Issue facing Compounding Pharmacies

[Guest guest]

Firm Seeks Crackdown on Custom Made Drugs By ANDREW BRIDGES

Associated Press Writer

WASHINGTON — Thousands of women who rely on custom-made hormone

drugs for relief from menopause symptoms have flooded the government

with letters opposing a drug company's effort to get health officials to

crack down on pharmacies that sell them. The drug company Wyeth wants

the Food and Drug Administration to rein in the market for bio-identical

hormone replacement therapy drugs. The hormones are custom mixed or

compounded by specialized pharmacies according to a doctor's

prescription.

[http://img.coxnewsweb.com/B/00/83/44/image_3344830.jpg]

<http://www.ajc.com/hp/content/shared-gen/ap/Health_Medical/Custom_Made_\

Drugs-image.html> (enlarge photo)

<http://www.ajc.com/hp/content/shared-gen/ap/Health_Medical/Custom_Made_\

Drugs-image.html> Donna Mabin, right, and cosmotologist Gladys Ayers,

left, look over a petition that they are having signed at the Park Layne

hair salon, Monday, Feb. 27, 2006 in New Carlisle, Ohio. Thousands of

women who rely on tailor-prepared hormones for relief from the symptoms

of menopause have flooded the federal government with letters opposing a

drug company effort to get health officials to act against the pharmaces

that sell the prescription preparations. (AP Photo/ Kohl)

Compounding pharmacists can alter the dosages of a medicine, prepare it

in creams or liquids that are easier to take than pills or eliminate

preservatives or other secondary ingredients that might cause allergies

in a patient. Wyeth claims that some compounding pharmacies that prepare

customized hormone preparations are duping women with products that pose

a serious health risk. It wants federal regulators to weigh in with

seizures, injunctions and warning letters. " FDA cannot allow this

practice to continue, " the Wyeth petition, signed by Washington attorney

S. Krulwich, reads in part. FDA spokeswoman Cruzan declined

to comment, other than to say compounded hormones are not FDA-approved.

The agency recently told Wyeth it needs more than six months to review

and respond to both the petition, filed in October, and the more than

27,000 comments it has elicited. Most are either form letters or

messages submitted through the agency's Web site. " They can't take these

away from us. Is there anything that can be done? " said Donna Mabin, 68,

a retired cashier from New Carlisle, Ohio, who was among those to write.

" Those drug companies want to get the money out of natural hormones and

they don't care if we get sick or not. " Many women turned to the

estrogen, progesterone and testosterone products sold by compounding

pharmacies after a 2002 study, part of the massive Women's Health

Initiative that tracked 161,000 women for 15 years, found replacement

hormones made by drug companies like Wyeth raised the risk of heart

attacks, breast cancer and strokes. Critics of the compounding

pharmacies want to dispel the notion that the hormone replacement

therapies such pharmacies make necessarily work better or are safer.

" They haven't been studied for safety or effectiveness and are not

produced in facilities that meet good manufacturing practices, " said

Larry Sasich, a pharmacist with the Health Research Group of the

consumer watchdog Public Citizen. " We suspect a majority of patients

aren't aware of this. " Medical researchers concluded in 2003 that

hormone replacement pills should be taken only as a brief treatment to

help women weather the worst symptoms of menopause. Those findings hit

Wyeth hard. Sales of the company's Prempro and Premphase, which combine

estrogen and progestin, and its Premarin, an estrogen-only pill, fell to

$880 million in 2004 from $2.07 billion in 2001, the year before the

Women's Health Initiative released its hormone-replacement results.

Compounding pharmacists and their backers allege that Wyeth seeks to

stifle competition by calling in the FDA. " It seems to be an attempt to

use the FDA to inappropriately to eliminate competition, " said L.D.

King, executive director of the International Academy of Compounding

Pharmacists, a Sugar Land, Texas, group. Wyeth counters it wants women

to realize the risks of what a spokeswoman for the Madison, N.J.-based

company characterized as a " growing, unlawful practice. " " We filed our

petition so that we can ensure that women who received these

bio-identical hormones also receive truthful information about the risks

of therapy, " Wyeth spokeswoman Candace Steele said. Thousands of

American women use the compounded hormones to alleviate the hot flashes,

flushes, sweats, sleeplessness and other hallmarks of menopause. The

hormones are derived from soy and yam but have an identical chemical

structure to the substances found in the body. The products sold by

Wyeth are based on the urine of pregnant mares. Women who use the

bio-identical hormones, along with their doctors and pharmacists, all

say the system is a throwback to when just about every medicine was made

to fit both a doctor's order and a patient's need. " Every woman is

different. There is blood work done to ensure where their hormone level

is at, so based on those results and their symptoms, we will come up

with a formula. It's sort of old-fashioned, " said Manhattan's Dr.

on of the process he uses with patients like Lynn

Leibowitz. The doctor-pharmacist-patient " triad " involves constant

adjustments that just can't be made to the mass-produced drugs that

Leibowitz, a Manhattan psychologist and psychoanalyst, used to take,

said , the New Jersey compounding pharmacist she uses.

" We'll keep going month after month until we find the right combination

for the patients, " said of his work at s of Wyckoff, the

New Jersey pharmacy his grandfather started in 1929. As for Leibowitz,

she says the custom-compounded hormones have left her feeling better

— and more in control — since switching a year ago. " I love

knowing what my hormone levels are, " said Leibowitz, who began taking

hormones eight years ago after she underwent a hysterectomy at 48. " I

feel much safer and it's more compatible with my body chemistry. " That

sort of anecdotal evidence doesn't sway other doctors. In November, the

American College of Obstetricians and Gynecologists said there is no

scientific evidence supporting claims of increased efficacy or safety

for estrogen or progesterone regimens made by compounding pharmacies for

women. The group said women should consider compounded hormones to have

the same or even additional safety issues as FDA-approved hormone

products. That same month, the FDA sent warning letters to 16 companies

marketing unapproved alternative hormone therapies. The FDA said the

companies were selling drugs without the agency's approval. The action

mirrored in part what Wyeth requested in its petition, but was not

linked to the filing of the document just weeks earlier, said Steele,

the company spokeswoman. And a 2004 review that appeared in Menopause,

the journal of the North American Menopause Society, found little to

recommend about compounded hormones: " In the absence of a sound

scientific basis, practitioners should not advocate the practice of

compounding (hormones) because it is not in the patient's best interest,

it is potentially harmful and it lacks a scientific underpinning, " the

review concluded.

[Guest guest]

Wyeth is the problem. Avoid their products.

They are a big fat drug company and it is

all about their profit, IMO.

>

> Firm Seeks Crackdown on Custom Made Drugs By ANDREW BRIDGES

> Associated Press Writer

> WASHINGTON — Thousands of women who rely on custom-made hormone

> drugs for relief from menopause symptoms have flooded the government

> with letters opposing a drug company's effort to get health

officials to

> crack down on pharmacies that sell them. The drug company Wyeth

wants

> the Food and Drug Administration to rein in the market for bio-

identical

> hormone replacement therapy drugs. The hormones are custom mixed or

> compounded by specialized pharmacies according to a doctor's

> prescription.

> [http://img.coxnewsweb.com/B/00/83/44/image_3344830.jpg]

> <http://www.ajc.com/hp/content/shared-

gen/ap/Health_Medical/Custom_Made_\

> Drugs-image.html> (enlarge photo)

> <http://www.ajc.com/hp/content/shared-

gen/ap/Health_Medical/Custom_Made_\

> Drugs-image.html> Donna Mabin, right, and cosmotologist Gladys

Ayers,

> left, look over a petition that they are having signed at the Park

Layne

> hair salon, Monday, Feb. 27, 2006 in New Carlisle, Ohio. Thousands

of

> women who rely on tailor-prepared hormones for relief from the

symptoms

> of menopause have flooded the federal government with letters

opposing a

> drug company effort to get health officials to act against the

pharmaces

> that sell the prescription preparations. (AP Photo/ Kohl)

> Compounding pharmacists can alter the dosages of a medicine,

prepare it

> in creams or liquids that are easier to take than pills or eliminate

> preservatives or other secondary ingredients that might cause

allergies

> in a patient. Wyeth claims that some compounding pharmacies that

prepare

> customized hormone preparations are duping women with products that

pose

> a serious health risk. It wants federal regulators to weigh in with

> seizures, injunctions and warning letters. " FDA cannot allow this

> practice to continue, " the Wyeth petition, signed by Washington

attorney

> S. Krulwich, reads in part. FDA spokeswoman Cruzan

declined

> to comment, other than to say compounded hormones are not FDA-

approved.

> The agency recently told Wyeth it needs more than six months to

review

> and respond to both the petition, filed in October, and the more

than

> 27,000 comments it has elicited. Most are either form letters or

> messages submitted through the agency's Web site. " They can't take

these

> away from us. Is there anything that can be done? " said Donna

Mabin, 68,

> a retired cashier from New Carlisle, Ohio, who was among those to

write.

> " Those drug companies want to get the money out of natural hormones

and

> they don't care if we get sick or not. " Many women turned to the

> estrogen, progesterone and testosterone products sold by compounding

> pharmacies after a 2002 study, part of the massive Women's Health

> Initiative that tracked 161,000 women for 15 years, found

replacement

> hormones made by drug companies like Wyeth raised the risk of heart

> attacks, breast cancer and strokes. Critics of the compounding

> pharmacies want to dispel the notion that the hormone replacement

> therapies such pharmacies make necessarily work better or are safer.

> " They haven't been studied for safety or effectiveness and are not

> produced in facilities that meet good manufacturing practices, " said

> Larry Sasich, a pharmacist with the Health Research Group of the

> consumer watchdog Public Citizen. " We suspect a majority of patients

> aren't aware of this. " Medical researchers concluded in 2003 that

> hormone replacement pills should be taken only as a brief treatment

to

> help women weather the worst symptoms of menopause. Those findings

hit

> Wyeth hard. Sales of the company's Prempro and Premphase, which

combine

> estrogen and progestin, and its Premarin, an estrogen-only pill,

fell to

> $880 million in 2004 from $2.07 billion in 2001, the year before the

> Women's Health Initiative released its hormone-replacement results.

> Compounding pharmacists and their backers allege that Wyeth seeks to

> stifle competition by calling in the FDA. " It seems to be an

attempt to

> use the FDA to inappropriately to eliminate competition, " said L.D.

> King, executive director of the International Academy of Compounding

> Pharmacists, a Sugar Land, Texas, group. Wyeth counters it wants

women

> to realize the risks of what a spokeswoman for the Madison, N.J.-

based

> company characterized as a " growing, unlawful practice. " " We filed

our

> petition so that we can ensure that women who received these

> bio-identical hormones also receive truthful information about the

risks

> of therapy, " Wyeth spokeswoman Candace Steele said. Thousands of

> American women use the compounded hormones to alleviate the hot

flashes,

> flushes, sweats, sleeplessness and other hallmarks of menopause. The

> hormones are derived from soy and yam but have an identical chemical

> structure to the substances found in the body. The products sold by

> Wyeth are based on the urine of pregnant mares. Women who use the

> bio-identical hormones, along with their doctors and pharmacists,

all

> say the system is a throwback to when just about every medicine was

made

> to fit both a doctor's order and a patient's need. " Every woman is

> different. There is blood work done to ensure where their hormone

level

> is at, so based on those results and their symptoms, we will come up

> with a formula. It's sort of old-fashioned, " said Manhattan's Dr.

> on of the process he uses with patients like Lynn

> Leibowitz. The doctor-pharmacist-patient " triad " involves constant

> adjustments that just can't be made to the mass-produced drugs that

> Leibowitz, a Manhattan psychologist and psychoanalyst, used to take,

> said , the New Jersey compounding pharmacist she uses.

> " We'll keep going month after month until we find the right

combination

> for the patients, " said of his work at s of Wyckoff,

the

> New Jersey pharmacy his grandfather started in 1929. As for

Leibowitz,

> she says the custom-compounded hormones have left her feeling better

> — and more in control — since switching a year ago. " I love

> knowing what my hormone levels are, " said Leibowitz, who began

taking

> hormones eight years ago after she underwent a hysterectomy at

48. " I

> feel much safer and it's more compatible with my body chemistry. "

That

> sort of anecdotal evidence doesn't sway other doctors. In November,

the

> American College of Obstetricians and Gynecologists said there is no

> scientific evidence supporting claims of increased efficacy or

safety

> for estrogen or progesterone regimens made by compounding

pharmacies for

> women. The group said women should consider compounded hormones to

have

> the same or even additional safety issues as FDA-approved hormone

> products. That same month, the FDA sent warning letters to 16

companies

> marketing unapproved alternative hormone therapies. The FDA said the

> companies were selling drugs without the agency's approval. The

action

> mirrored in part what Wyeth requested in its petition, but was not

> linked to the filing of the document just weeks earlier, said

Steele,

> the company spokeswoman. And a 2004 review that appeared in

Menopause,

> the journal of the North American Menopause Society, found little to

> recommend about compounded hormones: " In the absence of a sound

> scientific basis, practitioners should not advocate the practice of

> compounding (hormones) because it is not in the patient's best

interest,

> it is potentially harmful and it lacks a scientific underpinning, "

the

> review concluded.

>

>

>

[Guest guest]

This is a post by Dr.nco

Good news!

The FDA has extended the public comment period on Wyeth's complaint

until May 4, 2006!

If you want to join the fight against Wyeth complaint against

compounding pharmacists, and keep your rights to compounded

medications and hormone replacement therapy, then write a comment to

the FDA at:

http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentsmain

..cfm?EC_DOCUMENT_ID=794 & SUBTYP=NEXT & CI D= & AGENCY=FDA

The Women's International Pharmacy has a complete webpage to make

your comments to the FDA, your US Senators, and your US

Congresspersons, along with sample letters for consumers and doctors:

http://www.womensinternational.com/bhrt.html

I would urge everyone to send their opinion in support of compounding

pharmacists and their rights to hormone replacement therapy to the

FDA, their Senators and their Congresspersons. I would also urge

everyone to contact their friends to also support compounding

pharmacists, and fight Wyeth pharmaceuticals.

__________________

Any statement I make on this site is for educational purposes only

and is subject to change. It does not constitute medical advice, does

not substitute for proper medical evaluation from physician, does not

create a doctor/patient relationship or liability. If you want

medical advice, you will have to pay for it. Thank you.

>

> Firm Seeks Crackdown on Custom Made Drugs By ANDREW BRIDGES

> Associated Press Writer

> WASHINGTON — Thousands of women who rely on custom-made hormone

> drugs for relief from menopause symptoms have flooded the government

> with letters opposing a drug company's effort to get health

officials to

> crack down on pharmacies that sell them. The drug company Wyeth

wants

> the Food and Drug Administration to rein in the market for bio-

identical

> hormone replacement therapy drugs. The hormones are custom mixed or

> compounded by specialized pharmacies according to a doctor's

> prescription.

> [http://img.coxnewsweb.com/B/00/83/44/image_3344830.jpg]

> <http://www.ajc.com/hp/content/shared-

gen/ap/Health_Medical/Custom_Made_\

> Drugs-image.html> (enlarge photo)

> <http://www.ajc.com/hp/content/shared-

gen/ap/Health_Medical/Custom_Made_\

> Drugs-image.html> Donna Mabin, right, and cosmotologist Gladys

Ayers,

> left, look over a petition that they are having signed at the Park

Layne

> hair salon, Monday, Feb. 27, 2006 in New Carlisle, Ohio. Thousands

of

> women who rely on tailor-prepared hormones for relief from the

symptoms

> of menopause have flooded the federal government with letters

opposing a

> drug company effort to get health officials to act against the

pharmaces

> that sell the prescription preparations. (AP Photo/ Kohl)

> Compounding pharmacists can alter the dosages of a medicine,

prepare it

> in creams or liquids that are easier to take than pills or eliminate

> preservatives or other secondary ingredients that might cause

allergies

> in a patient. Wyeth claims that some compounding pharmacies that

prepare

> customized hormone preparations are duping women with products that

pose

> a serious health risk. It wants federal regulators to weigh in with

> seizures, injunctions and warning letters. " FDA cannot allow this

> practice to continue, " the Wyeth petition, signed by Washington

attorney

> S. Krulwich, reads in part. FDA spokeswoman Cruzan

declined

> to comment, other than to say compounded hormones are not FDA-

approved.

> The agency recently told Wyeth it needs more than six months to

review

> and respond to both the petition, filed in October, and the more

than

> 27,000 comments it has elicited. Most are either form letters or

> messages submitted through the agency's Web site. " They can't take

these

> away from us. Is there anything that can be done? " said Donna

Mabin, 68,

> a retired cashier from New Carlisle, Ohio, who was among those to

write.

> " Those drug companies want to get the money out of natural hormones

and

> they don't care if we get sick or not. " Many women turned to the

> estrogen, progesterone and testosterone products sold by compounding

> pharmacies after a 2002 study, part of the massive Women's Health

> Initiative that tracked 161,000 women for 15 years, found

replacement

> hormones made by drug companies like Wyeth raised the risk of heart

> attacks, breast cancer and strokes. Critics of the compounding

> pharmacies want to dispel the notion that the hormone replacement

> therapies such pharmacies make necessarily work better or are safer.

> " They haven't been studied for safety or effectiveness and are not

> produced in facilities that meet good manufacturing practices, " said

> Larry Sasich, a pharmacist with the Health Research Group of the

> consumer watchdog Public Citizen. " We suspect a majority of patients

> aren't aware of this. " Medical researchers concluded in 2003 that

> hormone replacement pills should be taken only as a brief treatment

to

> help women weather the worst symptoms of menopause. Those findings

hit

> Wyeth hard. Sales of the company's Prempro and Premphase, which

combine

> estrogen and progestin, and its Premarin, an estrogen-only pill,

fell to

> $880 million in 2004 from $2.07 billion in 2001, the year before the

> Women's Health Initiative released its hormone-replacement results.

> Compounding pharmacists and their backers allege that Wyeth seeks to

> stifle competition by calling in the FDA. " It seems to be an

attempt to

> use the FDA to inappropriately to eliminate competition, " said L.D.

> King, executive director of the International Academy of Compounding

> Pharmacists, a Sugar Land, Texas, group. Wyeth counters it wants

women

> to realize the risks of what a spokeswoman for the Madison, N.J.-

based

> company characterized as a " growing, unlawful practice. " " We filed

our

> petition so that we can ensure that women who received these

> bio-identical hormones also receive truthful information about the

risks

> of therapy, " Wyeth spokeswoman Candace Steele said. Thousands of

> American women use the compounded hormones to alleviate the hot

flashes,

> flushes, sweats, sleeplessness and other hallmarks of menopause. The

> hormones are derived from soy and yam but have an identical chemical

> structure to the substances found in the body. The products sold by

> Wyeth are based on the urine of pregnant mares. Women who use the

> bio-identical hormones, along with their doctors and pharmacists,

all

> say the system is a throwback to when just about every medicine was

made

> to fit both a doctor's order and a patient's need. " Every woman is

> different. There is blood work done to ensure where their hormone

level

> is at, so based on those results and their symptoms, we will come up

> with a formula. It's sort of old-fashioned, " said Manhattan's Dr.

> on of the process he uses with patients like Lynn

> Leibowitz. The doctor-pharmacist-patient " triad " involves constant

> adjustments that just can't be made to the mass-produced drugs that

> Leibowitz, a Manhattan psychologist and psychoanalyst, used to take,

> said , the New Jersey compounding pharmacist she uses.

> " We'll keep going month after month until we find the right

combination

> for the patients, " said of his work at s of Wyckoff,

the

> New Jersey pharmacy his grandfather started in 1929. As for

Leibowitz,

> she says the custom-compounded hormones have left her feeling better

> — and more in control — since switching a year ago. " I love

> knowing what my hormone levels are, " said Leibowitz, who began

taking

> hormones eight years ago after she underwent a hysterectomy at

48. " I

> feel much safer and it's more compatible with my body chemistry. "

That

> sort of anecdotal evidence doesn't sway other doctors. In November,

the

> American College of Obstetricians and Gynecologists said there is no

> scientific evidence supporting claims of increased efficacy or

safety

> for estrogen or progesterone regimens made by compounding

pharmacies for

> women. The group said women should consider compounded hormones to

have

> the same or even additional safety issues as FDA-approved hormone

> products. That same month, the FDA sent warning letters to 16

companies

> marketing unapproved alternative hormone therapies. The FDA said the

> companies were selling drugs without the agency's approval. The

action

> mirrored in part what Wyeth requested in its petition, but was not

> linked to the filing of the document just weeks earlier, said

Steele,

> the company spokeswoman. And a 2004 review that appeared in

Menopause,

> the journal of the North American Menopause Society, found little to

> recommend about compounded hormones: " In the absence of a sound

> scientific basis, practitioners should not advocate the practice of

> compounding (hormones) because it is not in the patient's best

interest,

> it is potentially harmful and it lacks a scientific underpinning, "

the

> review concluded.

>

>

>

[Guest guest]

Hi All,

PREMPRO was a hormone product that included daily progesterone and was

responsible for the halt of the WHI or WIH study. This product caused

problems because the company did not wish to hear the criticism coming

from endocrinologists before they started manufacturing it and then

starting the study.

Daily progesterone had not been studied and the company got approval

to harm women it turns out.

Many women stopped hormone therapy all together and now endure

unecessary discomfort.

Compounding pharmacies can not produce pills but can produce compounds

that pharmaceutical companies are not supposed to be able to package

and sell.

ernestnolan

>

> Firm Seeks Crackdown on Custom Made Drugs By ANDREW BRIDGES

> Associated Press Writer

> WASHINGTON — Thousands of women who rely on custom-made hormone

> drugs for relief from menopause symptoms have flooded the government

> with letters opposing a drug company's effort to get health officials to

> crack down on pharmacies that sell them. The drug company Wyeth wants

> the Food and Drug Administration to rein in the market for bio-identical

> hormone replacement therapy drugs. The hormones are custom mixed or

> compounded by specialized pharmacies according to a doctor's

> prescription.

> [http://img.coxnewsweb.com/B/00/83/44/image_3344830.jpg]

>

<http://www.ajc.com/hp/content/shared-gen/ap/Health_Medical/Custom_Made_\

> Drugs-image.html> (enlarge photo)

>

<http://www.ajc.com/hp/content/shared-gen/ap/Health_Medical/Custom_Made_\

> Drugs-image.html> Donna Mabin, right, and cosmotologist Gladys Ayers,

> left, look over a petition that they are having signed at the Park Layne

> hair salon, Monday, Feb. 27, 2006 in New Carlisle, Ohio. Thousands of

> women who rely on tailor-prepared hormones for relief from the symptoms

> of menopause have flooded the federal government with letters opposing a

> drug company effort to get health officials to act against the pharmaces

> that sell the prescription preparations. (AP Photo/ Kohl)

> Compounding pharmacists can alter the dosages of a medicine, prepare it

> in creams or liquids that are easier to take than pills or eliminate

> preservatives or other secondary ingredients that might cause allergies

> in a patient. Wyeth claims that some compounding pharmacies that prepare

> customized hormone preparations are duping women with products that pose

> a serious health risk. It wants federal regulators to weigh in with

> seizures, injunctions and warning letters. " FDA cannot allow this

> practice to continue, " the Wyeth petition, signed by Washington attorney

> S. Krulwich, reads in part. FDA spokeswoman Cruzan declined

> to comment, other than to say compounded hormones are not FDA-approved.

> The agency recently told Wyeth it needs more than six months to review

> and respond to both the petition, filed in October, and the more than

> 27,000 comments it has elicited. Most are either form letters or

> messages submitted through the agency's Web site. " They can't take these

> away from us. Is there anything that can be done? " said Donna Mabin, 68,

> a retired cashier from New Carlisle, Ohio, who was among those to write.

> " Those drug companies want to get the money out of natural hormones and

> they don't care if we get sick or not. " Many women turned to the

> estrogen, progesterone and testosterone products sold by compounding

> pharmacies after a 2002 study, part of the massive Women's Health

> Initiative that tracked 161,000 women for 15 years, found replacement

> hormones made by drug companies like Wyeth raised the risk of heart

> attacks, breast cancer and strokes. Critics of the compounding

> pharmacies want to dispel the notion that the hormone replacement

> therapies such pharmacies make necessarily work better or are safer.

> " They haven't been studied for safety or effectiveness and are not

> produced in facilities that meet good manufacturing practices, " said

> Larry Sasich, a pharmacist with the Health Research Group of the

> consumer watchdog Public Citizen. " We suspect a majority of patients

> aren't aware of this. " Medical researchers concluded in 2003 that

> hormone replacement pills should be taken only as a brief treatment to

> help women weather the worst symptoms of menopause. Those findings hit

> Wyeth hard. Sales of the company's Prempro and Premphase, which combine

> estrogen and progestin, and its Premarin, an estrogen-only pill, fell to

> $880 million in 2004 from $2.07 billion in 2001, the year before the

> Women's Health Initiative released its hormone-replacement results.

> Compounding pharmacists and their backers allege that Wyeth seeks to

> stifle competition by calling in the FDA. " It seems to be an attempt to

> use the FDA to inappropriately to eliminate competition, " said L.D.

> King, executive director of the International Academy of Compounding

> Pharmacists, a Sugar Land, Texas, group. Wyeth counters it wants women

> to realize the risks of what a spokeswoman for the Madison, N.J.-based

> company characterized as a " growing, unlawful practice. " " We filed our

> petition so that we can ensure that women who received these

> bio-identical hormones also receive truthful information about the risks

> of therapy, " Wyeth spokeswoman Candace Steele said. Thousands of

> American women use the compounded hormones to alleviate the hot flashes,

> flushes, sweats, sleeplessness and other hallmarks of menopause. The

> hormones are derived from soy and yam but have an identical chemical

> structure to the substances found in the body. The products sold by

> Wyeth are based on the urine of pregnant mares. Women who use the

> bio-identical hormones, along with their doctors and pharmacists, all

> say the system is a throwback to when just about every medicine was made

> to fit both a doctor's order and a patient's need. " Every woman is

> different. There is blood work done to ensure where their hormone level

> is at, so based on those results and their symptoms, we will come up

> with a formula. It's sort of old-fashioned, " said Manhattan's Dr.

> on of the process he uses with patients like Lynn

> Leibowitz. The doctor-pharmacist-patient " triad " involves constant

> adjustments that just can't be made to the mass-produced drugs that

> Leibowitz, a Manhattan psychologist and psychoanalyst, used to take,

> said , the New Jersey compounding pharmacist she uses.

> " We'll keep going month after month until we find the right combination

> for the patients, " said of his work at s of Wyckoff, the

> New Jersey pharmacy his grandfather started in 1929. As for Leibowitz,

> she says the custom-compounded hormones have left her feeling better

> — and more in control — since switching a year ago. " I love

> knowing what my hormone levels are, " said Leibowitz, who began taking

> hormones eight years ago after she underwent a hysterectomy at 48. " I

> feel much safer and it's more compatible with my body chemistry. " That

> sort of anecdotal evidence doesn't sway other doctors. In November, the

> American College of Obstetricians and Gynecologists said there is no

> scientific evidence supporting claims of increased efficacy or safety

> for estrogen or progesterone regimens made by compounding pharmacies for

> women. The group said women should consider compounded hormones to have

> the same or even additional safety issues as FDA-approved hormone

> products. That same month, the FDA sent warning letters to 16 companies

> marketing unapproved alternative hormone therapies. The FDA said the

> companies were selling drugs without the agency's approval. The action

> mirrored in part what Wyeth requested in its petition, but was not

> linked to the filing of the document just weeks earlier, said Steele,

> the company spokeswoman. And a 2004 review that appeared in Menopause,

> the journal of the North American Menopause Society, found little to

> recommend about compounded hormones: " In the absence of a sound

> scientific basis, practitioners should not advocate the practice of

> compounding (hormones) because it is not in the patient's best interest,

> it is potentially harmful and it lacks a scientific underpinning, " the

> review concluded.

>

>

>

[Guest guest]

PREMPRO was a hormone product that included daily

progesterone and was responsible for the halt of the WHI or WIH

study. ... Daily progesterone had not been studied and the company

got approval to harm women it turns out.-----

Hi Ernest, Good to see you back on-line. I've been off-line myself

lately due to other interests and commitments. Just a few comments

about points you bring up, as well as those of the originator of this

topic...

There is nothing inherently wrong with Prempro, except that it is

administered as an oral pill. The digestive system breaks down

hormones, rendering them largely ineffective.

A small daily amount of progesterone is proven to lower the incidence

of uterine cancer in women taking replacement estrogen. The WHI and

other previous smaller studies reached this conclusion. This benefit

was downplayed or completely ignored by the media.

A VERY slim rise in the occurance of breast cancer in the

progesterone & estrogen arm of the WHI study (as opposed to the

estrogen only arm) can be attributed specifically to the oral means

of administering progesterone.

Dr. A. , Memorial Medical Center, North Adelaide, South

Australia, in an interview with Reuters Health says this of the

suspected increased risk when oral progestin is added to estrogen HRT:

" That issue could possibly be circumvented by administering the

progestin via an intrauterine device rather than orally. After all,

why give progestin to the breast when all you want to do is give it

to the uterus? "

Perhaps the most glaring error in the WHI study was the fact that

only two (estrogen & progesterone) of the three essential hormones

lost at menopause were given to the test subjects. Androgens

(testosterone) were completely omitted.

Another quote from the source listed above:

" Before menopause, the ovaries produce both testosterone and

estrogen. Conventional HRT " tends to interfere with the protective

effect of testosterone, thus increasing the risk of breast cancer.

If testosterone had been used by subjects in the Women's Health

Initiative study, it may have stopped the rise in breast cancer risk.

It's possible the trial would not have needed to be stopped early. "

To say nothing of the heart protective qualities of testosterone:

" In other words, no matter what sort of cholesterol or other blood

fat abnormalities these ladies had, the lower the testosterone, the

more likely they were to have a heart attack. " .....Dr. Alan Altman,

a Boston gynecologist, citing a variety of clinical findings.....

Another vital aspect of the WHI study that has been under reported by

some news sources and simply omitted by others is the protective

effect that estrogen, with or without progesterone, has on bone

density. Taking into account the phenomenal number of women over 60

who suffer permanent loss of mobility due to osteoporosis, and an

accompanying higher mortality rate, this is a considerable health

benefit. (With testosterone added to the mix, the benefit increases

substantially.)

-----Compounding pharmacies can not produce pills but can produce

compounds that pharmaceutical companies are not supposed to be able

to package and sell.-----

Compounding pharmacies can and do produce medicines for oral use in

capsule form, and some may have the facilities to produce compressed

powder (pills). They can also mix powdered compounds, as well as

injectible medicines.

What compounded pharmacists cannot legally do is to replicate a

patented medicine. In other words if Pfizer has an estradiol pill on

the market that is produced in 5mg and 10mg tablets, a compounding

pharmacy can mix and sell their own 7mg estradiol capsules, estradiol

tablets (of a different color, size and shape than the Pfizer pills),

estradiol powder with a measuring scoop, or an estradiol gel or cream

formulation.

Unfortunately instead of using a fact-based slogan such as " topical

is more effective and safer " to promote their compounded HRT

products, these pharmacies and doctors who prescribe compounded HRT

use the " all-natural " and " bioidentical " sales pitch, catering to an

unfounded public perception that natural is safer. (There are plenty

of products in nature that are more lethal than anything produced in

the lab.)

The current FDA takes their orders from big pharmaceutical companies

out to destroy their competition, from the DEA who seeks to expand

the number of anabolic steroids on their list of controlled

substances to include estrogen and progesterone, from political

groups, and from the media who reports what these powers tell them to

report. Science and health are no longer motivating forces within the

FDA, and at least one senior official has resigned in protest.

My contempt for this agency knows no limits. I applaud the effort to

solicit mail to the FDA in support of compounding pharmacies, but I

am very pessimistic. This FDA does not care about the opinions,

health or safety of the average joe (or jane). I wish it were

different and hope that a new administration will make better

appointments to the agency.

[Guest guest]

Hi,

Nice to hear from you and this is a young book but will try to respond

to those items I may have heard something about.

I do not do research but ask Dr. Gambrell about specifics.

1. The use of Progesterone has been used by Dr. Gambrell for decades

with women being given HRT therapy. He specifically requires the use

of pregesterone for 7 - 9 days out of the month to bring about a period.

As I understand PrePro was a blend of P & E hormones. There was no

period of time when progesterone was not to be take in a high daily dose.

Dr. Gambrell insisted to the PrePro pharmaceutical company that 24/7

use of progesteropne was never studied and would be harmful as this

blocks estrogen receptors of some type in the body. Some parts of the

body starve for estrogen. No further details here.

2. In Dr. Gambrell's experience, Progesterone taken orally works very

well and has never been a problem bringing about a period.

3. The Progesterone taken daily was to eliminate the monthly period,

which women were supposed to jump at, elevating sales of the " hormone

pill without a period " . Isn't this proof the digestive process does

not interfere with progesterone in those women where the period

happened as required.

Betty could not digest oral estrogen and get her liver to metabloize

it so it would appear in her blood stream. From 10% - 20% of women

have trouble metabolizing oral estrogen and never get tested when they

complain about no relief.

4. In pre-menopause women the progesterone level drops back to a very

low level most of the month and then rises to bring aout the period.

This natural amount is beneficial but the dose in PrePro was not near

that as I understand it. That pill is still being marketed in a lower

dose if I hear the adds right.

>

> A VERY slim rise in the occurance of breast cancer in the

> progesterone & estrogen arm of the WHI study (as opposed to the

> estrogen only arm) can be attributed specifically to the oral means

> of administering progesterone.

>

This study has not been a big study and did not have a large percent

difference in cancer did it? It is not enough to make a big case for

PrePro is it?

I can't comment on Dr. study as I do not have the credentials.

The premenopause woman has what she needs for good health and surely

the breasts are not harmed by these natural hormone levels.

I agree androgen is an absolute essential hormone in HRT for women.

Betty got that from Dr. Gambrell.

Dr. Gambrell felt the women were being overdosed with daily

progesterone causing them probable harm.

5. I stand corrected on the legal aspects of the boundry between

pharmaceuticals and compounding pharmacies. Yes, you are absolutely

correct. Where not patent protected any company can produce an

identical product, right?

Politics rules the FDA I heard from Dr. Gambrell. Insurance companies

do not want to have to pay for HRT or TRT. This was why approval was

very slow for pellets to be approved for andropause.

If you got this far down, I owe you a cup of coffee.

ernestnolan

[Guest guest]

1. The use of Progesterone has been used by Dr. Gambrell for

decades with women being given HRT therapy. He specifically requires

the use of pregesterone for 7 - 9 days out of the month to bring

about a period. ----

That is one method.

Another method is using *low dose* *continuous* progesterone in

conjunction with estrogen to prevent buildup of the uterine lining in

which case there is no need to use high doses of progesterone

periodically to cause monthly shedding.

Both methods have been in use over the past decade by women with no

adverse effects that I'm aware of.

----As I understand PrePro was a blend of P & E hormones. There was no

period of time when progesterone was not to be take in a high daily

dose.-----

Prempro was originally marketed as a birth control pill and if taken

continously it would prevent monthly periodic bleeding. There were

health problems with this method if I recall correctly, but in any

case most women preferred a schedule of 3 weeks on and one week off

(with a period materializing during the week off of course).

At that time in history all oral contraceptives contained high doses

of hormones. Later it was discovered that lower doses were equally

effective and safer.

Prempro was later also used as combination HRT.

---Dr. Gambrell insisted to the PrePro pharmaceutical company that

24/7 use of progesteropne was never studied and would be harmful as

this blocks estrogen receptors of some type in the body. Some parts

of the body starve for estrogen. -----

This may well be true if high doses of progesterone are taken

continuously, hence Dr Gambrell's well founded complaint against

continuous prempro use for contraception or for HRT.

Continuous estrogen and progesterone should be taken in low doses.

And for *lower* doses to work they need to be administered by

parenteral (not oral) means.

From my experience, and from comparing notes with other women on

various HRT protocols, we pre-menopausal women do not require the

cataclysmic fluctuations of high hormone levels that exist in women

of reproductive age to maintain our health in later years. Expelling

the uterine lining once a month is not necessary if the balance

between estrogen and progesterone prevents the lining from gaining

mass.

---- 2. In Dr. Gambrell's experience, Progesterone taken orally works

very well and has never been a problem bringing about a period.---

If high dose oral progesterone is being taken only a few days out of

the month probably the risk of breast cancer is slim to nil.

But this is a different protocol from continuous use investigated by

the WHI study. Dr Gambrell discusses a variety of HRT protocols in

his book.

---- 3. The Progesterone taken daily was to eliminate the monthly

period, which women were supposed to jump at, elevating sales of

the " hormone pill without a period " . Isn't this proof the digestive

process does not interfere with progesterone in those women where the

period happened as required.-----

I'm not quite sure what you mean. Are you referring to breakthrough

bleeding? There are a variety of things that can cause this. Women

who took prempro continously did not have periods, while those who

followed the 3 wks on & 1 wk off cycled normally.

Oral hormones will work if you take a high enough dose, but the

health risks also increase accordingly. The oral route poses risks

of its own by exposing the major organs and breast tissues in that

first pass through the body.

In my experience topical progesterone need only be taken at about

half the ratio to estrogen that most continuous oral

estrogen/progesterone replacement protocols specify. I think many

compounded estrogen/progesterone creams and gels have the correct

ratio.

---Betty could not digest oral estrogen and get her liver to

metabloize it so it would appear in her blood stream. From 10% - 20%

of women have trouble metabolizing oral estrogen------

That is a VERY LOW estimate. Oral hormones have much lower

bioavailability than parenteral formulations...for all women. Most

women assume they cannot hope to feel better. After all they're

taking the HRT pills prescribed by the doc. They do not realize that

if they took these meds topically or intravaginally the improvement

would be immense. And that adding testosterone to the mix would

restore them to normal. So they report that HRT works, since it does

help a small bit.

---- This study has not been a big study and did not have a large

percent difference in cancer did it? It is not enough to make a big

case for PremPro is it?-----

I lost track of which study you referred to here (the WHI study of

course was immense) but I'm certainly not making a case for prempro

nor is anyone else.

----The premenopause woman has what she needs for good health and

surely the breasts are not harmed by these natural hormone levels.---

Premenopausal women are YOUNG. Most cancers are diseases associated

with aging. The likelihood of getting cancer increases with age.

Hormones do not cause cancer, but they can feed early cancerous cells

and cause them to grow and multiply.

----Dr. Gambrell felt the women were being overdosed with daily

progesterone causing them probable harm.---

I agree with this. The doses should have been lower and given

topically.

----5. I stand corrected on the legal aspects of the boundry between

pharmaceuticals and compounding pharmacies. Yes, you are absolutely

correct. Where not patent protected any company can produce an

identical product, right?----

Any compounding pharmacy can mix unpatented medical formulations per

a physician's rx. And any pharmaceutical company can market a

generic version of another drug co's patented med when the original

patent has expired. To produce a new medication, a pharmaceutical

company must develop and test it and then get it approved by the

FDA. Supplement companies can produce amino acid, vitamin, herbal

etc formulations for sale over the counter.

-----Politics rules the FDA I heard from Dr. Gambrell. Insurance

companies do not want to have to pay for HRT or TRT. This was why

approval was very slow for pellets to be approved for andropause.---

That is an understatement and only part of the picture but very true,

yes. Far more so in the past 5 yrs. FDA suffers from the FEMA

syndrome.

If pellets are FDA approved, then I'm surprised. Are you sure about

this?

Insurance cos and the DEA both would like to have andropause declared

nonexistent and women's HRT declared unsafe. Insurers don't want to

pay for it, and the DEA wants more work policing more illegal

steroids, even if it is the 1% testosterone in a tube of testim or a

jar of estradiol pills. And the media is willing to misreport

research findings to serve the aims of these two interest groups.

Big pharmaceutical cos don't want competition for their patented HRT

products from compounding pharmacists. And then you have power-mad

religious fanatics who want to dictate health matters to private

persons, pharmacists, and scientists.

---If you got this far down, I owe you a cup of coffee.----

Cream and no sugar. :-) But I'm buying, since you probably read

both my anti-FDA rants in their entirety.

[Guest guest]

Hi,

I will clip and reply as the note is long.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

>

> Both methods have been in use over the past decade by women with no

> adverse effects that I'm aware of.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

If you have seen these studies, It is new to me. I'm not well read on

the subject.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

> Prempro was originally marketed as a birth control pill and if taken

> continously it would prevent monthly periodic bleeding. There were

> health problems with this method if I recall correctly,

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

This is what I think Dr. Gambrell was concerned about.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

> Expelling

> the uterine lining once a month is not necessary if the balance

> between estrogen and progesterone prevents the lining from gaining

> mass.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

I thought Dr. Gambrell felt this was fooling with Mother Nature and

was against it. I did not read his book that you mentioned. Glad to

hear you took the trouble to read it. Hope it was worth the expense

and read.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

> I'm not quite sure what you mean. Are you referring to breakthrough

> bleeding? There are a variety of things that can cause this. Women

> who took prempro continously did not have periods, while those who

> followed the 3 wks on & 1 wk off cycled normally.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

> After all they're

> taking the HRT pills prescribed by the doc. They do not realize that

> if they took these meds topically or intravaginally the improvement

> would be immense. And that adding testosterone to the mix would

> restore them to normal. So they report that HRT works, since it does

> help a small bit.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

Are women able to get the patches or do you mean another form like

salve or ointment when you mention " topically " ?

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

> Insurance cos and the DEA both would like to have andropause declared

> nonexistent and women's HRT declared unsafe. Insurers don't want to

> pay for it, and the DEA wants more work policing more illegal

> steroids, even if it is the 1% testosterone in a tube of testim or a

> jar of estradiol pills. And the media is willing to misreport

> research findings to serve the aims of these two interest groups.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

This I know about. Pellets were approved by the FDA for men before the

death of Dr. Sipi who Betty saw in NJ probably about 1998. Insurance

companies do not want to pay for pellets for andropause and have been

hiding from this approval.

Dr. Gambrell is no small potato in GA and has been under the

fingernails of the Medicare organization. There is a set of doctors

that allocate how they are going to use the government funds that

support Medicare. It is still not covered for women for some technical

reason like the FDA did not approve pellets for women because of

political pressure he says.

He has gotten approval under some method for Medicare in GA like no

other location in the US. Most of my expense of replacing pellets

every 4 months is paid for by Medicare. The cost would be about $450

for my 20 pellets including the visit.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

> Big pharmaceutical cos don't want competition for their patented HRT

> products from compounding pharmacists. And then you have power-mad

> religious fanatics who want to dictate health matters to private

> persons, pharmacists, and scientists.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

When working for IBM it was explained you can not cut a board to a

special length and claim a patent. To patent you have to develope thru

research, investigation and a study that a medication is not dangerous.

Mixing two safe substances together and claiming a patent is really

stretching the patent concept. Tylenol PM for instance should be able

to be duplicated by any company.

The hormone carrier thru the skin may have been used for other

medications and found effective.

There are doctors who have reactions like religious objections to

giving testosterone to men and women as though it were sinning to

create more desire for sex. I think they see testosterone for men and

women like giving poor people whiskey.

ernestnolan

[Guest guest]

>Both methods have been in use over the past decade by women with no

>adverse effects that I'm aware of.

-----If you have seen these studies, It is new to me. I'm not well

read on the subject.------

I'm not referring to studies. Probably few have been done, just as

none have been done (to my knowledge) on Dr Gambrell's method of

pelleted E & T w/ P added a few days a month.

I'm simply stating that women have been using compounded estrogen,

progesterone, and testosterone gels and creams for at least a decade

if not longer, using a variety of protocols, including continuous

daily low doses of all 3 hormones.

> Prempro was originally marketed as a birth control pill and if taken

> continously it would prevent monthly periodic bleeding. There were

> health problems with this method if I recall correctly,

----This is what I think Dr. Gambrell was concerned about.---

This was a valid concern but it is OLD news (1950s vintage) and has

nothing to do with the recent WHI hormone replacement study.

> Expelling the uterine lining once a month is not necessary if the

> balance between estrogen and progesterone prevents the lining from

> gaining mass.

---I thought Dr. Gambrell felt this was fooling with Mother Nature and

was against it.-----

No, he is against pre-menopausal women using continuous oral

contraceptives to suppress the menstrual cycle. (Or so I gather from

what you have written, and this makes sense.) Most pre-menopausal

women are/were not keen on this idea either.

Any woman taking bc pills to prevent conception by fooling her body

into thinking it is already pregnant is fooling with nature. As well

as older men and women taking replacement hormones. Nature is not

our friend when we pass reproductive age.

Dr Gambrell's book is not a dissertation of his own HRT prescription

preferences, but an instructional manual for other gynecologists

detailing the various HRT protocols, their applications, advantages,

and disadvantages.

-----Are women able to get the patches or do you mean another form

like salve or ointment when you mention " topically " ?----

Topical refers to patches, gels, creams. A better term

is 'parenteral' (meaning outside the digestive tract) and includes

rings, inserts, as well as patches etc.

My website on women's HRT is far from completion, but I have a

partially completed illustrated page that describes most of the

available options.

main page is at:

http://infowoman.freewebpage.org/index.htm

Click on " Your Options "

If you click on " Recommended Reading " you will find Dr Gambrell's

book (in good company) with ordering links to all the books listed.

---This I know about. Pellets were approved by the FDA for men before

the death of Dr. Sipi who Betty saw in NJ probably about 1998.

Insurance companies do not want to pay for pellets for andropause and

have been hiding from this approval.----

Hmmm, that sounds like the grey zone of semi-legality where estratest

(oral estrogen/testosterone pill for women) resides.

----It is still not covered for women for some technical

reason like the FDA did not approve pellets for women because of

political pressure he says.----

The same political pressure that sent the female testosterone patch

into permanent limbo, no doubt.

----He has gotten approval under some method for Medicare in GA like

no other location in the US. Most of my expense of replacing pellets

every 4 months is paid for by Medicare. The cost would be about $450

for my 20 pellets including the visit.-----

I'm glad you are able to get your treatments covered since they work

so well for both you and Betty.

I agree totally with your last 3 or 4 paragraphs (as do most of the

people on this board who've had to deal with greedy pharmaceutical

cos, stingy insurance cos, the FDA, the DEA, doctors who have been

misled or cowed by the former, and the current sexist/anti-sex/anti-

science/unhealthy political climate.)

Cheers,

[Guest guest]

Hi I need to read you link.

http://infowoman.freewebpage.org/index.htm

But some thing is wrong with it add's look like they are over lapping some of

the words and it is hard to read.

Phil

Summers <rsummers@...> wrote:

>Both methods have been in use over the past decade by women with no

>adverse effects that I'm aware of.

-----If you have seen these studies, It is new to me. I'm not well

read on the subject.------

I'm not referring to studies. Probably few have been done, just as

none have been done (to my knowledge) on Dr Gambrell's method of

pelleted E & T w/ P added a few days a month.

I'm simply stating that women have been using compounded estrogen,

progesterone, and testosterone gels and creams for at least a decade

if not longer, using a variety of protocols, including continuous

daily low doses of all 3 hormones.

> Prempro was originally marketed as a birth control pill and if taken

> continously it would prevent monthly periodic bleeding. There were

> health problems with this method if I recall correctly,

----This is what I think Dr. Gambrell was concerned about.---

This was a valid concern but it is OLD news (1950s vintage) and has

nothing to do with the recent WHI hormone replacement study.

> Expelling the uterine lining once a month is not necessary if the

> balance between estrogen and progesterone prevents the lining from

> gaining mass.

---I thought Dr. Gambrell felt this was fooling with Mother Nature and

was against it.-----

No, he is against pre-menopausal women using continuous oral

contraceptives to suppress the menstrual cycle. (Or so I gather from

what you have written, and this makes sense.) Most pre-menopausal

women are/were not keen on this idea either.

Any woman taking bc pills to prevent conception by fooling her body

into thinking it is already pregnant is fooling with nature. As well

as older men and women taking replacement hormones. Nature is not

our friend when we pass reproductive age.

Dr Gambrell's book is not a dissertation of his own HRT prescription

preferences, but an instructional manual for other gynecologists

detailing the various HRT protocols, their applications, advantages,

and disadvantages.

-----Are women able to get the patches or do you mean another form

like salve or ointment when you mention " topically " ?----

Topical refers to patches, gels, creams. A better term

is 'parenteral' (meaning outside the digestive tract) and includes

rings, inserts, as well as patches etc.

My website on women's HRT is far from completion, but I have a

partially completed illustrated page that describes most of the

available options.

main page is at:

http://infowoman.freewebpage.org/index.htm

Click on " Your Options "

If you click on " Recommended Reading " you will find Dr Gambrell's

book (in good company) with ordering links to all the books listed.

---This I know about. Pellets were approved by the FDA for men before

the death of Dr. Sipi who Betty saw in NJ probably about 1998.

Insurance companies do not want to pay for pellets for andropause and

have been hiding from this approval.----

Hmmm, that sounds like the grey zone of semi-legality where estratest

(oral estrogen/testosterone pill for women) resides.

----It is still not covered for women for some technical

reason like the FDA did not approve pellets for women because of

political pressure he says.----

The same political pressure that sent the female testosterone patch

into permanent limbo, no doubt.

----He has gotten approval under some method for Medicare in GA like

no other location in the US. Most of my expense of replacing pellets

every 4 months is paid for by Medicare. The cost would be about $450

for my 20 pellets including the visit.-----

I'm glad you are able to get your treatments covered since they work

so well for both you and Betty.

I agree totally with your last 3 or 4 paragraphs (as do most of the

people on this board who've had to deal with greedy pharmaceutical

cos, stingy insurance cos, the FDA, the DEA, doctors who have been

misled or cowed by the former, and the current sexist/anti-sex/anti-

science/unhealthy political climate.)

Cheers,