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WSJ: FDA Shuts Out Its Own Experts in Authorizing Another Vaccine Booster

re: ethics in medicine
re: follow the money
re: Marty Markary

The gravy train is hard to shut down.

Marty Makary is generally spot-on and well worth reading, and is the author of The Price We Pay: What Broke American Health Care and How to Fix It @AMAZON.

WSJ: FDA Shuts Out Its Own Experts in Authorizing Another Vaccine Booster

2022-04-03, by Mary Markary. Emphasis added.

Decisions like this only reinforce the perception that Covid policy is driven by groupthink and politics.

The Food and Drug Administration last week authorized Americans 50 and over to get a fourth Covid vaccine dose. Some of the FDA’s own experts disagree with the decision, but the agency simply ignored them. It will convene its advisory committee this Wednesday to discuss future vaccine needs. That’s like having lawyers present arguments to a judge who’s already issued a verdict.

Eric Rubin, editor in chief of the New England Journal of Medicine, sits on the advisory committee. He told CNN last month that he hadn’t seen enough data to determine whether anyone needs a fourth dose whose immune system isn’t seriously deficient.

Another committee member, Cody Meissner, agrees. Dr. Meissner, chief of pediatric infectious diseases at Tufts Children’s Hospital, told me last week that the fourth dose is “an unanswered scientific question for people with a normal immune system.” 

A third member of the committee, Paul Offit of the Children’s Hospital of Philadelphia, told the Atlantic that he advised his 20-something son to forgo the third shot, which the FDA recommends for everyone 12 and over.

...Two top FDA officials quit the agency in September complaining of undue pressure to authorize boosters...

Hours after the FDA authorized the fourth dose, the Centers for Disease Control and Prevention gave its formal approval to the move—also without convening its external vaccine experts. Director Rochelle Walensky asserted that the additional doses are safe. But the jury is still out on vaccine-related complications. One of the most common reported adverse events is tinnitus, or ringing in the ears. Gregory Poland, director of the Mayo Clinic Vaccine Research Group, developed a severe case while driving home after his second vaccine dose. He toldMedPage Today he believes tens of thousands of people may be affected in the U.S. and he thinks more research is needed. 

But neither the CDC nor the National Institutes of Health has made a priority of studying vaccine complications. The CDC isn’t even transparent about its investigations into young people who have died after Covid vaccination. A Seattle Children’s Hospitals study published in the Journal of Pediatrics March 25 found that 69% of children who presented with myocarditis after the vaccine had late gadolinium enhancement, a related abnormality, in an MRI three to eight months later.

...

Trust in public health is at an all-time low. When agencies bypass their own experts, it only reinforces the perception that health policy is driven by groupthink and politics. 

WIND: trusting the CDC or FDA is for children and idiots. Follow the money is the single best way to predict human behavior.

Tinnitus is a terrible problem (I have a mild case of it), a horrible and typically lifelong side effect. That alone should disqualify the vaccines for most of the population.

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