and her mom, Jackie, answered questions in an online Guest Chat
Wednesday, February 16, 2005 in the
Sam was born with Cyclical Cushing's Syndrome on
March 22nd 1999 and is thought to be perhaps the ONLY child in medical
literature born with Cyclical Cushing's Syndrome.
The Discovery Health Channel aired Sam's
show, Mystery Diagnosis, Mon. Nov. 15, 2004 with several repeat
performances. This show was the first in a series called Diseases Doctors Miss.
Every year, millions of Americans fall prey to ailments that go undiagnosed or
misdiagnosed. Medical professionals struggle to understand their baffling
The next reruns will be Mar 07 2005,
10:00 PM EST; Mar 08 2005, 01:00 AM EST; Mar 11 2005, 05:00 AM EST; Mar 13 2005,
07:00 PM EST.
Sam's story was also presented by
Dr. Stratakis in Grand Rounds at Seattle Children's Hospital
November 18, 2004.
Read Sam's Bio. It's a
truly amazing story about what one determined Mom can do for her child.
The NIH (National Institutes of Health)
made a poster of Sam's rare case in Adobe PDF format. If you don't have that,
you'll be prompted to add the Adobe program to your computer to view this file.
You can view Sam's NIH poster here.
The transcript is available at
Cushing's Awareness Day. We are currently petitioning to
have April 8 be declared as Cushing's Awareness day. This date was chosen
because it was Dr. Harvey Cushing's Birthday.
Print out a sample letter
to send to your congress person or senator or download it in
See what Jayne has done! She wrote to her
representative and she's now in the
Congressional Record. She has her first response and it's a fantastic one!
A new Message Board area has been added to discuss ideas for
making Cushing's Awareness Day a reality. Please do what you can to help
the cause! Thank you for helping to make this
Cushing's Awareness Day a reality!
welcome your articles, letters to the editor, bios and Cushing's
Submit a Story or Article to either the snailmail CUSH Newsletter or to
an upcoming email newsletter at
These articles are provided in furtherance of the mission of
Cushing's Help and Support to help people with Cushing's or other endocrine
problems, their friends and families through research, education, support,
and advocacy. These news items are intended to serve as background
concerning its subject for patient-physician discussions and discussions
Cushing's Help and Support Message Board Members.
These articles contain
information by authors and publishers that is subject to the Copyright Act
of 1976, and "fair use doctrine" therein, effective on January 1, 1978 (17
U.S.C. § 101 et seq.). Cushing's Help and Support makes no representation
that the information and any of the views or comments contained in these
articles are completely accurate or current. Cushing's Help and Support
takes no responsibility for any of the content.
of Health and Human Services
|Public Health Service
Food and Drug Administration
Los Angeles District
Irvine, CA 92612-2506
August 19, 2004
RETURN RECEIPT REQUESTED
Mr. Stephen Cheng, President
Window Rock Enterprises, Inc.
601 Valencia Ave., Suite 150
Brea, CA 92823
Dear Mr. Cheng:
The U.S. Food and Drug Administration (FDA) conducted an inspection of
your firm, Window Rock Enterprises, Inc., located at 601 Valencia Avenue,
Suite 150, Brea, CA 92823, on April 5th and April 7th, 2004. During this
inspection, you provided our investigator with the following promotional
materials for your product CortiSlim, which are shipped to customers with
- CortiSlim Brochure
- CortiSlim Information Sheet (includes supplement facts, ingredients,
and directions for use)
- Cortisol Stress Test
- CortiSlim Instant Savings and Money Back Guarantee Certificate
- CortiSlim Quick Start Guide
Our investigator also collected information, including copies of
scientific research and studies, you provided to substantiate the claims
made for your product CortiSlim. In addition, after our inspection of your
firm, we reviewed labeling for CortiSlim on your website at http://www.cortislim.com.
A review of your labeling for CortiSlim, including the promotional
materials listed above, indicates serious violations of the Federal Food,
Drug, and Cosmetic Act (the Act) (21 U.S.C. 321 et seq.). Specifically, we
have determined that your CortiSlim product is misbranded under sections
403(r)(6)(B) and 403(a)(1) of the Act (21 U.S.C. 343(r)(6)(B); 343(a)(1))
because the product’s labeling includes unsubstantiated claims. Under the
Act, as amended by the Dietary Supplement Health and Education Act, dietary
supplements may be legally marketed with claims to affect the structure or
function of the body (structure/function claims), if certain requirements
are met (21 U.S.C. 343(r)(6); 21 C.F.R. 101.93(g)). The manufacturer of a
dietary supplement containing a "structure/function" claim in the product’s
labeling must have substantiation that the claim is truthful and not
misleading (see 21 U.S.C. 343(r)(6)(B)). You can find the Act and FDA
regulations on the Internet through links on FDA’s web page: www.fda.gov.
Examples of some of the structure/function claims made in the labeling
for your CortiSlim product include:
- CortiSlim Product Label: "Eliminate Cravings," "Controls Appetite"
- CortiSlim Brochure: "Ease ‘stress eating,"’ "Suppresses appetite,"
"Burn calories more efficiently and naturally through thermogenesis,"
"Controls cortisol levels within a healthy range, " "control appetite,"
- CortiSlim Quick Start Guide: "curb appetite and cravings," "weight
- CortiSlim Instant Savings and Money Back Guarantee Certificate: "lose
weight," "reduce cravings for carbohydrates and sweets, " "take the edge
off your appetite," "enhance metabolism through thermogenesis"
- Cortisol Stress Test: "cravings for sweets and carbohydrates will
- Under "The SENSE Program," Exercise topic section: "appetite
- Under the "Ingredients" section: "controls cortisol levels within
healthy range and help[s] you lose weight," "control appetite," "helps
to reduce cravings"
- Under the "FAQ (frequently asked questions)" section: "reduce
cravings," "Appetite and craving control," "weight loss," "control
- Under the "User Guide" section: "curb appetite and cravings
We have reviewed these claims, along with the substantiation package you
provided, and concluded that they are not supported by reliable scientific
evidence. Because these claims lack substantiation, they are false or
misleading, and cause your product to be misbranded within the meaning of
section 403(a)(1) and 403(r)(6)(B) of the Act. It is a violation of section
301(a) of the Act (21 U.S.C. 331(a)) to introduce or deliver for
introduction into interstate commerce any food, including a dietary
supplement, that is misbranded.
This letter is not intended to provide an all-inclusive list of
violations concerning your firm and its products. You are responsible for
ensuring that all products marketed by your firm comply with applicable
United States laws, including the Act and its implementing regulations.
We request that you take prompt action to correct these violations.
Failure to promptly correct violations may result in enforcement action
being initiated by FDA without further notice. The Act provides for seizure
of illegal products and for an injunction against the manufacturer and/or
distributor of illegal products.
You must notify this office, within fifteen (15) working days of the
receipt of this letter, of the specific steps you have taken to correct the
noted violations. Copies of the revised labeling for CortiSlim should also
be submitted. If corrective action cannot be completed within 15 working
days, state the reason(s) for delay and the time at which the corrections
will be completed.
During the April 2004 inspection, you provided our investigator with
information to substantiate the following claims for CortiSlim:
- "supports healthy cortisol levels"
- "supports weight maintenance efforts"
Although these claims do not appear to be used in your current labeling
for CortiSlim, we have reviewed them because they were referred to in your
substantiation package. Based on the information provided in your
substantiation package, we conclude that these claims are not supported by
reliable scientific evidence. Unless you have additional information that
would adequately substantiate these claims, any present or future use of
such claims in the CortiSlim labeling would misbrand your product under
sections 403(r)(6)(B) and 403(a)(1) of the Act.
Your written reply should be addressed to Compliance Officer John Stamp
at the above address.
Alonza E. Cruse
This page was posted on September 15, 2004.
Polycystic ovarian syndrome is a treatable condition
Date published: 2/20/2005
DO YOU sometimes go months at a time without having a period only to fear
that you're bleeding to death once it finally starts? Are you doing all the
right things to lose weight, but the weight just won't come off--in fact,
you're gaining weight?
Have you noticed hair growth in places where women just aren't supposed to
have hair? Have you had trouble getting pregnant?
If you answered yes to any of these questions, you may have polycystic
PCOS is a common condition affecting approximately 5 percent of all
pre-menopausal women. Although the exact cause of PCOS is not fully
understood, insulin resistance and over-secretion of androgens (male
hormones) are important factors.
When we eat carbohydrates, our pancreas secretes a substance called insulin,
which allows our cells to use the glucose in our food. Some people's cells
are resistant to insulin, so the glucose isn't absorbed as well. The
pancreas responds by secreting more insulin, and blood levels of this
important hormone rise.
Among other things, this overabundance of insulin affects the ovaries,
causing them to secrete excessive amounts of androgens--which leads to
abnormal hair growth and anovulation (the failure of the ovaries to release
an egg on a regular schedule). That then leads to irregular periods and
PCOS can be diagnosed by symptoms alone, but sometimes laboratory studies
are necessary to make or confirm the diagnosis, and to rule out conditions
that can have similar symptoms.
For an overweight woman with infrequent periods and hair on her chest,
there's a good chance that PCOS is the problem. However, the diagnosis is a
bit trickier in a woman of normal weight with no abnormal hair growth.
The work-up of women with suspected PCOS includes lab tests to rule out
tumors, adrenal gland and pituitary problems. It's also important to
commence routine screening for associated conditions such as high blood
pressure, diabetes and elevated cholesterol. A pelvic ultrasound also may be
Once the diagnosis is made, one of the best and longest-lasting treatments
in those who are overweight is weight loss. This can be difficult because
insulin promotes weight gain, but it's not impossible.
Lower-carbohydrate diets are often more effective than lower-fat diets.
Also, simple sugars should be avoided; instead, opt for complex
carbohydrates such as whole grains.
Among the medications that are helpful in alleviating the symptoms and
physical signs of PCOS are: the birth control pill/patch/ring; drugs
commonly used for diabetes such as metformin; and a host of medications
aimed at reducing abnormal hair growth.
For those women trying to get pregnant, medications to induce ovulation are
Women with PCOS are at higher risk for endometrial cancer (cancer of the
lining of the uterus) so it's important for them to have periods, which can
be induced using birth control.
The higher cancer risk stems from anovulation, which leads to a secretion of
estrogen without a counteracting secretion of progesterone. This is called
It stimulates the endometrium, which is the lining of the uterus, and the
part that partially sloughs off during a period. If there is no progesterone
around to counteract the estrogen, then the endometrium is under continual
stimulation, and this can lead to endometrial cancer.
The missed periods, infertility, hair growth and weight gain of PCOS can be
very unnerving. If you happen to recognize yourself in this description,
don't fret--you're not turning into a hairy, overweight man. It's infinitely
more likely that you have PCOS, and effective treatments are available.
DR. ARLENE LEWIS welcomes reader comments and questions. She can be reached
by writing at Free Lance-Star, 616 Amelia St., Fredericksburg, Va., 22401 or
by e-mail at
Date published: 2/20/2005
Despite teen’s surgery ‘She still is our Zannah’
By SHERRI CONER
Daily Journal staff writer
Feb. 16, 2005
Health problems prevent Zannah Harbert, 18, from sprinting along the fast
track like most high school seniors.
But Harbert’s ability to jog along at her own pace, despite the setbacks,
keeps her goals intact and her attitude positive.
When she was a youngster, Harbert’s parents, Ed and Nancy Harbert of White
River Township, noticed their second child did not appear to be growing
At age 4, Harbert weighed only 29 pounds. By the time she was 9, she was
experiencing headaches and peripheral blindness. And she was still much
shorter than other children.
Hospital tests discovered a non-cancerous tumor wedged near Harbert’s optic
nerve and pituitary gland. Doctors at Riley Hospital for Children monitored
the growth of the tumor, hoping to delay brain surgery as long as possible.
But when Harbert was in eighth grade, surgery loomed in her future.
"That year, for unknown reasons, the tumor doubled in size and was causing
significant blindness," her father, Ed Harbert, says. "There had to be
relief. And Zannah adamantly wanted it out."
In March 2001, Zannah Harbert was wheeled into surgery.
Knowing that brain surgery might affect their daughter’s personality, the
family prayed for a specific result, Nancy Harbert says. "We prayed so hard
that she would just be our Zannah," her mother says. "That she would still
be who she is: kind, sweet and loving."
As she looks across the living room at her second daughter, Nancy Harbert
smiles and says, "And she still is our Zannah."
Not long after Zannah Harbert was discharged from the hospital, she was
readmitted with complications. Though her pituitary gland was left intact
after the surgery, it was no longer functioning.
While other kids her age made summer plans and shopped for a high school
wardrobe, Harbert’s life now included a pediatric neurosurgeon, an
endocrinologist, a neuro-ophthalmologist and a health issue she would likely
struggle with for the rest of her life.
When the pituitary gland no longer functions correctly, various other bodily
functions are affected. So Harbert is dependent on daily medications. She
also has very low resistance to bacterial infections. She developed diabetes
and battles chronic fatigue.
Frequent absences kept their daughter from enjoying her freshman year of
high school, Nancy Harbert says. Instead of attending classes, Zannah
Harbert received tutoring at home.
Her high school experience, overall, has been riddled with frequent
illnesses. Her free time is limited. She requires a lot of extra time to
muster the energy to complete homework assignments.
But her parents are more worried about that lost time than she is, Harbert
"Even though I am home a lot, I still have friends who come by and see me,"
Harbert says with a smile. "I still have to work pretty hard to get the good
grades. I still struggle with being tired. And I’m absent more than other
Medications to offset the lack of a pituitary gland caused Harbert to gain
weight. And she takes that side effect in stride. She prefers to focus on
the success of ingesting an oral growth hormone, which added nine inches to
"I’m 4 foot, 11 inches and a hair," Harbert says with a laugh.
Faith helps her deal with day-to-day challenges, Harbert says.
"And I have a lot of people praying for me," she adds.
Right now, Harbert is not sure where she would like to attend college next
fall. But she says she does feel ready to move away from home. And she is
fairly certain that nursing will be her field of study.
"I think I would be able to connect with my patients quite well," she says.
Hypothyroid condition requires medication
Q. Please address weight and women with hypothyroid condition. Twice
I've gone on hypothyroid medicine and then gained weight. I'm 60, eat less
than ever (both types and portions of food), work out with weights two to
three times per week, walk on a treadmill and take vitamins. The weight just
creeps upward. Others must have the same frustrations.
A: Satirist Ambrose Bierce defined "patience" as "A minor form of
despair, disguised as a virtue." Dealing with thyroid problems requires
patience in spades.
The thyroid gland looks like a butterfly sitting on the front of the
windpipe. It pumps out the hormones, which affect cell growth, development
and metabolism. This means that virtually every organ in the body can be
affected if it is malfunctioning. "The thyroid is like a battery. It charges
up all the other organs," says Barbara Glass, executive director of the
Thyroid Society for Education and Research. "If it runs too low or too high,
it throws off the entire body." Left untreated, a wonky thyroid can cause
high cholesterol, heart disease, osteoporosis and infertility.
One in 10 women over 40 have undiagnosed thyroid disorder and are five to
eight times more likely than men to have a thyroid problem. If you start
feeling unusually exhausted, suddenly start gaining or losing weight, feel
depressed, become mentally foggy, start losing hair, begin having vision
problems, have chronically cold hands and feet, an irregular heartbeat or
changes in your menstrual cycle, do not assume it is menopause. Instead, go
to your physician and request two simple blood tests: thyroid-stimulating
hormone (TSH) and free-T4 to see if your thyroid is on the fritz.
The caveat with the TSH test is that "normal" range is anywhere from 0.4 to
4.4 milliunits per liter. It is recommended, therefore, that young women in
their 20s and 30s get a baseline thyroid test to determine their normal
range. Even slight changes from what is normal for you can cause problems.
If the TSH levels are too high, the pituitary gland is working overtime to
normalize the thyroid, causing hypothyroidism, which is characterized by
weight-gain, mental fogginess and sluggishness. Eighty percent of the
thyroid cases fall into this category. The opposite condition is
hyperthyroidism, characterized by bulging eyes, rapid heart rate,
nervousness and sudden weight loss. This is because hormones are
overproduced, which makes the thyroid operate on full throttle.
The solution is two-fold. First, work with your doctor to find a thyroid
medication that works for you, and then stay on it until your thyroid
becomes balanced. This may require blood work every four to six weeks; and,
it may take as long as six to eight months for your thyroid to achieve
balance. Second, exercise is very important, but only once you are balanced.
Pushing yourself too hard before you are balanced could cause harm, so stick
with light activity, no more than 40 minutes, three times a week, starting
at an easy pace.
Contrary to popular assumptions, hypothyroidism does not make anyone fat.
The fatigue and deep weariness that characterize this condition have much
more to do with weight gain than the malfunctioning thyroid.
Linda Buch is a certified personal trainer and co-author of "The
Commercial Break Workout." She will answer fitness questions in her
column but not individually. Send questions to Body Language, Bay Area
Living, 4770 Willow Road, Pleasanton, CA 94588 or e-mail her at
|To add or edit
please click here »
Helen has these auto-immune diseases: Sjögren's Syndrome, Rhuematoid Arthritis, Lupus, diabetes and Cushing's.
Upper Penisula of Michigan
1 year pituitary anniversary.
Roxi has an adrenal tumor and has had 7 surgeries within 2 years.
Susan has a tumor in each of her adrenal glands.
• If you've been diagnosed with Cushing's, please
participate in the
Cushing's Register »
The information you provide will be used to create a register
and will be shared with the medical world. It would not be used
for other purposes without your expressed permission. Note:
This information will not be sold or shared with other
Lynne Clemens, Secretary of
CUSH Org is be the
person responsible for the creation of this register. If you
have any questions you may contact her at
do not have to be a member of CUSH to fill out this
questionnaire, as long as you are a Cushing’s patient. We do not
believe that the world has an accurate accounting of Cushing’s
patients. The only way to authenticate accuracy is with actual
numbers. Your help will be appreciated. Thank you."