There is enthusiastic support of SCINetUSA in many states. For example, I recently came back from a fundraiser held in Austin (TX) by the Lone Star Foundation. The excitement and the interest in getting clinical trials going is not only palpable but manifested by significant donations that will support the trial at Brackenridge.
I have only recently begun to realize that the pessimism and even nihilism expressed by some CareCure members on the Cure Forum are not representative of the spinal cord injury community in the United States. On the other hand, we are facing something that is even more difficult to overcome, i.e. skepticism.
Many people, particularly those who have been injured for a long time, have seen many potential "cures" come and go. Many have put their hope into certain procedures, only to be disappointed. I don't blame people, particularly those who have gone and paid for unproven therapies, for hesitating to involve themselves again.
Most people initially think that I am just pushing for umbilical cord blood cell transplants and lithium. They are accustomed to other doctors or scientists advocating a particular therapy. When they realize that I am not advocating a particular therapy but rather I am pushing for a systematic clinical trial approach to ascertaining whether a therapy works or does not work, they are not sure that they want to donate.
People want therapies but they don't believe in the clinical trial approach. After all, if something works, then all the proof that one needs is to put it into somebody and see whether or not it works. Why does one have to do randomized clinical trials? Some of my best friends and supporters have asked me that question in earnest.
We all know people who have recovered this or that function even long time after injury. I can take any treatment and apply it to a population of chronic spinal injured people and find some of them, even as many as half of them, recover some function and reporting that they have benefitted from the therapy. If a therapy works, it must get more improvement of function than a placebo control.
To obtain convincing data that the therapy being tested actually works, we have to do double-blind randomized controlled trials where neither the doctors nor subjects know which therapy they are receiving. The therapy must be standardized and extensively tested for safety. The doctors must be trained to assess the subjects in the same way.
There is the problem of money and advocacy of the therapy. No matter how pure the doctors' motives, taking money for unproven treatments corrupts. Even though the doctors may believe that they are objective, they cannot be objective when their operations and institution depends on the income from the unproven therapy.
This is particularly true when the so-called trials are not blinded. Doctors are not objective when they have invested substantial time and their careers into a therapy. They often see improvements where there may be none. Believe me, I have seen this in my students and fellows. They want so badly for the rats to walk that I insist that studies in my laboratory be double-blinded.
Neither the doctor nor the subject can be objective about the therapy. That is why double-blinding (of both the doctor and subject) is necessary. Also, people running the clinical trials must work very hard to keep distance between themselves and the therapies being tested, to avoid any potential conflict of interest, and to not oversell the therapies.
Many people here who have known me for a long time can probably see the struggles that I am having not to slip into an advocacy mode concerning the umbilical cord blood and lithium therapy. As the head of clinical trials testing these therapies, I must refrain from too much enthusiasm and always present a balanced picture.
Likewise, I am very careful to avoid all conflicts of interest concerning the therapy that the clinical trials are testing. I do not receive any payment from companies providing therapies for the trials. For example, I do not get consulting fees or any other compensation and own no stock in Stemcyte, the company that is providing the umbilical cord blood cells for our trial. Whether the trial succeeds or fails, I will not be financially enriched or impoverished.
We have also been careful to segregate fundraising from the clinical trials. For example, the fundraising arm (HKSCIFund) is separated from the actual running of the clinical trials in ChinaSCINet. This way, there would not be undue influence from donors. We of course listen to the donors and try to implement what they want but there is no quid pro quo.
Finally, I want to comment that while things may seem to be moving slowly in ChinaSCINet, they are actually moving much faster than industry trials and especially considering our small budget. We are recruiting subjects for the phase 2 trials in Hong Kong and I hope that we will have 20 subjects soon. In the meantime, we are working very hard optimizing the shipping and testing of the cells. We are also awaiting for word from the Chinese government for permission to start the trial in Kunming. I hope that we will receive such permission in May. There is no problem with shortage of subjects in China. In the meantime, I am heading to Norway at the end of May to discuss the possibility of clinical trials there but I must emphasize that Norway may want to test their own therapies and not become a mirror of ChinaSCINet or SCINetUSA. I would do everything that I can to help them.