How bad health regulation leads to unsafety medical devices in Europe

Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Unión and United States: cohort study

The topic sould be at the top of health policy agenda (at least as it is in this blog). New evidence confirms the additional safety risks of european bad regulation.

In the European Union, medical devices are approved by private notified bodies if they meet performance criteria and are likely to be safe, but notified bodies generally do not require evidence of effectiveness for most devices. Many high risk devices are approved faster in the EU than in the United States, where the Food and Drug Administration usually requires prospective clinical trials of such devices.

And the results are in BMJ:

The unadjusted rate of safety alerts and recalls for devices approved first in the EU was 27% (62/232) compared with 14% (11/77) for devices approved first in the US. The adjusted hazard ratio for safety alerts and recalls was 2.9 (95% confidence interval 1.4 to 6.2) for devices approved first in the EU.

This means exactly 2.9-fold greater rate of safety alerts and recalls and a 4.6-fold greater rate of recalls than devices approved first in the US  (and if you look at the confidence intervals you'll get more worried).  How can we trust the european regulator?. For decades, European Union has leaved its citizens with less safety protection than is required for medical devices. A perfectly designed absurdity to disseminate risk for european citizens that the new proposed regulation is unable to correct.

PS. If you wnat to understand the differences between EU and US regulation, read this NEJM article or Milbank one..

European Union Health: in the middle of nowhere

Joint Report on Health Care and Long-Term Care Systems and Fiscal Sustainability

If there is an example of how one part of an organization can't speak with the other is the European Union and Health Policy. If we are talking about medical devices, health issues are at the back, industry is writing the regulations. If we are talking about options for improvement, economics unit  explains what health unit has to do. A perfectly designed mess.
Take the example of this week. A Joint report, that is an economics report with elementary mistakes for any health economist. Take this statement:

"Competition between hospital providers can lead to higher quality under strict price regulation." (p.70)

Does anybody know what does really mean strict regulation? Who is writing such things and being paid with our taxes?.
If you check another report on the topic by experts of the European Union you'll find an opposite recomendation.

"The conditions for competition to be a useful instrument vary across countries, health care subsectors and time. There is no golden rule or unique set of conditions that can be met to ensure that competition will always improve the attainment of health system goals." (p.4)

Definitely, the EU is in the middle of no judicious health policy.
In summary, an avoidable report that you can skip reading and devote your time to hearing Bob Dylan music for example, the new Nobel Prize.

 

The Times They Are A-Changin'

Bob Dylan

Come gather 'round people where ever you roam
And admit that the waters around you have grown
And accept it that soon you'll be drenched to the bone
If your time to you is worth savin'
Then you better start swimmin' or you'll sink like a stone,
For the times they are a' changin'!
Come writers and critics who prophesy with your pen
And keep your eyes wide the chance won't come again
And don't speak too soon for the wheel's still in spin
And there's no tellin' who that it's namin'
For the loser now will be later to win
For the times they are a' changin'!
Come senators, congressmen please heed the call
Don't stand in the doorway don't block up the hall
For he that gets hurt will be he who has stalled
There's a battle outside and it's ragin'
It'll soon shake your windows and rattle your walls
For the times they are a' changin'!
Come mothers and fathers throughout the land
And don't criticize what you can't understand
Your sons and your daughters are beyond your command
Your old road is rapidly agin'
Please get out of the new one if you can't lend your hand
For the times they are a' changin'!
The line it is drawn the curse it is cast
The slow one now will later be fast
As the present now will later be past
The order is rapidly fadin'
And the first one now will later be last
For the times they are a' changin'!

Written by Bob Dylan • Copyright © Bob Dylan Music Co.

A new missed opportunity

After all these years, a new proposal for regulating in vitro diagnostics and medical devices in EU is available. Current regulation was enacted in 1998, and this one could be applicable in 2022, 24 years after, pas mal for the busy politicians!.
And this is a proposal, there were previous unapproved proposals, and this one has to pass the Council and the Parliament. I will not enter into the details.
It was supposed to increase safety and efficacy, but the main problem remains with who has to enforce them. Notified bodies, a subcontracting regulatory firms network, with vested interests with industry can't claim independence. And specifically, the methods for evaluate the analytical validity, clinical validity and utility is uncertain. No regulator will confirm us that the cut-off values of diagnostic tests are set according to the best evidence and greatest benefit. In US, FDA is the responsible.
In summary, a new missed opportunity for european citizens. A greater risk and uncertain effectiveness in diagnostic tests and medical devices.

PS. The latest known example of the impact of wrong regulation is this one. Those affected can't read this blog, they are blind.

Josep Moscardó

Is there room for healthcare in blockchain?

BLOCKCHAIN REVOLUTION: How the Technology Behind Bitcoin is Changing Money, Business, and the World

Blockchain, the technology behind bitcoin, the virtual currency, could be the new tool that could change the current state of health records and healthcare information. Up to now we have been discussing about interoperability between systems. What would happen if the citizen is the owner of the information and he has all data available everywhere anytime?. This is what certain initiatives try to define right now. Something like this initiated by the physician would be the data owned by the patient:

 

We are at the begining of a great transformation. I don't now if the appropriate word is revolution. Anyway, if you are interested in the topic you may check som details here.

However if you want a deep review of whats going on in 12 critical disruptions, read chapter 6 of the book "Blockchain revolution". You'll find there the potential impact on health:

In the health care sector, professionals use digitization to manage assets and medical records, keep inventory, and handle ordering and payments for all equipment and pharmaceuticals. Today, hospitals are full of smart devices that oversee these services, but few communicate with one another or take into account the importance of privacy protection and security in direct patient care. Blockchain-enabled IoT can use emerging applications to link these services. Applications in development include monitoring and disease management (e.g., smart pills, wearable devices to track vital signs and provide feedback) and improved quality control. Imagine an artificial hip or knee that monitors itself, sends anonymized performance data to the manufacturer for design improvements, and communicates with a patient’s physician, “Time to replace me.” Technicians will be unable to use specialized equipment if they haven’t taken prerequisite steps to ensure their reliability and accuracy. New smart drugs could track themselves in clinical trials and present evidence of their effectiveness and side effects without risk of modified results.

If you are interested in innovation and want to follow the next wave, the internet of value, then you need to read such book. Definitely, there is wide room for health in blockchain.

European health regulation on lab tests, the final round?

Medical devices: Council getting ready for talks with EP

Last June 15th, there was a small but significant step towards the final agreement on Medical devices and in vitro diagnostics regulation in Europe. The need for reform has been widely requested but the lack of political consensus and the low priority given to the issue has delayed its approval in many ocasions. It seems that now is the right opportunity, however if finally passes, it will be applied on 2020!!!. It really sounds weird that it would take 5 years to be fully developed.
Anyway, if you want to have a look at the details check here and here. Right now, the lobbies are not on vacation, they are fighting against some provisions that limit their current freedom of market access. Pay attention to final result, just to check who wins and who loses, and the current state of power balance between society and the lobbies.

 



NESBITT, Lowell. Dos ponts a Nova York, 1975

Exhibition at Espai Carmen Thyssen. San Feliu de Guixols

TTIP and health

The Transatlantic Trade and Investment Partnership (TTIP) Towards an EU-US trade deal
EU position paper on medical devices
EU position on pharmaceutical products

Up to now the negotiation about the TTIP has avoided health care and has focused on pharmaceuticals and medical devices. This is the latest summary:

Round 9
Pharmaceuticals
The progress of the task force in charge of assessing the equivalence of EU and US Good Manufacturing Practices (GMP) systems was reviewed. Audits of Member States GMP inspectorates observed by US FDA took place and will continue during 2015. The EU will audit the US inspectoratate in September 2015. Other areas such as biosimilars, generics and international cooperation were discussed. The EU welcomed the first authorisation of a biosimilar by FDA. EU committed to submit a proposal for cooperation on generics ahead of next round. 

Medical devices
The EU presented its position paper on medical devices recently published in the web site. The US asked clarifications on the mutual recognition of quality management system audits concept (one of the objectives detailed in the paper) and its relation with the international Medical Devices Single Audit Programme (MDSAP). The EU noted that while it is committed to MDSAP work, a legal basis needs to be established for it to be able to accept audit reports carried out by US inspectors (TTIP could serve as such legal basis). Both sides took stock of progress on the two other TTIP priorities (Unique Device Identifier -UDI and Regulated Product Submission - RPS). Next steps were agreed for each topic.

On May 27th, a meeting in Brussels will be held with all stakeholders. Position papers on both issues are available. The assesment of the whole implications of this Treaty is still pending. A general approach is available in the paper by LSE scholars. The key documents and position papers are here.
A summary of the current regulation is here. As far as there is only limited information I will avoid any opinion about it by now.

PS. Alberto Alemanno paper on TTIP

The risk society

One of the most important achievements of our society is how we have been able to manage certain risks in the last century. The mandatory pooling of health risks is in my opinion the most crucial one. Risk regulation on different hazards has protected population from many damages. Medicines regulation agencies would be a good example of that if they worked properly, and we all know it is not always the case. However, it is much better to have them than not, as happens with medical devices in Europe.
Last week, Ulrich Beck died. He is one of the most prominent sociologists of our times. His book, The Risk Society, is still a key reference after four decades. Anthony Giddens has written an excellent obituary that reflects his contributions. We all have to learn from Beck's clever perspectives and observations. In my opinion, up to now we have been able to improve the social management of risks, however there are many shadows that raise doubts about the future. Some people call them the end of the welfare state, while I would like to focus is on new ways of risk protection that are affordable, given the current (and critical) state of public finances.

Health and income 2013

Is nudging ethical?

The challenges and opportunities of ‘nudging’

A forthcoming Editorial in the Journal of Epidemiology and Community Health provides some amunition for those interested on nudging.

The answer to the question if nudging is an ethically acceptable way of governing people’s behaviour depends on the ethical principles one adheres to. Our core point is that there is no magic trick, any form of policy intervention will impose a criterion against someone’s will, and democracy requires: (1) transparency from the political system in terms of the values selected in deciding and designing an intervention; (2) and at least an evidence-based justification of choice.

If the preferences of an individual change, then we cannot state that his first choice is better/equal/worse than his second one without introducing a ranking among his preference systems. As a result, value-free interventions cannot be defined.

If no magic bullet is available on the policy side, the same applies to research. In the domain of health, behavioural approaches must cope with the challenge of not neglecting the socioeconomic and contextual determinant of health inequalities

We argue that neglecting socioeconomic variables would be clearly a mistake also in the design of nudge. However, our point is precisely that behavioural science (and nudge as its policy implication) can incorporate an analysis of social and cultural factors, and avoid cognitive universalism.

Easier said than done. For an op-ed, it fits with the audience, for a strict and concrete policy recommendation requires further elaboration. I can't see  a practical and concrete applicable approach nowadays. Let's continue waiting.

PS. Must read, on medical devices in BMJ.A systematic review of new implants in hip and knee replacement

PS. A flawed PNAS article unveiled. Again and again, where is peer-review?

Jordi Pintó at Galeria Banadas

Enough is enough

If there is a grey area in medical devices and services regulation, this is the Laboratory Developed Tests one. Up to now, FDA has refused to define the rules of the game for 11,000 diagnostic tests performed at 2,000 labs in USA. This means that no official or external reviewer has analysed the clinical validity and clinical utility as it is done in any reagent and instrument. I can't understand why we have arrived at such a situation.
Fortunately NYT reports that on July 31st, FDA announced that this will change.

The agency said on Thursday that such discretion must end because circumstances had changed. Lab-developed tests once were fairly simple, often developed by a hospital for tests on its own patients. Now the tests can be complex and are being developed by  companies and marketed widely.

Some widely used commercial tests have never had to be reviewed by the agency. These include Myriad Genetics’ breast cancer risk test, the subject of a Supreme Court patent decision last year; the Oncotype DX test from Genomic Health, which is used to determine if women with early-stage breast cancer need chemotherapy; and noninvasive prenatal tests for Down syndrome that are rapidly catching on.

In this blog I have supported several times for a clear regulation of these tests . Just the other day when looking at the statements of FDA commissioner, I was astonished:

Just as drugs need to be safe and effective for treating diseases, medical devices used to help diagnose disease and direct therapy also need to be safe and effective, Faulty test results could lead patients to seek unnecessary treatment or to delay or to forgo treatment altogether.

These statement raise more concerns about what US regulator has done after all these years. And european regulation is still worse in this sense. I have explained such disaster previously and up to now there is no news. Some times I wonder why do we pay taxes, why do we have to be part of Europe. Enough is enough.

Unsafe medical devices regulation

Improving Medical Device Regulation: The United States and Europe in Perspective

The regulatory differences between Europe and US are quite well known since the breast implants scandal. A US citizen was not able to receive such implant because FDA had not approved. The rationale is not related to such a case, it is the current system of notified bodies that really doesn't protect population health. However, US needs also to improve. Milbank Quarterly article says:

Overall, US and European evidence requirements for devices introduce not only risks to patients but also the wrong incentives to generate the needed evidence to better understand and evaluate the benefits and risks of new devices. Considering that manufacturers often take advantage of existing evidence from already marketed devices to gain approval for a new device, they are reluctant to undertake new clinical studies. In addition, because later devices may be able to claim equivalence, the first manufacturer to market does not have a very strong incentive to undertake extensive clinical studies.

The steps to improve regulation are detailed in the article. Surprisingly, notified bodies is again the chosen option in the current review of the legislation. Citizens should know it before voting.

PS. Milbank says it is an original investigation, you may check the same title and authors some months before in Value in Health

Full overhaul needed

A full-fledged overhaul is needed for a risk and value-based regulation of medical devices in Europe


This is exacty what medical devices regulation in EU needs: a full overhaul. The weaknesess of current process have been on the press for the case of breast implants. But this is only an extreme case that has shown the failures and conflicts of interest.
Carlos Campillo article in Health Policy shows clearly the details and examples of the current mess.

In Europe, the first step should be to understand thefull extent of the problem and bring it to public attention.Comprehensive, reliable and constantly updated registriescould play an important role in this endeavor. Secondly,all the improvement measures described in connectionwith both sides of the problem (assessment, appraisal andapproval, on the one hand, and postmarketing on the other)should be urgently implemented. The fact that we already know what these measures are would delegitimize any delay in implementation.

A clear alert for any politician with eyes to read.

PS. On non-profit boards

Fer-ho bé i amb més seny

Central de Resultats. Tercer Informe Desembre 2011

Sabem que hi ha variacions a la pràctica mèdica i algunes d'elles poden tenir justificació i d'altres no tant. La publicació del darrer informe de la Central de Resultats mostra senzillament que depèn d'on vius tens el teu sistema sanitari particular, amb excel·lències i deficiències.
Esdevé difícil d'explicar les variacions en la taxa estandaritzada d'hospitalització (per 1.000 habitants) que va de 108 a 145, amb una mitjana de 122. O que les hospitalitzacions evitables vagin del 5,7% al 12,2%, amb una mitjana de 8,5%. I podríem seguir amb indicadors de mortalitat segons malaltia i demés.
Si algú ha de limitar l'accés, ho ha de fer amb allò que és evitable. I ha d'utilitzar els recursos alliberats per a resoldre problemes de salut que requereixen atenció, com per exemple la llista d'espera.
Aquells que mostren els indicadors de resultats pitjors s'han de preguntar el perquè, i fer tot el que puguin i més per a millorar-los. I finalment les dades econòmiques. N'escolliré tant sols una. La despesa farmacèutica estandaritzada per habitant va de 211€ a 391€, amb una mitjana de 254€.
Per favor, que algú s'ho miri amb deteniment i faci alguna cosa assenyada.

PS. Per cert, hi ha un hospital de la XHUP amb 60% de cesàries (p.67). Algú sap quin és o es tracta d'un error?

PS. A la CBS, un recomanable reportatge "When medical devices fail".

Quina porada

Regulation of Medical Devices in the United States and European Union

La lectura del darrer NEJM on es compara la regulació dels subministraments mèdics entre Europa i USA afegeix preocupació. Ja ho sabíem, però quan es posa una evidència darrera l'altra provoca sorpresa i angoixa. Des del meu punt de vista esdevenen sorprenents qüestions com aquesta:

For example, a distal protection system for coronary-artery interventions received a CE mark after a single-group study involving 22 subjects showed that the device worked as intended. In the United States, FDA approval came several years later on the basis of a randomized study involving 800 subjects, in which a clinical end point of major adverse cardiac events was used.

Vull evitar d'afegir altra informació que les dades objectives que mostra l'article, qualifiqueu la situació vosaltres mateixos després de llegir-lo. Tant sols voldria assenyalar que l'impacte potencial en el benestar d'una regulació inexistent, és tant pels que han rebut la prestació (problemes de qualitat) com per la societat que ha d'assumir el cost públic de la reparació del dany a causa d'un regulador absent. El cas de les pròtesis PIP ho exemplifica.

PS. Ahir vam poder assistir al Concert de la temporada, en majúscules. Estic parlant de Ben L'Oncle a la Sala Apolo, és clar. No tenc paraules per descriure una vetllada inoblidable, un geni amb uns músics encara més genials, una estètica cuidada al mínim detall, una posada en escena impecable. I així és com va començar:

Veure-les passar

El tema segueix sobre la taula. El debat sobre les proves genètiques i com regular-les preocupa a la FDA i encara que ja ha dit que cal aplicar els mateixos criteris que als subministraments mèdics (medical devices), hi ha molts dubtes sobre els detalls.

Els de Genomics Law Report expliquen el que ha passat a les compareixences recents. Si n'esteu interessats feu-hi una ullada.
Les preguntes clau:

Should the agency require proof of analytical validity, clinical validity and/or clinical utility prior to approving a particular test and, if so, what standards of proof should be required?
Should the agency regulate tests SNP-by-SNP, claim-by-claim or test-by-test, and what should be done to prepare for the inevitable arrival of tests based on whole-genome sequence data?
Should the agency oversee the labeling and advertising claims offered by companies in association with such tests?
Should the agency require companies to collect and submit data regarding the post-test benefits and harms and the actual (as compared to intended) uses of their tests?
Should the agency impose requirements on companies to prevent unauthorized testing, protect data privacy and limit companies’ ability to share genetic information without their customers’ consent?

While these questions, and countless more, will be critical to the development of sensible genetic testing regulation, one question clearly generates more and more emotional responses than any other:

Should regulators require some or all genetic tests to be routed through a clinician, or should tests be made available directly to consumers who desire them?

I mentrestant per aquí, les veiem passar...i ens costen una pasta...

PD. El gran Ferran Torrent representa una alenada d'aire fresc els diumenges, tant en directe a Rac1 com els comentaris a ARA. Cita Josep Renau: "Quan arribes a València i et menges una paella o una sípia t'oblides de la lluita de classes". I mentrestant els de FT ens recorden que "Valencia is burning"