August 23, 2006
Women & Horses
I’m back — from a writing intensive workshop in Taos, given by the husband and wife author-writer team of Sean Murphy and Tania Caselle. Working with Sean and Tania is always both challenging and productive. I can highly recommend their classes to any writer, whether beginning or experienced.
Actually got to spend an entire evening with noted author John Nichols, of The Milagro Beanfield War fame — the treat of a lifetime for me — will have more to say on that next time.
When I got home I found a press release and editorial in my e-mail by my good friends Susan and Terry Turner, about Wyeth Pharmaceuticals’ “Citizen Petition,” and bio-identical hormones.
If you have read my July ’06 articles, you will have an understanding that big pharma controls the FDA by writing the regs and carving the way to bring everything beneath government control.
This time, again, it is Wyeth Labs, who in November of ’05 hand-delivered the “Citizen Petition on Behalf of Wyeth.” to the FDA. It is an enigma to me how a corporation can speak either as a citizen, or for a citizen; both of which are people, and in the same phrase include the fact that it is on their (Wyeth’s) behalf — a corporation.
Nevertheless, they did so, and basically by this petition, they are opening the door for substances which are not drugs, to be declared drugs, in yet another attempt to bring them under the FDA umbrella.
In this case it is about bio-identical hormones. These are natural substances used as hormone replacement therapy (BHRT) by millions of women. The term “bio-identical” is used to signify that the form is identical to what our body manufactures. The problem about this for big pharma is that they do not manufacture these. Big pharma manufactures FDA approved products that are synthetically produced, yet which clinical studies have shown to be extremely harmful to the very women who use them.
It was the Women’s Health Initiative (WHI) and Heart and Estrogen/Progestin Replacement Study (HERS), released to the public in the summer of 2002 that put the fear of cancer into every woman.
What we did not hear about was, as Dr Elizabeth Vliet, M.D. writes in her book It’s My Ovaries, Stupid, a must read for every woman, is that the WHI “clinical trials used only one form of estrogen—Premarin—derived from the urine of horses, and a synthetic progestin—Provera—both hormones not at all identical to anything our bodies ever made naturally, a point rarely mentioned in the coverage. There are many well-studied, alternative, bio-identical (or “natural” forms of hormones available, with fewer negative side effects.”
But big pharma does not manufacture these. They want to outlaw the manufacture of bio-identical hormones by anyone but themselves, and this Citizen's Petition is a just a step along the way. Presently a woman can find these products on the shelf at the health food store and on the web, to be bought without a prescription.
Some women feel the need to have a doctor tell them what to take and will only do so with a doctor’s prescription. Other’s such as myself, who are health professionals in our own right, and who also do a great deal of investigation and research, wish to have the choice to decide for ourselves. Many of us are the ones who keep medical doctors informed. Frankly, I am fed up walking into an M.D.’s office and having to educate the doctor, and then be the one to pay them the fee, contrary to what happens when the Wyeth sales rep walks in to the doctor's office on a regular basis, and gets free time with the doc to peddle Wyeth drugs.
It’s about choice. Big pharma wants to eliminate choice and make their products the only alternative — this is their attempt to put the manufacturers of bio-identical hormones out of business.
With that said, I present here the press release by Susan Turner, and an editorial written by Terry Turner on this subject. Both hold excellent information and corroborative links.
Until next time —
Women Rally Against Horse Urine in Favor of Natural Hormones
by Susan Turner
COLORADO, Aug 19, 2006 (HMS MONITOR)
Millions of American women, who daily rely on natural progesterone creams and natural hormone compounds — natural bio-identical hormone replacement (BHRT), are up in arms over the FDA’s proposed ban of these products.
In Oct, 2005, Wyeth — a multi-billion dollar drug company who manufactures Premarin, the controversial hormone replacement products derived from horse urine, issued a Citizen’s Petition to the FDA which would make compounding and selling natural progesterone creams illegal. (FDA Docket # 2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement”)
Wyeth is a huge pharmaceutical company and has limitless financial muscle and a team of powerhouse attorneys. Individual consumers, however, are fighting back. Letters, faxes, and electronic posting to the official FDA website are pouring in daily from outraged women demanding freedom of choice in regard to their health issues; and internet emails are running rampant.
The FDA reports that September 8, 2006 is the deadline for comments to the Wyeth Citizen’s Petition Docket, and women are working rapidly to spread the word that unless they act now they may have no freedom of choice in a democratic nation.
Wyeth, in its Citizen’s Petition, which can be found in its entirety on the FDA website, states that natural substances should fall under the same federal guidelines and regulations as drugs, but the public, who uses and relies on natural products does not agree.
According to an August 2006 posting on the FDA Website, “Progesterone is a natural hormone made by the ovaries; and for me bio identical replacement creams and compounds are the only hormone replacement therapies that have been beneficial for my menopausal symptoms such as hot flashes and mood swings. I refuse to ingest Wyeth’s Premarin horse urine pills and as a United States citizen I demand freedom of choice in regard to my own health, if indeed the USA is still a free and democratic country.”
“Few small compounding labs have the financial budget that Wyeth has to conduct million dollar double blind clinical studies to prove a product’s efficacy which already appears to be working on menopausal symptoms of all who use it. I do understand why the FDA would need to regulate the safety of ingesting horse urine, which is not the same as a natural hormone produced from edible plants. The two are in no way the same.”
“If the FDA were to set a precedent for double blind studies for health benefits of edible plants, almost all nutritious foods would be considered new drugs and on a banned list. This and the FDA’s consideration of Wyeth’s petition are preposterous,” according to the FDA public post.
Many medical doctors are now prescribing natural bio-identical hormone replacement and some are conducting their own scientific and clinical studies.
The late John R. Lee, M.D, internationally acknowledged as a pioneer and expert on progesterone and natural hormone replacement therapy for women, used transdermal progesterone extensively in his clinical practice for nearly a decade, doing research demonstrating that progesterone can reverse osteoporosis. According to his research associate Virginia Hopkins, Dr. Lee also famously coined the term "estrogen dominance," meaning a relative lack of progesterone compared to estrogen, which causes a list of symptoms familiar to millions of women.
Ms. Hopkins notes that Dr. Lee began telling his menopausal patients to try using a natural progesterone cream and to his amazement they were delighted with the results. They reported relief from menopausal symptoms such as hot flashes, night sweats and insomnia, and they also reported relief from a wide array of other symptoms as diverse as dry eyes, bloating, irritability, gall bladder problems, osteoporosis pain, hair loss, and lumpy or sore breasts, for example.
As a result of this unanimously positive feedback, Dr. Lee began to collect detailed data on these patients, and also began to research progesterone more in-depth, gathering studies from his local medical library, and communicating with scientists around the world to discuss their work. He realized that progesterone probably had a positive effect on bone health and began to get bone density tests for his patients on progesterone. Within a few years he realized that these women were gaining significant bone density — particularly those with the worst bone density to begin with.
Helen B. Leonetti, MD, board certified gynecologist in Bethlehem, PA, and author of "A Healthier You and Menopause: A Spiritual Renaissance", says she has been using BHRT for 15 years, and her patients are thriving.
“In fact, I have published three clinical trials using natural transdermal progesterone cream and am working on my last one to prove osteoporosis protection."
"Wyeth should be stopped. Torturing and killing horses to make an estrogen that can be made from soy is reprehensible. We are here to protect our animals, not destroy them. Wyeth's agenda is financial: they have never cared about the health of women. It is time they retreated.” she said.
According to Dr. Leonetti, natural progesterone is known to be osteoblastic, that is, it helps to build bones. “Moreover, it is safe enough to give to women who have breast cancer, and even women who are pregnant. Osteoporosis is a very prevalent, and very deadly disorder, which can be controlled by drugs, but not prevented. And the drugs used, called antiresorptives such as Fosamax and Actonel have side effects that preclude many from their use.” she said.
Because Dr. Leonetti prefers drugless treatment of osteoporosis, she is now recruiting participants for more clinical studies.
“Research protocol”, she says will use women age 70 and over, who will be given a transdermal natural progesterone cream or a placebo. Pre and post bone density and blood work will be compared.
For more information on the study, send an email to her research director at email@example.com
In the recent past, the FDA itself affirmed that women had choices in regards to their own health. Former FDA Commissioner Mark B. McClellan, M.D., Ph.D., said in 2003 that "Postmenopausal hormone therapy is a major, personal decision for women, and they should be armed with the latest key facts and useful tools to make the best decision for their needs." Protesters of the Wyeth Citizen’s Petition believe that its acceptance would deny them of any freedom of choice.
In noting that she has been using a natural progesterone cream for almost two years, Caroline Collinske reported to the FDA that it works great for her. “I tried using both premarin and prempro and they did nothing to alleviate the symptoms of para-menopause, in fact they made them worse. Using bio-identical hormones has almost stopped hot flashes and I no longer have night sweats. I feel much more balanced emotionally and don’t suffer from anxiety, sleepless nights, and depression.”
“The thought of losing this as an option causes anxiety to say the least,” says Ms. Collinske. ‘How dare Wyeth feel they have the right to control what products I use. I choose not to use synthetic products because they cause more problems than they solve and I will not put my life in danger using them. I will never use premarin/prempro even if they take away bio-identical hormones.”
Betsy Mikalacki of Medina, Ohio writes, “Dear FDA, I am writing to plead with the FDA to continue to allow women the choice of the bio-identical hormone treatment. Finally we have a safe, effective and natural way to regulate hormonal change that WORKS!”
“Do NOT support Wyeth Pharmaceutical because they are losing profits and producing drugs that can cause harm after long-term use. Support a woman's right to choose this healthy alternative because it’s the right thing to do.”
Ms. Mikalacki said that when her aunt had a radical hysterectomy as a young woman and was placed on the lowest dose of Wyeth’s Prempro, "After 30 years of continued use she has had a severely debilitating brain stem stroke. Her neurologists at the Cleveland Clinic have determined that is was due to the long-term exposure to Prempro that has caused the stroke. It's Wyeth who has endangered my Aunt's health.”
According to Ms. Mikalacki’s post, “Hysterectomy and menopause can have severe affects on women's hormones. I work at a hospital whose many medical doctors actively support, speak on, and subscribe the use of bio-identical hormone replacement therapy.”
Mikalacki continues, “They have witnessed that it is both a safe and a very effective treatment for women. My sister, who had a hysterectomy, and several friends going through severe menopausal symptoms have finally found a healthy solution in bio-identical hormone treatment. Through saliva testing and customized bio-identical hormone crèmes compounded by registered pharmacists, it has made a WORLD OF DIFFERENCE. They have their lives back -- they are themselves again.”
"Don't take this choice away. Our taxes support the federal government. You are there for our safety. Let us continue to be able to choose the safe, individualized choice of bio-identical hormone treatment.” Sincerely, Betsy Mikalacki / Medina, OH.
In a fax to the FDA, Debbie J Smith said that she is a consumer and advocate of bio-identical hormones as an alternative to what was the conventional hormone therapy, She says that “Premarin and Prempro are hormones have been proven to cause breast cancer, blood clots to the lungs, heart attacks and strokes.”
“If Wyeth was actually concerned about the patient risks associated with use of their “patented” products instead of their bottom line, they would take them off the market—sounds like the Vioxx scenario to me. They should be less concerned about small compounding pharmacies that are providing a safer alternative to menopausal hormone therapy and invest their time in developing safe hormonal therapies. I will NEVER take Premarin or Prempro, I would rather have hot flashes and night sweats the rest of my life!” she noted.
Ms. Smith says she trusts that “the FDA will see through the ploy of the big and powerful drug company and not be swayed by their claims that they are in jeopardy because women are choosing NOT to put a cancer-causing, life-threatening drug into their bodies. Do not take away the best choice we now have by prohibiting compounding pharmacies from dispensing bio-identical hormones!”
Dr. Tracy McAlvanah of Marietta, GA informed the FDA that she has been taking natural, bio-identical hormones for some time. “It has been very effective for me as it alleviates many symptoms and allows my body to function optimally leading to a more efficient and effective life.”
“The importance of the FDA's decision on the Wyeth complaint is crucial to CONSUMER'S RIGHTS to choose safe, effective and natural treatments using BHRT. We should not be forced to subsidize Wyeth's profit loss at the expense of a patient's right to choose an alternative therapy. The FDA should and needs to reject Wyeth's petition (Docket # 2005P - 0411),” said Dr. McAlvanah.
“I will continue to educate as many people and patients as possible about the benefits of natural, bio-identical hormone therapy. I will educate as many people as possible concerning Wyeth’s petition and will fight endlessly for consumer’s rights,” she said.
In some cases, women are using natural hormonal creams and compounds for their HRT treatments for financial reasons as well as therapeutic ones. Natural progesterone is currently available over the counter in almost every health food store in America, as well as on approximately four million Internet sites.
The price for a quality natural cream ranges from $10 to $20 an oz. One fear among women is that if the pharmaceutical giants gain control of natural progesterone, the price could increase tenfold. Instead of paying $20 to $40 for a month’s supply, the price could be $200 in addition to the doctor’s visit and prescription.
In a post to the FDA, Dana Stelske said, “I am 57 years old, and do not have health insurance. I could not afford the doctor's fees and his lab work-up necessary to get synthetic hormones to manage the severe menopausal symptoms I was experiencing at age 55, when my menopause began. I studied the bio-identical hormone literature, and decided they were safer than synthetic hormones. After blood work, I was prescribed progesterone cream. I got relief from the menopausal symptoms within a month. I still use the progesterone cream, which has proven effective to stop the rampant bone loss I was experiencing. I am energetic now, sleep through the night, and am learning new cognitive tasks without the awful 'forgetfulness' that came with menopausal stress."
“With semi-annual clinic visits and annual blood analysis . . . I am confident to continue bio-identical hormones. By contrast, I will not use synthetic hormones, because of the data against them, and the method of formulation of estrogen compounds from mares' urine. I believe it is my right to have this choice. I believe it is discrimination against women who cannot afford or choose not to use synthetic drugs, when natural alternatives are available. My health depends on the choices that I've made. Using bio-identical hormones is medically appropriate for me, they work, they are affordable, and they are my choice. The pharmaceutical compounding companies who provide bio-identical hormones are necessary to this choice.”
Editor’s Note: Because the FDA site is so complex, it is a little difficult to maneuver.
The keyword to find the public posts on http://www.fda.gov was 'bio-identical hormone replacement' with results totaling 3610. However, only six showed initially with the tag line.“In order to show you the most relevant results, we have omitted some entries very similar to the 6 already displayed.” If you like, you can repeat the search with the omitted results included.When you click on this link, the public outrage of American women is more than evident.- Susan Turner, the writer, grants permission to use any of the material or the story in its entirety under your own byline.* You can add your own comment directly to the FDA docket at this link
September 8, 2006 is the deadline for comments to the Wyeth Citizen’s Petition Docket.
>>>>>>>>> <<<<<<<Editorial written by Terry Turner
There are so many world emergencies here, there, and everywhere that it has become a chore to decide what to focus on.
At the moment I am focused on the public’s right to ordinary free access to natural progesterone, which was proven very beneficial to women by Dr. John R. Lee---the great advocate of women’s health. A very affordable natural product that is vital to many women and some men. If Wyeth-Ayerst Laboratories is successful in their attack on some of our best citizens (the highly trained, highly educated Compounding Pharmacists of America) and on natural progesterone, American women will be left with no reasonable alternative to a product they have safely used for many years.
I am writing to strongly protest the efforts of Wyeth-Ayerst Labs to suppress a natural ingredient, plain old natural progesterone, which is properly the private and sole property of the American public. I feel they are only doing this because of profit issues.
The National Institutes of Health released a 2002 study that linked Premarin and Prempro®, synthetic hormone drugs manufactured by Wyeth, to increased risk of stroke, breast cancer, heart attacks and circulatory disease. Wyeth took a big financial hit as a result of the study. Sales of the drugs crashed from $1.3 billion in 2002, to $880 million in 2004. And there is the timing, and the motive, for Wyeth's latest attempt at burying BHRT. It has nothing to do with concerns for women's health or the safety and effectiveness of bio-identical hormones. It has everything to do with revenue and profit.
There is absolutely no reason to remove it from public access in order to boost demand for a proprietary drug belonging to the pharmaceutical czars of the world—they have control of the mismanagement of enough drugs now. Let them spend a few bucks and invent something better instead of prohibiting natural proven products that already belong to the public.
Anyone in America can tell you one thing that is universally true about drugs and there is not a sober citizen who does not know it: There are too many drugs, many are dangerous, and all are too expensive---no where in the world do drugs cost as much as they do here. And, in the main, often do more harm than good. Vaccines, for example, are thought to cause ADD and there are pretty good reasons to believe that statins hurt or kill more than they help. I cannot conclude that suppressing a natural product now (which is in effect giving a natural product to the pharmaceutical giants because they will bring it back as a new drug) will make anything better for the pubic.
The pharmaceutical giants (the Giant World Spanning Drug Monopolies) sucked about fifteen percent of the US economy into their treasure trove recently, nearly two trillion dollars; and they are looking to drive that horde of gold even higher. Some estimates say they will be raking in around three trillion dollars from our poor tax payers around 2010—again no where on the planet do we witness this insanity which corresponds to our education: the more we spend the less we get.
The American public is already sickened by many things from which the FDA purports to protect us. For, example the FDA continues to allow a common type of poison under many names in our food--- it is bad, everyone knows and everyone has known it for decades yet the FDA still approves of the use of MSG----an outrage against the health of adults and children (just as everyone knows and has know for nearly fifty years that hydrogenated oils of all types are a crime against humans).
And in exchange for our taxpayer’s millions in drug expense, we have super-bacteria that the drug czars cannot easily defeat except with thousands and thousands of patient dollars and at great risk to human life. And then we also have a plethora of drugs being recalled or defended in courts across the land.
And now Wyeth wants the FDA to hand them a literal fortune by criminalizing a safe natural product, a product that the public has already proven efficacious and safe over decades. Why is Wyeth to be the sole heir to what the public has developed and proven at its own expense? Are they to be rewarded and the public punished?
Wyeth----world class seller of horse urine from pregnant mares that are tortured in terrible ways to create their questionable Premarin---wants the FDA to suppress natural progesterone, a safe, simple, proven, natural product, used by millions of women and men who pay on the average around nine dollars per ounce for it and among whom there is not a whisper regarding adverse side-effects. Does anyone think there is any motive here except greed and profits?
What is going to happen if the FDA allows Wyeth to steal this rightful resource of the American public?
If Wyeth wins with the FDA, and it seems likely, the hapless consumer, in need of this perfectly harmless and natural product, will have no alternative at all.
But it will strengthen Wyeth’s ability to push horse urine. The doctors and the doctors’ patients typically do not even know that animals are dying in the process of producing the urine Wyeth uses to make Premarin. Many of the doctors, if they knew the factual condition of the horses, might reconsider Premarin. Is all this grief and pain to be generated only to satisfy the greed of the horsemen of Wyeth-Ayerst Laboratories?
This is robbery; this is theft; this is rape and pillage; and this is immoral on personal, professional, and corporate grounds.
And nothing is served, not a single purpose except to enrich Wyeth-Ayerst Laboratories, increase the stranglehold of the AMA over consumer health, and to punish and rob our citizen taxpayers both immediately and into the deep and irrevocable future.
If the FDA continues to transfer and oppress the natural rights of choice and the availability of natural things to the benefit of Wyeth and other Giant Pharms, in the end the FDA will have disenfranchised the citizenry, and themselves, now and forever.
And such decisions, like taxes, are never reversed and citizen must continue to bear the burden forever--- at least it is also true that the guilt of the betrayal public trust also can never be outlived. The FDA and its associated senatorial committees should give such guilt some consideration. The road of the pubic servant is clearly quite narrow whereas the road to public plundering is very wide and greased with something — perhaps dead horses?
People do not need the government or Wyeth to tell them how much natural progesterone they need, when to take it, or how much to pay for it. Nor do we need to further empower the AMA or enrich its doctors for an unnecessary visits, tests, and prescriptions.
And, I would like to remind all that the FDA is supposedly formed in the capacity of a public servant acting on behalf of American citizens; we are not paying the FDA to be an advocate much less a pimp for horse killers such Wyeth-Ayerst Laboratories or any other Giant Pharms for which there is no satiety at any price.
Give the Wyeth horsemen and their pharmaceutical buddies this dark deal and they will just want more. Natural progesterone today, garlic tomorrow, perhaps the air we breathe in ten years.
There is no end to the greed and treachery while deals can be made to plunder the public of every natural treasure and all its rights.
Make no mistake, it is the intent, by fault or default, of scheming companies like Wyeth-Ayerst Laboratories, along with the FDA, and the AMA to establish absolute control over the human body—they actually do not believe that our bodies belong to us but are merely consumer units to be managed by them; but I pray to God that our citizens will awaken to this steady erosion of our choices and freedoms.
I think it regrettable that we can all see, more and more, that the government acts consistently against the interests of the private citizen and the tiny sole proprietor business, and it is more and more supportive of giant business interests such as world spanning riders at Wyeth-Ayerst Laboratories.
I humbly ask my fellow citizens to consider the crime, the intended crime, this immoral foolishness, and to strongly object to the FDA prior to the deadline on September 8, 2006 for comments. First of all, we should request that the hearings be extended to be sure that the citizens can be made aware of the pending crime. And, secondly, please plainly tell the FDA to DENY Wyeth’s request to rape the American public of its inherent right to all natural products, progesterone in particular.
I would suggest a brief note to Andrew von Eschenbach, M.D,. Acting FDA Commissioner and to the FDA Division of Dockets Management, FDA, 5630 Fishers Lane, Room 1061 (HFA-305), Rockville, MD 20852. The FDA’s official designation of this proposed crime matter is "FDA Document 2005P-0411."
And, my fellow citizen, I also suggest you consider calling your own senators with this question: Since the FDA has received thousands protests from ordinary citizens on this topic, why is it that you have to almost be an experienced webmaster to find more than six protests on the FDA site?
Is the FDA intentionally hiding the protests of the public? Is the FDA trying to mislead the congress? Mr. Ted Kennedy is up to his eyeballs in such matters; what does he think of obscuring public opinion in this manner?
President Bush appointed von Eschenbach to direct the FDA. What do they think about obscuring the public outcry?
I sincerely implore you to act on behalf of our freedom of choice and against public tyranny by the FDA, the AMA, Wyeth, and horse killers of any fashion. Freedom of choice is my horse, I call her Natural Progesterone, and I do not want Wyeth-Ayerst riding her now, or ever.
**** Further Information on bio-identical hormones *****"Making Sense of the Hormone Hysteria" - Elizabeth Lee Vliet, MD
"Hormone Levels In Women With Chronic Fatigue And Fibromyalgia"