The Unscientific Bioidentical Hormone Debate

I have sympathy for the lay public who try to stay informed about life-and-death medical issues. With doctors making so many contradictory claims, it is no wonder that confused consumers die from lethal ignorance!

When the media attempts to sort out fact from fiction, the public hears biased doctors proclaim that their opposition’s position is reckless and risks killing those who implement it. The tragic result of these kinds of sound bite debates is that most people do nothing, and miss out on proven methods to reverse premature aging.

Drug Propaganda Wars

Today’s battleground is over who will derive the most economic benefit from the sale of female hormone drugs. All sides seem to have spokespersons to emphatically state that their product is the safest and most effective.

We at Life Extension® are in the unique position of arguing against what is in our economic interests. For the past two decades, we have advised women needing estrogen drugs to use individualized combinations of - and estradiol topical creams.

The problem is the FDA has effectively forbidden the sale of estriol.1 This ban is in direct response to pressure from a pharmaceutical company2 that wanted the FDA to censor your right to obtain estriol, which we consider a safer3 form of estrogen.

It is in the Life Extension Pharmacy™’s economic interest to sell you dangerous FDA-approved estrogen drugs. We instead refer callers to compounding pharmacies that are still providing estriol topical creams.

Dangerous Estrogen Drugs Still Sell Briskly

The market for female hormone replacement drugs is gargantuan. The lethal side effects of Premarin® (horse urine-derived estrogens) and Prempro® (horse urine-derived estrogens and a synthetic progestin) were revealed in the Women’s Health Study in 2002 and 2004.4,5 These drugs, however, continue to be sold to unsuspecting female patients.6

The fact that medical doctors continue to prescribe horse urine-derived estrogens and synthetic progestins with proven risks is a testament to mainstream medicine’s apathy and ignorance.

That the FDA allows the continued sale of horse urine-derived estrogens and synthetic progestin, under the guise that the agency is not sure if plant-derived estrogens and progesterone are safer reveals how much political influence pharmaceutical companies wield in government.

That the maker of Premarin® and Prempro® doesn’t even make the effort to bring out “new and improved” versions of their brand-name drugs (using plant-derived estrogen and natural progesterone) shows how little pharmaceutical companies care about the public’s health.

I see innovation in the natural products industry virtually every day, yet the same formulas for Premarin® (horse urine-derived estrogens) and Prempro® (horse urine-derived estrogens and a synthetic progestin) have been used for decades.

Premarin®, in fact, was approved by the FDA way back in 1942.7 What else do you know that was brought out 67 years ago that still sells briskly today? The only answer is antiquated drugs protected by a federal regulatory agency called the FDA.

Plenty of Plant-derived Estrogen Drugs to Choose From

There is no shortage of drug companies that sell estrogen drugs that cost them virtually nothing to make. For example, pharmaceutical manufacturers will produce tens of millions of tablets at a time containing 1 mg of a potent estrogen called estradiol.

These drug companies (and the Life Extension Pharmacy™) make money when women buy these 1 mg estradiol tablets. As you will read in this month’s issue, however, the scientific literature indicates that it is safer and more effective if aging women are prescribed individualized doses of topical creams that provide about 80% estriol and only 20% estradiol.

To reiterate, while it is in Life Extension®’s economic interest to sell mass-produced estradiol and/or conjugated estrogen tablets, we instead recommend that women in need of estrogen drugs obtain them from compounding pharmacies that provide the more scientifically substantiated estriol. (Our pharmacy does provide compounding services, but we can’t offer estriol because of the FDA’s ban.)

Why Drug Companies Attack Estriol

Pharmaceutical companies make their money in an assembly line style which involves selling you the same drug as everyone else. The problem is that you are not like everyone else as far as your individual hormone needs are concerned.

In order to deceive the public into believing they need to be “protected” against compounded estriol-based creams, drug company shills proclaim that compounding pharmacies are “unregulated” and lack the quality control found in FDA-approved manufacturing facilities. These deceptions frighten most of the public into using toxic mass-produced drugs in lieu of safer compounded versions.

To expose the charade being perpetrated against aging women, this month’s Life Extension® magazine publishes a landmark white paper titled Bioidentical Hormones: Why Is There Still a Controversy?

The bottom line is that there are billions of dollars to be made if American women can be deceived into using dangerous mass-produced estrogen and synthetic progestin drugs. You can believe pharmaceutical giants will leave no stone unturned to sic regulatory agencies against those who sell natural forms of these hormones. An even more sinister tactic is to pay doctors to attack those who seek to alert the public about the suffering and deaths caused by these unnatural and toxic hormone drugs.

Corrupt FDA Actions Cause Consumers to be Financially Raped

There is a financial downside for women seeking compounded estriol-based creams.

Since the FDA was so kind (to big pharma) to ban the sale of estriol, its gray market price has sharply increased. The FDA’s biased action causes US consumers to now pay grossly inflated prices for estriol.

In order to protect the economic interests of the pharmaceutical industry, the FDA has no qualms about bankrupting the healthcare system of the United States. Life Extension® exposed this back in the early 1980s, and little has changed since then—except that the medical system is facing virtual insolvency because of unrelenting corrupt FDA practices.

A study this year in fact revealed that more than 60% of personal bankruptcies are caused not by lavish spending, but by medical bills!8

Oprah Winfrey Criticized for Airing Scientific Truths

On January 29, 2009, Oprah Winfrey dedicated an entire one-hour program to the bioidentical hormone debate. Oprah did her research and identified numerous maturing women who suffered horrendous quality-of-life deficits that were reversed by bioidentical hormones.

Oprah assigned one of the most prestigious medical doctors in the United States (Dr. Mehmet Oz) to go inside a compounding pharmacy to show the audience how much quality control goes into making a compounded natural hormone cream.

Suzanne Somers was the featured guest, along with doctors who urged aging women to have their blood tested and their hormones naturally restored.

In her O magazine, Oprah Winfrey stated: “After one day on bioidentical estrogen, I felt the veil lift. After three days, the sky was bluer, my brain was no longer fuzzy, my memory was sharper. I was literally singing and had a skip in my step.”9

Unfortunately, Oprah Winfrey tried to air a “balanced” report on her TV show, in which the opposition got to torpedo scientific reality with sound bite scare tactics that have no basis in fact. Oprah found mainstream doctors who supported the FDA’s biased position against bioidentical hormones. These doctors attacked the safety of bioidentical hormones and suggested that aging women should do virtually nothing to restore youthful hormone balance, or rely only on FDA-approved hormone drugs.

After the program, some media sources were critical that Oprah favored the bioidentical side of the debate, and claimed that Oprah was “damaging” women’s health by suggesting women could benefit from bioidentical hormones.

News Media Disseminates Blatantly False Information

Drug companies appear to be terrified of Oprah Winfrey. Many months after Oprah’s bioidentical hormone show aired, the news media was still finding doctors to criticize her. Drug companies spend huge amounts of money on public relations firms for the purpose of influencing the public, as well as the FDA and Congress.

One prominent news magazine quoted a doctor as stating:

“Despite (Suzanne) Somers’s claim that her specially made, non-FDA-approved bioidenticals are “natural” and safer, they are actually synthetic, just like conventional hormones and FDA-approved bioidenticals from pharmacies—and there are no conclusive clinical studies showing they are less risky.”10

As you will read in the White Paper on Bioidentical Hormones appearing in this month’s issue, numerous clinical studies substantiate the safety and efficacy of these “natural to the human body” hormones3 extolled by Oprah Winfrey, Suzanne Somers, and tens of thousands of anti-aging doctors and their patients.

Most appalling are the innuendos that bioidentical hormones are no different than FDA-approved Premarin® and Prempro®. Both Premarin® and Prempro® contain horse estrogen extracted from pregnant mares’ urine. Unlike bioidentical estrogen creams that provide the hormones found naturally in the human female body, horse estrogen contains equilin and other equine estrogens found exclusively in horses!11,12

The human female body contains enzymes to metabolize the natural proportion of estriol, estradiol, and estrone, but not horse estrogens such as equilin. These horse estrogens produce estrogenic effects that are much more potent and longer-lasting than those produced by natural human estrogens.13

As two leading reproductive physiologists point out, when women take Premarin®:

“Levels [of equilin] can remain elevated for 13 weeks or more post-treatment due to storage and slow release from adipose [fat] tissue. In addition, metabolism of equilin to equilenin and 17-hydroxyequilenin may contribute to the estrogen stimulatory effect of [conjugated estrogen] therapy.”14

Another metabolite of equilin, 17-dihydroequilin has been found to be eight times more potent than equilin for inducing endometrial growth, a possible precursor to cancer.14

The drug Prempro® consists of conjugated equine estrogens and medroxyprogesterone acetate, a synthetic progestin that has been implicated in many of the adverse effects uncovered in the Women’s Health Initiative study.4 Medroxyprogesterone acetate is not the same as natural progesterone found in bioidentical hormone creams, yet establishment doctors are telling the news media that there is no difference.

There are other FDA-approved estrogen drugs that provide too much estrone and estradiol (and no estriol). These so-called “natural estrogen” drugs are also not the same as bioidentical hormone creams that can be obtained from compounding pharmacies.15

On the January 29th 2009 show, Oprah Winfrey warned the medical establishment: “We have the right to demand a better quality of life for ourselves, and that’s what doctors have got to learn to start respecting.”10

Profit-driven pharmaceutical companies don’t want patients to revolt and seem willing to disseminate egregiously falsified propaganda to protect their multi-billion dollar assembly line franchise of dangerous estrogen/synthetic progestin drugs.

Follow the Money and Ye Shall Find the Truth

The Oprah Winfrey Show strongly supported the anti-aging benefits women could attain from bioidentical hormones. Regrettably, the conventional doctors Oprah used to “balance” the program served their purpose, i.e., they cast doubt on the safety of natural hormones. These sound-bite scare tactics (often used by those running for political office), will cause most aging women to do nothing to restore their hormones based on imaginary fears.

The fully referenced White Paper on Bioidentical Hormones that appears in this month’s issue provides irrefutable scientific evidence, but perhaps a simpler method to discern the truth is to see who economically benefits from the hormone debate.

Pharmaceutical companies lavish conventional doctors with enormous financial rewards in exchange for these doctors’ support of FDA-approved drugs. The economic incentive for mainstream doctors is thus to toe the pharmaceutical industry’s party line and attack those who offer natural alternatives.

But what are the financial motivations of Oprah Winfrey, Suzanne Somers, and the numerous beneficiaries of bioidentical hormones that appeared on Oprah’s show? The fact is that NONE of them sells bioidentical hormones. They represent the uncompensated majority who only seeks out the truth, without money influencing their decision-making process.

As I stated earlier in this article, the Life Extension Pharmacy™ does not sell estriol-based natural estrogen creams because of the FDA’s ban. I am, however, standing behind the hard science in recommending that women who choose to use estrogen drugs obtain them from compounding pharmacies that are small enough to avoid the FDA’s draconian ban against estriol.

When listening to future debates about whether women should use FDA-approved hormone drugs that are proven to kill, as opposed to bioidentical hormones whose safety and efficacy are strongly supported, follow the money and you will see who has your best interests at heart.

Using Hard Science to Silence Our Critics

An entire book could be written about the absurd lies promulgated by pharmaceutical company-funded doctors who seek to frighten aging women away from natural hormones. In a recent national news magazine, for instance, a board-certified endocrinologist was quoted, “There is no medical reason to use progesterone after a hysterectomy.”16 When one considers the multitude of essential bodily functions dependent on progesterone, you have to wonder what board certifies these “endocrinologists” for competence.

The in-depth report in this month’s issue presents irrefutable scientific evidence in support of the safety-efficacy of estriol and natural progesterone. This Bioidentical Hormone White Paper may forever silence our uninformed and/or corrupted critics, at least in the minds of those fortunate enough to read it.

It is the masses who are victimized by self-serving pharmaceutical company propaganda and FDA edicts (such as banning estriol). They suffer either the agonies of lifelong hormone deprivation—or the lethal effects of chronic exposure to dangerous forms of hormone drugs.

I am proud to be able to pub-lish the article in this month’s issue that provides lifesaving scientific facts that are not tainted by financial bias.

For longer life,

William Faloon

Bioidentical Hormones: Why Are They Still Controversial?