Scientific issues are another matter. The science-based approach to diabetes follows several broad arcs that are dependent on developments in science and engineering:
1. Basic research has been responsible for the discovery of insulin, and the complex interplay of hormones and external signals that are involved in glucose, fat and related metabolism;
2. Development of specific medications for controlling glucose, blood pressure and lipids has contributed significantly to improved longevity and reduced morbidity for people with diabetes. Drug discovery is dependent on science and also on a bit of luck; and
3. Creation of devices such as pumps and monitors has grown along with developments in computing and materials science. Science tends to move at its own pace and is not linear.
Insulin was first injected into a patient with diabetes in 1922 but sulfonylurea based medications were not discovered until 1942. Metformin was first described in 1922. Two other biguanide medications were developed but with drawn from the market. Metformin was not approved until 1972.
Recently, one pharmaceutical company ended the development program for a new basal insulin based on insulin lispro instead of insulin glargine. Peglispro was unique in that it targeted impacted liver glucose metabolism and transport more than muscle glucose activity. This property, which could have proved valuable through reduction in hypoglycemic episodes, eventually proved the undoing of the drug because it led to increasing fat deposits in the liver.
This illustrates both the complexity of glucose metabolism, but also the difficulty in developing drugs with new mechanisms of action or new, and perhaps desirable, properties.
Over the past several years a handful of new drugs, many in the same class, have been approved for use in diabetes (see graph). The most recent additions have been in the SGLT-2 inhibitor class, which not only have a novel mechanism of action (glucose wasting in the kidney) but which are now proving useful in the treatment of diabetic patients with advanced heart disease.
Although the pipeline is not large, we continue to have progress in meeting needs of patients with diabetes. Over time, we can hope to see new drugs that are easier to use, have fewer side effects, and help to reduce complications over time.
In the meantime, screening, diagnosis, appropriate prescribing, and patient adherence to medication, diet and activity regimens will continue to help many patients with diabetes live a long and healthy life.
NME: New Molecular Entity Drug
Data source: CenterWatch.Com
Edmund Pezalla, MD, MPH, is vice president and national medical director for pharmaceutical policy and strategy, Aetna.