Several years ago I was involved providing counsel on the largest switch of a drug from prescription (RX) to over-the-counter (OTC) in history – Prilosec. It was a very valuable experience, that allowed me to go back and analyze the nature of the switch environment for several years. It was also a good candidate for a switch.
One lesson learned then stands out. Prilosec was historic, not only in terms of its size, but because it was the first time, at least in this category that I know of, that OTC patients were treating their condition (GERD) and not merely a symptom (heartburn).
That is emblematic of the fact that drugs that are in the OTC pipeline are those that are, generally speaking, a shade more sophisticated than their predecessors. Take, for example, that there have been attempt to take statins OTC for the treatment of high cholesterol. That would treat a condition, not a symptom. Or to take Zovirax OTC to treat genital herpes, which like the statins, also failed to gain approval from the FDA.
These attempts signal a higher demand on labeling (and consequently labeling studies) and on actual use by consumers (and therefore actual use studies). It also makes demands on marketing to promote products in a way so that they can be used safely without the intervention of a physician.
What does this mean for the future? Well, there are more complicated drugs in the pipeline. That means that there are more complicated drugs that stand to switch.
But in fact, I do not believe that doctors test people for herpes, they listen to patients who say they have herpes and then prescribe the drug. They don’t really examine or test the patient to determine whether or not they have herpes. And, once patients have tested for high cholesterol, they know they have it, otherwise there would not be commercials for high grain foods lowering cholesterol, thereby motivating patients to take action.
That is why the OTC switches fail often for condition-related ailments, because there was no showing that, as in the case of herpes, doctors don’t generally follow guidelines on this issue, they listen to patients. And further, there is no showing of evidence that patients can, in fact move or can treat their own conditions, as in the case of high cholesterol, once they know their status.
This represents several lessons for health care communicators.
- First, the pipeline is more complicated, so there need to be studies that demonstrate that patients are ready for more complicated drugs on the OTC front – that not only treat their symptoms, but treat their conditions and that show they can readily self-diagnose in this era of heightened ability given the Internet.
- Secondly, it means that companies need to demonstrate that what guidelines predict should happen in a doctor’s office, are not necessarily what is happening. In other words, theory of practice does not always equal fact of practice.
- And lastly, there needs to be a demonstration that consumers are actually able to take more complex medical conditions in hand and treat conditions, as opposed to treating symptoms.
That poses a challenge to industry. There need to be more studies that can demonstrate that patients can self-diagnose, or once they have a diagnosis, can manage their conditions. Without such studies, the OTC pipeline is going to grow much more narrow.