On Monday, The Food and Drug Administration is examining at data from published studies to determine the risks with commonly used Gonadotrpoin, Releasing Hormone against drugs. It may be noted that six studies showed a small increased risk of diabetes or heart disease in patients treated with the drug when compared with the other prostrate cancer therapies. Richard Green berg MD, chief of urologic oncology at Fox Chase Cancer Center in Philadelphia, Pennsylvania said , “It's not a home run. The median improvement in survival was about 4 months, compared with placebo. That's not insignificant, but it's not a big change in the treatment of metastatic prostate cancer”.

It may be noted that due to the news coverage and for other reasons, patients may expectations might need to be dampened and some education provided, Dr. Greenberg added, “Patients may think that Provenge is like a vaccine for polio. It's not preventative or a cure — that must be communicated to patients. It's really not a vaccine. It's an immunotherapy. Another important point is that Provenge is only for men with metastatic disease who have progressed on hormonal therapy and, among those men, only those with asymptomatic or minimally symptomatic disease”.

FDA said that the studies included limited information about drug exposure, varying definitions for heart diseases, missing data on heart disease risk factors and other problems. Company Spokesperson Emmy Tsui, said, “Sanofi is evaluating cases of elevated insulin and blood clots "to determine whether labeling changes or other actions are required”. FDA also met the investigational therapy and the criteria for the designation because it demonstrated a potential survival benefit and an excellent safety profile in a randomized , placebo controlled phase 2 trail with 122 men , mentioned the company press statement.