Only “researchers, trial participants, regulators, and others” who act in what Pfizer deems to be “the best interest” of patients have access to the pharmaceutical company’s clinical trial documents that reveal injuries and deaths from their Covid-19 mRNA drug.
QUICK FACTS:
- A federal judge in Texas ordered the Food and Drug Administration (FDA) in January to make public the data it relied on to license Pfizer’s COVID-19 vaccine, Reuters reports.
- The FDA had initially asked for 75 years to release the data.
- U.S. District Judge Mark Pittman in Fort Worth ordered the agency to turn over 55,000 a month.
- However, instead of making the data available to the public, Pfizer’s website says only “researchers, trial participants, regulators, and others acting in the best interest of patients to have access to clinical trial information to advance medical understanding and progress.”
- The pharmaceutical giant also specified it would only give the data “in response to scientifically valid research proposals.”
- The public may not see Pfizer’s trial data. Instead, “data requestors must complete a data request on the Vivli platform,” Pfizer’s website goes on to say.
- “Pfizer will review the request using an internal committee, composed of Pfizer colleagues who are responsible for the asset program, statistician, and data sharing experts.”
- “[T]here may be instances in which retrieval or delivery of data is not feasible,” Pfizer warns.
REASONS PFIZER WILL DENY ACCESS TO THE DATA:
- “Patient privacy – For example, the request seeks clinical data for which patient de-identification is difficult or for which there is a reasonable likelihood of re-identification, or where there are limitations or restrictions due to privacy rights of individuals in accordance with applicable privacy laws,” Pfizer’s website reads.
- “Permissions – Where the request seeks clinical data that was collected subject to legal, contractual, and/or consent provisions that prohibit transfer to third parties; where the request seeks data from locally conducted studies in which data and results are only available in languages other than English.”
- “Where the request is for case narratives, documentation for adjudication, imaging data (e.g. x-rays, MRI scans, etc.), genetic data and exploratory biomarker data.”
- “Where there are substantial practical constraints to providing access via the Vivli platform (e.g. retrieval of older, pre-electronic data).”
- “Data will not be provided to requesters with potential or actual conflicts of interest, including individuals requesting access for commercial, competitive or legal purposes.”
- “Where Pfizer has a co-research, co-development or co-marketing/co-promotion agreement or where the product has been out-licensed, it is recognized that the responsibility for disclosure may be dependent on the agreement between parties. Under these circumstances, Pfizer will endeavor to gain agreement to share data in response to requests.”
WHAT ELSE PFIZER SAID:
“Pfizer will consider requests from qualified researchers for access to Pfizer clinical data. All requests from qualified researchers for access to Pfizer clinical data and information will be managed by Vivli and Pfizer. Qualified researchers [sic] proposals are submitted via the Vivli platform.”
LIST OF QUESTIONS PFIZER REQUIRES DATA REQUESTORS TO ANSWER PROPERLY:
- “Is the research question clearly defined with a scientifically valid rationale?”
- “Is there a well-documented and rigorous statistical analysis plan?”
- “If the proposal includes combining data across different Pfizer trials, is there a clear plan to standardize data sets to ensure they are comparable?”
- “Is there an adequate publication plan to disseminate findings in a peer reviewed [sic] journal or scientific meeting?”
- “Has the applicant certified that the stated research purpose has been declared fully and openly and that the research as described will be conducted and reported in good faith?”
- “Is the applicant willing to declare all professional interests, affiliations, possible conflicts of interest, and all sources of support for the research as part of the dissemination of their results?”
- “Does the research team have sufficient expertise and qualifications to perform the proposed investigation?”
WHAT ELSE IS REQUIRED OF DATA REQUESTORS:
- “All those receiving access to data will be required to enter into a Data Use Agreement (DUA),” Pfizer demands.
- “Once the DUA is completed Pfizer will upload the de-identified data into the Vivli platform for use by researchers. Access to data needed for research is provided on a password-protected platform via Vivli.”
- “This platform allows researchers to conduct research on the site and to download their analyses,” Pfizer explains.
- “Access is provided for 12 months,” and “[e]xtensions are possible when justified and upon review and approval.”
BACKGROUND:
- American Faith reported on Tuesday how One America News host Pearson Sharp Pfizer tweeted that Pfizer’s newly released safety data included nine pages of recorded adverse vaccine events.
- “In a 3 month period, 1223 out of 42k died after getting injected, or roughly 1 in 35 people,” Pearson reported.
