May 10, 2010
Responding to Dr. Patricia Yarberry Allen:
I was reluctant at first to put up this post. I know of Dr. Allen by reputation as a New York gynecologist with a well-known practice and devoted patient list of prominent women, some of whom I know personally. I have no doubt she has been a caring physician to many women.
But I’ve come upon her recent writings about “bio-identical hormones” on the Huffington Post and her own website, and I began to wonder, why is she writing these pieces?
It’s as if the boat has left the pier, and Dr. Allen is standing on the dock stamping her feet, making wild statements and outright slurs: “Bio-identical charlatans.” “Epidemic.” “Infectious agents on the PR trail.” “Pro-compounded drug shills.”
I was particularly startled at what seemed a not-so-indirect attack on my own books and this website, where we have been giving women doctor referrals for bio-identical hormones since 1997. Dr. Allen claims in one post “Women are flocking to infomercial doctors referred by lists of [in] popular books…”
The NWI has a doctor database of over 2,500 doctors in every state in the U.S., and Canada, a large proportion of whom are gynecologists, most are MD’s, and I personally don’t know of any who have made a so-called “infomercial.”
After writing "Natural Woman, Natural Menopause" in 1997, I established the non-profit Natural Woman Institute (NWI), mindful of my own problems getting proper treatment. I felt that if women couldn’t find a doctor to treat them, my job was only half done. For the last thirteen years we have been giving out referrals, and thousands of women have written to us expressing gratitude for their successful treatment; it’s what keeps us going!
So I began wondering, why is Dr. Allen now writing these pieces? But then I came upon a story that Dr. Wulf Utian had retired. (See below posting). Dr. Utian had been the leading apologist for the Wyeth Premarin/Provera regime since the 1960’s and then later head of the North American Menopause Society (NAMS), funded by Wyeth. I discovered that they were close colleagues. Perhaps Dr. Allen feels obliged now to take up the mantle from Dr. Utian as spokesperson for NAMS and the American College of Obstetrics & Gynecology (ACOG) also significantly funded by Wyeth, or has been asked to do so. (Frankly, I think Dr. Utian got out while the going was good; he is now off playing golf and out of the fray).
Dr. Allen apparently has a two-fold mandate: Attack compounding pharmacies and attack the compounded bio-identical products produced by these pharmacies. Then at the same time, bury the culpability of Wyeth, NAMS and ACOG, revealed by the 2002 NIH studies, for promoting the disastrous Premarin/Provera for life regimen.
“Bio-identicals” came into use in the US slowly since the 1980’s to counter the hegemony of Premarin and Provera. In Europe, they had been in use since the 1960’s. Wyeth not only controlled the marketplace for hormone therapy, but also controlled related scientific studies; and with their advertising dollars, controlled the reporting on “hormone therapy” in the mainstream media.
On Nov 17 2009, on her website Women’s Voice for Change, Dr. Allen titles her article: “A call to gynecologists: Don’t let menopausal women down.”
She worries that “highly educated, board-certified, responsible doctors have become reluctant to prescribe hormone therapy.”
Well, God bless her, but her fellow gynecologists let women down beginning 50 years ago when they signed on lock-step to the Premarin, then Premarin/Provera regime.
Her gynecologists were knee-jerk prescribers controlled by Wyeth and now apparently they don’t know what to do.
She then writes,
'“Infectious agents on the PR trail” always point out that doctors who follow general guidelines for treatment of menopausal symptoms either refuse to listen to patients, or prescribe only Premarin ("IT COMES FROM A PREGNANT MARE'S URINE !" they scream) and a dreadful chemical form of progestin, known as Provera.'
It’s very hard to parse this paragraph. Is what the patients are saying untrue? What exactly is Dr. Allen’s point here? She is exhorting her fellow gynecologists to listen to patients -- but then she wants the patients to just shut up already -- not an uncommon experience for a female patient.
And what does she mean by “doctors who follow general guidelines”
What “general guidelines”?
At another point, Dr. Allen says,
“I don't know any gynecologist personally who still prescribes Premarin and Provera as the hormones of choice for management of menopause syndrome.
The truth is that most gynecologists who care for women in the menopausal transition do work with their patients to evaluate what works best for each of them. It may be that hormone therapy is not the right choice for each woman.”
Along with this bland blahblah, she acknowledges that Premarin and Provera are off the table; but she doesn’t explain why this is so.
Then Dr. Allen goes on to claim that bio-identicals are now an “epidemic.”
She seems to forget the “epidemic” of Premarin then Prempro that provided Wyeth with billions of dollars in yearly profit since the 1960’s and endangered women’s health by encouraging women to take these drugs for life. Still etched in my memory is the woman who told me that although she felt fine and was perfectly healthy at 54, her gynecologist insisted that she begin taking Prempro and continue it indefinitely. She found the side effects very unpleasant and wanted to stop taking this drug, but her doctor bullied her by saying, “Don’t come back to me when you have heart disease and are bent over with osteoporosis.”
Dr. Allen puts remarks in quotes in her articles that imply the compounders and their “shills” endorse “the odd idea that hormonal drugs compounded without oversight are not really drugs at all.”
Who said this? Where’s the reference for this? This is false, and another example of Dr. Allen just lashing out without supporting her attacks.
She uses a lot of rude words, but perhaps someone could say she is “shilling” for Wyeth and other drug companies by attacking compounding pharmacies. Wyeth after all, tried to put compounders out of business. Fortunately, at least so far, they have failed.
The most recent outbreak occurred in the Oprah Media empire -- as noted in a much-discussed cover story in this week's Newsweek. Each time the epidemic occurs, you will hear the following mis-statements in the media:
"There is great confusion over the term bio-identical hormones. Only those who take blood tests and then compound the individualized replacement of hormones that are just right for you can manage your menopausal symptoms."
Where is the reference for this? Who wrote this, and in what media outlet? This quote seems completely made up.
"In order to have the benefit of hormone therapy, blood or saliva tests are necessary -- both before starting and then throughout the therapy."
Again, Dr. Allen puts this statement in quotes, but what is she quoting from?
She goes on,
In truth, there is NO confusion about the term bioidentical hormone therapy.
Really? Dr. Allen, for one, seems very confused. This is an awkward and not very well executed rhetorical gambit on her part.
Dr. Allen is in a rage and frankly I can’t blame her. She writes,
'The agents frighten women with floods of lists of side effects and potential bad outcome from hormone therapy.'
“The agents”? What agents is she referring to?
"And those "tests" may do little but cost lots of money and drive business to the practitioners who are part of this consortium."
Consortium? What consortium?
She goes on,
"The North American Menopause Society and the American College of Obstetrics and Gynecology state clearly that spending increasingly scarce health care dollars on tests to measure hormones in a menopausal woman's body is not only financial inappropriate, it will not affect treatment."
Really? They “state this clearly” but where is the data behind it? Where are the studies behind the assertion that measuring hormones is useless?
This kind of mudslinging is not Dr. Allen’s long suit, and frankly I think it is beneath her.
She forgets -- or doesn’t actually know -- why bio-identical hormones came into use.
A backlash against Premarin/Prempro and their significant side effects was building by the time my first book, "Natural Woman, Natural Menopause," came out fifteen years ago. It was released almost simultaneously with books by Dr. John Lee, and Dr. Jonathan Wright. Dr. Lee was a Harvard-educated doctor (please note, Dr. Allen) who wrote a ground-breaking monograph "Natural Progesterone." Dr. Wright came up with the bio-identical formula that was called tri-est.
Over the next ten years, drug companies began marketing proprietary bio-identicals, such as Prometrium, which was a huge step away from the complete domination of Premarin/Provera. This was a good thing.
Dr. Allen says:
"The important issue here is that these bio-identical hormone drugs, compounded in a non-regulated pharmacy, carry the same risk as bio-identical hormones produced by FDA-regulated pharmaceutical companies.
This is completely garbled and false. Pharmacies are regulated, but by individual states. And these pharmacies also dispense the proprietary bio-identical hormones produced by pharmaceutical companies.
It is also inaccurate for Dr. Allen to say that the pharmaceutical companies themselves are FDA regulated. Only their individual products come under FDA scrutiny.
Dr. Allen further asserts,
"In addition, women who choose to take compounded hormone therapy have no assurance that the dose or purity is what the pharmacist or doctor claims it to be.
Again, the target here is the issue “compounding.”
Dr. Allen claims,
"We are just exhausted from the onslaught of every Suzanne Somers media appearance and next book that repeats the same infomercial with just another PR-driven title.”
Tearing your hair out over Suzanne Somers is pointless. She is the good news and the bad news. She came to the story very late in the game, piggypacking on earlier ground-breaking books. But she could get on television.
Here are facts about media coverage: Until the 2002 NIH studies it was impossible to get any coverage that questioned the Premarin/Provera hegemony. When I wrote "Natural Woman, Natural Menopause", we got media coverage in newspapers and TV stations outside of New York, but at that time the New York Times and the major networks would not even mention the word bio-identical,or discuss anything that questioned Premarin and Prempro. It was only after the 2002 NIH studies, that cracks began to appear in the media blackout.
Still complaining about Oprah, Dr. Allen says,
"With the invited physicians hovering in the audience, Oprah featured on the dais Somers and the gynecologist Dr. Christiane Northrup, who has in recent years created a cottage industry of nurse practitioners who diagnose hormone deficiencies and prescribe compounded hormonal drugs. Thus were the pro-compounded drug shills, placed much closer to her, seen as clearly in line with Oprah's point of view."
Here we get to the crux of Dr. Allen’s anger. Her organizations have lost control of the dialogue. Until the NIH studies these doctor groups owned menopause. They created the “disease model” for menopause.
Dr. Allen’s fellow doctors were in the audience for Oprah's program about bio-identicals and then, not invited to speak, apparently felt humiliated. Perhaps she was there too. I get the feeling that Dr. Allen thought she should have been talking on the stage with Oprah, but wasn’t asked.
Complaining about Oprah is pointless. NAMS and ACOG lost control of the story because they didn’t do the right thing. The doctor organizations were compromised by drug company money, at the expense of doing their best for women. And these organizations are still not owning up to their part in creating confusion for women about hormone therapy.
So then put the blame on bioidenticals and Oprah – who at least had the courage to step out about her own treatment!
Which brings us to the Newsweek article with Oprah on the cover.
Dr. Allen says,
"Gynecologists everywhere are grateful to Newsweek for the outstanding investigative journalism of Weston Kosova and Pat Wingert (co-author of Is It Hot in Here or Is It Me? A Complete Guide to Menopause). The two award-winning reporters paint a sharp portrait of the chaos Oprah has encouraged.
It took Newsweek to speak for us, and we are really grateful for this unbiased and clear reporting."
In fact, the Newsweek article with Oprah on the cover reads like paid advertising for the disgruntled NAMS and ACOG. The authors give the game away by repeatedly referring generically to “medical experts” and “doctors” without naming them, except for resurrecting Dr. Wulf Utian, who is, of course, shocked and outraged about Oprah's shows on bioidenticals.
Dr. Allen says with relief,
"It took Newsweek to speak for us, and we are really grateful for this unbiased and clear reporting."
For us? Who is this “Us”? "Us” clearly refers to her fellow doctors, who are completely outraged that they have lost control of the dialogue.
"Unbiased and clear reporting?" Really. Was anyone with even a tiny, tiny counterpoint to the “medical experts” and “doctors” everywhere asked to provide a balancing point of view? Did the authors interview compounding pharmacists, or their organizations, even to slam them or undermine them?
And here is a curious coincidence: These postings from Dr. Pat came out the same week as the Newsweek article.
The responsibility for the “chaos” needs to be owned up to by these anonymous "medical experts".
But let me say this, underneath Dr. Allen’s angry words there is a level of pleading to her fellow doctors. She seems to be saying, come on you guys, stop making us look bad. Start treating your female patients with some empathy. And get on board with responsible treatment.
This I can appreciate.
Wulf In Sheep’s Clothing”
I have just come across two recent articles by Dr. Wulf Utian of the North American Menopause Society (NAMS), one in NAMS’s “Menopause Management,” the other in “Contemporary OB/GYN.” Both publications are editorially controlled -- surprise, surprise -- by Dr. Wulf Utian.
Have you no shame, sir? These articles surpass all your previous pronouncements against bio-identicals for their jaw-dropping hypocrisy and flat-out lies.
In “Feminine Forever," Round 2: The Bioidentical Cult,” Dr. Wulf writes:
"George Santayana’s admonition that 'those who cannot remember history are condemned to repeat it' is a warning and not a cliché. 'Feminine Forever' – the Amazing New Breakthrough in the Sex Life of Women,' by Robert A. Wilson, MD, was published in 1966. In that book he claimed that 'for the first time, a leading doctor in the field of menopause prevention explains why no woman—no matter what her age—need ever feel a day over forty.'
...He [Wilson] went on to state that 'Your body’s health and your soul’s contentment may hinge on just one decision: to have your estrogen level checked.' Then he promised that 'these (natural estrogen) preparations are entirely free of side effects.'
The book caused a sensation. Women worldwide demanded hormones and physicians took sides for and against the concept. The euphoria was jolted in December 1975 when two papers were published in The New England Journal of Medicine linking continuous unopposed estrogen with an increase in uterine cancer...The addition of progestogen to the mix rescued hormone treatment, and it was off to the races again. Hormone sales boomed as women anticipated the prevention of Alzheimer’s disease, heart disease and osteoporosis, as well as longer lives and other potential benefits."
Dr. Wulf begins the above fiction by putting on the hat of a great sage and going on further in the article to point out the ironic link between Suzanne Somers’s "Ageless" and "Feminine Forever." There is certainly good reason to indict "Ageless" for being reckless in its promises and for forgetting the terrible legacy of "Feminine Forever," but astoundingly Dr. Wulf leaves out the fact that Dr. Wilson’s book was funded by Wyeth Pharmaceuticals, his long-time employer and the primary funder of NAMS. And the drug Dr. Wilson was discussing as free of side-effects is Premarin. Dr. Wulf actually tries to slip in the lie that Wilson was promoting “natural estrogen.”
Notice, by the way, the use of the word “cult” in the article’s title. This is one of Dr.Wulf’s favorite demonizing tactics relating to bio-identicals -- using words like snake-oil, cocktails, substances concocted in back rooms, etc.
But the extraordinary understory of these paragraphs is that women brought hormone catastrophe on themselves: Women world-wide began demanding Premarin after reading Dr. Wilson’s book, and Wyeth Pharmaceuticals was apparently just a compliant provider. Perhaps women were advertising Premarin on TV to themselves? And Dr. Wulf presents himself as a disinterested commentator, when in fact he picked up the mantle from Dr. Wilson for Wyeth after Wilson’s death with articles such as “The fate of the untreated menopause”(1987), wherein Dr. Wulf predicted epidemics of heart attacks and bone fractures that would overwhelm the medical system if something wasn’t done. Putting women on Prempro for life was the solution.
But it is in the article “Sign Out: Our 40 year ride on the hormone therapy rollercoaster,” that Dr. Wulf truly surpasses himself in his over-the-top hypocrisy by intoning:
“It is one thing to bring scientific clarification to all issues about menopause, or to deliver state-of-the science, high-quality, preventive, and therapeutic health care to all women going through (and beyond) the menopause transition. It is quite another to use menopausal women as a 'market,' to knowingly attempt to industrialize, commercialize, and sell inappropriate 'remedies' purely for the sake of gathering the almighty dollar. The obscene haste with which some health-care professionals have jumped onto this bandwagon is troublesome. Remember—ultimately, when you sign the 'compounding' prescription, you accept the liability.”
It is Wyeth Pharmaceuticals that is culpable for turning menopausal women into a “market,” not the other way around. It was Premarin that in 1965 was sold to women with "obscene haste" and without adequate testing –which ultimately came to roost with the 2002 NIH studies. Bioidenticals came into being as a way to counter the tyranny of the Premarin/Prempro stranglehold on hormone therapy and the corruption of science relating to hormones that came with it.
Since the 2002 NIH studies repudiating Premarin and Prempro, it has been Dr. Wulf’s task on behalf of Wyeth to demonize bio-identicals in any way he can. According to Dr. Wulf, Wyeth, the Goliath in this story with its mega-billion dollar profits, is now being threatened by David, the compounding pharmacies providing bio-identicals, who haven’t even remotely the financial resources of Wyeth. We can only hope the ultimate outcome is true to the bible.
I really don’t know how Dr. Wulf can sleep at night…I have thought this for many years. But maybe now, as he is reaching retirement, he is twisting and turning in his bed trying mightily to spin his legacy and wipe out his personal culpability. Perhaps he has been so used to controlling the dialogue as Wyeth’s official obfuscator – wrapping himself in the length of his curriculum vitae, heretofore always being taken seriously by the media as the pre-eminent menopause expert – and now doesn’t realize just how ludicrous these articles are.
How Do the Recent NIH Study Results Relate to Natural/Bio-Identical Hormones?
"Oh what a tangled web we weave, when first we practice to deceive."
Ever since the cancellation in July of 2002 of a National Institutes of Health (NIH) study relating to HRT, I have been asked repeatedly by women how the study findings relate to natural/bio-identical hormones.
News that this large study had been cancelled unleashed a firestorm in the media and throughout the medical profession. The results of the study demonstrated that, contrary to the claims of the manufacturer, Wyeth Pharmaceuticals, women using Prempro did not receive the benefits relating to heart disease and osteoporosis that justified long-term use. Even more alarmingly, these women were in fact more at risk for heart disease and more at risk for breast cancer, blood clots, and stroke. The leaders of the study made the difficult decision to halt the trials three years early for fear of harming more women needlessly. Shortly thereafter, a study of women using Premarin alone was also cancelled.
There had been other studies in the preceding ten years that gave results linking Prempro and Premarin, the only hormone drugs used in this study, to accelerated risk of diseases, principally breast cancer. But the results of this particular study, because of its size and its government auspices, could not be downplayed and would prove a "tipping point" that would put a brake to prescribing Premarin and Prempro to women for lifetime use.
What was gospel in the medical profession for over thirty years suddenly became heresy.
The good news was that the prevailing medical standard of care of prescribing the predominant HRT drugs, Prempro and Premarin, for the prevention of disease was discredited. The not-so-good news was that all hormone therapies were tarred with the same brush.
Even as it reported the results of the study, the media didn’t give the whole story. The New York Times, in its lead article on the NIH study, quoted a spokesperson from Wyeth as saying the results relating to Prempro were dismaying but "it was the only product available for hormone replacement." The reporter let the statement stand without qualification, despite the fact that it was false.
Proponents of natural/bio-identical hormones were not surprised by the study results. It was primarily because of their opposition to Premarin/Prempro and other synthetic hormones that the movement to make bio-identical hormones more widely available began over twenty years ago in the US. A pioneering group of MDs, nurse practitioners, pharmacists, and other health professionals worked to provide an alternative to Premarin and Provera, which often came with significant side effects with daily usage: headaches, bloating, and severe mood swings, to name a few. The bio-identical hormones had been in use in Europe for fifty years, and in the US to a limited extent. Today there are thousands of US doctors who prescribe bio-identicals to hundreds of thousands of women. Yet in reports of the NIH study, almost all of the major newspaper and TV stories neglected to mention the bio-identical hormone regime. And almost all the media stories failed to answer the crucial questions: Why had doctors emphatically advised women for over two decades to take Prempro indefinitely, when it was only in 1997 that the NIH began a full-scale study? How could it be that an astonishing six million American women were taking this single drug, along with millions more worldwide?
Needless to say, it will be impossible to untangle all the causes of this debacle, but one point is clear: The NIH studies were not a repudiation of natural/bio-identical hormones. In fact, they represent a significant vindication for proponents of the bio-identical regime…
(read the complete chapter in A Woman's Guide to Natural Hormones, 2005 edition.)