Category: PLoS Medicine

Autores de articulos legalmente responsables en caso de lesiones del paciente


Proponen que los autores firmantes de un artículo sean legalmente responsables en caso de que el paciente sufra lesiones

JANO.es · 30 Enero 2012 1
Un triunvirato de expertos plantea que los médicos que avalen trabajos realizados según las directrices de laboratorios farmacéuticos sean legalmente responsables ante la posibilidad de que un paciente sufra lesiones.

Proponen que los firmantes sean legalmente responsables ante la posibilidad de que los pacientes sufran lesiones.
El investigador español Xavier Bosch, del Hospital Clínic, ha planteado en un artículo publicado en PLoS Medicineque se adopten medidas legales para luchar contra el llamado ‘medical ghostwriting’, práctica consistente en conferir autoridad a un texto pseudopublicitario por el procedimiento de contratar la firma de un ‘autor invitado’.
Bosch y los coautores del artículo, Bijan Esfandiari, abogado en un bufete de Los Ángeles especializado en malas prácticas médicas, y Leemon McHenry, investigador del Departamento de Filosofía de la Universidad Estatal de California, recogen tres modelos teóricos de responsabilidad penal que afectarían principalmente a estos ‘guest authors’.
Así, los expertos proponen que los firmantes sean legalmente responsables ante la posibilidad de que los pacientes sufran lesiones por causa de una práctica que aquéllos han avalado, y plantean que esas mismas responsabilidades se extiendan a las empresas patrocinadoras. Ambos planteamientos se basan en que los artículos pueden influir en el juicio clínico, aumentar las ventas de productos y los costes de atención sanitaria del gobierno, y poner a los pacientes en riesgo.
Los autores también consideran una forma de ghostwriting “las conferencias y los congresos médicos sobre enfermedades en los que se habla de los beneficios de un producto, si el discurso ha sido preparado a partir de las directrices de una compañía”.

►Ver artículo en PLoS MEDICINE

  • Despite growing concern about medical ghostwriting, pharmaceutical companies, universities, medical journals, and communication companies employing ghostwriters have thus far failed to adequately stem the problem. As a result, some commentators have proposed that legal remedies could be sought by patients harmed by drugs publicized in ghostwritten papers.
  • In this Essay, we build on a recent analysis by Stern and Lemmens in PLoS Medicine to outline specific areas of legal liability.
  • For example, when an injured patient’s physician directly or indirectly relies upon a journal article containing false or manipulated safety and efficacy data, the authors, including guest authors, can be held legally liable for patient injuries.
  • In addition, guest authors of ghostwritten articles published by Medicare- and Medicaid-recognized peer-reviewed medical journals used as clinical evidence for indications for off-label uses may be liable under the federal False Claims Act for inducing the United States government to reimburse prescriptions under false pretenses.
  • Paying guest authors of ghostwritten papers may influence clinical judgment, increase product sales and government health care costs, and put patients at risk by misrepresenting risk-benefit. Therefore, both physicians and sponsor companies may be liable under the federal Anti-Kickback Statute.
  • Although guest authors and pharmaceutical defendants may argue a First Amendment right to participate in ghostwriting, the US Supreme Court has firmly held that the First Amendment does not shield fraud.
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Disease Mongering


Disease mongering

A collection of articles on disease mongering. PLoS Medicine. 2006

Disease mongering is a pejorative term for the practice of widening the diagnostic boundaries of illnesses, and promoting public awareness of such, in order to expand the markets for those who sell and deliver treatments, which may include pharmaceutical companies, physicians, and other professional or consumer organizations.[1] Examples include male pattern baldness and certainsocial phobias.[1]
In discussions specifically about psychiatric diagnosis, the term is frequently used by proponents of the antipsychiatry movement[2] and Scientology-based critics[3] as just one part of their criticism of psychiatry or specifically biopsychiatry. Examples include ADHD and bipolar disorder.[4]
Proponents of this practice argue that the pharmaceutical industry is only providing the public with information about its options and that actual prescription is a matter to be discussed between patient and doctor. Opponents, however, claim that this approach leads to the unnecessary prescription of drugs, that its motivation is primarily or only to profit the drug companies, and that it may actually harm instead of help patients.[1]
A 2006 Newcastle, New South Wales international conference, reported in PLoS Medicine, explored the phenomenon of disease mongering.[5] Journalist Ray Moynihan satirised disease mongering in a BMJ “news” item that appeared in its April Fool’s Day edition 2006, titled “Scientists find new disease: motivational deficiency disorder”.[6]

Contents

 [hide]

[edit]See also

[edit]References

  1. ^ a b c Moynihan R, Heath I, Henry D (2002). “Selling sickness: the pharmaceutical industry and disease mongering”. BMJ 324 (7342): 886–91. doi:10.1136/bmj.324.7342.886. PMC 1122833. PMID 11950740.
  2. ^ Fred Baughman (2000-09-25). “The Rise and Fall of ADD/ADHD”. ICSPP. Retrieved 2007-06-03.
  3. ^ Stephen Barlas and Psychiatric Times staff (2006-04-16). “Psychiatric Profession Current Target of Citizens Commission on Human Rights”.CCHR. Retrieved 2007-06-03.
  4. ^ Healy D (2006). “The latest mania: selling bipolar disorder”. PLoS Med. 3 (4): e185. doi:10.1371/journal.pmed.0030185. PMC 1434505.PMID 16597178.
  5. ^ Moynihan R, Henry D (eds).. “A Collection of Articles on Disease Mongering.”. PLoS medicine, 2006.. Retrieved 2007-06-12.
  6. ^ Moynihan R (2006). “Scientists find new disease: motivational deficiency disorder.”. BMJ 332 (7544): p. 745. doi:10.1136/bmj.332.7544.745-a.

[edit]Further reading

  • Saddichha S (2010).”Disease Mongering in Psychiatry: Is It Fact or Fiction?” World Medical & Health Policy: Vol. 2: Iss. 1, Article 15. DOI: 10.2202/1948-4682.1042
  • Peter Conrad (2007), The Medicalization of Society: On the Transformation of Human Conditions into Treatable Disorders, Baltimore:Johns Hopkins University Press.
  • Payer, Lynn (1992). Disease-Mongers. New York: John Wiley. ISBN 0-47100-737-4.
  • Moynihan, Ray; Alan Cassels (2005). Selling sickness: How the world’s biggest pharmaceutical companies are turning us all into patients. New York: Nation Books. ISBN 1-56025-697-4.
  • Cassels, Alan (2007). The ABCs of Disease Mongering: An Epidemic in 26 Letters. Victoria, British Columbia, Canada: EmDash Publishing. ISBN 978-0-9780182-3-8.
  • Melody Petersen (2008), Our Daily Meds: How the Pharmaceutical Companies Transformed Themselves into Slick Marketing Machines and Hooked the Nation on Prescription Drugs.
  • Christopher Lane (2008), Shyness: How Normal Behavior Became a Sickness.

[edit]External links

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Association of Mild Anemia with Cognitive, Functional, Mood and Quality of Life Outcomes in the Elderly: The “Health and Anemia” Study


Asociacion de anemia leve con calidad de vida en ancianos. Estudio “Health and Anemia”.

Texto en PDF

Ugo Lucca1*, Mauro Tettamanti1, Paola Mosconi2, Giovanni Apolone3, Francesca Gandini1, Alessandro Nobili1, Maria Vittoria Tallone4, Paolo Detoma4, Adriano Giacomin5, Mario Clerico6, Patrizia Tempia6, Adriano Guala7, Gilberto Fasolo8, Emma Riva1

1 Laboratory of Geriatric Neuropsychiatry, Istituto di Ricerche Farmacologiche “Mario Negri”, Milano, Italy2 Laboratory for Medical Research & Consumer Involvement, Istituto di Ricerche Farmacologiche “Mario Negri”, Milano, Italy3 Laboratory of Translational and Outcome Research in Oncology, Istituto di Ricerche Farmacologiche “Mario Negri”, Milano, Italy4 Laboratory of Analysis, Ospedale degli Infermi, Biella, Italy5 County Cancer Registry, Local Health Authority, ASL12, Biella, Italy6 Department of Oncology, Ospedale degli Infermi, Biella, Italy7 Department of Medicine & Geriatrics, Ospedale degli Infermi, Biella, Italy8 Community Medicine, Local Health Authority, ASL12, Biella, Italy

Abstract

Background

In the elderly persons, hemoglobin concentrations slightly below the lower limit of normal are common, but scant evidence is available on their relationship with significant health indicators. The objective of the present study was to cross-sectionally investigate the association of mild grade anemia with cognitive, functional, mood, and quality of life (QoL) variables in community-dwelling elderly persons.

Methods

Among the 4,068 eligible individuals aged 65–84 years, all persons with mild anemia (n = 170) and a randomly selected sample of non-anemic controls (n = 547) were included in the study. Anemia was defined according to World Health Organization (WHO) criteria and mild grade anemia was defined as a hemoglobin concentration between 10.0 and 11.9 g/dL in women and between 10.0 and 12.9 g/dL in men. Cognition and functional status were assessed using measures of selective attention, episodic memory, cognitive flexibility and instrumental and basic activities of daily living. Mood and QoL were evaluated by means of the Geriatric Depression Scale-10, the Short-Form health survey (SF-12), and the Functional Assessment of Cancer Therapy-Anemia.

Results

In univariate analyses, mild anemic elderly persons had significantly worse results on almost all cognitive, functional, mood, and QoL measures. In multivariable logistic regressions, after adjustment for a large number of demographic and clinical confounders, mild anemia remained significantly associated with measures of selective attention and disease-specific QoL (all fully adjusted p<.046). When the lower limit of normal hemoglobin concentration according to WHO criteria was raised to define anemia (+0.2 g/dL), differences between mild anemic and non anemic elderly persons tended to increase on almost every variable.

Conclusions

Cross-sectionally, mild grade anemia was independently associated with worse selective attention performance and disease-specific QoL ratings.

Citation: Lucca U, Tettamanti M, Mosconi P, Apolone G, Gandini F, et al. (2008) Association of Mild Anemia with Cognitive, Functional, Mood and Quality of Life Outcomes in the Elderly: The “Health and Anemia” Study. PLoS ONE 3(4): e1920. doi:10.1371/journal.pone.0001920

Editor: Bernhard Baune, James Cook University, Australia

Received: October 3, 2007; Accepted: February 27, 2008; Published: April 2, 2008

Copyright: © 2008 Lucca et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Funding: This study was supported by a research grant from Amgen Italy. The sponsor of the study had no role in the conception and design of the study; collection, management, analysis, and interpretation of data; preparation and writing of the report or in the decision to submit the manuscript for publication.

Competing interests: The authors have declared that no competing interests exist.

* To whom correspondence should be addressed. E-mail: lucca@marionegri.it

Introduction

Mean blood concentrations of hemoglobin progressively decline with aging [1]. In the elderly persons, hemoglobin concentrations slightly below the lower limit of normal are common and are usually viewed by the physician as having no clinical significance or as a chronic disease marker with no independent effect on health. In recent years however, anemia has been increasingly shown to be associated with a number of health indicators. Fatigue and weakness are common consequences of anemia. Several cross-sectional studies in the elderly persons have reported the association of anemia with functional disability and poorer physical performance [2], decreased muscular strength [3], fall injury events at home [4], and increased frailty risk [5]. Two longitudinal studies suggested that elderly persons with anemia are at increased risk of physical decline and recurrent falls [6], [7]. Anemia can thus have a relevant effect on healthcare needs and, with the increasing rate of growth of the elderly population, become a significant healthcare burden [8], [9].

The hypoxic condition caused by anemia may not only negatively affect physical function but also the cognitive performance, mood, and quality of life (QoL) of the elderly person. Very few studies in community-dwelling elderly persons have explored the relationship of anemia with cognitive performance or mood, and none with QoL. Moreover, those few studies did not exclude moderate to severe anemic individuals from the analyses whose scores likely affected the results.

The main aim of the study was to investigate the association of mild grade anemia with significant health-related variables such as cognitive performance, functional status, mood, and QoL in a sample of community-dwelling elderly persons.

A Randomised, Blinded, Placebo-Controlled Trial in Dementia Patients Continuing or Stopping Neuroleptics (The DART-AD Trial)


Clive Ballard1*, Marisa Margallo Lana2, Megan Theodoulou3, Simon Douglas4, Rupert McShane5, Robin Jacoby3, Katja Kossakowski1, Ly-Mee Yu6, Edmund Juszczak6, on behalf of the Investigators DART AD

1 Wolfson Centre for Age-Related Diseases, King’s College London, London, United Kingdom, 2 Northgate Hospital, Morpeth, Northumberland, United Kingdom, 3 Department of Psychiatry, University of Oxford, The Warneford Hospital, Oxford, United Kingdom, 4 Department of Psychiatry, Newcastle University, Newcastle upon Tyne, United Kingdom, 5 Oxfordshire and Buckinghamshire Mental Health NHS Trust and University of Oxford, Department of Psychiatry, Fulbrook Centre, Oxford, United Kingdom, 6 Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom

Background

There have been increasing concerns regarding the safety and efficacy of neuroleptics in people with dementia, but there are very few long-term trials to inform clinical practice. The aim of this study was to determine the impact of long-term treatment with neuroleptic agents upon global cognitive decline and neuropsychiatric symptoms in patients with Alzheimer disease.

Methods and Findings

Design: Randomised, blinded, placebo-controlled parallel two-group treatment discontinuation trial.

Setting: Oxfordshire, Newcastle and Gateshead, London and Edinburgh, United Kingdom.

Participants: Patients currently prescribed the neuroleptics thioridazine, chlorpromazine, haloperidol trifluoperazine or risperidone for behavioural or psychiatric disturbance in dementia for at least 3 mo.

Interventions: Continue neuroleptic treatment for 12 mo or switch to an identical placebo.

Outcome measures: Primary outcome was total Severe Impairment Battery (SIB) score. Neuropsychiatric symptoms were evaluated with the Neuropsychiatric Inventory (NPI).

Results: 165 patients were randomised (83 to continue treatment and 82 to placebo, i.e., discontinue treatment), of whom 128 (78%) commenced treatment (64 continue/64 placebo). Of those, 26 were lost to follow-up (13 per arm), resulting in 51 patients per arm analysed for the primary outcome. There was no significant difference between the continue treatment and placebo groups in the estimated mean change in SIB scores between baseline and 6 mo; estimated mean difference in deterioration (favouring placebo) −0.4 (95% confidence interval [CI] −6.4 to 5.5), adjusted for baseline value (p = 0.9). For neuropsychiatric symptoms, there was no significant difference between the continue treatment and placebo groups (n = 56 and 53, respectively) in the estimated mean change in NPI scores between baseline and 6 mo; estimated mean difference in deterioration (favouring continue treatment) −2.4 (95% CI −8.2 to 3.5), adjusted for baseline value (p = 0.4). Both results became more pronounced at 12 mo. There was some evidence to suggest that those patients with initial NPI ≥ 15 benefited on neuropsychiatric symptoms from continuing treatment.

Conclusions

For most patients with AD, withdrawal of neuroleptics had no overall detrimental effect on functional and cognitive status. Neuroleptics may have some value in the maintenance treatment of more severe neuropsychiatric symptoms, but this benefit must be weighed against the side effects of therapy.

Trial registration: Cochrane Central Registry of Controlled Trials/National Research Register (#ISRCTN33368770).

Funding: The DART-AD project was made possible by a grant from The Alzheimer’s Research Trust, Cambridge, UK (http://www.alzheimers-research.org.uk) to Profs Ballard and Jacoby and to RM. The peer review process undertaken by the funder did result in some modifications to the study design. The funder has no other role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing Interests: CB has received honoraria from Novartis, Pfizer, Shire, Lundbeck, Myriad, Janssen, Astra Zeneca, and Servier pharmaceutical companies and research grants from Novartis, Lundbeck, Astra-Zeneca, and Janssen pharmaceuticals. The remaining authors have declared that they have no competing interests.

Academic Editor: Carol Brayne, University of Cambridge, United Kingdom

Citation: Ballard C, Lana MM, Theodoulou M, Douglas S, McShane R, et al. (2008) A Randomised, Blinded, Placebo-Controlled Trial in Dementia Patients Continuing or Stopping Neuroleptics (The DART-AD Trial) . PLoS Med 5(4): e76 doi:10.1371/journal.pmed.0050076

Received: May 31, 2007; Accepted: February 15, 2008; Published: April 1, 2008

Copyright: © 2008 Ballard et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Abbreviations: AD, Alzheimer disease; ANCOVA, analysis of covariance; BADLS, Bristol Activities of Daily Living Scale; CGIC, Clinician’s Global Impression of Change; CI, confidence interval; DMC, data-monitoring committee; EPS, extrapyramidal signs and symptoms; FAS, Verbal Fluency Task; FAST, Functional Assessment Staging; IQR, interquartile range; NPI, Neuropsychiatric Inventory; SD, standard deviation; SIB, Severe Impairment Battery; (S)MMSE, (Standardised) Mini Mental State Examination; STALD, Sheffield Test for Acquired Language Disorders; UPDRS, Unified Parkinson’s Disease Rating Scale

* To whom correspondence should be addressed. E-mail: clive.ballard@kcl.ac.uk

Editors’ Summary

Background

The number of people with dementia (currently 25 million worldwide) is expected to increase by 5 million each year. The risk of dementia, including Alzheimer disease, increases sharply with age: Alzheimer’s Disease International estimates that 1.4% of people 65–69 have dementia, whereas almost a full quarter of those over the age of 85 years are affected. Almost all older dementia patients will experience, along with the cognitive and functional decline typical of the illness, some neuropsychiatric symptoms. These symptoms can include agitation, aggression, and psychosis, and are often devastating for the older patient and his or her family and caregiver. Managing these symptoms is often a prime concern for health-care providers and families. Neuroleptics (sometimes called antipsychotics) are the class of drugs often used to manage or control neuropsychiatric problems, but there have been questions about their safety and appropriateness. Safety concerns involve risk of stroke, parkinsonism, sedation, edema, and chest infections but also include a worsening of cognitive decline with prolonged use of neuroleptics.

Why Was the Study Done?

Previous studies on the effectiveness and safety of neuroleptics in older people have been short term. Ballard and colleagues wanted to study over a longer period of time the impact of neuroleptic drugs on elderly patients with dementia. Specifically, they wanted to know if being on a neuroleptic was associated with more cognitive decline than coming off the drug. They also wanted to investigate whether discontinuing the drug exacerbated any neuropsychiatric symptoms, Parkinson disease-like symptoms, or other functional, language, and cognition difficulties frequently associated with dementia.

What Did the Researchers Do and Find?

The researchers recruited older patients with Alzheimer disease from across England who had been on neuroleptics for at least three months. They randomised patients to one of two groups: the first group continued taking the same neuroleptic at the same dosage level while the second group was switched to an identical-looking placebo. The researchers assessed the patients’ cognitive status and neuropsychiatric symptoms upon their entry into the study. Six and 12 months later the researchers assessed any cognitive decline and the level of neuropsychiatric and other problems that patients were experiencing.

At both 6 and 12 months, the researchers found that there were no differences between the two groups (continued treatment and placebo) in terms of cognitive decline. The placebo group may have had less cognitive decline, but this was not statistically significant. They also found no overall differences between the two groups in the change in the number of neuropsychiatric symptoms over these time periods. Patients with severe neuropsychiatric problems at the outset of the trial did better on continued neuroleptic therapy, but this advantage was not statistically significant. There was a significant decline on the verbal fluency language tests among the patients who continued on their neuroleptic.

What Do these Findings Mean?

The researchers report perhaps the first trial of this duration on continued versus withdrawn neuroleptic treatment among older dementia patients. The findings do not indicate any benefit of continuing neuroleptic therapies in older patients on either cognitive or neuropsychiatric outcomes. The researchers conclude that neuroleptics, with their known safety issues, should not be used as first-line treatment to manage problems such as agitation or aggression. For older dementia patients whose neuropsychiatric symptoms are not remedied by nonpharmaceutical treatments, the researchers advise caution. More studies are urgently needed to find better solutions to help older patients with dementia who have agitation, aggression, and psychosis.

Additional Information

Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0050076.

Articulo completo en PLoS

Estimating Incidence from Prevalence in Generalised HIV Epidemics: Methods and Validation


Fuente: PLoS Medicine

Timothy B. Hallett1*, Basia Zaba2,3, Jim Todd4, Ben Lopman1, Wambura Mwita3, Sam Biraro4, Simon Gregson1,5, J. Ties Boerma6, on behalf of the ALPHA Network

1 Imperial College London, London, United Kingdom, 2 London School of Hygiene and Tropical Medicine, London, United Kingdom, 3 National Institute for Medical Research, Mwanza, Tanzania, 4 Medical Research Council/Uganda Virus Research Institute, Uganda Research Unit on AIDS, Entebbe, Uganda, 5 Biomedical Research and Training Institute, Harare, Zimbabwe, 6 World Health Organization, Geneva, Switzerland

Background

HIV surveillance of generalised epidemics in Africa primarily relies on prevalence at antenatal clinics, but estimates of incidence in the general population would be more useful. Repeated cross-sectional measures of HIV prevalence are now becoming available for general populations in many countries, and we aim to develop and validate methods that use these data to estimate HIV incidence.

Methods and Findings

Two methods were developed that decompose observed changes in prevalence between two serosurveys into the contributions of new infections and mortality. Method 1 uses cohort mortality rates, and method 2 uses information on survival after infection. The performance of these two methods was assessed using simulated data from a mathematical model and actual data from three community-based cohort studies in Africa. Comparison with simulated data indicated that these methods can accurately estimates incidence rates and changes in incidence in a variety of epidemic conditions. Method 1 is simple to implement but relies on locally appropriate mortality data, whilst method 2 can make use of the same survival distribution in a wide range of scenarios. The estimates from both methods are within the 95% confidence intervals of almost all actual measurements of HIV incidence in adults and young people, and the patterns of incidence over age are correctly captured.

Conclusions

It is possible to estimate incidence from cross-sectional prevalence data with sufficient accuracy to monitor the HIV epidemic. Although these methods will theoretically work in any context, we have able to test them only in southern and eastern Africa, where HIV epidemics are mature and generalised. The choice of method will depend on the local availability of HIV mortality data.

Funding: TBH, SG, BL, and WM thank the Wellcome Trust; BZ was supported by a grant from Global Fund to Fight AIDS, Tuberculosis and Malaria; JT and SB were supported by UK MRC. The funders had no role in the study design, analysis, and preparation of the manuscript or the decision to publish.

Competing Interests: The authors have declared that no competing interests exist.

Academic Editor: Peter Ghys, Joint United Nations Programme on HIV/AIDS, Switzerland

Citation: Hallett TB, Zaba B, Todd J, Lopman B, Mwita W, et al. (2008) Estimating Incidence from Prevalence in Generalised HIV Epidemics: Methods and Validation. PLoS Med 5(4): e80 doi:10.1371/journal.pmed.0050080

Received: May 21, 2007; Accepted: February 15, 2008; Published: April 8, 2008

Copyright: © 2008 Hallett et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Abbreviations: ART, antiretroviral therapy; DHS, Demographic and Health Surveys; PYAR, person-years at risk

* To whom correspondence should be addressed. E-mail: timothy.hallett@imperial.ac.uk

When Conflicts of Interest Threaten Scientific Integrity | Public Library of Science


The growing commercialization of scientific research has increasingly forced biomedical publishers to grapple with real and perceived conflicts of interest. Every scientist has a competing interest when it comes to getting published in a high-profile journal—a prestigious publication record brings status, research funds, job security, and other personal benefits—but more and more scientific research is funded by companies with a vested interest in the outcome of that research. A 2003 systematic review of 37 high-impact biomedical journals published in JAMA concluded that “Financial relationships among industry, scientific investigators, and academic institutions are widespread. Conflicts of interest arising from these ties can influence biomedical research in important ways.” Yet, the authors found, in 2001 just 43% of the journals surveyed had policies requiring disclosure of conflicts of interest. PLoS defines a competing interest as “anything that interferes with, or could reasonably be perceived as interfering with, the full and objective presentation, review, or publication of research findings, or of articles that comment on or review research findings. Competing interests can be financial, professional, or personal; hidden or declared; actual or perceived.” PLoS editors may decide not to publish original research or other articles if the editors believe the competing interests may have compromised the work, analyses, or interpretations presented in the paper. Though the PLoS competing interest policy applies to all PLoS journals, the potential for industry corruption of science raises the most concern among the medical editors. The main difference between medical and basic biology journals is that the research results in medical journals typically have greater practical application. Medical results often have implications for health policy and clinical practice, and might affect the viability of a prospective commercial product when, for example, a study suggests that a prospective drug or chemical in mass circulation poses a risk to human health. For the most part, results published in a more basic biology journal like PLoS Biology do not have such direct implications and potential conflicts. There are exceptions, of course – for example, a set of results might doom a planned development project because it threatens an endangered species. Industries with a substantial financial interest in the outcome of a study often do everything in their power to protect their interests by funding their own studies and publishing only those results they like, for example, or by manufacturing uncertainty around studies reporting results they don’t like, or by attempting to influence the promulgation or implementation of policies and rules at the appropriate regulatory agencies: FDA (drugs), FWS (endangered species), or EPA (toxics). Biases arising from industry-sponsored studies are well documented in clinical medicine. The lastest evidence comes from a recent PLoS Medicine study of potential biases in drug-drug comparisons, which found that randomized controlled trials comparing statins with other drugs are more likely to report results and conclusions favoring the sponsor’s product over the other drug in the study. But knowing a study is industry funded isn’t enough. More important is having independent reviewers evaluate the validity of the study design, methods, protocols, and determine whether the conclusions are consistent with the data. This is how rigorous peer review is supposed to work. But peer review can miss fatal flaws in studies—even when authors provide disclosure statements. That’s why many researchers working at the intersection of science and policy want to see transparent review processes and independent scientific review panels oversee research results destined for use in policymaking (or drug approval) decisions.In “Why Not the Best: How Science Failed the Florida Panther” (which I wrote), former Conservation Biology editor Reed Noss argued that endangered species management policies should be modeled after California law, which requires independent scientific review at several stages of the conservation planning process, “so consultants working for counties or developers are not able to get away with using flawed scientific methodologies.” The published reports of such independent reviews can help the public navigate an otherwise impenetrable, seemingly arcane debate. A new feature article published this week in PLoS Biology called “The Toxic Origins of Disease” (which I also wrote) describes how the chemical industry hired scientists to “replicate” the work of a researcher who reported that in utero exposures to a mass-produced chemical (called bisphenol A) caused developmental and reproductive defects in mice. Industry scientists found no such effects, but when an independent review panel assessed their studies, they found fatal flaws in both study design and interpretation of the results. Toxicology journals, like medical journals, have a long history of publishing studies biased toward industry interests. Just as a 2003 study published in the British Medical Journal found that “studies sponsored by pharmaceutical companies were more likely to have outcomes favoring the sponsor than were studies with other sponsors”, a 2005 commentary published in Environmental Health Perspectives found that of 115 published studies concerning effects of low doses of bisphenol A in experimental animals, 94% of publicly funded studies found evidence of harm while 100% of chemical industry studies found no evidence of harm.When researchers have a vested interest in the outcome of a research question, readers have a right to know that information. The 2003 JAMA study reported that industry investment in US biomedical research and development almost doubled between 1980 and 2000, as federal support dropped. As the line between science and business becomes increasingly blurred, transparency about conflicts of interest is the minimum requirement to give readers all the information they need to evaluate scientific results. The Center for Science in the Public Interest has been leading efforts to manage conflicts of interest that allow corporations to exploit the credibility of peer-reviewed journals to advance their own interests. CSPI urges all journals to adopt a strong policy regarding disclosing conflicts of interest and publishing those disclosures “to allow scientists, the public, and policy makers to make more informed judgments about research reports, letters, commentaries, editorials, book and literature reviews, and news articles, and to safeguard the credibility of scientific peer review.” Although such dislosures can’t guarantee that policymakers will base their decisions on the best scientific evidence available, they at least flag studies that may require more careful scrutiny.

When Conflicts of Interest Threaten Scientific Integrity | Public Library of Science

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Cochrane Child Health Field


The Cochrane Child Health Field, whose tag line is “promoting best evidence in child health,” has announced that a trials register will shortly be available.

The register will be a searchable database of over 30,000 pediatric RCTs and CCTs published from 1948 onwards.

One valuable aspect of the register, says Denise Thomson, Cochrane Child Health Field Administrator, is that “it will facilitate study of the development of paediatric research over the past sixty-odd years.”

With this in mind, Denise has put out a call for nominations for “classic” RCTs in paediatrics.

The criteria for being a “classic,” she says, are innovation in design characteristics, the consequence of their results on medical practice, or the fact that, in their absence, patients would have been denied access to beneficial treatments or would have been exposed to deleterious or ineffective approaches to treatment.

If you’ve got ideas for a classic, send her your nominations by Friday, October 12 at denise.thomson@ualberta.ca.

Meanwhile, if you are ready to report the results of a recently completed paediatric trial, please do submit the trial report to PLoS. Along with the report (which, if it is an RCT, should follow the CONSORT reporting guidelines), please also submit the original protocol. All of the PLoS journals support the International Committee of Medical Journal Editors (ICMJE) statement on trial registration.