From Dr. Joel S. Hirschhorn: He is the author of Pandemic Blunder and many articles and podcasts about the pandemic, has worked on health issues for decades, and has been Pandemic Blunder Newsletter is on Substack. As a full professor at the University of Wisconsin, Madison, he directed a medical research program between colleges of engineering and medicine. As an officer in charge of the Congressional Office of Technology Assessment and the National Governors Association, he led major studies on health-related issues; he testified in over 50 US Senate and House hearings, and authored hundreds of articles and opinions in major newspapers. For more than 10 years he worked as a volunteer manager in a large hospital. He is a member of the Association of American Physicians and Surgeons and America’s Frontline Doctors.
The mainstream media, leaning towards the pharmaceutical industry, is insanely positive about Pfizer’s new FDA approved COVID antiviral treatment pills.
The drug, paxlovid, received emergency approval from the FDA for use in patients 12 years and older who tested positive for COVID-19 and are at high risk.
Now is the time to talk calmly and precisely about Paxlovid. First of all, everyone should understand that the short and long term safety of this product has been very little tested, just like the COVID vaccines. A really good trial of a new drug should take many months or even years.
All you get is positive news about this new drug – actually a combination of drugs.
Here are brief summary statements about this new product:
It was approved by the FDA with no outside meetings, serious review of the test data, or an opportunity for public comment. Virtually all of the regulatory work has been done behind closed doors. Great for Pfizer. Bad for the public.
Significantly, in the studies only 21% of patients had a comorbid condition, while in reality 94% of COVID deaths have at least one comorbid condition and the average number of underlying conditions is four.
As for antiviral science, protease enzymes must be present in order for the virus to successfully infect by completing the cycle before taking over the cell. Paxlovid, or any other medicine classified as a ‘protease inhibitor’, works by blocking or reducing the protease enzyme that affects the virus. Paxlovid stops the 3CLPro protease from chopping the long protein into pieces. The virus cannot choose which parts to cut out and put together. It cannot make copies of itself. The Covid infection stops quickly
Contrary to what the government claims, ivermectin is the most successful and proven protease inhibitor used worldwide. Just like paxlovid, ivermectin reduces the protease enzyme, but … ivermectin has benefits in covid treatment that paxlovid does not. The additional effects of ivermectin include anti-coagulant and anti-inflammatory effects, both of which are seen with Covid infections. Ivermectin has been used safely for decades, and there are numerous medical studies, as well as clinical results, to demonstrate its antiviral and anti-inflammatory effects.
Paxlovid must be combined with an HIV / AIDS drug, ritonavir, to prevent paxlovid from breaking down so it can inhibit or decrease the enzyme that interrupts the viral life cycle. Ritonavir acts like a booster for paxlovid, keeping it active in a person’s body. Ritonavir also has its own black box warning, and side effects include life-threatening liver, pancreas and heart problems. Does the public really want to take an HIV / AIDS drug?
A course consists of 20 paxlovid tablets and 10 ritonavir tablets, which are taken over five days. Taking 6 tablets a day can be a challenge, especially for many elderly people.
the Pfizer press release According to Paxlovid, if taken within three days of symptoms appearing, paxlovid reduces hospital stays / deaths by 89% in people with proven COVID infection. So in the treatment group, 5 out of 697 people were hospitalized with no deaths compared to 44/682 who were hospitalized and had 9 deaths.
Reflect on this statement if you are taking this combination of drugs within three days of symptoms appearing. These are critical issues common people face: How exactly to distinguish COVID symptoms from similar symptoms of the flu or bad cold; how to do a quick test; how can you get in touch with your doctor within a day or two and decide if you really have COVID (with no drug interactions) and if so, get a prescription; how can you have the prescription issued quickly? None of these problems are easy to solve and maneuver. All of this makes this new combination drug unrealistic and impractical for almost everyone.
An approximately 10-fold decrease in viral load on day five compared to placebo has also been reported, suggesting robust activity against SARS-CoV-2 and (supposedly) the largest decrease in viral load seen to date for an oral antiviral COVID -19 mean was reported.
It would have been very interesting to compare the Pfizer supplement to an ivermectin protocol.
For example, how does the Pfizer supplement compare to the protocol by Dr. George Fareed and Dr. Brian Tyson off? Well, Fareed and Tyson had many more patients (about 7,000) taking the combination drug, and yet they had fewer hospitalizations (4) and the same number of deaths (0). So you’re better off with Fareed and Tyson’s protocol. And IVM’s security protocol has been proven far better than the Pfizer product after billions of uses around the world.
For a good discussion of how IVM compares to Paxlovid, see this one article. Specifically for the scientific proof of the ability of ivermectin to block the 3CL protease.
For safety, the most common side effects reported during treatment and up to 34 days after the last dose of Paxlovid were dysgeusia (taste disturbance), diarrhea and vomiting. But what more serious side effects can you experience months or years later?
Paxlovid must not be taken at the same time as certain other medicines, either because its effects can cause harmful increases in your blood levels or, conversely, because some medicines can themselves make Paxlovid less effective. The list of medicines that must not be used concomitantly with Paxlovid is included in the suggested conditions of use. This list includes a very large number of medicines and dietary supplements that are used by many millions of people, including Lipitor and St. John’s wort, for example. Paxlovid must also not be used in patients with severely impaired kidney or liver function.
Paxlovid is not recommended during pregnancy or in people who can become pregnant and are not using contraception. Breastfeeding should be interrupted during treatment. These recommendations are based on laboratory studies in animals that suggest that high doses of Paxlovid can affect the growth of the fetus.
In terms of availability, Pfizer CEO Bourla recently said the company will be able to produce more than 80 million packages by 2022, of which 30 million will be available in the first half of the year. That’s not enough to care for the many millions of Americans who come to us with symptoms and a positive test result.
That was also said, tens of thousands of the pills will be shipped in the US before the end of 2021 and hundreds of thousands more are expected in early 2022, a Pfizer spokesman told the Wall Street Journal. The US government is paying Pfizer $ 5.3 billion for 10 million treatment units due to be shipped by the end of next year, according to the newspaper. Does the health insurance fund $ 530 per course?
Always follow the money. A month ago, Geoffrey Porges, an analyst at SVB Leerink, predicted the drug will generate sales of $ 24.2 billion in 2022. Combined with the company’s mega-blockbuster COVID-19 vaccine, Pfizer could make $ 50 billion in peak sales of pandemic vaccines and drugs, Cantor Fitzgerald analyst Louise Chen wrote earlier this month. It’s no surprise that some of Pfizer’s top executives have become billionaires.
Do you want to do what’s right for you or what’s great for Pfizer?
Dr. Joel S. Hirschhorn, author of Pandemic Blunder and many of the articles and podcasts on the pandemic, has worked on health issues for decades, and his Pandemic Blunder newsletter is on Substack. As a full professor at the University of Wisconsin, Madison, he directed a medical research program between colleges of engineering and medicine. As an officer in charge of the Congressional Office of Technology Assessment and the National Governors Association, he led major studies on health-related issues; he testified in over 50 US Senate and House hearings, and authored hundreds of articles and opinions in major newspapers. For more than 10 years he worked as a volunteer manager in a large hospital. He is a member of the Association of American Physicians and Surgeons and America’s Frontline Doctors.