Ethicon Media Monitoring 11/14/2018

Client Attorney Privileged/Attorney Work Product/At Request of Counsel

Online Sources

1. NICE responds to surgical mesh article

   Nov 13, 2018 | The British Medical Journal

   By Gillian Leng and Kevin Harris
   
   
   The life changing complications that affect some women after vaginal mesh procedures should prompt us all to reflect on how the health system should monitor and respond to potential harms from any intervention, medicine, or device.
2. Mesh scandal: lessons from Wall Street ignored

   Nov 13, 2018 | The British Medical Journal

   By Mark Wilson
   
   
   The mesh scandal is all too familiar.

Client Attorney Privileged/Attorney Work Product/At Request of Counsel

Online Sources

1. NICE responds to surgical mesh article

   Nov 13, 2018 | The British Medical Journal

   By Gillian Leng and Kevin Harris

   The life changing complications that affect some women after vaginal mesh procedures should prompt us all to reflect on how the health system should monitor and respond to potential harms from any intervention, medicine, or device.

   The National Institute for Health and Care Excellence first made recommendations about the use of mesh in its interventional procedures guidance in 2005.1 This was cautious advice with requirements for notifying clinical governance leads, informing patients about uncertainties in the procedure’s safety, and the need to audit outcomes. This advice is reinforced in our new draft clinical guideline on stress urinary incontinence and pelvic organ prolapse.2

   In their editorial, Heneghan and Godlee refer to NICE guidance as “ineffectual,”3 and we agree that it should have had more impact. Of course, responsibility for implementing guidance does not rest with NICE but requires a system-wide approach. A systematic approach after our recommendations in 2005 could have identified more quickly, or avoided, many of the adverse outcomes of mesh.

   In future, the healthcare system should provide more robust implementation of all NICE guidance on interventional procedures, not just those relating to mesh. We should act on the requirements for implementing this guidance, endorsed by NHS policy makers from the four nations of the UK.4 Interventional procedures guidance aims to protect the safety of patients, and its recommendations should be seen as mandatory rather than advisory.

   Mechanisms to reinforce these recommendations include oversight by the regulator to ensure effective governance structures, and trust appraisal systems should ensure that clinicians take due account of our guidance. Clinicians should comply with requirements for consent, data collection, and audit, and should report complications.

   Data submitted to national registers must be properly analysed and published to ensure that patterns of complications or harms are identified quickly. Coherent and coordinated action can then be taken where necessary to reduce future risks to patients.

   https://www.bmj.com/content/363/bmj.k4748
   

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2. Mesh scandal: lessons from Wall Street ignored

   Nov 13, 2018 | The British Medical Journal

   By Mark Wilson

   The mesh scandal is all too familiar.1 It joins a growing list of scandals where commercial conflicts of interest (COIs) and effective marketing of a defective product have led to serious injury and loss of life. Against the backdrop of Avandia, Vioxx, Praxil, the opioid crisis, and now the mesh scandal, one wonders what kind of tipping point is needed to prevent a disturbing pattern from repeating itself. And where will the leadership come from, given that sectors of the medical community are enmeshed with private industry?

   Politicians might step up to the plate. The United States passed the Sunshine Act, but, as Godlee notes, it did not solve the problem.1 Unbeknown to many people, the Sunshine Act reflected how Wall Street and politicians manage their own commercial COIs. Disclosure has been the governance option of choice on Wall Street for years,2 and it has failed to prevent ongoing scandals underpinned by commercial COIs, including the global banking crisis of 2008. Calls to end commercial COIs on Wall Street continue. Politicians also accept campaign financing from the banking sector and the drug and medical device industry that have been involved in fraud and scandal and have had a profound negative effect on the public. Managing these financial relations through disclosure has allowed politicians to have their cake and eat it too. Responding to public concerns about these kinds of financial COIs, politicians say that it does not compromise their ability to act in the public interest.3 It’s a familiar response, heard on Wall Street and in many areas of medicine. Self denial has helped to sustain the status quo.

   Until politicians end their own financial conflicts through legislation, scandals in both medicine and in the marketplace will likely remain a familiar—albeit disturbing—pattern. The need to go beyond disclosure in tackling commercial COIs cannot be stated enough. And it needs to start at the top.

   https://www.bmj.com/content/363/bmj.k4753
   

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