Breast cancer patients were put at an increased risk of the disease 
recurring as a result of the “unacceptable” decision by NHS Tayside to treat women with lower than normal doses of chemotherapy. 

Experts warned that the regime administered to more than 300 women over a 16-month period offered “less benefit” than the higher doses of chemotherapy drug Docetaxal, routinely used in the rest of NHS Scotland, and meant that “there may be a proportion of patients who are being undertreated”. 

The policy, which was suspended as a result of a highly critical report by Scotland’s healthcare watchdog earlier this month, has exposed patients to an increased risk of breast cancer relapse “probably of the order of 1-2 per cent”, according to the expert review. 

This would be in line with around one patient per year suffering an “adverse outcome”, they said. 

They added: “Whilst the decision to reduce doses in 2016 was taken in the best interests of patients, and based on an audit of toxicity, this decision lacked robust challenge or consultation. 

“It reflected a unilateral internal decision to adopt practice which was judged by the [Immediate Review Group] as being out with best current practice, and close to being unacceptable.”

Of the 304 women treated for breast cancer at NHS Tayside between December 1 2016 and the end of March 31 2019, when the policy was in place, 14 have since died. 

Their deaths are being investigated separately to determine whether a higher dose of chemotherapy may have increased their chances of survival. 

NHS Tayside has been under fire after it emerged that breast cancer patients had been routinely given 75-80mg rather than 100mg doses of Docetaxal, which oncologists insisted was in the best interests of patients to reduce side effects and serious infections. 

Breast cancer patients were not informed, however, and the practice only became public as a result of a pharmacist-turned-whistleblower concerned that the prescriptions were at odds with other health boards. 

The Immediate Review Group (IMG) commissioned by the Scottish Government to conduct a risk ment said there appeared to have been a breakdown in regional medical governance arrangements which enabled Tayside consultants to alter chemotherapy policy “without multi-professional scrutiny and agreement”. 

Ashleigh Simpson, policy and campaigns manager for Breast Cancer Care and Breast Cancer Now in Scotland said patients deserved a consistent standard of care wherever they lived. 

She said: “It is reassuring to hear that the report concludes that the risk of negative impacts following the lower chemotherapy doses is small. 

“But for the small number of patients who may have benefitted from a higher dose, this variation in practice in NHS Tayside remains completely unacceptable. 

“This will be an extremely distressing time for those affected and their families, and it’s essential they are given the support and care they need.”

NHS Tayside has re-opened a telephone helpline for patients and families affected after criticism when it was shut down after only a week. 

Ms Simpson welcomed the move, but added: “This report raises a series of concerning red flags over governance processes in NHS Tayside, and we welcome the recommendations for a review of its decision-making and patient communication procedures.

Scottish Labour’s shadow cabinet secretary for health, Monica Lennon, called on Health Secretary Jeane Freeman to make an urgent statement to parliament on the issue. 

She said: “This report exposes an unacceptable failure in governance at NHS Tayside, with patients put at risk by reducing chemotherapy doses without robust checks and controversially failing to offer tests aimed at preventing recurrence.

“This scandal has badly shaken public confidence in NHS Tayside, leaving breast cancer survivors, and sadly the families of fourteen women who have died, deeply distressed and with many unanswered questions.”

Scottish Conservative shadow health secretary Miles Briggs MSP added: “What is clear from this report is that despite there being provisions for a regional approach to cancer treatment, this wasn’t followed.

“There now needs to be a review of these procedures to ensure there is a consistent, well informed approach to cancer care for every patient in Scotland.
“The effect of these doses could have a profound impact on those who were treated, and we owe it to them and other cancer patients to get this right.”

It is the latest crisis to rock NHS Tayside after its former chief executive Lesley McLay - who was in charge at the time when the controversial chemotherapy regime was introduced - was ousted from her post last year after it emerged that more than £3 million had been diverted from charity donations to fund general spending.

Other members of NHS Tayside’s leadership team in charge in December 2016 - including medical director Professor Andrew Russell and chairman Professor John Connell - also stepped down. 

Professor Peter Stonebridge, NHS Tayside’s acting medical director, said: “We fully accept the findings of the Immediate Response Group (IRG) report which was commissioned by the Chief Medical Officer and the Chief Pharmaceutical Officer.

“We have taken immediate action in response to the IRG report and the Healthcare Improvement Scotland (HIS) Report which was published earlier this month.

“The key change is that we have adjusted the breast cancer chemotherapy dose regime to make sure patients in Tayside are offered the same as those in the rest of Scotland. We will also be offering Oncotype DX testing to eligible patients.

“We can also confirm that we have been back in contact with all patients affected to offer them an appointment with an oncologist, and all but 13 of those who want to take up the offer of an appointment have already been booked in to a clinic.

“A number of patients have already been seen by an oncologist and we have written again to those 13 patients who have not yet been appointed and we are awaiting their response.

“Patients and their families should be assured that we are taking this issue extremely seriously and putting in place all the necessary changes to ensure we provide a high-quality breast cancer service in Tayside.”