Marketing Risperdal Part III: Marketing to the Elderly

von freakoutcrazy

by Scott Bartz

In 1993, J&J subsidiary, Janssen Pharmaceutica, won FDA approval to sell Risperdal for the treatment of psychosis in patients with schizophrenia. Only about 1.1 percent of adults suffer from this condition, according to the National Institute of Mental Health, so the market potential for Risperdal was apparently quite small.

But Johnson & Johnson, recognizing an opportunity to expand the Risperdal market beyond its approved indication, immediately implemented a strategy to promote the drug for unapproved uses.

Ivo Caers, a Janssen executive, wrote in a 1994 report that “Schizophrenia represents only 35 percent” of antipsychotic prescriptions. “Aggressive expansion of Risperdal use in other indications is therefore mandatory.”

As the amount of money spent promoting Risperdal and other new generation ”atypical” antipsychotics for off-label use grew; schizophrenia made up an ever smaller portion of the antipsychotic market. By 2006, Risperdal use in schizophrenia represented just 19 percent of total Risperdal use.

When Risperdal lost patent protection in 2008, the drug had generated more than $20 billion in revenue in the United States alone. The majority of that revenue came from off-label sales. A sizable portion of those off-label sales came from Risperdal sales to elderly patients with dementia.

FDA Warnings Unheeded

In 1999, the FDA warned J&J and its Janssen subsidiary that its marketing materials for geriatric patients overstated Risperdal’s benefits and minimized risks. Yet according to documents turned over to the state of Louisiana; a J&J business plan for the next year called for increasing the drug’s market share for elderly dementia sales, an unapproved use.

“The geriatric market represents Risperdal’s second wave of growth,” wrote J&J officials in the 2000 business plan. “The aging population will continue to drive market growth well into the next century.”

Janssen set sales goals for the year 2000 of $302 million in geriatric sales, or 57 percent of the market, according to the business plan. J&J reached that sales goal with help from its ElderCare sales force, comprised of 50 sales reps who marketed Risperdal directly to psychiatrists with large geriatric patient populations.

The ElderCare sales reps promoted Risperdal off-label, primarily for the treatment of aggression in elderly dementia patients. This off-label marketing strategy continued even after J&J received research data in 2002 showing increased strokes and mortality in elderly dementia patients taking Risperdal. Johnson & Johnson’s meek response to these findings was to send a Dear Doctor Letter in October 2002 to physicians in Canada citing 37 reports of Risperdal stroke or Risperdal stroke-like events, including 16 deaths. The letter said in part:

Recent analysis of some clinical trials in elderly patients with dementia suggests that the use of RISPERDAL in dementia patients may be associated with an increased incidence of reports of cerebrovascular adverse events (CVAEs) such as stroke and transient ischemic attacks (TIAs), including fatalities.

In April 2003, J&J sent a Dear Doctor letter to physicians in the United States. The letter repeated the findings referenced in the letter sent months earlier to Canadian doctors, and also cited two additional clinical trials of elderly dementia patients in which “a higher proportion of patients taking Risperdal experienced strokes or related events than those who received placebo.”

Also in 2003, the FDA required J&J to revise the WARNINGS section of the prescribing information for Risperdal:

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Risperdal® (risperidone) is not approved for the treatment of patients with dementia-related psychosis.

Despite this new FDA-mandated Black Box Warning, Johnson & Johnson did not reduce its efforts to promote Risperdal for use in elderly dementia patients. Quite the opposite in fact.

The potentially deadly side-effects associated with Risperdal use in certain elderly patients led J&J to simply tweak its marketing strategy and implement a training program to teach the ElderCare sales reps how to overcome objections voiced by doctors concerned about the adverse-events associated with Risperdal use in the elderly. I know this, because at the time of the Risperdal label change, I was in charge of designing, implementing, and monitoring sales incentive compensation programs for several Johnson & Johnson sales forces, including the ElderCare sales force.

The ElderCare sales force had grown from 50 sales reps in 1999, to 283 reps in 2003. They marketed three drugs: Razadyne (for Alzheimer’s Disease), Duragesic (a narcotic for treating pain), and Risperdal (for treating psychosis).

Since Alzheimer’s Disease almost exclusively strikes the elderly, one might reasonably assume that the ElderCare sales force focused primarily on promoting Johnson & Johnson’s Alzheimer’s drug, Razadyne (then known as Reminyl). But that wasn’t the case. The ElderCare sales force was first and foremost a Risperdal sales force.

How Big Pharma Motivates Pharmaceutical Sales Reps

The standing of a pharmaceutical sales rep is largely a function of his or her latest quarterly bonus.

In 2004, the ElderCare Incentive Compensation Plan paid a quarterly bonus of $5,500 ($22,000 per year) to a sales rep in a territory with average sales performance. (Link to actual 2004 Incentive Compensation Plan)

Twenty percent of the targeted bonus was based on “discretionary” factors, such as call plan achievement and completion of administrative duties. Eighty percent of the targeted bonus was based on “quantitative” sales results.

The sales performance of all 283 ElderCare sales reps’ territories were ranked according to sales results. Quarterly quantitative bonuses ranged from $0.00 (for the rep in the lowest performing territory) to $12,375 (for the rep in the highest performing territory).

The incentive compensation plan was designed to induce ElderCare sales reps to promote Risperdal for unapproved uses in elderly patients. Risperdal was the first drug detailed in most sales calls, and it was weighted most heavily in determining the quarterly bonuses paid to ElderCare sales representatives.

In 2004, Risperdal sales results made up 50 percent of an ElderCare rep’s performance rating, making it the most important factor in the calculation of quarterly bonuses.

Every sales rep had a unique call plan directing them to call on psychiatrists with the largest geriatric patient populations. In 1999, Omnicare, the nation’s largest pharmacy service provider to long-term care facilities, had even provided J&J with a physician prescriber list of physicians who were not prescribing much Risperdal. The names were intended “to increase the call frequency on these resistant prescribers and to eventually influence them to use more Risperdal in the elderly demented patient.“

The quarterly bonuses, performance reviews, and annual raises of ElderCare sales reps were all based primarily on sales performance, as measured in the quarterly bonus/performance reports.

In 2005, the ElderCare Incentive Compensation Plan was designed to put even more emphasis on promoting Risperdal to physicians with large geriatric patient populations. The product weight of Risperdal was increased from 50 percent to 70 percent. (Link to 2005 Incentive Compensation Plan)

The ElderCare incentive compensation plan also included a “kicker” bonus, paid to reps whose sales performance ranked in the top 15 percent of the entire ElderCare sales force. Again, the kicker was designed to reward Risperdal sales growth first, and Reminyl growth second.

Other incentive bonuses paid to sales reps in high performing territories included a 5-day all-expense-paid vacation and additional cash payments to the top reps in each district and region, and in the nation.

The Incentive Compensation plan was an extremely successful tool for motivating ElderCare reps to promote Risperdal for unapproved uses in the elderly. In 2006, Risperdal use in geriatric patients made up 13.5 percent of total Risperdal use (RIS O). Of the approximately $4 billion in Risperdal sales in the U.S. that year, about $538 million came from sales to the elderly.

The ElderCare sales force was finally disbanded after the Justice Department initiated an investigation in September 2005 into Johnson & Johnson’s marketing of Risperdal and other drugs to Omnicare. By then, the prescribing of Risperdal and other atypical antipsychotics for unapproved uses in the elderly was standard practice. Yet no data had ever been submitted to the FDA supporting this off-label use.

Time and time again, the FDA had warned Johnson & Johnson to stop promoting Risperdal for unapproved uses in elderly patients. However, when Johnson & Johnson continued to market Risperdal for use in these very same patients, the company was not sanctioned.