Even in well designed studies there are limits of entailment, and these limits are often shoved aside by a press more concerned with ratings than the truth, and with pleasing advertisers.  For example both New Week and Time Magazines--two of the best sources in the popular press for medical news published articles advising the discontinuation of HRT (hormone replacement therapy) for women based on the WHI (Women’s Health Initiative 1991-2002, see bottom of page for details) study that showed an increased incidents of breast cancer (had been known for over 4 decades) and a surprising increase in cardiac events.  What was known and not considered, the financial

gains for Big PhARMA for getting women off of generic HRT (a topic developed below).  Major defects in the WHI studies were not given proper press. 

In an effort to right the record Dr Robert Langer, UCSD Professor of Medicine, spoke in November of 2002 before an audience of medical students about the WHI study, which he was involved in (the talk was broadcasted on UCSD channel in December).  He used for both his introduction and summation the articles in Time and Newsweek about WHI, especially the conclusions they drew.  It provided an avenue for him to discuss other studies and limits

upon conclusions that could be drawn from the WHI, limits violated by these two magazines.  Times article The Truth about Hormones, 7/22/02, was short on truth, so too the Newsweek article.  They noted that one portion of the study was stopped because of health consequences from the use of Prempro, but failed to note the large body of research which showed very significant benefits for other forms of estrogen used with progesterone or used estrogen unopposed.  Doctor Langer discussed these alternatives, among other things.     

Time's article failed for 4 major reasons and numerous minor ones.  First and fundamental failure was that the very study was designed to fail because it used a combo of hormones (equine estrogen & MPA) were known prior to be atypically ineffective (see “Setup to Fail” below for details). Second the results for Prempro (the hormone combination of equine estrogen and medroxyprogesterone) cannot be generalized to other HRTs, namely esterified estrogen alone and estrogen with progesterone.  Third the increased risk in breast cancer was caused by MPA (medroxyprogesterone--see article below).  And fourth, since the study was of menopausal women, it could not be applied to postmenopausal women or the effects of such women using long-term HRT.  For example for post menopausal women using good HRT for 10 years reduced Alzheimer’s disease 83%, also breast cancer and thrombosis (supporting studies below).  These limits of the WHI study and more were brought before the audience at UCSD by Doctor Langer.

With distant glasses a look at the performance of the pharmaceutical industry reveals that they replace inexpensive off-patent drugs with new patented, expensive drugs, especially for health issues which can produce what the industry terms “a block buster.”   This has been done over and over again.  One block buster, the treatment for osteoporosis with the class of drugs bisphosphonates, has as a competitor the much more effective estrogen.  The near elimination of the use of estrogen to prevent & treat osteoporosis has produced billions in profits.  Significant profits are also derived from treating other age related conditions that would have been less frequent if a different HRT was used then Prempro.  This is a serious abuse of trust.  Other examples corporate greed occurs with the replacing of diuretics with patented drugs for the control of blood pressure, and the use of aspirin as an arthritic medication.  This website contains a detailed examination of the COX-2 inhibitors such as VIOXX and the efforts of Merck to keep it adverse consequences hidden (an estimated 55,000 deaths and 125,000 strokes and heart attacks prior to its being pulled).  As the article below “Setup to Fail” argues the choice of drugs for the WHI was done knowingly.   

There is a large body of research on HRT, which help put the WHI in proper perspective.  For HRTs other than Prempro by Wyeth the results depend on the progestogen used.  With progesterone there was no increase (see French study below).   With Prempro there is a significant increase in blood clots, heart attacks, breast cancer, and Alzheimer’s disease. For all HRTs with progesterone there is a decrease in the rate of colon cancer, heart attacks, osteoporosis, and Alzheimer’s disease (see page 1).  Given these differences in HRT, it speaks poorly of the FDA that Prempro is still available and widely used.  Of particular importance was a study that compared statins to either estrogen or estrogen and prostaglandin.  Statins are given to women with high levels of cholesterol and low-density lipoproteins.  These women had done just as well if given either estrogen or estrogen and progesterone instead of a statin in improving their lipid profile.  Since statins have some serious side effects and none of the additional benefits of estrogen, estrogens should be the treatment of choice.  Unfortunately, the Prempro therapy does not confer these benefits. 

There are 3 immediate reasons for HRT therapy.  One is the control of hot flashes.  Second are cosmetic and psychological reasons:  the skin remains suppler, breasts firmer, memory improved, and less depressions.  All these effect self-esteem and thus quality of life.  Third is sexual performance:  the control of vaginal dryness and the wall of the vagina is thicker.  Medical intervention for social and psychological benefits is common in our society. 

There are many older long-term benefits (well beyond the scope of the WHI) that show very significant reduction of Alzheimer’s, of atherosclerosis, of heart attacks, of osteoporosis, of colon cancer, no increase in breast cancer, and a reduction of THROMBOSIS with esterfied estrogen with progesterone (see studies below, and on this website http://healthfully.org/fhr/).  When one adds to this the cosmetic and sexual advantages plus the managing of hot flashes, the choice is crystal clear.  Because of its common usage as contraception for over 50 years, the use of female hormones has been the best studied of all drugs. There is enough data available to put to rest any of the Big PhARMA generated uncertainties over HRT treatment.  

Because of the complexities of issues and the limited time that health professional have to review studies and keep abreast of new treatments, they look to “opinion makers” and follow accepted practices.  Medical societies such as the American Heart Association also receive significant “donations” from Big PhARMA; the same for medical schools. The industry selects directly or indirectly researchers for their studies, and thus who will become “opinion makers”.   We have corporate medicine.  The harm done is incredible.  Millions of women have died early because they have discontinued (or not started) HRT due to incorrect coverage in the popular press and the role of Big PhARMA in changing the once very common practice of managing the side effects of menopause and post menopause, and of treating & preventing osteoporosis with HRT. 

Every aspect of medical science and treatment has been compromised by corporate medicine.  This website along with worstpill.org attempt to address the misinformation--BY JK.

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Setup to Fail:

http://www.nature.com/news/2010/100907/full/news.2010.453.html#comment-id-13486  Published in the highly acclaimed science journal Nature September 2010

Prempro  (Premphase) is conjugated Estrogens (.625 mg) & Medroxyprogesterone acetate (2.5 mg)----jk emphasis:

• 2010-09-09 12:24:18 AM    Posted by: Anna Michaels, PhD     #13486

 Millions of women took a mix of the hormones oestrogen  and progesterone called Prempro.

Is Nature ignorant of the vital fact that Prempro contains no progesterone, but instead the artificial progestogen Provera? The other component is Premarin (conjugated estrogen), which is a very uncertain, patent mixture of substances from the urine of pregnant mares. Whilst that in no way invalidates the main point of the report, or the research, indeed the it makes the need for clear statements and open scientific evidence absolutely clear, it completely invalidates all the material in the report generalising about HRT, because Prempro is totally unrepresentative of any other product used for HRT purposes.

Provera (artificial progestogen) has crucially different effects to the natural hormone progesterone. And Premarin has different effects to the natural hormone estradiol.    The literature has detailed those, and explained them, over many years. Much of it was known before the NIH chose to use Prempro in its intended landmark study.

Using a study of the effects of Prempro to attack the entire use of HRT has, through needless fear, caused millions of women to forgo considerable benefits of HRT using better products.

This point has been repeatedly made by endocrinologists. Why does Nature not know it?--END OF ARTICLE.

This published comment appeared in a section on the pervasive practice of pharmaceutical companies hiring companies that specializes in ghost writing.  These companies produce books, journal articles, news releases, lecture materials with the supposed review of these materials by the researchers whose name appears thereon or who gives the lecture--jk. 

Hormone Hysteria ---Scientific American, Dennis Watkins, 9/2003, edited by jk http://www.scientificamerican.com/article.cfm?id=hormone-hysteria

…Postmenopausal women have for decades relied on estrogen supplements to control the hot flashes, memory loss, osteoporosis and other ailments that can occur when their bodies no longer produce the compound. But hormone replacement therapy (HRT) is no longer considered the best way to treat menopause, ever since a report last year found that women receiving a certain type of HRT were at increased risk for dangerous side effects, such as breast cancer. Many health professionals have concluded that altering a woman's physiology will always increase risks over time. But a handful of respected scientists are calling for another look at HRT, arguing that not all therapies are created equal.

… A RESEARCH STATES:  "I think that it borders on a tragedy that Premarin and Provera were chosen as the only HRT treatments."   {AS JK STATED ABOVE IT IS THE PROSTOGLANDIN in Provera & Premarin that caused the serious side effects}   Another researcher finds that hat Provera--and no other progestin--blocks the mechanisms that allow estrogen to fight the brain's immune response to Alzheimer's. This immune response wears away at brain cells and causes them to leak neurotransmitters such as glutamate, which overloads and kills neurons. "It's basically as if someone were to open your mouth and shove down gallons" of soft drink, Brinton explains. "It's caustic, and you can't metabolize it enough."

{After the usual journalistic waffling, the Scientific American articles gets to the issue}  For many scientists, a critical question yet remains: To what extent do the results of the initiative study apply to other forms of hormone replacement? "We cannot be sure whether other hormone combinations will have the same effects," Rossouw cautions, "but in my opinion we should assume they do until proven otherwise." But neuroendocrinologist Bruce S. McEwen of the Rockefeller University is unequivocally critical of the study: "I think that it borders on a tragedy that Premarin and Provera were chosen as the only HRT treatments."

A growing number of researchers believe that Provera is a poor substitute for progesterone. For example, medroxyprogesterone will bind in the breasts to progesterone receptors, which causes breast cells to divide after puberty and during the menstrual cycle, and also to glucocorticoid receptors, which causes cell division during pregnancy. This double-barreled assault on breast cells, explains C. Dominique Toran-Allerand, a developmental neurobiologist at Columbia University, probably led to the high rates of breast cancer in the study. "With Provera you are activating two receptors involved with cell division in the breast," she says, "and that's the culprit, not estrogen."

In addition, recent research shows that Provera interferes with estrogen's ability to prevent memory loss and dementia. "Estrogen is able to protect neurons against toxic assaults that are associated with Alzheimer's disease," notes Roberta Diaz Brinton, a neuroscientist at the University of Southern California. Using in vitro studies of several types of progestin, she found that Provera--and no other progestin--blocks the mechanisms that allow estrogen to fight the brain's immune response to Alzheimer's. This immune response wears away at brain cells and causes them to leak neurotransmitters such as glutamate, which overloads and kills neurons. "It's basically as if someone were to open your mouth and shove down gallons" of soft drink, Brinton explains. "It's caustic, and you can't metabolize it enough." 

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