(clinical) trials and tribulations

Hi all,

Val began writing something about our latest adventures but she’s out of town for a week so for now I’ll fill you in.  Bottom line: things remain approximately status quo.  Here’s the latest:

A week ago I came in from taking out the compost to find a message on the answering machine from Dr. T., the oncologist: “I’ve got some new information about the clinical trial you’re on; give me a call this morning so I can fill you in.”

Val called the various numbers but the doctor was at the hospital, and although they said she’d call back in half an hour, she never did.  After a couple strung-out hours of trying to rein in our speculation Val got through to one of her oncology nurses, TerriSue’s colleague Diane, who said “They found — oh, I’m not supposed to be the one telling you this…” which, as you might imagine, made Val briefly but acutely crazy (Fill in the blank: “They found…”) until Diane stopped dithering and finally got the words out: “Well… They are canceling the trial you’re on.  They found that the drug [Apomab] didn’t really seem to help people, and it caused some serious side effects.  They strongly recommend that you stop taking the drug.”

Terrific.  By then I had shifted my schedule around and was hanging out with Val, while we tried to process the little info we had and find someone who could tell us more.  Such a sudden reversal of happenstance.  What are the implications?  What happens if they take her magic juice away?  We tried to be reasonable: Well, if they’ve found that it hasn’t helped people overall, it must be the regular, kick-ass chemo, and the Avastin Val’s still on, that are making the difference.  And she can keep on with the Avastin.  We think.  Come on, Doctor, call us back!

The doctor never did call back that day, but we did have a few more conversations with oncology staff and the next morning, a treatment day, we had our regular appointment with Dr. L, the other oncologist, and got to ask her all the questions we could think of.

The trial is canceled.  It’s not clear if the trial sponsors are shutting off all access to the Apomab or not, but they are certainly strongly recommending everyone go off of it. Which raised the question of the great double-blind secret we’ve been living with all year:  For the last 13 months, has Val been on the drug or the placebo?

(Do you want to pause and take a guess?)

The answer is:

It turns out that Val was on the drug.

The fact that they were finally able to tell us that helped me really get it that the trial is, abruptly, actually over.  After we’d had Dr. T’s phone call, of course we sort of hoped Val had been getting her great results on the placebo.  Because then they could take it away and we could predict that the great results will keep rolling in.  Now I am trying to shake off the uneasy feeling that everything’s up in the air again.

On the reassuring side, we found out that the other local person who has been participating in the trial, a man whose identity we don’t know but who began the trial a few months before Val and whose results have also been terrific, was on the placebo.  So there you are.  Even without the aid of magic mystery juice, the old warhorse chemicals (Carboplatin and Paclitaxal) together with the newbie (Avastin) have apparently produced both people’s dramatic results.  For now, Val and the doctors’ decision about whether to continue Apomab is on hold, as we wait to learn more from the drug people.  Meanwhile, we’ll keep relying on the Avastin, the supplements, the clean living, and the love and support of all you good people.

D