on February 25, 2010, we, the New Thread volunteers, had published an Open Letter of Complaints against the Xiao Procesure. Our appeal had caught the attention of the
Office for Human Research Protections (OHRP), which recently initiated an evaluation of the ongoing clinical trials on the procedure in the US.

In this letter, we wish to provide an update on more recent developments related to Dr. Xiao Chuanguo and his procedure, including newly-uncovered evidences that, had it been revealed earlier, might have disqualified the clinical trials and the practicing of the procedure. We call for a serious investigation into the Xiao's procedure and the misconducts that might have occurred during its research and implementation in the US and elsewhere in the world.

In the past months, an unexpected and dramatic event put Dr. Xiao Chuanguo into the spotlight in China. He was convicted of masterminding two violent attacks on his
critics and is currently serving a five-and-a-half-month sentence. This vicious act drew condemation from many organizations in China. The scandal was well covered in
all major international media.

Also in China, more than 300 patients who had received Xiao's procedure are planning lawsuits against Dr. Xiao and hospitals, claiming ineffectiveness, serious side
effects, and deception. Several of Dr. Xiao's "success stories" have now been revealed as actual failures. The procedure is now under review by China's Ministry of Health.

Outside of China, Beaumont Hospital's preliminary results was published in the Journal of Urology. It received harsh critical comments in the same issue.

Meanwhile, new findings are emerging from the muddied history of Xiao's procedure:

1. There is a huge discrepancy between Xiao's 2003 paper and his earlier 1998 abstract on his first human trials of 14 or 15 SCI patients [] {What exactly is the discrepancy?}

2. The success rate of Beaumont team, measured by either the objective or subjective results, is not comparable to Dr. Xiao's earlier claim.

3. In the report published by the Beaumont team, there is no correlation between the establishment of reflex arc and the improvement of bladder capacity and voiding, shown in Table 2 of the report, undermining the very premise of the procedure.

4. Independent experts both inside and outside of China are able to attribute some patients' voiding ability to intra-abodminal pressure rather than the detrusor contraction.

5. Previous NIH projects on the research of the procedure were completed with very poor outcomes:

The first grant awarded to Dr. Xiao (R01DK44877, $357,067 []) was initially proposed for the canine model, but the final result turned out to be merely a journal paper on 6 cat models [], while the preliminary result of 5 cat models had already been reported by Dr. Xiao [] far before the grant awarded.

The second grant awarded to Dr. Xiao (R01DK053063, $2,423,082 []) had been used to supported only a clinical trial with 2 patients and resulted in only one conference abstract [].

We note that in Dr. Xiao's 1998 abstract on his first 14 SCI patients [], it was indicated that NIH was one of the sources of funding. NIH has the responsibility to investigate how tax-payer's multi-million dollars were spent in these cases.

Our investigation also led us to several concerns about possible ethical violations:

1. Dr. Xiao' human trials started in China only one year after his rat results were published in a peer-reviewed journal and six months after the NIH grant (R01DK44877) was awarded for the canine model. Even worse, it was four years after human trials started did he publish cat results in a peer-reviewed journal (supported by R01DK44877). In his paper on cat, Dr. Xiao wrote that, if his technique "can be further perfected in larger animals, it may eventually be applied to patients", even though his preliminary human results were already reported two years ago. Also, no result on the canine model or higher taxonomic species have ever been published so far.

2. Doctors at Beaumont started their clinical trial on the sole basis of dubious data from Dr. Xiao, without due diligence. They also provided mileading information to patients and the public, claiming the procedure was "standard of care" and "done every day in hospitals in China." They have also exaggerated the number of patients of the NIH sponsored trial at New York University in their publication [] and news release [], while understating the risks of the procedure.[]

3. Doctors at Beaumont have consistently avoided to report their three patients with spinal cord injury, neither in their conference abstract nor journal paper, not even in their review article on bladder reinnervation of both spinal cord injury and spina bifida.

4. Shortly after Dr. Xiao's arrest for attacks, 34 international scientists, most of whom urologists involved in the clinical trials of the procedure, issued an open letter in support of Dr. Xiao. The letter showed no sympathy to the victims and did not bother to condemn the crimes. Instead, the authors trumpeted Xiao's achievements by citing the clinical trial results at Beaumont, while conveniently neglecting to mention the criticisms to that very results.

Based on the information presented above, we would like to raise questions about the current NIH grant awarded to Beaumont Hospital and its approval.

Specifically, it is clearly indicated in the project information [] that the grant application was based on the data from Dr. Xiao [], as well as on "very promising"[] one-year result of the pilot study. Of these, the former was unpublished and, more importantly, unverified while the latter has been pointed out to be "not at all similar"[] to Dr. Xiao's.

We urge the NIH, OHRP, ORI, related institutions, and the journals that publish Dr. Xiao's results, to investigate the misuse and the mis-approval of the research fundings, the breach of medical ethics of the clinical trials, the fabrication and falsification of research data in Dr. Xiao's publications, as well as the moral and academic misconducts of related parties.