Thread by @EmpireinWinter

Editors of world-leading independent medical journal want to 'follow The Science' so are demanding immediate access to the data, not Pharma's report on the data.

Have they gone over to the dark side of vaxx skepticism?

bmj.com/content/376/bm…

'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regulatory approval and government stockpiling of oseltamivir (Tamiflu) were sponsored by the manufacturer; most were unpublished, those that were published were ghostwritten by writers paid by the manufacturer, '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.'

Sound familiar?

'The Tamiflu saga heralded a decade of unprecedented attention to the importance of sharing clinical trial data....
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.'

'This is morally indefensible for all trials, but especially for those involving major public health interventions.'

'In the words of the European Medicine Agency’s former executive director and senior medical officer, “relying solely on the publications of clinical trials in scientific journals as the basis of healthcare decisions is not a good idea ...'

'Drug regulators have been aware of this limitation for a long time and routinely obtain and assess the full documentation (rather than just publications).'

'anyone looking for participant level datasets may be disappointed because Health Canada and the EMA do not receive or analyse these data' while the FDA has proposed, and has been denied permission by the courts, to delay release of data to 2076.

'As well as access to the underlying data, transparent decision making is essential. Regulators and public health bodies could release details such as why vaccine trials were not designed to test efficacy against infection and spread of SARS-CoV-2.'

'Had regulators insisted on this outcome, countries would have learnt sooner about the effect of vaccines on transmission and been able to plan accordingly.'

'Big pharma is the least trusted industry. 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 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. The same applies to treatments for covid-19.'

'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 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.1 We reiterate that call now. Data must be available when trial results are announced, published, or used to justify regulatory decisions.'

'There is no place for wholesale exemptions from good practice during a pandemic. The public has paid for covid-19 vaccines through vast public funding of research, and it is the public that takes on the balance of benefits and harms that accompany vaccination.'

'The public, therefore, has a right and entitlement to those data, as well as to the interrogation of those data by experts.

Pharmaceutical companies are reaping vast profits without adequate independent scrutiny of their scientific claims.'

'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.'

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