Straight to the point

In a leafy London suburb, there’s a smart little clinic that promises miracles. Run by Dr Andrew Greenland, an NHS consultant in emergency medicine, the Greenland Centre claims to be able to do something that the drug industry has failed to, despite spending billions on research over several decades: “Reverse the cognitive decline of early Alzheimer’s disease”.

The centre runs a protocol which claims patients can expect to see results within six months. And, according to its website, “to maintain improvements and prevent further cognitive decline, participants should consider the program as a long-term prospect”. This miracle treatment — the Bredesen Protocol — doesn’t come cheap. Patients are charged almost £3,000 for their first three appointments with any additional consultations costing another £475.

But with questions hanging over the effectiveness and harms of the two new Alzheimer’s wonder drugs, lecanemab and donanemab, expected to arrive on the market soon, any treatment that claims to reverse cognitive decline would be worth paying over the odds for. And right now, people are queuing up to pay. There are 21 practitioners and centres across the UK offering the Bredesen Protocol — or treatment plans based on his approach — charging anywhere up to £6,000 for consultations. Two say they are at “capacity”: suffering patients and their families are desperate to find something that might help their loved ones.

Desperation feeds exploitation and the Bredesen Protocol has been described by some scientists as quackery. The Alzheimer’s Society UK told us the regime was “not supported by scientific evidence”, while in Canada it is described as “offering ‘false hope”; and across various medical journals, academics suggest its use and promotion is ethically questionable.

Dr Dale Bredesen, however, claims that Alzheimer’s is “literally becoming optional”. A professor of molecular and medical pharmacology at UCLA, he has identified the 36 multifactorial “contributors” to the disease, and targets them “with a precision medicine type of approach”. This involves regular brain-training exercises, stress reduction plans and a ketogenic diet.

Deborah was diagnosed with Mild Cognitive Impairment aged 49 and told she was likely to develop Alzheimer’s. She had been having difficulty recognising people’s faces and switching words for a few years. After her sister-in-law discovered Dr Bredesen’s protocol, she signed up and was prescribed a plant-based diet, with virtually no red meat and plenty of intense exercise which she does on her Peloton bike. “All of a sudden, my brain started to work clearly. It was like the light went back on,” she says.

But mild cognitive impairment — MCI — is not the same as dementia. It refers to memory glitches which may be noticeable but don’t affect the person’s ability to function. Alzheimer’s Research UK says that about one in 10 people who have been diagnosed with mild cognitive impairment develop dementia each year. However, they also say that five in 10 will either stay the same or get better, with their memory returning to normal. Memory problems can be triggered by all manner of things: depression and anxiety, vitamin deficiencies, thyroid disorders — even some types of medication and being generally unwell, for example with a chest infection. Nonetheless, stories such as Deborah’s have been used as the basis of the evidence that the Bredesen Protocol works.

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Another is Bredesen’s “Patient Zero”. She was so depressed about her symptoms and prognosis that she had been saving up prescription pills to end her life. “I was so desperate at that point,” she says, “that I just wanted to check out.” She contacted Bredesen anonymously because she was afraid of losing her security clearance in her job. And after three months on the protocol, she noticed a transformative change. “I was just running around the house saying ‘I got my brain back I got my brain back.’ I was just so overjoyed,” she says. Convinced this proved the protocol worked, Bredesen reported her as a case study in a paper published in 2014.

When we wrote to Dr Bredesen saying his protocol had been described as “quackery”, he sent us this case report along with other research papers that he claimed provided the evidence for his treatment plan. He highlighted his medical qualifications obtained from some of the most prestigious establishments, that he’d worked in famous Nobel Prize-winning labs and had more than 230 peer-reviewed publications. “Few clinicians, and no reporters, understand the fundamental science that underpins what we are doing,” he says. “I doubt if any has read all of our publications.”

But according to Rob Howard, professor of Old Age Psychiatry at UCL, Bresenden’s claims are largely based on poor science that no reasonable practitioner would consider indicates efficacy. “He doesn’t really have any data that’s worth debating with him,” he says.

Indeed, the research that Dr Bredesen produced for us highlights problems with the way this sort of material is published and disseminated. He sent links to three studies, which he had previously referred to as “anecdotal reports” — the least reliable form of evidence. Another paper referred to the “trial” that clinics point to when they claim: “84% of the patients showed improvement.” But in fact the paper, published in the Journal of Alzheimer’s Disease, does not prove the protocol works. The 25 patients studied had a mixture of “dementia or mild cognitive impairment”, and given that many patients with MCI improve by themselves, we would expect to see improvements over time, regardless of treatment.

In any case, because the protocol uses multiple interventions, even if we did see genuine improvements, we would not know whether it was the simple advice that “worked” (prioritise sleep; eat a plant-rich diet; exercise for 45 minutes six days a week) — or if it was the complex regime of herbal supplements, “brain training”, “gut healing nutrients and digestive enzyme support” along with, for some patients, naltrexone (a drug used to treat opioid addiction and alcohol dependance). Bredesen’s conclusion that “it is possible to reverse cognitive decline in MCI and early dementia with a personalised, precision medicine” is astonishing, given that the nature of their study design meant they could prove no such thing.

Meanwhile, Bredesen has put these 230 peer-reviewed studies on his CV and is using them as proof that his method works, pushing out lucrative clinics across the country. The trouble is, just as not all studies are created equal, nor are medical journals. There’s a dark underbelly in medical publishing which Bredesen has chosen to exploit, publishing in a section of the medical press that might be best described as “predatory journals”. These journals best thought of as financial scams, says Dr Richard Smith, former editor of the BMJ and author of the book, The Trouble with Medical Journals. The publishers will commission your study for a fee; there is no peer reviewing or editing involved.

In other words, unwary doctors, journalists, patients and families can easily be misled into thinking a published paper in a medical journal is a sign of quality when it may simply be a sign that the author has paid to be published.

“When predatory journals first appeared more than a decade ago, it was widely assumed that authors published in them because they had been deceived,” says Smith. “But it’s become apparent that many authors chose to publish in them because they know that the paper will be published. The authors can put the papers on their CVs, and appointments committees or grant-giving bodies will not know that the reference is to a predatory journal,” he explains.

This isn’t the only place where the medical establishment has opened a rich seam for people such as Bredesen to exploit. Those complicated financial relationships between dementia charities and the drug companies manufacturing the new treatments have proved useful for Bredesen. He has called out the Alzheimer’s Association for praising the medical treatment aducanumab, after it received a significant amount of money from the drug’s manufacturer, Biogen. As Bredesen phrased it: “Well yeah, they were paid over a million dollars. No kidding they thought it was a good drug. It’s been surprising how incredibly powerful the infrastructure of money making is.”

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So, how do patients and families work out who is offering treatment that might be worth the money — especially when clinics are run by bona fide, GMC-registered doctors? As we have seen, medical journals aren’t all sound — just because something has been published doesn’t necessarily mean we should take it at face value — and it also seems that those who are supposed to uphold the integrity of medicine might not necessarily be protecting patients either.

We told the Advertising Standards Authority (ASA) about the claims Greenland Medical Centre were making in November 2023, who agreed they should be changed and they referred our complaint to the compliance team. However, six months later, Greenland Medical’s website still says they can “reverse the cognitive decline of early Alzheimer’s disease”.

We also raised our concerns with the General Medical Council, the doctors’ regulator, that false claims were being made to a potentially vulnerable group of patients by a registered doctor. The Council refused to investigate, saying “no information has been provided to show that the treatments offered by the doctor are a danger to patients” or that “patient safety is at risk”. They also said that “It does not seem like the information provided that there is clear indication Dr Greenland has been deliberately dishonest about the treatments and what it offers to patients.”

Instead, the GMC told us to raise concerns with the Care Quality Commission, which we did, in November 2023: they have yet to respond.

Dr Greenland told us: “We are prepared to engage with the Advertising Standards Association to ensure that our communications are in compliance and accurately represent the scientific evidence supporting the protocol.” They also stated that “the Bredesen Protocol represents a novel and evidence-based approach to Alzheimer’s treatment”.

There are people in public health medicine who are providing credible, useful work. Professor Carol Brayne, for example, says that we should have a more holistic approach to looking at Alzheimer’s rather than focus on individual theories. “What the clinics are doing is trying to package all interesting hypotheses that are out there,” she says, “as well as sensible stuff that’s been around for centuries and put them all together as a magical prevention package. There is some reasonable stuff mixed up with speculative stuff.”

But the truth is that there is no magic cure, and we should be honest about this and the ongoing need for high quality research. Considering the potential to exploit people, the lack of effective regulation around highly priced but ineffective interventions is deeply troubling. Caring for patients with dementia should also mean protecting them from false, expensive hope. Our regulators need to proactively step up.

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Source: UnHerd Read the original article here: https://unherd.com/