I guess so from a, a money point of view I know these drugs are hugely expensive and if we continue the NHS as we want it to continue, you know, any savings that can be made on these thousands and thousand of pounds into new breast cancer drugs and all sort of things, I think that’s only a good thing. And the less time you have to be on chemotherapy and go through this, because it is like putting your life on hold for six months and then it, you know, going back to work, how you’re going to feel afterwards, you know. So the less time you spend doing all of that I think would be fantastic.

The only information that I heard about clinical trials was bad information. And the few, about a year ago when all those boys had clinical trials* and they all went wrong and I know that they’re still fighting for compensation, trying to prove it with the drug companies, and I don’t agree anybody would ever be able to fight drug companies. They have too much money behind them. I knew that, but had I have known it was a foreign drug company and not my NHS research team, I wouldn’t have agreed. But I just thought that it was because I knew nothing about trials and it was put to me from an NHS hospital that it would be NHS. I don’t know why I thought that because I was totally ignorant about trials but I thought it would be done through my local hospital research.

*FOOTNOTE:Marie is referring to a Phase 1 trial at a commercial research unit based at Northwick Park Hospital in 2006 when 6 healthy volunteers became extremely ill. A copy of the Inquiry Report of this incident can be downloaded from the Department of Health website.

One of the challenges for trials, I think, is that it’s highly unlikely we’ll ever see dramatic results. it’s all about making improvements on the periphery. If the, you know, penicillin’s already been found. I don’t imagine, although I’m not a medical person, that there’s many more penicillins about, you know? So therefore if you’re going into a trial, you shouldn’t expect a eureka moment. it’s going to be improvements on the margins. And so your expectations should be placed like that accordingly, I think, really. I think some people get very nervous and concerned about trials sponsored by drug companies. Well, drug companies are set up to make money for their shareholders. I quite understand that. And so therefore the work they do will be about trying to find a therapy that is so good that they make a lot of money out of it. Nothing wrong with that, really, as long as they don’t take chances with wild cards that affects people’s health, on the hope that it might do something. Now that would be a fear of a lot of people. My view on that is that within the country you have sort of a very strong ethics governance and the risks of that happening are very, very low.

What I do think is important, though, for drug companies is if they do a trial and it doesn’t work, they publish that as well. Because you can learn as much about what doesn’t work than you can – I mean, that’s a trite phrase, but you can. And I think whilst it would be a heck of a disappointment for them, I think it’s just a civil duty to share that with everybody.

Well, yes, I mean I think more money does need to be put into research definitely. When you think of all the money that they waste on Trident and wars and all the rest of it. You know, I just think there’s so many more important things in life. And more money does need to be put – and, you know, they, they rely so much on the charitable organisations, Cancer Research and all the different charities – which are great and we need them, and that’s all right, because that also spreads the word to ordinary people about research, when they hear about what the charities are doing. But I still think it’s the government’s responsibility. And they have the access to the really big amounts of money.

What about drug company-funded trials? Do you have any worries about that?

Yes, I mean obviously, because they’re only interested in making money, as far as I’m concerned, which is okay, again, if they do get a breakthrough and, and, and come up with some really good treatment. But the trouble with them is that they put money into providing treatments for the same diseases. In other words, they just change, you know – for instance look at high blood pressure. There’s so many different treatments for high blood pressure, and, and we don’t need them all, do we? As far as I know we don’t need all of these different treatments, and they only go in for new treatments for the same disease because they can make more money out of it.

Some people worry about trials being funded by drug companies. Is that an issue for you or does it not worry you at all?

No, I don’t think there’s any way of avoiding that. I mean, the sums involved in developing a new drug are enormous, so the estimate is for every drug that succeeds – I mean you must know this better than I do – every drug that succeeds and makes it to market, the cost is something like half a billion pounds, depending a little bit.

So that’s an enormous cost which is paid by the drug company that develops the drug. And I suppose you could have government financing that, but as things are, without enormous restructuring of the way that medical services and medical research are funded, it’s unavoidable that drug companies must foot the bill.

I suppose the thing that I do worry about, that again is being tackled now in various ways, is the unfairness of allocation of resources. So there are drugs which are desperately needed to treat infectious disease in the third world, for instance, which could benefit enormous numbers of people, which, until recently, have not been developed because the rewards from developing drugs for poor people in poor countries are rather small, even though the benefit of the drug may be huge. But I think foundations like the Gates Foundation are beginning to remedy that problem by providing incentives for drug companies to develop those drugs.

I know that there is a great, shall we say, conspiracy theory [laughs] about big pharma, and up to a point I keep an open mind about this. It is big business. There are multi millions of pounds involved. And I don’t for one second begrudge the profits that the big pharmaceutical companies make, because I know how much it costs them to start new drugs. Whether they sometimes abuse the relationship they have with some medical practitioners, I’m in no position to judge or pass comment. I can see that it could happen.

Well, most trials, drug trials, are funded by the pharmaceutical industry, and I find that very worrying because they own the data then, and they can control the data. There was one rheumatoid arthritis drug called anakrina, for example, that we systematically reviewed, looked at the scientific evidence, and the drug company had suppressed some of the evidence. There were three trials that they used to get the drug licensed with about a thousand people in, which suggested it worked, and then after it was licensed for use there was a great big trial, bigger than the other three trials put together, a safety trial, in which they wouldn’t publish whether it worked or not, the efficacy data. In fact they claimed they hadn’t measured it, but we did have the protocol so we knew that wasn’t true. And it turned out, you know, they, they just suppressed that data. They claimed it hadn’t been measured. They said, Oh well, you couldn’t, this was a trial done in a different population. This was now done in a standard rheumatoid arthritis population instead of a highly selected population, and therefore it was too confounded to be usable But it was a randomised controlled trial, so the two groups were comparable. So my conclusion was that actually this didn’t work, if you use it in ordinary people, a drug that they were trying to promote for use in ordinary people. So yeah, the fact that trials are published by the pharmaceutical industry our defence has to be that the data is made public domain. But I, I think the government should be funding more trials. I think participation in research should be just built in to the health service, in such a way that it becomes very cheap and painless. You know, there’s not huge costs because part of the way we routinely collect data anyway.

What are the obstacles to that at the moment, do you think?

Research is not cheap. It costs. I mean, it isn’t cheap because it has to be done well. I think there’s absolutely no point doing research badly. I mean, I’ve seen people put together protocols and then cut down their sample size* calculations because it’s coming out at too costly. But I actually think what’s, you know, £2 million sounds like a lot of money, but if you’re preventing a lot of deaths it actually becomes quite trivial in terms of health costs. So no, I think it should be nationally funded, and I think it, more should be funded.

*FOOTNOTE’ The number needed for each trial (the sample size’) is proposed by statisticians doing power calculations. In some cases a small number of participants may be enough, but if you are looking for fairly small changes in outcome you will need large numbers of participants to pick these up reliably.

I think it’s desirable that people should know the results, I mean, that’s why we go into it. I personally feel worse, what’s worse, and is for a trial to come out and then not get published at all, you know, rather than the individuals being informed. And interestingly enough on the research ethics committee I’ve sat on and I’ve tried to bring up, They have no publication policy, they have no strategy for publishing this tria and being told that we’re not allowed to discuss that. Whereas I always think it ought to be built in that this data will be put into the public domain. I mean, I have a colleague who works in another country who was part of a multicentre trial for a major pharmaceutical company, and in the trial protocol it said results will be published within, I think it was 24 months of the close, after recruitment of the last patient. And they added into their, their centre, Should the results not have been published within 24 months of the closure of the trial, our centre reserves the right to publish the results for this centr, and they were excluded from the trial, because they insisted on that. They were told that could not be put in. Well, if they’re going to be published within 24 months, why could that not be put in? And so they refused to do the trial without that in. And they, and they – so that’s, that’s an insight. So who owns the data? I think the data ought to be owned by the people who are in the trial.

So I like the new strategies that are coming out, that data has to be put into the public domain and it should be a prerequisite, certainly for funding from government bodies. You know, if our government’s going to fund a trial, well, let’s have the results, and I – more than just the results, let’s have the data, suitably anonymised to protect patient confidentiality, in the public domain to be re-analysed, because even in the analysis there could be bias. So, I’m a great believer in transparency.

The trial that I was involved with lasted for three years and it’s finished now. And what happens is that all the data is collected. it’s anonymised, that’s to say none of us ever know who the individuals were. it’s just on numbers and averages. And that goes through an independent committee. And then the results are published, really.

Now, there are quite a lot of issues with all of that. Number one, it takes a long time for data to be published in a trial. And that’s one of my disappointments, if you like, that because people quite rightly are frightened to jump to early conclusions, they say, Oh, we’ve got to get all the data in before we publish Well, sometimes if you’ve got a three-year trial or a four-year trial, you might know after a year what’s really going on, but people very rarely publish it. And that then puts the people going into the trial at years two, three and maybe four at a disadvantage, because more is known about the likelihood of success than what they may be told. So I wish there were ways in which data could be more freely available. I think – and I’m not talking necessarily about my own experience – but I think one of the risks is, if you’ve got a group of people who are absolutely passionate about a trial for a therapy that might work, if in the early part it isn’t giving them what they expect, there was a very natural, understandable reluctance to publish that or to tell anybody. You just sort of keep on, Well, maybe this is a bit of a tweak. Maybe it will get better I feel almost guilty saying that, because that’s making them feel that they’re less than honest. they’re not. they’re just human. And I think it’s absolutely understandable. I could sort of take it back to my time in the bank. If we were trying to sell a particular – if my team, my colleagues were trying to sell a particular mortgage and it wasn’t selling, you wouldn’t sort of very often look back and say, Gosh, is the mortgage right You’d just try and keep selling it a bit harder and hope it would go through and ignore the customer complaints. You know, you’d set up a call centre. it’s human nature. You don’t do it out of nastiness. it’s just how it is.

FOOTNOTE’ Researchers are right to be cautious about jumping to conclusions too early in a trial. Large trials can take a long time to get enough people and enough data to draw reliable conclusions. However, sometimes results are so obvious that a trial has to be stopped early, either because the one of the treatments is strikingly better than the other, so it becomes unethical to withhold it, or because risks are revealed that are too great.