FDA Calls for New Warnings on GnRH Agonist Labels

[Guest guest]

Would a succinct way of putting this be:

The overall approach I believe in is doing the Minimal

Intervention that the patient feels comfortable about combined with the Maximum

Surveillance that medical science allows.

J

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 Dr Barken PCREF Coach

Sent: Monday, 25 October 2010

12:07 PM

To:

ProstateCancerSupport

Subject:

FDA Calls for New Warnings on GnRH Agonist Labels

Hi Chuck,

I agree with you that physicians should absolutely tell patients about the

potential dangers of LHRH/GnRH, and I'm glad that you are

bringing the new FDA warning to the attention of the readers.

I'd like to raise an even more fundamental question. Are patients being

informed that the FDA ruling is: " GnRH agonists are indicated

for the palliative treatment of symptoms of advanced prostate

cancer. " When an oncologist or urologist prescribes LHRH/GnRH

to the patient who does not have symptoms of advanced prostate cancer, does the

patient realize that this is actually off label use not recommended by the

FDA as a standard of care treatment?

So giving primary hormonal blockade indiscriminately or giving it to

patients after failure of primary treatment is actually not the FDA

approved usage. That does not mean that I think that no one should

get hormonal blockade for situations not approved by the FDA; in some cases it

is called for. All I am saying that we should avoid overtreating patients

that do not need it and exposing them to potential side effects. In the case of

LHRH/GnRH, these potential side effects, particularly the cardiac side effects,

can be quite significant.

To combine the question that you raised with the question I raised, I will

summarize our discussion points this way.

First, all doctors should tell their patients whether hormonal blockade is

indicated in their case in line with FDA recommendations. Patients

should understand it may be off label use and still experimental by

definition.

Second, all doctors should tell their patients about all the potential side

effects and weigh risk versus benefit with the patient.

Our goal should be to become more discriminating with patient selection

and not over treat with combined hormonal blockade. When we say that

prostate cancer patients are overtreated, we should not look only at surgery

and radiation, but we should look more intelligently at how we are treating

with LHRH/GnRH as well.

Chuck, thank you again for raising the flag and opening the discussion, and I

wish you many more years of good health. We need good men like

you leading the prostate cancer cancer community.

Coach Barken (Israel

Barken, M.D.)

--

Coaching with Dr Barken --- http://www.pcref.org/per.coaching.php

To listen to previous recording of Ask Dr Barken Show go to-- http://www.pcref.org/call_past.php

To open your own Medical Smart Chart go to -- www.pcref.org/MedSmartChart

Material posted here is for general education purposes only and does not take

the place of medical advice from your treating physician. No patient-doctor

relationship is created or implied.

Israel

Barken, M.D.

Medical Director

Prostate Cancer Research and Eduction Foundation (PC-REF)

501©3 non profit organization

6823 Deer Hollow Pl

San Diego, CA 92120

www.pcref.org

info@...

[Guest guest]

Would a succinct way of putting this be:

The overall approach I believe in is doing the Minimal

Intervention that the patient feels comfortable about combined with the Maximum

Surveillance that medical science allows.

J

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 Dr Barken PCREF Coach

Sent: Monday, 25 October 2010

12:07 PM

To:

ProstateCancerSupport

Subject:

FDA Calls for New Warnings on GnRH Agonist Labels

Hi Chuck,

I agree with you that physicians should absolutely tell patients about the

potential dangers of LHRH/GnRH, and I'm glad that you are

bringing the new FDA warning to the attention of the readers.

I'd like to raise an even more fundamental question. Are patients being

informed that the FDA ruling is: " GnRH agonists are indicated

for the palliative treatment of symptoms of advanced prostate

cancer. " When an oncologist or urologist prescribes LHRH/GnRH

to the patient who does not have symptoms of advanced prostate cancer, does the

patient realize that this is actually off label use not recommended by the

FDA as a standard of care treatment?

So giving primary hormonal blockade indiscriminately or giving it to

patients after failure of primary treatment is actually not the FDA

approved usage. That does not mean that I think that no one should

get hormonal blockade for situations not approved by the FDA; in some cases it

is called for. All I am saying that we should avoid overtreating patients

that do not need it and exposing them to potential side effects. In the case of

LHRH/GnRH, these potential side effects, particularly the cardiac side effects,

can be quite significant.

To combine the question that you raised with the question I raised, I will

summarize our discussion points this way.

First, all doctors should tell their patients whether hormonal blockade is

indicated in their case in line with FDA recommendations. Patients

should understand it may be off label use and still experimental by

definition.

Second, all doctors should tell their patients about all the potential side

effects and weigh risk versus benefit with the patient.

Our goal should be to become more discriminating with patient selection

and not over treat with combined hormonal blockade. When we say that

prostate cancer patients are overtreated, we should not look only at surgery

and radiation, but we should look more intelligently at how we are treating

with LHRH/GnRH as well.

Chuck, thank you again for raising the flag and opening the discussion, and I

wish you many more years of good health. We need good men like

you leading the prostate cancer cancer community.

Coach Barken (Israel

Barken, M.D.)

--

Coaching with Dr Barken --- http://www.pcref.org/per.coaching.php

To listen to previous recording of Ask Dr Barken Show go to-- http://www.pcref.org/call_past.php

To open your own Medical Smart Chart go to -- www.pcref.org/MedSmartChart

Material posted here is for general education purposes only and does not take

the place of medical advice from your treating physician. No patient-doctor

relationship is created or implied.

Israel

Barken, M.D.

Medical Director

Prostate Cancer Research and Eduction Foundation (PC-REF)

501©3 non profit organization

6823 Deer Hollow Pl

San Diego, CA 92120

www.pcref.org

info@...