Tuesday, December 3, 2013

The Ethics of Clinical Trials

A week ago, on the DAY of the BAD MAMMOGRAM, I get a call from a nurse giving me detailed instructions for my upcoming biopsy complete with many prohibitions (didn't recall getting any instructions for the first one) No flaxseed products, for example. Towards the end of her spiel, she asked if I would like to take part in a clinical trial. Someone is testing a new type of mammogram. With just one scan, multiple (21) angles are somehow taken giving a 3-D image. I assume one could see potential tumors more readily.

Will there be any benefit to me? 


Will the results of this new imaging be used  to determine whether I even need this biopsy? Will I be able to see the scan or will my doctors?

No, no and no.

Do I at least get a cookie at the end of it?

I didn't really ask the last question but it did get me to thinking. Why would anyone want to do this? She testily told me I didn't have to do this if I didn't want to and there would be absolutely no cost to me, aside that I would have to get there even earlier on a very early appointment and I'd be exposed to even more radiation though at this point it is like worrying whether peeing in the ocean will contribute to the melting of the polar icecap. I resented being made to feel like a bad person for not possibly contributing to the better good (and to the profits of some unspecified equipment maker). But I really resented that they maybe could tell that I really don't need this painful biopsy anyway or even worse, there is another tumor that the other less sophisticated mammogram didn't detect and they would not tell me or anyone that counted. Swine!!!!

Designers of clinical trials take note!! There must be a benefit to your little lab rats!!!!

Back in Cancerland (and now it seems that I haven't truly escaped it..damn), I was offered (if indeed that is the term) a spot in a clinical trial that was designed to possibly prevent mets. I would be given one of three drugs, two which had not been approved yet in the US but would be taken orally or the third which had been approved for the treatment of bone mets but needed to be infused monthly over the next year. I would not get to chose which arm I'd be in. Furthermore, these drugs had serious side effects in which they would not be responsible for the treatment of and even though I had 'nicer' insurance then, I assume they would balk at treating me for the effects of experimental drugs. The benefit or the costs could not be quantified. The thing that made me most upset though is that they had some sort of  test that could possibly predict your tumor's potential for spreading through some unspecified marker (to me) and they would not share the results with me or my doctor lest she succomb to my wheedling. My onc justified the lack of transparency because this test had not been approved.  Nein Danke!

You would think they would get few takers for this protocol but I kept running into people on it. Maybe people aren't as cynical as me or they seized on the idea that this MIGHT prevent mets and they would do anything, no matter the cost, to prevent that.

Past readers of this blog might remember I did participate in the chemobrain study. Functional MRIs were taken while I performed memory tasks, before chemo, during chemo and a year after. I did this contingent on them sharing my personal results with me. They initially balked at this but then, as they needed me, agreed to it though I have yet to cash in on this. I really don't think I have chemobrain but I bet my brain works differently than anyone elses. This would give me proof.  I did get some benefit, a new coffee mug and some token money to make up for gas (this place was 3 miles away). Most important I got to see static images of my brain, me scanning for brain tumors and early signs of Alzheimers'. I did get the pooled results recently in the mail. Basically there was no difference between before chemo and during chemo but there was a considerable difference between people facing chemo and people who did not have cancer. Apparently the shock of it all causes poor performance.

And our household along with half of Ann Arbor is participating with some accident avoidance study. Equipment is installed on one of our cars and Naomi's car. We do get some token money and lots of car washes. Luckier participants such as one of the Moms got a new car for 6 months saving wear and tear on her own.

Recently I was watching an old House rerun. Thirteen is on a  double blind clinical study for something that might slow the progression of her Huntington's Chorea. Her then boyfriend Foreman is conveniently the local administer of the study. He notices that some of the patients are getting better, though not Thirteen, and assumes Thirteen must be on the placebo. He makes the unilateral decision to put her on the probable drug even though this might cost him his license (in real life, I don't think this will be true. The drug company will be pissed with him and this might invalidate this arm of the trial) But suddenly Thirteen develops side effects including total blindness!!!! He has to come clean. Thirteen is not amused, not just because she is now blind (though that passes) but the fact he was willing to risk his career for her freaks her out. In the end, she gets better, he doesn't lose his license but he has lost his girlfriend, who later turns out to be bisexual, and House thinks he's stupid. But the whole episode does raise some interesting questions about clinical trials.

I do realize that for Stage 4 patients, clinical trials are their only hope and they are getting some life out of them. I do know several people that are alive because of them. And without the brave souls who did not have stage 4 breast cancer but were willing to take Herceptin, we would have many less survivors.


jadek said...

Hang in there Sue, I'm sorry you are having to go through this. I'm sending hugs and lots of positive thoughts your way.
Kathy B.

Sue in Italia/In the Land Of Cancer said...

Thanks Kathy


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