Seeing through the spin

Light touch regulation on medical devices is a threat to patient safety. Labour must be ready to stand up for patients by requiring the drugs and medical devices industries prove its products are safe and effective.

In 2015 journalist Kath Sansom was treated with a mesh implant for incontinence. She soon knew something was wrong. “The pain in my legs and feet was so intense, along with burning pains in my vagina-like being cut with a cheese wire”. Unfortunately Sansom’s case was far from isolated, with complications of meshes likely to have affected many thousands of women. Despite being initially dismissed by medical professionals and regulators it was largely the persistence of campaigners like Sansom that led to vaginal mesh surgery being suspended in England in July 2018.

Eclipsed by Brexit chaos, a wider scandal in medical regulation has gone almost unnoticed in recent months. In November 2018, the International Consortium of Investigative Journalists, which include journalists from the Guardian, BBC, and BMJ, exposed extensive failures in the safety regime for implantable medical devices.

The ‘implant files’ investigation has exposed lax regulation across the European Union that has allowed manufacturers to market new products with barely any clinical trial data or safety evidence. Examples include Nanostim, a pacemaker which was approved based on trial evidence on only 33 patients with only a 90 day follow up period. Nanostim was eventually withdrawn from the market after the implantation of over 14,000 devices after it was found to be prone to battery failure.

As well as exposing the lack of scrutiny and rigor in the development of new medical devices, the implant files revealed just how difficult it is to obtain access to the research data for new devices, making any independent evaluation by patients or doctors virtually impossible. The journalists were denied access to the Nanostim data by the UK’s Medicines and Healthcare Regulatory Authority who cited the commercial confidentiality of the manufacturer.

Much of the safety regime for medical devices are built on flimsy assumptions. Devices, including some transvaginal mesh devices, were approved on the basis of supposed ‘equivalence’ with products which have already been approved. Thus, generations of products, each with substantial modifications, receive rubber-stamped approvals based on their predecessors. Devices can be approved based on decades-old clinical evidence relating to an entirely different product. Despite the urgent need for effective regulation industry lobbyists have succeeded in maintaining light touch regulation in the EU’s regulation on medical devices policy which is due to come into effect in 2020.

While medicines regulation requires much greater evidence of safety than for new devices and implants, pharmaceutical lobbyists have also argued that hastening access justifies taking regulatory and safety shortcuts. A narrative around over bureaucratic regulation that has been cultivated over many years is steadily gaining traction, particularly in the United States. Promises to liberate the boffins from red tape can make for good politics and are often heartfelt and supported by some patient groups. They are also usually misguided.

Despite the perception that drug regulators are sluggish and inefficient, in fact, the majority of delay in the regulatory process comes from the pharmaceutical industry rather than the regulators, mostly through postponing their applications or failing to provide accurate and comprehensive information^[1]. The expectation that drugs are shown to work is necessary to incentivise industry to invest in clinical trials. Gathering evidence following market authorisation is incredibly difficult and such promises are generally unfulfilled. Once ineffective drugs are available to prescribe, restricting their use is immensely challenging and leads to huge amounts of wasted healthcare spend.

Some in the pharmaceutical industry and academia continue to resist measures to increase research transparency, by refusing to register and publish all trial data. As highlighted by the AllTrials campaign, this allows researchers and academia to effectively cherry pick studies that show positive results. The refusal to share data that is vital to understanding whether or not treatments work should make us all angry and probably requires effective legislative intervention.

The partnership between the NHS and the drugs and medical devices industries has delivered truly transformative outcomes for millions of patients. Unfortunately, the implant files have demonstrated huge failures in regulation. This is an ongoing threat to patient safety that requires transparent and effective regulation.

For patients to understand how well devices work in the long term, the industry and the NHS may also need to be supported to establish registries for many different types of devices. Patients must also be taken seriously when they tell doctors that things have gone wrong. When Labour comes into office we must be prepared to see through the spin and work with industry to put patients and their safety first.