Discover more from Dr. Tenpenny's Eye on the Evidence
The Scam of Tamiflu
And its sister drug, Paxlovid
During the Bird flu Pandemic of 2005/6, two drugs were introduced to the market for the treatment and prevention of influenza and were given the protective designation called ‘covered countermeasures.’ The ideal antiviral drug is effective against all types of influenza viruses, regardless of strain and irrespective of antigenic drifts and shifts. The drug companies thought they had found the answer when GlaxoWelcome capitalized on the concept through its drug, Relenza.
A New Class of Drug: Neuraminidase inhibitors
There are two protein antigens that project from the surface of influenza viruses. One is called hemagglutinin (H), which plays a role in binding the virus to the receptors on the host’s mucus membrane. The other protein is an enzyme called neuraminidase (N), which helps the virus spread from person to person.
A virus enters the host’s cell when the (H) protein binds to a molecule of sialic acid sitting on the surface of mucous cells. This lock-and-key configuration opens the door to the cell, allowing the virus to enter and start the process of self-replication. After the new viral particles are formed, they are released to find a new cell to invade.
On the way out, the particle becomes coated with the sialic acid. The virus has a self-cleaning solution: The neuraminidase enzyme (N) scrubs the molecules of sialic acid off the (H) binding sites so the (H) is ready to bind to the next cell. Without the work of neuraminidase, the virus can’t spread. This led to the development a class of drugs called neuraminidase inhibitors. When the enzyme is disabled, the virus can’t spread.
Zanamivir (Relenza): First to be released
Zanamivir was discovered in 1989 by scientists at the Victorian College of Pharmacy, Monash University in Victoria, Australia in conjunction with Biota, a biotech company that was working on a host of antiviral agents. In 1990, zanamivir was licensed to Glaxo for exclusive worldwide development and marketing. In February 1999, the Antiviral Drug Products Advisory Committee convened within the FDA to discuss zanamivir which was being accelerated into the market by what was then GlaxoWelcome. Zanamivir, marketed at Relenza, is a powdered medication delivered through an inhaler. It was developed to treat uncomplicated flu-like symptoms caused specifically by influenza viruses.
The Committee immediately raised concerns about the conflicting data GlaxoWelcome presented from its three clinical trials. The effectiveness of zanamivir was robust in vitro, but the results in human trials were dismal. All three trials showed inconsistent findings, with the largest of the three, the North American trial, demonstrating no effect at all. When the numbers were reworked by an FDA statistician, the results show the drug shortened the duration of symptoms by a barely noticeable 1.1 day.
In addition, the committee was concerned over the paucity of data involving high-risk patients as they are the group targeted with drugs at the first sign of the flu. In the end, the Committee voted 14 to 3 against approval of the drug. Incredibly, despite concerns and lack of support by her own committee, Heidi M. Jolson, MD, MPH, Director of the Division of Antiviral Drug Products at the FDA, proceeded to approve zanamivir (Relenza) for use five months later and became the first neuraminidase inhibitor to be marketed in the US.
No about face, just ‘caution’
The committee had justifiably raised concerns about the safety of Relenza in high-risk patients. Soon, reports of serious complications started to roll in just as the first flu season was getting into full swing. Six months after approval, the FDA was forced to issue a Public Health Advisory highlighting problems in patients with underlying asthma or chronic obstructive pulmonary disease (COPD) such as emphysema. The FDA was receiving reports of deteriorating lung function, ranging from bronchospasm (wheezing) to respiratory arrest (cessation of breathing) after using Relenza. During that same 1999-2000 flu season, the Canadian Adverse Drug Reaction Monitoring Program received 16 reports of suspected adverse reactions, including one death. (Ref: October 2000; 10(4)-New influenza drugs: unexpected serious reactions.)
But instead of issuing a product recall, the FDA issued a warning that recommended “careful monitoring, proper observation, and appropriate supportive care, including the availability of short-acting bronchodilators” when prescribing this Relenza.
Why would any doctor prescribe a potentially life-threatening drug that only decreases flu symptoms by one day?
Side note: as of 1/27/23 Relenza is not available but they are bringing it back soon.
Tamiflu - Equally Poor Second Choice
Three months after the approval of Relenza, oseltamivir (Tamiflu) became the first FDA-approved oral neuraminidase inhibitor. Its 1999 approval was based on the results of two double-blind trials involving 1,358 patients. In one trial, only 62% had laboratory testing done to confirm an influenza virus was the cause of their symptoms even though Tamiflu has no effect against other microbes.
Similar to the Relenza trials, the effectiveness of the drug was judged by having participants complete self-assessment symptom scores to evaluate a reduction of influenza-associated symptoms. Despite the fact that symptom relief was only 1.3 days sooner with Tamiflu vs the use of a placebo, the FDA approved the drug for use. And, to achieve even that marginal effect, the medication needs to be started within 48 hours of the onset of symptoms.
Do people even know if they are getting the flu within 2-days of the first sign of a scratchy throat they need to rush out and get a prescription for Tamiflu?
Reports that viruses were developing resistance to Tamiflu began to surface soon after it was approved. Resistance was more widely observed in children than in adults as demonstrated by a Japanese study (2000) that included 50 children.
When samples of influenza viruses were collected before and during treatment with Tamiflu, resistance was found in 18% of the viruses within four days of use. Certain genes within the viruses seemed to be associated with much more resistance than others. Sensitivity testing revealed that viruses in persons treated with Tamiflu could be 300-fold to 1,000,000-fold more resistant.
Roche, the manufacturer, resolutely denied the study’s assertion, and pushed to smooth over the FDA’s concerns that mutant viruses are “less pathogenic (less disease-causing) than wild-type influenza viruses.”
The FDA wasn’t convinced, responding, ‘“It appears that mutant viruses may be shed at high titers [i.e., in large amounts] by some subjects before being cleared. Therefore, this reviewer has not been reassured that these viruses are harmless to the general population”
Hmmm. Maybe the shedding of ‘mutant mRNA’ or the viruses or the spike proteins may not be harmless either.
More Bad News: Tamiflu and Children
Information about Tamiflu became increasingly unsettling. The FDA approved Tamiflu oral capsules on October 27, 1999, for the treatment of uncomplicated acute influenza in patients one year of age. An additional indication for prophylaxis of influenza in adults and children 13 years and older was added on November 20, 2000. Pediatric use was granted on March 22, 2004.
Almost immediately, the VAERS reports started to pour in. Within 13 months, 1,184 case reports for adverse reactions were posted with 190 events (16%) in children. The reports included 75 children who had serious side effects, including 32 neuropsychiatric events and 4 deaths.
The reports of neuropsychiatric events were highly disturbing and included cases of delirium, convulsions, and encephalitis. However, the most alarming report was one about abnormal behaviors exhibited by three patients after receiving Tamiflu:
“Two children, a twelve- and a thirteen-year-old male, jumped out of the second-floor window of their homes after receiving two doses of Tamiflu. Head CT scans showed no abnormalities in either patient.
A third case was an eight-year-old boy who also exhibited abnormal behavior when he experienced frightening hallucinations and rushed out of his house onto the street three hours after receiving his first dose of oseltamivir. He was rescued by his family from potential traffic injury.”
Beyond the lackluster results for the treatment and prevention of influenza, nearly 10 percent of people who are prescribed Tamiflu can’t tolerate the most common side effect—persistent nausea. With the course of treatment costing more than $200, perhaps the best course of action is using a nebulizer with saline nasal and a drop of Lugol’s iodine and making sure your Vitamin D level is at least 80ng/ml. which may be at least as effective and at a minimal cost.
The New Kid: Paxlovid
Let’s start with the FDA package insert used by Pfizer regarding the use of this medication:
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of the unapproved product PAXLOVID for the treatment of mild-to-moderate COVID-19 disease in adults and pediatric patients (12 years and weighing at least 40 kg) with positive results of SARS‑CoV‑2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
And then, at the bottom of the page, it says this:
PAXLOVID is not approved for any use, including for use for the treatment of COVID-19.
So which is it?
In a separate paper, we find this:
Paxlovid is not recommended for people who are unlikely to get seriously ill from covid. In June, the drug’s manufacturer, Pfizer, announced it was discontinuing a clinical trial for standard-risk people because Paxlovid didn’t significantly reduce hospitalization and death in that group. The trial included both vaccinated and unvaccinated people.
Paxlovid is composed of two drugs, nirmatrelvir and ritonavir. The generally recommended dosage is nirmatrelvir 300 mg with ritonavir 100 mg (orally) twice daily for 5 days. Of note, ritonavir is an AIDS drug contraindicated with 32 common drug categories taken by seniors, such as statins and steroids.
An article written by Daniel Horowitz for TheBlaze.com, includes this revelation (you may want to read his entire article here:)
Last year, the U.K. Daily Mail reported on a study that found Paxlovid can increase the risk of blood clots when taken with blood thinners and irregular heartbeat when taken with heart pain medications. Researchers also found it can cause liver toxicity when taken with statins. Do you really believe every doctor has made sure to take his patients off statins before prescribing this drug?
Remember, this drug is being dispensed in pharmacies without a doctor’s prescription as if it’s candy. Do we even know all its potential safety concerns? No, but we do know it’s contraindicated with many drugs. Also, keep in mind that technically Paxlovid was only accorded EUA status for high-risk patients – the very sorts of people who will largely be dependent upon drugs with such contraindications.
Given the “it’s all good” attitude of pharmacies and doctors regarding Paxlovid (just like the Pfizer shots), can we really trust that these contraindications are being taken into account when prescribing? It’s become more of a religious sacrament than a choice of therapeutic.
Why trust any of these drugs?
It goes without saying the best things you can do for your health are zinc, Vitamin C, Vitamin D, Quercetin, NAC, good food, lots of sleep and purified water. Many have written on these and you can find a full bundle of our recommendations at our store.
Avoid the jabs and avoid their horrible drugs. That sums it up!
SUNDAY SUBSTACK - ON WALKING WITH GOD.