Test to Treat and Paxlovid At A Glance:
- Biden offering free prescriptions of Paxlovid with a positive COVID test.
- EUA for Paxlovid data is concerning and raises many red flags.
- Paxlovid likely contraindicative for much of the American population.
On Tuesday, Joe Biden’s State of the Union address took place just after the mask mandate was lifted in the House of Representatives. Many lawmakers and their guests met in the chamber without masks, while some were still unable to attend due to the vaccine passport mandates put into place.
During the hour-long speech, Biden acknowledged the need for early, at-home treatment through his newly launched “Test to Treat” strategy. When a person tests positive for a COVID test at any of the participating pharmacies, they’ll receive a regimen of the newly FDA-authorized Pfizer antiviral drug, Paxlovid on the spot.
Paxlovid is a 30-tablet regimen with three tablets taken twice daily for five days. Paxlovid has been authorized for individuals over 12 years and 88 pounds and high risk for severe COVID, for up to five days.
According to the FDA’s announcement of the EUA, participants in the study to determine authorization were:
Patients were adults 18 years of age and older with a prespecified risk factor for progression to severe disease or were 60 years and older regardless of prespecified chronic medical conditions. All patients had not received a COVID-19 vaccine and had not been previously infected with COVID-19. The main outcome measured in the trial was the proportion of people who were hospitalized due to COVID-19 or died due to any cause during 28 days of follow-up.
The safety and effectiveness of Paxlovid for the treatment of COVID-19 continue to be evaluated.
Paxlovid was given EUA in December 2021. The safety and efficacy data to determine EUA was based on a 28-day follow-up. Pfizer is required under the Letter of Authorization to submit data, including safety and efficacy data in an ongoing manner.
FDA Acknowledges False Positive Test Results
The FDA recognizes the risk of false-positives due to testing. A letter was issued to clinical laboratory staff and health care providers indicating:
- Remember that positive predictive value (PPV) varies with disease prevalence when interpreting results from diagnostic tests. PPV is the percent of positive test results that are true positives. As disease prevalence decreases, the percent of test results that are false positives increase.
- For example, a test with 98% specificity would have a PPV of just over 80% in a population with 10% prevalence, meaning 20 out of 100 positive results would be false positives.
- The same test would only have a PPV of approximately 30% in a population with 1% prevalence, meaning 70 out of 100 positive results would be false positives. This means that, in a population with 1% prevalence, only 30% of individuals with positive test results actually have the disease.
- At 0.1% prevalence, the PPV would only be 4%, meaning that 96 out of 100 positive results would be false positives.
- Health care providers should take the local prevalence into consideration when interpreting diagnostic test results.
- Consider positive results in combination with clinical observations, patient history, and epidemiological information.
Vaccine Induced False Positives
People have also questioned the possibility of a false-positive following a COVID vaccine. The vaccine teaches the body to create the spike protein so that it can launch an immune response to it, based upon information delivered through mRNA technology.
The tests function by detecting a bit of protein from a virus:
These rapid at-home tests, also known as lateral flow tests (because the sample flows laterally along the test pad), are testing for the presence of a protein found on the surface of the coronavirus. That protein is known as an antigen, because it triggers an immune response in the body. The tests are therefore also known as antigen tests.
There hasn’t been a conclusive answer to this question yet. It seems hope is the strategy here as it’s been with much of the pandemic:
Like many things with this novel coronavirus, there are no definitive answers, but experts hope the Covid tests will be accurate, and the vaccine will be effective.
Profit Windfalls or Free Falls? How will Paxlovid Bolster?
Over the past two years, vaccine manufacturers have profited immensely from products provided to the public at “no charge.” The total financial obligations of the U.S. government in response to COVID is $4.2 trillion of tax-payer funds.
According to Joe Biden’s State of the Union:
We’ve ordered more of these pills than anyone in the world. And Pfizer is working overtime to get us 1 Million pills this month and more than double that next month.
Pfizer forecasts $32 billion in revenue for their vaccine and another $22 billion for Paxlovid in 2022 alone.
Many states have a surplus of vaccines as interest and uptake have waned nearly as sharply as the efficacy of the vaccines. As early as last summer, many were reporting the surplus as expiration dates on the products loomed. When the FDA issued approval for the Pfizer produced Comirnaty shot, the expiration dates were also extended.
Recent data revealed that people who had received the 2-dose regimen could expect a vaccine effectiveness of 37% after 5 months. In those who received the third dose, effectiveness fell to 31% in the same time. These numbers continue to fuel the push for more and more boosters.
During Pfizer’s recent fourth quarter and year end investors meeting, it indicated there might be concerns regarding data that could affect business.
Hold the Phone — Doc’s Thoughts:
There are several very concerning parts to this “Test and Treat” plan. First of all, the pharmacist who is dispensing the Paxlovid appears to also be prescribing it unless these pharmacies are now hiring a bunch of new practitioners. In the past, these tests were conducted by laypeople who worked in the pharmacy. The question I have is, who is actually prescribing these red-flag waving drugs? Because that person would be practicing medicine without a license if they are not authorized to write the prescription. It appears as though that person may be Joe Biden, just as he ran ahead and tried to push boosters before they had even made it to the FDA for consideration!
According to the FDA approved Fact Sheet for Healthcare Providers: Emergency Use Authorization for Paxlovid:
PAXLOVID may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants.
Immediate prescriptions could be given to people without thorough consideration of other prescriptions and the long list of contraindications. Especially if someone without the right credentials is handling individual cases. According to the American Council on Science and Health:
For people who aren’t taking prescription drugs, the plan is straightforward, but, as I wrote last month, Paxlovid consists of two different medicines: nirmatrelvir, the antiviral drug, and ritonavir, a “booster,” which significantly decreases the metabolism of nirmatrelvir, permitting it to remain in the blood at higher levels and for longer. (See The Drug That Makes Paxlovid So Effective Can Also Make It Dangerous.) The ritonavir has the potential to cause serious problems for people who are taking certain prescription drugs such as statins (for high cholesterol), antiarrhythmics, blood thinners, sedatives, and at least two asthma drugs.
It is here where the program could face difficulties. To prevent dangerous drug-drug interactions, the dispensing pharmacist must have an accurate list of other drugs (and herbal supplements) being taken by every patient.
And that list of dangerous interactions is long and common. Contraindications also include hormonal birth control, anticonvulsants, sedatives, antipsychotics, antifungals, several anti-cancer drugs, and antidepressants. The list goes on for several pages. As mentioned above, statins, are a concern. These cholesterol lowering drugs alone are taken by up to 40 million Americans.
All people would need, according to Biden’s State of the Union, is a positive test. Did you see that quote on false positives? How many people could be taking this dangerous drug due to an inaccurate test? There’s a potential recognized by the FDA of 70%?! And somehow, these unreliable tests are dictating the whole process.
Paxlovid is authorized for people who are at high risk for severe COVID, not the entire population. Also, I find it disturbing the EUA was granted for people aged 12 and up, however the studies were done on those ages 18 and up. We have no idea how this drug will affect a young, pubescent, developing teen.
In reality, we don’t know how it will affect anyone long-term. It is still being evaluated. This drug was just authorized in December with only 28 days of follow-up. We don’t have any data to consider for long-term effects. I guess in that way it will match the vaccines!
Let’s look at that “main outcome” benchmark used under the FDA’s EUA:
The main outcome measured in the trial was the proportion of people who were hospitalized due to COVID-19 or died due to any cause during 28 days of follow-up. (emphasis added)
Nowhere is safety mentioned as a concern. And anyone who died due to any cause affected the numbers? So, wait, an untreated person in a car accident could skew numbers for efficacy? Is that what they are saying? Because that’s what it sounds like they are saying.
Follow the Numbers
I see this plan ending much like many of the policies and procedures surrounding COVID. Costing the American tax-payer a lot of money, especially in waste and unwanted product, as well as the potential for devastating effects on those who take the drug. Nearly half of Biden’s 500 million “free” tests he launched in January have gone unclaimed. And with mask mandates crumbling around the nation, how many of those 400 million “free” N-95 masks that he just started handing out in January are going to be claimed anytime soon?
According to an internal memo, it seems less and less of this is being dictated by science, and more and more is being indicated by poll numbers and mid-term elections. One thing’s for sure, they can’t keep their science and plans straight as polls plummet.
If You’re Going to Test, Test Right!
If you are concerned about your health and immune response, the focus should be on supporting your body and it’s function. At The Wellness Way, we have numerous tests that provide actual answers and can help you restore health. Knowing your body’s function and needs will set you up for health in the fact of disease and illness. Contact a clinic today to get your health restoration and support plan in place before you are faced with tests riddled with false-positives and drugs that are dangerous for a large share of the population.