Monday, December 1, 2014

Clinical trial ethics

I've been amusing myself playing with editing on the new iphone. Black-eyed Susans adjacent to my patio. Just ugly brown stalks left now in bleak December

ice plant from California trip
Without clinical trials, we'd have no new treatments or devices. Sometimes though, I believe the good that comes from them benefits society as a whole and the companies sponsoring the trial much more than the individuals that serve as the guinea pigs.

Case in point: last year's mammogram revealed a suspicious lesion that could have  been  a recurrence or a new primary. It needed to be biopsied. At the same time, I was offered a slot in a clinical trial testing a 3D mammogram that could better visualize this lesion to decide if indeed  it was biopsy worthy. It could possibly discover lesions that weren't visible in the standard mammogram (and some cancers just don't show up). Cost to me? An extra 30 minutes and more exposure to radiation though I've been exposed to so much, especially in my treatment, it would be like worrying that peeing in the ocean contribute to the melting of the ice cap. In the statement given to me to sign, it stated there would be no benefit to me whatsoever. Hmmm..not so much of an incentive. I contacted the powers that were to express my concern that this was unethical that they could discover a lesion and not tell me possibly leading to my death. Oh but they would. So there was a benefit and I did it. However I suspect the image revealed that I really did not need the biopsy (that resulted in much anxiety, pain and very high copays) and this was not told to me. I was just a data point to them. I really think it is unethical to collect medical data on a patient and not share that with the patient.

When I first entered the dark world of cancerland, I was asked to sign off on them keeping my tumor for scientific research. I was told that this information would not be shared with me, even if it could help me. Then why would I give them my tumor? To help mankind and other patients making me sound selfish for not wanting to do that. When I sighed and meekly said that this all doesn't seem right, she said that they would just throw the tumor away then if I wanted it. I could have argued but she was just the messenger for what I believe is a very unethical system. I let them keep the tumor in the hope that someday, they see the error of their ways, not likely.

In 1951, a 31 year old African-American woman, Henrietta Lacks, presented with an advanced case of cervical cancer. Cells were taken from her to start the first immortal cancer cell-line still used today called HeLa cells. She and her family did not benefit from these cells, sold over the years. There has been much criticism directed towards these scientists. What is the difference between her case and mine? They did not get informed consent from her. So they have my SuKe cells legally but not ethically IMHO.

I was offered to be in a clinical trial that would possibly prevent recurrence of my cancer. I'd be either be in a placebo arm, an oral arm or the iv arm (which meant monthly infusions for 18 months). They would test my original tumor and collect blood work. None of the info would be shared with me or my doctor. They were also testing a blood test predictive of recurrence..again no sharing with me. Furthermore, if I developed side effects from their drug, it would be up to my insurance to treat me, which I suspect they would balk at. The whole thing seemed highly unethical to me but they found plenty of takers. Meanwhile on my own, I am taking a baby aspirin a day that has prevented recurrence by 50% in a huge metanalysis. The only downside is that it is not helping my stomach lining that had been shredded by the Red Devil.

I did do the chemobrain study because the benefit to me was that I would see my brain. Also they promised to share my individual results, which I have not taken them up on yet. I suspect I learn and memorize things differently than others just because I am so weird. People they excluded from their study? Lefties and depressed people. I snorted when I heard about the latter (and questioned about the former..lefties think differently and would confound their research). Here they were calling newly diagnosed with cancer patients. I suspect they were reaching lots of unhappy people. Her screen for depression? Asking me whether  I still found joy in other aspects of my life.

Tomorrow: my  annual mammogram. As last year's was such an ordeal, I am not looking forward to it.



Lisa said...

I agree, clinical trials seem terribly unethical to me. I understand the importance of the research, but not the importance of not benefiting the research patients. For me, it's not such a big deal. They don't like my pre-existing heart condition nor the fact that I'm a lefty. I don't qualify for them. I was actually disqualified for a study of the heart condition that I have because I'm a lefty. When you consider that the condition is so rare I have never met anyone outside of my family who has it, that's placing a lot of power on handedness.

What intrigued me about what you said was that you blame the red devil for shredding your stomach. Since chemo, I have an ever increasing list of nutrients that I can no longer absorb. When I brought up the possibility that it may be an effect of the chemo, I was dismissed. I would have taken possibly, we just don't know better than outright dismissal. It amazes me what they deem as "safe".

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

When I was given Adriamycin, I was told that it would probably attack the stomach lining cells and that I would need Prilosec to block stomach acid formation so I would not be in pain. I still continue to take this. I tried to wean myself off of it (I now take it every other day) but I still need it. As I said, the baby aspirin might be hurting the stomach lining but if it indeed cuts recurrences by 50%, it's a trade off I am willing to take (plus it can prevent strokes and heart attacks) Did Adriamycin cause your heart condition? They had to warn you of that. As with most patients, they studied my heart function before giving me the drug.

Are you taking Prilosec? Maybe some nutrients need to be absorbed in that acid salt form. Iron comes to mind though I must be absorbing it fine since my blood work is always good.

Strange that being a lefty excluded you from a heart study.

Elephant's Child said...

Clinic trials have often bothered me. A lot of them (but not all of them) here will share information. Which should be a given.
Some scientists, like some doctors, are too quick to ignore the human side of their work.

Lisa said...

The heart condition that keeps me out of clinical trials is a rare genetic condition that I was born with. It made treating cancer a trade off, but I so far have managed to survive both. AC&T have caused heart and kidney failure as well as pernicious anemia and iron and magnesium absorption. Still it's all a trade off. I live with these now, but I got to raise my daughter.

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

Well Lisa, the trade off was worth it. Do you need frequent transfusions?


Blog Archive