Deborah Cohen reports from the Parliamentary Select Committee on the regulation of implants

Deborah Cohen Parliamentary Select Committees are only as good as the evidence they receive. Evidence is taken in the form of written submissions, then MPs of various political persuasions gather— along with their civil servant advisers —to hear a handpicked group of people give oral presentations. But, as frequently reported in the BMJ, evidence on devices is hard to come by in Europe for a variety of reasons.

Through the course of over two years of investigation into medical implant regulation, the BMJ has been confronted with a host of issues—a lack of trial data; publication bias; conflicts of interest; underreporting of side effects; regulatory inertia; hostility towards surgeons and doctors raising concerns; payments and bribes paid to doctors. The list runs the gamut of what’s wrong in medicine.

With clinicians risking the wrath of fellow doctors and being pursued for libel by companies, what incentive is there to come forward to present evidence? (They are supported by privilege in Parliament). There is little support in the UK offered to those who speak out and —unlike the US— the UK doesn’t offer the incentive of large sums of money to whistleblowers.

And so it was that the Science and Technology committee took evidence on the regulation of implants in the grand rooms inside the Palace of Westminster. The MHRA gave its perspective in private first followed by doctors and professors in medicine, surgery, and engineering, talking in front of the public and TV.

Professor Stephen Westaby, a cardiothoracic surgeon, at John Radcliffe Hospital—who has recently developed a heart pump— told the committee that devices can go through any one of about 80 notified bodies. These are located in different countries and are overseen by the national health regulators there.

Westaby said that the MHRA supervises the UK carefully and the system was far better than in the US or Japan, where they have to wait longer for sophisticated devices—although it’s unclear if people in America or Japan are unduly suffering as a result. However, this begs the question of whether speed of decision making compromises safety or not. Under the current system it’s near enough impossible to find out.

He told the committee he had the privilege of testing devices in Europe for the American market. Westaby’s only experience with a faulty device was a heart valve—made by Brazilian company Labcor— that needed to be washed in a certain way preoperatively. He put the failures down to the complex instruction manual and an inability of nurses with poor language skills to follow the correct procedure.

It was his view that most implants worked well —although how he knows this for sure is unclear as the MHRA doesn’t even know what implants are being used by doctors. The MHRA had acted quickly when there were problems with the heart valve, he said. “The MHRA do post-market surveillance very well,” Westaby added. His main concern was not that the NHS is slow to remove faulty devices, but that it rations lifesaving technology.

But Carl Heneghan, from the Centre of Evidence Based Medicine, pointed out clinicians don’t necessarily know where to report problems. There’s the yellow card system for drugs, but there’s no equivalent system for devices, he said. Much vaunted registries are only as good as the people who run them and only work properly if they are independent.

By way of example, Heneghan said that the Australian National Joint Replacement Registry flagged up problems with DePuy’s ASR three years before the National Joint Registry of England and Wales. Registries are also a blunt tool—they don’t actually tell you what is going wrong quickly enough.

Both Heneghan and Westaby agreed more clinical trials were needed. Animal tests do not necessarily translate. Some doctors will look for an evidence base before they use a product, but most devices are sold by enthusiasts. Clinicians often make a subjective decision depending on which company they like the best, Westaby added.

“But what’s the incentive to do clinical trials?” Dr Heneghan said. He pointed out that there was a total lack of transparency so it was near enough impossible to say which implants had undergone any premarket studies.

Westaby essentially agreed. He is on NICE’s medical technology committee. They only look at devices that companies submit to them to appraise—they don’t have to be assessed by NICE to be used across the NHS in the way that drugs are. “There’s a lack of devices submitted by US companies,” Westaby said. “The most important devices don’t go near NICE,” he said.

Heneghan had concerns over the constitution of the Committee on Safety of Devices at the MHRA. It lacked independent statisticians and epidemiologists who could really demonstrate benefit and risk. It’s also not rigorous enough in chasing up conflicts of interest.

What the select committee will eventually decide about the best way for implants to be regulated remains to be seen. A civil servant admitted that this inquiry is a quick turnaround job that aims to input into the European Commission’s review on regulation that is due to report in a few months.
Will this snapshot be enough to get a sense of how well the system works? And will there be enough evidence generated to improve part of the health care system plagued by poor evidence?

If anything, it is abundantly clear how important  it is for the press to provide the evidence to hold the health system to account. They’re also needed to act as the voice for people who have genuine concerns about failures in the system.

Deborah Cohen is investigations editor, BMJ

  • Pappy2036

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