What you are about to read will make perfect sense when you know that two high-level regulatory officials with the FDA involved in vaccine oversight accepted jobs at Moderna just months after signing off on the licensure of the company’s COVID-19 vaccine, according to a British Medical Journal (BMJ) investigation. This is not the first time issues have been raised with the FDA’s “revolving door”—a concept defined in an October 2005 paper by the Revolving Door Working Group (RDWG) as the “movement of individuals back and forth between the private sector and the public sector.”
Feb. 15, 2022
Cole, who claims his role with the FDA is to ensure the agency uses a framework of safety, security, and effectiveness as a part of its preparedness and response protocol, specifically cited concerns over “long term effects, especially with someone younger.”
• FDA Executive Officer Chris Cole: “The drug companies, the food companies, the vaccine companies. So, they pay us hundreds of millions of dollars a year to hire and keep the reviewers to approve their products.”
• Cole on FDA fees: “Congress approved user fees for [the] FDA. Basically, we charge the industry millions of dollars in order to hire more drug reviewers and vaccine reviewers which will speed up the approval process. So, they [pharmaceutical companies] make more money.”
• Cole: “They [FDA] tone down the impact of the user fees on their operations because they know they’re dependent on the drug companies, and the vaccine companies, and these other companies for their agency to operate.”
• Cole on blowing the whistle: “There’s not an incentive to speak out in government, surprisingly. You would think there would be, but there’s not. It’s better just to just not say anything and just ignore it.”
• Cole on retaliation in government: “You’ll be marked from getting other jobs because another office is not going to want to hire you if you’ve spoken out about something, right or wrong. They don’t look at what you’ve spoken out about. They’re just not willing to- government’s about rocking the boat and they don’t want to- which is the problem I have with- one of the problems I have with government is, like, they don’t like people rocking the boat, for right or wrong, at all costs. They want to hire a safe person that can do the job but doesn’t necessarily- is a great hire.”
[WASHINGTON, D.C. – Feb. 16, 2022] Project Veritas published Part Two of its series on the FDA on Wednesday night which featured FDA Executive Officer, Christopher Cole, speaking about the inner workings of the agency including the FDA’s conflicts of interest, overspending, and why it’s hard for those within the agency to speak out on such abuses.
In the footage, Cole talks about the impact that pharmaceutical companies have on the agency including the process for approving drugs.
“A long time ago, Congress approved user fees for [the] FDA. Basically, we charge the industry millions of dollars in order to hire more drug reviewers and vaccine reviewers, which will speed up the approval process, so they make more money,” Cole says in the hidden camera footage.
He then reveals that the FDA tones down the impact that these user fees have on the agency’s operations because, “they’re dependent on the drug companies, and the vaccine companies and these other companies for their agency to operate.”
The incendiary footage, which features Cole talking about how the additional money the FDA brings in “gets banked” to be spent on “whatever you can, whether it’s right or wrong,’’ also features Cole discussing reasons why it’s difficult for anyone in government to speak out about practices he sees as “probably excessive.”
“I don’t think there’s enough people saying — they’re, like, ‘Look, that’s fine, but that’s not right. So, we’re not going to charge that.’ You don’t want to be that person. You’re not going to have a long shelf life in the agency if you’re always that person,” Cole said.
“There’s not an incentive to speak out in government, surprisingly. You would think there would be, but there’s not. It’s better just to just not say anything and just ignore it. The whistleblower, well, it’s high-profile whistleblower statutes and everything, that’s kind of ridiculous,” Cole said before adding “it’s better to just stay quiet and accept.”
Cole’s LinkedIn page lists him as an Executive Officer within the agency’s Countermeasures Initiatives, which plays a critical role in ensuring that drugs, vaccines, and other measures to counter infectious diseases and viruses are safe. He made these revelations on a hidden camera to an undercover Project Veritas reporter.
A spokesperson for FDA issued a statement yesterday saying, “The person purportedly in the video does not work on vaccine matters and does not represent the views of the FDA.”
This statement appears to contradict a phone call released Wednesday afternoon by Project Veritas wherein Cole reiterated, during the conversation with Project Veritas Founder and CEO, James O’Keefe, that he is “a manager in the office that helps oversee the approval of the COVID vaccines for emergency approval.”
Please see below in the link that indeed, Dr. Robert Califf was voted in to head the FDA. We can only expect the corruption to continue under his reign.
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Apparently Robert Califf did such a good job of helping Big Pharma shield themselves from any liabilities due to the opioid crisis that destroyed the lives of so many Americans while he was head of the FDA under President Obama, that he is being brought back to lead the FDA again to help Big Pharma continue growing in record profits and sales as they get ready to expand the market for the COVID-19 gene-altering shots by having Americans get vaccinated every year, along with the already profitable flu shots.
While he was approved to lead the FDA by the Senate in an overwhelming vote of support with an 89-4 Senate vote on his confirmation in 2016, this time around he barely survived the confirmation vote which was 50-46, facing bi-partisan opposition to his confirmation.
Senators Joe Manchin and Republican Senator Mike Braun from Indiana paired up to write an op-ed piece published at USA Today to voice their opposition to Califf’s confirmation as head of the FDA.
Since OxyContin was approved by the Food and Drug Administration in 1995, more than 500,000 Americans have died from overdoses related to opioids and synthetic opioids.
Nearly three decades later, more than 101,000 Americans – over 1,500 West Virginians and nearly 2,500 Hoosiers – died between June 2020 and June 2021. It’s clear that not much has changed in the way the FDA approves and manages these highly addictive, destructive drugs killing Americans at an astonishing rate.
In fact, it has become increasingly clear that the FDA has stood by, and even enabled, the pharmaceutical industry’s decision to choose profits over American lives.
High overdose rates, not enough treatment facilities
Many families across the United States have been impacted by the drug epidemic that continues to ravage our nation. In our beloved states of West Virginia and Indiana, our communities continue to face disproportionately high overdose rates, with not nearly enough treatment facilities to care for our neighbors in need.
However, instead of reining in opioid prescribing, the agency in charge of regulating these substances continues to approve even more deadly opioids. It is crystal clear that the FDA has not done enough to address the drug epidemic ravaging our nation.
Given the dire situation facing our communities, it makes absolutely no sense to install a candidate who has already led the FDA in its most senior position but failed to address this crisis in any meaningful way.
A poor record on opioids
The current FDA commissioner nominee, Dr. Robert Califf, has significant ties to the pharmaceutical industry, and his leadership of the FDA would take us backward, not forward. His nomination is an insult to the many families and individuals who have had their lives changed forever as a result of addiction.
During Dr. Califf’s previous tenure as FDA commissioner, drug-related overdoses went up, a clear indicator the FDA hadn’t made any necessary, meaningful changes to address the crisis facing our country. In 2016, then-Commissioner Califf announced the FDA’s plan to overhaul its opioid policies.
But between 2016 and 2017, the FDA approved five new opioids and only removed a single opioid from the market. Dr. Califf also commissioned a report on opioids, but the report failed to review the flawed enriched enrollment randomized withdrawal (EERW) methodology used to approve new opioids.
Reports have also indicated that Dr. Califf intends to keep Dr. Janet Woodcock on board as a senior adviser if confirmed to lead the FDA. During her tenure at the FDA, Dr. Woodcock has directly overseen the approval of numerous highly addictive drugs to market.
She also decided to ignore the advice of an FDA advisory committee when she chose to approve Zohydro, a questionable pure hydrocodone drug with strong risk of overdose and death.
The pharmaceutical industry has benefitted from the status quo at the FDA under the leadership of Dr. Califf and Dr. Woodcock, and the American people have suffered for it. (Full article.)
