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

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

On ets Europa? (en relació a la recerca de nous dispositius mèdics)

 Development Pipeline and Geographic Representation of Trials for Artificial Intelligence/Machine Learning–Enabled Medical Devices (2010 to 2023)

L'any passat teníem els fabricants de subministraments mèdics europeus preocupats per la nova regulació de la Intel·ligència Artificial (AI). Deien que afectaria negativament als negocis i que introduïa incertesa legal i càrrega burocràtica.

Doncs jo crec que haurien d'estar molt més preocupats de la competència que ve de la Xina que no pas de la regulació europea. Quan dic molt, vull dir moltíssim. Em refereixo al nombre d'assaigs clínics en marxa relatius a subministraments mèdics amb AI, amb la informació de gran qualitat acabada de publicar per en Miquel Serra et al. al New England AI, que diu:

When analyzing the geographic distribution of the 2451 clinical trials for AI/ML-enabled medical devices conducted in single countries, most of them were conducted in China (1095 clinical trials), followed by the United States (196 clinical trials), Japan (162 clinical trials), India (139 clinical trials), and Republic of Korea (118 clinical trials)

Els països europeus serien residuals en nombre d'assaigs clínics amb AI. Només quan considerem el nombre de participants en assaigs clínics llavors en sorgeixen alguns.

China had a total enrollment of approximately 12 million patients in the AI/ML-related trials, followed by Germany (5.5 million), the United Kingdom (3.7 million), the Republic of Korea (1.3 million), Japan (1.1 million), Australia (1.03 million), the United States (441,282), New Zealand (402,534), India (369,323), and Taiwan (265,756).

Però el que compta sobretot són els productes en desenvolupament amb AI a hores d'ara. I en això Europa s'ha esvaït. Si el nou xip del BSC pogués ajudar en canviar això ja seria molt. Recordeu que la competència al mercat a hores d'ara es troba a la fase anterior, a la de desenvolupament de processadors i la tecnologia de semiconductors. Ha tornat el proteccionisme, USA ha barrat el pas a exportació (USA Chips Act), Xina segueix els passos, i Europa ha fet un proteccionisme light via finançament públic de l'oferta (European chips Act). Aquest nou proteccionisme està passant davant dels nostres nassos i no  veig cap reacció.

La significació d'aquest retorn al proteccionisme és molt més important del que podem imaginar, es tracta de limitar la competència en el mercat de productes on hi ha xips, i el dels subministraments mèdics n'és un.

Llavors cal preguntar-nos, què farem amb tants productes xinesos (imagineu que els 1095 assaigs clínics acabessin en producte), haurien de registrar-los com subministrament mèdic amb la llei europea, i entraran com si res? i en canvi als USA els barraran el pas?

L'article del New England hauria de fer-nos reflexionar novament, i preguntar-nos si ja s'ha perdut el tren o encara hi podem pujar.

PS. Si voleu complementar aquesta informació amb la relativa a medicaments, mireu aquí, vaig explicar la mateixa tendència.

 PS. Tinc pendent de llegir aquest llibre:

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.

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

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

Regulating Artificial Intelligence as a medical device

 The need for a system view to regulate artificial intelligence/machine learning-based software as medical device

The starting point:

AI/ML-based SaMD raise new challenges for regulators. As compared to typical drugs and medical devices, we argue that due to their systemic aspects, AI/ML-based SaMD will present more variance between performance in the artificial testing environment and in actual practice settings, and thus potentially more risks and less certainty over their benefits. Variance can increase due to human factors or the complexity of these systems and how they interact with their environment. Unlike drugs, the usage of software and generally Information Technologies (IT) is known to be highly affected by organizational factors such as resources, staffing, skills, training, culture, workflow, and processes (e.g., regarding data quality management)8. There is no reason to expect that the adoption and impact of AI/ML-based SaMD will be consistent, or even improve performance, across all settings.

on unlocked and adaptive algorithms,

 All AI/ML-based SaMD that the FDA has thus far reviewed have been cleared or approved as “locked” algorithms, which it defines as “an algorithm that provides the same result each time the same input is applied to it and does not change with use”. The agency is currently developing a strategy for how to regulate “unlocked” or “adaptive” AI/ML algorithms—algorithms that may change as they are applied to new data.

Therefore,

 AI/ML-based SaMD pose new safety challenges for regulators. They need to make a difficult choice: either largely ignore systemic and human factor issues with each approval and subsequent update or require the maker to conduct significant organizational and human factors validation testing with each update resulting in increased cost and time, which may, in turn, chill the desire of the maker to engage in potentially very beneficial innovations or possible updates. 

 

Cap on va la indústria Medtech?

Medtech Pulse: Thriving in the next decade

Ara es parla de la indústria Medtech quan abans parlàvem de Medical Devices o subministraments mèdics. Medtech té més glamour.  Per a mi el llibre de referència per aquest sector és el d'en James Robinson, "Purchasing Medical Innovation: The Right Technology, For the Right Patient, At the Right Price". Ja té uns anys, però segueix vigent.

A data d'avui el que cal llegir és l'informe que ha publicat McKinsey per saber que té el sector al seu davant i com enfrontar-s'hi. La credibilitat que li vulgueu donar és una opció personal. Com a qualsevol informe de consultors, el manual diu que primer cal crear angoixa, mostrar la incertesa i les coses que no van o no aniran bé.

Un sol gràfic és capaç de resumir-ho tot, fins abans de la pandèmia tot anava bé, però després s'ha capgirat. La rendibilitat financera/borsària ha baixat del 21% al 2%. Elemental!. El que caldria és comprendre com la pandèmia va afectar al sector, i no projectar ombres com si l'efecte pandèmic persistís després de 2023...

Les tendències estan ben dibuixades, d'això en saben molt i per això cal llegir l'informe. Però llavors els consultors apareixen per assenyalar quines són les opcions de futur, i si no saps gestionar ecosistemes no ets ningú, excepte que els consultors (ells) t'ajudin.

Aquestes són les fonts d'ingressos basades en ecosistemes, diuen:

Aquí tothom pot fer les prediccions que vulgui per als propers 10 anys, i si no l'encerten ningú se n'adonarà perquè som poc amants dels arxius i hemeroteques. Si hi anéssim més sovint trobaríem grans sorpreses i alhora molts motius per no fer cas de prediccions.

PS. A l'informe no hi veig referències al desori medtech europeu amb una regulació esbiaixada cal al lobby medtech precisament, que fa que la indústria americana provi devices per aquí quan la FDA encara no ho ha aprovat.

L'incert impacte de la nova regulació de dispositius mèdics i diagnòstic in vitro

After the four-year transition period: Is the European Union’s Medical Device Regulation of 2017 likely to achieve its main goals?

Una de les grans diferències regulatòries respecte l'efectivitat i seguretat entre els Estats Units i Europa es troba precisament en els dispositius mèdics. Molts metges i empreses innovadores dels Estats Units consideren que el procés de la FDA als USA és restrictiu en comparació a la rapidesa de la seva introducció a Europa. El procés d'aprovació de la FDA obliga a que un dispositiu es demostri eficaç en comparació amb un control o sigui substancialment equivalent a un dispositiu existent, mentre que el procés d'aprovació de la Unió Europea obliga que el dispositiu compleixi la funció prevista. I alhora el punt clau és que a Europa les entitats certificadores tenen un paper clau, mentre que als USA el procés és centralitzat a la FDA.

La nova regulació europea de maig de 2017 no s'aplicarà efectivament al maig de 2024 per a dispositius mèdics i fins a maig de 2025 per a diagnòstic in vitro, i fins i tot encara més tard en alguns casos. Com es pot acceptar que la regulació vigent a data d'avui sigui la de 1998, hauran passat més de 25 anys per canviar una norma!. Definitivament han estat 25 anys de vacances del Parlament i Comissió Europea, tot un èxit davant d'una innovació mèdica impressionant. Fins que alguns es van adonar dels múltiples errors de la regulació, recordeu els implants mamaris, no va fer-se públic un escàndol monumental. I el Parlament va tardar cinc anys més en fer una llei (!).

Ara que ens apropem a la seva implantació és moment de preguntar-se si anem pel bon camí per garantir seguretat i eficàcia a la ciutadania. Això precisament és el que es pregunta aquest article, i la conclusió és prou clara:

We conclude that while the MDR is highly likely to strengthen the internal market of the EU, its impact on patient safety will remain unclear as long as there are no comprehensive studies on this topic that are based on empirical data.

Per tant la incertesa regulatòria s'ha instal·lat novament en relació a la seguretat i eficàcia dels dispositius mèdics i diagnòstic in vitro. La forma de corregir els errors anteriors és del tot insuficient amb les noves normes segons els autors. Destaco un paràgraf sobre el paper dels organismes certificadors, diuen:

 Notified bodies tend to establish strong relationships with manufacturers, some of whose business may constitute a large share of their turnover. This interdependence is unlikely to disappear under the MDR because medical devices are placed on the market largely in the same way as under the former directives, albeit subject to reinforced designation and monitoring procedures.

No hi ha ningú que no hagi pogut copsar aquest conflicte d'interès evident i elemental? Es podia fer una millor regulació i no caure en errors del passat amb resultats greus per la salut dels pacients.  L'article paga la pena llegir-lo i guardar-lo pel moment que algú es pregunti on ha fallat la regulació. Allà tindrà bona part de les respostes.

Cadaqués

PD. Una entrada anterior al blog sobre el mateix tema.

Making competition work

 Antitrust Policy in Health Care Markets

After reviewing all these issues included in the book, do you still think that true competition could work in health care?

In US, the evidence is that remedies doesn't cure the disease (collusion, monopoly, dominant position abuse).

Contents:

1. Health Care Markets and Competition Policy 1

1.1 The Marketplace of Health Care Spending 1

1.2 Competitive Concerns 3

1.3 Antitrust Policy 4

1.4 Plan of the Book 5

1.5 Concluding Remarks 12

2 Antitrust Policy in the United States 14

2.1 Introduction 14

2.2 The Economic Rationale for Antitrust Policy 14

2.3 Political Foundation of Antitrust Policy 19

2.4 Antitrust Treatment of Monopoly and Cartels 23

2.5 The Clayton Act 26

2.6 Private Antitrust Suits 27

2.7 Class Action Suits 31

2.8 Concluding Remarks 33

PART I MONOPOLY 35

3 Patents and Monopoly Pricing of Pharmaceuticals 37

3.1 Introduction 37

3.2 The Patent System 39

3.3 Patents and Monopoly Pricing 42

3.4 Patent Licensing 47

3.5 Antitrust Remedies 51

3.6 Government Policy Proposals toward Prescription

Drug Pricing 52

3.7 Extensions: Medical Devices and Orphan Drugs 64

3.8 Concluding Remarks 68

4 Patents and Exclusionary Product Hopping 74

4.1 Introduction 74

4.2 Exclusionary Product Hopping 75

4.3 Legal Challenges to Product Hopping 78

4.4 Solutions, If Any 88

4.5 Concluding Remarks 92

5 Bundled Discounts and PeaceHealth 95

5.1 Introduction 95

5.2 Bundled Discounts 96

5.3 Bundled Discounts in Health Care Settings 99

5.4 Anomalies of the Discount Attribution Test 105

5.5 Antitrust Treatment of Bundled Discounts 109

5.6 Concluding Remarks 112

PART II SELLER CARTELS 113

6 Collusion in Health Care Markets 117

6.1 Introduction 117

6.2 A Basic Cartel Model 117

6.3 Collusion among Physicians and Surgeons 121

6.4 Collusion among Hospitals 126

6.5 Collusion among Pharmaceutical Manufacturers 128

6.6 Collusion among Medical Device Manufacturers 131

6.7 Collusion among Health Insurers 132

6.8 Concluding Remarks 134

7 Collusion in Generic Drug Markets 136

7.1 Introduction 136

7.2 The Competitive Promise of Generic Pharmaceuticals 137

7.3 The Incentive to Collude 140

7.4 The Alleged Conspiracies 142

7.5 Economic Consequences of Collusion 150

7.6 Deterring Price Fixing 152

7.7 Concluding Remarks 154

Appendix: Alleged Participants in Generic Pharmaceutical

Drug Conspiracy 154

8 The Hatch-Waxman Act, Patent Infringement Suits,

and Reverse Payments 168

8.1 Introduction 168

8.2 The Hatch-Waxman Act 169

8.3 Reverse Payment Settlements 172

8.4 The Actavis Decision 177

8.5 The Post-Actavis Experience 186

8.6 Legislative Remedies 192

8.7 Private Damage Actions 197

8.8 Concluding Remarks 200

Appendix: The Economics of Settlements 200

9 The Alleged Insulin Conspiracy 204

9.1 Introduction 204

9.2 Insulin: A Brief History 205

9.3 The US Insulin Market 207

9.4 Pharmacy Benefit Managers 215

9.5 Collusion in the Insulin Market 220

9.6 Concluding Remarks 225

10 Licensing of Health Care Professionals 230

10.1 Introduction 230

10.2 Economic Concerns with Professional Licensing 232

10.3 North Carolina Dental and the State Action Doctrine 236

10.4 Licensing to Exclude Competition 242

10.5 Economic Effects of Mandated Supervision 245

10.6 The Empirical Evidence 249

10.7 Concluding Remarks 250

PART III MONOPSONY 255

11 Monopsony, Dominant Buyers, and Oligopsony 257

11.1 Introduction 257

11.2 Basic Model 258

11.3 Dominant Buyer Model 267

11.4 Oligopsony 270

11.5 Monopsony in Health Insurance Markets 273

11.6 Antitrust Treatment of Monopsony 275

11.7 Concluding Remarks 277

12 Countervailing Power: Physician

Collective Bargaining 279

12.1 Introduction 279

12.2 Bilateral Monopoly 280

12.3 Physician Cooperative Bargaining 286

12.4 Competitive Concerns 296

12.5 Concluding Remarks 298

13 Group Purchasing Organizations, Monopsony, and

Antitrust Policy 300

13.1 Introduction 300

13.2 What Do We Know about GPOs? 301

13.3 GPOs and the Exercise of Monopsony Power 302

13.4 Foreclosure of Suppliers 307

13.5 GPO Funding Mechanisms 312

13.6 Antitrust Enforcement Policy 315

13.7 Concluding Remarks 319

PART IV BUYER CARTELS 323

14 Collusion in the Nurse Labor Market 325

14.1 Introduction 325

14.2 The Shortage of Nurses 326

14.3 A Simple Analysis of an Employer Cartel 329

14.4 Recent Antitrust Litigation 333

14.5 Antitrust Damages 336

14.6 Antitrust Policy 341

14.7 Concluding Remarks 343

15 Collusion in the Oocyte Market 345

15.1 Introduction 345

15.2 Collusion in the Oocyte Market 346

15.3 Antitrust Standards 348

15.4 Economic Effects of Price Ceilings 351

15.5 Rule of Reason Analysis 352

15.6 Antitrust Injury and Damages 357

15.7 Disposition of Kamakahi 362

15.8 Concluding Remarks 365

16 No-Poaching Agreements and Antitrust Policy 368

16.1 Introduction 368

16.2 Background 370

16.3 No-Poaching Agreements in Health Care:

Seaman v. Duke University 373

16.4 Damage Theory 375

16.5 Government Regulation 381

16.6 Concluding Remarks 383

PART V MERGERS AND ACQUISITIONS 385

17 The Economics of Horizontal Mergers 389

17.1 Introduction 389

17.2 Mergers to Monopoly 390

17.3 Mergers of Producers to Realize Efficiencies 393

17.4 Mergers of Buyers to Realize Efficiencies 397

17.5 Merger Efficiencies Resulting in Increased Quality 401

17.6 Concluding Remarks 404

18 Horizontal Merger Policy 405

18.1 Introduction 405

18.2 Horizontal Merger Policy 406

18.3 Defining the Relevant Antitrust Market 410

18.4 Economic Evidence of Competitive Effects 412

18.5 Mergers and Their Anticompetitive Effects: Sutter

Health 415

18.6 Agency Analysis of Mergers in Health Care Markets 419

18.7 Concluding Remarks 431

19 The Economic Theory of Vertical Integration 434

19.1 Introduction 434

19.2 Vertical Integration 435

19.3 Vertical Integration and Competitive Distribution 439

19.4 Successive Monopolies in Production and Distribution 444

19.5 Competitive Concerns with Vertical Mergers 448

19.6 Empirical Evidence on Vertical Mergers 450

19.7 Mergers of Complementary Input Suppliers 451

19.8 Concluding Remarks 455

20 Vertical Merger Policy 457

20.1 Introduction 457

20.2 Legal Foundation 458

20.3 The 2020 Vertical Merger Guidelines 461

20.4 A Merger in Biotechnology: Illumina/GRAIL 465

20.5 The Merger of a Health Insurer and a Physician Group:

UnitedHealthcare/DaVita 469

20.6 The Merger of a Hospital System and a Physician Group:

St. Luke’s/Saltzer 472

20.7 Concluding Remarks 476

21 Concluding Remarks

Medtech regulatory affairs

 Medical Regulatory Affairs. An International Handbook for Medical Devices and Healthcare Products

IA pertot arreu (5)

 Artificial intelligence in healthcare. Applications, risks, and ethical and societal impacts

El parlament europeu va encarregar un informe sobre la intel·ligència artificial a l'assistència sanitària i abans de vacances ha publicat el resultat. En realitat veig que és un informe sobre el risc que representa i que es pot fer per regular-lo. 

Les idees que proposa no són pas noves. I tinc la impressió que el més important hauria de ser disposar d'una regulació general. En aquest sentit la proposta de 2021 es troba pendent de no sé ben bé què.

In 2021, the European Commission (EC) published a long-awaited proposal for AI regulation and for harmonising the rules that govern AI technologies across Europe, in a manner that addresses safety as well as human rights concerns (European Commission, 2021). In a similar fashion to the 2018 proposal of the German Data Ethics Commission, the draft EU framework provided a definition of AI that is risk-based, together with mandatory requirements for high-risk AI systems. Concretely, the document recommended to classify AI tools according to three main levels of risk: (i) unacceptable risk, (ii) high risk, and (iii) low or minimal risk.

I pel que fa a alt risc, els requeriments serien aquests:

• Use high-quality training, validation and testing data (relevant, representative).

• Draw up technical documentation & set up logging capabilities (traceability & auditability).

• Ensure appropriate degree of transparency and provide users with information on

capabilities and limitations of the system & how to use it.

• Ensure human oversight (measures built into the system and/or to be implemented by

users).

• Ensure robustness, accuracy and cybersecurity.

Obligations:

• Establish and implement quality management system in its organisation.

• Draw-up and keep up to date technical documentation.

• Undergo conformity assessment and potentially reassessment of the system (in case of

substantial modification).

• Register AI system in EU database.

• Affix CE marking and sign declaration of conformity.

• Conduct post-market monitoring.

• Collaborate with market surveillance authorities.

• Inform the provider or distributor about any serious incident or any malfunctioning.

• Continue to apply existing legal obligations (e.g. under GDPR).

Quin és el problema sense entrar en detalls del document? Doncs que s'hauria de complir la regulació de Medical Devices vigent, que obliga a aprovar software as a medical device i que s'incompleix generalitzadament. I que quan més tardin en aprovar la regulació general d'intel·ligència artificial més desfasada estarà. Crec que ja fan tard. 

 

Bo Bartlett

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".

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

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"

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

When the regulator doesn't care about the danger within us

A must see Netflix documentary: The bleeding edge. It explains how medical devices are introduced in the market without appropriate control.
CBS news explains some details:

Just because it's new doesn't mean it's better, it may be dangerous and damage you for life. Unfortunately, this is the summary.
And the book to read:

Drug approval and geographic differences

 Approval of Cancer Drugs With Uncertain Therapeutic Value: A Comparison of Regulatory Decisions in Europe and the United States

We know that the regulation of medical devices is quite different between US and Europe, and with COVID tests we have experienced such divide. In drugs, one could expect a closer approach to approval. However, this is not the case. 

Regulatory agencies may have limited evidence on the clinical benefits and harms of new drugs when deciding whether new therapeutic agents are allowed to enter the market and under which conditions, including whether approval is granted under special regulatory pathways and obligations to address knowledge gaps through postmarketing studies are imposed.

In a matched comparison of marketing applications for cancer drugs of uncertain therapeutic value reviewed by both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), we found frequent discordance between the two agencies on regulatory outcomes and the use of special regulatory pathways. Both agencies often granted regular approval, even when the other agency judged there to be substantial uncertainty about drug benefits and risks that needed to be resolved through additional studies in the postmarketing period.

Postmarketing studies imposed by regulators under special approval pathways to address remaining questions of efficacy and safety may not be suited to deliver timely, confirmatory evidence due to shortcomings in study design and delays, raising questions over the suitability of the FDA’s Accelerated Approval and the EMA’s Conditional Marketing Authorization as tools for allowing early market access for cancer drugs while maintaining rigorous regulatory standards.

 Hockney

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.

Connected health

 Improving Access to Care: Telemedicine Across Medical Domains

Access to health care relies on the use of available resources in attempts to achieve optimal health outcomes. It is composed of three main components: entry into the health care system, an adequate supply of services available, and timely provision of care

The article provides some useful views on telemedicine. It says,

 Frequently cited clinical limitations of telemedicine include the inability to perform comprehensive physical examinations, sacrifice of patient–provider relationships, fragmentation of care, and the potential for overprescribing/excess health care utilization. These concerns are often unsubstantiated, and while it is important to anticipate the potential shortcomings of telemedicine, innovative solutions are continuously being adopted to overcome potential barriers to implementation. Examples of such solutions include the use of user-friendly devices to gather vitals and data to facilitate remote clinical assessment, as well as utilization of interchangeable electronic health records to enable sharing of information among various providers.

Overall, the promise of telemedicine seems encouraging, and we look to further examine notable examples of its efficacy through the lens of four diverse, prototypical medical conditions with the goal of recognizing common themes and identifying areas of needed improvement. These medical conditions include stroke, heart failure, diabetes, and pregnancy.

L’home que sabia mirar el món, Manuel Castro Galeria Jordi Barnadas de l'11 de març al 9 d'abril de 2021