Those who know me know that I've been reticent to wave flags over the next miracle drug.... I now find myself taking one, very reluctantly. Before you say I'm crazy, please hear me out.
The history of Cancer drugs has been promising us cures for as long as pharmaceutical companies have been in existence. There's gold in them there hills. Lots of it... more in the sizzle than the actual steak. The Markets rise and fall on the next announcement at ASH and other conferences. But that same road to Oz is littered with the corpses of the ones that never made it. Some even did very well for some people, but were dropped for lack of a market, or due to too many undesirable side effects or AE's, adverse events, a nice way of saying , bad stuff.
To understand why this happens over and over one must learn to read abstracts critically. Any trial is only as good as it's design.... how many patients, what sort of patients, age, condition, etc. Often they don't say, or they don't share that.... How much follow up and what sort,,, How many phases did it go thru before it was called a miracle and pushed in front of the FDA ? How many actual patients actually were treated and how did they do? We also must remember that those in trials are presumably watched by those who research the drug and tho they know very little about how it will or may perform, they sure know more than your local doctor. Many drugs make it to the market now in very short order... I realize it seems forever to those of us waiting. Often only a few hundred patients, very carefully selected have taken the drug. We who get it next are actually the real 'trial' subjects,,,, guinea pigs for the drug company, the researchers and those who will or won't get it later. Are we the lucky ones? don't be too quick to be jealous of us.
Ok the day arrives and you know you need to begin treatment, or do it yet again. You've heard or read about this drug and you are anxious... but depending on how realistic you are and how well prepared you are, you're also nervous. you read the list of side effect, and especially in the case of ibrutinib, it boggles your mind. Read that list critically as well. Most drugs that have been on the market for a while, some say five years is the very earliest one can feel a bit safe.... will show side effect of <10% or in some cases a bit more for one or two... rarely over that for any one effect. too many at high percentages, now that the drug has been given to more people, the drug will likely get pulled, or redesigned or blessed with black box warnings.... Ibrutinib has very high percentages for each of it's many side effects... largely that's due to the very small number of those taking it and possibly the fact that they may have been treated before, or are late stage, or older or other factors play in. The real trial comes now for those of us who are perhaps more middle of the road CLL patients or at least a different mix than those who were in the trials.
With so many side effects possible, if one has a bout of diarrhea the question arises ,,,, is it real or is it ibrutinib? Now lets say we get a clot.... possibly not related to taking ibrutinib..(clots are listed, as is dieahhreah, some really bad bouts and rashes) . or is it? do we reduce the dose, or stop the drug, or keep plugging on to see what happens. No local doctor will know. No local emergency room doctor will even want to hear about it... you're a bad dream to him... you're as much of a mystery as a kid brought in with a suspected drug overdose... does he treat with x or y or do nothing? might he make it worse? what else are you on? does he have access to your whole history? do you?
I'm not saying no to a new drug because I have few better options now, and I am far from a typical CLL patient. In fact I am again coming late to the table this time, PCR just in time last bout, and now stalled following the CLL due to a rare cancer found in my mandible requiring a major surgery, a jaw transplant, chemo and radiation... result, my marrow is again nearly 90% CLL... and as luck such would have it I came down with Lyme disease two weeks into ibrutinib.... doxycylcine is the fix for that we hope, but it too can cause diahhreah. you begin to see where I'm going? And the unknown also applies to the drugs that may or may not react differently with ibrutinib, or any other 'new' drug, even if it's not yet listed.
If you are going to take a new drug, or even enter a trial, PLEASE become the best self advocate you possibly can. read, study, and keep scrupulous records of what you are taking, what you have taken, do a full history and have that and your drug list on you at ALL times. either electronically or on paper.
The truth is with any new drug, we don't even know what we don't know..... don't be too upset if you are in a place where you are only offered an "older'" drug... those drugs have proven history in all types of people, and their quirks can be searched easily by even a triage doctor in your local ER. Not so with the new miracle pills. This is true of ALL new drugs, whether cancer treatment or not.
There is always another bus, and there's always another new drug around the corner..... the newest isn't always the best.. It may boil down to what choices you have and your tolerance for risk. But it's your body, your life. Get involved like your life depended on it, because it does.
Good luck to all, and stay alert. best, Beth