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Pfizer, FDA Ask Court to Further Delay Release of COVID Vaccine Safety Data

Days prior to today’s scheduled release of a tranche of documents related to the Pfizer COVID vaccine, the pharmaceutical company asked a federal court to let it intervene before any information is released.

It’s the latest development in an ongoing court case that began with a Freedom of Information Act (FOIA) request filed in August 2021 by Public Health and Medical Professionals for Transparency (PHMPT).

PHMPT asked the U.S. Food and Drug Administration (FDA) to release all documents related to its Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID vaccine and full approval of the Pfizer-Comirnaty COVID vaccine.

Judge Mark Pittman of the U.S. District Court for the Northern District of Texas on Jan. 6 issued an order requiring the FDA to release 12,000 pages of documents by Jan. 31 and an additional 55,000 pages per month thereafter, until the release of the nearly 400,000 pages of documents is complete.

Pfizer claims to support the disclosure of the documents, but asked to intervene in the case to ensure that information exempt from disclosure will not be “disclosed inappropriately.”

In a memorandum it submitted to the court, Pfizer said it:

“[S]eeks leave to intervene in this action for the limited purpose of ensuring that information exempt from disclosure under FOIA is adequately protected as FDA complies with this Court’s order.”

Attorneys for Pfizer also claimed while it was not asking the court to reconsider the Jan. 6 order, it would consider challenging the order at an unspecified later date, telling the court:

“Pfizer does not presently intend to move the Court to reconsider its January 6, 2022 order, but Pfizer is not in a position at this time to waive its ability to do so if circumstances change such that there is good cause at a later time to do so.”

Pfizer did not clarify what such a change of circumstances might entail.

Lawyers for PHMPT, in a brief submitted Jan. 25 to the court, asked Pittman to reject Pfizer’s motion and requested the judge ask Pfizer to clarify how, exactly, its intervention would help expedite the release of the documents, arguing that Pfizer:

“… provides no reason why it needs to intervene in this matter to render that purported assistance. Nor can Plaintiff discern why Pfizer needs to intervene in this matter to assist the FDA with expediting release of the requested documents—it can render this assistance without intervening.”

PHMPT, a group of more than 30 medical and public health professionals and scientists from institutions such as Harvard, Yale, and UCLA, in September 2021 filed a lawsuit against the FDA when the agency denied its original FOIA request.

In that request, PHMPT 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.

The first batch of documents released in November 2021, which totaled a mere 500 pages, revealed there were more than 1,200 vaccine-related deaths within the first 90 days following the release of the Pfizer-BioNTech COVID vaccine.

Arguments regarding Pfizer’s motion are scheduled to be heard in court on Jan. 28, though as of this writing, no further updates regarding the case or this scheduled hearing have been publicly disclosed.

Pfizer represented by world’s third-largest law firm

Pfizer on Jan. 21 submitted two filings to the court: a motion to intervene in the case “for a limited purpose,” and an accompanying“memorandum of points and authorities” supporting the motion.

It remains unclear how Pfizer defines “inappropriately” or “for a limited purpose,” or why it waited two weeks after Judge Pittman’s order, and only days before the Jan. 31 scheduled release of 12,000 pages to file its motion.

Pfizer claims it was unaware of the case until executives read news reports about it in December 2021, despite the fact that the case garnered coverage from major news outlets, including Reuters, in November of that year.

Still, the company hired DLA Piper LLP, one of the world’s most high-powered law firms, to represent it. DLA Piper is headquartered in London and maintains offices in 40 countries.

In 2014, the firm had revenues totaling $2.48 billion, making it the third-largest law firm in the U.S. by revenue.

DLA Piper was the 12th largest donor to President Obama’s 2012 re-election campaign and the 9th largest donor to Hillary Clinton between 1999 and 2018.

Douglas Emhoff, spouse of U.S. Vice President Kamala Harris, was employed at the firm until 2020, earning $1.2 million in partnership income that year.

FDA supports Pfizer’s motion, requests extension

In a response to Pfizer’s motion, the FDA said it welcomed Pfizer’s “help,” claiming that this is “due to the unprecedented speed with which the Court has ordered [the] FDA to process the records at issue.”

In addition to supporting Pfizer’s motion, the FDA also requested an extension from the court that would further delay the scheduled release of the documents.

Aaron Siri of the Siri & Glimstad law firm, who is representing PHMPT in its lawsuit against the FDA, explained:

“The FDA now insists it must delay its first 55,000-page production until May 1, 2022 – four months after the Court entered its order.

“However, the FDA’s own papers seeking this delay make plain it can produce at a rate of 55,000 pages per month in February and March.”

The FDA claimed Pfizer is entitled to intervene in the case and the process of redacting the documents in question, due to the “Trade Secrets Act,” signed into law by President Obama in 2016, stating:

“FDA anticipates that coordination with Pfizer to obtain the company’s views as to which portions of the records are subject to Exemption 4, the Trade Secrets Act, 18 U.S.C. § 1905, or other statutory protections will be a necessary component of the agency’s endeavors to meet the extraordinary exigencies of this case.”

However, according to The Gateway Pundit, the Trade Secrets Act is being misinterpreted by the FDA and Pfizer:

“[T]he protections provided under that law allow for an owner of a trade secret to sue in federal court when its trade secrets have been misappropriated and does not even imply that a company could intervene in a public records request through the FOIA.”

PHMPT, in its Jan. 25 brief, also rejected the FDA’s continued claim that it cannot adhere to the disclosure schedule Pittman ordered on Jan. 6, arguing “the FDA has more than sufficient resources to expeditiously produce the requested documents.”

Siri, on his blog, also questioned this aspect of FDA’s argument, writing:

“The FDA … attests that over the coming weeks, it will have 28.5 full-time people reviewing the documents. Working 7.5 hours per day for 20 business days per month, 28.5 people reviewing 50 pages per hour can review a total of approximately 213,750 pages per month.

“The FDA affirms it has already ‘allocated the equivalent of nearly 11 full-time staff to this project’ and that ‘a review speed of 50 documents per hour was within the normal range for document review in a complex matter’ in private practice; and here the 50 document per hour rate would be faster since there is only a need to review for personally identifying information (‘PII’) for most pages. Hence, if the FDA’s 11 full-time reviewers work only 7.5 hours per day and review 50 pages (not documents) per hour, the FDA could review over 88,000 pages per month in February and March. That is more than sufficient to produce the 55,000 pages per month currently ordered for these two months.”

Instead of complying with this court’s “reasoned order,” Siri Wrote, the FDA claims these 11 reviewers can only review a total of 10,000 pages per month.

What the FDA does not say, and what basic math shows, according to Siri, is that a rate of 10,000 pages a month for 11 full-time reviewers amounts to only 5 pages per hour.

Siri also questioned the FDA’s commitment to transparency and hinted at a cover-up, stating:

“The Court is, other than Congress, the only check on the FDA.  In a free country, transparency is paramount, and the FDA has chosen to thwart transparency and the requirements of FOIA by anemically understaffing the office it maintains to respond to FOIA requests.

“It is also incredible for the FDA to claim that compliance here would harm its health policy objectives. Even if the FDA really does need to spend $4 to $5 million which … is an absurd overestimate, that is an inconsequential amount of its overall $3.41 billion discretionary budget.

“It is understandable that the FDA does not want independent scientists to review the documents it relied upon to license Pfizer’s vaccine given that it is not as effective as the FDA originally claimed, does not prevent transmission, does not prevent against certain emerging variants, can cause serious heart inflammation in younger individuals, and has numerous other undisputed safety issues.”

Siri said the FDA’s “potential embarrassment” over its decision to license the Pfizer vaccine must take a back seat to the transparency demanded by FOIA and “the urgent need and interests of the American people to review that licensure data.”

source: the defender children health defense news and views by Michael Nevradakis, Ph.D

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