Medtech Innovators Are Under Attack Again – But When Aren't They?

US medtech industry association AdvaMed issued a statement on Nov. 25 in reaction to recently published claims from a group of investigative reporters seeking to highlight what is wrong with the medical technology industry and what drives global innovators. The group, the International Consortium of Investigative Journalists (ICIJ), says it polled 250 journalists from around the world in a bid to assess how devices are tested, approved, marketed and monitored. Is their work balanced and fair, In Vivo asks?

By now, people working in the medical devices industry will be aware of the latest project of the International Consortium of Investigative Journalists (ICIJ), a US-based, non-profit global network of reporters and media organizations who work together to "investigate the most important stories in the world."

That is how they describe themselves and they are back in the news because they have reached the tick box on their list that says, 'Medical Device Industry.' Their recent report has inspired news segments and TV documentaries.

The report, ICIJ Implant Files – Medical Devices Harm Patients Worldwide As Governments Fail On Safety, and preamble carry claims that would surprise no one in an industry that is often the target of wildly critical ("untested devices") or ludicrously over-enthusiastic reports of early experimental-stage cures and medical technology becoming available. These stories get readers. Medical device and health care stakeholders factor it into their work.

It is standard fare, but why does it happen? (Also see "The Implant Files: EU Blamed For Regulatory Inadequacies The World Over While 'Wrath'-Behrendt Fumes" - Medtech Insight, 26 Nov, 2018.) Reporters in the general media who compile documentaries or reports for blogs, websites or hardcopy are subject to many pressures. Do not underestimate their drive to be read first or break a news story. Do not even assume it is their headline, or even all their own work. And in the competitive environment for readers, there is no way the general media would spike such a report.

Medtech innovators will be frustrated at being in the spotlight again, even if the industry has effective responses. The investigative work by the ICIJ is a tale of "health authorities failing to protect millions of patients from poorly-tested implants, flawed devices lingering on the market, oversight lacking, complex devices being approved too quickly, the US FDA loosening its rules get new devices onto the market with substantially less testing, the EU gathering rapidly rising numbers of injury and malfunction reports each year, but refusing to publish the data…" etc.

The group's information is based on public record requests, recall notices, safety warnings, legal documents, contacts, interviews and corporate financial filings. Adverse event reports sent to the FDA over the past decade are a major source of the information – documents that are all publicly available, not shrouded in any sort of mystery and nothing that anyone has either privileged or limited access to.  Because of that, the ICIJ has been able to look at recall notices from international sources and put them together, a task made easy by the ready availability of such information.

But the ICIJ seeks to play on communication issues between stakeholders, failing to highlight adequately the improvements that have taken place over the past 15-20 years. ICIJ reporting partners in 16 European countries claim to have sought access to "detailed injury and malfunction data" held by national regulators. "But in each case, freedom of information requests were denied or led to incomplete responses," they said.

How Will The Public React?

The industry may find nothing new in the content, nor will it be surprised that the EU regulatory system comes in for particular attack. How the public picks it up and assimilates the various claims is another matter; and while mature and balanced attitudes will likely prevail for the most part, there will be an element of controversy that certain groups will be keen to play on.

More use of registries and greater transparency is recommended by some people allied to or interviewed by the ICIJ, and greater tracking of active implants is recommended. No one would argue. It will also surprise no one that Dagmar Roth-Behrendt, a serving MEP until 2014 with the Party of European Socialists group and a hardliner on medical device regulation as the forthcoming EU Medical Device Regulation (MDR) was being drafted, is among the ICIJ's media interviewees.

A Justified Attack?

The interesting aspect here is that medical technology regulation and supervision has never been stronger – and is still going from strength to strength in every measurable aspect: quality, availability, safety, compliance, quality of life, and effectiveness. Codes of conduct abound to prevent unfair competition and promote ethical practice. The EU medical device regulatory arena has never been tougher, high standards are promoted globally by the IMDRF, pockets of the world – from South Africa, to Ukraine, to the ASEAN countries, to Russia – are all building regulatory systems for the future, with durability, patient protection and patient-centricity uppermost.   

The investigative work by ICIJ picks on familiar territory, such as faulty mesh products, “metal-on-metal” hips implants, etc. – issues that are no longer news and have been dealt with and learnt from, as has the PIP scandal in the EU. Recall numbers are quoted by ICIJ, possibly accurately, but by themselves, they are more a headline opportunity than real information; no analysis is made of the other figure – the hundreds of thousands of non-recalls.

Similarly, the project claims to have done hundreds of interviews as part of the Implant Files investigation – some of them of patients who said they were not warned of risks of their implants. The question though, is "hundreds" really enough when making such strident claims regarding health care delivery? This report should be set against the millions of procedures performed annually in any given health care system.

But there is no complacency within industry, and indeed US industry was bracing for the onslaught last week (Also see "Device Sector Braces For Investigative Stories Critical Of Industry" - Medtech Insight, 21 Nov, 2018.). AdvaMed says that the medical community can never completely eliminate risk, but strives to improve technologies and care delivery. No one should ever discount any patient's experience, it says, but by "magnifying the stories of only a few individuals, we overlook the overwhelmingly positive experiences of millions of others." The ICIJ does not dispute this point, volunteering that for most people, medical devices are of clear benefit, and complex implants can radically improve health… and save lives. But its claim that the industry operates with questionable safety and is "putting millions of patients at risk of serious harm in its quest for profit," is hardly a balanced view.

European Reaction

Germany's BVMed agrees with its US counterpart, and adds that devices are often the last course for some patients in whom drug therapy has failed. It adds that deep partnerships with doctors, regulators and the government have brought a maturity and a higher level of safety to the medical device sector. The UK's Association of British HealthTech Industries (ABHI) has been tracking events and released an update notice on Nov. 23, 2018. CEO Peter Ellingworth said, "This is a coordinated international campaign, and we are working on a coordinated international response with colleagues at MedTech Europe and AdvaMed. Given the concerns expressed by the ICIJ relate primarily to the European regulatory system, it is appropriate that our response is at this level."

The ICIJ survey polled 250 journalists from around the world in a bid to assess how devices are tested, approved, marketed and monitored. The project took a year to produce, the group says. They did not poll me or quote any of In Vivo's or Medtech Insight's years-long reported content by journalists who have spent two or three decades, or more, covering the sector. Pity.