Health authorities across the globe have failed to protect millions of patients from poorly tested medical implants, an investigation of the medical device industry by the International Consortium of Investigative Journalists has shown.
Modern medicine saves millions of lives. This is true for both medicines and medical devices. However, if regulation and oversight are weak, products that cause more harm than good can enter the market, causing injury and death. This, too, is true for both medicines and medical devices.
In this context, it is surprising that drugs and medical devices are often held to different standards by regulators. One example:
(Some) clinical trials of drugs are required to publicly post their results under the EU Clinical Trials Regulation, but this common-sense transparency rule does not apply to clinical trials of medical devices.
The European trial registry only lists clinical trials that are subject to the EU Clinical Trials Regulation. Because medical device trials cannot be registered on the EU registry, European companies and universities often register device trials on the American registry Clinicaltrials.gov instead. Many of the European trials listed there are missing results.
For example, UK universities have registered 2,393 trials on Clinicaltrials,gov whose results are due, but only 47 of those trials have posted results onto the registry, in breach of WHO standards.
Meanwhile, in the United States, (some) medical device trials do have to post results, but the FDA has so far failed to enforce this rule.
Founder of TranspariMED Till Bruckner said:
"There are serious transparency shortcomings in how the European Union regulates medical devices. For example, while the results of clinical trials of new drugs have to be posted onto a public database [EudraCT], the same disclosure rule does not apply to device trials. Why do companies have to make public the evidence they hold on heart drugs, but not on pace makers? This is absurd. Doctors and patients need access to the full evidence on all drugs, devices and treatments. The new EU regulation for medical devices will fail to deliver on this basic transparency principle.
It will take years for the European Union to put adequate transparency measures into place. Patients cannot wait that long. National governments need to act now to ensure that all clinical trials conducted in their country, including trials of medical devices, are registered and report their results. A recent report by UK parliament found that national monitoring of clinical trials could help safeguard patient safety at minimal cost."
Transparency International yesterday called for more transparency in the development of both medical devices and medicines, noting that:
“It’s deeply worrying that the regulation for medical device research is even worse than what is already a poor situation with pharmaceuticals. Those that fail to properly report the findings of medical research must be sanctioned."
Looking at European device regulation more broadly, observers have warned that the European Union’s new device regulations will "fail to protect the public". One senior academic has even dismissed them as a "smokescreen".