When medical historians look back on the last 70 years of medicine, they will refer to it as the Dark Ages of drug therapy. There are numerous examples: non-steroidal anti-inflammatory drugs in the treatment of osteoarthritis, sedative hypnotic drugs for insomnia, and perhaps the most glaring example of all, the use of oral hypoglycemic drugs in the treatment of the major epidemic of our time – type 2 diabetes. The statistics on the growing epidemic of type 2 diabetes are staggering as it is now estimated that one-half of all Americans adults will develop the disease by 2020. What is even more alarming is the failure of the medical system to adopt natural treatments that focus on curbing this epidemic and instead utilize drug therapies that may cause more harm than benefit.
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Background Information
In 1970, the Dark Ages of type 2 diabetes was officially ushered in with the published results from UGDP (University Group Diabetes Project) study. In this study, the group receiving the drug tolbutamide showed a 250% increase in mortality due to heart disease compared with the group on diet therapy alone. The death of tolbutamide was met with something very interesting – the drug industry simply stopped comparing deaths due to cardiovascular outcomes for forty years and the FDA adopted a policy that new diabetes drugs only needed to show that they lower blood glucose levels.
In essence, the drug companies and the FDA did not feel the effect of these drugs on the critical outcome of actually extending a patient’s life was important. Eventually, the “see no evil” approach was exposed when the drug Avandia (rosiglitazone) was shown to increase the risk of a fatal heart attack by 64% and was attributed to causing nearly 100,000 heart attacks since it was launched. The problem with Avandia is just the tip of the iceberg.
Steven Nessen, M.D., and his colleagues of the Cleveland Clinic have played a major role in guarding against the unbridled focus on fasting glucose, hemoglobin A1c levels, and blood lipid levels with type 2 diabetes medication. It was Dr. Nessen’s group that blew the whistle on Avandia by reanalyzing documents filed by the drug’s maker to the FDA to look for the effect of the drug on heart attack risk. Their 2007 follow up analysis based on study-level data that became available after a court settlement required the drug maker to disclose all clinical trial results further uncovered the link.
By 2010, Avandia was removed from the European market and severely restricted in its use in the U.S. In 2012, GlaxoSmithKline, Avandia’s maker, paid a record $3 billion fine for civil and criminal penalties for concealing safety data for rosiglitazone.
New Data
The most popular drug treatment for type 2 diabetes is metformin (Glucophage) – classified as a biguanide, an older diabetes medication based upon compounds from the plant goat’s rue (Galega officinalis). Despite its popularity, there has never been a double-blind study to show that it does not cause the same issue with increased risk of cardiovascular death as tolbutamide or Avandia, but there is some circumstantial evidence that it is much safer.
In a very detailed comprehensive analysis of medical records 250,000 veterans receiving care in Veterans Health Administration hospitals throughout the United States, metformin was shown to be safer than glyburide and glipizide – two popular drugs in the same class as tolbutamide. For every 1,000 patients being treated with metformin there were two fewer heart attacks than those taking the other drugs. These results are encouraging given the tremendous popularity of metformin and further calls into question the use of sulfonylurea drugs like glyburide and glipizide. But, the key question has yet to be answered – “Does metformin reduce death rates for heart disease in type 2 diabetes compared to diet therapy?”
Reference
Roumie CL, Hung AM, Greevy RA, et al. Comparative effectiveness of sulfonylurea and metformin monotherapy on cardiovascular events in type 2 diabetes mellitus: a cohort study. Ann Intern Med. 2012 Nov 6;157(9):601-10.
See also
Nissen SE. Cardiovascular effects of diabetes drugs: Emerging from the Dark Ages. Ann Intern Med. 6 November 2012;157(9):671-672
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