Good afternoon, everyone. I warmly welcome you to the ninth meeting in 2008 of the Public Petitions Committee. First, I have some domestic advice. Please ensure that all mobile phones and other electronic devices are switched off. We have received apologies from the convener of the committee, Frank McAveety, who has another engagement, and from Nigel Don.
Thank you for inviting us back to discuss our petition and for your good wishes. I know that Michael would have been extremely proud and delighted that the committee and the Scottish Parliament are taking the petition so seriously.
Thank you. Does George Darroch want to say a few words?
No, I am happy to try to answer questions.
Likewise, convener.
Other MSPs with an interest in the case are present, and they may have some questions later.
Thank you very much for that helpful opening statement, which leads to my first question. You said that you feel that the clinician was happy to prescribe cetuximab. Would you argue that clinicians do not have the freedom to prescribe the drugs that they want to prescribe to patients?
Yes, I think that that is the case. Our clinician wrote to the head pharmacist in September, requesting that Michael be prescribed cetuximab and giving extra data regarding the drug. He received a letter in October, saying that his letter had been passed on to one of the other pharmacists for a decision. That makes us wonder whether they knew about the exceptional circumstances procedure in NHS Grampian. The information that we eventually received from NHS Grampian stated that a clinician had to fill in a form. Why did that not happen in September? Why did we have to wait to find out about the exceptional circumstances procedure? We are not sure whether NHS Grampian knew the proper procedure for exceptional circumstances. Certainly, the clinician was not given the opportunity to prescribe cetuximab—that was not at his discretion at all.
You are saying that, in writing the letter, the clinician was making the case for exceptional circumstances but perhaps did not complete the proper paperwork.
Yes. The letter does not mention exceptional circumstances. Nevertheless, our clinician was willing to prescribe cetuximab. On a number of occasions, he stated to us both in writing and verbally that he was more than willing to give Michael the drug. He mentions Michael's quality of life in the letter.
So the clinician made it quite clear to you that the drug was of benefit to Michael and should be prescribed.
Yes.
Do you think that a lack of clarity and guidance caused the misunderstanding and the problems in Michael's case?
Yes, I do. In the past, there had been only two cases of exceptional circumstances in NHS Grampian. I do not think that the process in NHS Grampian was transparent, as we had to find out for ourselves about exceptional circumstances.
No information was given to you—you had to seek out the information.
We had to seek it out and, eventually, at a meeting, I had to ask, "What do you mean by ‘exceptional'?" George Darroch was with me. At that time, they could not tell me. They later looked into the clinical side of things, but at the time they were not sure. Eventually, we received papers regarding exceptional circumstances and what would happen but, originally, when we asked about the procedures, we were not told them—we had to wait for them.
As Tina McGeever has said, it took determination and effort to find out the information. Generally, we would like information to be made available at an early stage when somebody is diagnosed with terminal cancer. We also contend that the information should be supplied in hard copy—on paper—as not everybody has access to the websites. There are those of us who are not very nimble in negotiating websites, so it is essential that the information is made available early.
In case there is any doubt about this, I add that, although some of our examples arise from our experience with NHS Grampian, we looked for information, for example about exceptional circumstances procedures, across health boards more widely. We found the same pattern throughout Scotland. Wherever people are in Scotland, they will face the same difficulties that Mike and Tina faced in trying to find out what happens next and what the procedures are. There is a national problem, not just a problem in Grampian.
The Scottish medicines consortium admits that there is a lack of useful data on hospital prescribing. We know about Michael's case through the witnesses' incredible efforts, but we do not know precisely how many other people are or have been in the situation that he was in. Mr Darroch mentioned 400 people. Do you have further comments on the lack of useful data?
In a previous life, I was a director of social work and I was much involved in negotiations and joint work with health authorities. At that time—it is not yesterday—a great deal of money was being spent on improving data collection systems in health authorities throughout Scotland, but we are no further forward. When I left social work more than 10 years ago, colleagues in health authorities were working hard to secure consistent systems throughout the country—never mind more sophisticated processes. Although there was very much a will on the part of health bodies to introduce proper data collection, there seemed to be small power bases in health authorities that were reluctant to make progress, for different reasons. I fear that that is why we are no further forward. It is a bit like the blindfolded leading the blind, but the trouble is that in this context the blind are seriously, and sometimes terminally, ill.
The SMC needs to bang a few heads together.
Yes, but millions of pounds have been spent on improving information technology and data collection in the health service over more than a decade, as I said, so I suspect that someone else might have to bang the heads together.
Thank you for your earlier comments. You have addressed questions that I intended to ask about the exceptional circumstances in your situation. As you have said clearly, and as other witnesses have indicated, there are no nationwide guidelines on exceptional circumstances procedure and how it should be initiated. I take it that you are calling for a more national approach.
Absolutely. As George Darroch said, it is not acceptable—I know that that is an emotive term—that someone who has been told that they are going to die should have to find ways and means of funding or getting a drug. Michael spoke about having to appear before 10 people in order to find out whether he would get the drug that he needed. George Darroch will say more about the process for determining exceptional circumstances, but I think that it is not acceptable. I know that every health authority is different, but there must be some standardisation of procedure across authorities. For the sake of the patient, who, I assume, is the most important person in the process, they must look into the matter.
When we gave evidence to the committee in January, we had little information about exceptional circumstances, because our experience was confined to NHS Grampian, which had dealt with two cases prior to Michael's. Since then, the issue has become clearer. Reg McKay alluded to the work of a woman called Kate Spall, who lives near London. Apparently, her mother was in circumstances similar to Michael's, except that she had terminal cancer of the kidney. A drug for the condition had been developed, but the National Institute for Health and Clinical Excellence had not approved it for use in the NHS. Clinical evidence suggested that the drug was capable of extending the life of a terminally ill kidney cancer patient by two to four years.
If my memory serves me right, previous evidence that we have received in our inquiry has put a lot of emphasis on the importance of clinical judgment, which I think is absolutely right. I think that NHS Grampian said that patients were under no compulsion to appear in front of the exceptional circumstances committee, as the clinician or oncologist will often do that without the patient. I know that Michael wanted to appear in front of that panel, stressful though that obviously was—
The feedback from those who have appeared before such panels indicates their determination to be involved in a process in which decisions are made about their life. Apparently, Kate Spall ensures that people have access to feedback from others when she is trying to prepare them for the difficult experience of taking part in the hearing. It appears that the majority of people decide to go through with that.
The point is that we should not need a Kate Spall to take people through exceptional circumstances hearings. I applaud her, but we should not need someone like that. The process should be clear and transparent. It should be easy for someone who is terminally ill to choose, as George Darroch said, whether they want to attend the hearing. In our case, if we had not attended the hearing, we would not have known what we were talking about if we had to appeal. The process needs to be made as transparent as possible.
We are looking for consistency and clarity.
Absolutely. I also think that the term "exceptional" is abhorrent. It is a terrible term.
I should add that Michael had to request to be allowed to attend the exceptional circumstances hearing. He simultaneously requested that he be allowed to be involved in the decision-making process at the end, not so that he could make any contribution but so that he could witness the decision-making process in operation. However, that was refused. The health board was prepared to be transparent to a degree, but then the line was drawn. Michael really wanted to attend that bit so that he could understand why the decision was yes or no.
I can understand where you are coming from. Clearly, there will always be situations in which difficult decisions need to be made, but the issue is how that difficult decision is arrived at. If a patient is ultimately told no, that will clearly be devastating, but the patient probably requires to know that a clear and transparent process has been gone through.
I think that Robin Harper has another question.
This question follows on from previous questions. When a patient—I will put this in general terms—is told that the required drug treatment will not be publicly funded, he or she obviously needs to consider other avenues. What do you think a patient's expectations are at that point?
Talking from personal experience, I should say that we were aware of cetuximab from the outset because Michael had been part of the clinical trial for the drug. Therefore, our case might be slightly different.
After Mike and Tina took action to bring the issue with NHS Grampian before the Public Petitions Committee, I had the honour of writing a feature on Mike's situation for the Daily Record. More than with anything I have ever written before—I write controversial crime books—ordinary people went out of their way to share with me their life experiences of similar situations to the one that Mike Gray had to go through. None of those people knew about exceptional cases, and none was told about other drug options and so on. I am talking about people with close relatives who had died mainly, but not solely, as a result of cancers. It seemed to me that they sought me out to say that the fight that Mike and Tina had taken on and the confrontation that they had to face in having to go through the exceptional cases procedure was news to them. They would love to have had the same dilemma—for people to have been asked how they were feeling and whether they could cope, albeit that they may have faced the horror of being told that a drug that could give extra life would not be given.
We expected to get proper information from the start. All the appropriate information should be made available to a person from the moment they are told that their illness is terminal. That is one of the problems. I sometimes worry that people judge who or what type of person a person is from the outset, when they are told that their illness is terminal and what to expect. We knew that a drug existed and was available when we were told that Mike's treatment was not working, but someone who goes to another clinician might not be told about such drugs—they might simply be told that their treatment is not working. Perhaps no other drugs will be mentioned, and the person might not know where they can find out information about them. The issue is difficult, but all the options are not made clear from the outset to terminally ill people. People need to be clear about what options exist. Even if patients or their families do not take things in at the beginning, they need to know what is available. The drug in question was licensed and we knew about it. That is the only reason that we were able to proceed.
Michael was propelled to considering private care because of the position he was in. Tina talked about private and public treatment. The NHS told Michael, "I'm sorry, but there's nothing else we can do for you," but there was something that could be done, although it would cost him. Michael was a very principled individual, and Tina had a very difficult job persuading him to go down the private and public treatment route. He had two main concerns, one of which was the cost. Tina threatened to sell the house and so on, but Michael said, "You can't possibly live in a council house"—he was a son of the manse. It was obvious that he had principles, but he was eventually convinced by us that the private and public treatment route was the route that he had to go down to extend his life. Having decided to do so, he was immediately penalised because the treatment that he received when he was having chemotherapy at the expense of the NHS ceased to be delivered by it. Michael and Tina then had the entire expenses to pay. The drug in question was very cheap, according to the medical director of NHS Grampian, Dr Dijkhuizen. He told the committee that it was relatively inexpensive, but the costs of the overheads became unbearable. In a sense, the current arrangements make it impossible for somebody to benefit from a mixture of private and public treatment; worse than that, it is a violation of article 2 of the consultant contract to enter into anything that even borders on private and public treatment.
So, when that decision was taken, no further support was available. That was it, and you were told that you were on your own.
Do you mean when we were told that there was no other treatment on the NHS?
Yes. Was there no further advice?
The advice from the oncologist was that there was a drug called cetuximab. As I said, it was a matter of research on my part. I went back to the internet and discovered that it was the drug that was being trialled at Aberdeen, in Grampian and throughout the country for people with advanced bowel cancer, so we looked into it. The only advice that we received was when we asked our oncologist for his advice on whether Michael should take the drug. He said that he was happy to prescribe it, but there was nothing else.
Mike had three treatments of cetuximab, which proved that it worked for him. Ironically, once he won the case at the exceptional circumstances committee, NHS Grampian decided to keep delivering cetuximab to him in the way that he had received it in private service because it worked out cheaper than delivering it to him in the way in which the NHS would have insisted on doing.
You mentioned that cetuximab was being trialled in Aberdeen. Was it possible for Michael to get on that trial?
He was on the trial, but it had three strands because it was a comparative study. His name went into a computer and he did not get cetuximab at the beginning; he had another treatment—continuous chemotherapy—because the different types of treatment were being compared with cetuximab for people with advanced bowel cancer. Cetuximab was being given; it is just that Michael did not get it. That is why I knew about it. It is the only reason that Michael was asked whether he would be willing to take part in the trial, and he said yes. I remember the drug being mentioned and then our oncologist mentioned it again later. That is when I went back on to the internet and discovered that it was being trialled at the hospital.
You say that you were aware of cetuximab before. To clarify, did Michael's oncologist say that he could benefit from its use?
In the letter to Mr Downie, our oncologist talks about Michael's relative quality of life and new data; in other e-mails, he said that he thought that Michael could benefit from cetuximab. I do not think that any clinician would say that a drug would make the patient better in such a case, nor would we have expected him to, but I assume that the fact that he was willing to prescribe it to Michael meant that he assumed that it could benefit him. However, I would never say "would"; I am sure that it is only possible to say that it could benefit a patient.
We were left wondering. We were confused that the letter was written to the pharmacist, because that was not the procedure. Therefore, we wondered whether the oncologist knew the procedure, or whether a procedure was followed. Once we had considered—with the chief executive, the oncologist and the medical director—the procedures for exceptional circumstances, the oncologist made the appropriate application, requesting a meeting. The case was clinically impressive. So why, if he knew the procedures, did he then write to the pharmacist? That caused a delay that then had to be remedied. It was about four weeks before information came back to Michael and Tina to tell them that he would not get the treatment. We then had to go through the whole process again of making an application—a proper application this time. By then, we knew the procedures and we had been told what had to be done.
At what point were you told about the procedures?
We went to a meeting in early December. By that time, we had been told that Michael was not going to be prescribed the drug. We have yet to see the letter, or the minutes of the meeting, in which that was discussed. We have never seen the letter, so we are assuming that there is no letter. The only letter we have is one that says that information had been passed on.
We have spoken about public-private funding quite a lot. You have read the evidence that we received on public-private funding and the evidence that we received from the cabinet secretary on liabilities and responsibilities. I guess that you have worked your way through the whole system, so have you any suggestions on how such issues could be dealt with more easily?
I find it very difficult. I know Michael's principles and the way he thought, and I also know that the idea of public-private treatment is very difficult for people who cannot pay for it. The first problem that I saw was the creation of another tier. Some people will be able to pay to prove something, or to get a drug, but others will not be able to do so. That creates another tier. However, although I have mentioned principles, we did it anyway, because Michael was going to die.
We do not pretend that there is an easy answer. However, underpinning our petition was the right to life. We have to consider how life can be preserved and promoted, even when somebody is terminally ill with only a little time left. The right to life does not become diluted just because a person is terminally ill; it still has to be promoted.
It was unacceptable that we had to pay the NHS privately to prove that the drug was working. It is unacceptable for patients to have to find the money to prove that a drug works. That is the job of the NHS.
The oncologist, the SMC and the others involved knew fine well that three treatments with cetuximab could prove whether or not it worked for somebody. Surely that must come under the NHS's role in health assessment and its duty of care. The NHS buys in private services anyway under its duty of care and for health assessment. In this instance, it seems black or white: the drug is either approved or it is not. That applies to many other drugs, too.
I think that that concludes the questions from committee members, but I invite other colleagues to contribute.
Thank you very much, convener—I will try to be brief. I respect the fact that I am not a member of the committee, and other members have been following the matter much more closely.
Absolutely. I do not see why that could not happen. The information that Kate Spall gathered dealt with the reasons that influenced exceptional circumstances committees in coming to their decisions. Kate listed such things as the amount of research that had been done, the amount of information that people were able to present, the quality of the presentations, the threat of legal involvement, the threat of requests for a judicial inquiry and the amount of media exposure that it was possible for people to obtain to give their cases as high a profile as possible. When we discussed the matter this week, Tina McGeever and I were of the view that it was doubtful that Michael would have been given the drug but for Reg McKay's efforts.
Does it follow that, when push comes to shove, the cases that you have described are not actually exceptional? Such cases have been excluded in some way, but when the evidence is examined, one sees that they are not truly exceptional. If the statistics had been the other way round, with two cases approved out of the 52, and 50 rejected, the two cases would clearly have been exceptional. Tina McGeever touched on that point earlier. Do you think that the approved cases were exceptional, given the circumstances?
Mike Gray used to say that he was not exceptional; he was just one of many. If he had been alive to hear the figures that you have just shared with us, he would have had the proof that he needed. You should remember that, in every case down south, as well as in Mike's situation, the oncologist said that, from a medical perspective, the drug should be given. Therefore, in 51 out of the 53 cases that we now know of, the doctor would have been proved right.
A concern was introduced through the QALY system of measurement—the quality-adjusted life year. The health economist, Dr Walker, explained the system to the committee on 29 April. More emphasis is now being placed on cost effectiveness than on clinical judgment and the humanitarian aspect, because a tool has been discovered that can help economists to measure the cost of preserving life.
I thank the witnesses for their evidence, which has been compelling. As has been said, real challenges undoubtedly arise in trying to sort out the Scottish health system to address some of the big issues that you have flagged up. If we draw international comparisons, we find that progress on cancer is more effective in other places. The issue is a big one and we need to grapple with it. The evidence that you have provided supports the case for an overhaul of the system. Somebody who is terminally ill is not exceptional in the health service, so they should be treated as a standard patient and should get all the resources and interventions that they require. Nonetheless, we need to separate out short-term improvements that could be made to the service and not let our grappling with some of the complex issues, particularly on drugs, prevent us from moving ahead on those. There are changes every day in the performance of drugs and new drugs come on the market.
I just make the point that the issue is no longer about Michael Gray.
I have a final question. From reading the evidence that we have received and from your experiences, do you have anything to add about the processes? At the end of our inquiry, we must draw up a report, which will go to the Government and will influence health boards and other bodies. Are there any points that you think we should make? Are there measures that would make the system simpler or easier for people who find themselves in the same circumstances as you were in?
I do not know who it should be, but somebody, perhaps the clinician or another person, should have training, so that, from the outset, they understand all the procedures that are in place when somebody is told that they are terminally ill. Clinicians rightly think about the health of the person and how they can get them through something, but they must also think of that person as a human being. People who are not as eloquent as Michael was and who cannot speak up for themselves are the ones who need assistance. From the outset, when someone is told that they are terminally ill, procedures must be in place to give them easy access to information.
I thank the witnesses for their evidence. You have come through what seemed like a David and Goliath situation remarkably unscathed. Given the effort that you have put in, I am sure that the responses that you have received have given you a lot of satisfaction. On behalf of the committee, I thank each of you for coming to the Parliament and giving us your evidence in a clear, sincere and measured way. We appreciate that very much.
Thank you—we appreciate it very much.