Re: Off Label Use was..... FDA panel rejects Merck drug for prostate cancer

[Guest guest]

Off-label use is often for well-documented effects. Consider finasteride, which

is a drug for benign prostatic hyperplasia. When the hair-growing side effect

was noticed, dermatologists started prescribing it for that before it was

approved to be marketed as Propecia. Benadryl's side effect of drowsiness was

long known, and it was being given as a very safe sleep aid when it was still a

prescription drug. Now it is in some OTC sleep meds. Flagyl taken orally was

long known to improve rosacea. Now it is marketed in an ointment for that.

Vitamin C is not a cold cure, no matter what Linus ing said. But a large

dose can have a small effect of drying the mucosa, so it is not unreasonable to

add it to a decongestant regimen for its small additive effect. Robitussin thins

mucus. While it is not approved for use in infertility treatment, it does thin

cervical mucus, so gynecologists use it for that purpose. Off-label use is

nearly always a matter of exploiting effects that are known but are not what the

drug is marketed for than a matter of blind experimentation, which would only be

done in dire circumstances. That is a far different matter than using something

that doesn't have any known evidentiary basis for use, except as a placebo.

From: Emerson

<davidemerson@ Subject: FDA panel rejects Merck drug for

prostate cancer To: " hrpca group " <hrpca <mailto:

hrpca%40yahoogroups.com , " PCa Under Yahoo Group "

<prostatecancerunder50 <mailto:

prostatecancerunder50%40yahoogroups. com , " PPML List " <PROSTATE@, " Yahoo

PCaGroup " <ProstateCancerSupport <mailto:

ProstateCancerSupport%40yahoogroups. com Date: Wednesday, December 1, 2010, 5:34

PM This is for Proscar and it sounds like Avodart is next on the hit list.

http://www.wtop.com/?nid=111 <http://www.wtop.com/?nid=111 & sid=2184761

& sid=2184761 Emerson

[Guest guest]

Off-label use is often for well-documented effects. Consider finasteride, which

is a drug for benign prostatic hyperplasia. When the hair-growing side effect

was noticed, dermatologists started prescribing it for that before it was

approved to be marketed as Propecia. Benadryl's side effect of drowsiness was

long known, and it was being given as a very safe sleep aid when it was still a

prescription drug. Now it is in some OTC sleep meds. Flagyl taken orally was

long known to improve rosacea. Now it is marketed in an ointment for that.

Vitamin C is not a cold cure, no matter what Linus ing said. But a large

dose can have a small effect of drying the mucosa, so it is not unreasonable to

add it to a decongestant regimen for its small additive effect. Robitussin thins

mucus. While it is not approved for use in infertility treatment, it does thin

cervical mucus, so gynecologists use it for that purpose. Off-label use is

nearly always a matter of exploiting effects that are known but are not what the

drug is marketed for than a matter of blind experimentation, which would only be

done in dire circumstances. That is a far different matter than using something

that doesn't have any known evidentiary basis for use, except as a placebo.

From: Emerson

<davidemerson@ Subject: FDA panel rejects Merck drug for

prostate cancer To: " hrpca group " <hrpca <mailto:

hrpca%40yahoogroups.com , " PCa Under Yahoo Group "

<prostatecancerunder50 <mailto:

prostatecancerunder50%40yahoogroups. com , " PPML List " <PROSTATE@, " Yahoo

PCaGroup " <ProstateCancerSupport <mailto:

ProstateCancerSupport%40yahoogroups. com Date: Wednesday, December 1, 2010, 5:34

PM This is for Proscar and it sounds like Avodart is next on the hit list.

http://www.wtop.com/?nid=111 <http://www.wtop.com/?nid=111 & sid=2184761

& sid=2184761 Emerson

[Guest guest]

Hi Terry:

Alot of "off-label" usage actually comes from the side effects of medication. Think Minoxidil, which originally was a blood pressure medication. One of the side effects was hair growth. Not good for the female poplulation, but it soon developed an off-label usage for men who were bald. And was approved then as a topical medication (Rogaine).

Another was amitriptyline, which is a medication with psychiatric indications. It was found that diabetic patients who had peripheral neuropathy saw their neuropathy improve when taking the amitriptyline. No real study at first, but something that physicians noticed and started using, with good result. It's been used for over 20 years for neuropathy, much of the time off-label.

So although the term "off-label" carries kind of a negative connotation, in many cases it is really not the case. It just means that the FDA (or whatever regulatory body) hasn't caught up to what is really going on in practice. And I agree, if it helps patients with whatever disease process they are fighting, who cares if it is "off-label".

To: ProstateCancerSupport From: ghenesh_49@...Date: Mon, 6 Dec 2010 07:43:36 +1100Subject: Off Label Use was..... FDA panel rejects Merck drug for prostate cancer

One of the things that I have always found amusing about the ‘off-label’ issue is that there is often no acceptable, scientific, balanced study to support the ‘off-label’ use. I’m not against that. If any doctor, from his personal experience can find another use for a drug, and it works, then that’s fine by me (although with unknown side effects it might be a bit rough for the patients!).

BUT…..what I cannot understand is what the difference is between this ’off label’ use and the use of alternative medications which have no acceptable, scientific, balanced study to support their use. Surely if thee are tried and found to work in individual patients, a case can be made for their use as well??

All the best

Prostate men need enlightening, not frightening

Terry Herbert - diagnosed in 1996 and still going strong

Read A Strange Place for unbiased information at http://www.yananow.net/StrangePlace/index.html

From: ProstateCancerSupport [mailto:ProstateCancerSupport ] On Behalf Of xenophonamiSent: Monday, 6 December 2010 1:22 AMTo: ProstateCancerSupport Subject: Re: Fw: FDA panel rejects Merck drug for prostate cancer

Off-label use is not illegal, unethical or uncommon. In 20 years as a practicing PA, I did it often, especially for AIDS patients, and had many a battle with Medicaid pharmacists because of it. Some drugs we prescribed were chosen for what were considered their side-effects, such as Megace and Marinol as appetite stimulants.Subject: FDA panel rejects Merck drug for prostate cancerTo: "hrpca group" <hrpca >, "PCa Under Yahoo Group" <prostatecancerunder50 >, "PPML List" , "Yahoo PCaGroup" <ProstateCancerSupport >Date: Wednesday, December 1, 2010, 5:34 PMThis is for Proscar and it sounds like Avodart is next on the hit list.http://www.wtop.com/?nid=111 & sid=2184761 Emerson

[Guest guest]

Believe me when I say that I do understand

how the use of drugs ‘off label’ is developed. As says <snip>

No real study at first, but something that physicians noticed and started

using, with good result. <snip>

That is the point I was trying to make. There

are many ‘natural’ or ‘alternative’ or call it what you

may ‘remedies’ where there are no real studies but there are

effects that have been noticed. Yet a doctor using such a remedy, without the

studies, in the same way as FDA approved drugs are used off label without

studies, can be prosecuted for quackery. That simply doesn’t make sense

to me.

Before anyone starts a diatribe about the

cruel people who fool people with their outrageous claims about a universal

panacea that will cure anything, that is NOT what I am talking about. But I do

believe that there should be a place for the so-called natural remedies that

have been observed to be beneficial to form part of the armory against disease

and illness and not to be dismissed purely on the grounds that there are no

double blinded prospective studies published in chosen peer reviewed journals

leading to FDA approval. The evidence of approved practitioners could and

should be used, as it is for off label usage of FDA approved drugs.

What is sauce for the goose should be

sauce for the gander.

All the best

Prostate men need enlightening, not

frightening

Terry Herbert - diagnosed in 1996 and

still going strong

Read A Strange Place for unbiased information at http://www.yananow.net/StrangePlace/index.html

From: ProstateCancerSupport [mailto:ProstateCancerSupport ] On Behalf Of xenophonami

Sent: Monday, 6 December 2010 4:11

PM

To: ProstateCancerSupport

Subject:

Re: Off Label Use was..... FDA panel rejects Merck drug for prostate cancer

Off-label use is often for well-documented effects.

Consider finasteride, which is a drug for benign prostatic hyperplasia. When

the hair-growing side effect was noticed, dermatologists started prescribing it

for that before it was approved to be marketed as Propecia. Benadryl's side

effect of drowsiness was long known, and it was being given as a very safe

sleep aid when it was still a prescription drug. Now it is in some OTC sleep

meds. Flagyl taken orally was long known to improve rosacea. Now it is marketed

in an ointment for that. Vitamin C is not a cold cure, no matter what Linus

ing said. But a large dose can have a small effect of drying the mucosa, so

it is not unreasonable to add it to a decongestant regimen for its small

additive effect. Robitussin thins mucus. While it is not approved for use in

infertility treatment, it does thin cervical mucus, so gynecologists use it for

that purpose. Off-label use is nearly always a matter of exploiting effects

that are known but are not what the drug is marketed for than a matter of blind

experimentation, which would only be done in dire circumstances. That is a far

different matter than using something that doesn't have any known evidentiary

basis for use, except as a placebo.

From: Emerson

<davidemerson@ Subject: FDA panel rejects Merck drug

for prostate cancer To: " hrpca group " <hrpca <mailto:

hrpca%40yahoogroups.com , " PCa Under Yahoo Group " <prostatecancerunder50

<mailto: prostatecancerunder50%40yahoogroups. com , " PPML List "

<PROSTATE@, " Yahoo PCaGroup " <ProstateCancerSupport

<mailto: ProstateCancerSupport%40yahoogroups. com Date: Wednesday, December

1, 2010, 5:34 PM This is for Proscar and it sounds like Avodart is next on the

hit list. http://www.wtop.com/?nid=111

<http://www.wtop.com/?nid=111 & sid=2184761

& sid=2184761 Emerson

[Guest guest]

Believe me when I say that I do understand

how the use of drugs ‘off label’ is developed. As says <snip>

No real study at first, but something that physicians noticed and started

using, with good result. <snip>

That is the point I was trying to make. There

are many ‘natural’ or ‘alternative’ or call it what you

may ‘remedies’ where there are no real studies but there are

effects that have been noticed. Yet a doctor using such a remedy, without the

studies, in the same way as FDA approved drugs are used off label without

studies, can be prosecuted for quackery. That simply doesn’t make sense

to me.

Before anyone starts a diatribe about the

cruel people who fool people with their outrageous claims about a universal

panacea that will cure anything, that is NOT what I am talking about. But I do

believe that there should be a place for the so-called natural remedies that

have been observed to be beneficial to form part of the armory against disease

and illness and not to be dismissed purely on the grounds that there are no

double blinded prospective studies published in chosen peer reviewed journals

leading to FDA approval. The evidence of approved practitioners could and

should be used, as it is for off label usage of FDA approved drugs.

What is sauce for the goose should be

sauce for the gander.

All the best

Prostate men need enlightening, not

frightening

Terry Herbert - diagnosed in 1996 and

still going strong

Read A Strange Place for unbiased information at http://www.yananow.net/StrangePlace/index.html

From: ProstateCancerSupport [mailto:ProstateCancerSupport ] On Behalf Of xenophonami

Sent: Monday, 6 December 2010 4:11

PM

To: ProstateCancerSupport

Subject:

Re: Off Label Use was..... FDA panel rejects Merck drug for prostate cancer

Off-label use is often for well-documented effects.

Consider finasteride, which is a drug for benign prostatic hyperplasia. When

the hair-growing side effect was noticed, dermatologists started prescribing it

for that before it was approved to be marketed as Propecia. Benadryl's side

effect of drowsiness was long known, and it was being given as a very safe

sleep aid when it was still a prescription drug. Now it is in some OTC sleep

meds. Flagyl taken orally was long known to improve rosacea. Now it is marketed

in an ointment for that. Vitamin C is not a cold cure, no matter what Linus

ing said. But a large dose can have a small effect of drying the mucosa, so

it is not unreasonable to add it to a decongestant regimen for its small

additive effect. Robitussin thins mucus. While it is not approved for use in

infertility treatment, it does thin cervical mucus, so gynecologists use it for

that purpose. Off-label use is nearly always a matter of exploiting effects

that are known but are not what the drug is marketed for than a matter of blind

experimentation, which would only be done in dire circumstances. That is a far

different matter than using something that doesn't have any known evidentiary

basis for use, except as a placebo.

From: Emerson

<davidemerson@ Subject: FDA panel rejects Merck drug

for prostate cancer To: " hrpca group " <hrpca <mailto:

hrpca%40yahoogroups.com , " PCa Under Yahoo Group " <prostatecancerunder50

<mailto: prostatecancerunder50%40yahoogroups. com , " PPML List "

<PROSTATE@, " Yahoo PCaGroup " <ProstateCancerSupport

<mailto: ProstateCancerSupport%40yahoogroups. com Date: Wednesday, December

1, 2010, 5:34 PM This is for Proscar and it sounds like Avodart is next on the

hit list. http://www.wtop.com/?nid=111

<http://www.wtop.com/?nid=111 & sid=2184761

& sid=2184761 Emerson

[Guest guest]

> The FDA “panel” rejection was the use of finasteride and

> dutasteride in a preventative role from development of prostate

> cancer.

Thanks, Chuck. You wrote exactly what I would have written if I

were quick enough ;-)

Yes, the reason claimed by the panel was disposed of as

ill-founded some time ago. I wonder whether this was addressed by

proponents during the investigation phase.

I'm afraid that now we'll hear from folks who, failing to grasp

the case, will likely claim that these 5AR inhibitors are of no

value to PCa patients.

Sigh.

Regards,

Steve J

" if you want First-Class oats, you go to the head of the horse. "

-- B. Strum, MD

Medical Oncologist

PCa Specialist

[Guest guest]

Do you know what you call alternative medicine that works?

You call it medicine.

From: Emerson

> <davidemerson@ Subject: FDA panel rejects Merck drug

> for prostate cancer To: " hrpca group " <hrpca

> <mailto:hrpca%40yahoogroups.com> <mailto: hrpca%40yahoogroups.com , " PCa

> Under Yahoo Group " <prostatecancerunder50

> <mailto:prostatecancerunder50%40yahoogroups.com> <mailto:

> prostatecancerunder50%40yahoogroups. com , " PPML List " <PROSTATE@, " Yahoo

> PCaGroup " <ProstateCancerSupport

> <mailto:ProstateCancerSupport%40yahoogroups.com> <mailto:

> ProstateCancerSupport%40yahoogroups. com Date: Wednesday, December 1, 2010,

> 5:34 PM This is for Proscar and it sounds like Avodart is next on the hit

> list. http://www.wtop.com/?nid=111 <http://www.wtop.com/?nid=111

> <http://www.wtop.com/?nid=111 & sid=2184761> & sid=2184761 & sid=2184761

> Emerson

>

[Guest guest]

This kind of silly response is fairly

typical of what happens if you ever try to have a reasonable discussion on this

kind of issue.

All the best

Prostate men need enlightening, not

frightening

Terry Herbert - diagnosed in 1996 and

still going strong

Read A Strange Place for unbiased information at http://www.yananow.net/StrangePlace/index.html

From: ProstateCancerSupport [mailto:ProstateCancerSupport ] On Behalf Of xenophonami

Sent: Tuesday, 7 December 2010 2:16

PM

To: ProstateCancerSupport

Subject:

Re: Off Label Use was..... FDA panel rejects Merck drug for prostate cancer

Do you know what you call alternative medicine that

works?

You call it medicine.

From:

Emerson

> <davidemerson@ Subject: FDA panel rejects Merck

drug

> for prostate cancer To: " hrpca group " <hrpca

> <mailto:hrpca%40yahoogroups.com> <mailto: hrpca%40yahoogroups.com

, " PCa

> Under Yahoo Group " <prostatecancerunder50

> <mailto:prostatecancerunder50%40yahoogroups.com> <mailto:

> prostatecancerunder50%40yahoogroups. com , " PPML List "

<PROSTATE@, " Yahoo

> PCaGroup " <ProstateCancerSupport

> <mailto:ProstateCancerSupport%40yahoogroups.com> <mailto:

> ProstateCancerSupport%40yahoogroups. com Date: Wednesday, December 1,

2010,

> 5:34 PM This is for Proscar and it sounds like Avodart is next on the hit

> list. http://www.wtop.com/?nid=111

<http://www.wtop.com/?nid=111

> <http://www.wtop.com/?nid=111 & sid=2184761>

& sid=2184761 & sid=2184761

> Emerson

>