Correspondence

Pulmonic Stenosis in Adolescents and Adults

N Engl J Med 1996; 335:1688-1689November 28, 1996

Article

To the Editor:

Chen et al. (July 4 issue)1 report excellent results with the use of the Inoue balloon catheter in treating congenital pulmonic stenosis in adolescents and adults. Missing from the article, however, is any mention that the authors obtained informed consent from the patients or approval by an institutional review board. This omission is striking, because at least some of the patients were children (age range, 13 to 55 years). An earlier report by the same authors 2 also does not refer to informed consent or approval by an institutional review board.

Several years ago, the Journal published a report on another clinical study 3 performed in China in which no mention was made of this information. The omission prompted an exchange of letters 4 in which the authors stated that they had in fact obtained informed consent and approval by an institutional review board but had deleted this information from the paper to save space. An editorial 5 in the same issue reaffirmed the importance of voluntary consent as outlined in the Nuremberg Code and the Declaration of Helsinki.

Did Chen et al. obtain informed consent from their patients, and did an institutional review board at the Guangdong Cardiovascular Institute approve the study? I would propose that such information not be deleted from clinical papers, for any reason.

Steven L. Bernstein, M.D.
St. Luke's–Roosevelt Hospital Center, New York, NY 10019

5 References

1
Chen C-R, Cheng TO, Huang T, et al. Percutaneous balloon valvuloplasty for pulmonic stenosis in adolescents and adults. N Engl J Med 1996;335:21-25
Full Text | Web of Science | Medline

2
Chen C-R, Cheng TO. Percutaneous balloon mitral valvuloplasty by the Inoue technique: a multicenter study of 4832 patients in China. Am Heart J 1995;129:1197-1203
CrossRef | Web of Science | Medline

3
Prout GR Jr, Lin C-W, Benson R Jr, et al. Photodynamic therapywith hematoporphyrin derivative in the treatment of superficial transitional-cell carcinoma of the bladder. N Engl J Med 1987;317:1251-1255
Full Text | Web of Science | Medline

4
Glass AT. Photodynamic therapy for bladder cancer: ethics of a collaborative trial in China. N Engl J Med 1988;319:1096-1097
Full Text | Web of Science | Medline

5
Angell M. Ethical imperialism? Ethics in international collaborative clinical research. N Engl J Med 1988;319:1081-1083
Full Text | Web of Science | Medline

Author/Editor Response

The authors reply:

To the Editor: We are very surprised that Dr. Bernstein has criticized our article in the Journal, 1 as well as our previous article in another journal,2 for not mentioning informed consent or approval by an institutional review board.

China observes the Nuremberg Code and the Declaration of Helsinki, as outlined in the editorial by Angell 3 cited by Dr. Bernstein. The principle of primum non nocere — “first, do no harm” — is universal.

What Dr. Bernstein failed to recognize is the big difference between the use of photodynamic therapy for bladder cancer, as carried out in China,4 which he cites, and the use of percutaneous balloon valvuloplasty for pulmonic stenosis1 and mitral stenosis,2 which we described. The former is an experimental procedure, as was clearly stated in the article,4 whereas the latter is not. Balloon valvuloplasty is an established procedure and the treatment of choice for pulmonic stenosis and mitral stenosis, as McCrindle and Kan5 and Kirklin6 note, respectively.

We wish to assure Dr. Bernstein that we obtain informed consent from every patient entering our cardiac-catheterization laboratory in China, as is done in the United States.

Tsung O. Cheng, M.D.
George Washington University, Washington, DC 20037

Chuan-rong Chen, M.D.
Shuguang Lin, M.D.
Guangdong Cardiovascular Institute, Guangzhou, China

6 References

1
Chen C-R, Cheng TO, Huang T, et al. Percutaneous balloon valvuloplasty for pulmonic stenosis in adolescents and adults. N Engl J Med 1996;335:21-25
Full Text | Web of Science | Medline

2
Chen C-R, Cheng TO. Percutaneous balloon mitral valvuloplasty by the Inoue technique: a multicenter study of 4832 patients in China. Am Heart J 1995;129:1197-1203
CrossRef | Web of Science | Medline

3
Angell M. Ethical imperialism? Ethics in international collaborative clinical research. N Engl J Med 1988;319:1081-1083
Full Text | Web of Science | Medline

4
Prout GR Jr, Lin C-W, Benson R Jr, et al. Photodynamic therapy with hematoporphyrin derivative in the treatment of superficial transitional-cell carcinoma of the bladder. N Engl J Med 1987;317:1251-1255
Full Text | Web of Science | Medline