You’re not going to be able to achieve success in eradicating this scourge with first world technology; you’ve got to get things that can be run out in the middle of nowhere with no electricity supply and really nothing but the sun as your energy source. Water may be available, but it is likely of poor quality in terms of contaminant content. When dealing with inhaled therapeutic needs in emerging countries, the key seems to be to put solutions together that work in the context of the often highly limited available resources.
Q: What about the question of cost in general? Even in the United States, a large percentage of asthma and COPD patients cannot afford their inhalers.
A: That’s partly why we, as the community of drug product and device developers, are continually being challenged to get cleverer at our “art.” This problem is a political issue as well. On a personal level, I think that affordability is something that we can do an awful lot more about.
The situation in Canada, where I now live, is somewhat better than in the USA, because there is government support for many medical-related costs, especially for the very young and elderly. However, affordability is not as good as it could be. I don’t like making political statements, but I think we’ve got to reconsider implementing a more socialistic approach to medicine, especially where it’s essential to save life.
My rationale for this statement is that in the long run the cost to the ultimate payers (insurers or government) will likely be less compared with the expense of remediating poorly or untreated chronic diseases, such as asthma and COPD. For instance, the cost of a single severe exacerbation for COPD, can be more than $10,000, so why not treat-to-prevent such occurrences at a cost of a few hundreds of dollars?
Q: What about the techniques you are developing to simplify inhaler testing – will they reduce the cost of these products?
A: That’s what we ultimately hope that AIM and EDA will do. However, we first need to garner enough support scientifically to prove that these concepts do what they are supposed to do. Both EPAG and IPAC-RS have active involvement in follow-up studies whose goals are to provide validation using currently marketed products.
Eventually, if we are successful at demonstrating the robustness of each concept to stakeholders, there is the prospect of being able to reduce testing associated particularly in both early-phase development and batch release of commercial products. However, we have to recognize that those charged with the responsibility for approving products in this tightly regulated industry, are reliant on records that provide proof that new ideas such as these do not add to the risk burden for either the patient or manufacturer.
Drug product and device manufacturers are very sensitive to this issue because there’s huge liability if something goes wrong, and because small changes to such processes can have a large effect on the balance sheet.
We are backing AIM and EDA concept-related experimental work with cross-industry studies intended to provide validation of robustness so that we can say to the regulators: “Look, there’s a scientifically justifiable reason why either or ideally both approaches can be adopted into the mainstream of practice, and here are the data to prove it.”
