Sunday, April 02, 2023
'Unacceptable incompetence': CDC made dozens of basic data errors on COVID, epidemiologists find
The CDC found itself hoist with its own petard by making 25 basic statistical and numerical errors related to COVID-19, particularly with regard to children, while purporting to expose COVID vaccine misinformation, according to an analysis led by University of California San Francisco epidemiologists.
The preprint, which has not yet been peer-reviewed, documented 20 errors that "exaggerated the severity of the COVID-19 situation" and three that "simultaneously exaggerated and downplayed" severity, while one each was neutral or exaggerated vaccine risks.
More than half were from 2022, but nearly as many were made in the first two months of 2023 as in all of 2021, they found. Several errors were related to the agency's COVID data tracker, which failed to align with its National Center for Health Statistics (NCHS), and the CDC corrected at least in part 13 of the 16 errors brought to its attention.
The paper emphasizes how widely CDC errors can spread even if they are later corrected, with YouTube and Spotify linking its website on videos and podcasts that discuss COVID and the wide deference to CDC guidance in schools, businesses and healthcare facilities.
"The errors are damning," coauthor Vinay Prasad, a former National Institutes of Health fellow, said on Twitter. "Basic counts of dead kids, causes of childhood death. Unacceptable incompetence."
UCSF's Alyson Haslam, a former CDC fellow who works in Prasad's lab, made the final call on CDC errors that Prasad, Tracy Beth Hoeg and independent Georgia COVID analyst Kelley Krohnert collectively agreed "were indisputable and incorrect, as a matter of fact, and not preference or opinion."
The trio conducted "real time" review of news sources, Advisory Committee on Immunization Practices (ACIP) meetings and materials, the agency's Morbidity and Mortality Weekly Report and the Twitter accounts of the CDC and its director, as well as reports sent to them by others, going back to 2021.
The errors were heavily weighted toward exaggerating COVID's risk to children. Fifteen of the 16 pertaining to children's data "enhanced the perceived risk" of the virus and more than half the total errors involved mortality statistics, with the CDC data tracker "consistently" reporting higher deaths for children and adolescents than did NCHS.
Perhaps the most consequential error was the CDC's repeated promotion of a preprint that deemed COVID a "top 5" cause of death in children, which the agency only corrected in one place months later.
That paper compared 26 months of COVID deaths, where the virus was "one of several contributing causes to deaths," to 12 months of deaths from other causes that were "identified as the single underlying cause of death ... which by design exaggerates" the COVID risk to kids, the paper says.
Not only was the claim made in ACIP and FDA Vaccines and Related Biological Products Advisory Committee meetings, but also at a White House briefing by CDC Director Rochelle Walensky and by ACIP's chair in a subsequent meeting "after the errors were identified." Only ACIP's page on "vaccination evidence for young children" includes the correction.
The agency was plain sloppy in other errors, the authors allege. It listed pediatric deaths as 4% of COVID deaths when it meant to write 0.04% and gave a lower estimated rate of pediatric infections than symptomatic illness, with some errors remaining live for seven months.
"These errors have been made repeatedly and were likely to have affected discussion of pandemic policies," particularly the CDC's guidance calling for "school closures, mask mandates, and strong recommendations for vaccinations and multiple boosters even among children who have recovered from the virus," the authors conclude.
The CDC did not respond to queries for its response to the paper.
The FDA's evidence for full approval of Pfizer's COVID antiviral Paxlovid, shared with its advisory committee on antimicrobial drugs, also came under scrutiny.
The advisers voted in mid-March to approve the two-drug treatment for high-risk adults while warning that many patients could have harmful drug interactions, CNBC reported. The agency will make the final decision in May. (Pfizer long ago acknowledged Paxlovid is not useful against household transmission.)
While the FDA's briefing packet emphasized the infrequency of Paxlovid "rebound" infections — which hit the president, his COVID adviser, first lady and both FDA and CDC commissioners, all up to date on COVID jabs — its cited evidence only applies to a sliver of potential Paxlovid patients.
The Pfizer studies gave five-day treatments to unvaccinated high-risk patients (EPIC-HR) and vaccinated high-risk or unvaccinated low-risk patients before and after the Omicron variant wave (EPIC-SR). Only EPIC-HR found "any meaningful difference" compared to a placebo, a 5.6% absolute reduction and 86% relative reduction.
The FDA emphasized the "symptom rebound" rates were similar between Paxlovid and placebo arms across both studies, around 10-16%. This shows that for a "subset" of infections, regardless of Paxlovid, "virologic and/or symptomatic rebound may occur as part of the natural progression and resolution of COVID-19 disease."
A different graph on "viral RNA rebound," however, found notably higher rates in the Paxlovid arm in EPIC-HR and EPIC-SR's Omicron period.
In a lengthy review of the FDA evidence, University of Minnesota infectious disease researcher David Boulware said it actually shows Paxlovid is "likely near zero benefit" for under-60s with a "normal immune system" and vaccine- or infection-induced immunity.
Before the Paxlovid vote, National Institutes of Allergy and Infectious Diseases scientist Margery Smelkinson questioned its emergency use authorization starting at age 12 in spite of dramatically different COVID risk by age. She noted Pfizer ended EPIC-SR early after finding no "statistically significant evidence of benefit."
A member of the Norfolk Group of scientists, physicians and policy experts that recently published a "blueprint" for a potential COVID truth commission, Smelkinson pointed to the Paxlovid section of their report, which emphasizes the lack of rigorous data on who actually benefits from the treatment.
Prasad also questioned the quality of evidence for Paxlovid, including a Lancet Infectious Diseases observational study that found "the curves already split" between treatment and placebo groups at "Day 0," which he said indicates immortal time bias.
"Non randomized evidence will forever be plagued by differences in people who get pax and those who do not (likely being rich, health literate and well connected gets you more pax!)," he wrote in his newsletter in February.
The FDA declined to comment on the criticism of its proffered evidence. "We can’t comment on pending applications," press officer Chanapa Tantibanchachai wrote in an email.
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Pfizer COVID-19 Vaccine Trial Whistleblower Case Dismissed by Judge
The legal case brought by a whistleblower from Pfizer’s COVID-19 vaccine trial has been dismissed by a judge.
Brook Jackson, who worked for Pfizer contractor Ventavia Research Group, did not prove violations of the False Claims Act, U.S. District Judge Michael Truncale ruled.
Jackson sued Ventavia, Pfizer, and another organization involved in the vaccine trial in 2021, alleging that trial violations she uncovered meant the government was defrauded when it paid for doses of Pfizer’s vaccine.
Internal records showed Ventavia officials acknowledging patients were unblinded, adverse events were not recorded, and vaccine doses were kept unlocked in “disorganized” rooms.
Under the False Claims Act, the government or a party suing on the government’s behalf—Jackson in this case—can recover money for false claims made by parties to secure payment for the government. Parties are liable if they knowingly present a false claim for payment or intentionally use a false record or statement material to make a false claim.
While Jackson presented evidence that violations occurred, the government’s prototype agreement with Pfizer only conditioned payment on delivery of a vaccine that had been authorized or approved by the U.S. Food and Drug Administration (FDA), Truncale ruled. The payment section states, “the Government will have no right to withhold payment in respect of any delivered doses, unless the FDA has withdrawn approval or authorization of the vaccine.” The FDA, which Jackson alerted to the violations, has not withdrawn approval or authorization.
“In sum, Ms. Jackson has failed to plead that the Government conditioned payment on Defendants’ certification of compliance with regulatory provisions or clinical trial protocol,” Truncale said in the new ruling.
While Jackson argued that the false record portion of the False Claims Act (FCA) was violated because of the trial violations, the defendants said that false records and statements alone did not create liability without a false claim seeking payment from the government.
“The upshot is that there is no liability under the FCA for making or using a false record or statement where the claimant is entitled to the payment,” Truncale said. “Pfizer was entitled to its claims for payment. Therefore, Ms. Jackson has not stated a claim for false record liability.”
The judge quoted a different ruling, which found that the False Claims Act was enacted by Congress “to vindicate fraud on the federal government, not second guess decisions made by those empowered through the democratic process to shape public policy.”
“When the government, at appropriate levels, repeatedly concludes that it has not been defrauded, it is not forgiving a found fraud—rather, it is concluding that there was no fraud at all,” the ruling stated.
Attorneys for Pfizer offered that argument during a recent hearing in the case.
“So if the FDA gets it wrong, they just get it wrong, and we live with it?” Truncale asked. “Exactly,” said Pfizer attorney Carlton Wessel.
“The Government has been aware of Ms. Jackson’s allegations for several years, has granted Emergency Authorization multiple times, and to this day continues to authorize and provide Pfizer’s vaccine at no cost,” the judge said in the new ruling.
He acknowledged the evidence Jackson offered but said her complaint did not “identify any safety risk that was hidden from the FDA in the data from the Ventavia sites, any symptomatic participants who Ventavia did not properly test for COVID-19 infection, or any COVID-19 infections in vaccinated participants that Ventavia falsely reported to have occurred in the placebo group.”
Retaliation Claim
Jackson was hired in September 2020. She reported problems with the trial to Ventavia management shortly after starting at the company. Dissatisfied with the response, she went to the FDA on Sept. 25, 2020. Ventavia fired Jackson that same day.
The False Claims Act protects whistleblowers from harassment, retaliation, and threats. The person must be engaged in protected activity, defined in a previous ruling as “motivated by a concern regarding fraud against the government.” Additionally, the employer must know the person was engaged in protected activity, and the punitive action or actions must be because of the activity.
Jackson’s activity does not meet the standard because she has not alleged she was concerned about potential fraud against the government, Truncale claimed.
“Rather, she alleges that she complained about participant safety and regulatory, protocol, and HIPAA violations,” he said, referring to the Health Insurance Portability and Accountability Act. “But that is not protected activity under the FCA’s retaliation provision—internal complaints about patient safety, or protocol and regulatory violations, are not the same thing as complaining about defrauding the Government.”
Even if Jackson was engaged in protected activity, the judge said that she did not show that Ventavia knew she was involved in such activity.
He dismissed the False Claims Act claims with prejudice, which means they cannot be brought again. The retaliation claim was dismissed without prejudice.
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Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH) Also here
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH) Also here
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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