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.

The outcomes of a bundled payment system

Evaluation of Medicare’s Bundled Payments Initiative for Medical Conditions

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

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 (!)

HCB in Palafrugell

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.

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.