The words diminishing returns and risk might make you think that you have stumbled onto a blog about playing the stock market. Nope. I am talking about when you reach the point when your medical condition might be at a standstill or even deteriorating. You begin to evaluate treatment decisions that cause you to weigh your chances of improving versus having side effects and adverse reactions (also known as risk).
Of course, if you were to go into the hospital for surgery or a medical procedure, you won’t get wheeled into the operating room or procedure lab until you have been advised of the risks and consented to take on these risks. Well, it is the same when you are part of a clinical study. You truly realize that there are no guarantees that treatment or surgery will be successful when you see the description of possible bad things that might happen.
Of course, some of the side effects and complications they tell you about happen to only a very very miniscule percentage of people. But they will in time happen to someone, perhaps even you. As you mull these risks over in your mind, you might think of the quote from the Dirty Harry movies: "You've got to ask yourself one question: 'Do I feel lucky?' Well, do you, punk?"
The level of risk involved in being treated for illnesses became abundantly clear when I reviewed and then signed the consent forms for the study I am in. The consent form package listed the risks inherent in procedures and tests that would be performed throughout the study such as blood draws, the cardiopulmonary exercise test, the electrocardiogram and the echocardiogram. Granted some of the risks and side effects were just annoying things like minor skin irritations. But even though I have experienced all of these procedures before – especially the blood draws – this is the first time it really dawned on me that some people, even me, could get an infection from a blood draw. Not likely, but again, it does happen to some people.
The more consequential risks are found in taking the investigational drug. The common side effects are palpitations, chest or throat tightness or discomfort, dizziness, shortness of breath and the ever popular low blood pressure. Happily, so far none of these things have caused me to be bounced out of the study. I mean, as part of heart failure, I have shortness of breath with some physical activity. But nothing has increased or become more pronounced. At each study appointment, my blood pressure meets the appropriate level. Of course, that could just mean I got the placebo and that is why there have been no adverse side effects – or maybe I got the real drug and it is doing such a wonderful job that my condition is improving.
The uncommon side effects, which may impact 1 – 10 people in ever 1000, include: decreased blood supply to the heart muscle, heart attack, fast heart rate, changes in heart activity, feeling hot, increased levels of heart muscle proteins in the blood. The latter is described as a marker used to detect potential injury to the heart muscle. I believe it is the BNP and Pro BNP tests that check for this protein also known as the B-type natriurectic peptide.
Each participant needs to let the study doctor know what drugs they are taking throughout the study, to include all prescription drugs, all over the counter drugs, all herbal remedies, and all supplements. Because the drug is in the investigation stage, not a lot, if anything, is known about how it interacts in combination with other drugs. I guess you could look at this as a risk as well, but to me, it is an important risk that is in the nature of intelligence gathering. How else will the pharmaceutical industry know what to put in patient inserts about a drug’s interaction with other substances unless this matter is carefully identified and evaluated with study participants?
I have talked in the past about how anxious I can get. So are the risks, even the miniscule ones, making me really anxious. The answer is no. I get anxious over stupid things that will almost surely not happen. Stupid things that are so improbable that no one would ever develop a consent form package for them. As I explained to the person who interviewed me for the study, sometimes I think we worry about these things to distract us from worrying about the bad thing that might happen to our bodies as a result of our medical conditions.
When it comes to real risks, my approach is more practical and less anxious. For example, when I found out that my heart failure had deteriorated and that the doctors recommended that my heart device be upgraded to include both a pacemaker and a defibrillator, I listened very carefully to the doctors. Their concern was that my heart could at some point beat erratically and this would mean that the very real risk of cardiac arrest was present. As I reviewed this possibility in my mind, anxiety was hovering over me but was quickly elbowed out of the way by my management skills.
Specifically, the skills that kicked in were related to risk evaluation, risk mitigation and risk elimination. Sure, there are some risks associated with the procedure to implant the device and having it inside your body. Plus, there is the pesky side effect of the device shocking your heart if it starts to go into cardiac arrest.
But let’s look at the risk of what happens if the device in your body only functions as a pacemaker to speed up a slow heart. if an erratic beat began, my heart could go into arrest and if I was by myself, there would be no one to call 911, perhaps no defibrillator nearby to pull of the wall, and no one to actually use the defibrillator on me. Because I live by myself, this mean there was a real risk that I could die – and even if I was out among people if it happened so suddenly without medically trained people nearby, I could also die.
My common sense told me that the real risk was cardiac arrest and it could be mitigated, if not eliminated by the implantable cardioverter that functioned both as a pacemaker and defibrillator. In other words, the anxiety stepped aside to let me work through the risk calculation and realize that as bad as a defibrillator might sound, the purpose was to get rid of an even more hideous risk.
When it comes to the participating in the study, even if I get the real drug, I don’t know if it is a drug will be effective for me and actually improve my heart pumping capability. But I know that right now it is a risk worth taking because I figure it is only a matter of time before the pumping capability deteriorates further. The question becomes do I sit here and analyze every symptom that might indicate that my heart failure is getting worse? Or do I do whatever I can to fight it?
I take after my Father, who always showed a fondness for action. One of his favorite sayings was: either lead, follow or get out of my way. I have decided that when I am given the opportunity, I want to be a leader or at least a doer. I want to work with the people involved in whatever clinical studies I am eligible for so that we can get more tools inside the heart failure treatment tool box. But because I recognize the fact that risk is involved, I keep the study team advised about what is going on in my health life so that we can hopefully avert all risks and concentrate on achieving success.
In my book, the bigger risk is not taking a chance on studies that could be risky, or could be inconvenient, or even could end up being unsuccessful. I have always found that the anxiety lessens when I am in the middle of a crisis but taking action. And while my health is not yet in crisis, who knows how long that will last. I would much rather act now when I still have some time and energy, rather than react later when it may be too late and I am reaching the point of no return.
Melanie discovered that she had heart failure in 2013. Since that time, she has been learning how to live with the condition, and how to achieve balance and personal growth.