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(Circulation. 1999;100:e108.)
© 1999 American Heart Association, Inc.

Circulation Electronic Pages

Myocardial Gene Transfer for Patients With Myocardial Ischemia

Ted J. Kaptchuk

Beth Israel Deaconess Medical Center Boston, Mass

	Introduction

 
To the Editor:

The report by Losordo et al¹ concerning myocardial gene transfer for patients with myocardial ischemia is promising. However, I believe their report merely demonstrates safety and does not provide substantial "evidence for a favorable clinical effect of direct myocardial injection of naked plasmid DNA encoding for VEGF [vascular endothelial growth factor]."¹ The clinical outcomes are equally compatible with placebo effects that result from surgical procedures.

Excitement often accompanies new cutting-edge scientific advances. This enthusiasm seems to be especially communicated through innovative surgical procedures.² Cardiovascular disease seems especially susceptible.³ The results reported in this phase 1 clinical study do not exceed outcomes reported from the 2 late-1950s randomized controlled trials comparing internal mammary artery ligation with sham operation.^{4 5} In these trials, subjective improvement was dramatic, especially in the sham procedure, and objective evidence, although more primitive by today’s standards, was substantial.

	References

 
1. Losordo DW, Vale PR, Symes JF, Dunnington CH, Esakof DD, Maysky M, Ashare AB, Lathi K, Isner JM. Gene therapy for myocardial angiogenesis: initial clinical results with direct myocardial injection of phVEGF₁₆₅ as sole therapy for myocardial ischemia. Circulation. 1998; 98:2800–2804.

2. Johns AG. Surgery as a placebo. Lancet. 1994;344:1140–1142.[Medline] [Order article via Infotrieve]

3. Bienenfeld L, Frishman W, Glasser SP. The placebo effect in cardiovascular disease. Am Heart J. 1996;132:1207–1221.[Medline] [Order article via Infotrieve]

4. Cobb LA, Thomas GI, Dillard DH, Merendino KA, Bruce RA. An evaluation of internal mammary artery ligation by a double-blind technique. N Engl J Med. 1959; 260:1115–1118.

5. Dimond EG, Kittle CF, Crockett JE. Comparison of internal mammary artery ligation and sham operation for angina pectoris. Am J Cardiol. 1960;5:483–486.[Medline] [Order article via Infotrieve]