Bangalore: As the cost of diabetes drugs rises and more expensive new ones arrive in the market, they do not necessarily translate into improved care and better outcomes, says a new study in this week’s issue of the Journal of the American Medical Association.
“Just because a drug is new or exploits a new mechanism does not mean that it adds clinically to treating particular diseases,” says Randall Stafford, co-author of the study and professor of medicine at the Stanford Prevention Research Center, California.
The study, based on data from an ongoing survey in the US, found the cost of diabetes treatment doubling between 2001 and 2007, also the case in India, where a study found that after accounting for inflation, the direct cost of diabetes treatment in urban India rose 113% between 1998 and 2005.
“This is absolutely true, we are running haywire with diabetes medication,” says S.M. Sadikot, a consultant in endocrinology at Jaslok Hospital and Research Centre in Mumbai. Even though clinical trials of new drugs are conducted in India, no long-term studies on the Indian population are done to assess the efficacy of those drugs, he says. A test on the diabetes drug rosiglitazone (brand: Avandia) “showed it had least efficacy in the Indian population,” says Sadikot.
Experts say this is because US Food and Drugs Administration approval does not require that a drug be compared against alternative treatments; it only has to be safe to use and better than a placebo. “Nor does a company have to demonstrate that a drug’s effectiveness justifies its price,” says co-author G. Caleb Alexander of the University of Chicago.
But practitioners offer several reasons for increasing costs of diabetes treatment. “The goals of control of blood sugar are stricter now than a decade ago, which often requires more than a single medication, sometimes two or three,” says Anoop Misra, director of the department of diabetes and metabolic diseases at Fortis Healthcare Rajan Dhall Hospital in New Delhi.
Moreover, newer drugs such as sitagliptin (brand: Januvia) or exenatide (brand: Byetta) may also have unique effects such as regeneration of insulin producing cells in the pancreas, says Misra.
Since Januvia costs about Rs1,260 and Byetta Rs7,000 for a month’s dose in India, physicians need to be more selective in prescribing them, says Sadikot. “Some of these newer drugs are better, no doubt, but if they are so tremendously superior, why doesn’t the government bring them under price control and let even the poor benefit?”
But the issue is more than just price control. One needs to undertake studies to correlate the short-term outcomes — such as improved average blood sugar over three months — to long-term outcomes, such as diabetes’ impact on heart and kidney functioning. It’s like correlating cholesterol with heart attacks. According to Alexander, no one would care about cholesterol levels if it hadn’t been proven to be a predictor of later heart attacks.
Sadikot says large, multi-centric trials of these drugs should be conducted in India. “Cheap drugs like metformin (for type 2 diabetes) have worked for years; if newer drugs have to come in, I need to see solid data,” he says.