In this final part of the series, “Pfizer PAXLOVID May Prove Dangerous, Buyer Beware”, the therapeutic regimen of PAXLOVID will be covered, along with warnings issued by some publications, and what Pfizer presented and omitted to its stakeholders.
Nirmatrelvir, part of the PAXLOVID regime, is a 3C-like protease inhibitor or Mpro inhibitor, while ritonavir, Norvir, is given in conjunction to inhibit the CYP3A metabolism of nirmatrelvir. When looking at the PDR for ritonavir, the patient fact sheet for PAXLOVID, and the fact sheet for health care providers, one can see the adverse reactions, contraindications, and drug-drug interactions appear to be mostly on the administration of ritonavir (Norvir). Yet, the patient fact sheet is very “modest” when it comes to informing potential recipients of the regimen of the extent of adverse reactions, contraindications, and drug-drug interactions. Moreover, the PubChem information for ritonavir confirms these issues. In fact, the patient fact sheet lists adverse reactions for PAXLOVID as liver problems (loss of appetite, jaundice, dark colored urine, stomach pain, light colored stools), resistance to HIV medications, altered taste (dysgeusia), diarrhea, high blood pressure, and muscle aches. That’s a far cry from what is listed in the PDR for ritonavir and on the health care provider fact sheet. For confirmation, the Pfizer webpage confirms the “limited” list of side effects.
Contraindications, which are related to ritonavir, include co-administration with drugs highly dependent on CYP3A for clearance and for which elevated concentrations are associated with serious and/or life threatening reactions; and, Co-administration with potent CYP3A inducers where significantly reduced nirmatrelvir or ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance.
The drug-drug interaction listing, organized by drug class, in the health care provider fact sheet does not include the extensive list of drugs in the PDR, which include common medications such as Acetaminophen (Tylenol), acetaminophen with other drugs such as caffeine, codeine, etc., aspirin with other drugs such as caffeine, codeine, etc., ibuprofen, Benadryl, pseudoephedrine (contained in Over-the-counter cold and sinus therapeutics), the herb echinacea, certain oral contraceptives, Fluticasone, Flonase, the expectorant guaifinesin, griseofulvin (used in ringworm and fungal infections), red yeast rice, and a plethora of others.
Even The Lancet voiced reservations with nirmatrelvir (PF-07321332) administered with ritonavir.
It is imperative that clinicians are aware of the pharmacokinetic properties of ritonavir. In addition to the drug’s potent inhibition of the CYP3A4 isoenzyme, ritonavir shows further inhibitory effects on CYP2D6, CYP2C19, CYP2C8, and CYP2C9. Furthermore, ritonavir inhibits ABCB5 P-gp and the cellular transport mechanism via the efflux pump, which might contribute to the pharmacokinetic boosting effect through disruption of the active transport of concomitant agents out of cells from the intestinal tract, liver, and kidneys. Additionally, ritonavir is a known inducer of CYP1A2, CYP2B6, CYP2C9, CYP2C19, and the UGT family.4 Other drug transporters inhibited by ritonavir include the breast cancer resistance protein (ABCG2), the organic anion transporting polypeptides (hOCT1) in the liver, and MATE1, which is important in renal drug handling.5
Although ritonavir has been expertly managed in the context of combined HIV antiretroviral therapy, the potent boosting and induction effects of the drug have led to various interaction issues with co-medications, encompassing prescribed, over-the-counter, and recreational agents. Concomitant use of ritonavir with some drugs is absolutely contraindicated because of the risk of clinically significant interactions that might lead to life-threatening adverse events. Such agents include statins, steroids, sedative hypnotics, anticoagulants, and antiarrhythmic therapies, many of which are prescribed separately in older populations (aged ≥70 years) at the greatest risk of complications from SARS-CoV-2 infection.
Despite how treatment of patients with COVID-19 with ritonavir-boosted antiviral agents is likely to be a short-term measure, the potential for clinically significant drug–drug interactions remains. For example, inhibitory effects are apparent within short timeframes. We would recommend that all prescribing clinicians become familiar with potential interactions by use of dedicated reference guides, such as the University of Liverpool antiretroviral drug interaction checker and existing antiretroviral treatment guidelines,6 and by liaising closely with colleagues experienced in the treatment of HIV infection, to reduce the potential for clinically significant iatrogenic adverse or life-threatening events
This seems a lot of risk versus benefit for an illness with an over 99.9% survivability rate. The FDA EUA letter requires Pfizer to report to the FDA any serious adverse events and all medication errors associated with PAXLOVID as well as the emergence of “variants” of SARS-CoV-2 and other studies. This is using the world population as lab test subjects. The treatment guidelines for PAXLOVID by the National Institute of Health (NIH) suggests “Clinicians who are not experienced in prescribing ritonavir-boosted drugs should refer to resources such as the EUA fact sheet for ritonavir-boosted nirmatrelvir (Paxlovid) and the Liverpool COVID-19 Drug Interactions website for additional guidance. Consultation with an expert (e.g., clinical pharmacist, HIV specialist, and/or the patient’s specialist provider[s], if applicable) should also be considered.” Yet, the EUA fact sheet for health care providers does not list Benadryl, griseofulvin, echinacea or others contained in the PDR. Even the Liverpool antiretroviral drug interaction checker doesn’t include all in the PDR. Check it for yourself.
There is plenty of controversy surrounding Pfizer’s PAXLOVID. Bloomberg Law reported there was a “row” concerning skipping a step in the approval process. “The FDA authorized Pfizer Inc.’s pill to treat Covid-19 without first getting input from a panel of clinical advisers, a move public health professionals say could further undermine trust in an agency already facing scrutiny over its rapid decision-making during the pandemic.” It is usually standard for the FDA to convene a panel of advisors to review information before “authorizing” a therapeutic for use. However, what we have come to expect from this agency is a “warp speed” authorization of anything that would benefit stakeholders in these pharmaceutical companies at the expense of the people.
In its presentation, Pfizer lumped its mRNA injection into the PAXLOVID presentation. Both will be covered here because it is imperative to see the slight of hand Pfizer is using.
Slide eight talks about “Comirnaty for prevention” and PAXLOVID for treatment. Yet, there is no Comirnaty available in the united States. It is the BNT 162b2 formula, which is EUA only, used in the US. Notice the ongoing clinical trials for PAXLOVID stated to stakeholders and compare that to the clinicaltrials.gov information.
Slide nine shows the manufacturing plan for the mRNA injection and the potential for 4 billion doses in 2022. Slide ten shows an 80 million treatment course for 2022 of PAXLOVID. The treatment is 2 pills of nirmatrelvir with one pill of ritonavir twice daily for 5 days or 10 doses.
Notice slide 11 indicates a “lightspeed” paradigm for “vaccine” and treatment production. It sounds very similar to “warp speed” that Trump initiated for the rollout of these bioweapons.
In reviewing slide 14, Pfizer again talks about Comirnaty, which is unavailable in the US and is the one approved by the FDA with the BNT 162b2 continuing under the EUA, illegally. Remember, Comirnaty and BNT 162b2 a distinct entities and the BNT 162b2 goes by the generic tozinameran. There is a distinct difference between generic and brand name medications. Also, risk reduction is shown related to Comirnaty. However, we know Pfizer used relative risk reduction (RRR) and not absolute risk reduction (ARR) in its presentations to the FDA, which requires ARR to be used in efficacy.
Slide 26 indicates Pfizer is preparing for multiple scenarios surrounding COVID-19. The goals are to make sure their products gain approval for all age groups and populations.
Slide 28 indicates the “light speed to market” of its injection. It’s value to investors in 2021 alone amounted to $36 billion dollars.
Slide 29 shows that Pfizer’s BNT162b2 enjoyed the most administration in the US and Europe on the left side graphs. Looking at the pie chart on the right side, it indicates Comirnaty projected doses delivered (millions) in the united States in 2021. Yet, there is no Comirnaty available for Americans.
Slide 30 shows the plan for Pfizer’s injectable. Going forward, Pfizer intends for its mRNA injection to become an annual event and be included in the pediatric vaccine table.
Slide 33 introduces the PAXLOVID presentation.
Slide 37 identifies the target population for PAXLOVID. Remember this is under an EUA for ages 12 and older without any data on individuals younger than 18 years of age.
Slide 38 indicates the rapidity of development of nirmatrelvir, which has not taken years as one would expect. Notice the phase 2 trials are missing. Refer back to the clinicaltrial.gov information previously discussed on Pfizer’s PAXLOVID.
Slide 39 provides the chemical diagram of nirmatrelvir and its mechanism of action while mentioning the administration of ritonavir with it. Yet, there is no mention of why ritonavir is given with nirmatrelvir in the slide.
Slides 47 through 50 indicate the relative risk reduction (RRR) again in using PAXLOVID, while omitting absolute risk reduction (ARR).
Slide 63 indicates the three critical success factors for launch of PAXLOVID: drive urgency to diagnosis and treatment; building confidence in protease inhibitor benefit/risk profile; support broad and equitable access and coverage.
Notice throughout the entire presentation there was not a slide on adverse reactions, contraindications, or drug-drug interactions.
Slide 64 indicates that driving urgency to diagnosis and treatment is critical. Not surprising is the support for “home testing kits for all” in the United Kingdom as well as telemedicine.
The title for slide 72 says it all – Pfizer-BioNTech Vaccine Supply Chain Project Lightspeed. As previously stated, this is a little too close to “warp speed” to be coincidence.
There is more information in these documents that you can review at your leisure. It appears the status quo is becoming normalization of short cuts when it comes to therapeutics for disease and illness, where safety is compromised in the name of profit for stakeholders and government officials who get their palms greased with kickbacks. Health care providers have been coerced, threatened or bought to remain silent as they push poisons – injections or pharmaceuticals – to “manage” illness and disease, instead of treating the causes.
Remain vigilant and buyer beware!
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