Mirvaso has been approved by the FDA.

[Birdie]

Reply from Reporter in Lake Charles, LA

I received a speedy reply. She states she has known Ginger for many years
And she indeed does suffer from rosacea. She indicated the derm uses mirvaso
As well. Both are having good results she reports.

I urged her to follow through with the treatment so the results
Would be more accurate. She indicated she is not interested
In investigating mirvaso further.

[Starlite]

I follow one of the Rosacea Facebook support groups in spanish, and one of the users commented he went to the dermatologist and he prescribed him BRIMONIDINA 0.5%, he did google it for some information before buying it and found this link (in spanish, sorry), he didn't get the link to this rosace group unfortunately, otherwise they could read all the negative comments about Mirvaso in this forum, so apparently the active ingredient is already been prescribed to treat rosacea in Spain.

http://sergiovano.blogspot.com.es/2013/06/brimonidina-un-nuevo-tratamiento-para.html

In this link, Galderma isn't exactly mentioning the name "Mirvaso" in the coference in Vienna but only the active ingredient.

Wow.. excellent link. Using google translator was helpful. They did not call it Mirvosa, it was a .5% and they claim an 85% effectiveness in the study. They also say "IS IT SAFE?

It is a drug with a good safety profile, as in clinical trials occurred only mild and transient adverse effects due to the application of this drug, mainly irritation, itching and burning sensation. These effects were reported in 9-12% of patients.

As for possible contraindications, it is a drug that could be used in cardiac and hypertensive patients without problems, as the percutaneous absorption of brimonidine appears limited."

The warning for brimonidine in the eye drops warns against use in these types of patience. Thank you for posting this. Very interesting. I will have to track down this study and the one for Mirvosa and compare them. I'll let you know what I find.

[Starlite]

Brady flee while you can, you've angered the naturopathy triumvirate

Flee!!!

[AdriH]

BRIMONIDINA 0.5 % prescribed in Spain

I follow one of the Rosacea Facebook support groups in spanish, and one of the users commented he went to the dermatologist and he prescribed him BRIMONIDINA 0.5%, he did google it for some information before buying it and found this link (in spanish, sorry), he didn't get the link to this rosace group unfortunately, otherwise they could read all the negative comments about Mirvaso in this forum, so apparently the active ingredient is already been prescribed to treat rosacea in Spain.

http://sergiovano.blogspot.com.es/2013/06/brimonidina-un-nuevo-tratamiento-para.html

In this link, Galderma isn't exactly mentioning the name "Mirvaso" in the coference in Vienna but only the active ingredient.

[Birdie]

I would urge great caution to anyone who contemplates trying this medication.
I am a brimonidine victim. I ended up in the ER twice with the most horrific rebound flushing. I had nose bleeds, split lips and terrible flushing as the blood surged through my face looking for the weakest route. It would dart about, first engorging the side of my nose, then upper lip area, then the cheek, etc. I have seen another post here where someone else experienced this phenomenon, although in lesser form than me. I suffered permanent damage. My upper right cheek being the worst area. The vasculature continues to be excessive and very dysfunctional. Also, there seems to be nerve damage. I tried it for a couple of months in late 2010 and it is only in these last few months that it has settled down to a point, but I have to be ever vigilante. Even another attempt at IPL didn't help, but it did cause more fat loss.

The derm who told the world about brimonidine claimed none of his rosacea patients suffered rebound flushing and in fact, only benefited from the drug.
Given the fact all members here suffered rebound, that is like saying the derms patients don't require oxygen to breathe.
The mechanics of rosacea and flushing don't change, no matter which physician oversees their care.

I don't believe the claim that the rebound flushing can be prevented due to the formulation of this newly released product.
Think about it. Brimonidine is a vasoconstrictor. The body will always try and regain homeostasis.
When you tinker with receptors, no matter what they are, the body will compensate. Trying to overcome this can only be done with another type of vasconstrictor and that would just add to the problem.

Even caffeine is a vasoconstrictor. The study done on rosacea and coffee consumption was flawed, only observing the effects of heat on rosaceans.
The pathways which result in flushing are different.
Heat is obvious. Caffeine interferes with adenosine receptors, docking in them, and preventing the effects of adenosine, which is vasodilating (there are other effects). So, for a while, the face pales. But as the drug wears off, there is rebound. In addition, caffeine upregulates adenosine receptors, so when caffeine is suddenly stopped, there are excessive receptors. Withdrawal sets in. It is the same process involved with other addictions.

It is my belief that those who try this drug will initially experience relief and be so delighted with it, they will continue to use it. Then they will find they need a bit more and a bit more as break through flushing sets in. They will require more drug and the rebound will become worse and worse, until the face can't cope at all and awful rebound will set in. The damage could be permanent.

For those who aren't flushers and think they are safe, think again. If you weren't a flusher to start with, you stand a high chance of becoming one. After all, flushing is simply neurotransmitters gone out of whack.

I have tried to keep this explanation very simple so it can reach everyone with varied levels of understanding. Those who are capable can always do additional research.

Some people here are familiar with Prof Ayers, a biochemist I used to chat with. He spent a lot of time trying to shed light on the process of rosacea and flushing. When I was going through brimonidine rebound hell, I pleaded to him for help to stop the process. He said he was not able to and I just had to ride it out. He did add, that my experiment was one of the most foolish things I ever did, as the effect of brimonidine was not unexpected in his view.
And there comes the problem. Most patients don't know how drugs work. We trust those who prescribe them.
I didn't know anything about G-receptors back then.

http://en.wikipedia.org/wiki/Alpha-2_adrenergic_receptor

Of course, it could be possible that the newly released drug is different and the scientists have found a way to overcome the problem, but I am highly suspicious they haven't. Even a dilute dose could have the same effects. I diluted mine, by the way.

Everyone needs to make up their own mind, but for those who try it, I advise a tiny test patch and not to increase that patch for several weeks. Just in case.

By the way, clonidine is similar. That causes rebound too.

This thread is long. Don't want Mistica's experience to buried. So bear with me as I periodically
Forward it. Thanks. Birdie

[Birdie]

Last May I went to the derm at a very reputable teaching hospital. They were touting a new drug to treat redness, due out the end of this year (2013). The primary derm (students there as well) told me the hospital had taken part in a massive study of this new drug with outstanding results. I asked if this new drug was based on brimonidine. The derm looked shocked and replied yes. I responded, wow that's fantastic news, no rebound huh? He replied that at first they did experience problems with rebound, but found if patients only used it occasionally when they needed it, the rebound was tolerable. I asked, what do you mean by occasionally when needed and what was considered tolerable? He responded, well you only use it when you know you'll be around triggers and that if it was used too often, the rebound was worse. I said oh, well, I'm around triggers every hour of every day, so how would I be able to use this? He responded that I would just have to give it a try and see. I nodded and thought to myself, hmmm, not sure I'm willing to give that a try based on this information.

My conclusion is, based on his information and the side effects listed on Mirvaso, that rebound or "flushing" can happen as a result of using this drug and that they knew it during the studies, modified the study to improve the outcome, listed "flushing" as a side effect and are hoping for the best. My advise after 2 plus years in the company of dermatologists? They really don't have a handle on the cause or causes of this disease, so they're treating symptoms. All the pretty pictures and videos in the world can't hide the fact, that if you constrict blood vessels, in some patients, the body will react by rushing blood to the area when it can. This is how the body protects itself and repairs damage. Some bodies do this with vigor, others don't. I would imagine that if you continually send signals to your brain that a certain area of your body is continually being starved of nutrients, those nerves will become more and more sensitive in order to protect you better. Common sense. Until science can find a cause for this disease, I'm not willing to be a guinea pig.

Further, I think the fact that this drug is causing substantial rebound in some patients is a huge clue in finding the cause and mechanism of actions in this disease. I hope some smarty pants investigates and leads us to a better understanding of the disease itself rather than simply treating its symptoms.

Flushedbean, Thanku for this very smart analysis. How hard was it to walk away from a potential " cure?"
And, how devastating it would have been if you had not been INFORMED!!!

[Birdie]

Starlite,

I am aware that local TV stations have news feeds they pull from and give the same reports since just about all TV stations have similar sources.

Is there evidence that there is the same story being broadcast on other local TV stations like the Louisiana report? You have lumped this report in with some kind of 'generic' report that they are using. So there should be some evidence to back this up, shouldn't there be? Or is everyone guilty until they have proved their innocence?

If you watched the Louisiana TV report, the reporter names the patient, Ginger Royer. The reporter names the local dermatologist, Maureen Olivier, MD, whom you can google which I just did and found that she practices in Lake Charles, Louisiana.

I would imagine that if Ginger begins to report rebound, that she might contact the reporter at the TV station, Britney Glaser, whom she can email and report her findings.

[ATTACH=CONFIG]2097[/ATTACH]
Britney Glaser

I find your criticism over the top and unwarranted. Is there evidence you can produce that someone is feeding these reports to TV stations in behalf of Galderma? If so, the little team at Lake Charles certainly did a lot of extra work finding the dermatologist and the patient willing to be videoed and speak to the camera for an interview.

Ok. I have emailed the reporter and also given my phone number. Thanks for this info Brady. You do
DO a lot of leg work for this community and I appreciate it~ even though in this instance it just
Does not seem logical to conclude it as success. I believe all of us can and should do our part to help
Rosacea sufferers attain accurate information so that if they choose the risk of mirvaso, they are aware
Of all potential side effects-- perhaps permanent ones. Doing our part in trying to get the
Info out there means action outside of this forum. So thanks again Brady. This new story has inspired me to contact this one news agency and go from there... So far these little "films" contribute and pander
Only to the culture that pervades our entire world: I'm only worthy if I look good. Now with mirvaso
I am looking great. ( and too bad I don't know what's gonna happen.)

[maskielli]

Brady flee while you can, you've angered the naturopathy triumvirate

[Starlite]

Your evidence that the report from Lake Charles TV station is like the 'I scream you scream' reports doesn't hold up. There should be at least one other local TV station doing the same story. Maybe you are right, and there will be other stations doing the same story, but for now there is no evidence of this and I think putting this report in the same category is a bit premature without evidence.

By the way there are no medical doctors from Galderma volunteering on the RRDi MAC. The two have Ph.D.s and serve as medical science liaisons.

I do understand your frustration with the medical system, the pharmaceutical industry, etc. (forming the RRDi and the frustration I felt motivated me to form the RRDi).

There simply are very few positive reports about Mirvaso and way more negative reports.

However, to validate any of these reports is quite a task. How do we know that any of them are valid? All we can do is make a judgement call. As you point out your opinion is as valid as mine.

I respect your view and encourage you to continue posting it.

No Brady, for goodness sakes. LOL Brady.. I am saying... pay close attention... Businesses pay advertizing agencies to create press releases. Press releases.. Being paid by a for-profit company to read a news story is NOT NEWs.. it's advertizing. All three news stories you posted about Mirvosa were "press releases".. in other words.. Commercials. The "I scream, you scream" videos were humor and providing evidence that news stations often use the same source to promote the same story for things like cell phone apps.. ect... I was not saying that several hundred news stations were now going to report on "Ginger." I gave you links for the info about advertizing agencies. You got stuck on the ice cream part.. sorry that threw you off. What they had in common is all the stories were about *for profit* companies and not real news.

What you did was provide more evidence that they all followed the same "script" in positive, common and easy to relate to woman on the street, along with a known and trusted reporter and someone in a white smock that knows waaay more then you or I, telling us abut this new wonder drug. This is not trust worthy positive reports.

What wiry says below is also my concern... "I feel your reporting system paints the best possible picture for Mirvaso:" However you say this ~> "There simply are very few positive reports about Mirvaso and way more negative reports." That's right.. and some of them are worrisome because they may be long term injuries.

Brady, why would you be arguing with anyone on behalf of a drug company? Especially sense there appears to be a huge discrepancy between what their "studies" show, and what is being reported here on the forum. flushedbean's report is very significant and they are a member here in pre-Mirvosa standing.

I would like to add that I feel your reporting system paints the best possible picture for Mirvaso:

- Positive reports are considered positive unless proven otherwise. Clearly we know that many of these positives would go negative if we heard back from users.
- Commercial type vidoes are considered positive. I think most people can see what is really going on here. Hint, its $ related.

Negatives can never turn positive so the current approach maximizes positive listings. And that is where the heartburn is for me. It is *my* personal belief that this forum should consider forum members first and foremost (and not put them at risk). Consistent with that would be a conservative reporting style (not one that creates the best possible scenario for the drug company).

[wiry]

I would like to add that I feel your reporting system paints the best possible picture for Mirvaso:

- Positive reports are considered positive unless proven otherwise. Clearly we know that many of these positives would go negative if we heard back from users.
- Commercial type vidoes are considered positive. I think most people can see what is really going on here. Hint, its $ related.

Negatives can never turn positive so the current approach maximizes positive listings. And that is where the heartburn is for me. It is *my* personal belief that this forum should consider forum members first and foremost (and not put them at risk). Consistent with that would be a conservative reporting style (not one that creates the best possible scenario for the drug company).

[wiry]

Starlite,

Now that I have done most of the work, why not make your own list which we can refer to for comparison? Everyone is entitled to make their own list.

If your grading criteria is suspect, informed members are going to challenge it. Personally, I do not agree with your grading system (clearly I am not the only one). This is not a personal attack Brady. At the heart of it, we want to prevent others from putting themselves in a potentially harmful situation with Mirvaso. Some of us truly understand the risk. A skewed list could be counter productive.

It is not practical for everyone to create their own list. We all know that, so can we get real? Really, if I made my own list (promoted users to look at it with dozens of links to it) and graded it anyone way I wanted, just how beneficial is that? It is just my interpretation. Would I really be seeking the best interests of the rosacea community? If it was me, I certainly would listen to the community or I would keep it relatively quiet (dozens of links is very "in your face" btw).

[Brady Barrows]

I also watched the other "commercial like" news reports you found on youtube and will address them but am only quoting this reply.

You can define my statement of the obvious as over the top criticism all you want to, but the "hurt and indigent" card on behalf on the news station and the pharmaceutical companies doesn't phase me at all. I provided you with clear information about how companies contact advertizing agencies to skillfully create "press releases" to both local and national level "news" agencies. How is that "news?" It's not. All three "news reports" on this new wonder drug were promoting it. These were not unbiased reports. That is obvious to anyone who watches it. Maybe a few people don't have very good BS detectors, but you don't have to be a genius to know when you have just been presented with an up close and personal, positively warm and fuzzy "common woman on the street" sales pitch by both a trusted and local "reporter" backed by a Professional (read knows way more then you) in a white lab coat. Give me a break.

You got hurt and indigent that I might imply that you had a less then objective reporter style sense you had a Galderma Doc join your Org. You are presenting yourself and your Org as unbiased. You do an awesome job of gathering data and collecting it in useful and effective ways. This does a huge service to anyone trying to solve their own skin problems. You are certainly entitled to your own opinions on things but so am I. It is my opinion that these "news stories" lack unbiased credibility. My opinion was and is backed by information and examples. If you are adding these to your collection of Mirvaso users with positive reports then it is my opinion it skews the data. But as you mentioned all the reports are anecdotal and subject biases.

Why do I care? Because real people are coming on this forum and reporting real pain and suffering. As someone who came from the medical system, who then became ill and was injured by that same system, I have discovered a large amount of corruption with in that system. To know how much harm has come to so many people at the hands of unnecessary corruption is a heavy burned to bear. I will not be silent when I have the information to help someone avoid injury. Even this last Dermatologist in the story you posted refused to say he would suggest using it every day. He danced away from that and promoted his laser treatments. I laugh because he was being driven by the need to increase his customers. But what's not funny is I could tell by the way he talked he knew something isn't right with this drug and he didn't come right out and say so. He also stated that rosacea is caused by sun damage. That's not true at all. You know that. But that story line sure sells laser treatments. The other Doc said it was a vascular inflammatory disease. They don't know. And if you ask me, any Doc promoting Botox for the sake of vanity and their personal profit is already suspect.

Your evidence that the report from Lake Charles TV station is like the 'I scream you scream' reports doesn't hold up. There should be at least one other local TV station doing the same story. Maybe you are right, and there will be other stations doing the same story, but for now there is no evidence of this and I think putting this report in the same category is a bit premature without evidence.

By the way there are no medical doctors from Galderma volunteering on the RRDi MAC. The two have Ph.D.s and serve as medical science liaisons.

I do understand your frustration with the medical system, the pharmaceutical industry, etc. (forming the RRDi and the frustration I felt motivated me to form the RRDi).

There simply are very few positive reports about Mirvaso and way more negative reports.

However, to validate any of these reports is quite a task. How do we know that any of them are valid? All we can do is make a judgement call. As you point out your opinion is as valid as mine.

I respect your view and encourage you to continue posting it.

[Starlite]

I agree. And satire worthy of a spot on the Super Bowl. Millions of " mild" rosaceans can laugh
Their only kinda sun kissed red faces off.

Lake Charles, Louisiana is not far from me where this misleading piece was broadcast. I'm going to
Do my best to contact the reporter and set this straight. I will let y'all know how it goes.
And Brady, honestly, that report needs to be filed under " I'm so beautiful and now after lifting
Heavy boxes I'm even more lovely."

OMG I just saw this Birdei! Oh PLEASE do let us know what you find out. LMAO Toooooo funny.

[Starlite]

Starlite,

I am aware that local TV stations have news feeds they pull from and give the same reports since just about all TV stations have similar sources.

Is there evidence that there is the same story being broadcast on other local TV stations like the Louisiana report? You have lumped this report in with some kind of 'generic' report that they are using. So there should be some evidence to back this up, shouldn't there be? Or is everyone guilty until they have proved their innocence?

If you watched the Louisiana TV report, the reporter names the patient, Ginger Royer. The reporter names the local dermatologist, Maureen Olivier, MD, whom you can google which I just did and found that she practices in Lake Charles, Louisiana.

I would imagine that if Ginger begins to report rebound, that she might contact the reporter at the TV station, Britney Glaser, whom she can email and report her findings.

[ATTACH=CONFIG]2097[/ATTACH]
Britney Glaser

I find your criticism over the top and unwarranted. Is there evidence you can produce that someone is feeding these reports to TV stations in behalf of Galderma? If so, the little team at Lake Charles certainly did a lot of extra work finding the dermatologist and the patient willing to be videoed and speak to the camera for an interview.

I also watched the other "commercial like" news reports you found on youtube and will address them but am only quoting this reply.

You can define my statement of the obvious as over the top criticism all you want to, but the "hurt and indigent" card on behalf on the news station and the pharmaceutical companies doesn't phase me at all. I provided you with clear information about how companies contact advertizing agencies to skillfully create "press releases" to both local and national level "news" agencies. How is that "news?" It's not. All three "news reports" on this new wonder drug were promoting it. These were not unbiased reports. That is obvious to anyone who watches it. Maybe a few people don't have very good BS detectors, but you don't have to be a genius to know when you have just been presented with an up close and personal, positively warm and fuzzy "common woman on the street" sales pitch by both a trusted and local "reporter" backed by a Professional (read knows way more then you) in a white lab coat. Give me a break.

You got hurt and indigent that I might imply that you had a less then objective reporter style sense you had a Galderma Doc join your Org. You are presenting yourself and your Org as unbiased. You do an awesome job of gathering data and collecting it in useful and effective ways. This does a huge service to anyone trying to solve their own skin problems. You are certainly entitled to your own opinions on things but so am I. It is my opinion that these "news stories" lack unbiased credibility. My opinion was and is backed by information and examples. If you are adding these to your collection of Mirvaso users with positive reports then it is my opinion it skews the data. But as you mentioned all the reports are anecdotal and subject biases.

Why do I care? Because real people are coming on this forum and reporting real pain and suffering. As someone who came from the medical system, who then became ill and was injured by that same system, I have discovered a large amount of corruption with in that system. To know how much harm has come to so many people at the hands of unnecessary corruption is a heavy burned to bear. I will not be silent when I have the information to help someone avoid injury. Even this last Dermatologist in the story you posted refused to say he would suggest using it every day. He danced away from that and promoted his laser treatments. I laugh because he was being driven by the need to increase his customers. But what's not funny is I could tell by the way he talked he knew something isn't right with this drug and he didn't come right out and say so. He also stated that rosacea is caused by sun damage. That's not true at all. You know that. But that story line sure sells laser treatments. The other Doc said it was a vascular inflammatory disease. They don't know. And if you ask me, any Doc promoting Botox for the sake of vanity and their personal profit is already suspect.

[nat007]

My conclusion is, based on his information and the side effects listed on Mirvaso, that rebound or "flushing" can happen as a result of using this drug and that they knew it during the studies, modified the study to improve the outcome, listed "flushing" as a side effect and are hoping for the best. My advise after 2 plus years in the company of dermatologists? They really don't have a handle on the cause or causes of this disease, so they're treating symptoms. All the pretty pictures and videos in the world can't hide the fact, that if you constrict blood vessels, in some patients, the body will react by rushing blood to the area when it can. This is how the body protects itself and repairs damage. Some bodies do this with vigor, others don't. I would imagine that if you continually send signals to your brain that a certain area of your body is continually being starved of nutrients, those nerves will become more and more sensitive in order to protect you better. Common sense. Until science can find a cause for this disease, I'm not willing to be a guinea pig.

Further, I think the fact that this drug is causing substantial rebound in some patients is a huge clue in finding the cause and mechanism of actions in this disease. I hope some smarty pants investigates and leads us to a better understanding of the disease itself rather than simply treating its symptoms.

Excellent analysis and very interesting story flushedbean, thanks so much