Many clinicians have treated female patients (for up to thirty years) with a natural form of estrogen called "estriol." I, too, have treated patients with this bio-identical hormone. My observations of the treated women confirm what the other clinicians have told me, which agrees with the FDA record—the hormone is both gently effective and safe. In all those years of use, the FDA admits that it has received no reports of adverse effects of estriol.[5]

Despite the safety record of estriol, Wyeth Pharmaceuticals and the FDA have moved to stop the use of estriol. As Dr. Steven Hotze recently wrote,^[4] "Wyeth has worked in collusion with the FDA to protect its profits by having the FDA issue a compliance policy guideline prohibiting the use of estriol." If Wyeth and the FDA have their way, women who need estrogen therapy will have no choice but to use products such as the dangerous sex hormones that Wyeth and other such corporations market.

Wyeth has two products with a bad safety profile: (1) Premarin^®, which contains conjugated estrogen from horse urine, and (2) Prempro^®, which contains the same estrogen and methoxy-progesterone acetate. The latter hormone is called a "progestin." This term means that the molecule isn’t truly progesterone; instead, it is similar to progesterone and has some of this natural hormone’s biological activity. Of course, by constructing a molecule that is not natural progesterone, drug companies have been able to patent and charge more for it. And while progestins have been enormously profitable for drug companies, they have devastated many women.

I’ve long known about the potential harm of progestins. I learned about it in the 1980s. Then, I treated almost exclusively patients who had myofascial pain syndromes due to trigger points. Some women came to me with severe recurrent neck and head pain from trigger points that were fully resistant to myofascial therapy. This therapy is so highly effective in relieving trigger point pain that I knew something was making the women treatment resistant.

I learned that these women took birth-control pills that contained progestins. In reading the research literature, I also learned that progestins can have two effects that cause an energy deficiency in cells. It was a reasonable deduction that the energy deficiency in muscle cells would induce muscle contractures that activate pain-referring trigger points.

First, progestins can decrease the number of insulin receptors on cells. This makes insulin less effective at getting sugar from the blood into the cells. Second, progestins can block an enzyme in cells called "glycogen synthase." This enzyme stimulates the polymerization of sugar molecules into starch, essentially storing energy for later use by the cells. Blocking this enzyme reduces the amount of sugar stored as an energy reserve.

In most instances, my patients’ gynecologists and family physicians cooperated when I asked them to take the patients off the progestins. Invariably, when the patients stopped taking the birth-control pills that contained progestins, they responded to myofascial therapy as most other patients did, and their neck and head pain ceased to recur.[1][2] (I describe this phenomenon extensively on pages 536-543 in The Metabolic Treatment of Fibromyalgia.)

Myofascial pain can be debilitating, but progestins and conjugated estrogens can do far more harm; indeed, they kill many of the women who use them. At one of its websites, Wyeth Pharmaceuticals lists some adverse effects of its products Premarin^® and Prempro^® [http://www.prempro.com/index.aspx]. What Wyeth describes are side effects such as breast pain/enlargement, vaginitis, leg cramps, vaginal spotting, and painful menstruation. And they mention in passing that using estrogens with or without progestins may increase the chances of having heart attacks, strokes, breast cancer, blood clots, and dementia.

Wyeth’s intention on this Premarin^® and Prempro^® advertising page may be to inform women and their clinicians of the dangers of the products. If so, the corporation falls far short of its target. The adverse effects it describes sound like slim chances and for the most part mere annoyances. By contrast, consider the researchers’ statements below about the effects of conjugated estrogens and progestins. In the studies they mention, called the "Women’s Initiative Studies (WHI)," adverse effects on many women were more than slim chances and annoyances. (All italics below are mine.)

In fact, as the National Institutes of Health stated: "The principal findings from the two WHI hormone therapy trials, which studied 27,347 postmenopausal women on estrogen plus progestin, estrogen-alone, or placebo, found that the overall risks of long-term use of hormone therapy outweigh the benefits. Both of these trials were stopped early because of increased health risks and failure to prevent heart disease, a key question of the studies."

Dr. Leslie Ford (Associate Director for Clinical Research in the Division of Cancer Prevention of the NIH's National Cancer Institute) commented on synthetic estrogens and progestins and breast cancer:[3] "The hormones’ effects on breast cancer appear to linger. These findings reinforce the importance of women getting regular breast exams and mammograms, even after they stop hormone therapy."[3]

Dr. Elizabeth G. Nabel is Scientific Director of Clinical Research at the National Heart, Lung, and Blood Institute (NHLBI). She said, "The good news is that after women stop taking combination hormone therapy, their risk of heart disease appears to decrease. However, these findings also indicate that women who take estrogen plus progestin continue to be at increased risk of breast cancer, even years after stopping therapy. Today's report confirms the study's primary conclusion that combination hormone therapy should not be used to prevent disease in healthy, postmenopausal women." The investigators reported a 24% increased risk of developing any form of cancer among women who had been in the group treated with conjugated estrogen and progestin.[3]

Dr. Marcia Stefanick, Professor of Medicine at Stanford University, coauthored the women’s health initiative study report, and she chairs the Women’s Health Initiative Steering Committee. She stated, "The continued increased risk of breast cancer clearly plays a role in the increased overall risk of cancer years after stopping long-term estrogen plus progestin therapy, and it is important that we continue to follow these women." She also said, "The new results provide further evidence that the health risks of long-term combination hormone therapy outweigh the benefits."[3]

Dr. Michael S. Lauer is Director of the NHLBI Division of Prevention and Population Sciences. "After being on combination hormone therapy for several years," he said, "the women's risk of cardiovascular disease was significantly higher—from a 29% increase in heart attacks to a 41% increase in strokes and nearly twice the risk of serious blood clots—compared to the women who did not take hormones." He added: "While it is reassuring that heart attack risk decreased and that the risks for stroke and blood clots did not grow after the women stopped taking hormones, this study provides further evidence that five years of combination hormone therapy is harmful. All the accumulated risks do not simply disappear."[3]

Pause and Earnest Consideration. The citations above more clearly describe the potential harm from Premarin^® and Prempro^® than does Wyeth’s passing and euphemistic mention of them. In view of the potential harm, I would ask officials at the FDA and executives at Wyeth to think about the logical course of their current action. I ask them to think about their own wives, mothers, sisters, or other female loved ones. Are these officials and executives willing to risk the health and even the lives of their own female loved ones to recover Wyeth’s lost $500 million in revenue?^[4] That loss of revenue resulted from the incontrovertible evidence that Premarin^® and Prempro^® can injure and even kill many women.

If the FDA and Wyeth are able to deny safer, bio-identical sex hormones to women, they will subject those women who need sex hormone therapy to grave potential harm by forcing them to use more dangerous products. So I ask each official at the FDA and each executive at Wyeth to pause and earnestly consider a possibility: it may be their spouses or life partners, or their mothers or sisters who die decades too soon, all because of the officials’ and executives’ willingness to sacrifice women at the alter of profit.

The Motive for the FDA’s Action. Why would the FDA cooperate with Wyeth Pharmaceuticals in this action? Dr. Steven Hotze recently explained:[4] "The FDA takes its direction from the pharmaceutical companies which fund the FDA by paying drug user fees on any drugs that the FDA approves. The drug companies provide the FDA with nearly 30% of its funding, accounting for $350 million in this fiscal year alone. Because the FDA is dependent upon the sale of drugs for a major portion of its income, whose interests do you think it will protect, yours or the drug companies?"

What To Do About this Vital Matter. Numerous other natural health activists and groups have taken the lead in blocking the likely human-harming actions of Wyeth and the FDA:

The International Academy of Compounding Pharmacists provides information on how to phone your member of Congress about this issue: http://iacprx.convio.net/site/MessageViewer?em_id=5401.0

The website of Project FANS also provides an easy-to-use method for writing to your elected officials: www.projectfans.org

I urge you to protest and to enlist the protests of as many other people as you can. By doing so, you’ll participate as an activist for health freedom, help counterbalance the endless efforts to augment corporate profit at the expense of U.S. citizens’ health and lives, and blockade the FDA in its anti-citizen actions in league with drug corporations.

To end on a positive note, consider the advice of Dr. Marcia Stefanick: "We continue to encourage women to use hormones only if needed for menopausal symptoms, and for the shortest time possible, and to adopt and maintain a healthy lifestyle, that is, engage in regular physical activity, maintain a healthy body weight, consume a diet low in saturated fat, and to not smoke, to reduce their risks of cardiovascular and other chronic diseases."[3] I would add the following to Dr. Stefanick’s list: that women (1) decline to use the estrogen and progestin marketed by Wyeth and other such drug companies, (2) use a wide array of nutritional supplements, and (3) balance their sex hormones with plant-derived, bio-identical products. If they adopt these practices, women are far more likely to live well into old age and in an optimally healthy state.

The journal Thyroid Science, published by McDowell Publishing Co., began publishing papers a couple of years ago. My personal editor of some twenty-five years, Jackie Yellin, is Executive Editor of the journal, and I am its Editor-in-Chief.

Last year, we took the liberty of including readers of drlowe.com in the list to be notified when the journal publishes a new paper. We did this because Thyroid Science extends the purpose of drlowe.com—that is, the journal provides scientifically-based studies and educational information of interest to those disenchanted with conventional medicine’s approach to thyroid problems.

Today, we accepted for publication a study report by Dr. P. Pasupathi and four other biochemists in India. They studied 200 people; 100 of these which had diabetes. They found a high incidence of TSH and thyroid hormone alterations among the diabetic patients. We will soon send out an email from Thyroid Science announcing publication of the study. Of course, as the journal is open-access, the full text of the report will be available online. I encourage you to read the report, for as the authors write, the finding is relevant to improving the quality of life and longevity of patients who have both diabetes and thyroid dysfunction.

I have most people I consult with, and patients I assess and treat, perform one or more home glucose tolerance tests (hGTTs). I have done this over the last three years, and I've found it to be among the most useful diagnostic tests I've ever had patients undergo. The test is especially important for a certain group of patients: those who can't use a fully therapeutic dose of thyroid hormone without adverse reactions. Results of the hGTT often enable us to help these patients resolve this problem.

For those of you who are interested in testing your blood sugar levels, Walgreen's offers an economical alternative to the other company's glucometer systems. A glucometer by a middle of the road company such as FreeStyle may cost from $50 to $80, and the test strips are usually $1.20 each. In contrast, Walgreen's TrueTrack glucometer costs about $18.00, and the test strips are about $0.52 each. Walgreen's glucometer system is a true bargain. It is the system that Tammy and I use.