The launch of a new drug to combat severe sepsis, the dreaded medical emergency commonly referred to as blood poisoning, has raised hopes among intensive-care therapists in town.
According to a research submitted during the Indian Society of Critical Care Medicine (ISCCM) meeting in February last year, severe sepsis strikes 26,550 Indians every year, with an average mortality rate of 45 to 50 per cent, and Calcutta accounts for a high incidence of the condition. It is also the leading cause of death in non-coronary intensive care units.
“There is no diagnostic marker for severe sepsis and the signs are often nebulous. Till now, we had nothing but antibiotics and general supportive therapy to manage the condition. Now, there could be a 20-25 per cent reduction in mortality with the new drug (Xigris, launched by Eli Lilly),” says Pavan Agarwal, consultant in respiratory medicine and intensive care attached to CMRI, B.M. Birla Heart Research Centre and RTIICS.
The major stumbling block for Indian patients would be the prohibitive price tag. The drug costs over Rs 5 lakh, which includes 57 per cent duty, as Eli Lilly’s plea to categorise the drug as ‘life-saving’ was rejected. The company will apply again next year. “It is the most expensive drug till date in terms of research and out of 100 patients who need it, may be only one will be able to afford Xigris,” laments Agarwal.
Severe sepsis occurs when an infection (bacterial, viral, fungal or parasitic) as a result of trauma, surgery, burns or cancer, triggers immune-system responses that can lead to acute organ dysfunction, and often death, through renal, respiratory and cardio-vascular failure.
“While patients who are already in hospital for any disease are more likely to develop severe sepsis, completely healthy people can also develop infections which can progress to severe sepsis. Sometimes, the body’s in-built defence mechanism can also play havoc,” says Subrata Moitra, in charge of the intensive therapy unit, Woodlands.
In severe sepsis, the host response to infection is very aggressive, resulting in inflammation and coagulation. Xigris, a genetically engineered version of the human-activated protein C molecule, acts as an anti-inflammatory, anti-coagulative and pro-fibrinolytic (clot-dissolving) agent.
Available at all major hospitals now, the drug (a result of 20 years of research by Lilly), has been used on around 100 patients all over the country in the past eight months, with around 50 per cent survival rate. “It is not a wonder drug, but it does provide some hope in an otherwise desperate scenario,” says Moitra. Phase III clinical trials for the drug have shown it reduces risk of death from overwhelming septic infections by almost 20 per cent.
To commemorate saving 50 patients in the country suffering from severe sepsis, Lilly had organised the first Asia-Pacific Centre of Excellence on Critical Care Interventions in Delhi in July. The Surviving Sepsis campaign was declared open in India in conjunction with India Society of Critical Care Medicine (ISCCM) and American College of Chest Physicians (ACCP Forum).