Wednesday, April 16, 2014

Clinical Trials and Patient Rights...An oxymoron????

A conversation about clinical trials has been ongoing on one of the forums.  Much of the discussion has been from voices frustrated with their inability to find out which drug they were actually given when they leave a trial so that they can plan their next step against their disease. Others seek lab results hidden from view.  And there are the voices of convention...saying..."Oh, you should ask more questions...apply for this or more carefully.  What did your papers really say?" Well, to that approach I say..."BULLOCKS!!!!"  The folks running these trials are fully CAPABLE of making themselves clear, in simple language, and providing answers to patients...IF THEY WANTED TO!!!!  I know some of you check both sites; I beg your indulgence.  But, I know many of you do not.'s what I DID say:

As many of you know, I have been a rattie in a clinical trial since Dec 2010. I started caring for patients when I was 19 years old. I have seen this world from all sides. It is complicated, often painful and un-pretty. Despite all I have seen and learned....I am thankful. Thankful to have had the honor to serve my patients all these years and lucky to have gained participation in my trial. Ipi wasn't even on the market when I started. I had no other options.

Which brings me to perhaps the most important point of this whole discussion. No one participates in a clinical trial for fun. Ratties are only there because they are running off a sinking ship. And the researchers? Many are wonderful, compassionate people who want to use their lives and careers to do good things for others. But, think about it. Where is their allegiance? It is to the drug company and their institution first. That is who is funding at least some of the research. The institution provides their paycheck. The drug company wants to do great wonders with the drug (read: make big bucks!$!$). And, if the researcher/institution wants to do more fab research...they've got to make the trial work so that they can get additional opportunities to participate in the next break-through trial. Next, they must have an allegiance to science. There is greater commitment to the results of the experiment, than to you, the individual. It is not really the patient's well being calling the shots. The participation forms are very clear on all of this. They say: You may do great. You may acquire any of PAGES of side effects. We (the doc, the institution, and the drug company) CANNOT be held accountable if you grow three heads, turn purple, or croak. Additionally, we will not be held financially responsible for any costs related to care for any side effects or extra head amputation that you may later need. And....if your scans or labs or wayward body doesn't play right, you will be dropped from the trial. Oh, can quit when you want, but...then you're done.

So, all this brings reams of papers and confusing medical terminology to patients in desperate circumstances. Signing up for a clinical trial is not for the faint of heart. Nor is the information presented in terms that most folks understand...especially when feeling sick, worn, and worried. Rather, patients feel they are completely at the mercy of the doc, the drug company, and the trial. They are afraid they are going to die. They are not going to quibble. In Chapter 3, from Cancer Clinical Robert Finn...he writes: "Cancer patients are in a one-down psychological position. They have to trust their doctor. They want a cure. They need a cure. They dare not risk any...alienation from the physician-researcher. So, they're very much inclined to do what the researcher wants and accede to the requests of the researchers."

I wrote my version here:

Bettin you are absolutely right. We need to make things consistent and better. There is no need for clinical trials to be so "random!" Yet, we ratties hope for good results for ourselves...and that even if we are not so lucky...then at least others will benefit from what is learned. WRONG again!!! In July of 2013, The Journal of Clinical Oncology published a review done of Phase II, III and IV cancer drug trials done between December 2007 and May 2010 and found that 50% of those results WERE NEVER PUBLISHED!!!!
My link:

Brian, my tumors were tested, because of the express desire from BMS, for PDL1 as well. The wording of the additional consent form was purposefully vague. Explanations from the researcher, clinical trial coordinator, and everyone else involved, ranged from..."Oh my hands are tied to give you more intel""I don't know nuthin bout birthin' babies!""Hmmmm." And trust me, honey. I'm a patient who asks! Most do not. I've made rounds with untold numbers of doctors. Some are very happy to escape the room as quickly as possible. But, others are perfectly willing to sit and really try to answer any question. Yet....more often than not...patients just nod and smile. But, when I return to the room after the doctor is gone, the questions flow. Sorry...just an aside. But, my expectations for getting the results of my testing??? Pretty much...NONE! Here's my rant:

When I see trials that are still comparing new meds to ineffective ones like interferon and dacarbazine, I feel physically ill. It is wrong. It is abusive. In a conversation reported from the European Cancer Congress in 2013, Ribas said, "taking all the studies...comparing ipi and dacarbazine vs dacarbazine, ...vemurafenib vs dacarbazine, dabrafenib vs dacarbazine, and trametinib vs dacarbazine - all of these studies have shown that another treatment was better than our old standard."

So what does all this mean and what can we do about it? It means that we still have a long way to go in attaining equal rights between drug companies, researchers, institutions and patients. I have no easy answers. All I can do is try to pay my fortunate circumstance forward, to make the path a little better, a little more comprehensible, for others. Some ratties squeak!!!

My best to you all. Celeste


  1. I'm new to those who comment. I've followed your blog to see the news on PD1. My daughter has metastatic melanoma. She has had IL2, Ipi, radiation, and chemo. The tumors keep growing. We may get into a trial in Denver, but we live in SLC. How do you do all this traveling? You are an awesome woman!

  2. Thanks for that, Joanne. I am sorry for all that your daughter (and YOU!!) have had to deal with. It is crazy, isn't it? I assume you live in South Carolina. Traveling for treatment is difficult and expensive, though there are some resources/institutions that can help out should you need that. Just juggling the time and effort is cost enough. I guess I did it, through plain personal stubbornness and tremendous support from my family. I still can't believe I made the trip routinely every two weeks, with some weekly trips thrown in there, for 6 months, before my trial requirements changed to every 3 months. It is a testament to the adaptability of the human spirit. We CAN accept and do that which we never dreamed! Details of the travel experiences are more frequent early in my blog. I wish you and your daughter my best. C