Lupron #5

[Guest guest]

Lynne's Story: A Preamble To RFW's Lupron Investigation

 

By Nicholas Regush

 

January 19, 2002 - This particular saga began a decade ago with

injections of a powerful prescription drug called Lupron. Lynne

Millican took the shot for endometriosis, a condition in which pieces

of the lining of the uterus are found in other parts of the body,

especially in the pelvic cavity.

 

Ten years later, Millican believes she is still suffering from the

effects of those injections. Her many symptoms have included the

development of a noncancerous tumor, breast cysts, cardiac

arrythmias, dizziness, swelling and fatigue.

 

Millican is a registered nurse (and paralegal) living in the Boston

area who has become deeply involved in a grass-roots movement to

force the U.S. Food and Drug Administration (FDA), and Members of

Congress to take a close look at Lupron.

 

The FDA first approved Lupron in 1985 for treatment of men with

advanced prostate cancer, and then approved it for treatment of

endometriosis in 1990 and, in 1995, for the pre-operative treatment

of anemia resulting from heavy bleeding associated with fibroids.

 

" There are thousands in the United States who say they have been

victimized by this drug, " Millican said, emphasizing that symptoms

can be severe, such as tremors, seizures and memory loss.

 

" Many women I know say their symptoms didn't stop when they stopped

taking the drug. "

 

The FDA has received a wide range of reports of serious side-effects,

including death, suspected to be associated with the use of Lupron,

but the agency, which holds that the drug's benefits outweigh the

risks, does not believe there is sufficient proof to blame Lupron.

 

TAP Pharmaceuticals Inc., jointly owned by Abbott Laboratories and

Takeda Chemical Industries of Japan, has steadfastly maintained that

Lupron is safe.

 

Millican, who feels that the FDA has been very slow on the draw with

Lupron, is also frustrated by the lack of response from almost all of

the many senators and representatives in Congress to whom she has

written. She has even submitted written testimony to various

committee hearings - but to no avail.

 

" It seems that no one but the people who suffer from Lupron are

interested in looking into this drug, " she said.

 

Millican cannot even recall anyone with an MD degree who has voiced

strong concern about Lupron.

 

At the very least, she feels Lupron's safety should be an issue

because doctors use it for purposes that were never approved by the

FDA. While legal under federal law - once approved for an indication,

a drug can be used for other purposes - unapproved use often occurs

without the benefit of appropriate safety and efficacy studies.

 

One of Millican's main concerns is Lupron's unapproved use in

fertility clinics. The drug is essentially used to suppress female

hormones which produce a mature egg. This allows fertility doctors to

then induce " controlled " stimulation of multiple eggs.

 

" I am concerned that women who undergo these procedures are not being

sufficiently informed about Lupron's side-effects, " Millican said.

 

There is even much more at stake, according to Millican. On September

5, she provided testimony to congressional committee hearings on stem

cell research, pointing out that the use of Lupron in the process of

creating embryos may cause " the very diseases that are being claimed

as those diseases necessitating embryonic stem cell research for a

cure. "

 

Millican finds it hard to swallow that the debate over stem cell

research has totally ignored Lupron.

 

Next Week: Part One of RFW's Lupron Investigation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Lynne's Story: A Preamble To RFW's Lupron Investigation

 

By Nicholas Regush

 

January 19, 2002 - This particular saga began a decade ago with

injections of a powerful prescription drug called Lupron. Lynne

Millican took the shot for endometriosis, a condition in which pieces

of the lining of the uterus are found in other parts of the body,

especially in the pelvic cavity.

 

Ten years later, Millican believes she is still suffering from the

effects of those injections. Her many symptoms have included the

development of a noncancerous tumor, breast cysts, cardiac

arrythmias, dizziness, swelling and fatigue.

 

Millican is a registered nurse (and paralegal) living in the Boston

area who has become deeply involved in a grass-roots movement to

force the U.S. Food and Drug Administration (FDA), and Members of

Congress to take a close look at Lupron.

 

The FDA first approved Lupron in 1985 for treatment of men with

advanced prostate cancer, and then approved it for treatment of

endometriosis in 1990 and, in 1995, for the pre-operative treatment

of anemia resulting from heavy bleeding associated with fibroids.

 

" There are thousands in the United States who say they have been

victimized by this drug, " Millican said, emphasizing that symptoms

can be severe, such as tremors, seizures and memory loss.

 

" Many women I know say their symptoms didn't stop when they stopped

taking the drug. "

 

The FDA has received a wide range of reports of serious side-effects,

including death, suspected to be associated with the use of Lupron,

but the agency, which holds that the drug's benefits outweigh the

risks, does not believe there is sufficient proof to blame Lupron.

 

TAP Pharmaceuticals Inc., jointly owned by Abbott Laboratories and

Takeda Chemical Industries of Japan, has steadfastly maintained that

Lupron is safe.

 

Millican, who feels that the FDA has been very slow on the draw with

Lupron, is also frustrated by the lack of response from almost all of

the many senators and representatives in Congress to whom she has

written. She has even submitted written testimony to various

committee hearings - but to no avail.

 

" It seems that no one but the people who suffer from Lupron are

interested in looking into this drug, " she said.

 

Millican cannot even recall anyone with an MD degree who has voiced

strong concern about Lupron.

 

At the very least, she feels Lupron's safety should be an issue

because doctors use it for purposes that were never approved by the

FDA. While legal under federal law - once approved for an indication,

a drug can be used for other purposes - unapproved use often occurs

without the benefit of appropriate safety and efficacy studies.

 

One of Millican's main concerns is Lupron's unapproved use in

fertility clinics. The drug is essentially used to suppress female

hormones which produce a mature egg. This allows fertility doctors to

then induce " controlled " stimulation of multiple eggs.

 

" I am concerned that women who undergo these procedures are not being

sufficiently informed about Lupron's side-effects, " Millican said.

 

There is even much more at stake, according to Millican. On September

5, she provided testimony to congressional committee hearings on stem

cell research, pointing out that the use of Lupron in the process of

creating embryos may cause " the very diseases that are being claimed

as those diseases necessitating embryonic stem cell research for a

cure. "

 

Millican finds it hard to swallow that the debate over stem cell

research has totally ignored Lupron.

 

Next Week: Part One of RFW's Lupron Investigation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Lynne's Story: A Preamble To RFW's Lupron Investigation

 

By Nicholas Regush

 

January 19, 2002 - This particular saga began a decade ago with

injections of a powerful prescription drug called Lupron. Lynne

Millican took the shot for endometriosis, a condition in which pieces

of the lining of the uterus are found in other parts of the body,

especially in the pelvic cavity.

 

Ten years later, Millican believes she is still suffering from the

effects of those injections. Her many symptoms have included the

development of a noncancerous tumor, breast cysts, cardiac

arrythmias, dizziness, swelling and fatigue.

 

Millican is a registered nurse (and paralegal) living in the Boston

area who has become deeply involved in a grass-roots movement to

force the U.S. Food and Drug Administration (FDA), and Members of

Congress to take a close look at Lupron.

 

The FDA first approved Lupron in 1985 for treatment of men with

advanced prostate cancer, and then approved it for treatment of

endometriosis in 1990 and, in 1995, for the pre-operative treatment

of anemia resulting from heavy bleeding associated with fibroids.

 

" There are thousands in the United States who say they have been

victimized by this drug, " Millican said, emphasizing that symptoms

can be severe, such as tremors, seizures and memory loss.

 

" Many women I know say their symptoms didn't stop when they stopped

taking the drug. "

 

The FDA has received a wide range of reports of serious side-effects,

including death, suspected to be associated with the use of Lupron,

but the agency, which holds that the drug's benefits outweigh the

risks, does not believe there is sufficient proof to blame Lupron.

 

TAP Pharmaceuticals Inc., jointly owned by Abbott Laboratories and

Takeda Chemical Industries of Japan, has steadfastly maintained that

Lupron is safe.

 

Millican, who feels that the FDA has been very slow on the draw with

Lupron, is also frustrated by the lack of response from almost all of

the many senators and representatives in Congress to whom she has

written. She has even submitted written testimony to various

committee hearings - but to no avail.

 

" It seems that no one but the people who suffer from Lupron are

interested in looking into this drug, " she said.

 

Millican cannot even recall anyone with an MD degree who has voiced

strong concern about Lupron.

 

At the very least, she feels Lupron's safety should be an issue

because doctors use it for purposes that were never approved by the

FDA. While legal under federal law - once approved for an indication,

a drug can be used for other purposes - unapproved use often occurs

without the benefit of appropriate safety and efficacy studies.

 

One of Millican's main concerns is Lupron's unapproved use in

fertility clinics. The drug is essentially used to suppress female

hormones which produce a mature egg. This allows fertility doctors to

then induce " controlled " stimulation of multiple eggs.

 

" I am concerned that women who undergo these procedures are not being

sufficiently informed about Lupron's side-effects, " Millican said.

 

There is even much more at stake, according to Millican. On September

5, she provided testimony to congressional committee hearings on stem

cell research, pointing out that the use of Lupron in the process of

creating embryos may cause " the very diseases that are being claimed

as those diseases necessitating embryonic stem cell research for a

cure. "

 

Millican finds it hard to swallow that the debate over stem cell

research has totally ignored Lupron.

 

Next Week: Part One of RFW's Lupron Investigation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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| Environment |

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WHERE'S THE SCIENCE?

LUPRON, INFERTILITY, AND WOMEN AS GUINEA PIGS

 

By Nicholas Regush

 

March 11, 2002 - It's a disgrace. A drug named Lupron that is

unapproved by the Food and Drug Administration for treatment of

infertility is being used widely at infertility clinics.

 

There is no surveillance to speak of, no adequate research being

done, and little or no informed consent. It's become a free-for-all

and a glaring example of why modern medicine, drug companies and the

FDA cannot be easily trusted.

 

Lupron, manufactured by Tap Pharmaceuticals Inc., is approved for

treatment of men with advanced prostate cancer and for treatment of

endometriosis and for the pre-operative treatment of anemia resulting

from heavy bleeding associated with fibroids.

 

That's it. Nothing more.

 

There is, however, a legal loophole, and one widened considerably by

tradition. Once the FDA approves a drug for a specific indication,

doctors can use it for any purpose. That's right, any purpose, and

the more doctors that use it for an unapproved purpose, the more it

becomes part of standard medical practice. It's assumed that along

the way some real evidence, beyond whispers in hallways of hospitals

or anecdotes spun at medical symposia (financed by drug companies),

has actually been gathered, and maybe even published.

 

That may be the case with some drugs being used for unapproved

indications, but I'd like to issue a challenge to Tap Pharmaceuticals

and any medical body or doctor to pony up the " real " science that has

been done to support the contention that the use of Lupron for

treatment of infertility is safe and effective, over both the short-

term and long-term.

 

Any public revelations that solid safety and efficacy data exist to

support the use of Lupron in the treatment of infertility could be

viewed as reassurance to women that they are not guinea pigs in some

giant medical experiment — which I believe they are.

 

As things stand, for example, there are already many serious

questions about the use of Lupron in the treatment of endometriosis,

an approved indication. The studies supporting the approval were

amazingly scant, and long-term research has seriously gone missing.

 

Endometriosis is a condition in which pieces of the lining of the

uterus are found in other parts of the body, especially in the pelvic

cavity. These pieces of endometrium respond to the menstrual cycle

and bleed. Because the blood cannot escape, it builds up and causes

the development of small or large painful cysts.

 

Lupron is a synthetic hormone that is said to act on this process by

suppressing the ovaries and is supposed to temporarily interrupt

estrogen output. This creates a drug-induced menopause. The goal of

treatment is to shrink any lesions produced via endometriosis.

 

Many women with endometriosis who are given Lupron injections have

horrendous side-effects, including cardiac arrythmias, dizziness,

swelling, chest pain, depression and confusion, bone pain, extreme

fatigue, vision loss, high blood pressure, and nausea. Some of the

women claim their side-effects last long after treatment is

completed.

 

TAP says its product is safe and that the normal function of the

pituitary-gonadal system is usually restored within three months

after Lupron injections are discontinued. The FDA agrees with the

company.

 

It's fine for TAP to say their product is safe, but quite another to

produce evidence on the basis of well-controlled long-term research

that the pituitary-gonadal system is not altered in any way by

Lupron.

 

Meanwhile, IVF doctors often use the very same drug — Lupron —for the

treatment of infertility, an unapproved indication.

 

Usually Lupron injections are begun approximately one week after

ovulation. The idea is to suppress female hormones that normally can

produce one mature egg. Shutting off the body's production of

hormones enables the IVF doctors to use hormonal preparations that

can lead to multiple egg development.

 

Fine, but where's the solid science on safety and efficacy?

 

Other Unapproved Uses Of Lupron

 

 

 

 

 

 

 

FALSE PROMISES, IGNORANCE AND FAST-PACED MEDICINE

A Doctor Speaks Out Against Lupron

 

By Nicholas Regush

 

February 2, 2002 - In this week's edition of redflagsweekly.com's

ongoing investigation of Lupron, a prominent surgeon speaks out

plainly about what he believes is wrong with Lupron, and, indeed,

broadens the scope of issues that touch on the drug's safety and

efficacy.

 

Our approach in publishing these reports is to provide one small

slice of the big picture each week, gradually extending the scope of

the investigation to include all players - such as more of the women

and some of the men who take Lupron for different medical conditions,

the manufacturer (Tap Pharmaceuticals, Inc.), the U.S. Food and Drug

Administration, the professional medical societies, and advocates and

other critics of the drug.

 

As is the case in any complex medical story, there are many

viewpoints and levels of argument and many will be represented in

this series. First and foremost, however, redflagsweekly.com has been

digging into the bottom line - the science behind Lupron. This will

become increasingly apparent as our segments continue.

 

" They feel their doctors have lied to them and they are angry and

disappointed. "

 

This is Dr. David Redwine's assessment of the predicament of some of

the patients that end up at his endometriosis treatment program at

the 181-bed St. Charles Medical Center in Bend, Oregon.

 

" Most of them have been on Lupron or other therapies, " he told

redflagsweekly.com this week in a long phone interview. " The stories

I hear from my endometriosis patients is that they were told Lupron

would take care of their problems - and it has not. "

 

A " minority " of the several thousand patients he has seen from the

U.S., Canada and Europe have lingering symptoms after taking Lupron,

including memory loss, severe joint pain, and emotional upheaval.

 

But he says that it is difficult to determine any real numbers

because " so many women are not getting the proper treatment for

endometriosis and are poorly followed by their doctors. "

 

Redwine, an ObGyn, has pioneered several diagnostic and treatment

approaches to endometriosis, and uses surgery to remove diseased

tissue.

 

According to Redwine, endometriosis patients, including those on

Lupron, get a raw deal in several ways:

 

To begin with, patients are sometimes misdiagnosed.

There is inadequate determination if a particular therapy, including

Lupron, is

achieving results.

There is inadequate long-term care and what happens to the patients

later is unclear.

" The typical ObGyn gives the drug because it's the easiest thing to

do and there is often just not enough time to do much else after

diagnosis, " Redwine said.

 

Endometriosis is a condition in which pieces of the lining of the

uterus are found in other parts of the body, especially in the pelvic

cavity. These pieces of endometrium respond to the menstrual cycle

and bleed.

 

Because the blood cannot escape, it builds up and causes the

development of small or large painful cysts.

 

Lupron, a synthetic hormone-like drug is supposed to temporarily

interrupt estrogen output. Hence, a drug-induced menopause.

 

The goal of treatment is to shrink any lesions produced via

endometriosis.

 

The problem is that there are conditions that mimic the pain of

endometriosis, such as fibroid tumors, chronic inflammation,

adhesions and cysts.

 

" There is a lack of studies that use biopsies to ensure that the

patients actually have endometriosis, " Redwine said. " This makes no

sense. "

 

Lack of biopsy control in studies, which sets the tone for everyday

diagnosis in the doctor's office, also makes it " extremely difficult

to determine whether the lesions have been eradicated. It's not

enough to use laparoscopy to view whether lesions have disappeared.

This can lead to false conclusions. "

 

And since there is little or no followup of many patients, you have

to wonder what happens to them. How many require surgery later? How

many have persistent endometriosis? How many have enduring side-

effects?

 

Redwine believes that while Lupron can treat the pain of

endometriosis, " albeit temporarily, " it has been his experience that

Lupron does not treat the disease effectively over time. " It just

doesn't do it, " he said. " My experience tells me that I'm right. "

 

And he added:

" There are thousands of women from around the world coming to a small

town in Oregon. Why? "

 

NEXT: WHAT DOES THE SCIENCE SAY ABOUT THE SAFETY OF LUPRON?

 

 

 

 

 

 

 

ARE PERSISTENT LUPRON-RELATED SIDE-EFFECTS DUE TO A MALFUNCTIONING

PITUITARY GLAND?

 

By Nicholas Regush

 

 

In our continuing long-term investigation of Lupron and its use in

the treatment of endometriosis and a wide range of other conditions,

from time to time, we shall provide you with a preliminary report on

an issue that we think is important. For example, it appears to us

after consultation with experts and a review of the medical

literature that a malfunctioning pituitary gland may be involved in

some of the persistent symptoms so many women claim to suffer after

ending Lupron therapy for endometriosis.

 

Therefore, consider some of the following issues we are pursuing and

the questions we believe need to be asked about Lupron and its

potential impact on women being treated for endometriosis, a

condition in which pieces of the lining of the uterus are found in

other parts of the body, especially in the pelvic cavity. These

pieces of endometrium respond to the menstrual cycle and bleed.

Because the blood cannot escape, it builds up and causes the

development of small or large painful cysts.

 

The pituitary, shaped like a bean, weighing less than a gram and

lying below the brain in the skull, is the " master gland. " IT AFFECTS

EVERY FUNCTION IN THE BODY.

 

Lupron suppresses the pituitary-gonadal system. This synthetic

hormone-like drug is used to temporarily interrupt estrogen output.

Hence, a drug-induced menopause. The idea is to reduce pain and

shrink lesions produced via endometriosis.

 

In the package insert for Lupron, which is made by TAP

Pharmaceuticals Inc., the claim is made that normal function of the

pituitary-gonadal system is " usually restored within three months

after treatment is discontinued. " Itís also made clear

that " diagnostic tests of pituitary gonadotropic and gonadal

functions conducted during treatment and for up to three months after

discontinuation of Lupron Depot may be misleading. " In other words, a

clear picture of, say, POTENTIALLY NORMALIZED pituitary functioning,

will likely be possible ONLY three months after stopping Lupron.

 

The package insert also indicates that patients have been treated

with lupron for up to three years with doses as high as 10 mg/day and

for two years with doses as high as 20 mg/day without demonstrable

pituitary abnormalities.

 

The problem is this: Most studies focused on Lupron and endometriosis

have been very small. Just how much testing and long-term follow-up

has been done to determine if there is pituitary dysfunction? The

answer? Very little. And meanwhile lupron is widely used for the

treatment of endometriosis.

 

With long-term studies missing, the obvious question is: just how

many women who were ill when they started taking Lupron did not have

the capacity to reverse the effects of Lupron treatment - in other

words, to get back the full capacity of the pituitary.

 

There are some leads that researchers must follow. Common symptoms of

pituitary disorders include irregular menses, sexual dysfunction,

infertility, changes in physical appearance, and unexplained mood

changes. These are the types of complaints some women have after

stopping Lupron.

 

There is also no research to determine whether Lupron

treatment " sticks. " That is, does Lupron continue to affect certain

receptors in the body, once treatment has stopped? Can Lupron

continue to have an effect in certain susceptible women?

 

 

 

 

LIVING HELL

Women Speak Out About Lupron

 

By Nicholas Regush

 

January 26, 2002 - Last week, we published a preview of a few of the

issues that we are examining in our investigation of Lupron. This

drug, made by TAP Pharmaceuticals Inc, a joint venture of Abbott

Laboratories and Takeda Chemical Industries of Japan, is used

commonly in the treatment of endometriosis (among numerous other

purposes), a condition in which pieces of the lining of the uterus

are found in other parts of the body, especially in the pelvic

cavity. These pieces of endometriuim respond to the menstrual cycle

and bleed. Because the blood cannot escape, it builds up and causes

the development of small or large painful cysts. Lupron, a synthetic

hormone-like substance, acts on this process by suppressing the

ovaries and is supposed to temporarily interrupt estrogen output.

Hence a drug-induced menopause. The goal of treatment is to shrink

any lesions produced via endometriosis.

 

In this edition of redflagsweekly.com, we present the stories of

several women diagnosed with endometriosis who say they have suffered

severely since taking Lupron. They have complicated medical

histories. Here is the essence of what they have experienced since

their Lupron injections. Later in our series, we shall deal with some

of these and other case examples in greater depth as they pertain to

key issues surrounding Lupron, particularly its safety.

 

Paulette Wilson, Age 41

 

Paulette was diagnosed with endometriosis in 1996. Her doctor

prescribed two monthly injections of Lupron.

 

" I was okay after the first month, but after the second shot I woke

up with chest pain and needed to go to the emergency room. "

 

She was told she had " reflux disease, " a gastrointestinal

disorder. " I never had any problem like that before, " she said. " I

was given a wide variety of medications but had no relief at all. "

 

In just one month, she lost forty pounds. " Tests showed that I had

acid burns from my esophagus to my rectum. " "

 

Her pain and discomfort was accompanied by suicidal feelings. " My

doctor told me that I was depressed. "

 

And there has been no shortage of prescriptions for antidepressants.

 

Paulette now lives with severe pain, which sometimes affects her

entire body. " I've seen forty doctors and only one has suggested that

Lupron might have done something to me. "

 

Her current diagnosis is fibromyalgia, which is essentially a chronic

and systemic pain condition.

 

Lisa Plante, Age 45

 

Lisa was diagnosed with endometriosis in the mid-1990s and given

several monthly injections of Lupron.

 

" I had been dealing with abdominal pain for ten years and was told

constantly that it was due to irritable bowel syndrome, " she

said. " But I finally found a doctor who concluded - wrongly I learned

later - that it was likely endometriosis. "

 

Lisa was told that any side-effects associated with Lupron would

likely go away after her injections ended. " He said it would be no

big deal. "

 

A few hours after the first injection of lupron, she developed

unbearable bone pain.

 

Her doctor gave her some hormone treatment, which helped a little,

and she carried on with her program of injections.

 

But after the third shot, she could not handle the pain any longer

and had surgery to remove an ovary.

 

Now six years after receiving Lupron shots, she still suffers

symptoms, such as bone and joint pain, extreme fatigue, vision loss

and confusion.

 

" I sometimes get lost in my housework. I have to try to remember what

I'm doing. And when I'm in the car at a street light, I sometimes

have trouble thinking about what a particular color means. "

 

Lisa has been told by doctors that she is stressed or is suffering

from fibromyalgia.

 

" Doctors tell me that I'm an aging woman and that I'm having hormone

problems, but no one wants to explore the possibility that Lupron did

something to me. "

 

Irene Rybicki, Age 40

 

Irene had been living with endometriosis for years. " It was painful,

but it was manageable, " she said.

 

But when she finally decided to undergo surgery and have an ovary

removed, she was prescribed Lupron injections. No other options were

discussed.

 

" I was told that it just dries you up. "

 

Irene had a " horrendous reaction " to the injections.

 

" I couldn't sleep well, I was anxious, had hot flashes and had been

put into a semi-menopausal state. I was told it would be temporary. "

 

Irene had previously been ill with a thyroid condition. " After

Lupron, my thyroid problems got much worse. I became extremely hyper,

sleepless, couldn't eat - and in my entire life eating had never been

a problem. "

 

She asked her doctor whether the symptoms were Lupron-related. " She

told me they weren't due to Lupron. My system would get back to

normal. She told me that nothing really had gone wrong. "

 

But her condition deteriorated so much that she eventually had to

quit her job as an occupational therapist.

 

" I was experiencing joint pain, severe memory loss, which was close

to amnesia because I sometimes would have no recall of what people

told me. I had mood swings. I got depressed. I cried, even though on

the job where I dealt with people in distress, I usually could keep

my emotions under control. "

 

Her entire life came apart. A relationship ended. Friends became

invisible. She would lie in her bed day after day.

 

Finally, she read a book that focused on hormonal issues, which led

her to a doctor willing to treat her. She is now able to better

manage some of her symptoms and has returned to part-time work.

 

But she still has bad headaches and becomes exhausted very quickly.

 

Melody Hampton, Age 43

 

Here are some of the symptoms that Melody has suffered after being

treated for endometriosis with Lupron. Some continue to the present

day.

 

Tremendous headaches.

Rash.

Joint pain.

Nausea.

Heart palpitations.

High white cell count.

Low iron count.

Bone loss in two vertebrae

High blood pressure.

Blood in urine.

Atrophy of muscles.

Leg swelling.

 

This all began shortly after Melody had the first of her six Lupron

injections in 1995.

 

" After my first injection, I had a tremendous headache and rash, but

my obgyn said it wasn't Lupron. But when it kept happening after each

injection, my family doctor thought it might be Lyme Disease or

Lupus, but he ruled those out. "

 

Instead, her doctor classified Melody's condition as " unidentified

autoimmune disease. "

 

He too said it didn't have anything to do with Lupron because Lupron

didn't cause those kinds of things.

 

Melody now sees a rheumatologist who dismisses the idea that Lupron

may have triggered a damaging process in her body.

 

More than six years after receiving Lupron injections, Melody says

that, " at 43, I often feel like 93. "

 

 

 

 

Lynne's Story: A Preamble To RFW's Lupron Investigation

 

By Nicholas Regush

 

January 19, 2002 - This particular saga began a decade ago with

injections of a powerful prescription drug called Lupron. Lynne

Millican took the shot for endometriosis, a condition in which pieces

of the lining of the uterus are found in other parts of the body,

especially in the pelvic cavity.

 

Ten years later, Millican believes she is still suffering from the

effects of those injections. Her many symptoms have included the

development of a noncancerous tumor, breast cysts, cardiac

arrythmias, dizziness, swelling and fatigue.

 

Millican is a registered nurse (and paralegal) living in the Boston

area who has become deeply involved in a grass-roots movement to

force the U.S. Food and Drug Administration (FDA), and Members of

Congress to take a close look at Lupron.

 

The FDA first approved Lupron in 1985 for treatment of men with

advanced prostate cancer, and then approved it for treatment of

endometriosis in 1990 and, in 1995, for the pre-operative treatment

of anemia resulting from heavy bleeding associated with fibroids.

 

" There are thousands in the United States who say they have been

victimized by this drug, " Millican said, emphasizing that symptoms

can be severe, such as tremors, seizures and memory loss.

 

" Many women I know say their symptoms didn't stop when they stopped

taking the drug. "

 

The FDA has received a wide range of reports of serious side-effects,

including death, suspected to be associated with the use of Lupron,

but the agency, which holds that the drug's benefits outweigh the

risks, does not believe there is sufficient proof to blame Lupron.

 

TAP Pharmaceuticals Inc., jointly owned by Abbott Laboratories and

Takeda Chemical Industries of Japan, has steadfastly maintained that

Lupron is safe.

 

Millican, who feels that the FDA has been very slow on the draw with

Lupron, is also frustrated by the lack of response from almost all of

the many senators and representatives in Congress to whom she has

written. She has even submitted written testimony to various

committee hearings - but to no avail.

 

" It seems that no one but the people who suffer from Lupron are

interested in looking into this drug, " she said.

 

Millican cannot even recall anyone with an MD degree who has voiced

strong concern about Lupron.

 

At the very least, she feels Lupron's safety should be an issue

because doctors use it for purposes that were never approved by the

FDA. While legal under federal law - once approved for an indication,

a drug can be used for other purposes - unapproved use often occurs

without the benefit of appropriate safety and efficacy studies.

 

One of Millican's main concerns is Lupron's unapproved use in

fertility clinics. The drug is essentially used to suppress female

hormones which produce a mature egg. This allows fertility doctors to

then induce " controlled " stimulation of multiple eggs.

 

" I am concerned that women who undergo these procedures are not being

sufficiently informed about Lupron's side-effects, " Millican said.

 

There is even much more at stake, according to Millican. On September

5, she provided testimony to congressional committee hearings on stem

cell research, pointing out that the use of Lupron in the process of

creating embryos may cause " the very diseases that are being claimed

as those diseases necessitating embryonic stem cell research for a

cure. "

 

Millican finds it hard to swallow that the debate over stem cell

research has totally ignored Lupron.

 

Next Week: Part One of RFW's Lupron Investigation