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Ethicon Media Monitoring 10/22/2018
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The damning vaginal mesh dossier: The shocking failures behind the scandal
Oct 20, 2018 | Infosurhoy
By Marta Subat
For the thousands of women caught up in the vaginal mesh scandal, the question must be: how did a product that’s caused them such agony ever come to be approved? -
Vaginal Mesh Implants – Australian Government Apologizes to Women for Years of Pain
Oct 19, 2018 | Citizen Truth
By Alex Muiruri
The Australian government has issued a public apology to women, acknowledging the pain and agony that has resulted from vaginal mesh implants. -
Marketing with real meaning: the importance of a good citizen marketing strategy
Oct 19, 2018 | The Drum
By Jennifer Wilson
I’ve worked in the marketing industry for over 20 years around the world and too often brands, particularly in the wellbeing space, stagger between pushy messages with veiled product promises to bland meaningless promotional tweets.
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The damning vaginal mesh dossier: The shocking failures behind the scandal
Oct 20, 2018 | Infosurhoy
By Marta Subat
For the thousands of women caught up in the vaginal mesh scandal, the question must be: how did a product that’s caused them such agony ever come to be approved?
And it was a seemingly innocuous email response last week from Johnson & Johnson that provided the final, damning piece in the jigsaw puzzle. ‘According to our records,’ it read: ‘TVT devices were launched in Europe in late 1997.’
It was an astonishing admission, because at that time a major trial in the UK to check whether TVT — tension-free vaginal tape — was a safe, or even effective, treatment for women with stress incontinence had not even begun recruiting patients. And yet this email showed that UK regulators had already approved the use of these mesh devices.
This was purely on the basis of evidence provided by Ethicon, the subsidiary of U.S. drugs and medical devices manufacturer Johnson & Johnson that made them.
That utter failure of regulatory oversight was bad enough. But we can also reveal that this evidence was tainted by a multi-million- dollar deal between that company and the Swedish doctor who invented TVT.
Furthermore, the professional organisations representing surgeons who do these procedures have accepted funding from implant manufacturers, while surgeons themselves have received fees for speaking and consultancy work.
TVT has been a public health disaster. Good Health has campaigned for eight years to raise awareness about problems with the surgery which, while it has helped many, has also left thousands of women with complications including chronic infections, agonising pain and bleeding.
For years, the medical profession — apart from a few, lone voices — failed to take the suffering of these patients seriously, refusing to accept that it was the mesh causing them so much distress. But now, across the world, mesh manufacturers are facing multiple claims for compensation.
Last week, as the National Institute for Health and Care Excellence (NICE) finally ruled that the mesh should be used to treat stress incontinence only as a last resort, and only by specialists, the BMJ published my investigation into how it was fast-tracked into widespread use.
The word ‘scandal’ is overused. But in the case of an unproven procedure, foisted upon tens of thousands of women in the UK alone, often with crippling consequences, no other word will do.
Stress incontinence, caused by a weakening of the ligaments or muscles that support the urethra and bladder, affects up to a third of women over the age of 40. It means that coughing, sneezing or other sudden exertion causes them to pass urine involuntarily.
Until 1998, the standard surgical treatment, in use since 1959, was colposuspension, a specialist operation where tissue around the urethra is raised and held in place by stitches attached to ligaments at the back of the pubic bone.
Still performed in a very small number of cases, colposuspension is a major operation. In the Nineties, it meant seven days in hospital and a long recovery — a daunting prospect for patients and a costly one for NHS trusts. Unsurprisingly, not many women were offered it.
Then, in 1996, a Swedish obstetrician and gynaecologist called Ulf Ulmsten published a paper reporting the results of a revolutionary new operation. He was about to become a very rich man.
Ulmsten and colleagues at Uppsala University Hospital had developed a procedure in which a narrow length of plastic mesh tape was inserted to act as a kind of hammock for the urethra.
As the name suggests, tension-free vaginal tape allows the bladder to work normally, until it is tightened by a sudden muscle contraction, such as that caused by coughing or sneezing, which closes the opening of the urethra.
The operation could be performed under local anaesthetic as an outpatient procedure in less than half an hour. The financial implications were immediately obvious — especially to Ethicon.
Ulmsten’s team had operated on 75 women and reported the results in a paper published in the International Urogynecology Journal in March 1996: 63 patients (84 per cent) were ‘completely cured’ throughout a two-year follow-up, and six (8 per cent) ‘significantly improved’.
Ethicon made Ulmsten an offer he couldn’t refuse. If the results of a larger trial due to be carried out across several hospitals matched those of the first, they would pay him $1 million to secure the rights to TVT — for starters. On February 25, 1997, Ulmsten filed a U.S. patent application naming himself and a colleague as the inventors.
He formed a company, Medscand, to which he assigned the patent, and the following month signed a licensing agreement with Johnson & Johnson. The results of his larger trial, involving 131 women in six hospitals in Sweden and Finland, appeared in the International Urogynecology Journal in July 1998. TVT performed even better than before: 119 patients (91 per cent) were declared ‘cured’, and a further nine (7 per cent) ‘significantly improved’.
Ulmsten’s million dollars would soon look like small change. A Johnson & Johnson spokesman confirmed that in 1999 it paid Medscand £18.6 million, at today’s exchange rate, for ‘all assets associated with the TVT business’.
Was the outcome of Ulmsten’s second trial influenced by that prospect? Ulmsten can’t answer that — he died in 2004.
But a systematic review of 75 studies (covering all kinds of medical treatments) by the authoritative Cochrane Library in 2017 concluded that industry-sponsored studies were more favourable to the sponsor’s products than non-industry- backed studies.
In the UK, mesh was adopted with indecent haste. In 1998-99, only 214 women in England had the treatment. The following year there was an explosion in its use, and by 2009 the number of annual operations using polypropylene mesh tape (not just Ethicon’s) had climbed to an all-time high of 11,365 in England alone. The use of colposuspension fell from 3,719 cases in 2000-01 to just 276 by 2008-09.
TVT wasn’t cheap — in 2003, each kit cost £425 plus VAT — but the major saving was in hospital time.
The advent of mesh meant that more women were being offered surgery for stress incontinence. Between 2000 and 2008 the overall number of surgical procedures a year in England and Wales more than doubled, to 13,201.
In the U.S., TVT had been approved thanks to a principle known as ‘substantial equivalence’ — approval is fast-tracked if a device works in a similar way to one already approved.
That was a woven polyester sling made by a rival company and approved by the U.S. Food and Drug Administration in 1996.
That product was recalled early in 1999 after it was found to cause erosion of the urethra and bladder, leading to infection and pain — all side-effects that have since been suffered by TVT patients. But by then, Ethicon had been able to use the original approval to piggyback Ulmsten’s product to market.
In the UK, TVT was nodded into use with no scrutiny by the Safety and Efficacy Register of New Interventional Procedures (SERNIP), the forerunner of NICE.
Evidence of this shocking regulatory failure came to light in the pages of a forgotten medical textbook, sent to me by an anonymous, concerned gynaecologist.
‘Incontinence in Women’, a collection of reports from a study group convened by the Royal College of Obstetricians and Gynaecologists in 2001, includes a verbatim record of a revealing exchange between members of the UK and Ireland TVT Trial Group, which was still in the throes of assessing the safety of mesh.
One gynaecologist said it was ‘astonishing’ that SERNIP had approved the use of TVT without evidence from any random controlled trials — where a new drug or product is tested on one group of patients and the results compared with those in another group having the standard treatment.
The lead investigator of the trial group said it was ‘highly regrettable’ that TVT had been approved ‘on the basis of no evidence at all’, other than ‘documentation submitted by the manufacturers of the device’. And as Johnson & Johnson confirmed, it was marketing TVT in Europe by late 1997.
Surgeons and hospitals in the UK were quick to jump on the cost-effective TVT bandwagon.
But in the process the medical profession, from individual surgeons and their trusts to the royal colleges responsible for the specialities involved, failed to ensure surgeons were properly trained to carry out the procedure which, although quick to perform, demanded a high degree of skill.
Insufficient care was also taken to ensure that only appropriate patients were selected to undergo the operation — some would have benefited better from non-invasive treatments such as pelvic floor and bladder training exercises.
Perhaps worst of all, in the scramble to adopt the new, cheap operation, no one bothered to set up a registry of procedures — a record of results and other outcomes that is a standard method of determining whether a procedure is safe.
At the same time, however, as my six-month investigation revealed, individual surgeons were — and still are — happy to accept money from mesh manufacturers in the form of fees for speaking and consultancy work, while many industry bodies are heavily subsidised by industry sponsorship.
In 2016-17 the Royal College of Surgeons had ‘funding partnerships’ with 68 companies, including Ethicon, while recently published accounts for the Royal College of Obstetricians and Gynaecologists show a contribution of £133,402 from Ethicon. The UK Pelvic Floor Society, whose members use synthetic meshes for prolapse and incontinence surgery, is supported by several mesh manufacturers.
Had a registry of procedures been in existence from the earliest days, many of the longer-term problems with mesh would have been spotted sooner, sparing countless thousands of women unnecessary suffering.
Yet time after time, calls for such a registry to be set up were ignored — NICE first suggested it in 2003.
Patient campaigners and concerned medics have also repeatedly called for it. It wasn’t until February 21, 2018 — 20 years after mesh was introduced — that Jeremy Hunt, then Health Secretary, announced his department would be investing £1.1 million ‘to develop a comprehensive database for vaginal mesh to improve clinical practice and identify issues’.
It was, as campaigners pointed out, much too little, far too late.
It took the scandal of a faulty hip replacement in 1998 to persuade the government to set up the National Joint Registry, which since 2002 has monitored all hip, knee, ankle, elbow and shoulder joint replacements.
Since then, the registry has been used to identify and remove unsafe devices from the market and shine a light on poor surgical practice.
Similarly, a registry of breast implants was launched in 2016 in the wake of the PIP scandal, in which thousands of women were found to have been fitted with implants made from non-medical grade silicone.
The only correct response is for the Government to introduce mandatory registries for all devices that companies would have doctors insert in our bodies. This should be an obligatory pre-condition of approval.
That way the suffering of the thousands of victims of mesh will not have been completely in vain.
http://infosurhoy.com/cocoon/saii/xhtml/en_GB/science/the-damning-vaginal-mesh-dossier-the-shocking-failures-behind-the-scandal/
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Vaginal Mesh Implants – Australian Government Apologizes to Women for Years of Pain
Oct 19, 2018 | Citizen Truth
By Alex Muiruri
The Australian government has issued a public apology to women, acknowledging the pain and agony that has resulted from vaginal mesh implants. Thousands of women across the world have used the mesh, which most of the time, has led to unforetold suffering. Lawsuits have now been filed to audit what is being called the “biggest medical scandal” ever.
“On behalf of the Australian government, I say sorry to all of those women with the historic agony and pain that has come from mesh implantation which have led to horrific outcomes,” said Greg Hunt, Australia Minister for Health. “My message to them is your voice has been heard, and not just heard but acted upon,” Hunt added, reassuring support for those affected in his country.
Hunt’s comments came after Australia’s Senate Community Affairs Committee made an inquiry into the number of women who had had vaginal mesh implants, as well as the implants’ related issues. The inquiry had been informed by the horror stories of women in the country who had mesh implants, and uncovered the debilitating effects and suffering the meshes caused.The “Biggest Medical Scandal”
From the inquiry, the Senate found that many women had complained to their physicians after the implant procedure; the physicians would then either brush off their concerns or make them believe they were the only ones experiencing the pain.
One victim commented: “Women are still not being believed by their doctors. [The doctors] are still implanting mesh and telling women it is new mesh and it is the same mesh.”
According to the inquiry, the doctors were either “clueless” of the effects of the meshes on women, or deliberately downplayed the women’s complaints.
Speaking to the committee, another woman spoke of how she had gone to her doctor for a period spanning over two years complaining of various pelvic problems, which she suspected were caused by her mesh implant. She said it took another 12 months for the doctor to finally suggest the mesh could be the problem, and she was then informed that she was the only patient with mesh complications.
Another woman confessed to the committee saying, “I began to dread attending the GP (general practitioner) for fear of being made to feel like a hypochondriac, again dismissed and told that it was very unlikely my symptoms were due to the mesh, and all the ‘hype on the internet’ was not to be believed anyway.”
Confirming these reports to the committee, Ms. Stella Channing of the Australian Pelvic Mesh Support Group (APMSG) said: “What happens is that women who are suffering with their pain and complications such as mesh erosion or they are bleeding go to their doctor – and, to be honest it starts at the GP level. The GPs don’t understand mesh or mesh complications and the women are usually fobbed off.”
“They might be sent for a scan or an x-ray and they are sent away. The x-ray comes back with nothing and then the doctors say ‘there’s nothing wrong with you because you don’t show anything.’ Women go back again and again to doctors and they are being sent away, and doctors are saying ‘we don’t know what it is.’ Some women go on for years in that same cycle,” she added.
Following these revelations, Senator Derryn Hinch, a participating member of the inquiry, called the situation “the biggest medical scandal ever” in the history of Australia.
Hunt promised that the government would look into the matter and involve all stakeholders in providing a lasting solution, as “too many women had suffered for too much long.”Vaginal mesh implants: a big problem worldwide
Australia isn’t the only nation where vaginal mesh implants are going wrong. Reports by the Food and Drug Association (FDA) show that about 100,000 implant procedures are performed every year, and of these, tens of thousands go wrong, and hundreds of deaths occur as a result.
Women from the U.S., U.K., Canada, Australia and other parts of the world have filed or joined class action lawsuits against mesh manufactures in a bid to seek compensation for their suffering. Companies facing these numerous lawsuits include American Medical Systems, Johnson & Johnson, C.R. Bard Coloplast and Cook Medical, who are some of the largest manufactures of vaginal mesh implants.
Acknowledgement of the suffering by the Australian government is a step in the right direction and an encouragement to all other women enduring the excruciating pain in silence. However, Danny Vadasz of the Health Issues Center thinks the apology is not enough: “I think people still need an explanation about why the various regulatory systems that are supposed to protect the public failed.”
https://citizentruth.org/australia-apologizes-over-vaginal-mesh-implants/
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Marketing with real meaning: the importance of a good citizen marketing strategy
Oct 19, 2018 | The Drum
By Jennifer Wilson
I’ve worked in the marketing industry for over 20 years around the world and too often brands, particularly in the wellbeing space, stagger between pushy messages with veiled product promises to bland meaningless promotional tweets. A different approach based on delivering real consumer value can cut through the noise, develop customer loyalty and engage your audience.
We throw around terms like ‘brand citizenship’, ‘corporate social responsibility’ and ‘reputation management’ as part of the concept of brands working to project an identity of themselves as caring, sharing, trustworthy members of society. I don’t feel this goes far enough and brands must push themselves to be Good Citizens and actively pursue this as a strategy.
Good Citizenship Marketing is when a brand understands its evolving role in society, proactively acts with purpose and chooses to invest in positive acts both to improve perception of it as a brand and as a tool to build trust. Good Citizenship goes hand-in-hand with reputation management but is a more active way of building trust.
Although it might seem obvious that brands need to do this, there are tangible reasons to work on Good Citizenship:It’s easier to hire staff - 93% of us are influenced by wanting to work for Good CitizensIt increases business - 70% of us are likely to not buy from a business that doesn’t demonstrate Good CitizenshipWe’re likely to be proud to work for Good Citizens – 72% of us want to work for companies led by CEO’s who actively work to build Good Citizenship practise
The ‘image’ of Good Citizenship
Brands always want to project a perception of good citizenship, but walking the walk is more important than talking the talk.
Johnson & Johnson, one of the world’s most successful medical devices, product, pharmaceutical and consumer packaged goods companies, also ranks highly when it comes to fines around products – most recently £3.6bn related to talc (currently subject to appeal).
Johnson & Johnson has traditionally worked hard to retain its good reputation and it will be interesting to see how it counters the negative effects of both this Baby Powder ruling, and the findings relating to their vaginal mesh products. Johnson & Johnson is an active participant in many clinical trials – a way to use good citizenship to rebuild its corporate credentials, which may be why the brand chose the good citizenship route.Advertisement
Coca-Cola is well known as a soft drink, but they are also one of the most reputable brands in the world – with solid leadership and vision, strong environment credentials (more than 40% of the bottle is plastic recycled by Coke), and increased emphasis on low/no sugar drinks. That said – producing over 110bn plastic bottles a year – most of which end up in landfill or oceans remains a problem for them they are yet to overcome. Good Citizenship would be a good focus to try and address this.
When trust is gone
Sadly, the Good Citizen Marketing Strategy is most useful and visible when something goes wrong. Mistakes happen, we know that, particularly in the health and wellness space and these stories get a lot of press and social commentary that can set a brand back years. Countering a situation can be hard – the trust that has been built up over the years can be destroyed by a single incident. Rebuilding trust is hard and will take time. Working out where to start can be a huge challenge that brands must face head on.
The same applies to brands or products linked to health or lifestyle outcomes, such as tobacco, fast food and gambling brands, getting on the front foot and positioning yourself differently in the mind of consumers can be critical to getting traction and, more importantly, an audience where you might otherwise be an outcast.
https://www.thedrum.com/opinion/2018/10/19/marketing-with-real-meaning-the-importance-good-citizen-marketing-strategy
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