We are pleased to include in Medwave a collection of final reports of studies commissioned after 2005 by the Public Health authority of the Chilean Ministry of Health. We have systematized these documents in a special issue of the journal that we have called "All health studies, all public", a play on words around the "All Trials" campaign in Europe.
To date these studies have not been available to the public. With our initiative, we are posting 25 reports that our readers will be able to see under our open access policy.
In mid-2013, we wrote about the importance of having public access to individual patient data submitted to health authorities for the marketing authorization of new drugs1. In that editorial we underscored the idea, applicable to the Latin American reality, that not only full disclosure of interventional trials are important to aid the decision-making process in healthcare, but that there should also be full disclosure of all publicly funded health studies, as this entails taxpayers money.
The Chilean Freedom of Information Act2 expresses this notion in the following words:
This Act defines as public information, actions and resolutions of the State, as well as all information produced on the basis of public budget, with the exceptions established by this law, if it affects: the proper performance of the functions of an organ of the State, the rights of individuals, national security or national interest and when a the law has declared certain information to be confidential or secret.
It binds the Administration to update at least once a month its websites with information on organizational structure, powers, staff and budget, audit results, etc. This is active transparency. The internal audit units of each institution, the Board of Transparency and the Comptroller General of the Republic will enforce this Act.
Furthermore, it states that everyone has the right to request and receive information from any organ of the Administration. This is passive transparency or access rights. The Act sets forth the requirements to request information.
There are few more discouraging circumstances for researchers than to see their studies disappear in a non-publication limbo. Numerous articles have ventured into the issue of non-publication of the results of biomedical literature and the consequences of this on the validity of the evidence, also called publication bias3-7.
Those of us who have done health technology assessments, systematic reviews or cost-effectiveness studies, know that too often final reports disappear in paper files put away in an inaccessible maze of government offices. No one will have access to these studies, neither concerned citizens nor policy makers of other countries who may have to face the same decisions that led to commissioning such studies in the first place.
Is this problem unique to a particular Administration in our country? No. Is this situation acceptable? No. Let us take it by parts.
The first paragraph of the summary of the Freedom of Information Act defines as “public information ... information produced by public budget." The studies included in this special issue were all commissioned between 2005 and 2012 using taxpayer’s money in the Health Ministry.
The second paragraph of the Act states that government departments should implement active transparency measures on their websites. Thus, in this case, the Chilean Ministry of Health should have published on its website all these studies. Some departments of the ministry do so, but others do not; in consequence, variability in reporting is high and it is not possible to assume that all studies are available.
The third paragraph of the Act stipulates that any citizen can request information, which cannot be denied. Therefore, our requests were submitted last year, in accordance with institutional mechanisms provided by the law, and after some time we came into possession of the requested studies (see below).
The unavailability of publicly funded health studies is an old practice. However, after the enactment of the Freedom of Information Act we had hoped that the health authorities in Chile would be proactive and put the documents on their websites. From 2008 to date, this has not happened, regardless of the Administration in power.
Therefore, it is not a matter of more or less will, but a structural failure of our health authorities to systematize their own information and make it available to its policy makers and the public. These studies are used to develop clinical practice guidelines, or to make investment decisions and to purchase medicines for the public sector.
Studies are a public good8 and it is a moral duty publish them9. That which applies to researchers, the pharmaceutical industry, or academia, must also apply to health authorities. There is no sensible reason to hide from the public the evidence to make informed health decisions (evidence-informed public health is the topic of this year’s Cochrane Colloquium in Hyderabad, India). The quality of evidence is inversely correlated to the degree of publication bias10 and if we have a big enough problem with the pharmaceutical industry playing hide and seek with their clinical trials11-16, we should not compound the problem by making it difficult or impossible to find commissioned health studies.
With this special issue, Medwave is contributing to put out into the public light what we obtained through the Freedom of Information Act. We hope this information will be helpful to all decision makers in the region, whether clinical or not. Here is the story of how these documents were obtained..
In June 2013, we sent our first request for access to all studies conducted between 2005 and 2013 in the Secretariat for Public Health (REF1). This request was refused on the grounds that the requirement was generic, involving a large number of administrative acts, and thus would unduly distract officials from their normal tasks (REF2).
On July 5, 2013, we prepared a new requirement, but this time with a detailed list of previously identified studies, so that no one could argue any difficulty in retrieving them (REF3). Several of these studies should have been used in the preparation of clinical guidelines for AUGE conditions, especially those guaranteed after 2010.
After the legal waiting period (20 days), on August 5, 2013, we were informed that the ministry needed more time to deliver the list invoking "difficulty in collecting all studies requested" (REF4). Finally, on July 31, and through an email, we were informed that the solicited studies were available on CD in the ministry. After reviewing the CD, we found that not all the studies were included, so we had to wait until August 14, 2013, when a second and final CD was provided.
The final list of studies is shown in the following table.
|N°||Type of review||Year||Title||Epistemonikos||Doi|
|1||Systematic review||2008||Systematic literature review and evaluation of health technologies in cervical cancer to develop clinical practice guidelines||http://www.epistemonikos.org/en/|
|2||Systematic review||2008||Systematic literature review and evaluation of health technologies for the development of clinical practice guidelines on the diagnosis, treatment and monitoring of patients with peptic ulcer||http://www.epistemonikos.org/en/|
|3||Systematic review||2008||Systematic literature review and evaluation of health technologies in bladder cancer to develop clinical practice guidelines||http://www.epistemonikos.org/en/|
|4||Systematic review||2008||Systematic review of the literature on the effectiveness of drug therapy and counseling to achieve smoking cessation in adolescents ages 10 to 19||http://www.epistemonikos.org/en/|
|5||Systematic review||2008||Interventions in the field of secondary and tertiary prevention, detection and treatment of sexual abuse in children: a systematic review of the literature||http://www.epistemonikos.org/en/|
|6||Systematic review||2009||Literature review for the development of protocols in the diagnosis, surveillance and forensic assessment of work-related musculoskeletal injuries||http://www.epistemonikos.org/en/|
|7||Systematic review||2008||Systematic review of the literature on the effectiveness and safety of pharmacological treatment with interferon and glatiramer acetate in relapsing and recurring multiple sclerosis||http://www.epistemonikos.org/en/|
|8||Scoping review||2012||Literature review and systematization of information available on the allocation of resources at the community level||http://www.epistemonikos.org/en/|
|9||Systematic review||2012||Systematic review of the literature on birth cohorts: recommendations for the implementation of a nationwide cohort||http://www.epistemonikos.org/en/|
|10||Bibliographic review||2012||Literature review on health effects due to exposure from metals||http://www.epistemonikos.org/en/|
|11||Literature review||2013||Evaluation of the use of complementary therapies in San Borja Arriarán and Barros Luco Trudeau hospitals||http://www.epistemonikos.org/en/|
|12||Systematic review||2008||Systematic literature review and evaluation of diagnostic methods, and the effectiveness and safety of treatments for ADHD in population from age 6 to 19||http://www.epistemonikos.org/en/|
|13||Systematic review||2008||Efficacy and safety of biological treatment in juvenile rheumatoid arthritis||http://www.epistemonikos.org/en/|
|14||Bibliographic review||2011||Literature review for the development of regulations on psychosocial work hazard||http://www.epistemonikos.org/en/|
|15||Bibliographic review||2012||Literature review on hyperbaric exposure in diving activities for the development of a surveillance protocol||http://www.epistemonikos.org/en/|
|16||Scoping review||2012||Systematic review of literature on the effectiveness of interventions for the prevention, detection, first response and treatment in children aged 0 to 4 years in situation of abuse||http://www.epistemonikos.org/en/|
|17||Bibliographic review||2012||Literature review for the development of a clinical guideline on occupational dermatitis||http://www.epistemonikos.org/en/|
|18||Systematic review||2008||Review of evidence on effectiveness and safety of biological treatment in rheumatoid arthritis in adults||http://www.epistemonikos.org/en/|
|19||Bibliographic review||2008||Literature review for protocol development in the diagnosis, surveillance and forensic assessment of occupational hearing loss||http://www.epistemonikos.org/en/|
|20||Systematic review||2008||Systematic review of the literature on the technologies available for diagnosis, staging, treatment and follow-up of adult patients with gallbladder cancer||http://www.epistemonikos.org/en/|
|21||Systematic review||2008||Systematic literature review and evaluation of health technologies in ovarian cancer to develop clinical practice guidelines||http://www.epistemonikos.org/en/|
|22||Systematic review||2008||Systematic literature review and evaluation of health technologies for the development of clinical practice guidelines in osteosarcoma||http://www.epistemonikos.org/en/|
|23||Systematic review||2008||Systematic review of the literature and evaluation of health technologies in colon cancer to develop clinical practice guidelines||http://www.epistemonikos.org/en/|
|24||Systematic review||2010||Literature review on chronic intermittent altitude effects for the preparation of labor legislation||http://www.epistemonikos.org/en/|
|25||Systematic review||2008||Systematic review on the use of fluoride toothpastes in preschool children||http://www.epistemonikos.org/en/|
We have decided to publish each original document as was delivered to us by the ministry officials, without any modifications. We have added a citation to facilitate the possibility of future reference, including the DOI (Digital Object Identifier). Additionally, in partnership with the Epistemonikos Foundation, all records have been included in the Epistemonikos data base, allowing thousands of users each day to find these studies17. What is even more important, Epistemonikos relates systematic reviews to others that answer a similar question. Health professionals or decision makers will easily be able to assess if new evidence is available.
No doubt, what we present here is a small sample of a larger production that takes place in the Chilean Ministry of Health. Being able to access these results allows us to:
However, it does not allow us to assess the depth of the studies conducted as we ignore the full universe of research being done in the Ministry. It is therefore impossible to have the bigger picture of what body of evidence our health ministry is basing their public health decisions on.
Just like the public is calling for the pharmaceutical industry to disclose all individual patient data to independent researchers so that they can corroborate what is known on safety and effectiveness of new or old interventions, governments should also be proactive and willing to share data that is used to decide on procurement or courses of clinical action.
We must take the lead in promoting an open and transparent culture in health systems and government agencies. There is no room for mysteries and poorly informed decisions that cannot be critically analyzed. Our people demand of us responsibility in the use of resources that belong to all, and expect righteousness in the interests that guide us as we make decisions that affect those who are in a vulnerable situation, either by disease, by poverty, or by both.
Declaration of interests
In her capacity as managing director of Medwave Estudios Limitada, VCB has been and will continue to be project leader of systematic reviews and health technology assessments commissioned by several government agencies, including the Ministry of Health. Several of these studies are mentioned in this editorial. She declares that the earnings from these commissioned studies has helped to finance some editorial and publishing activities of the journal she heads.
Citación: Bachelet VC. Let there be light on publicly funded health studies. Medwave 2014;14(2):e5921 doi: 10.5867/medwave.2014.02.5921
Fecha de publicación: 20/3/2014
1. Editores. Masthead Mar;14(2). Medwave 2014;14(2):5932 | Link |
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