Trust and transparency in medical device regulationBMJ 2019; 365 doi: https://doi.org/10.1136/bmj.l4166 (Published 18 June 2019) Cite this as: BMJ 2019;365:l4166
All rapid responses
Kramer and Kesselheim’s informative editorial about medical devices, and their call for transparency, must be taken further, as their statement “[the Federal Drugs Agency, FDA] continues to refine premarket and post-market regulation” will not be enough.(1)
Firstly, their analysis is based upon one specific set of affairs. E.g. in the US, 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-res...), and Abiomed agreed to pay $33m to resolve allegations of providing lavish meals (eg. $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-in-m...). Happily, there were no such allegations nor need for settlements in Europe!
Secondly, “refining” might be an inadequate response. Regulatory requirements have always been weak so refining might prove to be merely window dressing.(2) Moreover, raising standards would first require a U turn, since the system has chosen to decrease requirements. For drugs, the motto is now to accelerate approvals, usually on non-validated surrogates in small series of highly selected patients, while drug withdrawal for safety reasons is delayed.(3) Lastly, hijacking Einstein, “We cannot solve the problems with those who created them”.
Thirdly, France provides evidence that a broken system cannot be fixed. Who can be relied upon?
a) Regulatory agencies? The French agency for medicines and medical devices (Agence Nationale de Sécurité du Médicament et des Produits de Santé) has sent several warning letters since 2016 to YSY Medical, a French corporation, due to the lack of CE Mark (the certification required to commercialize medical devices in the European Union, which verifies that a device meets all regulatory requirements) for several medical devices. The Agency has waited until March 2017 to suspend the use and require the YSY Medical’s devices. The company challenged the Agency’s decision in a regional court which issued an emergency ruling to suspend the Agency’s decision and the Conseil d’Etat, the highest French court, confirmed the rulling from regional court. https://www.legifrance.gouv.fr/affichJuriAdmin.do?oldAction=rechJuriAdmi...
b) The industry? The 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 Dec 2016) requiring a Summary of Product Characteristics for class III and implantable devices. This won’t help patients, but they rightly wanted to protect their interests. Was the formulation of the decree as flawed as the Agency’s decision (see above)?
c) The media? While the International Consortium of Investigative Journalists released its most frightening investigation about implants in 2018,(4) the French public broadcaster produced a most reassuring interview. Was the interviewee chosen because: a) he was the representative of the French regulatory agency for the updating of the European Union directive about Medical Devices Regulation (2017/745); or because of his genuine pledge to industry to avoid evaluation as “rapid obsolescene of the products … is hardly compatible with the delay necessary for clinical trials, particularly morbidity-mortality data” and for providing an alternative “predictive equivalence”?(5)
Lastly, could, or should, clinical investigators and their universities, mostly funded by citizens, play a greater role by: a) recruiting patients only towell-designed trials with adequate comparators and follow up; b) providing full access to data (as they seem to belong to the patients first of all); c) avoiding nurturing predatory publishers with seeding trials?
1 Kramer DB, Kesselheim AS. Trust and transparency in medical device regulation. BMJ 2019;365:l4166.
2 Sharma RA, Fumi L, Audisio RA, Denys A, Wood BJ, Pignatti F. Commentary: how will interventional oncology navigate the "valleys of death" for new medical devices? Br J Radiol 2018;91:20170643.
3 Braillon A, Menkes DB. Balancing Accelerated Approval for Drugs With Accelerated Withdrawal. JAMA Intern Med2016;176:566-7.
4 Braillon A. Assessment of medical devices: the Emperor’s new clothes. Br J Radiol 2018;91:20180242.
5 Bowers S. Doctors demand to see evidence on safety of medical devices approved in Europe. BMJ2018;363:k5105.
6 Braillon A. Medical devices and the approval processes: United States vs France. Arch Intern Med. 2010;170:2040-1.
Competing interests: AB serves as unpaid expert for several taskforces for the French agency for medicines and medical devices (Agence Nationale de Sécurité du Médicament et des Produits de Santé), none of which were related to the topic. SB chairs Healthwatch, a charity promoting science and integrity in healthcare (https://www.healthwatch-uk.org/).