If you were to buy a toy for a child, you’d expect it to have been assessed for safety, lest it contains parts that can be easily ingested or inhaled or, say, has sharp bits that may harm a child. You might also imagine that stringent safety rules would exist for medical devices including pacemakers, breast implants and joint prostheses. However, if a recent joint investigation by the British Medical Journal the Telegraph is anything to go by, nothing could be further from the truth (in Europe at least).
A manufacturer seeking to have a new device licenced for sale in Europe can apply through any one of about 80 ‘notified bodies’ spread throughout and even beyond the region. For a fee, these bodies assist manufacturers gain approval for their products. Reporters from the BMJ and Telegraph sought to see how this system works and how well it assesses new devices for effectiveness and safety. The team invented a fictitious artificial hip, and then made enquiries with a number of notified bodies with a view to getting it licenced.
The individuals involved in this investigation deliberately designed the hip to have a number of inherent flaws that should have rung loud alarm bells for assessors. Here’s a summary of these problems:
- The hip was tested for how it wears out on a simulator machine. The wear tests show inaccuracies and inconsistencies throughout the report
- The wear test results also show that the prosthesis will wear at a catastrophic rate after implantation, leading to levels of chromium and cobalt that are a threat to general health
- Two of the three equivalent devices have been withdrawn from use. The third is subject to legal action
- Reports in the dossier showed that a patient implanted with this device would have a very restricted range of motion, more than with any other implant
- Data in the test reports indicated that the cup was likely to deform and fall out
Yet, wherever the investigators went with their dodgy device, they were given repeated assurances that the licencing of this device would be very unlikely present any problems. The findings were published this week in the BMJ . Here’s an excerpt from that piece:
We…found evidence that some competed with each other on price and speed of certification, accepted low levels of evidence on the effectiveness and safety of high risk devices, compromised their independence by offering advice on how to get through the approval process, and provided guarantees of success. Some notified bodies were prepared to assess our prosthesis without any experience of assessing hip implants.
Fiona Godlee, editor of the BMJ describes the findings in a linked piece as evidence of a “fragmented, poorly regulated, market driven system, with financial incentives to prioritise manufacturers’ interests over those of patients, and with no requirement for clinical evaluation of a device’s safety or effectiveness” . Because the notified bodies take money from manufacturers, there is a clear conflict of interest. The temptation is to get results for their clients and perhaps help ensure some repeat business, rather than focus on the effectiveness and safety of the devices they assess.
In an accompanying editorial  the case is made for the “radical idea” “devices, like drugs, should require evidence of efficacy as well as safety before being given a full licence.”
In the US, devices and drugs are assessed and licenced by a single body – the Food and Drugs Administration (FDA). Is the situation any better here? I don’t know, but it is true that in recent years the decision was made for those seeking a licence to pay the FDA for its assessment, thus introducing a conflict of interest that before did not exist. Plus, we do have some evidence that the FDA does seem to sometimes act very much in favour of manufacturers. In this blog post I write about how the FDA seems to have suppressed information about the hazards of the drug valdecoxib. And see here for how FDA insiders have in the past accused this organisation of corruption, wrongdoing and intimidation.
None of this, I suspect, will offer much joy or comfort to regular people who sometimes rely on regulatory authorities to ensure the treatments that they are subjected too are effective and safe. But I think there is some silver lining to this cloud, in the sense that the problems inherent in the healthcare system are at least coming more to light, and some are calling for things to change. My overall impression is that the medical ‘industry’ is going to find it increasingly more difficult to get away with things and ‘pull a fast one’ on the unsuspecting public. Like it or not, I see the industry as being increasingly forced to clean up its act. About time too.
1. Cohen D. How a fake hip showed up failings in European device regulation BMJ. 2012;345:e7090 (Published 24 October 2012)
2. Godlee F. The scandal of medical device regulation, BMJ 2012;345:e7180 (Published 24 October 2012)
3. McCulloch P. The EU’s system for regulating medical devices. BMJ 2012;345:e7126 (Published 24 October 2012)