"The worse the data on the elderly got, and the worse the potential for the FDA reaction to it got, the more J&J seemed to intensify its sales effort."
So writes investigative journalist Steven Brill in his chilling, meticulously researched "docuserial" America's Most Admired Lawbreaker, concerning Johnson & Johnson's efforts to market the antipsychotic Risperdal off-label -- that is, without authorization -- to seniors with dementia and children diagnosed with pediatric bipolar disorder. The series ended its fifteen-day run on The Huffington Post last week. It follows the spring publication of Brill's compelling, widely reviewed book America's Bitter Pill: Money, Politics, Backroom Deals, and the Fight to Fix Our Broken Healthcare System (Random House, 2015).
What did we learn from the series? Among other things, that in September 2000 the FDA told Johnson & Johnson it would not approve the use of Risperdal for children with "conduct disorder" (a term, officials said, that "could mean anything"). J&J also should scale back the drug's accepted treatment indicators -- from management of "psychotic disorders" to the "treatment of schizophrenia" alone. Among other concerns, the agency warned that J&J had "failed to fully explore and explain what appeared to be an excess number of deaths" among the elderly treated with Risperdal -- chiefly, a sharp increase in strokes and heart-related fatalities.
The FDA's Division of Drug Marketing, Advertising and Communications had warned the drugmaker the previous January that it was distributing information about Risperdal that the agency "considered to be false or misleading," including by listing side effects in "pale and tiny font" on published ads and industry presentations. "The warning regarding tardive dyskinesia" -- involuntary twitching -- "is minimized" on the literature, regulators added. (Johnson & Johnson was invited to comment on this post; its response will be included.)
By the fall of 2000, according to the drugmaker, off-label prescriptions of Risperdal accounted for 46 percent of the drug's sales -- 25 percent to seniors; 21 percent to children and adolescents -- while the market for schizophrenia (the only one authorized for Risperdal) was, in the company's words, "flat." The profit margin relied increasingly on off-label prescribing, which, according to one study, accounted for 66 percent of the drug's sales.
Additionally, notes Brill, Johnson & Johnson had already made a sizeable marketing commitment to prescribing Risperdal off-label, on the assumption that the FDA would approve the drug for the treatment of dementia and pediatric bipolar disorder. The company had commissioned from one marketing firm a "Risperdal 1997 U.S. Strategic Defense Plan: Advancing the Front," with a banner for the drug pictured as covering the planet. Two years later, in 1999, it hired Excerpta Medica, another medical marketer whose sub-specialty," writes Brill, "was producing ghostwritten, data-filled studies on the efficacy and safety of a client's drugs, finding the right academic scholars to be listed as the authors, and then placing the articles in prestigious academic journals."
One such article was given a conclusive title before the data accompanying it could be added: "The Safety and Efficacy of Open-Label Risperidone in Conduct Disorder in Mild, Moderate and Borderline Mentally Retarded Children Aged 5 to 12 Years." "You have been identified as the lead author to this manuscript," Excerpta wrote the designated "thought leader" of the draft document, in a telling if surreal phrase. Attached, the would-be author would find a "preliminary outline for your manuscript."
By the year 2000, according to Brill, again from court-released documents (all of them added to The Huffington Post to verify the series), Excerpta was working on a plan to place dozens of Risperdal articles in medical journals. "Awareness articles" and "original reports," of which a total of 39 were planned, would cost $22,000 each in fees, plus fees for the "authors." Shorter pieces would be $9,000 each. Comparable efforts were made by other drug makers to ensure that favorable, ghostwritten claims would find their way into medical journals.
Additional steps were taken to downplay the results of the largest study then completed on the effects of Risperdal on children. In November 2000, following a study involving 319 children (266 of them male), 5.5 percent of the males developed gynecomastia, or breasts. According to an Excerpta proposal, Johnson & Johnson then commissioned a "core message" piece that would fend off such results by concluding, in another predetermined outcome, that "prolactin elevation"--the development of breasts in boys and adolescents--"sometimes seen with Risperdal treatment is not (directly) linked to clinical abnormalities."
Meanwhile, sales groups targeting pediatricians -- who would be rewarded in proportion to the number of prescriptions they wrote off-label -- were equipped with a training manual called "Handling the Most Common Objections Voiced By Prescribers," which advised sales reps to tell doctors that "Risperdal has an excellent combination of efficacy and safety." It referred them to the ghostwritten article that Excerpta had generated.
The broader strategy, one sales manager of the drug in Texas noted, would be known as "Risperdal Popcorn" -- according to a sales primer, it would "butter up docs." Another favored sales device, to be distributed in the waiting rooms of doctors who prescribed the most Risperdal off-label: children's toys imprinted with the drug's logo. The FDA nonetheless warned the drugmaker not to market Risperdal to children.
At a time of heightened, much-needed attention to corporate wrongdoing, including the "defeat devices" that German carmaker Volkswagen added to its diesel engines, enabling them to emit up to 40 times more toxic fumes than permitted, Steven Brill's devastating exposé of Johnson & Johnson still has the power to shock and amaze. It gives us Big Pharma's own "defeat devices" front and center: massaged data, ghostwritten articles, children's toys adorned with pharma advertising, and "popcorn" strategies for "buttering up docs" -- not to counter noxious fumes, but to promote the use of medicines among unapproved groups.
Johnson & Johnson has so far paid more than $2 billion in fines and settlements concerning Risperdal. The CEO of Volkswagen stepped down following revelations of its deception; at J&J, the person responsible for marketing Risperdal was rewarded by being appointed the company's CEO.
America's Most Admired Lawbreaker is required reading for everyone involved in medicine and health care -- not just the millions of people who have taken Risperdal, but every parent concerned about the safety of the medication prescribed off-label for their child or ailing parent.