Thread by @cmrherder

‘From Discovery to Delivery’ – our paper detailing who did what + when in developing the recently approved Ebola vaccine known as “rVSV-ZEBOV” / Ervebo published today in @J_Law_Biosci by me @JEGanthro + @IP_policy academic.oup.com/jlb/advance-ar…

Accompanying oped published in @statnews statnews.com/2020/01/16/pub…

Spoiler alert: Public sector science did the vast majority of the work | @PHAC_GC scientists at the National Microbiology Laboratory in Winnipeg not only invented the vaccine, but ran pre-clinical studies, procured + helped generate clinical grade vaccine for clinical trials

During the 2014-15 Ebola epidemic in West Africa, the public sector in Canada + elsewhere also financed, designed, and played critical roles in running the @WHO led clinical trials in collaboration with @MSF + others

Despite these massive contributions, control over the ZEBOV patent was given to a small company in Iowa known as BioProtection Systems in 2010, which in turn sub-licensed the patent to @Merck at the height of the ’14-15 epidemic

Through an analysis of >1,600 government records that we secured through Canada’s access to information laws, we show that the private sector contributed minimally to the development of the vaccine for four years prior to the epidemic

The Iowa company promised to:
#1 conduct preclinical research
#2 run toxicology studies,
#3 assist with the manufacturing of the vaccine for clinical trials
#4 meet with the @US_FDA to gain insight into the regulator’s expectations

Our review of govt documentation reveals that, apart from participating in teleconferences, BioProtection Systems only contributed to #4

Meanwhile, government scientists in the Winnipeg lab, under increasingly difficult conditions, continued the development of the vaccine – without their efforts, it is unclear that clinical grade (“GMP”) vaccine would have been ready for clinical trials in 2014

The efforts of one government scientist in particular, Dr Judie Alimonti, were essential | Alimonti’s contributions were enormous: she ran experiments, problem solved numerous technical challenges encountered during the manufacturing process, coordinating everything

With 1 or 2 important exceptions, Dr Alimonti’s role has been left out of many accounts of this vaccine’s development (e.g. cmaj.ca/content/189/43…) | We hope our article helps to bring her critically important contributions to public attention

Tragically, once the epidemic in West Africa waned, Dr Alimonti’s employment contract with the government lab was not renewed; she found new work briefly with the @NRC_CNRC but fell ill and died of cancer in 2017 ottawacitizen.com/news/local-new…

But we also draw an important link between her role – her precarity + the precarity of the lab’s funding – and the patent deal with BioProtection Systems in the paper:

In short, our approach to vaccine development, and medical innovation more broadly, is—paradoxically—not very innovative at all

We continue to adhere to a model of drug/vaccine R&D predicated on market-driven, public-private partnerships even in the context of diseases/conditions where we know there is little market interest like Ebola

We adhere to this because we assume that the private sector is better positioned to do late stage drug/vaccine development through regulatory approval

But examples like the ZEBOV vaccine show this sets an artificial ceiling | The public sector *can* and in cases like this actually does far more than discovery and preclinical research

Unless we fundamentally address the precarity of scientists like Dr Alimonti and the funding they rely upon to do translation research, however, new ways of doing innovation will remain out of reach

How can we ask someone like Dr Alimonti to challenge the assumption that only the private sector can do late stage vaccine development, or experiment with promising alternatives like open science, when she herself does not know if she’ll have a job in 6 months time?

Our case study of the Ebola vaccine shows that public sector science can do a great deal even under significant constraints...

...Imagine if we provided secure funding and employment for government + university scientists not just to do experiments *but experiment with how* knowledge is generated + advanced?

There is a growing policy conversation about public sector drug/vaccine development, highlighted by recent work of @DemocracyCollab @akesselheim @AmeetSarpatwari + many others

See here: bmj.com/content/367/bm…

And here: thenextsystem.org/medicineforall

We hope our new publication contributes to this critically important conversation while also drawing attention to the structures + practices that work to preserve the status quo, and bury the contributions of public sector scientists like Dr. Judie Alimonti

//end

ps. We have made a number of the most important documents we obtained publicly available here:

academic.oup.com/jlb/advance-ar…

The full ~1,600 can be obtained upon request.