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Guest Jenny

MAC-Australian Meat & Livestock-Study on Diet/Rosa

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Guest Jenny

One of our volunteer Grant Writers, Joanne Whitehead, has agreed to investigate the possibilities of applying for a grant via Australian Meat and Livestock, as suggested by Dr Cordain:

"Neil Mann's study was funded by the Meat and Livestock Association of Australia & cost about $100,000 and started with an n=47. I believe that a similar study could easily be pulled off with rosacea patients. A well executed pilot project would make a tempting carrot for further diet/rosacea projects..."

The two studies are the following:

Smith R, Mann N, Braue A, Varigos G. Low glycemic load, high protein diet lessens facial acne severity. Asia Pac J Clin Nutr. 2005;14 Suppl:S97.

Smith R, Mann N, Braue A, Varigos G. The effect of a low glycemic load, high protein diet on hormonal markers of acne. Asia Pac J Clin Nutr. 2005;14 Suppl:S43.

In order for Joanne to move on this, I would be grateful if you (our MAC members) could vote on this proposal, in principle. This will give Joanne the opportunity to formulate the study design and what factors will be looked at. Once this is achieved, full approval from the MAC will be sought.

Please indicate "Yes" or "No" in a reply post to this thread and add any comments you may wish to add.

Many thanks

Jenny Nairn

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A well designed study on diet and rosacea would always be welcome...keep in mind that a large number of patients will be required....my experience with patients suggests that a "slam dunk" diet that works for a majority of patients every time...is just not likely to be found. We are looking for subtle changes...and this will require many patients to sort out. Bob Brodell

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Many of the MAC members are having problems accessing the private forum

and have responded by email as well. Here are their votes:

Dr. Cordain: YES

Dr. Schaller: YES

Dr. Brodell: YES

Dr. Latkany: YES

Dr. Cremers: YES

Dr. Sun: YES

Dr. Johnson: YES

Dr. Tseng: YES

Dr. Wedrychowski: YES

Dr. Boes: NO

Dr. Plewig: NO

Dr. Lehmann: NO

I received these replies by email which you can read the full comments:

From: Robert Latkany, M.D.

Subject: Re: RRDi Medical Advisory Committee [MAC]

Date: August 18, 2006 2:36:47 AM HST

To: director@irosacea.org

Dr Latkany gives the okay but questions what

the exact grant is because all I see is a proposal

for diet and rosacea and there are plenty of books devoted

to this so please clarify so I could better answer this.

relief@dryeyedoctor.com

--

Robert Latkany, M.D.

Founder/Director Dry Eye Clinic NY Eye & Ear Infirmary

Center for Ocular Tear Film Disorders at Laser & Corneal Surgery

____________________________________________________________________

From: Andrzej Wedrychowski

Subject: Re: RRDi Medical Advisory Committee [MAC]

Date: August 18, 2006 1:29:09 AM HST

To: director@irosacea.org

No, we should not pursue this diet idea. If anybody is able to show me that I am wrong I will listen.

Take care, Brady

Andrzej

On August 24 Andrzej changed his vote to YES - see this post >

http://www.members.irosacea.org/viewtopic.php?t=66

_________________________________________________________________

From: Sandra Cremers, MD

Subject: RE: RRDi Medical Advisory Committee [MAC]

Date: August 18, 2006 9:45:11 AM HST

To: director@irosacea.org

Hi Brady,

I´ll be on vacation till beginning of Sept, but a quick note: a project on diet & rosacea is not a bad idea. It has been researched before without conclusive data on the underlying etiology (ie it is known that red wine makes rosacea sx worse in some rosacea pts but it is unclear why). Thus if a full literature review reveals a gap in the understanding of which foods trigger rosacea & why, then such a project would be a good one.

S

_________________________________________________________________

From: Jenny Sun, MD

Subject: Re: RRDi Medical Advisory Committee [MAC]

Date: August 18, 2006 12:52:54 PM HST

To: director@irosacea.org

Jenny

Dear Mr. Barrows,

I am not sure how to use the post so I just write to you directly.

I think it is a good topic because in real life we know that alcohol and spicy food could worsen Rosacea. To study how alcohol and the active incredients in spices effect the smooth muscle cells and endothelium cells may provide insight for possible mechanism of the development of Rosacea. Thanks,

Jenny

_________________________________________________________________

From: Marianne Boes, Ph.D.

Subject: Vote

Date: August 21, 2006 4:42:33 AM HST

To: director@irosacea.org

Dear Mr Barrows,

I voted against pursuing the grant proposal on diet and rosacea. I think

time and money would be more wisely spent on investigating why certain

populations develop rosacea more than others. While I am not familiar to

rosacea research as such, my fulltime job here at the Harvard hospitals for

the last 8 years focuses on immune responses. A more routine step to take to

investigate underlying mechanisms that cause the development of rosacea

would be to compare immunological backgrounds of afflicted individuals, in

comparison to a control group. It may well be that, as in many disorders, a

genetic predisposition is found. I would focus on HLA typing initially (as

HLA has a clear link with many autoimmune diseases). Then perhaps focus on

questionnaires to afflicted individuals and their non-afflicted siblings on

their life-time exposure to direct sunlight. Both genetic background and

sunlight appear to me as more valid lines to pursue than diet, which is

widely variant amongst individuals.

Marianne Boes

--

Marianne Boes, Ph.D.

Assistant professor,

Department of Dermatology,

Brigham and Women's Hospital,

Harvard Medical School

On Aug 23, 2006, at 6:26 AM, Marianne Boes wrote:

While most voted yes, most MAC members appear skeptical as I gather from their comments. Only deciding based on their yes/no vote would be an unwise decision, I think.

Best,

Marianne Boes

___________________________________________________________________

From: Loren Cordain, Ph.D

Subject: RE: acne diet studies

Date: August 22, 2006 11:57:04 AM HST

To: director@irosacea.org

Hi Brady,

I spoke with Neil last November while in Melbourne & I believe that he plans to publish a series of papers on his diet/acne study. I dont know the status of these papers to date except that they are not yet in print. To my way of thinking a free form grant proposal may be premature at this point, particularly if the grant writer is unaware of the molecular and endocrine data linking diet to rosacea. Perhaps a better strategy would be for the scientists in your group to write a hypothesis paper showing the biochemical and endocrine links between diet and rosacea. Perhaps some of the best evidence surrounds the EGF cascade I have previously pointed out and that EGF-R blockers elicit a non-comedonal acne similar to rosacea. Once a peer review paper has been written outlining the theoretical link between diet and rosacea, it may be possible to approach a private agency with vested interest (ala the MLA) to provide modest funding to obtain pilot data similar to Neil's study.

Cordially,

Loren Cordain, Ph.D.

Professor, Department of Health and Exercise Science

Colorado State University

Fort Collins, CO 80523

___________________________________________________________________

From: Dr. Gerd Plewig

Subject: RRDi Medical Advisory Committee

Date: August 22, 2006 6:10:45 AM HST

To: director@irosacea.org

Dear Brady Barrows

You asked for my opinion about the proposed research project concerning diet and rosacea.

Without knowing details, I feel that this is not an appropriate way to study a disease. Dietary factors have long been suspected in almost any disease. Except for very rare genetic diseases or hypersensitivity situations like gluten-enteropathy diets play no role in the prevention, therapy or aggravation of a disease. This certainly is true for rosacea.

Therefore I cannot recommend such a project. You say time and especially money should be spent for serious projects.

Sincerely yours

Prof. Dr. Dr. h.c. mult. Gerd Plewig, FRCP

Ludwig-Maximilians-Universit?§t M?ºnchen

Klinik und Poliklinik f?ºr Dermatologie und Allergologie

Frauenlobstr. 9-11

D-80337 M?ºnchen

___________________________________________________________________

From: Dr. Tseng

Subject: RE: acne diet studies

Date: August 23, 2006 2:21:58 AM HST

To: director@irosacea.org

Of course, YES.

Scheffer C. G. Tseng, M.D., Ph.D.

___________________________________________________________________

From: Dr. Lehmann

Subject: AW: Diet/Rosacea Grant Proposal

Date: August 24, 2006 4:07:07 AM HST

Dear Brady Barrows,

I have difficulty in foloewing the PC pathways since I do not have my

password available.

Anyhow, I do not think from the available data that there is any evidence on

the relationship of rosacea and special diets. I therefore, would vote

against the promotion of this project.

Since there is evidence, tthat rosacea may be related to an increased

activity of reactive oxygen species (ROS) and a deficient function of the

antioxidant system, the study of these related systems would be much more

promising.

With best regards

Prof.P.lehmann

___________________________________________________________________

NOTE:

My advice is that if we can't get at least seven of the MAC members to agree to the initial proposal to discuss this and give at least a tacit approval there is no point in pursuing this. We can't ignore the advice of the MAC or we will use all credibility as an organization. However, if seven of the MAC members give at least a nod of approval to pursue this, the board of directors should then be given the task of deciding whether to approve this, since the board makes the final decision. I am abstaining from voting on this so four of the board of directors will need to vote and approve this before Joanne (our volunteer grant writer) begins pursuing this proposal (I don't want anyone to accuse me of a conflict of interest). I know all this is a bit cumbersome and awkward, but this is actually the FIRST time we have ever done this, make a decision about what the MAC approves of or not. Eventually we will streamline this process but for now we are all learning how to go about making a decision on something. This is a historic moment for the RRDi. The MAC is still learning how to use this forum, the public corporate members are still very new to this process, and not to mention the board of directors is just as new to this as everyone else. Everyone needs to be patient, kind, respectful, and above all dedicated to volunteering their talents and energy to this.

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Drs Cremers & Sun both mentioned lacking understanding of mechanisms with respect to known triggers. I have just seen that the National Center for Complementary & Alternative Medicine (a branch of the NIH) lists as their first research priority 'mechanisms of action'.

http://nccam.nih.gov/research/priorities/index.htm#5

If we play our cards right, we could demonstrate a dietary correlation in the MLA study, then use it as leverage to apply for an NCCAM grant to explore the mechanism.

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Diet and rosacea have been well documented with a host of food triggers and even the amount and type of food consumed. It can difficult seperating anectodal reports and research. Rosaceans have some simularities in food triggers, but wouldn't it be nice to nail this down better? I vote "yes".

Dr Steve Johnson

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A more routine step to take...

Point taken, but I think the idea is not to take a routine step, but to try a novel approach!

There are of course widely varying incidences of rosacea across populations, but genetic factors are not the only variables. As documented by Dr Weston Price, traditional societies eating traditional diets did not suffer from rosacea or other visible chronic diseases, but within a single generation of taking on westernized diets and habits, many of the modern western diseases started to become apparent in these people. I think this argues very strongly for dietary factors.

And while diets vary within a population, there is a steadily growing body of literature linking modern western diseases to overly acidicfying diets. I think it is not a matter of trigger factors individually, but the overall balance in our diets, which is why it has been difficult to pin down universal triggers for all rosaceans, or even consistent triggers within an individual. There have been recent papers describing simple methods to calculate net acid load of our diets, and so there is a single quantifiable variable we can test.

I'm sure genetic susceptibility plays some part in the equation, but it cannot be the only part.

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On Aug 21, 2006, at 6:29 AM, Dr. Scheffer C.G. Tseng wrote:

Can you append as an attachment of this grant proposal for me to reveiw? For any proposal, we at least should identify the missing link between what is known and what is not known. The two papers cited need to be reviewed as well to see the validity before a new proposal can be best judged. Can you send pdf files of these two papers?

Scheffer C. G. Tseng, M.D., Ph.D.

Director, Ocular Surface Center

Medical Director, Ocular Surface Research & Education Foundation

Director, R & D Department, TissueTech, Inc.

Brady Barrows responded:

Dr. Tseng,

Here is what I came up with and will contact Dr. Cordain to see if he has copies of the entire articles:

Loren Cordain, Ph.D., says, "I believe that like acne vulgaris, rosacea results from interactions between genetic and environmental factors, and that diet plays a key role in the etiology of this disease via its modulating influence upon cytokine and hormonal homeostasis. In support of this notion are recent studies showing that EGF receptor blockers elicit non-comedo acne symptoms similar to rosacea. We now have preliminary evidence to show that a substance found in whole wheat, wheat germ agglutinin (WGA) competitively binds the EGFR in gut (thereby displacing the endogenous ligand) and enters plasma via this pathway. Because WGA displaces the endogenous ligand, it will upregulate the EGFR in a manner similar to pharmaceutical EGFR blockers. We believe that diet also elicits a number of other endocrine responses that are intimately linked to the pathophysiology of rosacea."

In an email to me on this subject, Dr. Cordain said, "My colleague Neil Mann at RMIT has just completed a dietary intervention showing that a high protein low glycemic load diet ameliorates acne symptoms. See attached abstracts. I believe a similar study could be easily conducted with rosacea patients. Neil failed to control for at least 2 dietary factors which I believe are also crucial in not only ameliorating acne symptoms but also rosacea symptoms. I have outlined these mechanisms in my book, "The Dietary Cure for Acne". Our research group is currently in the middle of a clinical trial testing the hypothesis that dietary WGA enters plasma via the EGFR I spoke of earlier. We believe that WGA adversely influences hormonal and cytokine function that underlie a number of skin diseases and other health problems."

Dr. Cordain further states, "In regards to sugar (sucrose) being a trigger for rosacea, I believe this phenomenon occurs because the fructose moiety of sucrose elicits a transient and/or chronic hypertriglyceridemia which upregulates keratinocyte EGF receptors. Additionally, high glycemic load carbohydrates like sucrose simultaneously may increase a number of pro-inflammatory cytokines such as IL-1a which is associated with opthalmic rosacea symptoms."

Dr. Cordain wrote the book, The Dietary Cure for Acne. as well as The Paleo Diet.

Here are the abstracts mentioned in paragraph above:

Smith R, Mann N, Braue A, Varigos G. Low glycemic load, high protein diet lessens facial acne severity. Asia Pac J Clin Nutr. 2005;14 Suppl:S97.

Background - Acne vulgaris is a multi-factorial skin disorder which affects the 85-100% of the adolescent population in Western civilizations. Despite its high prevalence in the West, acne prevalence is extremely low or rare in non-westernized societies. It has been proposed that refined, high glycemic foods common in Western societies may accentuate underlying causal factors responsible for its proliferation. Objective - To determine whether a low glycemic load diet, comprised of high levels of protein and low GI foods, can alleviate the severity of acne symptoms in young males. Design - Male acne sufferers [n=43, age=18.3 +/- 0.4 (mean +/- SEM)] were randomly assigned to either the dietary intervention (n=23) or control groups (n=20). The intervention diet consisted of 25% energy from protein and 45% energy from low glycemic index carbohydrates. The control group received no information about diet nor were they given dietary instruction. The efficacy of dietary treatment versus control was clinically assessed by a dermatologist using a modified Cunliffe-Leeds acne scale. The dermatologist assessed facial acne by means of lesion counts and was blinded to the subject's group. Outcomes - Dietary intervention resulted in a reduction in total lesion counts (-23.1 +/- 4.0 lesions, P <0.001) and inflammatory counts (-16.2 +/- 3.0 lesions, P <0.001). The control group also showed a reduction in total lesion counts (-12.0 +/- 3.5 lesions, P <0.01) and inflammatory counts (-7.4 +/- 2.5 lesions, P <0.05). However, between group analyses showed that the reduction was significantly greater in the intervention group for total counts (P <0.05) and inflammatory counts (P <0.05). Conclusion - These data indicate that a low glycemic load diet, comprised of high levels of protein and low GI foods, significantly decreased the mean number of facial acne lesions, therefore alleviating the severity of acne symptoms. However, the multi-factorial nature of this condition is reflected in the fact that the control group also showed a decrease over time, thereby suggesting that other factors are at play.

Smith R, Mann N, Braue A, Varigos G. The effect of a low glycemic load, high protein diet on hormonal markers of acne. Asia Pac J Clin Nutr. 2005;14 Suppl:S43.

Background - Acne vulgaris is a common endocrine condition affecting adolescents in Western civilizations. Acne typically manifests during puberty when there is a transient decrease in insulin sensitivity. It has been suggested that high glycemic nutrition during puberty induces hyperinsulinemia which increases the bioavailability of androgens and certain growth factors. These changes may induce follicular epithelial growth and increased sebum production - two factors responsible for acne proliferation. Objective - To determine the effect of a low glycemic load diet, comprised of high levels of protein and low glycemic index (GI) foods, on hormonal makers of acne vulgaris. Design - Male acne sufferers [n=43, age=18.3+/-0.4 (mean +/- SEM)] were randomly assigned to either the dietary intervention (n=23) or control groups (n=20). The intervention diet consisted of 25% energy from protein and 45% energy from low glycemic index carbohydrates. The control group received no information about diet nor were they given dietary instruction. Venous blood was collected at baseline and 12-weeks for an assessment of testosterone, sex hormone binding globulin (SHBG), free androgen index (FAI), dehydroepiandrosterone - sulfate (DHEA-S), insulin-like growth factor (IGF)-I and IGF-binding proteins -I and -3. Outcomes - Dietary intervention resulted in a significant reduction in FAI (-9.1 +/- 4.5, P<0.05) and DHEA-S (-0.72 +/- 0.33 umol/L, P<0.05) and an increase in IGFBP-1 (5.3 +/- 1.6 ng/mL, P<0.01). No significant changes were observed in levels of IGF-I, IGFBP-3, testosterone or SHBG following dietary intervention. The control group showed no change in any of the blood parameters measured. Conclusion - These data suggest that a low glycemic load diet may reduce androgenic activity (as indicated by a reduction in FAI and DHEA-S) and may oppose the growth promoting effects of IGF-I by increasing levels of its binding protein, IGFBP-I. This implies that a low glycemic load diet may reduce hormonal influences involved in acne pathogenesis.

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Dr. Cordain sent me this email today:

From: Dr. Loren Cordain

Subject: RE: First Grant Proposal Considered

Date: August 24, 2006 7:56:59 AM HST

Brady,

I really think you are putting the cart before the horse and will make

legitimate scientists shy away from this project. You need to have

strong theoretical justification for doing a diet/rosacea study with a

testable hypothesis or hypotheses. A grant writer without knowledge of

the molecular and biochemical underpinnings of the disease is like an

airplane without an engine -- it simply wont fly. A necessary and first

step in writing any grant will be to uncover and logically present the

role that diet may play in rosacea. Without identifying potential

mechanisms, you have no hypotheses to test. Whether or not a random

group of scientists think or don't think a proposal should be written is

completely irrelevant without first knowing what objective issues the

proposal would address. Diet and disease is a huge ocean to randomly

dwell. You have taken the first step in generating interest among some

of the players in the field, but to my eye, a fund raising campaign for

your organization would be a more logical next step. Without sounding

overly pessamistic, I don't believe that the people with the potential

knowledge to pull this venture off will participate gratis. Thus, the

need to generate a funding base is not an afterthought but an essential

step that will make the difference of whether this ship will sink or

sail.

Regards

Loren Cordain, Ph.D., Professor

Department of Health and Exercise Science

Colorado State University

Fort Collins, CO 80523

_________________________________________________________________

My reply to Dr. Cordain:

Dr. Cordain,

If you would discuss this with the grant writer that would be great. I can forward all

this to her for you. All we are doing at this point is simply deciding whether or not

Joanne Whitehead should even spend any time on this or not. If we told her to take

on this project and then later find out that the MAC disapproves of this grant from

the get go she would be wasting a lot of time. The grant will have to go through

many hoops to get the MAC's final approval. If you would read the discussion in

the private forum at this url you would see that Dr. Wedrychowski has changed his

vote to YES >

http://www.members.irosacea.org/viewtopic.php?t=59

We are all very new to all this and learning as we go. From this experience we

are trying to streamline the process of decisions.

You are the only one to propose a grant and tell us where the money is. Others

have mentioned some proposals and having us figure out where to go to get

the money. Maybe we do put the cart before the horse, but at least we are trying

to do something.

Brady Barrows

director@irosacea.org

_______________________________________________________________

Dr. Cordain replied August 24 >

Brady,

First, I have not proposed a grant. I merely suggested that for any diet/rosacea project to get off the ground it will require funding. Secondly, any grant proposal will have to be written by someone with knowledge of the underlying dietary mechanisms that may be involved in rosacea. A quick MEDLINE search revealed that there is next to nothing directly related to the topic. So, unless your grant writer is an independent thinker capable of connecting the molecular dots linking certain dietary elements to rosacea, the project is doomed from the start. You must have a testable hypothesis with a reasonable rationale for testing it. To date, except for a few comments I have previously made, you have zilch. To be even more blunt, most legitimate scientists will not donate any substantial time or effort to any project without some form of remuneration, as most have real jobs that take priority. Now, if you were first able to raise a funding pool, and then write what is called a RFP (request for proposals) and submit it to the academic community, you would have a fighting chance. Money talks, and you will be able to turn scientific heads with a funding base and an RFP. Asking a group of scientists to say yea or nay to having a professional grant writer (whatever that means? what are her qualifications?) write a grant without aims, or testable hypotheses is a complete joke and a waste of time for all involved. Finally, writing a grant without an RFP to direct it to represents an effort in futility.

A brief check of the names of scientists on your list is indicative that they are not new to the grant writing and funding process. You are the one who is new to the process and you need to understand the NIH model before you proceed. Additionally, I have not told you where "the money is". The MLA was interested in Neil's project because he had prior contact with them and knew that they would have vested interest in a diet/acne project. He wrote the grant based upon the hypothetical mechanisms I had outlined in prior publications and in numerous email correspondence we had. MLA is not a cash cow like NIH, but rather a private entity with modest resources for funding diet related research. Neil's funing represented a one off situation. The MLA may or may not be interested in doing a diet/rosacea study, but the crucial element will be to generate interest among scientists capable of pulling the study off.

I applaude you for "trying to do something" but your approach is naive. Again, you need to first initiate a funding campaign and generate sufficient monies to get key players involved at a level and committment that will make a difference -- 15 minutes a month wont work.

Cordially,

Loren Cordain, Ph.D., Professor

Department of Health and Exercise Science

Colorado State University

Fort Collins, CO 80523

_______________________________________________________________

Brady replied:

Dr. Cordain,

Joanne Whitehead replied to your last email with this response:

"Dr Cordain makes some valid points, and I understand his reasoning. Of course we are missing much in the work plan, as we can't proceed even to a preliminary application without having a principle investigator. However, at this early stage, a positive response from the MAC and corporate members would simply allow me to make the first step, which is to communicate with researchers who do have the expertise and resources to carry on a study of this type.

Whether we can convince anyone to take on this project is of course a long shot, given that reserchers have their own agenda to pursue. On the off chance that we do have a positive response from a qualified specialist, then we can begin to work out the study design - what factors do we want to address and how do we want to address them. This would be mainly up to the investigator, of course, with us at RRDi giving as much support as we possibly can.

I realize there is a very real possibility that this will not progress even to a preliminary application to the MLA, and that is fine. But I strongly believe there are different ways of addressing the issue. One is to have a hypothesis based on molecular mechanism, which can be tested with a direct dietary intervention. The other is to demonstrate what we (almost) all intuitively know, which is that diet affects rosacea, in a manner which would elevate this principle from anecdote to experimental data. Once we are firmly in the realm of science, we will have the credibility to make further exploration possible.

These are only my personal opinions, but I think we have nothing to risk by putting the word out to scientists that we would like to pursue this line of research. This is all we are asking of our members at this point.

Joanne Whitehead"

As to your reply below I posted it as well in the private forum in the ASK THE MAC section. All I went by when you initially made the 'proposal' was what you said in an email to me dated July 9, 2006 which reads as follows:

Hi Brady,

"My colleague Neil Mann at RMIT has just completed a dietary intervention showing that a high protein low glycemic load diet ameliorates acne symptoms. See attached abstracts. I believe a similar study could be easily conducted with rosacea patients. Neil failed to control for at least 2 dietary factors which I believe are also crucial in not only ameliorating acne symptoms but also rosacea symptoms. I have outlined these mechanisms in my book, "The Dietary Cure for Acne". Our research group is currently in the middle of a clinical trial testing the hypothesis that dietary WGA enters plasma via the EGFR I spoke of earlier. We believe that WGA adversely influences hormonal and cytokine function that underlie a number of skin diseases and other health problems.

Cordially,

Loren Cordain, Ph.D."

Joanne picked this ball up and went with it. When she posted she was going to try to do what you suggested above, I thought it best to run this by the entire MAC before she spends many volunteer hours on this and then later finding out the MAC disapproves her trying to get this grant. So far, the results are a tacit approval of Joanne pursuing this grant with the following votes:

Dr. Cordain: YES

Dr. Schaller: YES

Dr. Brodell: YES

Dr. Latkany: YES

Dr. Cremers: YES

Dr. Sun: YES

Dr. Johnson: YES

Dr. Tseng: YES

Dr. Wedrychowski: YES

Dr. Boes: NO

Dr. Plewig: NO

Dr. Lehmann: NO

Dr. Wedrychowski initially voted against this but after Joanne posted her comment in the ASK THE MAC section as follows:

"Drs Cremers & Sun both mentioned lacking understanding of mechanisms with respect to known triggers. I have just seen that the National Center for Complementary & Alternative Medicine (a branch of the NIH) lists as their first research priority 'mechanisms of action'.

http://nccam.nih.gov/research/priorities/index.htm#5

If we play our cards right, we could demonstrate a dietary correlation in the MLA study, then use it as leverage to apply for an NCCAM grant to explore the mechanism.

Joanne Whitehead"

Dr. Wedrychowski changed his vote to YES and posted this statement in the ASK THE MAC section:

"In my opinion we should proceed with it. This site convinced me: http://nccam.nih.gov/research/priorities/index.htm#5 "

The above post can be found at this url > http://www.members.irosacea.org/viewtopic.php?t=66

Joanne is a very capable grant writer and will address all the MAC's concerns so that we can get a well respected, non biased, clinical research scientist that the MAC will approve awarding this grant to. If the Australian Meat Association awards this grant, I would like to ask the American Beef Council to match it. We could attract someone at Cambridge or Oxford or other reputable research center to do this grant. Maybe I am naive but I am also hopeful and had a dream that will hopefully come true.

Brady Barrows

director@irosacea.org

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Dr Cordain makes some valid points, and I understand his reasoning. Of course we are missing much in the work plan, as we can't proceed even to a preliminary application without having a principle investigator. However, at this early stage, a positive response from the MAC and corporate members would simply allow me to make the first step, which is to communicate with researchers who do have the expertise and resources to carry on a study of this type.

Whether we can convince anyone to take on this project is of course a long shot, given that reserchers have their own agenda to pursue. On the off chance that we do have a positive response from a qualified specialist, then we can begin to work out the study design - what factors do we want to address and how do we want to address them. This would be mainly up to the investigator, of course, with us at RRDi giving as much support as we possibly can.

I realize there is a very real possibility that this will not progress even to a preliminary application to the MLA, and that is fine. But I strongly believe there are different ways of addressing the issue. One is to have a hypothesis based on molecular mechanism, which can be tested with a direct dietary intervention. The other is to demonstrate what we (almost) all intuitively know, which is that diet affects rosacea, in a manner which would elevate this principle from anecdote to experimental data. Once we are firmly in the realm of science, we will have the credibility to make further exploration possible.

These are only my personal opinions, but I think we have nothing to risk by putting the word out to scientists that we would like to pursue this line of research. This is all we are asking of our members at this point.

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I don't know if you want a layman's opinon or not but speaking from a rosacea sufferer's point of view I would rather not see this study take place. I think diet does play a role in inflammation and can thus help with facial swelling and acne and probably to an extent blood vessel dilation but I believe it plays no role role in the cause, and a minimal one at best in the progression of rosacea, especially the heaviy flushing type with no acne.

Also, isolating study participants to those following or not following a particluar diet would be extremely difficult to do and the conclusions would be iffy at best and would probably just add yet another layer of restrictions to an already severely limited lifestyle of a rosacea sufferer.

I vote to devote time/funds to gene therapy, topicals and/or light therapies that can make a hard difference in a sufferers life.

Tricia

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First, I strongly second Tricia's comments on funding priorities.

But I guess I am a little confused as to the exact funding mechanism being proposed here. Are you suggesting that AML would fund specifically Smith, Mann, Braue, Varigos to do a similar study of diets as they pertain to rosacea? Or would AML fund any qualified principal investigators, again to study diet and rosacea? If it is the former, then I am not clear what RRDi's role would be, since Smith etal should write the grant and obtain the funding. If it is the latter, then it seems you need to identify the proposed PIs, and have them write the grant since they are the experts on the methodology.

Rick

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Basically, this has been the first 'proposal' put forth with any discussion. No one has come up with anything until this was suggested by Dr. Cordain, who now says he wasn't making a proposal. My understanding of this is that from what some have told me we are going about this all wrong, but at least we are discussing something. If anyone would like to come up with something better they can begin a new thread.

Here is what an acquaintance suggested to me:

Begin forwarded message:

It sounds like you are asking the MAC to vote on whether your grantwriter should investigate the funding potential of the meat industry for a yet-to-be-designed study on rosacea and diet. Dr. Tseng asked for the grant proposal, which means he thought the study was already designed. Some of the other replies suggest similar confusion. What you and your grantwriter are suggesting isn't how it's traditionally done.

So it seems there are two key points to consider as you evaluate the voting: First, are all MAC members aware that RRDi will ultimately be conducting the study (without at the moment a principle investigator or study design, only the desire to prove what feels intuitively clear to some of you, that diet causes rosacea)? There's a big difference between being a source of funding for others conducting research (the more traditional approach), and being a research institute that seeks funding to conduct it's own studies. Second, are all MAC members aware that the funding source being considered for this diet study is the meat industry, bringing to RDDi all the conflict of interests such a source entails?

Dr. Cordain made a great suggestion: "Perhaps a better strategy would be for the scientists in your group to write a hypothesis paper showing the biochemical and endocrine links between diet and rosacea." I don't know which scientists he is referring to -- unless you know, he should explain if he is referring to members of MAC, or is he under the impression that RDDi has scientists in the background working for RDDi, to write papers and perform research? So while I don't know who would write it, such a paper could form the basis of a research proposal (making it much easier for your grantwriter). Also, having it published in a good peer-review journal would help legitimate your hypothesis of diet in some manner causing rosacea, and so make it easier to find funding.

I think Dr. Cordain's last two emails to you, both dated 8/24, made critical observations about RRDi's approach in a gentle and tactful manner.

___________________________________________ end of email

I sent the above suggestion to our grant writer, Joanne, who replied with this to me:

Hi Brady,

Okay, I think there seems to be agreement that we are going about things in an unusual way. But that was due to the type of grant we were hoping to ask for, which requires the investigator to be identified first. Otherwise, we need to put our efforts first into the fundraising campaign, meaning we ask for money for yet-to-be-determined projects. Perhaps the best thing would be to leave the meat association aside for the moment then, and I will look into the possibility of writing a hypothesis paper. I will also need to look closely at my work contract, as I suspect the rights to all my scientific thoughts now belong either to the institute where I work or the agency who pays my fellowship. But if the institute is happy for me to use their name, it would give this paper a good boost of credibility.

I will be away most of the coming week, but will be in touch when I return.

I like the new logo, by the way.

Joanne

__________________________________________________end email

So I suppose Joanne will hopefully begin something with what we have learned from this first discussion on what to do about our first grant 'proposal.'

We are still waiting on the board of directors to decide what to do about this. The board may decide to not do this and tell Joanne to forget about it. Diet and rosacea has always been a very big contraversy. Yet the NRS lists a long list of diet triggers that have never been clinically researched ever and are totally anecdotal reports. Everyone knows the list of diet triggers that the NRS publishes and no one cares that any of this has ever been researched. Yet when we discuss doing anything about studying the relationship of diet and rosacea you can see how the professionals feel about this subject simply by reading this thread. That is why the RRDi was formed and at least we have a membership that can discuss such subjects with professionals.

There is one point that should be made clear. The RRDi is the 501 © (3) approved non profit organization sponsoring the research. Corporations like Galderma, Pfizer, and the American Beef Council can donate to the RRDi and receive a tax deduction for their donation. The RRDi can then use the money as they see fit and give the money to a respectable clinical researcher who will no doubt use the money to do the research. I am confident that once the money is received by the RRDi that clinical researchers will be happy to apply for the grant and take the money. In what order this is done remains to be seen, but I am happy to follow the traditional approach or create novel new ways to do research.

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The Board of Directors have reached a decision and Joanne, our professional grant writer, has been given the go ahead to come up with something for this initial 'proposal' or thought on research involving rosacea and diet.

Dr. Cordain suggested that a "a hypothesis paper showing the biochemical and endocrine links between diet and rosacea" could begin this process. Who writes this paper is the big question and Joanne no doubt has her hands full and could use any volunteer help or suggestions on what steps she should take next.

This topic is still open for discussion. All we did with this thread is give Joanne the nod to go ahead and spend some volunteer time trying to come up with something. We still have a long way to go on this.

For the record, I want everyone to know that I abstained from voting on this and four board members voted yes, one voted no, and one still is undecided or has not responded to any of this. But four votes carries the measure and gives Joanne the go ahead on this.

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Brady,

Thanks for the update -- I understand that this is a preliminary action.

But I feel obligated to extend the arguments that Tricia made. The RRDi logo is "Finding the Cure". I fail to see how pursuing a connection between diet and rosacea addresses this broad objective. No cure can be found until the underlying mechanisms of flushing and rosacea are better understood. While doing "a hypothesis paper showing the biochemical and endocrine links between diet and rosacea" is of some interest, a much broader study might be framed about finding statistically significant differences in complete endocrinological workups in those who exhibit flushing and paired examples of those who do not. I suggest focussing on the root of the problem, not peripheral issues involving diet.

Rick

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Rick,

You may be right. I asked Dr. Cordain for some advice and got this reply today:

Hi Brady,

My plate is really full this semester, with two grant proposals to write, numerous papers and two major talks on top of my normal teaching load, so my time is precious -- I can give a little, but probably not what will be needed to steer this in the direction needed. I see extensive MEDLINE work ahead -- The best clue I can give you at this point is the EGF and EGF-R axis which I have mentioned previously -- the other clue is endogenous EGF in bovine milk and the ability of WGA to bind EGF and also act as a chimeric molecule pulling in peptide fragments in gut (both pathogenic and dietary) -- Also both the glycemic load and the n3 FA connection need to be thoroughly examined. Finally, a grant writer without an academician and facilities backing the project is a effort in futility. I cant really get behind this project until monies have been committed to do it right. Once again you are putting the cart before the horse. Your first priority as a private, non-profit entity will be to generate funds to underwrite and attract people capable of executing the project. A minimum of $100 K will be required to do a bare bones project (assuming you can get a researcher to take on the project basically gratis. Getting good control over diet for a sufficient sample size (power calculations needed) will take between $250-500K. Without a hypothesis to test, your grant writer will be groping in the dark. Since, the molecular basis for rosacea is currently unknown, it will take a creative and skillful mind, thoroughly familiar with not just rosacea, but also with an expansive knowledge of nutrition to get the project even slightly off the ground.

Cordially,

Loren Cordain, Ph.D.

Professor, Department of Health and Exercise Science

Colorado State University

Fort Collins, CO 80523

__________________________________________end email

It must be pointed out that since no research on diet and rosacea has ever been done, it can not be stated conclusively that the cause of rosacea is not related to diet any more than one can say the cause of rosacea is not related to flushing. The cause of rosacea is not known. The NRS lists a long list of dietary triggers for rosacea, which you no doubt are well aware of since most physicians will repeat this list of triggers, particularly spicey foods and alcohol. However there are no clinical research papers on this and this is based purely on anecdotal reports.

What I suggest is that you begin a new thread in the ROSACEA RESEARCH section or another thread in the ASK THE MAC section on what research you would like done and get the MAC members to reply to this. Remember, the MAC members have only agreed to spend 15 minutes a month volunteering. They are busy professionals and we have spent most of their time this month on this topic. What we have here is unique. Try to get the Medical Advisory Board of the NRS to answer your questions. So write a good question or hypothesis and begin a new thread on what you would like researched. I think this thread barely passed and you can see the controversy this causes. Diet and rosacea is a hotbed of controversy. Always has been and always will be until we get some clincial research that settles this issue once and for all. Problem is that it is so difficult to even discuss it without emotion getting involved. The RRDi was formed because the members are not satisfied with the status quo research being done and we want some novel rosacea research that allows rosacean input into the process. Try suggesting your research to the NRS or any other non profit organization. What we are doing is unique and this first thread proved it. I appreciate your suggestion and hopefully Joanne will use your suggestion you make here about "finding statistically significant differences in complete endocrinological workups in those who exhibit flushing and paired examples of those who do not.'

Brady,

Thanks for the update -- I understand that this is a preliminary action.

But I feel obligated to extend the arguments that Tricia made.  The RRDi logo is "Finding the Cure".  I fail to see how pursuing a connection between diet and rosacea addresses this broad objective.  No cure can be found until the underlying mechanisms of flushing and rosacea are better understood.  While doing "a hypothesis paper showing the biochemical and endocrine links between diet and rosacea" is of some interest, a much broader study might be framed about finding statistically significant differences in complete endocrinological workups in those who exhibit flushing and paired examples of those who do not.  I suggest focussing on the root of the problem, not peripheral issues involving diet.

Rick

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Brady,

This thread has raised two basic issues:

- what is the funding model of RRDi?

- what specific research related to rosacea should be funded?

While the second is perhaps more fun to debate, it is a bit moot without a clear picture of the former.

So far, I have detected several proposed models implied in this discussion:

(1) RRDi operates much like NRS or RRF in that it raises funds from individuals and companies, and funds research grants submitted by outside researchers, with funding decisions and priorities set by the RRDi MAC and Board

(2) RRDi uses its volunteer "grant writers" to submit proposals to some outside agency, and conducts the proposed research, using third-party funding, under its own auspices

(3) RRDi acts kind of as a "clearinghouse" for rosacea research, bringing together potential funding agencies (e.g the Australia Meat and Livestock group) with potential principal investigators (e.g. R. Smith etal) to address rosacea-related research (e.g. the relationship between diet and rosacea).

My understanding is that (1) is the dominant model. If this is the case, then your "grant writers" need to focus on raising funds, not writing grants, since you need a minimum of 25K (ala NRS) to attract any reasonable proposals. First step then would be to speak to David Pascoe and other RRF officers/alumni to understand how they raised $18K during their relatively short tenure. You also need to figure out how it is that the NRS raises enough money to fund on the order of $100K worth of grants annually. Once you have some funds, then you can solicit proposals, evaluate them via MAC expertise, and make decisions.

I am not sure that you are in a position to pursue model (2) at this point.

And model (3) is an option, but one wonders what value-add RRDi is providing in this model.

Listen, I greatly admire your initiative to get RRDi started, and attract such a notable MAC. But you need to provide reasonable differentiation between RRDi and NRS. It is not enough to argue that

(a) RRDi is run by rosaceans unlike NRS

(B) RRDi has an accessable MAC, and NRS does not

© NRS has a broken financial model, with unacceptable administrative overhead that funnels too little money to actual rosacea research

(d) NRS does not fund relevant or leading-edge research in rosacea

With respect to (B), I have corresponded privately with several members of the NRS medical board, and found them to be surprisingly resposnive and open to suggestions.

With respect to ©, please see Sam Huff's letter at http://www.rosacea-research.org/pdfs/NRSThankYou.pdf. Please note that every single dollar donated by individuals since the grants program began in 1999 has gone to rosacea research. And if one gives $1000 to the NRS, then $1000 is immediately available to fund research because they have the remaining $24K to reach the required critical mass of $25K. Frankly, you need to provide a stronger motivation for participation via RRDi over NRS.

You and I differ on (d). I do not necessarily support 100% of their funding decisions, but overall, I think Jonathan Wilkin and their advisory board have done a very respectable job. It is encumbent on all of us to share our own views of research priorities with them -- so far, I see no evidence that they do not welcome outside technical discussion.

The bottom line is you need to focus on nuts-and-bolts marketing: raising funds, both from individuals and corporations, and providing differentiation of the RRDi funding model relative to NRS.

Again, I commend you, the other officers, and the MAC or your efforts -- and I hope you are successful in the long term.

Rick

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Guest Jenny

Hi Rick

Hey, it's good to see members posting in the RRDi Forum. Everyone's comments and suggestions are welcome.

I don't fancy getting into a discussion on comparisons of the NRS/RRF/RRDi. From a personal point of view, I joined the RRDi with the hope of being able to offer my skills on a volunteer basis to get some more research done on Rosacea. The more out there doing the research, the closer we will get to conquering the red beast!

I don't know how it all works and I hope more members start to post their thoughts and ideas.

Rick, are you willing to join a committee? I would love to have you onboard the Funding Committee. The more help and ideas, the faster we will move. Feel free to e-mail me funding@irosacea.org I can be quite impatient but I know that I have to bide my time and go with the flow. Things have certainly moved along at a good pace since the 501©(3) was awarded to the RRDi earlier this year.

I always look forward with a positive attitude and know that one day, in my life time, the cause and cure will be found.

Jenny

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Rick,

The rosacea world is big enough for the RRDi. Many have explained to me, like you, that the NRS is just fine and think what they are doing is just great, including David Pascoe, who gave all the RRF money (just about) to the NRS.

The NRS obtains funding through corporation and public donations. The RRF obtained all is funding through appeals to the r-s yahoo group.

We are trying to get corporate sponsors to donate to the RRDi just like the NRS does and not focusing our appeals to the public for donations. If the public wants to donate to the RRDi we will obviously accept donations, but we are not relying on the public for donations and instead, are appealing to the public to volunteer. That is the major difference. The NRS and the RRF allow very little volunteering.

Volunteering is obviously not for everyone. If you take the time to read the Articles of Incorporation, the By Laws, the Mission Statement, the Rules, and the Conflict of Interest Policy of the RRDi you will find the major difference. When you joined the RRDi, you agreed to all of these items. The NRS and the RRF has never disclosed to the public how they operate (except for their mission statements).

The cool thing about the RRDi is that the corporate members can change the board of directors if they are not happy with the direction of the RRDi, can influence the board to change the Articles of Incorporation, the By Laws, the Rules, the Mission Statement and the Conflict of Interest Policy. Can you do that with the NRS or the RRF?

If you don't like what the RRDi is doing, you can voice your concerns just as you have done here. Try doing that with the NRS?

The RRDi was founded on the principles outlined above and obviously only a handful of rosaceans think that these principles are worth pursuing. Not everyone can volunteer and the RRDi isn't for everyone. We have been at this since June 2004 and we are slow and steadily improving. We will engage in rosacea research someday. We have to convince the corporations that are donating to the NRS that the RRDi is just as worthy a donation if not better, since we will use the funds primarily on rosacea research rather than on administration. One day the corporations will see that, but it takes time to convince people that we are worthy. For the first year and half there were literally only a handful, say ten or less, who stayed with the RRDi when the RRF was formed. As of this date we have 100 members. Even though out of 100 members only a handful actually volunteer and do anything substantial you can see what the power of a few rosaceans who have some motivation can do. Critics are a dime a dozen, but one volunteer with spirit can move mountains. The largest mountain obstacle is that so many say it can't be done. But look at what has been accomplished so far. We have brought together a team and it is working. If you care to step up to the plate we can use your help. Join a committee. Or form your own committee. That is what volunteering is all about.

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First of all Brady, I would like to second Rick's comments on the work you've done to create this forum and bring on such a qualified Mac Board, truly remarkable!

I guess I'm more than a little bit disappointed to see this study move forward though because I think that after all the time and money spent putting it together and running trials, the end result will be much of what we now already know. Which is to say that some people get affected by some foods and some don't, with varying levels of severity.

Me personally, I can usually drink red wine, eat spicy foods and tomatoes with little ill effect unless I'm starting from a point of where I'm already flaring. In fact, sometimes I get pale after drinking alcohol because it relaxes me. Put me outside in direct sunlight for 15 minutes and/or in a warm room and that's a different story all together, with immediate flushing occurring.

Others have a much different reaction with food but it usually depends on the individual as to what types cause a reaction or how many other triggers they've experienced throughout the day. Or maybe it's allergies or maybe there are even some psychosomatic factors involved. And to make things even more complicated it could take several days for a reaction show up so you're really never going to know for sure what cause is having an effect.

My point is we are all so varied as to what sets us off (if at all)and there are so many unereliable factors involved that I think a study like this is doomed from the start and the results will not move us forward at all in curing rosacea or offering any type of strong relief for sufferers.

Thanks for letting us offer feedback.

Tricia

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Whether this study ever gets any further than this will be remarkable since it is such a controversial subject. If Joanne wants to pursue this she is the lone grant writer trying to come up with something regarding this subject, and since nothing else has been prosposed that has generated as much discussion as this hot topic, unless you come up with something that Joanne feels more passion for, volunteering is something that very few want to do, especially grant writers, not to mention rosaceans in general.

If the RRDi ever gets a substantial donation, say $25K or more, then the MAC can try to come up with a general consensus on what the money should be spent on. Right now, since we have basically zilch in the bank, there is no need to worry that the RRDi would be wasting any funds on a project that wouldn't be "curing rosacea or offering any type of strong relief for sufferers." Basically, it would be a miracle if Joanne pulls this off.

Now that you have critiqued this thread, could you come up with a postive suggestion in a new thread on what should be researched and then if it generates as much discussion as this one, maybe the MAC can vote on it? Looking forward to your insight on what should be done.

First of all Brady, I would like to second Rick's comments on the work you've done to create this forum and bring on such a qualified Mac Board, truly remarkable!

I guess I'm more than a little bit disappointed to see this study move forward though because I think that after all the time and money spent putting it together and running trials, the end result will be much of what we now already know.  Which is to say that some people get affected by some foods and some don't, with varying levels of severity.

Me personally, I can usually drink red wine, eat spicy foods and tomatoes with little ill effect unless I'm starting from a point of where I'm already flaring.  In fact, sometimes I get pale after drinking alcohol because it relaxes me.  Put me outside in direct sunlight for 15 minutes and/or in a warm room and that's a different story all together, with immediate flushing occurring.

Others have a much different reaction with food but it usually depends on the individual as to what types cause a reaction or how many other triggers they've experienced throughout the day.  Or maybe it's allergies or maybe there are even some psychosomatic factors involved.  And to make things even more complicated it could take several days for a reaction show up so you're really never going to know for sure what cause is having an effect.

My point is we are all so varied as to what sets us off (if at all)and there are so many unereliable factors involved that I think a study like this is doomed from the start and the results will not move us forward at all in curing rosacea or offering any type of strong relief for sufferers.

Thanks for letting us offer feedback.

Tricia

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I agree, adding positive input is much more productive than just putting down someone else's idea. Although I hope you are not taking my criticism the wrong way as I really think the discussion was good as a whole. Feedback was asked for and honest opinions were given. I think this board is great that in that everyone can offer their ideas in a safe environment.

What would I like to see researched?

1. Things that slow down or stop blood vessel proliferation. There are already drugs like this on the market for cancer and to a smaller effect some antibioitics. i'd love to see a study set up to see if these can contribute to the effectiveness of laser treatments and/or if new topicals can be created to target just the facial area to provide a one two punch. Zapping the vessels first and then preventing them from coming back would be huge!

2. Anti-flushing creams? Anyone? There are ingredients out there that supposedly constrict vessels like caffeine, green tea and whatever the heck the magic Sans Rosa potion is. Has there ever been any experimentation with creating a rosacea friendly cream that stops and/or prevents flushing? It would be great see some experimentation with this.

3. Laser/IPL effectiveness for different sub-types of rosacea. Which ones work better for the sever flushers? Which ones for acne? Are there important steps that patients should take for a more effective treatment (like pre-flushing and is it really necessary to not flush for the first 2-3weeks post treatment?). Are we missing the boat by not developing lasers targeted specifically for rosacea?

4. Anti-inflammatories-there are some exciting new drugs out for Psiorsasis (I know I completely butchered the spelling of this). Are there some we can piggy back off of and taylor more for rosacea? Might be fun to find out.

Just a few thoughts.

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Hi all,

I'm back from vacation, but would like to add my 2 cents. I think the connection between diet and rosacea is very interesting, but I'd rather see grants exploring the basic pathophysiology of rosacea. It's true that studying diet may shed light on the mechanisms involved, but I think exploring diet would be a very indirect route to this, and very difficult. I'd rather see more directed basic immunology work.

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