All treatment and trials must have informed consentBMJ 1997; 314 doi: https://doi.org/10.1136/bmj.314.7087.1134a (Published 12 April 1997) Cite this as: BMJ 1997;314:1134
In 1987 I was diagnosed with late stage cervical cancer–despite three negative smears that year and numerous visits to the doctor. I was told that I was having radiotherapy. I asked many questions, and my consultant explained the treatment as though it was a tried and trusted method, established for years. Eventually I was given the “all clear” and resumed my career. Six months later I returned to the hospital with severe faecal incontinence. I was advised that I might have radiotherapy damage and that I was “unlucky.” I was then referred to a bowel specialist. He gave me unstinting support and inexhaustible, honest explanations. I never saw my radiotherapist again.
I was shocked to realise that I had not been informed of any risks before I consented to what turned out to be experimental treatment, only tested on mouse tails. I was admitted for a temporary colostomy and to have my rectum rebuilt. I met other women with radiotherapy injuries on the ward, and we had all been led to believe that we were unique. I was admitted over 100 times and had 24 operations, for adhesion attacks, a hernia operation, a permanent colostomy and urostomy, an operation to remove compacted faeces, formation then removal of both a rebuilt rectum and a mucus fistula, thrombosis, and so on. At present I have a vaginal fistula which intermittently allows faeces to escape through my vagina.
The repeated line of defence to patients who ask for explanations is: “Your injuries are a one off.” A group of damaged patients joined together for mutual support and to prove otherwise. We called ourselves RAGE (Radiotherapy Action Group Exposure). A similar group of patients with breast cancer started in the south of England, so those of us in the north were called RAGE National.
We discovered that we had been guinea pigs in a clinical trial of a new radiotherapy protocol. We felt totally betrayed. We trusted the doctors, yet none of us had given our written consent even to treatment (only to the anaesthetic), and we were not given details about possible complications. An investigative journalist found out that we had been involved in trials without our knowledge. We could hardly believe him: this was Britain in the 1980s, not Hitler's Germany.
The more we discovered, the worse it became. Hundreds of women had been involved in clinical trials of radiotherapy to the pelvic area, and the morbidity rate rose to 57% in 1982. This was five years before I was treated: had nothing been learnt from earlier trials? Worse still, there was an almost complication free alternative, still being used, but no one gave us a choice.
Most women had no idea that their treatment was so toxic when they consented; not one of the women I have spoken to was told she was in a clinical trial; many have attended the hospital since for corrective or even life saving surgery. When a friend with early stage cervical cancer died from her treatment, not the cancer (which could have been cured by hysterectomy), we decided to go public and allow our names and photos to be published. Women are angry that others are still not being informed.
Women have tried to commit suicide as their lives have been ruined. Few have been offered counselling, marriages have broken, careers ended, children fostered. Many women cannot have intercourse. Some have developed social phobias, some are housebound through agonising pain and incontinence. RAGE has members from each year of the trials, all receiving different treatment schedules.
A RAGE member wrote: “Somewhere, somehow, I have to expose this abuse of power. The doctors never got my informed consent. This is abuse of society's most vulnerable people. Where is there a platform for my voice to be heard, to make the public aware and the establishment accountable?” Some women only wanted an apology, or more understanding, or psychological support. More than compensation, patients want to protect future generations by ensuring that they are fully informed and do not suffer. Some consultants have shown humanity, by sharing information and giving examples of better practice: despite NHS pressures they have not lost sight of compassion.
Attitudes are slowly changing. Patients now expect to be told the details of the treatment proposed, together with side effects and complications. It is the doctor's duty to state the facts, whether or not they are painful. Reading the Helsinki Declaration, I was troubled to think that clinicians today may even believe that sometimes there is no need for informed consent. We are living proof that nothing should be assumed. Protocols for the trials we were involved in were not even submitted to the local research ethics committee.
Our experience with RAGE tells us that patients are still not involved in their treatment decisions. Clinicians should understand that with new technology, patients can actively access information. If doctors do not provide this information some patients will obtain it anyway. Patients phone us saying that they have read the cancer charity leaflets and spoken to their consultants; now they want “the truth.” Patients want to talk to real patients, not those who purport to represent them, and current literature is not specific enough on toxicity. We have found that with careful questioning one can usually provide the level of information each individual wants to receive.
Many people are too shocked at the time of diagnosis to take in details about any treatment proposed. Consent to treatment or research should be sought later, at a second multidisciplinary consultation where the patient is accompanied by a relative or friend. Participants in trials should have easy access to the results of those trials, as a condition of partnership. Joint ownership of the work being done keeps patients involved, instead of isolating them. Psychological morbidity is as significant as physical morbidity; this too goes unrecognised and untreated.
There must be clinicians who genuinely want to learn about the patient's perspective, who are brave enough to accept constructive criticism. When scientists have academic arguments about clinical research they should remember that they are dealing with people's lives. We have feelings and opinions. We don't want to be just another statistic: we're real, we exist, and it is our bodies that you are experimenting with.
RAGE National, 24 Lockett Gardens, Trinity, Salford, Manchester M3 6BJ (tel: 0161 839 2927).