Wednesday, December 21, 2016

Concern over “unethical practices” by US drug maker Abbott in India

BMJ: A US drug maker encouraged Indian doctors to prescribe a drug unproven for diabetic neuropathy (nerve damage) that until recently lacked central government approval, finds a special report in The BMJ today. Frederik Joelving, a journalist based in Denmark, reports how US drug company Abbott Laboratories advertised free neuropathy tests outside doctors’ offices throughout India for anyone with symptoms of neuropathy, such as tingling or numbness in the feet. He also describes how people who tested positive at the drug maker’s “neuropathy camps” (free events across India where people are tested for the disorder) were prescribed Abbott India’s Surbex Star, a mix of antioxidants, minerals, and B vitamins that the company promotes for the treatment of diabetic neuropathy.

But The BMJ was unable to find any evidence that this product had been clinically tested, much less proved effective for this indication.
At more than 17 Indian rupees a capsule (£0.21,€0.23; $0.26), Surbex Star can be a substantial expense for many people in India, explains Anurag Bhargava, a professor of medicine at Yenepoya Medical College in Mangalore. He worries that poorer patients may skip essential drugs like metformin to be able to fill a prescription for this unproved product. Yet Abbott has repeatedly denied any link between its health camps and sales. Like many of the drug cocktails for sale in India, Surbex Star was put on the market without the approval of the Drugs Controller General of India (DCGI), writes Joelving. In August 2016 - more than a year after the documented neuropathy camps took place - the DCGI approved Surbex Star as a prescription drug, according to a certificate seen by The BMJ. But the neuropathy camps were not the only means by which Abbott India sought to win new customers, adds Joelving. To help promote the drug after it was launched in 2013, the company offered doctors 5000 rupees (£61; €69; $75) for completing a market research survey, according to a contract seen by The BMJ. But Vivek Gupta, a former Abbott sales manager who was involved in collecting the completed questionnaires, called the survey a bribe in disguise. “It was a marketing tool to get prescriptions from doctors,” he told The BMJ. According to the booklet, seen by The BMJ, the survey aimed to determine “the number of patients seen, the duration of therapy of Surbex Star, and the overall opinion about use of Surbex Star in the management of neurological disorders.” But Christopher Gibbons, head of the neuropathy clinic at the Joslin Diabetes Center in Boston said: “This is pure and outright pandering and manipulation through payment.” Professor Bhargava added that the booklet promoted “irrational practice” by referring to neuropathy as if it were a single entity needing the same treatment regardless of aetiology - “like talking about an antibiotic for ‘fever.’”