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FDA Departures Spell Big Trouble

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FDA Leadership depart for politics

The FDA is the regulatory agency in charge of approving or denying drugs and medical devices. Marion Gruber is leaving her position as director of FDA’s Office of Vaccines Research & Review in October, and her deputy, Dr. Philip Krause, is leaving in November.

Gruber and Krause reportedly said they don’t believe there’s sufficient data to support the rollout of COVID boosters in September 2021. They also objected to involvement by the U.S. Centers for Disease Control and Prevention and its advisory panel on immunizations in the decision making.

The departure of Marion Gruber, a 32-year veteran of the FDA’s Office of Vaccines Research & Review (OVVR), is leaving in October to join Merck. Dr. Philip Krause, who has served as the deputy for 10 years in the OVVR, is leaving in November.

The loss of key regulatory authorities who move to the pharmaceutical industry is a continuing issue. These long-tenured government officials going to work for the companies they used to regulate raises obvious concerns about objectivity.

The FDA has come under fire recently for their decisions to be swayed by political pressure rather than good science. This is not the first time. In August 2018, former Secretary of Health and Human Services Alex Azar testified that his bosses at the Trump administration had interfered with science-based policies more than any other presidential administration he’d ever seen.

The FDA needs all hands on deck to help provide oversight. The decisions are complicated because there’s a need for more data, but the agency is under pressure from President of the United States Joe Biden, National Institute of Allergy and Infectious Diseases (NIAID) director Anthony Fauci, and other stakeholders who want vaccine boosters rolled out now. Resigning top directors at this critical time will make it difficult to fulfill their responsibilities in good faith.

“Normally, what you do is lay out the data first, and then say how the data supports the decision. When the White House made its announcement on booster shots, it did essentially the opposite. This was a serious mistake in how it was handled.” – Dr. Jesse Goodman, a former chief scientist with the FDA, told STAT News.

On August 12, 2021, the CDC authorized a third booster shot for those who had previously received Pfizer or Moderna vaccines and had weakened immune systems. Since then, at least 955,000 COVID-19 boosters have been given.

The CDC is monitoring the population for adverse reactions and is still collecting data. There are now over 500,000 “adverse events” entered into the CDC’s Vaccine Adverse Event Reporting System, (VAERS,) including 14,000 deaths, 41,000 hospitalizations, 13,000 permanent disabilities, 11,000 “life threatening,” and 300 birth defects. One-third of the deaths occurred within 48 hours, in one large sample.

Although the pharmaceutical companies deny any causal relation, requests for medical reports and autopsies to confirm this have been ignored.Typically, as few as a dozen deaths related to a vaccine rollout have been sufficient cause to shut down the vaccine and go back to the drawing board.

Other countries have been following the rollout of mRNA vaccines as well. In Canada, there’s been some pushback from those who think their government is too involved with industry and not enough on protecting public health.

In June ’21, during a meeting of the Advisory Committee on Immunization Practices (ACIP), a panel of expert advisors to the Centers for Disease Control and Prevention (CDC), discussed instances of heart inflammation among mRNA COVID-19 vaccine recipients. The committee agreed the vaccines are likely linked to cases of myocarditis and pericarditis but said the benefits of vaccination outweigh the risks. That’s unfortunate for the sufferers who were otherwise completely healthy.

In the United Kingdom, all children 12 to 15 years old should be vaccinated against Covid-19 unless they opt out, according to the country’s chief medical officers. All eyes are now turned to Australia where a the Pfizer vaccine was recently approved for use in children age 12 years and older. Male teens in particular have increasingly experienced inflamed heart tissue that does not heal.

We are moving rapidly in the direction of seeing our regulatory bodies overwhelmed and overruled by legislators. The virus has been the impetus behind the massive campaign to indiscriminately give almost every person on the planet the mRNA injections, although long-term effects have never been adequately studied, which can take on average 10 years with 6 of that on animals – which was completely skipped over for the mRNA COVID vaccines which went directly to human trials of only a few months.

The drug companies are increasingly hiring deeply connected regulators where they can earn much more than the did working for the Government. And this is something that’s happening all around the world. One might assume that good science is being neglected in favor of politics and profiteering, while human suffering continues to escalate.

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