Dr. Centeno's insight into Yorkere's question
These reports, as far as I can see, are all from ongoing FDA approved clinical trials in the US (the outside of US trials I can't comment on). These are sponsored by big pharma companies. This approach is a two edged sword. On the one hand, it does create the appearance of a safety net by focusing on extensive due diligence and research of the therapy. However, over the past 10 years we have seen drug after drug approved by the FDA that has eventually been pulled off the market as unsafe. Why? My best educated guess is that because of the extreme cost of these trials, companies often hide bad data. In addition, since the cost is extreme (tens of millions of dollars), there must be a rich business plan supporting the therapy for the trial to make any business sense. Regrettably, this is one reason why our current medical care system is broken and failing. Too often, because of this system, what we get served up as the public is not the best available treatment, but the most profitable available treatment. If we want real healthcare reform that will reduce the cost of medical care, we have to have a system that promotes the best treatment, even if it doesn't make a company billions of dollars. In pain management we see this dilemma everyday. What insurers will pay for is these big pharma/big device sponsored treatments, which are often the most invasive, most expensive, and sometimes least long-term effective options. What we know as doctors will often work for the patients is a less invasive and less costly option, but because there is no big business model behind the treatment, insurers won't cover that option. This is because these treatments don't have business models that will support the big research that needs to be done. A good example is lumbar fusion for patients with severe low back pain. The average insurer will gladly pay tens of thousands for a fusion that has never been shown to be an effective treatment, but refuse to pay hundreds of dollars for the patient to see a good chiropractor or acupuncturist (both of which have been shown to likely be more effective than fusion and far less invasive). Why? Fusion is supported by big device manufacturers who get paid thousands of dollars for pieces of hardware manufacturered in China for pennies. Again, an example of how business models drive medicine. Our current healthcare reform bill in congress will eventually fail for this same reason. The same companies who drive these healthcare decisions are now heavily lobbying congress for a seat at the table when the medical guidelines get produced (what will and won't be covered in this new system). So these guidelines won't really be focused on what does or doesn't work, but instead on what treatments had the best business models that allowed for the biggest lobbying reprenstation at the guidelines meetings.
ICMS represents an opportunity for doctors to take control to fix some of this broken system. Physician controlled cellular therapy and the ICMS clinical/lab guidelines and treatment registry process will allow small business plan medicine to flourish again. It used to be that you went to the doctor and based on the best published research and his or her clinical experience, the best treatment option was offered. Your insurance company paid for the treatment. The downside of this was that physicians often didn't have the best evidence available and ineffective treatments were often used. The fix for this was supposed to evidence based medicine (EBM). EBM's promise was that more research would give doctors better evidence to produce better decisions. However, the cost of producing this evidence has often led to the above cycle (big business model medicine).
ICMS will allow doctors on the ground who treat real patients decide which of the patient's own stem cells for disease x makes sense. The registry we're working on will allow medical practices to share efficacy and complications data (something big pharma would never do). The ICMS lab and clinical guidelines will make sure physicians take safe, measured steps in deploying these cells.
The existing big pharma system (the subject of the article you referenced) will eventually produce some great things, but all must be very profitable big businesses to make it through the regulatory gauntlet. Your doctor offering safe stem cell therapy, using a common re-implant registry can see that 50 other doctors have successfully used stem cell x to treat disease Y in hundreds of patients with minimal side effects and no serious complications. He won't care if the stem cell line being used is profitable enough to produce billions for a big company, only that it may help your particular disease and that he or she is appropriately compensated for that service. That will eventually put a dent in the healthcare mess.
