BMJ’s Peter Doshi Tells FDA About Serious Concerns Over Pfizer Trial Data and Lack of FDA Oversight

dailyexpose.uk ^ | MAY 11, 2022 | RHODA WILSON

[ransomnote]

Dr. Peter Doshi is an editor at the British Medical Journal (“BMJ”).  He dialled in to the most recent FDA committee meeting on vaccines and related biological products to give them his views regarding the integrity of the Pfizer “vaccine” trials.

On 2 November 2021, the BMJ published information disclosed to them by whistle-blower Brook Jackson, a former regional director for Ventavia Research Group.  Ventavia is a company that was contracted by Pfizer to help with the decisive trial.

Jackson provided BMJ with company documents, audio recordings, emails and photographs to support her claims.  She told BMJ: “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.” 

By The Naked Emperor

I have written a few posts about Dr. Peter Doshi as he seems to be a man of integrity, reporting on issues that most mainstream publications don’t or won’t. Dr Doshi is an associate professor of pharmaceutical health at the University of Maryland School of Pharmacy, as well as a senior editor at the British Medical Journal. “His research focuses on the drug approval process, how the risks and benefits of medical products are communicated, and improving the credibility and accuracy of evidence synthesis and biomedical publications.”

In the most recent US Food and Drug Administration (“FDA”) Vaccines and Related Biological Products Advisory Committee meeting in the US, 6 April 2022, Dr. Doshi dialled into the Open Public Hearing Session. This is where members of the public can present their own information to the FDA. The committee was meeting to discuss considerations for the use of Covid vaccine boosters and the process for Covid vaccine strain selection to address current and emerging variants.

Dr. Doshi told the FDA about Brook Jackson, a whistle-blower from Ventavia, which ran Pfizer’s vaccine trials. He discussed how unblinding of trial participants seems to have occurred and how this creates serious concerns about data integrity. Dr. Doshi also highlighted the lack of FDA inspection.

The video for the FDA meeting is below. We have embedded the video to begin with Peter Doshi’s statement (start 5:34:44). But all of the public presentations are interesting and these begin at around 5:15, wrote The Naked Emperor.

US FDA: Vaccines and Related Biological Products Advisory Committee, 6 April 2022

A transcript of his comments is below.

Hi, I’m Peter Doshi, thanks for the opportunity to speak. Hopefully, you can see my title slide with my financial disclosures. For identification purposes, I am on the faculty at the University of Maryland and an editor at the BMJ. I have no relevant conflicts of interest and my comments today are my own.

Last November, The BMJ reported the disclosures of a whistle-blower named Brook Jackson, who worked for Ventavia – a contract research company that ran three of the clinical trial sites for Pfizer’s vaccine. Jackson alleged the company had falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events. She provided The BMJ with company emails, internal documents, text messages, photos and recordings of her conversations with company employees.”

This photo, for example, shows vaccine packaging materials that are only supposed to be seen by unblinded staff, just left out in the open.

An unblinding may have occurred on a far wider scale. Here you can see the document containing the instructions Ventavia staff were given to file each trial participant’s randomisation and drug assignment confirmation sheet into each participant’s chart. This contained unblinded information.

Unblinding, as I think everybody knows, creates serious concerns about data integrity. Once this massive error was discovered, Ventavia asked staff to go through each and every chart to take out the randomisation and drug assignment confirmations. You can see here an email from Ventavia’s COO reacting after discovery of the problem. They had not even realised that the drug assignment confirmation contained unblinding information.

In the heat of a pandemic, it’s not hard to imagine that corners were cut and mistakes were made. Some mistakes are benign but others carry serious consequences to data integrity. One hopes Ventavia is an extreme outlier, but we need more than just hope. We need evidence that the data were dealt with properly. We need regulatory oversight. But despite whistle-blower Brook Jackson’s direct complaint to the FDA, FDA never inspected Ventavia. In fact, FDA only inspected 9 of the trial’s 150-plus sites before approving the vaccine. Just 9 sites. And Pfizer continues to use Ventavia for trials.

What about Moderna? FDA had over a year and inspected just one – ONE – of the trial’s 99 sites. How can FDA feel confident in the Moderna data based on a 1% sample?

Data integrity requires adequate regulatory oversight. Trustworthy science requires data transparency. It’s been over a year, but anonymised participant-level data remain inaccessible to doctors, researchers, and the public. The public paid for these products, and the public takes on the balance of benefits and harms post-vaccination. The public has a right to data transparency and FDA has an obligation to act.

Thank you.

Further Resources: Covid-19 vaccines and treatments: we must have raw data, now, BMJ, 19 January 2022

 

[ransomnote]

PING

[DugwayDuke]

More fake news from the Expose:

Here’s an analysis of doshi’s claims:

https://www.covid-datascience.com/post/refuting-peter-doshi-s-claims-doubting-trustworthiness-meaningfulness-of-covid-vaccine-results

[ransomnote]

Your bought-and-paid-for source of pro 'vaccine' propaganda:

The owners of your propaganda source:

Penn Medicine: $14 Million NIH Grant, $8 Million Transplantation Research Grant, and $2 Million in CDC Grants | University of Pennsylvania Almanac (upenn.edu)

FAUCI has been cultivating allegiance with billions in grant money for decades. He OWNS your sources at University of Penn and MANY, many other similar universities, medical schools, research centers. Lap it up, shill.

[DugwayDuke]

You do realize your anti-vaxxer heros are making millions on their opposition to vaccines?

[ransomnote]

In the General/Chat forum, on a thread titled BMJ’s Peter Doshi Tells FDA About Serious Concerns Over Pfizer Trial Data and Lack of FDA Oversight, DugwayDuke wrote:

You do realize your anti-vaxxer heros are making millions on their opposition to vaccines?

*

Only shills believe being 'cancelled' and smeared by the MSM, fired/threatened by employers/medical boards etc. is a money making venture. They were successful before they objected to toxic, unneccessary experimental gene therapy 'shots' that kill far more than they help.

[Triple]

This is huge. Short PFE! Fraud in trials again? Death penalty…

[SecAmndmt]

Only a total dumbass would claim that the ppl losing their jobs over cv mandates were “making millions”. All the MDs against the cv19vx are facing attacks on their licenses and mounting legal bills. And meanwhile, Pf just made a multi-billion dollar profit off the backs of taxpayers.

[DugwayDuke]

ransomnote wrote: “Only shills believe being ‘cancelled’ and smeared by the MSM, fired/threatened by employers/medical boards etc. is a money making venture.”

Malone, one of your favorites, has a newsletter with over 134,000 paid subscribers. A subscription costs $60/year. That’s over $8 million annual. Do you think he would have this gold mine if it wasn’t for his constant criticism of vaccines to lure the naive? FWIW, his net worth exceeds Fauci.

Then there is Mercola who “In 2017, he filed an affidavit claiming his net worth was “in excess of $100 million.”:

https://www.nytimes.com/2021/07/24/technology/joseph-mercola-coronavirus-misinformation-online.html

ransomnote wrote: “They were successful before they objected to toxic, unneccessary experimental gene therapy ‘shots’ that kill far more than they help.”

Regardless of how many times you claim, the vaccines have saved millions of lives, they are not toxic, and they are fully approved, not experimental.

[ransomnote]

In the General/Chat forum, on a thread titled BMJ’s Peter Doshi Tells FDA About Serious Concerns Over Pfizer Trial Data and Lack of FDA Oversight, DugwayDuke wrote:

ransomnote wrote: “Only shills believe being ‘cancelled’ and smeared by the MSM, fired/threatened by employers/medical boards etc. is a money making venture.”

Malone, one of your favorites, has a newsletter with over 134,000 paid subscribers. A subscription costs $60/year. That’s over $8 million annual. Do you think he would have this gold mine if it wasn’t for his constant criticism of vaccines to lure the naive? FWIW, his net worth exceeds Fauci.

Then there is Mercola who “In 2017, he filed an affidavit claiming his net worth was “in excess of $100 million.”:

https://www.nytimes.com/2021/07/24/technology/joseph-mercola-coronavirus-misinformation-online.html

ransomnote wrote: “They were successful before they objected to toxic, unneccessary experimental gene therapy ‘shots’ that kill far more than they help.”

Regardless of how many times you claim, the vaccines have saved millions of lives, they are not toxic, and they are fully approved, not experimental.

You can't keep your talking points straight. You make the point that Malone doesn't need money, he's supposedly worth more than Fauci. Malone was enjoying the fruits of his labor after decades in science until he unwittingly got the 'vaccine'. He learned the Covid 'vaccines' were toxic and came out of retirement to withstand cancellation harrassment and threats to warn others. Only shills say that he would turn aside a life of luxurious retirement to go through the furnace of the propaganda storm that now hounds him and his family. He's not safe from the people who want to conceal the truth about the 'vaccines. You're just sure all he wanted to do in his retirement is operate a controversial blog and use the proceeds to hire consultants, travel to public hearings, publish content at his own expense.

You make my point for me re Mercola - his net worth was 100 million BEFORE Covid 'vaccines'. He wasn't hurting for money and he's been threatened and harrassed as a result that he takes his articles down within 24 hours of posting them on his website.

You're acting like a vulture, wheeling high above threads, looking for people to mislead into trusting the 'gene therapy' shots. The only people who agree with you that they are 'safe and effective' are traitors like Anthony Fauci and Walensky. 

The Covid 'vaccines' have triggered massive safety signals that are 100% ignored and denied while your kind look for your prey.

Christian Elliot's excellent article (linked below) includes a chart showing deaths per dose reports the CDC has elected to publish to its publicly accessible database, VAERS (Vaccine Adverse Events Reporting Sytem). In the past 10+ years, Covid 'vaccines' have resulted in 20 times the number of deaths reported post 'vaccination' than any other vaccine. The number is an under estimate because of the politicization of reporting.

17 More Reasons I Won't Be Getting a Covid Vaccine
deconstructingconventional.com ^ | Oct 27, 2021 | Christian Elliot

[mewzilla]

And that guy uses the word we, then there’s no info on the rest if the so-called team.

Not transparent, is it...

[ransomnote]

In the General/Chat forum, on a thread titled BMJ’s Peter Doshi Tells FDA About Serious Concerns Over Pfizer Trial Data and Lack of FDA Oversight, mewzilla wrote:

And that guy uses the word we, then there’s no info on the rest if the so-called team.

Not transparent, is it...

*

Zero transparancy. Creepy picture of him on the supposed 'debunk' site. Interesting the shills can be taken in by one guy providing his name and workplace, while his department receives millions in grants from the CDC/NIH. Whatever he says must be true? Right? Nothing to see here.....

[DugwayDuke]

ransomnote wrote: “You can’t keep your talking points straight. You make the point that Malone doesn’t need money, he’s supposedly worth more than Fauci. Malone was enjoying the fruits of his labor after decades in science until he unwittingly got the ‘vaccine’. He learned the Covid ‘vaccines’ were toxic and came out of retirement to withstand cancellation harrassment and threats to warn others. Only shills say that he would turn aside a life of luxurious retirement to go through the furnace of the propaganda storm that now hounds him and his family. He’s not safe from the people who want to conceal the truth about the ‘vaccines. You’re just sure all he wanted to do in his retirement is operate a controversial blog and use the proceeds to hire consultants, travel to public hearings, publish content at his own expense.”

No, Malone, Mercola, et al, are not the altruistic you would have them be. If what you say is true about Malone, then why does he charge for his newsletter?

[ransomnote]

One of those waste-of-time posts you make to lead away from the importance of the content of the thread. There’s nothing you won’t try to dilute or distract from if it’s otherwise helpful to FReepers.

[cgbg]

The FDA has been taken over by animal rights activists.

There is no point in risking the lives of lab rats when humans will stand in line for medical experimentation.

[SecAmndmt]

They are not fully approved, and they are experimental. If they were fully approved, they would not have the lawsuit protection that they currently enjoy. What the clot shot producers want, is to put the clot shots on the childhood schedule, so that they then enjoy the no-fault protection (underwritten by the taxpayer) which all childhood scheduled vaccines enjoy. An approved cv19vx which is not on the childhood schedule would be a disaster for your buddies at Pfizer, Fauci-derna and JJ. All would be reduced to penny stocks as the thousands of injured and families of dead sued them into the ground.

You’re a liar. We all know that.

Malone’s newsletter income is nothing compared to what Pharma is raking in. And he’s got a bullseye on his back and his license. My friends in the Frontline nursing group are even less well compensated: they save lives for free. One of them has gotten dozens of death threats in exchange for successfully treating your bioweapon spike.

[SecAmndmt]

People can pay if they want. Not everyone subscribes. Consider the volume of paid subscribers as a gauge of our dislike of what you represent (genocide).

[DugwayDuke]

SecAmndmt wrote: “They are not fully approved, and they are experimental. If they were fully approved, they would not have the lawsuit protection that they currently enjoy.”

All vaccine makers enjoy lawsuit protection. Covid is not unique.

SecAmndmt wrote: “Malone’s newsletter income is nothing compared to what Pharma is raking in.”

A red herring since Malone doesn’t have to share the income with stock holders, doesn’t have large manufacturing facilities, or hundreds of thousands of employees to support.

[DugwayDuke]

SecAmndmt wrote: “People can pay if they want. Not everyone subscribes. Consider the volume of paid subscribers as a gauge of our dislike of what you represent (genocide).”

Completely irrelevant to the question of whether Malone is making a fortune from his anti-vaccination stance. Anti-vaxxers love to criticize others for making money from vaccines while ignoring the fact that their anti-vaxxer heros are also making a fortune.

Furthermore, the only ones advocating genocide are those campaigning against the safe and effective vaccines.

[DugwayDuke]

ransomnote wrote: “One of those waste-of-time posts you make to lead away from the importance of the content of the thread. There’s nothing you won’t try to dilute or distract from if it’s otherwise helpful to FReepers.”

Pushing incorrect and dangerous information such as the threads you publish are not helpful to FReepers. The real importance of these garbage threads are the forum they provide for those posting accurate information to rebut the misrepresentations you publish.
Here’s some additional information about how misleading this thread actually is:

12% effectiveness

The claim:
Those against COVID vaccines are claiming that newly released documents prove that they are only 12% effective.

The facts:
The documents released during a FOIA request have clearly shown that the vaccine efficacy was, as stated, 95% at the time those documents were released. Those claiming otherwise, specifically that vaccine efficacy was only 12%, are 1) misunderstanding how vaccine efficacy is calculated and/or 2) misunderstanding the definitions of status as used in those documents.

The vaccine efficacy was calculated using the number of people who tested positive for covid during the trials in both the vaccine group (8) and the placebo group (168). These people making the claim of 12% are instead insisting that rather than using positive covid results as an indicator of covid, “suspected but unconfirmed” cases should be counted as well.

The problem, however, is the definition of “suspected but unconfirmed.” In this trial, anyone with any symptom of COVID (many of which are also symptoms of other respiratory diseases) was required to be given a PCR COVID test to determine whether that case was COVID or not. Those who tested positive were then “confirmed COVID” cases, while those who tested negative were listed as “suspected but unconfirmed”.

In other words, these people got sick, or were even experiencing the effects of the vaccine, but did not test positive COVID. And since the COVID vaccine was not created to reduce *all* sources of fever, cough, etc, it would be dishonest to include these “suspected but unconfirmed” cases in the calculations of vaccine efficacy for the COVID vaccine.

https://mailchi.mp/voicesforvaccines/just-the-facts-july-30-1045533?e=bdf3721c5d