RUTHFULLY YOURS

https://issuesinsights.com/2022/07/25/fda-violated-own-safety-and-efficacy-standards-in-approving-covid-19-vaccines-for-children/

The FDA recently authorized Pfizer’s and Moderna’s Covid-19 vaccines for children as young as six months. Troublingly, the evidence the FDA used for those decisions violates at least three safety and efficacy standards from earlier FDA publications about Covid-19 vaccines:

In 2021, the FDA warned that “antibody tests should not be used to evaluate a person’s level of immunity or protection from Covid-19 at any time, and especially after the person received a Covid-19 vaccination.” Yet, antibody tests are the main evidence the FDA cited when approving these vaccines for young children.
In 2021, the FDA declared, “We know from our vast experience with other pediatric vaccines that children are not small adults,” and thus, a “comprehensive evaluation of clinical trial data” is necessary to “support of the safety and effectiveness” of vaccines before they are “used in a younger pediatric population.” Yet, the FDA used small studies with narrow data and claimed these vaccines are effective and safe for children by extrapolating from studies done on adults.
In 2021, the FDA wrote that “the primary study objective” is that the vaccines are at least 30% effective with 95% confidence in preventing Covid-19. Yet, none of the studies on young children met this threshold, and some were negative, meaning that the vaccine could increase the chances of catching Covid-19.

https://www.wsj.com/articles/a-revolution-is-coming-to-heart-care-cardiac-hospital-systems-asc-outpatient-market-11657744203?mod=opinion_lead_pos8

A cancer-care revolution that started in the 1980s is spreading to cardiac care. In the 1980s, cancer was treated almost exclusively in hospital settings. These days, more than 80% of all cancer care happens in community outpatient centers, which achieve better outcomes, keep costs low, and offer a more agreeable environment to both patients and caregivers.

Heart disease is poised for a similar revolution, with the potential to have an enormous positive effect on the U.S. healthcare system. Cardiovascular disease already accounts for 1 out of 7 healthcare dollars spent, and the total cost is expected to double and then some, to $1.1 trillion by 2035. Advances in cardiovascular medicine are creating a shift toward preventive care, shorter hospital stays, lower costs and better outcomes.

The Centers for Medicare and Medicaid Services recently approved 14 new reimbursement codes for outpatient ambulatory surgical centers, or ASCs, with more codes likely to be approved in the coming years. The reimbursement rates for these new codes are an average of 50% cheaper for ASCs than they are for hospital outpatient departments. In addition to significant savings for payers, patients will benefit from fewer physician visits, same-day treatments and better outcomes. (We are both board members, and Dr. Gheewala is a staff member, of a company that owns an ASC and has two more under development.)

Medicare has paid hospital outpatient departments nearly twice as much as it pays independent physicians or ASCs for the same services. Even off-campus facilities, which are hospital-owned but otherwise identical to independent physicians, have until recently enjoyed higher rates. Making payments site-neutral and shifting more services to outpatient settings would reduce Medicare spending by more than $150 billion in the next decade. It would reduce beneficiary spending on premiums and cost sharing by more than $90 billion over that time.

https://www.realclearhealth.com/articles/2022/07/11/follow_the_science_not_the_scientists_111367.html

During the pandemic, our public health community was forced to address an unprecedented number of controversies– from extended lockdowns and school closures to mask mandates and nursing home directives. At the same time, the Covid response saw a number of uncontroversial victories of medicine, such as Operation Warp Speed and the expansion of telemedicine.

When public health officials followed the science, good policies translated into good health outcomes. When we followed the scientists without the science, the pandemic response went sideways, and our public health recommendations proved unfruitful or counterproductive.

The public discussion was often minute and technical, with cable channels offering 24 hours of rapidly evolving medical “facts,” theories, and hunches proffered by a gaggle of doctors, scientists, and public health professionals. Conventional wisdom holds that, ‘When you are sick, do not google your symptoms’. Yet the televised version of symptom googling was broadcasted into our living rooms nightly, for the better part of two years.

Do not get me wrong. There was a public demand – and need – for information and advice. But some of this advice was not really advice. Instead, experts issued decrees accompanied by threats of enforcement – with governments and businesses recruited to provide the muscle. Because so much scientific “advice” was transformed into legal edicts, it is prudent to examine the proper role of science and scientists in future public health crises.

In response to a medical crisis, it makes sense to rely on medical science. But science produces all kinds of information, often contradictory and changing. Hopefully, this information continuously converges to a better understanding of the matters at hand. Scientists who have the task of generating, sorting through and understanding masses of data are performing vital, life-saving work. We should be grateful to them. It is often dry, confusing, and unrewarding work that must be done right. However, the need to leverage science in the service of saving lives induced some doctors and scientists to take on a role for which they were ill-suited: that of political leader.

https://www.tabletmag.com/sections/science/articles/cdc-is-endangering-childhood-vaccination-progress

On June 18, the U.S. Centers for Disease Control and Prevention (CDC) officially recommended Pfizer and Moderna COVID-19 vaccines for all children between the ages of 6 months and 5 years. While the Food and Drug Administration (FDA) is the agency responsible for authorizing emergency use of vaccines, it’s the CDC that crafts subsequent messaging, makes specific recommendations, and prioritizes who can, should, or should not get vaccinated. In her briefing, CDC Director Rochelle Walensky strongly urged all parents of the nearly 20 million American children in this age group to vaccinate them as soon as possible.

For some parents, Walensky’s briefing came as a huge relief. But if polling from May is anything to go by, a larger number of parents likely greeted the recommendation with skepticism. Even before the underwhelming trial results came out, only 18% of surveyed parents reported that they planned to vaccinate their babies and toddlers. Nationally, uptake in minors between the ages of 5 and 11 as of June 22, 2022, was 29% receiving two doses, and 36% receiving one, but vaccine requirements for sports, camps, and other activities likely drove an unknown percentage of vaccination in this age group.

There remains, moreover, no solid consensus among physicians about the importance of vaccinating healthy children against COVID-19. A survey from December 2021 indicates that as many as 30%-40% may not be recommending COVID vaccination for children ages 5 to 17, to say nothing of infants. A recent editorial in The Lancet expressed uncertainty about whether the benefits of vaccinating healthy 5- to 11-year-olds outweigh the risks, especially in those with a history of infection.

https://brownstone.org/articles/are-the-covid-mrna-vaccines-safe/

A new scientific study entitled “Serious adverse events of special interest following mRNA vaccination in randomized trials” provides the best evidence yet concerning the safety of the mRNA Covid vaccines. For most vaccines in common use, benefits far outweigh risks, but that may not be the case for the mRNA covid vaccines, according to this study by Joseph Fraiman and his colleagues. It depends on your age and medical history. 

The randomized controlled clinical trial is the gold standard of scientific evidence. When regulators approved the Pfizer and Moderna mRNA vaccines for emergency use in December 2020, two randomized trials showed that the vaccines reduced symptomatic covid infection by over 90% during the first few months after the second dose. 

Pfizer and Moderna did not design the trials to evaluate long-term efficacy or the more important outcomes of preventing hospitalization, death, or transmission. 

The randomized trials did collect adverse event data, including the presence of mild symptoms (such as fever) and more serious events requiring hospitalization or leading to death. Most vaccines generate some mild adverse reactions in some people, and there were considerably more adverse such reactions after the mRNA vaccines compared to the placebo. 

That is annoying but not a major issue. We care about severe health outcomes. The key question is whether the vaccine’s efficacy outweighs the risks of severe adverse reactions.

https://www.realclearhealth.com/articles/2022/07/02/stop_the_war_on_doctors_111360.html

Anyone in America who deviates from the group-think enforced by public health bureaucrats runs the risk of cancellation. Politicians, parents, comedians, teachers – now they’re even coming for the doctors.

As a lung and ICU specialist, I have practiced medicine for 14 years and successfully treated more than 450 patients during the pandemic. Long before anyone had heard of Covid-19, I was studying and implementing cutting-edge methods to treat critically ill patients. I’m the Senior Editor of a best-selling textbook in my field, now in its second edition, which has been translated into seven languages.

For my efforts, I now find myself on the receiving end of “disciplinary sanctions” from the American Board of Internal Medicine (ABIM), who sent me a letter threatening “suspension or revocation of board certification.”

The “sin” threatening to end my medical career was my unwillingness to go along with Fauci’s monolithic vaccines-above-all-else strategy. The failure of this approach is plain to see, and anyone with an ounce of curiosity knows there are many methods of treating the virus.

Ivermectin is one of them. This cheap, readily available generic medicine is approved by the FDA for certain uses in humans – but not for Covid-19, despite 85 controlled trials from around the world demonstrating its effectiveness. In Brazil, the largest study to date found a reduction in Covid mortality rate of 70%. In India, the second most populated country in the world, the drug has been credited with near eradication of the disease. Studies attempting to discredit ivermectin have been debunked again and again.

https://issuesinsights.com/2022/07/01/the-fda-is-blocking-game-changing-new-drugs-for-kidney-disease/

Imagine you’ve been diagnosed with chronic kidney disease, told by your physician that if it can’t be managed, you may eventually need a transplant or long-term dialysis. This scary situation is one faced by hundreds of thousands of Americans every year.

Chronic kidney disease (CKD) is an illness that affects an estimated 37 million people in the U.S. That’s more than one in seven adults across the country, or nearly the entire population of California. Despite this alarming statistic, investment in kidney disease research and therapies lags other sectors. We must redress that imbalance.

CKD is a serious condition that, if unaddressed, leads to organ failure. Without early interventions and disease management, CKD leads to an increased chance of heart disease, stroke, vascular disease, and even early death. Another serious, common complication – renal anemia – can cause debilitating symptoms that severely impact patients’ quality of life. Physicians and the millions of Americans living with CKD need more, and better, treatment options. 

While there have been increased efforts toward innovation in the kidney care community to provide new, effective treatments for patients, the U.S. Food and Drug Administration (FDA) has rejected most of the drugs for kidney disease that it has reviewed in recent years. Perhaps for that reason, nephrology has historically had one of the lowest rates of new drug applications submitted to the FDA, particularly when compared to other therapeutic areas like oncology and cardiology. 

Although the Department of Health and Human Services (HHS) has championed advancements in kidney care through initiatives like the public-private Kidney Innovation Accelerator (KidneyX), the FDA seems not to be onboard. By failing to approve drugs to treat patients with CKD and renal anemia, the FDA is out of step with the administration’s efforts to advance the development and access to cutting-edge treatments that have the potential to greatly improve patients’ lives and appear to have demonstrated a favorable risk-benefit profile.

The development of new kidney drugs such as vadadustat, one of a class of drugs called HIF-PHI, has given hope to the community that more options will be available to patients. Like other drugs in this new trailblazing class, it works by using the body’s innate oxygen sensing mechanism to stimulate red blood cell production, a great help to patients with anemia due to CKD.

https://www.frontpagemag.com/fpm/2022/07/dr-vladimir-zev-zelenko-rip-frontpage-editors/

Boca Raton, Florida, June 30th 2022 – It is with immense sorrow that we announce the passing of Dr. Vladimir “Zev” Zelenko. Dr. Zelenko was a physician, scientist, and activist for medical rights who touched the lives of millions of people. Some were saved through his role as a doctor, and even more were inspired by his words. His “Zelenko Protocol” saved millions and earned him a Nobel Prize nomination and the admiration of a U.S. President, among other prominent world leaders.

Born in socialist slavery, and then immigrating to the United States, Dr. Zelenko was the embodiment of the American dream – the child of poor immigrants who rose to success as a physician and a businessman. But Dr. Zelenko was more than a physician. As an activist and a businessman, he was also a man of deep faith, incredible love for his family, and a tireless inspiration to the company. But, perhaps most of all, Zev was our friend. The world knows the dynamic firebrand who never feared speaking truth to power or speaking up for issues he cared deeply about. Dr. Zelenko was a man of great, subtle humor and deep intellect. For every verbal jab he threw at the tired and incompetent establishment, a dozen more light-hearted laughs were spent with him and the team. Dr. Zelenko could laugh at himself as easily as others, and was always in great spirits, no matter the darkness that surrounded him – something that’s easily overlooked in today’s climate of hypersensitivity.

Some have already asked us what is next for Zelenko Labs. Though we have lost a leader, a friend, and an inspiration, the answer is simple: Keep Fighting.

This is not only what we think Dr. Zelenko would want, it is what he told us to do. And it is exactly what we will do. We will fight for his legacy. We will fight for the company that sustains his eight children and dozens of employees, and we will fight for you, our loyal customers and friends. Zelenko Labs will continue to deliver high-quality products, and we will protect Dr. Zelenko’s legacy with the creation of the Z Freedom Foundation, which will support the causes that matter most to our beloved Zev.

Though Zev’s chapters in the Book of Life have closed, his legacy is yet to be written. Join us and help write those next powerful and impactful chapters by helping us keep Zev’s main mission of helping every single American live a healthier, happier, and more informed life, front and center. Help us keep that honorable vision a vibrant one in our hearts and woven into the very fabric of this great nation.

We look forward to standing shoulder to shoulder with you in the coming days. Stay tuned for more news from Zev’s best and most powerful work.

https://www.foxnews.com/opinion/cdc-recommends-covid-19-vaccines-babies-kids-under-5-6-things-parents-need-know

On Saturday, CDC Director Rochelle Walensky announced a new recommendation to vaccinate all 20 million children 6 months to 5 years of age. Here are some things left out of the announcement that parents should know.

1. The research was inconclusive

The studies were too small to achieve statistical significance when evaluating efficacy against mild or severe COVID-19 infection. As a result, the FDA allowed both companies to extrapolate effectiveness by measuring antibody levels, pointing to data from older children and adults.

There were no cases of severe COVID illness in either the vaccine or placebo group. The Moderna vaccine had 4,774 children and the Pfizer vaccine had 4,526 (including those who received the placebo).

Pfizer concluded that their vaccine was 80% effective in preventing symptomatic COVID-19, but based it on 3 cases in the vaccine group and 7 cases in the placebo group in a subset of children who received a third dose.

Even this was not statistically significant. In fact, it had a confidence statistic so wide, you could drive an aircraft carrier through it. (They reported the largest confidence interval I have ever seen in my 20-year research career). At one end of the range of possibilities indicated by the confidence interval, the vaccine could be associated with a 370% increased risk of getting COVID-19. The Moderna trial reported a short-term efficacy of 38% in preventing symptomatic illness–an effect well-known to be transient. 

Ironically, there were more overall hospitalizations (unspecified) in the vaccine group. Out of a total of 7 children requiring hospitalization, 6 were in the vaccine group and 1 was in the placebo group, which was half as large. 

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The CDC even said in its own slides at their deliberation meeting that data assessing efficacy were poor, characterizing them as “very low certainty” and noting that there are “very serious concerns for imprecision due to study size”. They also noted the very short follow-up time of 1.3 months.

2. The FDA lowered their standards for acceptable vaccine efficacy needed to approve

https://www.nationalreview.com/corner/the-cdc-just-pushed-fake-news-on-covid-child-mortality/

Only because “an internet rando is more knowledgeable and paying closer attention than our top scientists and doctors” do we know that the CDC just publicized false information about the deadliness of Covid-19 to small children. This misinformation, presented at a conference among top experts, went viral and was promoted, notes Substack columnist Matt Shapiro, by dozens of well-known physicians and other media commentators and specialists, including CNN mainstay Dr. Leana Wen and a former surgeon general of the United States. Wen’s promotion of the false claim is still up on Twitter as of 6:45 p.m. on June 22.

The CDC displayed a slide at a conference that falsely claimed Covid-19 was the fourth or fifth leading cause of death for all pediatric age groups. A writer who is publicly known only by the name Kelley immediately saw that the claim was “completely and utterly false.” Among several errors, which are so blatant as to seem like intentional massaging of the numbers, Kelley discovered that all data from a 26-month period were being crammed into one year, and that deaths were attributed to Covid, regardless of whether the death was caused by Covid, if the disease was mentioned on the death certificate. The CDC slide, which cited a pre-publication British study that is now being re-examined, also bumped up the numbers by altering the definition of pediatric (ordinarily understood to mean under 18) to include 18- and 19-year-olds.

The danger to children from Covid is very, very low. For instance, babies and toddlers are 25 times likelier to die of an accident than of Covid. And all-cause pediatric mortality in the pandemic era for young children (up to 12) is 30 percent lower than it was a generation ago, in 1999. All-cause mortality for children over 12 has spiked in the pandemic era because of accidents, drug abuse, and other factors unrelated to disease. Covid barely registers as a cause of death for teens or small children.