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In the prestigious British Medical Journal (BMJ), editor-in-chief Peter Doshi published (in early 2022) another article on the issue of clinical data on anti-covid vaccine trials titled Covid-19 vaccines and treatments: we must have raw data, now (Vaccines and Covid-19 treatments: we must have raw data now).

Below is the translation

The data should be fully and immediately available for public scrutiny.

In the pages of the BMJ a decade ago, in the midst of a different pandemic, it emerged that governments around the world had spent billions accumulating influenza antivirals that had not been shown to reduce the risk of complications, hospitalization or death. . Most of the trials that supported regulatory approval and government storage of oseltamivir (Tamiflu) were sponsored by the manufacturer; most were unpublished, the published ones were written by “ghost writers” paid by the producer, the people listed as lead authors did not have access to the raw data and such access was denied even to academics willing to do an independent analysis.

The Tamiflu saga marked a decade of unprecedented attention to the importance of sharing clinical trial data. Public battles for pharmaceutical company data, transparency campaigns with thousands of signatures, strengthened requirements for sharing journal data, explicit commitments by companies to share data, new website portals for data access, and key transparency policies for drug regulatory agencies, all promised a new era in data transparency.

Progress has been made, but clearly not enough. The mistakes of the last pandemic are repeated. Memories are short. Today, despite the global launch of covid-19 vaccines and treatments, the anonymized participant-level data that underpins the clinical trials for these new products remains inaccessible to doctors, researchers, and the general public, and is likely to remain so. for years to come. This is morally unacceptable 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, conducted, analyzed and written by Pfizer employees. The company and the contract research organizations that conducted the trial hold all data. And Pfizer has indicated that it will not begin receiving requests for trial data until May 2025, 24 months after the completion date of the primary study, which is listed on ClinicalTrials.gov as May 15, 2023 (NCT04368728).

Lack of access to data is widespread among vaccine manufacturers. Moderna says the data “may be available … with the publication of the final results of the study in 2022”. The datasets will be available “on request and will be subject to review upon completion of the study,” which has an estimated primary completion date of October 27, 2022 (NCT04470427).

As of December 31, 2021, AstraZeneca may be ready to receive requests for data from many of its large-scale phase III studies. But actually getting data might be a slow process. As the company’s website explains, “timelines vary based on the request and can take up to a year from the complete submission of the request.”

Basic data for covid-19 therapies are equally difficult to find. Published reports from Regeneron’s Phase III study of its REGEN-VOC monoclonal antibody therapy clearly state that participant-level data will not be made available to others. In case of drug approval (and not just emergency authorization), 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 data set offered is limited. An accompanying document explains: “The longitudinal dataset contains only a small subset of the objectives of the protocol and the statistical analysis plan”.

We are left with publications but no access to underlying data upon reasonable request. This is of concern to study participants, researchers, physicians, journal editors, policy makers and the public. The journals that published these primary studies may argue that they faced an embarrassing dilemma, trapped between making summary results quickly available and upholding the best ethical values ​​that support timely access to underlying data. From our point of view, there is no dilemma; anonymous data of individual participants from clinical trials should be made available for independent review.

Journal editors, systematic reviewers, and authors of clinical practice guidelines generally get little beyond the publication of a journal, but regulatory agencies receive much more detailed data as part of the regulatory review process. In the words of the former executive director and senior medical officer of the European Medicines Agency, “relying solely on clinical trial publications in scientific journals as the basis of health decisions is not a good idea… Drug regulators were aware of this limitation for a long time and regularly obtain and evaluate the complete documentation (rather than mere publications). “

Among regulators, the U.S. Food and Drug Administration is believed to receive the rawest data but not proactively release it. After a request to the agency under the Freedom of Information Act for Pfizer’s vaccine data, the FDA offered to publish 500 pages per month, a process that would take decades to complete, arguing in court that the release data public was slow due to the need to amend sensitive data first. This month, however, a judge rejected the FDA’s offer and ordered the data to be published at a rate of 55,000 pages per month. The data must be made available on the website of the applicant organization (phmpt.org).

In publishing thousands of pages of clinical trial documents, Health Canada and the EMA have also provided a degree of transparency that deserves recognition. Until recently, however, the data remained of little use, with copious editions aimed at protecting the mechanism of blinded studies. But study reports with fewer omissions are available since September 2021, and missing appendices can be accessed through requests made under the Freedom of Information Act.

Even so, anyone looking for participant-level datasets could be disappointed because Health Canada and the EMA do not receive or analyze this data and it remains to be seen how the FDA will respond to the court order. Additionally, the FDA is only producing data for the Pfizer vaccine; data from other manufacturers cannot be requested until the vaccines are approved, and Moderna and Johnson & Johnson vaccines are currently not approved. The industry, which holds the raw data, is not legally obliged to fulfill the access requests of independent researchers.

Like the FDA, and unlike its Canadian and European counterparts, the UK regulatory authority, the Medicines and Health Products Regulatory Agency, does not proactively release clinical trial documents and has also stopped publishing. on its website the information released in response to requests made under the law on freedom of information.

Transparency and trust

In addition to accessing the underlying data, transparent decision making is essential. Regulators and public health bodies could release details 27 such as why vaccine trials were not designed to test efficacy against SARS-CoV-2 infection and spread. 28 If regulators had insisted on this result, countries would have learned earlier about the effect of vaccines on transmission and would have been able to plan accordingly.

Big pharma is the least trusted industry. At least three of the many companies that manufacture covid-19 vaccines have in the past been convicted of criminal and civil offenses that have cost them billions of dollars. One pleaded guilty to fraud. Other companies have no pre-covid history. Now the covid pandemic has spawned many new pharmaceutical billionaires, and vaccine manufacturers have posted tens of billions in revenue.

The BMJ supports evidence-based vaccination policies. As the global roll-out of the vaccine continues, it cannot be justifiable or in the best interests of patients and citizens that we should simply trust “the system” with the distant hope that underlying data may become available for independent scrutiny at some point. in the future. The same goes for treatments for covid-19. Transparency is the key to building trust and is an important path to answering people’s legitimate questions about the efficacy and safety of vaccines and treatments and the clinical and public health policies established for their use.

Twelve years ago we called for the immediate release of raw data from clinical trials. We reiterate this request now. Data must be available when study results are announced, published or used to justify regulatory decisions. There is no room for discounting good practices during a pandemic. Citizens have paid for covid-19 vaccines through massive public research funding, and it is the public who bears the balance of benefits and harms that accompany vaccination. Citizens, therefore, have to such data, as well as to the consultation of such data by experts.

Pharmaceutical companies are reaping huge profits without proper independent scrutiny of their scientific claims. The purpose of regulators is not to dance to the notes of wealthy global corporations and enrich them further; is to protect the health of their populations. We need complete data transparency for all studies, we need it in the public interest and we need it now.

Translation Corrado Penna

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