There is an incredible amount of money to be made by pharmaceutical companies foroff-label use of their drugs. When the FDA approves a drug, it will only approve it for uses that the data shows are safe and efficient treatments. If a drug is only approved for a small sector of the market, then the big-pharma companies are limited in the amount of money they will make from that drug.
When we say small market of people, we’re talking about people rare debilitating conditions like rheumatoid arthritis. Drugs to help individuals with diseases that affect their quality of life are often fast tracked—meaning the drugs are only tested on a small sample size of people with these debilitating conditions before they are approved. Most of these drugs are never tested on the average consumer, so their side effects are almost totally unknown—mass marketing a drug like this is like a disaster waiting to happen, but pharmaceutical companies do it anyway. According to a report from Cozen O’Connor’s Life Sciences Practice Group, this type of prescription brings in about $40 billion each year for pharmaceutical companies or about 20% of all revenue. Studies show that people who are prescribed drugs for off-label use are 44% more likely to experience an adverse reaction. Despite this potential impact on people’s lives, these kinds of profits enable pharmaceutical companies to sacrifice a few hundred million dollars in fines years down the line in order to market drugs and treatments for conditions outside of those the drugs were intended to treat.
Through the late 1990s, Johnson & Johnson promoted Risperdal to children. The company focused on bringing in professionals who could help make Risperdal the prime choice for pediatricians. By 2000, 21% of the drug’s sales were for off-label use in children and adolescents—with the directive to sales teams that expanding this market was the company’s highest priority.
Some of the signature sales tactics that went along with selling this drug as a safe and efficient option for treating ADHD in kids were popcorn and LEGO-type toys with the product’s logo. According to the papers given to sales reps, the purpose of the popcorn was “to butter up docs”. One sales rep testified in the trial that the doctors who prescribed the most Risperdal were recruited to be speakers. The LEGOs were for the kids in the waiting room—for marketing of course, and to normalize the drug as a treatment for kids.
By 2000, Johnson & Johnson learned that 5.5% of male children using this drug in the trial developed adult female breasts, a usually rare condition called gynecomastia that requires a mastectomy to remove. Despite this, J&J continued to aggressively pursue pediatric use of the drug.
By 2002, 75% of Risperdal sales were for off-label use in kids and the elderly. This marketing strategy increased the sales of the drug from over $100 million in 1994 to over $1 billion in 2005.
Individuals and their families and the U.S. Department of Justice eventually came after J&J for its aggressive marketing tactics. The DOJ demanded a $2.2 billion settlement in 2013—almost 20 years’ worth of profits later.
By early 1999, Johnson & Johnson had expanded its ElderCare sales team from 83 to 136 reps to account for their sales of the drug. J&J sent sales materials to care facilities and doctors headlined “Hostile Outside, Fragile Inside” to advertise Risperdal for use in the elderly. J&J partnered with nursing home pharmacy manager, Omnicare, to help persuade physicians to write prescriptions for behavioral disturbances associated with Dementia. All this despite the FDA’s explicit concern that the company failed to explain what appears to be an unusual amount deaths among seniors using the product.
