The “Sick Care” System Strikes Again with Ivokana and Type 2 Diabetes

Let’s get one thing straight – the U.S. has a “health care” system, but it’s sick. There is no money to be made in developing cures. After all, if diseases are cured, how will Big Pharma continue to profit? It is why the pharmaceutical industry continually manufactures and markets “treatments.” In many cases, Big Pharma even creates non-existent conditions and hawks them like the snake oil salesmen of 19th-Century traveling “Medicine Shows” to a gullible, frightened and uninformed public. Ad campaigns even target those who are attempting to take responsibility for their own health. How many ads have you heard warning that “diet and exercise may not be enough!” This, despite the fact that an overwhelming number of diseases are preventable and curable simply by adopting a healthier lifestyle.

Case in point – Type 2, or “adult onset” diabetes. This is a completely different disease from Type 1, or “childhood onset.” In fact, beyond exhibiting similar symptoms, they have little in common. Type 1 diabetics do not produce insulin; the pancreas has lost its functionality. It is a genetic condition that at present has no cure (and is unlikely to have one, given the profitability of insulin sales).

With Type 2 diabetics, the pancreas functions and does produce insulin. However, in large part because of diets loaded with sugar and high-fructose corn syrup and lack of exercise, the cells in these patients’ bodies have been overloaded and no longer respond to insulin. This illness affects almost 12 percent of the population, with another thirty percent at risk for developing it. And that’s just in the U.S.

That means big bucks for Big Pharma. It’s not exactly motivation to find a cure, but the major players in the pharmaceutical industry are chomping at the proverbial bit to get the biggest share of that pie they can. And if a few people get hurt and lawsuits have to be paid – well, that’s just the cost of doing business.

There has been a veritable parade of drugs over the past two decades designed to treat Type 2 diabetes that have wound up causing serious injuries and even death. Avandia was trotted out in 1999. It targeted cellular receptors in order to get them to respond to insulin. By 2006, it was making Glaxo-Smith Kline $2.5 billion a year. The following year, a study in the New England Journal of Medicine linked Avandia to heart attacks. Despite this, it remains available in the U.S., albeit with a black box warning – and is prescribed only after other treatments have failed.

Actos, a product of Japanese drugmaker Takeda, was the tenth biggest selling prescription in the U.S. by 2008, when sales topped $2.8 billion. Like rival Avandia, it worked on those cell receptors in order to “wake them up.” Although it wasn’t linked with heart attacks, it was shown to increase the risk of bladder cancer. Because of this, it was banned in a number of countries – but again, remains on pharmacy shelves in the U.S.

Januvia, a product of global pharmaceutical giant Merck & Company, took a different approach. Instead of working on cellular receptors, it prevented the action of a certain enzyme involved in how the body produces and utilizes glucose. Revenues from Januvia grossed the company $4 billion a year (and that was less than a tenth of Merck’s total revenue that year). Unfortunately, that particular enzyme also helps in the formation of cancerous tumors, as was discovered when some patients started developing cancer of the pancreas.

The latest entry goes by the name of “Invokana.” Unlike earlier drugs, Invokana bypasses the cells altogether and operates on a form of protein, known as SLGT2. Normally, the kidneys reabsorb blood glucose with the help of this protein. Invokana prevents this process, allowing the patient to get rid of excess glucose through urination. However, in doing this, it causes a dangerous rise in blood acidity in some patients. This condition, known as diabetic ketoacidosis, is ironically, one of the conditions that Invokana was supposed to prevent.

This news no doubt comes as a wrenching disappointment to the investors who were hoping to make a killing on Janssen Pharmaceutica and Johnson & Johnson stocks as a result. One appalling – but not surprising – aspect to this story is that last year, a similar drug of the same class, known as Forxiga, was rejected by the FDA. The reason: links to liver damage and bladder cancer. Yet the FDA approved Invokana.

It is true that Invokana was subjected to fourteen long-term studies, the last five of which focused on harmful side-effects on the heart, liver and pancreas in addition to possible cancer links. But somehow, adverse events involving the kidney were overlooked. It’s hard to imagine that when a drug is subjected to that many clinical trials, involving well over 10,000 subjects, that something so potentially serious went unnoticed.

Ned McWilliams, who is handling Invokana lawsuits for the law firm of Levin Papantonio, points out that when lawsuits are filed and such cases go to trial, it comes out that defendants were aware – or should have known – of such dangers, yet chose not to reveal this information. “Considering the huge profits at stake, it seems likely,” Mr. McWilliams says. He adds, “Corporations such as drugmaker Mitsubishi Tanabe and their marketing partners at Janssen and J&J have a tendency to weigh these profits against possible expenses that include paying out judgments in lawsuits. If the former outweighs the latter, it’s simply considered the cost of doing business.”

After all, what’s a paltry few hundred million in settlements against sales of almost half a trillion dollars?

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There are many more diabetic drugs in the pipeline given the track record of Big Pharma I expect we will see more reports of adverse effects in the near future.

Graham