Dr. Draelos: Demanding excellence in OTC products

May 25, 2002

With all this discussion about the testing methods for Cutanix, I

thought I'd add the article below written by the derm who was in

charge of the clinical studies.

I'd like to try a sample of Cutanix myself and am hoping that Dr.

Pilcher will make those available to interested people in our group.

Take care,

Matija

December 1, 2001

By: Zoe Draelos, M.D.

Dermatology Times

Demanding excellence in OTC products

Dermatologists responsible for raising bar in cosmetics,

cosmeceuticals

Dermatologists are a group of gifted individuals with the innate

desire for excellence. It requires superior academic performance in

college to achieve admission to medical school. Furthermore, it

requires an outstanding medical school performance to obtain a

dermatology residency position. There can be no doubt that

dermatologists are accustomed to putting forth the extra effort

necessary to rise to the top. I am always amazed at dermatology

meetings to find out how special my colleagues are in many dimensions

beyond medicine.

The specialty we practice of dermatology is also based on excellence -

excellence achieved through years of scientific research that has

resulted in a better understanding of skin physiology and better

pharmaceuticals to treat skin disease processes. There is perhaps

more excellence in dermatology than other areas of medicine due to

the exactness with which we can diagnose disease processes due to the

easy accessibility of the skin for observation and biopsy. This is

one of the key attributes that attracted me to dermatology. I vividly

remember the frustration of trying to determine the etiology of

obscure chest pain as a medical student. Was it cardiovascular? Was

it musculoskeletal? Was it gastrointestinal? I do not find these same

issues in dermatology. When a patient presents with a " terrible rash "

and I cannot see anything present on the skin, I do not spend hours

trying to determine whether a rash is or is not present. I simply

take my visual findings into account and proceed to logically arrive

at a diagnosis and treatment plan.

The dermatologic armamentarium is also based on pharmaceuticals

developed to standards of excellence. The topical pharmaceuticals

that we use are no less scientifically formulated than oral

medications and must adhere to the same standards as other FDA-

approved oral medications. They must go through the same phases of

testing in double blind placebo controlled studies to demonstrate

efficacy. Dermatologists are accustomed to reading the scientific

literature regarding a new topical pharmaceutical to determine

whether it might provide a valuable benefit to patients. We review

how well the active group performed as compared to the placebo group.

We look at before and after clinical photographs, expert investigator

assessments, noninvasive measurements, histology, etc. These

standards are applied not only to our prescribing practices, but also

to judgments made on the suitability of research manuscripts for

publication. In short, we demand excellence in all information we

receive regarding the use of topical pharmaceuticals developed for

dermatology.

Now, let's turn for a moment to the newly developed area of

biologically active cosmetics and cosmeceuticals. I have noticed a

tremendous increase in the number of exhibitors at our annual

American Academy of Dermatology meeting detailing dermatologists on

these over the counter products. As a matter of fact, I make a point

of speaking to each of these exhibitors simply to keep abreast of new

technology. However, in this arena I am dismayed by the lack of

excellence. The sales representative who opens her discussion by

telling me that I can greatly increase my practice revenue by buying

their $5 bottle of cream and easily selling it for $20, without any

discussion of product efficacy, is not respecting my position as a

physician. The company president who tells me that I should sell his

cream because his 15 best friends have all used the product and love

what it has done to minimize their pores is wasting my time. The

zealous gentlemen who wants to rub his cream on my hand to let me see

how great it feels is missing the whole concept of product

performance. I do not dispense in my office, but I do take a few

minutes with each these people and explain to them that their

communications with the dermatologist must take a more science-based

approach, since we are not cosmetic counter salespeople.

I think it is necessary for dermatologists to demand excellence from

those companies who manufacture over-the-counter cosmetic products

and cosmeceuticals. Some of these well-meaning companies do not know

exactly what it takes to credential a product. We need to train them

through our conversations. We must explain that scientific studies

conducted in a blinded fashion with a parallel placebo group are the

only way to document true cutaneous value. We must also insist that

suitable sample sizes to achieve statistical significance are

imperative. A loose study involving 20 personal acquaintances is

insufficient. By demanding this information we will not only improve

the quality of these products, but we will also maintain our

professional excellence.

This demand for scientific excellence must also extend beyond the

Academy exhibit hall into our meeting rooms and our journals.

Dermatologists or other scientists with corporate interests should

not give presentations with obvious commercial ties based on mediocre

data from poorly designed studies. I have attended several sessions

where a dermatologist has given a presentation based on data obtained

from a sample size of 16 patients and no placebo group with poor

quality before and after photos. The dermatologist has clearly stated

their proprietary interest in the product studied, but I still feel

that the presenter should have been pulled from the podium with a

long cane for even considering turning an educational meeting into a

forum for commercial enterprise. These same standards, of course,

extend to manuscripts accepted for publication in dermatologic

journals. There is merit in presenting and publishing new ingredients

and new formulations with documented efficacy that have been

evaluated in a well-designed scientific study. All studies designed

to assess the value of cosmetics and cosmeceuticals can and should

meet the requirements for pharmaceutical studies.

Who is going to raise the bar for excellence in cosmetic and

cosmeceutical products? Dermatologists must raise the bar for

excellence in cosmetic and cosmeceutical products. Why? Because we

are the only people with the background knowledge and training to

accomplish the job. Only we know what excellence in this realm truly

means. There are many meritous products marketed by companies who

have performed large scale testing which have demonstrated both

safety and consumer benefits. Yet, I think that we can do better. We

can demand better. We can ask salespersons for their published study

results. We can tell fellow dermatologists to leave their poorly

studied proprietary projects off the podium. We can reject articles

that do not follow the scientific method. We can and should demand

the excellence we expect in every other aspect of lives from cosmetic

and cosmeceutical products. DT

May 26, 2002

That's an interesting and timely article, Matija. I agreed partly

with what she said about studies; just saying that a study is blinded

and controlled is not regarded as enough. The study design itself

must conform to acceptable scientific standards, where blinded and

controlled are necessary -- but not sufficient -- critera.

As I've already noted, in Dr. Draelos' study for Cutanix, two huge

design flaws were obvious: the parameters did not match the features

of rosacea, and the scale was subjective to one physician's

interpretation (even if that physician is blinded, the accepted

research standard is an objective scale that can be rated by anyone,

thereby excluding bias. This is referred to as interrater reliability

and validity, and the best studies provide statistics for this study

variable, to show that any rater would come up with the same rating.

It may sound counterintuitive, but having only one person rate all

participants is regarded as a potential source of bias.) Neither of

these core design flaws were addressed.

I agree, in general 20 (or 30) patients is usually too small a

sample, especially for conditions with varied expressions. And don't

get me started on the other features of the imperfect study, or

especially how the results " speak for themselves. " They do, but not

the way I believe the company wishes they did.

Marjorie

Marjorie Lazoff, MD

> With all this discussion about the testing methods for Cutanix, I

> thought I'd add the article below written by the derm who was in

> charge of the clinical studies.

>

> I'd like to try a sample of Cutanix myself and am hoping that Dr.

> Pilcher will make those available to interested people in our group.

>

> Take care,

> Matija

>

> December 1, 2001

> By: Zoe Draelos, M.D.

> Dermatology Times

>

> Demanding excellence in OTC products

>

> Dermatologists responsible for raising bar in cosmetics,

> cosmeceuticals

>

> Dermatologists are a group of gifted individuals with the innate

> desire for excellence. It requires superior academic performance in

> college to achieve admission to medical school. Furthermore, it

> requires an outstanding medical school performance to obtain a

> dermatology residency position. There can be no doubt that

> dermatologists are accustomed to putting forth the extra effort

> necessary to rise to the top. I am always amazed at dermatology

> meetings to find out how special my colleagues are in many

dimensions

> beyond medicine.

>

> The specialty we practice of dermatology is also based on

excellence -

> excellence achieved through years of scientific research that has

> resulted in a better understanding of skin physiology and better

> pharmaceuticals to treat skin disease processes. There is perhaps

> more excellence in dermatology than other areas of medicine due to

> the exactness with which we can diagnose disease processes due to

the

> easy accessibility of the skin for observation and biopsy. This is

> one of the key attributes that attracted me to dermatology. I

vividly

> remember the frustration of trying to determine the etiology of

> obscure chest pain as a medical student. Was it cardiovascular? Was

> it musculoskeletal? Was it gastrointestinal? I do not find these

same

> issues in dermatology. When a patient presents with a " terrible

rash "

> and I cannot see anything present on the skin, I do not spend hours

> trying to determine whether a rash is or is not present. I simply

> take my visual findings into account and proceed to logically

arrive

> at a diagnosis and treatment plan.

>

> The dermatologic armamentarium is also based on pharmaceuticals

> developed to standards of excellence. The topical pharmaceuticals

> that we use are no less scientifically formulated than oral

> medications and must adhere to the same standards as other FDA-

> approved oral medications. They must go through the same phases of

> testing in double blind placebo controlled studies to demonstrate

> efficacy. Dermatologists are accustomed to reading the scientific

> literature regarding a new topical pharmaceutical to determine

> whether it might provide a valuable benefit to patients. We review

> how well the active group performed as compared to the placebo

group.

> We look at before and after clinical photographs, expert

investigator

> assessments, noninvasive measurements, histology, etc. These

> standards are applied not only to our prescribing practices, but

also

> to judgments made on the suitability of research manuscripts for

> publication. In short, we demand excellence in all information we

> receive regarding the use of topical pharmaceuticals developed for

> dermatology.

>

> Now, let's turn for a moment to the newly developed area of

> biologically active cosmetics and cosmeceuticals. I have noticed a

> tremendous increase in the number of exhibitors at our annual

> American Academy of Dermatology meeting detailing dermatologists on

> these over the counter products. As a matter of fact, I make a

point

> of speaking to each of these exhibitors simply to keep abreast of

new

> technology. However, in this arena I am dismayed by the lack of

> excellence. The sales representative who opens her discussion by

> telling me that I can greatly increase my practice revenue by

buying

> their $5 bottle of cream and easily selling it for $20, without any

> discussion of product efficacy, is not respecting my position as a

> physician. The company president who tells me that I should sell

his

> cream because his 15 best friends have all used the product and

love

> what it has done to minimize their pores is wasting my time. The

> zealous gentlemen who wants to rub his cream on my hand to let me

see

> how great it feels is missing the whole concept of product

> performance. I do not dispense in my office, but I do take a few

> minutes with each these people and explain to them that their

> communications with the dermatologist must take a more science-

based

> approach, since we are not cosmetic counter salespeople.

>

> I think it is necessary for dermatologists to demand excellence

from

> those companies who manufacture over-the-counter cosmetic products

> and cosmeceuticals. Some of these well-meaning companies do not

know

> exactly what it takes to credential a product. We need to train

them

> through our conversations. We must explain that scientific studies

> conducted in a blinded fashion with a parallel placebo group are

the

> only way to document true cutaneous value. We must also insist that

> suitable sample sizes to achieve statistical significance are

> imperative. A loose study involving 20 personal acquaintances is

> insufficient. By demanding this information we will not only

improve

> the quality of these products, but we will also maintain our

> professional excellence.

>

> This demand for scientific excellence must also extend beyond the

> Academy exhibit hall into our meeting rooms and our journals.

> Dermatologists or other scientists with corporate interests should

> not give presentations with obvious commercial ties based on

mediocre

> data from poorly designed studies. I have attended several sessions

> where a dermatologist has given a presentation based on data

obtained

> from a sample size of 16 patients and no placebo group with poor

> quality before and after photos. The dermatologist has clearly

stated

> their proprietary interest in the product studied, but I still feel

> that the presenter should have been pulled from the podium with a

> long cane for even considering turning an educational meeting into

a

> forum for commercial enterprise. These same standards, of course,

> extend to manuscripts accepted for publication in dermatologic

> journals. There is merit in presenting and publishing new

ingredients

> and new formulations with documented efficacy that have been

> evaluated in a well-designed scientific study. All studies designed

> to assess the value of cosmetics and cosmeceuticals can and should

> meet the requirements for pharmaceutical studies.

>

> Who is going to raise the bar for excellence in cosmetic and

> cosmeceutical products? Dermatologists must raise the bar for

> excellence in cosmetic and cosmeceutical products. Why? Because we

> are the only people with the background knowledge and training to

> accomplish the job. Only we know what excellence in this realm

truly

> means. There are many meritous products marketed by companies who

> have performed large scale testing which have demonstrated both

> safety and consumer benefits. Yet, I think that we can do better.

We

> can demand better. We can ask salespersons for their published

study

> results. We can tell fellow dermatologists to leave their poorly

> studied proprietary projects off the podium. We can reject articles

> that do not follow the scientific method. We can and should demand

> the excellence we expect in every other aspect of lives from

cosmetic

> and cosmeceutical products. DT

May 26, 2002