On-X in FDA trials

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John-3919

Member
Joined
Aug 7, 2019
Messages
16
I was asked to participate in this study. I decided against it because I’d rather get back to as normal of a life as possible right now post-op and not worry about whether I would end up with a bad reaction to a drug in testing.
I would hard pressed to believe that the chairman of cardiology at the Cleveland Clinic would be leading a study with bias to pad the pockets of big pharma.
I’m happy to stick with warfarin currently due to all the reasons listed by others above, but I don’t see new medications as bad moving forward. Costs come down with time (hopefully).
It certainly seems that most people on this board are more proactive about their warfarin management and play a more active role in their personal care, but for the large amounts of valve patients who don’t have the will or means to do so these sorts of advancements could be life savers.
 

rwsp768

Well-known member
Joined
Sep 15, 2005
Messages
63
Location
Olympia, Washington
Here is my take on this. Back in 05 when I found out that I was in need of a AVR and because to my age I would get a mechanical valve which meant I would be on Warfarin the rest of my life. I then went on line and found this site and that the ON-X was the best around, in that in Germany studies were being done on reducing the warfarin and increasing aspirin to 100mg. Now I know had slow our government works I felt it would be at least ten plus years before the FDA would adopt this if ever. The following year I received a email from a gentlemen locally that had gotten selected to take part in a study on reducing warfarin with the ON-X. This program was being given at Tacoma General, I never heard of the results but ten years later FDA approved of the reduction, however no mention was made to the 100mg aspiring. So don't hold your breath that FDA will approve this.
 

pellicle

Professional Dingbat
Joined
Nov 4, 2012
Messages
6,922
Location
Queensland, OzTrayLeeYa
Hi

I was asked to participate in this study. I decided against it because I’d rather get back to as normal of a life as possible right now post-op and not worry about whether I would end up with a bad reaction to a drug in testing.
fully understandable ...

I would hard pressed to believe that the chairman of cardiology at the Cleveland Clinic would be leading a study with bias to pad the pockets of big pharma.
well actually that's pretty much exactly what part of his role is. It is to (subject to ethics considerations) seek out any study which will bring research funding into his organisation. Hospitals like Cleveland are research hospitals. While he may have some questions about is this a warfarin replacement (which nobody is suggesting it is) he may indeed be very pleased to have a warfarin suppliment for reasons like patient compliance and testing.

It certainly seems that most people on this board are more proactive about their warfarin management and play a more active role in their personal care, but for the large amounts of valve patients who don’t have the will or means to do so these sorts of advancements could be life savers.
well personally I think being proactive and dilligent in managing the drug which we need to ensure good health is a bad thing.

Exactly as yo usay however there are some patients who (perhaps infirm, perhaps even mentally incapable, perhaps even stuck in a pernicious system which mis manages them and badgers them to not leave it) who would be benefited from a new drug which fulfilled the promises of no side effects, no testing needed and doing a good job of preventing thrombosis.

Equally though there is the wider world than the USA participating on this forum and many of us (even some American Citizens) are just out of pocket for everything. Actually (having read here) that can also be a good thing, because it also brings freedom. For instance I'm an Australian and fully free to self test and self administer. At first my Dr was involved (he writes the prescriptions after all) but it didn't take much for him to see that I was doing a better job than the Clinics.

Self testing also brings with it a freedom to travel, and depending on where you are in your life being free to pack up and go to Finland with no return date needed is valuable, nay liberating. There are others I know who are often travelling for their work (still in their 40's) and self testing is just a small thing to pack in their bag.

Sure, its possible that the drug under evaluation here will work better in the day to day (for years and years) for the patient, but we just don't know yet. Meantime there are still people working with warfarin and who will perhaps feel that the price of warfarin and testing is lower than a new drug.

Still, all this is premature because it has not yet completed trials, nor has it been approved.

All I see in this thread is a number of us old hands expressing "we don't mind the way it is" and other people getting unhappy with that. Research is good and welcome, but I don't place advance bets on the outcomes especially when the existing system serves me well.

Lastly unlike yourself I make a significant effort to stick around (no judgement, just obvervation) to actually provide practical help to people who are bound to manage their INR. I know those people have benefited from my assistance in a tangible way, not just a "emotinallly supportive" way. Not that both aren't needed, its just I'm more a practical man than a hugger.
 

Protimenow

Well-known member
Joined
Aug 10, 2010
Messages
3,130
Location
California
"So don't hold your breath that FDA will approve this."

Doctors prescribe drugs 'off label' all the time. If they see that it's already been approved for people with A-Fib, and is now being investigated for people with mechanical valves, some 'brave' doctors may risk their patients' lives by jumping ahead of the study and prescribing Apixaban to some of their mechanical valve patients. They may not want to wait for the outcome of the clinical trials -- especially because it takes SO LONG for FDA approvals. There may be some anecdotal reports of its success (or failure) at managing prosthetic valve patients' INRs. There may even be some journal articles about use of Apixaban as an off label prescription to prosthetic valve patients.

If Apixaban wasn't so expensive, and warfarin so inexpensive, there may be more 'testing' of 'off label' Apixaban for patients with prosthetic valves. A few more free lunches for a doctor's office staffs, a few more expensive dinners, and maybe a free trip or two, and, without specifically advising the doctors to prescribe off label, we may begin to see an increase in doctors 'brave' enough to try it on some of their patients - On-X or other valves.

The fact that a clinical trial has been approved may inadvertently give some credibility to the safety of off label use for On-X (and maybe other) prosthetic valve recipients.
 

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