A private clinic is pioneering a treatment with cheap drugs but NHSbureaucracy is delaying its adoption, says Lois Rogers
lmost three years ago, just weeks after her wedding, Rosie Garrett, a 31-year-old children’s nanny, was told she would soon die.
AAfter she had complained about vision problems and dizziness, doctors discovered a huge malignant tumour, called a glioblastoma, spreading across her brain. An operation removed most but not all of the tumour, and the outlook was bleak.
“I was absolutely devastated,” she says. “They told me it was a grade-four tumour, which is the worst kind you can get. They gave me a maximum 12 to 15 months to live.”
She believes the fact she is still alive is down to a trial cocktail of cheap, entirely safe drugs that disrupt the life cycle of cancer cells.
“I don’t know for sure, but I believe the drugs are working. I have a scan every three months and they have even seen shrinkage in the bit of tumour that’s still there,” she says.
“It does seem to surprise my oncologist that I’m not having any blackouts or seizures. They keep telling me it’s definitely going to come back, but I’ve decided it won’t. If you sit there and think you’ve got a tumour that’s going to kill you, it will do.”
Rosie has returned to her job as a nanny, and although she has been cleared to resume driving, her biggest frustration is the delay in the DVLA returning her licence.
She is one of around 1,000 cancer patients, many of whom have dramatically outlived predicted lifespans, apparently helped by the same cocktail that has been approved by the Medicines and Healthcare Products Regulatory Agency (MHRA).
The patient group, which includes scientists, relatives of cancer specialists and hospital managers, are being treated by the private Care Oncology Clinic (COC) in London.
They are receiving the drugs alongside conventional NHS chemotherapy, and with the blessing of their NHS oncologists who share clinical notes with Care Oncology, but are prohibited from “promoting” the treatment via the NHS.
The clinic – which charges patients a £450 enrolment fee, followed by £250 a quarter for drugs, consultations and access to a 24-hour helpline – is planning to compare its patients’ five-year survival rates with NHSpatients on standard care.
However, health service regulations say it must have ethical approval to collect its patients’ data for the comparison, and because the process is outside normal NHS trial procedures, ethics approval has been a stumbling block.
Without this approval, the clinic cannot advertise or promote its service, and it needs a steady stream of patients to keep costs down and provide the database of patients to show the benefit of the treatment.
Now, the COC doctors have resorted to launching a unique crowdfunding appeal, to raise money to get the treatment to more patients – and prove that it works.
The plan is to use the trial results to compel the NHS to provide the cheap drugs to everyone in Britain who might benefit, while the COC would expand its model by opening clinics to provide affordable cancer treatment around the world.
Some patients who cannot afford the charges are already offered the treatment for free, and it is hoped the crowdfunding will cover the costs of many more non-paying patients.
Seedrs, the crowdfunding website – which is hosting COC’s £350,000 appeal – confirmed it was the first time a health care provider had launched such a scheme. It is a development that has highlighted the sclerotic attitude to innovation in the NHS, which is now facing a £17 billion annual drugs bill.
The bill is rising at around 8 per cent a year as the NHS has struggled in negotiations with pharmaceutical manufacturers to keep costs down.
Meanwhile, these drug multinationals recruit cancer sufferers to demand new treatments that may buy a few weeks of extra life for some, but often at a cost of more than £100,000 per patient.
The daily drugs COC is prescribing are metformin, normally given to diabetics to limit glucose overload, and statins, given to heart patients to cut cholesterol. Alongside these are doxycycline, an antibiotic, and mebendazole, an antiparasitic drug.
There is evidence to suggest that, together, these four drugs disrupt the metabolic pathways of cancer cells, slowing down or preventing their reproduction. They are among a number of Continued on page 19 CONTINUED FROM PAGE 1 7 published scientific studies to disrupt tumour growth by reducing cancer cell nutrition.
“If you’re used to looking at patient data, there’s not much evidence for the COC drugs, but the scientific evidence is fairly compelling,” said Dr Nick Kerton, 65, the director of a Cambridge medical diagnostic company, who had been given weeks to live after he was found to have advanced gall bladder cancer in 2015. “I’m still taking them. Obviously, I don’t know how effective they are, but the fact is I have gone through something pretty awful and now I’m well again.”
Claire Davies, 60, a teacher from Putney in west London, was diagnosed seven years ago with breast cancer that had already spread to her lungs, liver and brain. She has undergone a variety of different treatments and has also been on the COC regime since October 2015.
In recent months, she has been told the cancer is again progressing. She recognises the COC regime is not a cure, but says: “There are senior NHS doctors privately involved in the clinic. I’ve looked at the data on these drugs. It is all there and makes perfect sense. I think I would be mad to stop taking them.”
Clinical trials have recently been set up by the Medical Research Council(MRC) to collect more data on the benefits of these “repurposed” drugs including metformin and aspirin for cancer patients, but results are at least a decade away, and the dose of aspirin being used in the MRC trial is not one that is commercially available anyway.
Max Parmar, director of the MRC clinical trials unit at University College Hospital in London, admitted that even if the trials were dramatically successful, there was no pathway for the drugs to be introduced by the NHS as cancer treatments. “We do need to find a mechanism and a structure for the regulators to allow these drugs that are out of patent to be used again,” he said. “We have had to work very hard even to get these trials offthe ground.”
Pan Pantziarka, the UK spokesman for the Anticancer Fund, a Belgian charity seeking to promote use of these repurposed drugs, said he was part of a group talking to the Department of Health to give “label extensions” for them, so they could be legally prescribed for cancer. “This would be the simplest way of getting these drugs used, but it has to be done by a manufacturer, and there are costs, paperwork and presentations to the regulators to be made,” he said.
Next week, Dr Robin Bannister, the chief executive of Care Oncology, will resume his discussions with the Health Research Authority to get approval for the planned trial.
“The ethics approval process is not set up to consider studies that involve safe drugs already approved for other purposes and patients who have already paid anyway to have their data collected,” said Dr Bannister, who established the clinic in 2014. “It is 65 years since the first studies showed aspirin inhibited cancer, and it is still not being used. We have got to do something to break this logjam.”
“I really can’t see the problem with this,” said Julian Savulescu, professor of practical ethics at Oxford University, and editor in chief of the Journal of Medical Ethics. “The main point is that it will generate knowledge that will benefit everyone. It if shows statins and the other drugs improve outcome, that’s something the NHS should embrace.
“I think these trials should be done without people having to pay, but if the only way they can be done is with co-payment then so be it, that doesn’t mean it shouldn’t be done.”
He believes a change of approach is needed. “The NHS has a levellingdown attitude – that if something can’t be offered to everyone then it shouldn’t be offered at all. But that’s bad for innovation, bad for short-term care and bad for people who would otherwise benefit.”