British Medical Journal calls for ‘complete data transparency’ from pharmaceutical companies

By Mason Quah

A LEADING medical journal has called for the full and immediate release of trial data on Covid-19 vaccines, slamming major pharmaceutical companies for damaging trust in medicine.

British Medical Journal (BMJ) editor in chief Kamran Abbasi, alongside senior editor Peter Doshi and former editor in chief Fiona Godlee, have criticised multiple pharmaceutical companies for withholding access to trial data on coronavirus vaccines.

They wrote: “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.”

This is a common practice in the pharmaceutical industry and enables the potential manipulation of data.

Publication bias is the trend of published or publicly available data to only support positive conclusions, with the owners of the data able to choose not to publish a study when the data does not provide the desired conclusion.

This means that medical practitioners can’t access accurate data about the efficacy of treatments, which can hurt patients.

This lack of transparency has caused massive harm in the past.

BMJ editors point to the 2000s, which saw governments spending billions of pounds stockpiling the drugs Tamiflu and Relenza against a potential influenza epidemic.

The evidence available from Tamiflu efficacy came from a collection of 10 trials, all funded by the manufacturer and 8 of which had not been published.

The BMJ and Cochrane institute campaigned for the release of the original trial information.

The lead author of one trial admitted in the resulting investigation that he had never been given access to the primary data.

When the data was published, four years later, it revealed the drug to be significantly less effective than previously believed.

Tamiflu did not positively affect survival rates, hospitalisation risk or complications in most risk groups.

The public should have access to this data, the BMJ argues, because the public have funded the research and are the ones receiving the treatment and any side effects that result.

“Big pharma is the least trusted industry,” the BMJ wrote.

“At least three of the many companies making Covid-19 vaccines have past criminal and civil settlements costing them billions of dollars.

“One pleaded guilty to fraud.”

The manufacturer that pleaded guilty to fraud was GlaxoSmithKline, who were forced to pay out three billion USD in 2012 for failing to report safety data about a medication they manufactured and unlawfully promoting prescription drugs for unapproved uses.

The BMJ editors continue: “The BMJ supports vaccination policies based on sound evidence.

“As the global vaccine rollout continues, it cannot be justifiable or in the best interests of patients and the public that we are left to just trust “in the system,” with the distant hope that the underlying data may become available for independent scrutiny at some point in the future.”

Regulatory agencies are provided a greater amount of data as part of the review process.

They are not legally required to make this data publicly available, outside of some limited Freedom of Information requests.

The US Food and Drugs Administration, believed to have the greatest amount of raw data among regulatory agencies, has been ordered by courts to release Pfizer’s vaccine data at a rate of 55,000 pages a month.

The amount of data provided to regulators is still not the entirety of the data the companies produce, and they have no obligation to provide data upon requests from journalists and independent researchers.

Vaccine manufacturers Moderna, AstraZeneca and Pfizer have been approached for comment.

Moderna has stated previously data may be made available in 2022, and Pfizer 2025. AstraZeneca have said they are willing to listen to requests for data, but may take up to a year to comply.

“The timelines vary per request and can take up to a year upon full submission of the request for analysis, decision, anonymization and sharing of the requested data or documents,” a statement said.

This means that both medical experts and the public will not have comprehensive access to the information needed to make informed decisions.

Vaccination is an important treatment tool that has been proven to reduce cases of serious infections, saving lives.

The Office for National Statistics in December last year noted that a  second vaccine dose reduced risk of death by between 78 and 99 per cent.

The editors note that making information available will likely be an important step in combatting vaccine hesitancy, saying: “Transparency is the key to building trust and an important route to answering people’s legitimate questions about the efficacy and safety of vaccines and treatments.”

The BMJ conclude that these pharmaceutical companies are reaping vast profits without the possibility of being scrutinised by independent experts.

They write: “The purpose of regulators is not to dance to the tune of rich global corporations and enrich them further; it 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.”

Featured Image: Pixabay

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