Eight things you need to know about Pfizer’s new COVID pill

Eliyahu Tulshinski

November 8, 2021

Pharmaceutical giant Pfizer Inc. Friday announced that its “game-changer” pill to treat COVID-19 had “overwhelming efficacy” in clinical trials. The company plans to request approval for the pill (an oral antiviral drug it named Paxlovid) from the Food and Drug Administration (FDA) before Thanksgiving on November 25th. Pfizer, like its competitor Merck, which is developing its own COVID pill, hopes to win approval for distribution of the drug before the end of the year. 1) No, Pfizer’s COVID pill does not mean the end of vaccine mandates. Shortly after issuing a press release about its COVID pill, Pfizer’s CEO Albert Bourla calmed investors concerned about a potential decrease in COVID vaccine sales. According to CNBC, Bourla told the Squawk Box that:

“The fact that we have a treatment is not at all a reason not to take the vaccine. In fact, we should take the vaccine. Some unfortunately will get the disease.”

Bourla’s claims are supported by academics like Dr. Grace Lee, professor of pediatrics at Stanford University School of Medicine, who insists:

"Vaccines are going to be the most effective and reliable tool that we have in this pandemic. These oral medications are going to augment our ability to really reduce the risk of severe disease, hospitalization and death, which is huge, but it won't prevent infection."

With investors reassured, Pfizer’s stock price leapt 11% on the hope that its vaccine sales would continue to soar, even as the company profits from the treatment of so-called “breakthrough infections” in the vaccinated. 2) No, Pfizer did not complete its clinical trial of its COVID pill. The Pfizer trial was stopped early, upon the recommendation of the independent Data Monitoring Committee overseeing its experiments, after Pfizer reported “overwhelming efficacy” of the drug. This early termination of a clinical trial is used to allow the drug company to more quickly present their findings to regulatory agencies. However, when truncating an experiment before it reaches its predetermined end points, “the estimated treatment effect may be exaggerated because statistical stopping rules are prone to stop a trial at a random high.” Indeed, Victor M. Montori, MD, MSc, reported in the Journal of the American Medical Association (JAMA) that:

“RCTs [Randomized clinical trials] stopped early for benefit are becoming more common, often fail to adequately report relevant information about the decision to stop early, and show implausibly large treatment effects, particularly when the number of events is small. These findings suggest clinicians should view the results of such trials with skepticism.”

Likewise, Professor Gordon Guyatt found that:

“Uncritical belief in truncated trials will often, therefore, be misleading—and sometimes very misleading.”

3) No, you cannot sue for adverse events, even though the new pill is a treatment and not a vaccine. The 2005 Public Readiness and Emergency Preparedness Act (PREPA) prevents victims of drug side effects, and their families, from suing pharmaceutical companies whenever the secretary of Health and Human Services (HHS) declares a public health emergency. This shield against liability applies not just to vaccines, but to any drug or biological product that the HHS secretary deems a "covered countermeasure" to the declared emergency. 4) No, Pfizer is not saying how many deaths or hospitalizations in their clinical trials were due to COVID. The Associated Press reported that all participants in Pfizer’s clinical trials for its new COVID drug “were considered high risk for hospitalization due to health problems like obesity, diabetes or heart disease.” With every single study participant suffering from such comorbidities, each of which may alone cause death even in the absence of an infection, it is impossible to determine the drug’s efficacy without first ascertaining whether deaths or hospitalizations occurred because of COVID-19 or merely with COVID-19 (or, more accurately, with a positive PCR test - see below). Additionally, the group used in the experiment, unvaccinated, high-risk individuals, may be a group particularly prone to death since, as Dr. Andrew Bostom has explained, unvaccinated, high-risk individuals are often unvaccinated not by choice, but because their doctors determine that their health is too fragile to handle the vaccine. Thus, it may not be possible to generalize the study’s results to the greater population. 5) No, Pfizer is not saying how many PCR cycles were performed before declaring trial participants to have been positive for COVID-19. The New York Times analyzed the reliability of PCR tests using high cycle thresholds in an article entitled, “Your Coronavirus Test Is Positive. Maybe It Shouldn’t Be.” As the paper reported,

“In three sets of testing data that include cycle thresholds, compiled by officials in Massachusetts, New York and Nevada, up to 90 percent of people testing positive carried barely any virus, a review by The Times found….Any test with a cycle threshold above 35 is too sensitive, agreed Juliet Morrison, a virologist at the University of California, Riverside. “I’m shocked that people would think that 40 could represent a positive,” she said … In Massachusetts, from 85 to 90 percent of people who tested positive in July with a cycle threshold of 40 would have been deemed negative if the threshold were 30 cycles, Dr. Mina said. “I would say that none of those people should be contact-traced, not one,” he said. Other experts informed of these numbers [of cycles] were stunned.”

According to these experts cited by the New York Times, without knowing the number of PCR cycles used by Pfizer’s labs, there’s no way to know whether the people hospitalized or dying with a positive PCR test had enough viral load to cause any health problems, let alone hospitalization or death. Nonetheless, Pfizer has not released any information on the number of PCR cycles it used to determine that a participant was indeed infected with Covid-19. 6) No, Pfizer has not announced who they expect to pay the $700 cost of each treatment course. If the government will foot the bill for this expensive treatment, either taxes will increase, or the federal debt will increase, or both. If insurance companies pay some or all of the costs of this therapy, insurance premiums may increase. Reuters estimates the cost at around $700 per patient since Pfizer CEO Albert Bourla “expects to price its treatment close to where Merck has priced its drug. Merck's U.S. contract price is around $700 for a five-day course of therapy.” 7) No, the “new” drug is not actually new. The new Pfizer pill, Paxlovid, is actually based on a small molecule inhibitor of a SARS-CoV protease discovered during research into the 2002-2004 Severe Acute Respiratory Syndrome coronavirus (SARS-CoV) outbreak originating in Asia. After shelving the medicine, which required IV delivery, for almost two decades, Pfizer renewed research into the formulation and created a similar molecule that can be delivered orally. This drug is combined with an even older drug, ritonavir (an HIV medication approved for use since 1996) and administered together as Paxlovid. 8) No, Pfizer did not explain why it expects COVID to continue for more than two winters. Despite the absence of a pandemic approaching the level of the 1918-1919 Spanish Flu in the subsequent 100 years, and despite health conditions far better than those of 1918, when much of the world suffered from malnutrition and bombardment during the food rationing at the end of the first World War, public health officials warned in 2019 that a new pandemic would soon strike and even ran simulations for it. Now, Pfizer expects this once-in-a-hundred-years pandemic to last longer than the two winters of the Spanish Flu. The company is planning to manufacture at least 50 million courses of its new pill by the end of next year, 29 million of which are for use in the second half of 2022, demonstrating their belief that the pandemic will continue into a third winter. In fact, Pfizer may be expecting the pandemic to continue beyond 2022. Its CEO said: