LAHORE
Bureaucratic red-tapism motivated by “vested interests” is creating hindrances in the clinical trial of locally manufactured interferon – a cure for deadly hepatitis – causing losses of millions of rupees to the national exchequer and depriving the poor of cheap treatment, Pakistan Today learnt on Thursday.
A group of researchers working at the Centre of Excellence in Molecular Biology (CEMB), Centre of Applied Molecular Biology and the Allama Iqbal Medical College (AIMC) undertook the research to manufacture interferon to reduce the cost of expensive treatment for the disease.
Both the Ministry of Education and the Ministry of Science and Technology approved the project, while the Higher Education Commission (HEC) released the requisite funds for the research, nearly Rs 20 million.
The domestically-developed interferon was tested in a German laboratory for safety and was found safe in experiments on mice and rabbits, at par with the interferon approved by the World Health Organisation (WHO).
Moreover, the locally-produced interferon injections are low-cost, with one of these costing between Rs 70 to Rs 100 compared with Rs 250 to Rs 900 for an imported injection.
In 2008, the Ministry of Health – the competent authority to permit the import and manufacture of any medicine – allowed the manufacturing of 0.1 million local injections, only for clinical trial on humans.
However, despite a lapse of over two years, the Health Ministry has not given a formal approval to conduct the drug’s trial on humans to determine its efficacy and its eventual production on a commercial scale. Sources told Pakistan Today that the proposal was currently pending with the Ministry of Health and the Pakistan Medical Research Council (PMRC).
The head of the research team, Dr Riazuddin, told Pakistan Today that if the delay persisted, 0.1 million interferon injections manufactured two years ago would expire in six months, resulting in the wastage of research efforts and material resources.
“Thousands of poor patients will be left with no choice but to seek expensive treatment,” he added. A hepatitis patient has to take three injections per week and the treatment continues for between six to 18 months, depending on the intensity of the virus.
The diagnosis and follow up costs more than Rs 50,000 per patient on average, and the treatment costs nearly Rs 0.15 million per patient. The situation in more worrying considering Hepatitis B and C is the most common cause of liver diseases in Pakistan. Local and international agencies involved in healthcare place the prevalence of Hepatitis B amongst the Pakistani population to be as high as 10 percent, while that of Hepatitis C is feared to be higher.
In 2005, the previous government initiated a five-year programme at a cost of Rs 2 billion to eliminate Hepatitis from Pakistan. The import bill for interferon was Rs 1.1 billion in 2005, Rs 1.4 billion in 2006, Rs 1.87 billion in 2007, Rs 2.3 billion in 2008 and crossed Rs 3 billion in 2009. Despite the massive funding, the fact remains that only five percent hepatitis patients get properly diagnosed and treated, while 90 percent die an untimely and accelerated death without getting any curative treatment at all.
AIMC Principal Professor Javaid Akram said the research was a result of many years of hard work and the world class research had been accredited by many scientific forums, but failed to achieve the desired objective of making the life-saving drug affordable for the masses.
“This has certainly discouraged me and my able researchers. The research remains confined to laboratories and the applicability of such hard work remains a dream. More than 55 brands of the bio-similar molecule – alpha interferon – are being imported. To the best of my knowledge, no registration authority in Pakistan has asked for such documentation from importers, as is being demanded from our group for over the last two years,” Akram said.
Federal Health Secretary Khushnud Lashari, however, said the “CEMB invented the drug and the Health Ministry not only approved it for clinical trials almost six months ago, but was also funding the trials. But there are certain ethical guidelines formulated to ensure that the drug has no harmful effects on humans and the whole process takes almost a year-and-a-half”.
He said the imported drug “is initially used in the country of manufacture for two years and its harmful effects come to surface during the time”. “I will take notice if some section in the ministry is creating hindrances in the procedure to serve vested interests,” Lashari added.
