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Newsroom
November 1st, 2012

Cook Medical Applauds Guidelines Released by Association of Clinical Researchers and Educators


Bloomington, Ind. — New recommendations from the Association of Clinical Researchers and Educators (ACRE) to guide relationships between physicians and industry could pave the way for a new era of medical advances and bring waves of breakthrough devices to patients worldwide.

Cook Medical on Thursday welcomed the efforts by ACRE to address interactions between physicians and industry and do it in a manner that does not build walls but instead leads to collaborations that advance medicine and education.

“Egregious misconduct by a few inappropriately colors the reputation of each and every health care stakeholder, whether they work in industry, in administration or as doctors,” said Bruce Gingles, vice president, global technology assessment and health policy at Cook Medical. “ACRE should be applauded for creating this fair and complete set of guidelines.”

“Egregious misconduct by a few inappropriately colors the reputation of each and every health care stakeholder, whether they work in industry, in administration or as doctors”

ACRE’s guidelines support collaborations between physicians and industry with recommendations that encourage rather than discourage innovation and education, with the ultimate goal of benefitting patients.

The guidelines define what constitutes “fair value” for receiving compensation and address areas of greater scrutiny that physicians should be aware of, such as formulary committees and institutional review boards. ACRE also offers recommendations on how physicians should disclose working relationships and calls for a formal rejection of the term“conflict of interest.”

The guidelines were co-authored by ACRE member J. Michael Gonzalez-Campoy, MD, PhD, FACE. Gonzalez-Campoy said rules must not get in the way of physicians who want industry input for breakthrough products and treatments.

“These guidelines achieve a much more reasonable approach to managing relationships so that physicians can actively participate in innovation and discovery of new treatments to enhance patient care and outcomes,” Gonzalez-Campoy said.

The universal model for medical innovation to enhance patient health and foster basic research stems from grants funded by industry and government to physicians and scientists. That funding in turn leads to published research, career advancement hile delivering patient care. Society benefits with medical advances and a stable academic health system.

In recent years a new model for innovation has been developed: university-affiliated translational research that brings together physicians, clinicians, scientists and industry to develop breakthroughs and patents. Revenues are reinvested in the university. New cures and advanced medical care benefit patients and society.

Freedom for physicians and industry to work together is critical to both approaches, Gingles said. ACRE’s guidelines will be published in the November/December issue of Endocrine Practice. In addition, the ACRE guidelines are available for download at http://aace.metapress.com/content/k12021244705x03w/?genre=article&id=doi%3a10.4158%2fEP12163.CO

“Most new product ideas address gaps in care, and they almost always come from clinicians rather than from industry,”Gingles said. But when there are complex regulations that discourage physician and industry meetings, innovation and patients pay the price.

“It’s a lot easier to blame an entire industry for isolated ethical problems than to create the sort of pragmatic relationships that lead to better patient care,” Gingles said.

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