Re: [Aisa.circuli] BJM: Covid-19 vaccines and treatments: we…

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Author: Roberto Caso
To: 380°
CC: aisa.circuli
Subject: Re: [Aisa.circuli] BJM: Covid-19 vaccines and treatments: we must have raw data, now

Più che crisi di nervi mi sembra una rivendicazione scontata.
Il dibattito sulla data exclusivity riguardanti i trials è in corso da anni.
Noi come AISA abbiamo iniziato a parlarne qui:

Si tratta di una delle tante forme di pseudo-proprietà intellettuale sui

A presto,

Roberto Caso

Il giorno lun 24 gen 2022 alle ore 23:49 380° via Aisa.circuli <
aisa.circuli@???> ha scritto:

> Buongiorno,
> scienza sull'orlo di una crisi di nervi.
> «Covid-19 vaccines and treatments: we must have raw data, now»
> --8<---------------cut here---------------start------------->8---
> [...] 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 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.
> --8<---------------cut here---------------end--------------->8---
> Saluti, 380°
> --
> 380° (Giovanni Biscuolo public alter ego)
> «Noi, incompetenti come siamo,
> non abbiamo alcun titolo per suggerire alcunché»
> Disinformation flourishes because many people care deeply about injustice
> but very few check the facts. Ask me about <>.
> --
> Aisa.circuli mailing list
> Aisa.circuli@???


Roberto Caso

Professore Associato di Diritto Privato Comparato

Università di Trento - Facoltà di Giurisprudenza
La società della mercificazione e della sorveglianza: dalla persona ai dati
Milano, Ledizioni, 2021

La rivoluzione incompiuta. La scienza aperta tra diritto d'autore e
proprietà intellettuale, Milano, Ledizioni, 2020