Refusing State funding of vaccine research in a corporate “double-blind”

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Original : Refuser de financer la recherche vaccinale en «double aveugle» 26 sept. 2020

The scale of the COVID epidemic has led to strong and rapid public commitments by national governments. In particular, more than 10 billion Euros have been released in just a few months for vaccine research. Public investment and collective risk should go hand in hand with full transparency in the use of funds and research results. But the reality is very different.

In normal times State support to medical research that takes place via funding of research programmes and public research institutions, partnerships with private firms, tax credits and of course, the purchase or reimbursement of health products, generally goes unnoticed. The billions being spent currently on for vaccine for Covid19 gives an unusually high-profile to the massive and dazzling involvement of public authorities in this medical research. This therefore justifies the common sense view that any effective vaccines that are developed should be considered and treated as common goods, i.e. an essential resource developed through a collective effort, whose production and access should be organised and governed in a transparent and collective manner.

However, the opacity which usually prevails in the pharmaceutical economy and the control by a few actors, is still in place. On the one hand, countries with more resources are seeking to monopolise the first (and best) future vaccines through bilateral contracts with firms: the United States, France, the United Kingdom, Italy, etc. have signed agreements with AstraZeneca, BioNTech and Pfizer, Novavax, Moderna, GSK, Johnson & Johnson, etc. They wish to cover themselves politically by securing access to possible vaccines for part of their population, but clearly do not feel more accountable than that for the use of public resources. They transfer massive amounts of public money to industry while leaving the corporations with property rights over future products, and keeping their people unaware of any of the details and the conditions of the use of the billions.

The big pharmaceutical companies, on the other hand, are proving to be very bold and are using the situation to push their lobbying agenda forward. In addition to colossal public funding for Research & Development (R&D) they require the advance purchase of large quantities of the potential vaccines that will be developed. They also demand streamlined product registration systems that exempt them from providing all the data for efficacy and safety usually required, and at the same time they wish to be relieved of responsibility in the event of side effects and even be compensated by governments. Meanwhile they claim the need for confidentiality of contracts, clinical trial results, manufacturing costs and pricing structures for future vaccines – all in the name of business secrecy.

The firms want to take the risk out of their actions as much as possible while still ensuring their profits. The public in contrast should assume the risks, both financial and health-related. The public finances and supplies hospitals, medical staff and volunteers by the hundreds of thousands throughout the world1. The public invests its resources without any guarantee of effectiveness or protection from dangerous side effects, or even any control over effectiveness or possibilities of dangerous side effects (since the requirements of the drug agencies are being revised downwards. The Food and Drug Administration (FDA) has led the way2 and the European Medical Agency (EMA) seems determined to do the same). The public to which we all belong does not have the capacity to appreciate what prices should be – since it has no access to cost data, nor to the exact sums that are granted to individual firms, the conditions under which these sums are allocated, or even to the CVs of the handful of “experts” who negotiate with the industry.

The leaders of many Western countries condemned or ridiculed the positions taken by former US president Donald Trump, denounced those of conspirators and demagogues of all stripes, and claim to be the proponents of science, the real science, the one based on evidence and validated methods (“evidence-based”). However, under the pretext of urgency, the requirements are being scrapped, the transparency within the pharmaceutical field that has emerged in recent years as an imperative social demand and a political necessity is being pushed aside3. The collective risks that the world’s population is currently taking for the development of vaccines justifies public access to the results of vaccine trials in real time, to allow the greatest number of scientists (from the public, private and civil society sectors) to independently analyse the data and understand what these candidate vaccines will do not only to the virus but also to the organisms of the individuals vaccinated. This is especially true when testing technologies that have never been validated before (such as messenger RNA vaccines).
And yet, things continue to be done in the secrecy demanded by a handful of firms – the new “double blind”.

In these conditions, in demanding equitable access to the COVID vaccine, there is a growing feeling that this is above all a manoeuvre in the service of a few firms. In the name of the right to access, and because we know that there will be no effective fight against the virus on a global scale without sharing technologies, we demand access for all. But we cannot ignore the fact that, despite the rhetoric, no real solidarity is being put in place. The COVAX initiative is collecting crumbs, and behind what looks like a charity mechanism on the fringes, we are witnessing the consolidation of an international practice of pre-purchasing (“market advance commitment”) without clear information on costs, funding received by each companies, contracts or prices, the vast majority of which benefits the multinationals. The social demand for access then serves above all to justify the rush of public commitments without transparency or conditions; and one accepts turning a blind eye to an absurd economy, which corrupts science and medicine and makes global health look like a playground for financiers and other investment funds.

As the experiences of 2020 have shown, and in particular with the fiasco in terms of care capacity and shortages of basic health products in wealthy countries, this global epidemic should lead us to seriously review the way we fund medical research and health: how we govern public resources, protect the public interest and involve the public in achieving access to health for all. Instead of this necessary reformulation of public health policies, we are witnessing a forced shift to a market logic that benefits only a few actors, and every day excludes a little more people from the right to health, in poor countries as well as in rich countries.

(*) The practice of double-blinding in clinical trials consists of ensuring that neither the doctor nor the patient knows whether it is the active product being tested or a placebo that is being used. On the other hand the “double-blind” approach to research funding, which consists of refusing to make public, information on the use of resources and the results of trials leaving the public “blind”, – is totally inappropriate. One scenario is designed to create impartiality and fairness the other to favour special interests and create injustice.

1 Many candidate vaccines have been or still are currently being tested in dozens of phase III trials, i.e. efficacy and benefit/risk ratio trials on volunteers; and nearly 200 candidate vaccines are being developed worldwide. See the Landscape of COVID-19, a World Health Organization (WHO) candidate vaccine: https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines

2 See statements by Stephen Hahn, Director of the Food and Drug Administration (FDA) at the end of August 2020: https://www.ft.com/content/f8ecf7b5-f8d2-4726-ba3f-233b8497b91a

3 See the resolution adopted by the WHO on 28 May 2019: https://apps.who.int/iris/bitstream/handle/10665/329301/A72_R8-en.pdf?sequence=1&isAllowed=yRefuser to fund “double-blind” vaccine research