Open access policies of leading medical journals: a cross-sectional study | BMJ Open

Abstract:  

Objectives Academical and not-for-profit research funders are increasingly requiring that the research they fund must be published open access, with some insisting on publishing with a Creative Commons Attribution (CC BY) licence to allow the broadest possible use. We aimed to clarify the open access variants provided by leading medical journals and record the availability of the CC BY licence for commercially funded research.

Methods We identified medical journals with a 2015 impact factor of ?15.0 on 24 May 2017, then excluded from the analysis journals that only publish review articles. Between 29 June 2017 and 26 July 2017, we collected information about each journal’s open access policies from their websites and/or by email contact. We contacted the journals by email again between 6 December 2017 and 2 January 2018 to confirm our findings.

Results Thirty-five medical journals publishing original research from 13 publishers were included in the analysis. All 35 journals offered some form of open access allowing articles to be free-to-read, either immediately on publication or after a delay of up to 12 months. Of these journals, 21 (60%) provided immediate open access with a CC BY licence under certain circumstances (eg, to specific research funders). Of these 21, 20 only offered a CC BY licence to authors funded by non-commercial organisations and one offered this option to any funder who required it.

Conclusions Most leading medical journals do not offer to authors reporting commercially funded research an open access licence that allows unrestricted sharing and adaptation of the published material. The journals’ policies are therefore not aligned with open access declarations and guidelines. Commercial research funders lag behind academical funders in the development of mandatory open access policies, and it is time for them to work with publishers to advance the dissemination of the research they fund.

Medicine needs to embrace open source | ZDNet

“I’m far from the only one to conclude that open-source methods are needed to break what amounts to broken pharmaceutical research methodology and drug price gougingOpen Source Pharma, an organization devoted to building on existing initiatives to develop an alternative, comprehensive, open-source pharmaceutical system, is leading the way.

Dr. Manica Balasegaram, executive director for the Access Campaign of Médecins Sans Frontières, aka Doctors Without Borders, explained:

There is something rotten in the kingdom of biomedical R&D . . . That the system is inefficient is probably difficult to dispute. It works in silos, encourages a protectionist, proprietary approach, promotes duplication, multiplies failure, is costly, and importantly, is directed at markets and not at public health needs. The consequences are fatal….

Open source can revolutionize our hunt for better, more affordable medicine. It has everywhere else. It can in medicine, too….”

Why Pfizer didn’t report that its rheumatoid arthritis medication might prevent Alzheimer’s – The Washington Post

A team of researchers inside Pfizer made a startling find in 2015: The company’s blockbuster rheumatoid arthritis therapy Enbrel, a powerful anti-inflammatory drug, appeared to reduce the risk of Alzheimer’s disease by 64 percent.

The results were from an analysis of hundreds of thousands of insurance claims. Verifying that the drug would actually have that effect in people would require a costly clinical trial — and after several years of internal discussion, Pfizer opted against further investigation and chose not to make the data public, the company confirmed.

Researchers in the company’s division of inflammation and immunology urged Pfizer to conduct a clinical trial on thousands of patients, which they estimated would cost $80 million, to see if the signal contained in the data was real, according to an internal company document obtained by The Washington Post….

Pfizer did share the data privately with at least one prominent scientist, but outside researchers contacted by The Post believe Pfizer also should at least have published its data, making the findings broadly available to researchers.

“Of course they should. Why not?’’ said Rudolph E. Tanzi, a leading Alzheimer’s researcher and professor at Harvard Medical School and Massachusetts General Hospital. “It would benefit the scientific community to have that data out there,’’ said Keenan Walker, an assistant professor of medicine at Johns Hopkins who is studying how inflammation contributes to Alzheimer’s. “Whether it was positive data or negative data, it gives us more information to make better informed decisions.’’ …

The broader market forces that critics say discouraged Pfizer from investing in Alzheimer’s clinical trials are rooted in Enbrel’s “life cycle,’’ the 20-year period of patent exclusivity when a brand manufacturer reaps monopoly profits from a drug. By industry standards, Enbrel, an injectable biologic drug, is relatively old, with FDA approval for rheumatoid arthritis in 1998….

A medical ethics expert argued that Pfizer has a responsibility to publicize positive findings, although it is not as strong as an imperative to disclose negative findings.

“Having acquired the knowledge, refusing to disclose it to those who might act upon it hides a potential benefit, and thereby wrongs and probably harms those at risk of developing Alzheimer’s by impeding research,’’ said Bobbie Farsides, professor of clinical and biomedical ethics at Brighton and Sussex Medical School in the United Kingdom….”

Affordable, life-saving medicines for all: McGill adopts Global Access Licensing Principles for research conducted on campus : Med e-News

McGill University, in conjunction with Universities Allied for Essential Medicines (UAEM), has committed to increasing access to life-saving medicines by adopting Global Access Licensing Principles. McGill is the third Canadian university to adopt the principles, demonstrating a dedication to ensure that any research and university-developed technologies created on McGill’s campus with potential for further development into a drug, vaccine, or medical diagnostic are made affordable to all.

Global Access Licensing Framework (GALF), the framework used to inform aspects of McGill’s new principles, provides goals and strategies for research universities to follow in the licensing of medicines developed at the universities. The framework aims to prevent patenting practices and intellectual property policies from creating barriers to the life-saving results of publicly-funded research conducted in universities’ laboratories. GALF was created with the help of Universities Allied for Essential Medicines (UAEM), a non-profit, student advocacy organization with chapters at universities around the world…”

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.