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Ethic’s Committee
Prague 2011 – ERA EDTA Congress
Ethic’s Committee
The public, clinicians, nurses, associates involved in nephrology care grant local, national and international medical profession leadership considerable discretion in setting its own standards because they trust that their leaders will place patients interests ahead their own or those of third parties.
Ethic’s Committee
To maintain this trust ERA-EDTA leadership must take the lead in addressing conflicts of interest in nephrology medicine, promoting a culture of accountability and developing education to analyze the advantages and disadvantages of medical and therapeutic options (treatments, drugs, recommendations, technologies) and of sponsored scientific education meetings or publication (congresses, scientific sessions, CME, journals).
Ethic’s Committee
Relationships between academia, physicians, researchers and industry have both benefits and risks (NEJM 2010, 362, 670).
Companies need to develop profitable new products.
Annual Scientific Society Meetings, CME programs cannot survive without industry financial input being too expensive for participants without external support.
Ethic’s Committee
If individuals have potential conflict of interest on topics discussed (council, committees, association's granted research program, scientific meetings organized by association's members) they may (must) have to recusethemselves from decisions making on such topics.
When the list of potential conflict of interest (often more than 9-10 financial relationships with industries) is not related at all to the topic(s) expected to be discussed by such individuals, participation to meetings is acceptable; common sense and reason dictate tolerance.
Ethic’s Committee
Many key discoveries have resulted from academic-industry partnerships and there is no inherent conflict of interest between them; in fact there is a commonality of interest healthy and beneficial (Health Aff 2008, 27, 1532; Endocr. Pract. 2009, 15, 669).
Life Sciences Faculty with industry relationships are more prodictive than those without such support (Health Aff 2009,28,1814).
Ethic’s Committee
Partnerships between grants-funded basic science and clinical researchers and industry are relevant to the process of moving discoveries from the bench to the bedside (JAMA 2010, 303, 2400).
But there have been reports of sponsors seeking to suppress or delay unfavorable data publications, and/or to publish selectively positive results (NEJM 2008, 358, 252).
Ethic’s Committee
Expectation of reciprocity may be the primary motive for gift giving (JAMA 2003,290,252).
Even small gifts (pocket guide, meals, drug samples) may have a powerful impulse to reciprocate while individuals may not always be conscious of such motives = psychology of gift receipt (JAMA 2006, 295, 429; Acad Med 1997, 72, 916).
Ethic’s Committee
Ethic’s Committee
– Decisions may be influenced by personal interest – Someone in position of trust has interests other that Ethic’s Committee
Elevated payments to leaders (same order of magnitude as regular salaries or more) present a real problematic risk of undue influence (health insurances, scientific organizations, publications). How to know?, what to do? suggest donations to nonprofit structures? Relationships reviewed and/or approved? by association's presidency ? council ? ethic's committee? representants of all instances? Ethic’s Committee
Recent studies have shown that it is difficult to remain objective when receiving even small gifts. 61% of physicians reported that promotions don't influence their practice but only 16% of these physicians believed that the same is true of other collegues(JAMA 2001, 110, 551).
Clinicians with industry ties are more likely to prescribe companies brandname drugs than generics (Academic Med 2005, 299, 665).
Ethic’s Committee
Ideally clinical decisions- making related to professional society guidelines, congress or CME organizations should not be influenced by financial relationships with industry.
Is it possible to prevent such interactions? Not sure.
Those who are so vocal regarding potential conflict of interest which is perceived as corrupting patient care (in favor of big pharma) fail to identify their own conflicts –failure to be nominated to serve on an advisory board or to speak at sponsored meetings. Jealousy is a curse (Med Law 2009, 28, 55).
Ethic’s Committee
Negative impact: publications (1)Ghost authorship, falsifications Ghost author: someone help design a study , analyze
results, and – or write manuscripts without acknowledgement in publication Guest author: author with superficial association
added as author to increase credibility and-or satisfy a collaborative agreement.
The reasons: extreme pressure to publish,
personal interest, maintain influence and leadership Ethic’s Committee
Negative impacts: publications (2)Ghost authorship, falsifications– Incomplete reports,– Inadapted statistical reports,– Eliminations of inappropriate results,– Research investigations without Helsinky human rights committee's agreement (example : DNA related research programs- geneticists investigations).
Why: "Publish or Perish"- pressure to discover, to
progress.
Ethic’s Committee
A disturbing example of inappropriate conduct: trial of rosiglitazone - Avandia(industry sponsored clinical trial) –a situation in which concerns about preserving market share apparently trumped concerns about the potential for causing patient harm (JAMA 2010,303,1196).
Ethic’s Committee
Negative impact questions- why would studies be published without complete assurance that data management is appropriate and statistical analysis accurate and ethically conducted - why would a peer reviewer for a medical journal violate ethical standards and provide a confidential manuscript to a for - profit company - why would physician managers in a company misuse that confidential information in attempts to counter research findings suggesting that a company's product was harmful.
- Why would any physician in a forprofit Company participate in, tolerate, condone sufficient ability to stop such conduct.
Ethic’s Committee
– Data accessibility for all authors and reviewers.
– Willingness to have independent analysis– Avoiding gifts to prevent conflict of interest – Transparency (disclosure) if financial compensation exists– Trust but verify– Integrity is crucial. Integrity is steadfast– Adherence to strict moral- ethical code.
– Perceived consistency of actions– Common honesty (The physiologist 2011, 54, 3).

Source: http://era-edta.inet2.it/dati/pagine/allegato_201108160941.pdf

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