Tuesday, March 2, 2010

My MS Story Chapter 32- The Conclusion of the Rituxan Epic

I try not to make this blog too depressing. The subject matter is often difficult, yet my life is not cheerless at all. My goal is to be genuine, with just a dash of uplifting. I hope people feel better after visiting here, not worse, or at the very least they become more informed about disabled life. One of these days I'm going to tell a story with a plain, simple, happy ending. But, unfortunately, this is not that day.

Here is a brief recap of what I’ve already written about the Rituxan clinical trial:
Boy meets Clinical Trial
They fall in Love
Trial gives Boy Rituxan; Boy reciprocates by showering Trial with Data
The first year is great
The second year is not great, but still good
Trial forsakes Boy, leaving him wondering, “What did I do wrong?”
Boy strikes out into the cold, hard world, on a quest to recreate what he once had with Trial
Eventually, Boy does find more Rituxan
Boy rejoices!
There. You are up to speed. If you’d like the whole story, please read the previous posts about my Rituxan experience, which can be found here.

After the trial I did find more Rituxan. In September of 2007 I had my first two out-of-trial infusions. We were surprised that the insurance company had covered the $20,000 cost of the drugs. I don’t think they meant to. We caught them snoozing. Due to the confusion around my departure from the trial, these infusions came a full 20 weeks later than they should have come, if I had stayed on the “2 infusions every 6 months” trial protocol. Better late than never though, right?

My third and fourth post-trial infusions were planned for six months later- March of 2008. We followed the same process we had followed earlier to get approval for the two infusions. But this time the insurance company woke up and said, “Wait, this is not an approved treatment for MS. Request DENIED.”

We were prepared for this denial. My doctor and I dusted off the battle plan that we had put together in 2007. The first item of business was to get a letter from the clinical trial administrators indicating that I had been given the trial drug and not the placebo. We strongly suspected this, but written proof would be the crux of our argument to the insurance company. We had data showing that “something” stalled the progression of my MS during the trial period. Now we only needed a document stating exactly what had been pumped into my veins for two years. That’s a reasonable request, right?

I asked the trial administrators for just such a document…an email…some hen scratching on the back of a napkin…anything proving that I had been on the trial drug and not the placebo. My request fell on deaf ears. The study was not yet unblinded. Therefore, this information was under lock and key. March, the scheduled month for my next pair of infusions, came and went- so did April, May, and June. I made phone calls. I wrote letters. While I waited to hear back, more irreversible damage occurred to the myelin sheath around some of my nerves in my spinal cord. While I waited, I accumulated more permanent disability. But, the important thing was that protocol was preserved. That’s what I’ll always remember about this trial. The damn protocol was preserved.

Finally, in July of 2008 I received the written confirmation that I needed.  My doctor and I threw together an appeal package and submitted it to my insurance company for review. In late August I learned that my appeal had been approved. For a period of one year they would reimburse me for Rituxan, a total of 4 infusions, and then they would re-evaluate. I got my next set of infusions in September of 2008, six months later than I should have, if it had not been for the insurance company denial, which was exacerbated by the pharmaceutical company’s hoarding of critical information. Finally, things were looking up, right?

In March of 2009 I had my first “on-time” infusions of Rituxan in a long while. Maybe I was back on track. Maybe I could recapture the magic I had felt during the clinical trial a couple of years earlier. In August of 2009, before I could receive my next scheduled infusions, the insurance company re-evaluated, as promised, and denied me again. My doctor asked me if I wanted to appeal.

I took an objective look at my situation, and I had to admit that Rituxan had not provided me any benefit since the clinical trial had ended. I’d fought so hard for the six post-trial infusions that I had received. But it simply wasn’t working anymore. Was the problem that I’d lost momentum with all the delays? If I had stayed on the trial schedule, with no missed infusions, would the Rituxan have continued slowing my disease progression? I’ll never know.

Rituxan is not a drug anyone should take lightly. It is heavy duty stuff, with potentially harmful long term consequences. Given this, and given its ineffectiveness, I told my neurologist that I’d had enough. For a period of four years, this drug had been my big hope. I’d need to find some other hope now.

My doctor agreed. So the great Rituxan adventure had ended not with a bang but a whimper.

To summarize this last chapter of the Rituxan epic:

breakup Boy finds Rituxan once more after Trial
However, Boy never again feels what he felt with Trial
Boy gives up on Rituxan altogether, and remains drug-celibate for a long, long time
With no treatment, Boy asks himself, “What now?”


  1. Mitch,

    I vividly remember reading those posts of your trial debacle and feeling your pain. It has definitely soured my opinion of all clinical trials ever since. I know it’s not much but I hope you can take some solace in knowing that you did every thing humanly possible to get the treatments that you so desperately needed. Something definitely needs to be changed with this system to better take the patients needs into account.

  2. What now? That is a huge question. If only you could look into a crystal ball and find the correct answer.

    I often ponder the same question. I want to know where to go next. I want to know how to make it stop. Better yet, I wish I had a magic wand and could make it all go away - so much for wishful thinking! Some days I can't stop thinking about MS and the life is has taken away from me. Other days I barely give it a thought. There are just too many unanswered questions.

  3. Mitch,
    Thanks for sharing this painful story. I have been secretly (well, sort of) harboring ill feelings about both Big Pharma and medical insurance companies, and your story makes me believe even more that my feelings are justified.
    "What now?" indeed -- if only we knew.

  4. Tuna,

    I worry that my accounting of my clinical trial experience will deter others from participating, and that's not the intended effect. I just want people to go in with their eyes wide open. Don't expect empathy. But sometimes these things do have a happy ending. Sometimes the drug works and everybody, even the placebo group, get free drugs at the end, but this is the exception. I don't believe this clinical trial model will survive. There's got to be a better way.


    I've got some ideas. I've always got some ideas. Sometimes they are not very good though.


    I'm a big believer in the free market as a means to maximize corporate efficiency. For example, government agencies like the postal service just can't compete with private companies like UPS. However, this breaks down as concerns medical research. With money being the primary driver for medical research, we end up with big pharma and insurance companies becoming the cold hearted bastards that they are. I'm not an advocate of government run health care (see the postal service analogy), but, again, something's got to change. This is not working. I wish I had some answers/suggestions, but I don't right now.

  5. Sometimes, All's Well That Ends.

    Sorry your Rituxan story didn't have a miraculous ending, or even a great one. But perhaps it did delay things for a while, and I'm glad you didn't suffer any ill-effects from it. It is a heavy duty drug.

  6. Thanks weeble. I think I did "buy" a year or two of slowed progression from this trial, and that's something.