How a Wikipedia for drug discovery is disrupting big pharma

“But what if there was another way of developing the medicines we need? A way that eschews market incentives that stop pharma companies from developing medicines for diseases of poverty and does away with the secrecy that shrouds drug development.

According to advocates of open source pharma, there is….

Inspired by the open source movement in software, open drug discovery projects make their data and ideas available on the internet to anyone.

Matthew Todd, a professor of drug discovery at University College, London and one of the founders of the open source pharmamovement believes that open source could potentially transform the way we find cures….”

Not Reporting Results of a Clinical Trial Is Academic Misconduct | Annals of Internal Medicine | American College of Physicians

Failure to report the results of clinical trials threatens the public’s trust in research and the integrity of the medical literature, and should be considered academic misconduct at the individual and institutional levels. According to the ethical principles for research outlined in the Declaration of Helsinki, researchers “have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports” (1). When participants volunteer to take part in clinical trials, and expose themselves to interventions with unknown safety and efficacy profiles, they have a tacit assumption, based on trust, that the evidence generated will inform clinical science (2). Health care providers and medical societies, who are responsible for evaluating and synthesizing evidence and filling the gap between research and practice, need for investigators to fully report their results in a timely manner. The utility of the diligent search for truth in the medical literature depends on its completeness. However, when research findings are not consistently disseminated, the literature provides a skewed view of the science, which may bias reviews of the evidence….

The conduct of research in humans comes with inviolable responsibilities, including the commitment to share what has been learned. No reason exists for the topline results of a clinical trial not to be made public. Failure to report is detrimental to the scientific process. When trial results are not publicly available for years after study completion, patients, institutional review boards, clinicians, researchers, and the public must rely on incomplete evidence, which may lead to misconceptions about the efficacy and safety of interventions. The time has arrived to address this threat to trust and science.”

Responsible data sharing in international health research: a systematic review of principles and norms | BMC Medical Ethics | Full Text

Abstract:  Background

Large-scale linkage of international clinical datasets could lead to unique insights into disease aetiology and facilitate treatment evaluation and drug development. Hereto, multi-stakeholder consortia are currently designing several disease-specific translational research platforms to enable international health data sharing. Despite the recent adoption of the EU General Data Protection Regulation (GDPR), the procedures for how to govern responsible data sharing in such projects are not at all spelled out yet. In search of a first, basic outline of an ethical governance framework, we set out to explore relevant ethical principles and norms.

Methods

We performed a systematic review of literature and ethical guidelines for principles and norms pertaining to data sharing for international health research.

Results

We observed an abundance of principles and norms with considerable convergence at the aggregate level of four overarching themes: societal benefits and value; distribution of risks, benefits and burdens; respect for individuals and groups; and public trust and engagement. However, at the level of principles and norms we identified substantial variation in the phrasing and level of detail, the number and content of norms considered necessary to protect a principle, and the contextual approaches in which principles and norms are used.

Conclusions

While providing some helpful leads for further work on a coherent governance framework for data sharing, the current collection of principles and norms prompts important questions about how to streamline terminology regarding de-identification and how to harmonise the identified principles and norms into a coherent governance framework that promotes data sharing while securing public trust.

Gilead profits from Tuvada HIV treatment funded by taxpayers and patented by the U.S. government – The Washington Post

“Thomas Folks spent years in his U.S. Centers for Disease Control and Prevention lab developing a treatment to block deadly HIV in monkeys. Then San Francisco AIDS researcher Robert Grant, using $50 million in federal grants, proved the treatment worked in people who engaged in risky sex.

Their work — almost fully funded by U.S. taxpayers — created a new use for an older prescription drug called Truvada: preventing HIV infection. But the U.S. government, which patented the treatment in 2015, is not receiving a penny for that use of the drug from Gilead Sciences, ­Truvada’s maker, which earned $3 billion in Truvada sales last year….

Gilead argues that the government’s patents for Truvada for PrEP, as the prevention treatment is called, are invalid. And the government has failed to reach a deal for royalties or other concessions from the company — benefits that could be used to distribute the drug more widely….”

Big pharma is embracing open-access publishing like never before

“Scientists who work in the pharmaceutical industry have begun to publish a higher proportion of their papers open access than academics who aren’t in industry, according to an analysis.

In a literature analysis, researchers found that the proportion of open-access papers published by 23 large drug companies, such as Pfizer and Roche, almost doubled between 2009 and 2016, and has overtaken the proportion of freely available papers published generally in medicine-related fields. The study was posted to the SocArXiv preprint server on 7 February1….”

roduction and uptake of Open Access publications involving the private sector: the case of big pharma

Abstract:  Over the last years Open Access has been ranked very high on science policy agenda’s both internationally as well as nationally. This resulted in many national mandates and international guidelines on OA publishing of scientific results. One of the reasons OA has been pushed so strongly by science policy is found in the argument that what is financed publicly, should be publicly available. This argument, also known as the ‘tax payers argument’ is used to support and legitimize the push for open accessibility, not only of scientific publications, but also of the underlying research data, in order to guarantee the nonacademic sector, with lower degrees of accessibility to otherwise ‘behind-the-paywall’ information, access to outcomes of scientific research in the public sector. In this study we will focus on the developments in the OA publishing in one particular institutional sector, the private sector. Business enterprises represent the main sector in terms of R&D investments. According to Eurostat, in the year 2016 this sector represented 65% of the total R&D expenditures within the EU28. While objectives and incentives in the private sector might not always been aligned with the disclosure of research results in the open scientific literature, there is no doubt that this is the main actor when it comes to R&D performance. Within the business sector, we will focus our study in the pharmaceutical sector, by selecting a number of large pharmaceutical companies. Pharmaceutical companies represent an interesting case of study, given that is it one of the most R&D intensive industries, while it si also known for its shift in R&D orientation, from an in-house focus in the development of R&D towards a model much more open and collaborative, with more interactions with academic partners and other companies. Despite the importance of industrial R&D, until now it remains relatively understudied how private sector institutions which are active in R&D have embraced the OA movement, hence it remains relatively unknown how the private sector adapts to and can benefit from the new paradigm of open scholarship. Our objective is to shed more light on the extent to which big pharma both has been publishing in OA and also has been benefiting from OA publications to build their own research.

Production and uptake of Open Access publications involving the private sector: the case of big pharma

Abstract:  Over the last years Open Access has been ranked very high on science policy agenda’s both internationally as well as nationally. This resulted in many national mandates and international guidelines on OA publishing of scientific results. One of the reasons OA has been pushed so strongly by science policy is found in the argument that what is financed publicly, should be publicly available. This argument, also known as the ‘tax payers argument’ is used to support and legitimize the push for open accessibility, not only of scientific publications, but also of the underlying research data, in order to guarantee the nonacademic sector, with lower degrees of accessibility to otherwise ‘behind-the-paywall’ information, access to outcomes of scientific research in the public sector. In this study we will focus on the developments in the OA publishing in one particular institutional sector, the private sector. Business enterprises represent the main sector in terms of R&D investments. According to Eurostat, in the year 2016 this sector represented 65% of the total R&D expenditures within the EU28. While objectives and incentives in the private sector might not always been aligned with the disclosure of research results in the open scientific literature, there is no doubt that this is the main actor when it comes to R&D performance. Within the business sector, we will focus our study in the pharmaceutical sector, by selecting a number of large pharmaceutical companies. Pharmaceutical companies represent an interesting case of study, given that is it one of the most R&D intensive industries, while it si also known for its shift in R&D orientation, from an in-house focus in the development of R&D towards a model much more open and collaborative, with more interactions with academic partners and other companies. Despite the importance of industrial R&D, until now it remains relatively understudied how private sector institutions which are active in R&D have embraced the OA movement, hence it remains relatively unknown how the private sector adapts to and can benefit from the new paradigm of open scholarship. Our objective is to shed more light on the extent to which big pharma both has been publishing in OA and also has been benefiting from OA publications to build their own research.

We need a Public Domain Day for drug patent expirations

“This Jan. 1, readers, archivists, and creatives in the United States celebrated a special holiday: the largest Public Domain Day in 21 years. The legal ownership of hundreds of works of classic literature — this year including well-loved Robert Frost poems like “Nothing Gold Can Stay” and “Stopping by Woods on a Snowy Evening” — was transferred into the hands of the people.

We suggest a plot twist: Let’s celebrate the same way when drug patents expire.

Every year, patents on high-profile branded drugs expire and these compounds “go generic,” allowing competitors to make and sell these same treatments at lower prices. Unlike literature, where copyright protection can last a whopping 95 years or more after initial publication, most drugs are under patent protection for just 10 to 15 years. Companies that successfully bring a drug to market have only that time to charge high prices before the drug goes generic. Patent protection is their window to profit from their investments and to plow some of that money back into developing new treatments. This system of incentives keeps the biotechnology innovation engine churning, rather than allowing it to milk cash-cow drugs forever….

Public Domain Day is clearly something to celebrate. The expiration of a copyright on a literary work merits a moment to admire its beauty, contemplate our gratitude to its creator, and mark the place it has held and will continue to hold in our collective human story.

 

We should do the same when branded drugs enter the public domain. These therapies keep working just as well as before, but they become much less expensive. In the case of oral drugs, there’s an average 90 percent drop in price within a few years as multiple generics come into the market. By anticipating when a branded drug is set to enter the public domain and publicizing the date as it approaches, the public might not only show innovators that they are appreciated but also apply some healthy social pressure to let them go generic with grace, instead of tying up patent expirations in complicated legislative battles that delay the entry of generics. In short, we need a Public Domain Day for drugs….”

For Innovation, Open Science Means Open for Business | Centre for International Governance Innovation

“Last week, Celgene – an American biotech company – invested the most ever for a Canadian-discovered early-stage drug. The US$40-million down and potentially US$1-billion deal only came about because of strategic funding by governments both for “open science” partnerships and for risk-taking, IP-generating research and commercialization centres. Open science partnerships openly share data and research results with the scientific community and do not seek patent rights over their results.

The Celgene deal is the fruit of a new innovation path – from open science to Canadian IP – that involves the Ontario government-funded Ontario Institute for Cancer Research (OICR) and its commercialization partner, FACIT Inc. This “made in Canada” approach does not copy U.S. approaches, which commonly result in Canadian IP rights being transferred to foreign firms for pennies on the dollar, as we are doing in the cases of Sidewalk Labs and investments in artificial intelligence. Rather, it leaves the IP in Canada for much longer, within a locally owned company that will continue to develop the drug and conduct clinical trials here, and thus extract fuller scientific and economic value from our investments….

Five years ago, OICR embraced open science as an early innovation strategy and partnered with the SGC. Both OICR and SGC appreciated that although IP is a key pillar of the innovation economy, seeking it too early or by the wrong entity creates barriers to collaboration, leads to redundant research, introduces significant transaction costs and, perhaps counterintuitively, slows down innovation. The open science collaboration allowed knowledge, materials and data to flow freely and enabled OICR and SGC to develop a new chemical probe against the WDR5 protein and to share it freely and rapidly with research groups around the world. Those groups revealed WDR5’s therapeutic role in leukemia, breast cancer and neuroblastoma….”