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Adam, the study on MK-869 you brought our attention to was conducted

on guinea pigs -- not human guinea pigs but oink-oink guinea pigs.

That, together with the fact that the drug is still be referred

to by number and not name (part of a drug company's promotion is to

use it's copyrighted name) leads me to believe the research is years

from human trials. Although, the article was from 1998, so we should

be seeing something about this in 2002.

But most important, the article only talks about use of MK-869 as an

anti-depressant/anti-anxiolytic. Nothing related to rosacea.

Medications that block Substance P are used *topically* for control

of neurogenic pain -- I know of one available on the market now.

although I understand it is not uniformly successful and has side

effects. I'm familiar with its use on diabetic feet or post-herpetic

zoster pain, not on the face. The trade name is Zostrix.

Perhaps Zostrix is what Dr. Nase was referring to, since as your

father correctly noted, Zofran is used to counteract the nausau and

vomiting of chemotherapy. I'm quite familiar with Zofran from my

residency days, and I can't fathom a use in rosacea for it.

Marjorie

Marjorie Lazoff, MD

> Ok, while I'm on the subject of things that I don't really

understand..

>

> In Dr Nase's book, he talks about how Substance P may play an

important role in cea. He mentions a doctor who has had success

in treating vascular cea using the drug Zofran. When I first got

this book months ago I went through all the medicines listed in it

with my dad and asked him which ones were safe to take, and he told

me Zofran was used for chemotherapy or cancer or something and had

alot of possible side effects. Anyway, Dr Nase mentions a selective

substance P blocker MK-869 " currently undergoing extensive testing in

human clinical trials " that " shows great promise " . Well, now

apparantly the studies have been done.

>

> Well, in the following article I found, it talks about substance

P's role in pain perception. The article talks about MK-869 which

has been tested, and found to be a useful antidepressant and

antianxiety medication. The article mentions that MK-869 has a very

low incidence of side effects. So, the way I understand it (please

Nobody misconstrue this as a fact)... MK-869 is a pain-relieving,

flush-reducing, antidepressant/anti-anxiety medication with minimal

side effects that no doctors anywhere are using to treat cea.

Can somebody please explain to me where exactly I got mixed up? This

doesn't sound right..

>

> Here is the link:

> http://www.hosppract.com/cc/1998/cc9812.htm

>

> Adam

>

>

>

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Guest guest

Adam, the study on MK-869 you brought our attention to was conducted

on guinea pigs -- not human guinea pigs but oink-oink guinea pigs.

That, together with the fact that the drug is still be referred

to by number and not name (part of a drug company's promotion is to

use it's copyrighted name) leads me to believe the research is years

from human trials. Although, the article was from 1998, so we should

be seeing something about this in 2002.

But most important, the article only talks about use of MK-869 as an

anti-depressant/anti-anxiolytic. Nothing related to rosacea.

Medications that block Substance P are used *topically* for control

of neurogenic pain -- I know of one available on the market now.

although I understand it is not uniformly successful and has side

effects. I'm familiar with its use on diabetic feet or post-herpetic

zoster pain, not on the face. The trade name is Zostrix.

Perhaps Zostrix is what Dr. Nase was referring to, since as your

father correctly noted, Zofran is used to counteract the nausau and

vomiting of chemotherapy. I'm quite familiar with Zofran from my

residency days, and I can't fathom a use in rosacea for it.

Marjorie

Marjorie Lazoff, MD

> Ok, while I'm on the subject of things that I don't really

understand..

>

> In Dr Nase's book, he talks about how Substance P may play an

important role in cea. He mentions a doctor who has had success

in treating vascular cea using the drug Zofran. When I first got

this book months ago I went through all the medicines listed in it

with my dad and asked him which ones were safe to take, and he told

me Zofran was used for chemotherapy or cancer or something and had

alot of possible side effects. Anyway, Dr Nase mentions a selective

substance P blocker MK-869 " currently undergoing extensive testing in

human clinical trials " that " shows great promise " . Well, now

apparantly the studies have been done.

>

> Well, in the following article I found, it talks about substance

P's role in pain perception. The article talks about MK-869 which

has been tested, and found to be a useful antidepressant and

antianxiety medication. The article mentions that MK-869 has a very

low incidence of side effects. So, the way I understand it (please

Nobody misconstrue this as a fact)... MK-869 is a pain-relieving,

flush-reducing, antidepressant/anti-anxiety medication with minimal

side effects that no doctors anywhere are using to treat cea.

Can somebody please explain to me where exactly I got mixed up? This

doesn't sound right..

>

> Here is the link:

> http://www.hosppract.com/cc/1998/cc9812.htm

>

> Adam

>

>

>

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Share on other sites

Guest guest

Adam, the study on MK-869 you brought our attention to was conducted

on guinea pigs -- not human guinea pigs but oink-oink guinea pigs.

That, together with the fact that the drug is still be referred

to by number and not name (part of a drug company's promotion is to

use it's copyrighted name) leads me to believe the research is years

from human trials. Although, the article was from 1998, so we should

be seeing something about this in 2002.

But most important, the article only talks about use of MK-869 as an

anti-depressant/anti-anxiolytic. Nothing related to rosacea.

Medications that block Substance P are used *topically* for control

of neurogenic pain -- I know of one available on the market now.

although I understand it is not uniformly successful and has side

effects. I'm familiar with its use on diabetic feet or post-herpetic

zoster pain, not on the face. The trade name is Zostrix.

Perhaps Zostrix is what Dr. Nase was referring to, since as your

father correctly noted, Zofran is used to counteract the nausau and

vomiting of chemotherapy. I'm quite familiar with Zofran from my

residency days, and I can't fathom a use in rosacea for it.

Marjorie

Marjorie Lazoff, MD

> Ok, while I'm on the subject of things that I don't really

understand..

>

> In Dr Nase's book, he talks about how Substance P may play an

important role in cea. He mentions a doctor who has had success

in treating vascular cea using the drug Zofran. When I first got

this book months ago I went through all the medicines listed in it

with my dad and asked him which ones were safe to take, and he told

me Zofran was used for chemotherapy or cancer or something and had

alot of possible side effects. Anyway, Dr Nase mentions a selective

substance P blocker MK-869 " currently undergoing extensive testing in

human clinical trials " that " shows great promise " . Well, now

apparantly the studies have been done.

>

> Well, in the following article I found, it talks about substance

P's role in pain perception. The article talks about MK-869 which

has been tested, and found to be a useful antidepressant and

antianxiety medication. The article mentions that MK-869 has a very

low incidence of side effects. So, the way I understand it (please

Nobody misconstrue this as a fact)... MK-869 is a pain-relieving,

flush-reducing, antidepressant/anti-anxiety medication with minimal

side effects that no doctors anywhere are using to treat cea.

Can somebody please explain to me where exactly I got mixed up? This

doesn't sound right..

>

> Here is the link:

> http://www.hosppract.com/cc/1998/cc9812.htm

>

> Adam

>

>

>

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Guest guest

Hi Adam,

The reason is that for the moment any use on rosacea is

largely " hypothetical " with only one or two doctors using it. Most

doctors are conservative and will not prescribe medications that

are " off-label " (i.e. they are not indicated by the manufacturer as

a application of the drug). At the very least many doctors will

want to see a well regarded initial study on a drug and its

application before they prescribe it... This is in some ways

unfortunate but we have to remember that Doctors have a huge amount

of drugs and diseases to keep up to date with. They can't find out

the safety and applicability of drugs within a single sitting with a

patient so (unforutanely for us) are sometimes dissimissive.

At the end of the day, they are reponsible for any " mishaps " and

with rosacea not a life threatening (but certainly life altering and

unpleasant) disease, they are unwilling to take risks. Lets hope

that someone does preliminary trials on drugs like the Substance P

blocker and the new topical medications on rosacea sufferers.

Perhaps Dr. Marjorie Lazaroff who is currently contributing actively

to the group can help us start this process.

.

> Ok, while I'm on the subject of things that I don't really

understand..

>

> In Dr Nase's book, he talks about how Substance P may play an

important role in cea. He mentions a doctor who has had success

in treating vascular cea using the drug Zofran. When I first

got this book months ago I went through all the medicines listed in

it with my dad and asked him which ones were safe to take, and he

told me Zofran was used for chemotherapy or cancer or something and

had alot of possible side effects. Anyway, Dr Nase mentions a

selective substance P blocker MK-869 " currently undergoing extensive

testing in human clinical trials " that " shows great promise " . Well,

now apparantly the studies have been done.

>

> Well, in the following article I found, it talks about substance

P's role in pain perception. The article talks about MK-869 which

has been tested, and found to be a useful antidepressant and

antianxiety medication. The article mentions that MK-869 has a very

low incidence of side effects. So, the way I understand it (please

Nobody misconstrue this as a fact)... MK-869 is a pain-relieving,

flush-reducing, antidepressant/anti-anxiety medication with minimal

side effects that no doctors anywhere are using to treat cea.

Can somebody please explain to me where exactly I got mixed up? This

doesn't sound right..

>

> Here is the link:

> http://www.hosppract.com/cc/1998/cc9812.htm

>

> Adam

>

>

>

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Share on other sites

Guest guest

Hi Adam,

The reason is that for the moment any use on rosacea is

largely " hypothetical " with only one or two doctors using it. Most

doctors are conservative and will not prescribe medications that

are " off-label " (i.e. they are not indicated by the manufacturer as

a application of the drug). At the very least many doctors will

want to see a well regarded initial study on a drug and its

application before they prescribe it... This is in some ways

unfortunate but we have to remember that Doctors have a huge amount

of drugs and diseases to keep up to date with. They can't find out

the safety and applicability of drugs within a single sitting with a

patient so (unforutanely for us) are sometimes dissimissive.

At the end of the day, they are reponsible for any " mishaps " and

with rosacea not a life threatening (but certainly life altering and

unpleasant) disease, they are unwilling to take risks. Lets hope

that someone does preliminary trials on drugs like the Substance P

blocker and the new topical medications on rosacea sufferers.

Perhaps Dr. Marjorie Lazaroff who is currently contributing actively

to the group can help us start this process.

.

> Ok, while I'm on the subject of things that I don't really

understand..

>

> In Dr Nase's book, he talks about how Substance P may play an

important role in cea. He mentions a doctor who has had success

in treating vascular cea using the drug Zofran. When I first

got this book months ago I went through all the medicines listed in

it with my dad and asked him which ones were safe to take, and he

told me Zofran was used for chemotherapy or cancer or something and

had alot of possible side effects. Anyway, Dr Nase mentions a

selective substance P blocker MK-869 " currently undergoing extensive

testing in human clinical trials " that " shows great promise " . Well,

now apparantly the studies have been done.

>

> Well, in the following article I found, it talks about substance

P's role in pain perception. The article talks about MK-869 which

has been tested, and found to be a useful antidepressant and

antianxiety medication. The article mentions that MK-869 has a very

low incidence of side effects. So, the way I understand it (please

Nobody misconstrue this as a fact)... MK-869 is a pain-relieving,

flush-reducing, antidepressant/anti-anxiety medication with minimal

side effects that no doctors anywhere are using to treat cea.

Can somebody please explain to me where exactly I got mixed up? This

doesn't sound right..

>

> Here is the link:

> http://www.hosppract.com/cc/1998/cc9812.htm

>

> Adam

>

>

>

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Share on other sites

Guest guest

> Adam, the study on MK-869 you brought our attention to was

> conducted on guinea pigs -- not human guinea pigs but oink-oink

> guinea pigs.

I'm sorry! I missed the second study, that WAS conducted on humans. I

was wondering how they could use a point scale system measuring

depression on guinea pigs -- especially when they came to the

conclusion that sexual side effects were infrequent!

Still, the MK-869 tests were for psychiatric conditions, not rosacea.

Perhaps there are topical MK-869 studies, similiar to Zostrix?

Marjorie

Marjorie Lazoff, MD

That, together with the fact that the drug is still be referred

> to by number and not name (part of a drug company's promotion is to

> use it's copyrighted name) leads me to believe the research is

years

> from human trials. Although, the article was from 1998, so we

should

> be seeing something about this in 2002.

>

> But most important, the article only talks about use of MK-869 as

an

> anti-depressant/anti-anxiolytic. Nothing related to rosacea.

>

> Medications that block Substance P are used *topically* for control

> of neurogenic pain -- I know of one available on the market now.

> although I understand it is not uniformly successful and has side

> effects. I'm familiar with its use on diabetic feet or post-

herpetic

> zoster pain, not on the face. The trade name is Zostrix.

>

> Perhaps Zostrix is what Dr. Nase was referring to, since as your

> father correctly noted, Zofran is used to counteract the nausau and

> vomiting of chemotherapy. I'm quite familiar with Zofran from my

> residency days, and I can't fathom a use in rosacea for it.

>

> Marjorie

>

> Marjorie Lazoff, MD

>

>

>

>

>

> > Ok, while I'm on the subject of things that I don't really

> understand..

> >

> > In Dr Nase's book, he talks about how Substance P may play an

> important role in cea. He mentions a doctor who has had

success

> in treating vascular cea using the drug Zofran. When I first

got

> this book months ago I went through all the medicines listed in it

> with my dad and asked him which ones were safe to take, and he told

> me Zofran was used for chemotherapy or cancer or something and had

> alot of possible side effects. Anyway, Dr Nase mentions a

selective

> substance P blocker MK-869 " currently undergoing extensive testing

in

> human clinical trials " that " shows great promise " . Well, now

> apparantly the studies have been done.

> >

> > Well, in the following article I found, it talks about substance

> P's role in pain perception. The article talks about MK-869 which

> has been tested, and found to be a useful antidepressant and

> antianxiety medication. The article mentions that MK-869 has a

very

> low incidence of side effects. So, the way I understand it (please

> Nobody misconstrue this as a fact)... MK-869 is a pain-relieving,

> flush-reducing, antidepressant/anti-anxiety medication with minimal

> side effects that no doctors anywhere are using to treat cea.

> Can somebody please explain to me where exactly I got mixed up?

This

> doesn't sound right..

> >

> > Here is the link:

> > http://www.hosppract.com/cc/1998/cc9812.htm

> >

> > Adam

> >

> >

> >

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Share on other sites

Guest guest

> Adam, the study on MK-869 you brought our attention to was

> conducted on guinea pigs -- not human guinea pigs but oink-oink

> guinea pigs.

I'm sorry! I missed the second study, that WAS conducted on humans. I

was wondering how they could use a point scale system measuring

depression on guinea pigs -- especially when they came to the

conclusion that sexual side effects were infrequent!

Still, the MK-869 tests were for psychiatric conditions, not rosacea.

Perhaps there are topical MK-869 studies, similiar to Zostrix?

Marjorie

Marjorie Lazoff, MD

That, together with the fact that the drug is still be referred

> to by number and not name (part of a drug company's promotion is to

> use it's copyrighted name) leads me to believe the research is

years

> from human trials. Although, the article was from 1998, so we

should

> be seeing something about this in 2002.

>

> But most important, the article only talks about use of MK-869 as

an

> anti-depressant/anti-anxiolytic. Nothing related to rosacea.

>

> Medications that block Substance P are used *topically* for control

> of neurogenic pain -- I know of one available on the market now.

> although I understand it is not uniformly successful and has side

> effects. I'm familiar with its use on diabetic feet or post-

herpetic

> zoster pain, not on the face. The trade name is Zostrix.

>

> Perhaps Zostrix is what Dr. Nase was referring to, since as your

> father correctly noted, Zofran is used to counteract the nausau and

> vomiting of chemotherapy. I'm quite familiar with Zofran from my

> residency days, and I can't fathom a use in rosacea for it.

>

> Marjorie

>

> Marjorie Lazoff, MD

>

>

>

>

>

> > Ok, while I'm on the subject of things that I don't really

> understand..

> >

> > In Dr Nase's book, he talks about how Substance P may play an

> important role in cea. He mentions a doctor who has had

success

> in treating vascular cea using the drug Zofran. When I first

got

> this book months ago I went through all the medicines listed in it

> with my dad and asked him which ones were safe to take, and he told

> me Zofran was used for chemotherapy or cancer or something and had

> alot of possible side effects. Anyway, Dr Nase mentions a

selective

> substance P blocker MK-869 " currently undergoing extensive testing

in

> human clinical trials " that " shows great promise " . Well, now

> apparantly the studies have been done.

> >

> > Well, in the following article I found, it talks about substance

> P's role in pain perception. The article talks about MK-869 which

> has been tested, and found to be a useful antidepressant and

> antianxiety medication. The article mentions that MK-869 has a

very

> low incidence of side effects. So, the way I understand it (please

> Nobody misconstrue this as a fact)... MK-869 is a pain-relieving,

> flush-reducing, antidepressant/anti-anxiety medication with minimal

> side effects that no doctors anywhere are using to treat cea.

> Can somebody please explain to me where exactly I got mixed up?

This

> doesn't sound right..

> >

> > Here is the link:

> > http://www.hosppract.com/cc/1998/cc9812.htm

> >

> > Adam

> >

> >

> >

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Share on other sites

Guest guest

> Adam, the study on MK-869 you brought our attention to was

> conducted on guinea pigs -- not human guinea pigs but oink-oink

> guinea pigs.

I'm sorry! I missed the second study, that WAS conducted on humans. I

was wondering how they could use a point scale system measuring

depression on guinea pigs -- especially when they came to the

conclusion that sexual side effects were infrequent!

Still, the MK-869 tests were for psychiatric conditions, not rosacea.

Perhaps there are topical MK-869 studies, similiar to Zostrix?

Marjorie

Marjorie Lazoff, MD

That, together with the fact that the drug is still be referred

> to by number and not name (part of a drug company's promotion is to

> use it's copyrighted name) leads me to believe the research is

years

> from human trials. Although, the article was from 1998, so we

should

> be seeing something about this in 2002.

>

> But most important, the article only talks about use of MK-869 as

an

> anti-depressant/anti-anxiolytic. Nothing related to rosacea.

>

> Medications that block Substance P are used *topically* for control

> of neurogenic pain -- I know of one available on the market now.

> although I understand it is not uniformly successful and has side

> effects. I'm familiar with its use on diabetic feet or post-

herpetic

> zoster pain, not on the face. The trade name is Zostrix.

>

> Perhaps Zostrix is what Dr. Nase was referring to, since as your

> father correctly noted, Zofran is used to counteract the nausau and

> vomiting of chemotherapy. I'm quite familiar with Zofran from my

> residency days, and I can't fathom a use in rosacea for it.

>

> Marjorie

>

> Marjorie Lazoff, MD

>

>

>

>

>

> > Ok, while I'm on the subject of things that I don't really

> understand..

> >

> > In Dr Nase's book, he talks about how Substance P may play an

> important role in cea. He mentions a doctor who has had

success

> in treating vascular cea using the drug Zofran. When I first

got

> this book months ago I went through all the medicines listed in it

> with my dad and asked him which ones were safe to take, and he told

> me Zofran was used for chemotherapy or cancer or something and had

> alot of possible side effects. Anyway, Dr Nase mentions a

selective

> substance P blocker MK-869 " currently undergoing extensive testing

in

> human clinical trials " that " shows great promise " . Well, now

> apparantly the studies have been done.

> >

> > Well, in the following article I found, it talks about substance

> P's role in pain perception. The article talks about MK-869 which

> has been tested, and found to be a useful antidepressant and

> antianxiety medication. The article mentions that MK-869 has a

very

> low incidence of side effects. So, the way I understand it (please

> Nobody misconstrue this as a fact)... MK-869 is a pain-relieving,

> flush-reducing, antidepressant/anti-anxiety medication with minimal

> side effects that no doctors anywhere are using to treat cea.

> Can somebody please explain to me where exactly I got mixed up?

This

> doesn't sound right..

> >

> > Here is the link:

> > http://www.hosppract.com/cc/1998/cc9812.htm

> >

> > Adam

> >

> >

> >

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Guest guest

> Most doctors are conservative and will not prescribe medications

> that are " off-label " (i.e. they are not indicated by the

> manufacturer as a application of the drug).

, once a drug is approved, it can be legally prescribed by a

physician for any use. As you note, the indications for use come from

the drug company's application to the FDA; it usually takes a few

years for physicians to become comfortable prescribing it for other

indications as new studies, word-of-mouth recommendations by

colleagues, and common sense suggests. Unless there are marketing

benefits, it's not worth the expense for drug companies to refile for

every new indication. So a good rule of thumb is that the older a

drug is, the more likely and appropriately it will be prescribed " off-

label. " (Physicians may be limited in prescribing based on their

patient's HMO formulary which may reimburse only for certain

conditions or manners of use, but that's a different problem.)

> At the very least many doctors will

> want to see a well regarded initial study on a drug and its

> application before they prescribe it...

I don't believe a single initial study, no matter how well regarded,

would satisfy most physicians. ly, many physicians I know like

to wait 2 years or so after a systemically-acting drug has been

approved by the FDA, before they feel comfortable using it. Patients

don't usually see all the recalls and post-production side effects

that quell physicians' desire to jump on any new drug bandwagon.

Topical medications are usually regarded as less suspect, especially

for physicians who manage many patients with dermatologic conditions,

so they're much more likely to be used immediately after FDA approval.

> This is in some ways

> unfortunate but we have to remember that Doctors have a huge amount

> of drugs and diseases to keep up to date with. They can't find out

> the safety and applicability of drugs within a single sitting with

> a patient so (unforutanely for us) are sometimes dissimissive.

> At the end of the day, they are reponsible for any " mishaps " and

> with rosacea not a life threatening (but certainly life altering

> and unpleasant) disease, they are unwilling to take risks.

Keeping up with the massive amounts of medical information is tough,

but physicians are not dismissive of new drugs! Quite the contrary.

It's not a " CYA " situation, it's a " first, do no harm " situation.

> Lets hope

> that someone does preliminary trials on drugs like the Substance P

> blocker and the new topical medications on rosacea sufferers.

> Perhaps Dr. Marjorie Lazaroff who is currently contributing

> actively to the group can help us start this process.

I'm willing to help whenever appropriate, but I need more information

from you to properly address this, as I just requested in email (or

you can post it publicly if you desire). As I told you, from what

I've seen, physicians don't use investigational drugs on a patient

outside of a highly structured clinical trial -- usually, an academic

setting involving hospital-based physicians -- or by compassionate

use, which wouldn't apply for non-lethal conditions.

Marjorie

Marjorie Lazoff, MD

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Share on other sites

Guest guest

> Most doctors are conservative and will not prescribe medications

> that are " off-label " (i.e. they are not indicated by the

> manufacturer as a application of the drug).

, once a drug is approved, it can be legally prescribed by a

physician for any use. As you note, the indications for use come from

the drug company's application to the FDA; it usually takes a few

years for physicians to become comfortable prescribing it for other

indications as new studies, word-of-mouth recommendations by

colleagues, and common sense suggests. Unless there are marketing

benefits, it's not worth the expense for drug companies to refile for

every new indication. So a good rule of thumb is that the older a

drug is, the more likely and appropriately it will be prescribed " off-

label. " (Physicians may be limited in prescribing based on their

patient's HMO formulary which may reimburse only for certain

conditions or manners of use, but that's a different problem.)

> At the very least many doctors will

> want to see a well regarded initial study on a drug and its

> application before they prescribe it...

I don't believe a single initial study, no matter how well regarded,

would satisfy most physicians. ly, many physicians I know like

to wait 2 years or so after a systemically-acting drug has been

approved by the FDA, before they feel comfortable using it. Patients

don't usually see all the recalls and post-production side effects

that quell physicians' desire to jump on any new drug bandwagon.

Topical medications are usually regarded as less suspect, especially

for physicians who manage many patients with dermatologic conditions,

so they're much more likely to be used immediately after FDA approval.

> This is in some ways

> unfortunate but we have to remember that Doctors have a huge amount

> of drugs and diseases to keep up to date with. They can't find out

> the safety and applicability of drugs within a single sitting with

> a patient so (unforutanely for us) are sometimes dissimissive.

> At the end of the day, they are reponsible for any " mishaps " and

> with rosacea not a life threatening (but certainly life altering

> and unpleasant) disease, they are unwilling to take risks.

Keeping up with the massive amounts of medical information is tough,

but physicians are not dismissive of new drugs! Quite the contrary.

It's not a " CYA " situation, it's a " first, do no harm " situation.

> Lets hope

> that someone does preliminary trials on drugs like the Substance P

> blocker and the new topical medications on rosacea sufferers.

> Perhaps Dr. Marjorie Lazaroff who is currently contributing

> actively to the group can help us start this process.

I'm willing to help whenever appropriate, but I need more information

from you to properly address this, as I just requested in email (or

you can post it publicly if you desire). As I told you, from what

I've seen, physicians don't use investigational drugs on a patient

outside of a highly structured clinical trial -- usually, an academic

setting involving hospital-based physicians -- or by compassionate

use, which wouldn't apply for non-lethal conditions.

Marjorie

Marjorie Lazoff, MD

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Share on other sites

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> Most doctors are conservative and will not prescribe medications

> that are " off-label " (i.e. they are not indicated by the

> manufacturer as a application of the drug).

, once a drug is approved, it can be legally prescribed by a

physician for any use. As you note, the indications for use come from

the drug company's application to the FDA; it usually takes a few

years for physicians to become comfortable prescribing it for other

indications as new studies, word-of-mouth recommendations by

colleagues, and common sense suggests. Unless there are marketing

benefits, it's not worth the expense for drug companies to refile for

every new indication. So a good rule of thumb is that the older a

drug is, the more likely and appropriately it will be prescribed " off-

label. " (Physicians may be limited in prescribing based on their

patient's HMO formulary which may reimburse only for certain

conditions or manners of use, but that's a different problem.)

> At the very least many doctors will

> want to see a well regarded initial study on a drug and its

> application before they prescribe it...

I don't believe a single initial study, no matter how well regarded,

would satisfy most physicians. ly, many physicians I know like

to wait 2 years or so after a systemically-acting drug has been

approved by the FDA, before they feel comfortable using it. Patients

don't usually see all the recalls and post-production side effects

that quell physicians' desire to jump on any new drug bandwagon.

Topical medications are usually regarded as less suspect, especially

for physicians who manage many patients with dermatologic conditions,

so they're much more likely to be used immediately after FDA approval.

> This is in some ways

> unfortunate but we have to remember that Doctors have a huge amount

> of drugs and diseases to keep up to date with. They can't find out

> the safety and applicability of drugs within a single sitting with

> a patient so (unforutanely for us) are sometimes dissimissive.

> At the end of the day, they are reponsible for any " mishaps " and

> with rosacea not a life threatening (but certainly life altering

> and unpleasant) disease, they are unwilling to take risks.

Keeping up with the massive amounts of medical information is tough,

but physicians are not dismissive of new drugs! Quite the contrary.

It's not a " CYA " situation, it's a " first, do no harm " situation.

> Lets hope

> that someone does preliminary trials on drugs like the Substance P

> blocker and the new topical medications on rosacea sufferers.

> Perhaps Dr. Marjorie Lazaroff who is currently contributing

> actively to the group can help us start this process.

I'm willing to help whenever appropriate, but I need more information

from you to properly address this, as I just requested in email (or

you can post it publicly if you desire). As I told you, from what

I've seen, physicians don't use investigational drugs on a patient

outside of a highly structured clinical trial -- usually, an academic

setting involving hospital-based physicians -- or by compassionate

use, which wouldn't apply for non-lethal conditions.

Marjorie

Marjorie Lazoff, MD

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Ahh, thanks. I get it now. Hopefully when it does become available it will

be a possible weapon in our fight against cea. I do think they had

begun testing on humans even when the article was written:

" A randomized double-blind study was conducted at four investigative sites,

comparing the effects of MK-869 with those of paroxetine or placebo in

depressive patients. "

So by now it may be very close to market. (I hope?) The article doesn't

mention anything about being used for cea, but Dr. Nase does briefly

mention MK-869 in his book. That would be pretty neat if one medication

could be used for depression and cea.

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Ahh, thanks. I get it now. Hopefully when it does become available it will

be a possible weapon in our fight against cea. I do think they had

begun testing on humans even when the article was written:

" A randomized double-blind study was conducted at four investigative sites,

comparing the effects of MK-869 with those of paroxetine or placebo in

depressive patients. "

So by now it may be very close to market. (I hope?) The article doesn't

mention anything about being used for cea, but Dr. Nase does briefly

mention MK-869 in his book. That would be pretty neat if one medication

could be used for depression and cea.

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Ahh, thanks. I get it now. Hopefully when it does become available it will

be a possible weapon in our fight against cea. I do think they had

begun testing on humans even when the article was written:

" A randomized double-blind study was conducted at four investigative sites,

comparing the effects of MK-869 with those of paroxetine or placebo in

depressive patients. "

So by now it may be very close to market. (I hope?) The article doesn't

mention anything about being used for cea, but Dr. Nase does briefly

mention MK-869 in his book. That would be pretty neat if one medication

could be used for depression and cea.

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>

> I'm sorry! I missed the second study, that WAS conducted on humans. I

> was wondering how they could use a point scale system measuring

> depression on guinea pigs -- especially when they came to the

> conclusion that sexual side effects were infrequent!

>

LOL ya, I would hate to be the guy who had to determine the effect of a

medication on a guinea pig's libido :)

> Still, the MK-869 tests were for psychiatric conditions, not rosacea.

> Perhaps there are topical MK-869 studies, similiar to Zostrix?

When Dr. Nase mentioned MK-869 in the book, he also mentioned that it was

going to be an oral drug. It would be nice if it turns out there are some

topical studies out there, but since Merck is testing it as a treatment for

depression, the odds probably are against this. Maybe this could be one of

the NRS's next experiments?

Adam

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>

> I'm sorry! I missed the second study, that WAS conducted on humans. I

> was wondering how they could use a point scale system measuring

> depression on guinea pigs -- especially when they came to the

> conclusion that sexual side effects were infrequent!

>

LOL ya, I would hate to be the guy who had to determine the effect of a

medication on a guinea pig's libido :)

> Still, the MK-869 tests were for psychiatric conditions, not rosacea.

> Perhaps there are topical MK-869 studies, similiar to Zostrix?

When Dr. Nase mentioned MK-869 in the book, he also mentioned that it was

going to be an oral drug. It would be nice if it turns out there are some

topical studies out there, but since Merck is testing it as a treatment for

depression, the odds probably are against this. Maybe this could be one of

the NRS's next experiments?

Adam

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>

> I'm sorry! I missed the second study, that WAS conducted on humans. I

> was wondering how they could use a point scale system measuring

> depression on guinea pigs -- especially when they came to the

> conclusion that sexual side effects were infrequent!

>

LOL ya, I would hate to be the guy who had to determine the effect of a

medication on a guinea pig's libido :)

> Still, the MK-869 tests were for psychiatric conditions, not rosacea.

> Perhaps there are topical MK-869 studies, similiar to Zostrix?

When Dr. Nase mentioned MK-869 in the book, he also mentioned that it was

going to be an oral drug. It would be nice if it turns out there are some

topical studies out there, but since Merck is testing it as a treatment for

depression, the odds probably are against this. Maybe this could be one of

the NRS's next experiments?

Adam

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> When Dr. Nase mentioned MK-869 in the book, he also mentioned that

it was

> going to be an oral drug. It would be nice if it turns out there

are some

> topical studies out there, but since Merck is testing it as a

treatment for

> depression, the odds probably are against this.

I agree, Adam, it doesn't look like MK-869 -- or Zofran, which

apparently also blocks Substance P centrally -- panned out as a oral

pain medication, for rosacea or anyone else. It could turn out to

have an off-label indication for pain syndromes, like Elavil when it

first started out, but from what we're hearing it doesn't sound very

hopeful.

Still, Substance P antagonists, whether peripheral or centrally-

acting, was never expected to treat or cure rosacea, or even impact

on the majority of rosaceas. But neurogenic pain -- if that's the

cause of the burning and stinging in rosaceans -- is an active area

of research in pain control. Again, another example of research not

involving rosacea will likely help that group of rosaceans.

I'm learning a lot. It's nice to read others' contributations to

these research threads. Thank you.

As an aside: has anyone with burning/stinging symptoms tried cea

Care's strontium lotion? I'm not recommending it, I'm just curious.

Marjorie

Marjorie Lazoff, MD

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