“Drug industry–led efforts, like the Allotrope Foundation, have advanced common terms for data management, Plasterer says. Most recently, the FAIR principles—guidelines for ensuring data in storage are findable, accessible, interoperable, and reusable—have been adopted by drug companies including AstraZeneca and Pfizer….”
“Federally funded research dramatically lowers barriers for scientists in the public and private sector to conduct research and accelerate technological development. Unlike its private counterpart, federally funded research can be open-access and makes knowledge and technologies publicly available. Open-access research benefits everyone, companies and academic researchers alike, and would prevent the siloing of intellectual property within specific companies. Such non-proprietary technology and knowledge can help bring new competitors into the market and help drive both competition and further innovation based on the open-access findings. Although open-access research will also benefit incumbents to the industry, federal support to develop the alternative can build the alternative protein industry’s capacity to compete with conventional products in the long term….”
“Commitment to sharing doesn’t mean you can’t work with industry, say Hamish Evans and colleagues
There are several ways for scientific research and innovation to have an impact on society. Different routes to impact are, however, often seen as being in tension. In particular, commercialisation and open science can sometimes seem to be mutually exclusive….”
“The U.S. Food and Drug Administration has just fired a warning shot across the bow of a second drug company over its failure to make a clinical trial result public as required by law….”
Abstract: Purpose
This study investigates the extent to which a company’s usage of open access (OA) literature for R&D activities depends on its size. The authors’ assumption is that smaller pharmaceutical companies have less access to (usually expensive) journal subscriptions.
Design/methodology/approach
A fixed-effect Poisson model was used to study a panel dataset of USPTO pharmaceutical company patents. The dependent variable is the count of citations to OA resources in a given company patent.
Findings
Results support current anecdotal evidence that many SMEs suffer from high journal prices.
Originality/value
This result justifies the assumption made by policymakers about the potentially positive impact OA mandates have on national innovation activity. It was also shown that collaborating with universities can be a potential coping mechanism for companies that struggle to gain access to the journals they need. In addition to the novelty of its findings, this study introduces a new way to study the impact of OA in nonacademic contexts.
Open Science holds the promise to make scientific endeavours more inclusive, participatory, understandable, accessible, and re-usable for large audiences. However, making processes open will not per se drive wide re-use or participation unless also accompanied by the capacity (in terms of knowledge, skills, financial resources, technological readiness and motivation) to do so. These capacities vary considerably across regions, institutions and demographics. Those advantaged by such factors will remain potentially privileged, putting Open Science’s agenda of inclusivity at risk of propagating conditions of “cumulative advantage”. With this paper, we systematically scope existing research addressing the question: “What evidence and discourse exists in the literature about the ways in which dynamics and structures of inequality could persist or be exacerbated in the transition to Open Science, across disciplines, regions and demographics?” Aiming to synthesise findings, identify gaps in the literature, and inform future research and policy, our results identify threats to equity associated with all aspects of Open Science, including Open Access, Open/FAIR Data, Open Methods, Open Evaluation, Citizen Science, as well as its interfaces with society, industry and policy. Key threats include: stratifications of publishing due to the exclusionary nature of the author-pays model of Open Access; potential widening of the digital divide due to the infrastructure-dependent, highly situated nature of open data practices; risks of diminishing qualitative methodologies as “reproducibility” becomes synonymous with quality; new risks of bias and exclusion in means of transparent evaluation; and crucial asymmetries in the Open Science relationships with industry and the public, which privileges the former and fails to fully include the latter.
“A particularly promising example of the kind of collective, cross-sector response needed to address this issue comes in the form of utility companies opening grid data up to competitors and even customers. Western Power Distribution has launched an open-access web portal offering detailed data on everything from consumption to generation across its network. The City of London is also working with utility companies to create a combined on-demand digital map of its subterranean pipes and cables where workers can see nearby underground infrastructure on mobile phones or laptop computers before a dig.
Geospatial data on the location and condition of frozen gas pipes could help to protect other underground infrastructure and avert disasters. Data predicting how vegetation growth might impact electricity lines could help a telecoms network operator anticipate potential interference with millimeter waves from nearby 5G antennae. In another example, we are working to integrate IBM Weather Group’s LIDAR and satellite data with geospatial network information to help electrical utilities predict and prevent encroachment on electric transmission and distribution lines….
The trend towards data sharing requires an industry-wide step-change in the capture and curation of data to ensure all companies have a comprehensive, current picture of their networks and use geospatial information systems built around open design principles. This would ensure a consistent standard of network data is captured and shared across the industry. Rich, real-time, and open data can help foster a utility sector built around cooperation that facilitates a higher standard of network resilience despite the challenging environmental issues we face today.”
“ICMRA1 and WHO call on the pharmaceutical industry to provide wide access to clinical data for all new medicines and vaccines (whether full or conditional approval, under emergency use, or rejected). Clinical trial reports should be published without redaction of confidential information for reasons of overriding public health interest….
Regulators continue to spend considerable resources negotiating transparency with sponsors. Both positive and negative clinically relevant data should be made available, while only personal data and individual patient data should be redacted. In any case, aggregated data are unlikely to lead to re-identification of personal data and techniques of anonymisation can be used….
Providing systematic public access to data supporting approvals and rejections of medicines reviewed by regulators, is long overdue despite existing initiatives, such as those from the European Medicines Agency and Health Canada. The COVID-19 pandemic has revealed how essential to public trust access to data is. ICMRA and WHO call on the pharmaceutical industry to commit, within short timelines, and without waiting for legal changes, to provide voluntary unrestricted access to trial results data for the benefit of public health.”
Abstract: Financial conflicts of interest, several cases of scientific fraud, and research limitations from strong intellectual property laws have all led to questioning the epistemic and social justice appropriateness of industry-funded research. At first sight, the ideal of Open Science, which promotes transparency, sharing, collaboration, and accountability, seems to target precisely the type of limitations uncovered in commercially-driven research. The Open Science movement, however, has primarily focused on publicly funded research, has actively encouraged liaisons with the private sector, and has also created new strategies for commercializing science. As a consequence, I argue that Open Science ends up contributing to the commercialization of science, instead of overcoming its limitations. I use the examples of research publications and citizen science to illustrate this point. Accordingly, the asymmetry between private and public science, present in the current plea to open science, ends up compromising the values of transparency, democracy, and accountability.
“In this case, the generated knowledge is a clear example of a positive spillover that creates a need for public intervention into the market for research and development. However, this relies on the results of translatable work on prototype pathogens—such as insights into antigen optimisation—being accessible to public use. Therefore, public funding of prototype pathogen work should seek to promote research that generates openly accessible and translatable insights as far as practicable, while also judiciously taking advantage of generating proprietary intellectual property. Even in the cases where a proprietary insight might primarily benefit the originating organisation, such as early preclinical evidence and safety data from clinical trials, the research remains worthy of subsidy because society benefits from having developers that are better prepared to respond to emerging infectious diseases….”
“Battle-scarred veterans of the medicines-access and open-science movements hoped the immensity of the pandemic would override a global drug system based on proprietary science and market monopolies. By March, strange but welcome melodies could be heard from unexpected quarters. Anxious governments spoke of shared interests and global public goods; drug companies pledged “precompetitive” and “no-profit” approaches to development and pricing. The early days featured tantalizing glimpses of an open-science, cooperative pandemic response. In January and February 2020, a consortium led by the National Institutes of Health and the National Institute of Allergy and Infectious Diseases collaborated to produce atomic-level maps of the key viral proteins in record time. “Work that would normally have taken months—or possibly even years—has been completed in weeks,” noted the editors of Nature. …
By then, however, the optimism and sense of possibility that defined the early days were long gone. Advocates for pooling and open science, who seemed ascendant and even unstoppable that winter, confronted the possibility they’d been outmatched and outmaneuvered by the most powerful man in global public health.
In April, Bill Gates launched a bold bid to manage the world’s scientific response to the pandemic. Gates’s Covid-19 ACT-Accelerator expressed a status quo vision for organizing the research, development, manufacture, and distribution of treatments and vaccines. Like other Gates-funded institutions in the public health arena, the Accelerator was a public-private partnership based on charity and industry enticements. Crucially, and in contrast to the C-TAP, the Accelerator enshrined Gates’s long-standing commitment to respecting exclusive intellectual property claims. Its implicit arguments—that intellectual property rights won’t present problems for meeting global demand or ensuring equitable access, and that they must be protected, even during a pandemic—carried the enormous weight of Gates’s reputation as a wise, beneficent, and prophetic leader. …
“Early on, there was space for Gates to have a major impact in favor of open models,” says Manuel Martin, a policy adviser to the Médecins Sans Frontières Access Campaign. “But senior people in the Gates organization very clearly sent out the message: Pooling was unnecessary and counterproductive. They dampened early enthusiasm by saying that I.P. is not an access barrier in vaccines. That’s just demonstratively false.”…
“Things could have gone either way,” says Love, “but Gates wanted exclusive rights maintained. He acted fast to stop the push for sharing the knowledge needed to make the products—the know-how, the data, the cell lines, the tech transfer, the transparency that is critically important in a dozen ways. The pooling approach represented by C-TAP included all of that. Instead of backing those early discussions, he raced ahead and signaled support for business-as-usual on intellectual property by announcing the ACT-Accelerator in March.” …”
“Battle-scarred veterans of the medicines-access and open-science movements hoped the immensity of the pandemic would override a global drug system based on proprietary science and market monopolies. By March, strange but welcome melodies could be heard from unexpected quarters. Anxious governments spoke of shared interests and global public goods; drug companies pledged “precompetitive” and “no-profit” approaches to development and pricing. The early days featured tantalizing glimpses of an open-science, cooperative pandemic response. In January and February 2020, a consortium led by the National Institutes of Health and the National Institute of Allergy and Infectious Diseases collaborated to produce atomic-level maps of the key viral proteins in record time. “Work that would normally have taken months—or possibly even years—has been completed in weeks,” noted the editors of Nature. …
By then, however, the optimism and sense of possibility that defined the early days were long gone. Advocates for pooling and open science, who seemed ascendant and even unstoppable that winter, confronted the possibility they’d been outmatched and outmaneuvered by the most powerful man in global public health.
In April, Bill Gates launched a bold bid to manage the world’s scientific response to the pandemic. Gates’s Covid-19 ACT-Accelerator expressed a status quo vision for organizing the research, development, manufacture, and distribution of treatments and vaccines. Like other Gates-funded institutions in the public health arena, the Accelerator was a public-private partnership based on charity and industry enticements. Crucially, and in contrast to the C-TAP, the Accelerator enshrined Gates’s long-standing commitment to respecting exclusive intellectual property claims. Its implicit arguments—that intellectual property rights won’t present problems for meeting global demand or ensuring equitable access, and that they must be protected, even during a pandemic—carried the enormous weight of Gates’s reputation as a wise, beneficent, and prophetic leader. …
“Early on, there was space for Gates to have a major impact in favor of open models,” says Manuel Martin, a policy adviser to the Médecins Sans Frontières Access Campaign. “But senior people in the Gates organization very clearly sent out the message: Pooling was unnecessary and counterproductive. They dampened early enthusiasm by saying that I.P. is not an access barrier in vaccines. That’s just demonstratively false.”…
“Things could have gone either way,” says Love, “but Gates wanted exclusive rights maintained. He acted fast to stop the push for sharing the knowledge needed to make the products—the know-how, the data, the cell lines, the tech transfer, the transparency that is critically important in a dozen ways. The pooling approach represented by C-TAP included all of that. Instead of backing those early discussions, he raced ahead and signaled support for business-as-usual on intellectual property by announcing the ACT-Accelerator in March.” …”
“Researchers who receive federal help consistently fail to report their results to the public. The government should hold them accountable….
Researchers using federal funds to conduct cancer trials — experiments involving drugs or medical devices that rely on volunteer subjects — were sometimes taking more than a year to report their results to the N.I.H., as required. “If you don’t report, the law says you shouldn’t get any funding,” he said, citing an investigation I had published in Stat with my colleague Talia Bronshtein. “Doc, I’m going to find out if it’s true, and if it’s true, I’m going to cut funding. That’s a promise.”
It was true then. It’s true now. More than 150 trials completed since 2017 by the N.I.H’s National Cancer Institute, which leads the $1.8 billion Moonshot effort, should have reported results by now. About two-thirds reported after their deadlines or not at all, according to a University of Oxford website that tracks clinical trials regulated by the Food and Drug Administration and National Institutes of Health. Some trial results are nearly two years overdue. Over all, government-sponsored scientists have complied less than half the time for trial results due since 2018. (A spokeswoman for the N.I.H. said, “We are willing to do all measures to ensure compliance with ClinicalTrials.gov results reporting.”)…
In 2016, Dr. Francis Collins, the director of the National Institutes of Health, announced that the agency would begin penalizing researchers for failing to comply with its reporting requirements. “We are serious about this,” he said at the time. Yet in the years since, neither the F.D.A. nor N.I.H. has enforced the law. …”
“The best currently available evidence shows that around half of all trials go unreported: this means that doctors and patients see only a partial, biased fraction of the true evidence. We cannot make informed decisions about treatments unless all the data is reported. Under EU rules, from December 2016, all trials on the European Union Clinical Trials Register (EUCTR) should post results within 12 months of completion. There has never been a rule as simple and clear as this, anywhere in the world. Our EU Trials Tracker shows which organisations are compliant, and which aren’t. Our paper in the BMJ analysed the data as of January 2018, and found that only 49% of Europe’s clinical trials reported results in the register.
This website is one of a series of Trials Trackers produced by the EBM DataLab at the University of Oxford….”
“The best currently available evidence shows that around half of all trials go unreported: this means that doctors and patients see only a partial, biased fraction of the true evidence. We cannot make informed decisions about treatments unless all the data is reported. Under EU rules, from December 2016, all trials on the European Union Clinical Trials Register (EUCTR) should post results within 12 months of completion. There has never been a rule as simple and clear as this, anywhere in the world. Our EU Trials Tracker shows which organisations are compliant, and which aren’t. Our paper in the BMJ analysed the data as of January 2018, and found that only 49% of Europe’s clinical trials reported results in the register.
This website is one of a series of Trials Trackers produced by the EBM DataLab at the University of Oxford….”