More Evidence the FDA Works for Pfizer as FDA Asks Pfizer to Submit Cancer Drug for Expanded Approval with Zero New Trials

by Brian Shilhavy
Editor, Health Impact News

As the alternative media is distracted by the unfounded claim that Pfizer is using gain of function technology to develop new variants of COVID for future vaccines, Pfizer is quietly working together with the FDA to build their portfolio of drugs to make up for the loss of income due to decreasing numbers of people willing to continue getting injected with COVID shots.

The evidence that Pfizer controls the FDA continues to mount.

We previously reported how Pfizer virtually came out of nowhere to secure the first FDA authorization for experimental COVID shots in 2020, when the two drug companies that had received the most funding and attention to become the first ones to obtain the FDA nod for a new COVID “vaccine” had been Moderna, with their close links to Anthony Fauci and the NIH, and Astrazenca with its close links to Bill Gates.

Pfizer’s contract with Operation Warp Speed to receive funding for COVID-19 vaccines was different than the other pharmaceutical companies, because it was conditioned on them gaining FDA approval, and it did not include intellectual property rights for the U.S. government.

It appears that this opened the door for them to grant an exclusive deal with Israel in exchange for data on how the experimental shots affected people in Israel, effectively making Israel and its citizens lab rats. See:

Trump Claims he could “Easily” be Israeli PM – Is this why Pfizer Received First COVID Vaccine Authorization in U.S. and Exclusive Rights in Israel?

And a year before Pfizer became a late entry in the contest to get the first FDA authorization for a COVID shot, Dr. Scott Gottlieb joined the Board of Directors for Pfizer in June of 2019, just two months after he finished his term as Commissioner of the FDA under President Trump.

A year later, Operation Warp Speed awarded Pfizer almost $2 Billion to develop the COVID shot. See:

Former FDA Director Gottlieb Now Pfizer Board Member Secures $1.95 BILLION for COVID Vaccine

This week, Pfizer reported that they expect the sale of their COVID-19 shots and their antiviral Paxlovid to dramatically decrease here in 2023:

Despite a plan to jack up the price of Comirnaty to between $110 and $130 per dose when the United States goes to a commercial model this year for COVID-19 vaccines, Pfizer expects revenue from the shot to plummet by 64% in 2023.

Pfizer also expects a 58% decrease in revenue from COVID-19 oral antiviral Paxlovid. The company revealed its 2023 expectations in its fourth quarter and 2022 full-year earnings report on Tuesday.

With the decreases, Pfizer is guiding to a revenue window of $67 billion to $71 billion in 2023.

The projections—which fell short of analyst expectations—put a damper on what might have been a day of celebration as Pfizer reported $100.3 billion in revenue for 2022, after generating $81.3 billion in sales in 2021. (Source.)

But what surprised people in the pharmaceutical industry the most about Pfizer’s forecast for 2023, was that in a “mysterious” FDA approval that was not reported in the media at the end of 2022, Pfizer received expanded use approval for their breast cancer drug Ibrance, and reportedly, the FDA is the one who approached them to expand the use of this drug!

Angus Liu of Fierce Pharma reported:

It’s unusual to have the FDA chase down a pharma company and ask them apply for a new drug indication. But Pfizer went through just that and has now quietly revealed a label expansion for blockbuster breast cancer med Ibrance.

The FDA has extended Ibrance’s approval in combination with an aromatase inhibitor to include newly diagnosed HR-positive, HER2-negative metastatic breast cancer patients regardless of menopausal status, Pfizer said Tuesday.

Previously, the combination of Ibrance and an aromatase inhibitor was limited to use in postmenopausal women. The FDA granted the new approval in mid-December, according to an approval letter (PDF), but Pfizer snuck the news into its fourth-quarter earnings announcement Tuesday.

There are other unconventional elements in this approval beyond Pfizer’s late, low-profile revelation.

For one, a review of Ibrance’s updated prescription information (PDF) shows no new efficacy data in the patient population.

The clinical efficacy section of Ibrance’s label still only includes results from the phase 3 PALOMA-2 trial—which tested a combination of Ibrance and Novartis’ aromatase inhibitor Femara in postmenopausal women newly diagnosed with HR+/HER2- breast cancer—and from the phase 3 PALOMA-3 study. The latter study tested Ibrance with AstraZeneca’s SERD drug Faslodex in previously treated patients regardless of menopausal status.

It was the FDA that proactively reached out to Pfizer in this case. In December 2021, the FDA requested that Pfizer file an application to include pre/perimenopausal women in Ibrance’s label, according to an FDA approval letter dated Dec. 13, 2022. Pfizer responded to the FDA’s request and submitted its application on March 11, 2022, the approval letter shows.

The new approval comes as Ibrance is under increased pressure from Novartis’ Kisqali and Eli Lilly’s Verzenio, particularly after the final overall survival analysis of the PALOMA-2 trial found Ibrance didn’t significantly improve patients’ life expectancy.

The unusual approval raises a question around the basis of FDA’s decision to request—and then approve—the Ibrance expansion. (Full article.)

Is there any doubt anymore about who controls the FDA? Pfizer is the largest criminal organization in the world, and they would not be able to continue earning huge profits without their control of the FDA.

And how many of you reading this article are co-owners and therefore co-conspirators with the criminal Pfizer company because your retirement fund owns stock in this company? How many members of Congress or State politicians own stock in this criminal organization?

Comment on this article at HealthImpactNews.com.

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The post More Evidence the FDA Works for Pfizer as FDA Asks Pfizer to Submit Cancer Drug for Expanded Approval with Zero New Trials first appeared on Vaccine Impact.