ScienceDaily (May 10, 2011) — Medicines regulators are protecting drug company profits rather than the lives and welfare of patients by withholding unpublished trial data, argue researchers on the British Medical Journal website.
They call for full access to full trial reports (published and unpublished) to allow the true benefits and harms of treatments to be independently assessed by the scientific community.
Despite the existence of hundreds of thousands of clinical trials, doctors are unable to choose the best treatments for their patients because research results are being reported selectively, write Professor Peter Gøtzsche and Dr Anders Jørgensen from the Nordic Cochrane Centre in Denmark.
Selective reporting can have disastrous consequences. For example, Rofecoxib (Vioxx) has probably caused about 100,000 unnecessary heart attacks in the USA alone, while anti-arrhythmic drugs have probably caused the premature death of about 50,000 Americans each year in the 1980s…..
P. C. Gotzsche, A. W. Jorgensen. Opening up data at the European Medicines Agency. BMJ, 2011; 342 (may10 1): d2686 DOI: 10.1136/bmj.d2686 [Links to the free full text of the article]
- Are overseas trials generating suspect data on new drugs? (fiercebiotech.com)
The Registry of Open Access Repositories (ROAR) exists to promote the development of open access by providing up to date information about repositories of information worldwide.
- Search page (options include country of origin, subjects [medical and non medical] as psychology, internal medicine, dermatology, nursing, environmental sciences, textbooks), keyword entry by user as description and title
- Browse registry with options country, year, repository type (as research, e-theses), and repository software
[Related to recent posting here Access to Knowledge for Consumers]
Excerpts from the interview with Melissa Hagemann about the Open Access Movement.
She is program manager in the Open Society Foundations Information Program. She’s also on the advisory board of theWikimedia Foundation, which operates Wikipedia
What is “Open Access”?
Open Access refers to the free online availability of research literature. It was first defined at a meeting organized by the Open Society Foundations in 2001, which led to the Budapest Open Access Initiative. This initiative outlined two strategies for developing OA:
- Open Access Journals, which are journals, freely available worldwide, which do not rely upon the traditional subscription-based business model to generate their revenue; and
- Open Repositories, or archives where all scholarly research articles published by those associated with a university or within a discipline can be deposited.
In 2003, we added a third strategy, which is to advocate for public access to publicly funded research.
What are some of the most notable accomplishments of the open access movement so far?
Probably the single most important victory was a mandate adopted by the U.S. Congress which stipulates that all research funded by the National Institutes of Health (about $29 billion annually) be made freely available online.
While the NIH is the largest funder of research in the world, the OA movement has worked with governments and universities throughout the world to adopt similar mandates, and today there are 230 of them. In addition, there are over 5,500 OA journals and over 1,700 open repositories.
What major obstacles does the movement face at this moment?
As Open Access is so new, one of our main challenges is simply raising awareness of it and explaining the benefits of this new model. At the same time, you can imagine that many within the publishing industry haven’t always been keen supporters of OA.
But I’m curious: How can the publishing industry benefit from Open Access? Wouldn’t they say they need the money to continue publishing? How do you persuade them that OA is a good thing?
While OA journals are freely available online, about half of them charge a processing fee (anywhere from $500 to $3,000 or so) per article. So there are commercial OA journal publishers which are doing quite well. Actually one of the largest OA publishers, BioMed Central, was purchased by Springer (the second largest scientific journal publisher) in 2008, and Springer pledged to keep all of the journals OA.
How can others get involved in advancing the issue?
Participating in an event during OA week is a great way to start! Then I would suggest learning more about OA, and OASIS is one of the best resources for information on the OA movement.
- If you’re a student, I recommend connecting with the Right to Research Coalition.
- If you’re an academic, you can self-archive copies of your research articles in your institutional repository or submit your article to anOA journal. You can also advocate for your institution to adopt an OA mandate at your university; 230 mandates have been adopted worldwide (see www.eprints.org/openaccess/policysignup).
- If you’re in a developing or transition country, the EIFL Open Access Program offers a wealth of support and services for librarians, academics, policymakers, and funders in these countries to tap into.
- If you’re based in the United States, you can support the Alliance for Taxpayer Access, which advocates for public access to publicly funded research in the U.S.