What's New?

February 23, 2005
To read the archives, on the Internet, please click here.

In This Issue: Happenings Site News Meetings Chat Info

Young Sam has debuted on the Discovery Health show, "Mystery Diagnosis". Sam and her mom, Jackie, answered questions in an online Guest Chat in the Cushing's Chatroom
FDA Warning Letter to CortiSlim.
Polycystic ovarian syndrome is a treatable condition.
(Pituitary) Despite teen’s surgery ‘She still is our Zannah’.
Hypothyroid condition requires medication.
Upcoming Meetings in Tampa Bay, FL, San Diego and Chicago; Local Meetings
Three new bios, one update.
Read all about them below.


Next Online Newsletter will be Wednesday, March 2
read archived issues here »
News!

SamSam and her mom, Jackie, answered questions in an online Guest Chat Wednesday, February 16, 2005 in the Cushing's Chatroom.

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 conditions.

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 http://www.cushings-help.com/transcripts/jackieandsam2-9-2005.htm.


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 Word format.

More information here

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!


News:
We welcome your articles, letters to the editor, bios and Cushing's information.
Submit a Story or Article
to either the snailmail CUSH Newsletter or to an upcoming email newsletter at http://www.cushings-help.com/newsletter_story.htm

Note: 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 among 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.

CortiSlim Source: http://www.infomercialwatch.org/fda/cortislim.shtml

Department of Health and Human Services

Public Health Service
Food and Drug Administration
Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506

WARNING LETTER

August 19, 2004

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Stephen Cheng, President
Window Rock Enterprises, Inc.
601 Valencia Ave., Suite 150
Brea, CA 92823

W/L 44-04    

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 the product:

  • 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.

VIOLATIONS

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," "reduce cravings"
  • CortiSlim Quick Start Guide: "curb appetite and cravings," "weight loss solution"
  • 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 diminish"
  • Website:
    • Under "The SENSE Program," Exercise topic section: "appetite control"
    • 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 appetite"
    • 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.

ADDITIONAL COMMENTS

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.

Sincerely,

/s/

Alonza E. Cruse
District Director

This page was posted on September 15, 2004.

PCOS Source: http://www.fredericksburg.com/News/FLS/2005/022005/02202005/1670562

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 ovarian syndrome.

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 infertility.

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 helpful.

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 available.

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 unopposed estrogen.

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 newsroom@freelancestar.com.

Date published: 2/20/2005

Pituitary Source: http://www.thejournalnet.com/Main.asp?SectionID=1&SubSectionID=113&ArticleID=49155

Despite teen’s surgery ‘She still is our Zannah’
By SHERRI CONER
Daily Journal staff writer
sconer@thejournalnet.com

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 normally.

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 says.

"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 kids."

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 her height.

"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.

Thyroid Source: http://www.insidebayarea.com/bayarealiving/ci_2579230

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 linda@ljbalance.com.



Newest Bios:
To add or edit your bio, please click here »
Helen (Flower) Helen has these auto-immune diseases: Sjögren's Syndrome, Rhuematoid Arthritis, Lupus, diabetes and Cushing's. Upper Penisula of Michigan
LeAnne Updated
1 year pituitary anniversary.
Provo, Utah
Roxi Roxi has an adrenal tumor and has had 7 surgeries within 2 years. Atlanta, Ga
Susan Susan has a tumor in each of her adrenal glands. Washington


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 companies.

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 lynnecush@comcast.net. You 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."

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Upcoming Conventions, Meetings and Seminars:
March 12, 2005, noon, Meeting in Oklahoma More info here »

April 1-2, 2005, Human Growth Foundation Annual Conference, Safety Harbor (Tampa Bay), FL. Families concerned about their child's growth and adults who wish to learn more about growth hormone deficiency from endocrinologists and other knowledgeable professionals. More info here »

Easter Weekend, 2005, April 26, 2005, Meeting in DC Metro Area More info here »

Spring 2005, (date TBA), Meeting in New England More info here »

May 15, 2005, 11 a.m. to 3:00 p.m., NIH Share the Health: Health and Fitness Expo More info here »

June 4-7, 2005, ENDO 2005, San Diego. Mainly for physicians, but patients may attend. More info here.

July 21-24, 2005, MAGIC Foundation Convention, Chicago, OHare Marriott. For Growth Hormone patients and their families. More info here »

More upcoming local meetings are listed here »

Sign up for notification of local meetings. You need not be a CUSH member to participate.

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The very first time you go in, you will have to register for this chat. Although you may use your user name and password from the message boards, you will still need to register those before being allowed into the room.

This room is always open, and has convenient links so that you can get needed information while you're chatting.

I hope to see you tonight!


~~~~~~~~~~~

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