How safe are the cutting edge treatments offered by private clinics?

How safe are the cutting edge treatments being offered by private clinics? Experts fear thousands are being spent on procedures that may be unproven and even harmful

With NHS waiting lists at record levels, more of us are being driven to spend precious money on private medical treatments.

With a staggering 6.7 million people currently waiting for hospital treatment in England, around half of us would consider going private for medical care, according to the Independent Healthcare Providers Network. Indeed, 40 per cent more people paid for private treatment last year than in 2019.

And while the vast majority will receive excellent care, this Good Health investigation reveals worrying gaps in the regulation of UK private healthcare, allowing some clinics to provide treatments that are clinically unproven and, according to some experts, dangerous.

Take a simple but important example, Kenalog. The NHS stopped using it as a hay fever treatment a decade ago after studies showed the side-effect risks outweighed its benefits.

Kenalog is a powerful prescription-only steroid injection licensed for arthritic joint pain and swelling.

For hay fever, it works by suppressing the immune system and dampening the allergic reaction — and its effects can last months.

But research shows that Kenalog can also leave patients vulnerable to infections such as chickenpox, shingles and flu, and raises the risk of an irregular heartbeat, depression and high blood pressure.

Yet despite the NHS withdrawing the treatment for hay fever, some private UK clinics have continued to offer it.

With a staggering 6.7 million people currently waiting for hospital treatment in England, around half of us would consider going private for medical care, according to the Independent Healthcare Providers Network. Indeed, 40 per cent more people paid for private treatment last year than in 2019

Furthermore, as a prescription-only medicine, it can’t be advertised, but some clinics flout these rules.

In August, the drug-safety watchdog the Medicines and Healthcare products Regulatory Agency (MHRA) and the Advertising Standards Authority (ASA) warned clinics to stop advertising Kenalog online or on social media as a hay fever injection.

The MHRA’s head of advertising, Claire Tilstone, said: ‘Advertising prescription-only medicines is banned under UK law. Private clinics should urgently review their websites and social media to ensure they are not advertising Kenalog, to avoid enforcement action.’

The MHRA’s notice gave clinics until August 29 to comply.

However, on September 16, Good Health found at least five UK clinics still advertising Kenalog injections for hay fever, for £75-£100 per treatment.

Furthermore, in May this year, the ASA ruled that a clinic advertising Kenalog injections on Instagram — Lucy Isabella Beauty & Aesthetics, based in Derby — must stop advertising the prescription-only jab. Again, when Good Health checked online just a few days ago, the company’s Instagram account was still carrying the advert.

An ASA spokesperson told Good Health: ‘Our compliance team are continuing to monitor advertisers using our monitoring technology. We have removed 52 posts on Instagram and Facebook that advertised Kenalog since the deadline ended. We cannot comment on the specific ads you have cited. However, we have passed these on so they can be assessed by our compliance team.’

An MHRA spokesperson said: ‘We wouldn’t comment on individual cases. The ASA takes the lead on internet monitoring of breaches, and we work closely with them on enforcement action needed.’

In another example, private clinics are offering a procedure UK experts warn is potentially dangerous as well as ineffective. It involves injecting stem cells to ‘repair’ diseased joints or as a beauty treatment.

U.S. safety watchdog the Food and Drug Administration is cracking down on private clinics that claim stem cells can treat or cure conditions such as arthritic knees and hips, or are a cosmetic surgery procedure for ageing skin. But in the UK, such treatments are slipping through a regulatory gap.

Stem cells are the body’s master cells and have the potential to develop into different types of cells, including those that make up blood and bones.

The use of stem cells is not without risk. When injected as ‘therapies’, they may, for example, become cancerous. This risk was discovered in the early 2000s, during initial attempts at using the therapy for Parkinson’s disease.

Such perils explain why scientists experimenting with stem cells in accredited UK medical research institutions are governed by strict safety guidelines from the Human Tissue Authority (HTA).

Medical stem cell surgery treatments are approved in the UK but for only a few conditions, including some blood cancers, skin grafts and in the repair of corneas. The NHS is also starting to use stem cells to treat multiple sclerosis, again under strict protocols.

Research shows that Kenalog can also leave patients vulnerable to infections such as chickenpox, shingles and flu, and raises the risk of an irregular heartbeat, depression and high blood pressure

This cautious approach, however, is not always matched by private clinics, which are offering stem cell injections for conditions ranging from arthritic knees to an anti-ageing cosmetic procedure — often at a cost of thousands of pounds.

With a wait of up to two years for knee surgery on the NHS, it’s easy to see how patients might consider spending this kind of money. (The jabs are also less invasive and cheaper than private joint replacement surgery.)

The Highgate Private Hospital in North London offers to extract patients’ own stem cells then, under general anaesthetic, inject them into a hip or knee joint to treat arthritis or joint damage.

When we contacted Nuffield Health, which owns the hospital, a spokesperson could not tell Good Health how effective or safe the procedure is — or even its cost. She did refer us to UK treatment watchdog NICE, for evidence of the operation’s effectiveness.

Draft guidelines on stem cells, published by NICE last April, state a lack of authoritative research means there is ‘insufficient evidence to determine the effectiveness of stem cells in people with osteoarthritis’.

Meanwhile, the Tiryaki clinic in Sloane Street, London, offers ‘facial rejuvenation’ treatments which involve stem cells being injected into the face.

The clinic’s website promises: ‘We are able to delay and repair the effects of ageing, replenishing deep-tissue volume and returning youthful elasticity to the skin . . . The stem cells will create a healing response from deep in the bone up to the surface of the skin to regenerate and restore your face.’

Again, the treatment involves using the patient’s own stem cells — a process known as autologous implantation.

This point is key, as using a patient’s own stem cells means private providers can offer both these procedures without licence or oversight.

The Highgate Private Hospital says it harvests the stem cells from the patient’s own bone marrow or blood, while the Tiryaki clinic takes them from fat from the patient’s hips, abdomen or thighs.

The clinic claims the procedure is safe and there is ‘zero risk of rejection’ because your own stem cells ‘are biocompatible’. While Good Health has no evidence that patients at either the Highgate or the Tiryaki clinics have been harmed by these treatments, the Tiryaki clinic did not respond to our questions about the evidence for its treatment or whether it is confident about its safety.

The regulatory picture here is somewhat cloudy, as responsibility falls between two organisations, the HTA and the MHRA.

A spokesman for the HTA told us that under rules drawn up in 2007, private clinics are exempt from regulation if they use a patient’s own cells ‘as part of a single surgical procedure’.

However, if those cells are modified or put into storage prior to use, ‘a HTA licence would be required’, and depending on the procedure, they may come under the jurisdiction of the MHRA.

When Good Health asked the MHRA whether it considers autologous stem-cell treatments provided by private clinics to be both legal and safe, a spokesman would only say: ‘Autologous stem cell treatments would be subject to review by MHRA to determine if they were caught by legislation governing medicinal products or medical devices. A determination is made on a case-by-case basis.’

It would not say how many clinics it has reviewed on a case-by-case basis, nor whether it has ever reviewed the Highgate or Tiryaki clinics.

This is not the first time Good Health has reported on this regulatory ‘gap’. In 2020 we warned how stem-cell clinics were injuring patients.

Fares Haddad, a professor of orthopaedic and sports surgery at University College Hospitals in London, told us he’d treated two patients who’d been harmed by stem cell injections administered by private clinics in the UK.

‘They had developed blood clots in their thighs as a result of private stem cell surgery that was supposed to repair damaged knee and hip joints,’ he said.

One had a pulmonary embolism, a blood clot in the lung — a medical emergency. The other patient’s joint tissues reacted so badly to the injection she needed a hip replacement.

Two years on, private clinics are still able to offer stem- cell injections.

John Martin, a professor of cardiovascular medicine at University College London, who runs fully regulated UK trials using autologous stem cells for patients with heart failure, says current supervision is inadequate.

‘We do our work under strictly regulated conditions,’ he says. ‘But no one has run any proper trials on autologous stem-cell transplants for orthopaedic or cosmetic uses. We don’t therefore know if such uses are safe. When you stick a needle in someone there’s always a risk. I wouldn’t want anyone injecting anything unproven into my knee.’

Dr Darius Widera, an associate professor in stem-cell biology and regenerative medicine at Reading University, adds: ‘Even with autologous transplants, there is a risk of the patient’s body rejecting the transplant.

‘There is plenty of evidence from the U.S., where many more unregulated clinics have offered these treatments, that there can also be serious complications, such as sepsis.’

Last year, the Pew Charitable Trusts, a global research foundation, identified 360 reports in the U.S. of injury and deaths linked to private clinic stem-cell transplants since 2004 — ‘almost certainly an underestimate’, it said.

Many of these incidents involved serious bacterial infection, including at least two cases of the life-threatening blood infection septicaemia.

Others included partial or complete blindness, paraplegia, cardiac arrest, tumours or other growths, as well as organ damage or failure in several cases that were fatal.

The most common procedure causing these problems was ‘autologous stem-cell transplants’, said Pew.

In the light of such evidence, Dr Widera questions why private UK health clinics are encouraging patients to take such risks when: ‘The clinical trial evidence on these treatments shows no proof of benefit for patients.’

He adds: ‘In the UK the relevant authorities don’t have any strong position on these clinics. What we need is a clear regulatory framework dictating how and whether these therapies should be conducted.

‘Direct-to-consumer clinics like these should be shut down. In the UK we should have the same regulations as in the United States. They should be enforced against clinics who can’t prove with reputable clinical-trial evidence that their procedures are both safe and effective.’

According to Dr Kevin Smith, a bioethics expert at Abertay University in Dundee, private UK stem-cell clinics are using misleading and untrue online marketing to lure potential patients.

Last year he analysed the websites of 24 private clinics offering stem-cell treatments in the UK, and concluded that almost 80 per cent feature dubious practices. These include making unjustified claims of effectiveness, downplaying risks and using celebrity testimonials that have no scientific basis, he reported in the journal Regenerative Medicine.

Dr Smith told Good Health that while no clinic guaranteed positive results, websites used phrases such as ‘expect improvement’ and ‘patients usually demonstrate a rapid and progressive improvement’.

Only three made it clear that results can’t be assured, with just one clinic mentioning that stem cell therapy is still experimental, he said.

Furthermore, only three clinics mentioned a risk of infection and one of these branded that risk as ‘theoretical’. ‘One clinic explicitly described their procedure as safe, and claimed there was neither a risk of rejection nor of infection,’ he told Good Health.

Separately, experts are concerned about a London clinic’s claims that its handheld gadget, a Neurolith, can ‘improve’ the symptoms of Alzheimer’s disease and slow their progress — even though it’s not an MHRA-approved medical device.

The London Alzheimer’s Clinic in Harley Street is charging £6,000 for a fortnight’s course of six sessions with a machine that emits high-frequency acoustic pulse waves against their skull.

The clinic calls this approach ‘transcranial pulse stimulation’ or TPS and claims that it stimulates blood vessels to grow and nerves to regenerate in clients’ brains.

A spokesman told Good Health: ‘There is evidence that TPS can initially improve and then slow decline in some cognitive symptoms in individuals with Alzheimer’s.’

Critics say this evidence comes only from small-scale, scientifically weak trials, co-funded by the Swiss maker of the device, Storz Medical. But the London Alzheimer’s Clinic says a reputable double-blind, placebo-controlled study ‘is currently being prepared for publication within the next couple of months’.

Dr Tim Beanland, head of knowledge management at the Alzheimer’s Society, told Good Health: ‘It’s concerning that claims are being made which describe TPS as able to reduce the symptoms of dementia.’

Rob Howard, a professor of old-age psychiatry at University College London, adds: ‘It’s impossible that putting ultrasound into someone’s diseased brain could actually do anything beneficial.

‘When patients ask me about private clinics’ dementia therapies, I tell them not to waste their money.’

He is concerned about the lack of regulatory oversight regarding the TPS machine. Because it’s non-invasive, its maker says it does not need UK approval as a medical device.

Instead, a report in the Journal of Translational Medicine this year, funded by Storz Medical, says: ‘TPS is clinically certified as therapy for Alzheimer’s disease (CE mark)’.

This is sufficient certification, says an MHRA spokesman, who explains: ‘Manufacturers of medical devices must have the relevant clinical data in their technical documentation to support their CE marking for the intended purpose they have assigned to their device, and any claims they make when marketing must be substantiated by the technical documentation they maintain for the device.’

But Professor Howard argues: ‘A European CE Mark says nothing meaningful about clinical efficacy and is fundamentally a reassurance about its basic safety. CE marks are found on things like hedge-trimmers, so you feel reassured that they won’t electrocute you.

‘Any equipment like the Neurolith that makes medical claims should be regulated properly and proven to be effective in reputable clinical trials before use.’

Surely such strictures should apply to any type of clinical treatment being offered in Britain, to ensure that private patients don’t waste their money or — worse — endanger their health.

Under the microscope

Journalist and author Lorraine Kelly, 62, takes our health quiz 

Can you run up the stairs?

Yes, because we’ve got stairs at work and sometimes they say to me: ‘Your trail for Good Morning Britain is in five minutes, oh no it’s in 30 seconds, run!’

Get your five a day?

Absolutely. I always have a banana in my bag and I love roasted vegetables — I could eat a whole plate of them.

Ever dieted?

Yes. I’m 5ft 4in and I weigh 10st 3lb, which is my ideal weight, but I was 11st 10lb in January having put on weight in lockdown. I decided I had to do something and so I joined WW (WeightWatchers).

How has the pandemic affected you?

I did a lot of comfort eating, and not enough exercise. I didn’t get Covid until July — as I was fully vaccinated, it wasn’t as bad as it could have been.

Any vices?

A glass of red wine. I also love cheese and chocolate orange.

Any family ailments?

A lot of people in our family have had bronchitis and lung disease. But my mum and dad are in their 80s and are pretty healthy.

Worst illness or accident?

Ten years ago I fell off a horse during a charity event. It trampled me. I lost a lot of blood and was in hospital for more than a week.

Pop any pills?

A multi-vitamin and vitamin D to make sure I get all I need.

Ever have plastic surgery?

Never. I’ve heard too many stories of people where it’s gone horribly wrong. And I quite like to look in the mirror and see my face.

Cope well with pain?

I’m pretty good actually.

Tried alternative remedies?

Yes. I had back pain when I was a reporter decades ago, I think it was because I carried a lot of stuff, but I had acupuncture and it was great.

Ever been depressed?

No, but during menopause I got very flat. It wasn’t depression, but it gave me a tiny insight into what it must be like to have it.

Hangover cure?

Irn-Bru. And a roll and butter with square sausage and HP sauce.

What keeps you awake at night?

I sleep pretty well but sometimes I’ll be thinking about questions for an interview. I’ve got a notebook by the side of the bed that I scribble in.

Any phobias?

Daddy long-legs. One flew in my face when I was a kid. To this day, if I’m staying with my parents and there’s one in the room, Dad has to get it out.

Like to live for ever?

If I was physically and mentally sharp, sure. I want to see if we do get to Mars, or even beyond that.

Interview by Roz Lewis 

ww.com/uk/ambassadors/lorraine-kelly

Source: Read Full Article