My third stem cell transplant in 2014 was part of a trial, and administered by this great healer, Dr. Muzaffar Qazilbash.
Does the term “drug trials” instantly raise your blood pressure? I think that’s true for many of us. I imagine a rat in a cage having been injected with some life threatening agent while a greedy scientist looks on, rubbing his hands together, a sinister sparkle in his eye.
Let me assure you that real human drug trials are no such thing.
In our country, the Food and Drug Administration (FDA) requires that new drugs undergo a series of tests, or “clinical trials,” in order to prove their safety and effectiveness before entering the consumer market. I’ve been on many trials. And though sometimes inconvenient (I had to travel out of town weekly for one of them), they are part of the reason I’m here today.
Even though none were “successful” in completely stopping the progression of the disease, drug trials lengthened my life—a few months for each trial—for years, long enough for the FDA to approve the drug that finally did put me into a lasting and complete remission.
Because drug trials still carry unanswered questions about efficacy and safety, you may have questions like:
Will this drug do me more harm than good?
Will I receive the same quality of care on a trial?
Will anyone be monitoring me closely enough?
Will I be able to go back to standard care (regular treatment) if I don’t want to stay on the trial?
Will people take personal offense if I get off the trial, and provide substandard care?
Will not getting on a trial or getting off the trial negatively affect my relationship with my doctor?
These are totally valid questions. There is no doubt risk associated with trials. So let’s start at the beginning. I want to be very clear on one point about clinical trials. People come first. Doctors are not going to put scientific study before your health. If you are doing poorly on a trial, and your numbers start going up again, you are under no obligation to continue the trial. In fact, your doc will probably recommend that you get off the trial immediately if other treatment is available.
As the name “trials” implies, they are literally testing an untried (to some extent) drug on you. There is risk. The further along the drug is in the approval process (Phases I, II, II, IV), the more accurately they can predict the possible side effects you’ll experience, and the less risk you’ll face, because more people have tried it before you. But because everyone’s body chemistry is different, there’s no anticipating with any certainty how yours will respond.
I have participated in Phase I, II and III trials. And I’ve experienced lots of side effects, almost all of which were forewarned. I experienced one life-threatening drop in platelets that required hospitalization. I will be honest here, this was one of my brushes with death. But because I was monitored so closely, it was caught in time and successfully treated. I immediately dropped the trial.
I am not going to negate the possibility of a terminal result from drug trials. A small percentage of people have an extremely adverse and rapid reaction like I did. And you will have to sign a waiver to be on the trial for this reason.
But it is rare. And much care has been taken—for years, by the time the drug reaches you—to do everything possible to assure your safety, before your body meets the drug, and during the time you’re taking it.
Ask your body how it feels about this drug, and release any attachment to the answer. Your body may surprise you with a strong “Yes!” or a hard “No!” or a casual “It doesn’t really matter.” Your body doesn’t have to ingest any of the drug to have an opinion. Your body holds the wisdom of the Universe. Pray. Ask for Divine guidance on whether you should do this trial. And follow your gut.
Unlike how I imagined a trial to be, you will receive a higher quality of care on a trial than with a standard treatment. Much more information about your progress is being collected—not just for your wellbeing, but for all those who come after you. Nurses and doctors ask you more questions and monitor you more closely.
Being on a trial is an act of service. Every trial I participated in improved the life of someone that came after me. If you’ve been diagnosed with Multiple Myeloma, there’s a very good chance that my body was used to assure the safety and efficacy of at least one of your drugs. And that drug kept me alive and raising my kids longer in the process. It’s a win-win!
So what does being on a trial look like? The only difference you’ll probably notice is that they take more vials of blood during your blood draws. Those go straight to the researchers. In the case of a couple of trials I’ve done, there was an extra bone marrow biopsy or two on my schedule, and more frequent imaging. It will depend on your diagnosis, of course.
So quality of care is a non-issue here. Trials carry more risk, but you will receive more careful monitoring. Again, always defer to the wisdom of YOUR body, and listen to what your body is communicating to you when considering participation in a trial. There were times that I had no other treatment options, so those were easy decisions. But if you have options, listen to your gut.
Happy Healing!
Holding you in the Light,
Deanna
