In 2015, Johnson & Johnson’s revenue fell by nearly 6%. However, sales of Invokana (canagliflozin) increased by over 120%, generating $1.3 billion for the New Jersey-based pharmaceutical giant. Apparently, that hasn’t been enough for J&J. In its unending quest to increase revenues and profits and keeping shareholders happy, J&J has been seeking opportunities to market Invokana for off-label purposes.
For those who aren’t familiar with the term “off-label,” it simply means prescribing a medication to treat a condition for which it was not designed. It is something that a qualified physician is allowed to do if, in his or her professional opinion, the benefits to the patient outweigh the risks. However, under FDA regulations, pharmaceutical companies may not market any product for off-label use without prior approval – which is granted only after the completion of clinical trials.
Last year, J&J got in trouble for allegedly promoting Invokana for off-label use without FDA approval. One advertisement claimed that one of the “secondary” benefits of Invokana was “greater reductions in body weight.” That could wind up being yet another factor in determining the company’s liability in lawsuits going forward. In the meantime, results of a “proof-of-concept” clinical trial was presented this past summer at the 76th Annual Scientific Sessions of the American Diabetes Association, demonstrating that Invokana could be effective as a weight loss medication for non-diabetics.
Although the clinical trial showed promise when it comes to treating obesity (a growing problem representing a huge market for J&J), there are a couple of reasons to question it. First of all, the weight loss benefit occurred when Invokana was administered in combination with a second drug, known as phentermine – which is a prescription appetite suppressant originally approved by the FDA in 1959. Secondly, the clinical trial was conducted by Janssen – the J&J subsidiary that actually manufactures Invokana.
Dr. James List, who works at Janssen Research & Development, was pleased at the findings, which he said “…support the potential clinical impact that canagliflozin could have on the lives of people constantly having to manage their weight.” He added, “We [at Janssen] are committed to pursuing transformational therapies and hope to grow our understanding of how canagliflozin can be used to help more patients in the future.”
They also hope to grow their revenues – and let’s face it, that’s their first priority. Given Invokana’s track record and growing evidence that it increases the risk of kidney failure, ketoacidosis, osteoporosis and a host of minor side effects such as constipation, nausea and yeast infections, it seems a bad idea for people desperate to lose weight – particularly when there are many safer alternatives. Unfortunately, those alternatives involve work and sacrifice, such as change of diet by reducing carbohydrates and eliminating sugar, eating high fiber foods and increasing physical activity.
And too many people are looking for a quick, easy fix – one that drug companies like Janssen and its parent company, Johnson & Johnson, are all too ready to offer.