Wednesday, December 23, 2009

My MS Story Chapter 23- There is life, and more Rituxan, after the trial.

(Photo credit: bfishadow)
I asked my local neurologist to set me up with $10,000 worth of the good stuff. This was a tremendous amount of money for me to spend for two infusions of Rituxan, each weighing only one gram, but I decided it was worth it.

Then I got some bad news. My information on the cost of Rituxan was wrong, by a factor of two. The amount was actually $20,000 for a pair of infusions, not $10,000. For me, this changed everything.  The extra $10,000 was the difference between feasible and not feasible, go and no go. Crap!

We moved on to plan B, or was it C? I lose track. We needed to make our case with the insurance company.  They should pay for the infusions, because I had proof that this treatment was very effective for me, whether or not it would work for the more general PPMS population. Maybe the phrase “make our case” is too soft. We were preparing to “go to war” with the insurance company.

Gun CrewThen the strangest thing happened. The battle that we were preparing for did not occur. Without a shot being fired, my insurance company pre-approved a pair of Rituxan infusions.  No questions asked. No data required. Undoubtedly, somebody at the insurance company screwed up. I suffered no moral dilemma though. If a clerk gave me five dollars too much change, then I would feel obligated to inform them of their error. But when an insurance company reimbursed me $20,000 for treatment that I desperately needed, even though I knew it was a mistake on their part, I followed the advice of the Steve Miller Band.  I took the money and ran.

We scheduled the infusions for August 22 and September 5, 2007. I would receive the IV in my own town, instead of two hours away in Worcester. These infusions would be 20 weeks later than they should have been if I had stayed on the trial schedule. I had wasted almost half a year in this process. After the infusions I waited to determine if Rituxan would once again stop or at least slow down my progression.

These two Rituxan infusions created a new problem. My commitment when I started the trial was that I would not take any out-of-trial treatments for my MS. Doing so would understandably corrupt their data. These two infusions of Rituxan were definitely out-of-trial, so I was informed that I had to withdraw 3 months before the finish line. At this point the trial was providing no benefit for me. That was a non-issue. But I was officially a quitter- something Mom and Dad and the President and Jesus told me I shouldn’t be. Despite the legitimate justifications for my decision, I was still disappointed that I didn’t finish.

I had my exit interview and examination with Peter. His final assessment reconfirmed significant disease progression beginning about six months after my last Rituxan trial infusion. We parted on good terms. Peter understood that I was simply doing what I had to do.

In a clinical trial, the doctors and nurses who administer the trial protocol on behalf of those nameless, faceless administrators are put in a difficult position. All of these clinicians, or at least folks like those I worked with at UMass Memorial Hospital, chose their career paths in part because they possessed the quality of empathy. As a requirement of their jobs, they listened to patients’ concerns, consulted with them about the best solutions, and shared emotionally in their success or failure. Medical professionals certainly must be careful of becoming too caught up in the lives of their patients, but these people are not robots. They are caring and thoughtful human beings.

But in a clinical trial environment these caring and thoughtful human beings are no longer allowed to consider empathy in their treatment decisions. They still care about their patients, but it doesn’t matter.  There is a protocol after all.

It's a perverse system. I'm not saying that I’ll never participate in another clinical trial, and I'm not advising other people to avoid clinical trials.  But if I ever do participate in another one I'll go in with my eyes wide open.

Although I try to be an understanding and forgiving person, I do harbor resentment towards my Rituxan clinical trial.  It didn't care that I was getting better on Rituxan. It didn't care that this was the first drug that had ever shown any hope for me. It didn't care that when the trial drug was withheld from me I started to suffer permanent, irreversible damage to my central nervous system. It didn't care about anything. But it wasn't the clinical trial’s job to care about its patients, other than to do them no direct harm. This cool detachment was possible because the trial’s administrators made sure to never look me in the eye, shake my hand, or even hear my voice. If the goal is to keep patients and scientists separated, physically and emotionally, our country’s standard clinical trial protocol is highly effective.

We don’t bother to keep scientists and their lab rats separated in this way, only scientists and their human subjects. I suppose, however, that there is less risk of lab rats eliciting unwelcome empathy from their researchers.

OK, I’ve beaten this dead horse enough.  Next week we’ll move on to some new subjects.

For the final installment in the series, click here.
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