Clinical trials: in the crossfire

Dr Gulhati has lamented about the unscrupulous methods adopted while conducting clinical trials and has called for strengthening regulatory authorities. While we appreciate the spirit of the article, we are sorry to note that Shantha Biotechnics has unnecessarily been mentioned in the opening paragraph. Now it is public knowledge that a tussle between two government agencies has dragged us into the controversy. Several articles are still appearing in Bio Spectrum, Business World, etc. questioning the GEAC’s stand in this case. How can a committee, formed to monitor environmental issues supervise and evaluate clinical trials?

We have not passed on the buck as alleged in the article. As per the new guidelines, the DCGI alone is competent to clear clinical trials and we have approached them. If GEAC has not updated its records, we cannot help the situation. Further, the GEAC has relied too much upon a Bangalore-based NGO’s false allegations such as trials being shifted to Bangalore in view of deaths, the volunteers not being insured, etc. Since the NGO inflated the number of deaths from two to eight and tried to blackmail us, we have filed a suit against them. It is unfortunate that Dr Gulhati did not crosscheck with us before writing the article.

Does Dr Gulhati sincerely believe that there would not have been any deaths during clinical trials had we obtained clearance from the GEAC? In any trial, volunteers are chosen at different stages of the disease to test the efficacy and safety of the drug. It is but natural for some of them to succumb during the trial. In the case of r-streptokinase comparative double-blind trials, out of 96 patients administered Shankinase (our r-streptokinase) three died (mortality rate 3.1%) and out of the 54 administered Streptase (comparative drug) another three died (mortality rate 5.5%). The Indian Heart Journal, in its latest issue states that the normal range is 8% – 12.5%. The DCGI informed GEAC that the accepted range is 6% (Economic Times; March 12, 2003).

Shantha Biotechnics values life highly and carries the logo ‘Inspired by life’. Our motto is to make world-class health care products at an affordable cost to improve the quality of life. Shankinase is our third product. Both our earlier products won prestigious DSIR and National Technology Awards individually. Anyone can look at our track record to see how we suffered while conducting interferon alpha trials on monkeys. We agree with Dr Gulhati that clinical trials have to be monitored closely to see that unethical practices are not allowed. But tagging our name along with violators is most painful and regrettable. We are ready to share further information with the author.