Recent reports of possible advances in Parkinson’s treatment have brought to mind the importance of clinical trials as a means to scientifically test the benefit and risks of such treatment. Inevitably clinical trials need sufferers to take part, which has posted through my door a big moral dilemma: is my sense of duty towards the Parkinson’s community who will potentially benefit most from new treatments or towards myself as the preserver of my health? I do see that I might benefit from being in the clinical trial (assuming I’m not on the placebo) or from a positive outcome of the trial (assuming there is one) but the main issue for me is the safety of clinical trials.
Potential new treatments are experimental, that’s why they need to go through clinical trials, so therefore they carry a greater risk of the unknown; of course any treatment (but in particular drug treatment) has gone through extensive testing before it is accepted for use in humans. But the unknown risk is a stumbling block for me. I am a scientist you see (I have a DPhil in Genetics) and I simply cannot go into something without looking at the current state of knowledge in the scientific literature. I am lucky in that I have acquired the skills to understand the science and I know (because I’ve done it) that research also deals largely with unknowns. Again, I hear the objection, “if you don’t take part in clinical trials we will never know”.
For me it comes down to this: with the current state of my Parkinson’s being fairly tolerant of periods of good movement I have too much to lose if something went wrong and it is my sense of duty to myself to preserve my health for as long as possible that stops me from signing up. I imagine in the future when the extent of my decline shifts the emphasis to “I’ve got nothing left to lose” it will break down the barriers and I will be game for anything; inject me, probe me, scan me, break me, mend me! But, for now, I don’t want to risk the life I have at the moment; I want to enjoy it while it lasts. Is this selfish? Maybe. Understandable?
Your call, dr jonny. I don't think we have a moral duty to put our own lives in danger to potentially save the lives of others. - whether that's jumping in the rapids, giving up a kidney, or taking part in clinical trials. I think this is probably absolute - ie, it doesn't matter if the rapids are very likely to kill you, the loss of a kidney fairly likely, and the clinical trial very unlikely. But if there is moral gradation here, maybe you could think about taking part in non-interventionist trial, like the Tracking Parkinson's study?
It's an important topic for us all. It is a very personal choice and I don't think there is any moral obligation to put your own health at risk.
Semele makes an excellent point - there are many studies that are observational and that carry no significant risk. Some of these require nothing more than carefully completing a few questionaires and perhaps being examined by an extra doctor or two. These can add significantly to the knowledge of the condition and its treatment.
There are other options that involve giving fluid samples (saliva, blood or in exceptional cases spinal fluid via lumbar puncture) or spending an hour or two in an MRI scanner (I like them - but maybe I'm strange)
Slightly more invasive than the above are trials of repurposed drugs - these are drugs already proven safe for human use for other conditions but which show potential for Parkinson's. Zolpidem and Exenatide are examples of these.
Dr Jonny's description of the risk vs reward tradeoff fits the invasive trials like the ones using cell implants or genetic infusions into the brain. These are clearly non trivial undertakings. I think the recent publicity around the GDNF trial based in Bristol portrays the risks and benefits very well.
Finally we can all participate after we are gone. The Parkinson's UK brain bank provides an invaluable resource for research. You have to be dead to get in (they insist on it) so it doesn't hurt a bit. The only risk with this option is that if you don't sign up while alive you will miss out and that would be a waste. You don't even need to have Parkinson's to join - all welcome.
so - I agree with Dr Jonny - it's a personal choice that each of us must make for ourselves. So far I have made the same choice as Dr Jonny and have done nothing more risky than MRI scans although I'm open minded about participation in more invasive trials later.
Finally finally - there are loads of different studies that you can participate in and whatever your attitude to risk there is probably one for you. One of the strong messages from World Parkinson Congress is that PwP who are active research participants deal with the condition better than those who don't.
The GDNF clinical trial at Bristol certainly isn't for everyone, possibly even if the trial outcome is positive. It's the surgically implanted delivery system that's being evaluated almost, if not more, than the GDNF being administered through the pipework. The placebo group will be equally invaluable in testing this method of traversing the blood brain barrier.
Risks, well it's brain surgery. Risk of not taking part for me is knowing I'm getting worse and watching it dismantle my current lifestyle, bit by bit. For this reason I'm looking to take part if I'm suitable that is.
I've actually been wrestling with these thoughts myself.
I was diagnosed about 2 years ago and it took more than 12 months to find a package of drugs that (more or less) help without too many issues. In that time I've taken part in a number of research studies (ie studies where I'm evaluated, tested, given blood, spinal fluid, skin, etc but do not take any new drugs.)
But I'm starting to think maybe its time to take part in a clinical trial (ie where a new drug or placebo is given for a reasonably long period.)
Now I'm not eligible for the Bristol GDNF trial - which is probably good news, because I'd be frightened to join that (and I think my wife would go ballistic if I suggested volunteering to have holes drilled into my skull!!.).
But maybe something I can swallow or have injected just into my skin, would be acceptable. Why would I? Well partly to benefit the future community but also, the next likely big advance in PD drugs will be neuroprotective, which means they'll stop you getting worse but wont make you better.
So, should I take part now, in the hope that I can remain at my current level, rather than wait until I've deteriorated further? The chance of a treatment which can actually restore neurons is probably further away.
Though then again I remember the disastrous clinical trail of TeGenero's TGN1412 at Northwick Park in 2006 - and think: "what if??"
But I think I may look around over the next few months and see if I can find an upcoming trial of a drug which looks hopeful but isn't too scary, and sign up. Anyone out there got any suggestions (in the southern part of the UK)?