Saving the coals for the Memorial Day BBQ, Dr. Pilcher

[Guest guest]

> I would urge you to look at the degree of improvement between

> control and treated groups rather than looking solely at numbers of

> those that improved.

You may have misread, Dr. Pilcher, because that was precisely the

point I raised to you: the difference lies solely in the degree of

improvement in those who did improve. Why do you think we don't see

an increase in the number of rosaceans who improved?

Again, when the parameters don't apply to rosacea and the rankings

are not standardized, it's hard to know how to interprete any degree

of improvement (or exacerbation, for that matter). Why were those

four parameters selected for rosaceans, when they don't reflect

features of our condition? What standard has been set for, say,

erythema 2 as distinguished from erythema 3?

> We fully agree that the control group did show

> improvement- in fact, it simply bolsters our confidence that we

> have a highly moisturizing lotion that aids in the treatment of

> symptoms such as desquamation. We have seen this consistently in

> our eczema studies as well.

It's a " control group " only from the prespective of one ingredient,

not for the product itself. But that's a separate issue. You're

right, a highly moisturizing lotion, esp one containing anti-

inflammatory ingredients, is likely to be well received by rosaceans,

as a number of other products have been. Each rosacean has their

favorite (and some of us are still looking .)

Why do you believe rosaceans have a need for desquamation? That's

true for some conditions, but regarding rosacea my understanding is

quite the contrary.

> Your point is well taken about dermal vs. epidermal

> inflammation. We have found in our Franz cell analyses that we are

> able to obtain biologically active amounts of compound in the

> dermis of human skin. So I personally believe that any effects in

> the epidermis will also be seen in the dermis as well.

But then wouldn't you have expected better results -- especially in

increased number of rosaceans responding to the Quadrinone lotion?

Maybe you aren't achieving a high enough percentage of active

compound in the dermis to combat chronic inflammation, or maybe it

takes longer than a month for improvement to show? (Or maybe the

data, such as it is, shouldn't be overanalyzed, one way or the

other.)

> If there were no limitations on claims why would we claim to have a

> cure if it didn't cure rosacea? I hope that you see we are not

> making those types of claims.

I agree, you clearly aren't making those types of claims, but I

assume the reason you aren't is based on what you said earlier: " It

will be sold as a cosmeceutical that one can purchase OTC. As such,

we are unable to make specific claims about CURING rosacea and are

limited to claiming that Dramatic Relief will treat symptoms

associated with the disease. " That sounds to me like you WANT to

claim it cures rosacea, but feel legally restricted from doing so

because it's sold OTC.

> In fact, all we have said since the firs post

> is that it helps in improving symptoms. I don't want to sound

> defensive and am truly trying to keep an open mind. Please forgive

> me if I feel just a little grilled over the coals J.

I'm not interested in " grilling you over the coals, " and I sincerely

regret that *our* conversation has left you feeling as such. I'm

deliberately distancing myself from others here in that regard, as I

think you can see, and bringing up classic weaknesses and limitations

in your study rather than nitpicking. I know you know that.

ly, I wish you were more forthcoming regarding the obvious

limitations of your study. I would love to elevate this discussion

into something beyond how terrific you think your product and

research is. Seriously, if there's any grilling, its goal is to

move us away from that level of discourse, not to give you a hard

time. (Really)

Besides, you can relax, most of the people in this group are going to

try your product anyway when it hits the market, and I'm sure at

least some will like it. Moisturizers with anti-inflammatory features

are crowd-pleasers among rosaceans.

> The sunscreen effect you refer to is due to the molecular structure

> of Quadrinone. It was discovered in one of our initial UV studies

> that it had the ability to absorb UVR. In the very first clinical

> study performed by Cutanix patients were pre-dosed with the lotion

> prior to UV exposure. Naturally, the data came back incredibly

> positive and we were extremely pleased. Then we decided to test for

> UV absorbing capacity and indeed Quadrinone in a 5% lotion had an

> spf of 8-9. We have since looked at 2% and 1% lotions and for those

> the spf is around 3-4 and 1-2, respectively. In all of our

> subsequent clinical studies we have post-dosed the subjects with

> control or active lotions after UV treatment to prevent skewing our

> data with the natural sunscreen characteristics of the molecule. In

> those studies Quadrinone effectively inhibit UV-induced erythema.

Those spfs aren't high enough for anyone who also wants to avoid the

cancerous or aging effects of the sun, are they? Does it protect

against UVA?

> It seems as though we are bound to disagree on much and I hope that

> none of our debate has been taken personally. Although, I have to

> admit that it has been hard for me at times. All that our company

> asks is that you give us a shot and see if the product works in

> your case.

I'm not criticizing your product -- I know nothing about your

product -- I'm criticizing your research, both the " laymen's " version

and what you filed here in the group. I don't take this personally,

and I suspect you don't either. I don't fully understand what's been

hard for you -- my points are pretty standard stuff, gentler that

what you can expect once your research is published.

Maybe what's hard is that your study flaws are being discussed in

public, rather than hidden away in professional circles?

My sole problem remains: the version of the study you filed with this

group is still so flawed. It's not just that it's company-funded --

in another post, I explained that I don't see that necessarily as a

restriction on excellence. It's the inaccuracies and the potential

for bias in the study design, as I addressed in this post and the

last.

[, you apologized to me privately for underestimating the

sophistication and intelligence of the group. That's very kind of you

to acknowledge, but why haven't you shared that apology with the

group?]

Marjorie

Marjorie Lazoff, MD