This post is in part two of the Cause and Effect Forum and it, with other posts centred on the New England Journal of Misinformation, will feature under NEJM-GATE. The third part will focus on RCTs. Once all Ten Cases are in place, it should be possible to print the forum off to support medical exemptions and to ask medical registration boards why they are trying to put doctors out of business.
Spoiler alert, Eric Rubin is editor of the New England J, which Americans think is the leading medical journal in the world
The medical world is changing fast. Just a year ago, some of us, who thought we knew the lie of the clinical trials and pharmaceutical company land, and could talk fluent CRO and ghostwriting speak, began to realize there was a new language and new vistas.
A language of Virtual Trials, with questionnaires on electronic devices that have fixed pre-populated items so that companies can only get the information they want. You might die, end up paralyzed on a new treatment, be unable to function sexually ever again, but none of this will register on the trial device you have been provided supposedly to enable you to participate from the comfort of your own home, while sipping a glass of wine.
A vista where electronic data from places like Hialeah in Florida, Fort Worth in Texas and Buenos Aires (see later this week) are monitored from Japan and fed seamlessly through to a ghost, based in Australia, who will write up the Study Reports for a Contract Research Organization (CRO) like Icon, based in Dublin, to be published in the New England Journal of Misinformation based in Boston.
Who had heard of Science37 who claim to be the world leader in decentralized trials?
Who knew this world now contains not just CROs but also SMOs, and this difference is important.
SMO – Site Management Organization – as a term has been around for a decade but some of us who thought we knew most of what went on hadn’t heard about it. I was aware that Pfizer contracted to Icon, a CRO, who subcontracted to other CROs like Platinum Research Network who subcontracted to what I assumed was a further layer of CROs like Ventavia.
This all fits an outsourcing business model. Organizational is a better word here than business in that universities, public services and the Catholic Church now do it as naturally as businesses. Universities outsource the firing of unvaccinated staff or students to HR companies. This outsourcing is part of what is now going wrong in Long-Term care. See Politics of Care Forum. This is management culture rather than a business or entrepreneurial culture – risk management rather than risk taking. This history is laid out in Shipwreck of the Singular; Healthcare’s Castaways.
It affects the hotel you go to where even if you are met by the ‘owner’ at the reception, the cooking is done by one company, the cleaning by another, booking rooms by a third, and promoting the venue by yet a fourth etc. It’s rare now to find a hotel as these were once understood where you could complain to someone who could put things right, or develop relationships that brought you back.
The vaccines have given a real push to the SMO business. Rather than CROs running trials in the Russian Federation, Colombia, India, or Africa, SMOs approach American Family Doctors with an appealing message.
Hey Doc, you are obviously a decent guy – we’re here to make life better. We can add clinical research to your portfolio, making your job more interesting, attractive to patients and more lucrative to you. Your name will appear in New England Journal articles as part of the Covid Vaccine Study Group – think how impressed your colleagues will be.
We will take over part of your office suite or a suite next door and move in the research staff who will assess, examine, consent, monitor and keep the books on volunteers for clinical trials. You get to be and get to be paid for being the investigator. You just need to be there to answer queries, sign off on the paperwork and let us email your patient database inviting them in to participate in the latest trial – which will give them free healthcare including meds and vaccines.
With the vaccines, all of sudden family doctors all around the USA, in states like Nebraska were recruiting patients to the tune of several million dollars of income for the 4 months the Covid trial took. They have since moved on to doing Respiratory Syncytial Virus (RSV) trials and hundreds of further vaccine trials – with the mandates these vaccines will bring in their train.
Having spent 20 years supervising the running of clinical trials, Brook Jackson knew the CRO-SMO scene inside out. She changed jobs to Ventavia because it was located close to where she lived. What she found was – clinical trials but not as we know them Jim – as Dr Spock might have said.
Ventavia got going in 2013 in Fort Worth, expanding from there to other sites in Texas. When the Pfizer Covid 19 vaccine trial came along in July 2020, Ventavia jumped on board. There was an eye-watering amount of money to be made that hinged on getting as many patients through the door as possible. They set up centers in Fort Worth, Keller and Houston.
We are seeking call center recruiters in Fort Worth. We’re looking for someone with strong communications skills, sales background, good organizational skills, bilingual is a plus. If interested, please send a resume or inquiries to email@example.com
The Fort Worth site was at 1307 8th Avenue in suite 202. There were two sub-investigators, Drs Norma Escamilla and Isaac Watemberg one floor down, whom Brook never saw. The Principal Investigator (PI) was Mark Koch, pronounced Cook in Texas not Cock. He was a family doctor who also had a hospital practice and was too busy to be on site other than occasionally when he signed off on documents that Escamilla and Watemberg had supposedly completed.
In suite 202, there were staff to greet volunteers, staff to check for eligibility to participate, get informed consent, take medical histories, do physical examinations including blood pressure, pregnancy tests, baseline blood tests, prepare and give the vaccine, and monitor the volunteer for 30 minutes afterwards.
There were freezers for the vaccine and centrifuges to separate plasma from blood and send to the laboratory, and biohazard disposal facilities that were often not used in the proper way.
Early on the doctor most closely linked to the trial in Houston, Dr Van Tran wanted to close his medical practice during certain times, scheduling “blocks” of time to examine clinical trial participants. But Ventavia decided this was not acceptable as the Houston site would not be able to “hit” its patient cap, maximizing payments from Pfizer. In his case, there was a doctor Renu Garg, an obstetrician who had a prior Pfizer email, one floor up. (See Houston Vaccine Trials in Children).
The staff mostly women, dressed in fetching slate gray uniforms, were hired from local fast-food outlets and other settings. Most had no training. Those giving the vaccines should have had a healthcare background but didn’t and some had no training prior to starting – taking courses afterwards to ensure boxes were ticked.
See Odaro’s Recruitment by David.
The Ventavia Operation:
Ventavia was required to scan or enter all data from volunteers into the “Complion” Clinical Trial Management System database, so that it could be passed on to Icon and Pfizer. In the scramble to enroll as many participants as possible, quality checking and uploading fell behind schedule. The “back log” of documents often lacked key information, such as patient or doctor signatures and blood draw times.
Ventavia brought in employees’ friends and family members on weekends to help “catch up” on quality control. These temporary employees were not listed on delegation logs, so should not have been accessing anything. Some of these temporary employees were also clinical trial participants – they shouldn’t have been. Some of the quality checking led to a falsification of missing data.
Koch and his sub-investigator signed off on a symptom log that was two months out of date and contained stuff they had not seen or examined
To be clear, if you attended a Ventavia site your prior Covid status might not have been tested, your pregnancy status might not have been tested, your vaccine might not have been active, your bloods or other measurements taken might not have been valid, your data may not have been recorded and might subsequently have been invented, you may have been entered into the trial even though ineligible.
Very few records from this trial have been released but among those that have there are some from Ventavia sites.
A 66-year-old man was the ninth person recruited at Fort Worth. He had a second dose on August 19. Two months later he had a heart attack. This was declared not related to the vaccine. This was not entirely unreasonable in that he had had a prior heart attack 4 years before, but it was more unreasonable than blaming it instead on a failed stent placement – which is bit like saying your broken hip after a fall is down to a failure of the prior hip joint operation.
After his heart attack he was recorded as having pneumonia from which he died 4 weeks later. The data managers asked for clarifications – was this a covid 19 pneumonia and what kind of cough did he have. The respondent at the Ventavia site, the husband of one of the owners of Ventavia, did not seem to know and seems to have invented answers.
Another patient had hepatocellular changes on placebo, which is odd. After an unblinding, she was give 2 doses of the vaccine and after the second was hospitalized with a septic state and a Serious Adverse Event – Hepatocellular injury, which the Data Managers changed without seeing the hospital record.
These Ventavia records are the raw data, not the material that ended up with Icon and later appears in the New England Journal of Misinformation, or even the material that FDA is now releasing slowly.
There is no reason to think Ventavia was any worse than any of the other sites. No-one actually seems to know for sure how many sites there were. EMA thinks 135 in the US, FDA thinks 153. There are pictures suggesting 154 and documents pointing to 155.
Ventavia received an award from Pfizer for their recruitment efforts, having recruited 1500 patients.
Pfizer have meanwhile contracted with Ventavia for a fast-track study on a vaccine for Respiratory Syncytial Virus – RSV. This turns Covid inside out – grandparents won’t be able to visit children without being vaccinated. GSK made the video for this four years ago – see Oh Granny in Reds under the Bed.
Four months after the start of phase 3 of the Covid vaccine trial and 43,000 assessed volunteers later, on November 18 Pfizer announced its completion. Pfizer applied for an Emergency Use Authorization (EUA) for BNT162b2 on November 20. FDA granted them an EUA on December 11, 2020.
The first publication from this trial with Fernando Polack as first author appeared in the New England Journal of Misinformation on December 31 (see next post).
En passant, Pfizer set up a retail outlet, selling teeshirts –
The lead investigator of the trial, Stephen Thomas, was the lead author of the first NEJM article that cited fake results. In a BMJ interview he has made it clear he never saw the data – he only saw aggregated data. Not even the ghostwriter will have seen the data.
Peter Doshi and colleagues have chased this issue of data access – see The New England Journal – Baden et al, The NEJM editors, Lindsey Baden Dan Longo and Eric Rubin, make it abundantly clear that they aren’t bothered what the underlying data looks like – even when an NEJM editor is first author on a paper.
As long as Baden, Longo and Rubin aren’t bothered, indeed are downright hostile to anyone who is bothered, clinical trials will get shoddier and shoddier. From Massachusetts Medical Society documents it appears Eric gets somewhere in the region of $750,000 per year for among other things batting away emails from people like Bri Dressen or the revelations provided by Brook Jackson. Money doesn’t seem to buy backbones.
Rubin was a member of the Vaccine and Related Biological Products Advisory Committee which approved the Pfizer vaccine for Children. His contribution was the immortal line –
‘We are never going to learn how safe this vaccine is unless we start giving it’
Based on the Thomas et al and related NEJM propaganda, both mainstream and social media are happy to accuse everyone in the case series featured in this Forum and anyone else harmed worldwide who claims a link to their vaccine of being misinformation mongerers.
Brook Jackson was fired by Ventavia in September 2020. She made efforts to inform people about what was happening, including filing a False Claims Act. This led to a phone call from Mark Barnes, Financial Times Litigator of the Year for 2019 who works for Ropes and Gray and is an author on Responsible Access to Clinical Trials Data an NEJM article from 2013.
She finally got through to BMJ, who published an account of what happened on November 2, 2021. This became one of the most cited medical articles of recent years. It now contains a Video of Brook in the middle of it.
Facebook branded this closer-to-the-truth article than anything that has appeared in NEJM as misinformation. The BMJ have called out Facebook on this issue. Facebook like Gollum seem to be hiding away in the dark somewhere, muttering something about My Precious.
Roughly 84% of the data in the Pfizer trial collected from US centres was generated by commercial entities like Ventavia operating from 101 sites. Roughly 8.5% of the data was generated at 17 academic sites but we don’t know how much of the operation at these sites was commercial.
Assuming the academic sites did ‘trials as we know them Jim’, the data from these sites might account for approximately 5% of the data collected in the Pfizer trial overall. But we have no reason to think these academic sites did trials as we know them – See the Fishy Goings On post later this week.
Brook is as heroic as Frances Kelsey who stopped thalidomide in its tracks. How long will we have to wait to see Brook celebrated in a major medical journal?
Medical Journal? What’s that?
What do you mean there were Adverse Events, Brook?
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