Who even trusts big pharma anymore and Dr. pill pushers?

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Jun 20, 2021
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The FDA publishes the information, but it does require educated interpretation of some findings that are in need of external interpretation and approval and the chain is not on the same report. At the same time, though, I can search the SrLC to see what adverse reaction labeling has changed this year and it tells me exactly what one might expect from that system.

Unfortunately a government program exposed to politics and the corruption of campaign funders getting their feelings hurt by people saying bad things about them is going to have its ability to provide quality finished reporting products damaged and require distillation from independent sources. People want the FDA to get a World Series ring and a whole town of Pete Roses are managing the team.

Also please don't promote questionable medical snake oil and cite yourself to boost your own credibility. This is the most absolutely filthy violation of credibility in scientific reporting and it is extremely repulsive. It's like circular citations in a homeopath's CV.
 

adam

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I put in the links so people can read the public data I found including a Harvard Univ research study on the FDAs adverse reporting carried out with and for the FDA and paid for by a $1 million Federal Government grant in around 2008-10.

This showed the adverse reaction reporting systems were failing to materially report the true scale of the issue and that the FDA would not allow access to its private data to compare the results of the real patient trials carried out even though this was the stated goal and purpose of doing the extended patient trials involving around 700,000 patients in the Boston area

This was further confirmed by a CDC study in 2015

There are indications from the CDC and others working with the CDC that VAERS data has quality issues.

A CDC study from 2015 (Tom T. Shimabukuro, MD, MPH, MBA, Immunization Safety Office, Centers for Disease Control and Prevention) states

"Quality and completeness of VAERS reports are variable and many reports lack valid medical diagnoses. The amount of VAERS reporting (30,000 U.S. reports annually) makes it impractical to conduct detailed follow-up on all reports to obtain missing and incomplete information and correct inconsistencies and errors. Because VAERS data do not include an unvaccinated comparison group, it is not possible to calculate and compare rates of adverse events in vaccinated versus unvaccinated individuals and determine if vaccination is associated with an increased risk of an adverse event"

Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS)
the purpose of the Harvard study which was to see if there was existing effective reporting of adverse vaccine events in approved FDA vaccines - ie could VAERS be improved.

So no placebo group was required as it was a real life study of what was already being done in routine and emergency vaccine health care to see if VAERS reporting was effective.

There were 715,000 normal medical patients from Atrius Health, a medical group with about 700 Doctors in the Boston area with patients from infants to the elderly

About 50% of the patients had their standard or routine vaccines - some vaccines involved multiple shots over time etc.

45 different types of vaccine were given.

Those who did not have vaccines were not due vaccines or did not get them because they forgot etc etc.

This was real life situation and showed what was going on by building a new ESP-VAERS CDC approved system from scratch, with proper adverse vaccine event reporting done by Artius Health. Based on the findings proper reporting was not and is not going on in the rest of the USA.

My concern is to have real data about Adverse Reactions for ADE, transparency about all adverse vaccine events and how long it took/takes to identify a vaccine risk.

This data is not available in a timely or simple way and the Harvard study and other examples below shows the risks are very real and/or badly under reported even for extended time frames

Also please remember the CDC is very clear 85-90% of the 48,000 VAERS reports in 2019 are minor but 10-15% are serious meaning

"permanent disability, hospitalization, life-threatening illness, or death."

See VAERS link and other info in my previous posts showing the same CDC 10-15% risks over time and in 2009

Its the 10-15% serious cases that concern me - it seems very clear that the

Harvard Study highlighted something the CDC still has not reviewed and it looks like it should have as the Harvard study data was presented and discussed by an FDA official and a Harvard researcher at an AIMA Conference in 2009

The Harvard Study Final Report (see PDF link at the end) states on page 6 under the heading

"Results"

The CDC vaccine safety system VAERS reports fewer than 1% adverse vaccine events [of all types both minor and serious] and that these Harvard findings were presented at an AIMA conference in 2009

Most of the info and links I have found are set out below

After the system was developed, coded, rolled out, real short term patient data was used for reporting adverse vaccine events and calculations.

The Artius Health Drs entered patient data into the new system and filled in the adverse vaccine event forms as and when an adverse vaccine event happened. Over time the data was studied

What happened was that 35,000 adverse events were properly recorded and a total of 1.4 million vaccines doses were given

There is even a sample PDF of the form used by the Atrius Health Drs to input the adverse vaccine event data into the system with the VSD/VAERS vaccine codes already inserted so that cross checking could be done to validate the existing VSD and VAERS data against the very detailed and well maintained trial data



The Harvard study was HHS/FDA funded for US$ 1Million until to 2009 and appears to have been so successful that Harvard continued unfunded for 2010

After the CDC failed to act on the vaccine findings Harvard developed the
system to cover and search patient records for a very wide range of medical conditions and treatments and this remains in use today

“Unfortunately, there was never an opportunity to perform system performance assessments because the necessary CDC contacts were no longer available and the CDC consultants responsible for receiving data were no longer responsive to our multiple requests to proceed with testing and evaluation.”

All the projects vaccine aims were achieved

(except the CDC allowing a validation of CDC data by cross checking with the high quality trial data. The CDC admits the VAERS data is of poor quality - see my previous posts for CDC studies )

The Harvard study achieved aims included a fully working ESP-VAERS system and a vaccine adverse event reporting system using real patients and real data - which identified 35,000+ adverse vaccine events of all types

Under CDC parameters 10-15% of these vaccine events would result in "permanent disability, hospitalization, life-threatening illness, or death." See VAERS link in my previous post

Some info on the Harvard Study reports on US gov web sites is set out below - also see pdf link for final report and other links later below

"The grant team has a functioning adverse event detection system capable of being expanded and modified to deal with a wide range of conditions. Testing and initial validation are complete. Additional validation was planned as part of dissemination to other sites."

"The team had planned to evaluate the system by comparing their adverse event findings to those in the Vaccine Safety Datalink project a collaborative effort between CDCs Immunization Safety Office and eight large managed care organizations.

Through a randomized trial, the team had also planned to test the hypothesis that the combination of secure, computer-assisted, clinician-approved, adverse event detection, and automated electronic reporting will substantially increase the number, completeness, validity, and timeliness of physician-approved case reports to VAERS compared to the existing spontaneous reporting system.

However, due to restructuring at CDC and consequent delays in terms of decisionmaking, it was ultimately not possible to move forward with discussions regarding the evaluation of ESP:VAERS performance in a randomized trial, or to compare ESP:VAERS performance to existing VAERS and Vaccine Safety Datalink data, as was described in the third aim.

However, the infrastructure is available and Dr. Lazarus is hopeful that the project may generate additional interest to complete this study."

After the CDC stopped co-operating with the study, Harvard researchers, developed the system and it sold across the USA to government and private groups - including to the original Artius Health group involved in the Harvard study trial.

Current system sales continue to date but it does not seem to be electionically linked into VAERS though some states appear to use it for vaccine monitoring in some way. See users in link below


The Harvard study details and quotes above are set out in the links below - US Gov website (HHS/FDA related funding etc)

There are several tabs near the top of the page on the links that take you to different reports and on different pages of info - titled

Project Description
Annual Summaries
Final report PDF
Etc etc




Its also clear that there was a population of patients who were vaccinated and unvaccinated that could have been researched in some way to easily provide some initial findings on if there were vaccine derived health events.

As set out at the start my concern is to have real data about Vaccine Adverse Event reactions such as Antibody-dependent enhancement / ADE, transparency about all adverse vaccine events and

how long it takes/took to identify an adverse event risks.

This last point is never really discussed currently or identified anywhere - its all very vague and not very scientific.

There appears to be no system that is publically available or any public reporting of the true figures of ADE or other adverse vaccine events for each vaccine or what if any delays there have been with VAERS identifying a vaccine problem.

More and better data should identify the problems sooner
There are also a range of opinions expressed on the posts I linked to by many people including leading researchers and those who are very pro vaccine

An example of the data is below and includes research data funded by the UK Govts Medical Research Council on Aluminum Toxicity the research was carried out.

Professor Chris Exley
Professor in Bioinorganic Chemistry Keele University
Honorary Professor, UHI Millennium Institute
Group Leader - Bioinorganic Chemistry Laboratory at Keele

Aluminium Adjuvants in Vaccines: Missing Information

I have been researching human exposure to aluminium for over thirty-five years. I am (sometimes affectionately) known as Mr Aluminium. About ten years ago, I became interested in aluminium adjuvants and specifically how they help to potentiate the immune response in vaccination.

Funded initially by the Medical Research Council (Nanotoxicity of Aluminium Adjuvants) we set about testing dogma associated with their mechanism of action in vaccines - read full article and research paper links below


Other data from links



 

adam

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This is not about Covid Vaccines it is too early to reach any long term conclusions and what has been lacking is clear data.

The post was about trusting Big Pharma and it influence over politicians, the media and the FDA

It seems sensible that it is

"unlawful under Section 5 of the Federal Trade Commission Act for any person, partnership, or corporation to engage in a deceptive act or practice

in or affecting commerce

associated with the treatment, cure, prevention, mitigation, or diagnosis of COVID–19...."

It is not deceptive in any way let alone for commerce to quote the CDCs own researchers and published data.

The post points people to published and unpublished research papers and news reported almost always by regular or mainstream media / news sources with links

There is no medical advice being given or commerce being promoted however medical trial data is referred to as it shows additional treatments that can be used with and at the same time as vaccines

We are already seeing from Israel that the Delta Covid mutation is infecting vaccinated people


Vaccines still appear to stop Covid infections getting very bad but alternative treatments are long over due.

People need to read the research and media and decide what they think.

A cancel culture does not help. If the Dr who helped invent and patent mRNA tech is not allowed to speak about it this is tragic.

Dr. Robert Malone: mRNA Vaccine Inventor Speaks Out Against Big Tech Censorship

View: https://m.youtube.com/watch?v=H3-nRqwqBgs


It could be argued that withholding or blocking information and data is a "deceptive act or practice" and may effect commerce

The CDCs researchers set out why the VAERS data cannot be relied on

A CDC study from 2015 (Tom T. Shimabukuro, MD, MPH, MBA, Immunization Safety Office, Centers for Disease Control and Prevention) states

"Quality and completeness of VAERS reports are variable and many reports lack valid medical diagnoses. The amount of VAERS reporting (30,000 U.S. reports annually) makes it impractical to conduct detailed follow-up on all reports to obtain missing and incomplete information and correct inconsistencies and errors.

Because VAERS data do not include an unvaccinated comparison group, it is not possible to calculate and compare rates of adverse events in vaccinated versus unvaccinated individuals and determine if vaccination is associated with an increased risk of an adverse event"

Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS)

The Harvard University / FDA study mentioned previously was done with the FDA and also concludes in its findings that VAERS may report only around 1% or less of adverse reaction events

See the links previously above for Harvard Study data and Federal funding applications

It is noted in the study summary FDA never facilitated or allowed the the trial to progress, as was planned and set out in the Federal funding application, to comparing the FDAs private VSD database with the real patient trials carried out using the newly developed Harvard University Study alternative VAERS system

The Harvard patient trials involved around 715,000 real patients and 700 Drs in the Boston area.

The Harvard Study found around 35,000 adverse reaction events were reported (vaccine doses being given across all age groups as patients normally required)

However about the same number of adverse reactions were reported by the FDA for the whole of the USA in a year (at that time)

VSD - Vaccine Safety Datalink project is a collaborative effort between CDCs Immunization Safety Office and eight large managed care organizations.

This VSD data is not provided to the public or independent researchers nor is there any public data for cross comparisons of VSD and VAERS data



What is clear is that there is some real data not getting reported to the public or independent researchers particularly for now the VSD data on Covid.

The CDC reported by email to the Epoch Times the adverse reactions / deaths in the FDA VAERS system from Dec 2020 to Feb 2021 for the Covid-19 vaccines.

This approximately exceeded the adverse effects / deaths normally reported for a full year for all vaccinations of any type.

It seems quite normal to ask what is going on, is this true and what is the explanation and data to support the findings


Here is a Reuters Fact Check link

There is no evidence that the deaths reported to VAERS after receiving the COVID-19 vaccine are caused by the vaccine.

https://www.reuters.com/article/factcheck-vaers-deaths-idUSL1N2MZ2H8

However what does seem true is that more adverse events and deaths are being reported to VAERS following Covid vaccines than was happening previously for all other vaccines in a full year prior to Covid vaccinations being used

More openness would be helpful
 
Jul 11, 2021
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Even failing drug trials are recorded/reported with the regulators. It's not a big conspiracy that failed drug trials do not get massive media attention as it is fairly common for a drug to show little to no effect. When it comes to big pharma making money, that is what private companies do: make money. Medicines being a special kind of product, your really needing a societal effort or shift that will let you have non-profitable treatments investigated/trialled and approved...

The Adverse Events Reporting is not a perfect system- a person csn be given a placebo and die the next day from a heart attack. Part of adverse events reporting could include innocuous symptoms that may not have anything to do with a treatment being monitored. Any issues with the entertainment complexes (i.e. pee pee parts) cpuld also be reported for adverse events.
 

adam

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You are right - pharma should report the data but independent studies show that they do not. The link is below

It seems likely that the media does not report failed drug trials for existing drugs or scandels involving failed existing drugs because of tge advertizing revenue conflicts.

Because a drug fails in one of multiple trials does not mean it is not approved by the FDA.

The threashold for approval of a drug by the FDA is an area of debate with some saying the hurdles to pass to show a benefit are too low


CNN and FOX have many shows sponsored by phrama


The study that a shows a significant number of medical trials are not reported despite being required to.

There have been cases where pharma has been caught withholding data - Glaxo had $billions in fines related to withholding trial data on paxil which resulted in suicides and Gilead has been sued for withholding data showing better less damaging drugs were available.

Given pharmas commercial motives the management needs to be liable for withholding data

Given past experience of phrama withholding data it was not obvious that data was withheld so it seems possible that pharma will not often be caught withholding data that would show negative effects as they control how the studies are done and the data presented.

Further trials can be cancelled or restructured mid way.

Dengue fever treatments are a simple example of data being ignored and withheld for many years even after it was deployed and adverse events often reported.

The Dengue fever saga is set out in the post on ivermectin.

Other studies on MMR and DTP treatments also raise serious concerns

For example a 2017 study funded by the Danish Govt and others concluded that the death rate among children vaccinated with DTP vaccine was up to 5 times higher than all children not vaccinated (and 10 times higher in girls) Other studies have come to similar conclusions

The Introduction of Diphtheria-Tetanus-Pertussis and Oral Polio Vaccine Among Young Infants

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5360569/

"DTP was associated with 5-fold higher mortality than being unvaccinated. No prospective study has shown beneficial survival effects of DTP. "

"It should be of concern that the effect of routine vaccinations on all-cause mortality was not tested in randomized trials."

Science examined more than 4700 trials whose results should have been posted on the NIH website ClinicalTrials.gov under the 2017 rule

It also seems reporting trials only applies to human trials not animal studies

It seems that phrama are supposed to report most trials but around 31% dont and 22% are materially late

There are some trials that dont have to report and it seems likely adverse results would not be reported in these cases.

Separately to trials that can withhold data

"many trials, such as industry-sponsored early-stage evaluations of drug safety, are exempt from reporting, about 326,000 have been registered, and results have been posted for more than 40,000"

Again it seems likely adverse trial data would be withheld

CONGRESS APPROVED THE CREATION OF ClinicalTrials.gov in 1997, after allegations that patients were harmed because companies withheld evidence showing their medicines were ineffective or hazardous. A widely cited case involved the GlaxoSmithKline antidepressant Paxil (paroxetine). According to legal filings and a report in The BMJ, the firm held secret data showing that in clinical trials the drug was ineffective and caused suicidal thoughts in teenagers, yet encouraged doctors to prescribe it for young people


Gilead litigation

We allege that individuals who took one or more of Gilead’s TDF drugs endured up to 10 years of additional toxicity even though Gilead had already developed a safer alternative.


The allegations Public Citizen brought forward concerning Gilead’s conduct with respect to Remdesivir and GS-441524 is remarkably similar to its alleged conduct in a lawsuit pending in San Francisco Superior Court on behalf of thousands of individuals represented by Kershaw, Cook & Talley and other law firms across the United States. In this lawsuit, plaintiffs allege that Gilead developed TDF-based drugs — commonly known as Viread®, Truvada®, Truvada for PrEP®, Atripla®, Complera® and Stribild® — for the treatment and prevention of HIV infection, while it simultaneously developed TAF-based drugs proved to be safer and at least equally effective at much smaller doses. Gilead’s own studies demonstrated that TDF had a much higher risk of severe side effects, including bone loss and kidney failure.


TDF Lawsuit – When Are Gilead Claims Likely to Settle?
Updated July 12, 2021

Based on similar mass tort claims that are based on defective drugs and a pharmaceutical company’s failure to warn people about serious risks, it could still be several years before settlements are made in Gilead lawsuits.

 
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They surly aren't out to help people get better but keep them sick to continue to make billions of profits.

I remember before my grandma died she was on 10 different types of pills for years. Each pill counteracted the problem of the other pills. What are your thoughts?
In the UK virtually every medication is free for the elderly - You could argue they paid during their lifetime or indeed their pension if high enough, but essentially medication is free.

Assuming you are from America, I assume the 10 different pills is to cover the doctor from a lawsuit should your grandmother have died after removing a medication.

The population have created a blame culture and it is just too risky to remove something unless forced or no other option - If you were to sign a disclaimer that the medical team had to responsibility for ill health/ death in removing a medication, I bet you would hesitate with the professional only able to advise everything carries a risk.

Pharmaceutical companies can;t do right... There is backlash if they do not invest or produce a medication and there is a backlash when they try to sell it... Look to make them Government owned and the population start new conspiracies...
 

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