Phase III Clinical Trials on Norplant-6 in India
NORPLANT-6 is currently undergoing Phase III clinical trial in India - probably a better record than that of Depo Provera which was licensed in the country without any trials whatsoever. But NORPLANT trials make a mockery of the whole process of clinical research. To begin with, the Indian Council of Medical Research (ICMR) wanted to licence NORPLANT-6 on the basis of trials conducted on NORPLANT-2. Country-wide protests by women's organisations and the active intervention of National Commission for Women forced the ICMR to carry out Phase III trials
Initially, the trials were planned on 1,000 women at ten research centres. The number of centres has gone on increasing without any logic. Rather than to offer it as a device being tested, the ICMR has adopted a protocol of offering it as a choice in the cafeteria. The purpose of these trials is to discover side effects of NORPLANT when used by a large number of women. According to this article the side effects are rampant, the cases point possibly to ovarian cysts, depression, weight gain, nerve damage at the site of implant, and of course menstrual chaos. But as usual, researchers refuse to acknowledge these as side effects. This in turn is based on their own ignorance, because the written protocol of the ICMR informs them that bleeding disturbances are the only problem associated with NORPLANT and this too is more of an inconvenience rather than a side effect. Callousness in follow up continues with doctors not keeping a record about women. In case of NORPLANT, follow up is crucial because the device must be removed at the end of its effective period. Recruitment of the so called volunteers again is violative of the written protocol because anaemic and obese women have been recruited and post abortion cases have also been included.
Women in Delhi who were recruited for this trial were told that they should not seek early removal, a unique method of ensuring a high continuation rate. Obviously, at the end of five years we are all going to see an excellent paper in some prestigious journal proclaiming that NORPLANT is highly acceptable to Indian women and is quite free from side effects.