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Self-test for menopause
marketing ploy presented as "news"

 
Despite the documented evidence that the FSH test is an unreliable indicator of menopause, in December 2001 a company selling a menopause supplement announced the approval of a "self test" for menpopause using the same technology. This was picked up by TV networks and announced as a medical advance, which sparked a scornful thread on the topic on alt.support.menopause:

Post to alt.support.menopause Date: 2001-11-28 13:47:35 PST
I can't believe this, a home test for FSH - FDA approved yet.  I can't believe this write up about the benefits of having the test either.
http://biz.yahoo.com/prnews/011128/phw004_1.html
First FDA-Cleared Menopause Self-Test Now Available 
Menopause Home Test Provides Easy, Convenient Detection of Early Menopause And Menopause in Privacy of Home
[small quote]

``The Menopause Home Test(TM) puts a simple and convenient menopause test into the hands of women, giving them fast and, more importantly, accurate results for which they can seek sound and appropriate treatment,'' said Aaron T.  Tabor,M. D., medical director of Physicians Laboratories.  ``Perimenopausal and menopausal symptoms, as well as potential related health problems, are serious in nature, so it is critical for a woman to be aware of changes in her body and effectively measure, track and plan her mid-life transition.''
[and then the kicker, I am sure the laboratory FSH test I had three years before my final period showing I was 'in menopause' was accurate too, an accurate measure of FSH but not of menopause status ]
"The Menopause Home Test(TM) delivers fast results that are extremely accurate and has shown in clinical trials a 99 percent agreement with laboratory blood tests for detecting levels of FSH."
And it would be on the basis of this clinical trial that this test received FDA approval?  And there is more, I wonder if the FDA approves the marketing methods for this product?
"Left unrecognized and unmanaged in the early stages, the menopausal transition can lead to various health problems, including the loss of bone and dental calcium, elevated blood pressure and an increased risk of heart disease.  Other consequences may include emotional loss of well being, depression, incontinence, and reduced sex drive.  Perimenopause, which can begin as early as age 35, is associated with a significant number of changes, such as irregular menstrual cycles, hot flashes, short-term memory loss, mood swings, depression and disturbed sleep resulting in fatigue."
and this test will do exactly what again?
Kathryn


..........and a response from Pat

A few factoids from Google.  Draw your own conclusions.

The company mouthpiece, quoted at length in the PRNewswire release, is one Dr. Aaron T.  Tabor, medical director of Physician Laboratories, a division of Physician Pharmaceutical Inc.

A Dr. Aaron T.  Tabor is also the medical director of Revival, a company that makes (and flogs all over the internet) Revival "Doctor Forumulated Soy Protein" supplements.  (http://www.healthrevival.com/index.html)

Dig a little deeper into that site, and you find a nice photo of young Dr. Tabor and the information that Physicians Laboratories is the parent company of Revival.  Tabor is also listed as the founder of Physician laboratories.

Not only that, but the Revival home pages features (alongside a photo of Tabor's mother with a testimonial about how "God used my son, Aaron, to create Revival soy protein ...") a big, fat announcement of the new "Revival Menopause Home Test."  Interesting how the first word of the product name is missing from the PRNewswire piece.

It took me all of 60 seconds to get this information. If I were a reporter (and I was), the lead on this story would go something like this:

The founder of a company that makes a soy protein supplement marketed heavily to menopausal women says his company has received FDA permission to market a test kit purported to "diagnose" menopause.
And then I'd ask him how much he expected his sales to increase as a result of this new test ...
- -Pat Kight [email protected]


Two weeks later, the Washington Post caught up with asm and published a sceptical article at
http://www.washingtonpost.com/wp-dyn/articles/A22926-2001Dec10.html 
Extracts only from A Poor Barometer for 'the Change'? by Sally Squires
A new home test -- approved by the Food and Drug Administrattion (FDA) and claiming to be the first to help baby boomer women learn if they've hit the "change of life" -- is being called unreliable by some menopause experts.
The trouble, experts say, is that while FSH levels tend to stay elevated in older women who have not had a menstrual period in a year or more, they also often spike in younger fertile women, typically just before ovulation.
FSH fluctuates so widely in women aged 45 to 55 that researchers at a joint meeting of the North American Menopause Society and the American Society for Reproductive Medicine in July called FSH "a completely unreliable marker" for menopause.  The World Health Organization also recommends against using FSH to determine if a woman is menopausal, in part because it can give women a false sense of security that they are no longer fertile.
"I am surprised that the FDA approved this test," said Wolf Utian, professor emeritus of obstetrics and gynecology at Case Western Reserve University Medical School in Cleveland.  "I cannot think of a reason why a woman should be doing a test like this."

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