Prospect patents, data markets, and the commons in data-driven medicine : openness and the political economy of intellectual property rights

Scholars who point to political influences and the regulatory function of patent courts in the USA have long questioned the courts’ subjective interpretation of what ‘things’ can be claimed as inventions. The present article sheds light on a different but related facet: the role of the courts in regulating knowledge production. I argue that the recent cases decided by the US Supreme Court and the Federal Circuit, which made diagnostics and software very difficult to patent and which attracted criticism for a wealth of different reasons, are fine case studies of the current debate over the proper role of the state in regulating the marketplace and knowledge production in the emerging information economy. The article explains that these patents are prospect patents that may be used by a monopolist to collect data that everybody else needs in order to compete effectively. As such, they raise familiar concerns about failure of coordination emerging as a result of a monopolist controlling a resource such as datasets that others need and cannot replicate. In effect, the courts regulated the market, primarily focusing on ensuring the free flow of data in the emerging marketplace very much in the spirit of the ‘free the data’ language in various policy initiatives, yet at the same time with an eye to boost downstream innovation. In doing so, these decisions essentially endorse practices of personal information processing which constitute a new type of public domain: a source of raw materials which are there for the taking and which have become most important inputs to commercial activity. From this vantage point of view, the legal interpretation of the private and the shared legitimizes a model of data extraction from individuals, the raw material of information capitalism, that will fuel the next generation of data-intensive therapeutics in the field of data-driven medicine

Biopiracy <i>versus </i>one-world medicine – from colonial relicts to global collaborative concepts

Background: Practices of biopiracy to use genetic resources and indigenous knowledge by Western companies without benefit-sharing of those, who generated the traditional knowledge, can be understood as form of neocolonialism.Hypothesis: : The One-World Medicine concept attempts to merge the best of traditional medicine from developing countries and conventional Western medicine for the sake of patients around the globe.Study design: Based on literature searches in several databases, a concept paper has been written. Legislative initiatives of the United Nations culminated in the Nagoya protocol aim to protect traditional knowledge and regulate benefit-sharing with indigenous communities. The European community adopted the Nagoya protocol, and the corresponding regulations will be implemented into national legislation among the member states. Despite pleasing progress, infrastructural problems of the health care systems in developing countries still remain. Current approaches to secure primary health care offer only fragmentary solutions at best. Conventional medicine from industrialized countries cannot be afforded by the impoverished population in the Third World. Confronted with exploding costs, even health systems in Western countries are endangered to burst. Complementary and alternative medicine (CAM) is popular among the general public in industrialized countries, although the efficacy is not sufficiently proven according to the standards of evidence-based medicine. CAM is often available without prescription as over-the-counter products with non-calculated risks concerning erroneous self-medication and safety/toxicity issues. The concept of integrative medicine attempts to combine holistic CAM approaches with evidence-based principles of conventional medicine.Conclusion: To realize the concept of One-World Medicine, a number of standards have to be set to assure safety, efficacy and applicability of traditional medicine, e.g. sustainable production and quality control of herbal products, performance of placebo-controlled, double-blind, randomized clinical trials, phytovigilance, as well as education of health professionals and patients

Harnessing Openness to Transform American Health Care

The Digital Connections Council (DCC) of the Committee for Economic Development (CED) has been developing the concept of openness in a series of reports. It has analyzed information and processes to determine their openness based on qualities of "accessibility" and "responsiveness." If information is not available or available only under restrictive conditions it is less accessible and therefore less "open." If information can be modified, repurposed, and redistributed freely it is more responsive, and therefore more "open." This report looks at how "openness" is being or might usefully be employed in the healthcare arena. This area, which now constitutes approximately 16-17 percent of GDP, has long frustrated policymakers, practitioners, and patients. Bringing greater openness to different parts of the healthcare production chain can lead to substantial benefits by stimulating innovation, lowering costs, reducing errors, and closing the gap between discovery and treatment delivery. The report is not exhaustive; it focuses on biomedical research and the disclosure of research findings, processes of evaluating drugs and devices, the emergence of electronic health records, the development and implementation of treatment regimes by caregivers and patients, and the interdependence of the global public health system and data sharing and worldwide collaboration

Reporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation.

BackgroundPrevious studies of drug trials submitted to regulatory authorities have documented selective reporting of both entire trials and favorable results. The objective of this study is to determine the publication rate of efficacy trials submitted to the Food and Drug Administration (FDA) in approved New Drug Applications (NDAs) and to compare the trial characteristics as reported by the FDA with those reported in publications.Methods and findingsThis is an observational study of all efficacy trials found in approved NDAs for New Molecular Entities (NMEs) from 2001 to 2002 inclusive and all published clinical trials corresponding to the trials within the NDAs. For each trial included in the NDA, we assessed its publication status, primary outcome(s) reported and their statistical significance, and conclusions. Seventy-eight percent (128/164) of efficacy trials contained in FDA reviews of NDAs were published. In a multivariate model, trials with favorable primary outcomes (OR = 4.7, 95% confidence interval [CI] 1.33-17.1, p = 0.018) and active controls (OR = 3.4, 95% CI 1.02-11.2, p = 0.047) were more likely to be published. Forty-one primary outcomes from the NDAs were omitted from the papers. Papers included 155 outcomes that were in the NDAs, 15 additional outcomes that favored the test drug, and two other neutral or unknown additional outcomes. Excluding outcomes with unknown significance, there were 43 outcomes in the NDAs that did not favor the NDA drug. Of these, 20 (47%) were not included in the papers. The statistical significance of five of the remaining 23 outcomes (22%) changed between the NDA and the paper, with four changing to favor the test drug in the paper (p = 0.38). Excluding unknowns, 99 conclusions were provided in both NDAs and papers, nine conclusions (9%) changed from the FDA review of the NDA to the paper, and all nine did so to favor the test drug (100%, 95% CI 72%-100%, p = 0.0039).ConclusionsMany trials were still not published 5 y after FDA approval. Discrepancies between the trial information reviewed by the FDA and information found in published trials tended to lead to more favorable presentations of the NDA drugs in the publications. Thus, the information that is readily available in the scientific literature to health care professionals is incomplete and potentially biased

A tale of two cinnamons: A comparative review of the clinical evidence of Cinnamomum verum and C. cassia as diabetes interventions

Objective: This review investigates the effectiveness of two cinnamon species, Cinnamomum verum and C. cassia, in diabetes management; their impact on related health conditions and relevant parameters in healthy individuals and safety issues. Methods: PubMed, Cochrane Library, and ScienceDirect were searched from 2000 up to April 2018 for clinical trials using either C. verum or C. cassia in controlling blood glucose and other diabetes-related parameters and conditions. Results: A total of twenty-five studies (n=997) were included for reviewing clinical evidence. Among these trials, fifteen studies investigated the effects on type II diabetes mellitus (T2DM) patients (n=831), four investigated subjects with related clinical conditions (n=82), and six investigated healthy individuals (n=84). Nineteen studies used C. cassia and six used C. verum. Results suggested C. cassia helped manage diabetes at 3-6g, while the effectiveness of C. verum remained inconclusive. In addition, the chemical properties of C. cassia and C. verum differ considerably. Of note, C. cassia contains high levels of the potentially hepatotoxic constituent coumarin. A skin rash was the only adverse event reported. Conclusion: While evidence supports the therapeutic benefit of C. cassia, interchangeability of C. cassia and C. verum remains inconclusive. Further research is warranted to address the effectiveness and safety of these cinnamon species. Given the potential hepatotoxicity of C. cassia, RCTs that include liver function tests are required. Robust RCTs on C. verum are recommended to establish if its efficacy can match its safety profile

Children in need of medical innovation

Children are therapeutic orphans and an underprivileged group in innovations derived from drug therapy. As the innovation process of pharmaceuticals is a long, risky and very costly business, economists typically emphasise lack of profit incentives and small market size as the most important obstacles to child-related innovative activity. Moreover, as new drugs need to be tested in medical trials, there are ethical concerns leading to a climate of reluctance towards medical trials on persons who are not able to give their "informed consent". Particularly in Germany, due to various reasons, a rather restrictive legislation is to be assumed, characterized by the idea of putting the protection of the individual human being before a more utilitarian view. Thus, economic incentives, legal restrictions and ethical concerns seem to be responsible for the lack of innovative activity targeted at drugs for children, though social cost-benefit considerations (i.e. welfare analysis) would most probably predict a high gain from the introduction of critical innovations. Grounded on a highly interdisciplinary view based on medical, pharmaceutical, psychopharmaceutical, psychotherapeutic and economic research as well as on ethical restrictions, this survey aims at analysing channels of influence that might be helpful both in the analysis of the innovation process of drugs for children, and in improving the uncertain situation of pediatric therapy.

Children in Need of Medical Innovation

As the innovation process of pharmaceuticals is a long, risky and very costly business, economists typically emphasise lack of profit incentives and small market size as the most important obstacles to child-related innovative activity. Moreover, there are ethical concerns because children are not able to give their ?informed consent? to requested clinical trials. Thus, economic incentives, legal restrictions and ethical concerns seem to be responsible for the lack of innovative activity targeted at drugs for children, though social costbenefit considerations (i.e. welfare analysis) would most probably predict a high gain from the introduction of critical innovations. Grounded on a highly interdisciplinary view based on medical, pharmaceutical and economic research, this survey aims at analysing channels of influence that might be helpful both in the analysis of the innovation process of drugs for children, and in improving the uncertain situation of pediatric therapy. --