"The patients did not receive unnecessary chemotherapy in the sense that they all required chemotherapy to treat their rectal cancers, it is just the schedule and duration of chemotherapy that differed and was non-standard.
The clinicians involved gave the chemotherapy because, at the time, they felt it was the best treatment for the individual patients, to give them the maximum chance of cure.
All chemotherapy causes side effects, and the patients would still have been exposed to the risks of side effects if they had received just standard therapy.
There is no evidence of long-term harm from chemotherapy in the internal or external reviews.
Several of the patients did develop neuropathy (nerve numbness or weakness) but this is a common and predictable side effect of therapy, and it is impossible to say whether such toxicity would be due to chemotherapy given before or after radiotherapy/surgery.
We are not aware of any post-mortems in any of these patients, none died within 30 days of non-standard chemotherapy. All deaths appeared to be due to disease progression. There is no evidence that any of the deaths were due to chemotherapy.
We based our statement on harm and disadvantage on review of the clinical records and survival and toxicity data. All the patients had been under clinical follow up.
When we did recall the patients the general sense was of distress caused by having the events of six to seven years ago brought up again.
By continuously pursuing this, the 'whistle-blower' is actively causing patients and relatives emotional harm, which is not in their best interests.
It is interesting to note that, to our knowledge, not one patient or relative is taking legal action as a result of this.
This is in contrast to the patients (we know of at least two) who are taking legal action against the 'whistle-blower's' poor practice.
This has been in the national and local media recently and, in our opinion, is of far more concern to patient safety.
We think it is clear that despite this case being investigated internally, externally and reviewed by the Trust Development Authority and Care Quality Commission, despite the confessed non-standard prescribing ceasing, despite the evidence of no significant harm that the whistle-blower refuses to accept the finding of all these bodies and continues to pursue this, having exhausted all appropriate professional channels, now via the Press.
This is highly damaging for patients. The whistle-blower is clearly not acting in the best interests of the patients or the NHS, as the practice ceased six years ago, but instead he is pursuing his own agenda."