The end of the intrahepatic pump?

I was amazed to learn today from a friend at the Cholangiocarcinoma Foundation that the sole manufacturer of the intrahepatic pump, also known as the “Codman pump” – which I have in my abdomen, and through which I’ve received chemotherapy since it was surgically implanted in August 2016 – plans to stop production. But this is in fact the case, as the New York Times reports.

Dr. Nancy Kemeny, a Memorial Sloan Kettering doctor who was “a pioneer in using the pump,” is quoted as saying: “I don’t know what we’re going to do …. We have enough for another month or so.” The Times reports that “[a]t least 10 operations to implant the pump at Sloan Kettering have been postponed” already, and apparently similar things are taking place at other medical centers.

The manufacturer in question is Cerenovus, which is owned by Johnson & Johnson. It “told doctors in a letter dated April 4 that it had decided to stop production effective April 1 ‘because of significant and multiple raw material supply constraints within the manufacturing process.’” That explanation is interesting for what it does not say: it doesn’t assert that in fact the supply constraints made production of the pumps impossible, nor does it say that these constraints even made production unprofitable. They evidently sell for $7000 - $11000 each, which you would think would cover quite a few supply constraints.

Perhaps Cerenovus could have said more, but the letter certainly permits the impression that the company just can’t be bothered with the burdens of producing this minor item on its product line. Apparently there are only about 300 of these pumps sold each year in the US (although medical interest in them is said to be growing just as they’re ceasing to be available), and somewhat more than 1000 people have received them in total.

1000 people isn’t that many – unless you happen to be one of them. I am. Though the pump is used for people with a number of different cancers, I react to this company’s decision as someone with a rare cancer, a cancer for which the pump is a valuable treatment that is now to be discontinued for reasons, at least according to what the company has said so far, not of necessity but of something less. (Fortunately for me, the pumps don’t have to be returned; the people who won’t have access to treatment are the ones who would receive them in the future. Maybe not so fortunately for me, Teresa tells me that the kits used to load and unload the pump every two weeks are also made by this same company. Will they decide to stop making these too?)

It’s also notable that Cerenovus only sent notice to doctors on April 4, telling them that its decision had already taken effect on April 1. There’s also no suggestion in the article that there was any prior discussion with doctors before the decision was made. This is not a company trying to proceed in a consultative manner.

Can anything be done? The Food and Drug Administration says that it doesn’t have the power “to compel manufacturers to sell a specific product,” and that’s not surprising in a society that respects private property as much as ours does. There may be substitute products from other companies, though whether they are as good as the Codman pump I do not know. 

But even though Cerenovus and Johnson & Johnson may be immune from legal requirements, they certainly aren’t immune from popular pressure. So I hope you will visit their websites, their facebook pages, and your representatives in Congress and express in every way you can how disturbed you are by this position. And if you feel like telling Johnson & Johnson that you’ll be boycotting their other products, such as Band-aids, Benadryl, Tylenol and Motrin, until they change their mind about producing the Codman pump, well, that would be really good too.

Back to treatment

Last Friday, March 9, Teresa and I made our way back to MSK. I wasn’t terribly optimistic. The last time I’d been taken off treatment because of my liver’s reaction to the chemotherapy – in the fall of 2017 – it had taken two months before MSK was satisfied that my liver was restored to health. This time it had just been two weeks. I also hadn’t been feeling that well (more on this below), so I didn’t have any strong intuition that everything was now working as it should inside me.

But our experience on March 9 was completely different from what it had been on our previous visit, on February 23. That time the whole process of getting my blood tested and the reports submitted to my oncologist had gone awry, with the result that when we left the oncologist’s office we didn’t know, and neither did she, what my blood numbers actually were. This time the testing took place promptly, and when we arrived in the oncologist’s office her staff already had my results (though they weren’t yet completely posted on the MSK portal so that we could see them too).

The results were good. In fact they were really good. All my liver numbers were back in normal range. Meanwhile my platelets, which had dropped quite sharply (platelets aren’t a liver issue, but platelet production can also be affected by chemotherapy; in fact, this is a quite common side-effect), were now also back solidly in normal range. This particular change no doubt owes a great deal to the many platelet-encouraging foods that Teresa had fed me since our February 23 visit. (Papayas, avocados, lentils – platelet foods are good!)

Even with these good results, the oncologist might have felt more time off was needed. I’d had pretty good blood work at one point during the previous chemo holiday, and MSK had felt that what I needed then was additional downtime. But this time there was no delay. The actual chemo dose was reduced – just a little, the oncologist said – and later that morning it was injected into my pump. So I’m actually on chemotherapy, via the pump, as I write this.

That’s the good news, and the main news. The only fly in this ointment is that I’ve had a return of the painful stomach cramping that I’ve written about on this blog in the past. The worst night was Tuesday, March 6. As it happened, that night we were at Teresa’s mom’s house because of an impending snowstorm. We knew that Teresa would need to be there to deal with the snow – her mom wound up with about two and a half feet in her backyard – and though the snow wasn’t really due in force till Wednesday, it seemed best to be there in advance. And Teresa was concerned that if she left me at home while going to take care of her mom, I might suddenly need her help too. I didn’t think that was very likely, since I hadn’t had any sudden episodes in quite a while, but I conceded the point. Up we went to her mom’s house (it’s about 15 miles north of ours), and almost as soon as we got there my stomach went on the blink. About 5 hours later, when I was completely emptied out, it settled down, and the next day I felt just about normal, and while the snow came down in really remarkable quantities I was able to do some writing. 

The best thing about this digestive trouble is that it doesn’t actually appear to be a symptom of my illness. Instead, the word the oncologist used – and Teresa had also picked up on – is “kinks.” Not kinks of the sensual kind, but rather of the plumbing variety. There’s a lot going on in my abdomen these days: the chemotherapy pump itself, the catheter leading from the pump on my lower left side over and up to my liver, the surgical staples and maybe some scar tissue left over from the surgery that installed the pump, and of course the liver itself, functioning pretty well but still hosting a bunch of tumors. The net result: sometimes things get blocked. The cure, besides patience, may actually have something to do with relaxation and visualization of unblocking – though in the middle of one of these episodes, peaceful visualization is not easy to achieve.

Anyway, no real harm done. Still, the issue hasn’t quite gone away. I haven’t had anything like a full-blown stomach episode this week but I’ve had more discomfort than I would have liked. I’m taking as many medications for digestive issues as I can, hoping to get things to become once again uneventful, and reminding myself that I should be visualizing an unkinked digestive system.

My current chemo -- an update

I’ve now had two rounds of the new regime – an infusion of mitomycin over a 45-minute period, and a two-week infusion of FUDR, both injected through my pump. Now I’m in the two-week off period that follows each round of treatment, and soon I will have a scan that will say whether the new treatment is working.

Meanwhile, I’ve learned more about the treatment itself. First, I’m pretty sure now that I was wrong to write after the first set of infusions that a single needle seemed to have been used for two separate insertions, one for each of the two drugs being injected into the pump. In hindsight, that doesn’t really seem conceivable, and my impression from the second set of infusions was that in fact a new needle was used for each of the two drugs. I guess the sheer size of those needles distracts me. (They need to be long, by the way, because they’re not primarily going into me – instead they’re going through a little bit of me on the way to their target in the pump. But even the nurse for one of the rounds agreed that they are big needles.)

Second, yesterday for the first time I grasped how much of the FUDR is actually going to my liver in the two-week infusion process. The answer for the past two weeks was: 18 cubic centimeters. I know this because the nurse drained 12 cc’s  of the drug from the pump, and she explained that they expect to drain between 10 and 15 cc’s – out of a total of 30 cc’s that they put in at the start of the process. (Once the medicine is drained at the end of the two-week treatment period, by the way, the pump is then loaded for the two-week off period with an inert substance, a mixture of saline solution and heparin, an anti-clotting agent.) So that means that over the two weeks of the infusion, just a shade over 1 cc of FUDR was making its way to my liver each day. That must say something about how powerful a drug FUDR is. I hope that power is making itself felt against the tumors. It’s also probably having some impact on my healthy liver cells, but fortunately the blood test results show that my liver is doing well despite these medical affronts.  

Third, after the latest infusion I had two or three days of abdominal discomfort. It appears that this may have been, essentially, acid reflux, and fortunately the treatment Memorial Sloan Kettering prescribed – increasing my anti-acid reflux medications, including the old standby, Pepto-Bismol – seemed to address my symptoms. But what was most surprising about this was the comment of the MSK nurse, who told me that any use of the pump, even with inert substances, can cause difficulties like this. This I suppose is further proof that you can’t fool Mother Nature – if you put a foreign object inside your abdomen and inject things through it to your liver, your body may acquiesce but it won’t necessarily be pleased.

-->

Still, if the scan results are good, I’ll be happy to continue treating acid reflux!