September 2009

Zannos G. Grekos, MD
Director of Cardiology and Vascular Diseases, Regenocyte Theraputic
Assistant Clinical Professor of Cardiology, Nova Southeastern University

Kitipan V. Arom, MD, PhD, FACS, FACC, FACCP, FRCST
Chairman Emeritus
President of the Society of Thoracic Surgeons of Thailand
Minneapolis Heart Institute & Minneapolis Heart Institution Foundation, USA
Founder and Past President Minnesota Society of Thoracic Surgeons, USA

Don Margolis
Founder and Chairman
don@repairstemcells.org

www.RepairStemCells.org
Bangkok, Thailand

Question_Mark2

IS THE FDA ANTI-REPAIR STEM CELL?

“THE FDA - What We Do (FROM THEIR WEBSITE):

“The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices...”
“The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.” http://www.fda.gov/AboutFDA/WhatWeDo/default.htm

If this is so, then how is it that while repair stem cells (RSCs) are often painted by the media as “highly experimental,” “potentially dangerous” and “snake oil,” in fact:

Thousands of RSC treatments have been performed with virtually no side effects and resulting in significant improvements to the patient’s health.
There are 2,572 clinical trials when you type "stem cell" into clinicaltrials.gov
There are 1,160,000 scholarly papers when you type "stem cell" into Google’s scholarly papers.
Evidence supports that the risk of RSC treatments are about the same as the risks associated with drawing blood. (Standard safe practice of lab protocols removes these risks almost entirely.)
AND WE STILL CAN’T GET THEM IN THE US DESPITE THE FDA’s EXPLICIT JOB DESCRIPTION OF: “…helping to speed innovations that make medicines and foods more effective, safer…”

While the FDA is stalling repair stem cells, they make a habit of evaluating and approving deadly products and deeming them perfectly healthy, such as:

· Raptiva

· Vioxx

· Cigarettes

· 40 year old swine flu vaccines

Dr. David Graham, a senior drug safety researcher at the FDA, blew the whistle on the Vioxx debacle and the FDA, stating:

“The FDA’s suppression and intimidation of scientists is a threat to public health. Unless it changes, and scientists can speak without fear, they cannot defend the public,”
“the FDA as currently configured is incapable of protecting America against another Vioxx. Simply put, FDA and the Center for Drug Evaluation Research (CDER) are broken.” - November 23, 2004 PBS Online News Hour Program

In short, the FDA seems to be taking an anti-RSC position, keeping powerful and safe medicine away from the people, while promoting deadly drugs that do more harm than good. Their most resent bungle is with a MS drug called Tysabri.

Note: PML is a rare disorder that damages the material (myelin) that covers and protects nerves in the white matter of the brain while MS is an autoimmune disease that affects the brain and spinal cord (central nervous system)..and nerves in any part of the brain or spinal cord may be damaged.

FDA continues to receive reports of PML

ROCKVILLE, Md., Sept. 22, 2009--FDA continues to receive reports of PML in patients receiving Tysabri…approved by the FDA for the treatment of relapsing forms of MS in November 2004…13 reported cases of Tysabri-related PML were confirmed worldwide…The risk for developing PML appears to increase with the number of Tysabri infusions received…the FDA is not requiring changes regarding PML to the Tysabri prescribing information or to the Tysabri risk management plan, called the TOUCH Prescribing Program.