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Mon, 8 Mar 2004 08:10:39 -0500

HSI - Jenny Thompson

'Round and 'Round and 'Round and...

 

'Round and 'Round and 'Round and...

 

Health Sciences Institute e-Alert

 

March 8, 2004

 

**************************************************************

 

Dear Reader,

 

You may have heard the news last week that another (yes,

ANOTHER!) major hormone replacement therapy (HRT) study was

shut down early to protect the health of subjects

participating in the study. Or maybe you didn't hear about

it. These studies are shutting down with such frequency

lately that they barely rate a mention in most news reports.

If it weren't so serious, it would pretty comical.

 

But what received even less attention was a recent report in

the British Medical Journal that revealed a shocking turn in

the HRT saga that will not make anyone laugh. Scream with

anger? That would be far more appropriate.

 

-----------------------------

Another one bites the dust

-----------------------------

 

The study that was shut down last week was just one of

several Women's Health Initiative (WHI) studies on HRT. This

eight-year study of 11,000 women was stopped in its 7th year

when it was determined that estrogen therapy may increase

the risk of stroke.

 

Because estrogen taken alone has been shown to cause cancer

of the endometrium (the glandular membrane that lines the

uterus), many doctors consider estrogen therapy to be

relatively safe for women who have had a hysterectomy. For

women who still have their uteruses, progestin is added to

the estrogen to prevent endometrial cancer. This combined

HRT is the therapy that was being used in the 2002 WHI study

that was abruptly halted when it became clear that the two

drugs combined caused an increased risk of breast cancer and

heart disease.

 

-----------------------------

Bad news bears

-----------------------------

 

As it now stands, the official recommendation from the

National Institutes of Health (NIH, which oversees the WHI)

is for menopausal women to discuss the risks and benefits of

these drugs with their doctors. The NIH also recommends that

all HRT therapy should be taken in the smallest effective

dosage for the shortest length of time necessary.

 

But you can be sure that many HRT advocates will continue to

insist that the risks are so small that women should still

strongly consider taking HRT. And it seems that no amount of

bad news about HRT will shake their belief in the safety of

these drugs - even though the news over the past two years

has been uniformly negative. For instance:

 

* A 2003 study showed that combined HRT increased the risk

of developing Alzheimer's disease and other forms of

dementia. The FDA now requires a warning about this on all

HRT drug labeling.

* A University of Rochester study reported just last month

that women who took HRT suffered from impaired hearing.

* Also reported last month was a study from Brigham and

Women's Hospital showing a sharply increased risk of asthma

for women taking either estrogen alone or combined HRT.

 

Arguably, none of these health problems are as significant

as the 2002 revelation that HRT increases the risk of heart

disease - the disease that kills more women than any other.

But it turns out that this risk was known years before 2002.

 

-----------------------------

Insert scream here

-----------------------------

 

In previous e-Alerts I've told you how drug makers conduct

trials in preparation for an FDA review and then withhold

the studies that could be damaging - submitting only the

research that encourages regulatory approval. This is like

giving a defendant in a court trial the power to reject

witnesses for the prosecution. The glaring weakness of this

system is obvious: When negative results are withheld,

doctors may end up prescribing a drug without knowing about

some of the associated problems. And that's exactly what

happened with HRT research.

 

Early observational studies (using questionnaires and

medical records) indicated that HRT might provide protection

against heart disease. For several years this association

was widely assumed to be a given. But when evidence to the

contrary began to emerge, much of it was kept under wraps.

 

In a recent issue of the British Medical Journal, a team of

two researchers (Klim McPherson and Elina Hemminki) reported

on their review of 23 HRT studies; all conducted well before

2002. A good number of these studies were mounted by drug

companies in support of applications to license HRT drugs in

Finland. McPherson and Hemminki successfully appealed to

Finland's High Court to obtain unreleased results. (A

similar appeal for study results failed in the UK.)

 

The 23 trials included data on about 3,300 subjects.

Analysis showed that HRT use actually put women at greater

risk of heart disease. When their review results were

initially released, McPherson and Hemminki say their

findings were " ridiculed. " That was in 1997 - five full

years before the WHI study was shut down.

 

For years these results were in hand! The researchers had to

go to court to obtain them, while drug companies argued that

the records should not be made public. Yet, they were

revealed over FIVE YEARS ago. Is there any wonder why people

are turning away from mainstream medicine in droves and

looking for alternatives to the status quo?

 

I'm sure that advocates of HRT will continue to put the best

possible spin on the deteriorating reputation of this

dangerous therapy. But statistics show that sales of HRT

dropped off sharply last year. Women are finally learning

that there are much safer ways to treat their menopausal

symptoms. Especially when the list of side effects is

getting longer and more serious practically every day.

 

**************************************************************

(if you can't open here use the HTML links listed below)

To start receiving your own copy of the HSI e-Alert, visit:

http://www.hsibaltimore.com/ealert/freecopy.html

Or forward this e-mail to a friend so they can sign-up to

receive their own copy of the HSI e-Alert.

 

**************************************************************

 

... and another thing

 

Want to know the reason why America is becoming the Obese

Nation? The Centers for Disease Control and Prevention (CDC)

offers a theory in a recent report: It's the carbs.

 

Tracking trends of calorie intake from 1971 through 2000,

CDC researchers found that the total calorie consumption of

Americans has increased steadily over three decades. And

most of that increase came from a jump of calories from

carbohydrates in both women and men. Meanwhile, calorie

intake from fats and other protein sources changed very

little.

 

The study cited two possible reasons for these trends: 1)

Americans are eating more " food away from home " (such

as " salty snacks, soft drinks and pizza " ), and 2) increased

portion sizes.

 

I'll agree with both of those and add two more to the list:

1) A longstanding mainstream fixation encouraging

consumption of low fat foods, and 2) The pyramid.

 

The USDA Food Guide Pyramid recommends 6 to 11 servings per

day from the grain group: bread, cereal, rice and pasta. The

maximum recommended servings per day of fruits, vegetables

and meats COMBINED is 12.

 

Gee, do you suppose it's a coincidence that the trends in

calorie intake exactly mirror the recommendations found in

the pyramid? Eat plenty of bread, cereal and pasta, but go

easy on the meats, fruits and vegetables, and what do you

get? An obesity epidemic of epic proportion!

 

To Your Good Health,

 

Jenny Thompson

Health Sciences Institute

 

**************************************************************

 

Sources:

" NIH Asks Participants in Women's Health Initiative Estrogen-

Alone Study to Stop Study Pills, Begin Follow-up Phase "

National Institutes of Health Press Release, 3/2/04, nih.gov

" Estrogen Study May Be Ending " Liz Szabo, USA Today, 3/1/04,

usatoday.com

" HRT Could Affect Ability to Hear " BBC News, 2/25/04,

news.bbc.co.uk

" Study: HRT Patients At Higher Risk For Asthma " WBAL TV,

2/23/04, thewbalchannel.com

" Synthesising Licensing Data to Assess Drug Safety " British |

Medical Journal, Vol. 328, 2/28/04, bmj.bmjjournals.com

" HRT Risks 'Were Known Years Ago' " BBC News, 2/27/04,

news.bbc.co.uk

" Trends in Intake of Energy and Macronutrients " Centers for

Disease Control and Prevention, Morbidity and Mortality

Weekly Report, Vol. 53, No. 4, 2/6/04, cdc.gov

" CDC Says Carbs to Blame for Rising Calorie Intake " Paul

Simao, Reuters Health, 2/5/04, reutershealth.com

 

Copyright ©1997-2004 by www.hsibaltimore.com, L.L.C.

The e-Alert may not be posted on commercial sites without

written permission.

 

 

**************************************************************

Before you hit reply to send us a question or request,

please visit here

http://www.hsibaltimore.com/ealert/questions.html

 

**************************************************************

If you'd like to participate in the HSI Forum, search past

e-Alerts and products or you're an HSI member and would like

to search past articles, visit http://www.hsibaltimore.com

 

**************************************************************

 

 

 

 

 

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