Concerns about the real independence of patient advocacy organizations

Patient Advocacy Organizations, Industry Funding, and Conflicts of Interest

Key Points

Question
What is the nature of industry funding of patient advocacy organizations in the United States?

Findings
This survey study found that 67% of a national sample of patient advocacy organizations, virtually all of which were not for profit, reported receiving funding from for-profit companies. Twelve percent received more than half of their funding from industry; a median proportion of 45% of industry funding was derived from the pharmaceutical, device, and/or biotechnology sectors.

Meaning
Most advocacy organizations receive money from industry; therefore, increased transparency and robust conflict of interest policies and practices are needed to help these non-profit organizations maintain their independence.

2017 Study Abstract

Patient Advocacy Organizations, Industry Funding, and Conflicts of Interest, The Jama Network, doi:10.1001/jamainternmed.2016.8443, January 17, 2017.

Image credit eyeforpharma.

Importance
Patient advocacy organizations (PAOs) are influential health care stakeholders that provide direct counseling and education for patients, engage in policy advocacy, and shape research agendas. Many PAOs report having financial relationships with for-profit industry, yet little is known about the nature of these relationships.

Objective
To describe the nature of industry funding and partnerships between PAOs and for-profit companies in the United States.

Design, Setting, and Participants
A survey was conducted from September 1, 2013, to June 30, 2014, of a nationally representative random sample of 439 PAO leaders, representing 5.6% of 7865 PAOs identified in the United States. Survey questions addressed the nature of their activities, their financial relationships with industry, and the perceived effectiveness of their conflict of interest policies.

Main Outcomes and Measures
Amount and sources of revenue as well as organizational experiences with and policies regarding financial conflict of interest.

Results
Of the 439 surveys mailed to PAO leaders, 289 (65.8%) were returned with at least 80% of the questions answered. The PAOs varied widely in terms of size, funding, activities, and disease focus. The median total revenue among responding organizations was $299 140 (interquartile range, $70 000-$1 200 000). A total of 165 of 245 PAOs (67.3%) reported receiving industry funding, with 19 of 160 PAOs (11.9%) receiving more than half of their funding from industry. Among the subset of PAOs that received industry funding, the median amount was $50 000 (interquartile range, $15 000-$200 000); the median proportion of industry support derived from the pharmaceutical, device, and/or biotechnology sectors was 45% (interquartile range, 0%-100%). A total of 220 of 269 respondents (81.8%) indicated that conflicts of interest are very or moderately relevant to PAOs, and 94 of 171 (55.0%) believed that their organizations’ conflict of interest policies were very good. A total of 22 of 285 PAO leaders (7.7%) perceived pressure to conform their positions to the interests of corporate donors.

Conclusions and Relevance
Patient advocacy organizations engage in wide-ranging health activities. Although most PAOs receive modest funding from industry, a minority receive substantial industry support, raising added concerns about independence. Many respondents report a need to improve their conflict of interest policies to help maintain public trust.

Financial ties between researchers and drug industry independently associated with positive trial results

Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study

2017 Study Abstract

Objective
To examine the association between the presence of individual principal investigators’ financial ties to the manufacturer of the study drug and the trial’s outcomes after accounting for source of research funding.

Design
Cross sectional study of randomized controlled trials (RCTs).

Setting
Studies published in “core clinical” journals, as identified by Medline, between 1 January 2013 and 31 December 2013.

Participants
Random sample of RCTs focused on drug efficacy.

Main outcome measure
Association between financial ties of principal investigators and study outcome.

Results
A total of 190 papers describing 195 studies met inclusion criteria. Financial ties between principal investigators and the pharmaceutical industry were present in 132 (67.7%) studies. Of 397 principal investigators, 231 (58%) had financial ties and 166 (42%) did not. Of all principal investigators, 156 (39%) reported advisor/consultancy payments, 81 (20%) reported speakers’ fees, 81 (20%) reported unspecified financial ties, 52 (13%) reported honorariums, 52 (13%) reported employee relationships, 52 (13%) reported travel fees, 41 (10%) reported stock ownership, and 20 (5%) reported having a patent related to the study drug. The prevalence of financial ties of principal investigators was 76% (103/136) among positive studies and 49% (29/59) among negative studies. In unadjusted analyses, the presence of a financial tie was associated with a positive study outcome (odds ratio 3.23, 95% confidence interval 1.7 to 6.1). In the primary multivariate analysis, a financial tie was significantly associated with positive RCT outcome after adjustment for the study funding source (odds ratio 3.57 (1.7 to 7.7). The secondary analysis controlled for additional RCT characteristics such as study phase, sample size, country of first authors, specialty, trial registration, study design, type of analysis, comparator, and outcome measure. These characteristics did not appreciably affect the relation between financial ties and study outcomes (odds ratio 3.37, 1.4 to 7.9).

Conclusions
Financial ties of principal investigators were independently associated with positive clinical trial results. These findings may be suggestive of bias in the evidence base.

Full study
dx.doi.org/10.1136/bmj.i6770 published 17 January 2017 by The BMJ.

Are Medical Faculty Students protected from Pharma Industry Influence during their Training?

Conflict of Interest Policies at French Medical Schools

January 2017 Study Abstract

Background
Medical faculties have a role in ensuring that their students are protected from undue commercial influence during their training, and are educated about professional-industry interactions. In North America, many medical faculties have introduced more stringent conflict of interest (COI) policies during the last decade. We asked whether similar steps had been taken in France. We hypothesized that such policies may have been introduced following a 2009–2010 drug safety scandal (benfluorex, Mediator) in which COIs in medicine received prominent press attention.

Methods
We searched the websites of all 37 French Faculties of Medicine in May 2015 for COI policies and curriculum, using standardized keyword searches. We also surveyed all deans of medicine on institutional COI policies and curriculum, based on criteria developed in similar US and Canadian surveys. Personal contacts were also consulted. We calculated a summary score per faculty based on 13 criteria. [range 0–26; higher scores denoting stronger policies]

Conflict of Interest Policies at French Medical Schools: Starting from the Bottom, PLOS one, dx.doi.org/10.1371/journal.pone.0168258, January 9, 2017.

Medical image credit thomashawk.

Results
In total, we found that 9/37 (24%) of French medical schools had either introduced related curriculum or implemented a COI-related policy. Of these, only 1 (2.5%) had restrictive policies for any category. No official COI policies were found at any of the schools. However, at 2 (5%), informal policies were reported. The maximum score per faculty was 5/26, with 28 (76%) scoring 0.

Conclusion
This is the first survey in France to examine COI policies at medical faculties. We found little evidence that protection of medical students from undue commercial influence is a priority, either through institutional policies or education. This is despite national transparency legislation on industry financing of health professionals and limits on gifts. The French National Medical Students Association (ANEMF) has called for more attention to COI in medical education; our results strongly support such a call.

In conclusion, the AAMC and others organizations have called for a profound cultural change in the medical profession that must begin with medical education. This is all the more important in that students who have the most contacts with industry are also those who tend to have the most positive attitudes to these relations and to believe themselves to be invulnerable to influence. Policies that restrict interactions contributing to conflict of interest have been shown to reduce industry influence on practice. Medical faculties in France have a responsibility to protect and educate their students and to support the best possible care, in the interests of patient and public health.

Les contrats entre médecins et industries seront rendus publics pour plus de transparence

Marisol Touraine renforce à nouveau la transparence des liens entre les acteurs du système de santé et les industriels

Communiqué de presse social-sante.gouv.fr , 30.12.16.

Marisol Touraine, ministre des Affaires sociales et de la Santé, annonce la publication ce jour d’un décret – n° 2016-1939 du 28 décembre 2016 relatif à la déclaration publique d’intérêts prévue à l’article L. 1451-1 du code de la santé publique et à la transparence des avantages accordés par les entreprises produisant ou commercialisant des produits à finalité sanitaire et cosmétique destinés à l’homme  renforçant la transparence des liens entre les acteurs du système de santé et les industriels du secteur. Prévues par la loi de modernisation de notre système de santé du 26 janvier 2016, ces dispositions viennent compléter les mesures déjà engagées pour préserver la nécessaire confiance entre les citoyens, les usagers et les acteurs du système de santé.

En juin 2014, Marisol Touraine a lancé la base de données publique Transparence-Santé, accessible sur un site Internet unique : www.transparence.sante.gouv.fr, qui répertorie l’ensemble des liens d’intérêts entre les entreprises qui commercialisent des produits de santé ou cosmétiques et les professionnels de santé.

Le décret relatif aux déclarations publiques d’intérêts et à la transparence des avantages accordés par les entreprises produisant ou commercialisant des produits à finalité sanitaire et cosmétique destinés à l’homme :

  • étend le champ des informations relatives aux liens d’intérêts entre les industries de santé et les différents acteurs, publiées sur le site Internet www.transparence.sante.gouv.fr : les montants des conventions signées entre les acteurs du système de santé et les industriels devront être publiés ; une rubrique dédiée permettra d’accéder plus facilement aux rémunérations perçues dans le cadre de ces conventions.
  • permet de rendre public le montant des rémunérations et participations financières des personnes soumises à l’obligation de remplir une déclaration publique d’intérêts.

“La loi de modernisation de notre système de santé a permis de nouvelles avancées pour la transparence des liens d’intérêts dans le secteur de la santé. Après la possibilité offerte par la loi d’extraire les données issues de la base, le public pourra accéder dès le 1er avril 2017 à de nouvelles informations sur le site transparence.sante.gouv.fr. S’il faut distinguer liens d’intérêts et conflits d’intérêts, il revient à chaque internaute, chaque citoyen, de connaître en toute objectivité la nature des relations qui lient les industries de santé aux autres parties prenantes du secteur”

a déclaré Marisol Touraine.

Une couverture vaccinale encore plus importante alors qu’aucune épidémie n’est crainte

La dictature des vaccins

Vidéo publiée le 7 décembre 2016 par TV Libertés.

15:25 – Santé : la dictature des vaccins

Medical, scientific organisations panel members problematic financial relationships with industry

A Comparison of DSM-IV and DSM-5 Panel Members’ Financial Associations with Industry: A Pernicious Problem Persists, 2012

Summary Points

  • The American Psychiatric Association (APA) instituted a financial conflict of interest disclosure policy for the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM).
  • The new disclosure policy has not been accompanied by a reduction in the financial conflicts of interest of DSM panel members.
  • Transparency alone cannot mitigate the potential for bias and is an insufficient solution for protecting the integrity of the revision process.
  • Gaps in APA’s disclosure policy are identified and recommendations for more stringent safeguards are offered.

Introduction

A Comparison of DSM-IV and DSM-5 Panel Members’ Financial Associations with Industry: A Pernicious Problem Persists, PLOS Medicine, dx.doi.org/10.1371/journal.pmed.1001190, March 13, 2012.

All medical subspecialties have been subject to increased scrutiny about the ways by which their financial associations with industry, such as pharmaceutical companies, may influence, or give the appearance of influencing, recommendations in review articles and clinical practice guidelines. Psychiatry has been at the epicenter of these concerns, in part because of high-profile cases involving ghostwriting and failure to report industry-related income, and studies highlighting conflicts of interest in promoting psychotropic drugs. The revised Diagnostic and Statistical Manual of Mental Disorders (DSM), scheduled for publication in May 2013 by the American Psychiatric Association (APA), has created a firestorm of controversy because of questions about undue industry influence. Some have questioned whether the inclusion of new disorders (e.g., Attenuated Psychotic Risk Syndrome) and widening of the boundaries of current disorders (e.g., Adjustment Disorder Related to Bereavement) reflects corporate interests. These concerns have been raised because the nomenclature, criteria, and standardization of psychiatric disorders codified in the DSM have a large public impact in a diverse set of areas ranging from insurance claims to jurisprudence. Moreover, through its relationship to the International Classification of Diseases, the system used for classification by many countries around the world, the DSM has a global reach.

After receiving criticism that DSM-IV had no financial disclosure of panel members, to its credit the APA instituted a mandatory disclosure policy. The DSM-5 panel members are required to file financial disclosure statements, which are expected to be listed in the publication, and the APA has made a commitment to improve its management of financial conflicts of interest (FCOIs).

This new APA requirement makes the DSM’s disclosure policy more congruent with most leading medical journals and federal policies on FCOI. FCOIs are widely recognized as problematic because of the data showing a clear connection between funding source and study outcome whereby results are favorably biased toward the interests of the funder —what has been referred to as the “funding effect”. Some have argued that greater transparency of financial interests may facilitate a decline in FCOIs and a decrease in the potential bias that accompanies them, and that it may encourage professionals and consumers to more critically evaluate medical information. Others are not sure that disclosure will reduce FCOIs and the potential for bias, because transparency alone just “shifts the problem from one of ‘secrecy of bias’ to ‘openness of bias’”. Additionally, there is the concern that disclosure may open the door for subterfuge. That is, when researchers or panel members list every affiliation that they have ever had, including funding from federal agencies, it can create a “signal-to-noise problem,” thereby obscuring the truth about deeply problematic financial relationships with industry.

We have reported elsewhere on industry relationships with DSM-5 task force members. Although the composition of the task force has changed slightly since its formation in 2007 (e.g., Pilecki et al. found 72% of the members had ties in early 2011) industry relationships persist despite increased transparency. Currently, 69% of the DSM-5 task force members report having ties to the pharmaceutical industry. This represents a relative increase of 21% over the proportion of DSM-IV task force members with such ties (57% of DSM-IV task force members had ties). This finding is congruent with emerging data from fields outside of psychiatry suggesting that transparency of funding source alone is an insufficient solution for eliminating bias.

In 2006 we analyzed all DSM-IV panel members’ financial associations with industry. We have undertaken a similar analysis for DSM-5 panels, which allowed us to compare the proportions of DSM-IV and -5 panel members who have industry ties. There are 141 panel members on the 13 DSM-5 panels and 29 task force members. The members of these 13 panels are responsible for revisions to diagnostic categories and for inclusion of new disorders within a diagnostic category.

Three-fourths of the work groups continue to have a majority of their members with financial ties to the pharmaceutical industry. It is also noteworthy that, as with the DSM-IV, the most conflicted panels are those for which pharmacological treatment is the first-line intervention. For example, 67% (N = 12) of the panel for Mood Disorders, 83% (N = 12) of the panel for Psychotic Disorders, and 100% (N = 7) of the Sleep/Wake Disorders (which now includes “Restless Leg Syndrome”) have ties to the pharmaceutical companies that manufacture the medications used to treat these disorders or to companies that service the pharmaceutical industry.

Gaps in APA’s Disclosure Policy

Although the APA has made the disclosure of FCOIs of DSM panel members more transparent, there are important gaps in the current policy that need to be addressed:

  1. The current APA disclosure policy does not require panel members to specifically identify speakers’ bureau membership but rather cloaks it under “honoraria.” (A speakers’ bureau usually refers to an arrangement between a commercial entity or its agent whereby an individual is hired to give a presentation about the company’s product. The company typically has the contractual right to create and/or control the content of the presentation.) Therefore, despite increased transparency, it remains unclear how many individuals participate on speakers bureaus, because panel members may simply list “honoraria.” None of the DSM panel members identified participation on a speakers bureau. When we did an internet search of the 141 panel members, we found that 15% had disclosed elsewhere that they were members of drug companies’ speakers bureaus or advisory boards. These internet searches were conducted for sources published in the years 2006 (1 year before the task force was appointed) to 2011, a time period congruent with published research on financial conflicts of interest. Searches included peer-reviewed articles, conferences, participation in continuing medical education events (i.e., courses and/or seminars for health professionals) and self-reporting of any industry ties following interviews with the media. Speakers bureau and advisory board participation were included in our analysis only when there was unambiguous information (e.g., “Dr. Smith discloses that he serves on the speakers bureau for Eli Lilly and Pfizer”) and both authors (LC, SK) were in agreement. The nature of these relationships needs to be spelled out more precisely; speakers bureau participation is usually prohibited elsewhere (e.g., for faculty in medical schools), as it is widely recognized to constitute a significant FCOI. Pharmaceutical companies refer to individuals who serve on speakers bureaus as “key opinion leaders” (KOLs) because they are seen as essential to the marketing of diseases as well as drugs.
  2. Exclusions to the APA DSM-5 disclosure policy include unrestricted research grants; that is, panel members are not required to disclose unrestricted research grants from industry. However, we would argue that this exclusion allows for commercial interests to be reflected in the revision process: there is no evidence to suggest that simply because money comes in the form of a large “unrestricted” research grant it does not create an obligation to reciprocate or invoke an implicit bias.
  3. The current policy places high and arbitrary threshold limits on monies allowed from industry: DSM panel members are allowed to receive US$10,000 per year from industry (e.g., for consultancies), and panel members are allowed to have up to US$50,000 in stock holdings in pharmaceutical companies.
  4. In contrast to other disclosure policies (e.g., the Physician Payments Sunshine Act of 2007 and the 2011 US National Institutes of Health policy on conflicts of interest), APA’s policy does not require disclosure of the amount of money received from industry.

However, transparency alone cannot mitigate bias. Because industry relationships can create a “pro-industry habit of thought”, having financial ties to industry such as honoraria, consultation, or grant funding is as pernicious a problem as speaker’s bureau participation. Over four decades of research from social psychology clearly demonstrates that gifts—even small ones—create obligations to reciprocate. Also, because of the enormous influences of diagnostic and treatment guidelines, the standards for participation on a guideline development panel should be higher than those set for an average faculty member.

Conclusion

The DSM-5 will be published in about 14 months, enough time for the APA to institute important changes that would allow the organization to achieve its stated goal of a “… transparent process of development for the DSM, and …an unbiased, evidence-based DSM, free from any conflicts of interest” . Toward that goal we believe it is essential that:

  1. As an eventual gold standard and because of their actual and perceived influence, all DSM task force members should be free of FCOIs.
  2. Individuals who have participated on pharmaceutical companies’ Speakers Bureaus should be prohibited from DSM panel membership.
  3. There should be a rebuttable presumption of prohibiting FCOIs among the DSM work groups. When no independent individuals with the requisite expertise are available, individuals with associations to industry could consult to the DSM panels, but they would not have decision-making authority on revisions or inclusion of new disorders.

These changes would accommodate the participation of needed experts as well as provide more stringent safeguards to protect the revision process from either the reality of or the perception of undue industry influence.

Our health care, health system and the pharmaceutical industry

Cartoon by Simon Kneebone, 1985

Cartoon by Simon Kneebone for a 1985 article “DES – the wonder drug you should wonder about“.
As pertinent today as 31 years ago!

What rules determines a treatment that a medical quiz would recommend?

With great power comes great responsibility

“It seems that no matter what I do, the quiz recommends the client’s drug as the best possible treatment. The only exception is if I say I’m allergic. Or if I say I am already taking it.” Bill Sourour.

Developers are often one of the last lines of defense against potentially dangerous and unethical practices.

We’re approaching a time where software will drive the vehicle that transports your family to soccer practice. There are already AI programs that help doctors diagnose disease. It’s not hard to imagine them recommending prescription drugs soon, too.

“Nothing that we were doing was illegal. In the end, I understood that the real purpose of the site was to push a particular drug.” Bill Sourour.

The more software continues to take over every aspect of our lives, the more important it will be for us to take a stand and ensure that our ethics are ever-present in our code.” 

Read The code I’m still ashamed of, on medium, Nov 13 2016. Code image by Thibault J.

Rupture de stock de certains vaccins dans les pharmacies

Il ne reste plus sur le marché que des formules enrichies mais controversées

Vidéo publiée le 25 mars 2015 par la chaîne Pour des vaccins sans aluminium.

Dans les pharmacies, impossible de trouver du DT-Polio. Ce vaccin obligatoire pour les nourrissons est en rupture de stock en France.
Ainsi, il ne reste plus sur le marché que des formules enrichies mais controversées…

“Les laboratoires s’organisent pour que les parents n’aient plus le choix de choisir (…) Pour la Sécurité sociale ça coûte beaucoup plus cher car on passe de 6,50 euros le vaccin DTP à plus de 40 euros. Donc à qui profite le crime ? Aux laboratoires pharmaceutiques”

assure Michèle Rivasi, Députée Européenne.

Vaccins: un biologiste dénonce la désinformation

Vaccinations – Les vérités indésirables

Vidéo publiée le 13 avril 2009 par la chaîne Expovaccins.

Ecoutez Michel Georget faire une analogie entre le gardasil et le distilbène…

Le Distilbène DES, en savoir plus