Buongiorno,
scienza sull'orlo di una crisi di nervi.
https://www.bmj.com/content/376/bmj.o102
«Covid-19 vaccines and treatments: we must have raw data, now»
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[...] 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.
[...] 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
[...] Transparency and trust
As well as access to the underlying data, transparent decision making is
essential. Regulators and public health bodies could release details27
such as why vaccine trials were not designed to test efficacy against
infection and spread of SARS-CoV-2.28 Had regulators insisted on this
outcome, countries would have learnt sooner about the effect of vaccines
on transmission and been able to plan accordingly.29
Big pharma is the least trusted industry.30 At least three of the many
companies making covid-19 vaccines have past criminal and civil
settlements costing them billions of dollars.31 One pleaded guilty to
fraud.31 Other companies have no pre-covid track record. Now the covid
pandemic has minted many new pharma billionaires, and vaccine
manufacturers have reported tens of billions in revenue.32
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.
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Saluti, 380°
--
380° (Giovanni Biscuolo public alter ego)
«Noi, incompetenti come siamo,
non abbiamo alcun titolo per suggerire alcunché»
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https://stallmansupport.org>.
