The innovator dreams of conditions that are common and for which there are untested treatments. There are many conditions that present in primary care that might fit the bill. Conditions that improve in time regardless of what is done for them. Here are a few examples from a very long list:
- Common Cold
- Plantar Warts
- Molluscum contagiosum
- Ankle Sprain
Yet there are a number of apparently effective treatments for some of these that have been known for decades. However few have been tested formally in randomised clinical trials. Our team recently attempted to test a traditional remedy in an RCT. Without that evidence the treatment cannot be recommended, even though the ‘gold standard’ can hardly be said to be effective. Ethics committees require patients who are offered participation in a trial to give informed consent. That’s as it should be. There are documents to read, special appointments to make, then follow up for a number of weeks to determine if the treatment is working and then yet more form filling to assess the impact of the treatment. Our team is good at this sort of thing. We design documents that are easy to read and procedures that are simple to follow.
So Jean turns up with 12 year old Megan after school because has been told by the teacher that Megan can’t go swimming until she has had her warts treated, or Megan has been complaining that the warts are bothering her. Mum knows, or has heard from the woman next door that the doctor can ‘burn’ them off. Not that in many cases the treatment has to be repeated and that mostly it doesn’t work. And then she is told- ‘ Well there is this trial we are doing…….. blah, blah.’
Never mind that just burn them off doc.
Cryotherapy stings as Megan will discover. The trial treatment is virtually cost free and painless and if it doesn’t work then you still have the cryo option. However mum has been persuaded that cryo works and isn’t interested in anything else- especially something that involves form filling. The woman next door says it worked for her little Freddie. Doctor may not have time to debate the case for testing an alternative in a busy clinic- so the idea is jettisoned and Megan is ushered into the treatment room for cryotherapy.
Here lies a major challenge in testing treatments for which an immediate commercial return is not on the cards. Pharmaceutical companies may not want to put effort into testing something that is unlikely to generate profits and what’s worse is that practitioners may not be willing to invest time promoting research that the patient deems inconvenient. It cannot be assumed that the beneficiary of innovation will participate in a trial if the established treatment is moderately effective and at that point in time convenient.
Picture by Mirko Fontemaggi