Where is the Patient in All of This?

There are few things that frustrate me more than the system. I have come to the conclusion that there is a system that effectively keeps patients dumbed down so that they become reliant on the system and those that keep “the system” going.

Clinical trials must be conducted if new treatments are going to be developed and made available to patients. For instance, if we consider rare diseases alone, there are over 7000 rare diseases, and more are being found all the time. There are treatments for only approximately two hundred of these rare diseases.

Most patients know very little about the world of medicine, drug development, clinical trials, and development of new medicines. Unfortunately, most patients will not be offered the opportunity to enter a clinical trial even if one is available for their disease.  Even if they do find their way into a clinical trial, most will be intimidated by the process. Few will question the physician investigator or the staff working for him or her. For instance, “What side effects might I expect to experience during this clinical trial?” “How will I know if I have experienced this side effect?” “What adverse effects have previous patients in early dose groups experienced?” are all good questions to ask.  

Despite tragedies from recent past, the “system” appears to be no more effective at empowering patients, judging by recent deaths in the NHS. Because I am from the United Kingdom, I take a particular interest in what happens there. I was dismayed when the events of the TeGenero debacle came to light. Healthy volunteers had entered a clinical trial at a Phase 1 unit at Northwick Park Hospital. All healthy volunteers who received the experimental drug nearly lost their lives.   As with other similar incidents involving clinical trials, they indicated, in my view correctly, that they were not adequately informed consented. Information that should have been made available to them, was not.

Clinical Trials, What Patients and Healthy Volunteers Need to Know was published by Oxford University Press in 2010, and quite quickly made available in the United Kingdom. It is troubling that when the book has been available in the United Kingdom for over two years, the uptake of the book by the very institutions (the NHS, hospitals, Trusts, Phase 1 units, clinical trial sites) that should be ensuring that they make it available to their patients has been in a word, dismal.

I once heard another consultant say that the best client is an ignorant client. I think this is a terrible way to do business. Given this premise, I sometimes wonder if “the system” believes that the best research subjects are the ignorant ones. They don’t ask questions because they don’t know which questions to ask. They can’t therefore challenge “the system”.  Let me give some examples of why I have began to wonder about this.

The book was written in the aftermath of the UK TeGenero incident. This type of book cannot be published by a normal publisher because they consider it too much of a niche market.  This means that for a work like Clinical Trials: What Patients and Healthy Volunteers Needs to Know, the system has to be behind the work for it to reach the very people it was written for.

Sadly, the very parts of “the system” that should exist to watch out for the research subject, patient and healthy volunteer, appear to be too much a part of it to be independent from it. There is nothing more disconcerting than to be told by a patient advocacy group or Foundation that exists to serve patients with a particular disease, and collects money for this purpose, that they cannot tell their patient groups about the book because they did not write it, and they therefore cannot be seen to endorse it.  I have come to the realization that for many of these organizations the disease and therefore the patient is the means by which they raise funds. The patient often gets lost in these efforts.

Getting back to the UK, numerous organizations exist to shore up various sectors of the NHS. Many of them claim to serve a purpose that should improve patient care. Naturally, they all have management teams with very impressive titles. Recently patients died in NHS hospitals that were found to be sorely wanting. I strongly believe that an empowered patient is a patient that will intelligently question the process and is more likely to remain uninjured as a result of incompetence and negligence.  Perhaps it is time for a re-look at the institutions that exist within “the system”. The question to ask about each one is who would lose if this organization were completely obliterated?

Many of the organizations that are funded by the NHS were developed to serve the patients, but most are failing in this respect judging by the recent evidence of patient deaths within “the system”. Patients must demand that all existing organizations within the NHS, and the individuals that work for them, are held to account. These individuals must ask themselves the question, “Where is the patient in all of this?”

Lorna Speid, Ph.D., is the author of Clinical Trials: What Patients and Healthy Volunteers Need to Know, published by OUP in July 2010.