ICMS Responds to Eschenbach Editorial

FOR IMMEDIATE RELEASE

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International Cell Medicine Society Responds to Editorial by Dr von Eschenbach

PORTLAND, OREGON – Tuesday, February 28, 2012. The Executive Board of the International Cellular Medicine Society (ICMS), a professional medical association dedicated to patient safety through the strict evaluation of cell-based therapies and the rigorous oversight of medical facilities and clinics has read with keen interest the editorial written by the former commissioner of the Food and Drug Administration (FDA) regarding the regulatory conundrum facing Regenerative Medicine in the US, particularly when using a patient’s own cells.

The ICMS and its 3500 members from over 30 countries agree with Dr von Eschenbach that the field is on the brink of great opportunity.  There is no argument that regenerative medicine will change healthcare.  Rather, the argument is how to best advance this emerging field. Thus far, two pathways for safe clinical translation have been defined: physician innovation and the FDA. Many have observed that while the FDA process for regulating new cell-based medicines is imperfect, it is preferable to the alternative. It has been argued that without FDA regulation the result would be the proliferation of unregulated ‘rogue’ clinics that prey on the hope of desperate patient-victims.

This is a false dichotomy.  Far from halting the proliferation of clinics, this activity has driven more patients overseas to seek treatment alternatives. By stymieing innovation and patient access in the US, where clinics can be monitored by licensing boards and held accountable for their actions, we have created an environment that drives desperately ill patients abroad. Instead of delivering on their mission of patient safety, the regulatory actions of the US government have nurtured a vibrant medical tourism industry. While many overseas clinics offer therapies based upon good patient care and sound science, others are substandard and unaccountable.

Patients, many of whom perceive these clinics as their only alternative, have no way of knowing the good from the bad, and are forced to make a healthcare decision based upon speculation and intuition. This reality is untenable. Patient safety cannot be assured without appropriate oversight and transparency.  We therefore applaud the efforts of the Texas Medical Board and the California Institute of Regenerative Medicine (CIRM) for their programs to translate promising autologous therapies to the clinic under appropriate oversight by state medical boards. We would like to add to this foundation a need for strict clinical and laboratory practice standards, accreditation of compliant facilities, and management of a safety and outcomes monitoring registry as the most effective pathways for the delivery of safe and effective treatments to patients in need.

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ABOUT THE ICMS

The ICMS is a 501(c)(3) nonprofit professional medical organization that is focused on the development of standards for the evaluation of point-of-care, cell-based therapeutics worldwide. With over 3,500 members from over 35 countries, the ICMS is a global leader in patient safety through strict evaluation of therapies and rigorous oversight of clinics and facilities providing cell-based medical therapies. The ICMS maintains an independent Institutional review Board and manages a comprehensive Treatment Registry that tracks patient outcomes. More information can be found at www.cellmedicinesociety.org

DISCLAIMER:  Cell-based medical therapies are an investigational treatment. All medical treatments carry risk. Patients are urged to consult with their physicians to weigh the risks prior to undergoing any investigational treatment. Accreditation by the ICMS should not be taken as a recommendation to seek treatment or substitute advice provided by a licensed and qualified physician.

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