team of 80 researchers from four continents has been studying the issue of antibiotic resistance and newborn sepsis in 19 hospitals.
“The observational study has been instrumental in providing the high-quality data that we need to design trials of appropriate treatments for sepsis in newborn babies. It has been a huge collaborative effort by researchers and clinicians in Africa, Asia, Latin America and Europe,” study co-author Dr. Neal Russell said in a news release from St. George’s, University of London, in the United Kingdom. He is with its Center for Infection and Immunity Research.
In the new study, hospitals used more than 200 different antibiotic combinations, frequently switching due to high resistance to treatments. In 15% of cases, last-line carbapenems were prescribed. These are classified by the World Health Organization (WHO) as “Watch” antibiotics because they need to be preserved.
The most common pathogen was Klebsiella pneumoniae, usually associated with hospital-acquired infections.
Pfizer Expects to Run Out of Some Antibiotic Supply for Children Soon
Pfizer (PFE.N) has warned that a drug used to treat syphilis and other bacterial infections in children could run out by the end of June because it has had to prioritize versions made for adults due to a spike in syphilis infections in that population.
Supply of the pediatric version of the drug, Bicillin L-A, is expected to be exhausted by the end of this quarter, the company said in a letter to the U.S. health regulator dated Monday. Pfizer said in an email on Tuesday that the pediatric formulations of the antibiotic are not widely used.
Still, the supply of that version of the antibiotic is likely to run out soon, exacerbated by other product shortages, Pfizer said. Pfizer’s penicillin products have been in shortage since April. The drugmaker said it is prioritizing the adult dosages of Bicillin L-A, which are also in shortage, but said it does not expect them to run out.
Another similar penicillin product, Bicillin C-R, which is used to treat infections related to the upper respiratory tract, is expected to run out of supply in the third quarter, Pfizer said.
New Evidence Links Calcium Channel Blockers to Increased Risk of Glaucoma — Meta-Analysis Shows Highest Glaucoma Risk With CCB Monotherapy, Reduced IOP With Beta-Blockers
The use of calcium channel blockers (CCBs), particularly cardioselective agents, had a modest but statistically significant association with glaucoma, a large meta-analysis showed.
Overall, patients with a history of CCB treatment had a 23% higher likelihood of developing glaucoma as compared with individuals who never used the antihypertensives. The likelihood almost doubled among patients who received single-agent cardioselective CCBs. In contrast, beta-blocker therapy was associated with modestly reduced intraocular pressure (IOP), which is associated with a reduced risk of glaucoma.
“A potentially harmful association of CCBs for glaucoma is particularly noteworthy, as this is a commonly prescribed class of medication,” the authors stated in Ophthalmology. “If further studies confirm a casual nature for this association, this may inform alternative treatment strategies for hypertensive patients with, or at risk of, glaucoma.”
Post-COVID Vaccination Syndrome: What Do We Know?
Like long COVID, post-COVID vaccination syndrome is characterized by a wide variety of symptoms and clinical pictures including chronic fatigue syndrome (CFS/ME), migraines, muscle pain or cardiovascular diseases.
As multifaceted as the symptoms may be, they have one thing in common: They can occur in those affected shortly after COVID vaccination. Many people think they have post-COVID vaccination syndrome because they developed such symptoms after their shot.
By October 31, 2022, almost 51,000 suspected cases of serious side effects after the COVID vaccination had been reported to the Paul Ehrlich Institute, the federal authority responsible for vaccines and medicines in Germany. The institute has published regular safety reports on COVID vaccines but experts like Harald Prüss from Berlin’s Charité hospital and the German Center for Neurodegenerative Diseases (DZNE) believe the vast majority of these cases are due to something other than vaccine side effects. Still, some injured parties want to sue vaccine manufacturer BioNTech for alleged vaccine damage.
Post-COVID vaccine syndrome is nearly impossible to prove, says the neurologist Prüss. “There is not a single biomarker that is widely accepted by science.”
A biomarker might be a specific antibody that the body produces in response to vaccination. For example, researchers discovered a special antibody in the blood of people who had developed inflammation of the heart muscle (myocarditis) after getting vaccinated. Myocarditis is considered a possible, rare side effect after vaccination with BioNTech/Pfizer and Moderna mRNA vaccines.
Tamiflu a Bust for Preventing Flu Admissions, Meta-Analysis Finds — “I Wouldn’t Prescribe It to an Otherwise Healthy Person,” Researcher Says
Oseltamivir (Tamiflu) has not panned out for reducing the risk of influenza hospitalization, according to a large meta-analysis.
Among over 6,000 flu patients across 15 studies, the 0.14-percentage point difference in hospitalization rate between those who took oseltamivir and those who did not was not significant (RR 0.77, 95% CI 0.47-1.27), Emily McDonald, MD, MSc, of McGill University Health Centre in Montreal, and colleagues reported in JAMA Internal Medicine.
“I wouldn’t prescribe it to an otherwise healthy person,” McDonald told MedPage Today. “There was little evidence that it would prevent you from going to the hospital.” What’s more, she added, “It’s not completely benign. It does cause uncomfortable side effects.”
Patients taking the antiviral were more likely to have gastrointestinal (GI) side effects, including nausea (RR 1.43, 95% CI 1.13-1.82) and vomiting (RR 1.83, 95% CI 1.28-2.63), according to the study.
Successful COVID Vaccine Injury Claims Double in 3 Months
Data obtained through Freedom of Information (FOI) requests have revealed a rise in successful COVID-19 vaccine injury claims which has nearly doubled in three months. U.K. government payouts for the vaccine injured have now surpassed £11.5 million but could be even more.
Under current rules, victims of COVID-19 vaccines in the U.K. are entitled to a one-off sum of £120,000 under the Vaccine Damage Payment Scheme, if someone can prove they have been severely disabled or have had family die as a result of vaccination.
According to an FOI dated May 22, 96 claimants have been notified they are entitled to a Vaccine Damage Payment. All of the claims were awarded where the AstraZeneca vaccine was used. This is up from March when 44 claimants were notified they were entitled to payment.
Victims who got paid have predominantly developed vaccine-induced immune thrombocytopenia and thrombosis/cerebral venous sinus thrombosis and Guillain-Barré syndrome.
Bernie Sanders Vows to Oppose NIH Nominee Until Biden Delivers Plan to Lower Drug Prices
Sen. Bernie Sanders vowed to oppose President Joe Biden’s pick to lead the National Institutes of Health — and any other health nominee — until the administration delivers a plan to lower prescription drug prices.
“I will oppose all nominations until we have a very clear strategy on the part of the government … as to how we’re going to lower the outrageously high cost of prescription drugs,” Sanders said late Monday in an interview with The Washington Post.
The administration announced its intent to nominate Dr. Monica Bertagnolli, a cancer surgeon who leads the National Cancer Institute, last month.
Sanders, a frequent pharma critic, along with the committee’s Democratic majority issued a report Monday analyzing the cost of prescription drugs that were developed with the help of NIH funding and research. The report concluded that Americans consistently pay higher prices for NIH-backed drugs compared with people in other countries.
European Alzheimer’s Experts Unconvinced by New Eisai, Biogen Drug
Alzheimer’s disease experts in Europe weighing the potential use of a new drug from Eisai (4523.T) and Biogen (BIIB.O) say its ability to slow cognitive decline may not outweigh its health risks, or be worth the toll on scarce healthcare resources.
Lecanemab, branded Leqembi in the U.S., is under regulatory review in Europe and likely poised for traditional U.S. approval next month based on trial data showing it slowed cognitive decline by 27% in patients with early Alzheimer’s.
In Europe, where cost-conscious countries rigorously weigh new drugs before adopting their use, nine neurologists and researchers across six countries told Reuters lecanemab is unlikely to be widely used if approved. Their views underpin analyst estimates suggesting Europe will be a small market for the drug.
Some doctors said its effect on the disease may not be clinically meaningful enough when weighed against the risk of brain swelling, its likely high price, and limited personnel and resources to administer twice monthly infusions and monitor for brain swelling with MRI scans.
First Vaccine for Chikungunya — an Emerging Mosquito-Borne Threat — Nears After Promising Trial Results
A vaccine for chikungunya — a mosquito-borne infection with similar symptoms to dengue and Zika — could finally be on the horizon after promising results from a late-stage trial were published in the Lancet on Monday, a key towards tackling the emerging global health threat as climate change creates increasingly ideal conditions for the virus to spread explosively, including in the U.S.
Researchers said the trial — which enrolled 4,115 healthy adults across the U.S., 3,082 of whom were given the vaccine — did not raise any safety concerns over the shot and Juan Carlos Jaramillo, Valneva’s chief medical officer, said an independent board evaluating the trial’s data and any adverse reactions reported afterward came to the same conclusion.
Common side effects reported in the trial included headaches, fatigue, muscle and joint pain and pain at the injection site, which were consistent across different age groups.
$500 million. That’s the estimated global market for chikungunya vaccines by 2032, according to Valneva.
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