The Disruption of #Healthcare to #PrecisionMedicine worst enemies

1: Shareholder value:

Let’s face it, when I talk internally with executives up to board level in Pharma everybody appreciates that many problems in R&D as well as clinical decision making are today “only” technical challenges that can be overcome with bold investments in converging technologies. Just look at the progress we see in diagnosing skin cancer or GRAIL announcing Data on Detection of Early-Stage Lung Cancers an achievement and progress unthinkable just few years ago.

But what would happen, if Abbie et al, the 10 leaders in the rheumatic disease field would come up with a solution to identify by 80% who is responding to their drugs at first diagnosis; i.e. if Humira would not create revenue by treating the wrong patient in up to 80% during the first year of application. Off note, in an earlier post I addressed the fatal consequences this has for patients and payers, since by the contemporary trial and error approach irreversible damage is the standard, not the exemption from the rule. How much suffering and damage is acceptable today? - The unbearably slow transition to #PrecisionMedicine

No let’s assume one player would end this game? Would he be a winner at a stock market, that expects maximized revenue, irrespective the paradox that most shareholders will eventually become patients sooner or later and face the consequences of their short term greed, not only in rheumatic conditions? Definitely not....

What if the 10 leaders would build a syndicate jointly develop a comprehensive diagnostics ecosystem for competing drugs like we see this in Foundation Medicine and other to emerge in cancer.

Still, this would not solve the shareholders “problem” since the market would shrink.

So the only solution to drive the disruption of healthcare away from sick care to #PrecisionMedicine is value based compensation asap.

 The fear factors for shareholders:

We recently say Sanofi & Regeneron struggle pushing a drug into the market with no added value for patients and payers, i.e. Rheumatoid arthritis med Kevzara (sarilumab) booked €7M (~$8.5M) also lagging by ~$7M. in this multi Billion US$ market.

Maybe this indicates a market is satiated with seeminly equally but not distinguishable products, a market that is now even open to biosimilar and next generation (from my view incrementially more effective if at all oral drugs). All together little progress, definitely not #PrecisionMedicine, while innovators lure around the corner and regulators seemingly expect significant added value for patients and payers from new products. Maybe taking a "risk" and engage early to safe a first mover advantage would not be a bad idea for big Pharma, Biotech and Diagnostics leaders?!

Off note, who needs biosimilars, if we still can not treat the right patient with the right drug first diagnosis as industry and academic protrait the bold future with their #PrecisionMedicine slogans? These copycat products only consume massive marketing budgets and bind resources from needed bold investments in R&D for the future and benefit of patients and societies.

2: ICD 10:

Why is a labelling system generated mainly for compensation purposes an enemy of innovation? First of all, for most diseases we have no molecular definition like we see this emerge in cancer, where the localization is not anymore the sole guidance for classification or therapy, but the genomics profile. Second, manmade diagnoses are simply very unprecise, change over time and thus, the labelling constitutes a major bias affecting all medical records, clinical databases, biobanks etc.

Just one example in lay terms: Humira works in very different ? conditions like Rheumatoid Arthritis, Psoriasis, Inflammatory Bowel Disease and more to come, but only in subsets of clinically diagnosed conditions. Is it not logical to assume that the responders to this specific treatment have more in common than this is evident in their medical record stratifying those to different diseases. In other word, what is needed are molecular maps of health and disease generated unbiased and agnostics from clinical diagnostics.

Honestly, given the current clinical settings, diagnostics approaches in order to comply with medical guidelines and reimbursement practices I do not see how we can overcome the barriers to generate what is key to disrupt medicine. Bold initiatives like All of US or Verily’s approach to data harvesting may be only one first step, while generating multi-omics longitudinal phenotypes will need much more aggressive engagement of all stakeholders. From a business prospective this is a unique and largely untapped opportunity for Pharma, Biotech and related investors to challenge the intruders in their home turf like Amazon, Tencent, Google and alike, as outlined in another earlier post Why and how AMAZON will disrupt and dominate health care in 2025 - Will AMAZON buy Roche?

The one that has the best data (and algorithms) will win, free after Andrew Ng.

Way to go (Sponsored by J&J):

“Our understanding of inflammatory disease etiology will be boosted further by studies using multiple omics platforms. By embracing big data and integrating host genetics with longitudinal proteomics, metabolo-mics, immune cell phenotyping, microbiome and clinical data, the extent to which host genetics modulate immune responses, and whether any particular factors are associated with disease may become apparent. Longitudinal data sets will also be helpful resources to define what con-stitutes a healthy human immune system, the degree of variability between individuals, and how host-environment interactions shape immune responses, disease susceptibility and response to therapy. If begun shortly after birth, these data sets might even allow us to track the development of the immune system.”

                                                ”Big data meets mechanism” Nature Medicine 21, 673 (2015)

Apparently it only needs someone to do it.....

3: MDs and payers:

Apologies to my colleagues serving in clinical etc.! The system MDs are embedded within fosters labelling patients in a way that maximizes optimal exploitations of the budgets that MDs have for a patient, at least in the German public compensation systems. This creates a biases to see and label what is ideally optimizing patients and MDs interest, where patients may not receive a certain treatment if they get not diagnosed a certain way or in a distinct decision trees and/or where an MD might be payed less even if she/he would try to save money. This is all legal, paradox and actually creating perverted divergence of interests.

Talking about chronic debilitating diseases ranging from depression over cancer to chronic inflammatory/autoimmune diseases: Again in Germany, the sooner a patient completely deteriorates, i.e. loses the capability to be productive and create his own income (also for his family) the sooner he will be pushed from the public healthcare system to the retirement plan, if his has one, otherwise he will be subject to social security and governmental support. Obviously payer want to get rid of chronic expensive patients asap.

This system comes not only close to insanity, but it is that cryptic, self serving and inert to change, that progress towards #PrecisionMedicine including precise prevention seems somewhat illusive in regulated “modern” healthcare systems. Other payer provider systems may face similar challenges to overcome, in particular the more they are subject to commercial interest in free markets with their own rules.

A bold vision:

It should be doable in less than 5 years to generate a multi-omics profiles like described in the Nature article above every year from an individual to compare this against a reference database and enable prevention ideally even of fatal diseases, if we could somehow generate the databases AND a compensation system that rewards maintenance of health and truly tackles the explosion of health care costs and challenges that will arise from an ageing populations.

Our roadmap @Innventis for #RheumatoidArthritis and other chronic inflammatory/autoimmune diseases including rare autoinflammation

“Given the heterogeneity of most rheumatic diseases, the diverse molecular pathways mediating their pathogenesis and the multifaceted roles that these pathways have in normal and pathological states, advances in treatment are likely to require approaches that integrate genomic, transcriptomic, proteomic, metabolomic and autoantibody profiles, such as the recently described integrative personal omics profile, or iPOP.”

                                              Nat Rev Rheumatol 2015 Nov; 11(11): 626–628

But where will progress arise?

The fear factor for the western world

I hope this fear factor will foster some actions in particular in executive boards and goverments. Nations and healthcare systems like China, UAE, i.e. very differently organized and regulated healthcare systems and markets have the potential and resources including $$$ to leapfrog our frozen healthcare and R&D ecosystems with disruptive solutions that will outpace any development we can foresee in our conventional ecosystems for innovation with the exception of countries like Israel, Estonia, Malta and few others that are truly going digital and have already modern healthcare systems.

3 ways China is leading the way in precision medicine @WEF

Israel to Invest $275 Million in Digital Health Project

Estonia Offers Free Genetic Testing to Residents

For futher discussions please connect and join the group (50% Senior/Director /CXO; 11.000+): PRECISION MEDICINE Insight The most active, content rich group re "Precision Medicine" @LinkedIn Here is the link: https://www.dhirubhai.net/groups/5180384

Look forward to your comments.