Chennai: A Chennai-based diabetologist, Dr. B Mukesh of the Mercury Hospital at Egmore, has approached the Madras High Court seeking direction to the Indian Council of Medical Research (ICMR) for taking against a group of diabetologists for their involvement behind the blanket ban on the anti-diabetic drug, pioglitazone, by the Union health ministry some time back.
After one decade, the ministry had put a blanket ban on pioglitazone, and immediately revoked the same after 44 days.
Accepting the petition the court served notices to the opposite parties including ICMR. The Union ministry of health and family welfare, ICMR and one Dr. V. Mohan, chairman, Madras Diabetes Research Foundation, Chennai are the opposite parties in the petition filed by the petitioner.
Dr. Mukesh is the petitioner who has been acting as a whistleblower for the last ten years alleging that there was the involvement of a group of diabetologists behind the ban of the drug and they had supposedly influenced the government and the DCGI to take the decision for withdrawing the medicine from circulation.
Soon after the suspension of the drug pioglitazone, an oral anti-diabetic from the thiazolidinedione (TZD) drug class, Dr. Mukesh had approached the union health ministry and the ICMR stating that the government was misled and misdirected to impose the ban on the drug and the decision was taken without conducting much clinical research and lack of adequate empirical evidence. He also lodged complaints with the chief vigilance commissioner (CVC) and with the Department of Biotechnology (DBT) regarding the manner in which the government was deceived, misled and misdirected to impose a ban on the drug by individuals allegedly with vested interests.
The sworn affidavit he filed in the court says that it would be fair to direct the ICMR to conduct an enquiry about the involvement of “vested interests” in suspending the affordable and effective drug with established safety profiles. He argues that the primary aim of the diabetologists’ group was to pave the way for a ‘pharma benefit scam’.
He continues to say that the drugs initially introduced for treating type 2 diabetes such as ciglitazone, englitazone, troglitazone and rosiglitazone were completely withdrawn on account of the side effects they caused on the patients. But, pioglitazone was left out of that category and it became the armamentarium of the medical practitioners of diabetes management. In India the drug, pioglitazone, was approved as an anti-diabetic medicine on 17.10.2000 by the Drug Controller General of India (DCGI) in the form of an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. Further, at the time when the drug was introduced in the country, the health ministry had taken the opinion of an expert committee on the benefits and side-effects of the drug on the type 2 diabetes patients.
Based on the letters sent by the petitioner to the Union home secretary and also to the health ministry, the Drugs Regulation Section under the department of health and family welfare forwarded his complaint to ICMR and asked the research council to take necessary action on all issues raised in the complaint including the role and association of the group of diabetologists who had supposedly influenced the government in January 2013 for recommending to ban pioglitazone and its formulations in India.
Dr. Mukesh argues that ICMR, the apex medical research body in the country, ought to have initiated appropriate proceedings against the alleged vested interest group involved in lobbying for banning the drug. According to him, the research council is lethargic in its attitude and so far not taken any action on his complaints although the union health ministry had wanted them to take necessary action.
The affidavit says that the ban was imposed without conducting much clinical research, without much empirical evidence and without seeking expert advice from practitioners and also from industry. So, an impartial investigation is necessary by an independent body to ascertain the role of any vested interested group of diabetologists in the suspension of the drug and whether any conspiracy was played to promote their vested interests.
The petitioner says that he came across certain articles published by Dr. V Mohan in some journals in the year 2012, in which he had stated that there was a need for robust data to analyze the risk of bladder cancer arising out of the usage of pioglitazone drug. But, even without obtaining such robust data he was seen to have sent a representation to the DCGI calling for a ban on the use of the drug and its FDCs. When this incongruity between the articles and his request to the DCGI was brought to his attention, his response was that ‘he might be erred in his judgment’, says the affidavit.
The petitioner further points out in his affidavit that Dr. Mohan along with one professor Dr. Rakesh Kumar Sahay of the Osmania Hospital in Hyderabad had made a statement that they had recorded several cases of bladder cancer in patients who were consuming the drug, pioglitazone. But, according to Dr. Mukesh, neither Dr. Mohan nor Dr. Rakesh Kumar Sahay could produce the proof of evidence of the cases despite repeated queries.
Pointing to the laxity on the part of the ICMR, the petitioner argues that the indifferent attitude of the council in initiating appropriate action is clearly discriminatory, illegal and dereliction of duty which is fully complied with ethics and specific code of conduct prescribed for medical professionals.
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