Open Access: A Basic Right Underlying Participatory Medicine
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An ESUN Article

Gilles Frydman
Founder & President
Association of Cancer Online Resources (ACOR)

What is "Open Access"?

Open Access is a method of publishing that meets the following two conditions:

For the biomedical sciences, PubMed Central is an example of such a repository. Two important points to note are:

  1. Open access is a property of individual works, not necessarily journals or publishers.
  2. Community standards, rather than copyright law, will continue to provide the mechanism for enforcement of proper attribution and responsible use of the published work, as they do now (1).
What Is "Participatory Medicine"?

Participatory Medicine is a model of medical care, based on the collaborative relationship of the individual patient, enabled by information, software and community, and the entire care team. It requires equal access to all the clinical and scientific data related to the patient and a shared decision-making process. Participatory medicine is based on the understanding that optimally treating an individual patient suffering from a complex medical condition is beyond any single individual's ability and that actively involving the patient (or the patients caregiver as appropriate) is actively sought and welcomed.

Open Access Could Be Detrimental To Your Health (Or So Some Would Have You Believe)!

Enabled and empowered patients are a pre-requisite to experience the benefit of participatory medicine. This empowerment requires unlimited access to medical information and, consequently, we cannot achieve the full potential of participatory medicine until Open Access publishing becomes the new standard for the biomedical sciences. Some still think that the results of the democratization of access to medical information are disruptive to their profession, if not frankly dangerous.

Just a few months ago Scott Haig, MD, a surgeon, wrote in Time magazine a well publicized rant (2) against the informed patients. Barely a week passes without some doctor complaining on TV, an interview or even a peer-reviewed article about the dangers of patients heaping piles of medical information on the 'expert' practitioner. Such statements and articles are merely the recent manifestations of views long held in the medical and scientific community about open access to technical information. Consider the following quote made by John Jarvis, Managing Director at Wiley Europe in 2004:

One of the things that intrigues me is that there is evidence that some of the support for open access is coming from outside the research community. There are some reports of members of the public wanting to read this kind of information. Without being pejorative or elitist, I think that is an issue that we should think about very, very carefully, because there are very few members of the public, and very few people in this room, who would want to read this type of scientific information, and in fact draw wrong conclusions from it. […] I will say again; let us be careful because this rather enticing statement that everybody should be able to see everything could lead to chaos. Speak to people in the medical profession, and they will say the last thing they want are people who may have illnesses reading this information, marching into surgeries and asking things. We need to be careful with this very, very high-level information. (3)

What is at stake here is limiting the potentially exponential growth of participatory medicine. But in order to see millions of people take greater responsibilities in their own care and working, as true partners, with their clinicians, we must insure unfettered access to all the current knowledge. Thankfully, we have a growing array of tools and technologies to obtain this medical and scientific information. Open Access (4) is one of these technologies and may very well end up being the most powerful change agent for the healthcare system, particularly if it becomes associated with social networking functions.

Since the publication of the Institute of Medicine 2001 report “Crossing the Quality Chasm: A New Health System For The 21st Century” everybody is talking about patient-centered medicine and shared decision-making. I suggest that these are empty words as long as patients do not have full access to both the full-text scientific literature pertaining to their condition and all of their entire medical files.

The Necessity Of In-Depth Medical Information

Hunters and gatherers of medical information (5) about a rare disease can have a profound impact when they are informed of the latest research evidence as well as other patients’ experience. When connected to an active online community these patient advocates can become a powerful force able to transform the quality of care received by thousands of other patients suffering from the same rare condition. Clearly, Open Access is an absolute necessity to maximize the effectiveness of this process. Sharon Terry, President and CEO of Genetic Alliance and a patient advocate for PXE (pseudoxanthomaelasticum, a rare connective-tissue disease that can lead to bleeding, skin lesions and blindness) makes the following compelling statement:

My entry into Open Access is personal, because in 1994 my two children were diagnosed with a rare genetic disease called PXE. Immediately, my husband Patrick and I had a very personal experience of what un-open access looks like. We wanted to get some quality information about the kids' disease, but instead we were subjected to what we could garner through filtered information in reviews or medical encyclopedias. What we got from those kinds of publications was often incorrect, but we didn't know it at the time because we had nothing to gauge it against. We didn't have a shard of medical information in our bones. As my husband likes to say, we didn't know a gene from a hubcap. […] At the beginning we really wanted to get more information. But when we went to try to find that information, we discovered that it was very hard to get. We lived in the Boston area at the time and were lucky to be able to go to one of the best medical libraries in the world. We went to the Harvard University library and found that we had to pay $25 to get in the door, which we understood because it's a private university. So we paid the $25, but after about ten trips to the library we decided we couldn't afford to continue that way." (6)

Like almost all patient advocates for rare diseases Sharon and her husband had no medical training: she was a college chaplain and he was a fire protection engineer. But as countless Association of Cancer Online Resources, ACOR (7) stories have shown, the initial lack of medical training does not prevent people in need from wanting to learn a lot more about a specific medical condition. Sharon Terry has spent the last decade energetically acquiring the skills necessary to contribute decisively to PXE research. Sharon Terry, like many other patients or caregivers dealing with rare diseases knows that Open Access was the game-changing development. Without it she would never have access to the information she found. And she would never have found the researchers, located the patients, and eventually advocated for gene discovery and catalyzed research.

How ACOR Started

Fifteen years ago, when ACOR was formed, access to medical and scientific information was significantly limited by various technology and legal hurdles, ranging from electronic content control and copyright limitations. Cancer patients experienced their version of a Berlin wall, with professional entities blocking them from accessing in-depth scientific information. That wall started to crumble in 1995 when the National Cancer Institute (NCI) allowed open access to Physician Data Query (PDQ) files over the internet using early browsers (8). PDQ statements had been available since 1987 (9) and in early 1995 the system was still designed specifically to deliver data only to clinicians:

The National Cancer Institute's computerized information systems have been designed to help physicians cope with the information explosion by translating the medical literature into usable forms. Systems developed by the NCI's International Cancer Information Center provide access to a comprehensive source of bibliographic citations on cancer research (the CANCERLIT database) and to current, peer-reviewed syntheses of state-of-the-art clinical information on cancer (the PDQ database). (10) [emphasis added]

Public access to the World Wide Web became a reality in 1993. In March of that year, the WWW traffic represented 0.1% of the internet traffic, and 10 times that amount just 5 months later! The public release, in November 1993, of Mosaic, the first web browser capable of displaying images, resulted in the swift and massive growth of the internet that followed. Soon after its introduction a new series of PDQ statements, written specifically for patients was made available. Suddenly the PDQ statement role was changed to “provide physicians and the general public with a responsible assessment of current screening, prevention, and treatment approaches to cancer.” [emphasis added] Originally the NCI team thought that lay people would only be interested in the patient statements, not the much more complete and scientific PDF statements for health professionals, full of references to peer-reviewed articles. Discussions at the NCI with patient advocacy representatives helped to make both patients and health professional statements available to anyone, although there was originally very strong opposition from more than a few doctors and other health professionals who believed that the original content for health professionals was too complex and possibly dangerous for patients. But to everyone’s surprise many visitors were instantly interested in the section designed for health professionals.

I remember having access to these documents when my wife was diagnosed with breast cancer. I used the patient statement for 10 minutes to familiarize myself with an overview of the disease and the medical terminology. Then I immediately started reviewing the statement for physicians to understand our options, from potential treatments and their side effects to statistics about the disease. After spending a while reading the PDQ statement on breast cancer I was able to confirm the scientific validity of what I had been told by a couple of very well informed members of the BREAST-CANCER mailing list (11), one of the original cancer “listserves”. (A listserve is a computer program that automatically sends messages to multiple e-mail addresses on a mailing list).

This was my initiation as an e-patient, and triggered my request for a second opinion. In an afternoon I understood that the first physician we saw had not provided some of the key information we needed to make an informed decision regarding the treatments to come. I became an e-patient just a few hours after I looked, for the first time ever, at the scientific literature on breast cancer.

It was incredible to compare that first internet experience with the incredible difficulty of finding in-depth medical information just six years prior. Then, in 1989, in pre-browser, pre-internet days, one had to go to medical libraries and spend many days collecting information about a complex medical condition to be an effective patient advocate. I had to spend a week to understand the cardiac problem that suddenly confronted a family member. My two experiences were so far apart that I instantly began to imagine how the new online connectivity could be leveraged to build a repository of patient-generated conversations about specific cancers. It was much later that I realized that the explosive spread of the internet and our concomitant ability to distribute large amounts of electronic data at no cost are strong arguments for Open Access.

The PubMed Effect

The National Library of Medicine (NLM) first released PubMed in January 1996 as an experimental database with full access to MEDLINE®. The word "experimental" was dropped from the Web site in April 1997, and on June 26, 1997, a Capitol Hill Press conference attended by Vice President Al Gore officially announced free MEDLINE access via PubMed:

MEDLINE...will henceforth be available free to the American people. […] This development...may do more to reform and improve the quality of health care in the United States than anything else we’ve done in a long time.

In a short period of time after the launch of ACOR in 1996, volunteers started to see mention of abstracts from PubMed and within 2 years PubMed had become the official tool to debunk misinformation in the ACOR online communities. That was the first obvious use for the abstracts. But many unexpected uses of PubMed produced remarkable results:

In a few years, with these few online tools, the old paradigm of medicine had been destroyed. For thousands of patients suffering from rare cancers, their experience had evolved into a much higher level of control over their treatments. Unfortunately this phenomenon was taking place in online communities that were barely noticed. The unspoken trust of the users of any ACOR online community rests on our strong will to protect their privacy. All of the community’s content is hidden from the search engines, blocking ACOR’s ability to advertize all the great innovations taking place in these groups.

Abstracts Are Good. Articles Are Much Better!

As the ACOR lists became a regular vehicle for the transfer of PubMed abstracts, a new phenomenon started to bubble up from some groups. As people became accustomed to PubMed searches they also understood the limitations of the abstracts and started looking for the full text articles. We started to see more and more conversations in the lists about the copyright implications. In almost every active online community a very small number of subscribers became the de-facto librarians for the group and started collecting and archiving full text articles that they would share, privately with other members of the group. Few people in our online communities had ever heard of Open Access and fewer yet wrote about the developments taking place in the scientific publishing world in parallel. After noticing the growing number of calls on ACOR to gain access to full text articles that I started looking into Open Access (12) when a friend mentioned ArXiv (13), an e-print service in the fields of physics, mathematics, computer science, quantitative biology and statistics, as a model we should emulate. As ArXiv’s founder Paul Ginsparg wrote in 2001 (14):

The essential question for "Electronic Publishing in Science" is how our scientific research communications infrastructure should be reconfigured to take maximal advantage of newly evolving electronic resources. Rather than "electronic publishing" which connotes a rather straightforward cloning of the paper methodology to the electronic network, many researchers would prefer to see the new technology lead to some form of global "knowledge network", and sooner rather than later.

Open Access: A Clear, Basic Right

The activities to promote Open Access accelerated in 2000. In less than 2 years, PubMed Central was made available, Wikipedia was started, the Budapest Open Access Initiative (15) was launched and the Creative Commons (16) was created. PubMed Central (PMC) is the National Institute of Health's (NIH) free digital database of full-text scientific literature in biomedical and life sciences. The Budapest Initiative is at once a statement of principle, a statement of strategy, and a statement of commitment from participants representing many points of view, many academic disciplines, and many nations, all with one purpose: to accelerate progress in the international effort to make research articles in all academic fields freely available on the internet. The Creative Commons is a non-profit organization with a mission to define the spectrum of possibilities between full copyright — all rights reserved — and the public domain — no rights reserved. Their various licenses help anyone creating an intellectual work in retaining their copyright while inviting certain uses of their work — a “some rights reserved” copyright.

The road to Open Access is still not completely constructed. In 2002, the Department of Energy (DoE), under strong lobbying from publishers and members of the Information industry, terminated PubScience, the equivalent of PubMed for various scientific fields. It is notable that the DoE terminated PubScience while almost all public comments strongly supported it.

The biggest funder of Scientific, Technical and Medical (STM) journal articles is the NIH. Not surprisingly the NIH has been the first federal agency to champion a policy for public access to the critical biomedical research it funds, through its Policy on Enhancing Public Access to Archived Publications Resulting from NIH-Funded Research, which was implemented in 2005. The NIH policy originally requested eligible investigators to deposit copies of their final, peer-reviewed manuscripts into PubMed Central, so that they may be made publicly available twelve months after publication. (While agencies around the world, including the Research Councils UK and the Canadian Institutes for Health Research, have backed six-month embargoes, the NIH adopted a twelve-month window as a compromise with journal publishers who feared a loss in revenues). Acting responsibly, the NIH adopted this voluntary deposit policy but participation was extremely low because STM publishers were opposed to it and the authors were not well informed about it. So, in the 2008 Labor-HHS Appropriations bill, Congress directed NIH to adopt a mandatory deposit policy. In April 2008 the NIH Public Access Policy was revised and, to ensure its success, it is now mandatory for researchers. Upon publishing its revised policy the NIH began a formal process to engage its stakeholders in enhancing the effectiveness of the policy and conducted a Request for Information from March 31 to May 31, 2008. A significant portion of those who commented were e-patients/-caregivers dealing with cancer or a rare disease. Most commented with very strong arguments for their absolute need for Open Access.

The revised policy is now under attack in Congress. The newly introduced “Fair Copyright in Research Works Act” (HR6845) is designed to amend current U.S. copyright law and permanently disable the public access to taxpayer-funded research that is so important for all of us.

In a recent testimony, about HR6845, before Congress, NIH Director Zerhouni demonstrated the undeniable and tremendous advances made possible when research is accessible and searchable:

When viewing a report in NIH PubMed and PubMed Central databases, at the touch of a button we can link to papers that are determined to be related, as well as to papers that were actually cited. We can also link to related chemical structures, proteins, viruses, and other data, allowing us to make discoveries that advance science and even prevent deaths.

For example, about three years ago, a child was hospitalized with an undiagnosed illness in Minnesota. The state health laboratory had isolated an unknown virus. After determining the DNA code of the virus, laboratory staff used the internet to access the 55 million DNA sequences at NCBI and immediately found a match. The virus turned out to be the first polio case in the United States since 1999…

Dr. Zerhouni also said:

… Scientists are accumulating new information at a staggering rate, and I am witness to an unprecedented explosion of knowledge.

There have been times I was informed of more discoveries in three months in such areas of research as genomics than I had in the previous five years combined – and the rapid pace continues today. These advances have illuminated previously hidden areas of the life sciences, including new and significant discoveries regarding the cellular underpinnings of disease. Our new knowledge of genes, proteins, and molecules is leading us to new areas for exploration in biomedical research.

[…] Every single week, scientists and the general public are downloading more information from NIH’s databases and web-based archives of publications than exists in the entire Library of Congress. Scientists are not the only beneficiary of publicly accessible information.

[…] Surveys indicate that more than 60 percent of American patients consult internet medical sites prior to seeing their physicians, and they would benefit from access to the most complete and unbiased information available.

[…] The second revolution emerged from our ability to manage and integrate these enormous quantities of data being produced and to make them available in ways to speed research that did not exist even ten years ago. We are now capable of taking individual discoveries and integrating them with all other research findings – both publications and data. Scientists can connect the dots between discoveries instantly, an advance analogous to moving from searching for fingerprint matches manually to matching prints in a database of millions in an instant.

Let's adapt the decision implemented at the NCI in 1995 to all of the biomedical sciences filed: any information written for scientists or doctors should be made available to the public without barriers. Summarizing and rewriting for lay audiences is definitely welcome and extremely useful. But so is access to the original text. And no one knows what is the best form of information for a particular individual, since conditions may change over time. Therefore Open Access to any scientific publication should be the norm. Last month I was at the biannual meeting of a rare cancer advocacy organization where patients, informed about the different manifestations of their disease based on the mutations on different exons of a single gene, were discussing, directly and one-on-one, as is normal in a Q&A session in a scientific meeting, the clinical implications of such scientific discoveries with some of the best clinical specialists. That was a prime example of what the future of participatory medicine can be when e-patients and health professionals recognize the benefits of informed and organized patients.

Conclusion

To recapitulate, the necessity of Open Access to promote participatory medicine is clear:

We have had enough examples on ACOR demonstrating the reality of “the wisdom of crowds” (17) and the power of serendipity. Each ACOR list has a core contingency of educated and journal-article informed members who set the bar for list discussion. Over the years too many significant pieces of information have been found by these members through PubMed and PubMed Central followed by extensive communication with group members to still think that access to the fast growing depositories of medical knowledge should be restricted in any way. The contemporary world of connected and informed patients can often show the limit of the experts’ omniscience and particularly when dealing with a rare disorder.

Now that Open Access material is becoming available on a large scale, social networks with their own brand of expert e-patients are starting to build advanced scientific sites becoming focused repositories of scientific data, including articles, clinical trials information, tests and reports expert analysis among other uses. At least one of these private sites are already providing information about clinical trials that one wouldn’t normally find through the central clinical trial website (19). We will hopefully see an exponential growth in this kind of websites, just as we have seen an exponential growth of health related social networks.

At least we are sure that we will see many unexpected uses of Open Access literature. What Ben Segal eloquently wrote, in April 1995, about the history of the internet (18): “the key words that came to my mind […] were: synergy, serendipity and coincidence” remains true today.

References

1. http://www.earlham.edu/~peters/fos/bethesda.htm; “Bethesda Statement on Open Access Publishing”; Released June 20, 2003

2. http://is.gd/3tom; “When the Patient is a Googler”; Scott Haig; Nov. 08, 2007

3. http://www.publications.parliament.uk/pa/cm200304/cmselect/cmsctech/399/4030102.htm; Oral evidence to inquiry, 03/01/2004; Select Committee on Science and Technology, UK Parliament; Examination of witnesses ; John Jarvis (Managing Director, Wiley Europe)

4. http://www.earlham.edu/~peters/fos/overview.htm; Open Access Overview; Peter Suber; 06/19/2007 and http://www.earlham.edu/~peters/fos/brief.htm; A Very Brief Introduction to Open Access; Peter Suber; 12/29/2004

5. http://www.acor.org/epatientswiki/index.php/Hunters_and_Gatherers_of_Medical_Information

6. http://www.biomedcentral.com/openaccess/archive/?page=features&issue=21; Interview: Sharon Terry; Oct 4, 2004; Patient advocate calls for Open Access

7. http://acor.org

8. http://www.cancernetwork.com/display/article/10165/87773?pageNumber=2; Oncology. Vol. 9 No. 4; Apr. 1, 1995; NCI's Cancer Information Systems-Bringing Medical Knowledge to Clinicians; Susan M. Hubbard, RN, MPA, Nicholas B. Martin, and Anne L. Thurn, PhD; International Cancer Information Center, National Cancer Institute

9. http://www.freepatentsonline.com/H000958.html; Patent Office: PDQ cancer treatment information system

10. http://www.cancernetwork.com/display/article/10165/87773?pageNumber=2; Oncology. Vol. 9 No. 4; Apr. 1, 1995

11. http://www.bclist.org

12. http://en.wikipedia.org/wiki/Open_access

13. http://arxiv.org/; ArXiv announced on Oct. 3,2008

14. http://people.ccmr.cornell.edu/~ginsparg/blurb/pg01unesco.html; Creating a global knowledge network

15. http://www.soros.org/openaccess/

16. http://creativecommons.org/

17. http://en.wikipedia.org/wiki/The_Wisdom_of_Crowds

18. http://pintopc.home.cern.ch/pintopc/www/divers/HistWebCern.html; A Short History of Internet Protocols at CERN; Ben Segal / CERN PDP-NS; Apr. 1995

19. http://clinicaltrials.gov

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