This week has seen the debacle over GlaxoSmithKline's diabetic drug Avandia. This FDA approved drug has been linked to "severe adverse effects" i.e. linked to increased risk of heart attack.
Many of us think that FDA approval automatically confers safety. Not so - just remember the horror outcomes of Thalidomide.
What has all this got to do with adult stem cells? Many say that adult stem cell therapy is experiemental - unproven, without sufficient clinical trails approved by the FDA etc etc. At this moment there are hundreds of trials in progress around the world but it will be quite some time before adult stem cells gain FDA approval. And when they do does that really mean they are efficacious and safe? I hope so, BUT we know right now that safety is the least concern over the use of adult stem cells - after all they come from the patient's own body so when re-introduced into the body there are absolutely no rejection problems.
The hundreds of patients treated to date with adult stem cells for heart failure, Cardiomyopathy, Ischemic Heart Disease and Periperal artery disease would have missed out on the opportunity to enjoy a more active and longer life if they had waited for FDA approval. These people have chosen to get help for their failing heart right now - safely and knowing that patient outcomes are leading the revolution in modern medicine.
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