FDA IS GETTING A MAKEOVER
Don’t sleep on this guy Makary
From Jeff Childers
Yesterday, pharma rag Stat News ran a terrific story headlined, “Makary says FDA will remove pharma representatives from advisory panels.”
In a wide-ranging interview with Megyn Kelly, the nation’s new FDA Commissioner laid out a revolutionary plan to remake America’s health landscape.
CLIP: FDA Commissioner Makary explains removing big pharma from FDA drug advisory boards (2:48).
https://x.com/Holden_Culotta/status/1913004011424276937?utm_source=substack&utm_medium=email
Johns Hopkins surgeon and public health researcher Marty Makary, newly confirmed as FDA Commissioner, was a key dissenting voice during the pandemic. He argued forcefully for natural immunity, against lockdowns and mandates, and even before the pandemic was a prominent voice on healthcare transparency and reform. Now he’s in the command room, and Dr. Makary is learning it is even worse than he thought.
“I was shocked,” Dr. Makary told Megyn, “when I learned that employees of Big Pharma companies sit on FDA advisory committees.”
In our more innocent, Halcyon days of blissful ignorance, you probably thought that having pharmaceutical reps sitting on the FDA’s drug approval advisory board would be an irresolvable conflict of interest, a fox-in-the-henhouse sort of thing. That shows how little you really understand science, dummy. Science runs on money.
But yesterday, amidst a shower of proposed reforms, Dr. Makary said that as soon as legally possible, the FDA will remove all pharma reps from advisory boards and replace them with patients and family caregivers. He didn’t completely ice them out; after all, pharma is a critical component of the nation’s healthcare system. “We’ll be inviting pharma companies to send representatives to the advisory committees, but they can sit with the rest of the public and watch and pose questions,” Dr. Makary explained.
Another way of looking at it is, their greedy pandemic excesses cost them their seats at the FDA’s table.
??In the same interview, Dr. Makary shed more light on how the Swamp works. He said that, as soon as he’d been nominated, he got swamped by pharma lobbyists offering to “help” him get confirmed, such as by writing letters to Senators on his behalf (0:51). One wonders why we never heard that before. Presumably, it happens every time.
Makary also explained that the FDA’s priorities would undergo a profound shift (0:38). “My predecessor in this role stated his number one goal was fighting misinformation,” Makary said. But, “our number one goal is delivering cures and meaningful treatments and healthier foods for Americans.” Imagine that.
He also said the FDA’s food pyramid was soon coming down (1:08). Which is great news, since the current offering has all the nutritional value of gas station sushi. “That dogma” —the ubiquitous idea that all calories are equal— “had no scientific basis,” Makary explained. “When you ignore a thousand chemicals, some of them petrochemicals, you can’t call that healthy just because it’s low in saturated fats. That’s all dogma.”
Everyone knows the current food pyramid (now, the food “plate”) is bad science, but nobody can do anything about it. The FDA didn’t just freeze a discredited, anti-scientific philosophy— it taxidermied it and mounted it above the cafeteria line. Scientists can’t get grants unless they climb the food pyramid, and kids must eat pyramid-friendly ultra-processed foods at school. Meanwhile, Big Food can label snackwells as “FDA approved.”
Delighting animal lovers, Dr. Makary also called for a moratorium on animal testing (2:29). “God did not make these animals on planet Earth for us to do cruel things to them and subjugate them,” he explained. He thinks computational models and lab-grown organs can handle most of the heavy lifting. “Those models should be replacing animal testing.”
??Finally, in a follow-up to yesterday’s autism announcement, Dr. Makary offered his own personal thoughts about the possible cause. “If I had to make a hypothesis as a scientist, not as a regulator,” Makary said, “I think it is the cumulative burden of all of these exposures, environmental and dietary, that alter the microbiome.” In other words, processed foods, antiobiotics, and plasticizers. He asked, “When you carpet bomb the microbiome with all of these ingredients that don’t appear in nature … what are we doing?”
In other words, it’s not just bad genetics and bad luck.
Makary’s “multi-hit” hypothesis isn’t bad. It fits the data like a glove. Starting in the late 80’s, ultra-processed food exploded, heavily relying on high-fructose corn syrup, preservatives, and emulsifiers. C-section births and early antibiotic use became popular, both of which deplete microbiome seeding in infants. And new types of food manufacturing chemicals became commonplace, such as titanium dioxide, artificial sweeteners, and seed oils.
A raft of emerging studies increasingly link gut microbiota, immune function, and brain development, especially in early childhood. Autism seems to involve neuroinflammation and immune dysfunction— and both types of dysfunction are influenced by gut health.
?? Dr. Makary wisely avoided the third rail of health politics, but I won’t. Guess what also exploded in the late 80’s? Jabs. In 1986, Congress passed the National Childhood Vaccine Injury Act, which instead of preventing jab injuries, opened the needle-tipped floodgates. It created a whole new market of mega-profitable, liability-free “vaccines.” In 1989, the CDC started adding new ones to the Childhood Vaccine Schedule and never looked back.
That, my friends, is why no one wants to discuss the EPA’s 1989 inflection point. But when Makary talks about “environmental exposures,” you can be sure that jabs are on the table, too.
If we had an honest science-media complex, the EPA’s 1989 inflection point would be on the cover of The Atlantic and Nature every six months. Instead, it’s buried in policy annexes and whispered by heterodox doctors who get called “conspiracy theorists” and “anti-vaxxers” for even noticing.
The FDA is on the verge of finally fulfilling its original promise to improve the nation’s health. Not a second too soon, either.
Godspeed, and bravo, to Dr. Makary!