It was the fall of 1994 and I was celebrating my 40th birthday with all of my family members, including my brother who surprised me by flying in from Hawaii; it was awesome! Life was great! I had everything going for me; a wonderful husband, loving children, blessed with having both of my parents still on this earth; I couldn’t be more grateful.

Then a week after my birthday, my life changed dramatically. I went in for my routine mammogram and what happened next changed my life forever. I was told that I had an abnormality on my mammogram and they wanted to do a biopsy. My doctor, herself, called me so I knew it was serious. I had the biopsy and then was told I had breast cancer. I couldn’t believe it. Me. I was healthy, I exercised 5 to 6 days a week, I ate a balanced diet, didn’t smoke or drink, and this still happened to me. I didn’t know why, but I knew I had to face it. I knew I would get through it with my husband and my family by my side.

I chose to have a lumpectomy and radiation for 5-1/2 weeks. I got through it all, tired a little, but ok. My life continued on and I moved on to the next chapter in my life. I thought, ok, this was a set-back, but only a minor one; I had so much more to do with my life, but not really knowing what that really would be until six years later.

In the summer of 1998 I went in to see my OB-GYN because of excessive bleeding during my period. Not knowing what to do, I believed my doctor would. She knew my history of breast cancer, but she still put me on the birth control pill to reduce the heavy flow. I was so naive and uninformed at this point that I took her professional opinion and believed in her.

After three months of being on the pill and getting no relief with the bleeding problem, I stopped on my own. I knew deep down inside that I shouldn’t be on this pill. Six months after taking the pill, I heard the words that I thought I’d never hear again, “your breast cancer has returned.” I felt this was caused by the estrogen that I was receiving through the pill, but of Seminar my doctor said “no” it wasn’t. The reoccurrence was in the same breast and this time, after the biopsy, they found 2+ tumors, again very small; less than 2 cm. My only option was to have a mastectomy. Chemotherapy was lingering in the background, but they couldn’t be sure until after the pathology report came back. The report showed there was a total of four tumors; two of which were infiltrating tumors, but still less than 2 cm which was good. Since they had taken out 15 of my lymph nodes the first go-round and they were clear, I didn’t have to do chemo. I was grateful and thanked God for that.

January 2008 marked my 9th year of recovery from surgery. I’m healthy, happy, and at peace with myself. It has been a long road, but so worth living. I’m blessed with every day I get to spend on this earth and I make the most of each one. I don’t do it perfectly, but I stopped trying that years ago; perfection is so over-rated!! I just keep putting one foot in front of the other and hopefully I’m on the right road!!

In July of 2001, I was invited to attend a presentation from a friend of mine on natural progesterone cream. I was amazed and excited about this alternative. Menopause wasn’t looking so scary anymore. I wanted to learn more and more about the product and its benefits.

One of the reasons I started on the cream was because of what I heard quoted from Dr. John Lee, who wrote the book What Your Doctor May or May Not Tell You About Menopause and his results with his patients. He stated that in his 30+ years of practice, he never had one woman who had a lumpectomy or mastectomy have a reoccurrence of breast cancer after putting her on natural progesterone cream. That was all I needed to hear. I decided to try this awesome product; I had nothing to lose and everything to gain.

Since using natural progesterone cream my fibrocystic breast has gone away; my moods are much more level; I don’t have any dramatic highs or lows; I’m a much happier person to live with. Ask my family. My complexion is better than it’s ever, ever been in my life. That alone has been a wonderful side effect. I sleep better than I have ever slept before which is such a benefit for me since I don’t function well on interrupted sleep. I don’t have to use my artificial tears anymore with my contacts. I also don’t have heavy periods anymore like I used to have.

The biggest impact for me was when I went to have an MRI Mammography Breast Scan done at AmeriScan in January 2003. It was an awesome experience and I will continue to do this type of screening for breast cancer over a mammogram any day. What a wonderful thing to hear from the doctor, “Your scan shows everything is normal and looks great!” Music to my ears. I actually sat down with him as he explained the pictures of the scan to me. It was amazing! Also, having had reconstruction he could see that there were no leaks in my implant. Yeah!

As I go along in my life, I have a mission to share this information with as many women as I can. It’s something our doctors don’t even know that much about.

Dr. Lee’s book covers the topics of PMS, fibroids, fibrocystic breasts, weight gain, fatigue, endometriosis, irregular or heavy periods, infertility, miscarriage, and other pre-menopausal hormone imbalance symptoms in detail. He also covers the topics of stress, birth control pills, hysterectomy and cancer. Many case histories are included, and Dr. Hanley adds a new dimension to this book by addressing the emotional issues of pre-menopause symptoms as well as the use of herbs and nutritional supplements to treat symptoms.

Please check out books by Dr. John Lee and others listed on the NPAN website.

Cheryl Rhodes

MARTIN MITTELSTAEDT
From Saturday’s Globe and Mail
March 8, 2008 at 9:32 AM EDT

In the summer of 1974, brothers Frank and Cedric Garland had a heretical brainwave.

The young epidemiologists were watching a presentation on death rates from cancer county by county across the United States. As they sat in a lecture hall at Johns Hopkins University in Baltimore looking at the colour-coded cancer maps, they noticed a striking pattern, with the map for colon cancer the most pronounced.

Counties with high death rates were red; those with low rates were blue. Oddly, the nation was almost neatly divided in half, red in the north and blue in the south. Why, they wondered, was the risk of dying from cancer greater in bucolic Maine than in highly polluted Southern California?

The two had arrived at Johns Hopkins a few days earlier, having driven their Mustang from their hometown of San Diego. Frank was about to begin graduate studies and Cedric his first job as a professor. It was July, and the trip through the sunny South gave them an idea as they studied the cancer maps: Exposure to sunshine varies dramatically depending on the latitude. What if that’s what was behind the varying cancer rates?

Their hypothesis, painstakingly developed and published six years later in the International Journal of Epidemiology, was that sunlight has a powerful anti-cancer effect through its role in producing vitamin D in bare skin. Those living at northern latitudes, they theorized, receive less sunlight and make less of the vitamin, which in turn increases their risk of dying from cancer.

Today, with vitamin D so much in the news, it’s hard to believe that it took decades for the Garlands’ hypothesis to gain traction in the mainstream medical community.

But the benefits of vitamin D are no longer restricted to cancer prevention: Studies have linked a shortage of the compound to such serious, chronic ailments as multiple sclerosis, diabetes, heart disease, influenza and schizophrenia.

Cedric Garland, now a professor of preventive medicine at the University of California, San Diego, is so convinced of this broad link that he says, “I think vitamin D is introducing a golden age in medicine.”

And he’s not alone. So compelling is the latest research that a number of credible medical researchers and public-health advocates, many of them in Canada, have started taking doses far above 200 to 600 international units - the daily intake recommended by Health Canada, depending on age with an upper limit of 2,000 IU.

Canada’s leading vitamin D researcher, the University of Toronto’s Reinhold Vieth, says he has been knocking back 8,000 units a day - four times the maximum - for years.

Should everyone be doing the same?

Dr. Vieth says he believes that what he’s doing is completely safe - after all, his intake is similar to the amount of vitamin D a sunbathing Canadian might make naturally on a summer day.

And Robert Heaney, a medical researcher at Creighton University in Omaha, says his Canadian colleague is hardly alone in his super-sized approach. “All the vitamin D researchers, to a person, I’ve not found an exception, are convinced enough by the data to walk the walk,” says Dr. Heaney, who last year helped to conduct a study, reported in the American Journal of Clinical Nutrition, that linked vitamin D supplements to an astonishing 60-per-cent decrease in cancer incidence among middle-aged and older women.

Cedric Garland argues that, rather than pollutants or some other cause, insufficient levels of vitamin D are at the root of the Western world’s cancer epidemic. What’s more, if more people took supplements, the population of northern regions would be a lot healthier all round.

“We will be preventing an extremely broad range of diseases in a single, inexpensive way with virtually no complications,” he explains. “It will affect every branch of medicine and public health favourably.”

Too good to be true?

It seems almost inconceivable that geography could damn someone to a life-threatening illness - that the mere fact of living in a northern country such as Canada could be a health hazard.

The Garland brothers’ hypothesis also defies the long-held conventional view that cancer is caused mainly by bad lifestyle habits, bad genes or carcinogens. Indeed, it suggests that some types of cancer could be better described as nutritional-deficiency diseases, much like scurvy or rickets.

Consequently, many experts have been skeptical, aware that much-touted nutrients in the past have often failed to live up to their initial hype.

“The problem with vitamins has been that generally the evidence, for whatever reason, doesn’t pan out,” cautions Len Lichtenfeld, deputy chief medical officer of the American Cancer Society.

Dr. Lichtenfeld says medical authorities have been burned so often over supplements that he would like to see a “substantial amount” of additional research before he is convinced that vitamin D is the real thing.

The idea that sunlight has beneficial health effects also flies in the face of advice to avoid sun exposure to reduce the risk of skin cancer.

Nevertheless, the idea that vitamin D insufficiency plays a role in cancer and other chronic adult diseases continues to gain scientific credence as a plausible theory, earned new respect for the long-underappreciated vitamin.

Though it first drew attention in the 1920s as a cure for rickets (bone health, not cancer, is why Health Canada even has a recommended intake), it has largely been treated like Rodney Dangerfield ever since. In our health-conscious age, it has been overshadowed by supplements such as vitamin C and beta carotene.

But since the Garland brothers kicked off interest in vitamin D with their data on colon cancer, other studies have shown that more than a dozen other cancers, including the big killers, breast and prostate, as well as an array of other diseases appear sensitive to insufficiencies of the vitamin.

The idea behind the research is simple: Humans evolved in a sunlight-filled environment near the equator, and still have countless biological processes exquisitely calibrated to the rich vitamin D levels we would have if we were still basking under the hot sun year-round.

But by migrating to higher latitudes, where strong sunlight is not present during the fall and winter, most humans upset their vitamin D metabolism, creating susceptibilities to chronic ailments that research is now linking to insufficiencies.

The question for Canadians is: If we’re so short of a crucial vitamin, shouldn’t we be compensating? And if we did, would vitamin D be a proverbial magic pill, capable of curing much of what ails us?

Although the guidelines jointly issued by the U.S. and Canadian governments say adults need only 200 to 600 IU of vitamin D daily, depending on age, the women in Dr. Heaney’s study took 1,100 IU daily, while he himself takes 1,500 IU daily.

(Although the international units nomenclature makes the numbers seem large, the actual weight represented by a single IU of vitamin D is dust-like, at less than a millionth of a gram. The vitamin, by acting like a hormone in the body’s cells, packs a big biological punch in minute amounts.)

Radical conservatives

The Canadian Cancer Society is one of the more conservative health-advocacy agencies, but last year became the first major organization in the world to embrace the idea of large-scale, population-wide vitamin D supplementation to combat cancer. It started recommending that white adults take up to 1,000 IU daily in fall and winter, and non-whites, because of their higher susceptibility to vitamin D insufficiency at northern latitudes, take that amount year-round. (Canada doesn’t keep national illness statistics by race, so the degree to which non-whites are being affected by ailments linked to low vitamin D levels isn’t known.)

The Canadian Pediatric Society followed suit shortly after, calling for pregnant and breastfeeding women to take 2,000 IU daily, with a goal of preventing childhood diseases.

The Canadian Cancer Society’s decision came after years of monitoring the research. Vitamin D “kept coming up. It kept hitting the bar that reaches your attention,” says Heather Logan, the society’s director of cancer-control policy.

“It wasn’t one study and that was the end of the story. There were multiple research studies continued to be published in peer-reviewed journals.”

One study, in the journal Circulation, found that those with low vitamin D status had a 62-per-cent increased risk of heart failure. Another, published in Archives of Internal Medicine, found that those who take vitamin D supplements cut mortality risk by 7 per cent. A third report, by scientists at the U.S. National Cancer Institute, found that, while vitamin D didn’t affect overall cancer-death risk, those with relatively high levels of it in their blood had a 72-per-cent lower risk of dying from colorectal cancer.

Other studies have found that low blood levels are an excellent predictor of who goes on to develop cancer and heart disease and that people diagnosed with cancer during the vitamin D-rich summer have a better prognosis than those diagnosed during winter.

Not everyone is convinced, however. Critics charge that most of the findings - such as the Garlands’ cancer maps - constitute only circumstantial evidence. And when the Canadian Cancer Society asked the American Cancer Society to join them in recommending more vitamin D, it refused.

“I think it’s fair to say we had discussions and we agreed to disagree on that. Our position is that we really want what I call solid evidence … that there in fact is a reduction in cancer mortality without a significant increase in risk with vitamin D supplementation,” Dr. Lichtenfeld says. He wants to see drug-style clinical trials to validate the benefits and assess the risks, he says, before telling 330 million Americans to start taking supplements.

Similarly, John McLaughlin, vice-president of preventive oncology for Cancer Care Ontario, says the research on vitamin D is too thin at this point to recommend taking higher doses to prevent cancer. He dismisses Dr. Heaney’s study as “largely uninformative” because of its small size (about 450 women) and because the subjects also took calcium supplements, which may have affected the results.

But even though Ms. Logan says the Canadian Cancer Society agrees that all the science on vitamin D may not be in yet, evidence to date strongly suggests that not acting on the implications of the research is risky. Cancers affected include such big killers as breast, prostate and colon, which will claim more than 10,000 Canadians this year.

“You don’t need to wait for every scientific question to be answered before you take action,” Ms. Logan says. “Where there is evidence of harm, even in the face of scientific uncertainty, you should so something about it.”

Martin Mittelstaedt is The Globe and Mail’s environment reporter.

Just D Facts

Vitamin D is measured by levels in blood. Many Canadians have 40 nanomoles/litre or less, particularly in winter. Many researchers believe levels need to be at least twice that high to reduce chronic disease risk.

Vitamin D is produced when exposed skin has a photochemical reaction to ultraviolet light rays from the sun. Nearly all the vitamin D circulating in our bodies is made this way, with a typical white-skinned person in a bathing suit under a noonday summer sun in Canada producing about 10,000 international units in 15 to 20 minutes. Non-whites need about five times longer to make the same amount, because the melanin in their skin acts as a sunscreen against UVB rays. During the fall and winter, sunlight at Canadian latitudes is too weak to cause any vitamin D production.

Vitamin D synthesis in skin occurs only when the UV index is three or higher, roughly the period around noon from March to October in southern parts of the country. A rule of thumb is that if your shadow is longer than you are, the sunlight is not intense enough.

Some of the very few foods that contain vitamin D are: cod liver oil (1,300 IU per tablespoon); wild salmon (1,000 IU per serving); farmed salmon (250 IU); sardines (600 IU); fortified milk or orange juice (100 IU); egg yolk (25 IU); fresh shiitake mushrooms and some organ meats (traces in both). Most multivitamins contain 400 IU. Over-the-counter pills and drops contain up to 1,000 IU.

Health Canada’s daily intake recommendations, based primarily on a 1997 study, are: newborns to 12 months, 400 IU; age 1 to 50, 200 IU; 51 to 70, 400 IU; over 70, 600 IU; with an overall upper limit of 2,000 IU.

Many vitamin D advocates say Health Canada is too conservative. The Canadian Cancer Society, for example, recommends that non-white adults take 1,000 IU daily year-round and whites take that amount in fall and winter. The Canadian Pediatric Society recommends 2,000 IU daily for pregnant and breastfeeding women.

Toxicity has occurred after long-term exposure to massive amounts, ranging from 50,000 IU to 150,000 IU daily. Effects such as bone demineralization may occur with chronic daily doses exceeding 10,000 IU. No illnesses have been reported for doses under 3,800 IU daily.

A U.S. study in 2007 found that overall risk of cancer in women was cut by 60 per cent when they were given 1,100 IU of vitamin D per day, plus a calcium supplement.

Another study estimated the dose to cut colon-cancer risk in half: 1,000 IU daily. The amount estimated to cut breast-cancer risk in half: 4,000 IU daily. Researchers say women could stay within Health Canada guidelines and still reach 4,000 IU daily by getting 2,000 IU from diet and supplements and the rest from modest sun exposure.

There is some evidence that girls can cut their future risk of breast cancer by taking high levels of vitamin D during their teens.

U.S. researchers estimate that vitamin D insufficiency causes up to 60,000 premature cancer deaths a year in the country, or nearly 10 per cent of total mortality from the disease. If the same percentage applies to Canada, low vitamin D status leads to about 7,000 premature cancer deaths here annually.

While there is a risk of skin cancer from overexposure to ultraviolet light, researchers say, the benefits of modest sun exposure in preventing serious, hard-to-treat cancers outweighs that risk. Furthermore, they say, skin cancer is relatively easy to treat.

A 2001 Finnish study found that children given 2,000 IU daily cut their risk of getting juvenile diabetes by 80 per cent.

The strong correlation between latitude and the incidence of multiple sclerosis has led researchers to suspect the trend is related to vitamin D status. In the U.S., for example, MS rates are four times higher in northern states, along the Canadian border, than in the southern parts of the country. Similarly, Australian research shows the incidence of MS increases the farther people live from the equator. The highest incidence rates in the world are found in Northern Europe and Canada.

Gene Genie

New insights into how the ‘magic pill’ works

The role of vitamin D in carcinomas could explain one of the biggest mysteries about the cause of cancer: why so many people who develop the disease have no known risk factors, such as a family history of the illness.

The simple answer may be that Vitamin D interacts with an unusually large number of our genes, working like a master switch to turn them on or off. Researchers believe a deficiency of the vitamin leads to a deficiency of the proteins manufactured under the direction of these genes, which then undermines key defences against seemingly unrelated diseases such as cancer, diabetes and multiple sclerosis.

John White, who has been studying the antimicrobial activities of vitamin D at McGill University in Montreal, says that “virtually every cell” in the human body has receptors for vitamin D and that hundreds of different genes may be regulated by it.

Vitamin D’s most profound gene-influenced activity appears to be in keeping healthy the broad category of cells known as epithelium, which line the outsides of our organs and the surfaces of the structures in our body.

Even though these lining tissues amount to only about 2 per cent of the weight of our bodies, they are the source of about 85 per cent of cancers, those known as carcinomas.

These include cancer of the colon, prostate, pancreas and uterus, along with the most common type of breast cancer, ductal carcinoma, which develops on milk-duct lining. (The other main type of cancer, sarcomas, appear in muscles and connective tissue, and don’t have a strong association with vitamin D insufficiency.)

“Vitamin D is a particularly effective agent in inhibiting abnormal growth or development of malignancies in epithelial tissues,” says Cedric Garland, a professor of preventive medicine at the University of California, San Diego.

Although many researchers view cancer as a hopelessly complex disease with different causes for each tumour type, Dr. Garland, who has been studying vitamin D for more than three decades, believes the carcinomas have a common origin in low levels of the vitamin. By his estimate, up to 75 per cent of these cancers could be prevented if vitamin D levels were raised through supplements. “I’m convinced that cancer is largely a vitamin D deficiency disease,” he says.

One important function of vitamin D at the gene level that may explain its anti-cancer properties is that it helps to regulate the production of E-Cadherin, a type of biological glue that holds cells together. When this glue is in short supply, it allows epithelial cells to lose adhesion to one another, permitting some to escape from the tissue they are supposed to be embedded in. Unconstrained, these cells start to multiply at a greater rate than they otherwise would and begin forming the lesions that ultimately turn into cancers.

Vitamin D plays a role in telling cells when to die, thus helping to prevent uncontrolled proliferation and curbing the growth of new blood vessels that nourish growing tumours.

It may also play a role in diseases unrelated to cancer. A main biological function of epithelial cells is to be a barrier against viruses and bacteria that cause infections.

Scientists speculate that when low vitamin D status weakens epithelial cells, the barrier function is compromised, exposing tissues to attack from disease-causing agents - in diabetes, for example, by weakening islet cells; in multiple sclerosis, by weakening glial cells in the nervous system; and in tuberculosis, by reducing the ability of the lung lining to repulse bacteria, according to Dr. Garland.

Some medical researchers have even begun to suspect a link between vitamin D insufficiency and schizophrenia, which occurs 10 per cent more often among those born in winter and early spring, when vitamin D from sunshine is less available.

Researchers in Australia are testing this hypothesis by studying the brains of rats born to pregnant mothers deprived of vitamin D - with alarming results. The vitamin-D-deprived rodent brains had more cell proliferation, enlarged ventricles and less of a protein necessary for nerve growth.

“What we see is that when you take [vitamin] D out of the brain in the rodent, you can break their brain basically,” says John McGrath, a professor at the Queensland Brain Institute at the University of Queensland in Brisbane. “We can change the way their brain develops.”

Dr. McGrath says it is too early to say whether the rodent-brain research applies to humans. But he adds that “even if only a small fraction of [the cases of ] schizophrenia could be averted by optimizing maternal nutrition, that is going to be a really important outcome.”

Martin Mittelstaedt

Vitamin D Council

In the last issue of the Health Watch (Will Wyeth Bully You out of Your Estriol?), I wrote about the drug company Wyeth using the FDA to attack pharmacies that offer natural hormones. I promised I’d let you know if any group called for a specific petition to elected representatives asking the FDA to leave our natural hormones—and specifically estriol—alone. Once again P2C2, an action group for compounding pharmacies, has provided an easy-to-use online petition: Oppose Wyeth & FDA Actions to Limit BHRT Access!

I’m not wild about the copy on their petition, so if you have your own point of view about it, please express it! If you have a personal experience you’d like to share, all the better. If you have a political bent, express your opinion politically. Assure your elected representative that this issue really matters to you.

How to Get Goliath’s Attention

I’ve been contemplating what it will take to get Wyeth to back off. While it’s important to let your elected representatives know your opinion, the amount of money this mega-corporation hands out to politicians may outrank citizen protest. Because didn’t we just do this last spring? They’re back at it again.

What corporations care about most is profits and stock prices. How about a boycott of Wyeth products? They have almost 80 products, and many of us are probably using at least one. What if we examine their list of Wyeth Products (http://www.wyeth.com/products), and then next time we’re shopping for a pain reliever (e.g. Advil) or a cold medicine (e.g. Robitussin), or anything else pharmaceutical, choose another brand. They also make a lot of pet medication products.

Now I have a quite a few readers, but it’s not a drop in the bucket compared to the millions of products Wyeth sells every month. This is a David and Goliath thing. But what if you forward this e-mail to three friends, and they forward it to three friends and so forth? I believe strongly in the power of grass roots movements, and with the power of e-mail, we might hit their bottom line enough to at least make them go “ow!” Oh, and consider calling the Wyeth Consumer Information line—800-322-3129—and let them know that you’re boycotting their products because they’re going after natural hormones. That way they’ll know what hit them.

Keep it natural,
Virginia Hopkins

Editor, Virginia Hopkins Health Watch

http://www.virginiahopkinshealthwatch.com

Patients: Oppose Wyeth & FDA Actions to Limit BHRT Access!

Two weeks ago we informed you via our newsletter that on January 9, 2008 the FDA agreed to support Wyeth in their campaign to end access to compounded hormone medicines and announced that it will “halt” compounding of hormone treatments that contain estriol. Estriol is a common and critical component of many bio-identical hormone therapies (including Bi-Est and Tri-Est). It has a monograph form the U.S. Pharmacopeia and meets standards that were established for compounded medicines in Congress’s 1997 FDA Modernization Act.

“If I were Janet Woodcock, FDA’s Chief Medical Officer, I would be embarrassed,” says Dr. Randolph. “Not only does the FDA not have official jurisdiction here as compounding medications are regulated by state boards of pharmacy, but more importantly, the FDA’s position paper about estriol includes several egregious errors.”

“I’ll address two flaming misstatements here. 1.) According to the FDA ‘no drug containing estriol has been approved by the FDA and 2.) The safety and effectiveness of estriol is unknown. Actually, in the 1970s there was an FDA approved drug on the market called Hormonin that contained the active ingredients estradiol, estriol and estrone. I know about this drug because I was a licensed pharmacist before I returned to medical school. The company manufactured Hormonin here in the U.S. was acquired and today that drug continues to be manufactured in Great Britain.”

“As for the question of estriol’s safety,” Dr. Randolph continues, “I would have thought that Dr. Woodcock would have done her homework. There are over 300 published medical (Pubmed) references indexed ‘estriol/therapeutic use’ going back more than 30 years and yet there are no reports of any adverse effects associated with estriol usage. Most of the references refer to the favorable effects estriol has been shown to have on health parameters such as blood lipids and beneficial effects on menopausal symptoms. In fact, results of recent research at both the Medical College of Georgia in Augusta and the University of Nebraska Medical Center in Omaha actually show that estriol can have anti-cancer effects.”

“I am deeply concerned that access to safe and efficacious bio-identical hormone replacement therapies (BHRT) could be at risk,” says Genie James, Executive Director and Dr. Randolph’s co-founder of The Natural Hormone Institute of America. “Even more, I am horrified that Wyeth would once again so brazenly attempt to use its corporate wealth and power to twist the facts, manipulate the research and, ultimately, push their mercenary agenda through a federal governing body.”

“In light of Wyeth’s most recent petition, I am forced to ask several seminal questions: First, does the pharmaceutical industry regard women’s health as a sacred arena of medicine or does it simply see women - particularly baby boomer women - as a burgeoning target market to be exploited via product sales? Is it any coincidence that Wyeth’s own Premarin is the brand leader in the synthetic estrogen product market? Can physicians and patients trust the FDA to be fair and unbiased in addressing this issue if the agency’s drug evaluation center receives over $300,000 per year (approximately half of its operation budget) from pharmaceutical companies, including Wyeth? Finally, is the power of pharmaceutical profit so great that even the FDA can be manipulated to turn a blind eye to the fact that the rate of female cancers continues decline in lockstep with the decline in the sales of synthetic estrogen products?”

“I can’t speak for the conscience of the FDA but I can speak for physicians like myself who have for years relied on BHRT to successfully and safely treat patients suffering from hormonal imbalances,” says Dr. Randolph. “I can also presume to speak for the tens of thousands of patients who have found that BHRT gave them not only relief from symptoms but a feeling of having “their life back”. In speaking, I hold out these truths:

• BHRT is a safe and effective option for treating hormonal imbalances. Side effects are minimal, if any. Unlike synthetic hormone therapies, there has been no evidence linking BHRT to any carcinogenic effect or increased
  risk for heart attack, stroke, blood clotting or Alzheimer’s disease.
• Clinical studies have linked prescriptions of Wyeth’s Premarin with an increased risk of breast and uterine cancers, heart attack, stroke, blood clotting and Alzheimer’s disease.
• The FDA often regulatory decisions based on industry-sponsored studies and research. In presenting their research, pharmaceutical companies often only publish selective results, even presenting the same selective findings in several different journals. The FDA had no control over this selective publishing. This practice is not unbiased research and evaluation of pharmaceutical products; it is plain and simple spin marketing.
• There is a need for more research on BHRT. While there are many credible and clinically significant published studies evidencing the efficacy and safety of BHRT, there is not enough data to once and for all squash the promotion of synthetic hormone therapies. Why not? Think about it. Who funds most clinical research? You got it: the
  pharmaceutical companies like Wyeth.”

“This is not the first time the FDA has attempted to prohibit doctors from prescribing compounding medications to their patients,” says Ms. James. “A similar attempt was made by Wyeth Pharmaceutical and the FDA in 2005 but over 70,000 persons (physicians, pharmacists and lay people) contacted the FDA and voiced their strong disfavor of such a move. Now we face that same challenge to raise our voices and insure that one-size-fits-all manufactured synthetic hormone therapies do not replace the much more safe and individualized option of prescribe bio-identical hormone replacement.”

“We are raising our voices to battle for the truth about BHRT and the dangers of synthetic hormone therapies. You can too. I urge you to voice your opposition to the Wyeth Complaint by going to IACP and telling the FDA your story.”

Best wishes,
C.W. Randolph, Jr., M.D., R.Ph., Medical Director, and Genie James, M.M.Sc., Executive Director of The Natural Hormone Institute of America.

Australian Implication of the recent FDA decision to cease the advertising and compounding of the Oestrogen, Oestriol (Estriol)

The U.S Food and Drug Administration’s (FDA) decision to stop compounding pharmacies from marketing the oestrogen, Estriol, on the grounds that “the safety and effectiveness of Estriol is unknown” was pre-empted by Wyeth’s petition of October, 2005 which asked the FDA to crack down on the hormone replacement products marketed by compounding pharmacies. Since 1942 Wyeth Pharmaceuticals, the maker of Premarin is the world’s largest manufacturer of prescription menopausal hormones. The sales of these products fell by more than 57% in just three years, from $2.07 billion in 2001 to $880 million in 2004 as a result of the increase in strokes, breast cancer, heart attacks and blood clots, as outlined in the massive 2002 Women’s Health Initiative (WHI) study.

Putting aside the political aspect of the FDA’s sudden attack on compounding pharmacies, the reasoning on a pharmacological basis is inherently flawed. Firstly, Oestriol has a monograph in the U.S. Pharmacopeia (as Estriol ) and as a result is legally able to be compounded by Compounding Pharmacists as a peer reviewed reference does exists to guide compounders as to the therapeutic limitations of Oestriol in the form of the “drug bible” namely the Pharmacopeia. Secondly, the FDA states that “Estriol is not FDA approved and has never been subject to safety studies by the FDA”.

Since the FDA is not the world authority on Estriol, it would be prudent for such an influential organisation to move beyond corporate pressure and look at the global safety and usage of Oestriol on a more humane level as Oestriol has been well studied in Europe and Asia for more than 60 years, where it’s commonly prescribed by physicians and Wyeth actually sells two types of Estriol in Europe.

Doctors Zava and Lemon has dedicated over 30 years of study to the safety and efficacy and to the clinical use of Estriol in breast cancer patients. Dr.Lauritzen has spent nearly five decades researching the effects of Estriol in women. In his pioneering paper of 1961, Dr.Lauritzen showed that an oral form of estriol is quite effective for relieving menopausal symptoms without causing the typical stimulation of the uterus as seen with estradiol. In the 1980s, Dr.Robert Greenblatt, one of the foremost researches in hormone therapy at the time, commented that “the ability of estriol to relieve vasomotor symptoms [hot flushes] and to improve vaginal maturation [prevent vaginal dryness] without inducing notable side effects, is sufficient reason for it to be included in the management of the post menopausal syndrome”. Dr.Wulf Utian, editor of the North American Menopause Society’s journal Menopause has stated that, “Estriol, it would appear, has the potential for reduced risk but similar benefit to alternative estrogen or estrogen-progestin combinations” Another quote by Dr. Utian says: “The potential to minimise risks yet maximise most benefits places estriol in a unique category amongst the estrogens”

As far as the correlation of the above with respect to the equivalent body to the FDA in Australia, albeit, the Therapeutic Goods Administration (TGA), I believe common sense will be the TGA’s modus operandi with respect to compounding pharmacists and patient safety. Believe it or not, the TGA is actually a more powerful body than the FDA in the aspect of its powers to act rapidly in the case of consumer safety. A recent example would be the TGA’s closure of Pan Pharmaceuticals. The FDA has a somewhat more cumbersome legal process to follow before it can do what the TGA did in the case of Pan Pharma. Having said that, the TGA at the current moment has taken the sensible and logical stance of organising various focus meetings with key stakeholders to see what can be done to understand what compounding pharmacists actually do and how best to put standards in place that will make sure that the pharmacy profession not only adheres to a good code of compounding practice, but also, that the public has access to a standard of compounding that meets certain professional standards that are accepted by all relevant parties and stakeholders. I have received feedback by people attending these meetings that the TGA is somewhat gobsmacked by the level of competency and variety of dispensing undertaken by these creative compounders who have raised the level of pharmacy practice in Australia.

As far as Oestriol is concerned in Australia, the TGA has already approved a product by Organon called “Ovestin” on the Pharmaceutical Benefits Scheme (PBS), thus I believe that the TGA will take a more measured stance than the FDA in the sense that if no studies show that Oestriol is harmful to patient care then it will see no reason to use the same illogical approach as undertaken by the FDA. Common sense would argue that to achieve the greatest benefit from oestrogen replacement therapy, we should try to mimic the body’s own production of Oestrogen. In other words, we should use the same proportions of oestriol, oestradiol and oestrone normally produced in the human body not that of a pregnant mare as in the manufacture of Premarin®. On this basis alone, I believe that the TGA will not be as unrealistic as the FDA and will allow compounders to be involved in the individualisation of patient hormonal care. When you have influential organisations like the American Medical Association saying: “ Estriol may not only be non carcinogenic but indeed anti-carcinogenic” one will fully realise that the FDA was somewhat “trigger happy” in its stance to target compounding pharmacists and at the request of lobby groups with vested fiscal interests. [ Follingstad, Alvin. Estriol, the forgotten Estrogen? JAMA 1/2/78 Vol.239, No.1, 29-30]

In summary, it is my opinion that the use of Oestriol (Estriol) should not be removed from the compounding pharmacopoeias of either the United States of America or Australia on the grounds of its unknown safety and effectiveness. The very person who first discovered the therapeutic effects of the combination of the three Oestrogens as Tri-Est, Dr. Jonathan Wright, who still practises today, has had extensive experience with the prescribing of this oestrogen combination for almost 30 years with no reported ill-effects. [Tri-Est usually contains: Oestriol 80%: Oestradiol 10%: Oestrone 10%]

The decision as to which type of Oestrogen best suits the patient should be entirely up to the patient and the doctor with the appropriate regulatory bodies (FDA or TGA) making sure that ALL the available data are used in the decision making process as to the safety thereof rather than just perusing the literature that is funded by the pharmaceutical companies. And if “natural hormones” or “bio-identical hormone replacement therapy (BHRT) “ does not cut the mustard with the FDA then let’s all go back to school and confuse all parties once again by giving them the correct scientific name, albeit : Iso-Molecular Hormone Replacement Therapy” or “IMHRT”.

Written by Bert Frigo, Consultant Pharmacist, Compoundia: Australia
Feb10, 2008

References:

• What your Doctor May NOT tell you about Breast Cancer: How Hormone Balance Can Help Save Your Life. Drs: John R. Lee/David Zava/Virginia Hopkins. (2002).
• The Miracle of Natural Hormones: Dr. David Brownstein. (1999)
• Textbook of Bio-identical Hormones: Dr. Edward Lichten. (2007).

The Medically Proven Way to Reshape Your Body

The recent release of From Belly Fat to Belly Flat by C.W. Randolph M.D., and Genie James offers our Network an invaluable resource with which to support women and men suffering the debilitating side effects of estrogen dominance, in particular persistent and unhealthy weight gain.

From Belly Fat to Belly Flat echos our Network’s body of evidence that we’re facing an estrogen epidemic that’s impairing our health in a major way, leaving us exposed to certain cancers and some pretty nasty side effects.

The obvious “give-away” for metabolic imbalance is that “middle-age spread” no amount of exercise or dieting can shift!

When we’re estrogen dominant, our body is unable to effectively use fat stores for energy, which means that our body’s ability to metablize or burn body fat for calories is compromised. In both men and women, higher estrogen levels predispose the body to store fat around the abdomen.

From Belly Fat to Belly Flat breaks down into simple steps how to sensibly and safely correct hormone imbalance through an easy-to-follow eating plan, coupled with bioidentical progesterone cream and nutritional supplements.

Step 1 lists non-negotiable foods that reduce our body’s estrogen load. Foods and drinks that increase our estrogen levels are, of course, highlighted. Meal plans for a full calendar month make for mouth-watering, healthy alternatives.

Step 2 explains how, when we boost our body’s progesterone levels, we can significantly correct our underlying condition of estrogen dominance, and drop those unwanted pounds. Our overall health and well-being will, ultimately, reflect the far-reaching benefits of progesterone supplementation.

Step 3 itemizes nutritional supplements that support hormone balance.

But there’s more!

The book outlines hormone-healthy choices that ensure we keep our flat belly for life. There’s no fear of rebounding weight gain. The book provides a simple framework we can put into action every day to keep our weight off for the long term.

Four key areas are discussed: managing stress, getting enough sleep, staying active, and boosting your adrenal glands.

There are over sixty pages of delicious, mouth-watering “Flat Belly For Life” recipes to choose from.

At the back of the book you’ll find a Journal & Food Diary, a Checklist to help you reduce your exposure to foreign estrogens, and a comprehensive Resource section.

When we consider that cancer is on the rise among both women and men, and researchers believe the obesity crisis may be to blame, then we owe it to ourself to purchase a copy of From Belly Fat to Belly Flat.

It’s a MUST READ for anyone over the age of 30!

In light, love & laughter,

Catherine P. Rollins
CEO, Making Plans Pty Ltd
Natural-Progesterone-Advisory-Network.com

Supporting Women in their Choice of Bioidentical Hormone Replacement Therapy (BHRT)

C.W. Randolph, M.D., has treated more than 100,000 women with hormone imbalances over the past twenty years. He is a board-certified obstetrician and gynecologist and a frequent speaker for medical and women’s organizations.
Genie James, M.M.Sc., cofounded the Natural Hormone Institute of America with Dr. Randolph and serves as the Executive Director of Women’s Medicine, Inc., an organisation dedicated to offering women natural medicine products.

The health, well being, and freedom of hundreds of thousands of pre-menopause and menopause women is at stake.

Jacksonville, Florida (PRWEB) January 16, 2008 — “The Food and Drug Administration’s (FDA) new policy about bio-identical hormones could potentially deny hundreds of thousands of women access to bio-identical hormone therapy,” urges C.W. Randolph, Jr., M.D., R.Ph, one of the nation’s leading bio-identical hormone physicians, and Genie James, M.M.Sc., his co-founder of The Natural Hormone Institute of America. “We want people to know that this is an egregious example of a multi-billion dollar pharmaceutical giant (Wyeth) wielding financial and political power in an effort to regain an eroding market share and female healthcare consumer trust.”

Last week, the FDA announced that there’s no evidence that “bio-identical” hormones therapies (BHRT) mixed by individual pharmacists are any safer than prescription hormones made by drug companies such as Wyeth. They warned seven pharmacy operations about misleading safety and effectiveness claims of BHRT products. The FDA stopped short of taking immediate action to stop the practice of mixing hormones or compounding them by individual pharmacists as Wyeth has sought since it filed a petition with them in 2005.

Dr. Randolph, who is the best selling author of “From Hormone Hell to Hormone Well” and “From Belly Fat to Belly Flat,” originally practiced as a compounding pharmacist before returning to medical school. He established his OB/GYN practice in Jacksonville, Florida in 1986 and - like most physicians at that time - prescribed synthetic hormone therapies such as Premarin, Provera and later Prempro. Dr. Randolph stopped prescribing these pharmaceutically manufactured synthetic hormones because of the side effects experienced by his patients.

“Long before the output of the Women’s Health Initiative (WHI) validated the health risks associated with synthetic hormone replacement [such as an increased risk of breast and uterine cancers, heart attack, stroke and increased risk of dementia I was concerned,” says Dr. Randolph. “I drew on my background as a compounding pharmacist to research safe and effective alternatives. For more than a decade, I have prescribed bio-identical hormone therapies (BHRT) for literally tens of thousands of patients. Not only do my patients report that they ‘feel like themselves again’, they also remain side effect free. My clinical experience validates the medical research substantiating the safety and efficacy of BHRT.”

Why is the FDA attacking BHRT? “Money, politics and power,” Ms. James, the co-author of Dr. Randolph’s books, responds. “There are currently close to 38 million women in the U.S. entering pre-menopause or menopause. This is a huge market. When the results of the WHI study were first released in 2002, the sales of synthetic hormone therapies dropped almost 50% immediately. It is worth noting that synthetic hormone formulations are patentable. Bio-identical formulations can not be patented because their molecular structure originates in nature, e.g. the human body.”

“The issue here is not the safety of women who are choosing BHRT as their treatment of choice for menopausal and pre-menopausal symptoms, it is dollars. Wyeth’s financial reports, which are available online at www.wyeth.com, suggest an ongoing and significant decline in the sales of the Premarin synthetic hormone family of products; e.g. from over $2 billion in 2002 to $880 million in 2004; a 68% decline in sales.”

“Many women who stopped taking synthetic hormones therapies began to do their homework and research alternatives,” continues Ms. James. “The result is that in the last five years there has been a significant upsurge of women choosing (and physicians prescribing) BHRT as an effective alternative that is formulated to match the structure found in the human body, a common practice in other medical treatment areas such as in the treatment of the thyroid.. No wonder Wyeth is worried. And, for anyone doubting the influence that a multi-billion pharmaceutical company might have on a government regulated agency such as the FDA, I would suggest that they read the book by Marcia Angel, M.D. (former editor in chief of The New England Journal of Medicine) The Truth About Drug Companies: How They Deceive Us and What To Do About It.”

Last week, when the FDA issued the warning to compounding pharmacies across the nation, they stated that they should halt the compounding of medications containing estriol. “The FDA is way out of bounds here,” says Dr. Randolph. “Like many commonly prescribed drugs (e.g, Phenobarbital, quinine, tinidazole), estriol has a monograph from the U.S. Pharmacopeia (USP), but is not currently a component of an FDA-approved drug. When it passed the FDA Modernization Act in 1997, Congress clearly indicated that drugs with a USP monograph could be compounded. In addition, the practice of medicine and pharmacy is legislated at the state level. The FDA officially does not have jurisdiction in this area.”

“As Ms. James stated, the fundamental issue at stake is much more critical,” says Randolph. “The larger issue is the health and well being of millions of American women who, with their physicians, want safe and effective hormone replacement therapy. The big pharmaceutical muscles are working to do away with BHRT, despite medical studies and clinical evidence validating it as a safe and effective solution for women suffering from symptoms of hormone imbalance.”

“There is now real data linking a decreased incidence in U.S. breast cancers with a decrease in the number of prescriptions written for synthetic hormone therapies. Now think about this: during these same years, we have seen lock-step increases in the number of prescriptions written for BHRT. Why isn’t the government funding a study examining the inverse relationship between the rise in the popularity and use of BHRT and the decline in the incidence of breast cancer?” asks Ms. James.

For more information on bio-identical hormones, go to www.hormonewell.com. For media inquiries, contact Nanette Noffsinger at nanette@burkehollowmedia.com or 615-776-4230.

Will Wyeth Bully You out of Your Estriol?

The FDA has begun 2008 by forbidding compounding pharmacists to use estriol in their natural hormone formulations because the agency doesn’t have a specified approved use for it. They took this action because Wyeth complained about it.

In case you’ve forgotten, Wyeth is the giant pharmaceutical company that makes Premarin and PremPro, synthetic hormones found to cause heart disease, strokes and cancer. If we do some rough calculations based on statistics from the Women’s Health Initiative (WHI), Wyeth’s hormone replacement drugs have killed tens of thousands of women over the past few decades. Sales of these dangerous drugs have plummeted since the WHI results were announced, and women who were injured by them and sued, are winning millions in damages in courtrooms around the U.S. (You go girls!)

Estriol is a Safe Alternative

Estriol, on the other hand, is a mild (natural) estrogen that’s primarily used in cream form for vaginal dryness and urinary tract problems in menopausal women. It’s been in common use in Europe for well over a decade, and its safety and effectiveness are well established. Many doctors in the U.S. who use natural hormones prescribe tri-est and bi-est, estrogen cream formulations made by compounding pharmacies that contain estriol. These formulations appear to be what Wyeth perceives as its competition. If you’d like to know more about estriol, Dr. David Zava wrote an entire chapter on it in What Your Doctor May Not Tell You about Breast Cancer.

The doctors and pharmacists can take the estriol out of the formulas and they’ll still work well because they also contain estradiol, but ironically they probably won’t be quite as safe. Estriol may have some protective properties that balance estradiol’s cancer-promoting effects. In fact, estriol is so safe that it’s the primary estrogen of pregnancy—the fetus is bathed in it.

The Bully in the Neighborhood

It’s shameful of Wyeth to use its clout and money to bully and beat on the competition through the FDA, but by now we expect that behavior from them. The real shame is that the FDA can’t seem to stop itself from being bullied. You can bet there was some major arm twisting going on to push the FDA into this action, because they just have to know that it’s been proven safe and effective in Europe, and that thousands of annoyed menopausal women are going to be sending them e-mails. We can only hope that the FDA responds by quickly reviewing the body of excellent research available on estriol and taking action to assign it some specific and approved uses.

Many for profit and nonprofit groups interested in defending a womens’ right to use estriol are putting together a unified message to send to the FDA. If they call for a petition I’ll be sure to let you know.

In the meantime, if big bad Wyeth succeeds in taking your estriol away, and you can’t have sex because of vaginal dryness, send your partner to Washington to march on the FDA’s doorstep. Just kidding. This is an especially poignant issue for women with breast cancer or who have had breast cancer, because estriol is a safe alternative to estradiol. The estrogen-blocking drugs such as tamoxifen that are used to treat breast cancer can cause terrible vaginal dryness and urinary tract problems, and even without the drugs, these are serious problems for many menopausal women.

Estradiol cream is an effective, albeit less safe, treatment for vaginal dryness and urinary tract problems. Please use the lowest dose possible that relieves symptoms and use progesterone cream for balance. For details I recommend that you read Hormone Balance Made Simple.

Keep it natural,
Virginia Hopkins

Editor, Virginia Hopkins Health Watch

http://www.virginiahopkinshealthwatch.com

Inept FDA Declares Misguided War on Bio-Identical Hormones, and Promptly Shoots Own Foot

Acting as agent for drug maker Wyeth this week, a dysfunctional and inept FDA fired the opening salvo in a misguided war on bio-identical hormones. Using typical Orwellian DoubleSpeak, the FDA issued a series of nonsensical and contradictory statements intended to serve the financial interests Wyeth, maker of synthetic hormones Premarin and Prempro, found to cause cancer and heart disease in the 2002 NIH sponsored Women’s Health Initiative Study.

Since the study’s release, millions of women have switched to the safe and more effective bio-identical hormones, currently prescribed by thousands of physicians, available as FDA approved products at local drug stores and compounding pharmacies. Wyeth has lost market share and suffered financial loss as synthetic hormone profits have declined from 4.4 to 1.2 billion annually from 2001 to 2006.

Click HERE to read full article

Coalition of Doctors Condemn FDA Decision to Deny Women Access to Bioidentical Hormones

A coalition of gynecologists, internists, allergists, ER physicians and general practitioners responsible for treating thousands of women today criticized the Food and Drug Administration (FDA) for taking action that threatens to deny hundreds of thousands of women access to customized medications they take for symptoms of menopause.

Click HERE to read full article

FDA Asserts New Policy to Restrict Women’s Access to Bioidentical Hormones

In a series of warning letters to compounding pharmacies across the country, the Food and Drug Administration (FDA) has asserted a policy that would deny hundreds of thousands of women access to many commonly compounded bioidentical hormones, substituting its judgment for that of doctors.? Wyeth Pharmaceuticals, the number one manufacturer of synthetic hormone products, petitioned the FDA to do so in October 2005.? More than 66,000 doctors, patients, and pharmacists filed comments with the FDA opposing Wyeth’s petition.

“Under this policy, patients will suffer while Wyeth profits,” said L.D. King, executive director of the International Academy of Compounding Pharmacists (IACP).? “Thousands of doctors are making patient-by-patient decisions that compounded hormones are medically appropriate, sometimes because Wyeth’s products are found to be ineffective or produce side effects.? This is a decision that should be left to doctors.”

Click HERE to read full article

Wyeth’s War on Women and Bioidenticals

The Food and Drug Administration has declared war on bioidentical hormones and plans to eliminate the compounding and availability of estriol.

This disgraceful action is the direct result of an intense lobbying petition by Wyeth, the leading manufacturer of synthetic hormone products, even though more than 60,000 doctors, patients and pharmacists filed comments with the FDA opposing Wyeth’s petition.

The lesson here: When Wyeth speaks, the FDA listens.

Click HERE to read full article

FDA’s New Release

FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs
FDA Cracks Down On Custom-Made Hormones

I am from Bangalore, South of India. We are dealing with a prostate situation (skeletal bone metastasis) for my father. I have attached the case summary for your perusal. I request you to kindly review the same and share your comments.

The subject is 71 year old male, 5′5″ height, 130 lb, Indian Caucasoid of Brahmin ethnicity. Doctors here offered multiple harmone ablation options.

Current treatment is through hidose Honvan DES Diphosphate (120*2 = 240mg) taken daily since 5 October 2007 (9 weeks ongoing). At high dose Honvan sort of chemically castrates and lowers Testosterone.

The primary purpose of this message though is getting clarity on harmone balancing and managing the treatment.

In early October, before studying your website I had almost made up my mind to try progesterone cream. After studying your site, which I must compliment is remarkable, I wanted to check with you before exploring such options.

Operating from India necessitates certain constraints - Prostate problems are not common here. In our extended family 3 generations (mine, my father’s/his siblings and our grand parents’), average longevity (~85 years, 75 to 92), we are yet to see any prostate problem. This can also be because we get enough sun here and don’t ever test PSA.

There are very few doctors that specialize in prostate treatment; the local oncologists typically recommend harmone ablation using zoladex and casodex (150mg).

Honvan DES Diphosphate (120*2 = 240mg) taken daily since 5 October 2007 (9 weeks ongoing). During Honvan course subject has perceived breast enlargement, shrinking penis and testicles. No libido/erections.

15 November 2007 PSA down to 50↓. Haemoglobin is 11.6↓. Alkaline Phosphatese 147(↑), Acid Phosphatese 15.5 (↓) No Symptoms.

Hormone Levels:

• Testosterone Free (g/mL) 0.46 ↓ (close to castrate level?)
• Progesterone (ngmL) 0.003↓ (close to castrate level)
• Estridiol - E2 (pg/mL) 40.61↑

Supplements:

• 1 x Mineral Capsule, 1 x Vitamin Capsule (both contain bare minimum of essential FDA approved constituents), 1 x Beta Glucan 1g Capsule
• 250g Calcium
• Vitamin D (800 IU)
• Selenium 90 mcg
• Melatonin 3 mg
• Takes Kyogreen (2 tea spoonfuls mixed with 100ml water)
• 200ml (~ 6 oz) each Pomegrenate Juice, (~ 6 oz) Carrot Juice (6 oz), Coconut water (6 oz)
• 2 x teaspoonfuls freshly ground flax seed with fat free organic cow’s curd (3 oz)

Diet:

• Indian wheat bread/brown Rice with boiled vegetables; legumes, (~half an ounce of home made butter, coconut oil)
• Indian food involves adding turmeric and grounded coconut
• Takes 1-2 banana and 1 orange daily
• Takes 8 oz of organic cow milk

Exercise:

• Moderate stretching posturing and breathing exercises (Asana/Pranayama of Yoga protocol)

Objective:

Cure PCa (minimum control the disease); maintain quality of life.

Dr Zava responds …

I have reviewed the clinical status of the referred patient with prostate cancer. The goal of cure is unlikely but control of the metastatic disease is more realistic.

Regarding the serum hormone status and prostate cancer, it is not unusual to see low testosterone, low DHEAS, and elevated estradiol. Treatment with androgen-lowering medications usually has a palliate effect, but when cancers return they tend to be more aggressive. Current thinking by some is that testosterone helps to allow for continued differentiation of the tumor cells. The prostate contains receptors for androgens (testosterone and DHT) as well as estrogens. Estrogens increase androgen receptors, growth of which is then stimulated by the most potent androgen DHT. The greatest growth would occur in men with high estrogens and DHT. Young men have a lot of testosterone and DHT, but little estrogen (estradiol or estrone). It may be this difference (high estrogens AND low androgens in the older male vs low estrogens and high androgens in the young male) that sets up conditions that lead to prostate cancer in the older male. Clinical studies using testosterone therapy in older men have not shown an increase in prostate cancer, which is inconsistent with the idea that androgen ablation therapies benefit a man with prostate cancer and cause tumor regression.

Now to the issue of progesterone in the male. Men don’t make much progesterone outside of their adrenal glands. John Lee put forth the concept that progesterone supplementation would be beneficial in men and help with prostate issues (BPH or cancer). This stemmed from the notion that progesterone has both anti-estrogenic properties (down regulates estrogen receptors and prevents estrogens from up-regulating genes involved in cell proliferation (e.g. BCL2), helps clear estrogens from target tissues, and competitively inhibits testosterone conversion to DHT. Overall, I could see where progesterone, assuming it did all of the above, would “hypothetically” force the hormonal milieu to more of a “young male” type.

In my opinion, one of the big mistakes with using progesterone, in both men and women, is that dosing is based on serum venipuncture levels following topical progesterone supplementation. A lot more progesterone gets into tissue than is apparent from serum derived by venipuncture. Saliva and capillary blood reveal that progesterone is readily taken up by tissue when delivered topically. A lot less progesterone is needed to create physiological conditions that benefit the reproductive tissues, immune system, brain, and heart. Enough said here, it’s my opinion.

When I was lab director at Aeron Lifecycles, John Lee and I were following five men with metastatic prostate cancer and elevated PSAs. These men began using progesterone in the hopes that it would cure their disease. Over the year or so I looked at their hormone profiles, PSAs, and symptoms, I didn’t find that progesterone did much for them. It didn’t change their outlook on life, alter their PSAs or how they did with their cancers. Men with upbeat attitudes did better. I learned some years later that two of these men had died, one of which I remember had a terrible attitude about everything (based on conversations with him). One of the other men I see often at A4M meetings, even last month. He has been taking testosterone for quite some time, and he looks healthy and is interested still in all this hormone stuff. While that’s n=1, it is what I have seen with cancer patients in general-better attitude, better outcome. Also, these people tend to stay away from conventional drugs and therapies (e.g. statins, chemo and radiation therapy).

The issue with testosterone, in my opinion, is that men tend to use too much of it. Again, they base topical dosing on serum levels and the assumption that only 10% absorbs through the skin. Big mistake! This overdosing with 50-100 mg of testosterone often results in high conversion to estrogens. Estrogen, in excess, is unhealthy both in women and men. Physiological estrogen, in both men and women, is essential for health. Also, excess of any hormone results in down-regulation of that hormone’s receptor, and subsequent tissue desensitization. Testosterone in men, like progesterone in women, allows for tissue differentiation. Too much estrogen (from aromatization of excessive testosterone) in both males and females results in to much proliferation and too little differentiation, which increases risk for cancer. Bottom line here is use a physiological dose of whatever hormone, and deliver it in a way that results in physiological levels IN TISSUE. What is physiological? In men, this would mean 5 mg testosterone and a very small amount of progesterone (1-5 mg) if it is delivered topically. John Lee agreed that no more than about 5 mg of testosterone was needed in men when it was delivered topically.

So, I would agree that restoring the hormone levels to a healthy youthful level can have benefits for men with or without prostate cancer. It won’t likely cure the disease, but it may tame it and allow coexistence for a normal lifespan.

If you want to know what I am thinking about hormone testing, this is what I would recommend. Since there is serum testing history, I would suggest testing for estradiol, testosterone, DHEAS, PSA and SHBG in blood spot and 4 x cortisol in saliva. It might also be worthwhile to look at hs-CRP and vitamin D in blood spot. In patients with active prostate cancer the hormone pattern is often high estradiol, low testosterone, very low DHEAS, elevated PSA, flat cortisol diurnal pattern (high night cortisol), elevated hs-CRP (reflecting inflammation of cancer), and very low vitamin D.

If progress is being made with natural therapies these profiles should be improved.

If you are interested in more popular alternative therapies that have been used for treating cancers you might want to check out the book “Outsmart Your Cancer” by Tanya Harter Pierce. I am particularly impressed with the Protocel therapy and have seen cancer regressions in several people I know personally.

I hope this helps.

David Zava, Ph.D.
CEO/President
ZRT Laboratory

Virginia Hopkins reponds …

I don’t think we really understand the prostate yet. The research is incredibly contradictory and there are way too many quirky theories.

When someone finally figures it out I think the light bulb will go on for all of us.

Meanwhile, just FYI, attached in a pdf file is an article by Dr. Russell Blaylock, the best piece I’ve seen yet on treating and preventing BPH, and it should also certainly be helpful in preventing prostate cancer.

Virginia
Virginia Hopkins Health Watch

Alan Altman, MD*, clinical professor at Harvard Medical School and an advisor to Women in Balance, has assembled the real facts on the Women’s Health Initiative (WHI), a landmark women’s health study that when reported by the government had wide (and detrimental) impact – creating mass fear for women about hormones, and forever changing practitioners prescribing of hormones. 

Even though this study has had far reaching impact, less than one-third of women are even aware of the WHI, a recent study by Stanford researchers have found, and many doctors still are unaware of the real findings that have emerged over time and through critical analysis.

So, here are the facts on the WHI from an expert who understood from the beginning what the study showed and did not show.  

What the WHI (erroneously) “concluded." 

• Hormones are BAD for women
• Hormones increased breast cancer risk
• Hormones increased heart attack risk
• Hormones caused dementia
• Hormones should not be used for prevention of heart disease
• Only use hormones for symptom relief at the lowest dose and the shortest time (WIB note: currently there is no research on this recommendation)

What the WHI CAUSED after their “conclusion” 

• Primary Care Providers took their patients off all hormones
• Women stopped taking their hormones
• Media driven hysteria and panic among hormone users
• FDA change language from HRT to HT (hormone therapy)

WHI – Here are the Facts – Straight Talk from Alan Altman, MD 

• The WHI did not study all “hormones."  In fact, the ONLY hormones studied were Prempro© and Premarin© (non-human identical hormones and only pill form)

• The WHI Study was not really about “all women”…average age of the women studied were 12 years after menopause…averaged 64 years old at outset of study

• What WHI actually did show was that a 72-year old woman should not be started on oral Prempro© to protect her heart.

• Also, there appears to be a risk of breast cancer concerned with use of the potent synthetic progestin (or Medroxyprogesterone Acetate - MPA) that was used in the WHI.

• Oral estrogens increase the risk of blood clots and of strokes related to blood clots. (We’ve known this for 30+ years, however we see no increase in clots or strokes on non-oral estrogen.)

• Any small increase in dementia was seen only in women ages 75 to 80! (Numerous studies of women starting HT at the appropriate age close to their final menstrual period have demonstrated a 50% to 65% decrease in the risk of Alzheimer’s disease.)

• Women saw no quality of life benefits from taking these hormones, because 88% of the women in the study had no menopausal symptoms to begin with.

• There was a slight increase in breast cancer risk when on Prempro© (estrogen and progestin) and slight decrease on Premarin© (estrogen therapy).

Key Facts:

• Non-oral estrogen (specifically estradiol via transdermal patch, gel or transvaginal ring) AND natural micronized progesterone taken orally is presently safer, healthier and more “natural” for use in hormone therapy.

• There is a serious lack of consensus in the data looking at estrogen use and breast cancer risk.

• Testosterone can be useful in the appropriate patients post hysterectomy.

* Alan Altman, MD is Assistant Clinical Professor of OB/GYN and Reproductive Biology at Harvard Medical School.  He is a practicing gynecologist, specializing in peri and post-menopausal health, hormone replacement therapy and female sexuality. 

Op Ed says Initial Conclusions Drawn by the WHI Investigators were in Part Misleading. Calls on Government to Reissue Findings

The October 2007 issue of CLIMACTERIC, a professional medical journal, says detailed evaluation and analysis of the WHI data showed that the initial conclusions drawn by the WHI investigators were in part misleading. Read here >>

Source: WomenInBalance.org

"Previously, patients with aggressive metastatic or locally advanced breast cancer no longer responding to currently available chemotherapies had limited treatment options," said Linda Vahdat, M.D., of New York-Presbyterian Hospital/Weill Cornell Medical Center, in a statement released by the company. "The approval of Ixempra means that we now have an important new option for patients with metastatic breast cancer who have rapidly progressed through currently approved chemotherapies."

Let’s therefore examine just how "important" this new option is likely to be to patients with metastatic breast cancer.

First of Two Trials

FDA’s approval of Ixempra was based on two clinical trials that included a total of 878 patients. The first of these studies was a phase II (non-randomized) trial of Ixempra as a stand-alone treatment. That study enrolled 126 patients with either metastatic or locally advanced breast cancer that had proven resistant to three prior therapies. There was an "objective partial response" in 12.4 percent of 113 evaluable patients. In other words, fewer than one out of eight patients who got the drug saw their tumors shrink. (And, by the way, whatever happened to the other 13 "unevaluable" patients in the study? Under the commonly observed intent-to-treat rule of medical statistics, they should have been included in this analysis.)

A partial response is generally defined as an incomplete shrinkage of the tumor by more than 50 percent for one month or more. As long-time readers of this newsletter will know, a partial response generally does not correlate with increased survival.

Side effects of Ixempra in this trial included the following:

• Peripheral sensory neuropathy in 62 percent of patients, with serious to severe effects (Grades 3 and 4) in 14 percent;
• Fatigue/asthenia 56 percent (Grade 3/4: 13 percent);
• Myalgia/arthralgia 49 percent (Grade 3/4: 8 percent);
• Alopecia 48 percent (Grade 3/4: 0 percent);
• Nausea 42 percent (Grade 3/4: 2 percent);
• Stomatitis/mucositis 29 percent (Grade 3/4: 6 percent);
• Vomiting 29 percent (Grade 3/4: 1 percent);
• Diarrhea 22 percent (Grade 3/4: 1 percent);
• Musculoskeletal pain 20 percent (Grade 3/4: 3 percent).

Major hematologic (blood-related) adverse events included neutropenia (Grade 3-4 in 54 percent) and leukopenia (Grade 3-4 in 49 percent).

Combination Trial

FDA also took into consideration a larger phase III randomized trial which evaluated the efficacy and safety of Ixempra combined with Xeloda (capecitabine) in comparison to Xeloda used as a stand alone treatment. This trial included 752 patients who were previously treated with anthracyclines (such as Adriamycin) and taxanes (such as Taxol), and whose tumors had already shown resistance to these therapies. In this trial, Ixempra in combination with Xeloda resulted in a slight improvement in progression-free survival (PFS) compared to Xeloda given alone.

The median progression-free survival with the combination of Ixempra and Xeloda was 5.7 months vs. 4.1 months for Xeloda alone - a gain of 1.6 months. But the side effects included peripheral sensory neuropathy in 65 percent, hand-foot syndrome in 64 percent, nausea in 53 percent, diarrhea in 44 percent, etc.

Again, readers will note that the above statistics do not yield any information on overall survival, i.e., how long on average Ixempra patients can be expected to live compared to those who got either Xeloda alone or no further treatment. The increase of 1.6 months (which you can be sure will be widely bandied about as indicative of the "value" of Ixempra) refers solely to an improvement in progression-free survival. But progression-free survival is not at all the same thing as improved overall survival. Progression-free survival is the time during which the disease appears stable before once again beginning to advance. It is entirely possible that two groups of patients could have a significant difference in this parameter, but the disease could still claim their lives at roughly the same time.

A Bristol-Myers spokesperson has been quoted as saying that the cost of a full course of Ixempra would be between $18,440 to $23,050.

There was a time when FDA required proof of increased survival before it would approve a new drug. Now Bristol-Myers has gotten Ixempra onto the market, having only shown a slight increase in a surrogate marker of doubtful benefit.

–Ralph W. Moss, Ph.D.

Source: www.cancerdecisions.com

Breast cancer rates soared in the 1980s, 1990s and peaked in 2001. Guess what? The increase in breast cancer diagnosis paralleled a surge in the number of prescriptions written for synthetic hormone replacement therapies (HRT) such as Prempro and Premarin. When the 2002 Women’s Health Initiative (WHI) study first reported that synthetic HRT could increase the risk of breast cancer, many women tossed their pills down the toilet despite the fact that their physicians and the drug manufacturers pooh-poohed the possible association. Today, new stats from Kaiser Permanente Northwest validate the wisdom of those women who took their health back into their own hands.

Breast cancer rates have dropped as much as 18% from 2003 through 2006. This decrease directly coincides with a drop in the number of prescriptions written for synthetic HRT (from approximately 90 million to less than 20 million) following the release of the WHI results. According to Phillip O. Warner, M.D., a well-respected physician and medical researcher in the field of menopause and hormone replacement, “The evidence that synthetic hormones cause invasive hormone positive breast cancer is now uncontroversial and generally accepted.”

Bio-Identical Progesterone: Possible Protector Against Hormone Positive Breast
Cancer

A hormone positive breast cancer tumor is a tumor that needs hormones, specifically estrogen, in order to grow and progress. The medical term for these types of tumors is
estrogen receptor-positive. A critical question is “Where does the tumor get the estrogen that feeds its growth?” The answer can be different for different women. Let me explain. Estrogen and progesterone hormones are produced by the female ovaries. Estrogen fuels cell growth, which, if unchecked, can be a precursor of cancer.

When the internal levels of estrogen and progesterone are balanced, however, progesterone neutralizes estrogen’s ability to stimulate cell growth. In other words, progesterone evidences a natural anti-estrogenic action. When internal progesterone levels are sufficient to balance estrogen levels there will not be enough “extra” estrogen circulating within the body to stimulate estrogen receptor-positive tumor growth.

In addition to synthetic hormone replacement therapy, two other common factors can cause the ratio of progesterone to estrogen to become unbalanced and thereby foster a condition of estrogen dominance. These are age and body fat. When the body is estrogen dominant, estrogen dependent tumors get “fed” and they grow.

• Age creates a naturally occurring condition of estrogen dominance. In all women, progesterone production begins to decline in the early to mid- thirties. Progesterone levels actually decline 120x more rapidly than estrogen levels.

• Fatty tissue within the body also produces estrogen. This means, that regardless of her age, if a woman is overweight she is more likely to be estrogen dominant.

Today, in the United States, Tamoxifen is the drug of choice to treat estrogen dependant breast cancer tumors. Tamoxifen acts as an anti-estrogen thereby blocking estrogen’s ability to stimulate cell growth. But Tamoxifen is prescribed after a woman has a breast cancer tumor. What can a woman do to proactively nullify her chances of getting an estrogen dependant tumor? Is there anything that can be done preventatively? Absolutely. The anti-estrogen action of bio-identical progesterone can help prevent the occurrence and metastasis of estrogen receptor-positive tumors. This is not just my opinion. Multiple medical studies examining the anti-estrogen action of bio-identical progesterone in breast tissue validate this premise. (Link www.womeninbalance.org/research/breast.html).

My clinical experience is a testimony. In over a decade of treating over ten thousand women suffering from hormone imbalances, I have only had two patients on my bio-identical progesterone therapy regimen develop breast cancer. The national average is 1 out of every 8 women.

A Large Round of Applause for Comcast ON DEMAND

I am very excited that, to help raise awareness and provide important information about breast cancer, Comcast is launching Breast Cancer Hope. This is a first-of-its-kind video-on-demand and online initiative that brings together educational and inspirational content for all women who want and need to know more about breast cancer.

Comcast is working with Lifetime, which is serving as the sponsor of Breast Cancer Hope, as well as The Style Network, HBO, Discovery Health, Exercise TV and breastcancer.org, the leading online site for medically reviewed and up-to-date information about breast cancer, to present dozens of programs about detecting and living with breast cancer, as well as discussion forums, health and fitness advice and relevant news clips.

Continuing throughout October, Comcast customers with ON DEMAND service will have access to more than 40 programs in five topical areas:

• Inspiration: six episodes of HBO’s Sex and the City featuring Samantha’s (Kim Cattrall) battle with breast cancer; segments from the Lifetime series Intimate Portraits featuring profiles of Ann Curry, Betsey Johnson and Rosanna Arquette, as well as the Emmy(R)-nominated Lifetime original movie, Why I Wore Lipstick to My Mastectomy, starring Sarah Chalke (Scrubs); the documentary Dear Talula, about a young mother who discovers she has breast cancer; and from Discovery Health, personal and motivational stories from cancer survivors such as I Have Breast Cancer: Janice’s Journey.
• Fact or Fiction: exclusive content created by Lifetime and breastcancer.org featuring interviews with doctors and other health professionals that offer a patient’s perspective about what to expect from visits to specialists like radiologists, breast surgeons, oncologists, plastic surgeons and genetics counselors.
• What’s My Risk: from Discovery Health’s series Breast Health: New Hope, programming on breast cancer causes, prevention and treatment are featured along with the experiences of families affected by the disease; healthy-cooking recipes from Comcast’s Digital Cookbook series; mini workouts from Exercise TV; and breast-cancer-related episodes from Comcast’s Seeking Solutions with Suzanne and It’s Your Call with Lynn Doyle.
• Breast Cancer Info: programs following women from the diagnosis stage through treatment and exploring plastic surgery and reconstruction options.
• Fashion Tips: advice for patients and survivors, from demonstrations of how to wear a scarf to makeover shows, including special segments from The Style Network’s popular series, How Do I Look? and Whose Wedding is it Anyway?

Comcast also is making a wide range of breast cancer information available online at www.comcast.net/breastcancer. On that site, visitors can view video news reports, read and post to message boards about breast cancer. If you are a “believer” in the breast health benefits of bio-identical progesterone, or if you simply want to learn more about the research behind its cancer-protective properties, join me in logging on to let Comcast know that in 2008 this is a topic that must be highlighted!

I wish you WELL!

Dr. Randolph

Source: http://www.hormonewell.com

It’s one thing to use recycled water for non-drinking purposes such as irrigation and flushing of toilets, quite another for the masses to be drinking it.

Endocrine disrupting chemicals (EDCs) are man-made synthetic chemicals that interfere with the endocrine systems of humans and animals by mimicking, blocking and/or interfering in some manner with the natural instructions of hormones to cells. The resulting disruption creates many problems with physical development, sex, reproduction, brain development, behavior, temperature regulation and more.

Known EDCs that can be found in wastewaters and the environment include the estradiol compounds commonly found in the contraceptive pill, phytoestrogens, pesticides, industrial chemicals such as Bisphenol A and nonyl Phenol, and heavy metals (Lintelmann et al. 2003).

While EDCs are present in untreated sewage effluent in concentrations much lower than natural hormones within the body and many have endocrine capabilities than are up to several thousand times less than natural hormones. Secondary treatment of sewage effluent is recognised to remove the majority of these chemicals from the effluent (Staples 1998, Wang et al. 2003).

While the health impacts for humans is considered low to negligible due to the very low concentrations in treated effluent, it has been demonstrated that wildlife that are in constant or near constant contact with water receiving treated effluent and other EDC-containing waters (eg, alligators in Florida and riverine fish in the UK) can be impacted (Guillette et al. 1994, Jobling et al 1998). The Floridian alligators were found to suffer from problems relating to the size and development of male gonads in Juvenile male alligators which was related to the presence of estrogenic-like compounds in the Florida everglades (Guillette et al. 1994). Joblin et al. (1998) observed that there was in increase in intersexuality of riverine fish which was linked to the presence of EDCs in UK water ways.

The research by scientists at the Battelle Marine Sciences Laboratory in Sequim focus on trout, which is related to salmon, and for looking at reproductive effects on adult fish rather than juveniles. How fish are affected by such chemicals in the wild remains unclear. “It’s something we’re concerned about,” said Irvin Schultz, a senior research scientist at the lab. In the experiment, adult trout in caged pens were exposed to ethynylestradiol, a synthetic estrogen. After two months of exposure, the fish were spawned with a healthy female. Researchers discovered that the exposed trout were half as fertile as fish kept in clean water.

Right now, the ecological effects of chronic low-level exposure to many EDCs are unknown.

Many of these chemicals are washed down our drains and toilets, and much of that is coming from the urine of pharmaceutical users. From there, many compounds are passing through wastewater treatment plants and into rivers, lakes and aquifers, many of which serve as public drinking sources.

While treatment plants are equipped to remove most solid waste and many chemicals before wastewater is released into surface water, they are not equipped to remove them all.

Among the contaminants that are not easily removed are antibiotics, antidepressants, and estrogen replacement drugs.

More than eight million women in the United States take estrogen replacement drugs to treat the symptoms of menopause and osteoporosis. Synthetic estrogen is a common ingredient in oral contraceptives. So what happens when estrogen is consumed, flushed down the toilet as urine, and then not filtered out in the wastewater treatment facility? As wastewater becomes “usable” again, as it seeps into the ground and is eventually assimilated into groundwater, this useable water may have significant levels of estrogen (and a variety of other chemicals).

We have good reason to be wary of exposure to foreign estrogens. Breast cancer is a major health issue. It is the most common cancer-related cause of death in women in Australia. One in twelve Australian women will develop the disease and each year many women die from it. We are now learning that many of these cancers are all known to be a result of hormonal imbalances. Specifically they are a result of excess estrogen or estrogen dominance. According to Dr Cavalieri, Professor at the Eppley Institute for Research in Cancer and Allied Diseases at the University of Nebraska Medical Centre in Omaha Nebraska, he and his team are at the brink of discovering that almost all the important human cancers that we get in Western civilization, have the same origin, which is estrogen. Estrogens, according to Dr Cavalieri, are initiators and promoters of cancer. The initiation of normal cells turning into cancer cells is the same for both the breast or uterus and the prostate gland. In these organs, cancer initiation is due primarily to estrogen dominance combined with lifestyle factors and/or toxic insults that predispose estrogen to become oxidised.

Researcher Dr Heather Chapman from the Cooperative Research Centre for Water Quality and Treatment writes, “We have demonstrated through our research that conventional wastewater treatment processes used in Australia remove 95-99% of hormones. Any remaining traces are removed by the advanced treatment processes, such as reverse osmosis, that are used in water recycling schemes” she said. Reverse osmosis is also used to produce the extremely high quality water required in industry.

The University of NSW report, commissioned by the Local Government Association of Queensland, reviewed recycled drinking water in the US and Singapore, as Queenslanders consider their views before a referendum in March 2007.

Despite concerns about the possibility of recycled water exposing human beings to high concentrations of hormones, they said southeast Queensland studies had shown estrogenic hormones were at concentrations too low to be measured after conventional sewage treatment. And advanced purification processes, such as reverse osmosis membrane treatment and advanced oxidation, were all highly effective in removing any remaining hormonal steroids.

Nevertheless, the report said a comprehensive health assessment was necessary before any Australian scheme went ahead.

Frederick vom Saal, a biologist and professor at the University of Missouri-Columbia, has been studying fetal development since the mid-1970s. He discovered vanishingly small amounts of free estrogen are capable of altering the course of development in the womb – as little as one-tenth of a part per trillion. Given this exquisite sensitivity, even small amounts of a weak estrogen mimic – a chemical that is one thousand times less potent than the estradiol made by the body itself – may nevertheless spell big trouble!

Howard Bern, a comparative endocrinologist at the University of California at Berkeley and a major figure in experimental DES research, has explored the effects of weak estrogens found that in experiments with mice that so-called weak estrogens seem to have a far more potent effect on the unborn than on exposed adults. What happens in adults, he stresses, is no basis for predicting what these chemicals can do to the unborn.

In truth, no one yet knows how much it takes of these synthetic hormone-disrupting chemicals to pose a hazard to humans. All evidence suggests that it may take very little if the exposure occurs before birth.