We live in a world where a sociopath like Florida governor Ron DeSantis says he will not enforce the U.S. Supreme Court’s upholding of the requirement of healthcare workers who work for institutions that receive federal funding to be vaccinated (but not businesses that employ 100 or more workers). Fox News sociopath Tucker Carlson doesn’t understand why anyone needs to talk about Covid anymore, even though some states are seeing record infections from the Omicron variant (like Florida). But why leave “liberals” out of it? Robert F. Kennedy Jr. seems to have wandered out of his area of expertise (environmental law) and ventured into the fantasy world of anti-vaccine conspiracies, becoming a “superspreader of hoaxes” and recently publishing an inane book on the “Real Anthony Fauci.”
Meanwhile, a Donald Trump-appointed judge, Mark Pittman of the U.S. District Court for the Northern District of Texas, has ruled that the United States Food and Drug Administration has eight months—rather than the 75 years it requested—to release all documents (without redactions) in regard to its approval of the Pfizer Covid-19 vaccine. This is the same court that barred mask mandates for federal Head Start programs, so obviously it takes a pro-conspiracy theory approach to public health in a state that is just behind California in Covid-19 deaths (but has a much higher rate per population) and has a notoriously underfunded health care system.
The FDA gave full approval of the Pfizer vaccine in August 2021 for persons 16 and over, and more recently approved its use for those 5 and older. This was based on 340,000 pages of data from its clinical trials. But the British Medical Journal had called on the FDA to “refrain” from full approval of any vaccine in 2021. It claimed that a complete public examination of “raw data” from its phase III trials was needed first; phases I and II generally are meant to discover side effects and what treatment actually does, while phase III seeks to confirm that the treatment is more effective than a “standard” treatment.
The BMJ appears to be the principle source for The Public Health and Medical Professionals for Transparency FOIA complaint, although its claim that this is being driven by a “national debate” on vaccines neglects to mention that this “driving force” is mainly far-right media and politicians delving in misinformation and conspiracy theories. It isn’t clear what ideology the PHMPT is (it suggests that it is “non-partisan”), but its “concerns” are not far afield of that of The Association of American Physicians and Surgeons, which was founded in 1943 to oppose universal health care and has ever since been the dinosaur in the room, pushing various anti-science conspiracy theories, including those in regard to Covid-19.
Interestingly enough, the Texas case is based in part on a whistleblower complaint from—interestingly enough—Texas. This past November, the BMJ reported that in regard to its trials, “Pfizer’s vaccine at several sites in Texas during the autumn (of 2020) speed may have come at the cost of the data integrity and patient safety. A regional director who was employed at the research organization Ventavia Research Group (a Texas-based company) has the told the BMJ that the company falsified data, unblinded patients (meaning they were told if they were given the vaccine or the placebo), employed inadequately trained vaccinators, and was slow to follow up on adverse events reports in Pfizer’s pivotal phase III trial.”
Pfizer is being targeted because its vaccine received full approval from the FDA before the others, and the lack of “whistleblowers” from the Moderna and J & J camps. Whether or not it matters that these testing anomalies are solely the responsibility of a Texas company’s lack of accountability (and we know from last year’s winter storm disaster that the state has lax regulatory standards anyways), or crosses over into its trials at other sites or in Europe is apparently not at issue. The FDA’s emergency approval in December 2020 noted 3410 cases of “unproven” Covid-19, although Covid-like symptoms existed. It is claimed that if these were counted as positive test results, the effectiveness of the vaccine would have been much lower on paper. However, it should be pointed out that the FDA’s full approval last August was presumably based on more up-to-date information, although its reluctance to release documentation (that is 340,000 pages of it) could be seen as “suspicious.”
Nevertheless, it is the FDA who is on “trial” here, and what information their decision to approve the Pfizer vaccine was based on. The problem, of course, is that this Trump-appointed judge is not doing his patron any favors, if the media does its job and reports the facts. Remember “Operation Warp Speed”? That seems to have received very little attention from the anti-vax and supposedly “concerned doctors” crowd. This is something the media should be looking at as well if they want to attack the FDA.
Let us recall that “Operation Warp Speed” authorized the FDA to allow Pfizer and Moderna to “jump the line” in the review process. And not just “jump the line”; the normal timeline for a vaccine to be developed and approved is at least five years, and the Covid-19 vaccines were approved for use in less than a year. This was ostensibly because of the rising death toll from Covid—this was a world-wide emergency, and “time” was of the essence. Pfizer was approved for emergency use 21 days after its paperwork was submitted, and Moderna’s in just 19 days.
Now let’s remember something else: in February and March 2020, Trump was telling us that Covid-19 was no worse than a common cold, and since there were relatively few cases recorded it would be all over in days. Well, he was wrong, and as months and deaths piled on he was desperate to escape censure for his incompetence. As always, Trump thought there was a “magic bullet” that he could take credit for to fix the problem, and of course something with a catchy title like “Operation Warp Speed” was the “fix.” This included the allowance of the overlap of clinical and animal trials, the use of data from other studies, and priority manufacturing.
This of course required the cooperation of the FDA to overlook its usual procedures and standards. This meant a certain amount of politicization of the department, starting with Scott Gottlieb, under whose auspices the FDA significantly increased its “oversight” of subjects of concern to conservative constituencies while significantly reducing its oversight overall. Yet even on controlling “vaping” by teenagers was an abject failure, with its use shooting up 80 percent during the first year of Gottlieb’s tenure.
Gottlieb has been on news shows recently as a “voice of reason” and even criticizing the Trump response to Covid-19. But Gottlieb resigned as FDA commissioner a year before the pandemic was in full swing; it also should be observed that he is currently a member of the Pfizer board of directors. What would he have done if he was still with the FDA during the pandemic? Hindsight has allowed him to make a lot of claims about what he would have done differently than those who succeeded him, but we can hardly say he would have had the courage of Fauci to stand up to Trump. While Gottlieb was said to support “strong enforcement,” that required the cooperation of the Justice Department, and Gottlieb was not known to “push” the department to act when it did nothing on the FDA’s recommendations for enforcement.
Gottlieb was replaced by Stephen Hahn, who was seen as a political hack to do Trump’s bidding. Trump wanted his “magic bullet” vaccine out before the 2020 election, and Hahn was under pressure to make it so. The health news website STAT, in a report by Lev Facher in August 2020, noted that under Trump during the pandemic, the FDA had become
“a political agency, and it has a political appointee at the head, but it has maintained a reputation for decades of being a science-focused agency,” said Holly Fernandez Lynch, a health policy expert and University of Pennsylvania professor of medical ethics. “There have definitely been slip-ups, but the level of interference that we’re seeing from the White House is so concerning.”
In the past two weeks alone, the Trump administration has installed a right-wing journalist best known for her gun-rights advocacy as the FDA’s top spokeswoman — empowering her to aggressively reshape the FDA’s typically nonpolitical, straight-laced public messaging. On Saturday, Trump, with no evidence, accused the FDA of taking part in a “deep state” political conspiracy to harm his reelection campaign. And two key White House aides, including Trump’s chief of staff, have taken the rare step of criticizing the agency publicly, with one reportedly advocating for the approval of an unproven plant extract as a Covid-19 cure…
The most striking change at the agency is the appointment of ultra-political conservatives — an emerging pattern that some FDA insiders see as the start of a takeover of an otherwise largely apolitical agency.
After his announced resignation from the FDA, Hahn told Politico that there was a “clash of cultures” in the Trump administration, with the White House demanding faster approval of a vaccine, and the FDA’s desire to “stick to the science.” Trump wanted the FDA to move “faster” and get something out before the election so he could take credit for it. To his credit, Hahn—perhaps more in response to a lack of public confidence in a properly-vetted vaccine, announced a delay in an emergency approval of a vaccine before the election. This of course only inspired more attacks from Trump and his stooges, and efforts to undermine FDA authority.
Even if the Pfizer documents suggest that some “shortcuts” were taken in the process of development, this was politically-driven all over the world and for all vaccines that had been developed; in regard to its Sputnik 5 vaccine, Russia has refused to provide any documentation publically about its development. The pressure from governments to develop these vaccines and get them approved for use was a runaway train, but in the U.S. political pressure was most obvious and Trump’s desire for a “cure” in time for the election was something that everyone knew was happening. Thus it doesn’t matter if the FDA “overlooked” certain things in the approval process; it was under the most cynical political pressure to “move,” and that is where any “concern” about vaccine approval should start. Trump and his political hacks driving this need to take their “lumps” on this as well as anybody.
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