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Major Medical Journal at Last Calls for Vaccine Data Transparency

At last, major medical journal calls for IMMEDIATE release of all raw data on COVID vaccine studies.


Robert Jay Rowen, MD


I just reported that one major publication house, Elsevier, unilaterally retracted a woman’s report of vaccine injuries. No warning, no reason given, no chance or opportunity for the author to discuss what she SURPRISINGLY learned from VAERS. Now BMJ is spontaneously coming forward and demanding release of data for public scrutiny. This is a strongly worded editorial and at last we are seeing some honesty from a medical journal.


The vaccine rollout, complete with mandates for jabs, has caused enormous contention in society. Families are bitterly divided. Seasoned employees lost at great cost to employer and worker. Injuries are mounting. The author of the Elsevier report went into her work innocently, not expecting the staggering numbers if death and injuries she found. In the meantime, FDA wants to dole out its papers over 50 years. Remember Vioxx? 110,000 Americans killed!


Suppose that data was withheld for 50 years. We would likely be at as many dead from the drug as we have dead from COVID. And, imagine if the journals would have been open to publishing on ozone. BMJ has skeletons in its closet as well as it would not publish my paper on ozone polishing off Ebola. I was told that the journal did not think it would be of interest to its readership of generalists. Meanwhile, it was publishing on vaccines and Pharma potions. In the meantime, I wonder how many thousands of needless deaths have occurred from the failure of the disease industry and governments to demand release of data that affects every man, woman and child on the planet.


Data should be fully and immediately available for public scrutiny


In the pages of The BMJ a decade ago, in the middle of a different pandemic, it came to light that governments around the world had spent billions stockpiling antivirals for influenza that had not been shown to reduce the risk of complications, hospital admissions, or death. The majority of trials that underpinned regulatory approval and government stockpiling of oseltamivir (Tamiflu) were sponsored by the manufacturer; most were unpublished, those that were published were ghostwritten by writers paid by the manufacturer, the people listed as principal authors lacked access to the raw data, and academics who requested access to the data for independent analysis were denied.1234


The Tamiflu saga heralded a decade of unprecedented attention to the importance of sharing clinical trial data.56Public battles for drug company data,78 transparency campaigns with thousands of signatures,910 strengthened journal data sharing requirements,1112 explicit commitments from companies to share data,13 new data access website portals,8 and landmark transparency policies from medicines regulators1415 all promised a new era in data transparency.


Progress was made, but clearly not enough. The errors of the last pandemic are being repeated. Memories are short. Today, despite the global rollout of covid-19 vaccines and treatments, the anonymised participant level data underlying the trials for these new products remain inaccessible to doctors, researchers, and the public—and are likely to remain that way for years to come.16 This is morally indefensible for all trials, but especially for those involving major public health interventions.


Unacceptable delay

Pfizer’s pivotal covid vaccine trial was funded by the company and designed, run, analysed, and authored by Pfizer employees. The company and the contract research organisations that carried out the trial hold all the data.17 And Pfizer has indicated that it will not begin entertaining requests for trial data until May 2025, 24 months after the primary study completion date, which is listed on ClinicalTrials.gov as 15 May 2023 (NCT04368728).


The lack of access to data is consistent across vaccine manufacturers.16 Moderna says data “may be available … with publication of the final study results in 2022.”18 Datasets will be available “upon request and subject to review once the trial is complete,” which has an estimated primary completion date of 27 October 2022 (NCT04470427).


As of 31 December 2021, AstraZeneca may be ready to entertain requests for data from several of its large phase III trials.19 But actually obtaining data could be slow going. As its website explains, “timelines vary per request and can take up to a year upon full submission of the request.”20

Underlying data for covid-19 therapeutics are similarly hard to find. Published reports of Regeneron’s phase III trial of its monoclonal antibody therapy REGEN-COV flatly state that participant level data will not be made available to others.21 Should the drug be approved (and not just emergency authorised), sharing “will be considered.” For remdesivir, the US National Institutes of Health, which funded the trial, created a new portal to share data,

https://accessclinicaldata.niaid.nih.gov/


but the dataset on offer is limited. An accompanying document explains: “The longitudinal data set only contains a small subset of the protocol and statistical analysis plan objectives.”


CONTINUE READING

https://drrowen.substack.com/p/major-medical-journal-at-last-calls


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