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Johnson and Johnson discontinuing HAI pump

zx10guy
Posts: 240
Joined: Dec 2013

Just found out Johnson and Johnson is discontinuing the manufacture of the HAI pump used by Dr. Kemeny/MSKCC for treatment of metastatic spread to the liver.  I found this out from Colontown.  There are a few individuals there organizing a formal petition to get Johnson and Johnson to reconsider.  In the interim, it appears other options are being explored.  Based on the information I saw in the posts at Colontown, the closest replacement is one manufactured in Europe but is not FDA approved.

This is a total mess for those dealing with metastatic spread to the liver with limited options.  The New York Times is going to run an article next week on this.  In the interim, if you're so inclined, contact Johnson and Johnson and voice your feelings on this.

Ruthmomto4's picture
Ruthmomto4
Posts: 641
Joined: May 2013

how this will effect my husband’s surgery next week

Slow-runner
Posts: 54
Joined: Oct 2017

My husband has had a TACE procedure done to target his liver tumors, he will actually have a second one done next week to target the other lobe of the liver.  With TACE, Trans Arterial Chemo Emobilization, the blood supply to the liver tumors is blocked and chemo beads (that's my understanding) are infused into this blood supply.  This is done via the femoral artery much like an angiogram.  They can infuse chemo or radiation beads (TARE).  He is being treated at Penn, no mention was ever made of a pump.  Is this similar to the HAI pump?

zx10guy
Posts: 240
Joined: Dec 2013

No.  The HAI pump is an actual pump loaded with 5FU and is implanted into the patient's abdomen and stays there.  The pump is connected to the liver where the tumors are and injects chemo directly to that area.  There are quite a few cases where people have been brought to NED status for quite some years.  Much of the medical community dismissed this technique when it was first explored.  MSKCC and Dr. Nancy Kemeny didn't give up on it.  Now doctors and various cancer centers are going to MSKCC to get trained on how to use this technique just in time for the pump to be pulled from the market.  The best study which is using some old data shows a significant improvement in patient survival.  On average 2 years more than someone going through standard treatment.  And the doctors point out while the data wasn't done in a fully scientific way, it is still valuable and they note the patients in the data were very sick to begin with; ie were starting in a very poor situation.  Given this fact, the 2 year increase in survival is even more remarkable.

Slow-runner
Posts: 54
Joined: Oct 2017

I will ask about this with our doc but if they're ceasing manufacturing I quess it's not much of an option for us. 

zx10guy
Posts: 240
Joined: Dec 2013

I'd still ask.  There are still some pumps out there.  Also not many docs know about this procedure.  The more the word gets out the more pressure that can be brought onto Johnson and Johnson (actually the company that produces the pump is a subsidiary of J&J) to reconsider their decision.  If anything another manufacturer may step up to fill the demand.

tanstaafl's picture
tanstaafl
Posts: 1292
Joined: Oct 2010

There are other brands of HAI pump, not sure of the differences. 

zx10guy
Posts: 240
Joined: Dec 2013

There are other pumps out there but none that are FDA approved for this type of application.  From what I've read, the closest replacement is one that is used for spinal therapy.  And the problem is the pump still needs to be modified for hepatic use.  And of course, because the pump is being used for an application it wasn't ceritfied for, it has to go through the whole FDA approval process.

Ruthmomto4's picture
Ruthmomto4
Posts: 641
Joined: May 2013

they didn’t tell us, he is still scheduled to get his put in on Tuesday.

zx10guy
Posts: 240
Joined: Dec 2013

MSKCC bought a bunch to have in surplus.  Once those supplies are gone, they're gone.  I don't remember how many MSKCC bought but I seem to recall 100 of them.

PhillieG's picture
PhillieG
Posts: 4906
Joined: May 2005

I’ve had my pump since September, 2004 and have no plans to remove it. I’m stunned that J&J is discontinuing production. Here’s the NYT article https://mobile.nytimes.com/2018/04/25/health/liver-pump-cancer-medical-device.html

Ruthmomto4's picture
Ruthmomto4
Posts: 641
Joined: May 2013

My husband is getting his put in tomorrow along with a liver resection and the literature on the don’t do list was making him want it immediately out. The no running, lifting anything heavy, and problems on airplanes were kind of bothering him. Is it really that restrictive?  At first I thought even without chemo it had to be filled every two weeks but then I saw non chemo can last up to six weeks. 

I know it will be an adjustment but I think he will do better than he thinks he will with the lifestyle change of it.

PhillieG's picture
PhillieG
Posts: 4906
Joined: May 2005

It is a long time. The reason I’ve kept mine in is that once it’s removed it can never be reinstalled due to the scar tissue that would be left behind. After this long with no problems with my liver since it was initially implanted I could probably have it removed and be OK. My thoughts are that 1: I don’t want another surgery unless it’s really needed. 2: It would be my luck that I’d need it after it’s been removed. I’m not willing to take that chance.

As far as the do’s and don’ts go, the reasons why they want you to avoid some activities made sense. You don’t want to jar it so it stops working. Over time my body accepted it with no problem. I wasn’t a runner but I’ve been an avid kayaker and bicycle rider and had no issues. I ran into a problem where I lifted something too heavy and wound up herniating my abdominal cavity. That was stupidity on my part. I should have worn a support belt or, dare I say it, asked for help. ;-) I think the flying restrictio was only for when the pump is actively pumping chemo, not when it’s just in maintenance mode. I rarely fly so it was a non-issue for me. I get mine ‘primed’ every 6-8 weeks which isn’t an issue since I’m still receiving treatment. 

I’m a strong believer in attitude. It sounds like you know your husband and I think he’s going to be ok with the adjustment. The payoff for me has been well worth it. From being given less than 1 year to being 14 years into this is great. 

I hope your husbands surgery goes very well today. Please post an update when possible. 

-p

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