29 d’agost 2018

The paucity of public information about medical devices

The need for transparency of clinical evidence for medical devices in Europe

Last year EU approved a new law for assessing safety and efficacy of medical devices. Unfortunately, it comes late and it is not enough to solve current situation of lack of information on evidence. An article in Lancet explains precisely what should be done to increase the transparency of information on medical devices.All the details in this list:




 A small task force of regulators and invited stakeholders has recommended what information should be included in the summaries of safety and clinical performance and which components of the Eudamed database need to be open to public access. Those recommendations are now under revision. The European Commission has been delegated authority to translate them into further legislation, but it has indicated that it does not consider that to be a priority. Any member of the public or any organisation with an interest in these issues should therefore make representations now to the European Commission. The medical device regulations will take effect from 2020.
The time is now.

28 d’agost 2018

The outcomes of a bundled payment system


The measurement of episodes of care is a precondition for understanding the cost-effectiveness of health care. Unfortunately there are few experiences on this issue. The largest demonstration in US, The Medicare Budled Payment for Care Improvement Initiative started in 2013 and finished in 2017. The NEJM publishes an article that evaluates the outcomes of such experience.
In summary, hospital participation in five common medical bundles under BPCI, as compared with nonparticipation, was not associated with changes from baseline in total Medicare payments per episode, case complexity, length of stay, emergency department use, hospital readmission, or mortality.
If this is so, it is necessary to understand the reasons behind such failure. The article provides some of them. My guess is that the episodes were not holistic in the scope of services (not including post-acute care i.e.) and were constrained to several episodes. Unless a holistic approach is taken into account (all episodes and all services), incentives will not be working in the appropriate way, the cost-effective one. Excellent article and research effort that explains an unexpected and unfavourable result, no bias of publication. Good example.

Maya Fadeeva

27 d’agost 2018

Everyone Deserves Good Health Care

The promise and peril of universal health care

Poorly functioning health systems are a central challenge to realizing the benefits of UHC. Health systems in LMICs commonly suffer from a variety of weaknesses, including absenteeism and insufficienttraining among health care workers, mistreatment of patients by health care workers, corruption, poorly functioning inventory systems and supply chains, electricity cuts and outages, and lack of clean water. These shortcomings in health care delivery often reflect higher-level problems in governance and market failures. Achieving UHC will therefore require innovations in the structure and operation of health systems to ensure that rapid expansion in coverage is not undermined by shortcomings in delivery and quality of care
This is the statement I have picked up as a key message in an excellent article about universal health care (UHC) in Science. The issue goes beyond appropriate financing, and unless countries take decisions for better organization and governance, more promises (on financing) may get more perils (unexpected outcomes).

PS. By the way, the paper is written by US scholars, that forget that US doesn't have UHC! They only talk about low and middle income countries.

PS. Check the latest change of universal health care in Spain, the weirdest health financing system of the world, neither social security, nor national health system, both at the same time (!)

26 d’agost 2018

Are we prepared for CRISPR?

¿Estamos preparados para la edición genética?

The July-August issue of La Maleta de de Port-Bou publishes several articles on ethical and societal implications of CRISPR. It is specially helpful for those that have never read anything about it before. Tomàs Marquès provides an introductory text in accesible language. The conclusion after reading all the articles is that we are not prepared for CRISPR, but we are never prepared to understand all the uncertainties surrounding any innovation. The key question is to analyze concrete implications of outcomes and define what should be done.
My surprise was that you'll not find any reference to the word epigenetics. And most of the articles seem to focus on the genes as our fate. As you know, "We are not our DNA". Therefore, take care while reading it.




25 d’agost 2018

The US opioid crisis: the public health epidemics that never should have happened

Pain Killer:An Empire of Deceit and the Origin of America’s Opioid Epidemic
DOPESICK: Dealers, Doctors & the Drug Company that Addicted America

In 2018, an opioid epidemic that began two decades earlier with OxyContin finally seized the nation’s attention. Over 250,000 Americans had died from overdoses involving prescription painkillers. Every day, hospital emergency rooms nationwide treated 1,000 people for abusing or misusing these drugs. Prescriptions written for narcotic painkillers—and overdoses associated with the drugs—had started to slowly decline. But counterfeit versions of fentanyl were rapidly driving up the overall numbers of overdose deaths.
The more you know about it, the more you get concerned about how this tragic epidemics could have been avoided. The details explained in a book written 15 years ago, and reedited now, are horrendous.
The connection between pharma sales promotion, lobbying and an inappropriate regulation is a dramatic story that has a known outcome: 65,000 deaths a year from addiction to oxycodone and fentanyl.
The “opioid crisis” is actually two separate crises, each with its own causes and solutions. One involves illegal narcotics, such as counterfeit fentanyl, and requires the attention of law enforcement as well as compassionate treatment for those addicted to these lethal drugs. The other crisis lies in the medical use of opioids, and its solution is much easier. There is no question that opioids, particularly when used at low dosages, work for some patients who can’t otherwise find relief. But if companies value their employees, if governments want to reduce the number of people addicted to opioids, if doctors want the best for their patients, then a new approach to the treatment of pain must become a priority. Many experts believe that most types of pain can be successfully treated with methods popular before the opioid era began, such as physical therapy, exercise, behavior modification, and non-narcotic drugs. Many institutions have begun to adopt these methods, and federal officials recently recommended that doctors limit opioid dosages and switch to another type of treatment, rather than raise the dosage, if patients don’t respond. Some states have taken the more draconian step of limiting the number of opioids a doctor can initially prescribe, to just a few days’ supply.
For two decades, drug companies such as Purdue used pain patients as shields and surrogates to advance their corporate interests. For pain treatment to change, patients will need to fight to put their concerns ahead of these interests, and doctors, employers, hospitals, and other institutions have to become fierce advocates for treatments outside the flood of narcotics that has proved so profitable and expedient for drugmakers and insurers. The lesson of the past two decades is a clear one. Change is not optional. It is essential if we are to alter the cascade of death, addiction, and despair that is now a fundamental part of American life.
In another recent book, you'll find the emotional side of the loss, how mothers lost their sons and the impact. Both books illustrate a national emergency that the government has recognised now, after two decades!

PS. Latest article in FT

PS. If you want to know what's going on in our country check this report. Five years growth in publicly funded opioid drugs: 45%!!!. Public health officials and prescribing physicians should read both books before it is too late.





20 d’agost 2018

Population-based genomic medicine in an integrated learning health care system

Patient-Centered Precision Health In A Learning Health Care System:Geisinger’s Genomic Medicine Experience
The Path to Routine Genomic Screening in Health Care
Medicine's future

If you want to know a latest development on the implementation of precision health, then Geisinger Health System is the place you have to go. And the Health Affairs article explains the details about the initiative and MyCode biorepository.
In 2014 the MyCode initiative began to conduct whole exome sequencing and  genotyping on collected samples, as part of a collaboration with Regeneron Pharmaceuticals and the Regeneron Genetics Center.12 Whole exome sequencing analyzes genes that code for proteins and associated gene regulatory areas—about 1–2 percent of the whole genome containing the most clinically relevant information. To date, nearly 93,000 exome sequences have been completed.
 The rapidly changing knowledge about gene-disease associations requires a process to reanalyze previously analyzed sequences and incorporate new knowledge about variants’ pathogenicity. Approximately 3.5 percent of participants have a reportable variant. As of January 2018, results had been reported to over 500 MyCode patient participants.
Interesting article, a private initiative of public interest. More info in: Science and Annals




19 d’agost 2018

Regulatory capture (once again)


Nowadays, news on pharma industry capturing the regulator are not new. When everybody thought that some laws would provide a new ethical framework to avoid such capture, the result is exactly the opposite. It has improved and increased its sophistication. Have a look at Science and you'll understand what I'm saying.
An analysis of pharma payments to 107 physicians who advised FDA on 28 drugs approved from 2008 to 2014 found that a majority later got money for travel or consulting, or received research subsidies, from the makers of the drugs on which they voted or from competing firms.
 Of the more than $26 million in personal payments or research support from industry to the 17 top-earning advisers—who received more than $300,000 each—94% came from the makers of drugs those advisers previously reviewed or from competitors
 Through web searches and online services such as LinkedIn, however, Science has discovered that 11 of 16 FDA medical examiners who worked on 28 drug approvals and then left the agency for new jobs are now employed by or consult for the companies they recently regulated.
Definitely, the regulatory system is broken.

12 d’agost 2018

Searching for principles to inform societal decisions

Health Economics from Theory to Practice: Optimally Informing Joint Decisions of Research,  Reimbursement and Regulation with Health System Budget Constraints and Community Objectives

Cost effectiveness analysis without a clear understanding of budget impact is a theoretical effort with limited consequences in practice. If you want a clear view of the whole process and go beyond cost-effectiveness, a new book tries to summarise the current state of the art.
I'm not so sure that the title "Health economics from theory to practice" really fits with content you expect, but think about a different title "cost-effectiveness from theory to practice" and this is precisely what you'll find.
This book provides a robust set of health economic principles and methods to inform societal decisions in relation to research, reimbursement and regulation (pricing and monitoring of performance in practice). We provide a theoretical and practical framework that navigates to avoid common biases and suboptimal outcomes observed in recent and current practice of health economic analysis, as opposed to claiming to be comprehensive in covering all methods. Our aim is to facilitate efficient health system decision making processes in research, reimbursement and regulation, which promote constrained optimisation of community outcomes from a societal perspective given resource constraints, available technology and processes of technology assessment. Importantly, this includes identifying an efficient process to maximize the potential that arises from research and pricing in relation to existing technology under uncertainty, given current evidence and associated opportunity costs of investment. Principles and methods are identified and illustrated across health promotion, prevention and palliative care settings as well as treatment settings. Health policy implications are also highlighted.
And the conclusion:
The framework and methods presented have been shown to enable optimising of joint research, reimbursement (adoption and financing) and regulatory (pricing and practice monitoring) processes and decision making. Jointly addressing these related decisions has been shown to be key in meeting current and future challenges of baby boomer ageing and more generally in identifying areas for policy reform to enable a pathway to budget-constrained optimisation of community net benefit. The bottom line for such reforms is that better use of existing programmes and technologies and associated research that reflect community preferences is required and particularly now in facing the challenge of budget-constrained successful ageing of the baby boomer cohort.

04 d’agost 2018

Why shopping for healthcare doesn't work

Austin Frakt says in his blog and NYT:
Each year, for well over a decade, more people have faced higher health insurance deductibles. The theory goes like this: The more of your own money that you have to spend on health care, the more careful you will be — buying only necessary care, purging waste from the system.
But that theory doesn’t fully mesh with reality: High deductibles aren’t working as intendedHe refers specifically to this NBER paper and the summary is :
We could provide physicians with price, quality and distance information for the services they recommend. Further, with financial bonuses, we could give physicians (instead of, or in addition to, patients) some incentive to identify and suggest lower-cost care. An alternative approach is for insurers to refuse to pay more than a reasonable price — like the market-average — for a health care service, though patients could pay the difference if they prefer a higher-priced provider.
Leaving decisions solely to patients, and just making them spend more of their own money, doesn’t work.
I you want to understand why shopping for healthcare doesn't work, have a look at this book:


03 d’agost 2018

Talent in healthcare

Talent Management in Healthcare Exploring How the World’s Health Service Organisations Attract,
Manage and Develop Talent

I've always thought that we devote too few efforts to understand current talent in health care and the ways for improving it. And a new book on this topic is really welcome. If you have a look at the index you'll be convinced that these are the issues to take into consideration:
1  No Health Service Without a Health Workforce
2 The Changing Landscape of Healthcare
3 Defining Talent in the Health Sector
4 The Boundaries of Talent Management
5 The Talent Management Evolution Matrix
6 Talent Strategy: Alignment and Integration
7 Succession Planning and Leadership Development
8 Whole Workforce Development
9 Attraction, Recruitment and Resourcing of Talent
10 Talent Management and Employee Engagement
11 Retaining Talent in Health Sector Organisations
12 The Role of the Board, the Executive Team, Line Managers and HR Professionals in Talent Management
13 Twenty Important Conclusions About Talent Management in the Health Sector


At least UK is really trying to define a new model, and the Topol Review summarises the whole effort. I suggest a close look at it. You'll find the interim report here.