Health: Medical Innovation

Lord Saatchi Excerpts

Wednesday 16th January 2013 Lords Chamber

Asked By

[Lord Saatchi]

To ask Her Majesty’s Government what steps it proposes to take to encourage best practice in medical innovation.

[Lord Saatchi]

My Lords, I express my gratitude to the usual channels for allowing the time for this debate. I have introduced the Medical Innovation Bill into your Lordships’ House. I will not be covering the details of that Bill in this debate; Second Reading will follow at some point in the year and we can discuss them then. However, this debate may illuminate the context of the Bill and give your Lordships’ House an opportunity to consider the whole complex question of what best practice is in innovation, particularly the application of research and knowledge to patient treatment.

In opening this debate among the judicial and medical experts in your Lordships’ House who have devoted a lifetime to this subject—compared to my own brutally short experience—a certain humility is appropriate. It will be my privilege to hear many noble Lords who are among the great innovators of our time. I particularly thank my noble friend and his team at the Department of Health for their wisdom; Dame Sally Davies, the Chief Medical Officer, for her viewpoint; the Secretary of State himself for making improved survival rates his key priority for healthcare; and the many patient groups, academics and practitioners who have contributed their thinking.

The Prime Minister himself has encouraged British medical innovation in the context of the global race, and the document on diffusion of innovation in the NHS by my noble friend, himself Minister for innovation, is, if he will allow me to say so, a model of agenda-setting by a government department.

Buoyed up by Bertrand Russell’s view that simplification is not always obfuscation and often serves to crystallise the issues, I will attempt first a simple description of the need, and then a specific suggestion of what steps your Lordships may consider to meet that need. I will concentrate on the most emotive word in the English language—cancer—and hope to draw wider conclusions from this area. To express the need, I am helped by an unexpected source, the Father of the House in another place. In his tribute to Her Majesty the Queen on the occasion of her Diamond Jubilee, he used a striking phrase:

“There is nothing more inspiriting in the whole world than a beautiful woman”.—[Official Report, 07/3/12; col. 852.]

I can amend that. There is no more distressing thing in the whole world than a beautiful woman being reduced to a sparrow.

Unfortunately, here is the status quo. A woman is told that her tests are “normal” and to come back in 12 months. She is removed from her home 12 months later and cut and drilled until she loses half her body weight. Wires and tubes are attached to her throat, nose, stomach and vagina. Drugs are given to her that cause nausea, vomiting, diarrhoea and fatigue. They open the path for fatal infections to enter the woman’s body and reduce her body’s defences against such infection. The woman is left for dead, and sooner or later the woman dies. The “process”, as it is called, involves scenes that would not be permitted in a Hollywood horror movie.

I hope that that is a fair description of the need for medical innovation. The screening techniques for such a cancer are inadequate; no reliable early detection method is available, and even if it was, it would improve the overall survival statistics but not the date of death. The treatment regimes, when provided—that is, the drugs, the cycles of their administration and the surgical procedures—are 40 years old. They are also ineffective; cancer quickly develops resistance. Not surprisingly, the survival rate for such cancers is the same as it was 40 years ago—in other words, nought; and the mortality rate is the same as it was 40 years ago—that is, 100%.

This disease is relentless, remorseless and merciless. Its treatment is medieval, degrading and ineffective. Why are we so forsaken? It is said that cancer is so complex that it is beyond the judgment and understanding of the human mind to comprehend its variables. Therefore, through ignorance, we kill people unnecessarily.

If that is true, it is not through lack of trying. Scholars in cancer have long sought general rules about the world as robust as the laws of physics and to verify statements, propositions and putative facts by the results of empirical studies. Unfortunately, it has not worked out quite like that. Instead, we find the stubborn fact that, after 2000 years of human progress, cancer is still outside Newton’s universe where physical laws govern reality.

In the natural sciences, even though, as Popper says, the closest approach to proof is just a succession of unsuccessful attempts at falsification, we can nevertheless make statements in the natural sciences, perhaps without finality but with a certain degree of probability. If I drop these papers, they will fall to the ground. Tomorrow the sun will rise. In cancer, though, the record seems to show that once we express opinions or beliefs or attempt to offer explanations, descriptions or predictions, then error, doubt and uncertainty come to the fore. In cancer you hear it said that, “Every case is different” and, “There is always hope”. Such well meaning sentiments are not science. There is no hope that if I drop my papers they will not fall. These statements are meant to bring cheer to the desperate, but instead the effect is the opposite. They bring despair—the dread revelation that cancer is a realm in which science has yet to achieve sovereignty.

In the end, all attempts to place cancer medicine within the canons of scientific objectivity have failed. There remains an irremediable tentativeness about the logically perplexing question of what is the cause or cure for cancer. Cancer science has not yet found its Newton. Why? There is a powerful deterrent to innovation at the heart of the current system. Economists would call it a systemic failure. Current law is a barrier to progress in curing cancer. Under present law, any deviation by a doctor from standard procedure is likely to result in a verdict of guilt for medical negligence. Current law defines medical negligence as deviation from standard procedure. As innovation is deviation, though, non-deviation is non-innovation. In this way, the fear of litigation for medical negligence is a roadblock to innovation in cancer treatment. The present pre-eminence in law of the standard procedure provides no inducement to progress. The self-interest of medical practitioners, as defined, for example, in doctors’ insurance policies, means that innovation—that is, deviation—is a form of self-harm.

In Clark v MacLennan, an important test case in 1983, the significance of departing from an approved mode of practice was treated by the trial judge, J Pain, as having the effect of reversing the burden of proof, so that once the plaintiff established a deviation the defendant had to disprove an inference of negligence. I quote Crawford v Board of Governors of Charing Cross Hospital, 1953:

“The practitioner who treads the well-worn path will usually be safer, as far as concerns legal liability, than the one who adopts a newly discovered method of treatment”.

In the standard Butterworth text on medical negligence, the authors Nathan and Barrowclough expressed in 1957 the following view, still applicable today, concerning deviation from accepted modes of practice and the ethics of new treatment research and experimentation:

“Medical men cannot be permitted to experiment on patients (Slater v Baker and Stapleton) (1767) ... On the other hand the courts will not press this proposition to a point where it stifles initiative and discourages advances in techniques … a line must be drawn between the reckless experimentation with a new and comparatively untried remedy or technique, and the utilization of a new advance which carries with it unforeseen dangers and difficulties”.

I hope that we can agree with Lord Diplock, who was looking for a better balance to be struck between therapeutic innovation and therapeutic conservatism. He warned of the dangers of so-called defensive medicine:

“Those members of the public who seek medical or surgical aid would be badly served by the adoption of any legal principle that would confine the doctor to some long-established, well-tried method of treatment only, although its past record of success might be small, if he wanted to be confident that he would not run the risk of being held liable in negligence simply because he tried some more modern treatment, and by some unavoidable mischance it failed to heal but did some harm to the patient. This would encourage ‘defensive medicine’”—

that is his phrase—

“with a vengeance”.

I am looking carefully at the time and will therefore bring these remarks to a close. Your Lordships will agree that optimal care is evidence-based care. Evidence-based medicine is therefore standard procedure for the protection of patients. However, as your Lordships are well aware, cancer is the least evidence-based disease of all. There is great uncertainty: either the evidence does not exist or, if it does, it is not clear what it means. Innovation is therefore more appropriate in cancer treatment and the consequences of not innovating are greater—poor life quality, followed by death.

I shall end with this. What can your Lordships’ House do—that is the point of this debate—to encourage the drive towards medical innovation, on which my noble friend has made such a great contribution? The advance of science depends upon the free competition of thought and thus upon freedom; that must come to an end if freedom is destroyed. Are the intellectual problems of cancer insoluble? I do not think so. What is more inspiring, apart from a beautiful woman, than the quest by scientists to explain the world; to find satisfactory explanatory theories—simple theories—and to test them? One of them will cure cancer. We should rise to our feet to applaud the great cancer doctors and scientists, many of them in this House, who are striving by their own best lights to serve the community. Let us erect statues in their honour or build bridges in their name, or parks, or avenues, or airports. Let us encourage them, not frighten them.