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At the tender age of 31, I became a widower and had a heart attack, all within a month. I was in the Cardiac Care Unit of the local hospital for a week before returning home to finish my recovery. Apart from a weekly attendance at a recovery class where I managed to start rebuilding my fitness, it was a lonely time as I had no other family within a hundred miles and having only recently moved into the area in any case, I had very few friends locally either. Work, which had been fairly physical, was not an option for the time being. My employer had essentially laid me off in the short term as I was not fit enough to carry out my usual duties and he had nothing else I could do. At least I was on sick pay and with minimal out-goings, I could survive for the time being. I was considered unfit to drive and so my car was SORNed and cost me nothing. I was several weeks into my recovery when I received a phone call from my local surgery. Would I mind making an appointment to see my doctor. There was no crashing urgency but if I could call within the next week, it would be appreciated. This was a rather strange request but I could see no problems in doing so, so the following morning, I rang the surgery and asked for an appointment. Pressure on the doctor's time was such that I wasn't expecting a result for at least a week so I was extremely surprised when I was told that I had an appointment for that afternoon. Was that OK? I could see no reason why not and, in any case, I was now intrigued by the sudden availability of my doctor for a non-urgent situation so I said yes and after a light lunch, I couldn't be bothered to cook, I set out for the surgery. I booked in when I arrived and sat down in the waiting area surrounded, as is always the case, with a choice of weird lifestyle magazines or old fashion journals full of clothes you never actually saw on a woman in the street. Boredom then! Surprisingly, I having arrived rather early, the PA sounded almost immediately. "Peter Simpson to Room 5, please." More and more peculiar! Why the rush if it wasn't urgent? I walked down the corridor and knocked on the door of Room 5. It opened almost immediately and I was greeted by Dr. Glover, my usual GP. "Ah, Peter! Please do come in." Entering the room, which wasn't his usual consulting room but more like a sitting room with easy chairs and an occasional table I saw a woman sitting in one of the chairs. She rose, smiling, to greet me as I came in. "Peter, I would like you to meet Dr. Claire Maidley. She is a cardiac researcher at the University who has been working on ways to reduce the incidence of various heart problems. Now, as I'm sure you know, I can't give her sight of your medical records without your permission but she is a fully qualified physician and I'm asking you personally if you will allow her to see them. They will remain fully confidential to her in just the same way as they are to me." I could certainly do without the terrible pain and discomfort I had suffered recently and if this woman was working on preventative methods, I could see no reason why she shouldn't see my records. "I don't suppose there is any reason why she shouldn't see my records, Doctor. If you are saying it's OK then I'll go along with it." "Good! In that case I'll leave you with Claire for the time being while I get on with my other patients. I suspect it will take her about a week to go through them in detail but I know she'll have a few questions and explanations for you now. So if you deal with that now I'll get Reception to set up another meeting between you for what, Claire? A week's time?" "That should do, I think. Can we do it all in here?" "Yes. This room isn't used that much so I'll make sure it's reserved for you. I'll leave you now, Peter, if you would like to get to know Claire and deal with some preliminary questions and answers." "Peter! Please come and sit down with me so we can talk. As Dr Glover said, I'm researching into cardiac problems and I'm looking for volunteers to help me with this. Obviously I need to go through your records but I understand from him that you are now unavoidably single and have no close relatives. Am I right?" It was obviously still a very sore subject but I nodded to her in agreement. "You are 31, 5ft 8 tall and about 11 stone?" "Yes. I haven't weighed myself recently and I may have lost a bit of weight over the last month or two but that's about right." "Before we proceed, I need you to sign here and here agreeing to allow Dr Glover to release your records to me. Is that OK?" I signed without demur. Something of a mistake, or shall we say, an error as it turned out but I'll come to that later. "And may I take some blood samples and a DNA sample, please?" "I suppose so. I feel a bit like a pin-cushion after that week in the CCU but I suppose another one won't make any difference, will it!" I was stabbed in the arm while what seemed like vast quantities of blood were taken and finally the inside of my cheek was scraped for a sample of DNA. "I'm not sure what I shall be doing with you yet, Peter. I have a number of trials I need to carry out but it will depend on what I see in your DNA, bloods and records as to exactly what I have in mind but I hope by next week to have some idea. Are you happy to meet me here in a week's time so that we can start discussions in detail. I promise you that as soon as I know what I would like to do with you I will give you every bit of information you could possibly want and probably a lot more than that. I give you my word that there will be no secrets and Dr Glover will always be able to intervene on your behalf if he thinks anything is unacceptable." Given that assurance I couldn't see any reason to stop at this stage. "Yes, I'll see you then." "Fine! Any questions, or would you rather wait until I have more to go on. My answers at this stage are likely to be so vague that they would be more or less meaningless!" I left the questions for next week, which was also something of a mistake but I wasn't to know this at that moment. I left for home after confirming with the receptionist that I had an appointment. She confirmed that the room would be free for us and that in future, there would be no need to make a specific appointment as Dr Maidley would make all future arrangements directly with me. I walked home carefully to keep my heart rate down as much as possible and thinking that I might benefit as well as helping one or two future sufferers as well. .oOo. Apart from a confirmatory phone call on the Friday reminding me that I had an appointment the following Tuesday, nothing happened for the next week. There were no enquiries from Dr Glover or Dr Maidley and I just quietly existed for the next week. I ate, I slept, I read, I watched TV and I went for the occasional walk but basically it was just another boring week with no company. I was fast getting to the state where my appointment was something to look forward to as I would at least be talking to someone! Tuesday finally arrived and there was something to do, someone to see! For no other reason than I thought it might be appreciated, I washed my hair, shaved and put on a complete set of clean clothes. I made my way up to the surgery and arrived at least half an hour early. What to do? I had no reason to be over-keen so I wasn't sure if I should go for a short detour before going in. A car turned into the carpark and Dr Maidley stepped out. "Hello, Peter! Am I late?" "No doctor, I'm rather early, I'm afraid." She smiled. "No problem. There's no real timetable, It's just you and me so we can go straight in and start now if you like. I know the room will be free. Oh! And do please call me Claire. This isn't the usual sort of doctor patient contact, you know!" We walked in together with her waving to the receptionist as we went through. The room was indeed empty and so we sat down together and started. "Now then, Peter. I've been through your records in detail. In fact, I haven't done much else this week! I've clarified one or two things with your doctor and in combination with the results of your bloods and DNA, I can tell you that I certainly do want to work with you and I do have a particular route in mind, subject to us both being happy about it." "OK, er, Claire. I suppose my first question would be have you found anything about me that is life-threatening in any way. I mean, I know I've just had a heart attack and the results of that must be detectable but is there anything else you've found?" "Nothing, Peter. As far as I can tell, you are every bit as healthy, other than the heart damage we know about, as could be expected." The look of relief on my face must have been very obvious as she smiled and went on, "I can see you are happy about that, and why shouldn't you be!" She leaned forward and tapped on my record folder. "Now then, I have a question for you. I need you to think about your answer carefully before you say anything as this is very important. How familiar are you with your medical records? Do you think you know what should be in them and is there anything which you would want treated as taboo subjects? Please remember that I'm a doctor and confidentiality is extremely important to me. Anything you tell me and anything we discuss is strictly between the two of us and I will need your permission before I even talk to Dr Glover about any aspect of what we do. So! Take a few minutes to think back through your past life and then tell me what you think" I have to admit that I really only had the most general idea of what might be in there and I couldn't really think of anything that I would want off the table, so to speak. I continued thinking for several more minutes before I finally answered, "I don't think so, Claire. Shall we just assume it's open season for the time being and if I find out something later we can sort of switch it off?" "If you're happy with that then yes, we can work that way for the moment. However, if we start your trial then it may be too late to turn back, so you really do need to be sure." I shrugged. What else could I do, other than ask to read through my records, most of which I was certain I wouldn't understand! "Then let's start by me telling you about the trial I have in mind for you. I'll try to keep it at a level you can understand but if I stray too far towards the scientific, tell me and I'll try again! I'm sure you'll understand that I'm really not trying to belittle you in any way. It's just important to both of us that you know what we are doing and why. OK?" I nodded and smiled a combination of agreement and understanding. "You have just had a heart attack. I'm not going to go into enormous detail about it. You've had it, to a great extent you are over it. It was a run of the mill job, nothing special, and it was quite typical of a male incident although virtually every one is unique in some way or another. You may have noticed that the CCU was full of men and not a woman in sight, and I have to tell you there is only one CCU, there isn't a separate one for women. Do you think this tells you anything about the incidence of heart attacks for men and women?" "I think I've heard from before sometime that many more men suffer them than women. Is this true?" "It is, and the difference is very striking indeed. This is where my work comes in. I have been working for several years to determine exactly what it is that either encourages the incidence in men or protects women." "I thought it was something to do with men's androgens, whatever they are?" "Testosterone and it's friends! It's certainly a major factor but it's been known for some time that there must be other factors at work as well and this is the area I've been looking at. I've now got to the stage where I think I've identified one route sufficiently well that I can do something to block it." "Doesn't this have to be checked out on a variety of laboratory animals first? I don't want to be a 'lab rat,' Claire." "The Law wouldn't allow you to be in any case, Peter. Don't worry about that side of it. It has all been done according to the book and I now have a license to carry out supervised human trials. I'll let you see it next meeting and you can take a copy to your solicitor for checking if you want to." That, at least, was re-assuring! If all the prior testing had been done properly then I probably wasn't in any danger. I would still have the license checked, though! "So! Would you like t hear about the trial I have in mind, Peter?" "Mm! Please tell me more about it." I sat back and listened. "Well, as I hinted at before, there is a major difference between men and women when it comes to heart disease. Women are by no means immune, of course, but the proportion of men to women displaying a problem is very one-sided. It's about double in numbers and women also seem to be less heavily affected as well" "What I have done is to search for those components other than the male and female sex hormones which might be a protection factor not found in men but present, perhaps at varying levels, in women. I think I have found at least one, which I call Factor 29. It's very rare indeed in men and yet usually present in women and seems to concentrate entirely within the heart tissues" "It's not a hormone like testosterone or oestrogen and it doesn't appear to be anything other than a natural material. I have never found it present in anyone who has had a heart attack, and that includes you incidentally, even though you aren't a woman, but it usually is present in as many women as I like to test." She grinned at me. "Have I managed to make it clear to you rather than blinding you with science?" "That seems perfectly clear. Factor, er, 29?" She nodded. "Factor 29 seems to seems to protect people from heart disease." "Possibly, but certainly not all heart disease, but at least it seems to protect from the usual causes of heart attacks." "Well I've already had a heart attack so what is my taking part in a trial going to prove?" "Good question! To put it simply, a combination of your personal situation and health history means that if, and I do stress really strongly if, there should be any side-effects from the trial, there will be few side-swipes elsewhere to deal with and we can concentrate on looking after you." I shot her a hard look and she looked me straight in the eye. "No trial is totally risk-free, Peter. You will be very closely observed during the trial and afterwards and also very heavily insured against any and all problems in the unlikely event that any problems occur at any time in the future. I need you to understand very clearly that this is the situation and that there is no pressure on you whatsoever not to do it. It will be entirely your choice and I will answer any questions you have as fully as I can and you have the right to get a second opinion from another doctor concerning any aspect of the trial at any time" "As to the point you made about already having had a heart attack, we know that there are certain chemicals that appear in the blood sometime prior to the actual attack and fade afterwards, so if you are given Factor 29 and we never see any signs of those chemicals afterwards, it will point towards you being protected from any future attacks." So it was worthwhile my doing the trial. "Apart from the trial license, there's a load of paperwork to sign and I'm quite happy for you to take your copies away and have them checked by your solicitor. What I suggest is that we finish up now and then you call me when you have got everything checked and you are satisfied about what I have in mind," She handed me her card. "And I'll arrange another meeting here. That's unless you have any questions now?" "I don't think so, Claire. Nothing comes to mind at the moment. Obviously I'll ring you if I come across anything in the paperwork." "Fine! You'll find a detailed test synopsis on top of this pile so hopefully you won't need to ask much after your solicitor has done his bit." "OK. By the way, what is the timescale on this trial?" "I don't want to rush you, Peter, but as soon as you are ready, we can start" .oOo. I read the test details as soon as I got home. It seemed reasonably straight-forward. I would go to the local private hospital where I would be given the medical examination to end them all! Every subject you could think of, short of the gynaecologist! I would be prodded, poked, sampled from every outlet - and then some - heart rate, blood pressure, you name it! If I was pronounced suitable then I would be given my own room, complete with PC, phone and TV where I would stay. After a day's rest, I would be given my trial injection and then monitored closely. I would have a semi- permanent blood sampler so that I didn?t need to keep on being stabbed anew. When Claire and her colleagues were satisfied that I was stable and that there were no short term adverse effects, I would be allowed home but would still be checked at a slowly decreasing rate for the effects of Factor 29 and for any possible longer term effects. Hey! I would also receive pretty generous and regular expenses payments, tax-free for as long as I had to be checked! Short of my solicitor coming up with something unacceptable I had decided at that point to go ahead. I rang for any appointment and was told I had one two days on. I started through the paperwork in general to see if it made any sense to me and I?ll admit to most of it being jargonese although what I could understand seemed to be perfectly reasonable. The license seemed to make it very clear that Claire and her team had government permission to carry out the trial, subject to this, that and the other, including my written and witnessed agreement. Two days later, I sat explaining to my solicitor that I wanted her to go through all the paperwork and make sure that I wasn?t being clinically mugged! She agreed to the work, which incidentally, would be paid for out of Claire?s trial funds, and told me she would be able to give me an answer in about a fortnight and would ring me to tell me when to come back for any discussion and, hopefully, her approval. I thought about what I had read quite a lot over the next two weeks but came up with nothing that overly worried me. Claire had been honest with me in saying that no trial was totally risk free, that was the nature of trials, but she seemed confident that I might, at best, have protection from future heart attacks and at worst, no change from my current situation! Finally the phone call came. Would I go in and see my solicitor again? I arrived at her office to find her smiling. A good sign, I thought! ?Good morning, Mr Simpson!? ?Hello! I must say I?m rather interested in whatever you have to say.? ?Having gone through the papers in detail, I really can?t see anything to worry about. I understood from our last meeting that Dr Maidley had explained the risks to you and as far as I can see, as long as you are prepared to accept them, totally voluntarily and without duress, which doesn?t appear to me to be the case? We both smiled. ?Then I can see no reason why you shouldn?t go ahead!? I thanked her and, after a few pleasantries, left for home with the bundle of papers. I was going ahead! .oOo. As soon as I was home, I got Claire?s card out and rang her with the news. ?Oh good! Are you free tomorrow at any time?? ?There?s nothing in my diary at the moment.? ?Then I?ll book the room at the surgery for 2 tomorrow afternoon if that?s OK, or would you rather I came to your house? It?s just as easy for me if you would prefer and it will save you the trip up to the surgery? ?Well, all the papers are here so come here by all means. I?ll expect you at about 2.? Having said that and put the phone down, I suddenly realised that I had better do a bit of cleaning up! I?m not a slob by any means but I have to admit that just recently, I had let things slide a bit as I had been in something of an unhappy mood for obvious reasons. Out with the duster and Hoover, make sure the washing-up is all done ? a pile of unwashed plates in the sink never gives a good impression ? and generally put away all those little bits and pieces which tend to accumulate when you don?t pay proper attention. It wasn?t that it was a woman visiting, just that my pride wouldn?t let me leave things untended and untidy! At almost exactly 2 the doorbell rang. Heavens! A punctual woman! I suppose that was actually a good sign as it suggested attention to detail, to me at least! ?Come in, Claire!? She stepped in and waited while I closed the door and led the way into the lounge. ?Please sit where you like. They?re all fairly comfortable? The usual pleasantries followed. You know the kind! Nice room, nice house, nice weather and so on before she started in earnest. ?If your solicitor is happy and you have no problems, Peter, there are, as you?ve seen, a number of papers to sign. We?ll go through each one, and if you are happy with them, I?ll get you to sign them.? It took nearly three hours with a break for a cup of tea each before the pile was down to one: my permission, which needed a witness. ?We have a Notary Public at the hospital, Peter. I suggest that you use him as your witness when you arrive to start the trial. Is that OK?? ?Sounds good to me.? ?Right! Well you have to sign in his presence so we?ll keep that sheet separate. Thank you for dealing with all the other boring stuff, but it has to be done!? ?Is that it then, Claire?? ?Just about. I have to lodge all these papers with the university solicitor but as soon as that?s done, we can start. What would be your reaction if I suggested next Wednesday, for example?? ?I?m not exactly the soul of activity at the moment, to be honest! Any day is as good as any other as far as I?m concerned so if you would like Wednesday that?s fine with me.? ?Right. I don?t know what arrangements you?ll have to make but you can expect to be with us for about a week to ten days. Will that cause any problems?? ?None as far as I know. What time do you want me there?? ?No need for you to arrange the trip, I?ll come and collect you at about 9.30 if that?s OK? All you?ll need to bring is your toothbrush, we?ll provide everything else.? She left shortly afterwards and I was left to think about what was in store for me the following week. I suspected my main problem would be boredom! Not much to do for the next week except make sure I had the house in order and nothing in the fridge which was going to die while I was away. I had a couple of internal security lights which might keep any potential burglars away although, to be honest, I didn?t live in a high crime area. .oOo. Wednesday seemed to take an age to arrive and even 9.30 seemed to keep me waiting! That was a bit funny as when the doorbell finally rang, I was in the middle of a cup of coffee and nearly dropped it in surprise! ?Come in, please, Claire. I?ll only be a minute. I just need to wash this cup up.? ?No! Please finish it. There?s no hurry. In fact, can I have one before we set out? I?ve been so busy this morning, I haven?t had my usual cuppa and I?m gasping!? We ended up having a fairly leisurely drink before setting out for the hospital. I picked up the three books I decided to bring with me to counter the expected boredom, checked to make sure all the doors and windows were properly closed and locked and locked the front door behind us. I?d told the neighbours that I expected to be away for up to a fortnight so there was nothing else I could really do except climb into Claire?s car and be driven off to the hospital. When we arrived, Claire led me through to an annex building which was apparently to be my home for the duration. Then the fun started. Fun? No not really! After signing my permission document in front of the Notary Public, who turned out to be a Staff Nurse, I was taken through into an empty ward with two beds in it as well as an armchair, two desks with chairs, one with a PC sitting on it and a flat-screen TV in the corner. It was hardly the Ritz but it was warm and dry and I thought it would do for a few days. After being asked to strip ? completely ? and put on one of those horrible patient gowns, I spent most of the rest of the day being weighed and measured in detail, having a number of electrodes an sensors stuck all over me and having a tapped catheter fitted on the back of my hand so that blood samples could be taken with as little inconvenience to me as possible. How nice! I really hadn?t realised just how thoroughly I was going to be monitored. The amount I drank would be measured and the amount I pee?d measured as well. Details of everything I ate would be recorded and I couldn?t even take a dump without that it being checked by someone. Poor soul! It was a good 24 hours into this before Claire and a nurse came along with my dose of Factor 29. ?This is it, Peter! We have enough baseline data on you now so it?s time for me to give you your dose. Now, are you absolutely sure you want to continue? There?s no duress and we won?t be cross with you or anything silly like that if you want to pull out.? She smiled as she said that. It really was up to me from this point on. I spent a few moment thinking about it again and came to my conclusion. ?Go ahead, Claire.? Decision made! ?Just a little prick in your arm, Peter. No worse than a flu jab. You may get a little bit of stiffness in this arm just as you do with most other injections,, but this is perfectly normal? She took my arm and gently ?stabbed? the needle in before pressing the plunger home. ?That?s it, Peter. All done!? Nothing happened, which I suppose was really what we were all expecting. My lights didn?t go out, There wasn?t any sort of funny feeling whatsoever. Well, that was a good start, anyway! ?Now, Peter, for your safety, a nurse will be staying with you for at least the next 24 hours on a ?just-in-case? basis. Obviously, we don?t expect there to be any problems, but we are very careful when it comes to trialist?s safety. Kelly here is a very experience Staff Nurse and she will be with you for the first shift and another nurse will replace her after 6 hours. There?s no need to have to entertain her as she has work to do at one of the desks but I?m sure she?ll be happy to have a chat if you want one? Well, to cut a long and extremely boring story short, nothing untoward happened whatsoever! I don?t know what I really thought I was expecting but after many blood tests and extensive examinations, I was ready, more than ready - I was bored stiff - to go home! ?The Factor 29 seems to have settled in nicely, Peter. We can?t find any physiological changes other than that it is still there so we think the critical time is well past and I can take you back home this afternoon? ?That?ll be a relief, Claire, I?m bored out of my skin!? ?I can understand that, but just remember how much is going into your bank account!? I hadn?t given it much though recently but a quick mental calculation brought a grin to my face. It really was going to be worth it! After all, with the follow up tests more money was still going to come rolling in. ?I?ll be round every two or three days to take a blood sample, Peter and I?ll always ring well before so you won?t need to do anything about ?being in? for me at an inconvenient time.? Returning home, I settled into something resembling a normal routine as well as getting used to the idea of being on my own. Claire started off coming three times a week and a couple of months later it was down to two and then one. .oOo. It was about 4 months later that I suddenly got a call from Claire. ?Peter! I?d like to see you as soon as possible! Will you be in all today? I?ll get there as soon as possible as I have some urgent news for you? ?I?m here all day. What?s the problem?? ?I?ll tell you as soon as I get there. I?m on my way!? What was the problem? I felt OK and there had been no indication of a problem from Claire at any time. I could only hope that she hadn?t suddenly detected cancer or a forthcoming heart attack or something. I suppose I just had to wait for her to arrive. It seemed as surprisingly short time before the doorbell rang and I let her in and led her to the sitting room. ?Peter, I?ll explain this as straightforwardly a I can. Although we have carried out a range of tests on your blood samples which have shown no changes, we obviously checked for the presence of Factor 29 in each one. After all that was the purpose of the trial!? ?And you?ve told me each time that it is still present.? ?It is, Peter. I set what we call a qualitative test, that is one that tells if Factor 29 is there or not, with a warning limit of 75 percent if it started to disappear. Well, every test has been positive and the limit alarm never went off so everything looked OK. Then this morning, a new technician made a mistake and did a quantitative test, that?s one that checks how much is there, instead.? ?The result she found has had me running round in circles all morning. We?ve done three things. We retained what I didn?t use with you and analysis this morning shows that it is at exactly the right concentration. We?ve repeated her test several times and then we?ve also done a quantitative test on each of your retained serum samples since you received your injection.? ?I have to tell you that you now have just over 3 times as much Factor 29 as I injected into you. When we checked the other samples we found a gradual increase in each one and so far, not signs whatsoever of a levelling off.? I sat there completely stunned for several minutes. Claire sat there saying nothing while I digested this information. ?Claire. Am I right in thinking my body is making more Factor 29? I mean, you didn?t make a mistake over the original amount, did you? ?No, we didn?t. As I said, that was the very first thing I checked. We didn?t expect Factor 29 to be degradable in any case so yes, you do appear to be manufacturing it internally.? I knew it was a total irrelevance, but I had to ask. ?I hope you are being very nice to your technician?? ?She was feeling bad. We had to have a disciplinary hearing where she received an official warning. After all, they are supposed to be very careful. However, we are, I hope, human and she also received a bonus cheque as she walked out of the office. She?ll be OK. But that?s not really the point at issue, is it?? ?I can?t see any point at the moment in moving you back into hospital. You aren?t suffering any adverse symptoms that we know of and the conclusion of a staff meeting this morning is that we see no other reasonable course of action at the moment than for you to carry on and we?ll monitor your blood quantitatively until we see a change in either you or the Factor 29 concentration? ?I suppose my next question has to be what effect is an increasing level of Factor 29 going to have on me, Claire?? ?It would be dishonest of me not to say that at this moment we just don?t know, Peter.? And it would be dishonest of me, dear reader, if I didn?t say that I know you do know. Don?t you! In the short term, nothing much changed except that Claire reported a steady increase in the amount of Factor 29 in my body. She showed me a graph of concentration against time and it was a steady march upwards. It was another couple of months before the first signs of what I assumed would be trouble, surfaced.