Monday, May 4, 2009

Will the FDA Kill Adult Stem Cell Medicine?

That's the title of a story in H+ Magazine, by Jeff Morris, AAMG and Stephen Coles, Md, Ph. D. The authors are interviewing Dr. Christopher J. Centeno, whose specialty is orthpedics. Dr. Centeno has been using adult stem-cells to treat his patients for over four years. The article begins:

"Within the next five years, it's quite possible that physicians will come into routine possession of a remarkable set of tools — a brand new way of dealing with the frailty and disabilities of aging. The tool kit is autologous stem cells derived from the patients themselves, amplified in culture, and infused back into the patient according to a precise protocol. It would be such a leap from today's medical diagnostics and treatments; it could only be called revolutionary.

The purpose of employing autologous cells is to prevent rejection of histo-incompatible cells by the patient's immune system. But it's also possible that these new therapies could slip from our grasp, at least in the US. If we're not careful, these therapies could become the exclusive domain of the pharmaceutical industry, as regulated by the Federal Food and Drug Administration (FDA). This could push the availability of this tool kit 15 to 20 years into the future. The opportunity-cost in terms of morbidity and mortality could be catastrophic....

The story then tells a little about Dr. Centeno:

Prior to becoming involved in stem-cell research, Dr. Centeno was already an international expert and specialist in musculoskeletal, spinal, and neurologic injury. Having trained at the Baylor College of Medicine, Texas Medical Center, and the Institute for Rehabilitation Research, he is an M.D. who is double-boarded in Physical Medicine and Rehabilitation as well as Pain Medicine. Dr. Centano has seen the results that are achievable in an orthopedic context. 'We've done this for four years for patients with orthopedic conditions. So, as a test case, we know it can work safely and effectively.'”

What's the danger? The FDA wants to classify your own stem-cells as a drug. We blogged on this back on March 26, 2009. The story continues:

"To Dr. Centeno, it is inconceivable that a person’s own cells could be classified as a drug — but that's exactly what the FDA wants to do. “The FDA is working to protect the interests of Big Pharma,” he says. 'If we wanted to insert some kind of new genes into these cells, we might all agree that could be a drug — a new entity. But what we're doing is simply culturing a person’s own cells. Most of the cells are bone-marrow derived; you can get them from synovial fluid in the knee or from other locations....'

The stakes for the pharmaceutical industry are obviously also high. 'You’re talking about replacing $60 billion in drug- and device-care with $6 billion in stem-cell care,' Dr. Centeno observes. The end result will either be individual physicians owning and controlling labs, or, says Dr. Centeno, 'It will all be controlled by Big Pharma, and innovation will move at a snail’s pace.'”

Dr. Centeno heads an organization created to define guidelines and standards for American adult-stem cell treatmet called The American Stem Cell Therapy Association (ASCTA). Their website is here.

h/t Instapundit.

Let's pray "The Science President" instructs his FDA not to get in the way of REAL science!


In other great adult stem-cell news, our friend Don Margolis has a story about a lady who has been treated with her own adult stem-cells for COPD (serious lung disease). The lady had been a smoker, and had been on oxygen 24/7 until being treated last December. She is now totally off oxygen. Pray God this sucess continues!

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