Healthcare activist and journalist Steven Brill took on one of BigPharma’s biggest guns — Johnson & Johnson — with an online “docubook” chronicling the behemoth’s unrelenting and profit-driven marketing efforts to push Risperdal onto children and elderly people with dementia when the drug’s risks and unwanted side effects for both these populations seem to far outweigh its disputed benefits.
The story, which goes back to the company’s founding in 1886, is meticulously documented, and it’s a riveting read. I am personally interested because my care partner, who lives with dementia, has been administered Risperdal for close to four years against my wishes.
J&J’s strategies and tactics to market the drug as a way to reduce responsive behaviours in elderly people with dementia are, well, you be the judge…here are some highlights from Brill’s piece:
- Johnson & Johnson has 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 would be misleading to suggest that the safety and efficacy of Risperdal has been established in the elderly,” regulators wrote (in the 1990s).
- In the 1990s, Dr. Paul Leber of the FDA wrote to Johnson & Johnson: “You appear to be exploring Risperdal’s potential value for a much broader and more diffuse clinical target, namely ‘behavioral disturbances in demented patients.’” That label, he continued, “would also encompass a range of other clinical findings, e.g., anxiety, depression, agitation, aggressiveness, verbal outbursts, wandering, etc. that would not necessarily be considered psychotic manifestations.”
- Seeming to anticipate the mental institutions and nursing homes that were a big part of the market targeted in Johnson & Johnson’s business plan, Leber added, “Some [of these symptoms]… might even be construed by some as appropriate responses to the deplorable conditions under which some demented patients are housed, thus raising an ethical question regarding the use of antipsychotic medications for inappropriate behavioral control.”
- An 83-person Risperdal ElderCare sales team was formed (in 1998)—creating a countrywide unit whose explicit, unabashed mission was to get Risperdal into the mouths of an off-limits population. Its only targets, according to internal budgets and sales plans, were doctors who primarily treated the elderly or who were medical directors at nursing homes.
- Lisa Stockbridge of the FDA’s Division of Drug Marketing, Advertising and Communications wrote to Janssen (a subsidiary of Johnson & Johnson), “the warning regarding tardive dyskinesia”—involuntary movements such as facial grimacing—“is minimized,” and “the claim[s]that ‘Risperdal can enhance daily living’ or that [it]offers ‘quality control of symptoms for daily living’ are considered to be false or misleading.”
- In January 1999 the US FDA refuses Janssen’s request to expand label for elderly, explaining it had failed to “fully evaluate the safety of [Risperdal] for use” by the elderly and had “failed to fully explore and explain what appeared to be an excess number of deaths” among Risperdal users.
- By the summer of 2000, Johnson & Johnson signed a new, more extensive deal with (Omnicare). One of the J&J executives on the account crowed in a memo about “Omnicare’s ability to persuade physicians to write Risperdal in the areas of Behavioral Disturbances associated with Dementia.” He continued: “Omnicare, Inc. has demonstrated its ability to partner in a true sense of the word and has generated well over 100 million dollars of Johnson & Johnson pharmaceuticals annually.”
- Doctors were reminded that medical care is all about treating the symptoms that bothered their patients (or, in the case of nursing homes, the staff members who had to control patients). It didn’t matter whether a nursing home resident was acting out because she had Alzheimer’s or was just plain unhappy, or was acting out because she was among the less than 1 percent of the elderly who were schizophrenic. The pill would calm her down.
- By 2001, Johnson & Johnson’s off-label marketing had been so successful that, (according to the company’s own records) “over one half of all antipsychotic-treated dementia patients are currently using Risperdal in the U.S.”