The diabetes “wonder drug,” Invokana (canagliflozin), has been demonstrated to cause a dangerous rise in blood acid levels (known as ketoacidosis) as well as serious loss of bone density (osteoporosis) – both of which manufacturer Janssen Pharmaceuticals and its parent company, Johnson & Johnson, allegedly had full knowledge.
These companies have also gotten in trouble with the FDA over advertising Invokana for “off-label” purposes , including weight loss and hypertension, through the use of “added value” marketing. Despite impending litigation and the possibility of having to pay out multi-million dollar judgments, however, J&J and Janssen are moving forward with plans to expand the market for Invokana even more – as a treatment for heart problems.
What is incredible about this move is that concerns about the risk of blood clotting have been expressed early on by Dr. Sidney Wolfe, who headed up the Research Group at Public Citizen at the time. According to Dr. Wolfe, who has dedicated his medical career to informing the public of the dangers of defective and harmful prescription drugs, patients taking Invokana are 50% more likely to suffer an adverse cardiac event (i.e., a heart attack or embolism) than those taking other gliflozin drugs, such as Farxiga.
Another physician, Dr. Hyon Kwon of the FDA, reported that in a study of the cardiovascular effects of Invokana, patients being treated with the drug for 30 days or less had a 690% greater risk of an adverse cardiovascular event than those who were treated with a placebo.
Despite this, J&J and Janssen are preparing to release the results from that research study, known as CANVAS (“CANagliflozin cardioVascular Assessment Study”) that began in 2009. The study, testing the effectiveness of canagliflozin in preventing heart attacks, involved 4,300 patients. If those results somehow demonstrate that Invokana can help to prevent heart attacks, it could mean more market opportunities for J&J.
Despite the reported dangers of Invokana, it continues to enjoy robust sales. According to data posted by Motley Fool, Invokana sales in 2015 alone totaled $1.3 billion. For just the first quarter of last year (2016), worldwide sales of Invokana totaled $325 million – an increase of nearly 12% over the same period a year earlier. At the same time, litigation costs for Q1 came to a mere $56 million, according to J&J’s quarterly statement. That hardly makes a dent in their net income for the period – which was over $5.8 billion.
Therein lies the problem. When drug companies such as J&J are held accountable for products that harm the public, the amount they wind up paying out in judgments, fines and settlements never amount to more than pocket change. To add insult to injury, these companies are able to write these legal expenses off as part of the cost of doing business – meaning that ultimately, the taxpayers pick up the tab.
Until the system that enables this dysfunctional corporate behavior is fixed and offenders such as J&J are punished in a meaningful way, we can expect more of the same – as well as drug manufacturers for whom eight-figure profits are not enough and continue to seek new markets for dangerous products.