AUSTRALIA’S college of women’s health specialists has denied being influenced by health industry funding after failing to declare sponsorships from pelvic mesh device manufacturers to a Senate committee investigating the pelvic mesh scandal.
Calls for a formal inquiry into industry funding of the health profession have increased after the Royal Australian and New Zealand College of Obstetricians and Gynaecologists declared $103,000 in magazine advertising and trade displays “over the years” from “the manufacturers and marketers of mesh”, during evidence to a Senate inquiry on September 19.
Related: The medical mesh investigation
The declaration did not state the figure was restricted to certain payments made by Johnson & Johnson between 2005 and 2015, and omitted substantial RANZCOG links with industry throughout the controversial pelvic mesh period.
Bond University academic researcher and former University of Newcastle conjoint lecturer Dr Ray Moynihan, who is globally recognised for his work on the business of medicine, said flows of money from industry “deeply compromises the ability of colleges to act as independent advocates for patients, the public, for women and consumers”.
“It’s a mess that really must be cleaned up,” Dr Moynihan said.
RANZCOG’s declaration to the Senate did not include Johnson & Johnson sponsorships before 2005, including a RANZCOG annual scientific meeting breakfast session in 2001 where the company discussed its TVT incontinence device with specialists.
It did not include a joint RANZCOG and British Royal College of Obstetricians and Gynaecologists “The Best for Women” annual scientific meeting in 2002 where Johnson & Johnson and mesh manufacturer Tyco Healthcare were thanked for their “generous support”.
It's a mess that really must be cleaned up.Dr Ray Moynihan
RANZCOG documents show companies were offered “Best for Women” platinum sponsorships for $100,000, and gold sponsorships for $50,000.
RANZCOG sought and received industry funding to establish its website, telling sponsors the funding would “enable the RANZCOG to further the electronic education of its fellows”.
The Senate declaration did not include $51,500 in American Medical Systems sponsorships and exhibitions during the pelvic mesh decade, and $26,000 from Tyco Healthcare. More than 500 Australian women implanted with AMS pelvic mesh devices are registered in a legal class action against the company.
Another 850 women are part of a legal class action against Johnson & Johnson. Tyco Healthcare (now Medtronic) marketed the Australian-invented IVS pelvic mesh device for prolapse, which a 2010 Melbourne review found had significantly higher rates of pain, mesh erosion and infection complication rates than eight other devices.
The Senate declaration did not acknowledge RANZCOG involvement with pelvic mesh industry-sponsored doctor training at public and private hospitals across Australia from 2001, where doctors received college credit points for attending lectures and live surgical procedures using mesh devices.
Documents obtained by the Newcastle Herald show representatives from companies including Johnson & Johnson presented “technical lectures” at some RANZCOG-credited training workshops, while mesh manufacturers AMS, Johnson & Johnson, Covidien, Boston Scientific, Cook Medical and Endotherapeutics featured prominently at a “RANZCOG-approved” pelvic floor symposium in Melbourne in 2009.
The aim is to put science back on the program.RANZCOG 2017 annual scientific meeting pledge
The Senate declaration also failed to declare “corporate sector support” for RANZCOG trainee scholarships at North Shore Private Hospital from 2002, through the Centre for Advanced Reproductive Endosurgery (CARE) which had Johnson & Johnson and Stryker as its major sponsors.
In a statement the college said it did not have records before 2005. It said it relied on industry funding to run its annual scientific meetings, with some profits used to support Indigenous and global women’s health initiatives. The statement was released after a sponsorship prospectus for RANZCOG’s 2017 annual scientific meeting in Auckland from October 29 to November 1 showed the potential for a minimum $750,000 in sponsorships and trade displays.
The prospectus said the 2017 annual scientific meeting aimed to “put science back on the program”. Sponsorships offered “prime exposure and first hand contact with a targeted audience”, and a program where meal breaks were scheduled in the trade display area to provide “opportunities for engagement” between sponsors and specialist “opinion leaders”.
RANZCOG offered $40,000 gold sponsorships at the 2017 Auckland conference, a $12,000 meeting app offering sponsors “a perfect brand reinforcement opportunity”, and other branding opportunities including a $12,000 “new Fellows reception” sponsorship allowing companies to “demonstrate your support of these Fellows as they embark upon their career”.
In November last year the RANZCOG board approved a new advertising and sponsorship policy that described the college as “a pre-eminent institution with unrivalled access to women’s health practitioners in Australia and New Zealand, and accordingly its brand has significant value”.
During a Senate inquiry public hearing on September 19 Queensland obstetrician and gynaecologist, Professor Chris Maher, said “interaction” between sponsoring companies and leading clinicians when pelvic mesh devices were introduced contributed to their “over-utilisation”.
“Sponsoring companies actively promote medical specialists who utilise their products to referring GPs and company-sponsored educational activities, where one of the aims of that activity is to increase utilisation of those products,” Professor Maher told the Senate inquiry.
“Sponsoring companies are also actively involved in the education and provision of training to medical specialists.”
Sponsoring companies actively promote medical specialists who utilise their products.... where one of the aims of that activity is to increase utilisation of those products.Obstetrician and gynaecologist Professor Chris Maher
He noted the activities were not illegal, but recommended specialist and GP training “should be conducted at arm’s length from sponsoring companies, by independent specialists who are free from any material or personal gain from the introduction or utilisation of that product”.
Dr Moynihan said there was “great disquiet within the senior echelons of the medical establishment about the overly-cosy relationship between the medical profession, their colleges and the industries that make devices and drugs”.
While there had been debate back to the Thalidomide scandal of the 1960s, and attempts at reform, there needed to be a formal inquiry into the relationship between health professionals and industry, he said.
“The fact that the regulatory system has failed women so miserably, so profoundly here, is deeply saddening. It’s deeply disappointing. But I think it’s an opportunity for a major, fundamental clean-up of the regulation of medical devices so that next time there’s a new device, a new mesh, a new product, a new implant, before people use it we can get a realistic and reliable idea of how well it’s going to work and what its harms are,” Dr Moynihan said.
The fact that the regulatory system has failed women so miserably, so profoundly here, is deeply saddening. It’s deeply disappointing. But I think it’s an opportunity for a major, fundamental clean-up of the regulation of medical devices.Dr Ray Moynihan
RANZCOG was “doing nothing different from any other medical college” in accepting industry funding, he said.
“To my knowledge this is the way in which medical colleges in Australia still operate, reliant on industry funding for many of their activities. It’s a problematic relationship, therefore there must be full disclosure and full transparency. But more than that there needs to be much greater independence, and the best minds in medicine are saying that.”
Dr Moynihan, now at Bond University, and Sydney and Newcastle University researchers released a study in July showing almost 3.5 million individual attendances at more than 116,000 sponsored medical education events between 2011 and 2015.
Previous research has shown even small flows of money, gifts or meals are associated with changes in doctors’ prescribing practices.
“Surveys show that many doctors feel they can take money and and still be independent, but they think that their colleagues can’t,” Dr Moynihan said.
His comments followed calls by University of Canberra academics Dr Wendy Bonython and associate professor Bruce Arnold for a complete overhaul of Australia’s drug and medical device watchdog, the Therapeutic Goods Administration, to distance it from the health industry and allow consumers to sue it for negligence. They told the Senate inquiry the current regulatory framework was “a complete bypass of the interests of consumers”.
They were backed by Monash University associate professor Dr Ken Harvey, who said a regulator that was completely funded by the industry it regulated was not in the public interest.
RANZCOG denied that industry sponsorships affected its decision not to make a submission to the TGA as it considered reclassifying all pelvic mesh devices to high risk.
To suggest that industry funding has an influence on RANZCOG statements, policies and guidelines is very inaccurate.Royal Australian and New Zealand College of Obstetricians and Gynaecologists
It was “not reasonable to state that RANZCOG did not put forward a submission because of funding arrangements and to suggest that industry funding has an influence on RANZCOG statements, policies and guidelines is very inaccurate,” a spokesperson said.
RANZCOG acknowledged that pelvic mesh devices had “led to terrible outcomes for many women”, but said it had been “very proactive in dealing with mesh-related queries and is committed to working with the various groups to address issues related to mesh”.
In October the TGA quietly announced moves to re-classify all pelvic mesh devices to high risk, involving “higher evidentiary requirements” of both new and currently-approved devices, after strong criticism of the regulator for approving many prolapse and incontinence devices with little or no evidence of safety and efficacy.