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Medwave 2014;14(2):e5921 doi: 10.5867/medwave.2014.02.5921
Hágase la luz sobre los estudios en salud financiados con fondos públicos
Let there be light on publicly funded health studies
Vivienne C. Bachelet
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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.

Type of reviewYearTitleEpistemonikosDoi
1Systematic review2008Systematic literature review and evaluation of health technologies in cervical cancer to develop clinical practice guidelineshttp://www.epistemonikos.org/en/
documents/78879a9be9d74ea
24b1c09937363d0c07c8cebb4
http://dx.doi.org/
10.5867/medwave.
2014.5758
2Systematic review2008Systematic literature review and evaluation of health technologies for the development of clinical practice guidelines on the diagnosis, treatment and monitoring of patients with peptic ulcerhttp://www.epistemonikos.org/en/
documents/0f7d46065426d5dd7
2e735dfafc6553f2b9cde6c
http://dx.doi.org/
10.5867/medwave.
2014.5762
3Systematic review2008Systematic literature review and evaluation of health technologies in bladder cancer to develop clinical practice guidelineshttp://www.epistemonikos.org/en/
documents/6959c07468482cc800
d603b35822649de8032b6e
http://dx.doi.org/
10.5867/medwave.
2014.5755
4Systematic review2008Systematic review of the literature on the effectiveness of drug therapy and counseling to achieve smoking cessation in adolescents ages 10 to 19http://www.epistemonikos.org/en/
documents/1829ee90915fe39f5
75d887c2008bb984c04c8f0
http://dx.doi.org/
10.5867/medwave.
2014.5769
5Systematic review2008Interventions in the field of secondary and tertiary prevention, detection and treatment of sexual abuse in children: a systematic review of the literaturehttp://www.epistemonikos.org/en/
documents/699c62e7fa785a1c1d
487a847a6539602d01569d
http://dx.doi.org/
10.5867/medwave.
2014.5770
6Systematic review2009Literature review for the development of protocols in the diagnosis, surveillance and forensic assessment of work-related musculoskeletal injurieshttp://www.epistemonikos.org/en/
documents/2b2cefdb09253d7810
62e79b2c905d37f75f1edb
http://dx.doi.org/
10.5867/medwave.
2014.5776
7Systematic review2008Systematic review of the literature on the effectiveness and safety of pharmacological treatment with interferon and glatiramer acetate in relapsing and recurring multiple sclerosishttp://www.epistemonikos.org/en/
documents/b60d4b603bbfaabfb9
2b5e3d16e32575edd04bf0
http://dx.doi.org/
10.5867/medwave.
2014.5759
8Scoping review2012Literature review and systematization of information available on the allocation of resources at the community levelhttp://www.epistemonikos.org/en/
documents/333e1bb9bfb7a7bbf7
f9d69ae82de4cdad6a0b3c
http://dx.doi.org/
10.5867/medwave.
2014.5781
9Systematic review2012Systematic review of the literature on birth cohorts: recommendations for the implementation of a nationwide cohorthttp://www.epistemonikos.org/en/
documents/9fdea55c7bf0444ebdfc9
ca7bf3abdecc576e660
http://dx.doi.org/
10.5867/medwave.
2014.5778
10Bibliographic review2012Literature review on health effects due to exposure from metalshttp://www.epistemonikos.org/en/
documents/944f02e07dedd0fd3e
1263b2f4af397f25ac02c6
http://dx.doi.org/
10.5867/medwave.
2014.5785
11Literature review2013Evaluation of the use of complementary therapies in San Borja Arriarán and Barros Luco Trudeau hospitalshttp://www.epistemonikos.org/en/
documents/4d45a2dede977e4f68
835474b18c49e63879921f
http://dx.doi.org/
10.5867/medwave.
2014.5782
12Systematic review2008Systematic literature review and evaluation of diagnostic methods, and the effectiveness and safety of treatments for ADHD in population from age 6 to 19http://www.epistemonikos.org/en/
documents/270998e6213d7e6361
a1b83c1eb2c3d2b452b99e
http://dx.doi.org/
10.5867/medwave.
2014.5772
13Systematic review2008 Efficacy and safety of biological treatment in juvenile rheumatoid arthritishttp://www.epistemonikos.org/en/
documents/c3c5a4afaf577ea4885
b20e64a2dcfedcb86a958
http://dx.doi.org/
10.5867/medwave.
2014.5760
14Bibliographic review2011Literature review for the development of regulations on psychosocial work hazardhttp://www.epistemonikos.org/en/
documents/0ed89eb08383ec3967
809287593335a7dc9d382d
http://dx.doi.org/
10.5867/medwave.
2014.5784
15Bibliographic review2012Literature review on hyperbaric exposure in diving activities for the development of a surveillance protocolhttp://www.epistemonikos.org/en/
documents/0fb33d6a953c816c29
a056610bbdfcc92658a8ab
http://dx.doi.org/
10.5867/medwave.
2014.5779
16Scoping review2012Systematic 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 abusehttp://www.epistemonikos.org/en/
documents/396cb9c8f5749db1549
ea56c1cf94ef3e703f69d
http://dx.doi.org/
10.5867/medwave.
2014.5780
17Bibliographic review2012Literature review for the development of a clinical guideline on occupational dermatitishttp://www.epistemonikos.org/en/
documents/8bbeb70eab85373ebd
2c35e2ec4688ee55c1547a
http://dx.doi.org/
10.5867/medwave.
2014.5777
18Systematic review2008Review of evidence on effectiveness and safety of biological treatment in rheumatoid arthritis in adultshttp://www.epistemonikos.org/en/
documents/a1d45d456cbc1cd185
5b59fb15225dbe53ff8083
http://dx.doi.org/
10.5867/medwave.
2014.5761
19Bibliographic review2008 Literature review for protocol development in the diagnosis, surveillance and forensic assessment of occupational hearing losshttp://www.epistemonikos.org/en/
documents/8f9586c9f916892192cf
437e2f947883f8821de8
http://dx.doi.org/
10.5867/medwave.
2014.5774
20Systematic review2008Systematic review of the literature on the technologies available for diagnosis, staging, treatment and follow-up of adult patients with gallbladder cancerhttp://www.epistemonikos.org/en/
documents/f91a07bb5d943d0fbc
636f95ee13a0dfc21a9bf9
http://dx.doi.org/
10.5867/medwave.
2014.5754
21Systematic review2008Systematic literature review and evaluation of health technologies in ovarian cancer to develop clinical practice guidelineshttp://www.epistemonikos.org/en/
documents/ed150f47b05b9b0cb
32d8df8edc9376914e2e685
http://dx.doi.org/
10.5867/medwave.
2014.5757
22Systematic review2008Systematic literature review and evaluation of health technologies for the development of clinical practice guidelines in osteosarcomahttp://www.epistemonikos.org/en/
documents/6e7e497e87e128bb17
8a010a16d6e53ac9edce49
http://dx.doi.org/
10.5867/medwave.
2014.5753
23Systematic review2008Systematic review of the literature and evaluation of health technologies in colon cancer to develop clinical practice guidelineshttp://www.epistemonikos.org/en/
documents/b7f39da825aa65ad3
13335f57a280310277d32ce
http://dx.doi.org/
10.5867/medwave.
2014.5756
24Systematic review2010Literature review on chronic intermittent altitude effects for the preparation of labor legislationhttp://www.epistemonikos.org/en/
documents/ac3f03531204cd9485f
3e7c101bd8fec7e90eae3
http://dx.doi.org/
10.5867/medwave.
2014.5783
25Systematic review2008Systematic review on the use of fluoride toothpastes in preschool childrenhttp://www.epistemonikos.org/en/
documents/6dd309d3060bdc96a7
97640ca79bebf5550dda6c
http://dx.doi.org/
10.5867/medwave.
2014.5773

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:

  • Increase the evidence base for public health decisions.
  • Critically analyze the quality of the evidence used for decision-making, especially with regard to clinical guidelines.

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.

Notes

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.

Licencia Creative Commons Esta obra de Medwave está bajo una licencia Creative Commons Atribución-NoComercial 3.0 Unported. Esta licencia permite el uso, distribución y reproducción del artículo en cualquier medio, siempre y cuando se otorgue el crédito correspondiente al autor del artículo y al medio en que se publica, en este caso, Medwave.

 

Autora: Vivienne C. Bachelet[1]

Filiación:
[1] Editora jefe, Medwave

E-mail: vbachelet@medwave.cl

Correspondencia a:
[1] Villaseca 21, oficina 702
Ñuñoa,
Santiago de Chile

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

Ficha PubMed


 

Citaciones asociadas

1. Editores. Masthead Mar;14(2). Medwave 2014;14(2):5932 | Link |

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  1. Bachelet VC. Missing clinical trial data, but also missing publicly-funded health studies. Medwave 2013;13(6):e5740. | CrossRef |
  2. Ley de Transparencia No 20.285. Biblioteca del Congreso Nacional de Chile, 2008. [on line] | Link |
  3. Munro AJ. Publishing the findings of clinical research. BMJ. 1993 Nov 20;307(6915):1340-1. | CrossRef | PubMed | PMC |
  4. Ross JS, Tse T, Zarin DA, Xu H, Zhou L, Krumholz HM. Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis. BMJ. 2012 Jan 3;344:d7292. | CrossRef | PubMed | PMC |
  5. Hart B, Lundh A, Bero L. Effect of reporting bias on meta-analyses of drug trials: reanalysis of meta-analyses. BMJ. 2012 Jan 3;344:d7202. | CrossRef | PubMed |
  6. Jones CW, Handler L, Crowell KE, Keil LG, Weaver MA, Platts-Mills TF. Non-publication of large randomized clinical trials: cross sectional analysis. BMJ. 2013 Oct 29;347:f6104. | CrossRef | PubMed |
  7. Riveros C, Dechartres A, Perrodeau E, Haneef R, Boutron I, Ravaud P. Timing and completeness of trial results posted at ClinicalTrials.gov and published in journals. PLoS Med. 2013 Dec;10(12):e1001566; discussion e1001566. | CrossRef | PubMed | PMC |
  8. Rodwin MA, Abramson JD. Clinical trial data as a public good. JAMA. 2012 Sep 5;308(9):871-2. | CrossRef | PubMed |
  9. Moher D. Reporting research results: a moral obligation for all researchers. Can J Anaesth. 2007 May;54(5):331-5. | CrossRef | PubMed |
  10. Nolting A, Perleth M, Langer G, Meerpohl JJ, Gartlehner G, Kaminski-Hartenthaler A, et al. GRADE guidelines: 5. Rating the quality of evidence: publication bias. Z Evid Fortbild Qual Gesundhwes. 2012;106(9):670-6. | CrossRef | PubMed |
  11. The PLoS Medicine Editors. An unbiased scientific record should be everyone’s agenda. PLoS Med. 2009 Feb 24;6(2):e1000038. | CrossRef | PubMed | PMC |
  12. Song F, Parekh S, Hooper L, Loke YK, Ryder J, Sutton a J, et al. Dissemination and publication of research findings: an updated review of related biases. Health Technol Assess. 2010 Feb;14(8):iii, ix-xi, 1-193. | CrossRef | PubMed | Link |
  13. Song F, Loke Y. Publication bias: what is it? How do we measure it? How do we avoid it? Open Access J Clin Trials. 2013 Jul;71. [on line] | Link |
  14. Bachelet VC. A tale of harm, waste and deception: how big pharma has undermined public faith in trial data disclosure and what we can do about it. Medwave 2013;13(4):e5671. | CrossRef |
  15. Bachelet VC, Rada G. Why the Helsinki Declaration now encourages trial registration, and publication and dissemination of the results of research. Medwave 2013;13(10):e5846. | CrossRef |
  16. Rada G. The requirement to disclose individual patient data in clinical studies will bring down the wall behind which the pharmaceutical industry hides the truth: the Kerkoporta is ajar. Medwave 2013;13(5):e5735. | CrossRef |
  17. Rada G, Pérez D, Capurro D. Epistemonikos: a free, relational, collaborative, multilingual database of health evidence. Stud Health Technol Inform. 2013;192:486-90. | CrossRef | PubMed |
Bachelet VC. Missing clinical trial data, but also missing publicly-funded health studies. Medwave 2013;13(6):e5740. | CrossRef |

Ley de Transparencia No 20.285. Biblioteca del Congreso Nacional de Chile, 2008. [on line] | Link |

Munro AJ. Publishing the findings of clinical research. BMJ. 1993 Nov 20;307(6915):1340-1. | CrossRef | PubMed | PMC |

Ross JS, Tse T, Zarin DA, Xu H, Zhou L, Krumholz HM. Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis. BMJ. 2012 Jan 3;344:d7292. | CrossRef | PubMed | PMC |

Hart B, Lundh A, Bero L. Effect of reporting bias on meta-analyses of drug trials: reanalysis of meta-analyses. BMJ. 2012 Jan 3;344:d7202. | CrossRef | PubMed |

Jones CW, Handler L, Crowell KE, Keil LG, Weaver MA, Platts-Mills TF. Non-publication of large randomized clinical trials: cross sectional analysis. BMJ. 2013 Oct 29;347:f6104. | CrossRef | PubMed |

Riveros C, Dechartres A, Perrodeau E, Haneef R, Boutron I, Ravaud P. Timing and completeness of trial results posted at ClinicalTrials.gov and published in journals. PLoS Med. 2013 Dec;10(12):e1001566; discussion e1001566. | CrossRef | PubMed | PMC |

Rodwin MA, Abramson JD. Clinical trial data as a public good. JAMA. 2012 Sep 5;308(9):871-2. | CrossRef | PubMed |

Moher D. Reporting research results: a moral obligation for all researchers. Can J Anaesth. 2007 May;54(5):331-5. | CrossRef | PubMed |

Nolting A, Perleth M, Langer G, Meerpohl JJ, Gartlehner G, Kaminski-Hartenthaler A, et al. GRADE guidelines: 5. Rating the quality of evidence: publication bias. Z Evid Fortbild Qual Gesundhwes. 2012;106(9):670-6. | CrossRef | PubMed |

The PLoS Medicine Editors. An unbiased scientific record should be everyone’s agenda. PLoS Med. 2009 Feb 24;6(2):e1000038. | CrossRef | PubMed | PMC |

Song F, Parekh S, Hooper L, Loke YK, Ryder J, Sutton a J, et al. Dissemination and publication of research findings: an updated review of related biases. Health Technol Assess. 2010 Feb;14(8):iii, ix-xi, 1-193. | CrossRef | PubMed | Link |

Song F, Loke Y. Publication bias: what is it? How do we measure it? How do we avoid it? Open Access J Clin Trials. 2013 Jul;71. [on line] | Link |

Bachelet VC. A tale of harm, waste and deception: how big pharma has undermined public faith in trial data disclosure and what we can do about it. Medwave 2013;13(4):e5671. | CrossRef |

Bachelet VC, Rada G. Why the Helsinki Declaration now encourages trial registration, and publication and dissemination of the results of research. Medwave 2013;13(10):e5846. | CrossRef |

Rada G. The requirement to disclose individual patient data in clinical studies will bring down the wall behind which the pharmaceutical industry hides the truth: the Kerkoporta is ajar. Medwave 2013;13(5):e5735. | CrossRef |

Rada G, Pérez D, Capurro D. Epistemonikos: a free, relational, collaborative, multilingual database of health evidence. Stud Health Technol Inform. 2013;192:486-90. | CrossRef | PubMed |