It’s Not Rocket Science

Market share, health scare and the truth about Bioidentical hormones.

By: Dr. Tamara Simon

There has been great controversy lately about the benefits and risks of Bioidentical hormone replacement vs. synthetic hormone therapy. This article will discuss the history of hormone replacement, talk about how big pharmaceutical companies try and fight to keep their market share, and the finally where we should go from there. Hormone replacement is not new and it’s not rocket science. The goal is to replace what your body used to make on its own so you can enjoy good health and a high quality of life.

We are bombarded with information daily-from television, radio, newspapers, magazines, brochures and the internet- and, for many people, these have become the primary sources of information about hormone therapies. However, while it may be helpful, the information disseminated may be only part of the story, or sometimes even biased, based on its sources.

The not so brief history of hormones.

Hormones for the treatment of menopause have been prescribed since the 1930’s. By the 1950’s research revealed that there were potentially harmful effects from oral estrogen, including blood clots and stroke (not breast cancer). For reasons unknown, the results were never published. Weird.

 Then in the 1960’s the book Feminine Forever was published and claimed that menopause was   “completely preventable”. Overnight it became a best seller. The book claimed that hormones could keep a woman happy, healthy and beautiful forever. Suddenly all the harmful effects were ignored and everyone looked the other way. The book’s author, Robert A. Wilson, started the equivalent of a rock star’s concert tour across the country, extolling the miraculous benefits of HRT, (hormone replacement therapy). The miracle drug was Premarin made by Wyeth Pharmacies.
Soon however reporters from The Washington Post disclosed that Dr. Wilson’s lecture tour and book were funded by the company that actually made the drug in question, Wyeth.
 Again Weird!

 However, by this time, 30 million women were being prescribed Premarin. Then in the 1970’s, studies revealed that estrogen by itself caused uterine cancer (PEPI Trials). This concern was quickly overcome by adding progestin (synthetic progesterone) to Premarin, creating Prempro. Now Wyeth had the two most prescribed hormones in the U.S. This is referred to in pharmacy lingo as a “99 Ton Gorilla”, meaning they had their golden goose.  

It should be noted that the rest of the world, however, refused to take Premarin and Prempro since they were manufactured using pregnant mares (female horse) urine, hence the name Pre (pregnant) mar (mares) in (urine).  Instead they continued taking their Bioidentical hormones, created by compound pharmacies to be equivalent to their own, as they had been for 50 years without any adverse effects. To clarify this point, Premarin would therefore be Bioidentical only if you were a horse! (Other examples of human Bioidentical hormones are Insulin and Thyroid. Nobody’s disputing these, though.)

By 2001, due to aggressive marketing and multimillion dollar advertising campaigns, 60 million women were on Premarin or Prempro. This is despite the fact that for decades there had been no further studies done to prove effectiveness or safety. In 2002, the WHI (Women’s Health Initiative) was published revealing an increase in blood clots, stroke, heart attacks and breast cancer. OOPS!

Now we have the great debate of the century. “Are Bioidentical hormones better tolerated, since they are similar to our own, or safer than synthetic (fake) hormones?”

Wyeth now scared out of their minds that the golden goose was about to croak, launched a multimillion dollar campaign to discredit Bioidentical hormones. They involved lobbyists, senators, NAMS (National Society for Menopause), ACOG ( American College of Obsetrics and Gynecologists) and lastly, but most importantly the FDA.
Fast forward to 2009 and several billion dollars later, (spent by Wyeth) to the results of the big controversy surrounding hormones.

Bioidentical versus Synthetic

The biggest question you should be asking yourself right now is, “Why doesn’t Wyeth just manufacture Bioidenticals?” Aah, good question. Here’s the problem. Since Bioidenticals are our own and Wyeth doesn’t have to do any research or development (R&D) to manufacture the hormones, they can’t obtain a patent. A patent is what makes gobs of money for drug companies. Without a patent the drug is virtually useless. That’s why when the patent runs out for drugs like Claritin and Prilosec, they become over the counter drugs. This lends me to the question, “Why did they ever need to be prescription then?” The answer- to make money. Once they go generic the company can’t demand the high prices anymore to recover their R&D.

The main estrogen in Bioidenticals is 17 beta estradiol and unfortunately for Wyeth it is produced naturally from our premenopausal ovaries and requires no R&D God owns the patent. Dang!

What to do? Some smart pharmaceutical companies (not Wyeth) have figured out how to make Bioidenticals and get them patented and FDA approved. Eureka!  They don’t mention the estrogen. They just patent the unique cream, gel or patch. In other words the delivery system the estrogen is embedded within.

Okay so now what? Wyeth can’t attack Bioidenticals anymore because their colleagues are making them as fast as the drugs fly off the proverbial assembly line!

Then they make what I think is their critical mistake. They claim it isn’t really Bioidenticals that they are concerned with but the OTHER estrogen (Estriol) that compounding pharmacies often mix with estradiol to create Biest and Triest. Estriol is the most gentle of the body’s estrogens that is produced by the placenta when a woman is pregnant. Ironically, compounding pharmacies are the Big Pharmaceutical Companies’ greatest competitor.