The Registration Trials that are ongoing are purposed not only to find out if the strong response rates seen in the earlier phase 1 and 2 trials hold up with larger and different populations of patients, but also to look for early signals of unanticipated side effects of adverse events.
But problems with medications can show up very late in the game.
Who would have guessed that pregnant mothers who received DES (Diethylstilbestrol)in what turned out to be a futile attempt to reduce the risk of miscarriage would see a problem a generation later when it was realized that their daughters exposed in utero had an increased risk of a rare vaginal and cervical cancer.
And while a good number of the brave first patients out of the handful that entered the phase 1 trial of ibrutinib are still doing well on drug, at the time of this writing I don’t believe that anyone has been on the medicine for even four years, and most of us for much shorter times.
Therefore we should not be surprised as our experience grows with the new generation of treatments heading rapidly for FDA approval when new possible concerns pop up.
I didn’t get a chance to ask Dr. Byrd when he spoke on the early results with ibrutinib in Stockholm at the same meeting where I too lectured (I gave a patient’s perspective on having CLL and how my life was impacted by both the disease and by my dramatic response to the new medicine) about the incidence or statistical significance of what to me was an unknown adverse event: brittle fingernails.
That explains why my career as a hand model will never get off the ground. My fingernails break easily and I must keep then very short at all times to avoid them tearing. Reaching in and out of my carry-on bag with its computer sleeve and tight pockets where I stuff my papers and medications is like a dance in a minefield for my fingertips, and they are often the worse for wear after my travels.
I also am certain just as we all know that when someone asks us if our nose is itchy, our noses are more likely to itch, awareness of the possibility of any problem increases the incidence of the problem. I will now join the ranks of those ibrutinib subjects reporting brittle nails, though for me the fashion consequences are much less significant compare to the women who enjoy growing and painting their nails and who, I bet, were much more astute and observant than me in pointing out this problem early on.
I just thought it was a consequence of my vegan way. Maybe it is.
In the big scheme of things, jagged fingernails are not a biggie. Sure beats pneumonia or neutropenia. Still could it be a marker of a bigger problem?
What’s next? Split ends? This isn’t so crazy. Many chemo drugs not only cause your hair to fall out, but when it grows back, it grows in curlier due to the broken bisulfide bonds.
Will our future doctors be able to walk into our exam room, check our fingernails, and assess if we have been compliant with taking our medications?
Time will tell, but I am pleased that so far, so few nasty signals are popping up.