Category Archives: Science

Doctor Turns Against Messenger RNA COVID-19 Vaccines, Calls for Global Pause

Source: Doctor Turns Against Messenger RNA COVID-19 Vaccines, Calls for Global Pause

By Zachary Stieber and Jan Jekielek
September 26, 2022 Updated: September 26, 2022

A doctor who promoted COVID-19 vaccines is now calling for health authorities around the world to pause administration of two of the most-widely utilized COVID-19 vaccines, asserting that the benefits from the vaccines may not outweigh the risks.

“There is more than enough evidence—I would say the evidence is overwhelming—to pause the rollout of the vaccine,” Dr. Aseem Malhotra, a British cardiologist and evidence-based medicine expert, told The Epoch Times.

A paper from Malhotra was published on Sept. 26 detailing the evidence.

Among the citations is a recent reanalysis of the Pfizer and Moderna clinical trials that concluded vaccinated trial participants were at higher risk of serious adverse events. Malhotra called the study a “smoking gun.”

Malhotra also pointed to the lack of reduction in mortality or severe disease in the trials, which were completed in 2020.

Taking into account death rates and other figures since then, the number of people who need to be vaccinated to prevent a single COVID-19 death ranges from 93,000 for people aged 18 to 29 to 230 for people aged 80 and above, according to an analysis of UK safety and effectiveness data by the Health Advisory & Recovery Team.

The author also noted that serious side effects have been detected after the trials, such as myocarditis, a form of heart inflammation.

Overall, looking at the absolute benefits and drawbacks of the vaccines, it’s time to halt their usage and allow authorities and other experts to closely examine the data to see if the vaccines should be used again down the road, according to Malhotra.

The paper was published in the Journal of Insulin Resistance in two parts following peer review.

Pfizer and Moderna did not return requests for comment.

Reversal

Malhotra received the Pfizer primary series in January 2021. He became a promoter of the vaccine, even appearing on “Good Morning Britain” to advise Indian film director Gurinder Chadha to get the shot. Chadha did so shortly after.

Malhotra said he began digging into vaccine data after his father, Dr. Kailash Chand, suffered a cardiac arrest at home approximately six months after receiving Pfizer’s vaccine.

The post-mortem showed two of Chand’s major arteries were severely blocked, even though Malhotra described his father as a fit person who did not have any significant heart problems.

Malhotra began reading about post-vaccination issues, including a study abstract in the journal Circulation that identified a higher risk of a heart attack following vaccination with the Pfizer and Moderna vaccines, and a study from Nordic counties that identified a higher risk of myocarditis. While authorities have claimed that myocarditis is more common after COVID-19 than vaccination, many studies have found otherwise, at least for certain age groups. Some papers have found no increased incidence of heart inflammation for COVID-19 patients.

Malhotra has come to believe his father’s death was linked to the vaccine.

“I’ve always approached medicine and science with uncertainties because things constantly evolve. And the information I had at the time is completely different to the information I have now,” Malhotra told The Epoch Times. “And in fact, it is my duty and responsibility as the information has changed to act on that information. And that’s what I’m doing.”

Response to Criticism

After the new paper was published, critics noted that Malhotra is a board member of the Journal of Insulin Resistance.

Malhotra acknowledged the position but said that the article went through an independent peer review process and that he has no financial links to the journal.

The doctor encouraged people to view his publication history, which includes articles in the British Medical Journal and the Journal of the American Medical Association.

He said he chose to submit the paper to the insulin journal for several reasons, including it being “one of the few journals that doesn’t take money from the pharmaceutical industry.”

“I don’t think that there’s any validity to question the integrity of the piece,” he said. “People can argue I’ve got an intellectual bias. We all have intellectual biases, but there’s certainly no financial bias for me.”

Gains Support

Leading scientists say the new paper is important.

“We fully believe that vaccines are one of the great discoveries in medicine that has improved life expectancy dramatically, however, mRNA genetic vaccines are different, as long-term safety evaluation is lacking but mandatory to ensure public safety,” Sherif Sultan, president of the International Vascular Society, said in a statement, adding that the findings “raise concerns regarding vaccine-induced undetected severe cardiovascular side effects and underscore the established causal relationship between vaccines and myocarditis, a frequent cause of unexpected cardiac arrest in young individuals.”

Dr. Jay Bhattacharya, a professor of medicine and epidemiology at the University of Stanford, added that Malhotra “makes a good case that there is considerable heterogeneity across age groups and other comorbid conditions in the expected benefits and expected side effect profiles of the vaccine” and “finds that while there may be a case for older people to take the vaccine because the benefits may outweigh expected harm that may not be the case for younger people.”

Dr. Campbell Murdoch, who advises the Royal College of General Practitioners, said that the study “describes multiple systemic failures in the provision of safe and effective evidence-based medicine,” and that the situation has made it “impossible for patients and the public to make an informed choice about what is best for their health and life.”

Some others criticized the paper, including Dr. Victoria Male, an immunologist at Imperial College London.

Male wrote on Twitter that the table in the paper outlining the number of people in each age group estimated to need a vaccination to prevent a COVID-19 death “is quite in favour of vaccination.”

Zachary Stieber covers U.S. and world news. He is based in Maryland.
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Study of the Week – Lessons from a Serious Medical Mistake

Source: Study of the Week – Lessons from a Serious Medical Mistake

At the heart of one of modern medicine’s greatest errors was confusing correlation and causation.

Sep 19, 2022

When I began medical training, experts felt they knew how to prevent heart disease in post-menopausal women. It was simple: extend their exposure to estrogen by giving hormone replacement therapy or HRT.

It made sense: estrogen worked in the liver to reduce levels of bad cholesterol. Rates of heart disease in women increased after menopause when estrogen levels dropped.

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And there were studies—lots of them.

In 1992, the prestigious journal, the Annals of Internal Medicine, published a meta-analysis (a combination study of studies) of hormonal therapy to prevent heart disease and prolong life in post-menopausal women.

I made a slide of the main findings and conclusions. In the right column are the many observational studies of HRT. Notice that most have estimates less than 1.00, which means that the group of women who took HRT had lower rates of coronary disease.

In the next slide I’ve highlighted the results and conclusions. Note the causal verbs.

HRT does not associate with better outcomes, it decreases the risk for coronary heart disease. I remind you that these were non-randomized comparisons of women who took HRT vs those who did not.

This had a serious effect on creating a therapeutic fashion.

Journalist Gary Taubes writes that by 2001, 15 million women were taking HRT for preventive purposes.

The exact number isn’t important; what’s important is that lots of women took preventive HRT—for years—in the absence of a proper randomized trial.

The trial finally came. JAMA published the Women’s Health Initiative trial in 2002.

It was a large trial with more than 8000 post-menopausal women in each group—HRT vs placebo. Their primary outcome was strong—heart attack or death due to heart disease. Breast cancer was a safety endpoint.

The results were stunning. Not only did HRT not prevent heart disease, it caused more heart disease, pulmonary embolisms, stroke, and breast cancer than placebo.

I did a little algebra to determine what a rate of 32 per 10,000 would look like in 2001 where 15 million women were taking HRT.

The numbers are staggering. In one year alone, HRT led to a nearly 50k women being harmed.

(An important caveat is that WHI looked at HRT for prevention.)

Two Main Lessons:

The first lesson is that bio-medicine is hard. No matter how much sense something makes, the likelihood is that it won’t work. From a Bayesian point of view, our prior expectations should mostly be pessimistic. This is especially true when it comes to preventing disease.

The second lesson is that observational research has serious limitations when it comes to making causal inference. Without random assignment, you don’t know if the comparison groups were similar.

In this case, women who decided to take HRT were likely healthier than women who did not. And it is those healthier attributes that led to the findings of lower risk.

Randomization fixes this flaw because it (mostly) balances characteristics that you can see and those that you cannot see.

And it doesn’t matter if these non-random studies contain large numbers of patients or if there are many studies. They can all be biased in the same way. A systemic bias is the same in a study of 100 or 10000 patients.

Cardiologist David Cohen succinctly states the existential problem with observational studies:

I want now to add two caveats about observational research.

It is not use-less. Observational studies can tell us things like what we are doing (e.g. the number of procedures), who we are doing these procedures on, and rates of complications. This is useful.

The second caveat is that there are groups, such as Miguel Hernan’s team, working on ways to simulate trials from observational studies. The important point here is that his target trial technique is best used in spaces where there are no randomized trials or when randomized trials are not feasible.

Conclusion:

Medicine is replete with examples where hubris led us to cause harm.

Most often, it is over-confidence in therapies that make sense and show positive results in observational studies. Always beware of non-randomized comparisons.

The antidote is randomization. The onus is on the proponents of new therapies to show that it works in a randomized trial. In the end, this mindset will lead to far less harm.

 

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Double standards: The Atlantic Tells the Story of a Doctor Whose Cancer Got Worse After Vaccination, but No Legacy Media Outlet Will Cover the Aftermath of a Boy Who Had Myocarditis

Source: Double standards: The Atlantic Tells the Story of a Doctor Whose Cancer Got Worse After Vaccination, but No Legacy Media Outlet Will Cover the Aftermath of a Boy Who Had Myocarditis

Why are we treating possible adverse events more seriously than a proven one?

Sep 25, 2022

This week the Atlantic published a long essay about a doctor: Michel Goldman, who has lymphoma, and who noticed that his cancer seemed to worsen after COVID19 mRNA boosting. Was the vaccine responsible?

Let me be clear: Is it possible his cancer got worse because of the booster? Absolutely, it is possible. Is it possible the cancer would have gotten worse without the booster? Absolutely, that often happens with lymphoma. Many patients experience what feels like a change in tempo, and it is hard to know what, if anything, precipitated it.

Imagine you put a gun to my head, and ask me to make the call. Is it related or unrelated? But you are a kind, and say you will give me 1 month, and allow me to use any data sources. I would do something very simple. I would go to a large electronic medical record with images. I would pick an incurable lymphoma where there is often repeat imagining— such as follicular lymphoma. I would extract images from patients (let us say 500). Some patients would have gotten boosters and others not— and it will not be random— this is a limitation. But, I can’t make excuses, I have a gun to my head.

I would use the raw images to calculate the g- or growth rate coefficient before COVID vaccination, and the g or growth rate after COVID vaccination (using established methods, see Fojo, et al.).

As a falsification test— (Learn about that here)— I would use the patients’ birthday to define a g before a birthday and a g after a birth day.

Here is the hypothesis: if the vaccine accelerates growth, the growth rate will change after boosting, but— let us be clear— it would not change at time of patient’s birthday. That’s the purpose of the falsification test— to serve as a negative control. You could also use a random day of the year for your falsification test. And you need a group of people to get a sense of the distribution.

With access to a nice dataset and omnibus IRB, a project like this could be done in 3 weeks. If I was allowed to involve Logan Powell— a Texas medical student who has done ~20 papers with me— we would be done in 2 weeks, because that kid doesn’t sleep. And, honestly, with Logan’s help (again, dude doesn’t sleep), I can think of 5 different studies to run to complement this analysis.

Do you know what I wouldn’t do? I wouldn’t extensively pour over the story of the individual Michel Goldman— because nothing can be found in one anecdote to help me. The yield will be low. And do you know what I really would not do: I wouldn’t broadcast this story in the Atlantic before I had strong evidence the link might be real!

Meanwhile, there is a proven safety signal I don’t hear much about in the legacy media. Myocarditis for boys after mRNA vaccination. It occurs as often as 1 in 3,000 after primary vaccination and 1 in 10,000 after boosting. It has very rarely but really resulted in young people ending up on Extracorporeal Membrane Oxygenation. It could be lowered (surely) if we banned Moderna in men <40, (possibly) if we lowered doses, (likely) if we spaced doses apart, and (surely) if we minimized doses in young men who already had COVID19. And yet, we have done nearly none of these things! The CDC only spread doses after a year of inaction, and we haven’t taken natural immunity seriously.

Vaccination means trying to maximize efficacy and minimize harm, but when it comes to young men, we haven’t taken the harm seriously and haven’t tried to minimize it. Yet, I don’t read this in the pages of the Atlantic. I just read about a famous old doctor who thinks the vaccine made his cancer grow faster. What is going on?

The entire episode led me to several conclusions:

  1. If he wasn’t a rich doctor; this would not be in the news. How sad is it that the experience of everyday Americans is not considered acceptable for news coverage. Many people have felt a range of medical issues were triggered or worsened by vaccination, but the media steadfastly refuses to cover those stories. Yet, in this case, they make an exemption because the individual is famous. I find this problematic. I prefer to not cover any anecdote, but this idea that if it happens to an electrician- it is anti-vax, but if it happens to a doctor- it is news— that’s problematic.
  2. Cancer accelerating after vaccination is not yet established as linked to COVID19 vaccination, but 2 things are fully established. Blood clots and runaway platelet activation after J&J vaccination is fully proven to be linked to the shot. And myocarditis, particularly in young men, has been linked to mRNA vaccines. And yet: I have never seen coverage of the human cost of either of these in any major news outlet!
  3. The news media could easily cover a poor young man who was forced to be boosted by his college or university, and experienced myocarditis. This occurs at the rate of 1 in 10k. One news story like this would be powerful— and strongly discourage these mid level managers from mandating novel medical products. And yet the media is silent on these stories. Why does the doctor get special treatment for a side effect that has not yet been vetted?
  4. What about this story of a 14 year old boy? Why is this (or a similar story) not in the Atlantic? Instead a doctor gets his unproven anecdote widely broadcast? 

     

  5. What about the young woman who had clot and brain damage from J&J? What about her family? Why no coverage of that? The news could also note that some (dim) scientists on Twitter compared runaway platelet activation after J&J to a blood clot in the leg after oral contraceptives. This was a deceptive and ignorant comparison that furthered preventable harm. Why does the media not cover this story? Why only a possible side effect— unproven— in a famous scientist?
  6. Consider the risk gradient here. Young people have far less to gain from each additional dose of vaccine, and even rare risks become salient. Older people who suffer from cancers that often lead to (or therapies lead to) b-cell inhibition face much higher risks of COVID19. Why are we covering an anecdote that might lead a higher risk population to forgo vaccination vs. lead colleges to consider that a lower risk population ought not be compelled? The whole thing is backwards.
  7. The White House is doing massive damage to our institutions— particularly the FDA— as they push a new booster based solely on mouse data. Their unethical pressure led Gruber and Krause to resign. They could have compelled Pfizer to run RCTs, but chose not to. The legacy media is largely complicit with this, writing many articles defending this choice, but it is entirely unprecedented. And yet, instead, they are happy to cover a putative side effect that might not even be related?
  8. I have no doubt there may be adverse events attributable to vaccines that are not yet established, but we don’t need to profile the people who have these (not yet), we need careful epidemiological studies. I agree the CDC’s passive collection is suboptimal, and I also no longer trust them, as I believe they have been captured by political winds, but the solution is better systems and independence, rather than covering anecdotes in the media.
  9. The Atlantic coverage is balanced and fair, but that’s not the point. The mere act of covering the anecdote to millions of readers, elevates it to something intensely plausible or true. No matter how much confidence you place in it, the truth is mycocarditis is more plausible and more true and should be preferentially covered. And yet there is no story of a boy who lost a football scholarship because he can’t play. Or a kid still ravaged with late gad enhancement after surviving mycocarditis. This discrepancy is fundamentally unfair.

The media coverage of vaccines and side effects is awful. They lack a philosophical framework and are unmoored. This article nicely shows how that is the case. Whether they choose to improve is beyond me. They have too much allegiance to the Biden administration, and have failed American boys as a result.

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Excess deaths keep rising across EU

Source: Excess deaths keep rising across EU – The Post

By Rob Lownie, Sept. 20, 2022

The latest figures from July show 15% more deaths than normal

EU excess deaths reached new highs in the month of July 2022, the latest EU figures show. Excess mortality hit +15.8% — equivalent to 53,000 excess deaths — compared to the same month in the years 2016-2019. This figure marks a steep rise from June and May 2022, both of which were around 7%.

Credit: EuroStat

While one EU member state, Latvia, recorded few or no excess deaths (-0.5%) in July, eleven countries had rates over 15%. The highest of these was Spain, with a rate of 36.9%, followed by Cyprus at 32.9% and Greece at 32.1%.

EU officials claim that July’s unusually high value “may be due to heat waves that affected parts of Europe”, which is why southern European countries suffered the highest rates of excess mortality. The spike is not attributed to Covid.

‘Excess mortality’ measures the number of deaths, from any cause, exceeding what would be considered normal during a particular period. Since April 2020, national statistical bodies from the EU and the European Free Trade Association (EFTA) have submitted weekly death figures to Eurostat. In this time frame, the four clearest peaks have come in April 2020 (25.2%), November 2020 (40.0%), April 2021 (20.9%) and November 2021 (26.5%), most of which was driven by the Covid pandemic.

Outside the EU, during an eight-week period between 11 June and 5 August the Continuous Mortality Investigation (CMI) listed 8,200 excess deaths in England and Wales, adjusted for age.

These statistics show cardiovascular issues such as heart failure and circulatory diseases to be overrepresented as causes for excess mortality. Diabetes and urinary problems also feature heavily, while numbers for respiratory infections are skewed by Covid-19.

However, according to the ONS’s most recent statistics, in the week ending 2 September only 3.5% of total excess deaths in England and Wales involved Covid as a contributing factor. In 182 of these 314 cases, the coronavirus was recorded as the underlying cause of death. This is down from the previous week, in which Covid-19 accounted for 4.1% of excess mortality.

For a discussion of potential causes, don’t miss the recent UnHerdTV discussion with actuary Stuart Macdonald.

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