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Note to reader: We report on industry
and related news as it comes out, this section is arranged
with the most recent news on top.
ESTROGEN ALONE ALSO INCREASES RISK OF
DEMENTIA
I had to look back on this one as I thought we had reported
on this last year. It turns out the study last year was specific
to estrogen combined with progesterone. This latest study
out the week of June 22nd 2004 in JAMA examined estrogen alone.
The reason researchers have speculated that HRT improves cognitive
function is that estrogen has been shown to increase blood
flow the brain. 3000 Women between the ages of 65 and 79 were
included in this study and it was found that women taking
estrogen alone versus placebo experienced a 49% greater risk
of dementia. Last year, for women taking the combined therapy,
the risk was 105%. While the actual risk to an individual
seems low at 12 cases of dementia in 10,000 women, the results
are disappointing as they clearly show no benefit as previously
believed. Doctors caution that this does not mean that women
who are perimenopausal and take HRT will experience the same
risk and continue to speculate that HRT for a few years during
menopause may still have a positive cognitive effect later
on in life.
http://news.bbc.co.uk/1/hi/health/3829925.stm
http://washingtontimes.com/upi-breaking/20040622-034320-2288r.htm
http://www.herald-sun.com/orange/10-493702.html
Newsletter
July 2004
THE PMS/PERIMENOPAUSE CORRELATION
Didn't we kind of suspect this all along? In a study published
in the May issue of the Journal Obstetrics and Gynecology,
investigators found that, "…PMS suffers were 2X
as likely to experience hot flashes and mood swings as they
approached 'the change' as women who did not have PMS."
Pamela Boggs the North American Menopause Society director
of education and development says, "Women with PMS tend
to be especially sensitive to fluctuating hormones, and fluctuating
hormones are also the cause of the symptoms associated with
the time prior menopause, known as perimenopause. We have
known for some time that if a woman has bad PMS in her younger
years this is a fairly good predictor of a bad perimenopause.
During this period estrogen levels are high some days and
low others, and this is especially troubling for women who
are sensitive." For more information go to:http://content.health.msn.com/content/article/86/99118.htm
or the source: Freeman et al., Obstetrics and Gynecology,
May 2004; Vol. 103: pp. 960-965.
Newsletter
June 2004
FIRST HERBAL SUPPLEMENT IS BANNED
The FDA has ruled to remove ephedra from the market citing
the risk of heart problems and strokes. In the supplement
industry this is seen as a positive action -- not only because
the evidence points to its harmfulness but also because the
FDA is exercising the authority that it has to enforce current
laws. The firms that make Ephedra and similar products in
my opinion are not firms that are focused on wellness and
play into our weaknesses of a "quick fix". Substances
like ephedra may help person lose weight in the short run,
but at what cost for whose ultimate benefit? Practically speaking,
I can't see these substances staying on the market long because
insurance companies will not cover them. I can tell you where
the industry and the laws are heading and we support this.
There will be mandatory reporting of adverse side effects
for herbal supplements in the future.
On a slightly different note, I had written
to Hillary Clinton's office who was sponsoring a bill that
didn't make much sense. Along with some other folks in the
industry, I also visited her office in October. That bill
#S 722 could take any supplement off the market with just
one ill effect - a level of scrutiny that is simply unwarranted.
She has since written me back, along with the millions of
others who wrote her, and it appears she has changed her mind
in support of another bill #S1538 - one that we support. #S1538
provides the FDA with more resources to enforce the law and
requires them to file annual reports to Congress on their
progress in regulating supplements. I've attached her letter
if you are interested and note her urging towards mandatory
reporting of adverse reactions. See ladies, we can make a
difference.
For more on ephedra go to:
http://www.fda.gov/oc/initiatives/ephedra/december2003/
To read the bill #S1538 go to:
http://frwebgate.access.gpo.gov/cgi-bin/useftp.cgi?IPaddress=162.140.64.21&filename=
s1538is.txt&directory=/diskb/wais/data/108_cong_bills
Newsletter
January 2004
WASHINGTON, D.C. RALLY
We're on our way to Washington, D.C. this month. The main
purpose is to educate Congresswomen/men and Senators about
the current bills on the hill and to make sure they understand
what the industry is about. The mix up goes something like
this: our elected officials have been convinced that this
is some "cowboy" industry that has no rules. The
truth is that there are regulations on the books but the reason
we have some "rogues" is because of the lack of
enforcement. The FDA says they don't have the funds to enforce
regulations and the FTC has actually stepped up enforcement,
which is good! (it curls my blood to see ads about breast
enhancement supplements) We support a bill that would give
FDA the funds to enforce the rules on the books - as well
as the new rules on Good Manufacturing Practices. There is
another bill that will take any supplement off the market
with just one ill effect, making herbal supplements much more
regulated than pharmaceuticals and over the counter medicines.
For more detailed information about herbs and how they are
regulated go to:
http://www.ahpa.org/herbal_faqs.htm
For more about the rally and sample letters to congress go
to: http://www.ahpa.org/rally.pdf
http://www.ahpa.org/samplelettercongress.htm
Newsletter
October 2003
INDUSTRY NEWS THAT EFFECTS YOU
I'm sure you've read a lot about how herbs are not regulated
through the FDA. In fact, that is not true. Herbs are regulated
as food products. In my opinion, there are more issues in
the herbal industry that include products that contain herbs
that have little or no substance (using stem instead of flower
as an example) or not the correct amount (leaving consumers
ripped off), as opposed to the opposite issue of safety, like
Ephedra, the weight loss supplement. There is no doubt that
safety is of primary concern, but overall the safety record
of herbal use in America is very high, in fact much higher
than food. In 1994, the Dietary Supplement Health and Education
Act (DSHEA) was passed - it states that the well-being of
our nation is a top priority and that the use of supplements
in health promotion and disease reduction is documented and
that consumers should be empowered to have easy access to
these choices. The DSHEA act also outlined good manufacturing
principals and other guidelines for the industry to follow.
Many have argued that the problems with Ephedra came from
the FDA's negligence to remove it from the market quickly,
when they had every power to do so.
On the heels of the Ephedra issue, and it
seems like a knee jerk reaction, Sen. Richard Durbin has proposed
a bill "The Dietary Supplement Safety Act" (S 722)
The problem with this bill is that it really doesn't add any
more safety than already exists under the DSHEA bill as explained
above and makes it possible for almost every supplement to
be removed from the market with just one reported negative
reaction. With virtually every vitamin or supplement, once
you stop taking it, any negative reactions disappear and there
are no long term effects.
I can tell you that industry groups, especially
AHPA (www.ahpa.org) have been working for so long and so hard
with government to help establish further guidelines for Good
Manufacturing Principals for herbal products. We all want
the bad apples thrown away and the industry groups are not
protecting those firms. They are working to protect the quality
of product on the shelf and fair choices for you and I. I
doubt very much that Sen. Durbin knows the amount of work
that has been going on before proposing such a sweeping bill.
Contrary to popular belief, this industry does not have powerful
lobbyists.
On the other side just before the
U.S. Senate recessed, Senator Tom Harkin (D-Iowa) and Senator
Orrin Hatch (R-Utah) introduced legislation to increase funding
to enable the Food and Drug Administration (FDA) to fully
implement the Dietary Supplement Health and Education Act
(DSHEA) - it has been argued that the FDA does not have the
resources to enforce DSHEA.
The DSHEA Full Implementation and
Enforcement Act (S.1538) would provide the FDA the funding
it needs to ensure the 1994 law is carried out as Congress
intended. It would also increase funding for the National
Institutes of Health's Office of Dietary Supplements, which
was created by DSHEA to expand research and provide consumer
information on dietary supplements, from $20 to $30 million
annually.
Your voice matters. For more information
go to:
http://www.supplementquality.com/editorials/Senate722.html
http://www.wholefoods.com/takeaction/
www.ahpa.org
Newsletter
September 2003
YOUR OPINION MATTERS
To be such a small business as ours, it's difficult to get
noticed which is why your recommendations to friends and family
mean so much in keeping Oöna a part of women's health
choices. Drugstore.com is now welcoming customer reviews and
we invite you to share your opinion.
http://www.drugstore.com/products/prod.asp?pid=
79247&catid=18466&brand=27670&trx=28045&tab=1#1
Newsletter
August 2003
BRAND MATTERS
In herbal supplements especially. The New York Times reported
that only 1 in 5 of the Ginko Biloba products tested to specifications
showed that the quality of Ginko was down since 1999. We want
you to know that at Oöna Health we remain vigilant about
quality of our active ingredients and make sure that you get
what you pay for. What frustrates us is that many women who
have tried a black cohosh product and found it didn't work
for them, believe that the "herbals" are just hocus
pocus. This couldn't be further from the truth, as you know.
It just may be that particular brand didn't work for them
because it does live up to the same quality standards that
we uphold. We certainly acknowledge that not every woman will
benefit from Oona (usually 80% do), but we feel that companies
that offer ineffective, low quality products do a disservice
to the industry they represent and more importantly, the customer
they serve. Our advice: Evaluate products carefully. Be careful
it something is at a really cheap price, it may not be worth
buying. For more info on Ginko Biloba go to
http://query.nytimes.com/gst/abstract.html?res=
F4091FFF3B580C758CDDAC0894DB404482
Newsletter
June 2003
IMPORTANT OÖNA NEWS
We have updated our formula by adding more chaste tree berry
to Oöna. Please note that each tablet now has 30mg. of
chaste tree per tablet instead of 10mg. The black cohosh is
the same at 60 mg. We felt that 10mg. was on the lower side
and the increase will provide better and more consistent relief.*
Newsletter
May 2003
*These statements have not been evaluated
by the Food and Drug Administration. This product not intended
to diagnose, treat, cure or prevent any disease.
NEW RULES PROPOSED BY THE FDA
The Food and Drug Administration has proposed new regulations
that require supplement makers, like ourselves, to abide by
good manufacturing principals. The ruling is designed to make
sure that consumers are getting what they pay for. These new
requirements include accurate labeling, validating identity,
purity, strength and composition. We applaud these new regulations
and agree that the few bad apples in our industry need to
be driven out. At Oona, we already take the measures the FDA
is proposing and look forward to greater consumer confidence
in our industry as a whole. For more information go to:
http://exchange.healthwell.com/nfm-online//nfm_backs/apr_03/news1.cfm
Newsletter
April 2003
OUR FAVORITE WOMAN OF THE YEAR, 2002
There are many deserving women who get recognized for their
work, but there is one that we feel deserves a bit more adulation
than she's received - her name is Deborah Grady, MD, M.P.H.
Dr. Grady is a woman who has been intricately involved in
the Women's Health Initiative study and has spoken out strongly
in defense of its results. What a tough job - not only is
she on the front lines of the pharmaceutical companies but
also addressing physician conferences filled with many angry
doctors. Grady's unflinching castigation of the medical community
and their long term use of HRT has given many women the information
they needed to get off of HRT for good. She's been clear,
concise and repeatedly on point. She is just what we women
need and we hope she receives the very big honor she's earned.
She is emphatic in her belief that women are at risk on HRT.
So who should take Prempro? Grady answered, "Nobody.
We don't need to go around trying to figure out which women
are going to benefit from it, because they are unlikely to
be any." Recently, Grady evaluated the numbers from the
halted Women's Health Initiative (WHI) study and believes
that out of the 10 million women now taking some form of estrogen
and progestin, some 20,000 will experience negative health
affects from taking these drugs each year. Grady is an internist
and epidemiologist at the University of California at San
Francisco. dgrady@itsa.ucsf.edu.
Deborah Grady, MD, M.P.H., Research Director, Women's Health
Clinical Research Center at UCSF.
Newsletter
January 2003
A CALL TO ACTION!
Recently, a new bill called H. R. 5204 was introduced to the
House of Representatives. Its purpose is "To provide
for coverage of hormone replacement therapy and alternative
treatments for hormone replacement therapy (HRT) under the
Medicare and Medicaid programs, group health plans and individual
health insurance coverage, and other Federal health insurance
programs." We at Oöna are very excited about this
development, first, because it may save our customers a lot
of money, but also, it demonstrates growing recognition (finally!)
that many women turn to alternative treatments for relief
from their menopausal symptoms without the risks of hormone
replacement. For the full text of the bill, go to http://thomas.loc.gov/cgi-bin/query/D?c107:1:./temp/~c107EgwQmX
To put your democracy to work-write or call your representative
and tell them you want H.R. 5204 to pass!!! Just click on
http://www.house.gov/writerep/
and enter your zip code and you can click right on your representative's
email address, or obtain their phone number or mailing address.
Newsletter
October 2002
That's it for this month! As always,
check out our website for lots more information at www.oonahealth.com. In Good Health,
The Oöna Team
Questions or comments? Write valerie@oonahealth.com
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