Αντιγράφω (19/01/2017) από τον τοίχο, στο facebook, του Καρδιολόγου Χρήστου Ντέλλου:Όχι πως δεν το ξέραμε, αλλά μια νέα μελέτη μας το θυμίζει:
Οι επιτροπές σύνταξης των οδηγιών (GUIDELINES), πχ για τη χοληστερίνη,
έχουν ισχυρότατους οικονομικούς δεσμούς με την ιατρική βιομηχανία.
Το ίδιο ισχύει και για τους Συλλόγους Ασθενών με παθήσεις που απαιτούν ακριβές θεραπείες.
Medscape Medical NewsKey Guideline Committees, Patient Groups Have Industry Ties.
January 17, 2017
Guideline committees and patient advocacy groups have substantial ties to industry, according to research published online today in JAMA Internal Medicine. The new findings raise questions regarding how much influence companies have had in the groups' decisions and recommendations.
Akilah A. Jefferson, MD, MSc, and Steven D. Pearson, MD, MSc, both from the Clinical Center in the Department of Bioethics, National Institutes of Health in Bethesda, Maryland, investigated how well two seminal guidelines committees adhered to Institute of Medicine (IOM) standards regarding conflict of interest (COI). COI included both financial and intellectual relationships.
They looked at the 2013 American College of Cardiology and American Heart Association cholesterol management guideline and the 2014 American Association for the Study of Liver Diseases and Infectious Diseases Society of America guideline for management of hepatitis C virus (HCV) because recommendations from both influence medications for millions of Americans.
Performance on IOM Standards
The IOM says no guideline committee chairs or cochairs should have commercial COI and fewer than 50% of committee members may have them.
However, according to disclosure statements, one of the three chairs/cochairs (33%) for the cholesterol guideline committee disclosed commercial COI. Among the 16 committee members, 7 (44%) disclosed commercial COI; all of those reported industry-sponsored research and 6 (38%) reported serving as industry consultants.
Among the HCV guideline committee members, 4 of 6 cochairs (67%) disclosed commercial COI. Among the 29 guideline committee members, 21 (72%) reported commercial COI, including 18 (62%) with industry-sponsored research.
Dr Jefferson and Dr Pearson also compared the disclosures listed in the guidelines with those listed for the authors in other articles in the same period and found many discrepancies, including additional COI reportings.
Although the presence of COI does not immediately indicate improper influence, the authors note "[t]he recommendations of the cholesterol and HCV guidelines evaluated herein differ from contemporaneous guidelines in a way that adds to questions about the possible influence of commercial COI."
"Adoption of consistent COI frameworks will help ensure that the clinical guidelines establishing appropriate care in the United States are developed in a way that can merit the trust of patients, clinicians, and the broader public," they conclude.
Patient Groups Taking in Big Money
Ties to industry also run through patient advocacy organizations (PAOs), which are becoming more and more influential in healthcare, according to a study also published online at the same time in JAMA Internal Medicine.
Besides offering counseling and education for patients, PAOs organize policy advocacy and can prioritize research and influence media coverage.
For the current study, Susannah L. Rose, PhD, from the Office of Patient Experience, Department of Bioethics, Cleveland Clinic, Ohio, and colleagues, sent surveys to 439 PAO leaders; 289 (65.8%) responded.
Of those, two thirds of the organizations (67.3%) reported receiving industry funding and nearly 12% received more than half of their funding from industry.
Among the PAOs that received industry funding, the median amount was $50,000 (interquartile range, $15,000 - $200,000).
The largest chunk of funding came from pharmaceutical, device, and biotechnology companies, which made up a median 45%, according to the study.
Nearly 8% of PAO leaders "perceived pressure to conform their positions to the interests of corporate donors."
When asked about how good their own COI policies were, only 55% of leaders said their written policies were very good at addressing key COI issues.
Better COI policies and more transparency for these nonprofit groups would help them maintain their independence and increase trust, the authors say.
Dangers of Industry Influence
The potential for damage is great when PAOs rely on industry funding, write Ray Moynihan, PhD, from the Centre for Research in Evidence-Based Practice at Bond University, Queensland, and the Sydney Medical School–Public Health at University of Sydney, New South Wales, Australia, and Lisa Bero, PhD, from Charles Perkins Centre, University of Sydney, and a member of the steering committee for the Cochrane Collaboration in London, United Kingdom, in an accompanying editorial.
"The very way we all think about disease — and the best ways to research, define, prevent, and treat it — is being subtly distorted because so many of the ostensibly independent players, including patient advocacy groups, are largely singing tunes acceptable to companies seeking to maximize markets for drugs and devices," they write.
They point to an example of potential harm in the lack of protest from industry-sponsored patient advocacy groups when the price of the EpiPen (Mylan) skyrocketed, as reported by Medscape Medical News. They note that it was grass-roots advocacy that brought the problem to light.
PAOs that want to be seen as truly independent need to reduce and eventually eliminate ties to industry, Dr Moynihan and Dr Bero say.
Until then, dollar amounts for contributions from sponsors and percentages of funding should be displayed on their websites and PAOs should be added to the Open Payments program under the Sunshine Act, they say.
"In our view this new work [by Dr Rose and colleagues] demonstrates an urgent need for patient advocacy organizations to explicitly focus much more on representing the interests of patients and citizens, rather than serving — inadvertently or otherwise — the interests of their industry sponsors," the editorialists write.
Funding for the study by Dr Rose and colleagues was provided by the Edmond J. Safra Center for Ethics at Harvard University. A coauthor of that study reported serving as a paid member of a data monitoring committee for Genzyme Sanofi until November 2012. The study by Dr Jefferson and Dr Pearson was supported by an intramural research grant from the National Institutes of Health. Dr Pearson reports grants during the past 2 years from the Blue Shield of California Foundation, the California Health Care Foundation, the Laura and John Arnold Foundation, and the National Pharmaceutical Council and reported membership dues paid to the Institute for Clinical and Economic Review during the past 2 years from Aetna, America's Health Insurance Plans, Anthem, Blue Shield of California, CVS Caremark, Express Scripts, Harvard Pilgrim Health Care, OmedaRx, United Healthcare, Kaiser Permanente, Premera Blue Cross, Prime Therapeutics, Health Care Service Corporation, AstraZeneca, Genentech, GlaxoSmithKline, Johnson & Johnson, Merck, the National Pharmaceutical Council, Takeda Pharmaceuticals, Pfizer, Novartis, and Eli Lilly and Company. No other financial relationships have been disclosed.
JAMA Intern Med. Published online January 17, 2017. Jefferson and Pearson abstract, Rose et al abstract, Editorial
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