Bio-identical hormones may be either from a natural source or synthetically made, and it’s more about the molecule being identical to the human molecule that our body normally makes, than whether it comes from a natural source.
With the exception of Premarin, which is extracted from the urine of pregnant mares, virtually all replacement and contraceptive hormones, in all forms, bio-identical or synthetic, are first extracted from soybeans or wild yams in a laboratory.
Those that are processed so that they exactly match the molecular structure of the hormones made by the human body have come to be called bio-identical, to distinguish them from synthetic hormones, which have a molecular structure that is not found in nature, and certainly not in the human body.
That Ms. Hopkins makes a distinction between Premarin® and other drugs used to treat menopausal and post-menopausal symptoms is an important one.
Some doctors are still telling patients that Premarin® drugs are no longer made with conjugated equine estrogens, but simply conjugated estrogens. These doctors are confused about this because that is how the FDA allows Pfizer to label these drugs on their packaging.
Conjugated estrogens can be made from plants.
Clearly. Premarin® drugs are made from pregnant mare’s urine and contain conjugated equine estrogens.
Beware. The World Health Organization has designated conjugated equine estrogens as known carcinogens.
RxList.com uses the phrase conjugated estrogens when referencing Premarin® drugs. However, if you look far enough on their website, you finally arrive at the drug’s description which makes the following statements:
Premarin® is a “mixture of conjugated estrogens purified from pregnant mares’ urine and consists of the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares’ urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. Seehttp://www.rxlist.com/premarin-drug.htm.
Is you scroll up just above “Drug Description”, there is grey box with a list of side effects. The title sums it up. In all caps, bold letters it says:
ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA
Say No to Premarin® Drugs
Premarin® is prescribed in two forms — cream and tablet.
Premarin® is also used in others ways that you may never be made aware of, for example, during surgery to act as a coagulent in cases of heavy bleeding. Tell you doctor you wish never to be treated with any of the Premarin® family of drugs.
Premarin Horse Resources
As Jane Allin states, “Nothing has been, or ever will be, appealing or beneficial about the PMU industry and the Premarin family of drugs; they are clearly harbingers of death from both sides of the equation”.
There has been a steady decrease in sales between 2013 and 2015 and now revenues are down another 3% in the current year.
A 3% decrease in revenues from 2015 represents an estimated profit margin for the Premarin family of about 987 million USD for 2016. When compared to 2013 this is a decline of approximately 9.6% in revenues or in dollar amounts 105 million USD.
Of their total revenue (~ 49 billion USD in 2015) this may not seem like a lot but it is an encouraging trend that we hope means that both women and their physicians are paying heed to the dangers of equine-derived HRT and prescribing alternatives, despite Pfizer’s aggressive ads promoting it.
What we don’t know is how large the drop in prescriptions really is. The revenues we see are of course dependent on the price of these drugs. If the costs have increased this means that prescriptions have declined even more so relative to 2013. The alternative of lower pricing options makes it more difficult to assess.
The saving factor here may be that we all know that Big Pharma is a money-making machine and trimming profits are not in their best interest.
Whatever the case, let’s hope this trend continues.
Contrary to popular belief, the FDA has yet to approve any generic as a substitute for Premarin and its daughter products (i.e. Prempro, Premphase, Duavee).
Accordingly no prescription drugs used to treat menopausal symptoms, other than the Premarin family, contain pregnant mare’s urine.
However much confusion arises when the subject of HRT is broached, particularly in terms of the safety aspect of FDA-approved versions that are not derived from pregnant mare’s urine.
The vast majority of FDA-approved HRT prescription drugs are synthetic bioidenticals — hormones identical on a molecular level to endogenous hormones that are synthesized in the lab from natural plant sources.
These are not to be confused with the compounded bioidenticals, none of which are approved by the FDA.
Premarin and its derivatives are also synthetics but, of course, sourced from an animal by-product.
Apart from Brisdelle, the only non-hormonal FDA-approved HRT, the rest fall into three categories of hormone combinations as follows:
A good proportion of these drugs contain estradiol or esterified estrogens (non-equine) as the estrogen component (e.g. Estrace, Femtrace, Activella, Femhrt, Angeliq). However several have identical equine estrogens that are derived from plant-based sources versus pregnant mare’s urine.
That said, these drugs are not entirely identical nor are they exactly equivalent in constituents. Cenestin, Enjuvia, and Menest are three such HRTs included in this group.
Cenestin was originally developed as a generic for Premarin by Duramed/Barr but in 1997, the FDA refused to approve the abbreviated new drug applications from Duramed and Barr Laboratories for a generic version of Premarin.
In any case, all three of these drugs – Cenestin, Enjuvia, and Menest – contain similar estrogen components that are found in Premarin and its derivatives.
Premarin however is a complex mixture of numerous hormonal components, of which only some of the estrogenic components are found in the plant-based synthetics.
The table below compares the ingredients of Premarin, Cenestin and Enjuvia. I was unable to locate the same information for Menest.
However the pharmacology is similar to the others and contains a mixture of esterified estrogenic substances, principally estrone, that are of the type excreted by pregnant mares (e.g. sodium estrone sulfate, sodium equilin sulfate).
Despite the fact that these alternatives contain several of the Premarin estrogenic components, a study comparing the pharmacokinetics and relative bioavailabilities of key estrogen components of Premarin with those of synthetic plant-based equivalents concluded that these are not in fact bioequivalent to Premarin and therefore cannot be assumed to be therapeutically equivalent. Seehttp://www.ncbi.nlm.nih.gov/pubmed/10865186.
But does this mean that these and other FDA-approved synthetics are safe?
Unfortunately these alternative synthetics carry with them the same or similar warnings associated with their use.
However it is often cited in scientific literature that estrogens derived from pregnant mares urine pose a greater risk due to the complexity and concentrations of the combined hormones together with the unmistakable fact that equine estrogens are foreign to humans.
Given that alternatives such as Cenestin and Enjuvia assimilate the equine equivalents in Premarin, despite the fact they are derived from plants, it is perplexing why anyone would elect to choose these to alleviate menopausal symptoms – purely from the aspect of being equine-related and extrinsic to the human endocrine system. More likely it is a case where they are unaware of what they contain.
And what about the rest that contain estradiol (e.g. Estrace) and other esterified non-equine estrogens, or those that contain progestins and androgens extracted from plant sources?
And let’s not forget the newest addition to the Premarin family.
Duavee (CEES/bazedozifene(SERM) http://www.rxlist.com/duavee-drug.htm
• Endometrial cancer, cardiovascular disorders, and probable dementia (> 65 yrs).
• The SERM bazedoxifene is believed to inhibit the formation of breast cancer cells by binding to the estrogen receptor thus interfering with its activity.
The picture is clear.
In effect the FDA-approved hormone-containing alternatives carry with them the same risks and warnings associated with drugs derived from conjugate estrogen estrogens, whether that be estrogen alone or combinations. Albeit the risks may not be of the same significance as those associated with drugs manufactured from pregnant mare’s urine.
Nonetheless they still exist, and potentially more so for susceptible individuals.
Although the hormonal ingredients are similar or equivalent, they may or may not function identically for any single given woman. This applies to the Premarin derivatives as well.
And so, as much as it may seem that these hormones are safer than the Premarin family of drugs, there is no solid evidence to prove this.
It is important to note that some of these drugs have been approved by the FDA because data collected from trials has proven their effectiveness in relieving menopausal symptoms and reducing the risk of osteoporosis.
However there have been no long-term studies like the WHI performed to assess their safety profile.
In the absence of comparable data, the risks are generally assumed to be similar to CEEs and other forms of estrogens.
Moreover, regardless of the source and type of hormones, it is always recommended that estrogens, with or without progestins, should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment.
Brisdelle as an alternative?
As mentioned there is only one FDA-approved non-hormonal HRT. In early June of 2013 the U.S. Food and Drug Administration approved the drug “Brisdelle” (paroxetine – Paxil) manufactured by Noven Pharmaceuticals for the treatment of hot flashes due to menopause.
Brisdelle contains the selective serotonin reuptake inhibitor paroxetine mesylate, making it unique from all other FDA-approved treatment for hot flashes which contain the hormones estrogen or progestin.
Brisdelle poses none of the risks associated with estrogens or estrogen combination therapies.
However it is a selective serotonin reuptake inhibitor (SSRIs) (antidepressant), which has been shown to increase the risk of suicidal thoughts and behavior in pediatric and young adult patients when used to treat major depressive disorder and other psychiatric disorders. Seehttp://www.rxlist.com/brisdelle-drug.htm.
Whether this risk applies to menopausal women is unclear.
As with any drugs and medications there are inherent risks, the nature of which can range from mild to life-threatening. Always consult your doctor to help decide what is best for your particular situation.
As an aside and for interest’s sake here is a list of some of the more common HRTs available and the costs associated with them. The list is by no means comprehensive and includes the tablet form of the drug only.
This information was taken from http://www.goodrx.com and pertains only to the U.S. Prices are per tablet and converted to monthly costs based on a 30-day interval.
For consistency, all of the costs were taken from Walgreen’s with the discount coupons applied. Obviously prices will vary depending on store, geographic location, available coupons, etc. and are only intended to provide a relative comparison using the same base source.
PATENT EXPIRATION DATE
PRICE PER TABLET
MONTHLY COSTS (APPROX)
Prempro / Premphase
CEEs / Progestin
CEEs / SERM (bazedoxifene)
Estrogen / Progestin
CEEs — plant based
Estradiol / Progestin
CEEs — plant based
Estradiol / Progestin
CEEs — plant based
Estrogen / Progestin
Clearly, Pfizer is laughing all the way to the bank at the expense of women and horses alike.
CANADA — The class action lawsuit launched by a Sechelt woman against Wyeth Canada Inc. for selling hormone replacement therapy drugs linked to breast cancer is now settled and a $13.65 million payment has been awarded by the B.C. Supreme Court.
A large portion of that settlement, about 43 per cent, will go to legal counsel for the plaintiffs in the class action suit. The approximately 1,100 plaintiffs themselves will split what’s remaining based on medical costs incurred to date and the ability to prove they took the hormone replacement drug Premarin or Premplus between 1977 and 2003.
Sechelt resident Dianna Stanway, who launched the class action suit, said this week that while the payout may be minimal in the end for the many women involved, she was “satisfied with whatever they can get us.”
“As long as everybody knows it can cause cancer. That was the main object of the court case, because people didn’t know it did at the time but now they do,” Stanway said.
“I’m quite pleased with the outcome of it all.”
Stanway started the class action suit in 2004 after taking the drug Premarin and subsequently being diagnosed with ductal and lobular breast cancer. Continue reading »
What this article does not mention is that Premarin and its sister drugs are made with the urine of pregnant mares.
The pharmaceutical industry now commonly refers to the estrogen component in Premarin drugs (including its latest Duavee) as conjugated estrogens conveniently omitting equine which indicates the true identity and alarming nature of these products. There is a hint in the name of the drug itself — pregnant mare’s urine.
The $13M payout is chump change to pharma giant Pfizer, who acquired Wyeth in a merger in 2009 and continues to make billions of dollars from the sales of these types of products.
And all those commercials you see for Premarin cream? Yessiree. Same drug. Same company. Same conjugated equine estrogens. Same horror for the horses.