In 1994, pharmaceutical giant Johnson & Johnson released Risperdal, an antipsychotic drug that, over the next few years, would yield hundreds of millions of dollars for the company. It has since been determined, however, that much of those profits were due to illegal, “off-label” promotions by Johnson & Johnson and the resulting lawsuits from Risperdal’s harmful effects continue to crop up, even today in 2015. Huffington Post Highline has now launched a new, in-depth series, “America’s Most Admired Lawbreaker,” chronicling the Risperdal scandal, Johnson & Johnson’s business-as-usual breaking of regulations, and the effect that big pharma continues to have on economies—and patients—around the world.The Risperdal Story
By the late 1980s, Haldol, Johnson & Johnson’s popular antipsychotic drug had come “off-patent” and effective, generic knock-offs began flooding the market. In response, the company developed Risperdal, an antipsychotic drug that was not only meant to replace Haldol, but expand its application into prominent mental disorder treatments, such as for depression and anxiety.
From the beginning, Johnson & Johnson sparred with the FDA over their plan to market Risperdal on two key points. One was that Johnson & Johnson wanted to claim that Risperdal was more effective than Haldol. Due to lacking clinical data to support that claim, the FDA prohibited it. Secondly, Johnson & Johnson wanted to market the drug for use in children and the elderly. Again, the FDA prohibited that course of action, due to insufficient data that supported safe usage in both of those patient types.
Issues with Johnson & Johnson’s compliance with the FDA’s ruling is best exemplified in the case of Austin Pledger, an Alabama boy (now 21) who was prescribed Risperdal to treat his autism. Because of the drug, Pledger developed breasts and an investigation into Johnson & Johnson’s internal documents revealed that the company not only knew of possible hormonal effects of the drug, but continued to promote it to pediatricians anyway.
Johnson & Johnson vehemently asserted that they never consciously violated “vague” government laws that prohibit the promotion of drugs to certain populations. A jury awarded the Pledger family $2.5 million and Johnson & Johnson has since settled thousands of other cases involving Risperdal. Even as more lawsuits loom, however, the company is gearing up to launch a whole new line of pharmaceuticals.
Big Pharma & Breaking the Law
Perhaps most troubling about “America’s Most Admired Lawbreaker” is its implications about the future of “big pharma” companies like Johnson & Johnson. The company and its competitors now have the eyes of Wall Street upon them and make more far more money than other perceived “boom” industries (such as Silicon Valley). Bringing legal action against the highest decision-makers at these companies is nearly impossible and bolstering profits by illegally marketing drugs may be built into the very framework of how the industry produces revenue. Even more concerning, the companies are so lucrative that they can easily absorb any legal penalties, even ones as big as the Pledger ruling.
“Oh, they’ve [the companies] already reserved for that stuff,” one stock analyst told the Huffington Post writer. “It’s their cost of doing business… It’s just not a big deal.”
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