risperdalSeptember 15, 2015 — The Huffington Post’s longform features section Highline is publishing a 15-chapter exposé on Johnson & Johnson, naming the drug-maker “America’s Most Admired Law Breaker.”

The inside story covers how Johnson & Johnson (J&J) created the anti-psychotic drug Risperdal (risperidone), marketed it to children and the elderly without FDA approval, and covered up side effects to protect billions of dollars in sales.

Highline will go in-depth over the coming weeks, but they began with the story of Austin Pledger — an autistic boy who was prescribed Risperdal “off-label” as a 12 year-old child and grew 46DD-sized breasts as a teenager, a condition called gynecomastia.

J&J has admitted instructing sales representatives to target doctors who treated children and the elderly. Pledger’s doctor was given thousands of samples of Risperdal in child-sized doses. His mother filed a lawsuit and was awarded $2.5 million in February 2015 — a verdict J&J intends to appeal.

J&J is one of the most prosperous healthcare companies in the world, with pre-tax profits of $20.6 billion in 2014. They make everything from baby powder to Tylenol, but over 91% of profits come from high-margin medical devices and prescription pharmaceutical drugs like Risperdal.

In the 1980s, J&J was searching for an antipsychotic drug to replace Haldol, which would soon lose patent protection and face steep competition from inexpensive generics.

Haldol and generics were used to treat a broad range of behavior disorders — including elderly people with dementia and children with ADHD. To compete, Risperdal would need to be prescribed to millions of people, and drug-makers would have to convince doctors that it was more effective than Haldol to justify the added expense.

The problem was that studies did not show Risperdal was better than Haldol. Even more problematic, the FDA only approved Risperdal to manage severe psychotic illness in adults — and specifically cautioned against assuming it was safe for children and the elderly.

J&J pushed forward with an aggressive marketing plan led by Alex Gorsky, the former head of Risperdal sales and the subsidiary that marketed Risperdal. Though his company admitted breaking the law to market Risperdal, no individuals were ever held accountable. Gorsky is currently the chairman and chief executive of J&J.

According to Highline:

“The Houdini act … raises equally significant questions about the standards of conduct we can expect from those who run what is becoming the world’s most powerful industry, and about how much we can rely on the medicines they sell.”

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