change to "proper assessment".

3.3 The Beaumont team started the clinical trial based on dubious information and hearsays from Dr. Xiao, without proper assessment and investigation. They also provided mileading information to patients and the public, as is shown in the following list of examples. These conducts represent significant scientific and ethical mis-judgement.

They misled potential patients by actively repeating the false claim that the procedure was "standard of care" and "done everyday in hospitals in China", and suggesting patients go to China for the surgery []. The information could have been easily proved to be false should they have spent the least effort to cross-check.

They also exaggerated the number of patients of the NIH sponsored trial at New York University in their publication [] and news release [].

Further, they had constantly understated the risks of the procedure on their website and to the media, claiming that, for example, there was "a small risk of some foot weakness" [] and that "recent changes in the surgical technique have dramatically decreased the incidence of these complications" []. Only in a recent interview did they tell the media that "the surgery ... carries serious risks" [].

The misleading information may have had serious consquences. According to the website of Dr. Xiao's Chinese Journal of Clinical Urology, more than 90 U.S. patients had been "successfully treated". These patients may have made the decision to take the operation based on the misleading information.

These patients are exposed to the serious risks of the operation. To give concrete examples of the risks, we note that, among the 9 patients in Beaumont's clinical trial, one child has had persistent drop foot, others developed "significant lower extremity complications that largely improve with physical therapy and time" [1year abstract], although how much improvement obtained was not specified. Please note that Dr. Xiao recently claimed in his blog that "patients with spina bifida do not need physical therapy" after the surgery.

As a side note, evidence suggest that Chinese patients are not so lucky in regarding to the rate of serious side effects after Xiao's procedure. Despite the difficulty in patients follow up, initial investigation by a law firm representing patients revealed that up 39 % of Chinese patients (from a total of XXXX that can be tracked) suffer much severer side effects after the operation by Dr. Xiao or his close associates.

(only have time for these)