Pharma R&D failure and success (2)

Estimation of clinical trial success rates and related parameters

The largest investigation thus far into clinical trial success rates and related parameters sheds light on the issue.

We find that the overall success rate for all drug development programs did decrease between 2005 (11.2%) and 2013 (5.2%), as anecdotal reports suggest. However, this decline reversed after 2013. The overall success rate is mainly driven by changes in POS1,2 and POS2,3. The timing of the upward trend coincides with the time period during which the FDA has been approving more novel drugs,compared to the historical mean.

Quite surprising. The accelerated approval by FDA ends with more drugs withdrawn from the market. Therefore, the probability of success is a flawed statistic. It should be adjusted according to regulator criteria.

The changing burden of disease

EVOLUCIÓN DE CARGA DE ENFERMEDAD YCOSTES ASISTENCIALES DE UNA COHORTE POBLACIONAL DURANTE 7 AÑOS

Today we've made a presentation at the Health Economics Conference. The rethoric of increasing chronic conditions requires a precise estimates and cohort analysis is the way to proceed. This is what we have done and you can check the details in p.70 of the abstracts book.

Long-term care funding mess

THE PUBLIC ECONOMICS OF LONG-TERM CARE. A SURVEY OF RECENT CONTRIBUTIONS

Everybody agree that long-term care funding is a complete mess. Ten years after enacting a law, access to services is constrained by funding restrictions and bad design of benefits. A lot of people wait for benefits until die and afterwards the family receive the approval for long-term care.
What should be done?. A recent article reviews the options.

LTC needs are increasing rapidly and neither the market nor the family seem to be able to meet such a mounting demand. Furthermore, the existing public programs are both insufficient and uncoordinated. For these reasons we advocate developing a full-fledge LTC public insurance scheme that would fulfill two objectives: assisting those who cannot count on any family assistance and do not have the financial means of purchasing LTC services and providing the middle class a program that would protect families against too costly spending

Is there enough public money to pay for this?

Obama by Kehinde Wiley 

Health microsystems as the unit of performance analysis

A comparative performance analysis of a renowned public-private partnership for health care provision in Spain between 2003 and 2015

A deep study has been released on performance of public-private partnerships in healthcare in Valencia compared to Spanish NHS. It is an:

Observational study on secondary data from virtually all hospital care episodes produced in 51integrated providers (i.e., administrative healthcare areas) and 67 hospitals, in 2003 and 2015. Alzira’s2015 performance (and its variation since 2003) was compared with all public-tenured peers in the SNHS,using 26 indicators analysing the differences in age-sex standardized rates of events or risk-adjusted mortality, severity-adjusted hospital expenditure and hospital technical efficiency

And the conclusion is:

 In this comprehensive comparative study on Alzira’s performance, this PPP has not generally outperformed public-tenured providers, although in some areas of care its developments have been outstanding.

I agree on the methodology, I can't asses the results and its conclusions because it requires data replication. What it is crucial is the clinical decision making within the health organization (the microsystem and its episodes of care), forget generalizations on public and private and focus on drivers for efficiency in each setting.

PS. Opioid Epidemic CDC data

Natalia Goncharova at Tate Modern 

Wellbeing economics: a prescription letter

A SPENDING REVIEW TO INCREASE WELLBEING
An open letter to the Chancellor

UK has setup an All-Party Parliamentary Group on Wellbeing Economics. That's great!. If there is one thing that should be on the public agenda is wellbeing. However, after reading the last report it's a little bit disappointing. The have decided 6 priorities to take into account in the spending review according to its importance on wellbeing.

1. Health: Scaling up treatment of mental illness
2. Education: Tackling children’s wellbeing in schools 
3. Further Education: A proper start to working life
4. Social care and community services: Investing in social support networks
5. Work: Better wellbeing leads to better productivity
6. Other priority areas

Not so easy...as they say, It's just a letter...

Cohen-Emanuel podcast

Ezekiel Emanuel on the Practice of Medicine, Policy, and Life

Ezekiel Emanuel is a reflection of his upbringing: a doctor for a father who loved to travel, a mother interested in policy and community activism, and all the competition and friendship that comes with growing up closely with two brothers. Put those together and you wouldn’t be surprised that the result is someone who has worked at both the highest levels of, medicine, policy and academia — though the intense interest in jam might surprise you.

Opioid epidemic and the need for urgent measures

Addressing Problematic Opioid Use in OECD Countries

Some months ago I explained my concerns about opioid epidemic. I said that the problem is closer than most people think. In the last five years, there has been a 45% growth in publicly funded opioid prescription  in our country. Now OCDE presents the current situation in a report that highlights where we are and what can be done. The key messages are these ones:

• Better Prescribing: Doctors can improve their prescribing practices, for instance, through evidence-based clinical guidelines (e.g. for opioid prescription, for adequate medication-assisted therapy for OUD patients), prescribers training, surveillance of opioid prescriptions, and regulation of marketing and financial relationships with opioid manufacturers. In addition, patients and the general public can also benefit from clear educational materials and awareness interventions to enhance their opioid-related literacy and reduce stigma.
• Better care: Including the expansion of coverage for long-term medication-assisted therapy (e.g. methadone, buprenorphine, naltrexone) coupled with specialised services for infectious diseases management (e.g. HIV, hepatitis) and psychosocial interventions. Some countries have implemented interventions such as the availability of overdose reversal medications for all first responders, needle and syringe programmes, and medically supervised consumption centres.Quality of care must be improved and measured. 
• Better approach: There can be better coordination across the health, social and criminal justice systems. Governments can consider setting up of coordinated networks among the three sectors aiming to facilitate access to integrated services for people with OUD. In addition to health services, social interventions around housing and employment support, and law enforcement uptake of a public health approach are central.
• Better knowledge and research: Including the use of big data and impact evaluations to generate new information from different sources along with the application of advanced analytics. In addition, quality of care measurement should be enhanced in areas such as opioid prescription, OUD health care services, and patient reported indicators (e.g. PROMs, PREMs). Research and development is needed in key areas such as new pain management modalities and OUD treatments.