Thanks Cavey, glad to see the pharma community acknowledging this concern.

Nothing new there that hasn't been said all along by the healthcare or patient community. The one-size fits all dosage that is currently being used has always been a concern. Even me as a non-heahcare professional has always stated that in the future as more research becomes available I suspected dosage would be individualized to each patient. Problem is, there still are a lot of unknowns. And by all means, patients should be well advised by their doctor before being put on any of the new anticoagulants.

The big difference between the new generation anticoagulants and warfarin is that warfarin is a narrow therapeutic index (NTI) drug and the new drugs are not, so warfarin needs to be monitored continually. I think what this article is implying about the newer drugs is that checking plasma concentration to determine effective dose would improve safety, not that regular monitoring is recommended. I would think once the ideal dose is established, monitoring wouldn't be necessary, since diet, etc. don't influence their efficacy. The same is done for most drugs in people with hepatic or renal insufficiency. Monitor blood levels to make sure they aren't toxic. People metabolize drugs differently, so everyone will respond differently. It just makes sense to do an initial test to make sure blood levels are within the "theraputic window." JMO

The issue Is about data and info being suppressed for marketing or approval purposes. I really doubt patients are aware of that. And I would be shocked that an average doctor really understands that as well. It's not just hematologists and cardiologists experienced with strokes, heart issues and clotting issues prescribing the new drugs. GPS and Internists with an array of anticoagulant patients prescribe them.

I'm not against the new anticoagulants at all and we need people to take them so we can understand long term use and effects, but I can see how being hell bent on marketing these meds as a more convenient alternative to warfarin makes it very easy for companies to not be entirely forthcoming with research.

Sorry should be GPs (not GPS, ha ha!).

Thank you all for your comments. RMB----

"The issue Is about data and info being suppressed for marketing or approval purposes."

I agree completely with you---- What happened to 'transparency'?

Jenner---- you said:
" I would think once the ideal dose is established, monitoring wouldn't be necessary, since diet, etc. don't influence their efficacy. "

Hmm. That's certainly sounds plausible. I wonder if it will shake out to be true.

Actually, I find that information to be really interesting and I'm glad cave shared it. I don't read absolutely everything about the new anticoagulants because what I do know of them, I already know they're not a viable option for my treatment right now. However, I am generally more aware than your average patient, but I wasn't aware of the benefits of blood monitoring for it.

What's a shame about the suppression of this information is that it seems to me that with blood monitoring, the medication has the potential to be far safer than warfarin (a 40% reduction in major bleeding risk vs well-controlled warfarin). That's extremely appealing to someone like me who needs to take anticoagulants for a very, very long time, although I still would like to see improved reversal procedures for it. I don't remember specifically seeing it, but my assumption is that the medication unmonitored is roughly as safe a well-monitored warfarin?

It is concerning, though, that this information has been held back from doctors and regulators, all in the name of making the drug more appealing as a one-size-fits-all model. Anyone who has to take anticoagulants long term has so many things to balance in order to decide which decision they are most comfortable with, and we depend on the partnership with our doctors to help us make those decisions. We need as much information as we can get to make the best decision. If information has been hidden to make a medication more appealing, and basically only comes to light due to litigation, it just kind of leaves a sour taste. Part of the reason why people like me hold back on new medications. I want for them to work for me, but I don't trust that the manufacturers of these medications have my best interest at heart, and I have too much to lose to be a guinea pig.

RetiredNavy, you say that this is 'nothing new' among the healthcare and patient community, but the thing with that comment is, first, the article said information WAS held back from doctors, so apparently not everyone in the healthcare community was aware. And second, I think don't think a majority of the target patients were necessarily part of the 'patient community' when they started treatment. I mean, when I got PE in the beginning, I was pretty much a complete innocent and had to trust my doctors to guide me. Most of the other patients here were probably in the same situation, and those who take the new anticoagulants were probably similarly guided by their doctors, and "sold" on it because they don't need to monitor. So yeah, I think there's value in having an article like this referenced here, for people to take into consideration, especially if they eventually need to use anticoagulation long term rather than just a few months.

In any case, while it was long, that was interesting to read, and I agree that people taking these medications should definitely be aware and take all of it into consideration.

Shilosmommy------ Because the newer meds are being fast tracked now it's often the patients that are replacing the last phase in a study. Well, that's all well and good (not!) except I don't want to be one of those guinea pigs. :)

You said:
" If information has been hidden to make a medication more appealing, and basically only comes to light due to litigation,"

Yes! So it's O.K. UNTIL you get caught!

A rush to publication for a book simply means there are typos and grammatical errors in the book. What happens when there's a rush to market for a serious drug?

Thank you for your comments.

Did anyone else beside me read the 2 comments for that article (by health professionals)?

Here is the link to it------ enlightening to say the least.

http://www.medpagetoday.com/comments.cfm?tbid=46901

Yeah, I did read the comments and it looks like more were added after reading this yesterday. I think the second comment is the most compelling. Also one of the comments mentioned initial monitoring which Jenner talked about.

I know from discussions with my own doc (who is not ready to prescribe the newer anticoagulants to his patients yet until more is known about the effects and experience) that the level of non compliance with his warfarin patients is really high because they don't test regularly or they screw up their dosing, so it would be a relief for providers to be able to have an alternative that requires less stringent management.

I really do support having new medications; I believe that the more options we have the more it does open the doors for more individualized treatment. But we should ask questions of our providers and look at the data critically. You can't do that if not all the information was provided at the get go during the research.

I believe the excitement over these new meds, and they way we advertise and market medications in the US can foster short cuts or spin in some cases. That's not to say don't take these new meds. Not at all. But I guess I'm realistic when it comes to who I think is looking out for me, and that would be no one but me. So it comes down to just making sure you know what you don't know, if that can even make sense, ha ha !

One of the responders, in the Comments, said:
" No monitoring is like driving blind-folded"

I HATE Coumadin. But at least I'm not driving blind-folded.
It's sad that in this Internet era that people don't take advantage of all the information there. I'm not talking about just reading USA News or FauxNews or Dr. Oz.

There are many 'watch-dog' sites now available to read. Those involving my health are the ones I read on a regular basis.

One is www.healthnewsreview.org
That is Gary Switzer's site (and others) who discuss from the journalistic point of view---- which is where most people get their health news (not PubMed readers).

Another is http://www.fiercepharma.com/

But I also read them with my Critical Thinking Cap on. :)

https://www.youtube.com/watch?v=6OLPL5p0fMg

Don't even get me started on Dr Oz...

Shilosmommy, my comment simply meant that from the beginning the medical community acknowledged there was not enough research to really know and understand if the recommended dosage was right for all individuals and that they don't truly know how long the new medications really stayed therapeutic in a persons system. This risk was explained to most new Xarelto patients I have spoken with. My doctor was up front with these concerns when we discussed switching of Coumadin to Xarelto. We were told that 20mg dosage was "supposedly" equivalent to a 2.5 INR according to pharma but acknowledged their doubt.

Many physician concerns go back to when Xarelto was only approved for hip/knee replacement. I'm not saying all doctors were up front with these concerns, but a majority of the patients I have spoken with were informed of this when making their decision. These concerns were realized even without knowing pharma was withholding information which now confirm the suspicions which we already suspected.

Of course I'm sure there are doctors who didn't address any if these concerns also. I'm also sure know that these medications are being prescribed more often then they initially were when I started that doctors may not be as upfront about concerns. In the beginning it was mostly specialist prescribing them which may reflect why some patients were more informed about potential risks/concerns. Now PCm are prescribing them.

Hope this makes some sense??

This is exactly the reason I think the US should outlaw brand-name prescription drug advertisement. I'm not saying the public shouldn't know that there are treatments out there for psoriatic arthritis or insomnia or anticoagulation or fibromyalgia, I'm just saying that the ads should stop there and be co-sponsored by all manufacturers of such drugs and be Public Service Announcements.

It would be enough to have an ad that said, "Do you suffer from acid reflux disease? There is help out there for you, with a wide choice of medications and treatments. Don't suffer needlessly. Make an appointment to see your doctor, who can help you make the right choice for you." Period.

Because I see these ads that say basically, "warfarin is inconvenient and decreases your quality of life, so take these new medicines, which are more convenient (and therefore better)". The one that really gripes me is the one where the lady is asked if she's going to the museum today and she says, "No, I'm going to Rome" and the next person asks if she needs a domestic flight and she says "Not this time" etc. etc. etc. implying that warfarin will keep you from living a perfectly normal, active life.

I know that people who are currently on warfarin know that this is so much bovine fertilizer, but I believe they are targeting two groups: those who can't be bothered to be compliant with warfarin who will see this drug as "easier" and those who will be making an anticoagulant choice in the future. They'll remember that word "warfarin" as meaning that they have to live a limited, inconvenient life basically as an invalid and the other brand's name as being the choice for hip, active people who want a "real" life.

I don't like the advertising of prescription meds either. It's not like I'm an anti capitalist or am against companies making money. That's not it. I just think it's a strange thing to advertise to the general public. A person can't purchase these without a doctor prescribing them. And they really are manipulative, although that's the crux of advertising anything I suppose. It's meant to persuade.

If see one more ad for Cealis where some middle aged man is giving his wife a loooong, creepy stare, I may vomit.

But, I digress...

Ah, yes, Cialis. (grin) You can get free Cialis but just try to get an antibiotic to help for a necessary disease!

BTW--- Unless Europe has changed recently there are no TV ads for prescription drugs. They should be banned in the US too, I think, given that most people won't bother to do the research necessary and given that many of our MDs here are too willing to throw a prescription at their patients to get them out of the room under the 12 minutes allotted face time.

RetiredNavy, thank you for clarifying what you said earlier, which when I read it sounded as if you were saying, Yeah, duh, everyone knows that. And my feeling is that most patients aren't aware of this, in particular since the medication has started to be heavily marketed. And I still feel like even among doctors, the go-to thing with this is 'you don't have to test, you can eat whatever you want'. My cardiologist (who I consider a specialist who works frequently with these medications) didn't mention anything other than that testing is unnecessary if I were to switch to Xarelto, and I've found him to be a very good doctor who stays abreast of the most current information available.

RMB, you crack me up talking about the Cialis ads! I can't stand those either, and I thought I was the only one who thought most of the men look more like stalkers than husbands!

LJHCNMT, I know exactly which ad you're talking for Xarelto or whatever it is that has the lady who's life is suddenly fantastic because she's not taking warfarin, I HATE that ad! The first time I saw it I couldn't contain my verbal disagreement with it, I was like, that's so stupid, there's no reason she couldn't have done that stuff before. And there's another where the guy makes a big deal that he can eat healthy foods again since he's not on warfarin, which is again just a lot of nonsense, and one of my biggest pet peeves that people are still being taught that they can't eat vegetables while they take warfarin! It's ridiculous, and an ad like that only solidifies in people's minds the misinformation which is already out there.