Joel S. Hirschhorn, Ph.D.
The unusual intense coverage of a new study showing benefits of the Pfizer antiviral drug Paxlovid can best be explained by the collusion between the media and the big drug industry.
In its 2022 financial guidance, the company reported Paxlovid revenue of $22 billion.
True, the new data are impressive in some ways. But some relevant questions can be raised and will be done here.
Here are some excerpts from the new study.
“In this work, we aimed to examine whether treatment with nirmatrelvir in the acute phase of COVID-19 is associated with reduced risk of post-acute sequelae. We used the healthcare databases of the US Department of Veterans Affairs to identify users of the health system who had a SARS-CoV-2 positive test between March 01, 2022 and June 30, 2022, were not hospitalized on the day of the positive test, had at least 1 risk factor for progression to severe COVID-19 illness and survived the first 30 days after SARS-CoV-2 diagnosis. We identify those who were treated with oral nirmatrelvir [this drug is just part of Paxlovid] within 5 days after the positive test (n=9217) and those who received no COVID-19 antiviral or antibody treatment during the acute phase of SARS-CoV-2 infection (control group, n= 47,123).”
“Compared to the control group, treatment with nirmatrelvir was associated with reduced risk of PASC (HR 0.74 95% CI (0.69, 0.81), ARR 2.32 (1.73, 2.91)) including reduced risk of 10 of 12 post-acute sequelae in the cardiovascular system (dysrhythmia and ischemic heart disease), coagulation and hematologic disorders (deep vein thrombosis, and pulmonary embolism), fatigue, liver disease, acute kidney disease, muscle pain, neurocognitive impairment, and shortness of breath. Nirmatrelvir was also associated with reduced risk of post-acute death (HR 0.52 (0.35, 0.77), ARR 0.28 (0.14, 0.41)), and post-acute hospitalization (HR 0.70 (0.61, 0.80), ARR 1.09 (0.72, 1.46)).”
“Nirmatrelvir was associated with reduced risk of PASC in people who were unvaccinated, vaccinated, and boosted, and in people with primary SARS-CoV-2 infection and reinfection. In sum, our results show that in people with SARS-CoV-2 infection who had at least 1 risk factor for progression to severe COVID-19 illness, treatment with nirmatrelvir within 5 days of a positive SARS-CoV-2 test was associated with reduced risk of PASC regardless of vaccination status and history of prior infection. The totality of findings suggests that treatment with nirmatrelvir during the acute phase of COVID-19 reduces the risk of post-acute adverse health outcomes.”
“Nirmatrelvir was associated with reduced risk of PASC across strata of baseline risk, and in people who were unvaccinated, vaccinated, and boosted; and in people with primary SARS-CoV-2 infection and reinfection.”
Though the study reports “reduced risk of 10 of 12 post-acute sequelae” note that various reports on long COVID usually refer to 20 to 30 typical symptoms. And it is not entirely clear which of the 10 were most helped by the expensive, prescription drug.
Ziyad Al-Aly, chief of research and development at the VA St. Louis Health Care System and lead author of the new report, said it showed the importance o f introducing an antiviral to reduce the severity of acute disease. It also lends credence to the idea that long covid symptoms may be driven, at least in part, by viral persistence, in which the virus is not fully cleared by infected individuals.. He said “Suppressing the viral load may reduce the problem of viral persistence.”
What has not received any attention, however, is whether the antiviral ivermectin might also offer similar benefits.
Nor has there been any research on whether high doses of vitamin D might also be beneficial for long COVID.
The people who enrolled qualified to receive the drug according to the emergency use authorization issued last year by the Food and Drug Administration, which is for anyone 12 and older at risk of severe disease including those 65 and older. As a result, the study did not include previously healthy young people, who represent the majority of patients seen at many long covid clinics, according to Benjamin Abramoff, director of the Post-COVID Assessment and Recovery Clinic at Penn Medicine.
There is no data to show whether those previously healthy young people would reap the same benefits as people at risk of severe disease.
Al-Aly, the lead author, said the study also highlighted for him the remarkable underutilization of an effective therapy, with 85 percent of people who were qualified to be prescribed the antiviral not taking it. “Is it because they were not offered it, or they had concerns?” he asked. “We are not saying any and all people should take Paxlovid,” Al-Aly said. “At this point, we do not know that. People need to understand that.”
Dr. Joel S. Hirschhorn, author of Pandemic Blunder and many articles and podcasts on the pandemic, 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 the colleges of engineering and medicine. As a senior official at the Congressional Office of Technology Assessment and the National Governors Association, he directed major studies on health-related subjects; he testified at over 50 US Senate and House hearings and authored hundreds of articles and op-ed articles in major newspapers. He has served as an executive volunteer at a major hospital for more than 10 years. He has been a member of the Association of American Physicians and Surgeons, and America’s Frontline Doctors.