Dec 22, 2023 08:37 PM
https://undark.org/2023/12/21/opinion-paxlovid-studies/
INTRO: Strong science, particularly vaccine development, helped us steer our way through the Covid-19 pandemic. Now, as the pandemic recedes, it’s time to hold drug companies accountable for the treatments they’ve developed. The evidence for these medications has not kept pace with major changes in the nature of the Covid-19 pandemic, and updated studies should be required to maintain approval for these very profitable drugs.
The Covid-19 drug development battlefield is littered with 479 failed or inactive drugs, while 358 are still in clinical or preclinical trials, according to a tracker maintained by the Biotechnology Innovation Organization, a trade group. The only oral Covid-19 therapy approved by the U.S. Food and Drug Administration that is recommended for first line outpatient use is Pfizer’s Paxlovid (nirmatrelvir-ritonavir), a two-drug combination that stops the SARS-CoV-2 virus from replicating in the body.
Hailed as a game changer, Paxlovid is a very good antiviral drug that has saved many lives, and its incredibly rapid development was a feat of science. The major study leading to its approval, called the EPIC-HR trial, showed that it reduced the risk of hospitalization and death by an impressive 89 percent in high-risk, unvaccinated people.
But there is a lack of high-quality research on how Paxlovid affects outcomes beyond severe Covid — such as duration of illness, how the drug affects transmission, and whether it prevents long Covid. Nevertheless, some physicians are promoting the drug for these uses based on weak, inconsistent data. The stakes are high: If we fail to set a requirement for well-designed studies of Paxlovid’s impact on all concerns besides hospitalization and death, we will be setting up a slow-moving, disastrous recreation of mistakes made with drugs for other diseases such as influenza.
Early in the Covid-19 pandemic, the explosive, unorganized growth of clinical trials for treatments was intended to save lives from this fearsome new disease. But many trials were small and of low quality, with a few exceptional trials providing much of our good data. In that initial desperate push for Covid-19 treatments, experimental, everything-but-the-kitchen-sink approaches became widely used.
The case of ivermectin is instructive: This antiparasitic drug was used in tremendous volumes based on poor quality and sometimes outright fraudulent data, despite advice against its use from the FDA and in formal treatment guidelines. Social media amplification of the increasingly dubious evidence base led to a near-delusional belief in its benefit — and impressive profits for some opportunistic doctors... (MORE - details)
INTRO: Strong science, particularly vaccine development, helped us steer our way through the Covid-19 pandemic. Now, as the pandemic recedes, it’s time to hold drug companies accountable for the treatments they’ve developed. The evidence for these medications has not kept pace with major changes in the nature of the Covid-19 pandemic, and updated studies should be required to maintain approval for these very profitable drugs.
The Covid-19 drug development battlefield is littered with 479 failed or inactive drugs, while 358 are still in clinical or preclinical trials, according to a tracker maintained by the Biotechnology Innovation Organization, a trade group. The only oral Covid-19 therapy approved by the U.S. Food and Drug Administration that is recommended for first line outpatient use is Pfizer’s Paxlovid (nirmatrelvir-ritonavir), a two-drug combination that stops the SARS-CoV-2 virus from replicating in the body.
Hailed as a game changer, Paxlovid is a very good antiviral drug that has saved many lives, and its incredibly rapid development was a feat of science. The major study leading to its approval, called the EPIC-HR trial, showed that it reduced the risk of hospitalization and death by an impressive 89 percent in high-risk, unvaccinated people.
But there is a lack of high-quality research on how Paxlovid affects outcomes beyond severe Covid — such as duration of illness, how the drug affects transmission, and whether it prevents long Covid. Nevertheless, some physicians are promoting the drug for these uses based on weak, inconsistent data. The stakes are high: If we fail to set a requirement for well-designed studies of Paxlovid’s impact on all concerns besides hospitalization and death, we will be setting up a slow-moving, disastrous recreation of mistakes made with drugs for other diseases such as influenza.
Early in the Covid-19 pandemic, the explosive, unorganized growth of clinical trials for treatments was intended to save lives from this fearsome new disease. But many trials were small and of low quality, with a few exceptional trials providing much of our good data. In that initial desperate push for Covid-19 treatments, experimental, everything-but-the-kitchen-sink approaches became widely used.
The case of ivermectin is instructive: This antiparasitic drug was used in tremendous volumes based on poor quality and sometimes outright fraudulent data, despite advice against its use from the FDA and in formal treatment guidelines. Social media amplification of the increasingly dubious evidence base led to a near-delusional belief in its benefit — and impressive profits for some opportunistic doctors... (MORE - details)