Risperdal has been licensed by the FDA since February 1994 for use in psychotic episodes, with a particular emphasis on schizophrenia. It is made by Johnson & Johnson, who most of us know from their range of consumer products, such as baby powder and Listerine mouthwash. However, what is less well known is that Johnson & Johnson make most of the company’s profits (91% in 2014) from their medical devices and drug division with drugs such as Invokana (diabetes), Topamax (migraines), Xarelto (heart disease) and Risperdal (schizophrenia) contributing the vast bulk of Johnson & Johnson’s profits.
One of the key factors with drug profitability is the size of the patient population that the FDA will allow it to be prescribed to. For example, the American Diabetes Association estimated that there were 29.1 million diabetics in the United States in 2012, or approximately 9.3% of the population. Therefore, J&Js diabetic drug Invokana has that as a potential consumer base. By comparison, it is estimated that only around 1% of the U.S population suffer from schizophrenia, which is what Risperdal is primarily licensed for, so the potential population, while significant, should still be much smaller. Yet the financial data tells a different story.
In the first quarter of 2015, Invokana produced worldwide revenues of $278 million, while Risperdal had very similar results, with revenues of $254 million, despite appearing to be targeting a portion of the population with 9-times less people.
The answer increasingly seems to be that Johnson & Johnson have been marketing Risperdal to a wider audience then the FDA has licensed the drug for use on. There have now been numerous judgements against the company for deceptive marketing of Risperdal, including a $327 million judgement in South Carolina (reduced to $124 million on appeal), $158 million by the state of Texas, $7.5 million by the state of Arkansas and a $2.2 billion settlement with the U.S Justice Department to settle allegations of dubious marketing practices.
It is interesting to note that worldwide sales of Risperdal have dropped by 18.1% in the first quarter of 2015, and were previously much greater in revenue terms than Invokana, so recent heightened scrutiny on the way that this particular drug is being promoted may now be showing up in the bottom-line figures.
One of the big issues with Risperdal has been the age range of the patients that it is prescribed to. Since 1994, Johnson & Johnson have made repeated attempts with the FDA to widen the demographic to which the drug can be actively marketed to include geriatric patients, but the FDA, based on a lack of evidence of benefit, have rebuffed these. It is licensed for use in adults and adolescents, but with many more indications of side effects showing up in children, there should have been much more emphasis placed on the potential problems that may arise from its use.
This is particularly the case in children, with gynecomastia, which is the unwanted growth of breast tissue in men, showing up in one study in 30% of boys who used Risperdal.
There are now many cases pending in the U.S courts, which address this particular side effect and how patients were not informed of the potential problems with the drug. A recent Philadelphia judgement for $2.5 million to an autistic boy, Austin Pledger, who suffered from gynecomastia as a result of taking the drug, will almost certainly not be the last.
For more information on J&J as well as the marketing and legal tactics employed by the company, we encourage you to read the the in-depth article entitled America’s Most Admired Lawbreaker.