Tag: vaccines
Why Trump's Latest FDA Appointee May Imperil Agency's Vital Work

Why Trump's Latest FDA Appointee May Imperil Agency's Vital Work

By appointing Dr. Vinay Prasad to run the Center for Biologics Evaluation and Research, the Trump regime has installed another prominent opponent of Covid-era public health policies to a key position at the Food and Drug Administration.

CBER is responsible for ensuring the safety and efficacy of vaccines, biologic drugs, gene therapies and the blood supply. When FDA Commissioner Martin Makary announced Prasad’s appointment yesterday, he noted the 42-year-old oncologist-epidemiologist has published hundreds of articles in the medical literature. I read their titles this morning. Only a few shed light on how he views the arenas he will soon oversee.

On the other hand, his recent writings on X (formerly Twitter), the substack Sensible Medicine, and his own substack Observations and Thoughts have plenty to say about school closures (“the great domestic policy failure of the last 25 years”); kids wearing masks outdoors (“whoever made the policy is an idiot”); and the annual Covid booster shot (“a public health disaster the likes of which we’ve never seen before”).

On the day after Trump’s election last November, he gave failing grades to the FDA and National Institutes of Health. He called for the elimination of 10,000 jobs at the Centers for Disease Control and Prevention, which he rated as an “abject failure.”

The rhetoric sounds more Trump/Muskian than even-handed or scientific. It is typical of his recent writings, which have taken on an increasingly strident tone since the pandemic. He has repeatedly attacked officials like Anthony Fauci and those at the CDC for ignoring alternative strategies and censoring proponents of herd immunity like Jay Bhattacharya, who now runs NIH.

One of Prasad’s recent posts called for large-scale, randomized clinical trials for the annual booster shots for COVID vaccines. That was in line with Makary’s order late last month that Novavax conduct a new clinical trial to test the annual update of its traditional Covid vaccine, which is the only alternative to the mRNA vaccines sold by Pfizer and Moderna. This new requirement may also be applied to the annual flu vaccines, which will cost the vaccine makers money (who cares?), but more importantly, will take much more time (something we should all care about).

“The FDA is a failure,” Prasad wrote last fall. “It rubber stamps too many useless products. It needs to either remove itself from the picture, or demand randomized trials measuring appropriate endpoints.”

Right turn

This rightward turn in Prasad’s public posture is a relatively recent phenomenon. He began his academic career by studying conflicts of interest in medicine (my own field when working at the Center for Science in the Public Interest). In 2017, he published a study in JAMA Internal Medicine that challenged the ridiculously high sum big drug companies claimed it cost to develop a new drug. (Full disclosure: I was invited to write the accompanying editorial, which was headlined “A Much-Needed Corrective on Drug Development Costs”).

To this day, the insidious role money plays in medicine remains central to how he views the relationship between the drug industry and government. “This is the core rot in American regulation. The revolving door politics. I find this behavior abhorrent, and it should be criminal,” he has written.

He has called for ending all conflicts of interest on FDA advisory committees and wants to set up a “new Phase IV safety detection system” for monitoring adverse vaccine events. “I think vaccine makers should face litigation, as drug makers do,” he has written. He’s also skeptical of using surrogate endpoints and accelerated approvals, which led the FDA to “rubber stamp dozens of drugs with no evidence they help Americans.”

So here we are again. A top Trump regime appointee is championing many positions held by left wing and progressive critics of weak government oversight. Indeed, Prasad has written he once considered himself a progressive Democrat. No wonder biotech stocks temporarily tanked on news of Prasad’s appointment to run CBER.

However, as I’ve said many times in writing about these appointments, let’s watch what they do, not what they say, past or present. Will the Makary/Prasad team slow or even stop vaccine approvals to please their boss, Robert F. Kennedy Jr., the secretary of Health and Human Services? Will Trump order the new team to back off from policies and decisions that tank the stock market (vaccines on their own could never do that; they’re too small a revenue item)?

If I were a gambling man, I’d bet the answer will be ‘yes’ to both those questions.

Reprinted with permission from Gooz News.

On Planet MAHA, Vaccines Are Bad But Bacteria-Laden Milk Is Good

On Planet MAHA, Vaccines Are Bad But Bacteria-Laden Milk Is Good

What's wrong with sriracha? And, by the way, what is sriracha? Sriracha is a hot sauce of Thai origin made from chili peppers, vinegar, garlic, sugar and salt. The rap against it centers on its high levels of sugar and sodium. But Sriracha is normally used in tiny amounts, so where's the problem? The other complaint, that it's "too hot," has an easy remedy. Use less of it, or don't use it.

Such debates are part of the sprawling MAHA movement. MAHA stands for Make America Healthy Again. The name's nod to MAGA makes it sound like part of the Trump agenda.

MAHA is a rummage pile of diverse interests ranging from organic farmers to homeschoolers to anti-vaxxers. It has spawned a swarm of "influencers," podcasters and, most definitely, entrepreneurs pushing products that nurture body, soul and gullibility. At the same time, its emphasis on fresh food and exercise is laudable.

Crackpot conspiracy theorist Robert F. Kennedy Jr. is Donald Trump's choice to head Health and Human Services. "Bobby" spreads unfounded accusations against life-saving vaccines and promotes dangerous "natural foods" such as raw milk. If confirmed, he would try to send health policy on a mission to planet Omicron Delta. Star Trekkers know Omicron Delta as a giant amusement park that can read people's minds and make real anything they imagine, from fairy-tale characters to deadly threats.

Back on planet Earth, Trump wants RFK Jr. to "go wild" on health care. Bobby claims that a worm has eaten at his brain, which makes one worry for the health of the worm.

The claim that unhealthy diets are contributing to childhood obesity, diabetes and other scourges is solid. But some arguments over what constitutes a bad diet are far from simple.

"Ultra-processed foods" have become the all-purpose villain. MAHA holds that food conglomerates are forcing ultra-processed foods onto the American public. Two problems here. One is that no one is forcing anyone to buy or eat food they don't want to. The other is that the term "ultra-processed" is both misused and hard to define.

The Washington Post and other classy news sources were recently suckered by a study claiming that consumption of ultra-processed plant foods, including plant-based meats, was associated with higher rates of heart disease and premature death. Researchers at the University of Sao Paulo and Imperial College London put out the report. Imperial College led its press release with a photo of plant-based burgers.

Trouble is, plant-based meats may be ultra-processed, but they can be healthier than the real thing. More concerning, plant-based meats were almost entirely absent from the study condemning them.

The report also used a cheesy method for categorizing foods. Foods with gluten were automatically put in the ultra-processed column, but gluten has long been a meat alternative (Seitan is made from wheat gluten.) Under these definitions, tofus with natural flavorings and thickeners can be categorized as ultra-processed.

"It's a concept prone to illogical free association, lumping together Cheetos with ultra-healthy fermented beans," Vox reported.

If the Senate confirms Kennedy, Trump would surely swat down any of his ideas that conflict with big money. He's already announced that Bobby cannot get near oil drilling, thus nixing one of his chief environmental causes.

Vaccines are another matter. One can be assured that Trump and family have all their shots, but if other adults die from preventable diseases, well, that's on them. And if their unvaccinated children die from polio or measles, I would not be alone in judging those parents guilty of child abuse.

Taking MAHA's dimmer demands seriously would be a gamble with the public's health. What happens on Omicron Delta should stay on Omicron Delta.

Reprinted with permission from Creators.

Trump Touts Polio Shot, Then Falsely Links Vaccines To Autism

Trump Touts Polio Shot, Then Falsely Links Vaccines To Autism

During a Monday press conference, President-elect Donald Trump told reporters that despite concerns over Robert F. Kennedy Jr., his anti-vaccine pick to head the Department of Health and Human Services, the polio vaccine is safe.

“You’re not going to lose the polio vaccine. That’s not going to happen,” Trump said. “I saw what happened with polio. I have friends that were very much affected by that. I have friends from many years ago, and .. they’re still in not such good shape because of it,” the 78-year-old added.

The topic was raised due to reports that Kennedy’s lawyer filed a petition for the Food and Drug Administration to revoke approval of the polio vaccine. The deadly viral disease has impacted 12 million people worldwide, according to the Centers for Disease control, and an estimated 300,000 Americans are still living with mild to severe symptoms including fatigue, muscle weakness, and pain.

Kennedy will be on Capitol Hill this week to meet with senators and shore up support for upcoming confirmation hearings for his proposed role in Trump’s Cabinet. According to The Wall Street Journal, the notorious vaccine skeptic plans to downplay the topic entirely despite his public, controversial, and debunked views on vaccines and their effects. Kennedy will reportedly also promote Trump’s views on abortion and “talk up healthy food preventing chronic disease.”

Trump did express his long-standing skepticism about vaccine mandates during Monday’s press conference and promoted the false claim of a link between vaccines and autism.

“I don’t like mandates. I’m not a big mandate person,” Trump said. “You take a look at autism today versus 20, 25 years ago, it’s like, not even believable. So we’re going to have reports.”

When Time magazine named Trump “Person of the Year” on December 12, the accompanying interview noted that he and Kennedy Jr. would have a “big discussion” about child vaccines, and he claimed that “the autism rate is at a level that nobody even believed possible.”

Scientific research has debunked any association between vaccines and autism numerous times over the years.

Despite the overwhelming scientific consensus, the supposed link between vaccines and autism remains a prominent point of contention for some crunchy to alt-right talking heads, with Trump and Kennedy among the most high-profile proponents of the debunked theory. Trump’s newest comments are likely to fuel the debate further, especially as vaccine hesitancy continues to rise.

This could have lasting implications on future public health policy, especially in the context of emerging diseases and the ongoing fight against COVID-19.

Reprinted with permission from Daily Kos.

Polio, Measles And The Trump-Kennedy Quackfest

Polio, Measles And The Trump-Kennedy Quackfest

Oh, boy, here we go with the Trump lie-o-rama on vaccines and healthcare. The New York Times reported this morning that Aaron Siri, identified as “Kennedy’s lawyer,” has petitioned the FDA to revoke its approval of the polio and Hepatitis B vaccines. Siri is further identified as helping Kennedy “pick federal health officials for the incoming Trump administration.” In that capacity, Siri has been interviewing prospective hires by asking them their opinions on vaccines.

Kennedy is said to want Siri to serve as the Health and Human Services Department general counsel, the top lawyer for the agency. Siri has sued to stop a requirement for children to get flu vaccines in New York City schools. He sued the state of Mississippi successfully to get a religious exemption from the state requirement that children be vaccinated to attend school. He sued in multiple states to stop requirements for the COVID vaccine.

So, the guy who has filed repeated lawsuits to have vaccines withdrawn from use, and to stop requirements that vaccines be administered for school children, will be in charge of defending the FDA and HHS against such lawsuits in the future. That’s like inviting the fox inside the chicken house and providing the fox with a file with which to sharpen his teeth while he guards the chickens.

You see, after nearly seven decades of saving lives and preventing paralysis with the polio vaccine alone, not to mention saving the lives of countless babies with the rubella vaccine and other vaccines regularly given infants, it will now be the correct thing in the Department of Health and Human Services to question whether vaccines have been effective in saving the lives of children.

Because, of course, opinions are equal to facts and evidence in the utterly upside-down scientific world of the new Trump administration. Siri has filed petitions and lawsuits on behalf of a group of vaccine skeptics called the Informed Consent Action Network, which believes in something called “medical freedom.”

"I love Aaron Siri,” Kennedy said recently on a podcast hosted by yet another vaccine skeptic. “There’s nobody who’s been a greater asset to the medical freedom movement than him.” Siri has either sued or filed petitions with the FDA to stop or suspend the use of 13 vaccines regularly given to children including vaccines that prevent tetanus, diphtheria, polio, and hepatitis A, according to the Times.

Trump, in his recent interview with Time Magazine for its cover story, said he wants Kennedy to “do some very serious testing” of vaccines. It goes without saying that all vaccines in use in the United States today have been tested again and again for safety and efficacy. “We’ll see the numbers,” Trump told Time, speaking of the prospective testing he wants Kennedy to do on vaccines. “A lot of people think a lot of different things. And at the end of the studies that we’re doing, and we’re going all out, we’re going to know what’s good and what’s not good. We will know for sure what’s good and what’s not good.”

Trump was asked by Time if his administration could cancel some vaccines. Here is the sum total of his response: “It could if I think it’s dangerous, if I think they are not beneficial, but I don’t think it’s going to be very controversial in the end.”

So, there it is, folks. Donald Trump is going to cut through all controversy that doesn’t exist in the medical community about vaccines that have been tested and proven safe, because he alone will make all future scientific medical determinations about what should be used and what shouldn’t. The standard for the FDA and the NIH and the Department of Health and Human Services will be what Donald Trump himself thinks is “good” or “not good.”

Allow me to interject some personal experience here as a kind of reality check. I recently went to the Gagnon Cardiac Institute of the Morristown, New Jersey hospital to have a stent inserted in one of the veins of my heart. This is not the first time I have undergone serious medical procedures. I had a heart bypass in 2010 and a spinal fusion in 1999.

All those procedures had one thing in common: when you walk through the doors of an American hospital for surgery or for any other serious medical procedures or care, that is it. You’re in there to be treated with whatever they’ve got. You had the choice of which doctor to treat you and which hospital you want the procedure done, but after that, inside the hospital, you’re going to get whatever they’ve got. You don’t choose the drug to relax you. You don’t choose which needle to use for your drip. You don’t choose the equipment they will use, which probe they’re going to send up your femoral artery or which scalpel will cut into the muscles of your back or which clamp they’ll use to shut off the blood flow where they’re working. If you need something to speed up or slow down your metabolism during surgery, you don’t choose that drug. You don’t even choose the brand of the blood pressure cuff that’s on your arm or the method by which they monitor your heart rhythms and breathing.

A hospital is not a marketplace. They don’t have racks of medical equipment like products in a Target store when you go into surgery. They don’t wake you up to ask you whether you’d like this anti-Afib drug or that one if your heart rhythm goes haywire.

This whole thing of “medical freedom” is a fiction that ends when you get out of your car and walk into a hospital and ask the people in an emergency room to save your life. If you fucked up and listened to Bobby Kennedy and Aaron Siri or Donald Trump and decided not to get a COVID shot, and you’re in a critical care unit and you’re being hooked up to a ventilator because your lungs have ceased to function, they don’t ask you why you neglected to get vaccinated. They just treat you. They don’t ask you which heart drugs you want them to inject into your IV connection, or what brand of tube you want them to insert through your chest to drain your chest cavity of fluids. They just do it, and if you survive and several days later can walk out of the hospital, you thank them. You don’t argue with them about which drugs or procedures or equipment they used to save your life.

We live in a country with the most expensive health care in the world, but because our federal government requires everything to be tested before it’s used, whatever they put into your body is safe. The FDA tests vaccines and drugs and medical equipment like ventilators and surgical gear like heart probes and whatever they shove up your ass to look around in your colon to make sure you don’t have cancer. The government has requirements that the hospitals you use meet certain cleanliness standards. That’s why the floors you’re pushed down on a gurney are shiny, and there isn’t any dust or germs that can blow up onto your body and get into your surgical suite and infect you when they open you up or stick a probe into you.

We should be thanking our lucky stars that we have a Department of Health and Human Services and an FDA to keep us safe, and the National Institutes of Health to study diseases and cures and preventatives for disease.

Donald Trump is appointing a person who has, during his lifetime, and during the lifetimes of his wives and his children, made use of our excellent hospitals and their excellent standards of care. He has benefitted from the vaccines that he was given after he was born and as a child when they were required for him to attend grade school and high school and college.

Vaccines probably saved Kennedy’s life, but because he’s a privileged, narcissistic monster who, the evidence tells us, cares for himself but not for others who would benefit from the same vaccines that probably saved his life, this country is likely to enter a new level of the spread of disease and infection that could be avoided if the people of this country had not elected an equally privileged and narcissistic monster as their president.

These monsters have already caused the deaths of women from bans on emergency care for problem pregnancies and other healthcare denials related to bans on abortion, all of which was done in the face of medical evidence of their necessity to save lives of women and newborns. Now Trump and his chosen crew of quacks will be in charge of the very federal departments that have successfully, until now at least, ensured the safety and efficacy of vaccines, drugs, medical equipment and hospitals, and they are set to drive our entire medical system into the same ditch they drove women’s reproductive healthcare.

Lucian K. Truscott IV, a graduate of West Point, has had a 50-year career as a journalist, novelist, and screenwriter. He has covered Watergate, the Stonewall riots, and wars in Lebanon, Iraq, and Afghanistan. He is also the author of five bestselling novels. You can subscribe to his daily columns at luciantruscott.substack.com and follow him on Twitter @LucianKTruscott and on Facebook at Lucian K. Truscott IV.

Reprinted with permission from Lucian Truscott Newsletter.

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