Jon,
I am sorry that it seems to be pouring down all of a sudden. However, I think that it has been pent-up and a long time in coming. I have generally refrained from commenting critically on the Beike claims to date in hopes that Beike would publish some of their results. The problem is not what Beike does not claim. It is what they (and through you) are claiming, i.e. that they have a therapy that is improving recovery in 80% of people with spinal cord injury, that is 100% safe, and that people would benefit from repeated therapies. You suggest that anecdotal data is acceptable. Please, as a person who has been in a medical familiy, you know what the problem is with anecdotal data and the reason why they are not accepted in the medical world. You know that what you are doing is wrong for the following reasons.
Anecdotal data are usually incomplete and therefore misleading. We don't know the denominator. Only the good cases are being presented. It doesn't seem that your web site is presenting any of the bad cases that don't turn out. You claim here that 80% of the people say that they have gotten improvements that they are satisfied with. What is the denominator? Where do you get this data... Are you repeating what you are verbally told by the doctors at Beike? When are people reporting their satisfaction, when they are being discharged, when they are told that the recovery will still take months to happen, and that they should expect recovery after they get home? Have there been any systematic effort to contact the patients and find out if they are actually recovering and finding out whether any of the people are having complications?
There is a strong placebo effect in situations such as these. Add to that a strong desire and expectation for recovery, you will see many people reporting positive effects of the therapy. This is true of any treatment, including ones that should have no effects whatsoever. Let me give you an example. About a decade ago, a couple named Vigil (Berverly and Tom) charged many people with spinal cord injury to treat them with a product called Neuralyn (
Source). They advertised their product on the web and they had many testimonials from people who swore that this ointment cured them. In fact, we had several of these people here on spinewire and cando (the precursors to CareCure). People were told (like you are telling them that the treatment is 80% effective) that Neuralyn was 85-95 percent effective. They were told that Tom Vigil is a doctor with training in biochemistry, that the work is supported by a distinguished board of physicians and scientists, and that the cost of research and patent applications justified the $300-$500 charge per vial of the ointment. This couple has been convicted of criminal fraud.
How is what Beike doing any different from what the Vigils did? The fact that Beike has not and is not following up on their patients is not reassuring. The fact that they don't seem to be doing standardized neurological examinations and publishing their results is bothersome. The fact that they are making claims of safety and efficacy, directly or indirectly through you, your web site, or anecdotal claims from patients, without publishing the results in respected medical journals suggest strongly that the data cannot and will not pass peer-review. Finally, the fact that they are charging for unproven therapies, even asking patients to come back and pay for repeated therapies is unethical. I have indicated my skepticism that the therapy by the Beike group would be effective for the following reasons.
- Non-HLA matched cells. The Beike group is using non-HLA matched cord blood cells to treat patients. Two decades of experience with cord blood transplants strongly suggest that HLA-matching is essential for engraftment of cord blood cells, particularly cells that are being given peripherally. For the Beike group to claim, with no data whatsoever that the expanded cells are not being rejected and are engrafting in the spinal cord, is not acceptable. The cells (particularly those that are injected intravascularly) are very likely to be rejected in most of the patients.
- Cell expansion and purification. The Beike group claims to be expanding the cells and purifying CD34+ cells for transplantation. Are they really doing this? What is the purity of the cells? Is the procedure GMP? Are the cells being grown in the presence of bovine serum? How are they ensuring that the cells are sterile and not contaminanted? Have the procedures been approved by any regulatory agency? Is there any evidence that the cells are surviving or are getting into the spinal cord? Incidentally, I know of no group that is consistently able to row and expand CD34+ cells. I would imagine that if the Beike group actually has a method that works, they would be crowing this from the roof-tops and publishing it in the best journals, and getting a lot of funding from venture capitalists.
- The lack of publications is concerning. Where are the publications, even in Chinese? I spend a lot of time in China and I have yet to talk to any doctor who thinks that this treatment has beneficial effects in spinal cord injury. The fact that Beike are setting up operations to so many cities is worrisome. It seems that no part of what they are doing has been subjected to peer- or regulatory review. While you claim that the procedures are safe, where is the data? The data should not be based on whether or not Cherry or whoever has personally talked to anybody who has had a problem with the procedure. It is the responsibility of the doctors who are carrying out the study to document adverse events. The problem is that I don't think that Beike is doing a study. It is just a business concern with a serious conflict of interest because the treatment is earning a great deal of money.
At the beginning, I was willing to adopt a wait-and-see attitude, hoping that they would come out with some publication, to provide some evidence of what they are doing and to support their claims. But, I just don't see any of this happening. I am seeing more anecdotal evidence being presented on your web site, the citation of unsubstantiated statistics such as 80% improvement of the patients, and continued unjustified scientific claims being made with no evidence to support the claims. I therefore cannot recommend that anybody goes to this group for treatment. It has all the hallmarks of a scam.
Wise.