Reporting adverse reactions

At a seminar on pharmaceutical drug discovery organised in Mumbai recently, a high profile foreign speaker mentioned that rapid advances in genetics and genomics would soon bring us to a stage where therapy would be individualized and that there would be no need for a doctor’s intervention because diagnosis too by then will be automated, accurate and specific. Hypothetically, it is envisaged that advances in the field of genomics will lead to better understanding of disease physiology leading to more targeted therapies. How far this hypothesis will get translated into reality is anybody’s guess at this point of time. Without being controversial, what the speaker intended to convey was the fact that biotechnology is moving from genetic engineering to discovery science and it may be possible to devise treatments ranging from rare diseases to highly complex polygeneic disorders. The representation of biotech drugs in the global drug discovery reservoir is far higher compared to conventional drugs. However, on the suspect side are the concerns over immunogenic side effects of biotech drugs. The recent controversy surrounding the “wonder” drug erythropoetin is a case in point. The drug is found to cause red cell aplasia in more than 140 patients across Europe, Australia and Canada. As more and more biotech drugs hit the market, the need for advanced adverse drug reaction surveillance systems will become extremely crucial for patient safety.

Coming back to the EPO controversy, there are a couple of suspected EPO-induced aplasia cases in Chennai and Kerala. In Chennai, the doctor treating the patient is not able to confirm this. There are no facilities in India that can conduct an antibody neutralising test, and since the patient is HCV positive, he is finding it hard to send the samples abroad for testing. In the absence of advance ADR reporting infrastructure, India will be at a unique disadvantage to realise the fruits of modern biotech innovations. In the absence of proper investigative mechanisms, the controversies surrounding adverse events in India may unreasonably damage the credibility of novel innovations. At present, whatever minimum ADR reporting takes place in India is restricted to consultative communications between the doctors and medical departments of pharmaceutical companies. Most doctors do not even know for fact that according to Indian laws, they are supposed to report ADRs to health authorities, particularly the Drug Controller General of India. Doctors should report all types of ADRs, even if a reaction is not severe and also if the reaction is already well known, even when severe. There is no culture of ADR reporting among the Indian medical community. This has to change. More so, because India is becoming an important hub for clinical trials, and, unless the practice of reporting ADRs is ingrained in the psyche of investigators, clinical trials will continue to be a controversial subject in India. The Indian Medical Association should take the lead and put pressure on the health ministry to activate and upgrade all ADR monitoring cells in the country and set up new centers wherever required. Also, it should suggest the regulators easy and effective ways to communicate identified reportable reactions to the concerned authorities. It is one project that is long overdue and absolutely crucial to the growth of Indian healthcare industry.

ananth_iyer@mailcity.com