LAUSR

To the Editor, Pane et al are rightly concerned about public health safety issues involving medical devices. We do not share their optimistic analysis of the European Union (EU) directive about Medical Devices Regulation (2017/745) and its chapter about postmarket clinical follow-up even “if properly developed and implemented.” The EU's aim is to “develop an internal single market through a standardized system of laws to ensure the free movement of goods, services, and capital” (http://europa.eu/european-union/topics/ single-market_en), not to protect the public's health. In the United States, action is taken about the substantial evidence of illegal practices: in March 2018, Abbott Laboratories' Alere agreed to pay $33m to settle allegations of selling unreliable cardiac marker testing devices for diagnosis of heart conditions in emergency setting (https://www. justice.gov/usao-ma/pr/abiomed-inc-agrees-pay-31-million-resolvekickback-allegations), and Abiomed agreed to pay $33m to resolve allegations of providing lavish meals ($450 per-attendee) to physicians and inducing them to use their line of heart pumps (https://www. law360.com/articles/1025645/alere-feds-reach-33-2m-deal-inmedical-device-fca-suit). By contrast, we are unaware that the EU has ever sued even one medical device corporation. EU regulatory requirements have been so weak that present improvements still seem mere window dressing. Raising standards would require a major U-turn as the system has, to date, chosen to decrease requirements: for drugs, the present mantra is to “accelerate” approvals, usually from nonvalidated surrogate measures in small series of highly selected patients, while drug withdrawal for safety reasons is delayed. France acts as an exemplar of broken systems showing that although the Directive is a step forward, its implementation at the country level by stakeholders will need close scrutiny from NGOs and independent experts. (a) The French regulatory agency for medicines and medical devices (Agence Nationale de Sécurité du Médicament et des Produits de Santé) waited until March 2017 to suspend the use, and, require withdrawal, of medical devices from YSY Medical, a French corporation, due to the lack of CE Mark (the minimalist certification required to commercialize medical devices in the EU, which only claims that a device meets regulatory requirements) since 2014. The company challenged the Agency's decision in a regional court which issued an emergency ruling to suspend the Agency's decision. The Conseil d'Etat, the highest French court, confirmed the regional court ruling. (b) The French National Union of Medical Technologies Industries (Snitem) and Medtech (an association of 40 companies) pleaded and won from the Conseil d'Etat a cancelation of the decree (#1716. 13 December 2016) requiring a Summary of Product Characteristics for class III and implantable devices. It appears that the formulation of the decree was as flawed as the Agency's decision (above)? (c) When the International Consortium of Investigative Journalists released its excellent investigation about implants in 2018, the French public broadcaster hosted a reassuring interviewer, possibly chosen because he was the representative of the French regulatory agency for the updating of the EU directive about Medical Devices Regulation (2017/745). However, his bias should have been exposed and challenged. He made a pledge to industry to avoid evaluation as “rapid obsolescence of the products ... is hardly compatible with the delay necessary for clinical trials, particularly morbidity-mortality data” and for providing an alternative “predictive equivalence”? Thus, this Journal must be commended for its genuine and early pledges for improving postmarket clinical follow-up of medical devices. Sadly, governments have failed to act and postmarket clinical follow-up will be too little, too late. First of all, clinical investigators and their universities, mostly funded by citizens must: (a) recruit patients in well-designed trials with adequate comparators and follow up on relevant clinical outcomes; (b) provide full access to data (that surely belongs to the patients); and (c) avoid nurturing predatory publishers with seeding trials.