Editorial Note

On p. 35 of Cynthia B. Cohen and Peter J. Cohen’s “International Stem Cell Tourism in Russia and India: Clinical Research, Innovative Treatment, or Unproven Hype?” (Kennedy Institute of Ethics Journal 20.1 [2010]: 27–29), a sentence incorrectly states that “it was also reported in 2005 that fetal stem cells had been transplanted into the eyes of more than 240 patients with retinitis pigmentosa in a study at the L.V. Prasad Eye Institute, a well-known private clinic in Hyderabad (Jayaraman 2005; Srinivasan 2006).” Sandhya Srinivasan and K. S. Jayaraman, from whom this information was derived, indicate that this research conducted at the L.V. Prasad Eye Institute in 2005 involved transplanting stem cells into more than 240 patients with damaged corneas, not patients with retinitis pigmentosa (Srinivasan, “Rogue Research in the Guise of Stem Cell Therapy,” Infochange Health, March 2005; Jayraman, “Indian Regulations Fail to Monitor Growing Stem Cell Use in Clinics,” Nature 434 [2005]: 259). All other information in the paragraph in which this sentence is found is derived from these sources and from Ganapati S. Mudur (Mudur, “Stem Cell March, Minus Checks—Lack of Research Rules Allows Doctors to Do as They Like,” Telegraph 16 November 2005).

Dr. Dorairajan Balasubramanian of the L. V. Prasad Eye Institute, who conducted the stem-cell transplant research, has contacted us with regard to this paragraph and indicated that the institute with which he is affiliated is “a not-for-profit, public-spirited eye care center recognized by WHO as a collaborating institution.” He states that the transplantation of stem cells obtained from the limbus surrounding the cornea to patients with damaged corneal surfaces “was tried by us first in 2001, with permission and funding from the Indian Government’s Department of Biotechnology, or DBT. We have continued to do so with DBT’s support.” He maintains that “only those experiments approved by the IRB are taken up. . . . In the 24 years of our existence, there has not been a single instance of our ever having been less than ethical. We welcome anyone to come and check our records.”

He goes on to state that in conducting studies on patients with retinitis pigmentosa, “we used retinal cell suspension from aborted fetal eye neural retina fragments (not fetal stem cells) on 14 patients,” adding that “the results are published” and referring us to Taraprasad Das, Manuel del Cerro, Subhadra Jalali, et al., “The Transplantation of Human Fetal Neuroretinal Cells in Advanced Retinitis Pigmentosa Patients: Results of a Long-Term Safety Study,” Experimental Neurology 157.1 (1999): 58–68. He points out that “we did not receive funding from anyone” and that their “work was cleared by the IRB” and that they also received “permission from the government of our state of Andhra Pradesh. We strictly followed the tenets of the Declaration of Helsinki, had prior informed consent from the people concerned. All these are clearly stated in our 1999 paper in Experimental Neurology. We did not apply for funding from the Indian Council for Medical Research (ICMR) and so there was no question of them denying it.”

Regarding his interview with Mudur (in “Stem Cell March, Minus Checks”), Balasubramanian indicates that “I lamented the fact that ‘guidelines are only guidelines. Any violations cannot be punished.’ This was the lament of a task force head and a lawful researcher, not the boast of a rogue practitioner! . . . I await the day these guidelines become legislated so that errants can be punished.”

The editors regret the error and thank Dr. Balasubramanian and colleagues for contacting us to set things straight.