Of all the antiviral medicines for Covid-19, Pfizer’s Paxlovid has been the most successful. Not for its security and efficacy, but for its potential to get paid the firm billions in revenue irrespective of remaining mostly ineffective for most men and women.
In November 2021, prior to any info experienced emerged, the Biden Administration committed to purchasing 10 million treatment method programs of Paxlovid truly worth $5.3 billion, pending authorisation by the US drug regulator.
One thirty day period later on, Paxlovid was granted emergency use authorisation (EUA) by the Food and drug administration for use in grownup and paediatric populations, 12 a long time or older.
The authorisation was dependent on early demo data showing the drug could minimize hospitalisations or dying (89% relative threat reduction, 6% absolute hazard reduction) in high-threat patients who were unvaccinated and had no prior exposure to Covid-19.
But the trouble was, most Americans by that time (Dec 2021) had now been vaccinated against Covid-19 or experienced prior exposure to the virus, earning the demo effects irrelevant to the vast majority of folks.
Pfizer had to confirm its drug could gain a broader market.
The producer commenced the EPIC-SR demo, investigating the use of Paxlovid in unvaccinated men and women and vaccinated individuals with at least one particular hazard factor for Covid-19 [clinicaltrials.gov].
By July 2022, on the other hand, Pfizer stopped enrolling participants “due to a quite lower charge of hospitalization or demise observed in the normal-threat patient population.”
In a press release, the company announced that Paxlovid failed to impression its “novel most important endpoint of self-noted, sustained alleviation of all indicators for four consecutive days.”
In other phrases, Paxlovid – a mixture of nirmatrelvir and ritonavir – made no major difference in alleviating indicators of Covid-19 in contrast to placebo amid non-hospitalised patients.
Pfizer said that it was tricky to uncover gain in a populace that was by now at a small rate of hospitalisation or loss of life from Covid-19.
A person 12 months afterwards, in August 2023, Pfizer quietly posted the unfavourable findings on clinicaltrials.gov, devoid of any fanfare or media focus. In fact, the media continued to market the advantages of Paxlovid to the wider public.
The New York Occasions, for case in point, ran several stories for the duration of the pandemic about the “Power of Paxlovid,” encouraging a lot more people today to acquire the drug and criticised its less than-use.
At the same time, Pfizer stoked community panic by overinflating the danger of Covid-19, paving the way for health professionals to prescribe medication like Paxlovid to deal with the ailment. Often, the promises have been deceptive.
Pfizer, for case in point, tweeted that 3 out of 4 American grownups had been at “high risk” for intense Covid-19, but then cited a analyze in the ad that did not help the assert – so considerably, the deceptive tweet has been seen 11.6 million moments.
“This is preposterous,” tweeted Walid Gellad, Professor of Medication at the College of Pittsburgh, “I do not know how it is legal…3 out of 4 older people are not at high threat of serious Covid.”
That did not quit Fda commissioner Robert Califf from getting to social media to encourage the positive aspects of Paxlovid.
He tweeted the drug could decrease the danger of establishing ‘long covid’ centered on weak evidence, and admitted to ‘cheerleading’ the use of Paxlovid mainly because he felt general “the evidence was solid.”
Califf copped criticism for his absence of impartiality as the head of the regulator, but justified his actions in a “public overall health unexpected emergency.”
Regulatory affairs skilled Jessica Adams stated it was a weak justification.
“Something is definitely improper with community wellbeing ‘leadership’ if it thinks that just about every norm can be thrown out the window in an crisis,” stated Adams. “The Fda has learned absolutely nothing through the pandemic and is placing horrible precedents for potential emergencies.”
By 2023, reports of individuals enduring “rebound” indications after making use of Paxlovid, were raising. Authorities could no longer claim it was “rare.”
High-profile officials these types of as previous CDC director Rochelle Walensky, former NIAID director Tony Fauci, President Joe Biden and First Lady Jill Biden all had described a rebound of Covid indicators soon after completing a training course of Paxlovid.
Califf dismissed concerns about rebound, saying it was all just a “distraction,” but a study published in JAMA Network confirmed that symptomatic rebound in men and women with delicate to reasonable Covid-19 was as high as 25% just after using Paxlovid.
In May perhaps 2023, the Fda granted Paxlovid full approval for running moderate to average Covid-19 bacterial infections in older people at superior possibility of creating serious disease (which includes vaccinated grownups, irrespective of no data demonstrating benefit in this population).
Last 7 days, Paxlovid was back in the highlight soon after the EPIC-SR trial was finally published in the New England Journal of Drugs, practically two many years soon after Pfizer announced the futility of the research in July 2022.
No matter of all the optimistic media coverage and promotion of Paxlovid by public wellness officers and federal government advisors, the proof is very clear.
Paxlovid, which now costs $1,400 for a 5-working day program, has only proven advantage in a really unusual populace – that is, unvaccinated men and women who’ve never encountered the virus and are at high danger of really serious Covid-19.
Republished from the author’s Substack