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Ethicon Media Monitoring 11/7/2018
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Conflicts of Interest in FDA Expert Panels
Nov 6, 2018 | Mesh Medical Device News Desk
By Jane Akre
Expert Panels often decide to approve drugs and devices, but how objective are the panelists and do conflicts make a difference? -
What Wales' major new report on endometriosis means for people affected
Nov 6, 2018 | WalesOnline
By Victoria Jones
..."It is important that serious health issues affecting women are dealt with effectively and appropriately. For this reason, I have directed the recently established Women’s Health Implementation Group, chaired by Tracy Myhill, Chief Executive of ABMU Health Board, to consider all the recommendations in this report alongside its work on vaginal mesh and tape."
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Conflicts of Interest in FDA Expert Panels
Nov 6, 2018 | Mesh Medical Device News Desk
By Jane Akre
Expert Panels often decide to approve drugs and devices, but how objective are the panelists and do conflicts make a difference?
A report in Science Magazine (here) has peeled back to revelations of the conflict of interests that exist among experts who advise the U.S. Food and Drug Administration (FDA).
The FDA convenes Advisory Committees made up of outside experts with experience in a particular field. Occasionally there is even a patient representative among the panel. Together they look at drug and device reviews, clinical trial data, safety and efficacy issues. They then vote on whether to recommend the drug/device approval.
The FDA generally follows the recommendation of its committee members.
Part of being a panelist means that conflicts of interest must be revealed. Does the medical expert have any research support, consulting contracts or any other payments from a drug or device company? What is not covered is if the committee member may received a financial incentive either after the drug/device is approved or after they are named to the panel, according to the Science investigation.
Using disclosures in Centers for Medicare & Medicaid Services from 2013 to 2016 posted in Open Payments Website, Science found 40 of 107 physician advisers received more than $10,000 in earnings or research support from the very companies whose drugs they voted to approve. Twenty-six received more than $100,000. Seven received more than $1 million. The FDA never disclosed many of the top committee members received funding from drug companies in years prior to serving.
The top 17 earning advisers received support either in personal payments or research funding paid by the drug companies amounting to $26 million.
Compare this to the European Medicine Agency. It prohibits the appointment of advisory committee members who have had any financial relationship with pharmaceutical companies three years prior to being on a panel.
Follow the Money generally rings true. Scientists on the panel have a lot to gain from being on a panel. One hematologist-oncologist, Dr. Vinay Prasad, tells Science. “It’s in their best interest to play nice with these companies.”
Studies looking at conflicted relationships between drug makers and the doctors who prescribe those drugs found doctors who are paid by the pharmaceutical companies are more likely to prescribe those drugs. See University of North Carolina, Yale University, the George Washington University and Harvard Medical School.
Carl Elliott, a medical ethicist at the University of Minnesota says, “Even in the best of circumstances, disclosure is a remarkably weak way of controlling conflicts of interest. A better way would simply be for the FDA to say, ‘We are not taking anybody with any kind of conflict on an advisory committee,’.”
INVESTIGATING CONFLICTS
On transvaginal mesh – The FDA convened an expert panel in September 2011 (here), after many complications reports were coming in concerning the use of surgical meshes in women to treat SUI (stress urinary incontinence) and POP (Pelvic organ prolapse).
It concluded POP mesh was a problem but slings were not.
It took until 2016 for the FDA to reclassify POP mesh as high risk or Class III and even then, the agency gave manufacturers the benefit by allowing 30 months for the devices to remain on the shelves and presumably used. Mesh News Desk has learned at least two panelists had conflicted relationships with industry.
Whether you think a financial conflict with a drug/device maker makes a difference to your care, you can research these relationships.
The Physician Payments Sunshine Act of 2010 requires manufacturers of drugs/devices to report payments to doctors and teaching hospitals. You can check that out on Open Payments and look up your doc on the Search Tools.
For example, Dr Andrew Brill, who was on the pelvic mesh panel, was scheduled to be on the 2014 Morcellator Advisory Panel but stepped down due to a conflict of interest with Johnson & Johnson. The San Francisco gynecologist received nearly $100,000 in consulting fees in 2013. The general cutoff that defines a conflict of interest is $50,000 under FDA guidelines.
Other panelists on the morcellator panel were also found to have conflicts, though not as large as Dr. Brill.
ProPublica, Investigative Journalism in the public interest, also has a database of payments to physicians. Dollars for Docs is user-friendly, easy to read and is based on data required under the Physician Payment Sunshine Act.
For example, look up Pelvic Organ Prolapse (here) and see the top docs who received money from Boston Scientific in 2016 – $3.4 million with Dr. Dennis Miller the top recipient at $1.16 million.
Boston Scientific, for example, made payments totaling $3.48 million to ten doctors and 10 teaching hospitals related to pelvic organ prolapse here.
Doctors on the receiving end include Dennis Miller from Milwaukee, WI, Roger Goldberg of Evanston, Illinois, Peter Rosenblatt of Cambridge MA. not only for vaginal mesh but for testing of other things like a Premarin cream drug and a sacral nerve stimulation device, consulting and licensing fees for devices co developed with the company.
Florida Hospital was the top recipient at $262 million.
Dr. Miller has a long history with Boston Science.
He claims to have helped Boston Scientific invent the Pinnacle Pelvic Mesh kit. See the background story here.
Pinnacle Pelvic Floor Kit
Miller claims to have brought the idea of using the Polyform mesh (a sheet of Marlex) and combing it with the Capio, a small hooked device with better access deep into the pelvis to more effectively affix the prolapsing organs. Using the Capio, one could avoid passing trocars or long needles through the pelvic space in a blind procedure.
Dr. Miller’s payments shown total more than $206- thousand from Boston Scientific as recently as December of last year here.
There are listed royalty or licensing fees delivered to Dr. Miller as recently as November 2016. See it here.
Pinnacle, a pelvic mesh used to shore up a pelvic floor and organs, was found to be defective in this country and was recalled here. However, label changes to Boston Scientific pelvic mesh devices (here) shows it is still being used overseas by Boston Scientific International.
As recently as February 2018, Germany’s research institute BfArM, sent out an Urgent Field Safety Notice on the Pinnacle Anterior Pelvic Floor Repair Kit and Pinnacle LITE Posterior with Capio device.
https://www.meshmedicaldevicenewsdesk.com/conflicts-of-interest-in-fda-expert-panels/
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What Wales' major new report on endometriosis means for people affected
Nov 6, 2018 | WalesOnline
By Victoria Jones
Services treating a health issue affecting one in 10 women have, for the first time, been reviewed in Wales.
A detailed report has been issued after the chief executive of the NHS in Wales established a group made up of experts and patients to review endometriosis services.
It has been described by Vaughan Gething, Cabinet Secretary for Health and Social Services, as just "the start of a process" that hopes to improve the lives of women in Wales affected by the incurable disease endometriosis, which is as common as asthma.
Endometriosis occurs when tissue similar to that lining the womb is found elsewhere, often but not exclusively, in the pelvis.
This tissue responds to hormones in the same way as the lining of the womb but, with no outlet, it can cause inflammation, scarring and adhesions, leading to severe pain and many other symptoms. It can affect many organs.
The classic symptoms of endometriosis are severe pain during or between periods; very long, heavy and irregular periods; painful bowel movements; pain in the bladder and pain during or after sex.
Extreme fatigue is very common, and fertility may also be affected. Misdiagnosis is common, resulting in delays to accurate diagnosis, unnecessary tests and sometimes unnecessary surgery.
There is no cure for endometriosis, but the condition is manageable and timely diagnosis could save women from many years of living in constant pain.The report found:Menstrual wellbeing should be part of the school curriculum, from upper primary school onwardsThere is a lack of education on disease recognition, diagnosis and first line management options for GPs and A&E doctorsMany gynaecologists are not sufficiently skilled or confident to excise endometriosis, particularly if the disease involves other organsThere is a lack of specialist teams which could mean fewer people receiving optimal careThe only endometriosis centre in Wales is inadequately funded leading to long waiting times for the most complex surgeryThere is only one endometriosis specialist nurse in the whole of Wales
The group, chaired by consultant obstetrician and gynaecologist, Dr Richard Penketh, was made up of a multidisciplinary team of clinicians, academics and patients. It considered many sources of data, including recent Nice guidelines and research as well as new evidence produced in Wales.
The findings show “a demonstrable lack of understanding” of the condition amongst “a considerable number of health professionals” resulting in significant delay in diagnosis, poor management of symptoms resulting in negative outcomes for those patients affected.
The group make a number of recommendations to improve endometriosis services and provide better outcomes for women. This includes raising awareness among health professionals and promoting education around menstrual wellbeing.
It comes after doctors were urged by a health watchdog to listen more carefully to women who suffer with crippling pelvic and period pain as they could be symptoms of endometriosis.
The National Institute for Health and Care Excellence (Nice) issued guidance in September 2017 to speed up diagnosis and urged GPs not to overlook signs of the disorder.
Three things that should be given immediate consideration, according to the report:
1. Treating complex cases
“As we write, there are women who have had severe and complex disease diagnosed by their secondary care gynaecologists, told there is nothing that can be done, and discharged without an onward referral to a tertiary, specialist centre for specialist informed decision-making.
“The Welsh Government could instruct health boards that, in such cases, GPs must be allowed to refer directly to the designated specialist centre, to prevent these patients from waiting unnecessarily extended periods to be seen in secondary care, and entering a costly cycle of repeated, ineffectual appointments and surgeries, as per the recent NICE guidance.”
2. Urgent clarity on the pathway for patients in Mid Wales
The report urges that their designated tertiary specialist centre (for example, Birmingham) should be identified as a matter of urgency.
3. An alternative endometriosis centre to the only one in Wales
“The Cardiff endometriosis centre is unable to cope with the current demand for its specialist service. Its waiting lists are escalating, and South Wales patients from outside of Cardiff and Vale are being declined producing inequality in care.
“An alternative centre outside of Wales could be commissioned centrally to meet the needs of those patients, and that pathway made known to both patients, GPs, and gynaecologists in secondary care.”These are the key points from the report:
Education
The report suggests knowledge of menstrual health should be embedded within the education service, and resources must be developed to support this for the whole of Wales.
It says: “Advisory agencies and occupational health services must recognise that endometriosis is covered under the Disability Section of the Equality Act 2010, and support women accordingly.”
It says the Welsh Government should endorse this message and ensure there is adequate training and asks Public Health Wales to develop and deliver a public education programme.
Primary care
This report says endometriosis needs to be made a priority for both training of GPs and on-going continuing professional development (CPD).
It says: “Primary care must be involved in implementing the Nice guidance on endometriosis and local pathway development.
“Each health board will be responsible for appointing endometriosis nurse specialists who will assist in the education of GPs and practice nurses.
“Primary care should have direct access to resources such as psychological support, pelvic physiotherapy and pelvic pain management to assist women with a known, prior or suspected diagnosis of endometriosis.
“Health boards should invest in the multi-disciplinary care of women with chronic pelvic pain. Services of this nature are of the sort which should meet the prudent healthcare principles of 'care closer to home' and with 'reduced variation'. Ideally, patients should be empowered to manage their own care where possible, so self-referral into these services should be facilitated.
Secondary care
Secondary care must be involved in implementing the Nice guidance strengthening the care pathways for women.
The report says: “An endometriosis lead for each health board must be appointed to ensure high standards of disease recognition, diagnosis, and treatment.”
The only conclusive way to determine if a woman has endometriosis is through a laparoscopy and excision is widely seen as the gold standard for treating endometriosis, where the disease is cut out.
The report urges: “Trainees and consultants must be empowered to excise the disease where possible and refer on if such skills are not available.
“The pathway for onward referral to tertiary care needs to be clearly mapped and adequately resourced. Women and healthcare professionals should be aware of how to access it.
“Health boards and obstetrics and gynaecology departments must recognise that endometriosis is a chronic condition and that symptoms may recur, potentially requiring an increased number of follow-ups.
“A specialist endometriosis nurse should be available in every department where women with endometriosis are cared for, and the role extended to include education of colleagues in primary care.
“There is only endometriosis specialist nurse in Wales. Her expertise must be utilised to train other specialist endometriosis nurses.”
Tertiary care
The report says: “Referral pathways to tertiary care for all of Wales must be clarified and enforced as a matter of urgency and the information be available for clinicians and patients.
“The pathway for onward referral to tertiary care needs to be clearly mapped and adequately resourced. Women and healthcare professionals should be aware of how to access it.
“Health boards and obstetrics and gynaecology departments must recognise that endometriosis is a chronic condition and that symptoms may recur, potentially requiring an increased number of follow ups.
“A specialist endometriosis nurse should be available in every department where women with endometriosis are cared for, and the role extended to include education of colleagues in primary care. There is only endometriosis specialist nurse in Wales. Her expertise must be utilised to train other specialist endometriosis nurses.”
Chronic pelvic pain management
The group calls for pelvic pain management and support to be integrated into the early assessment of women suffering from endometriosis, and adds this can ideally be undertaken by an endometriosis nurse practitioner
It says: “Pelvic floor physiotherapy forms an integral part of chronic pelvic pain management (CPP), and physiotherapists with training in CPP should be accessed within secondary care. This will require training of physiotherapists in CPP management.
“Tertiary endometriosis services in North and South Wales should have access to a multidisciplinary CPP management service with gynaecologists, anaesthetists, psychologists, physiotherapists, and dietetic input. This should be a rapid access service triaged via the endometriosis nurse practitioner. Options for women from Mid-wales must be facilitated.”
Quality standards
“The Nice quality indicators when finalised in July 2018 should be adopted in Wales. All health boards should utilise existing diagnostic data, or establish registers of women with endometriosis to facilitate audit. The number of women added to the BSGE database should be reported to Welsh Government as a quality standard.”
The report also highlights a lack of research in profiling of women with endometriosis in Wales.
Vaughan Gething, Cabinet Secretary for Health and Social Services said: "Last year, following a report by Fair Treatment for the Women of Wales (FTWW), the Chief Executive of the NHS in Wales established a Task and Finish Group to review endometriosis services in Wales.
"I wish to express my thanks to all members of the group for their hard work in the preparation of their report, which I am pleased to publish today.
"This report is the start of a process that will improve the lives of women in Wales affected by endometriosis. Additionally, it highlights the benefits of collective working between clinicians and patient groups to achieve a positive outcome.
"The report describes a lack of understanding of endometriosis among some health professionals and how current provision fails to meet the level of need. This has caused delays in diagnosis and sub-optimal clinical care on some occasions, with a consequent impact on the quality of life of users of these services.
"The group make a number of recommendations to improve endometriosis services and provide better outcomes for women. This includes raising awareness among health professionals and promoting education around menstrual well-being.
"Health boards have a responsibility to deliver high quality gynaecology services and it is vital they provide a robust and effective pathway, including early diagnosis, for the management of endometriosis. My officials have written to health boards seeking assurance that they are operating their services so they deliver the NICE guidance on endometriosis.
"It is important that serious health issues affecting women are dealt with effectively and appropriately. For this reason, I have directed the recently established Women’s Health Implementation Group, chaired by Tracy Myhill, Chief Executive of ABMU Health Board, to consider all the recommendations in this report alongside its work on vaginal mesh and tape."
"The Women’s Health Implementation Group will provide strategic leadership to ensure an all-Wales approach to break down barriers and join up pathways between primary, secondary and tertiary care, so women’s health is managed in the community wherever possible, with minimal need for intervention."
Commenting on the report, Debbie Shaffer who runs the organisation Fair Treatment for the Women of Wales (FTWW), said: "We're cautiously optimistic about the future for endometriosis patients in Wales, as well as women's health more generally with the Welsh Government's focus on the wellbeing of future generations.
"It seems that now is the time to start taking the health of our girls and women seriously, and we're very pleased to be playing a vital part in making sure that happens."
https://www.walesonline.co.uk/news/health/what-wales-major-new-report-15344512
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