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Reproduced from original article:
Analysis by Dr. Joseph Mercola Fact Checked November 24, 2020
- From 1955 to 1963, hundreds of millions of people worldwide — in North and South America, Canada, Europe, Asia and Africa — received inactivated and live oral polio vaccines that may have been contaminated with simian virus 40 (SV40), a monkey virus
- During the 1950s, the inactivated polio vaccine created by Dr. Jonas Salk was made using rhesus monkeys that were infected with SV40; the original seed stocks of the oral polio vaccine created by Dr. Albert Sabin were also contaminated with infectious SV40
- The late Bernice Eddy, a researcher at the National Institutes of Health, conducted a study in 1959, injecting hamsters with the rhesus monkey kidney substrate used to make the vaccines; the majority of them developed cancerous tumors
- In animal studies, SV40 has been linked to a number of cancers, including mesotheliomas, lymphomas, brain and bone tumors and sarcomas; such tumors in humans have also been found to contain SV40 DNA and proteins
- Research from 1992 revealed that half the choroid plexus tumors and most of the ependymomas studied — both forms of rare brain cancers in children — contained a segment of T-antigen gene related to SV40
- The controversy highlights the serious consequences that can occur from vaccine contamination using animal cell substrates to create vaccines — consequences that may not be realized until many years later
As the world races to fast-track a COVID-19 vaccine, bringing an experimental shot to market faster than has ever occurred in history, the potential risks of medical procedures like vaccination must be carefully weighed. Unintended harms can and do occur following vaccination, and the inactivated and live polio vaccines are prime examples.
From 1955 to 1963, hundreds of millions of people worldwide — in North and South America, Canada, Europe, Asia and Africa — received polio vaccines that may have been contaminated with simian virus 40 (SV40), a monkey virus.1 The video above is a decade old, but it succinctly summarizes the serious consequences that can occur from vaccine contamination — consequences that may not be realized until many years later.
In the video, Dr. John Bergsagel, then a pediatric oncologist, looks at laboratory slides of tumors taken from children who died of extremely rare brain cancers. When SV40-like DNA sequences were detected in them, he said, “I almost fell out of my chair. I was very surprised.”
The finding, published in The New England Journal of Medicine in 1992, revealed that half the choroid plexus tumors and most of the ependymomas studied contained a segment of T-antigen gene related to SV40.
“These results suggest that SV40 or a closely related virus may have an etiologic role in the development of these neoplasms during childhood,” they wrote2 — and this was only the beginning of findings linking monkey virus-contaminated polio vaccines to cancer.
How a Monkey Virus Ended up in Polio Vaccines
During the 1950s, the inactivated polio vaccine created by Jonas Salk was made using rhesus monkeys that were infected with SV40. As explained in a 2004 perspective published in The Lancet:3
“When Salk developed his vaccine, instead of using human tissues, as did the scientists who won a Nobel Prize for first growing poliovirus in tissue culture, he used minced-up rhesus macaque monkey kidneys, which were remarkably efficient poliovirus factories.
Those who sought to supplant Salk’s formaldehyde-inactivated vaccine with live, attenuated oral vaccine also used monkey kidney cultures. Despite a manufacturing problem that, at best, left six children who received the vaccine paralyzed in the arm, and despite concerns about wild simian viruses, Salk’s shots were declared safe and effective after 1954 field trials.
The next year, after grudging approval by skeptical government regulators, free Salk shots were made available throughout the USA. By 1960, scientists and vaccine manufacturers knew that monkey kidneys were sewers of simian viruses.”
The late Bernice Eddy, a researcher at the National Institutes of Health, conducted a study in 1959, injecting hamsters with the rhesus monkey kidney substrate used to make the vaccines. The majority of them developed tumors.4
“Eddy’s superiors tried to keep the discovery quiet, but Eddy presented her data at a cancer conference in New York. She was eventually demoted, and lost her laboratory,” The Atlantic reported,5 but soon after researchers with Merck pharmaceutical company identified the cancer-causing virus in rhesus monkey kidney cells, naming it SV406 because it was the 40th monkey virus discovered.
According to Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center (NVIC), in a presentation before the U.S. House of Representatives in 2003:7
“Sadly, the American people were not told the truth about this in 1960. The SV40 contaminated stocks of Salk polio vaccine were never withdrawn from the market but continued to be given to American children until early 1963 with full knowledge of federal health agencies.
Between 1955 and early 1963, nearly 100 million American children had been given polio vaccine contaminated with the monkey virus, SV40.”
SV40’s Cancer Link
In animal studies, SV40 has been linked to a number of cancers, including mesotheliomas, lymphomas, brain and bone tumors and sarcomas.8 Such tumors in humans have also been found to contain SV40 DNA and proteins. Brain tumors and mesotheliomas appear to be the most common tumors associated with SV40, with some studies showing a positivity rate of up to 60%.
While there wasn’t an “epidemic” of cancers that followed the widespread administration of vaccines contaminated with SV40, which suggests the virus alone may not be causing the cancers, researchers noted, “it seems possible that SV40 may act as a cofactor in the pathogenesis of some tumors.”9
As further reported in Oncogene, at least three independent scientific panels agreed “there is compelling evidence that SV40 is present in some human cancers and that SV40 could contribute to the pathogenesis of some of them.”10
It was also revealed that, in Finland where no SV40-contaminated polio vaccine was used, researchers did not find any SV40-like DNA in frozen tumor tissues from Finnish mesothelioma patients.
The results suggest that the SV40-like DNA sequences detected in other mesothelioma tissue did come from contaminated polio vaccines, though, “It is a matter of speculation whether the absence of SV40 infection has contributed to the relatively low incidence of mesothelioma in Finland.”11
In 2002, meanwhile, The Lancet published evidence showing SV40 is significantly associated with some types of Non-Hodgkin lymphoma after detecting it in 42% of Non-Hodgkin lymphomas tested.12 And in a 2004 review of the then-available evidence, it’s noted:13
“Persuasive evidence now indicates that SV40 is causing infections in humans today and represents an emerging pathogen.
A meta-analysis of molecular, pathological, and clinical data from 1,793 cancer patients indicates that there is a significant excess risk of SV40 associated with human primary brain cancers, primary bone cancers, malignant mesothelioma, and non-Hodgkin’s lymphoma.”
It’s often claimed via the media and even by some prominent health organizations that the link between SV40 from vaccines and cancer has been debunked as a myth, but in 2002 the Institute of Medicine released a report that found “evidence is inadequate to accept or reject a causal relationship between SV40-containing polio vaccines and cancer,” adding:14
“… biological evidence is of moderate strength that SV40 exposure could lead to cancer in humans under natural conditions … biological evidence is of moderate strength that SV40 exposure from the polio vaccine is related to SV40 infection in humans.”
Is SV40 Spreading Through Human Populations?
Controversy still remains over the SV40-contamianted vaccines, including whether the monkey virus is still spreading among humans. There is evidence, for starters, that SV40-contaminated live oral polio vaccines (OPV) continued to be used for many years after SV40 contamination was discovered, including until 1978 in the former USSR and until 1999 in Italy.15
In fact, in 2005 researchers with Loyola University in Chicago conducted a study to test for SV40 in OPV prepared after 1961. They tested vaccine samples from 13 countries, revealing that OPV from “a major eastern European manufacturer” produced from the early 1960s to about 1978 contained infectious SV40:16
“Our findings underscore the potential risks of using primary monkey cells for preparing poliovirus vaccines, because of the possible contamination with SV40 or other monkey viruses, and emphasize the importance of using well-characterized cell substrates that are free from adventitious agents.
Moreover, our results indicate possible geographic differences in SV40 exposure and offer a possible explanation for the different percentage of SV40-positive tumors detected in some laboratories.”
Once exposed to the SV40 virus via a contaminated vaccine, it’s also possible that it has spread among humans via other methods. The monkey virus was found to spread for weeks in children’s stools following vaccination with SV40-contaminated vaccines, for instance,17 which suggests SV40 may replicate in gastrointestinal cells and could be spread via a fecal-oral route.
DNA sequences from SV40 have been found in a wide range of tissues among those vaccinated with SV40-contaminated vaccine, including pituitary tissues and leukocytes from organ and blood donors, as well as blood samples. “These data cumulatively demonstrate that SV40 is circulating in the human population,” researchers wrote in Frontiers in Oncology.18
Viruses Found in Other Vaccines
While it’s often believed that only Salk’s inactivated polio vaccines were infected with SV40, the original seed stocks of the oral polio vaccine created by Sabin were also contaminated with SV40. While this isn’t something that’s widely talked about, especially by public health officials, the 2005 Loyola University study revealed that SV40-contaminated vaccines were produced until about 1978 and were used worldwide.19
The inactivated and live oral polio vaccines were the primary ones contaminated by SV40, but they weren’t the only ones. The monkey virus was also found in the respiratory syncytial virus vaccine.20
In another vaccine contamination scandal involving use of animal cell substrates, in 2010 GlaxoSmithKline’s Rotarix vaccine was found to be contaminated with “a substantial amount” of DNA from a pig virus known as porcine circovirus (PCV).21 That same year, Merck’s rotavirus vaccine Rotateq was also found to contain PCV.22
Disturbingly, it’s not entirely uncommon to find unexpected viruses lurking in vaccines. In her commentary on the Rotarix contamination issue, Fisher added:23
“The surprising discovery reportedly was made after the independent lab used new technology to evaluate the purity of eight live virus vaccines for polio, rubella, measles, yellow fever, human herpes 3 (varicella or chicken pox), rotavirus (Rotarix and RotaTeq) and MMR.
In addition to pig viral DNA found in Rotarix vaccine, low levels of DNA fragments from avian (bird) leukosis virus (a retrovirus) was found in measles vaccine and DNA fragments of a virus similar to simian (monkey) retrovirus was found in RotaTeq vaccine.”
Viruses and other contaminants may be common in the cell cultures from which vaccines are made. Judy Mikovits, Ph.D., a virologist, researcher and founding research director of the Whittemore Peterson Institute, is among those who has detected infectious human retroviruses in cell cultures used to make vaccines.
In her book, “Plague: One Scientist’s Intrepid Search for the Truth About Human Retroviruses and Chronic Fatigue Syndrome (ME/CFS), Autism and Other Diseases,” she details how infectious retroviruses are still likely infecting many biological solutions used clinically today, including vaccines and other therapies.
While some biologicals, like the blood supply, may be decontaminated for retroviruses others, like vaccines, are not likely to be, Mikovits said in our 2018 interview, in part because there’s no requirement to do so and vaccine makers are not liable for any vaccine-induced harm.
So while the SV40 polio vaccine contamination occurred decades ago, the controversy continues, as does the potential for present-day vaccines to be contaminated. Many types of cells continue to be used as growth mediums during vaccine production, including animal cell strains24 from chickens, dogs, monkeys, hamsters25 and insects,26 as well as cells from bacteria or yeast.
With more vaccines in development and some being fast-tracked to market, it’s more important than ever that scientists, manufacturers and regulators take a step back to ensure that the means of prevention or treatment doesn’t end up being worse than the disease.
- 1, 17, 18, 20 Front Oncol. 2019; 9: 670, Epidemiology of SV40 Infections in Human Populations
- 2 N Engl J Med. 1992 Apr 9;326(15):988-93. doi: 10.1056/NEJM199204093261504
- 3, 4, 6 The Lancet July 31, 2004
- 5 The Atlantic February 2000
- 7 NVIC September 10, 2003
- 8, 9 Expert Rev Respir Med. 2011 Oct; 5(5): 683–697
- 10 Oncogene. 2003 Aug 11;22(33):5173-80. doi: 10.1038/sj.onc.1206552
- 11 Mol Carcinog. 1999 Oct;26(2):93-9
- 12 The Lancet March 9, 2002
- 13 Clinical Microbiology Reviews 2004 Jul; 17(3): 495–508
- 14 Research on SV40 … Statement of James Goedert
- 15 Front Oncol. 2019; 9: 670
- 16, 19 Cancer Res. 2005 Nov 15;65(22):10273-9. doi: 10.1158/0008-5472.CAN-05-2028
- 21 CNN March 22, 2010
- 22 University of Minnesota, Center for Infectious Disease Research and Policy May 7, 2010
- 23 NVIC April 7, 2010
- 24 Vaccine Ingredients
- 25 FDA.com Shingrix (PDF)
- 26 Medpage Today December 22, 2017
Reproduced from original article:
Analysis by Dr. Joseph Mercola Fact Checked November 25, 2020
Video not available on this site. To view video, go to original site above.
- There are no excess deaths. The same number of people have died in 2020 that, on average, have died in previous years. This simply wouldn’t be the case if we had a lethal pandemic
- The slight uptick in deaths now being reported in the U.K. aren’t due to COVID-19. Data show these deaths — primarily people aged 45 to 65, with equal distribution between the sexes — are mainly due to heart disease, stroke and cancer, which suggests they are excess deaths caused by lack of routine medical care due to the pandemic restrictions
- The PCR test is not a valid diagnostic tool and should not be done on the scale we’re now doing it. The high rate of false positives is only fodder for needless fearmongering
- Virtually no one who is asymptomatic has the live virus, but when you run the test at a cycle threshold over 30, meaning you amplify the viral RNA more than 30 times, you end up with a positive test even if the virus is inactive and noninfectious
- According to Michael Yeadon, Ph.D., a former vice-president and chief scientific adviser of the drug company Pfizer, very few people will need the COVID-19 vaccine as the mortality rate is so low and the illness is clearly not causing excess deaths
I’ve written several articles about scientists and medical doctors who question the official narrative about the COVID-19 pandemic and the global measures put into place because of it, from useless testing, mask wearing and social distancing, to lockdowns, tracking and tracing and the baseless fearmongering driving it all.
In the video above, British journalist Anna Brees interviews Michael Yeadon, Ph.D., a former vice-president and chief scientific adviser of the drug company Pfizer and founder and CEO of the biotech company Ziarco, now owned by Novartis.
In it, he discusses several concerns, including his belief that widespread PCR testing is creating the false idea that the pandemic is resurging, as the total mortality rate is completely normal. He also discusses his concerns about COVID-19 vaccine mandates.
PCR Testing Is Causing a False ‘Casedemic’
As I explained in “Asymptomatic ‘Casedemic’ Is a Perpetuation of Needless Fear,” by using PCR testing, which cannot diagnose active infection, a false narrative has been created.
Currently, rising “cases,” meaning positive tests, are again being used as the justification to impose more severe restrictions, including lockdowns and mandatory mask wearing, when in fact positive tests have nothing to do with the actual spread of illness.
According to Yeadon, the U.K. has now tested an estimated 30 million people, or close to half of the population. “A large number of those tests have been recent,” Yeadon says, noting that the definition of a “coronavirus death” in the U.K. is anyone who dies, from any cause, within 28 days of a positive COVID-19 test.
So, what we’re seeing now is a natural death rate — about 1,700 people die each day in the U.K. in any given year, Yeadon says — but many of these deaths are now falsely attributed to COVID-19. “I’m calling out the statistics, and even the claim that there is an ongoing pandemic, as false,” he says.
He challenges anyone who doesn’t believe him to seek out any database on total mortality. If you do that, you will find that the daily death count is “absolutely bang-on normal,” Yeadon says.
For some months, the death count is actually slightly lower than the average norm over the past five years. And, he adds, “You cannot have a lethal pandemic stalking the land and not have excess deaths.”
Lack of Routine Medical Care Is Causing Uptick in Deaths
The slight uptick in deaths that are now being reported simply aren’t directly due to COVID-19, he insists. Data show these deaths — primarily people aged 45 to 65, with equal distribution between the sexes — are mainly from heart disease, stroke and cancer, which suggests they are excess deaths caused by inaccessibility of routine medical care as people are either afraid or discouraged from going to the hospital.
These deaths may be characterized as being COVID related, but that’s only because they have been falsely lumped into that category due to false positives being recorded within 28 days of death.
Again, people are being tested very regularly, and the rate of false positives is extremely high. All hospital patients are also tested upon admission, so when they die — regardless of the cause — they’re likely to have a false positive on their record, which then lumps them into the death tally for COVID-19.
“The longer you stay in hospital, the more likely you are to die, obviously,” Yeadon says. “You would be released if you were well and improving. So … long-stay patients are both more likely to die statistically, and much more likely to be tested so often that they’ll have a false positive test.
That is what I think is happening … It’s a convenience for someone playing some macabre game, because I don’t think it’s an error anymore … I’ve spoken to people in [public health] and they’re embarrassed that they’re not even being allowed to characterize and publish the information you would need to know to work out how useful the test is. That’s not being done.”
Can You Get Reinfected?
Yeadon also says he’s “sick and tired” of people claiming that immunity against SARS-CoV-2 may wane after a short time, leaving you vulnerable to reinfection. If you’ve been ill with COVID-19 and recover, you will have antibodies against the virus, and you will be immune, he says.
He understands that journalists may get this wrong, or may be given incorrect information, but if a scientist says this, “they are lying to you,” he says. Yeadon categorically denies the premise that you can recover from COVID-19 and later get reinfected and experience severe illness again.
According to Yeadon, there are only two ways by which COVID-19 would not provide lasting immunity. The first would be if it destroys your immune system. The HIV virus, for example, which causes AIDS, disarms your immune system, causing permanent impairment. Hence you do not become immune to the HIV virus. Coronaviruses do not do that.
The second way is if the virus mutates, which is common among influenza viruses. If the virus mutates, your immune system may not fully recognize it and will have to mount a defense again, thereby creating another set of antibodies. However, coronaviruses are genetically stable, Yeadon says.
(For transparency, there have been reports of SARS-CoV-2 mutating,1 so it’s not impossible that some people might get reinfected with a slightly mutated version of the virus that might make them sick again.)
Hidden Agenda in Plain Sight
As noted by Yeadon, people are now changing the laws of immunology, which simply shouldn’t happen. This should not be a political issue, but somehow it is being treated as one. He claims to have no ideas at all as to why these false narratives are being created, and why scientific truth that contradicts the mainstream narrative is being censored.
Others, however, have become more outspoken about this issue, pointing out how the pandemic is being used as a convenient excuse and justification for redistribution of wealth and the technocratic takeover of the whole world under the banner of a Great Reset to a “more equitable” social order and greener commerce.
It’s being used to usher in social changes that simply could never be introduced without some sort of calamity, be it war or a biological threat, because they involve a radical limitation of personal freedoms and the elimination of privacy. Those in charge of pandemic response measures also refuse to take into account the price of these measures.
When making public health decisions, you need to calculate the cost in terms of lives saved and the price in dollars and cents of saving those people, against the cost of not implementing the measure in question. This is not being done. The question is why is such an illogical stance being taken?
Yeadon on Vaccination
Toward the end of the interview, Yeadon addresses the issue of COVID-19 vaccination. Many are nervous about it becoming mandatory, and rightfully so. Vaccine passports are already being rolled out, and all the indicators point to vaccination becoming a requirement for travel, perhaps even within national borders.
Having spent his career in the pharmaceutical industry, Yeadon fully supports vaccination, believing they prevent large numbers of deaths. However, when it comes to SARS-CoV-2, he believes the vaccine will only benefit the elderly. For those over 80, a vaccine might give them a few more months of life.
“Nobody else needs this [vaccine],” he says. “You don’t vaccinate a population because 1 in 1 million might have a bad outcome [from the infection].” He also strongly believes the vaccine must be voluntary:
“It’s an appalling … public platform to suggest that the only way we get our lives back is to mass vaccinate the population. Something very smelly is going on. It’s simply not appropriate. I don’t even think it would work.”
In an open letter to the British health minister, Yeadon wrote:2
“I have read the consultation document. I’ve rarely been as shocked and upset. All vaccines against the SARS-COV-2 virus are by definition novel. No candidate vaccine has been in development for more than a few months. If any such vaccine is approved for use under any circumstances that are not EXPLICITLY experimental, I believe that recipients are being misled to a criminal extent.
This is because there are precisely zero human volunteers for whom there could possibly be more than a few months past-dose safety information. My concern does not arise because I have negative views about vaccines (I don’t).
Instead, it’s the very principle that politicians seem ready to waive that new medical interventions at this, incomplete state of development, should not be made available to subjects on anything other than an explicitly experimental basis. That’s my concern.
And the reason for that concern is that it is not known what the safety profile will be, six months or a year or longer after dosing. You have literally no data on this and neither does anyone else.
It isn’t that I’m saying that unacceptable adverse effects will emerge after longer intervals after dosing. No: it is that you have no idea what will happen yet, despite this, you’ll be creating the impression that you do …
I don’t trust you. You’ve not been straightforward and have behaved appallingly throughout this crisis. You’re still doing it now, misleading about infection risk from young children. Why should I believe you in relation to experimental vaccines?”
What Can You Do?
In his interview with Brees, Yeadon suggests medical professionals, especially those who are members of a professional society, who disagree with further pandemic measures — based on the medical facts — write an open letter to the government, urging them to speak to and heed the recommendations from independent experts.
Arm yourself with mortality statistics and the facts on PCR testing, so you can explain how and why this pandemic simply isn’t a pandemic anymore. First and foremost, there are no excess deaths. The same number of people have died this year that, on average, have died in previous years. This simply wouldn’t be the case if we had a lethal pandemic.
Second, the PCR test is not a valid diagnostic tool and should not be done on the scale we’re now doing it. The high rate of false positives is only fodder for needless fearmongering. “People should demand to know what [the false positive] rate is,” Yeadon says.
Additionally, “testing people who are well — it’s just a madcap thing,” he says. Virtually no one who is asymptomatic has the live virus, but when you run the test at a cycle threshold over 30, meaning you amplify the viral RNA more than 30 times, you end up with a positive test even if the virus is inactive and noninfectious.
“Let’s get back to the facts,” Yeadon says. “There are no excess deaths. But that’s not what you hear from the BBC now, is it? I’m never going to trust the BBC again, by the way. I’ve watched BBC for 41 years. [They’re] never coming back into my ears, because they’ve lied in my face all year … There’s a fraud going on …
You’re walking into voluntary house arrest when there are no excess deaths. Why are you doing that? Seriously? … I’m fearful, because it doesn’t make any sense and there are no benign outcomes.”
It’s easy to get so confused that you can no longer think straight these days. As explained by Dr. Peter Breggin, featured in “Psychiatrist Blows the Whistle on Pandemic Fearmongering,” when you add uncertainty to fear you end up with anxiety, a state in which you can no longer think logically.
If this applies to you, I urge you to turn off mainstream media news and turn to independent experts, such as Yeadon. Do the research. Read through the science. Reorient yourself to the facts and turn off the propaganda. Next, join a group so that you can have support.
A number of groups have formed around the world that are now rising up against mask mandates, mandatory vaccinations and lockdowns. A few examples of such groups include:
- Us for Them, a group campaigning for reopening schools and protecting children’s rights in the U.K.
- Keep Britain Free
- The COVID Recovery Group (CRG), founded by 50 conservative British MPs to fight lockdown restrictions3
- In the U.S., a team of attorneys, doctors, business owners and parents started the Freedom to Breathe Agency, which is fighting to protect freedom and liberty
Additional sources of information and groups fighting for truth and transparency that are worth checking out include:
- The Great Barrington Declaration,4 which calls for an end to lockdowns. As of November 18, 2020, it had been signed by 34,973 medical practitioners, 12,070 medical and public health scientists, and 634,838 concerned citizens5
- Robert F. Kennedy Jr.’s The Defender, a new newsletter that publishes “banned” news
- The German COVID-19 Extra-Parliamentary Inquiry Committee (ACU2020.org), which is launching an international class-action lawsuit against a long list of authorities over the global pandemic response
- In Spain, more than 600 doctors have formed Doctors for the Truth (Medicos por la verdad)
- In the U.S., doctors have formed a group called America’s Frontline Doctors, which is fighting to make hydroxychloroquine available across the nation
Reproduced from original article:
Analysis by Dr. Joseph Mercola Fact Checked November 18, 2020
- Pfizer, in a joint venture with BioNTech, announced that their mRNA-based COVID-19 vaccine candidate, BNT162b2, was “more than 90% effective” in a Phase 3 trial
- While Pfizer did release a clinical protocol of its trial, it only issued a press release; data for the interim analysis has not been peer reviewed or published
- Infectious disease expert William Haseltine criticized COVID-19 vaccine trials, including Pfizer’s, saying their protocols reveal that they’re “designed to prove their vaccines work, even if the measured effects are minimal”
- Asymptomatic infections aren’t regularly being tested for in Pfizer’s trial, so it’s possible that those who have been vaccinated could still be asymptomatic carriers of COVID-19, spreading the disease to others
- Also missing from Pfizer’s press release is how the vaccine fared in different age groups, a key data point since older people are those most at risk of serious disease outcomes
- There is concern that COVID-19 vaccines could cause antibody-dependent enhancement, or ADE, in which the vaccine enhances the virus’ ability to enter and infect your cells, resulting in more severe disease than had you not been vaccinated
- It’s far too soon to know whether the vaccine is safe, as, on average, it can take 10 to 12 years for a vaccine to be developed and go through the normal licensing process
With more than 180 COVID-19 vaccines currently in development1 — 53 of them undergoing clinical trials in humans2 — manufacturers are racing to be the first to reach the market. Pfizer, in a joint venture with Germany-based BioNTech, may have just taken the lead, with an announcement that their mRNA-based vaccine candidate, BNT162b2, was “more than 90% effective” in a Phase 3 trial.3
BNT162b2 was selected to move forward to a Phase 2/3 trial after an earlier version of the vaccine, BNT162b1— another mRNA-based vaccine candidate — resulted in considerable adverse events,4 including fever, which occurred in 50% of individuals who received the highest dose (100 micrograms), fatigue, headache and chills.
Side effects were even more common following the booster dose, after which more than 70% of participants experienced a fever at the mid-range (30 microgram) dose. In fact, those in the high-dose group didn’t even get the booster dose after the side effects were deemed to be potentially too severe.
While the vaccines are similar, with the BNT162b2 vaccine, mRNA encodes the full-length spike protein. A spike protein is a glycoprotein protruding from the envelope of a coronavirus that allows entry into the cell.5 In an earlier study, while BNT162b2 appeared to cause fewer side effects, antibody titers were lower in a group of older individuals, ranging in age from 65 to 95 years, than in younger individuals.6
Geometric mean titers (GMTs), which are used as a measure of immune response, were about 40% lower among older individuals given Pfizer’s BNT162b2 COVID-19 vaccine than they were in younger age groups, a concerning finding considering it’s the older individuals who are most at risk from severe COVID-19.
Is Pfizer’s COVID Vaccine Really 90% Effective?
In a Phase 3 efficacy trial, a vaccine is given to thousands of people, while researchers wait to see how many end up infected compared to those given a placebo.7 Pfizer’s Phase 3 clinical trial began July 27, 2020 and enrolled 43,538 participants8 to date ranging in age from 12 years to over 55, with a minimum of 40% of participants in the over 55 age range.9
Participants received either a two-dose series of BNT162b2, given at the 30-microgram dose 21 days apart, or a placebo. Initially an interim analysis was set to be conducted after 32 COVID-19 cases, but “after discussion with the FDA,” they increased it to after a minimum of 62 cases. According to Dr. Albert Bourla, Pfizer Chairman and CEO, in a press release:10
“Upon the conclusion of those discussions, the evaluable case count reached 94 and the DMC (Data Monitoring Committee) performed its first analysis on all cases.
The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90%, at 7 days after the second dose. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule.”
Bourla added the caveat, “As the study continues, the final vaccine efficacy percentage may vary.” In fact, there are many questions that remain unanswered regarding the reported 90% efficacy rate.
While Pfizer did release a clinical protocol of its trial,11 data for the interim analysis have not been released. “This is science by public pronouncement,” William Haseltine, an infectious disease expert and former Harvard medical professor, told Business Insider.12
COVID-19 Vaccine Trials ‘Designed to Succeed’
In September 2020, Haseltine criticized COVID-19 vaccine trials, including Pfizer’s, saying their protocols reveal that they’re “designed to prove their vaccines work, even if the measured effects are minimal.”13
He points out that prevention of infection is a critical endpoint in a normal vaccine trial, but prevention of infection is not a criterion for success for COVID-19 vaccines in development by Pfizer, Moderna, AstraZeneca or Johnson & Johnson. According to Haseltine:14
“Any vaccine trial should include regular antigen testing every three days to test contagiousness to pick up early signs of infection and PCR testing once a week to confirm infection by SARS-CoV-2 test the ability of the vaccines to stave off infection. Prevention of infection is not a criterion for success for any of these vaccines.
In fact, their endpoints all require confirmed infections and all those they will include in the analysis for success, the only difference being the severity of symptoms between the vaccinated and unvaccinated. Measuring differences amongst only those infected by SARS-CoV-2 underscores the implicit conclusion that the vaccines are not expected to prevent infection, only modify symptoms of those infected.”
He also explains that while most people expect that a vaccine will prevent serious illness in the event they’re infected, “Three of the vaccine protocols — Moderna, Pfizer, and AstraZeneca — do not require that their vaccine prevent serious disease only that they prevent moderate symptoms which may be as mild as cough, or headache.”15
Pfizer Didn’t Release Key Vaccine Data
While Pfizer is touting its vaccine as more than 90% effective based on 94 cases in their trial, “There are many, many outstanding questions which are left unanswered,” Haseltine said.16
One of the main unanswered questions has to do with asymptomatic infections, which aren’t regularly being tested for in Pfizer’s trial. It’s possible, then, that those who have been vaccinated could still be asymptomatic carriers of COVID-19, spreading the disease to others.
“That’s a major point that I don’t think most people appreciate,” Haseltine told Business Insider. “It doesn’t mean an end to the epidemic.”17 It’s also unknown whether the vaccine reduced the number of cases of serious disease, hospitalizations and deaths, as no distinction was made between serious COVID-19 cases and those causing only minor symptoms.
Also missing from Pfizer’s press release is how the vaccine fared in different age groups, a key data point since older people are those most at risk of serious disease outcomes. It also remains to be seen how long any protection offered by a vaccine may last, as the study just began in July.
As for side effects, Pfizer’s Bourla said, “The DMC has not reported any serious safety concerns and recommends that the study continue to collect additional safety and efficacy data as planned.”18 Again, however, it’s far too soon to know whether the vaccine is safe. The timeline of the experimental COVID-19 vaccine is unprecedented as, on average, it can take 10 to 12 years for a vaccine to be developed and go through the normal licensing process.19
“We don’t know anything about groups they didn’t study, like children, pregnant women, highly immunocompromised people and the eldest of the elderly,” Dr. Gregory Poland, director of the Mayo Clinic’s Vaccine Research Group in Rochester, Minnesota, told NBC News.20
As for potential adverse effects, in their clinical protocol Pfizer listed the following, noting that the first five participants in each group in phase 1 would be monitored for four hours after vaccination to assess adverse effects, while others would be observed for “at least 30 minutes.”21
|Injection site redness, swelling and pain||Fever|
|Joint pain||Unknown adverse effects and laboratory abnormalities associated with a novel vaccine|
|Potential for increased exposure to SARS-CoV-2 because of the requirement to visit health care facilities during the trial||COVID-19 enhancement, stating, “Disease enhancement has been seen following vaccination with respiratory syncytial virus (RSV), feline coronavirus, and Dengue virus vaccines.”|
Coronavirus Vaccines May Enhance Disease
Even Pfizer acknowledged in their clinical protocol that COVID-19 disease enhancement is a real risk following certain vaccinations.22 In what’s known as antibody-dependent enhancement, or ADE, or sometimes called paradoxical immune enhancement (PIE). In these scenarios rather than enhance your immunity against the infection, the vaccine enhances the virus’ ability to enter and infect your cells, resulting in more severe disease than had you not been vaccinated.23
Th2 immunopathology, in which a vaccine induces a faulty T cell response, triggering allergic inflammation, poorly functional antibodies and airway damage, is another serious risk.
Both ADE and Th2 immunopathology occurred in the 1960s when a vaccination for respiratory syncytial virus (RSV) was being developed, resulting in the death of two toddlers and serious illness in several other children who received the experimental vaccine.24
Similar concerns again surfaced in testing for a potential vaccine against another coronavirus, SARS, about 20 years ago. At the time, even long-time pro-vaccine advocate Dr. Peter Hotez, dean of the National School of Tropical Medicine and professor of pediatrics and molecular virology and microbiology at Baylor College of Medicine, was shaken. According to a feature published in PNAS:25
“When SARS, also a coronavirus, appeared in China and spread globally nearly two decades ago, Hotez was among researchers who began investigating a potential vaccine.
In early tests of his candidate, he witnessed how immune cells of vaccinated animals attacked lung tissue, in much the same way that the RSV vaccine had resulted in immune cells attacking kids’ lungs. ‘I thought, ‘Oh crap,’’ he recalls, noting his initial fear that a safe vaccine may again not be possible.”
Despite years of additional research and alternative development strategies, immune enhancement concerns remain, and, as explained by Robert F. Kennedy Jr. in our 2020 interview, coronavirus vaccines remain notorious for creating paradoxical immune enhancement.
mRNA Is a Novel Vaccine Technology
Pfizer’s COVID-19 vaccine is relying on novel mRNA technology that has never previously been used in vaccines.26 It essentially instructs your cells to make the SARS-CoV-2 spike protein, which is what attaches to the ACE2 receptor of the cell. This is the first stage of the two-stage process viruses use to gain entry into cells.
The idea is that by creating the SARS-CoV-2 spike protein, your immune system will be stimulated to produce antibodies, without making you sick in the process. However, another key question that needs to be answered is which of two types of antibodies are produced through this process.
Coronaviruses produce both neutralizing antibodies,27 also referred to as immoglobulin G (IgG) antibodies, that fight the infection, and binding antibodies28 (also known as nonneutralizing antibodies) that cannot prevent viral infection. Instead of preventing viral infection, binding antibodies can trigger an abnormal immune response like ADE or PIE.
In trials of Moderna’s experimental COVID mRNA vaccine, 25 participants who received two doses of its low or medium dose vaccine had levels of binding antibodies — the type that are used by the immune system to fight the virus but do not prevent viral infections — at levels approximating or exceeding those found in the blood of patients who recovered from COVID-19.29
Data for the more significant neutralizing antibodies, which stop viruses from entering cells, were reported for only eight people.
Pfizer Has $1.95 Billion Deal With US Government
While the results of Pfizer’s Phase 3 trial remain murky, as part of Operation Warp Speed the drug giant has already struck a $1.95 billion deal with the U.S. Department of Health and Human Services and the Department of Defense to provide Americans with 100 million doses of its COVID-19 vaccine after it is licensed — at no cost to recipients — with an option for 500 million additional doses.30 The agreement is part of Operation Warp Speed.
Pfizer and BioNTech also have a deal with the U.K. government for 30 million initial doses.31 The FDA’s guidance for a vaccine to receive Emergency Use Authorization requires only a median of two months of safety data following the second dose, which Pfizer expects to have by the third week of November.
At that point, they’re hoping to bring the experimental vaccine to market, with promises to produce up to 50 million vaccine doses in 2020 and up to 1.3 billion doses, globally, in 2021.32 Upon Pfizer’s announcement that their vaccine showed 90% effectiveness, shares rose 16%. The next day, CEO Bourla sold 62% of his stock, an amount worth about $5.6 million.33
Does the Pfizer CEO know something we don’t? If and when the vaccine does become available, be sure to carefully weigh the risks versus the benefits before making a choice of whether or not to receive it.
It may help in your decision to know that if you’re under the age of 40, your risk of dying from COVID-19 is just 0.01%, meaning you have a 99.99% chance of surviving the infection34 — and you could improve that to 99.999% if you’re metabolically flexible and vitamin D replete.
- 1 Nature volume 586, pages516–527(2020)
- 2, 7 The New York Times November 10, 2020
- 3, 8, 10, 18, 32 Pfizer November 9, 2020
- 4, 6 Nature volume 586, pages516–527(2020), BNT162b1 and BNT162b2 from Pfizer
- 5 Merriam-Webster, Spike Protein
- 9 Pfizer, A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, Immunogenicity and Efficacy of RNA Vaccines Against COVID-19, Pages 14, 15
- 11 Pfizer, A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, Immunogenicity and Efficacy of RNA Vaccines Against COVID-19 in Healthy Individuals
- 12 Business Insider November 9, 2020
- 13, 14, 15, 16, 17 Forbes September 23, 2020
- 19 Eureka June 9, 2020
- 20 NBC News November 9, 2020
- 21, 22 Pfizer, A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, Immunogenicity and Efficacy of RNA Vaccines Against COVID-19, Pages 29 and 30
- 23 PNAS.org April 14, 2020 117 (15) 8218-8221
- 24, 25 PNAS.org April 14, 2020 117 (15) 8218-8221, Rogue responses
- 26 Pharmaceutical Technology May 1, 2020
- 27 Science Direct Neutralizing Antibody
- 28 Science Direct Binding Antibody
- 29 BioPharmaDive May 19, 2020
- 30 Pfizer July 22, 2020
- 31 Diazhub July 20, 2020
- 33 Zero Hedge November 11, 2020
- 34 Annals of Internal Medicine September 2, 2020 DOI: 10.7326/M20-5352
Reproduced from original article:
Analysis by Dr. Joseph Mercola Fact Checked October 21, 2020
- While the U.S. Food and Drug Administration itself does not accept corporate money, it does receive money funneled via a nonprofit foundation, which receives money from other nonprofits funded by private interests
- The Reagan-Udall Foundation is a nonprofit foundation created by Congress in 2007 to support scientific research that is of interest to the FDA. It accepts grants from government, individual donors and other nonprofits — even when those nonprofits are created and funded by industry
- The Reagan-Udall Foundation has received large donations from the Bill & Melinda Gates Foundation
- Ellen Sigal, who currently chairs the Reagan-Udall Foundation’s board of directors, is also vice president of the Cancer Moonshot program, funded by the Gates Foundation, and she’s on the board of the Parker Institute, which is partnered with Inovio, a Gates-funded company that is currently working on a COVID-19 vaccine
- According to the rules, no more than four of the 14-member board of the Reagan-Udall Foundation are supposed to be representatives of FDA-regulated industries, yet in 2017, nine of the then 13-member board had financial ties to industry at the time of their appointment
If you’re like most people, you probably assume that the U.S. Food and Drug Administration is funded by the U.S. government and therefore isn’t catering to private industries.
The agency itself certainly tries to present itself as independent from the industries it regulates but, in reality, legal loopholes have led to the FDA receiving money from, and being captured and corrupted by, private interests.
While the FDA itself does not accept corporate money, it does receive money funneled via a nonprofit foundation, which in turn receives money from other nonprofits funded by private interests. It’s really all a façade because the end result is the same. Those donating the money ultimately end up with the ability to pull strings, when needed.
The Reagan-Udall Foundation
As explained by NPR1 back in 2012, the Reagan-Udall Foundation is a nonprofit foundation created by Congress in 2007 to support scientific research that is of interest to the FDA. According to NPR:2
“The idea was that this foundation could do things the FDA can’t. It would raise money from private sources, fund research in areas where the FDA lacks expertise, and organize collaborations involving industry, patient groups and academia.”
As explained in a 2008 article3 in the Journal of the National Cancer Institute, the creation of the Reagan-Udall Foundation was part of a larger plan to establish a private-public partnership to facilitate the Critical Path Initiative.
The Critical Path Initiative was part of the FDA’s attempts to streamline and modernize the drug approval process by having companies pay user fees. Part of the Reagan-Udall Foundation’s responsibilities was to set goals and priorities for the Critical Path Initiative, and then award grants to meet those goals.
Massive Loophole: Nonprofits Funded by Industry
However, critics voiced concern, saying the Reagan-Udall Foundation might allow the food and medical industries “to sway FDA decisions,” since it could raise money from private, including industry, sources. To quell some of these fears, the Reagan-Udall Foundation said it would only accept grants from government, individual donors and other nonprofits, not industry.
After a few years of scraping by on small, private donations, the foundation received a $150,000 grant from the PhRMA Foundation, another nonprofit foundation funded by drug companies. Being a nonprofit, the PhRMA Foundation fit the description of an acceptable funding source, but just how independent can it actually be when it’s founded and funded by drug companies?
As noted by consumer advocate Sidney Wolfe with Public Citizen, while the PhRMA Foundation is technically a nonprofit, “one can hardly expect that they’re going to do things that are not in the interests of their funders.”4
Indeed, and this influence is in addition to the influence food, drug and medical device companies already have, by way of user fees. Again, the Prescription Drug User Fee Act established an accelerated application process for new drugs. The sped-up process is funded through industry-paid fees.
This fee, however, works more like a payoff or soft bribe. When a company pays the FDA for an accelerated review, the agency no longer has an incentive to find fault with the product or demand more extensive testing.
FDA Foundation Funded by the Gates Foundation
Not surprisingly, the Reagan-Udall Foundation has received large donations from the Bill & Melinda Gates Foundation, which we now know rarely does anything that doesn’t benefit Gates’ personal bottom line and overall agenda.
As detailed in “Bill Gates — Most Dangerous Philanthropist in Modern History?” Gates has used his philanthropy to shape public policy in ways that benefit his own agenda.
A March 17, 2020, article5 in The Nation titled, “Bill Gates’ Charity Paradox,” even points out that the Gates Foundation has given $2 billion in tax-deductible charitable donations to private companies, including GlaxoSmithKline, Unilever, IBM, Vodafone, the Mastercard affiliate MasterCard Labs for Financial Inclusion,6,7 Scholastic Inc. and NBC Universal Media.8,9
Many of these so-called donations end up benefiting the Gates Foundation, as it also invests in the very same companies and industries that it donates money to. This circular economy is why Gates just keeps getting richer, the more money he gives away.
Part of this wealth growth also appears to be due to the tax breaks given for charitable donations. In short, it’s a perfect money-shuffling scheme that limits taxes while maximizing income generation.
If donating to for-profit companies sounds oddly illegal to you, you’d be right. Gates is a tax evader for doing so — he’s simply getting away with it. The nonprofit foundation is a disguise to avoid taxes while funding the research arms of for-profit organizations that his foundation is invested in, which is illegal.
The image below shows donations received by the Reagan-Udall Foundation in 2013. Topping the list is the Gates Foundation, whose contributions for the year amounted to $977,165, followed by a string of drug companies.
Board Members With Ties to Industry
In addition to all of this financial clout, food, drug and medical device makers also have the ability to exert influence over the FDA via the members10 of the Foundation board, and this was a concern right from the get-go.
As reported in the 2008 Journal of the National Cancer Institute article,11 members of the then-newly created Reagan-Udall Foundation executive board had troubling ties to industry — and to the Gates Foundation, which years later (see above) ended up being a top financial donor. The article, written by Joel B. Finkelstein, reads, in part:12
“The Food and Drug Administration’s most recent steps toward modernizing the drug approval process have renewed some old questions about the FDA’s relationship with the industries it regulates.
Several public advocacy groups affiliated with physicians and researchers have voiced their concern over the appointment of certain members to a newly formed agency board. The groups have warned that some members may have conflicts of interest due to past or current roles as board members of pharmaceutical and biotechnology firms …
The [Reagan-Udall] foundation’s board of directors, appointed by the FDA commissioner, will be largely responsible for establishing by-laws, selecting an executive director to oversee day-to-day operations, and reporting to Congress on foundation activities and operations.
The federal statute stipulates that of the 14 members named to the board, four members should come from industry, three from academia, two from consumer or patient advocacy organizations, and one from the health provider community. The remaining four spots are open to anyone with relevant expertise.
The FDA has already chosen the members and is organizing the Reagan–Udall Foundation. However, some advocacy groups are concerned that several nonindustry members have strong ties to pharmaceutical and biotechnology companies, including one who is currently under investigation by the Senate Finance Committee.
Tadataka ‘Tachi’ Yamada, M.D., currently heads the Bill and Melinda Gates Foundation’s global health program but until 2006 worked as head of research for the pharmaceutical company GlaxoSmithKline.
Senate investigators have uncovered evidence suggesting that, during his tenure with the company, he may have been involved in an effort to intimidate a scientist who was raising questions about the heart risks associated with the company’s blockbuster diabetes drug rosiglitazone maleate (Avandia).”
While the Reagan-Udall Foundation is the nonprofit arm of the FDA, the agency does not have the authority to set conflict-of-interest policies for the foundation.13 This, of course, leaves the door wide open for conflicts of interest and allows the Foundation to become a hidden back door of sorts, for corporate influence.
Industry Dictates Level of Evidence FDA Should Use
A more recent article,14 published in 2017 in The BMJ, points out that when the Reagan-Udall Foundation is using “big data” assess drug risks and device complications, they’re using “levels of evidence recommended by industry.” The potential for manipulation should be obvious. The article, written by BMJ associate editor Jeanne Lenzer, reads, in part:15
“Big data can be used cautiously to examine real world outcomes and to improve surveillance of drug safety … However, big data are a noisy mess, and analyses by entities with profit motives may identify spurious associations that support fast track approvals and indication creep (broadening the indications for drugs and devices).
The Reagan-Udall Foundation curates real world evidence or ‘big data’ derived from routinely collected health data from insurance claims, electronic health records, voluntary registries, and social media.
The U.S. drug and device regulator, the Food and Drug Administration, says that such data can speed up research, ‘saving time and money’ for ‘therapeutic development, outcomes research [and] safety surveillance.’
In January , Robert Califf, then FDA commissioner, announced the launch of Innovation in Medical Evidence Development and Surveillance (IMEDS), a foundation project that he said would collect and analyze big data to identify ‘important safety issues.’
However, critics of the move say that big data are poor for identifying adverse events … Financial conflicts of interest, they worry, could influence the way big data are used, including exploitation of the weaknesses inherent in observational data to win FDA approval for new uses of drugs and devices and to exonerate drugs of previously detected harms. There is evidence and precedent to support both concerns.”
Lenzer also points out that the Foundation’s board of directors still has financial ties to the drug and device makers that the FDA is supposed to regulate. She notes that while no more than four of the 14-member board should be representatives of FDA regulated industries, in 2017, nine of the then 13-member board had financial ties to industry at the time of their appointment.
The Ties That Bind
To give just one example of how conflicts of interest can have real-world implications, take the case of Ellen V. Sigal, Ph.D.16 Sigal currently chairs the Reagan-Udall Foundation’s board of directors.17
She’s also vice president of the Cancer Moonshot program, and it too is funded by the Gates Foundation. Sigal’s colleague at the Cancer Moonshot Program, Dr. Doug Lowy, is a co-inventor of the HPV vaccine Gardasil, and Sigal’s son, David Sigal, is married to New York State Sen. Brad Hoylman, who recently sponsored a bill to make Gardasil mandatory for all school children in New York.
Hoylman is also supporting a bill that would allow children as young as 9 to receive the HPV vaccine at school without the knowledge or consent of their parents. Gates, of course, is also a supporter of HPV vaccination and funds HPV vaccine research.
Lastly, Sigal is on the board of the Parker Institute, which is partnered with a company called Inovio. Inovio, which is funded by the Gates Foundation, is working on a COVID-19 vaccine.
What are the chances Sigal’s son-in-law might support efforts to make the COVID-19 vaccine mandatory in New York as well? When you start tracing relationships, it’s amazing how often you find the Gates Foundation involved in matters relating to forced vaccinations and the destruction of legal protections.
FDA’s Lax Oversight of Clinical Research
Sad to say, it’s hard to find a government agency that hasn’t been captured by private interests. I’ve written several articles detailing the corruption at the CDC, for example, including “CDC Petitioned to Stop Lying About Pharma Funds,” “How Conflicts of Interest Have Corrupted the CDC” and “Public Health Agency Sued for Coke Collusion.”
The same can be said about the World Health Organization which, of course, is also funded by the Gates Foundation. In fact, when the U.S. withdrew its funding, Gates stepped in and became the largest funder — larger even than entire nations.
Without doubt, the FDA can be added to the list of agencies that largely serves corporate masters, hidden as they may be behind nonprofit façades. A recent investigative report18 by Science Magazine highlights the agency’s failures when it comes to overseeing clinical research, which is one of its many duties.
FDA documents obtained via Freedom of Information Act requests reveal it rarely sanctions or penalizes researchers or research companies even when grave problems — including fraud — are found.
Inspectors conduct routine visits to research trial sites and review trial records to make sure research parameters and safety protocols are followed. They also respond to complaints by whistleblowers.
However, FDA documents obtained via Freedom of Information Act (FOIA) requests reveal it rarely sanctions or penalizes researchers or research companies even when grave problems — including fraud — are found. What’s more, there’s a marked trend toward less and less adequate oversight.
Case in point: Aspen Clinical Research, run by Dr. Michael Harris, has on numerous occasions over the past decade been cited for “egregious errors” in its clinical trials, yet the FDA never followed through on its threats to fine, prosecute or disqualify Harris from conducting clinical research in the U.S. According to the report, written by Charles Piller:19
“FDA found there were serious lapses in obtaining informed consent from trial volunteers, unqualified staff made medical assessments, and Harris failed to properly report abnormal lab test results. He also did not disclose that trial participants were taking opioid, antidepressant, or antipsychotic drugs — which could have skewed results or posed safety concerns.
The agency said Aspen’s records were disorganized, contradictory, and sometimes backdated in a way that ‘begs the question of the authenticity and veracity of data collected.’ Those ‘serious, ongoing deviations’ might constitute ‘fraud, scientific misconduct,’ and ‘significant human subject protection violations,’ according to FDA documents …
Repeat problems and a raft of new ones emerged during inspections in 2014, 2015, and 2019. Each time, in responses to FDA, Harris admitted some transgressions, strenuously disputed others, and promised to improve.
Through all that, FDA never formally sanctioned Harris or pursued other penalties. The agency never made public the alleged offenses or told trial participants they might have been put at risk. Nor did it tell companies sponsoring some of the trials that their data might have been compromised …
Meanwhile, pharmaceutical and medical device companies continued to contract with Aspen. Since 2011, they have paid the firm millions of dollars for work on at least 65 trials, and Aspen is now recruiting people for nine new trials on Alzheimer’s disease, autism, depression, and other serious disorders.”
According to Piller, this isn’t a rare case. After reviewing some 1,600 FDA inspection and enforcement documents, Piller’s conclusion is that the “FDA’s enforcement of clinical research regulations is often light-handed, slow-moving, and secretive.”
“Clear corrections of inspector-reported dangerous or unlawful clinical trial practices were the exception, even amid signs that trial participants were harmed and that data underpinning evidence-based medicine were corrupted,” Piller writes.
“On the rare occasions when FDA formally warned researchers of findings that they had broken the law, the agency often neglected to ensure that fixes occurred … Moreover, the agency frequently closed cases on the basis of unverified claims by those accused.”
I recommend reading Piller’s report in its entirety. It’s a sobering read that raises all sorts of questions about drug safety.
If a drug trial is riddled with errors, omissions and outright fraud and falsification of documents and data — examples of which are given in Piller’s report — and this research is then used to gain FDA approval, the chances of that drug being harmful can be considerable. Clearly, oversight without follow-up and follow-through when problems are found is about as useful as no oversight at all.
- 1, 2, 4 NPR April 3, 2012
- 3, 11, 12, 13 Journal of the National Cancer Institute March 5, 2008; 100(5): 296-297
- 5, 8 The Nation March 17, 2020
- 6, 9 Jacobinmag.com November 2015
- 7 PND December 8, 2014
- 10, 17 Reagan-Udall Foundation Board of Directors
- 14, 15 The BMJ 2017;358:j3275
- 16 The Fedup Democrat June 19, 2020
- 18, 19 Science Magazine October 1, 2020