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.
July 15, 2024
The Medical Community Must Stop Gaslighting COVID Vaccine Victims Like Me
Vaccine adverse effects are real. I know it makes some people uncomfortable to acknowledge this, but alongside the benefits of vaccines, there are cases of profound harm.
I am living this reality daily, and I want to live in a world where these harms are adequately addressed. Recently, the New York Times covered my story: “Thousands Believe COVID Vaccines Harmed Them. Is Anyone Listening?” Sadly, no one is listening yet, and very few people are willing to help.
Three years ago, when the COVID-19 vaccine emerged, I stepped forward to receive it. What followed was unexpected and devastating. Within hours I developed tingling along my right arm, which over days radiated across my body. A neurologist and colleague recommended that I proceed with a second dose. With the vaccine mandate from my employer at the top of my mind, I proceeded, against my own medical judgment.
After the second dose, my condition rapidly worsened. I developed positional tachycardia, wildly fluctuating blood pressures, internal tremors, electrical zap sensations on my legs, intense right-sided headaches, abdominal pain and severe tinnitus. I struggle to live with all of this and more to this day.
Medical gaslighting, coupled with the absence of legal recourse or adequate compensation, compounds the challenges we endure. When I reach out for help, my pleas often fall on deaf ears, or I am disparaged as a misinformed “anti-vaxxer.”
It’s Shockingly Easy to Buy Off-Brand Ozempic Online, Even if You Don’t Need It
The healthcare industry has never encountered anything quite like Ozempic before. First approved to treat Type 2 diabetes, this drug and others like it — known as GLP-1 agonists — hit blockbuster status because of their remarkable success rate as weight-loss aids. (Although it’s become shorthand for this type of drug, Ozempic is actually only prescribed for weight-loss off-label.) With relentless demand, they’ve been in shortage in the United States since 2022. They’re the Taylor Swift Eras Tour of pharmaceuticals: Supply is limited, prices are sky-high, and even people who couldn’t care less are at least ambiently aware of what’s happening.
When drugs are officially in shortage, the U.S. allows pharmacies to make their own “compounded” versions of them. Compounded medications are essentially custom copies; unlike generic medications, which are FDA-approved drugs without brand names that are introduced into markets after patents expire, compounded drugs are intended as substitutes provided for specific reasons (like drug shortages) and are not subject to the same approval processes. In essence, dupes are legalized. And there’s no need to wait for any patents to expire to sell off-brand options of GLP-1 meds. Telehealth startups have jumped into the GLP-1 marketplace to sell these compounded drugs, offering easy-to-access copies at a far more affordable price.
Over the past two months, WIRED tested the process of ordering compounded semaglutide — the active ingredient in Ozempic and Wegovy — from a sample of the most prominent telehealth companies offering the medication in the United States. We focused on some of the brands we saw regularly advertising on social media. We wanted to observe the vetting process for potential patients and see what sort of documentation someone who wants to purchase these medications needs to produce.
We found that it is remarkably easy to purchase these prescription drugs, even if one has no medical need. Most companies do not require lab work or medical records. Many do not even require a quick video conference or telephone call.
After ‘Historic Backslide’ During Pandemic, Global Childhood Immunization Rates Stall, New Data Shows
Although the COVID-19 pandemic saw unprecedented speed in the development and distribution of coronavirus vaccines, experts say it was also marked by a significant and concerning drop in the rate of routine vaccinations. New data from the World Health Organization and the United Nations International Children’s Emergency Fund shows the world has yet to recover.
The pandemic signified a “historic backslide,” according to Dr. Katherine O’Brien, director of the Department of Immunization, Vaccines and Biological at WHO. Now, she says, the race is on to reach children who missed shots during the pandemic and to restore and strengthen immunization services beyond pre-pandemic levels.
WHO and UNICEF’s 2023 immunization coverage report, released Sunday, is the world’s largest dataset on immunization trends for vaccinations against 14 diseases. It analyzed estimates from 185 countries and used a third dose of the diphtheria, tetanus and pertussis (DTP3) vaccine — which is recommended for 1-year-olds — as the global marker for immunization coverage.
The data revealed that previous progress in reaching pre-pandemic immunization levels has stalled. Worldwide DTP3 coverage was 84% in 2023, the same as in 2022 but below 86% recorded in 2019. The report’s authors say this is a derailment on the trajectory toward the Immunization Agenda 2030 goal of 90% coverage for essential childhood and adolescent vaccines.
Bird Flu Could Become a Human Pandemic. How Are Countries Preparing?
As cases of avian influenza continue to rise in cattle in the United States, countries are preparing for the possibility that the virus could start spreading in people. Many nations are ramping up surveillance, as well as purchasing vaccines or developing new ones.
“This virus in its current state does not look like it has the characteristics of causing a pandemic. But with influenza viruses, that equation could entirely change with a single mutation,” says Scott Hensley, an immunologist at the University of Pennsylvania in Philadelphia.
The highly pathogenic avian influenza H5N1 has so far been detected in 145 cattle herds and 4 farm workers in a dozen states across the United States. Researchers say many more cases in cows and people have probably gone undetected. The chances of quashing the outbreak get “more slim by the day,” says Angela Rasmussen, a virologist at the University of Saskatchewan in Saskatoon, Canada.
Last month, the European Commission purchased roughly 700,000 doses of a flu vaccine manufactured by CSL Seqirus, in Maidenhead, U.K., with the option to buy another 40 million. The vaccine protects against H5 strains of influenza A. Also in June, Finland began vaccinating people against avian influenza, focusing on high-risk workers at fur and poultry farms.
Don’t Try ARBs for Severe COVID, Trial Indicates — Harms Seen Without Any Compensating Survival Benefit
The angiotensin receptor blocker (ARB) losartan led to hypotension and failed to improve mortality in patients hospitalized for acute COVID-19, according to the randomized, prospective — and prematurely terminated — ARBs CORONA II trial.
Among 341 patients in Canada and France hospitalized for acute COVID-19, 39.8% of patients who were prescribed losartan developed serious adverse events (SAEs) versus 27.2% in the usual care group (P=0.01), largely due to hypotension in the losartan arm, James Russell, MD, of the University of British Columbia in Vancouver, and colleagues reported in Clinical Infectious Diseases.
Of those prescribed losartan, 30.4% developed new-onset hypotension compared with 15.3% of patients in the usual care group (P<0.001). The findings included both ward and intensive care unit (ICU) patients.
Chemotherapy Drug Could Have a Serious and Surprising Side Effect, Study Finds
A chemotherapy drug could cause “significant” hearing loss among cancer survivors, according to a study from the University of South Florida and Indiana University.
Researchers tracked 100 testicular cancer survivors who received a chemo drug called cisplatin for an average of 14 years, as a press release from USF noted.
Among the participants, who averaged 48 years of age, 78% of them reported experiencing “significant difficulties in everyday listening situations.” This was reportedly the first study to assess potential hearing loss among cancer survivors.
“Patients receiving cisplatin-based chemotherapy are at high risk for permanent hearing loss, and for some, that hearing loss will progress years after chemo treatment,” lead author Victoria Sanchez, associate professor in the USF Health Department of Otolaryngology Head & Neck Surgery, told Fox News Digital in an email.
Flu Vaccine Makers CSL Seqirus, Sanofi and GSK Kick Off Initial Shipments Ahead of Upcoming Season
The dog days of summer might be in full swing, but for flu vaccine makers, it’s a busy time prepping for this fall’s influenza season.
CSL Seqirus said it kicked off influenza vaccine shipments on July 9, when it began to ship out its three options, according to a press release. The company’s portfolio includes unique offerings such as Flucelvax, the “first and only” cell-based influenza vaccine and Fluad, which is recommended by the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) for people 65 and older.
CSL Seqirus also makes the egg-based vaccine Afluria for people six months of age and older. Sanofi, for its part, said it began its initial vaccine shipments on July 10, with more planned through October. Sanofi’s 2024/2025 flu vaccine portfolio includes its Flublok — a quadrivalent shot that’s made using insect cells — as well as standard and high-dose versions of its Fluzone.
GSK said it started shipping its doses on July 11 following a licensing and lot-release approval from the FDA, according to a release. The company said it “worked quickly” to get doses produced and shipped after vaccine strain recommendations were made in February.
Boosting Vaccines for the Elderly With ‘Hyperactivators’
As we age, our immune systems start to flag, leaving us more susceptible to cancer and infections — and less responsive to vaccines and cancer immunotherapies.
Going to the heart of the problem, Jonathan Kagan, Ph.D., a researcher in immunology at Boston Children’s Hospital, has identified a way to rejuvenate the elderly immune system. His team’s findings, published in the journal Cell, could lead to stronger vaccine adjuvants to help fight cancer and infectious diseases in older people.
When the team gave hyperactivators to elderly mice, dendritic cells did indeed migrate to the lymph nodes — at more than 250 times the rate seen with commercially available vaccine adjuvants like alum and LPS.
In the lab, Kagan now wants to demonstrate that hyperactivators are effective in more human-like cancer models, as well as in infectious diseases — starting with influenza. His ultimate goal is to create cancer vaccines as well as next-generation infectious disease vaccines that mobilize dendritic cells.
First Asian Elephant Vaccinated in Fight Against Deadly Herpes Virus
An Asian elephant at Houston Zoo in the U.S. has received the first mRNA vaccine against herpes, which is the leading killer of Asian elephant calves in captivity.
Tess, a 40-year-old Asian elephant, was injected with the trial vaccine at the Texas zoo in June, after a spate of deaths in juveniles in zoos around the world from the elephant endotheliotropic herpesvirus (EEHV).
Dr. Paul Ling, who researches herpes in humans at Baylor College of Medicine in Houston, developed the elephant mRNA vaccine, which is designed to boost the immunity of young elephants.
The mRNA vaccine is similar in design to the COVID-19 vaccines used in humans during the recent pandemic and aims to prevent serious illness and death from EEHV in young Asian elephants.
Scientists to Launch Human Tests of Marburg Virus Vaccine
Scientists have launched their first-in-human vaccine trial for a highly fatal virus. The Marburg virus is in the same family as Ebola and was discovered in 1967.
There are currently no approved vaccines or treatments for the virus, which is listed as a ‘high consequence’ infectious disease by the U.K. Health Security Agency.
Now, 46 people have received doses of the ChAdOx1 Marburg vaccine for the first time at the University of Oxford. The Oxford Vaccine Group has administered the vaccine to people aged between 18 and 55.
The trial is being funded by the Department of Health and Social Care as part of the U.K. Vaccine Network (UKVN), a U.K. Aid program developing vaccines for diseases with epidemic potential in low and middle-income countries.
The Defender Staff
The Defender is the news and views website for Children’s Health Defense. Our mission is to end corruption to save democracy. Our content exposes the corporations, elected officials, government agencies and individuals who put profits before people and planet.
