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Ely Lilly’s sales organization is under fire now for aggressively promoting off-label use of its schizophrenia drug, Zyprexa. Normally, this practice is neither as black-and-white nor as egregious as today’s New York Times makes it out to be, but Lilly’s denial that it aggressively promoted Zyprexa for dementia patients is, to say the least, disingenuous.
There are three issues at work here: how Pharma reps are trained and monitored; how and why off-label drug use occurs; and how Pharma measures the performance of its sales force. I use the generic term “Pharma”, rather than Lilly or any other specific case, because this is an industry problem, and is not limited to one company.
Managing the Sales Force
Sellling prescription drugs is not like selling any other product I know, though current Pharma advertising practices might cause one to wonder. The manufacturer does not sell directly to the ultimate consumer, but through a chain of middlemen which includes the physician and a benefits manager. The sales rep has to get the physician to prescribe a drug and the benefits manager to approve the drug for insurance coverage, as few patients can afford to pay the entire cost themselves.
When a sales rep calls on a physician, if he is lucky, he gets to spend about 10 minutes making his pitch. The FDA has established some pretty strict guidelines concerning what the rep can and cannot say about a drug. For example, he cannot say that his company’s drug is superior to any competing drug unless there is a published, independent study to back it up. Instead, he is limited to discussing the benefits and the risks that have been documented in clinical trials and follow-up studies. He can describe findings in published studies that suggest off-label applications, but he cannot aggressively promote such applications. He can also tell the physician when a drug has been listed in the formularies (lists of approved drugs) of hospitals and insurers.
Managing the sales reps is a tough job. The manager gets to spend one or two days out of every couple of months, in which he has to evaluate the rep’s presentation, his organization and his business management. He travels with the rep on his rounds to see how he handles both a scripted presentation and the physician’s questions, and how the rep measures up in general to the goals that have been set for him. After this, the manager has to evaluate the impact the rep has had on prescriptions written. This is information that is obtained from the IMS drug information service. An automated sales management system should be able to correlate the manager’s scoring of a rep’s performance with the statistics provided by the IMS data, to show whether the rep had negative, zero or positive impact on prescription sales.
In other words, the reps are generally policed very closely as to what they can and can’t say, and Pharma cannot plead ignorance when off-label promotion is occurring.
Off-label drug use is not uniformly bad
The consumer may not be aware of the extent to which doctors prescribe drugs for off-label uses, but it is quite common, and for very good reasons. The FDA is glacially slow to give its approval to any New Drug Application (NDA). This is for the consumer’s protection, but the lack of approval does not mean a physician cannot prescribe the drug for a condition he knows it will help. Two good examples are the rheumatoid arthritis drugs Enbrel and Humira. RA is an autoimmune disease that is virtually identical with another condition, psoriasis and psoriatic arthritis, except for the way the conditions manifest themselves. The autoimmune mechanisms are identical. So the off-label prescribing of Enbrel, Humira, and a number of other established RA drugs for psoriasis was inevitable. The results have been generally satisfactory, as reported in numerous clinical studies. Enbrel now is approved for psoriasis treatment, and Humira soon will be.
Sales Performance and IMS statistics
IMS is a business intelligence service for the pharmaceutical and health care industries. Among other things, it reports on prescriptions filled at pharmacies all over the world. IMS data tells Pharma manufacturers how big a share of a therapeutic class their products have in the market place, along with other useful information (if you are interested check out their website). In a properly structured sales management system, a sales manager can assign a numerical score to his evaluation of how well a sales rep is performing specific tasks he has been assigned, based on the manager’s personal observation. This scoring has to be done at regular intervals. Then the scores over time can be compared with prescription sales data over the same time periods, to determine whether the sales rep’s performance is having a positive effect.
IMS data can’t discern off-label prescribing, but it does indicate what kinds of practitioners are prescribing the drugs. Since it is known that Primary Care Providers do not treat schizophrenia, it is difficult to see how they would prescribe a schizophrenia drug unless they were encouraged to do so by the manufacturer. The fact that PCPs were prescribing Zyprexa, which would be reported by IMS, indicates that Lilly reps who were calling on PCPs were being told to promote off-label use of the drug.
Here we have an example of a business intelligence failure. Assuming Lilly did not, in fact, condone promoting off-label use of Zyprexa, the appearance of Zyprexa prescriptions written by PCPs should have been spotted by someone in Lilly’s sales or marketing organization, and questioned. Business Intelligence is not just for analyzing the competition. It is for covering your own backside, too.
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