The U.S. Commitment to Global Health Recommendations for the Public and Private Sectors (2009) / Chapter Skim
Currently Skimming:
Appendix F: Commissioned Paper: Sharing Knowledge for Global Health--Anthony D. So and Evan Stewart
Appendix F: Commissioned Paper: Sharing Knowledge for Global Health--Anthony D. So and Evan Stewart
Pages 247-276
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 247... ...
The United States alone generates nearly twice the number of scientific publications (32.7% of the world total) than the whole of the developing world (17.3%)
|
From page 248... ...
Increasingly, biomedicine is turning to the growing pools of talent in the developing world. The conduct of clinical trials is burgeoning in the developing world -- no doubt lured, in part, by reports that a top-notch academic center in India charges a tenth per case report of what a second-tier medical center in the United States would in mounting a clinical trial.2 Pharmaceutical firms in the developing world may face different opportu nity costs than large multinational corporations, and this may lead to gap-filling R&D investments, such as in more cost-effective processes for producing drugs.
|
From page 249... ...
Using public sector monies, product development partnerships have embarked on drug discovery programs for neglected diseases. Half of these partnerships involved multinational corporations that conducted these projects on a "no profitno loss" basis.
|
From page 250... ...
Not relying on the serendipity of finding incidental applications for neglected diseases, government and philanthropic funders have also invested in product development partnerships. Sharing knowledge requires an enabling environment.
|
From page 251... ...
These building blocks for research include access to scientific publications, the norms for data and material sharing, and patenting and licensing practices. Characterizing the obstacles and opportunities at each stage can help point the way to solu tion paths that lower the barriers to sharing knowledge and improve the scientific community's ability to respond to the challenges of global health.
|
From page 252... ...
Access to Scientific Publications The challenges to sharing knowledge through scientific publication come both from the supply and the demand side. On the supply side, studies suggest that industry funding may not only occasionally introduce potential bias into the conduct of research, but also possible delays in its publication.
|
From page 253... ...
This problem not only faces some institutions in the developing world, but also among patients in the developed world. For many patients, especially those with rare diseases, the high cost of accessing individual journal articles can pose an obstacle to learning about one's condition or treat ment options.
|
From page 254... ...
In so doing, open-access journals enable wider distribution of the research published in these outlets, and at the same time, the copyright licensing of these works allow greater potential of "remix." For example, if a developing country research institution sought to pull together a compendium of key articles on schistosomiasis and to share such a resource with sister institutions, the transaction costs of assembling an open-access collection of journal articles are far lower than doing so with non-open-access articles, where reprint rights would have to be negotiated with each journal holding the copyright. Open-access publishing has benefited from Creative Commons licensing.
|
From page 255... ...
, a funding body set up by the European Union (EU) to promote research in the region, has also put forward an open-access policy requiring its grantees to post all publications to a research repository within six months of publication.40 This marked the first EU-wide open-access policy and ERC has stated that it has interest in shorten ing the six-month window period in the future.41,42 The Wellcome Trust requires submission of scientific publications resulting from its grants into U.K.
|
From page 256... ...
Dual use of technologies have the potential both to advance scientific knowl edge and to pose threats to public health or the environment, and such research activities as well as resulting data and materials require governmental oversight. 46 However, denying data access not only imposes additional costs and barriers to research along these lines, but also can place patients at risk of redundant or unnecessary clinical trials.
|
From page 257... ...
Called the "Bermuda Rules," these rules were created to prevent the patenting of DNA sequences through defensive publishing.55 Providing further incentive to follow the Bermuda Rules, the NIH subsequently suggested that the patenting of work emerging from the publicly funded Human Genome Project would negatively impact the likelihood of receiving future grants.56 Data sharing has also been supported by other initiatives since the adoption of the Bermuda Rules -- by the Merck Gene Index,57 the International Nucleotide Sequence Database Collaboration,58 and the Worldwide Protein Data Bank among others.59 Traditionally, the sharing of data and materials involves both informal and formal norms. Informally researchers sometimes bypass negotiation over material transfer agreements (MTAs)
|
From page 258... ...
Among them, the Broad Institute and the pharmaceutical company Novartis have collaborated to share freely genetic data about diabetes online as part of the Diabetes Genetic Initiative.67 In addition to this public-private partnership, Broad has partnered with a disease-based foundation in order to create the Multiple Myeloma Genomics Portal, which publishes the sequence of the myeloma genome,68 and with several other research teams to create the Tuberculosis Database Project.69 The Multiple Myeloma Genomics Portal prohibits patenting of any DNA sequences discovered, and all data must be posted to a public site upon completion of the analysis. The TB Database Project allows for both the options of posting data for public access and as private data pending publication or the resolution of intellectual property claims.
|
From page 259... ...
A registry of clinical trials allows patients and providers to find treatments undergoing testing or uncover negative findings that might otherwise remain unpublished or hidden. A pool of compound libraries might diversify the spectrum of available druggable compounds, allow researchers to pursue novel compounds from parts of the genome considered "undruggable," and bring useful data and annotation information to a larger group of researchers, some pursuing neglected diseases otherwise without the benefit of such resources.
|
From page 260... ...
Users can undertake searches ranging from genomic or protein structural data to information on target druggability on neglected diseases from leprosy and filariasis to Chagas disease and leishmaniasis. In the first 16 months since the database's launch, the site has logged more than 10,000 visits, with more than 30% coming from developing countries or regions where these neglected diseases are endemic.76 This web-based initiative complements efforts to bring together the partnerships and multidisciplinary networks needed for drug discovery for neglected diseases.77 Now the vision for TDR is considerably more ambitious: a virtual drug discovery network with negotiated access and screening of proprietary compound libraries on a contractual and confidential basis, spon sored scientists to work in pharmaceutical companies on these neglected disease projects, and a clearinghouse to help coordinate these efforts.
|
From page 261... ...
Nearly half of the unfavorable findings found in trials submitted for FDA approval did not make it into the published papers of these clinical trials.81 When post-marketing studies found increased suicide among children using Paxil82 and of increased incidence of heart failure from the use of Vioxx,83,84 companies delayed the release of clinical trial data that reflected the risks associated with their products. Responding to this need, the NIH has developed a clinical trial registry and results data bank for both federal and privately supported clinical trials conducted around the world.
|
From page 262... ...
93 The U.S. Copyright Act of 1976 and the NIH Public Access policy lower barriers to the sharing of knowledge through scientific publications, and OMB Circular A-130, similarly kept the price of government databases to the marginal cost of dissemination.
|
From page 263... ...
For example, the Institute for OneWorld Health has secured exclusive license from the University of Washington and Yale University to develop azole compounds that might help treat Chagas disease in the developing world.100 Similarly, the University of British Columbia licensed an oral formu lation of Amphotericin B to iCo Therapeutics for treating blood-borne fungal infections in the developed world on condition that the company provides subsi dized pricing of the drug to treat leishmaniasis in the developing world. 101 Such licenses often promise little revenue return from the developing world, but by reserving rights for application in the industrialized world, revenues from paying markets remain possible.
|
From page 264... ...
At each link in the chain, various approaches to sharing knowledge have been discussed. Whether scientific publications, data or material transfer, or the licensing of patented inventions are the critical input to innovation, the scientific community has gravitated to solution paths that share some common elements.
|
From page 265... ...
Selecting what countries belong to which tier is a key consideration. With the support of Gates Foundation funding, the University of California, Berkeley, provided royalty-free licenses for the microbial synthesis of artemisinin to Amyris Biotechnologies and the Institute for One World Health.104 The University limited the field of use to the nonprofit production of artemisinin for treating malaria in the developing world.
|
From page 266... ...
There certainly have been fledgling efforts to create a SARS patent pool,108 to develop UNITAID's proposed patent pool for HIV/AIDS drug products,109 and to seed a technology trust for neglected diseases.110 Recently though, GlaxoSmithKline stirred renewed interest in this approach with its announced commitment to donate more than 800 patents to a pool open to researchers working on developing treatments for neglected diseases.111 Going beyond patent pools, the "technology trust" model explores the potential for pooling across the value chain, from open-access databases to pool ing of patented inventions. Using various arrangements for collectively managing intellectual property, it emphasizes the normative role that public sector pooling and its strategic use of IPRs can play in encouraging greater scientific exchange and innovation.112
|
From page 267... ...
in agricultural biotechnology for the public good, while at the same time improving privatesector interactions by more efficiently identifying collective commercial licensing opportunities."113 Acting more as a clearinghouse than a pool, its public database comprised of patented inventions from member institutions makes it easier to identify socially useful bundles of intellectual property for commercialization. Public sector and philanthropic funders seldom foot these transaction costs for pooling in biomedical R&D.
|
From page 268... ...
The online platform allows a community of scientists to share and collaborate on projects, from gene sequencing to new drug development, on Mycobacterium tuberculosis. Backed by US$38 million in commitments from the Indian government, this open-source website has already engaged 700 participants from 130 cities across 56 active projects.120 OSDD differs from previous open-source drug discovery projects in that it has the support of a leading research institution in a major developing country, promises to adopt 30 colleges throughout India where students will have the opportunity to contribute research to this initiative, and importantly, has substantial financial resources to leverage research collaborations.
|
From page 269... ...
The recently approved NIH funding for comparative effectiveness trials is a useful first step in this direction.123 Reengineering the value chain might also involve investing in alternative business models, one that might lower the cost of R&D for neglected diseases. The Gates Foundation grant to the Institute for One World Health, the University of California, Berkeley, and Amyris Biotechnologies to produce artemisinin at no profit for the developing world is one such example.
|
From page 270... ...
With Wellcome Trust and UK govern ment funding, investigators from Imperial College and the London School of Pharmacy reengineered not only the existing version of hepatitis C treatment, pegylated interferon, but also the approach to help ensure its scale-up as a product affordable to the many afflicted with this disease in the developing world.124,125 Through a university spin-off, they licensed the drug to Shantha Biotechnics, bypassing the more customary route of licensing it to a multinational pharma ceutical firm. Facing different clinical trial costs, Shantha Biotechnics will try to produce a more affordable treatment than the one currently available.
|
From page 271... ...
2008. Open Access to Research for the Developing World.
|
From page 272... ...
2008. Policy on Enhancing Public Access to Archived Publications Resulting from NIH-Funded Research.
|
From page 273... ...
1995. Uniform Biological Material Transfer Agreement: Discus sion of Public Comments Received; Publication of the Final Format of the Agreement.
|
From page 274... ...
2004. Clinical Trial Registration: A Statement from the International Committee of Medical Journal Editors.
|
From page 275... ...
2008. Breakthrough Business Models: Drug Development for Rare and Neglected Diseases and Individualized Therapies: Workshop Summary.
|
From page 276... ...
So. The Case for Public Funding and Public Oversight of Clinical Trials.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.