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February 25, 2013

Why Drug Companies Make Non Bioidentical Hormones

bioidentical hormones
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Why Drug Companies Make Non Bioidentical Hormones

Non-bioidentical hormones (sometimes called synthetic hormones) are more profitable for pharmaceutical companies than are bioidentical hormones. Why are non-bioidentical hormones more profitable than bioidentical hormones?

Non-bioidentical hormones are patentable and bioidentical hormones are not. And, with a patent comes exclusive rights to produce, market, and sell a drug at a premium since there is no other competition for that particular drug.

Drug companies cannot receive a patent on a compound that is naturally produced by the human body. A reason for this is a patent is given for inventions that are novel. Hormones naturally made by the body are not novel. They’ve been “clinically tested” in humans for at least 6,000 years of recorded history making them the “most studied” drugs in history.

To get a patent drug companies simply tweak the naturally produced hormones the body makes with the goal of maintaining as much function that the naturally produced hormone possesses. But, by altering the chemical structure of the body-derived hormone the non-bioidentical hormone is more likely to cause side effects and increase the risk of some diseases.

There’s little structural difference between estrogen and testosterone, but a huge difference in their functions. But, non-bioidentical hormones are where the profits are steep. To some degree pharmaceutical companies have used women as guinea pigs.

Are Patented Hormones Better Than Bioidentical Hormones?

Let’s take a philosophical approach to that question. Does anyone think that drug companies can make hormones that are both safer and more effective than what God has created? And, if we are just an end result of evolution and are on this planet by pure evolutionary chance, do we think drug companies are more adept than “natural selection”?

I don’t think drug companies think that they are smarter than God or natural selection. They make patented non-bioidentical hormones for profit, not out of arrogance thinking they are better than a Creator or evolution.

I believe in free markets and there is nothing wrong with profit. The problem is a shortage of education of the public as well as physicians (what your are now reading is unknown to most physicians) on patented non-bioidentical hormones versus hormones identical to what the body makes so that each individual can make a better informed choice. There’s little doubt in my mind what a truly informed person would choose.

FDA approval supposedly means that approved non-bioidentical drugs are safe and effective. But, “effectiveness” just means in comparison to a placebo. It does not mean that these hormones that are foreign to the human body are safer or more effective than bioidentical hormones – just that they meet a low criterion to be approved.

We now know from the findings of the Women’s Health Initiative that were reported in 2002 that these non-bioidentical hormones (Premarin and Prempro) are associated with increased health risks, though the magnitude of these risks were vastly overstated by the media. And, that study made no attempt to quantify symptomatic improvement in women to see if they outweighed the slight increase in risks.

This paper from PostGraduate Medicine reviews 196 studies comparing bioidentical hormones to non-bioidentical (synthetic) hormones.

Drug Companies and Bioidentical Hormones

The findings of the Women’s Health Initiative dealt a severe blow to pharmaceutical companies heavily invested in non-bioidentical hormones. After that study women either stopped taking hormone replacement altogether, or they went the bioidentical route which was being supplied by the compounding pharmacies. At that time compounding pharmacies were the only places a woman go for hormones identical to what the body makes..

Tired of losing market share drugs companies have started to offer bioidentical hormones for women that have gone through the FDA approval process.

Bioidentical Hormones and Choice

So now women who are interested in hormone replacement therapy have many choices. They can continue with non-bioidentical hormones (though I don’t why they would), or they can obtain hormones identical to what their body once made. These hormones can be mass-produced by drug companies, or individually prepared for them by a compounding pharmacy.

See related articles.

How The FDA Defines Drug Effectiveness

Synthetic, Natural, And Bioidentical Hormones




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Dr. Joe Jacko

Dr. Joe is board certified in internal medicine and sports medicine with additional training in hormone replacement therapy and regenerative medicine. He has trained or practiced at leading institutions including the Hughston Clinic, Cooper Clinic, Steadman-Hawkins Clinic of the Carolinas, and Cenegenics. He currently practices in Columbus, Ohio at Grandview Primary Care. Read more about Dr. Joe Jacko

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