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Author: Richard Jaffe

Another Piece to the Other Side of the Judy Mikovits Story

Another Piece to the Other Side of the Judy Mikovits Story

My recent piece on Judy Mikovits was based on a commentary written by two University-based scientists who presented a detailed history of her rise and fall. here is that post. https://rickjaffeesq.com/2020/08/09/the-other-side-of-the-judy-mikovits-story/

The commentary had two big and very specific scientific points, 1. that her result was that ME/CFS patients had an XMRV (mouse retrovirus) was false and that her findings of XMRV in the samples was just lab contamination. 2. she spiked her samples with a material (plasmid) that a researcher had sent her and that the material could not have come from the patients, as she claimed. I made no conclusion about either being true but said if either is true, the vaccine concerned shouldn’t listen to anything she says.

I missed something important in the commentary. It was pointed out that in 2012, she participated in a “replication” study, to see if she could duplicate her prior results. There had been several other prior studies that failed to replicate her results, but she tried to explain away all of them. But this time she participated in the study. And guess what. The replication study failed to replicate her prior findings. Here is the actual study, in which she is listed as a co-author.
miknew

It is discussed on page 548 of the Neil and Campbell commentary. (here is the commentary again) aid.2020.0095(1)

Arguably, the new study is a direct admission that she was wrong about her earlier paper and that her earlier results were just lab contamination. If so, then I suppose she gets some credit for agreeing to participate in the new study and allowing her name to be listed as an author in a study that refuted (again) her prior work.

But I still have no conclusion about her alleged spiking the samples which I think would be scientific fraud. It’s going to take someone with some lab/technical and scientific expertise to evaluate that claim. Between trying to listen to her book, reading the commentary, and the replication study, I’ve made up my mind. I have more important and pressing things to think about (hint, the UC flu mandate, and stay tuned for the next post), so I do not plan on addressing this subject in the future, that’s the hope and plan anyway.

Rick Jaffe, Esq.

The other side of the Judy Mikovits story

The other side of the Judy Mikovits story

When the documentary Plandemic came out a few months ago, I didn’t think much about it. A doctor client of mine saw it and told me that he had no reason to believe it wasn’t true and accurate. I said nothing. In my work for medical mavericks, I have been involved in a number of documentaries (I even have an IMDB co-starring credit in a very popular one), so I have a good sense of what I’ll call advocacy documentaries are made. As a result, and again, because I represent mavericks for a living, I come to the table with a healthy degree of skepticism.

Then the book came out, Plague of Corruption, and like the documentary, a firestorm erupted. I hadn’t planned on reading it or writing about the controversy. However, the book had a foreword by Bobby Kennedy, who is a both a thought-leader and the most cogent and effective advocate of the vaccine issue and important health issues in general. As a result, I pay very close attention to what he says. So I got the book (the audible version).

Bobby’s foreword blew me away, and I said as much in a recent post I did about it, and how important it was since a group of clinicians using HCQ called a press conference to challenge the accepted rejection of the treatment they have seen work in their patients. Here is that post.

https://rickjaffeesq.com/2020/08/04/bobby-kennedys-intro-to-plague-of-corruption-is-even-more-important-now-after-the-attacks-on-the-frontline-doctors-and-the-firing-of-board-certified-physician-dr-simone-gold/

If you haven’t read his foreword, the general part (non-Judy Mikovits story) of which is quoted in my post, you should because as I said in my post, these clinicians are right in line with the kind of brave professionals Bobby wrote about in his foreword.

I didn’t say much about the actual Judy Mikovits story for a few reasons, not the least of which is that I had a hard time getting through the book. I’ll leave it at that for now.

After writing the post, I got an email from someone accusing me of spreading misinformation, and that he had proof that she had, in fact, stole lab books or and maybe other stuff, and attached some affidavits. More directly, that he had personal knowledge about some of it and was listed in some book about her, him working with her or something like that. Honestly, the whole theft issue doesn’t interest me because she was never convicted nor even ever formally charged with a crime. (I would feel differently if the lab books showed the problems discussed below, but I don’t know that anyone has suggested that.)

But what did highly interest me was a commentary written by two scientists which contain a very, very detailed summary of the whole Mikovits XMRV story, the other side of the story if you will. (I quoted the email and all the links referenced in a comment to the post here: https://rickjaffeesq.com/2020/08/04/bobby-kennedys-intro-to-plague-of-corruption-is-even-more-important-now-after-the-attacks-on-the-frontline-doctors-and-the-firing-of-board-certified-physician-dr-simone-gold/#comment-21900 , if you want to look at the other links and points I am not addressing in this post).

The article was published in a journal that is part of the Mary Ann Liebert journal publishing house. I know it and respect their work. They publish highly regarded journals about integrative medicine, so they are not nonthinking conventionalists. (One of their journals did a positive article about me and my work. Well, no one gets it right all the time.)

The title of the article is harsh: “Fake Science: XMRV, COVID-19, and the Toxic Legacy of Dr. Judy Mikovits”. But if valid, it is well deserved.

If you are what the article calls the “In Judy we trust” camp, don’t bother reading it, as it will have your anti-analytical defense mechanisms working overtime. But if you have an open mind, then you should read it. Also, it has an excellent and short summary exposition about retroviruses.

The article lays out chronologically what happened, all the players, and how she became an academic pariah, (well deserved if true and the related lab evidence is accurately reported).

There are two big claims. First, that her XMRV findings in ME/CFS patients are invalid and what she really found was laboratory contamination in her samples. That is based on the fact that there was just one virus sequence which she found in the many patients she tested. That never happens with retrovirus as there are more like “swarms of related sequences.” So what she really found was just one sample of the retrovirus which contaminated the rest of her samples.

The second, related and even more damming finding was that her samples contained genes that had been engineered in someone else’s lab and which could not have possibly come from the ME/CFS patients themselves. This finding led to the likely conclusion that she had “spiked” her samples with this other researcher’s material, presumably to create or amplify the XMRV retrovirus to justify her conclusion that the retrovirus caused ME/CFS. And if so, then that my friends is a textbook definition of scientific fraud. (My view. The article said it was “prima facie evidence of scientific fraud.”)

These arguments are laid out starting at the last paragraph on page 546 to page 547. Maybe people who have more technical knowledge than me might have a different view, but that’s the way I read it.

The rest of the commentary tells the rest of the other side of the story, why she was fired, and how her paper(s) was(were) retracted.

The end has a particularly damming summary and is worth quoting to fully tell the other side of the story: “So all in all Mikovits has form as a serial scientific fantasist who has consistently made unsubstantiated claims about mouse retroviruses as the cause of a number of human diseases. The only “evidence” she has ever published by her was unequivocally shown to stem from laboratory contamination and explicit fabrication of data. She was never a leading researcher in the field; her doctorial studies were only very minor contributions to the field and until the XMRV debacle, very few had ever heard of her. Her subsequent “research” took advantage of people desperate to have an explanation for their debilitating symptoms, giving them false hope and many a false narrative where they are the victims of a massive medical cover up.”

I don’t know about the last part, but to me, the important part is whether her results were really lab contamination and scientific fraud resulting from her spiking her samples to justify her results. If what the commentary says about that is accurate and scientifically sound, then she’s toast and deserves the scorn she has received.

Read the commentary and decide for yourselves. Here it is:

aid.2020.0095(1)

Finally, Why I am writing this?

Two reasons: It is an important issue and I think it is very, very important for people who have legitimate concerns about vaccines amid all the public health debates swirling around, to be informed and get it right. If Judy Mikovits is not the hero she portrays herself to be in the documentary and book, it would be better for the vaccine concerned community to acknowledge it and move on (or just allow her to fade back into Pariah world).

Second, and more much importantly, I hear she is coming out with a new book about why masks are not necessary in this pandemic. That view could have major and negative consequences for the health of millions. If it turns out that she is who and what the authors of this commentary say she is, maybe you should listen to someone else and stop promoting her.

But again: read the commentary and judge for yourselves.

Rick Jaffe, Esq.

Bobby Kennedy’s Intro to “Plague of Corruption” is even more important now, after the attacks on the Frontline Doctors and the Firing of Board Certified Physician Dr. Simone Gold

Bobby Kennedy’s Intro to “Plague of Corruption” is even more important now, after the attacks on the Frontline Doctors and the Firing of Board Certified Physician Dr. Simone Gold

In the future, when they write about how and why the current pharma controlled and corrupted medical paradigm was replaced, I think they will point to the Frontline Doctor’s July 27th press conference, the resulting dismissal of board-certified physician Dr. Simone Gold from her job, and the world-wide public outcry relating to the suppression of information about Hydroxychloroquine by the social media monopolies as the fulcrum point. We are seeing in real-time the dysfunction and failures of the public health apparatus. But we are also seeing how the defenders of the current paradigm wage war against those who question the current medical paradigm, namely the vilification, marginalization, and harassment of the professionals who challenge the church of medical orthodoxy.

A few months ago, Plague of Corruption was published, which is Judy Mikovits’ story about how she was attacked by the medical establishment. Predictably, her book and the documentary about it have been attacked and suppressed. Her book had a forward by Bobby Kennedy.

I’ve been doing this medical maverick stuff for a long, long time, and I have written quite a bit about it, including my own book about some of the mavericks I have defended. But in all that time, and with all my words, I don’t recall ever seeing as cogent and succinct a summary of the perils facing these mavericks as Bobby’s forward to the Mikovits and Heckenlively book. In light of the recent attacks on the Frontline Doctors, it is well worth rereading and sharing Bobby’s words.

(I am only going to share the general parts of his forward. For the entire forward which contains a good summary of Judy’s story, his forward is posted at his group’s (Children’s Health Defense) web site: https://childrenshealthdefense.org/news/moral-courage-and-our-common-future-a-foreword-to-plague-of-corruption/ .

Bobby and his group of committed activists do great and important work, so if you can, please make a donation to them. Here is the link. https://childrenshealthdefense.org/about-us/donate/
The posting of his introduction was on CHD’s web site, published on May 12, 2020.

(I will have a few things to say after his Introduction)

©”Moral Courage and Our Common Future—A Foreword to Plague of Corruption”

By Robert F. Kennedy, Jr., Chairman, Children’s Health Defense

“And yet, it moves!” Galileo whispered those defiant words in 1615 as he left the Roman Inquisition tribunal before which he repudiated his theory that the Earth—the immovable center of the Universe according to contemporary orthodoxy—revolves around the sun. Had he not recanted, his life would be forfeit. We like to think of Galileo’s struggles as the quaint artifact of a dark, ignorant, and tyrannical era where individuals challenged government-anointed superstitions only at grave personal risk. Dr. Judy Mikovits’s story shows that stubborn orthodoxies anointed by pharmaceutical companies and corrupt government regulators to protect power and profits remain a dominant force in science and politics.

* * *
[parts about Judy’s case omitted, see the link above for the entire Introduction]

“Challenging contemporary orthodoxies is an occupational hazard

The persecution of scientists and doctors who dare to challenge contemporary orthodoxies did not take a rest after Galileo: it has always been, and remains today, an occupational hazard. Henrik Ibsen’s 1882 play An Enemy of the People is a parable for the pitfall of scientific integrity. Ibsen tells the story of a doctor in southern Norway who discovers that his town’s popular and lucrative public baths were actually sickening the visitors who flocked to them for rejuvenation. Discharges from local tanneries had infected the spas with lethal bacteria. When the doctor goes public with the information, local merchants, joined by government officials, their allies in the “liberal-minded independent press,” and other financially interested parties move to muzzle him. The medical establishment pulls his medical license, the townsfolk vilify and brand him “an enemy of the people.”

Ibsen’s fictional doctor experienced what social scientists call the “Semmelweis reflex.” This term describes the knee-jerk revulsion with which the press, the medical and scientific community, and allied financial interests greet new scientific evidence that contradicts an established scientific paradigm. The reflex can be particularly fierce in cases where new scientific information suggests that established medical practices are actually harming public health.

The real-life plight of Ignaz Semmelweis, a Hungarian physician, inspired the term and Ibsen’s play. In 1847, Dr. Semmelweis was an assistant professor at Vienna’s General Hospital maternity clinic, where around 10 percent of women died from puerperal “birth bed” fever. Based on his pet theory that cleanliness could mitigate transmission of disease-causing “particles,” Semmelweis introduced the practice of mandatory hand washing for interns between performing autopsies and delivering babies. The rate of fatal puerperal fever immediately dropped to around 1 percent. Semmelweis published these findings.

Rather than building a statue to Semmelweis, the medical community, unwilling to admit culpability in the injury of so many patients, expelled the doctor from the medical profession. His former colleagues tricked Dr. Semmelweis into visiting a mental institution in 1865, then committed him against his will. Semmelweis died mysteriously two weeks later. A decade afterward, Louis Pasteur’s germ theory and Joseph Lister’s work on hospital sanitation vindicated Semmelweis’s ideas.
Modern analogs abound

Modern analogs abound. Herbert Needleman of the University of Pittsburgh endured the Semmelweis reflex when he revealed the brain-killing toxicity of lead in the 1980s. Needleman published a groundbreaking study in 1979 in the New England Journal of Medicine showing that children with high levels of lead in their teeth scored significantly lower than their peers on intelligence tests, on auditory and speech processing, and on attention measurements. Beginning in the early 1980s, the lead and oil industries (leaded gasoline was a lucrative petroleum product) mobilized public relations firms and scientific and medical consultants to lambast Needleman’s research and his credibility. Industry pressured the Environmental Protection Agency, the Office of Scientific Integrity at the National Institutes of Health, and the University of Pittsburgh to launch investigations against Needleman. Ultimately the federal government and the University vindicated Needleman. But the impact of the industry’s scathing assault ruined Needleman’s academic career and stagnated the field of lead research. The episode offered an enduring demonstration of industry power to disrupt the lives of researchers who dare to question their products’ safety.
Trade journals and the popular media disparaged [Rachel Carson] as a ‘hysterical woman.’

Rachel Carson ran the same gauntlet in the early 1960s when she exposed the dangers of Monsanto’s DDT pesticide, which the medical community then promoted as prophylactic against body lice and malaria. Government officials and medical professionals led by the American Medical Association joined Monsanto and other chemical manufacturers, attacking Carson viciously. Trade journals and the popular media disparaged her as a “hysterical woman.” Industry talking points derided Carson as a “spinster,” the contemporary euphemism for lesbian, and for being unscientific. Vicious criticisms of her book appeared in editorial pages in Time, Life, Newsweek, the Saturday Evening Post, US News and World Report, and even Sports Illustrated. I am immensely proud that my uncle, President John F. Kennedy, played a critical role in vindicating Carson. In 1962, he defied his own USDA, a captive agency in league with Monsanto, and appointed a panel of independent scientists who validated every material assertion in Carson’s book Silent Spring.

The experience of British physician and epidemiologist Alice Stewart offers a near-perfect analogy to the Medical cartel’s lynching of Judy Mikovits. In the 1940s, Stewart was one of the rare women in her profession and the youngest fellow ever elected at the time to the Royal College of Physicians. She began investigating the high occurrences of childhood cancers in well-to-do families, a puzzling phenomenon given that disease often correlated with poverty, and seldom with affluence. Stewart published a paper in The Lancet in 1956 offering strong evidence that the common practice of giving X-rays to pregnant women was the culprit in carcinomas that would later afflict their children. According to Margaret Heffernan, author of Willful Blindness, Stewart’s finding “flew in the face of conventional wisdom”—the medical profession’s enthusiasm for the new technology of X-rays—as well as “doctors’ idea of themselves, which was as people who helped patients.” A coalition of government regulators, nuclear promoters, and the nuclear industry joined the US and British medical establishments in launching a brutal attack on Stewart. Stewart, who died in 2002 at the age of ninety-five, never again received another major research grant in England. It took twenty-five years after the publication of Stewart’s paper for the medical establishment to finally acknowledge her findings and abandon the practice of X-raying expectant mothers.
Punished, exiled, and ruined

Judy Mikovits is heir to these martyrs and, more directly, to a long line of scientists, whom public health officials have punished, exiled, and ruined specifically for committing heresy against reigning vaccine orthodoxies.

Dr. Bernice Eddy was an award-winning virologist, and one of the highest-ranking female scientists in NIH history. She and her research partner Elizabeth Stewart were the first researchers to isolate the Polyomavirus—the first virus proven to cause cancer. In 1954, NIH asked Eddy to direct testing of the Salk polio vaccine. She discovered, while testing eighteen macaques, that Salk’s vaccine contained residual live polio virus that was paralyzing the monkeys. Dr. Eddy warned her NIH bosses that the vaccine was virulent, but they dismissed her concerns. The distribution of that vaccine by Cutter Labs in California caused the worst polio outbreak in history. Health officials infected 200,000 people with live polio; 70,000 became sick, leaving 200 children paralyzed and ten dead.

In 1961, Eddy discovered that a cancer-causing monkey virus, SV40, had contaminated ninety-eight million Salk polio vaccines. When she injected the SV40 virus into newborn hamsters, the rodents sprouted tumors. Eddy’s discovery proved an embarrassment to many scientists working on the vaccine. Instead of rewarding her for her visionary work, NIH officials banned her from polio research and assigned her to other duties. The NIH buried the alarming information and continued using the vaccines.

In the autumn of 1960, the New York Cancer Society invited Eddy to address its annual conference. Eddy chose the subject of tumors induced by the polyoma virus. However, she also described tumors induced by the SV40 viral agent in monkey kidney cells. Her NIH supervisor angrily reprimanded Eddy for mentioning the discovery publicly and banned her from public health crisis statements. Eddy argued for publication of her work on the virus, casting the contaminated vaccine supply on an urgent public health crisis. Agency bigwigs stonewalled publication, allowing Merck and Parke-Davis to continue marketing the oncogenic vaccine to millions of American adults and children.

On July 26, 1961, the New York Times reported that Merck and Parke-Davis were withdrawing their Salk vaccines. The article said nothing about cancer. The Times ran the story next to an account about overdue library fines on page 33.

While two drug companies, Merck and Parke-Davis, recalled their polio vaccine in 1961, NIH officials refused to pursue a total recall of the rest of the supply, fearing reputational injury to the vaccine program if Americans learned that PHS had infected them with a cancer-producing virus. As a result, millions of unsuspecting Americans received carcinogenic vaccines between 1961 and 1963. The Public Health Service then concealed that “secret” for forty years.

In total, ninety-eight million Americans received shots potentially containing the cancer-producing virus, which is now part of the human genome. In 1996, government researchers identified SV-40 in 23 percent of the blood specimens and 45 percent of the sperm specimens collected from healthy adults. Six percent of the children born between 1980 and 1995 are infected. Public health officials gave millions of people the vaccine for years after they knew it was infected. They contaminated humanity with a monkey virus and refused to admit what they’d done.
Today, scientists find SV-40 in a wide range of deadly tumors, including between 33 percent and 90 percent of brain tumors, eight of eight ependymomas, and nearly half of the bone tumors tested.

Today, SV-40 is used in research laboratories throughout the world because it is so reliably carcinogenic. Researchers use it to produce a wide variety of bone and soft-tissue cancers including mesothelioma and brain tumors in animals. These cancers have exploded in the baby boom generation, which received the Salk and Sabin polio vaccines between 1955 and 1963. Skin cancers are up by 70 percent, lymphoma and prostate by 66 percent, and brain cancer by 34 percent. Prior to 1950, mesothelioma was rare in humans. Today, doctors diagnose nearly 3,000 Americans with mesotheliomas every year; 60 percent of the tumors that were tested contained SV-40. Today, scientists find SV-40 in a wide range of deadly tumors, including between 33 percent and 90 percent of brain tumors, eight of eight ependymomas, and nearly half of the bone tumors tested.

In successive measures, NIH forbade Bernice Eddy from speaking publicly or attending scholarly conferences, held up her papers, removed her from vaccine research altogether, and eventually destroyed her animals and took away access to her labs. Her treatment continues to mark an enduring scandal with the scientific community, yet NIH’s Bernice Eddy playbook has become a standardized template for Federal vaccine regulators in their treatment of dissident vaccine scientists who seek to tell the truth about vaccines.

Dr. John Anthony Morris was a bacteriologist and virologist who worked for thirty-six years at NIH and the Food and Drug Administration (FDA), beginning in 1940. Morris served as the chief vaccine officer for the Bureau of Biological Standards (BBS) at the National Institute of Health and later with the FDA when the BBS transferred to that agency in the 1970s. Dr. Morris irked his superiors by arguing that the research carried out by his unit demonstrated there was no reliable proof that flu vaccines were effective in preventing influenza; in particular, he accused his supervisor of basing HHS’s mass vaccination program for the swine flu primarily on a scientifically baseless fear campaign and on false claims made by pharmaceutical manufacturers. He warned that the vaccine was dangerous and could induce neurological injuries. His CDC superior warned Dr. Morris, “I would advise you not to talk about this.”

When vaccine recipients began reporting adverse reactions, including Guillain-Barré, Dr. Morris disobeyed that order and went public. He declared that the flu vaccine was ineffective and potentially dangerous and said that he could find no evidence that this swine flu was dangerous or that it would spread from human to human.

In retaliation, FDA officials confiscated his research materials, changed the locks on his laboratory, reassigned his laboratory staff, and blocked his efforts to publish his findings. The FDA assigned Dr. Morris to a small room with no telephone. Anyone who wished to see him had to secure permission from the chief of the lab. In 1976, HHS fired Dr. Morris on the pretext that he failed to return library books on time.
Among the vaccine’s victims were 500 cases of Guillain-Barré, including 200 people paralyzed and thirty-three dead.

Subsequent events supported Dr. Morris’s skepticism about the swine flu shot. The 1976 swine flu vaccination program was so fraught with problems that the government discontinued inoculations after forty-nine million people had received the vaccine. Among the vaccine’s victims were 500 cases of Guillain-Barré, including 200 people paralyzed and thirty-three dead. Furthermore, the incidence of swine flu among vaccinated was seven times greater than among those who were unvaccinated, according to news reports.

According to his New York Times obituary, Dr. Morris said, “The producers of these (influenza) vaccines know they are worthless, but they go on selling them anyway.” He told the Washington Post in 1979, “It’s a medical ripoff I believe the public should have truthful information on the basis of which they can determine whether or not to take the vaccine,” adding, “I believe that given full information, they won’t take the vaccine.”

FDA used the same playbook in 2002 to isolate, silence, and drive from government service its star epidemiologist, Dr. Bart Classen, when his massive epidemiologic studies, the largest ever performed, linked Hib vaccines to the juvenile diabetes epidemic. FDA ordered Dr. Classen to refrain from publishing the government-funded studies, forbade him from talking publicly about the alarming outbreak, and eventually forced him out of government service.

In 1995, the CDC hired a PhD computer analytics expert, Dr. Gary Goldman, to perform the largest-ever CDC-funded study of the chickenpox vaccine. Goldman’s results on an isolated population of 300,000 residents of Antelope Valley, California, showed that the vaccine waned, leading to dangerous outbreaks of chickenpox in adults and that ten-year-old children who received the vaccine were getting shingles at over three times the rate of unvaccinated children. Shingles has twenty times the death rate of chickenpox and causes blindness. CDC ordered Goldman to hide his findings and forbade him from publishing his data. In 2002, Goldman resigned in protest. He sent a letter to his bosses saying that he was resigning because “I refuse to participate in research fraud.”
Our corrupt medical officials have systematically disgraced and silenced them.

Recent medical history overflows with other examples of the brutal suppression of any science that exposes vaccines’ risks; its casualties include brilliant and compassionate doctors and scientists like Dr. Waney Squier, the railroaded British gastroenterologist Andy Wakefield, the steadfast father/ son research team David and Dr. Mark Geier, Italian biochemist Antionetta Gatti, and Danish epidimiologist Peter Goetzsche. Any just society would have built statues to these visionaries and honored them with laurels and leadership. Our corrupt medical officials have systematically disgraced and silenced them.

In England a neuropathologist, Dr. Waney Squier of the Radcliffe Hospital in Oxford, testified in a series of cases on behalf of defendants accused of inflicting shaken baby syndrome. Squier believed that, in these cases, vaccines and not physical trauma had caused the infants’ brain injuries. In March 2016, the Medical Practitioner’s Tribunal Service (MPTS) charged her with falsifying evidence and lying and struck her from the medical register. Squier appealed the tribunal’s decision in November 2016. The High Court of England reversed the MPTS’s decision, concluding, “The determination of the MPTS is in many significant ways flawed.”

Professor Peter Gøtzsche co-founded the Cochrane Collaboration in 1993 to remedy the overwhelming corruption of published science and scientists by pharmaceutical companies. Over 30,000 of the world’s leading scientists joined Cochrane as volunteer reviewers hoping to restore independence and integrity to published science. Gøtzsche was responsible for making Cochrane the world’s leading independent research institute. He also founded the Nordic Cochrane Center in 2003. On October 29, 2018, pharmaceutical interests, led by Bill Gates, finally succeeded in ousting Professor Gøtzsche. A stacked board controlled by Gates fired Gøtzsche from the Cochrane Collaboration after he published a well-founded criticism of the HPV vaccine. In 2018, the Danish government, under pressure from pharma, fired Peter Gøtzsche from Rigshospitalet in Copenhagen. His findings about the HPV vaccine threatened the pharmaceutical industry’s earnings.
A search for existential truth

Science, at its best, is a search for existential truth. Sometimes, however, those truths threaten powerful economic paradigms. Both science and democracy rely on the free flow of accurate information. Greedy corporations and captive government regulators have consistently shown themselves willing to twist, distort, falsify, and corrupt science, hide information, and censor open debate to protect personal power and corporate profits. Censorship is the fatal enemy of both democracy and public health. Dr. Frank Ruscetti often quotes Valery Legasov, the courageous Russian physicist who braved censor, torture, and threats on his life by the KGB to reveal to the world the true cause of the Chernobyl disaster. “To be a scientist is to be naïve. We are so focused on our search for the truth, we fail to consider how few actually want us to find it. But it is always there, whether we can see it or not, whether we choose to or not. The truth doesn’t care about our needs or our wants. It doesn’t care about our governments, our ideologies, our religions. It will lie in wait for all time.”

This account by Judy Mikovits and Kent Heckenlively is vitally important both to the health of our children and the vitality of our democracy. My father believed moral courage to be the rarest species of bravery. Rarer even than the physical courage of soldiers in battle or great intelligence. He thought it the one vital quality required to salvage the world.

If we are to continue to enjoy democracy and protect our children from the forces that seek to commoditize humanity, then we need courageous scientists like Judy Mikovits who are willing to speak truth to power, even at terrible personal cost.”

That’s his forward, and it is even more relevant now with the latest attack on clinicians whose crime is that they are speaking out about a treatment they are using which is working to save lives. Bobby’s forward is as good as it gets, so please reshare. Here it is again: https://childrenshealthdefense.org/news/moral-courage-and-our-common-future-a-foreword-to-plague-of-corruption/

AND LET ME BE CLEAR

I am not advocating that you should take this drug if you get COVID-19 or if you want to prevent it. I don’t think anyone knows for sure how effective it is and/or in what subset of patients it may work or work best in. But I am very sure that because it is an FDA approved drug which has been in widespread use for decades, a licensed physician has the right to prescribe it off-label if, in the physician’s judgment, the potential benefits outweigh the risks for a given patient, so long as there is proper informed consent.

Of course, some state government authorities are trying to interfere with that right, but that should be resisted by the public, because it should be each patient’s right to decide on which FDA approved treatment that patient should receive, in consultation with her physician. That is one of the bedrock principles of modern medicine, or at least it used to be.

How the change is going to happen

Like all paradigm shifts, this one is and will continue to be bumpy, and there are always casualties, like the attacked and discredited scientists who are later vindicated.

There have been and will continue to be some lawsuits, but lawsuits will not be a significant part of this, due to the judiciary’s inherent conservative nature and institutional bias.

Standard social media may help somewhat, despite its attempt to suppress the message of these mavericks. However, I think the change will ultimately happen because of workarounds created by innovators who will better serve the large swaths of people who just are not buying what is being fed to them. There is a physics to the demand for information; The unmet demand for information will be satisfied by the marketplace, probably by what comes next after Facebook.

In the meantime, keep organizing, share the opinions of the frontline physicians using this and natural treatments (and prophylactics like Vitamin D) with the local and state authorities, listen to and share the opinions of thought-leader advocates like Bobby K, watch for the innovators and help them make what’s next, next, and most importantly, keep the pressure on!

Rick Jaffe, Esq.

The FDA’s California stem cell case has a new trial date, sort of

The FDA’s California stem cell case has a new trial date, sort of

When last I reported on the FDA’s injunction action against the California stem cell treatment operation, the judge had adjourned the July trial date because of the recent alarming uptick in COVID-19 cases in the area. The court ordered the parties to confer and come up with a new proposed date in November or thereafter.

The defense’s response to the order was unusual. It attempted to seek an earlier remote video trial. The judge was not prepared to do that just yet, but after further discussions, a few days ago, he issued an order setting a new trial date for November 10, 2020. HOWEVER, the judge ordered a telephone conference on October 19, 2020, to determine whether “1) [the] trial . . . can safely be conducted in-person, consistent with public health guidance; and/or 2) trial can fairly and reliably be conducted through remote appearances by witnesses and counsel.” Meaning, it is not at all clear that the trial will go forward on November 10th.

We already know that the Defendants want to go forward with a remote video trial. My guess is that the FDA might be reluctant. Based on the judge’s decision denying the FDA summary judgement, (the details of which I explained in a previous post, and here is that post: https://rickjaffeesq.com/2020/01/28/stem-cell-shocker-cali-federal-judge-denies-the-fda-summary-judgement-and-orders-a-trial-in-the-cell-surgical-network-case/ )
the judge agrees with the defense’s position that the procedure removes and reimplants the same thing, namely SVF. Hence the procedure is covered by the same day surgery exception. Therefore, it is not subject to the FDA’s regulatory authority. In short, the FDA is going to have to change the judge’s mind. I would speculate that the feds think they have a better chance of doing that in a live trial. If so, that would suggest that the feds will hold out for a live trial.

There might be another reason for the feds trying to delay the trial. Right now, there is a giant storm cloud over SVF and the California Stem Cell operation. I do not have any direct knowledge, but my experience tells me that kind of cloud is very bad for business. Since the FDA can read the tea leaves, it knows it has an uphill battle with this judge, and it will take the agency at least a year to get an appellate review of the district court’s decision. In the meantime, the FDA is continuing with its PR campaign on the illegality of this and other stem cell products and procedures. So, delaying this case might appear to the agency to have some benefit. But that is all speculation on my part. All we know for sure is that there is a new trial date, but in these uncertain times, it cannot be said that the case will actually be tried on that date.

Rick Jaffe, Esq.

Can My Employer Make Me Wear a Mask at Work, and What if I have a Medical Condition Which Makes Wearing a Mask Dangerous to Me?

Can My Employer Make Me Wear a Mask at Work, and What if I have a Medical Condition Which Makes Wearing a Mask Dangerous to Me?

This is a popular question these days, so let me lay out the law as I understand it.

Actually, the basic law is pretty straightforward. Mostly what I will do is quote from the federal government’s EEOC (Equal Employment Opportunity Commission) web site which deals with employment discrimination issues. And yes, the ADA (Americans with Disabilities Act) does come into play in the analysis.

Here is the URL for the EEOC document I am quoting from:
https://www.eeoc.gov/laws/guidance/pandemic-preparedness-workplace-and-americans-disabilities-act. It contains much useful information about employment issues and has been updated to reflect the present pandemic.

Here is the answer in short:

“• 12. During a pandemic, may an employer require its employees to wear personal protective equipment (e.g., face masks, gloves, or gowns) designed to reduce the transmission of pandemic infection?
Yes. An employer may require employees to wear personal protective equipment during a pandemic. However, where an employee with a disability needs a related reasonable accommodation under the ADA (e.g., non-latex gloves, or gowns designed for individuals who use wheelchairs), the employer should provide these, absent undue hardship.

• C. REASONABLE ACCOMMODATION
A “reasonable accommodation” is a change in the work environment that allows an individual with a disability to have an equal opportunity to apply for a job, perform a job’s essential functions, or enjoy equal benefits and privileges of employment.(23)(footnotes ommitted)

An accommodation poses an “undue hardship” if it results in significant difficulty or expense for the employer, taking into account the nature and cost of the accommodation, the resources available to the employer, and the operation of the employer’s business.(24) If a particular accommodation would result in an undue hardship, an employer is not required to provide it but still must consider other accommodations that do not pose an undue hardship.(25)
Generally, the ADA requires employers to provide reasonable accommodations for known limitations of applicants and employees with disabilities.(26)”

Does that mean I don’t have to wear a mask if I can show it could/would be harmful to my health?

Not really, because a “reasonable accommodation” would more likely be an unpaid leave or working from home. Perhaps in the right setting, working in complete isolation in an office might be a public health safe reasonable accommodation, but even if so, I think it would likely create an “undue hardship” for the employer, for a variety of reasons, including the morale/fear/resentment of the other workers. But still, I suppose it might still be possible depending on the kind of work you do and the specifics of the work environment.

Be advised that if you seek to obtain a “reasonable accommodation,” it will involve a back and forth process with your employer in which among other things, you will have to prove your disability under the ADA, as well as provide other pertinent information. (And no, you can’t both claim a medical disability/request a reasonable accommodation and assert HIPAA protection for the health information which is the basis of the accommodation.)

But why couldn’t I just not wear a mask in the office?

In a pandemic, not wearing the required PPE would be (and is) considered a “direct threat” which is defined as “a significant risk of substantial harm to the health or safety of the individual or others that cannot be eliminated or reduced by reasonable accommodation.”(20) If an individual with a disability poses a direct threat despite reasonable accommodation, he or she is not protected by the nondiscrimination provisions of the ADA.”
Meaning they don’t have to let you work without a mask despite your medical inability to wear one.

So, while I suppose some employers might go for it, in these time of the politicalization of mask wearing, I think that if an employer has an employee mask requirement, most likely it will not make an exception to allow a person (or a small group of the medically unable) not to wear one and work in an office where everyone else is masked.

What About my Constitutional right not to wear a mask?

Sorry, there is no such animal, not now, nor will there ever be IMO. Your constitutional rights stop when you endanger others. Governments have to right to take measure to protect the public under its police powers.

Events of yesterday and today (July 29 and 30) back this up. That idiot Texas Congressman who was flaunting his refusal to wear a mask in Congress and in recent televised committee hearings tested positive. Fellow congressfolk are outraged, which has prompted the Speaker to impose a mask order. We will see if the Texas Congressman or any other challenges it in Court, but I sort of doubt it will be challenged. If Congress can order its members to wear a mask, what chance do you think you would have in convincing a court that the Constitution gives you a right not to wear one? And the irony of course is that I think most court houses have mask requirements, so you would probably be making the argument to a judge and her staff who are all wearing a mask (or hearing the case via zoom). Good luck with that!

But I don’t think masks stop the spread of the virus and I have read on the internet that there are other doctors who agree with me, and isn’t that what those doctors who stood in front of the Supreme Court said?

Yes, they did say it, and other physicians have also challenged whether mask wearing really helps, but the majority and accepted opinion is that masks helps. In this game, the majority opinion prevails, and so the courts will find.

But still, why can’t I go to court and ask it allow me to not to wear a mask at my job because of my medical condition?

Well, you can file a lawsuit about just about anything, but the law is pretty clear under the ADA, and you’d lose (even assuming you had a ADA recognized disability. In fairness, I don’t think there are any appellate court decisions yet on mask wearing and the ADA. I am sure there will be (or maybe ever are already) some cases, but I feel confident that no court will find that an employee has a constitutional right not to wear a mask if an employer requires marks during this pandemic.

So, to ask the basic question in another way:

If I have a doctor’s letter saying that wearing a mask is dangerous for me, would that force my employer to allow me to work without a mask?

I think the answer is no.

Rick Jaffe, Esq.

Digging into the Moderna Vaccine Clinical Trials Protocols and Results

Digging into the Moderna Vaccine Clinical Trials Protocols and Results

Moderna has just announced that its RNA based vaccine is starting a phase 3 clinical trial with 30,000 subjects, so I thought it might be useful to take a look at the publicly available information about the trial, and how they got there. Let’s go logically and chronologically and start with the phase 1 safety study.

The Phase 1 study

A phase 1 study is a safety study. They usually have relatively few subjects, and different doses are given because dosing in terms of side effects is usually an important endpoint in a safety study.

Here is the “Brief Summary” of the Phase 1 study published by Moderna
“Brief Summary:

This is a phase I, open-label, dose-ranging clinical trial in males and non-pregnant females, starting at 18 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of mRNA-1273 manufactured by ModernaTX, Inc. mRNA-1273 is a novel lipid nanoparticle (LNP)-encapsulated mRNA-based vaccine that encodes for a full-length, prefusion stabilized spike (S) protein of SARS-CoV-2. Enrollment will occur at up to 3 domestic clinical research sites. One hundred and fifty-five subjects will be enrolled into one of thirteen cohorts (10 micrograms [mcg], 25 mcg, 50 mcg, 100 mcg, and 250 mcg). Subjects will receive an intramuscular (IM) injection (0.5 milliliters [mL]) of mRNA-1273 on Days 1 and 29 in the deltoid muscle and will be followed through 12 months post-second vaccination (Day 394). Follow-up visits will occur 1, 2, and 4 weeks post each vaccination (Days 8, 15, 29, 36, 43, and 57), as well as 3, 6, and 12 months post-second vaccination (Days 119, 209, and 394). The primary objective is to evaluate the safety and reactogenicity of a 2-dose vaccination schedule of mRNA-1273, given 28 days apart, across 5 dosages in healthy adults.”

Here is the study information from clinicaltrials.gov

https://pubmed.ncbi.nlm.nih.gov/32663912/

I will be referring to other parts of it later on

The important parts of this summary are (IMO):

1. 155 subjects
2. All subjects have to be in good health, over 18 and not pregnant females
3. 2 shots of the vaccine, the second on day 29 (so 28 days from the first to the second shot)
4. There will be 13 different subgroups stratified by age group and vaccine dose.
5. Periodic follow up to assess response and report side effects for 13 months following the initial vaccine shot.

From the Study Design section, we learn the following:

Actual Enrollment: 120 participants
Actual Study Start Date: March 16, 2020
Estimated Primary Completion Date: November 22, 2021
Estimated Study Completion Date: November 22, 2021

(And by the way, phase 1 studies are not blinded, double-blinded, masked in any way, nor are they placebo-controlled, because the endpoint is just safety and lab values of the study vaccine. All that blinding and comparative stuff comes in later in phase 3 studies.)

The first big take away from this phase 1 study is that it is not over, meaning, that although it is no longer accruing new subjects, the data collection and subsequent evaluation will not be completed until sometime after November 22, 2021, roughly sixteen months hence.

That is pretty interesting in light of all the optimism about an FDA approved vaccine by late 2020 or early 2021 because if it’s Moderna’s vaccine that is approved/licensed, it will have been approved before even the phase 1 study had been completed. Yes, that’s a little disconcerting, but we’re in a pandemic, but not cutting any safety corners, so they say.

More on the sub groups/stratification

It looks to me that there was a three age-group stratification: 18-55, 56-70, and 71 and older. A second stratification was by dosage, 10, 25, 50, 100, and 250 mcgs. Each of the 13 sub-groups had between 10 and 15 participants.

The preliminary results of the study were reported in a NEJM article published on July 14, 2020, and linked to the bottom of the clinicaltrials.gov entry referenced above, but here is a direct link to the journal article.

https://pubmed.ncbi.nlm.nih.gov/32663912/

So, what were the results?

The vaccine had some immunogenicity benefit (i.e. antibodies, titers which are surrogate endpoints to vaccine efficacy/protection). In terms of side effects, here what was said:

“Solicited adverse events that occurred in more than half the participants included fatigue, chills, headache, myalgia, and pain at the injection site. Systemic adverse events were more common after the second vaccination, particularly with the highest dose, and three participants (21%) in the 250-μg dose group reported one or more severe adverse events.”

Actually, unless I am misreading the chart, I think the authors are understating the results. The way I read the chart, 100% percent of the study participants who took either 100 or 250 ug’s of the vaccine had a systematic symptom, the overwhelming majority of which were characterized as “moderate” (After the second injection). And 100% of the same groups had a local symptom, the majority of which were “moderate” with about 5% being considered severe, (also after the second injection.) The first injection also produced substantial local and systemic symptoms, but less than after the second shot.

(Hint: Remember these doses and their side effects during my discussion of the phase 3 study protocol, as I will be circling back to them)

And of course, the study just started four-plus months ago, and who knows what new or continuing symptoms/adverse effects might show up.

So, what was the authors’ conclusions?

“Conclusions: The mRNA-1273 vaccine-induced anti-SARS-CoV-2 immune responses in all participants and no trial-limiting safety concerns were identified. These findings support further development of this vaccine. (Funded by the National Institute of Allergy and Infectious Diseases and others; mRNA-1273 ClinicalTrials.gov number, NCT04283461).”

My translation: no one died yet, so let’s keep moving forward on this.

The Phase 2 studies

Actually, I could not find any information about the phase 2 studies. Given the fact that (a) the phase 1 study started in mid-March 2020 and is scheduled to continue until November 2021, (b) the results of the phase 1 study were just published two weeks ago, and (c) the announcement that the phase 3 study started yesterday, July 27, 2020, I am going to go out on a limb and say there weren’t any phase 2 studies.
But this is a pandemic, but no safety corners were cut.

The Phase 3 study

Here is the basic information about the study:

“Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 30000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older
Actual Study Start Date: July 27, 2020
Estimated Primary Completion Date: October 27, 2022
Estimated Study Completion Date: October 27, 2022”

here is the link to the study information on clinicaltrials.gov:

https://clinicaltrials.gov/ct2/show/NCT04470427

The important points: It started July 27, 2020, and is supposedly going to run until October 27, 2022, and accrue up to 30,000 subjects. It will be randomized and fully blinded.

The study will have three categories of outcomes they are looking at (my interpretation/restatement of what they are looking to find out):

1. Will the drug prevent people from getting the virus by comparing the post-injection infection rates between the vaccine group and the control group?
2. What kinds of adverse events the subjects have (and AE’s will be stratified in many different ways, which I will discuss later)
3. Lab value results in terms of antibodies and titers, i.e., the surrogate endpoints for the vaccine doing what it’s supposed to do, prevent people from contracting the virus (or as recently restated, you still catch it but won’t be as likely to kill you.)

Who can be in the study?

Well, it’s not quite as limited as the Phase 1 study which was just for healthy people. The phase 3 study is open to “Healthy adults or adults with pre-existing medical conditions who are in stable condition. A stable medical condition is defined as a disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment.”

Who is excluded?

All kinds of immunocompromised patients of course, and interestingly, people who have had a significant reaction to a prior vaccine (“History of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine”). But since these kinds of reactions are so exceedingly rare, I wouldn’t expect that many people would be excluded on that basis (cough). But it is a voluntary study, so what kind of idiot would you have to be to volunteer to get an entirely new kind of vaccine if you had a significant reaction to a prior vaccine which had already been proven to be safe and effective (cough, sorry I must have a scratchy throat, but since I’m basically quasi isolating, I’m pretty sure it’s not the virus).

Of course, the big exclusions are kids and actively sick old people. Regrettably, those are the two groups which are most likely to be forced to get it (kids via an amendment to the ACIP vaccine schedule used by every state, and sick older adults because of their increased risk of death from the virus and their resulting fear).

And that is probably the biggest problem with the study if it is used as the sole basis for approval. It would not have been tested on the people most likely to get it. Granted, there are legitimate ethical reasons to do initial studies and even phase 3 studies with healthy or not actively sick adults. But usually, there would be further studies pre-approval/license. My guess is that this one study is going to be it for this vaccine before an application for approval/license is filed. Further, I am also guessing that the approval license application will be submitted before the conclusion of this phase 3 study, and even before the conclusion of the phase 1 study in November 2021. As has been oft said, what can possibly go wrong with giving a vaccine (or as here, a new type of vaccine) to very old people many of whom have multiple co-morbidities where the vaccine has not been tested in actively sick old people?

And speaking (again) of side effects, what’s the dose given in the vaccine arm?

“Participants will receive 1 intramuscular (IM) injection of 100 micrograms (ug) mRNA-1273 on Day 1 and on Day 29.”

That is the same 100 ug dose that produced mostly moderate local and systemic symptoms in 100% of the completely healthy 120 phase 1 subjects. Again, what could possibly go wrong with giving it to those who are not completely healthy?

I confess to being unclear about what exactly was meant by the phase 1 study’s use of a “moderate symptom” as opposed to a severe or mild one. Thankfully, the AE/symptom stratification is much more refined in the phase 3 study. Here is the breakdown of AE’s: “Number of Participants with Adverse Events (AEs) or Medically Attended AEs (MAAEs) Leading to Withdrawal [ Time Frame: Up to Day 759 (2 years after the second dose) ]; Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) [ Time Frame: Up to Day 8 (7 days after the first dose) and up to Day 36 (7 days after the second dose) ] Number of Participants with Unsolicited AEs [ Time Frame: Up to Day 57 (28 days after each dose)]”.
(Ok, so maybe it is just a smidgen better.)

Note that AE reporting as a stated “outcome measure” is limited to 28 days after each dose or 57 days after the first injection. I guess they think that any problem, local or systemic which happens on the 58th day or after is presumptively not a result of the vaccine so is not reported as an AE. (I know how much my vaccine concerned doc clients will be outraged by that.)

BUT HERE IS THE REALLY, REALLY BIG GOOD NEWS (really!):

The study will be true placebo controlled!

Here is the language:
“Placebo Comparator: Placebo
Participants will receive 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29. Biological: Placebo
0.9% sodium chloride (normal saline) injection”

This is huge. The biggest problem with vaccines according to the vaccine concerned is that they are not safety tested against a true placebo, but rather against another vaccine, or the test vaccine less the antigen. Therefore, it is impossible to know the actual safety profile of the study vaccine. The only safety conclusion that can be reached is a relative safety profile compared to some other vaccine. And since none of the ACIP required vaccines were safety tested against a placebo, there is nothing but relative safety data comparing one vaccine’s safety (or lack thereof) to another, from which you cannot make a safety analysis, according to the vaccine concerned medical and scientific professionals. Thus, the protocol which requires an actual real, inert placebo is, as I said, huge.

Alas, I have to point out that the Oxford trial protocol originally had a real placebo as well, (I learned that from Bobby Kennedy’s debate with Alan Dershowitz. If you haven’t seen it, here is a link to the post which has a link to the debate.https://rickjaffeesq.com/2020/07/27/the-kennedy-dershowitz-debate-must-see-tv/) but was changed to the meningitis vaccine as the control, which I am told is particularly noxious and harmful.

So, we will have to see if they stick to the actual inert placebo in the trials. If they don’t, it will have to be disclosed, I would think, but it will likely be buried in some footnote and further obscured in gobbledygook faux scientific language and justifications.

That is about all I can tease out of these documents, at least at a first pass, given my time constraints. The big problem I fear will be transparency. How much will the public really get to see the data? Not much I expect. It will be critical to follow this and the other studies very closely, and let’s see what happens.

The big tell/sign that the fix is in is if the protocol is amended to eliminate the saline placebo. If that happens, that means that the side effects are too severe and widespread to make the vaccine palatable to the public, so that’s when they would make the change to compare it to a more toxic vaccine and proclaim its (relative) safety. If they stick with the saline placebo, then let the chips fall where they may. But to my mind, the phase 1 study results do not bode well, and my bet is on them dumping the true placebo, no later than halfway through the study, with some scientific-sounding justification, but I hope I am proven wrong.

Rick Jaffe, Esq.

The Kennedy-Dershowitz Debate: Must See TV!

The Kennedy-Dershowitz Debate: Must See TV!

A few days ago, the Bobby Kennedy/Alan Dershowitz debate was released. As a lawyer involved in the vaccine issue, it was very heartening to see such a high quality debate on the subject. It was very enjoyable to watch these two extremely smart, deep thinkers talk about these issues with open mindedness, clarity and mutual respect for each other, and for the opinions of the other with which they did not agree. I can’t personally recall anything like this ever happening in the vaccine area. I hope that there will be more of them.

If you haven’t seen or shared it on social media, please do. If you have seen and shared it, share it again! Here is a link:

https://childrenshealthdefense.org/news/vaccine-debate-is-on-robert-f-kennedy-jr-vs-alan-dershowitz/

I made some notes and have some thoughts about what I particularly liked about the debate, and I thought I’d share them.

First, it wasn’t so much of a debate as a discussion among two people with very different areas of expertise. AD is a long-time legal scholar and extremely well versed on constitutional law. Bobby Kennedy is a health and environmental advocate, and knows a zillion times more about the science and policy than AD. Bobby himself acknowledged the differences in their areas and expertise and jokingly said he would try to keep the discussion on the science and policy rather than constitutional law. And he succeeded in doing so, providing AD with a much-needed education of the many of the mainstream-suppressed scientific facts concerning vaccines.

AD’s basic initial and general point was that based on Jacobson and other cases, the government had the right under its police powers to forcibly inject everyone with vaccines.

BK thanked AD for participating in this debate and lamented the difficulty he has had getting people on the other side (like Offit and Hotez) to debate him.

BK correctly pointed out that Jacobson didn’t force anyone to get a vaccine. It only upheld a law that mandated a small pox vaccine or pay a $5.00 fine. AD came back that there were other cases which upheld compulsory medical procedures. The debate didn’t get into the specifics, but AD was talking about Buck v Bell, a case from the late 1920’s in which Oliver Wendall Holmes upheld a Virginia law for forced sterilization for a woman (incorrectly) claimed to be mentally defective. The most significant eugenics-like quote from the opinion was that “three generations of imbiciles are enough.” AD didn’t talk about that case, which is probably a good thing, since it is viewed as one of the worst Supreme Court decisions ever (along with the Dred Scott and the Korematsu decisions). (Here is an article about OWH which discusses the opinion, for anyone interested. https://education.blogs.archives.gov/2017/05/02/buck-v-bell/

My comment: I think BK is correct that forcibly injecting people with vaccines is fundamentally different from the issue in Jacobson. In addition, it has been over a hundred years since our government has had mandatory universal adult vaccines. That, plus the likely shortages of a COVID-19 once it is released could mean that the issue of a mandate for the vaccine will not come up. The caveat is that, despite the shortages and priorities of vaccine delivery, some states try to pass mandatory vaccine laws, either for adults or for children. That is something we’ll have to watch out for.

BK made the important point that unlike almost every other medical procedure, vaccines are given to healthy people, so there should be a higher standard for safety.

My comment: that argument should resonate with open-minded people.

BK made the point that vaccines are for others, not the individual. AD pushed back a little. However, I think most vaccine experts believe that most vaccines are for the protection of the recipient as well as the public. Even the HPV vaccine is thought to protect others (and specifically, the sexual partner of the HPV vaccinated). So not the strongest point, in my view, at least based on the accepted view of vaccine experts.

AD asked BK to agree that vaccines have been spectacularly effective in the past like with polio and small pox. BK said it was a complicated issue and cited literature about how it was sanitation and other public health measures, rather than the vaccines. Since this isn’t AD’s wheelhouse, he didn’t have much to say in response. BK would have had a much harder time with a vaccine expert, and I would think that this would be where the debate would have broken down, with the vaccine expert calling BK a crazy anti science anti vaxxer.

What about Masks? Twice (at least) AD asked BK to agree with him that ordering masks was constitutional. BK ducked the issue. It’s complicated

BK’s most important point was about the lack of true placebo testing in vaccines in general, and in one of the leading COVID-19 drug trials underway now. He pointed out that the protocol originally called for an actual placebo as the control, but during the trial, the protocol was changed to a meningitis vaccine as the control (a fauxcebo according to vaccine policy thinker Mary Holland, Esq.) BK pointed out that this vaccine had one of the worst safety profiles of any vaccine. Therefore this trial will grossly overstate the safety of the COVID-19 vaccine candidate, and there will be no way to actually assess the safety profile of this vaccine candidate, just like there is no way to assess the safety profile of any current mandated vaccine because in none of the testing was a true, actual, real placebo used as the control. This is the heart of the vaccine-concerned argument against vaccines (and you can expect to see this pointed argued in all of the cases I am working on for the California doctors fighting the medical board).

What Bobby is pointing out about the switcheroo in the control group is catching vaccine manufacturer in the act of scientific fraud, or at least showing why vaccine trials are flawed, unscientific, intellectually dishonest, but regrettably how all these medical products are actually approved. This is an extremely powerful point. I hope it will be repeated and be reshared in social media.

While the lack of placebo testing was the most important point substantively in the discussion (in my opinion anyway), I think the most important takeaway by AD was that his annual flu and pneumonia vaccines given by his long-time and trusted physician might be doing him more harm than good. BK made the point, supported by a high-quality study, about the overall deterioration of the immune system with the use of these vaccines in older people. I think that really shook-up AD, and I expect he has already sent his physician the study BK cited. I don’t think AD will be too excited in the future about getting these annual sticks.

And BTW: one of the things I really liked about the debate, format-wise, was the showing the first page of the studies and articles which they were talking about. Hey Bobby, if all the references you cited are not already up on your web site, please put them up, so we all can easily access them.

All in all, I think Bobby Kennedy did an excellent job presenting the case against mandatory vaccination and how vaccines are much less safe than most people think and most vaccine experts are willing to acknowledge. It was a pleasure to see such a high-level and cordial discussion amongst very smart and highly accomplished professionals, which regrettably is all too rare in the days we live in.

One further thing:

Bobby’s organization, the Children’s Health Defense, is being partially suppressed by FB and some of the other social media entities. So, keep visiting their web site directly and if possible, donate to the group. Here is the link to donate:
https://childrenshealthdefense.org/about-us/donate/

They are doing excellent advocacy work, and they also financially support some key lawsuits around the country on vaccine and freedom issues. (That would include yours truly’s defense of Ken Stoller against the Medical Board of California. Thx for that Bobby. Keep up the fight and keep debating!

Rick Jaffe, Esq.

The Texas GOP’s Right to Have a Live, In-Person Convention in Houston; It’s a real head-scratcher.

The Texas GOP’s Right to Have a Live, In-Person Convention in Houston; It’s a real head-scratcher.

At the beginning of last week, a prominent Houston physician and highly influential Republican big-wig, Steven Hotze, filed an amended complaint and a request for emergency complaint against Houston Mayor Sylvester Turner to overturn the Mayor’s decision stopping the GOP’s state convention from taking place live in the convention center. The basis of the lawsuit was that the Mayor violated the free speech and assembly rights of the GOP conventioneers.

Initially, the rub was that the state GOP had elected not to join the lawsuit and had decided to go forward with a virtual convention on Thursday, July 16th. Based on the GOP’s decision not to join the lawsuit and proceed with a virtual convention, federal district judge Lynn Hughes denied Hotze’s request. According to a Hotze press release issued after the ruling, Judge Hughes said that Mayor Turner’s actions were in fact unconstitutional, but that since the GOP was not a party, there was nothing he could do. (It might have been a standing issue, or a practical issue that the convention was already set to take place virtually. I haven’t read the decision.)

However, the rub to the rub was that because of technical difficulties, the convention did not start on Thursday. Because of these technical difficulties and most likely because of the intensive pressure put on the party by the aforementioned Dr. Steven Hotze, the GOP changed its mind, and decided to join in the lawsuit.

Hotze’s attorneys filed a motion to reconsider, got a hearing yesterday, and Judge Hughes issued an injunction permitting the GOP to hold its convention live in the convention center/ stopping Turner from barring it.

But we’re not done yet!

Notwithstanding the granting of the injunction, the GOP is still going to try to do the convention virtually, starting later today. Here is a recent article about this mess.

https://www.texastribune.org/2020/07/17/texas-gop-convention-houston/

The Mayor’s office has filed a request for an emergency stay and is appealing Judge Hughes decision. But the appeal should become moot if the virtual convention goes forward, as it appears to have done, and that would probably be best. Constitutional rights, even the First Amendment are not absolute, and as I often say, the Constitution is not a suicide pact. The conventional center is just the kind of place health officials think act as super spreaders. Yes, no one said boo when protesters were chanting BLM, but that was outdoors, which may be the critical difference. I know and respect Judge Lynn Hughes, but I think he got this one wrong.

(this is a revised and shorter version of the original post)

Rick Jaffe, Esq.

Stem Cell Breaking News: Cali Stem Cell Trial Adjourned until Sometime After November

Stem Cell Breaking News: Cali Stem Cell Trial Adjourned until Sometime After November

Yesterday, California federal district court judge Jesus G. Bernal on his own adjourned the the FDA’s trial against Cell Surgical Network (“CSN”) and their owners Mark Berman and Elliot Lander. The parties were ordered to meet and confer about a new trial date to take place after November, 2020. The trial had been scheduled to commence on July 28th. Because of my deep interest in the case, I have been checking the Riverside Ca. Covid-19 numbers and once the numbers started to rise, and based on what has been happening in California in general (which is another area of interest and which I write about), I was pretty sure the the judge would have to knock the case off the docket. This is too big and too important to do via Zoom, and the judge really had no choice. Too bad, as this is for sure the most important stem cell case in the country right now, and in general, and for reasons having to do with my stem cell work, I was really hoping to get some clarity, or more specifically, another ruling similiar to the judge’s seminal summary judgement decision.

For my own needs, I have recently reviewed some of the pre-trial filings in the case, and in particular the proposed findings of facts and conclusions of law filed by the parties. (Findings of fact and conclusions of law are the main documents filed in a bench trial. In a jury trial, the parties would file proposed jury instructions. But in a bench trial, the findings of fact and conclusions of law are what the parties expect to show fact wise, and what they argue how the law applies to the facts, and of course, present the proposed outcome. In case you were wondering, there is no federal (7th Amendment) right to a jury trial in cases in which the relief is equitable, like injunctions and declaratory judgments).

CSN’s findings and conclusions, prepared by Venerable’s LA office’s team headed by Celeste Brecht are about the best I have ever seen in an FDA case (or maybe in any case). They clearly lay out CSN’s position in the case. If you want to understand exactly what the defendants did and why they think all of it is legal, and how the FDA improperly used industry guidance procedures to substantively change the law without going through the proper and required procedure, then read this document. (I know I am being alittle redundant, but I just love saying how the government acted improperly; it’s a defense lawyer’s thing, and spoiler alert, I’m not done yet!) Here it is.

csnproposedfindings

This document also cogently and succinctly lays out the evolution of the same day surgical procedure exception, from whence MSC/SVF procedures were considered 21 CFR 1271.15 EXEMPT, to the FDA’s illegal transformation of the procedure and a person’s body part into an illegal, unapproved, adulterated and misbranded drug.

In all my years doing this law thing, this one action, (and did I mention that it was illegal and improper?) is the single stupidest thing I’ve ever seen. Your body part removed and reimplanted during the same surgical procedure is a drug! In my opinion, this is perhaps the most extreme case of over regulation and lack of common sense that I have ever seen in the field.

For a long time, I thought the FDA would get away with its improper transformation, and that this case would reach a similiar result as the US Stem Cell case in Florida, because of the deference federal courts are required to give federal agencies like the FDA when it interprets its own regulations. However, in 2019, (after a few Justices gave some heart warming hints), the Supreme Court came out with a couple decisions which limit deference to laws and regulations which were ambiguous. This might well prove to be the death-knell of the FDA’s decade plus effort to (improperly) rewrite the the same day surgical exception.

So getting back to Venerable’s findings of fact and their succinct history of the FDA’s regulation of this issue, here it is:

“Regulatory History of the SSP Exception
6. Until 1997, the FDA exerted little to no control over human cellular and tissue-based products.
7. In 1997, the FDA introduced Guidance providing that:
the agency would not assert any regulatory control over cells or tissues that are removed from a patient and transplanted back into that patient during a single surgical procedure. The communicable disease risks, as well as the safety and effectiveness risks, would generally be no different than those typically associated with surgery.
(Ex. 88 (emphasis added).)
8. In 2001, the FDA then promulgated the Same Surgical Procedure Exception (“SSP Exception”) based on the 1997 Guidance.
9. The SSP Exception exempts from any FDA regulation:
[A]n establishment that removes HCT/P’s from an individual and implants such HCT/P’s into the same individual during the same surgical procedure.
21 C.F.R. § 1271.15(b).
10. The FDA has not amended the SSP Exception since its promulgation.
11. HCT/Ps are defined as “articles containing or consisting of human cells or tissue that are intended for implantation, transplantation, infusion, or transfer into a human recipient.” 21 C.F.R. § 1271.15(b).
12. In 2014, the FDA released a draft guidance that sought to create ambiguity in the SSP Exception. (Ex. 89.)
13. The draft guidance proposed substantive changes that interpret the SSP Exception to exclude surgical procedures that would otherwise qualify for exemption by requiring that the patient’s transplanted HCT/P be implanted in its
“original form,” which is very narrowly defined and otherwise limits the types of surgical procedures that would fall within the SSP Exception. (Id.)
14. The “original form” language is not included anywhere in the regulation, see 21 C.F.R. § 1271.15(b). Instead, the SSP Exception unambiguously states that a tissue or human cell is not a drug if it is removed from an individual and then re-implanted in the same individual.
15. The FDA adopted the draft guidance, which was improperly signed by Ana Abrams, in December 2017. (Ex. 87.)”

Ahh, this is music to my ears and will be to many in the stem cell field (on this side of the fence anyway). Only thing that’s needed is the judge’s signature. But alas, that can’t/won’t happen until sometime after November. We’ll all have to stay tuned until then.

Rick Jaffe, Esq.

BREAKING NEWS: NY Federal Court Enjoins NYC and State from enforcing unequal religious indoor gatherings and all outdoor gathering laws!

BREAKING NEWS: NY Federal Court Enjoins NYC and State from enforcing unequal religious indoor gatherings and all outdoor gathering laws!

This morning, Albany federal district judge Gary I. Sharpe issued a preliminary injunction against New York City and New York State from enforcing restrictions specific to religious gatherings, both indoors and outdoors. For indoor gatherings, the judge basically held that the defendants could only enforce restrictions imposed for Phase 2 businesses. (“Phase 2 allows a wide range of businesses to reopen, including most office-based businesses, administrative services, commercial building management, real estate services, and repair and cleaning services.” (from https://www.natlawreview.com/article/new-york-state-releases-reopening-guidance-phase-2-businesses)

And, the Judge barred enforcement of any limitation for outdoor gatherings for religious activities, so religious families in NY should now be able to have publicly attended funerals.

Here is the judge’s decision
soos

Of course, the judged cited and discussed the Supreme Court’s recent decision in S. Bay United Pentecostal Church v Newsom. Here is my post about that case.

http://rickjaffeesq.com/2020/05/30/how-significant-is-yesterdays-supreme-courts-decision-in-south-bay-pentecostal-church-v-newsom/

Basically, the judge held that NYC and state exceeded their authority because they treated religious gatherings differently from other kinds of equivalent social activities. It seems like the judge was particularly impressed (negatively that is) by the oft-pointed out hypocrisy in permitting and indeed encouraging outdoor social protests against racism, while at the same time prohibiting outdoor religious activities like funerals.

However, the court did not enjoin the City and State from enforcing the social distancing rules set out in the laws and executive orders.

Read in the context of the recent Supreme Court’s decision, government authorities need to make sure that their regulations do not differently/unfairly burden religious entities and activities compared to similiar non-religious activities. The rub of course is figuring out what are the equivalent non-religious activities, which sometimes can be challenging.

There are plenty of weeds to get into maybe sometime later, but for now:

in New York, religious activities are permitted outdoors, and indoors to the same extent which similiar businesses and business activities are permitted, and that is very good news for the religious, and some needed judicial pushback.

Rick Jaffe, Esq.