Re: WHI - terminates Estrogen arm of study due to increased risk of stroke

From: Joanne Bulley, MD (islesannie@yahoo.com)
Tue Mar 2 21:34:06 2004


Agreed.

Several things - this has NOT been a study about prevention in healty women at the time of menopause.

50% of the women were smokers (much fewer than 50% of women smoke in reality).

The average age at onset of the study was 63 (1/3 50-59, 1/3 60-69 and 1/3 70-79) and we already have the HERS study that says if you take older women with pre-existing CVD - you do some bad to them in the first year or two of treatment with treatment. Autopsies of presumed healthy individuals have shown cardiovascular damage with age - and by using older smokers ... duh ... there was pre-existing arteriosclerotic damage.

The "Global Index" was invented for use with this study - and for usefulness - a new type of statistical analysis needs to have a study of it before it should be used in a clinical study. So it was an inappropriate tool for analysis.

The final data of the PremPro arm showed NO STATISTICAL difference between the treated and placebo groups for cardiovascular events, stroke and insitu breast cancer.

The study began saying they were not going to evaluate the cognitive issues. Then they threw in the WHIMS - studying a small subgroup of the oldest women in the study - and studying them for only a short portion of the time - and produced some information that did not reach statistical significance - and then said maybe there was a cognitive problem.

I have not looked it up - but I understand that Dr Wolf Utian has a letter published in either JAMA or NEJM within the past month where he got hold of the data and looked it over and actually found significant misrepresentations - evidence of a possible dishonesty there.

I am one of a growing number who are very bothered by the WHI and the integrity of 1. the study itself 2. the press conferences being called before the journals arrive for our review 3. the part that even if you take the nominal results as reported as "truth" the "excess adverse events" were 20 per 10,000 - or 0.02%. Then they say use other drugs for osteoporosis prevention and treatment - but isn't the risk of using the bisphosphonates greater than 0.02% per year?

The more conferences I go to with various Repro Endo folks talking about this the more distrust I have of the researchers involved in the WHI.

Joanne

At Mon, 1 Mar 2004, Rafael Haciski wrote: >
>This is so damningly frustrating!
>
> From the very first set up, the WHI study was flawed:
>...there was too long an interval from menopause onset to treatment
>initiation
>...there was too frequent switching of patients from one arm of study
>to another
>...most importantly HT arm (estrogen AND progesterone) was stopped but
>the accusing finger was pointed at estrogen as the one causing increase
>in breast CA (resulting in masses of women ceasing their treatment
>while we are inundated with querying patients, while reimbursemnt for
>such explanations is woefully in short supply) all while the arm of
>estrogen alone patients is doing just fine.
>
>How is that possible if estrogen is responsible for increased breast CA
>risk???
>
>Do they not see the disconnect in this junk?
>
>Sorry for venting - but I am tired of these "academics" making
>proclamations without sufficient sense, while we are left to clean up
>the mess!
>
>--
>Rafael Haciski, MD FACOG
>

--
Joanne Bulley, MD
Keene, NH, USA

----- "It is easier to understand a nation by listening to its music than by learning its language" -Anonymous





use when must restrict search to only the ob-gyn-l forum...
Enter search keywords:
Returns per screen: Require all keywords:

Return to  OB-GYN-L Mail a New Message to the Forum: ob-gyn-l@obgyn.net
Forum Administrator: geffrey.klein@obgyn.net
Report Technical Problems: webmaster@obgyn.net
Last Updated: Thu Oct 2 04:45:54 2008

The American Medical Association is no longer designating CME hours for AMA Category II CME credit. However, physicians themselves may self designate learning activities as Category II CME credit hours if they feel it is of sufficient educational merit and meets the formal definitions of continuing medical education. OBGYN.net believes these interaction in this forum meets these criteria. For further information see the AMA web site.