Micro customization

Recent news (1) that a gastric resident delivery mechanism can deliver reliable, sustainable doses of agents for the long term is important. Innovation in chemical agents has moved ahead of mechanisms that would deliver them at the right time, in the optimum dose, by the best route and to the most receptive site. The ability to optimally deliver the agent is likely more important than the agent itself. In the absence of such delivery mechanisms, manufacturers have stuck to the original blue print - mass manufacturing of pills in a singular dose that shows the best therapeutic index in the population. Personalized medicine, thus, has remained elusive and more importantly, outside the business models of manufacturers.

It may be changing. Ironically, providers have moved ahead of other participants in the healthcare value chain, in the implementation of personalized medicine. Recent advancements in Artificial Intelligence and the availability of abundant data have better  positioned the providers to understand, treat and manage patients, individual by individual. If delivery mechanisms improve and become individually customizable, we can rapidly move into the next level of personalized medicine. Here, we can envision devices that can measure, decide and disburse micro doses to assure optimum delivery and complete compliance. Intelligent devices could be just round the corner, taking advantage of IoT. With embedded intelligence on board, such devices can not only operate as initially primed but also self learn and adjust over time. A couple of decades from now, medical professionals will likely view the current regime to be completely archaic.

More generally, any business that is driven by scale, a blind adherence to singular specifications, will have great difficulty to survive in the future. Technology is readily available, not just for mass customization but rather for individual intervention. This is a regime change that will affect every industry and every business. Getting ahead of this rapid transformation is a necessary condition for success.

(1) A gastric resident drug delivery system for prolonged gram-level dosing of tuberculosis treatment. Verma et al. http://stm.sciencemag.org/content/11/483/eaau6267

Type 2 Debate

A recent article (1) brings the current diagnostic and treatment regimens for those who are deemed to be at risk for progressing into Type 2 Diabetes, into question. The arguments are fair and the conflicts are clear. But what the article misses is the risk/return trade-off for the wretched condition. The total cost of diabetes related cost in the US alone is fast approaching $0.5 Trillion. With India and China running fast to the precipice, happily feeding on Western food, we do have a significant issue to deal with.

So, there are two important questions. First, do we have a reasonable idea of the risk of incidence and progression? Age old heuristics such as fasting blood sugar has been shown to be utterly useless.The current golden metric, A1c, is likely equally flawed. The answer to this question appears to be an emphatic no. And second, are the people in charge of prescribing the thresholds for diagnosis and prevention influenced by factors outside science. Unfortunately, the answer to this is likely yes.

Medicine has always shunned data and analytics in making decisions. This has set them so far behind, the US spends close to 20% of its GDP for worse outcomes. And aging regulators, still using century old statistical measurements to make decisions, makes this worse. The manufacturers, bloated with conventional statisticians, ever ready to prove what the regulators seek, are progressing backward in time. So, it is not surprising that we have ended up in a confusing muddle regarding a disease state that affects close 20% of the world population.

Now, what? It is easy to show statistics that claims only 2% of the pre-diabetics progress into diabetes. Since we are unclear as to the "precise," demarcation between pre and post diabetes, a more relevant question is what the total cost is on the system. A few thousand years ago, humans invented agriculture - and it clearly had an impact on their health. Meat eating humans for millennia, moved to stuff their bodies are not designed to process. In the last hundred years, they had too much to eat and that will certainly create problems not only for their organs, efficiently designed for very little food but also their infrastructure, designed for a slim body. Half the world's population now exceed the parameters of original designs.

Medicine has to embrace modern technology. Doctors should not be simply following rules put down blindly, regulators have to open their windows and realize that the "p-value," is a dead construct and manufacturers need to understand that their job is not a constrained optimization based on what the regulators think.

It is time for the industry to move on.


(1) https://www.sciencemag.org/news/2019/03/war-prediabetes-could-be-boon-pharma-it-good-medicine