Cosmetic surgeon says doctors should disclose their financial links with medical device manufacturers
A high-profile cosmetic surgeon has backed calls for mandatory reporting of the financial relationship between doctors and medical device manufacturers.
- Australia has no legislation requiring doctors to disclose financial relationships with medical device manufacturers
- A surgeon who advised the TGA on breast implant risks and previously consulted for implant manufacturer says this needs to change
- It comes after a worldwide investigation revealed the extent of harm caused by medical devices
Daniel Fleming is described on his webpage as a “world expert” who has performed more than 5,500 breast implant procedures since 1995, more than any of his peers.
But the Brisbane-based specialist has also been a paid consultant for Silimed, which previously made implants that have been linked to a rare form of blood cancer — something the company denies.
Dr Fleming’s past connection to the Brazilian manufacturer is acknowledged in academic papers, but may not be immediately obvious to the women who walk through his clinic’s doors.
There is no requirement for medical practitioners to disclose the benefits they receive from private interests, but even Dr Fleming argues that has to change.
“I just think it’s a good thing because it removes any doubt that anybody can conceal any kind of financial relationship,” he said.
Dr Fleming has provided expert advice to the Therapeutic Goods Administration (TGA), which is responsible for assessing and approving medical devices.
He advised the TGA on the risk posed by breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) — the cancer found in some patients with textured implants.
Dr Fleming has argued in academic circles that BIA-ALCL is not a cancer and should not be recognised as such.
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The consensus among experts puts the risk of BIA-ALCL at between 1-in-1,000 and 1-in-10,000.
“The media coverage has tended to sensationalise the issue and as a result cause anxiety for patients that is disproportionate to the real risk,” Dr Fleming wrote in June.
But Dr Fleming insists he never had a financial relationship with Silimed while conveying this view to the TGA and said he has always disclosed any actual, or perceived conflicts of interest.
“I think nearly all of the doctors who sit on that panel have had financial relationships with implant companies at one time or another, certainly the doctors that use implants do,” he said.
Dr Fleming said his patients were always told about the risk of BIA-ALCL when visiting his clinic, and if they receive a positive diagnosis, they must get the implants removed.
“Anybody who has this diagnosis at the moment must follow the advice to have the implants and the membrane around the implants removed because we know that’s 100 per cent safe,” he said.
Pharmaceutical sector on political donations list
Dr Fleming’s comments follow an investigation by the International Consortium of Investigative Journalists (ICIJ) that revealed the extent of the harm caused by medical devices across the world.
The investigation, which involved more than 250 journalists from 36 countries, also showed how manufacturers downplayed the risks associated with their devices during the approval process.
Sydney University’s Barbara Mintzes, an expert in conflicts of interest and issues of integrity in the medical industry, has long supported a mandatory reporting regime.
“It’s important because we know that there is an influence from those financial relationships so making those relationships public is part of the solution,” Dr Mintzes said.
When reforms to the regulations governing medical devices were being considered in Australia earlier this year, medical device companies were working hard behind the scenes.
Political donations from the pharmaceutical and health sector climbed from $1 million to $1.5 million, making the industry the fourth-biggest donor in 2016-17.
The medical devices lobby, the Medical Technology Association of Australia (MTAA), declined to answer specific questions about their spending on lobbyists, political donations, and their dealings with the federal Health Minister.
In a statement, the MTAA said it was a strong supporter of “a robust and transparent MedTech industry in Australia”.
“[The MTAA] plays an active role engaging with stakeholders, media and government, including participating in various government consultative committees and parliamentary inquiries in order to share information and insights,” the statement said.
Dr Mintzes said it was not just political funding that needed to be made public, but the relationships between doctors and the device and drug manufacturers that supply them.
“Doctors tend to think they’re not affected: ‘You can’t buy me for the price of a pizza,'” she said.
Dr Mintzes said health professionals were often oblivious to the impact of the benefits they received from pharmaceutical companies.
“Even a very cheap meal, so less than $20 on average, is linked to an increase in the prescribing rate for the promoted drug,” she said.
“The more of those meals that a doctor will receive, the more likely they are to prescribe that drug.”
In 2010, the US enacted legislation that requires pharmaceutical companies to publicly disclose their financial relationships with doctors.
Every free flight, conference ticket, and sandwich can be searched and its influence examined.
In Australia, there is a similar but weaker regime for drugs. When it comes to medical devices, however, the best check on accountability is the MTAA’s Code of Practice.
There are financial penalties for breaches, and if companies refuse to pay, the MTAA will publish their refusal in an industry magazine.
But the code only applies to its members, and even the MTAA describes it as a “guide”.
In a statement, the MTAA said it would support new laws to strengthen the obligation on device companies and suppliers to report their financial ties to doctors.
“MTAA has called for the implementation of a harmonised industry code of practice that all device manufacturers and suppliers would be required to adhere to by law or regulation,” the statement said.
“MTAA’s own code would be an appropriate basis for such a harmonised code.”