HEALTH NEWS
· Nicotinamide riboside improves genetic disorder
· Eating This One Food Strengthens Beneficial Brainwave Frequencies
· Warming up before exercise really does improve performance
· Practicing mindfulness can help people make heart-healthy eating choices, new study shows
· Lower magnesium levels linked with increased mortality risk during up to 40 years of follow-up
· Research shows one sleepless night can rapidly reverse depression for several days
Investigation raises concerns over ‘cozy relationship’ between the FDA and Moderna
An investigation published by The BMJ raises concerns about a revolving door culture between the US Food and Drug Administration (FDA) and Moderna after two regulators who held oversight roles for COVID vaccines went to work for the company.
During the COVID-19 pandemic, Doran Fink served on the FDA’s senior leadership team for COVID vaccine review and policy activities and took part in the ultimate decision to license the Pfizer and Moderna vaccines, explains Peter Doshi, senior editor at The BMJ.
Fink’s LinkedIn profile states that he finished his role at the FDA in December 2022. Two months later he was working at Moderna, heading the translational medicine and early clinical development program in infectious diseases.
Similarly to Fink, Jaya Goswami started at the FDA in its Center for Biologics Evaluation and Research in March 2020 and was responsible for evaluating whether the clinical data for Moderna’s COVID vaccine met regulatory standards for approval. Licensure was granted at the end of January 2022.
Goswami’s LinkedIn profile states that she left the FDA in June 2022 and that same month started a new role as director of clinical development in infectious diseases at Moderna.
Jeremy Kahn, FDA press officer, told The BMJ that the FDA has “more enhanced ethics restrictions than most other federal agencies” and “provides robust information and resources to employees regarding the steps that must be taken to fulfill these ethics obligations.”
But The BMJ has found that the FDA keeps no records on where employees go after they leave government service. Nor does it require employees to undergo an approval or clearance process before taking up an industry job.
Employees are required to adhere to certain post-government employment restrictions, but as Doshi notes, adherence is inevitably self-enforced.
Craig Holman, government affairs lobbyist for the consumer advocacy organization Public Citizen, says safeguards are needed to make sure those in the public sector are serving the public interest. He suggests a “cooling-off” period of at least two years in which former FDA officials are prevented from lobbying their previous agency.
Studies also suggest that post-FDA industry employment is not uncommon.
For example, in a 2016 study published in The BMJ, researchers followed 55 medical reviewers involved in drug approvals in FDA’s hematology-oncology division over several years. Of 26 officers who left the FDA, 15 later worked or consulted for industry.
A separate investigation by Science magazine in 2018 similarly reported that “11 of 16 FDA medical examiners who worked on 28 drug approvals and then left the agency for new jobs are now employed by or consult for the companies they recently regulated. This can create at least the appearance of conflicts of interest.”
Goswami and Fink did not respond to requests for an interview and the FDA instructed The BMJ to file a Freedom of Information Act request for information on whether either of the former regulators sought guidance from the FDA’s Office of Ethics and Integrity before moving to Moderna, as well as whether they recused themselves from any FDA matters related to their employment search.
Meanwhile, at Moderna, Goswami has been involved in the company’s efforts to bring to market an mRNA vaccine against respiratory syncytial virus (mRNA-1345). Doshi notes that Moderna’s application for regulatory approval in the US is likely to be judged by the FDA’s Office of Vaccines Research and Review, the group Fink and Goswami departed.
More information: Peter Doshi, The FDA and Moderna’s cosy relationship: how lax rules enable a revolving door culture, BMJ (2023). DOI: 10.1136/bmj.p2486
Journal information: Science , British Medical Journal (BMJ)
A quarter of Americans Say Someone They Know Died from COVID-19 Vaccine Side Effects
and other related news
11/2/2023
It has been a busy and productive week, with a lot of air travel.
As we have been driving back and forth to the airport, I have been listening to the audible version of K$h Patel’s book “Government Gangsters: The Deep State, the Truth, & the Battle for Our Democracy.” It is simultaneously one of the most damming and one of the best exposés of the deep state I have ever read or heard. His writing is compelling, logical and engrossing. So, I highly recommend!
“A brilliant roadmap highlighting every corrupt actor, to ultimately return our agencies and departments to work for the American People…we will use this blueprint to help us take back the White House and remove these Gangsters from all of Government!” (Donald J. Trump)
Jill and I are now sitting in the United Lounge in the San Diego Airport waiting for our flight. We are both frantically writing and working – trying to get our “chores” done before we board.
So, today I am going to share a few of the interesting stories and tidbits that have been brewing this week.
The big story that just came my way today is from Rasmussen reports. They report that polling released today shows that 24% say that they know someone who died from the COVID-19 vaccine.
“Nearly a quarter of Americans believe someone they know died from COVID-19 vaccine side effects, and even more say they might be willing to become plaintiffs in a class-action lawsuit against vaccine makers.”
Strong stuff!
The article goes on:
The latest Rasmussen Reports national telephone and online survey finds that 24% of American Adults say they know someone personally who died from side effects of the COVID-19 vaccine. Sixty-nine percent (69%) don’t know anyone who died from being vaccinated against the virus. (To see survey question wording, click here.)
Forty-two percent (42%) say that, if there was a major class-action lawsuit against pharmaceutical companies for vaccine side effects, they would be likely to join the lawsuit, including 24% who say it’s Very Likely they’d join such a lawsuit. Forty-seven percent (47%) aren’t likely to join a class-action lawsuit against vaccine makers, including 25% who say it’s Not At All Likely. Another 11% are not sure.
But here is another important fact that this poll highlights, beyond the absolute tragedy that we are witnessing.
There are almost no political differences on these questions. For example, 25% of Republicans say they know someone personally who died from side effects of COVID-19 vaccine, as do 24% of Democrats and those not affiliated with either major party.
People from all walks of life, from both sides of the aisle are waking up. The damage done to people from these vaccines can no longer be hidden and swept under the rug by government officials and scientists who garner funding through USG grants and contracts, with often repeated non-specific assurances of “safe and effective”.
What people are increasingly able to discern is also being documented by independent sources. This week, there was an article in a trade magazine for the life insurance industry called, Insurance Newsnet titled ‘Excess mortality’ continuing surge causes concerns”. The article cites industry and health authorities who are concerned about the excess mortality rates for 2022 and 2023, which rose during the initial COVID-19 wave, haven’t significantly diminished as COVID infection rates have declined.
Particularly worrying were statistics from the CDC that showed mortality rates are still rising. For example, younger adult mortality rates are up more than 20% in 2023.
“Insurance Newsnet” image, displayed for educational purposes only.
It is clear that the general public is well aware of the unusual rate of excess mortality, as they have witnessed it in their daily lives. They can readily correlate date of vaccine uptake with adverse reactions and death of people who know. People aren’t stupid.
In other news, I got an email from Michael Kane, who is one of the plaintiffs in the NYC court case regarding the fired teachers, who are still fighting for reinstatement and backpay. He has a disappointing but not surprising update on the status of the case . Below is a quote from the update in the Defender in an article titled, “Fired Unvaccinated New York City Teachers Still Fighting for Reinstatement and Back Pay After Supreme Court Win”:
New York City appealed last month’s state Supreme Court ruling reinstating 10 teachers fired for refusing the COVID-19 vaccine on religious grounds. Despite confusion on social media, the appeal means the teachers have not returned to work or received back pay.
In a precedent-setting victory last month, a New York State Supreme Court judge ruled that 10 New York City school teachers fired for refusing the COVID-19vaccine on religious grounds must be reinstated with back pay, benefits, seniority and attorney fees.
But the city immediately appealed the decision, so none of those teachers have returned to their jobs or received any payments.
“These workers absolutely did win reinstatement and back-pay,” Sujata Gibson, the teachers’ attorney told The Defender. “Unfortunately, in New York State courts, the government is entitled to an ‘automatic stay’ of any such relief pending resolution of the appeal.”…
Thousands of workers were subjected to the very same processes the judge ruled were “arbitrary and capricious,” and they could sue individually based on that precedent, if it is upheld by the appeals court, Gibson said.
Michael Kane, one of the plaintiffs and a member of Teachers For Choice, told The Defender that after filing the appeal, the city has six months to take the next step in the case — so even though they won with the last ruling, the fired teachers will have to continue to fight for their rights and the relief they are entitled to
As these stories highlight, we have to keep up the great work exposing the deep state’s lies and cover-ups in manipulating public opinion. As people reading this substack are on the frontlines in this battle, we all have to work to bring real data and developing news to people who might not otherwise know that there is alternative news available which is not “fringe” or radical.
A new FDA analysis finds COVID vax probably causes seizures in young kids (2-4/5)
Likely vaccination in this age group was harmful. We don’t know b/c no good studies of efficacy. That’s not good enough
11/1/2023
Recently, I was reading this paper
The paper makes two claims. First, COVID19 vaccination with mRNA products is linked to myocarditis in young men. We knew that. This study confirms that. But more concerningly, it finds increased risk of seizures/ convulsions in young kids.
As a first pass check when I read vaccine safety data, I look at safety signals I know. Multiple datasets show that myocarditis in young men should occur as often as 1 in 3000 to 1 in 5000. This dataset does not have that frequency. It combines men and women (also classic mistake — see paper by Knudsen and Prasad), but back calculating, I get a rate of approximately 1 in 10,000 in men. This means that it is likely this dataset is missing at least half of the events, since it uses administrative claims.
For this reason, my first concern is that other safety signals represent floor risk and not ceiling risk. In other words, that the real risk is higher than what is seen. The authors find the safety signal of seizures for 2 different products in comparable ages in kids, which lend clearance to the fact it is real. Yes, it vanishes in sensitivity using 2022 baseline rates (not 2020), but I am far more concerned the real signal is higher in magnitude (it is reported as 1 in 12k, but perhaps double? triple?). Moreover it is supported by trial data as well (divide 3k by 5)
Are we ever going to get an accurate estimate of this risk?
I doubt it. Not from the US at least. The US system is not designed to find safety signals that providers do not know to look for, or may wish to discount or ignore (as they doggedly pursue what they view as an unalloyed good— vaccination). US vaccine safety methods are broken. We learned of both myocarditis and VITT from abroad. The US needs a revamp.
Is vaccination always good?
Just as some drugs can be beneficial, some vaccines can be wonderful. But not all drugs are great, and not not all vaccines are good and useful to people. In the case of COVID19 vaccines, we have shown a net harm to young men getting boosters— that is easy to demonstrate— it is possible there is a net harm to vaccinating young kids (2-4/5) based on these data?
How much does vaccinating kids 2-4/5 improve COVID19 outcomes?
Here is the key point. There is no way to weigh the excess in seizures against the gains from vaccination. First, we don’t have a precise estimate of the seizure risk, and second, we have no idea what the absolute risk reduction in bad COVID19 outcomes is from vaccinating kids of this age.
Remember, vaccines were not debuted in young kids until much later than adults(years later!), and based on very low credibility data that was not significant for clinical endpoints (detailed here).
We have no data showing us the absolute risk reduction for severe disease or death at the time it was debuted. The virus had already evolved towards less mis-c and less lethality (it was always less than flu level risk for healthy kids). The few studies we do have on VE (vaccine effectiveness) in kids are confounded.
So is the gain of covid vaccines in young kids (2-4/5) bigger than 1 in 5k, 1 in 10k, 1 in 20k? We have no clue. Given the absolutely low risks of COVID to healthy kids in this age group, I doubt it.
As such, I would be concerned that vaccinating kids of this age group might represent a net harm. Ultimately, the available datasets are inadequate to adjudicate the question.
That just isn’t good enough.
The FDA and CDC have gambled with the health of young kids. They did not demand appropriately sized randomized data to demonstrate net benefit. They added these vaccines to the childhood schedule without these data.
As time goes on, the FDA and CDC won’t be able to hide the fact that boosting young men was harmful and that, very likely, vaccinating young kids was harmful. If that is conclusively proven, I suspect credibility in these agencies will go down further.