Recently, Levin Papantonio posted an article on early concerns expressed over the latest SGLT2 inhibitor, Invokana. Among those concerns, presented at a meeting of the FDA Endocrinologic and Metabolic Drugs Advisory Committee (EMDA) in January 2013, was a question of whether or not Invokana was even effective. The question was raised by Dr. Sidney Wolfe, who heads up advocacy organization Public Citizen's Health Research Group.
As it turns out, Dr. Wolfe was not the first, nor the only medical expert to note such a concern. More than four months earlier, an article appeared in the professional journal Diabetes. The title: “Why Do SGLT2 Inhibitors Inhibit Only 30–50% of Renal Glucose Reabsorption in Humans?”
At the time, SGLT 2 inhibition was still being studied. It seemed promising; instead of operating on insulin cell receptors (glitazones such as Actos and Avandia) or slowing the production glucose (sitagliptin, sold as Januvia), SGLT2 inhibitors simply prevented the kidneys from reabsorbing glucose, allowing the excess to be excreted in the urine.
SGLT2 – short for “sodium glucose co-transporter 2” – is part of family of “membrane proteins” involved in the transport of glucose, the body's essential fuel. It assists in the reabsorption of glucose filtered in the kidneys and putting it back to work. In a healthy (non-diabetic) patient, SGLT2 is responsible for about 90% of the glucose reabsorbed in the kidneys. When the action of this protein is “inhibited,” glucose is not reabsorbed; instead it is passed in the patient's urine. The effect is to lower patient's glucose (blood sugar) levels.
All other harmful and potentially fatal side effects aside, the researchers posed this question: if SGLT2 handles 90% of renal glucose reabsorption, how come SGLT2 inhibitors only pass 30-50% in the urine? The conclusions raised even more questions.
Almost three months after Dr. Wolfe presented his concerns to the FDA, a diabetic blogger and author published a post with information demonstrating that Invokana (at approximately $235 a month) was no more effective than the inexpensive and relatively harmless old standby, metformin (based on prescribing information on the label). In December 2012, Consumer Reports released its own guidelines on the six classes of diabetic drugs. In its recommendations on page 3 of the publication, it is noted that the new drugs are no better and no safer than metformin or sulfonylurea drugs, both of which have been available for decades.
What this indicates is that at best Invokana doesn't have an appreciable positive effect on patient health at all. At worst, however, it can result in severe injury and even death.
For more information on the Invokana litigation, visit Levin Papantonio's Invokana Lawsuit web page.