awareness

[warrenr]

The FDA says nothing about bridge therapy.

Evidence-based medicine has a serious flaw in that their "gold standard" is the randomized, double-blind, placebo-controlled study. Obviously this is impossible to perform in many cases. Who wants to be in the group that gets the salt water instead of the Lovenox. The neurosurgeon at our hospital is fond of saying that most of what he does has no evidence to support it. For instance if he gets someone with a broken neck, there is no evidence showing that people do better if he repairs it. This is because there has never been a large group of people who were assigned to the group to have nothing done to see if people who had their neck repaired really did do better than those who did not.

There are many studies showing that bridge therapy is effective, but they do not meet the gold standard level. When a drug is approved, then physicians may use it for "unapproved uses". However, there is some resistance. Hospital legal departments may express reservations - limiting its availability. Insurance companies may say that it is experimental and refuse to pay. Then there is always the threat of a lawsuit lurking in the background. So this puts doctors in the position of being liable if they do nothing as in the case of Warren's dad and being liable if Tom's bleeding from his hernia surgery had resulted in the need for a blood transfusion which could have caused him to become a victim of another disease.

As I wrote this, I became aware of another solution. Why not instigate a letter-writing campaign to the FDA. Somebody can find the address for public comments. It would also not hurt to follow-up with a copy to your representative and senator. After all this is an election year - who knows what strange things happen in those years.
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Al Lodwick, R.Ph.
Certified Anticoagulation Care Provider
www.warfarinfo.com
Warfarin Institute of America

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#35 Today, 10:05 AM
warrenr
Registered User Join Date: Apr 2004
Posts: 3

Awareness

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Last week, the Today Show ran a series on Colonoscopy. They made it sound like the best thing since sliced bread. I agree with the importance of the procedure but they did not talk about any of the complications which most of you on this sight face because of your valve replacements and or warfarin/coumadin therapy. I emailed "[email protected]" all of the replies that are on this sight concerning what happened to my father. Don't think that they will fully understand the problems that can be encountered by all of you when preparing for colonoscopy. Maybe if they understood the gravity of the situation and the ignorance of most of the medical profession concerning bridge therapy they would talk about it on national television. Maybe if everybody on this sight emailed "[email protected]" they would get the message out and that would be great for everyone, even the hard headed no it all doctors.

 

[tommy]

I'll write a letter to the FDA.

Warren, thanks so much for sharing your story and spearheading this conversation. I'm so sorry about your dad.

Hank/Ross, my continual thanks for this site and forums where we can learn, share, and help each other.

 

[ccrawford]

Katie - I've been out of town and without access to the net. In reply to your question, I have a query pending with one of my docs. Actually two: Number one is : If bridge therapy is not a universally accepted standard, what do we have to do to make it one ? Please realize this is a very big question. Only somewhat smaller is #2: If Lovenox (being more cost effective than a Heparin drip) is not approved as a bridge therapy, how does one get it approved without a full blown drug trial ? Al can probably add a little welcome perspective to these two questions. Chris

 

[Guest]

I have never heard of any medication having an FDA approved use forced upon it. The drug company has always sponsored the research.

 

[ccrawford]

If I may paraphrase, Al, what you are saying is that to get Lovenox approved for use as bridge therapy, the maker of this drug would have to incur additional cost in its process of applying to FDA to get approval to use the drug in a different way. What we don't know is how much this might cost and whether or not to drug manufacturer is willing to do this. Assume, for the moment, that we were successful in getting this done. Then an obstacle would be removed. There is still a huge awareness issue to deal with. One of the first steps in the process is to figure out who the audience is. In our case, we have two, and they would have to be approached differently: The docs would need some authoritative source (that they respect) to make a strong case for bridge therapy per se, and this message would have to get out to all of them who play a role in invasive procedures on Coumadin/Warfarin users. Patients are the second large group. There are about 8000 new valvers each year, and some portion of these are mechanical valvers and therefore are Coumadin/Warfarin users. I'm not aware of any one list of these patients, but I'm guessing that the makers of the artificial valves are the best source; if they would release the names. I'm not trying to be pesamistic, just trying to get at a realistic method for making a difference. Would sure encourage as many other thoughts as possible. By the way, who the heck makes Heparin and Lovenox ?- these are not pills so my pill book is of no use.

 

[Guest]

The cost to get a new Indication (reason) for using a drug runs into the millions. There is very little incentive to go through this process. For one thing the patent probably expires soon and then it will be generic. Hardly any research is funded for generic drugs. The generic companies move in and the price goes down which is a strong disincentive to research. Also the doctors who want to use bridge therapy are already doing so - thus the company gets the money without paying for research and they have much less liability than if they recommended it.

Heparin being the old drug that it is has several generic manufacturers. It mainly comes from hog mucosa (the lining of the stomach). Aventis makes Lovenox and it is made by chemical modification of heparin.

 

[ccrawford]

Al - Am I reading you right in saying that you do not think it is necessary to get additional usage approval for Lovenox as a bridge therapy tool ? Is lack of official approval a barrier to some docs ? Chris

 

[Guest]

Once a drug is on the market there is no legal restriction against a physician using it for anything deemed necessary. UNLESS there is some specific prohibition in the official package insert. In fact, most drugs are used in doses or for reasons that are not in the official package insert. That is why there are so many medical journal articles about the use of various medications. There is always research being done.

The official Coumadin package insert only says that warfarin may be used to prevent clots in people with mechanical heart valves. The FDA has never ruled on what INR level should be maintained for various conditions. This is all expert opinion.

In fact, as recently as 1988 the FDA allowed a study to be done on people with mechanical heart valves where some of the people did not take warfarin. Some took dipyridamole and aspirin. So many more people in the non-warfarin group had clots that warfarin became the standard therapy. This is why I say that everyone owes a word of thanks to RCB who started taking warfarin back in 1960. He was truly a ground-breaking pioneer.

This lack of approval can always be used as a roadblock by people who do not want to do something. It can also be used by insurance companies to deny payment.

I think that the best thing to do at this point is to wait and see what the Amercian College of Chest Physicians recommends in their new guidelines that are due to be released on the 22nd.