How Fauci Fooled America

[Joe Money]

How Fauci Fooled America

When the pandemic hit, America needed someone to turn to for advice. The media and public naturally looked to Dr. Anthony Fauci—the director of the National Institute of Allergy and Infectious Diseases, an esteemed laboratory immunologist and one of President Donald Trump's chosen COVID advisers. Unfortunately, Dr. Fauci got major epidemiology and public health questions wrong. Reality and scientific studies have now caught up with him.

Here are the key issues:

Natural immunity. By pushing vaccine mandates, Dr. Fauci ignores naturally acquired immunity among the COVID-recovered, of which there are more than 45 million in the United States. Mounting evidence indicates that natural immunity is stronger and longer lasting than vaccine-induced immunity. [Eds.: Long-term trends are still unclear. A recent study reached the opposite conclusion, but was criticized by an author of this op-ed.] In a study from Israel, the vaccinated were 27 times more likely to get symptomatic COVID than the unvaccinated who had recovered from a prior infection.

We have known about natural immunity from disease at least since the Athenian Plague in 430 BC. Pilots, truckers and longshoremen know about it, and nurses know it better than anyone. Under Fauci's mandates, hospitals are firing heroic nurses who recovered from COVID they contracted while caring for patients. With their superior immunity, they can safely care for the oldest and frailest patients with even lower transmission risk than the vaccinated.

Protecting the elderly. While anyone can get infected, there is more than a thousand-fold difference in mortality risk between the old and the young. After more than 700,000 reported COVID deaths in America, we now know that lockdowns failed to protect high-risk older people. When confronted with the idea of focused protection of the vulnerable, Dr. Fauci admitted he had no idea how to accomplish it, arguing that it would be impossible. That may be understandable for a lab scientist, but public health scientists have presented many concrete suggestions that would have helped, had Fauci and other officials not ignored them.

What can we do now to minimize COVID mortality? Current vaccination efforts should focus on reaching people over 60 who are neither COVID-recovered nor vaccinated, including hard-to-reach, less-affluent people in rural areas and inner cities. Instead, Dr. Fauci has pushed vaccine mandates for children, students and working-age adults who are already immune—all low-risk populations—causing tremendous disruption to labor markets and hampering the operation of many hospitals.

School closures. Schools are major transmission points for influenza, but not for COVID. While children do get infected, their risk for COVID death is minuscule, lower than their already low risk of dying from the flu. Throughout the 2020 spring wave, Sweden kept daycare and schools open for all its 1.8 million children ages 1 to 15, with no masks, testing or social distancing. The result? Zero COVID deaths among children and a COVID risk to teachers lower than the average of other professions. In fall 2020, most European countries followed suit, with similar results. Considering the devastating effects of school closures on children, Dr. Fauci's advocacy for school closures may be the single biggest mistake of his career.

Masks. The gold standard of medical research is randomized trials, and there have now been two on COVID masks for adults. For children, there is no solid scientific evidence that masks work. A Danish study found no statistically significant difference between masking and not masking when it came to coronavirus infection. [Eds. A recent study showed that masks do reduce infections.] In a study in Bangladesh, the 95 percent confidence interval showed that masks reduced transmission between 0 percent and 18 percent. Hence, masks are either of zero or limited benefit. There are many more critical pandemic measures that Dr. Fauci could have emphasized, such as better ventilation in schools and hiring nursing home staff with natural immunity.

Contact tracing. For some infectious diseases, such as Ebola and syphilis, contact tracing is critically important. For a commonly circulating viral infection such as COVID, it was a hopeless waste of valuable public health resources that did not stop the disease.

Collateral public health damage. A fundamental public health principle is that health is multidimensional; the control of a single infectious disease is not synonymous with health. As an immunologist, Dr. Fauci failed to properly consider and weigh the disastrous effects lockdowns would have on cancer detection and treatment, cardiovascular disease outcomes, diabetes care, childhood vaccination rates, mental health and opioid overdoses, to name a few. Americans will live with—and die from—this collateral damage for many years to come.

In private conversations, most of our scientific colleagues agree with us on these points. While a few have spoken up, why are not more doing so? Well, some tried but failed. Others kept silent when they saw colleagues slandered and smeared in the media or censored by Big Tech. Some are government employees who are barred from contradicting official policy. Many are afraid of losing positions or research grants, aware that Dr. Fauci sits on top of the largest pile of infectious disease research money in the world. Most scientists are not experts on infectious disease outbreaks. Were we, say, oncologists, physicists or botanists, we would probably also have trusted Dr. Fauci.

The evidence is in. Governors, journalists, scientists, university presidents, hospital administrators and business leaders can continue to follow Dr. Anthony Fauci or open their eyes. After 700,000-plus COVID deaths and the devastating effects of lockdowns, it is time to return to basic principles of public health.

Martin Kulldorff, Ph.D., is an epidemiologist, biostatistician, and Professor of Medicine at Harvard Medical School. Jay Bhattacharya, MD, Ph.D., is a Professor of Health Policy at Stanford University School of Medicine. Both are Senior Scholars at the newly formed Brownstone Institute.

The views expressed in this article are the writers' own.

How Fauci Fooled America

Unfortunately, Dr. Fauci got major epidemiology and public health questions wrong. Reality and scientific studies have now caught up with him.

www.newsweek.com

@xfactor

 

[Joe Money]

Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial

BMJ 2021; 375 doi: https://doi.org/10.1136/bmj.n2635 (Published 02 November 2021)Cite this as: BMJ 2021;375:n2635
Revelations of poor practices at a contract research company helping to carry out Pfizer’s pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight. Paul D Thacker reports

In autumn 2020 Pfizer’s chairman and chief executive, Albert Bourla, released an open letter to the billions of people around the world who were investing their hopes in a safe and effective covid-19 vaccine to end the pandemic. “As I’ve said before, we are operating at the speed of science,” Bourla wrote, explaining to the public when they could expect a Pfizer vaccine to be authorised in the United States.1

But, for researchers who were testing Pfizer’s vaccine at several sites in Texas during that autumn, speed may have come at the cost of data integrity and patient safety. A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration (FDA). Ventavia fired her later the same day. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails.

Poor laboratory management
On its website Ventavia calls itself the largest privately owned clinical research company in Texas and lists many awards it has won for its contract work.2 But Jackson has told The BMJ that, during the two weeks she was employed at Ventavia in September 2020, she repeatedly informed her superiors of poor laboratory management, patient safety concerns, and data integrity issues. Jackson was a trained clinical trial auditor who previously held a director of operations position and came to Ventavia with more than 15 years’ experience in clinical research coordination and management. Exasperated that Ventavia was not dealing with the problems, Jackson documented several matters late one night, taking photos on her mobile phone. One photo, provided to The BMJ, showed needles discarded in a plastic biohazard bag instead of a sharps container box. Another showed vaccine packaging materials with trial participants’ identification numbers written on them left out in the open, potentially unblinding participants. Ventavia executives later questioned Jackson for taking the photos.

Early and inadvertent unblinding may have occurred on a far wider scale. According to the trial’s design, unblinded staff were responsible for preparing and administering the study drug (Pfizer’s vaccine or a placebo). This was to be done to preserve the blinding of trial participants and all other site staff, including the principal investigator. However, at Ventavia, Jackson told The BMJ that drug assignment confirmation printouts were being left in participants’ charts, accessible to blinded personnel. As a corrective action taken in September, two months into trial recruitment and with around 1000 participants already enrolled, quality assurance checklists were updated with instructions for staff to remove drug assignments from charts.

In a recording of a meeting in late September2020 between Jackson and two directors a Ventavia executive can be heard explaining that the company wasn’t able to quantify the types and number of errors they were finding when examining the trial paperwork for quality control. “In my mind, it’s something new every day,” a Ventavia executive says. “We know that it’s significant.”

Ventavia was not keeping up with data entry queries, shows an email sent by ICON, the contract research organisation with which Pfizer partnered on the trial. ICON reminded Ventavia in a September 2020 email: “The expectation for this study is that all queries are addressed within 24hrs.” ICON then highlighted over 100 outstanding queries older than three days in yellow. Examples included two individuals for which “Subject has reported with Severe symptoms/reactions … Per protocol, subjects experiencing Grade 3 local reactions should be contacted. Please confirm if an UNPLANNED CONTACT was made and update the corresponding form as appropriate.” According to the trial protocol a telephone contact should have occurred “to ascertain further details and determine whether a site visit is clinically indicated.”

Worries over FDA inspection
Documents show that problems had been going on for weeks. In a list of “action items” circulated among Ventavia leaders in early August 2020, shortly after the trial began and before Jackson’s hiring, a Ventavia executive identified three site staff members with whom to “Go over e-diary issue/falsifying data, etc.” One of them was “verbally counseled for changing data and not noting late entry,” a note indicates.
At several points during the late September meeting Jackson and the Ventavia executives discussed the possibility of the FDA showing up for an inspection (box 1). “We’re going to get some kind of letter of information at least, when the FDA gets here . . . know it,” an executive stated.

A history of lax oversight
When it comes to the FDA and clinical trials, Elizabeth Woeckner, president of Citizens for Responsible Care and Research Incorporated (CIRCARE),3 says the agency’s oversight capacity is severely under-resourced. If the FDA receives a complaint about a clinical trial, she says the agency rarely has the staff available to show up and inspect. And sometimes oversight occurs too late.

In one example CIRCARE and the US consumer advocacy organisation Public Citizen, along with dozens of public health experts, filed a detailed complaint in July 2018 with the FDA about a clinical trial that failed to comply with regulations for the protection of human participants.4 Nine months later, in April 2019, an FDA investigator inspected the clinical site. In May this year the FDA sent the triallist a warning letter that substantiated many of the claims in the complaints. It said, “t appears that you did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations and the protection of human subjects.”5

“There’s just a complete lack of oversight of contract research organisations and independent clinical research facilities,” says Jill Fisher, professor of social medicine at the University of North Carolina School of Medicine and author of Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials.

Ventavia and the FDA
A former Ventavia employee told The BMJ that the company was nervous and expecting a federal audit of its Pfizer vaccine trial.
“People working in clinical research are terrified of FDA audits,” Jill Fisher told The BMJ, but added that the agency rarely does anything other than inspect paperwork, usually months after a trial has ended. “I don’t know why they’re so afraid of them,” she said. But she said she was surprised that the agency failed to inspect Ventavia after an employee had filed a complaint. “You would think if there’s a specific and credible complaint that they would have to investigate that,” Fisher said.

In 2007 the Department of Health and Human Services’ Office of the Inspector General released a report on FDA’s oversight of clinical trials conducted between 2000 and 2005. The report found that the FDA inspected only 1% of clinical trial sites.6 Inspections carried out by the FDA’s vaccines and biologics branch have been decreasing in recent years, with just 50 conducted in the 2020 fiscal year.7

The next morning, 25 September 2020, Jackson called the FDA to warn about unsound practices in Pfizer’s clinical trial at Ventavia. She then reported her concerns in an email to the agency. In the afternoon Ventavia fired Jackson—deemed “not a good fit,” according to her separation letter.

Jackson told The BMJ it was the first time she had been fired in her 20 year career in research.

Concerns raised
In her 25 September email to the FDA Jackson wrote that Ventavia had enrolled more than 1000 participants at three sites. The full trial (registered under NCT04368728) enrolled around 44 000 participants across 153 sites that included numerous commercial companies and academic centres. She then listed a dozen concerns she had witnessed, including:

• Participants placed in a hallway after injection and not being monitored by clinical staff
• Lack of timely follow-up of patients who experienced adverse events
• Protocol deviations not being reported
• Vaccines not being stored at proper temperatures
• Mislabelled laboratory specimens, and
• Targeting of Ventavia staff for reporting these types of problems.

Within hours Jackson received an email from the FDA thanking her for her concerns and notifying her that the FDA could not comment on any investigation that might result. A few days later Jackson received a call from an FDA inspector to discuss her report but was told that no further information could be provided. She heard nothing further in relation to her report.

In Pfizer’s briefing document submitted to an FDA advisory committee meeting held on 10 December 2020 to discuss Pfizer’s application for emergency use authorisation of its covid-19 vaccine, the company made no mention of problems at the Ventavia site. The next day the FDA issued the authorisation of the vaccine.8

In August this year, after the full approval of Pfizer’s vaccine, the FDA published a summary of its inspections of the company’s pivotal trial. Nine of the trial’s 153 sites were inspected. Ventavia’s sites were not listed among the nine, and no inspections of sites where adults were recruited took place in the eight months after the December 2020 emergency authorisation. The FDA’s inspection officer noted: “The data integrity and verification portion of the BIMO [bioresearch monitoring] inspections were limited because the study was ongoing, and the data required for verification and comparison were not yet available to the IND [investigational new drug].”

Other employees’ accounts
In recent months Jackson has reconnected with several former Ventavia employees who all left or were fired from the company. One of them was one of the officials who had taken part in the late September meeting. In a text message sent in June the former official apologised, saying that “everything that you complained about was spot on.”

Two former Ventavia employees spoke to The BMJ anonymously for fear of reprisal and loss of job prospects in the tightly knit research community. Both confirmed broad aspects of Jackson’s complaint. One said that she had worked on over four dozen clinical trials in her career, including many large trials, but had never experienced such a “helter skelter” work environment as with Ventavia on Pfizer’s trial.
“I’ve never had to do what they were asking me to do, ever,” she told The BMJ. “It just seemed like something a little different from normal—the things that were allowed and expected.”

She added that during her time at Ventavia the company expected a federal audit but that this never came.

After Jackson left the company problems persisted at Ventavia, this employee said. In several cases Ventavia lacked enough employees to swab all trial participants who reported covid-like symptoms, to test for infection. Laboratory confirmed symptomatic covid-19 was the trial’s primary endpoint, the employee noted. (An FDA review memorandum released in August this year states that across the full trial swabs were not taken from 477 people with suspected cases of symptomatic covid-19.)

“I don’t think it was good clean data,” the employee said of the data Ventavia generated for the Pfizer trial. “It’s a crazy mess.”

A second employee also described an environment at Ventavia unlike any she had experienced in her 20 years doing research. She told The BMJ that, shortly after Ventavia fired Jackson, Pfizer was notified of problems at Ventavia with the vaccine trial and that an audit took place.

Since Jackson reported problems with Ventavia to the FDA in September 2020, Pfizer has hired Ventavia as a research subcontractor on four other vaccine clinical trials (covid-19 vaccine in children and young adults, pregnant women, and a booster dose, as well an RSV vaccine trial; NCT04816643, NCT04754594, NCT04955626, NCT05035212). The advisory committee for the Centers for Disease Control and Prevention is set to discuss the covid-19 paediatric vaccine trial on 2 November.

Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial

Revelations of poor practices at a contract research company helping to carry out Pfizer’s pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight. Paul D Thacker reports In autumn 2020 Pfizer’s chairman and chief executive, Albert Bourla, released an open...

www.bmj.com

 

[SamSneed]

 

[Mrfreddygoodbud]

How Fauci Fooled America

When the pandemic hit, America needed someone to turn to for advice. The media and public naturally looked to Dr. Anthony Fauci—the director of the National Institute of Allergy and Infectious Diseases, an esteemed laboratory immunologist and one of President Donald Trump's chosen COVID advisers. Unfortunately, Dr. Fauci got major epidemiology and public health questions wrong. Reality and scientific studies have now caught up with him.

Here are the key issues:

Natural immunity. By pushing vaccine mandates, Dr. Fauci ignores naturally acquired immunity among the COVID-recovered, of which there are more than 45 million in the United States. Mounting evidence indicates that natural immunity is stronger and longer lasting than vaccine-induced immunity. [Eds.: Long-term trends are still unclear. A recent study reached the opposite conclusion, but was criticized by an author of this op-ed.] In a study from Israel, the vaccinated were 27 times more likely to get symptomatic COVID than the unvaccinated who had recovered from a prior infection.

We have known about natural immunity from disease at least since the Athenian Plague in 430 BC. Pilots, truckers and longshoremen know about it, and nurses know it better than anyone. Under Fauci's mandates, hospitals are firing heroic nurses who recovered from COVID they contracted while caring for patients. With their superior immunity, they can safely care for the oldest and frailest patients with even lower transmission risk than the vaccinated.

Protecting the elderly. While anyone can get infected, there is more than a thousand-fold difference in mortality risk between the old and the young. After more than 700,000 reported COVID deaths in America, we now know that lockdowns failed to protect high-risk older people. When confronted with the idea of focused protection of the vulnerable, Dr. Fauci admitted he had no idea how to accomplish it, arguing that it would be impossible. That may be understandable for a lab scientist, but public health scientists have presented many concrete suggestions that would have helped, had Fauci and other officials not ignored them.

What can we do now to minimize COVID mortality? Current vaccination efforts should focus on reaching people over 60 who are neither COVID-recovered nor vaccinated, including hard-to-reach, less-affluent people in rural areas and inner cities. Instead, Dr. Fauci has pushed vaccine mandates for children, students and working-age adults who are already immune—all low-risk populations—causing tremendous disruption to labor markets and hampering the operation of many hospitals.

School closures. Schools are major transmission points for influenza, but not for COVID. While children do get infected, their risk for COVID death is minuscule, lower than their already low risk of dying from the flu. Throughout the 2020 spring wave, Sweden kept daycare and schools open for all its 1.8 million children ages 1 to 15, with no masks, testing or social distancing. The result? Zero COVID deaths among children and a COVID risk to teachers lower than the average of other professions. In fall 2020, most European countries followed suit, with similar results. Considering the devastating effects of school closures on children, Dr. Fauci's advocacy for school closures may be the single biggest mistake of his career.

Masks. The gold standard of medical research is randomized trials, and there have now been two on COVID masks for adults. For children, there is no solid scientific evidence that masks work. A Danish study found no statistically significant difference between masking and not masking when it came to coronavirus infection. [Eds. A recent study showed that masks do reduce infections.] In a study in Bangladesh, the 95 percent confidence interval showed that masks reduced transmission between 0 percent and 18 percent. Hence, masks are either of zero or limited benefit. There are many more critical pandemic measures that Dr. Fauci could have emphasized, such as better ventilation in schools and hiring nursing home staff with natural immunity.

Contact tracing. For some infectious diseases, such as Ebola and syphilis, contact tracing is critically important. For a commonly circulating viral infection such as COVID, it was a hopeless waste of valuable public health resources that did not stop the disease.

Collateral public health damage. A fundamental public health principle is that health is multidimensional; the control of a single infectious disease is not synonymous with health. As an immunologist, Dr. Fauci failed to properly consider and weigh the disastrous effects lockdowns would have on cancer detection and treatment, cardiovascular disease outcomes, diabetes care, childhood vaccination rates, mental health and opioid overdoses, to name a few. Americans will live with—and die from—this collateral damage for many years to come.

In private conversations, most of our scientific colleagues agree with us on these points. While a few have spoken up, why are not more doing so? Well, some tried but failed. Others kept silent when they saw colleagues slandered and smeared in the media or censored by Big Tech. Some are government employees who are barred from contradicting official policy. Many are afraid of losing positions or research grants, aware that Dr. Fauci sits on top of the largest pile of infectious disease research money in the world. Most scientists are not experts on infectious disease outbreaks. Were we, say, oncologists, physicists or botanists, we would probably also have trusted Dr. Fauci.

The evidence is in. Governors, journalists, scientists, university presidents, hospital administrators and business leaders can continue to follow Dr. Anthony Fauci or open their eyes. After 700,000-plus COVID deaths and the devastating effects of lockdowns, it is time to return to basic principles of public health.

Martin Kulldorff, Ph.D., is an epidemiologist, biostatistician, and Professor of Medicine at Harvard Medical School. Jay Bhattacharya, MD, Ph.D., is a Professor of Health Policy at Stanford University School of Medicine. Both are Senior Scholars at the newly formed Brownstone Institute.

The views expressed in this article are the writers' own.

How Fauci Fooled America

Unfortunately, Dr. Fauci got major epidemiology and public health questions wrong. Reality and scientific studies have now caught up with him.

www.newsweek.com

@xfactor

dont forgot dr fugazi, aka dr baby dracula,

aka the little nazi doctor..

was the man who pushed the toxic as fuck drug azt,

which WAS killing folks.. once they stopped adminstering

AZT people stopped dying from 'aids'...

dont fall for big pharma damage control bullshit,

they KNEW it was toxic and just unleashed it on

the masses and blamed Africa...

I remember all that shit....

• Dr. Anthony Fauci, who has been the director of the National Institute of Allergy and Infectious Diseases at the National Institute of Health since 1985, led efforts to find a treatment for AIDS at the onset of the epidemic throughout the 1980s. One such treatment was azidothymidine, commonly called AZT, which was created decades earlier as a cancer treatment but shortly shelved for its high toxicity and adverse side effects.

 

[lightbright]

....BAN

.

 

[Joe Money]

....BAN

.

For what?

 

[blackpepper]

dont forgot dr fugazi, aka dr baby dracula,

aka the little nazi doctor..

was the man who pushed the toxic as fuck drug azt,

which WAS killing folks.. once they stopped adminstering

AZT people stopped dying from 'aids'...

dont fall for big pharma damage control bullshit,

they KNEW it was toxic and just unleashed it on

the masses and blamed Africa...

I remember all that shit....

• Dr. Anthony Fauci, who has been the director of the National Institute of Allergy and Infectious Diseases at the National Institute of Health since 1985, led efforts to find a treatment for AIDS at the onset of the epidemic throughout the 1980s. One such treatment was azidothymidine, commonly called AZT, which was created decades earlier as a cancer treatment but shortly shelved for its high toxicity and adverse side effects.

Not saying I agree with all of this, but its good to discuss it. The problem is we'll never have an unbiased investigation of these allegations because at the time it happened the victims were despised by society at large, politically irrelevant, and the country has now seemingly moved on.

 

[dade305]

I just came in here to say, Fuck Fauci.

 

[Mrfreddygoodbud]

Not saying I agree with all of this, but its good to discuss it. The problem is we'll never have an unbiased investigation of these allegations because at the time it happened the victims were despised by society at large, politically irrelevant, and the country has now seemingly moved on.

Yeah but that ghost is following Fauci... the purpose of the post is...to remind folks...

if we did..

dr fugazi wouldve been ran out of town a long time ago, with all his ilk

and I mean ALL of his ilk... !!

 

[Mrfreddygoodbud]

Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial

BMJ 2021; 375 doi: https://doi.org/10.1136/bmj.n2635 (Published 02 November 2021)Cite this as: BMJ 2021;375:n2635
Revelations of poor practices at a contract research company helping to carry out Pfizer’s pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight. Paul D Thacker reports

In autumn 2020 Pfizer’s chairman and chief executive, Albert Bourla, released an open letter to the billions of people around the world who were investing their hopes in a safe and effective covid-19 vaccine to end the pandemic. “As I’ve said before, we are operating at the speed of science,” Bourla wrote, explaining to the public when they could expect a Pfizer vaccine to be authorised in the United States.1

But, for researchers who were testing Pfizer’s vaccine at several sites in Texas during that autumn, speed may have come at the cost of data integrity and patient safety. A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration (FDA). Ventavia fired her later the same day. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails.

Poor laboratory management
On its website Ventavia calls itself the largest privately owned clinical research company in Texas and lists many awards it has won for its contract work.2 But Jackson has told The BMJ that, during the two weeks she was employed at Ventavia in September 2020, she repeatedly informed her superiors of poor laboratory management, patient safety concerns, and data integrity issues. Jackson was a trained clinical trial auditor who previously held a director of operations position and came to Ventavia with more than 15 years’ experience in clinical research coordination and management. Exasperated that Ventavia was not dealing with the problems, Jackson documented several matters late one night, taking photos on her mobile phone. One photo, provided to The BMJ, showed needles discarded in a plastic biohazard bag instead of a sharps container box. Another showed vaccine packaging materials with trial participants’ identification numbers written on them left out in the open, potentially unblinding participants. Ventavia executives later questioned Jackson for taking the photos.

Early and inadvertent unblinding may have occurred on a far wider scale. According to the trial’s design, unblinded staff were responsible for preparing and administering the study drug (Pfizer’s vaccine or a placebo). This was to be done to preserve the blinding of trial participants and all other site staff, including the principal investigator. However, at Ventavia, Jackson told The BMJ that drug assignment confirmation printouts were being left in participants’ charts, accessible to blinded personnel. As a corrective action taken in September, two months into trial recruitment and with around 1000 participants already enrolled, quality assurance checklists were updated with instructions for staff to remove drug assignments from charts.

In a recording of a meeting in late September2020 between Jackson and two directors a Ventavia executive can be heard explaining that the company wasn’t able to quantify the types and number of errors they were finding when examining the trial paperwork for quality control. “In my mind, it’s something new every day,” a Ventavia executive says. “We know that it’s significant.”

Ventavia was not keeping up with data entry queries, shows an email sent by ICON, the contract research organisation with which Pfizer partnered on the trial. ICON reminded Ventavia in a September 2020 email: “The expectation for this study is that all queries are addressed within 24hrs.” ICON then highlighted over 100 outstanding queries older than three days in yellow. Examples included two individuals for which “Subject has reported with Severe symptoms/reactions … Per protocol, subjects experiencing Grade 3 local reactions should be contacted. Please confirm if an UNPLANNED CONTACT was made and update the corresponding form as appropriate.” According to the trial protocol a telephone contact should have occurred “to ascertain further details and determine whether a site visit is clinically indicated.”

Worries over FDA inspection
Documents show that problems had been going on for weeks. In a list of “action items” circulated among Ventavia leaders in early August 2020, shortly after the trial began and before Jackson’s hiring, a Ventavia executive identified three site staff members with whom to “Go over e-diary issue/falsifying data, etc.” One of them was “verbally counseled for changing data and not noting late entry,” a note indicates.
At several points during the late September meeting Jackson and the Ventavia executives discussed the possibility of the FDA showing up for an inspection (box 1). “We’re going to get some kind of letter of information at least, when the FDA gets here . . . know it,” an executive stated.

A history of lax oversight
When it comes to the FDA and clinical trials, Elizabeth Woeckner, president of Citizens for Responsible Care and Research Incorporated (CIRCARE),3 says the agency’s oversight capacity is severely under-resourced. If the FDA receives a complaint about a clinical trial, she says the agency rarely has the staff available to show up and inspect. And sometimes oversight occurs too late.

In one example CIRCARE and the US consumer advocacy organisation Public Citizen, along with dozens of public health experts, filed a detailed complaint in July 2018 with the FDA about a clinical trial that failed to comply with regulations for the protection of human participants.4 Nine months later, in April 2019, an FDA investigator inspected the clinical site. In May this year the FDA sent the triallist a warning letter that substantiated many of the claims in the complaints. It said, “t appears that you did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations and the protection of human subjects.”5

“There’s just a complete lack of oversight of contract research organisations and independent clinical research facilities,” says Jill Fisher, professor of social medicine at the University of North Carolina School of Medicine and author of Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials.

Ventavia and the FDA
A former Ventavia employee told The BMJ that the company was nervous and expecting a federal audit of its Pfizer vaccine trial.
“People working in clinical research are terrified of FDA audits,” Jill Fisher told The BMJ, but added that the agency rarely does anything other than inspect paperwork, usually months after a trial has ended. “I don’t know why they’re so afraid of them,” she said. But she said she was surprised that the agency failed to inspect Ventavia after an employee had filed a complaint. “You would think if there’s a specific and credible complaint that they would have to investigate that,” Fisher said.

In 2007 the Department of Health and Human Services’ Office of the Inspector General released a report on FDA’s oversight of clinical trials conducted between 2000 and 2005. The report found that the FDA inspected only 1% of clinical trial sites.6 Inspections carried out by the FDA’s vaccines and biologics branch have been decreasing in recent years, with just 50 conducted in the 2020 fiscal year.7

The next morning, 25 September 2020, Jackson called the FDA to warn about unsound practices in Pfizer’s clinical trial at Ventavia. She then reported her concerns in an email to the agency. In the afternoon Ventavia fired Jackson—deemed “not a good fit,” according to her separation letter.

Jackson told The BMJ it was the first time she had been fired in her 20 year career in research.

Concerns raised
In her 25 September email to the FDA Jackson wrote that Ventavia had enrolled more than 1000 participants at three sites. The full trial (registered under NCT04368728) enrolled around 44 000 participants across 153 sites that included numerous commercial companies and academic centres. She then listed a dozen concerns she had witnessed, including:

• • Participants placed in a hallway after injection and not being monitored by clinical staff
  • Lack of timely follow-up of patients who experienced adverse events
  • Protocol deviations not being reported
  • Vaccines not being stored at proper temperatures
  • Mislabelled laboratory specimens, and
  • Targeting of Ventavia staff for reporting these types of problems.

Within hours Jackson received an email from the FDA thanking her for her concerns and notifying her that the FDA could not comment on any investigation that might result. A few days later Jackson received a call from an FDA inspector to discuss her report but was told that no further information could be provided. She heard nothing further in relation to her report.

In Pfizer’s briefing document submitted to an FDA advisory committee meeting held on 10 December 2020 to discuss Pfizer’s application for emergency use authorisation of its covid-19 vaccine, the company made no mention of problems at the Ventavia site. The next day the FDA issued the authorisation of the vaccine.8

In August this year, after the full approval of Pfizer’s vaccine, the FDA published a summary of its inspections of the company’s pivotal trial. Nine of the trial’s 153 sites were inspected. Ventavia’s sites were not listed among the nine, and no inspections of sites where adults were recruited took place in the eight months after the December 2020 emergency authorisation. The FDA’s inspection officer noted: “The data integrity and verification portion of the BIMO [bioresearch monitoring] inspections were limited because the study was ongoing, and the data required for verification and comparison were not yet available to the IND [investigational new drug].”

Other employees’ accounts
In recent months Jackson has reconnected with several former Ventavia employees who all left or were fired from the company. One of them was one of the officials who had taken part in the late September meeting. In a text message sent in June the former official apologised, saying that “everything that you complained about was spot on.”

Two former Ventavia employees spoke to The BMJ anonymously for fear of reprisal and loss of job prospects in the tightly knit research community. Both confirmed broad aspects of Jackson’s complaint. One said that she had worked on over four dozen clinical trials in her career, including many large trials, but had never experienced such a “helter skelter” work environment as with Ventavia on Pfizer’s trial.
“I’ve never had to do what they were asking me to do, ever,” she told The BMJ. “It just seemed like something a little different from normal—the things that were allowed and expected.”

She added that during her time at Ventavia the company expected a federal audit but that this never came.

After Jackson left the company problems persisted at Ventavia, this employee said. In several cases Ventavia lacked enough employees to swab all trial participants who reported covid-like symptoms, to test for infection. Laboratory confirmed symptomatic covid-19 was the trial’s primary endpoint, the employee noted. (An FDA review memorandum released in August this year states that across the full trial swabs were not taken from 477 people with suspected cases of symptomatic covid-19.)

“I don’t think it was good clean data,” the employee said of the data Ventavia generated for the Pfizer trial. “It’s a crazy mess.”

A second employee also described an environment at Ventavia unlike any she had experienced in her 20 years doing research. She told The BMJ that, shortly after Ventavia fired Jackson, Pfizer was notified of problems at Ventavia with the vaccine trial and that an audit took place.

Since Jackson reported problems with Ventavia to the FDA in September 2020, Pfizer has hired Ventavia as a research subcontractor on four other vaccine clinical trials (covid-19 vaccine in children and young adults, pregnant women, and a booster dose, as well an RSV vaccine trial; NCT04816643, NCT04754594, NCT04955626, NCT05035212). The advisory committee for the Centers for Disease Control and Prevention is set to discuss the covid-19 paediatric vaccine trial on 2 November.

Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial

Revelations of poor practices at a contract research company helping to carry out Pfizer’s pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight. Paul D Thacker reports In autumn 2020 Pfizer’s chairman and chief executive, Albert Bourla, released an open...

www.bmj.com

whats even more fuckin insane, is these satanic big pharma phucks,

dont even believe in their own products, they lobby hard, for states

to pick up LAWSUITs tabs

they KNOW are coming...

thats whats crazy everybody wants you to take this high tech experimental drug,

but NOBODY WANTS ACCOUNTABILITY FOR ANY ADVERSE REACTION...

and folks think IM going to take someshit the creators of it, dont even

believe in..

its amazing how many people cant incorporate simple logic to form sound conclusions..

it be the "educated" ones too...

 

[RAY V.]

I just came in here to say, Fuck Fauci.

& don't forget about Trump too

Fuck Trump!

 

[Supersav]

For what?

U know they gonna hate u for this lol...how dare you anti vaxxer