Many readers will remember that my friend and neighbor of over 30 years died in the hospital from Covid. I have kept in touch with her sister since the death of Donna.
Donna’s sister and her husband got Covid and she told me about an “amazing” new therapeutic which was fast-tracked recently. She said that she was very ill and that she was given Paxlovid. She even said that she found it to be amazing that this drug was made available by the FDA so quickly. She told me that it did make her feel better, but she woke up in the middle of the night with a metallic taste in her mouth. Hmmmm……not good.
Oh, did I mention that Pfizer makes Paxlovid?
Many scientists made a career fighting for better regulatory standards. Strangely, when it comes to the regulatory policy around COVID-19, they are dead quiet.
First, consider that EUA ( emergency use authorization ) is like accelerated approval. Both require lower levels of evidence, and are predicated on the fact that we’re dealing with a situation that is dire, with few available options. That’s the justification for lower standards, including acceptance of surrogates.
Next, consider that COVID-19 is a life-threatening illness in an older person, for instance someone over the age of 80. For an older person, it rivals cancer or heart disease.
But also consider that COVID-19 is a flu-like illness for most children, particularly in the era of Omicron. It would be incorrect to say children have ever faced an ’emergency’.
Now think about what regulatory experts have said for years. We should be cautious with accelerated approval. We should use it sparingly, and when appropriate. We can’t use accelerated approval for high blood pressure.
It’s naturally follows from this logic that the use of EUA for kids was unjustified. There was no emergency in those ages. The IFR was always comparable with flu. The appropriate regulatory pathway was biological licensing authorization. However, with the exception of a single article that I co-authored in the BMJ, I’m not aware of any one making this case.
Regulatory experts have told us for year that if outcomes are generally favorable, you need a very large randomized control trial to show a benefit. You can’t use a surrogate endpoint. They say, you have to use a measure of what matters to people. This means we should not accept disease-free survival, as it is an unreliable surrogate for adjuvant breast cancer.
But now think of boosting a 20-year-old man. Antibody titers are also an unreliable surrogate endpoint. Boosting 20-year-olds should not come under the auspices of an EUA. You should do a very large randomized trial to show it has a benefit. And if you can’t run the trial because the sample size is too large that tells you something about how marginal the effect size is.
Think about what regulatory experts said about aducanumab. They said that only 6% of all Alzheimer’s patients would be eligible for the trial. Therefore, we should be careful about generalizing.
Similarly, take Paxlovid. The only trials that have been published to support its use are in unvaccinated people. There are zero trial data published for vaccinated people. And yet the majority of the uses in vaccinated people.
Why are the experts who say you can’t extrapolate aducanumab to all’s Alzheimer’s patients not saying you can’t extrapolate Paxlovid to all vaccinated people?
Why are those who say accelerated approval is abused not saying that EUA authority is abused when you move to children, who face thousandfold less times the risk?
Why are the same people who say we need large randomized trials for clinical outcomes for blood pressure pills dead silent on the question of boosting adolescents?
There are at least 3 possible reasons:
Number one. They have not made the connection between the same principles in their mind. This explanation should be rejected. Because you would have to be quite dense to not see the parallels.
Number two. They think that it is a stronger argumentative position to press the issue in the world of non COVID-19 drugs than COVID-19 drugs. This is the great blunder of their thinking. When you push for the equal application of rational principles, you must push for the equal application of rational principles. If you think you can omit or make sacrosanct some category, then you are irrational. And your opponents can rightly argue that their categories should be exempted. Why should cancer have a higher standard than COVID?
If you want to persuade people on issues, you won’t persuade them if you don’t issue principles. Consistency and clarity hallmarks of clear thinking.
Number three: They are scared to voice their opinion on COVID-19 issues because they are afraid of the mob. Quite possibly, this is it. And this is likely paired with the fact that it is to there career benefit to not comment on issues outside their perceived scope. And thus they can go to conferences for another 40 years saying the same thing they’ve always said without any progress or advancement. Or, as a friend of mine likes to say, no new ideas.
I fear the right answer is number three. Even though most of these people run large groups or have tenure. They still are thinking of themselves.
And I think it has logical consequences. It’s the reason why people don’t want to be in the academy. You don’t have the freedom, or the incentive to fight when it actually matters. You labor under a curse. You can’t speak of the things that truly matter, when they matter. Your focus is narcissistic, and you will not accomplish any meaningful goals. And we will all fail together. Because regulatory science is just going to get worse and worse.
And the industry is going to take advantage of the crack we have shown in our foundation.
FDA admits Pfizer antiviral oral drug paxlovid causes life-threatening reactions when taken with common medicines
The antiviral oral drug, paxlovid, that was developed by Pfizer to treat the Wuhan coronavirus (COVID-19) can cause severe or life-threatening effects when used with common medications. The pill is also not recommended for people with severe kidney or liver disease.
On Dec. 22, the Food and Drug Administration (FDA) granted emergency use authorization for paxlovid. The drug supposedly prevents COVID patients with initial symptoms from becoming too ill and getting hospitalized. But the agency is now admitting that the drug can be fatal when used with common medications like statins, blood thinners and some antidepressants.
Pavloxid is recommended for patients 12 years old and above with mild to moderate symptoms of COVID-19.
Patrizia Cavazzoni, FDA’s director for Drug Evaluation and Research, said that the granting of EUA to paxlovid will provide a new tool to fight the virus as new variants emerge. “Paxlovid promises to make antiviral treatment more accessible to patients who are at risk for progression to severe COVID 19,” Cavazzoni said.
The Biden administration in November had already purchased some 10 million courses of paxlovid. It inked an agreement with Pfizer amounting to $5 billion.
The paxlovid cocktail is made up of two tablets of the antiviral nirmatrelvir and one tablet of ritonavir. Ritonavir suppresses a key liver enzyme called CYP3A, which metabolizes many medications, including nirmatrelvir. But when the paxlovid treatment is paired with other medications that are also metabolized by the CYP3A enzyme, the ritonavir component may boost the co-administered drugs to toxic levels.
Pfizer announced in December that the pill can reduce the risk of hospitalization and death by 89 percent when taken by those with COVID-19 symptoms. Pfizer CEO Albert Bourla on Dec. 8 told CNBC that shipments of the pill have already arrived in the United States.
Paxlovid is said to be effective when taken by a suspected COVID-19 positive within three days. Data also suggests that it will be effective in combatting the omicron variant. But doctors and researchers agree that the pill will not stop the transmission of the COVID virus. (Related: Pfizer, Merck launch trials for new oral COVID-19 drugs you’ll have to take ALONGSIDE vaccines.)
Some doctors also expressed concerns that the availability of the oral drug will lead people away from vaccination. According to the Centers for Disease Control and Prevention (CDC), millions of Americans remain unvaccinated.
UK approves use of second oral COVID-19 pill
Meanwhile, the U.K.’s drug regulator also approved the use of paxlovid. According to the Medicines and Healthcare products Regulatory Agency (MHRA), paxlovid can be given to to people aged 18 and older with mild to moderate symptoms and who are at risk of developing severe disease.
For those who are particularly vulnerable to COVID-19, “this treatment could be life-saving,” said June Raine, chief executive of the MHRA.
The omicron coronavirus variant rapidly spreading across the U.K. has squeezed the availability of effective treatment options. The variant has mutations that can dodge the protective effects of Roche/Regeneron’s monoclonal antibody ronapreve, which has been used for some time in the country.
Paxlovid is the second oral antiviral to be conditionally approved for use in the United Kingdom. MSD/Ridgeback’s molnupiravir was also authorized on November 4, 2021. Both are used to treat people at home and both medicines must be given within five days of symptoms. SOURCE
Brothers and sisters, did you know that Remdesivir (a so-called therapeutic) was made by Gilead Health which is owned by Fauci, Gates and Soros??
Were you also aware that Remdesivir is a deadly drug which can cause multi-organ shut down?
Are the puzzle pieces falling into place??