Read the latest HealthWatch newsletter:  Issue 111, Winter 2019-2020

Investigative journalist and GP, Dr Faye Kirkland received the 2019 HealthWatch Award at the HealthWatch AGM in October. Here is her compelling presentation.

In my early 30s I was a GP partner in a practice I had wanted to join for years. A training practice, a very traditional surgery – where the doctors knew theirpatients and generations of families were all known by one doctor. This was the view of family practice I had been given as a medical student, seeing and treating people in the context of their families and communities.Faye Kirkland

But an internal voice started to grow in intensity. The pressure on the NHS, and the movement of care from hospital to GPs, often made continuity of care for patients more difficult. Qualified GP colleagues I knew left the UK altogether and went abroad, saying their quality of life was better, while I found myself staying at work later and later to provide the type of care I would want as a patient.

The nagging noise in my mind grew louder, and I started to wonder how I could use my knowledge in a different way. On a day off, I managed to get an interview at Cardiff University for a course in broadcast journalism, and to my surprise I got in. In just a week I had resigned from being a GP partner, moved my home into storage and my life from Brighton to Bristol, where I spent 18 months in my Dad’s spare room working as a GP at the weekend to fund the course in Cardiff.

I started to learn the craft of journalism, and realised I wanted to use investigative techniques and my knowledge to shine a light on areas of medicine that other journalists or patients might not see.

Access to diagnostic tests

A few years before starting the course, a close friend of mine had become seriously unwell. He had been to Accident & Emergency several times, collapsed at home and was even told by ambulance staff to pull himself together, that he had a virus. He was finally diagnosed with a brain tumour. Dif

ficultly in accessing imaging, and people not recognising symptoms, were both major hurdles to him getting his diagnosis. The skills I had acquired allowed me to investigate whether his experience was reflected across the country. I knew from when I had worked as a GP that in some areas I couldn’t even refer for an MRI scan, but in others I could. Despite the Department of Health saying that all should be able to access this, different clinical commissioning groups had different rules. I established a picture that showed this post code lottery. It was my final piece of work on my course but ended up as an hour of live radio for BBC 5 Live Investigates.(1)

Vitamin and mineral infusions

Within months of qualifying, I became interested in the world of vitamin and mineral infusions. While researching one programme I went to Harley Street undercover, posing as a patient.

I asked doctors if the vitamin and mineral infusions they advertised would treat my supposed eczema and anxiety. At one clinic a practitioner asked me to hold up my left hand, and with my right touch various organs of my body. The practitioner pressed down on my left arm and seemed to growl as if the diagnostic technique had revealed something about the state of my body. I was provided with vials of different vitamins to hold against various organs, and again asked to repeat the arm test. This time, it seems, I was stronger. This diagnostic revelation meant I needed vitamins – and fast. An urgent infusion was offered. I politely declined.

The cost of this miraculous arm test ran to hundreds of pounds and the infusions which, apparently, I needed every few weeks were approaching £200 each time.

The importance of my investigative work became apparent to me as I looked in a 

room and saw a very frail man hooked up to two drips – one in each arm.

I found more than 100 webpages claiming that vitamin and mineral infusions such as these could help treat Parkinson’s Disease, asthma, depression and hepatitis, with no evidence to support the claims.(2) It was clear at the time – this was 2015 – there were huge gaps in regulation. Were these infusions, which were straight into your vein, a medicine or not? Up to then, no one had decided. The drugs regulator, the MHRA, took the investigation seriously. They had to write to each clinic, to analyse each of the vials to decide if these drugs were medicines or not. Eventually they decided medical claims could not be made against these products, as to do so, might imply they were a medicine. The claims, they say, had to be removed. The majority of the medical claims for these infusions have now gone from the websites – in doing so I hope protecting patients. However, unfortunately, un-evidenced generalised claims of improving your well-being or giving you a glow persist.

Online health care

That was the year I came across a burgeoning new area of medicine: care online, ever accessible, at a click of a button and often at a price. 

Private, glossy websites often featuring celebrity doctors and well-known brands, offering care I would not give in the surgery. You filled in an online form with pre-set questions, send it off. A doctor reviews the form, prescribes medication for you without speaking or seeing you or having access to your NHS notes, and then a UK chemist would send the drugs to your home within 24 hours.

Four years ago, I found sites offering to cure sexually transmitted diseases after a few questions, with no warnings that their treatments were suboptimal and might not cure your infection.(3)

The familiar brand, Superdrug, was at that time making antibiotics available online for gonorrhoea, without the customer necessarily having proved they had it, and providing antibiotics which did not meet national guidelines. This was at a time when some patients were having to be treated for gonorrhoea in hospital, having acquired multi-resistant strains.(3) Following the investigation for BBC 5 Live Investigates, there was intervention from the British Association of Sexual Health and HIV, and a letter from The Chief Medical Officer and Chief Pharmaceutical Officer to all online clinics and GPs.(4) Since then there has been a massive change. Superdrug no longer provides antibiotics for this indication – instead they advise you, correctly, to seek treatment at a suitable clinic.

This experience made me wonder what else you might be able to buy online.

As with all such things, digital health care has stayed one step ahead of the regulators. In 2016, again with BBC 5 Live, we went undercover posing as patients. My colleague was able to buy drugs for an ear infection, supposedly of three days’ duratio

n, therefore probably viral and hence not curable by antibiotics. Some halfway through the questionnaire we were abruptly asked about sexually transmitted disease and a vaginal discharge. Following this, drugs were prescribed that I have never given for an ear infection. This was all delivered to the house and was signed off by a practising UK doctor.(5)

How could this be allowed to happen?

We asked the company which had provided this medication. They blamed a computer problem saying the questionnaire about vaginal discharge had got mixed up with the one for ears and actually we had been sent antibiotics for the wrong condition.

We asked the Care Quality Commission (CQC) – the health regulator in England – and the General Medical Council (GMC), the doctor’s regulator, to respond. The CQC brought forward a wave of inspections, with the clinic exposed being one of the first. It was suspended. The GMC investigated the doctors. Clear online health care standards for online companies were published by the CQC the following March.(6)

A step forward you may think? But last year, with the BBC’s Panorama, I found the sites were once again one step ahead. Not only were they supplying antibiotics but often drugs of misuse, such as opiates.

Some sites moved their headquarters out of England and therefore avoided regulation by the CQC, most choosing to base their companies in Romania. Now their online doctors’ care could not be regulated, and the prescriptions could be sent electron

ically from Romania to pharmacies in the UK and still delivered to your door.(7)

Panorama ‘Online doctors uncovered’

Still with Panorama, I wanted to see these Romanian companies – the supposed hub for these online doctor sites – for myself. But instead of finding a hive of doctors doing online consulting, I found empty flats. Just an address, that means the CQC cannot regulate and keep patients safe.Faye Kirkland and Nick Ross

After the Panorama programme was broadcast last year I was contacted by a family whose daughter had been able to buy codeine from 18 online UK pharmacies, as well as continuing to obtain these drugs from her GP, who had not been informed. She had collapsed and died behind her front door. She was in her early 40s. Her inquest is yet to take place but her family believe the codeine contributed to her death.(8)

Also following the programme, and in part as a result of it, the General Pharmaceutical Council has also moved to stop pharmacies in Great Britain from dispensing certain high-risk medications to patients without their family doctors being informed.

Also in response to Panorama, the CQC asked the Government to change legislation. They are still waiting for this to happen.

Investigative journalism has taken me to places I never imagined, secret meetings, being given leaked documents and holding power to account. Continuing to be a doctor is a privilege but helping to create change on a national level can be an even greater one.

Faye Kirkland
Freelance investigative journalist and GP, London

References

1. BBC Radio 5. 5 Live Investigates – Brain tumours. 26 Oct 2014. https://www.bbc.co.uk/programmes/b04mbk68  
2. BBC Radio 5. 5 Live Investigates - Discharging mental health patients & Phishing emails, 18 Jan 2015. https://www.bbc.co.uk/programmes/b04yg8f1 
3. Kirkland F. Concern over online gonorrhoea treatment. BBC News, 1 Mar 2015. https://www.bbc.co.uk/news/health-31649099 
4. Gallagher J. Gonorrhoea 'could become untreatable'. BBC News, 27 Dec 2015. https://www.bbc.co.uk/news/health-35153794 
5. BBC Radio 5. 5 Live Investigates - Online antibiotics. 2 Oct 2015 https://www.bbc.co.uk/programmes/b07xf2xr 
6. Kirkland F. Buying medications online 'can put health at risk'. BBC News, 3 Mar 2017. https://www.bbc.co.uk/news/health-39134061 
7. Kirkland F. Safety concerns over websites selling prescription drugs. BBC News, 6 Aug 2018. https://www.bbc.co.uk/news/health-45084555 
8. Kirland F. Clampdown planned for British online pharmacies. BBC News, 16 Apr 2019. https://www.bbc.co.uk/news/health-47933346 

From GP to MP: How to lose friends but try to influence peopleSarahWollaston

Sarah Wollaston, MP for Totnes, Devon, spoke at the 2018 HealthWatch Annual General Meeting on Wednesday 31 October 2018. It had already been an eventful week. Our AGM took place the day after the House of Lords Science and Technology Committee had published the results of their inquiry: Research integrity: clinical trials transparency. Earlier that week, the Chancellor of the Exchequer had presented his 2018 Budget to Parliament. The following text is adapted from her presentation and the question and answer session that followed.

There is a real challenge ahead of us about how we present evidence within our politics, and value evidence. Something that I have noticed in my role chairing the Health and Social Care Select Committee, is how within politics you have to find a balance between the idea that everything should be based on popular demand, and presenting the evidence.

Nowhere is this more evident than in public health. When you go out and consult the public about where they would like to spend investment within the health service, public health is always at the bottom of the list. Yet the evidence shows that if you really want to tackle health inequalities and make a difference, that’s where the money should be going. But I’m afraid it always tends to get deprioritized, as we’ve seen over the last 24 hours, as we unpick what the Budget numbers mean. There’s been a bit of smoke and mirrors, in that some of the funding for NHS England is actually going to come out of public health budgets, which I think is a tragedy because it’s through public health that we’re going to really tackle the issues that governments all pay lip service to, about burning injustices, and reducing inequalities.

My point is that you’ve got to look at the evidence about how you’re going to achieve those aims. And in a week when we’ve got the Chancellor talking about how he wants to reduce the tragedy of lives lost to suicide, while we would all agree that’s extraordinarily important, you shouldn’t at the same time delay implementing evidence based policy around reducing gambling addiction because you’re caving into industry lobbying that is fighting the introduction of the maximum £2 fixed-odds stake for betting terminals. We absolutely need people in Parliament to make the case relentlessly for evidence and how you actually make a difference, rather than what the lobbying industry says makes a difference, or what is popular. And right now we are in the midst of the fight of our lives, against the “Trumpification” of politics, the downgrading of evidence, the ridiculing of any expertise, and I think nothing has exemplified that more than the referendum campaign and the way it was conducted.

That’s my job in parliament, to be rattling a few cages and to keep doing that! But there’s something you in HealthWatch can do. Never underestimate the effect of going to see your MP in person. If you write an e-mail, send a postcard, or re-tweet, you’re not actually going to shift the dial. And it doesn’t help for us to be talking to people who already agree with us. What we need to be doing is talking to the people that don’t agree with us, and having somebody actually turn up in your constituency surgery makes an MP think, I have to look at this. Tomorrow I’m launching our committee’s report into prison health care, and that for me came out of a grandmother coming to talk to me in tears about the death of her grandson in prison, and the authorities’ failure to follow up on reports that had been coming out from inspectors about circumstances that had led to that avoidable tragedy.

So, going to see your MP really has an impact. I hear time and again from colleagues that it is the person who takes the trouble to make that appointment that makes the lasting impression. Encourage your members to get out and talk to your MPs and talk to them about the importance of evidence and science.

Any questions?

Q: The Science & Technology Committee have done two reports on research integrity, but if you read them, nearly all the concerns are about medical research - I gave evidence to that committee, and it’s entirely about medical research. Should the Science and Technology Committee co-ordinate efforts more with other areas of research?

SW: Increasingly committees are doing joint enquiries where something is of mutual interest, for example, the report we recently published on anti-microbial resistance follows up on many of the points from previous committees. So we do try.

Q: At a meeting today at the Royal Society we heard about TARGIT (TARGIT IORT is targeted intraoperative radiotherapy treatment for breast cancer, see ), a well-researched innovation that has been reviewed and recommended by NICE, that would save NHS money, and which offers huge benefits to patients, yet has not been adopted by Public Health England. How can we free NICE so that their recommended good practice actually gets implemented?

SW: It’s a huge challenge in many areas of the NHS where you see good evidence based practice and it’s not being effectively rolled out. I would advise you (1) to go to your MP and try and get them to stand up and talk about it in Parliament; (2) there are all party parliamentary groups within parliament, for example there is one on breast cancer specifically, you could raise it with them; (3) although the Health and Social Care Select Committee tends not to look at single disease issues, we do hold regular accountability session with bodies like NICE, so there’s the possibility we could use a session to raise such an issue and ask whether we could help if their recommendations aren’t being implemented. You are very welcome to write to me, and although we wouldn’t hold a specific enquiry I might be able to raise in correspondence or queries issues that people raise with me.

Q: Do you have any thoughts on the matter of a people’s vote?

SW: Who would want to be wheeled into the operating theatre on the basis of a consent form we had signed two years ago, or in the case of younger voters, one their parents signed, and if you didn’t even know which operation you were going to have! And the surgeons are still arguing amongst themselves, and there is no majority for anything. The implications of Brexit will last for generations.

Q: At our recent HealthWatch symposium on debunking false health information, one of the issues was the level of confidence people have in their source of information – how do you and your committee decide whether a group or individual presenting you with evidence is credible or not?

SW: There are some markers for not being credible, for example, people who write to you with a sample size of ten to support a view that something is important should be implemented straight away. Essentially in an inquiry we publish everything, but we choose the witnesses we then hear from selectively. Unfortunately there are always more fantastically credible witnesses we’d like to hear from than we have time, so we have to prioritize based on what they write to us in their evidence. And we also try and get out of London and meet as many people from different areas as we can.

Q: The Science and Technology Committee report on clinical trials reported yesterday on Research Integrity; the govt now has two months to respond to this report, is there anything we can do to tip the scales towards a favourable response? Secondly, looking at the various NHS foundation trusts that sponsor clinical trials, the reporting rates are bad, and there’s now going to be a lot of inefficiency as each individual trust tries to figure out how to improve their clinical trial reporting – how can we ensure economies of scale to do this? Who is responsible in each trust and can they nominate someone to do it?

SW: Some people have got considerable expertise already – it is encouraging that Matt Hancock has appointed Ben Goldacre to be chair of his advisory panel, who has done fantastic work in this area and is not afraid to hold Public Health England to account. But it is not easy to identify who is responsible. When asking government to respond to a report, you can put in a recommendation to the government to identify who is responsible and who to hold to account.

Q: Part of the problem is that the Science and Technology Committee have put this back to UKRIO (the UK Research Integrity Office), the UK universities, who have consistently failed to self-regulate, and who have a concordat that only 30% of them adhere to, and none of the hospitals where human research is conducted are part of the concordat, so the committee has come up with a solution that has failed in the past and doesn’t anyway apply to medicine.

SW: It would be worth speaking to Norman Lamb MP about that. (Questioner's reply: “I have!”)

Q: Would you agree to introducing clear guidelines on minimum staffing levels for the NHS?

SW: I would agree that in an ideal world we would have minimum staffing levels, but the trouble is, there is overall a workforce staffing shortfall. If you were to impose a minimum staffing level on wards, if there was limited flexibility to move staff around you might find unintended consequences, such as you might not be able to transfer people out of ambulances into the emergency department, and end up with people being cared for in corridors or in ambulances. The workforce challenge across the NHS and across social care is extraordinary. In my area, there is a 8% vacancy rate in social care, and 7% of the workforce are from the EU, of the nursing workforce in Devon it is nearly 30%. What is going to happen if we make it much more difficult to recruit and people don’t feel welcome here?

Q: Granted, you can’t say, if you’re understaffed you’ve got to shut the doors and stop. But are there halfway houses? Supposing an acute hospital trust had to be on amber, so that if something goes wrong we can’t blame the person on the coalface?

SW: People make comparisons with airline safety but this is different in that you can ground an aircraft, but you can’t close a hospital - although there is a precedent even for that in critical areas - or you end up with people being cared for in sub-optimal conditions. I agree with the suggestion of a very clear amber alert where a hospital is understaffed, though if we imposed such measures too rigidly I would have concerns.

Q: Mass cancer screening – why don’t we have proper standards of informed consent in cancer screening? And how can we improve decision-making so that we can stop doing something that doesn’t work? On screening, there are also concerns over vested interests and charities running awareness campaigns that create fear and havoc and end up sending healthy people to add to their GPs workload?

SW: Margaret McCartney has done some amazing work highlighting this, and my congratulations to her for highlighting the losses and harms resulting from the rise of the private screening industry, with the costs falling back to the NHS, and harms to people who are persuaded to have these tests. Just yesterday I asked the Care Quality Commission what they are doing to ensure these clinics are operating in an ethical manner. Certainly there’s more that can be done. Drop me a line.

Q: Do you feel reassured about the provisions for medicines supply after we leave the EU?

SW: There has been a phenomenal amount of money diverted into contingency planning, which is going to feed back into the cost of drugs and healthcare. When you look at the amount of time it can sometimes take even now to source medicines – for example, my daughter is a junior doctor in pediatrics at the moment, and she recently spent two hours trying to source an epipen for a patient - I can’t begin to imagine what it will be like if these problems occur on an industrial scale after we leave the EU. The public is used to being able to take a prescription to the pharmacy and expect the medicine to be there. What is going to happen when the medicine is not there and no-one can find it for you? When my constituents get cross with me for banging on about Brexit, I say to them, when we are three months on after a hard Brexit, and these issues are still ongoing, I want to be able to look you in the eye and say that I tried my best to present the evidence of what would happen as a result. I hope these problems won’t happen, I hope I’m wrong, but even if I am, it’s been a most tragic waste of resources.

Q: Has the NHS become a religion? We are spending £150bn a year on the NHS alone, about a quarter of all public spending, yet it’s nothing like enough? Where is this going?

SW: There’s a huge success story we shouldn’t forget - we’re helping people live longer. Yes, we’re living with more years of ill health and multiple morbidity, so it’s a success story not a disaster. But did we adequately plan for this? For generations people have failed to take the long view and look at what longer life means for the health workforce, and people’s readiness to put money in. The trouble is, we promised people they can have all this for free. This week’s budget was an opportunity to say to people, honestly, this extra commitment has to be paid for somehow. But what we’ve seen is talk about Brexit dividends, and giving people a tax cut a year early, rather than being straight with people and saying that if we value our NHS we’re going to have to pay more. When something is a religion, criticism is not very welcome, and you can be vilified for it. We should guard against treating the NHS like a religion, because we should be able to challenge bad practice.

Q: A lot of what I do as a GP only results in marginal gains, we are given the impression we are saving lives, but in practice we are throwing money at the end of life.

SW: The biggest gains in healthcare have resulted from public health measures. If you were going to start somewhere, start with the first 1000 days of life – it is the subject of our current inquiry. Look at education, housing, dealing with poverty, the things that make the biggest difference to health.

Q: How do you cope with being an MP in Totnes?

SW: It is a wonderful and interesting place, but let’s take just one issue, that of vaccination. Totnes has the lowest vaccination rate in Devon, and there is a very strongly held belief by many people in town that homeopathic vaccines are the way to go. There are many children there who have not been vaccinated against anything at all, not even tetanus. This can be a challenge, because some people can become very cross if I point out that some of the claims made against vaccination are untrue, and they may say I have no business to represent Totnes when I do not support the alternative community. But my view is that it is absolutely my job, to speak the truth it as it is. The rise of the anti-vaccination movement and the resulting resurgence of measles is deeply worrying. Fortunately Totnes is much happier about my stance on Brexit.

Based on Sarah Wollaston’s presentation at the HealthWatch 2018 AGM, adapted by Mandy Payne.

Poking your nose in where it’s not wanted: the dark side of investigating healthcare

The 25th HealthWatch Award was presented to the former BMJ Investigations Editor Deborah Cohen, in recognition of her courageous reporting of medical issues in the face of attack from vested interests. She received her award from HealthWatch president Nick Ross at the 2017 HealthWatch AGM on Tuesday 17 October 2017, and the following text is adapted from her presentation.

It has meant a lot to me to know that others recognise that you’re reporting in the face of vitriol and attacks from vested interests.
The first big story I did was in 2009. HealthWatch members will already be familiar with the Tamiflu story and how the Cochrane Collaboration struggled to access clinical trial data for their review of this flu drug. The investigation into the missing data ended in my in-tray. I have degrees in medicine and medical journalism, so it was something to get my teeth into, and it turned out to be an interesting journey. As you’ll recall, the lead authors of the clinical trials had told us they didn’t have access to the primary data. The manufacturers, Roche, gave us observational data. But not the clinical trial data.

One of the privileges of working at the BMJ is you have access to some really good academics who will drop everything to help you out – they know who they are. So we set them to work making sense of this observational data that we had. Roche maintained that Tamiflu not only reduces the incidence of secondary complications by 67%, but it also reduced the rate of hospital admissions by 61%. But when we re-analyzed the observational data we found it didn’t say that. We published our report,(1) and the allegations we made were quite controversial. No satisfactory explanations had been given for the missing clinical trial data. Yet there were journalists who’d been covering the flu pandemic for a while, who’d taken it at face value that Tamiflu must be effective enough to merit the UK government stockpiling it – at a cost of £424m between 2006 and 2013.

Conflicts and controversies

In the course of our search we came across whistleblowers who had written up the clinical trial paper that was published in The Lancet. We were told they’d been instructed to include key words and phrases that were important for the marketing of the drug. It also became apparent that the people who were involved with the companies marketing the product were also key advisors to the World Health Organization (WHO), the European Medicines Agency (EMA), and others. Roche, together with some other manufacturers of influenza drugs, are the funders of a group called the European Scientific Working Group on Influenza (ESWI). This industry-funded group wrote WHO’s first influenza pandemic preparedness plan.

So, as a result of this investigation we did a follow up piece about the conflicts of interest of the advisors.(2) This proved even more controversial than the first, and we came under attack. The WHO would not release any information about whether their advisors declared conflicts of interest or not. The scientists said they had, but WHO would not confirm or deny.

Embarrassingly I ended up on an American “shock jock” show, where they took the line that this is a big pharma conspiracy, which was very far from what we had intended with this story. We’d been very careful to make the point that when you are making policy decisions, which could have huge impact in terms of finances and patient harm, should you really be using the people who have been marketing the drug? You would think not.

But the attacks continued. Nature did an exposé,(3) and people tweeted that our research had been discredited. In our article there had been a sentence that maybe could have been worded more carefully, so we ended up conceding one or two points in relation to the story, and the result was taken as an admission that our story was wrong, starting a back and forth between Nature and the BMJ. It became one of the most read articles on the BMJ website at the time.

Hip devices

The next thing we looked into was medical device regulation. We started with the European Union directives, which took some reading. Ours was a joint investigation between the BMJ and Channel 4’s Dispatches, so we had a whole team to help us go through the directives. Then in 2011 a very useful study was published by a group at the Cleveland Clinic, in Ohio. They looked at the US Food and Drug Administration (FDA)’s regulatory system for medical devices. The FDA have two processes, one is pre-market authorisation, and the other is called 510(k). To get a device onto the market using pre-market authorisation you have to have clinical evidence, such as from randomised control trials, or a case control study. But for 510(k) you only need to show something called equivalence, which means that your new device is “substantially equivalent” to an old one, a predicate device, that is already authorised.

It is possible to trace the history of some 510(k)-authorised devices, and to track the tweaks and changes that have been made to the design over time, so that a device approved in 2015 might not have had any clinical studies to support it, and gone through so many changes since, say, 1980, when the original version was approved, that you can end up with virtually a whole new device but without any clinical evidence for it. The Cleveland team’s study found that two thirds of device recalls were in respect of devices that had gone through the 510(k) route, that is, there was no direct clinical evidence for those versions of the devices.(4)

Working with the Centre of Evidence based Medicine at Oxford University, we thought it would be interesting to replicate this study in Europe. But we couldn’t. Because we kept coming up against the words: “commercial, in confidence”.

Devices come in different risk categories. In Class I, you have low-risk items like plasters and syringes; in Class II there are insulin pumps. Class III is for hip implants, pacemakers, things that need surgery to get them in place. I phoned the Medicines and Healthcare Regulatory Authority (MHRA) and asked if they had a list of Class III devices that are used in the NHS.

And they said “No”. No such list exists.

We knew that some implants must have been causing problems, so we put in a freedom of information request to look at reported harms. Again, “commercial in confidence”. We learned that under the Freedom of Information Act you can get clinical data related to pharmaceutical trials, but you can’t get it for medical devices.

So, we were thwarted from the outset by a lack of transparency. We wrote a story(5) about a hip implant called the ASR, which is made by DePuy, a subsidiary of Johnson & Johnson, and which was recalled in 2010. The ASR was used for two types of orthopaedic surgery – total hip replacement (ASR XL) and hip resurfacing (ASR resurfacing). The ASR in the United States had gone through 510(k) for total hip replacements. For the hip-resurfacing application it should have gone through the full pre-market authorisation process, but the FDA had called a halt to the approval because of problems with the trial. That didn’t happen in Europe. It has been used in tens of thousands of patients.

We later looked at all large diameter metal on metal total hip replacements. We reviewed the medical literature, and whole 510(k) daisy chains, and found that among an entire class of implants there was no publicly available clinical data to support their use. Now, bear in mind that these are made of cobalt and chromium. In the 1970’s and 1980’s surgeons were debating the toxic effects of cobalt and chromium, and in 2007 a comment piece in the Lancet(6) pointed out that little is known about the transport, distribution, excretion of metal ions in the body; toxic effect thresholds have not been characterised. So wouldn’t you think there would be a need to proceed with caution? We know a lot about the local effects of metal ions in the body, but about the systemic effects we know very little because if we’re talking about pharmacovigilance of medical devices like you have with drugs, well, it just doesn’t happen.

Under cover

My question was, in this article, surely we should proceed cautiously with these devices, given that there is no known toxic threshold for these compounds? In the media it became, the BMJ hip replacement cancer scare, which had not been our intention at all. Suffice to say, that the bullying I encountered as a result gave me a glimpse into the business side of orthopaedic surgery and how things run when there is a great deal of money at stake, and some of it is very unsavoury.

After that, we went under cover. I should point out that it is actually really hard to get clearance to go under cover. There has to be a strong public interest reason, and you have to demonstrate that you can’t get the information any other way. We had a good reason – this was health. We created a fake metal hip. We called it the TMH (total metal hip) and tried to get our metal hip onto the market. We had a fake dossier, and gave it some disastrous data, failures, ions all over the place.

The system here in Europe is that you have to go through what are called notified bodies. There were about 70 of these, they are private organisations, and these are where manufacturers go to get a CE mark. Once they have this mark they can sell the device anywhere across Europe. The various regulators in the different countries then regulate those bodies. It’s an incredibly complex system.

You have to pay these bodies to review your dossier, before they decide if it should receive a CE certificate. That already seems like a conflict of interest, as these companies are paid for approving the device and then are paid again to do follow up audits every few years. An officer at one of the notified bodies in the Czech Republic admitted to us that it is “on the side of manufacturer and their products, not on the side of patients.”

We set up a fictitious company called Changi, and we hawked our new device around notified bodies, pretending to be their PR people. We found that not only are regulators out-sourcing the regulation of medical devices to private companies, but some of these private companies are further out-sourcing their device regulation activities to other private companies. We found ourselves at a branch of a Czech notified body which was in South Korea, where a small group of companies came together to operate as a one-stop-shop. Device manufacturers would go to one for advice about how to create their dossier, then another to receive the CE certificate, and then the next company offered marketing. We were told that it is easy to get products approved in Europe, and they are not worried about inspections by European officials, though they were really scared of the FDA.

We got our design approved for a CE certificate for our non-existent hip implant. That investigation had an impact.(7) We presented our evidence at the Science and Technology Committee and at the European Parliament when they were updating their medical device regulations.

Sugar and water

We were at a meeting just before the 2012 Olympics, when sports medics told us that sports drinks are one of the most controversial thing ever. What could be controversial about sweetened water? Again working with the Centre of Evidence based Medicine, we decided to take the top 10 best selling UK and US sports and fitness magazines, and pulled out the adverts to see what health claims they were making for sports drinks. Then we looked at the references to see what evidence we could find to support them. Then we tried the manufacturers’ websites to find references, before approaching the companies for evidence to support their claims.

We were told things like, water doesn’t quench thirst.

Anecdotally, we heard that one company was telling kids that if they drank water rather than sports drinks they would get cerebral oedema. An idea had been created, that of ‘exercise induced dehydration’. Now, any doctor who has treated someone with genuine dehydration, well, it’s not quite about jumping on the treadmill and getting a bit thirsty. But this idea had been created that if you exercise you get exercise-induced dehydration, and the solution is to drink more sports drinks. This then led to a genuine health concern which is, hyponatremia – a reduction in the body’s electrolyte levels due to drinking too much, which was leading to cerebral oedema, and there was a study in the New England Journal of Medicine that looked at the Boston Marathon and people who had had exercise-induced cerebral oedema, because they’d actually been taking in too much fluid.(8)

The backlash against our “The truth about sports drinks”(9) was incredible. The attacks kept on coming. One company held up what they said were over 100 clinical trials that underpinned their science. We critically appraised all of them, and found that most were poor quality and didn’t support the main claims made.

Fertility clinics

We did a programme with BBC’s Panorama about in vitro fertilisation (IVF).(10) You get to a certain age and lots of your friends are going through IVF, and if you listen to their stories you find they’re all having different kinds of treatments and also being sold extras, on top of IVF, so-called “add-ons”. We again teamed up with Oxford University, we scraped lots of websites from fertility clinics looking at the claims made for add-on treatments, and then looked at the evidence. We found very few were able to support their claims that these add-ons could actually improve your chances of having a baby. We used undercover again – and came under criticism for this – to look at the lack of fully informed consent for these treatments, and the lack of evidence, and how poorly regulated they are by the HFEA. Needless to say we experienced a backlash from private clinics in the UK.

There are times when you get home, shut the door, and you’re looking at the door, wondering what’s going to happen next. You can take the professional attacks, but worse than that is the sexual harassment. As a female reporter on a heavyweight subject I have my authority questioned, because I’m young and female, and I am constantly challenged about my ability to carry out these investigations. It’s a constant battle, and that is probably the biggest challenge in this area.

Based on Deborah Cohen’s presentation at the HealthWatch 2017 AGM, adapted by Mandy Payne

References
1. Cohen D. Complications: tracking down the data on oseltamivir. BMJ 2009;339:b5387. http://www.bmj.com/content/339/bmj.b5387
2. Cohen D, Carter P. WHO and the pandemic flu “conspiracies”. BMJ 2010;340:c2912. http://www.bmj.com/content/340/bmj.c2912
3. Butler D. Flu experts rebut conflict claims. Nature 2010;465:672-673. http://www.nature.com/news/2010/100608/full/465672a.html
4. Zuckerman DM1, Brown P, Nissen SE. Medical device recalls and the FDA approval process. Arch Intern Med. 2011 Jun 13;171(11):1006-11. https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/227466
5. Cohen D. Out of joint: The story of the ASR. BMJ 2011;342:d2905. http://www.bmj.com/content/342/bmj.d2905.full.print
6. Learmouth ID, Case CP. Metallic debris from orthopaedic implants. The Lancet 2007;369(9561):542–544. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(07)60251-7/fulltext
7. Cohen D. How a fake hip showed up failings in European device regulation. BMJ 2012;345:e7090. http://www.bmj.com/content/345/bmj.e7090
8. Almond CSD et al. Hyponatremia among Runners in the Boston Marathon. N Engl J Med 2005; 352:1550-1556.
9. Cohen D. The truth about sports drinks. BMJ 2012;345:e4737. http://www.bmj.com/content/345/bmj.e4737
10. BBC One Panorama. Inside Britain's Fertility Business. First broadcast Monday 28 November, 20:30. http://www.bbc.co.uk/programmes/b084ngkd (not currently available).

Why is it controversial to tell the truth about health care?

Peter Gøtzsche, physician, medical researcher and leader of the Nordic Cochrane Centre at Rigshospitalet in Copenhagen, Denmark, received the 2016 HealthWatch Award at the charity's 28th Annual General Meeting on Thursday 20th October 2016 at the Medical Society of London.

This article is adapted from a transcript of his talk.

 People ask me, why do you look for controversies? And I tell them, I don’t, they come to me. My work is something like that of a medical detective. People come to me if they feel something is wrong in healthcare. When I start looking into these issues, I usually dig very deep. I find skeletons, and when I expose these skeletons, the people who buried them can get very angry.

Even in my most routine work, I dig deep and I still find skeletons.

I started digging many years ago when I looked into drug trials of the NSAIDs – arthritis painkillers. These were head-to-head trials, comparing one drug with another. I collected every trial I could find, and used meta-analytic methods to find out if the results were plausible. I found that they were not, in a statistical sense, and I published my conclusions in my thesis. Doug Altman, professor of statistics in medicine at the University of Oxford, saw my work and in 1990 he sent it to his colleague Iain Chalmers. I’d published three meta-analysis by this time and felt I was quite prolific, but Iain told me his group had published hundreds in Cochrane, a database I’d never heard of. He invited me to Oxford for the 1992 opening of the UK Cochrane Centre, of which he was the director. In 1993 we opened the Nordic Cochrane Centre and four years later I became a full time researcher there, reasoning that as a doctor I could only help one patient at a time, but if I did a good review I could help one hundred thousand.

Shocking results were not unusual

It was felt that my results with NSAIDS had been so shocking that it must be something that only applies to arthritis drugs. But this was the first time anyone had trawled through a whole medical area and done a statistical overview, and we would soon find out that the phenomenon was not unusual at all. In 1997 my wife Helle, a clinical microbiologist, did a study on antifungal agents for people with, for example fever, cancer, or neutropenia, who were at risk of dying from a fungal infection. We did a routine comparison between fluconazole and Amphotericin B, the two most promising drugs at that time. We found that some of the trials were three-armed, with a third arm consisting of nystatin, which is effectively no more than a placebo. The manufacturer, Pfizer, had lumped the data from a drug that didn’t work, with amphotericin B to show that their drug, fluconazole, was better than when you handicapped your comparator. What is more, they had also given amphotericin B by mouth, even though it is poorly absorbed and not prescribed orally with these patients. We tried to talk to the investigators about our results, and they referred us to Pfizer, who wouldn’t answer our questions.1

We couldn’t even see whether one trial publication was re-using the same patients that were included in another trial publication, so we might be counting the patients twice. We asked Pfizer about that, too, and they didn’t reply. We published it in JAMA2 and Helle presented it at a conference on microbiology in Toronto in Canada. There were 800 people and her presentation went way over time, not because she over-ran, but because there were so many questions. Drummond Rennie, one of the JAMA editors, wrote in an editorial that “fluconazole raced against a heavily handicapped opponent”.3 In a response letter to JAMA, Pfizer conceded that the comparison drugs did not work and that it would change how it reported results of trials.4

So, we ended up in the New York Times because we’d reported misleading research being published by the biggest drug company in the world.5 Two years later we were there again.6 My PhD student had studied the placebo effect. We’d thought it could be powerful, as did most doctors. But most doctors make the mistake of asking, what is the placebo effect? And then attempt to answer it by observing what happens to a group of patients treated with placebo. That is wrong. Think about regression to the mean, and the way many conditions heal by themselves.

We couldn't find evidence for placebo effect

Well, that is NOT placebo. To study placebo, you need to take an untreated control group, and compare that with the placebo group, then in most trials you can also have a third group, using an active drug. We collected results from 113 trials, we published in the New England Journal of Medicine and the Cochrane Library. We couldn’t see much effect with placebo. Maybe a little effect on pain, but we didn’t even know if it was a true effect because you cannot blind an untreated control group, and when you measure subjective effects people tend to hope that they’ll get some benefits because they think they are receiving a drug. So, we couldn’t find evidence for placebo effect. It was terrible for the placebo community and made a lot of work for us, dealing with questions and criticisms.

There is too much unreliable research published by people in order to sustain their erroneous beliefs. So it is fundamental that we try to persuade politicians that we cannot leave people to be their own judges. I can’t go to the car inspection with my 18-year-old car and reams of paper and say, I’ve already done the inspections myself, no need for you to do it! Yet that is how we approve drugs. I have worked a lot with psychiatric drugs, and I published a book last year on the subject,7 and there will be documentaries to follow. People are starting to realize that psychiatric drugs are not the solution to psychiatric problems, in fact they make them worse. They disable the brain. People may think it’s useful that they do this because the effect is to sedate the patient, but they also cause many side effects. The clinical trials in psychiatry are the worst I have ever seen. And the more psychiatric drugs we use, the more people end up on disability pensions because they can’t work. There is more and more pressure to establish helplines for people who want to come off psychiatric drugs, so things are moving in the right direction.

On mammography screening: I think it should be stopped. In 1999 a Swedish study compared regions which had taken up mammography screening early, and they compared them with other regions that hadn’t implemented it yet. They couldn’t find any difference in mortality.8 At that time we had screening in 20% of Denmark. The Danish Medical Association asked the Danish Board of Health, can’t we trust the randomized trials which said the screening worked? That hot potato landed in my lap. We were asked to review the randomized trials of mammography screening. Five weeks after I had this assignment, there would be questions in Parliament about whether we should have screening.

A real "Yes, Minister" moment

We worked fast – in four weeks we had produced a report, with meta-analysis, and it concluded that we cannot exclude the possibility that mammographic screening does more harm than good. We took it to the National Board of Health and were immediately called to a meeting, with the result that two days later we were told that our paper was a non-paper. It didn’t exist. This was a real “Yes, Minister” moment. Fortunately, we were able to prove that it really did exist, because we’d sent it to the Danish Board of Health by messenger and its delivery had been recorded! I was told to change my letter, to say there had been misunderstandings, and to say that the report was only preliminary. I didn’t accept that. A promise was made to send it to the Minister of Health. It never arrived.

Two weeks later the scandal broke loose. Journalists got hold of both copies of the letters, my original and one that had been changed and which I had not signed. Both on a full page of the newspaper. As you all know, “Yes Minister” tells you how government discredits an unwelcome report. Step one – refuse to publish in the public interests, saying you are waiting for the results of a more detailed report, still in preparation. If there isn’t one, commission it! And that’s what happened. We were told to prepare a Cochrane review about this, and our original report would not see the light of day. So, we did a little more work, we published our findings in the Lancet,9 then two years later we published the Cochrane review which, naturally, confirmed the original findings. But we were blocked.10 [Editor’s note: the paper was removed completely from the journal website without any formal retraction. The authors later published it in the Danish Medical Bulletin11] You can see why, when life gets tough, I like to watch “Yes Minister”.

I published another paper in the Journal of the Royal Society of Medicine last year, calling for mammography screening to be stopped.12 What does breast cancer screening mean for total mortality? Mortality rates with and without mammography screening are identical. Except, of course, if you include deaths caused by screening overdiagnosis – if you do that, you find that screening increases mortality. Why deaths by overdiagnosis? Well, if you are diagnosed with breast cancer you get chemotherapy and radiotherapy, and that kills some women. Do you think you could have sold mammography screening if this was what you’d shown to the politicians 25 or 30 years ago? And because the NHS leaflet on breast screening was no good, we produced a new leaflet and published it in the BMJ, it’s been translated into many languages and it’s on our website.13

Screening is the best way to earn money, if you are a private doctor

But of course screening – to investigate and find illnesses before people even know they are ill – is the best way to earn money, if you are a private doctor.
So I thought we should also look into health checks, looking at morbidity and mortality from disease. To our big surprise there were already 16 randomised trials with many participants and long follow-ups – 9 years – and almost 12,000 deaths, so much material! And what did we find? No effect whatsoever. Total mortality, around 1, and the same for cancer, cardiovascular mortality. We published in the BMJ.14 Then a huge Danish study was published after our review, that one included 3,000 deaths, and it didn’t find anything either. Extensive screening for risk of ischaemic heart disease followed by repeated lifestyle counselling, a beautiful ten-year study that was also published in the BMJ.15 So there are no lives saved by screening but there is a lot of harm because you make diagnoses and then treat them with drugs that might make your patients impotent, etc., when they might never even have noticed the symptoms of the original condition or just put it down to old age.

Look at England – there is a universally applied health check for everyone aged 40-74. It was launched in 2009. The Department of Health argued that by spotting people who are at risk from heart attack, diabetes, stroke, kidney disease, these conditions could be prevented. Finally we’d had enough and wrote to the Times, who published on the front page to say that health checks are utterly useless.16 They now claim that, although the programme is not supported by direct evidence from randomized controlled trials, there is an urgent need to handle the growing burden of disease associated with lifestyle behaviours. Six months later, NICE was helping local authorities to encourage people to attend health checks and to support them making changes to improve their health.

Now, this is how the mob operates. You don’t ask the boss questions. You just do what you are told, otherwise you might get a bullet in your head. NICE has prostituted itself to the politicians’ message. This is a side of medicine that students aren’t taught about.

I am kind of fed up with being introduced all over the world as controversial. Why is it controversial to tell what you find when you try to do good science?

Peter Gøtzsche’s books include Deadly Psychiatry and Organised Denial (People's Press, 2015); Deadly Medicines and Organised Crime: How Big Pharma has Corrupted Healthcare (Radcliffe Publishing, 2013); and Mammography Screening: Truth, Lies and Controversy (Radcliffe Publishing, 2012).

The HealthWatch Award is presented annually to an individual who has made significant steps either in medical research or in improving the public’s understanding of health issues by clarifying complicated and often misunderstood medical matters for the general public.

References
1. Gøtzsche P. Deadly Medicines and Organised Crime. Radcliffe Publishing, London, 2013
2. Krogh Johansen H, Gøtzsche PC. Problems in the Design and Reporting of Trials of Antifungal Agents Encountered During Meta-analysis. JAMA. 1999;282(18):1752-1759 http://jamanetwork.com/journals/jama/fullarticle/192088
3. Rennie D. Fair Conduct and Fair Reporting of Clinical Trials. JAMA. 1999;282(18):1766-1768 http://jamanetwork.com/journals/jama/fullarticle/192075
4. Panzer H. Improving the Conduct and Reporting of Clinical Trials. JAMA. 2000;283(21):2787-2790 http://jamanetwork.com/journals/jama/fullarticle/1030783
5. Grady D. Medical Journal Cites Misleading Drug Research. New York Times, 10 Nov 1999 http://www.nytimes.com/1999/11/10/us/medical-journal-cites-misleading-drug-research.html
6. Kolata G. Placebo Effect Is More Myth Than Science, Study Says. New York Times, 24 May 2001 http://www.nytimes.com/2001/05/24/us/placebo-effect-is-more-myth-than-science-study-says.html
7. Gøtzsche P. Deadly Psychiatry and Organised Denial. People's Press, London, 2015
8. Sjönell G, Ståhle L. Hålsokontroller med mammografi minskar inte dödlighet i bröstcancer. Läkartidningen 1999; 96: 904–13.
9. Gøtzsche PG, Olsen O. (January 2000). "Is screening for breast cancer with mammography justifiable?". Lancet 2000;355:129-134 http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(99)06065-1/abstract
10. Zahl PH et al. WITHDRAWN: Results of the Two-County trial of mammography screening are not compatible with contemporaneous official Swedish breast cancer statistics. European Journal of Cancer 2006 Mar 9 [epub ahead of print] https://www.ncbi.nlm.nih.gov/pubmed/16530407
11. Zahl PH et al. Results of the Two-County trial of mammography screening are not compatible with contemporaneous official Swedish breast cancer statistics. Danish Medical Bulletin 2006;53:438–440 https://web.archive.org/web/20070621235925/http:/www.danmedbul.dk/Dmb_2006/0406/0406-artikler/DMB3890.htm
12. Gotzsche PG. Mammography screening is harmful and should be abandoned. J R Soc Med 2015 Sep;108(9):341-5. http://journals.sagepub.com/doi/abs/10.1177/0141076815602452
13. Nordic Cochrane. Mammography screening leaflet, 2012. http://nordic.cochrane.org/mammography-screening-leaflet
14. Krogsbøll LT et al. General health checks in adults for reducing morbidity and mortality from disease: Cochrane systematic review and meta-analysis. BMJ 2012;345:e7191. http://www.bmj.com/content/345/bmj.e7191.long
15. Jørgensen T. Effect of screening and lifestyle counselling on incidence of ischaemic heart disease in general population: Inter99 randomised trial. BMJ 2014;348:g3617 http://www.bmj.com/content/348/bmj.g3617
16. Smyth C. NHS checks on over-40s condemned as ‘useless’. The Times, 20 August 2013 http://www.thetimes.co.uk/tto/health/news/article3847530.ece

Why evidence matters

The 23rd HealthWatch Award was presented to Dr Mark Porter MBE; GP, journalist, media doctor and presenter of BBC Radio 4’s ‘Inside Health’.

Receiving his award at the Medical Society of London, Dr Porter gave an insight into his unique career, and explained that his listeners, readers, and patients are why evidence matters.

‘For me, it’s not about the data, but how it influences clinical practice — what difference is made to the man or woman sitting in front of me in my consulting room.

Like most, I was a naïve young doctor who did what his boss told him, whose boss did what his boss told him because it was what his boss did, and that’s how we based a lot of our practice. It’s been a gradual transition to the importance of evidence, and now, I’m a complete convert.

My job is not to be an expert. It is to put experts into the public domain. It is to ask questions, and to give them the chance to explain the rationale behind evidence-based medicine; what it is and why it matters to the public, so that everybody out there can make an informed decision about their future.

I don’t need to sell evidence to my listeners  they absolutely ‘get it’. Less straightforward is the way that research is reported. It’s hard to see through the veneer of gloss that’s put upon it by the journalists, or the journal, or by the researchers themselves. Press releases from journals ‘big things up’  it’s not surprising that the story gets slightly confused.

Significance is not well understood. I’m not talking about statistical significance here; I’m talking about what difference this finding might make to their lives. If something doubles the chance of you getting something, but your chance of getting something is pretty near zero in the first place, it’s irrelevant.

Terminology is a struggle. I’m hopeful that there will be a third series of ‘Inside Language’, a series with Professor Carl Heneghan and Dr Margaret McCartney looking at terminology, from surrogate markers to t-tests, which has proved popular.

My job is to teach the public to be a little bit sceptical, a little bit cynical about what they read, look for vested interests, understand why something might be, and understand how to ascertain if it’s relevant to them.

But, I do have concerns, and I just want to share a couple of those with you.

The first is the relevance of the data.

As we bow to the altar of evidence-based medicine, sometimes we’re blinded by the light. We need to be critical about the relevance of the data that we’re looking at, in terms of clinicians like me, working at the coalface of the NHS. A lot of that data ends up informing and producing guidelines, and we need to look at how rigidly we adhere to those guidelines when faced with very different individuals.

The vast majority of patients that I see, perhaps 90%, wouldn’t get into a clinical trial because they don’t meet the criteria - yet they’re the patients that we’re treating. Still a large proportion of the data that we’re looking at is coming from on high. We don’t know how relevant it is to the people we’re actually seeing on a day-to-day basis.

An example I use is that of the contraceptive pill. The early explanatory trials show a failure rate of 1 in 300, so if you had 300 women on the pill for a year, one would expect to get pregnant. But in the real world, where trial conditions don’t apply and all sorts of things arise, that failure rate approaches 1 in 10. That’s a huge, huge difference. But it’s the sort of difference that patients can grasp straight away, and suddenly they see the rationale behind long acting contraceptives.

I’d like to see more pragmatic trials  but they’re not the be all and end all, either. I just want to emphasise that the evidence that we’re looking at is not always pertinent to the people that we’re treating.

My second concern is that the selective data is then used to produce the guidelines. I’m all for guidelines. I’m all for best evidence based practice. But I worry about how rigidly we apply it, because of external pressures. We have QOF, prescribing initiatives, pressure to follow published guidance. Even if the guidelines were perfect - how do we know that we’re applying them correctly to the person that’s sitting in front of us?

External pressures mean that guidelines get rigidly applied. They become tramlines. And I think that’s a problem.

I recently met an elderly gentleman with a humeral fracture in a falls clinic. He had diabetes, atrial fibrillation and other conditions, and had felt lightheaded for months. A number of doctors, consultants, had seen him and treated him according to the guidelines. He was taking sixteen different medicines, including six that lowered his blood pressure. I have no doubt that getting blood pressure to target improves outcomes for 1,000, 10,000, 100,000 diabetic patients. But that doesn’t tell me what’s going to happen to the patient sitting in front of me. He could have hit his head, or broken his hip. We could have killed him. That’s something that we need to consider in general practice.

Scepticism doesn’t stop once you have some evidence, or have guidelines.

I don’t have answers. If pushed, I’d like to revert to that basic tenet of clinical practice: Primum non nocere  or, as I say to my patients if in doubt, do nowt.

(Edited transcript)

 

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