Blow to current On-X patients.

[Moo]

I asked my surgeon about the aspirin trial and he fowarded it to the On-X folks, this is the e-mail from the VP at On-X:

Dear Mr. Eodice:

2) Concerning an aspirin-only trial in the USA. We do have something akin to the European trial that is still in the planning stages. The final protocol has not yet been approved by the FDA. Unfortunately, I have been told that the FDA is also loathe to approve retrospective recruitment in such endeavors. When/if we have a trial of this type in the US, it will almost assuredly be with prospective patients only; that is, the patients have to agree to participate in the study before they get their new valve, not afterwards. To construct a retrospective trial would require the active participation of the institutions whose patients participate. In your case, Columbia Presbyterian would have to sign on (internal review board approval, doctors? agreements to participate, contracts, insurance, permissions to access confidential medical records, etc. etc. etc.) before such a study could take place. It is a rather massive and expensive undertaking for all concerned. I hate to disappoint you because I truly appreciate your willingness to participate in such a study, but I also want you to understand the reality that it is very unlikely to be available to you.

So, no guinea pig for me. Just thought I'd share.

Rich.

 

[jayaresq]

Take 2 Aspirin & Call Me In The Morning??

Take 2 Aspirin & Call Me In The Morning??

Rich -- The only other surgeon I consulted also presented the aspirin-only trial notion to me when recommending the On-X valve. However, that surgeon also indicated that such trials were 5 - 10 years away and faced significant regulatory hurdles. I, too, was intrigued, but later elected bovine. Still, I'll consider the On-X again, assuming I'll outlive the mooer I have now.

Of course, the good news about you not being a retrospective guinea pig is that if it turns out that the On-X Valve still requires a stronger anti-coagulant than aspirin, better that you read the lab results than be one. On the other hand, if it turns out for the best, you can happily (and safely) jump on the bandwagon then.

Until then, I'll root for a positive aspirin-only On-X clinical trial with you. Thanx for the info. -- Jim

 

[Ross]

On the plus side of things, at least they aren't lying or buffaloing you any about it. Too many others like to do that and get you hyped, all for a big let down.

 

[Guest]

I have to agree with jayaresq. I have seen many drugs in development over the years and the first thing I thought when I read Moo's posting was - minimum of 5 years.

For instance, if there should be a snowstorm on the day that just one hospital was going to have a meeting of one of these committees they mentioned, it might take 3 to 6 months before all of the members had a clear schedule to meet again.

Last year on Sep 10, AstraZeneca had champagne on ice for the party after the FDA approved Exanta. Instead the panel voted it down. There has been no apparent action in the last year.