What Are IDEAs Made Of: Hurdles
Mike Rea
IDEA Pharma
Measuring how well a drug works is not easy. The regulators like to put hurdles out - if the drug jumps them all cleanly, it is approved. However, in pharma, the hurdles are loosely described, despite being many yards high. Safety, tolerability and efficacy are all rather vague concepts, and all dependent on which patients you're asking for.
In other industries, the lines between what is allowed to be marketed and what will appeal to deciders is more blurred. Changes in the regulations on fuel economy in the automotive industry, for example, have changed the kinds of car that will be developed and sold in the future. In the EU, for example, the way that claimable economy figures are derived allows manipulation. Because the EU economy test involves driving on a light throttle, and gearchanges are made at a certain predefined spot, the test favours diesel engines, and increasingly favours hybrid engines and turbo engines over naturally-aspirated engines, automated gearboxes over manual changes (the rules allow automatic gearboxes to choose when to change, but specifies when manual gearshifts must be made). Does this reflect the engines' economy in actual driving? Not at all. Is there any pressure to make the test more 'real world'? No. Where would that pressure come from? It should come from consumer groups, but manufacturers are happy to play the game, even though it reduces choice for their eventual purchasers.
"...as long as regulators have panels who vote, you know that humans who have to deal with drugs in the real world are in charge - for right or wrong."
In the food industry, changes in the regulation on what can be promoted to children classified some foods as 'junk' or unsuitable for promotion (effectively ending their business potential). Of course, because the definition can't be subjective, rules had to be set around what classes as junk and what doesn't. Those regulations are now open to 'loopholing' in exactly the same way as any rules are open to players. A TV programme in the UK showed a cereal manufacturer quite openly saying that they had reformulated a Coco Pops sub-brand, not to make it actually healthier for children, but to enable them to re-promote to children. Rules on what schools will buy for lunches enabled one food manufacturer to include pea fibre, which is of no nutritional value, in their pizza recipe, so that the pizzas then reached an overall 'fibre' value, and made it back onto menus (and profit centres).
Never have the statements 'you get what you measure' and 'careful what you ask for' been more true than today. Fortunately, in pharmaceuticals, judgement is used more than hard rules, at least as far as development to launch is concerned (promotion of medicines is, of course, somewhat different…). For as long as regulators have panels who vote, you know that humans who have to deal with drugs in the real world are in charge - for right or wrong.
That introduces a challenge, of course. If the hurdles are even moderately hard to predict, what are your options? Well, you can do what worked before, or what worked for someone else before, and hope that precedence will help. If you choose to do something different, you're into a whole world of unknown. Therein lies the paradox - if you want to launch something that brings something new to the game, you may need a new set of hurdles. Innovating dictates that you either use a set of hurdles that don't fit your product well, but at least don't kill your product, or come up with an entirely new set.
"Therein lies the paradox - if you want to launch something that brings something new to the game, you may need a new set of hurdles."
Most companies opt for the former. Companies that innovate, however, see the opportunity in engaging with people who can change or set the rules, early enough to make a difference. So, panels of (real world) experts decide what will be acceptable in the real world, and then rule on whether the data they're seeing are indeed acceptable. This flexibility is hugely advantageous, and is something that the industry should treasure.
The flip side of this is that those companies who choose to go with precedent can get products approved that no-one is asking for - who can say 'no' when they said 'yes' to something that jumped the same hurdles earlier? This kind of product sits in the 3 in 4 marketed drugs that never return their investment - approvable but undesirable in the real world.
With a choice between certainty and uncertainty, there is a clear driver for the more predictable outcome. However, as the drive to launch innovative products increases, more and more companies will have to start choosing the road less travelled.
About the author:
Mike Rea is a Principal with IDEA Pharma, who enjoys taking a look outside the industry to learn how it can think differently. For direct enquiries he can be contacted on mike.rea@ideapharma.com and for more information on IDEA Pharma please see http://www.ideapharma.com/what/default.htm.
Should we aim for products that are approvable or innovative?
