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Editor of the British Medical Journal tells the FDA about Serious Concerns over Pfizer Trial Data Integrity

Suhrthing

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Transcript of Peter Doshi's presentation to the FDA Vaccines and Related Biological Products Advisory Committee meeting.
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.


And 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 randomization 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 randomization and drug assignment confirmations. You can see here an email from Ventavia’s COO reacting after discovery of the problem: they had not even realized 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 whistleblower 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.
 

JD08

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NC_Canes_11

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I for one am shocked, that a company with a rich history in bribing officials, and paying huge fines for breaking the law, cut a few corners and lied about a vaccine that they produced in record time and were given legal immunity for. A vaccine that they used tax payer dollars to develop, and were guaranteed billions in profit off of.

I mean those circumstances just scream accountability and thoroughness to me.
 

OriginalGatorHater

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The more I learn about data, statistics, and data science, the more seeing things like this troubles me. There are a lot of questionable studies out there and it's like nobody bothers to actually investigate.
Good doctors do. You may have some schitty Medicaid doctor that will just look at the abstract, but real elite doctors are careful with the studies they take into consideration. Same with good scientists, if they see some sort of flaw in another study, if they feel its worth it, they will investigate it.
 

JD08

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Good doctors do. You may have some schitty Medicaid doctor that will just look at the abstract, but real elite doctors are careful with the studies they take into consideration. Same with good scientists, if they see some sort of flaw in another study, if they feel its worth it, they will investigate it.
I agree, but a lot of problems arise in data acquisition. That's the best place to skew results or hide incompetence.
 

OriginalGatorHater

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I agree, but a lot of problems arise in data acquisition. That's the best place to skew results or hide incompetence.
I agree. Its the reason why I am very careful with which doctors I use/trust for medical advice and why I pay out of pocket for any important procedures my family members need to take. It is crazy how many doctors are incompetent, I grew up only going to docs that accepted medicaid, so I know firsthand.
 

surfcane

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Good doctors do. You may have some schitty Medicaid doctor that will just look at the abstract, but real elite doctors are careful with the studies they take into consideration. Same with good scientists, if they see some sort of flaw in another study, if they feel its worth it, they will investigate it.
I can only agree to some degree - most that I interact with do not know how to really access a study and then do not have the time on top of that. I would say about 50% of the studies would not get published if data was objectively examined. One example is the TNT study - somehow all the doctors I know missed the issues here, and I have asked some leading specialist about it (cardiology) - but it is not realized or acknowledged the issue(s). - Way too much to type but one can figure this out in about 30 sec if you look at data and understand it without someone else's filter on the data.
 

Suhrthing

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I agree. Its the reason why I am very careful with which doctors I use/trust for medical advice and why I pay out of pocket for any important procedures my family members need to take. It is crazy how many doctors are incompetent, I grew up only going to docs that accepted medicaid, so I know firsthand.
I spent all of February in the hospital as dozen's of doctors misdiagnosed a perforated appendix as covid-related ileus... I lost much faith in doctors after that.
 

OriginalGatorHater

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I can only agree to some degree - most that I interact with do not know how to really access a study and then do not have the time on top of that. I would say about 50% of the studies would not get published if data was objectively examined. One example is the TNT study - somehow all the doctors I know missed the issues here, and I have asked some leading specialist about it (cardiology) - but it is not realized or acknowledged the issue(s). - Way too much to type but one can figure this out in about 30 sec if you look at data and understand it without someone else's filter on the data.
You really didn't disagree with what I said. You just happen to interact with the scrubs like I was mentioning before. Its like comparing Artur Sitkowski to Tom Brady. They are both QBs, but they are nowhere near close to the same level. The docs you interact with and the ones that are truly elite are not even close to the same level.
 

OriginalGatorHater

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I spent all of February in the hospital as dozen's of doctors misdiagnosed a perforated appendix as covid-related ileus... I lost much faith in doctors after that.
Sorry to hear that. Lucky for me, I am still young enough, that I have never had any sort of serious illness. But when I have family members that have issues like that(perforated appendix for example). I would never use regular hospitalists. The only way to ensure good care is find the top minds for that field and pay them out of pocket to go above and beyond the type of treatment you would usually receive for for the "fee schedule" or "treatement level" or whatever that particular insurance company refers to it as, that the MDS specialists/case managers have deemed you worthy of.
 

JD08

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Most doctors treat for the most likely cause and rarely look past until their treatment doesn't work.

I had an infection in a finger, went to urgent care, got basic antibiotics. The wound got a little better but didn't heal. Followed up with PCP*, got a different prescription. Didn't heal, got referral to dermatologist. Dermatologist took a culture, started a different antibiotic. Culture came back and all the antibiotics I'd taken weren't effective. Put me on the recommended antibiotic. Wound healed, but still swollen and red, referred me to infectious disease doctor. Continue antibiotics, MRI to make sure infection isn't in the bone or the joint because it's been so long.

Almost 5 months from the first time I went to urgent care I was off antibiotics, but now that joint is swollen and painful with arthritis that wasn't there prior to all this, but no infection. If they'd just done a culture to begin with, I wouldn't have spent nearly as much and I might not have arthritis. But that's not the way it works.


*My PCP retired and a medical group bought his practice. I hate them and we're shopping around right now.
 

OriginalCanesCanesCanes

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Most doctors treat for the most likely cause and rarely look past until their treatment doesn't work.

I had an infection in a finger, went to urgent care, got basic antibiotics. The wound got a little better but didn't heal. Followed up with PCP*, got a different prescription. Didn't heal, got referral to dermatologist. Dermatologist took a culture, started a different antibiotic. Culture came back and all the antibiotics I'd taken weren't effective. Put me on the recommended antibiotic. Wound healed, but still swollen and red, referred me to infectious disease doctor. Continue antibiotics, MRI to make sure infection isn't in the bone or the joint because it's been so long.

Almost 5 months from the first time I went to urgent care I was off antibiotics, but now that joint is swollen and painful with arthritis that wasn't there prior to all this, but no infection. If they'd just done a culture to begin with, I wouldn't have spent nearly as much and I might not have arthritis. But that's not the way it works.


*My PCP retired and a medical group bought his practice. I hate them and we're shopping around right now.

When it comes to a simple situation, I’m assuming it was simple, say an infected finger, which is pretty common, especially with people that work with their hands, hardly ever will they do a culture.

First of all it’s unlikely that the insurance company would pay for it, and second of all most broad-spectrum antibiotics should take care of it. But of course that’s not full proof if you have something deep in the tissue like maybe an anaerobic infection. Doctors are like anybody else they just play the averages.

Was your infection due to an injury, or a cut where the skin was broken, or was your skin intact?
 

Suhrthing

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For you medical folks in the know... is not getting a bill for the hospital for the stay for over 2 months+ abnormal at all? All claims for radiology, docs etc have been submitted - but still i've not received the actual stay bill yet.
 

JD08

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When it comes to a simple situation, I’m assuming it was simple, say an infected finger, which is pretty common, especially with people that work with their hands, hardly ever will they do a culture.

First of all it’s unlikely that the insurance company would pay for it, and second of all most broad-spectrum antibiotics should take care of it. But of course that’s not full proof if you have something deep in the tissue like maybe an anaerobic infection. Doctors are like anybody else they just play the averages.

Was your infection due to an injury, or a cut where the skin was broken, or was your skin intact?
Oh, I know. I get how it works which is why I'm not livid. Somehow I got a less common bacteria and Bactrim didn't do the trick, neither did Omnicef. Ironically, plain old ampicillin was the one I needed.

I got and broke a blister removing old flooring while remodeling my office. That was all it took.
 

OriginalCanesCanesCanes

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For you medical folks in the know... is not getting a bill for the hospital for the stay for over 2 months+ abnormal at all? All claims for radiology, docs etc have been submitted - but still i've not received the actual stay bill yet.

That’s not unusual at all. I’m pretty sure you’re going to get a bill. Expect to pay your full deductible this year.
 

OriginalCanesCanesCanes

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Oh, I know. I get how it works which is why I'm not livid. Somehow I got a less common bacteria and Bactrim didn't do the trick, neither did Omnicef. Ironically, plain old ampicillin was the one I needed.

I got and broke a blister removing old flooring while remodeling my office. That was all it took.

Hey thanks. I’m kind of a microbiology nerd even though my major was chemistry.

There could have been a myriad of bacteria that causes infection, most people would lean towards a gram-positive, less likely but possible are gram-negative infection. Not likely anaerobic, but it’s always a possibility if it was deep in the tissue. If ampicillin finally did the trick, I’m going take a wild guess and say it was either Staph or Streptococcus
 

Suhrthing

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That’s not unusual at all. I’m pretty sure you’re going to get a bill. Expect to pay your full deductible this year.
Luckily I have a max, yearly out of pocket (which is surprising low) that I didn't even know I had until after getting out.

Starting around week 2 this was me...

1652137719573.png



I must have great insurance because I've been shocked on how little I owe (could be normal but insurance only paid half of the surgery claim, and the rest was 'discounted' - all but a couple hundred). The highest $ doc consult was the gastro consult I asked for when the surgeons / hospitalists were throwing darts, he came in for 5 minutes (not sure even gave more than a passing glance to my charts because he's asking me questions that they would have answered) and basically said 'ok I agree with whatever the surgeons are saying' and took off.

I wonder how much wtf pushback my insurance is giving them for keeping me 30 days for appendicitis.
 
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