The Miracle Industry: America’s Most Admired Lawbreaker, Johnson & Johnson

Steven Brill, The Miracle Industry: America’s Most Admired Lawbreaker, Johnson & Johnson. The Huffington Post Highline, 15 September 2015. Chapter I of 15, “The Credo Company. Backstage at Johnson & Johnson.” “The Johnson & Johnson Risperdal story is a complex, roller coaster tale. The details count. They are important in understanding the people and impulses behind the drugs we take. To tell that story in a way that is digestible but complete, The Huffington Post Highline and I are trying something new: a DocuSerial. It’s a reconstruction of an old story-telling genre that allows us to deploy the modern tools of digital communication to engage readers in old-fashioned, long-form feature journalism.

Every day for the next 15 days, a new chapter of the Johnson & Johnson story will be posted here. Along with the text, we will post not only a rich array of photos and graphics, but also links to every document—court transcripts, internal emails, FDA staff memos—referred to in that day’s chapter. That way, you will be able to delve more deeply into the materials that are quoted. (You’ll also be able to make sure I held true to the context of the material I quote.)”

The Food and Drug Administration had prohibited Johnson & Johnson salespeople from trying to promote Risperdal to doctors to treat children because of its feared side effects, including hormonal disorders. The company was also not allowed to promote it to treat the elderly except for the most serious psychotic disorders; it was thought to cause strokes, diabetes and other ailments in that population. But by the time young Austin [Pledger] started growing breasts [at the age of 12 in 2006], Johnson & Johnson was reaping more than half of its Risperdal sales from prescriptions written for children to alleviate all kinds of behavior disorders, and for the elderly, who were given the drug for simple symptoms of dementia or restlessness.

Johnson & Johnson emails, sales training manuals and business plans produced as evidence in the case revealed that the company organized special sales units illegally targeting doctors who treated the elderly and children. State mental institutions treating children, whose drugs would be paid for by Medicaid, were targeted, too….

Johnson & Johnson has already settled thousands of cases involving illicit promotion of Risperdal, including Department of Justice civil and criminal complaints, for a total fast approaching $3 billion…. ‘It’s their cost of doing business,” [a stock analyst said]…. Indeed, with before-tax profits of $20.6 billion for 2014, putting aside $500 million or even $1 billion a year over 15 years to cover payouts for boys with 46DD breasts and other claims that might come along doesn’t put much of a dent in the company’s financials…. ‘All the big pharmas have lawsuits,’ the analyst concluded, sipping an espresso. ‘It’s just not a big deal.’…

True, eight of the other nine largest pharmaceutical companies in the world have settled federal claims over the last decade related to allegations similar to what Johnson & Johnson was accused of in selling Risperdal, although their conduct was arguably less egregious. They, too, seem to have settled the charges without torpedoing their profit and loss accounts.

However, the fact that this illegal conduct is not a “big deal” on Wall Street and only the occasional subject of news coverage should make it a big deal to the rest of the world: The drug companies seem to be able to break the rules with relative impunity, or at least without suffering the kind of punishment that would actually hurt—their stock prices taking a hit or senior executives being held personally responsible….

Amid the swirl of multi-billion dollar takeover deals generated by the prospects of a promising new drug, can we trust these [pharmaceutical] companies? Can the data from the trials conducted to test their products that they submit to the Food and Drug Administration be trusted? Can we rely on corporations that are looking over their shoulders at Wall Street not to inflate revenue by selling a drug to people that the FDA has walled off as targets or for purposes that have not been sufficiently tested and for which the FDA has not granted approval?

Or are the lawsuits like those brought against Johnson & Johnson and other drug companies less about corporate wrongdoing and more about trial lawyers and whistleblowers (who get paid a portion of the winnings) looking for a payoff when drugs that comfort or even save the many result in side effects that afflict the few?

These questions are only going to loom larger as miracle drugs and miracle profits increasingly dominate the news, our budgets and our quest to live long, healthy lives. That is what makes the Johnson & Johnson Risperdal story important….

The documents…demonstrate that as head of Risperdal sales and then head of the Johnson & Johnson subsidiary that marketed Risperdal, Alex Gorsky, the current Johnson & Johnson chairman and chief executive, had a sustained, hands-on role in what the company has since admitted in a plea bargain (that nonetheless named no individuals) was illegal activity. That raises significant questions about whether our legal system can, and will, ever hold the high-ranking people who run our largest corporations, rather than inert corporate entities, responsible for wrongdoing.

The Houdini act that enabled Gorsky, the then-Risperdal sales manager, not only to escape responsibility but also to be promoted to the top of his industry’s most admired company 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….

Risperdal could never replace Haldol [Johnson & Johnson’s ‘first-generation’ antipsychotic drug that came ‘off-patent in 1986] as Johnson & Johnson’s latest bestseller if it was sold as only appropriate for psychotic disorders….

[The label approved by the FDA for Risperdal in 1993] limited Risperdal to the ‘management of manifestations of psychotic disorders’ in adults—severe illnesses causing hallucinations or delusions….

‘It would be misleading to suggest that the safety and efficacy of Risperdal has been established in the elderly,’ the regulators wrote [in 1994]….

[When Johnson & Johnson submitted a proposal to the FDA in August 1996] the agency rebuffed the company, declaring, ‘Your supplement [to the approved label] proposes the expansion of Risperdal use into pediatric patients, however, you never state for what child or adolescent disorders Risperdal would be intended. Indeed, you acknowledge that you have not provided substantial evidence from adequate and well-controlled trials to support any pediatric indications, nor developed a rationale to extend the results of studies conducted in adults to children.’

‘Your rationale for proposing this supplement,’ the agency concluded, ‘appears to be simply that, since Risperdal is being used in pediatric patients, this use should be acknowledged in some way in labeling.’

That last sentence hinted at efforts Janssen [a pharmaceutical company of Johnson & Johnson] had already quietly made to expand the sale of Risperdal beyond the limits of the label. By 1997, overall Risperdal sales in the U.S. had reached $589 million. That was a huge jump from launch-year revenue of $172 million in 1994, and it meant that the drug was somehow being prescribed for patients outside the narrow boundaries of the label.