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.

Me and my pump

So this, I believe, is a picture of a pump much like the one that’s now inside me. It’s a clever device: one compartment holds the chemotherapy, while the other holds freon, and my body heat causes the freon to expand and push the chemo in the other compartment out via a catheter to the vein serving my liver.

It’s also, as the picture suggests, surprisingly big! I think the true size is about 4 inches in diameter, probably a couple in depth. You might ask – I certainly wondered – how can this thing fit? I mean, wasn’t all the space inside my abdomen already in use? The answer, however, is that it fits in with no trouble at all. The surgeon makes a horizontal incision, to the left of and just a little higher than my navel, and pops the pump in. All right, he probably doesn’t do anything that should be called “popping.” But he (my surgeon was a man) inserts the pump, and evidently everything else in the area shifts around a bit and the pump is in! Then he closes up the incision and glues it shut (yes, literally, glues it shut; the glue on mine is slowly wearing away now, which is fine since my own healing process has taken over), and if all goes well it remains there for the rest of my life.

Just to be clear, inserting the pump isn’t the whole surgery. It’s also necessary to connect the catheter from the pump to the vein serving the liver; this catheter is probably 8 – 12 inches long because that vein is actually some ways away from the pump’s resting place in my lower left abdomen. And to make sure that the chemo that will flow through the pump actually reaches the whole liver, the surgeon had to redesign my liver circulatory system somewhat – cutting off, as I understand it, a vein that used to serve part of the liver but which branched off the main liver vein too early to receive the chemo from the catheter a bit downstream. They also took out a couple of lymph nodes, as part of this redesign. And they took out my gall bladder: that’s a cholecystectomy, in case you were wondering, and is necessary because the chemo to the liver is likely to cause the gall bladder to die. The gall bladder is almost as useless as the appendix, but like the appendix you don’t want it dying inside you.

Doing all this other stuff required a second incision, straight down the middle of my abdomen from a little below the breastbone down to the navel. The incision actually bends around the navel; I thanked the surgeon for keeping my navel intact and he told me it’s “bad form” to cut through it. This is the incision that I had staples in – but they’re now long gone, and the incision itself is a straight and narrow line down my abdomen. I wouldn’t say I’m going to look great on the beach, but the fault won’t be with this incision. The only remaining problem is that one small part of the incision opened up – leaving me with a hole maybe a centimeter and a half long, and part of a centimeter wide and deep. I found this completely creepy, but the surgeon and his nurse were unfazed, and instructed Teresa on how to dress this small wound with gauze twice a day. She’s been doing that as if she’d been dressing wounds all her life, and just as the doctor said, the wound is filling itself in – from the inside out!

Meanwhile, a wonderful thing is happening. The most lasting effect of the surgery on my overall condition was that it robbed me of energy. Walks that I’d have thought as a month ago as very short now left me clammy with sweat. But all of a sudden – I’ve felt it over the past three or four days – my energy has begun to return. I’m not at 100 per cent by any means, but I feel much more like myself. And that’s even though I’m now 10 days into the first round of chemotherapy delivered via the pump; precisely because this chemo goes directly to the liver, and evidently is almost entirely absorbed there, the side effects on my body as a whole are likely to be modest. They watch the liver carefully, though, to make sure it’s not being overwhelmed by the medicine it’s receiving. So: so far, so good.