I added the picture above to this post.
ChildrensHealthDefense.org
written by Michael Nevradakis, Ph.D.
Friday December 10, 2022
The U.S. Food & Drug Administration (FDA) now says it needs 75 years — up from the 55 years the agency initially requested — to fully release redacted versions of all documents related to the agency’s approval of Pfizer’s Comirnaty COVID-19 vaccine.
In a legal brief filed Dec. 7, the FDA said 59,000 additional pages of documents, not included in the agency’s earlier filings, need to be processed. The agency did not offer an explanation for why those documents initially were overlooked.
The agency said it can release an initial batch of approximately 12,000 pages by the end of January. Past that date, the FDA said it can process and disclose only 500 pages of documents per month.
This would mean the entire cache of documents would not be fully released until 2096. The FDA’s initial timeline would have meant the release of the documents would not be completed until 2076, or 55 years from now.
The FDA did not divulge the criteria it will use to select the initial 12,000 pages of documents, or how the agency will prioritize the release of those pages, or of additional pages going forward.
The documents in question stem from a Freedom of Information Act (FOIA) request filed in August by Public Health and Medical Professionals for Transparency (PHMPT).
In its FOIA request, the group asked the FDA to release “all data and information for the Pfizer vaccine,” including safety and effectiveness data, adverse reaction reports, and a list of active and inactive ingredients.
In a filing submitted to a federal judge in November, the U.S. Department of Justice (DOJ), arguing on behalf of the FDA, initially claimed the agency could process some 329,000 pages of documents at a rate of only 500 pages per month, in order to have time to redact legally exempt material.
According to the DOJ, such material includes “confidential business and trade secret information of Pfizer or BioNTech and personal privacy information of patients who participated in clinical trials.”
Attorney Aaron Siri, who represents PHMPT, requested the FDA release the documents within 108 days — the amount of time needed by the FDA to license the Comirnaty vaccine.
Remarking on the FDA’s latest request to extend the timeline from 55 to 75 years, Siri stated:
“[I]f you find what you are reading difficult to believe — that is because it is dystopian for the government to give Pfizer billions, mandate Americans to take its product, prohibit Americans from suing for harms, but yet refuse to let Americans see the data underlying its licensure.
“The lesson yet again is that civil and individual rights should never be contingent upon a medical procedure.”
Prior to the FDA’s request for the additional 20 years, U.S. Rep. Ralph Norman (R-S.C.), on Dec. 2, introduced legislation that would require the agency to release all records of information related to Pfizer COVID vaccines within 100 days.
Oral arguments set for Dec. 14
PHMPT, a group comprised of more than 30 medical and public health professionals and scientists from institutions such as Harvard, Yale, and UCLA, initially requested expedited processing of its FOIA submission on the basis there is a “compelling need” for the swift release of the documents in question.
When, in September, the FDA declined the request, Siri’s firm, Siri & Glimstad, filed a lawsuit against the agency on behalf of PHMPT. The lawsuit was filed in U.S. District Court for the Northern District of Texas.
PHMPT argued the release of the documents is a matter of urgency at a time where millions of Americans are facing mandates to get vaccinated or face repercussions.
As stated in PHMPT’s most recent brief demanding timely production of the documents:
“The entire purpose of FOIA is government transparency. In multiple recent cases, in upholding the FOIA’s requirement to ‘make the records promptly available,’ courts have required agencies, including the FDA, to produce 10,000 or more pages per month, and those cases did not involve a request nearly this important — i.e., the data underlying licensure of a liability-free product that the federal government requires nearly all Americans to receive.”
In its latest brief, the FDA cited several reasons justifying its proposed disclosure schedule.
The FDA claimed its Center for Biologics Evaluation and Research, which maintains the records in question, has only 10 staff members, two of whom are “new.”
Additionally, the FDA argued an accelerated rate of release for the documents in question will divert “significant resources away from the processing of other FOIA requests that are also in litigation,” as well as other pending FOIA requests submitted prior to that of PHMPT.
According to Siri, response briefs from both sides are due on Dec. 13, and an oral argument will follow in court on Dec. 14.
Federal law prescribes a 20-day period for processing “complex” FOIA requests, although this timeframe is frequently exceeded.
Reuters News
written by Jenna Greene
Friday January 7, 2022
Jan 7 - Score one for transparency.
A federal judge in Texas on Thursday ordered the Food and Drug Administration to make public the data it relied on to license Pfizer’s COVID-19 vaccine, imposing a dramatically accelerated schedule that should result in the release of all information within about eight months.
That’s roughly 75 years and four months faster than the FDA said it could take to complete a Freedom of Information Act request by a group of doctors and scientists seeking an estimated 450,000 pages of material about the vaccine.
The court “concludes that this FOIA request is of paramount public importance,” wrote U.S. District Judge Mark Pittman in Fort Worth, who was appointed to the bench by former President Donald Trump in 2019.
The FDA didn’t dispute it had an obligation to make the information public but argued that its short-staffed FOIA office only had the bandwidth to review and release 500 pages a month.
While Pittman recognized “the ‘unduly burdensome’ challenges that this FOIA request may present to the FDA,” in his four-page order, he resoundingly rejected the agency’s suggested schedule.
Rather than producing 500 pages a month — the FDA's proposed timeline — he ordered the agency to turn over 55,000 a month. That means all the Pfizer vaccine data should be public by the end of the summer rather than, say, the year 2097.
Even if the FDA may not see it this way, I think Pittman did the agency — and the country — a big favor by expediting the document production.
I’ve been chronicling this fight since November and have heard from of readers who said they felt something was suspicious, even nefarious, in the FDA’s proposed slo-mo timeline. Making the information public as soon as possible may help assuage the concerns of vaccine skeptics and convince them the product is safe.
Pittman in his order nodded to this as well, including a quote from the late senator John McCain, who said that excessive administrative secrecy “feeds conspiracy theories and reduces the public’s confidence in the government.”
Still, the FDA is likely to be hard-pressed to process 55,000 pages a month.
The office that reviews FOIA requests has just 10 employees, according to a declaration filed with the court by Suzann Burk, who heads the FDA’s Division of Disclosure and Oversight Management. Burk said it takes eight minutes a page for a worker “to perform a careful line-by-line, word-by-word review of all responsive records before producing them in response to a FOIA request.”
At that rate, the 10 employees would have to work non-stop 24 hours a day, seven days a week to produce the 55,000 pages a month (and would still fall a bit short).
But as lawyers for the plaintiffs Public Health and Medical Professionals for Transparency pointed out in court papers, the FDA as of 2020 had 18,062 employees. Surely some can be dispatched to pitch in at the FOIA office.
Aaron Siri of Siri & Glimstad, who represents the plaintiffs, in an email said the decision "came down on the side of transparency and accountability."
His clients — a group that includes more than 200 doctors, scientists, professors and public health professionals, including some who have publicly questioned the efficacy of lockdown policies, mask mandates and the vaccine itself — have pledged to publish all the information they receive from the FDA on their website.
The Justice Department, which represented the FDA in the litigation, did not immediately respond to a request for comment on Thursday evening. Pfizer, not a party to the suit, also did not immediately respond to a request for comment.
Pittman in his order made clear that the FOIA request, even if burdensome, has to be a priority for the FDA.
Quoting from remarks made during the hearing before him on December 14, he wrote that “there may not be a ‘more important issue at the Food and Drug Administration . . . than the pandemic, the Pfizer vaccine, getting every American vaccinated," and assuring the public that the vaccine was not "'rush[ed] on behalf of the United States.'"
NIH
written by Jeanne Lenzer, British Medical Journal
May 27, 2006
A secret Nigerian government report concluded that the drug manufacturer Pfizer undertook an “illegal trial of an unregistered drug” when the company enrolled nearly 100 Nigerian children with meningitis in a trial testing its antibiotic trovafloxacin (Trovan) against ceftriaxone during a 1996 meningitis epidemic.
Families of the children, their attorneys, and the media have been seeking the results of the report for five years without success until the report was leaked last week to the Washington Post (7 May, sect A: 1) by a source who asked to remain anonymous because of “personal safety” concerns.
The Washington Post article said that “aspects of the affair remain mysterious, such as why the report remains confidential.” The head of the investigative panel behind the report, Abdulsalami Nasidi, a virologist and senior Nigerian health official, told the Washington Post he did not know why the report was never released. The panel was set up in 2001 to determine whether the trial was conducted legally (BMJ 2001;322:194).
A class action suit filed on behalf of the children’s families in a federal court in New York alleges that Pfizer did not inform families that trovafloxacin was an experimental treatment and that it failed to obtain informed consent (BMJ 2001;323:592). The lawsuit was dismissed last summer after a judge decided that the US court did not have jurisdiction to hear it, a decision the plaintiffs are appealing.
Court documents filed by the plaintiffs said that “most tragically, Pfizer purposely … low-dosed the control drug” and did not tell families that free, approved treatment was available at the same hospital from Médecins Sans Frontières.
The plaintiffs cited, in turn, a whistleblower lawsuit filed by Juan Walterspiel, a former associate medical director of Pfizer’s central research division, who had responsibility for international protocol development. Dr Walterspiel claimed that Pfizer fired him after he warned the company—before and after the study was conducted—that the study methods employed by Pfizer in the Nigerian trial were “improper and unsafe.” Dr Walterspiel’s action has since been settled.
Pfizer issued a news release on 7 May after being shown the Nigerian government report. It said: “Trovan unquestionably saved lives, and Pfizer strongly disagrees with any suggestion that the company conducted its study in an unethical manner.”
Pfizer stated that it “conducted this trial with the full knowledge of the Nigerian government and in a responsible way consistent with Nigerian law.” The news release also stated that local nurses had explained the experiment to parents of children being treated and had obtained their verbal consent. “Trovan achieved the highest survival rate (94.4%) of any treatment available at the Kano Infectious Disease Hospital, including ceftriaxone (93.8%),” the company added. “For patients receiving treatment at the hospital who were not in the Pfizer program, the survival rate was 89.9%.”
Elaine Kusel, attorney for 30 plaintiff families, said Pfizer’s claim that trovafloxacin outperformed ceftriaxone and community treatment was meaningless, because the children in the trial were not properly randomised. “They [the researchers] simply picked kids out of a line of families waiting for care outside the hospital.”
Critics who question the study’s methodology and data have been stymied by Pfizer’s failure to publish the study. Pfizer acknowledges that the only occasion on which it presented the results was at a meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy in New Orleans in 1996.
In response to queries by the BMJ , Pfizer denied the allegations made by the plaintiffs in the lawsuit. Although the Pfizer spokesperson Bryant Haskins admitted, in an email message, that the daily doses of ceftriaxone given to the children in the study had been reduced by two thirds, from 100 mg per kg to 33 mg per kg, he claimed they still “significantly exceeded the recommendations of the WHO.”
“There is no FDA [the US Food and Drug Administration] approved dose for ceftriaxone for treating epidemic meningococcal meningitis,” he said, adding that the doses used by Pfizer far exceeded the dose needed to kill meningococcus in cerebrospinal fluid. As for how children had come to be recruited to the study, Mr Haskins said that triage nurses sent children suspected of having meningitis to a building where their parents were offered the option of participating in the study.
“If any parent preferred that his or her child be treated by [Médecins Sans Frontières],” he added, “the child was immediately taken to the appropriate building.”
As for why Pfizer didn’t win FDA approval to use trovafloxacin to treat meningitis in light of its claimed superiority, Mr Haskins said, “Pfizer won approval from the FDA to use Trovan for more than a dozen indications.
“After discussions with the agency, the company withdrew its claim for the treatment of epidemic meningococcal meningitis primarily for regulatory reasons; for example, a requirement to have brain stem auditory evoked response assessments at post-study follow up visits was impossible in the primitive setting in which the trial was conducted.”
Trovafloxacin was withdrawn from European markets after reports of fatal liver disease and since 1999 has been recommended only for emergency use in the US.
UPDATE 2/4/22 at 5:24pm: Added info below.
For more information please visit NIH.gov website at:
Yeah, the same NIH Dr. Fauci is in charge of.
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