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Barbara Clark

Motion made, and Question proposed, That this House do now adjourn.— [Mr. Roy.]

6.1 pm

Mr. Ian Liddell-Grainger (Bridgwater) (Con): I am privileged and enormously grateful for the chance to hold this short debate. The House has a precious half hour in which to talk about the plight of one of my constituents. That is important, because Parliament represents the highest court in the land, and today Barbara Clark has 30 minutes of our undivided attention. Let us hope that that 30 minutes will be enough, because the crux of this issue is time. Thirty minutes to hon. Members is like a flake of snow, but to Barbara Clark it is a precious bonus, an extension of life itself. She is watching and listening to us at the moment, hoping on our every word. I would do likewise if I were in her shoes, and I suspect that all hon. Members would.

Barbara's case has come to Parliament because her existence is under mortal threat. She will die if we do nothing, because she is sick with a disease that will certainly kill her unless we act decisively and quickly. I have brought her here to urge common sense and joined-up thinking to address a medical case that has huge implications for thousands of people in this country, particularly women. My constituent has breast cancer, but not an easily treatable form of the disease. The variety that she has contracted does not grow slowly. It gallops, taking over cells and multiplying. It is a frightening and violent insurgent that behaves unpredictably and unpleasantly. It attacks the next target—perhaps a lymph node—going on and on until ultimately it kills.

The bald arithmetic is terrifying. Around 40,000 people are diagnosed every year in the United Kingdom with some form of breast cancer. One in five of those cases—8,000 individuals like Barbara—have the aggressive form. It can be slowed down by existing tried and trusted medicine, but it is desperately hard to stop. This particular cancer contributes heavily to the annual death toll. There are 13,000 funerals every year in Britain because of breast cancer; 35 suffering souls succumb every single day.

We have only half an hour, so I will not waste a single second. The cancer in question has a name—HER2. That stands for human epidermal growth factor receptor 2, a protein. If one has the right amount in one's body, no problem. If, however, one produces too much of it, one may be HER2 positive and be more likely to produce and develop an aggressive cancer. Barbara is HER2 positive. She is also one of the most positive women I have ever met in my life. Her courage is outstanding. She has a total determination despite the disease, which, left to its own cruel devices, will inevitably rob her of life itself.

Barbara found a lump in her breast that grew with terrifying speed. Surgery was inevitable, and chemotherapy followed. The signs are that it has now spread to the lymph system. Her regime of treatment is uncomfortable in the extreme. When a human body is slowly drip-fed a cocktail of chemicals designed to wipe out the bad, the good is also likely to be damaged. Hair loss, nausea, memory lapses and lack of energy—
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chemotherapy is a medicinal sledgehammer. It can work well in lesser cancers, but has a far lower rate of success against Barbara's disease.

There is, however, one drug already on the market and in the national health armoury, which could very probably help Barbara right now. I am always wary of using the term "miracle drug". It is a phrase much over-used by tabloid newspapers to describe the latest developments and advances in the ongoing fight against all disease. Too often it is sloppy shorthand for something potentially good but totally untried and untested. Real miracles are, after all, extremely elusive.

However, Herceptin is different. This drug was deliberately designed to target and block the HER2 protein. It came out of an American laboratory in the late 1990s and has been used extensively ever since. Herceptin is already licensed and approved for prescription in the UK. Let me qualify that statement, if I may. Herceptin is already licensed and approved for some limited use in the UK, but in order to get Herceptin, one needs to be extremely sick.

The official guidelines from the National Institute for Health and Clinical Excellence state that patients must be on level 3-plus of their disease. I am not a doctor, but I am told that the calibration runs from one to 10. At level 10, treatment of any type is a waste of time, but at level 3 the disease will already be on its way. HER2, remember, moves like an express train. The official guidance states that patients must already have undergone two full courses of conventional chemotherapy or be able to show that they are ineligible for one of the main agents contained in conventional chemotherapy.

To cut a detailed story short, Herceptin has only been cleared for use with patients who have little hope of survival. It may sound alarmist to call the drug "a last resort", but that is how the national health service currently describes it. Unfortunately for Barbara, she is not quite level three, but it is only a matter of time—probably a short time. Herceptin could save her life now, but the guidelines seem to prevent doctors from acting.

Barbara Clark is not only brave and intelligent, but, having spent her career in nursing, she is not the sort of woman who will take "no" for an answer. She learned about Herceptin in the press and on the internet. If one types "Herceptin" into any of the main search engines, one encounters hundreds of different, highly favourable, worldwide references. When Barbara asked one of her consultants about Herceptin, however, she was greeted with a blank stare—the man had apparently never heard of it.

That should be an isolated horror story, but if clinicians stick to the letter of the NICE guidelines, there is no reason why they should know anything about the drug. We operate the most vigorous licensing regime in this country, and rightly so. The Medicines and Healthcare products Regulatory Agency is answerable to the Minister's Department, but it does its business through a slow system. There is nothing wrong with that in principle, and we have a valued reputation for the scrupulous examination of any new drug, but this is a matter of life and death.

The people who might benefit from Herceptin are not at all scared by small risks that might be associated with taking it. If I had a fast-moving HER2 cancer—yes; men
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can contract it, too—I would do precisely what Barbara Clark is doing. This is a moral issue, and the moral rights of the individual should not be muddled by rules which were set in good faith three years ago, but which are now woefully out of date. In stark truth, if an individual is doomed to die, the decision about the efficacy of any new treatment should be left to them, not a body of experts, however worthy.

In America, where this drug was first developed, the Food and Drugs Administration licensed Herceptin for advanced cancers when Herceptin first went on sale seven years ago. In America, Herceptin is still officially a drug for advanced cancer, but America, by bypassing its own regulations, has led the way in making it available for wider use, because its worth has been recognised.

Recent extensive American trials have indicated the value of Herceptin in early breast cancer treatment. Any drug that saves lives, inevitably saves money, and perhaps, in the end, the matter comes down to money. Barbara Clark has been told that she could obtain a private medical opinion tomorrow and be prescribed Herceptin at the going rate of £1,500 a dose, and she is now contemplating selling her house in Bridgwater just to buy the drug. That is understandable for Barbara, but completely dotty in terms of running a health service that prides itself on effective cancer care.

I do not denigrate the enormous effort that has been put into cancer care in recent years. There are now centres of excellence in many parts of the UK, and I single out the new Nottingham breast cancer clinic—I am sure that the Minister will do the same—as a shining example of diagnosis and treatment. In spite of many valuable advances, however, there are still pockets of—how can I put it?—"resistance". There are still consultants who have never heard of Herceptin; there are still health authorities and trusts that will not prescribe it, presumably because they think that they cannot afford it; and there are still dangerous gaps in the diagnostic process, too.

Barbara Clark may have been lucky. She was given an HER2 test, and I have been assured that only 28 per cent. of all breast cancer patients are routinely and progressively tested. Tests also have a monetary implication—each has a price tag of £50—but the price of failing to discover the disease surely has a much higher cost in turn to the NHS.

Many UK oncologists say that Herceptin can save lives. I asked for this debate in order to clarify some essential questions on behalf of one of my constituents. I do not wish to interrupt the existing licensing process. Licensing demands strict patient trials and a rigid timetable that may not help Barbara and others like her. Changing the licensing process would require legislation and more precious time, but I must point out the real possibility of finding legitimate ways around the existing licensing process. America's FDA is sometimes seen as even stricter than our own agency, yet Herceptin is now freely available for early breast cancer. Only last week, in Ontario, the Canadians found ways around their rule book. France and Germany have also made the drug available to a wider range of patients.
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When I took on Barbara's case, I wrote to Professor Mike Richards, the national cancer director. His reply, just received, seems to offer a glimmer of hope. He wrote this about Barbara:

I am heartened by those words. I believe that he is trying to find a way to get a good drug into wider use; I hope that I am right. I invite the Minister to confirm that interpretation so that many hundreds of other brave Barbara Clarks can hold out genuine hope that they will soon qualify to get this important treatment.

In government, as in life, money talks. The manufacturer, so I am informed, is keen to talk to the Government about reducing the unit cost if this drug can be given to a wider range of patients. Some of the hospital trusts may need a greater nudge from the centre. Barbara Clark could go to several NHS hospitals in London today, right now, and be prescribed the drug as a matter of routine. Where she lives—Somerset—clinicians are sticking rigidly to the NICE guidelines, which were written in early 2002, and have been overtaken by mounting evidence of the success of the drug worldwide.

Barbara Clark is a lady who is prepared to sell everything to save her life. Because of what she has done, she has helped to highlight a much wider issue. We cannot afford to ignore her tonight. This has been her debate, and she may not have very long to wait for the right answer.

6.17 pm

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