Handling study objections: Part 2
In the October issue of Pharmaceutical Representative, I presented (using the acronym DEAF) two of the four actions sales representatives should avoid when discussing clinical data with physicians: defending the study and extrapolating from the study. In this month’s column, I will discuss the final two actions: making assumptions and drawing false comparisons.
The trouble with assumptions
Some assumptions can get you into trouble, especially assumptions about what the physician wants to know when you are communicating clinical information. Here is one example of what I mean:
Doctor: So, what’s new?
Representative: Glad you asked! Have you seen this most recent paper [pulls out reprint] about WonderDrug in patients with toe pain? In this study of fifty patients, WonderDrug worked really well in toe pain and was shown to be safe.
In this scene, the representative made assumptions in his statements that, if reported to the Food and Drug Administration, could get his company in compliance hot water. First, the representative assumed that when a doctor asks, “What’s new?” it is an open invitation to dump data. The representative further assumed that the clinical “message” would be relevant to the physician’s interests or patient population. Finally, the representative assumed that “worked really well” and “shown to be safe” were appropriate conclusions to draw for the physician about the drug.
Here are three ways that a physician might respond to the representative’s statement, in order of increasing risk to the representative’s company:
Doctor (response one): How well? How safe?
The doctor is responding with clues for the representative — in this case, the physician is wondering just what “really well” and “safe” mean. This is probably the best response the WonderDrug representative can get in terms of compliance risk to the company, although how he follows up with the physician may pose additional risks depending on how he answers.
Doctor (response two): I don’t see many patients with toe pain.
This is a blanket rejection response a customer uses when he does not believe that the service or product is relevant to his needs. There really isn’t a good follow-up question or comment that the WonderDrug representative can make now without appearing pushy or oblivious.
Doctor (response three): Thanks. Have a good day.
This is probably the most dangerous response the representative can expect. The physician is not giving any feedback other than verbally showing the representative out the door. We do not know whether the doctor will ignore the exchange as a waste of time or pick up the phone and call the FDA about the incident. What the representative said is equivalent to his company making false claims about its drug’s safety and efficacy. These statements would fall under what the FDA calls “unsubstantiated effectiveness claims” and “omission of risk information” in its warning letters to drug manufacturers that violate rules for communicating clinical information to healthcare practitioners.
This rep could have avoided making assumptions by:
- Asking the physician what he meant by “What’s new?”
- Asking the physician which part of the clinical reprint he would find most relevant to discuss.
- Stating the facts or data without drawing any conclusions and avoiding general statements like “it’s safe” and “it works” (statements about efficacy and safety must be accurate and accompanied by a heavy dose of qualifiers about patient characteristics).
False comparisons and lost credibility
The definitive comparison between the efficacy and safety of two drugs is a head-to-head clinical study. Many studies are done with a placebo comparator. Drug trials also tend to use what the medical community accepts as the “gold standard” treatment in the control group, and the gold standard is often an old drug rather than a newer drug in the same therapeutic category.
There may be a real temptation to make false comparisons by discussing the results of two separate studies as if the drugs were clinically tested in a head-to-head trial. This is especially the case if two or more newer drugs are competing in the same therapeutic market. Discuss clinical data within the confines of that specific study rather than making piecemeal use of other studies to make your product appear favorable. When you are using clinical data to sell the science of the product, making false comparisons can risk your credibility with physicians as a reliable source of clinical information.