My doctor hero

Dr Cecil Ross

The ICMR Ethical Guidelines for Biomedical Research on Human Participants refers to Helsinki Declaration of 2000 and recommends that whenever possible the ethics committee should consider a post trial access arrangement in the a priori agreement. Only recently, Indian regulators have started asking companies to give an undertaking to ensure post-trial access, free of cost for subjects who benefit clinically.

But there are opinions on both sides of the debate. Most investigators are in favour of post trial access because they would like their patients to continue to benefit from the investigational drug if their health parameters have improved during the trial.

However, sponsors are wary of giving access immediately on trial completion because there is approximately a time gap of a year between completion of the trial and the availability of trial results and sponsors would not like to give access to what is in essence still an unproven compound.

It also presents an ethical dilemma because considering the socio-economic realities of India, post trial access could be construed as undue incentive/exploitation of clinical trial participants. Globally, the debate on post trial access ranges from the medico-legal (morality, legality) to more prosaic aspects (feasibility and practicality.)

Dr Cecil Ross, Professor of Medicine and Hematology at St Johns Medical College Hospital Bangalore was faced with this choice, when he recruited some of his patients to a global multi centre study to study a new injection meant for haemophilia patients.

Haemophilia patients suffer from a genetic defect, due to which their blood does not clot. Hence they bleed spontaneously. This condition has no cure, and their only recourse is regular replacement of clotting factor concentrates. This injection gives them relief for eight hours only and costs Rs 10,000. Thus these patients end up spending upto Rs 2.5 lakh every year on injections to keep their bleeding under check.

The new injection on trial was a major boon for patients as it needed a once-a-week dosage, and thus improved quality of life to a large extent. If this medication works, haemophilic patients across the world will benefit immensely, given that the age of these patients range from toddlers to 25 years. Children will get a chance to have as normal a life as possible, while young adults can access a world of opportunities.

If found efficacious and safe, post the clinical trial and in order for the haemophilia patient to continue receiving treatment, the investigators negotiated with the sponsoring company that the patients would continue to get the same medication in the post trial stage, till such a time as the drug is officially approved and marketed in India.

They did this to ensure that the company would then consider seriously marketing the drug in India, at reasonable rates after the approvals are done. And also the patient would continue to get access to the superior quality medication, so that he is not left high and dry after the trial.