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
46 comments
Comments are closed.
What would it cost Pfizer to scuttle/stall the action by buying enough of the Texas legal team? I assume the costs of losing EUA legal protection are much higher. If so, what prevents them from doing this?
The action is brought by the state. The AG has another suit against Pfizer and clearly sees them as a good target: high profile bad actor. And the public no longer believes much in the vaccines, so the thesis would not be hard to sell to a jury.
This is why you have elected Attorneys General. The only way to buy the case off is to hand bags of money to an AG willing to take them, and after publicly declaring his crusade and filing suit, that’s not going to happen.
Other agencies in state government are directed by ‘will-and-pleasure’ chiefs, who are one phone call away from the governor of being out of a job, or one bag of money away from scuttling regulatory actions. Much easier therefore to pressure health departments, environmental departments, etc.
The Texas AG, iirc, was put through an impeachment process in the Texas lege this year and won acquittal on all counts, much to the unhappiness of many in the Texas lege. I think that matters in case Pfizer decides to try undermining the case by going through lege pols.
Re elected AGs: recall how state AGs starting with Iowa’s Tom Miller were bought off when they threatened to sue the big banks over mortgage fraud, and how absolutely wimpy the final settlement was (as Yves pointed out).
It did happen in the mortgage fraud settlement, which was a large group of state AGs, and which was preceded by a bold declaration of the kind we see here (albeit immediately followed by a U-turn that was so hard it practically left skid marks).
This one seems quite detailed and well put together, and TBTF isn’t in play, so I’m hopeful that it won’t happen this time. It’s still a reminder not to put too much faith in the crusading powers of AGs. All the same, it seems like a vote winner with the vaccine skeptic crowd, and probably good for public health generally if government can be seen to be punishing bad behavior in that space.
[Edit: ScottB made the same point above]
Bushies tried to take out the Texas AG.
Never understood why the Bushies tried to take out Paxton, a Republican attorney general.
Perhaps this case is a clue.
Anyone else out there recall that Pfizer and the FDA/CDC re-defined vaccine around the time of the rollout of the Covid non-sterilizing shots?
Lotta this sticks in my jabbering craw.
I still call them “the shots.”
And I do too. Still grateful for what I learned here at NC during 2020-21.
That knowledge led to my decision to avoid these shots. As time goes on, I feel even better about this decision.
Thank you, Naked Capitalism!
Yes, many thanks to NC and the commentariate. Also, cheers to FLCCC, Dr.s Mobeen and Campbell, Kirsch, Dark Horse, Children’s Health Defense, Vanden Bossche, Martinson with my favorite being Dr. Tess Lawrie. NC is the heart of The In Crowd.
For once, I am proud to have grown up in TX. I’ve been asking people to show me real evidence that the mrna ‘vaccines’ work since day 1.
Really brightens my day, thank you.
Kinda’ makes me feel like Riverdancing.
My understanding is that there were earlier (pre-Covid) attempts at conventional coronavirus vaccines that had similar issues to current ones — rapidly fading immunity etc. The mRNA aspect may be a different (additional) kettle of fish…
mRNA tech has had a long track record of failure and there was no evidence of any new innovations that would have changed this in 2020.
And of course shots made with proven vaccine tech were mysteriously suppressed/removed from the market.
This is the gist of it, yes. I still recall my wife (then a vet student) at the time of the announcement of vaccines saying “well that’s unlikely, there’s no effective vaccines for coronaviruses, they mutate too fast”. And pointing to the detailed description of the history of trying to vaccinate coronaviruses in her textbooks.
It would be interesting to see detailed analysis of the non-mRNA covid vaccines efficacy over time, to see if that has been the case with these modern versions. Maybe one of the BRICS nations will supply that eventually.
And it shows many reasons why some considered all that happened with opioids (a prime example) and that became a factor in their acceptance of the promoted “science” about the shots.
I had the impression some people at Pfizer and connected with Pfizer walked away with some large chunks of change as harvest from their alleged lies. If the Texas case succeeds and some interesting details emerge from discovery, will these persons get away with lethal fraud and get to keep most of their winnings? Will the Pfizer Corporate shield — shield this human personal criminality and protect their rewards? I think I have seen this movie several times before.
And the reek of Operation Warp Speed — one of the many gifts of the CARES Act — might acquire greater pungency. Perhaps it may be renamed Operation Warped Speed.
What science can be trusted?
https://en.wikipedia.org/wiki/Replication_crisis
The replication crisis (also called the replicability crisis and the reproducibility crisis) is an ongoing methodological crisis in which the results of many scientific studies are difficult or impossible to reproduce. Because the reproducibility of empirical results is an essential part of the scientific method,[2] such failures undermine the credibility of theories building on them and potentially call into question substantial parts of scientific knowledge.
Retraction Watch always a fun read. I love the new and inventive ways researchers find to scam the system.
https://retractionwatch.com/
Honestly Hunter had it right with the Coke and Hookers, time kills us at least he enjoyed it while he could.
Replication crisis really comes down to money, underfunding of scientific research in general and also poaching of scientific funding by the business community. Cost of equipment and research materials has skyrocketed, so it’s difficult to do experimental validation, for example by measuring using different instruments or measurement techniques. Scientists in general are poorly paid, most of the actual work is done by graduate student and post docs, who have zero incentive to do validation work, and faculty are too busy with chasing funding and publications to do actual research.
To quote the old saying in the Serbian car factory that churned out Yugo’s, “door fit is proportional to the salary” (kakva plata takva vrata :). Same applies to science.
I’ll be interested to see how this goes. Use of relative risk reduction is standard in medical advertisement, so if Pfizer is found liable, that would wreak havoc with the whole industry. Ironically, if pharma/medical sector has to halt advertising, even temporarily, it would be a big blow to cable companies as this is 30% of total advertising revenue.
Good for Texas, and a reminder that a courageous AG can in fact make positive changes. Pharma needs some hard slaps to wake up and stop acting imperial. If the legislators want to keep sucking up to them, it’s up to the courts to jerk their chains. I hope some courageous MDs whose careers were damaged find a junkyard tort lawyer to get damages from these thugs, too.
It seems like an eon ago that Big Tobacco was considered unassailable, til Mike Moore decided to take them on. He/the state won, and it’s no concidence smoking is now a fading and much rarer thing.
Not sure “courageous” is the word I would choose to describe Ken Paxton.
There is a long road ahead on this action, and Pfizer has powerful friends.
Nonetheless, it seems like extensive research went into this filing and it might serve as a source for other actions, as well. It’s also useful as part of a salvo in the information war.
All of this likely further reduces confidence in vaccination generally, sort of like when the CIA took advantage of a polio eradication campaign to find bin Laden, discrediting another vital public health campaign.
Paxton may be right wing and unlikeable, but taking on a corporation with powerful friends is kind of one definition of courageous.
The more time goes by, the more scum rises to the surface. I hope something positive results in this litigation.
I was forced, like millions of others, to get an injection or lose my job. No job in ‘merka means, no “health care”, no income. (being fired for insubordination means no unemployment benefits), career destroyed and effectively black-listed. I opted for the J&J vax, as it only required one shot. Thankfully, I was not “mandated” to get the “boosters”, only strongly encouraged.
The irony of this authoritarian policy is that if they cared about people’s health, why were they going to fire so many people and jeopardize their health by denying health care? My cynical side says this was use of state coercion to boost sales of a private product – truly dystopian.
The big-picture, rhetorical question I have is how can we trust a private oligopoly when their only interest is maximizing profit and return to shareholder value? And when our “elected” officials are bought-and-paid for by private interests (especially after Citizens United) , how can we trust any of them?
The lack of trust will contribute to accelerating the social collapse that appears to be happening, slowly but surely. But maybe I’m just too pessimistic?
If politicians cared about “public health” like they claim, we’d have #M4A instead of the privatized, rent-seeking, complex cluster\we have now.
As much as I dislike Pfizer this is just as misleading. It should state “In other words, more people in the trial’s treatment group experienced COVID-19 than in the placebo group *over the period of time between 1st shot and 1 week after second“. There is not enough information presented to determine overall which group was more likely to get Covid.
Pfizer has always argued that the Vaccines temporarily reduced your immune system for a short period afterward and this is why that time frame should be removed from the data. While the AG is correct that this is misleading, it does not change that both time periods need to be added together for each to draw any real conclusion
If the “temporary immune system effect” means you contract the illness the shot is meant to protect you from, I don’t think it’s reasonable to remove that window from the data or discount it as an irrelevant side effect. It’s a primary effect directly impacting efficacy, as well as being a side effect that may lead to contracting other illnesses.
Although you’re right that we cant conclude overall efficacy from this one piece of information, we can definitely draw the conclusion “the vaccine made you more likely to get covid in the next month after getting the shot”, which is very pertinent to the use case.
If you read the document the vaccine test population and placebo population only differed by a count of 8 people out of over 14,000 per group.
Paxton, and the Governor appear to be selling this as a suit about not ending Covid when we could have. Nothing in their social media suggests that this is a good faith effort to address failures by pharmaceutical companies. He’s also sued to stop mask mandates.
Thanks. Of course readers of NC knew that the vaccine wasn’t a true “sterilizing” vaccine from the getgo so the attitude of some of us has always been “why take the risk?”
And there are risks although perhaps Texas doesn’t have the standing to sue over that.
Thanks a lot Yves for dissecting the Texas AG filing! Got neither the time nor the expertise but consider this very important! Here´s from Germany!
And now the fact comes out that using pseudo uridine instead of true uridine in the make up of the mRNA leads to incorrect protein synthesis due to what we would call in electrical engineering land, slipped bits. The change was necessary to keep the mRNA from being immediately destroyed by the immune system. But the result is the creation of proteins that don’t exist in nature, and the immune system goes after them, causing inflammation. This paper demonstrates that this effect is measured in Pfizer vaxxed individuals.
“We detected a significantly higher IFNγ response to +1 frameshifted antigen in the BNT162b2 vaccine group, compared to ChAdOx1 nCoV-19 ”
Interferon gamma is an inflammatory marker. They are saying only Pfizer vaxed people had this, and +1 frameshifted is the mRNA transcription error caused by the pseudo uridine.
there is a lot of twitter talk that this may explain a lot of the severe adverse effects that are associated with the vax. Also, this effect (of frame shifting due to pseuso uridine) was reported years ago….loong before these vaxes.
https://www.nature.com/articles/s41586-023-06800-3
And what if that incorrect synthesis becomes a permanent feature of your system? … shudders.
Thanks for the link to this very interesting paper. Great read. Great work.
I’ve recently read a book by Paolo Barnard, Dr. Steven Quay, and Prof. Angus Dalgleish called ” The Origin of the Virus, the hidden truths behind the microbe that killed millions of people.” This book provides strong evidence that the covid 19 virus could NOT have come from nature. This book was written so that non scientists can understand. I was able to get the book through Amazon, however, a week later I told a friend to get the book and they couldn’t. It might well be censored. They got it through Kindle. One fascinating fact is that the virus was actually designed so that it can attack the cells of all the organs because of other other human induced mutations. One reason is the placement of amino acids on the spike protein that have positive charges which causes an affinity to bind to cell walls.
Dalgleish is on John Campbell’s YouTube videos quite a bit. He actually claims that a boiled water killed big virus is effective against Covid. He also did one episode where he talks about seeing increased cancer relapses in older patients after covid booster doses. BTW, I got a booster in late October before an India trip. Landed there Nov 9th and got Covid on Nov 30. Sam thing happened in May this year. Took a booster went to India and promptly got Covid. All my shots were Pfizer.
If cancer is increasing related to Covid (and it does seem to be), it is an artifact of both the disease (including asymptomatic cases) and the shots. Anthony Leonardi has been writing early on about the impact of Covid on T-cells, and it looks like the shots do too, particularly if you are boosted a lot. The layperson terms (crude) are T-cell exhaustion and/or immune dysregulation. T-cells are a major line of defense against cancer. Your body makes cancer cells all the time and T-cells are a big mechanism for stopping them from getting anywhere. T-cells having a sad = less cancer patrol in your body.
This also got mentioned on Ars Technica, in a more pro-narrative way.
Thanks very much for this post. If Texas can prove fraud and void the EUA liability shield on these products that would be huge.
We already know of specific instances of fraud such as calling Maddie Garay being paralyzed as having stomach upset. One of Pfizer’s employee’s Brook Jackson is a whistleblower with documentation showing systemic fraud.
Pfizer and the FDA also had to release clinical trial documents/data they wanted to keep secret for 75 years because ICANN won in court. That data shows over 12 anomalies in the data which show fraud was committed on a systemic level.
https://wherearethenumbers.substack.com/p/anomalous-patterns-of-mortality-and
Remember when Fauci said this? About 99.2% of recent COVID-19 deaths in the U.S. involved unvaccinated people, a “tragic” situation that could easily be remedied, Dr. Anthony Fauci said Sunday.
That was in July 2021 at the height of the push to get everyone vaccinated.
I just want to comment on this contention by the Texas government, which is ridiculous, and false:
In fact “relative risk” is a more reliable measure than “absolute risk” reduction. The reason is that “relative” risk measures the effectiveness of the vaccine consistently, regardless of the prevalence of the virus in the community, whereas “absolute” risk is a measure of not only the effectiveness of the vaccine but also the prevalence of the virus in the community.
So if a virus is highly prevalent when risk statistics are gathered, then a vaccine’s effectiveness against the virus, when measured as “absolute risk reduction”, will be much higher than if the virus had been scarce at that time. But the “relative risk reduction” will be the same regardless of the prevalence (so long as the virus is prevalent and virulent enough that there’s any measurable risk at all).
A measure of a vaccine’s effectiveness whose value fluctuates dramatically between time and place is clearly not “more reliable” than a measure that adjusts for those fluctuations (as relative risk measurement does), and that’s precisely why it’s the relative measure that’s generally used to describe the effectiveness of vaccines (and other drugs) against infectious diseases, which are prone to wild fluctuations in prevalence.
Even though I could have rebutted your comment myself, and also invoked from the Texas suit that the FDA also treats relative risk reduction as a less preferred measure of vaccine efficacy, I decided to turn this over to IM Doc, who for years has criticized the misleading use of relative risk reduction in Big Pharma marketing. Oh, and IM Doc was a professor in a major med school, taught statistics among other things, AND was on an institutional review board, as in oversaw clinical drug trials, for 15 years and was the chair for five.
Your best defense is that you are in Pharma marketing and speaking up for your meal ticket. Otherwise, from IM Doc by e-mail: