In vitro, veritas

El Diagnóstico In Vitro Hoy. Un cambio de paradigma en la calidad de vida y en el proceso de atención a los pacientes

A new report highlights the role of clinical laboratory in medical decision making. Though its increasing complexity, it requires larger recognition in terms of the value that creates. Some selected statements:

Desde el punto de vista de los costes, el IVD es económicamente muy accesible, tanto por su competitividad en costes de producción como por no necesitar de grandes inversiones iniciales en equipamiento: – El IVD consume una proporción de recursos de los hospitales muy baja, inferior en todos los estudios al 4% del coste hospitalario y supone en promedio un 0,8% del total del gasto sanitario4. – La mayoría de equipamientos se ceden mediante la contratación de los reactivos, lo que elimina la barrera de inversión inicial para su adquisición 

El Diagnóstico In Vitro es sin duda el proceso diagnóstico más utilizado con carácter habitual. A diferencia de otros grandes equipamientos diagnósticos que se utilizan muy selectivamente, el IVD se utiliza masivamente para la gran mayoría de pacientes y en la mayoría de los actos asistenciales.

Paradójicamente, y a diferencia de otros equipamientos, el IVD es cada vez más complejo tecnológicamente, pero también más simple en su utilización. La innovadora y alta tecnología incorporada internamente contrasta con la apariencia de simplicidad. – Si se compara con otros equipamientos médicos de alta tecnología, como los de diagnóstico por la imagen o de cirugía robótica, los equipamientos de IVD, cada vez más pequeños, automatizados y fáciles de utilizar, tienen una visibilidad más bien escasa.

I suggest a close look.

 Yesterday Impressionist Art Auction at Christie's

Resource allocation principles and process

Public Preferences About Fairness and the Ethics of Allocating Scarce Medical Interventions

Fair allocation of health care resources is a challenge that we can't solve strictly with some criteria or principles. Of course, we do need some benchmark but we require a fair and transparent process. This is precisely the focus of a chapter by Govind Persad in a recent book. The key issue is how in fact resources should be allocated.

Society is ultimately interested not only in empirical surveys of how its members believe medical interventions should be allocated, but also in answers to the normative question of how medical resources should be allocated.

Survey methods, experts opinion,...

Even though public attitudes do not directly determine the solution to moral problems, empirical research into public attitudes can be useful in a variety of  ways. By showing which beliefs are popular among the public, or which beliefs are points of division, empirical research can help to focus moral inquiry on those claims or beliefs, thereby ensuring that philosophical reasoning is relevant to real-world problems. Furthermore, even though popularity does not constitute correctness, the unpopularity of a normative position can justify placing it under scrutiny.

Pharma R&D failure and success

Clinical Development Success Rates 2006-2015

In the russian rulette as a lethal game of chance you may have 1/6 chance of being shot. If the chamber of the revolver holds 6, a 16,6%.
In drug industry the probability of R&D failure is 90.4%. We all know that in the drug cost we are paying also for failures, but we forget the figure.

These are the key takeaways of the report:

• The overall likelihood of approval (LOA) from Phase I for all developmental candidates was 9.6%, and 11.9% for all indications outside of Oncology.
• Rare disease programs and programs that utilized selection biomarkers had higher success rates at each phase of development vs. the overall dataset.
• Chronic diseases with high populations had lower LOA from Phase I vs. the overall dataset.
• Of the 14 major disease areas, Hematology had the highest LOA from Phase I (26.1%) and Oncology had the lowest (5.1%).Sub-indication analysis within Oncology revealed hematological cancers had 2x higher LOA from Phase I than solid tumors.
• Oncology drugs had a 2x higher rate of first cycle approval than Psychiatric drugs, which had the lowest percent of first-cycle review approvals. Oncology drugs were also approved the fastest of all 14 disease areas.
• Phase II clinical programs continue to experience the lowest success rate of the four development phases, with only 30.7% of developmental candidates advancing to Phase III.

PS. The growth in R&D expenses was 14% in 2016, while revenues grew 4% (p.36).

Public funding of succesful Pharma R&D

Contribution of NIH funding to new drug approvals 2010–2016

If we consider the 210 new molecular entities (NMEs) approved by the Food and Drug Administration from 2010–2016, then you'll find that NIH funding contributed to published research associated with every one. A PNAS article explains that:

Collectively, this research involved 200,000 years of grant funding totaling more than $100 billion. The analysis shows that 90% of this funding represents basic research related to the biological targets for drug action rather than the drugs themselves. The role of NIH funding thus complements industry research and development, which focuses predominantly on applied research. This work underscores the breath and significance
of public investment in the development of new therapeutics and the risk that reduced research funding would slow the pipeline for treating morbid disease.

This public funding is forgotten in the costs of a new molecule. Although in the price, the manufacturer surplus doesn't remunerate such contribution. Some adjustment should be applied, to be fair.

 Brassai at Mapfre Foundation in Barcelona

Digital medicine, or just medicine

Digital medicine, on its way to being just plain medicine

You may remember at the begining of this century. Everybody was talking about e-business and right now nobody talks about it, because it is just business.The same will happen with digital medicine, it ill be just medicine in the next future. A future that is closer than you may think. And this is what E. topol explains in the editorial of the new open journal, and says_

And finally, quite paradoxically, we hope that npj Digital Medicine is so successful that in the coming years there will no longer be a need for this journal, or any journal specifically focused on digital medicine.

I agree. But meanwhile, somebody should review current syllabus and studies of medicine, to introduce a change in the profession and the scope of practice.

Spending a lot for many years: understanding persistence

Long-Term Health Spending Persistence among the Privately Insured in the US

If you don't want to read this article, check this presentation. It is one of the best efforts to understand persistence of health expenditures. Summarised findings:

First, persistence by demographic characteristics is generally lower than persistence by co-morbidities. Because co-morbidities are harder to assess, particularly for new enrollees, than demographics, this highlights the need for robust risk prediction models. 

Second, people with a co-morbid condition relative to those without the condition are considerably more likely to be in the top 10 per cent of spenders in year t regardless of whether they were in the top 10 per cent in year t–1. However, people with a co-morbid condition are even more likely to be in the top 10 per cent in year t if they were also in the top 10 per cent in year t–1.

Third, those most likely to be in and remain in the top 10 per cent are those with myocardial infarction, congestive heart failure and peptic ulcer disease and in several psychiatric diagnostic groupings, which indicates that these conditions might be appropriate targets for longer-term disease management programmes.

Fourth, although most conditions are less common at younger ages, when they do occur they are more predictive ofpersistently high spending at younger ages, as almost all conditions have the highest predicted probabilities on being in the top 10 per cent of spenders in the following year when they occur at ages under 25 and the lowest predicted probabilities when they occur in the 65-and-over population. Essentially, the presence of a condition at a younger age more clearly differentiates a person’s health care trajectory from that of their peers.

These are conclusions for US population, closer studies are needed.
PS. An article written 23 years ago, on concentration and an abstract 11 years ago.

How morbidity explains health expenditures in ageing

Ageing and healthcare expenditures: Exploring the role of individual health status

Everybody admits that ageing increases health expenditures. However the dynamics of this growth, and the factors that contribute it, are less known. In our recent article, we explain why morbidity is the main factor that explains growth of health expenditures in ageing. In our analysis, closeness to death is not the main cause.

Regardless of the specific group of healthcare services, HCE at the end of life depends mainly on the individual health status. Proximity to death, sex, and marginally age approximate individual morbidity when it is excluded from the model. The inclusion of morbidity generally improves the goodness of fit. These results provide implications for the analysis of ageing population and its impact on HCE that should be taken into account.

We do need further research on the cost and intensity of care in the last months of life, and this is our next challenge.