Just what is FDA, Well if you work for a drug company chances are you will work there at some time in your life as well. FDA is the Food And Drug Administration. They regulate the Food and the Drugs that are allowed to be marketed into the United States. So, they are the ones that say if you can or cannot sale a product to the consumers. The objective is to keep drugs safe.. But they actually are very good at keeping the market free of competition. Not enough room here for that discussion so. Here is the post.  

Miserable in menopause, Elizabeth Alsgaard pondered an awful choice: Drenching hot flashes or hormone therapies that might raise the risk of cancer. What former actress Suzanne Somers raved about held much more appeal — custom-mixed "bioidentical" hormones, just like ones the body makes.

"Anything I can put into my body that’s natural has to be better," said Alsgaard, a California audiologist who admitted having "no knowledge base to go on other than fear" when she took Somers’ advice.

STUDY: Firmly ties hormone use to breast cancer

Q&A: When changes come, your body knows it

Millions of women have tried custom-compounded hormones or herbal supplements like black cohosh and red clover since 2002, when a big federal study found risks from traditional hormone replacement therapy, or HRT.

Alternative remedies are especially popular with upscale, educated women who like to research and find their own solutions to medical problems. They like the idea of personalized treatments versus off-the-shelf prescription drugs.

However, instead of a safer option, they are getting products of unknown risk that still contain the estrogen many of them fear, women’s health experts say.

"Misinformation is rampant" about bioidenticals, said Dr. JoAnn Manson, preventive medicine chief at Harvard-affiliated Brigham and Women’s Hospital in Boston. "It really is buyer beware."

She and other experts explain:

• "Bioidentical" is a marketing term that has no accepted medical meaning. Its implied benefit is not unique to alternative remedies; many prescription drugs contain hormones that chemically match estrogens and progesterones made naturally by the body.

• Custom-compounded hormones are not approved by the federal Food and Drug Administration and have not been proved safe or effective. They may carry the same cancer and heart risks as traditional treatments and have had even less testing to find out.

• Hormone preparations do not need to be customized for each woman; a few standard doses work for almost everyone, medical experts say. The saliva tests that some women are given to tailor formulas are of dubious value because hormone levels fluctuate widely throughout the day.

• Compounding pharmacists use such different methods that a customized prescription can contain widely varying amounts of hormones depending on who fills it.

• Many compounders use estriol, a form of estrogen not approved for sale in the United States. The FDA is in a battle with compounding pharmacies over its use.

The bottom line?

"Women need to understand there’s no rigorous evidence these preparations are any more effective or any safer than traditional hormone therapy. In fact, there’s much less evidence for efficacy and very little research on long-term safety," said Manson, who has no industry ties and was a key researcher in the big federal study that warned women in 2002 of the health risks from long-term hormone use.

For years, medical groups have warned against custom-compounded hormones. The American College of Obstetricians and Gynecologists has denounced claims about their safety. The American Medical Association has urged more FDA oversight. The Federal Trade Commission has filed complaints against online sellers who made health claims for natural progesterone creams without supporting evidence.

In 2001, the government tested 29 products from compounding pharmacies and found that one-third did not meet standard quality benchmarks, including potency problems, Manson writes in her book, Hot Flashes, Hormones and Your Health.

That has not stopped their popularity, and Somers has promoted them in several best-selling books and on The Oprah Winfrey Show earlier this year.

"I laugh when they call me a quack," said Somers, who rubs hormones on her arms, injects them vaginally and takes some 60 supplement pills each day. In a phone interview, Somers said she is not trying to play doctor but to share with women what worked for her.

The issue flared last year, when the FDA declared that custom-mixed hormones were no safer than traditional treatments and warned pharmacies to stop using estriol, which is not approved in the United States for any use. (Most traditional menopause therapies use a different form of estrogen with a similar name — estradiol.)

The industry claimed it was being persecuted and fought back. In full-page ads in major newspapers, several alternative medicine groups claimed that estriol is safe, criticized "synthetic, hyper-expensive" prescription drugs, and asked, "Why is the FDA so hostile to ‘natural’ medicine?"

There are several thousand compounding pharmacies in the United States and hormones are a significant part of their business, said L.D. King, executive director of the International Academy of Compounding Pharmacists in Missouri City, Texas. No one knows how many women use these products, but "we believe the FDA action on the estriol issue would have affected hundreds of thousands of women," King said.

A group of nine compounding pharmacies sued the FDA. After a murky ruling by a federal court in Louisiana centering on federal versus states’ authority, neither side appealed, King said.

"It gets complicated and there’s not a win," he said. "We continue to advocate that FDA’s action is wrong."

Alsgaard was not aware of the flap. She was 52 and living in San Diego when she stopped taking birth control pills, and menopause symptoms "hit me like a brick wall." Her doctor, a specialist in women’s health, urged traditional hormone replacement therapy.

"She was just so aggressive it really flipped me out," said Alsgaard, who feared a cancer risk from the pills. After reading one of Somers’ books, Alsgaard went to a different doctor specializing in bioidentical hormones.

"She spoke at a physician’s level, talked about metabolic things I didn’t understand and sold me a couple hundred dollars of supplements I never took," Alsgaard said. "I was so desperate it was like, ‘OK, OK, just give me whatever I need."’

Although Alsgaard did not use the supplements, she did spend about $1,000 for saliva tests, hormone creams and custom-compounded hormone pills the doctor prescribed. Six months later, she was still miserable.

Disgusted with the doctor and in the middle of moving to Los Angeles, she found a new doctor and asked again for a natural remedy, believing those are safer than traditional hormone pills.

"He did a lot more extensive workup on me and put me on a bioidentical implant, a pellet implanted into the hip," she said.

Pellets containing estrogen, testosterone or both are the latest craze in this field. They are implanted just under the skin every few months under a local anesthetic, and are not FDA-approved for treating menopause. Problems that have been reported include difficulty removing the pellets if the therapy has to be discontinued, infection or pain at the injection site and fluctuating blood levels of estrogen, including a potentially high cumulative effect over several years.

Alsgaard did not know the pellets lack FDA approval. Her first, implanted in April, has done the trick, she said.

"I feel awesome. I have no night sweats, no hot flashes, no mood swings. After feeling so terrible, I’d forgotten how good it feels to feel normal," she said.

Whether her estrogen pellet is any safer than traditional estrogen pills is unknown.

Her physician, Dr. Kevin Pimstone, an internist at UCLA, said hormone pellets are "a very small part of my practice" — a few patients a month.

"I’m a really conventional doctor who offers this to patients who ask for it," he said. "I don’t think there’s any evidence that bioidentical hormones are any safer than conventional hormones."

Eye-opening news

Evidently, thyroid problems can mimic menopause – and peri-menopause symptoms – quite cleverly.  (Oh boy!)

In other words, if you are experiencing any of the following "challenges", it may be menopause – or maybe not.  Take a look at this list of menopause "mimics" that might be thyroid:

    * menstrual irregularities

    * sleep problems

    * weight changes

    * mood changes

    * loss of sex drive

    * hair loss

    * skin changes

    * elevated cholesterol

    * bone loss

    * fatigue and lack of energy

    * digestive disturbances

    * dryness

    * concentration or memory problems

According to Shomon, this is just a starter list!  In other words, if you have been to doc for sleep disturbance, mood swings and "brain fog", you may have been told "menopause!"….though the finger may really need to be pointed at thyroid problems.

Diagnosing thyroid is no easy task

As an opener to her keynote speech at the T-Tapp Fitness Retreat last weekend, Shomon asked the crowd, "Who has been told my their doctor that ‘Your thyroid is normal’?"  A majority of the women raised their hands.  And this is not an uncommon experience.

If you have felt foiled by all the confusing – and sometimes conflicting – information out there about thyroid problems, Shomon’s new book will shine light into previously dark corners for you.

She presents several tools for self-analysis to help you draw closer to your own conclusions and put you in a more informed position from which to ask your own doc some questions.

    To diagnose hypothyroidism, in addition to the symptoms, and clinical examination, conventional doctors consider the TSH results.  A TSH level above the reference range is considered hypothyroid and will be flagged as high on test results.  Remember, however, that there is controversy over the reference range, with some groups recommending the new range of 0.3 to 3.0, and many labs and doctors still use the old range of 0.5 to around 5.5.  (pg. 96, The Menopause Thyroid Solution).

For this reason, Shomon recommends multiple measures when trying to draw a more precise bead on the condition of your thyroid.

In addition to the rich profile of symptoms as described in her book, you should also ask doc for the following:

    * Free T4 (free thyrosine)

    * Free T3 (free triiodothyronine)

A low level of either or both of these, along with an elevated TSH, may indicate hypothyroidism.

Chapter 8:  Mindful Movement with T-Tapp

Of significant note is the exercise chapter (pgs. 228 – 268) featuring Mary’s favorite workout, T-Tapp.  Teresa Tapp created a custom pictorial and instructional for Shomon’s book that spans nearly 30 pages:  "Mindful Movement for Menopause Management".   Yay Mary for "getting" that movement – purposeful and targeted – is essential for all things well-being.

Night Sweats, Menopause night sweats, sleeping hot, sleepless nights, or trying to save money on your air conditioning. The Bedfan ® cooling system is for you.

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If you are are sleeping hot, you are most likely suffering from night sweats as well. Night sweats can be due to menopause, medical conditions, medications or you may just be a naturally hot sleeper. Regardless of the reason the Bedfan ® will help you sleep cool and stop night sweats and menopause night sweats too. 

The Bedfan ® cooling system is designed to remove body heat that causes night sweats while you are sleeping. At the same time the Bedfan ® will help keep your body cool so that night sweats don’t have a chance to start and you will no longer be sleeping hot. The Bedfan ® will instantly cool you down for a peaceful night’s sleep.

Visit www.bedfan.com for more information

Gains in body fat are common over the course of midlife and the menopausal transition. To investigate whether these gains might be related to menopausal symptoms, researchers studied 1,659 American women 47 to 59 years old for four years. Every year, they checked women’s hormone levels, percentage of body fat, and frequency of hot flashes and night sweats.

During follow-up, 53 percent of the women showed an increase in body fat – on average, about a half percent. In 24 percent of the women, body fat percentage shrank, while it remained stable for the remaining 23 percent.

The women who gained fat were 1.2 times more likely to report having hot flashes. The relationship remained after they accounted for the women’s hormone levels, but was not significant for night sweats, which could be because it is harder to keep track of night sweats, largely because they happen while one is sleeping.

The researchers noted that fat might worsen hot flashes because it acts as an insulator and makes it harder for the body to get rid of heat. Hot flashes and night sweats may happen because it’s tougher for a woman’s internal thermostat to maintain a steady core body temperature during menopausal hormone shifts.

The researchers recommended women to avoid gaining weight by maintaining a healthy diet and being active to prevent gaining body fat as well as symptoms of hot flashes.

The pain, discomfort and inconvenience of menopause symptoms are hormone related. Change will come when you commit to change. It’s about ‘wanting’ to make changes to feel ‘yourself’ again. It’s definitely possible. After all, I did it!

Let’s just start with what are probably the most well known symptoms – Hot Flushes and Night Sweats.

Hot Flushes always catch you out when you least expect them. It’s a feeling of intense heat that seems to start around the shoulder/back area and works its way up through your neck and face and down to your chest. Can be triggered by stress, hot drinks, hot showers. Hot flushes are merciless.

Treatment
* Re-balancing your hormones will be your true salvation. Naturally or pharmaceutically, don’t let hot flushes rule your life.
* Change your diet, eat more naturally, more fresh fruit and vegetables and some exercise.
* Discuss using natural bio-identical hormones(private doctor), or pharmaceutical HRT (hormone replacement therapy) from your GP.
* Ask if the surgery has a Menopause Clinic.
* A few drops of sage in a drink every day, can be helpful. Available at health food shops.
* Try to keep a ‘fan’ handy, manual or battery type. Other people may think you are nuts, but who cares, as long as it makes you more comfortable.
* Hot flushes can be attributed to psychological problems – stress and anxieties in your life that need sorting.
* Say ‘NO’ more often and learn to delegate and ask for help – multi-tasking is not all it’s cracked up to be!

Night Sweats can happen at any time, perspiring profusely and regularly. It’s a feeling you have just been immersed in a bath and remain covered in water – it’s quite awful and difficult to convey your distress. You will feel more comfortable with cotton or natural fabrics. If you really suffer badly, take a fan and a change of top with you, to work; drink plenty of water. Also, your sleep cycle will change; this sleep disturbance causes tiredness and distress. Is there no end to this!

Changing sheets at night and taking cooling showers is more common than you think. These sweats can last well into post-menopause.

Treatment
* Cut down on alcohol, caffeine (including fizzy drinks) and processed food.
* Eat fresh fruit and vegetables, lots of them, daily!
* Embark on a more natural diet
* Other methods are Bio-identical natural hormones, or pharmaceutical HRT (hormone replacement therapy).
* Red Clover and Black Cohosh have been shown to work in some women but Black Cohosh can have side-effects when taken with other medication. Always consult your GP. Caution: If you have high blood pressure and/or are taking Tamoxifen please consult your doctor.
* Sage, in liquid form can be beneficial. Take about 15 drops in water or juice, every day. It takes about a month to work.
* Red Clover, is endorsed by the British Menopause Society. It is cholesterol lowering and may combat hot flushes.

About the author
Kathryn Colas is founder and author of SimplyHormones.com providing specialist advice and support for women at all stages of menopause. She is a regular speaker on radio, to women’s groups and the medical profession.

Contact information:
Kathryn Colas www.simplyhormones.com, email kathryn@simplyhormones.com, or call 01825 700492.

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