Selling Out: Johnson and Johnson and the Shameful Story of Risperdal

Reporter Steven Brill’s stellar 15 chapter “docu-serial” about Johnson and Johnson’s illegal, immoral, yet highly successful campaign to achieve blockbuster status for the antipsychotic drug Risperdal is now available on the Huffington Post.  The series is a remarkable tale of greed, phony science, and dirty doctors that garnered billions for a company that once prided itself on putting people before profits.

For over a decade, Johnson and Johnson managers and its salesforce expressly marketed Risperdal for conditions for which it had not been approved.  This practice, called off-label marketing, occurs frequently despite federal law that prohibits it.  The primary lesson of Brill’s story is that the money to be made from drug sales generated by off-label marketing is more than enough to cover any costs in the form of penalties or lawsuits that follow; hence, expect off-label marketing to continue regardless of the harm it may cause for patients.

A key focus of J&J’s off-label marketing efforts were physicians for elderly people with dementia.  Despite a growing number of studies showing dubious efficacy and deadly side effects for Risperdal and elderly people with dementia, J&J entered into an illegal kickback scheme with nursing home pharmacy Omnicare and created an “eldercare salesforce” whose mission was to leverage sedation into sales.  Labeling people with dementia as “hostile outside, fragile inside,” Risperdal was touted for its ability to calm “restless patients.”  That kind of language has served as a euphemism for ugly chemical restraints for at least 40 years.  Attorney Tom Melsheimer expertly summed up J&J’s Risperdal success as “not a medical breakthrough, a financial breakthrough.”

While the role of pharmaceutical manufacturers in the overselling of psychotropic drugs for elderly people with dementia is well known, the Brill story nonetheless adds a disturbing depth of details.  The notes from salespeople pushing doctors to prescribe Risperdal for “sundowning” and to “treat” the behaviors associated with dementia are hard to stomach.  But it is the words of an FDA official, Dr. Paul Leber, that strike the most chilling note in the series.  In 1995, just before J&J’s Risperdal sales strategy went into overdrive, Dr. Leber wrote:

“some [of the behavioral “symptoms” of dementia] … 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.”

In another document, the FDA explained its reluctance to approve Risperdal for “aggression associated with dementia” because the drug may be curtailing a patient’s ability to communicate displeasure or pain.  The FDA further stated that Risperdal may have shown a treatment effect but questioned whether the effect was actually beneficial.

In other words, the desired treatment effect that was about to launch sales of Risperdal and other atypical antipsychotic drugs into the stratosphere was chemical restraint.  Restraining people with dementia is inviting because of the failure to recognize that behavior associated with dementia is not a symptom of the disease but rather the natural reaction to painful, uncomfortable, or distressing circumstances for people who have trouble processing and communicating information.  The FDA saw this plainly 20 years ago; nonetheless, here we are today still trying to undo the harm of desperate, insistent, and facile off-label marketing.

Paraphrasing dementia care expert Tena Alonzo, instead of trying to change the way people with dementia act or even think, we ought to be changing the way they feel.  Bring them joy and happiness and human connection.  Leave the Risperdal behind.

About achicotel

Anthony Chicotel is a staff attorney for CANHR. His areas of expertise include the rights of long-term care residents, nursing home litigation, health care decision-making, and conservatorships.
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