NEW MEDICAL ALTERNATIVES FOR MENOPAUSE
MANAGEMENT ON THE HEALTH CARE HORIZON
By Cheryl D. Munson, CMunson
Creative Solutions, Writer/Producer
TESTING OF SEVERAL PHARMACEUTICAL ALTERNATIVES
UNDERWAY NOW AT THE ATLANTA RESEARCH CENTER
ATLANTA, GA - Until late July of this year, the 38 million
American women who regularly use hormone replacement therapy (HRT)
for relief of menopausal symptoms or as a means of preventing common
chronic diseases such as heart disease and osteoporosis, were shaken
to learn the results of a major new study. The findings forced them
to revisit a problem they thought they had finally resolved.
The
National Institute of Health (NIH) halted The Women’s Health
Initiative (WHI) study prematurely when they found that the use of
HRT by postmenopausal women resulted in an increased rate of breast
cancer, heart attacks, strokes, and blood clots.
HRT
means taking a combination of two female hormones, estrogen and
progesterone.
Now,
with the abandonment of HRT, many women nationwide are forced to
make a choice on just how to deal with menopause, again. Some have
elected to continue using hormone replacement therapy medications
despite reported and documented risks. Some have decided to switch
to so-called natural, soy-based alternatives. Many women have made
no choice at all for hormone replacement therapy and literally
continue to sweat it out.
Much
attention is given to the largely discomforting symptoms of
menopause – hot flashes, night sweats, emotional mood swings, and
overall lack of energy. Yet while HRT was abandoned by the NIH
because of its potential risks – an additional, extremely high risk
looms for “pre” and post-menopausal women alike: developing
osteoporosis. Physicians and health care providers the world over
agree that osteoporosis is a real “culprit” of menopause. They also
agree that using estrogen can help prevent osteoporosis.
Osteoporosis is a bone weakening disease effecting one out of three
Atlanta women after age 50. Osteoporosis is known as the silent
killer because most people don’t even know they have it until they
break or fracture a bone, or begin to notice a loss in height.
NEW HRT AND OSTEOPOROSIS HELP IS ON THE HEALTH
CARE HORIZON
According to the Dr. Grattan Woodson, Medical Director of the
Atlanta Research Center (ARC), “New help for postmenopausal women
concerned about traditional HRT is less than four years away. Right
now, we’re conducting clinical trials on several highly promising
new drugs that look useful for preventing the loss of bone density
due to osteoporosis. We are also testing a new combination of drugs
for treatment of hot flushes and other discomforts of menopause.
Our hope is that they will reduce or eliminate many of the risks of
HRT discovered in the WHI study while repeating all the benefits”.
One
of the new pharmaceutical agents being tested at the ARC and around
the US and in Europe acts like estrogen is some areas of the body
while blocking it in others.
“This
new drug is in a class called SERMs, which stands for Selective
Estrogen Receptor Modulator.” say Dr., Woodson. “While all SERMs
differ in effect, the one we are testing currently prevents loss of
bone and lowers the “bad” LDL cholesterol. We expect these aspects
of the drug will translate into prevention of osteoporosis and heart
disease. What is exciting to me about this drug is that it also
blocks estrogen in the breast and uterus, an effect that has been
found in other SERMs and one that is associated with a big, 44-72%
reduction in the risk of developing breast cancer”.
THE FUTURE HRT AND OSTEOPOROSIS CURE BEGINS
RIGHT HERE AT HOME
The
Atlanta Research Center conducts Phase III clinical research studies
on therapies for women’s health, osteoporosis, and arthritis. Phase
III trials are typically the last step before a pharmaceutical
company files for Food and Drug Administration (FDA) approval. Once
obtained, the medication then becomes available by prescription.
The
Atlanta Research Center is one of the most sought-after and highly
recognized research facilities in the United States. The ARC is the
leading osteoporosis research center in the Atlanta area and
currently has studies on six different osteoporosis research
protocols underway.
“In
one of our studies, we are combining low doses of estrogen with our
new SERM. The goal of this study is to see if this novel
combination will allow us to reap the benefits of estrogen on
symptoms like hot flushes and osteoporosis and colon cancer
prevention while at the same time garnering the positive actions of
the SERM like breast and uterine cancer prevention” says Woodson.
ATLANTA WOMEN PLAY A VITAL ROLE IN FINDING AN
ALTERNATIVE TO TRADITIONAL HRT FOR MENOPAUSE SYMPTOMS AND
OSTEOPOROSIS PREVENTION
Should ARC’s new SERM receive FDA approval, thanks will be due to
over 100 Atlanta area women who are serving as research
volunteers. These women are now participating in one of several
mulit-year clinical research trials at the Atlanta Research Center.
They will participate in the studies until 2005.
The
Atlanta Research Center began its recruitment efforts for Phase III
clinical trials on its new SERM in July of 2001. Emily Kuhnmuench,
Clinical Research Coordinator at ARC is responsible for recruiting
new research patients. “We’re striving to reach our total study
participant goals by early 2003” says Kuhnmuench. “Our phone call
volume picked up dramatically after the NIH suddenly ended the WHI
study on HRT” reports Kuhnmuench, but we are always looking for and
in need of more Atlanta volunteers. There’s a big need.”
The
Atlanta Research Center makes announcements about current and
upcoming clinical trial studies on local television and by letter to
present and prior participants. Kuhnmuench interviews all potential
volunteers and conducts a general health questionnaire with them by
telephone.
If
the volunteer is eligible for the study, they are invited to come to
the Atlanta Research Center for a formal screening visit. At that
time, the full spectrum of risks and benefits for participating in
the clinical trial are disclosed to volunteers. This important step
in recruitment is referred to as informed consent.
After
the volunteer consents to participate in the research study, several
tests and examinations are performed to confirm they have the
condition the study focuses on, and most importantly, to insure the
volunteer does not have any medical problem that could make it
unsafe for them to participate. Finally, those that pass the
battery of tests are then randomly placed into one of several
treatment groups.
“While we still include placebos or “sugar pills” for some of the
patients in our studies, today most of the patients, 75% plus,
receive an active treatment” say Jennifer Elston, Assistance
Clinical Research Coordinator at the Atlanta Research Center.
“This
study design is called a randomized controlled trial and is the most
powerful study designs used in human research,” says Dr. Woodson.
In addition to random treatment assignment and the use of placebos,
no one knows, not even the Atlanta Research Center staff members,
whether a participant is receiving actual medication or a placebo.
This feature of the research trial is known as being “double
blind.”
The
present roster of osteoporosis research studies being conducted at
the ARC are expected to conclude between 2005 and 2007 according to
Paula Thompson, LPN, and ARC Clinical Research Coordinator. “During
this time period, the patients participating in these studies will
receive extensive medical testing, including physical exams,
gynecological tests and examinations, mammograms, many laboratory
assessments, and overall monitoring of their general health and
safety” Thompson says.
VOLUNTEER RECRUITMENT: AN ONGOING CHALLENGE
“Recruiting volunteers to participate in research poses ongoing
challenges. The sponsoring pharmaceutical companies,
understandably, have extremely stringent criteria for who can and
cannot participate in clinical trials. Achieving the required
number of participants for a study can take anywhere from 3 to 18
months, “said Jennifer Elson, Assistant Clinical Research
Coordinator at ARC.
Another important recruitment challenge is getting a volunteer
participant “population” that reflects racial diversity in order to
determine whether there are any adverse risks, and higher or lower
effectiveness traits specific to racial make-up. The Atlanta
Research Center reports that recruiting African Americans for
clinical trial studies has been specifically difficult.
Atlanta Research Center Medical Director, Dr. Woodson says, “I view
volunteering for medical clinical trial research studies as the
ultimate selfless act. It enables you to truly be instrumental, and
directly contribute to improving, extending and saving lives for
generations now – and generations next.”
COMING SOON TO A MEDICINE CABINET NEAR YOU
The
Atlanta Research Center projects that the final verdict on their new
SERM will be in by 2006. Some of the other advanced products being
tested will not undergo final assessment by the FDA until 2008.
Should these drugs receive final FDA approval, women the world over
will at long last have a medication to improve their quality of life
after menopause and reduce the debilitating and life threatening
effects of osteoporosis. Whether the women who stand to benefit
from these promising new investigational drugs, or for that matter
any new drug, have ever even visited Atlanta or even know where it
is on a map, they’ll owe a great deal of thanks to the hundreds of
Atlanta women who donate their time and effort by making the
sacrifice to be a research volunteer.
THE
ATLANTA RESEARCH CENTER is one of the most sought-after and highly
recognized clinical trial research facilities in the United States.
The center focuses on investigational drug therapies for common
chronic diseases affecting adults, with an emphasis on new drugs for
the prevention and treatment of osteoporosis, arthritis, menopause
and cardiovascular diseases. |
