By Amy Price PhD
My email informs me people are hungry for real help on finding medical providers who can offer stem cells. They want to know are stem cells a viable alternative, Can you find me quality information instead of hype, and what is your view on the FDA in this regard?
This field is moving very rapidly and what was not possible only a year ago is happeneing today.I have sen great and not so great results for orthopedic, heart, blood and some wound healing applications but it is important to realize that this therapy is still in experimental stages and there are no guarantees.
A few pioneers have moved through the opposition and fear of new therapies to pave the way for university hospitals who are now offering up stem cells in the way of research. One good example is new heart tissue grown out in Los Angeles "We seek to actually reverse the injury that has been caused by the heart attack, by re-growing new heart muscle to at least partially replace the scar that's formed," says Dr. Eduardo Marban of Cedars-Sinai Heart Institute
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A tale of two hearts summarizes this nicely. Both hearts were damaged. The first heart was in a young man whose parents are dedicated medical professionals. They waited eagerly for FDA clearance so they could take their son for a legal stem cell repair. The wait was too long and emergency surgery ensued. The young man lived but sustained brain damage and paralysis. This heart could have been repaired with adult stem cells. A company that developed the stem cell technology was less than one hour from them. The cultural mindset opinion that procedures performed outside of North America because of FDA restrictions were too risky cost them deeply.
On the other spectrum was a banker friend well known in the diplomatic community? His heart was damaged and he was urged to change his lifestyle and lose weight. He picked up over the counter diet pills later banned by the FDA and marched to the treadmill like a soldier in boot camp to the acclaim of family and treating professionals. Noticing his lips and finger tips had an ominous bluish tinge, I asked to see the pills. They contained amphetamines in the form of herbs. We urged him to see his cardiologist and to stop the pills but he chose to soldier on until a month later he collapsed on the treadmill and was taken to hospital where his chest was sawed open and major heart surgery took place as it was the only way to save his life.
The FDA found a niche because when humans are physically vulnerable they will pay or do almost anything for survival. They keep us safe from predators in the marketplace. They help us with food labels and medical warnings. Dieters have been known to ingest tapeworms, destroy their stomachs, livers, kidneys, hearts and intestines to lose a few pounds. Doctors who see patients on whom they conduct treatment for a fee will say I have to be honest with you the chances aren’t great but if it is your choice we can proceed. They are applauded for their ‘honesty’ whether the treatment succeeds or not. We say go ahead because even false hope is better than none at all. Likely none of us would hire a roofer who said I will work on your roof but because of pre-existing structural damage it likely won’t work out! The FDA has a tough job and emotional stakes run high.
On the other hand the FDA is a bureaucracy with allegiances and political agendas, not because they are necessarily evil but because this is a given for group behavior. They are shaped by society and moved by mass public opinion. They also make mistakes and if some of the lifesaving drugs we have today would have needed FDA approval masses would be dying while wars were fought that have little to do with how well something works.
Do I think most people or their doctors have enough medical training to make an informed choice about stem cells? No…but I am not sure the FDA is in a position to make this choice for the best interests of the people and I would welcome some of the transparency they have promised.
Would I consider not having FDA approval for a therapy before using it on myself or family? I would not consider a banned or illegal substance but I would have non FDA sanctioned treatment or off label use of pharmaceuticals. It has in the past improved my quality and likely my length of life. I would not consider a choice like this lightly. The risks need to be weighed against the benefits and I would have to know and trust the doctor involved whether in this country or somewhere else on the globe.
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