A great deal of flak has been fired at the pharmaceutical industry in recent years, much of it justified in my view. The AllTrials campaign, while still guilty of the questionable claim that half of clinical trials are unpublished, is basically correct. But I have always said that any business will do whatever it can get away with, so the buck really stops with the regulator. Society is best served by a balance between freedom to innovate and to trade, and limits set by regulation.
The medicines and medical devices industries are regulated in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA), an executive agency of the Department of Health. The real issue of unpublished research is one which the MHRA could address, although to be fair it must be remembered that the agency is not funded by central government but by fees it charges for services. Broadly, these divide into product licence applications, and compliance inspections.
What about traders who decline to apply for a licence and blithely market their product illegally? While the MHRA has the legal responsibility to regulate such non-compliers, it does not have the resource, as these are people who don’t pay licence application fees. While for these reasons I sympathise with the MHRA, it could do a great deal better with what it has, especially regarding the industry which is best labelled as quackery. Here are two examples.
My colleague Dr Roger Fisken at HealthWatch came across the Asyra device, marketed by NutriVital Health Limited of Petersfield in Hampshire. The story is in the HealthWatch newsletter number 102, so I won’t repeat it all here. You will see from the article that the MHRA actually did nothing at all. Their defence was to hide behind a wall of spurious confidentiality. Not only did they refuse to say what they were doing, they refused to say whether they were doing anything. We can hardly be blamed for assuming the worst, as the machine is still being marketed.
Another device that claims to be able to diagnose health issues is the QXCI machine. On 8th August this year I asked the MHRA whether it had a medical device licence. Here is their first automated response, dated 10th August:
Thank you for your enquiry to the Medicines and Healthcare products Regulatory Agency. This automated response confirms that we have received your email and that it will be dealt with as quickly as possible.
You can expect a reply from us within a few days for a straightforward request, however where a more detailed response or contribution from a specialist is required this is likely to take longer. We endeavour to respond to requests within the Department of Health’s target response time of 18 working days, or 20 working days if your request is a Freedom of Information request.
Three days later I submitted a complaint about a practitioner who was (and still is) promoting the device, and the next day I received this reply from MHRA Customer Services, presumably to my original enquiry about the licence:
Thank you for your email which we have referred onward for consideration; we will respond to you as soon as possible.
The reference number for your enquiry is XXXXXXXXXXX; please quote this number in any future correspondence on this matter.
Our maximum response time is 18 working days, but the vast majority of our enquiries are responded to before this time.
…and a week later this came:
Thank you for contacting the MHRA. Your correspondence has been forwarded to the Devices Compliance Unit.
Please accept this response as confirmation that your correspondence has been received and will be reviewed and actioned appropriately.
Please note – The MHRA are unable to provide updates as to the state of any referrals or investigations. This is in accordance with section 237 of the Enterprise Act 2002 (“the Act”). Section 237 of the Act, read with schedule 14 thereof, restricts the disclosure of information about the affairs of an individual or any business if that information comes to the MHRA in connection with the exercise of any function it has under or by virtue of the Devices Regulations.
That was two months ago, and nothing has been heard since. But the interesting bit is the last paragraph. The agency seems to be using the Enterprise Act as an iron curtain against any sort of accountability to the public. This can’t possibly be the intention of the Act, and I would be very interested in an opinion from any lawyers out there. What about this standard response time of 18 working days? We are far beyond twice that now, and they can’t even answer a simple question about a product licence. I have found an online database of device licences but search options are very poor and I could not find the QXCI machine. It has quite a long history, none of it good, and there is an excellent explanation from 2009 by Stephen Barrett at QuackWatch. Note Barrett’s last sentence:
If you encounter a practitioner who uses one, please ask the appropriate government agencies to investigate.
…which is exactly what I am doing. Today I thought it time to chase up the MHRA yet again. Within seconds, in addition to the standard auto-reply this hit my inbox:
Thank you for your complaint concerning the above company.
As the UK’s Competent Authority responsible for the compliance and enforcement of all the various medical device regulations, I can assure you we take correspondence like yours extremely seriously. Accordingly your email has been allocated to one of our compliance inspectors who will look into your allegations immediately.
As you will appreciate, we are unable to provide you with information relating to this investigation at the present time as this information is subject to Section 237(2) of the Enterprise Act 2002 which applies to specified information, which is defined in section 237(1) and section 238 (by reference to Schedule 14 and the regulations made under section 11 of the Consumer Protection Act 1987) to include information held by MHRA and relating to any business of an undertaking. Section 237(2) provides that such information must not be disclosed while the undertaking continues in existence. There are a number of exceptions to this general rule in Part 9 of the Enterprise Act 2002. These include disclosure required to fulfil the functions of this or other public bodies, European community obligations, consent and criminal investigations or proceedings etc. The MHRA’s position is that none of the exceptions in Part 9 apply to the information apply at this present time.
A brief explanatory guide to Part 9 of the Enterprise Act 2002 is available at this link: http://www.bis.gov.uk/files/file41381.pdf
Er, what “above company”? I hadn’t mentioned one in the subject line, which had been changed to “MEDICAL DEVICES REGULATIONS 2002 (AS AMENDED)”. Nobody could have written this in the time it took to arrive, and anyway it’s Sunday. It’s rather poor form to send an auto-response that purports to be written by a real correspondent. This time the confidentiality stonewall is even more verbose, which looks pretty defensive to me. Don’t you love “we take correspondence like yours extremely seriously”, and that they will act “immediately”? If “immediately” means at least two months, what might “in due course” mean? As this email arrived within five seconds it’s hardly plausible that the matter had been “allocated to one of our compliance inspectors”.
As I have suggested above, there is a fundamental conflict between the mandatory responsibility of the MHRA to enforce the law regulating health care products, and its willingness to do so. Really, how hard is it to answer a simple question about a product licence? Note from QuackWatch that the QXCI machine has been banned by the US FDA and its inventor has fled to Hungary. The MHRA is a very poor regulator, and treats the public with disdain by sending silly auto-responses. We deserve better.