PART 4: Discovering the Truth About Sheila’s Chemo
It had been a long year for Sheila and I, with the shock of the diagnosis, operation, its aftermath and now the very real frustration of a lack of clarity regarding the dosing of her chemotherapy. On this issue, it felt like we were just not being listened to, never mind actually heard. Despite my best efforts to discuss dosing with her oncologists, they refused to engage on any need to check that their calculated BSA dose was actually right for her as an individual, to make sure they were not over or under-dosing her. Every time we raised it, they, figuratively speaking, just stuck their fingers in their ears and went la-la-la-la-la.
It was just infuriating me, so with help from DeWayne at Saladax, who had one of his Research Fellows send me a blood draw kit to stabilise Sheila's blood plasma at room temperature for long enough to get it to a lab for analysis easily and with his help to identify a lab that could do the test, I got on my way to doing something about it without Sheila's oncologists. Unfortunately, the lab identified that is set up to run the test is in Germany - and I only eventually got to it through another lab in Germany. Now, it has to be said that my German is rudimentary and limited at best, however over the course of another week or so, with some phone calls and emails to two separate labs, I was able to make myself understood and slowly got to the right person at the right lab, who confirmed they were properly accredited to IS0/IEC 17025 and agreed to help me and undertake the analysis as long as I could get the sample to them in time.
Then I had to figure out who was going to take a blood sample from Sheila; I was willing to try, but Sheila was having none of it. I kept telling her, trust me I'm an engineer, but it fell on deaf ears. LOL. Over the course of another week, I found out that a local private hospital has a walk-in blood draw service, so I called their head of phlebotomy who assured me that they were used to drawing blood using various different kits that people brought with them so it would be no bother - and best of all, they were open on a Saturday morning, which is when the time would be right to have Sheila's blood drawn whilst she was still a few hours ahead of the end of her 5-FU infusion; essential to ensure we were getting a steady state sample of 5-FU concentration in her system. It only has a 13 minute half-life, so timing is critical.
Before deciding on a Saturday to go for, I had to arrange shipping from the UK to Germany of a blood product. Hmm - that was the hardest part of doing this it turned out. I only know a little of international shipping through what I do at work and about shipping blood products across borders, I knew nothing at all. What could possibly go wrong?!
A search on the internet led me to TNT (now, Fedex) who have an appropriate service and provide appropriate packaging. Making the necessary arrangements wasn't easy. I'm lucky that I have my own company because Fedex only offer this service under a company to company agreement. If I didn't have my own company, I don't think I could have made this happen. Once the agreement was in place, we were able to move ahead; all the pieces of the jigsaw were now in place, but delivery and pick-up of a special box to ship the sample in, would be tight and critical.
The sample would be taken and prepared on a Saturday morning, Fedex don't ship blood products over the weekend because there's no one at customs to clear them and the shipping box has a finite life for temperature control and has to come from Belgium for some reason. That meant it wouldn't arrive with us until Monday morning for pick-up again, with the sample in it, the same afternoon for arrival at the lab the next day. Analysis would then need to take place no later than the Thursday because the life of the stabilised sample would be done by the Friday morning. It was nail biting stuff!
Anyway, all went well on the Saturday morning, Sheila bled well apparently, and in half an hour, we had three small vials of her blood plasma in our possession. Good job too, because the day before, I had had to confirm with Fedex to send their box on Monday! Monday morning, the Fedex box arrived as promised, I printed off the required Commercial Invoice (I knew about this bit from what I do at work), packed the box and sealed it and in the afternoon, it was picked up again, all as promised - it was such a relief to wave that off, I can tell you! I was then able alert the lab to its expected arrival the next day and track it all the way to Dortmund, where it arrived early on the Tuesday morning. By 10:30, the sample was being analysed using High Performance Liquid Chromatography, regarded as the gold standard of analysis, the results from which, are not disputed. Amazing - it had all worked! The difference in size and weight of the sample and its box will always seem somewhat anomalous to me though!
Then I had to figure out who was going to take a blood sample from Sheila; I was willing to try, but Sheila was having none of it. I kept telling her, trust me I'm an engineer, but it fell on deaf ears. LOL. Over the course of another week, I found out that a local private hospital has a walk-in blood draw service, so I called their head of phlebotomy who assured me that they were used to drawing blood using various different kits that people brought with them so it would be no bother - and best of all, they were open on a Saturday morning, which is when the time would be right to have Sheila's blood drawn whilst she was still a few hours ahead of the end of her 5-FU infusion; essential to ensure we were getting a steady state sample of 5-FU concentration in her system. It only has a 13 minute half-life, so timing is critical.
Before deciding on a Saturday to go for, I had to arrange shipping from the UK to Germany of a blood product. Hmm - that was the hardest part of doing this it turned out. I only know a little of international shipping through what I do at work and about shipping blood products across borders, I knew nothing at all. What could possibly go wrong?!
A search on the internet led me to TNT (now, Fedex) who have an appropriate service and provide appropriate packaging. Making the necessary arrangements wasn't easy. I'm lucky that I have my own company because Fedex only offer this service under a company to company agreement. If I didn't have my own company, I don't think I could have made this happen. Once the agreement was in place, we were able to move ahead; all the pieces of the jigsaw were now in place, but delivery and pick-up of a special box to ship the sample in, would be tight and critical.
The sample would be taken and prepared on a Saturday morning, Fedex don't ship blood products over the weekend because there's no one at customs to clear them and the shipping box has a finite life for temperature control and has to come from Belgium for some reason. That meant it wouldn't arrive with us until Monday morning for pick-up again, with the sample in it, the same afternoon for arrival at the lab the next day. Analysis would then need to take place no later than the Thursday because the life of the stabilised sample would be done by the Friday morning. It was nail biting stuff!
Anyway, all went well on the Saturday morning, Sheila bled well apparently, and in half an hour, we had three small vials of her blood plasma in our possession. Good job too, because the day before, I had had to confirm with Fedex to send their box on Monday! Monday morning, the Fedex box arrived as promised, I printed off the required Commercial Invoice (I knew about this bit from what I do at work), packed the box and sealed it and in the afternoon, it was picked up again, all as promised - it was such a relief to wave that off, I can tell you! I was then able alert the lab to its expected arrival the next day and track it all the way to Dortmund, where it arrived early on the Tuesday morning. By 10:30, the sample was being analysed using High Performance Liquid Chromatography, regarded as the gold standard of analysis, the results from which, are not disputed. Amazing - it had all worked! The difference in size and weight of the sample and its box will always seem somewhat anomalous to me though!
 |
| The sample |
 |
| The box - officially, a UN3733 Package |
On the Friday, the result came back and confirmed my suspicions that Sheila was being mis-dosed, BUT, my biggest fear had not been realised thank goodness. She was receiving too much 5-FU, in fact, a toxic level of it, 33% too much of it - she wasn’t being under-dosed after all, which was far more likely (from the papers I have been reading, around 65% of patients are unknowingly under-dosed); she was being over-dosed and whilst not as bad as being under-dosed, it’s still not good (around 20% of people are unknowingly over-dosed). It doesn't take a rocket scientist then, to work out that only a small proportion of people actually get the right dose without Therapeutic Dose Monitoring, does it!
We were so relieved to finally have this information, but I was also more than a little angry about it. I wrote a letter to Sheila’s oncologist right away and hand delivered it to The Christie, providing him with our result and giving him an opportunity to adjust Sheila’s dose, taking it into account.
You can read what I said to him by scrolling through my letter below:
You can read what I said to him by scrolling through my letter below:
At our next meeting with Sheila’s oncologist, we got his response, and believe me, it was way less than adequate.
Its horrific what you have had to go through.People's lives and quality of life is priceless. It shouldn't be about money or time restraints because there are too many patients.You are not statistics or guinea pigs
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