Informed Consent

When I was first diagnosed with my secondary breast cancer, my oncologist said that the disease was “treatable but not curable” and those words ring regularly in my head. It’s the neatest description of metastatic cancer that I know and I use the phrase to explain the disease myself every time I have to describe my health situation.

What this description also does is starkly outline the end point for anyone living with metastatic breast cancer… We die when there are no more treatment options left to keep the cancer in it’s box. This makes secondary breast cancer patients a fantastic advocacy group for the research and development of new drugs. We all want more treatment options because the number of drugs we have access to seems to define how long we can stay alive.

Of course this conveniently ignores the complications that come with the disease that we are living with and the difficulties that many of these drugs can cause us. One of the drugs that I currently take, Palbociclib, suppresses my blood cell counts, making my immune system weak and ineffective. Herceptin (not a drug that I take) causes heart problems. Most medication leaflets contain a lengthy list of risks and side-effects.

I have been living with this disease for four years and I remember being so tired that I had to stop and rest on my way across the room to use the toilet when my lungs were showing signs of disease progression as the medication I was taking came to the end of it’s usefulness for me. That “pleural effusion” had to be drained in order for my breathing to recover and without a change of medication I have no doubt that the fluid would have returned and continued to increase. I “consented” to the drain procedure and I “consented” to my new medication despite the extensive list of side-effects because my choice was between a drug that could help me live, or a slow uncomfortable death as my lungs became increasingly unable to supply my body with the oxygen it needs.

When a survey of patients involved in Phase 1 Clinical Trials reports that 70% of those patients assume that they will benefit from that trial, I think it’s important to contextualise those patients assumptions. If those patients are late stage cancer patients who have run out of treatment options (or have treatment options remaining that they are nervous of), a Phase 1 trial may offer them the only tool they have for buying more time to live. This patient cohort may also be particularly adept at seeking out silver linings and painting medications with “hope” and it’s likely that they will have had some experience of both the ill-effects of their disease AND the drugs that are used to treat it. It is also possible that they have become dislocated from a grounding of what “normal” health should feel like.

Current informed consent processes heap risk onto exactly this cohort of patients. Metastatic incurable patients are the patients responsible for bringing newly developed drugs into the public domain and making them available to future patients that will need them. Indeed, this is a process that many patients actively seek out involvement with because if you know you are going to die soon, one of the things you often want to do is to leave a positive legacy for the world that you are departing. For sick people, this can present a wonderful opportunity to reassert usefulness.

Although patients are integral to clinical trials and to the drug approval process, the only thing we are asking for in return are that drugs are in some way effective and that they are safe for the majority of people who will take them. In practical terms, the first step towards getting a drug approved for use by the people who need it is simply to ensure that it is safe to give to patients, the second step will then be to work out how to dose the drugs in order for them to have maximum effect on disease control and minimal effect on the patients quality of life. Perhaps as patients we could start to ask for more. Perhaps we could engage with our trial teams and clinicians and transform the consent process into something more reciprocal.

A big barrier to this sort of bargaining becoming a reality is that patients on clinical trials very rarely have any contact with each other, and have limited time with the professionals who are looking after them. There are also barriers to patients communicating with pharmaceutical companies on a one to one basis, and communication with researchers and laboratories is carefully controlled by process and procedure. While the pharmaceutical company developing a drug for a trial will have a team of professionals and experts finely combing through every detail of the paperwork that will accompany the trial process, the test subjects are individuals who are being guided by people they believe to have their best interests at heart.

Technology is beginning to shift things in this area however. Social media connects patients in ever more intimate ways and raises awareness of the power (and price) of data, wearable technologies collect data in less time-consuming ways and make clinical teams less reliant on the communication skills of their patients, while machine learning and A.I. push the boundaries of the optimisation work that can be done on a drug before it has to be tested in humans. Is it time that clinical trials began to take a look at their ethical frameworks as though they were engaging in field-work rather than laboratory research? Could working with “informants in an atmosphere of mutual trust and respect” (Mead, 1969, p. 371) perhaps spring-load cancer research to make some of the breakthroughs that society believes are on their way?

Beginning to develop some reciprocity in the process of informed consent could transform the pharmaceutical market. We could contemplate commitments to transparency, effective data collection, patient access to that data, and molecular or genetic testing that could equip patients with the means to make better choices about future treatments.

If patients learned to use their value within the drug development process as a bargaining tool we could demand that drugs reach the market with prices that are affordable for all.

Emma Robertson