The state of Texas filed suit against Pfizer, accusing the drug giant of widespread misrepresentation about the efficacy of its Covid 19 vaccine, focusing particularly on its “95% efficacy” claim, its misrepresentation that the vaccine prevented transmission, its false depiction that vaccine-conferred immunity was durable, its insistence the vaccine remained highly effective against the Delta variant, and its censorship of critics, such as Alex Berenson and former FDA Director Brett Giroir, to conceal vaccine underperformance.
Texas is making what conceptually is an advertising/marketing fraud case, using state law theories to accuse Pfizer of engaging in deceptive trade practices, and contending they were made to secure lucrative government contracts and increase sales. This case could wind up being significant, since if and when it gets to discovery, Texas may be able to unearth information that confirms that Pfizer knowingly deceived the public and potentially the FDA and CDC. If so, this case could provide a foundation for class action attorney to attack the EUA as having been made only as a result of Pfizer misrepresentations (such as cherry-picking of measurement periods and thresholds), and therefore fraudulent. Voiding the EUA would open Pfizer to vaccine injury claims.
Mind you, anyone who has followed the drug industry would know that lying with data is hardly uncommon, with Vioxx as a particularly dramatic and deadly example. IM Doc has repeatedly inveighed against against the use of relative risk reduction as a primary indicator of effectiveness. It turns out the FDA agrees yet weirdly does pretty much nothing to combat this misdirection.
The filing comes off as well argued and substantiated. For instance, it does a fine job of explaining how conventional drug approval and EUA procedures differ.
We have embedded a version of the complaint below. We were unable via simple means to compress the file enough to upload it in WordPress. So we had to open it in Word and pdf it from there. This version is very readable and pretty much all of the formatting came over but the pagination changed. So fans of native documents might want to look at the filing on the Texas Attorney General website.
To go through the bill of particulars:
Misleading focus on relative risk reduction. The case directly attacks the use of the relative risk reduction metric and contends Pfizer hid the more reliable absolute risk reduction measure, which was only 0.85% (no typo) in the original trial, versus its much touted 95%.1 The number of vaccinations required to prevent a single case was 119, also not a compelling number. The filing further indicates that Pfizer manipulated study endpoints, such as excluding as Covid cases ones where there was a positive test but no symptoms.
Texas also alleges that Pfizer manipulated investigation time frames so as to exclude findings that would have vitiated its claims about efficacy. From the filing (emphasis original):
Other results from the initial Phase 2/3 trial called into significant question how efficacious the vaccine was in a more practical sense. As noted above, Pfizer designed the trial such that “defined COVID-19 cases” were counted starting only seven days after a participant received the second of two shots (at least 28 days after the first shot). Put differently, COVID-19 cases that occurred before that point—that is, between shot one and seven days after shot two— were not considered when evaluating the efficacy of Pfizer’s vaccine. That was a highly significant qualifier because 409 “[s]uspected” COVID-19 cases occurred after the participant received the first vaccine shot, but before seven days elapsed after taking the second shot. Id. at 41. By contrast, only 287 suspected COVID-19 cases occurred among placebo recipients in that same interval. In other words, more people in the trial’s treatment group experienced COVID-19 than in the placebo group, even though the former had taken at least one ostensibly immunity enhancing dose.
Consider also the serious caveats in the FDA’s EUA approval, which oddly were seldoom heard in polite company. Again from the filing:
Notably, FDA went out of its way to expressly state that Pfizer’s results did not support several important vaccine characteristics that are highly relevant to Pfizer’s representations to the public. Id. at 49-51. Specifically, FDA made the following findings:
A. “[I]t is not possible to assess sustained efficacy over a period longer than 2 months.” In other words, the clinical trial thus far showed nothing about long-term efficacy.
B. “Data are limited to assess the effect of the vaccine against asymptomatic infection.” The clinical trials, after all, primarily evaluated symptomatic infection.
C. The clinical trials did not provide meaningful data on mortality—instead, “A large number of individuals at high risk of COVID-19 and higher attack rates would be needed to confirm efficacy of the vaccine against” death.
D. Finally, that “[a]dditional evaluations . . . will be needed to assess the effect of the vaccine in preventing virus shedding and transmission.”
Misrepresenting the durability of protection. The lawsuit sets forth multiple instances of Pfizer CEO Albert Bourla and Pfizer statements depicting the vaccine offering strong protection at six months, which in context implied it would continue past then. I recall seeing that formulation as deceptive and may have even harrumphed in comments, but I don’t think I did so in a post, since Pfizer could fall back and claim its depiction was narrowly accurate. However, the filing shows that efficacy was waning (recall it was dropping markedly in all age groups in the Pfizer monoculture of Israel inn 2021) and Pfizer continued to stick with its “six month” mantra until there was enough external contrary data that it had to retreat.
Falsely claiming the vaccine prevented transmission. This bit of supporting evidence from the filing is noteworthy:
To advance its commercial interests, Pfizer began laying groundwork to mislead the public well before it received the EUA for its vaccine. For example, in July 2020, Pfizer CEO Albert Bourla talked about how “the vaccine [works] in humans.” He said that it creates immune responses that are “able to kill the virus” and that “th[e] vaccine can neutralize the virus.” But, as the EUA data later showed, Pfizer measured efficacy only against symptomatic COVID-19—not whether the vaccine “neutralized” or “killed” the virus. Time, Pfizer CEO Albert Bourla Raises Expectations That the Pharmaceutical Giant Can Deliver a COVID-19 Vaccine by Fall (Updated: July 12, 2020, Originally Published: July 9, 2020).
Deceiving about protection against new variants. Pfizer insisted that its Covid vaccines were super duper effective against Delta, when again data showed efficacy fell after Delta became the dominant variant. On top of that, as the filing pointed out, some studies showed negative efficacy after three months, again proof that the Pfizer vaccine packed much less punch against variants and could arguably be detrimental.
In a point that has more general importance, Texas also points out that the FDA came to criticize the use of antibody testing as a proxy for vaccine efficacy. I can’t recall how many studies I read by Pfizer, Moderna, and independent researchers, that treated antibody responses after vaccination as if they were gospel. From the suit:
Pfizer’s untested “antibodies only” approach to demonstrating efficacy against Delta was also remarkable because, at the very same time, FDA was publicly taking the position that antibodies did not constitute evidence of protection. For example, on May 19, 2021, FDA explained in a publicly issued report that “results from currently authorized SARS-CoV-2 antibody tests should not be used to evaluate a person’s level of immunity or protection from COVID-19 at any time.” FDA, Antibody Testing is not Currently Recommended to Assess Immunity After COVID-19 Vaccination: FDA Safety Communication (May 19, 2021).
Censorhip to Hide Vaccine Underperformance. This discussion is delicious if also sadly predictable. It prominently features Scott Gottlieb, then on Pfizer’s executive committee, successfully smearing Alex Berenson as a conspiracy theorist despite Pfizer knowing Berenson’s charges were accurate or at least plausible. For instance:
On August 28, Berenson tweeted that Pfizer’s vaccine “doesn’t stop infection . . . [o]r transmission,” as well as that it has a “limited window of efficacy.” These were indisputably true statements based on the scientific record at that time, including data from Pfizer’s own studies, as well as FDA’s own findings. Nevertheless, Gottlieb emailed this tweet to senior Twitter employees. Given the context of Gottlieb’s communications with Twitter at that time, this was likely intended to provoke Twitter into banning Berenson’s account. Later that same day, Twitter permanently suspended Berenson’s account.
And Pfizer engaged in an open campaign of intimidation:
137. For example, on November 9, 2021, CEO Albert Bourla charged that persons who spread so-called “misinformation” concerning COVID-19 vaccines are “criminals” who have“literally cost millions of lives.”
138. On that same day, Pfizer Tweeted a message with the clear implication that persons
questioning the efficacy of Pfizer’s vaccine are spreading “misinformation.
Remember, this was in the period that doctors who expressed concern about vaccine injuries or efficacy were at risk of losing their licenses. These threats by Bourla were meant to keep pressure up on state medical boards and public health officials to punish apostates.
Needless to say, this salvo is all very juicy and we wish Texas well. But you can be sure that Pfizer will try to tie the state in knots, including procedurally. But this may be a sign that the effort to hide all the bad faith, profit-seeking behavior during the Covid crisis is starting to break down.
1 I believe you could determine the absolute risk reduction from the clinical trial data, but narrowly the filing is likely correct, since I never recalled seeing any mainstream mention of 0.85% absolute risk reduction.00 Texas v. Pfizer via Word