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March 19, 2015

Pharmaceutical Companies and Non-Bioidentical Hormones

In the last article we addressed some of the statistical mumbo jumbo that confuses the benefits and distorts the risk of hormone replacement therapy (HRT). One major point of confusion regarding HRT has to do with the differences between bioidentical versus non-bioidentical hormones. Today we will focus on why pharmaceutical companies make non-bioidentical hormones. All things being equal why would you want to take hormones that are foreign to your body (non-bioidentical) rather than exact replicas called bioidentical hormones?

* some prefer to use the term “synthetic hormones” rather than non-bioidentical hormones. But, technically most hormones are made synthetically (artificially) produced these days including bioidentical hormones. At the end of the day how a hormone is made is irrelevant. What is relevant is this. Is the hormone the same thing as my body makes or not?

Non-Bioidentical Hormones are More Profitable

There is one main why pharmaceutical companies produce and sell non-bioidentical hormones. They are more profitable.

Pharmaceutical companies cannot receive a patent on any chemical the body naturally makes. Patents enable pharmaceutical companies to charge premium prices and the patent precludes the manufacturing of generics for several years. Thus, non-bioidentical hormones are more profitable for pharmaceutical companies.

It’s the same reason they make antidepressant drugs that prevent the breakdown of serotonin (selective serotonin reuptake inhibitors or SSRIs) rather than simply make a serotonin pill. Have you ever wondered about that? Well, they cannot get a patent if they do that. If you are low in serotonin why not simply give you serotonin or one of its precursors? Why just a drug that prevents the breakdown of serotonin? And, the same is true for the neurotransmitters dopamine and acetylcholine.

Here’s the problem with that approach to drug manufacturing. When a drug prevents the breakdown of a chemical it also prevents the production of downstream metabolites of that chemical. Those metabolites many times also have important biologic actions. For instance, one breakdown product of serotonin is melatonin which helps us sleep.

Same is true for hormones – they get metabolized into other hormones and chemicals. It can take 6-9 months to rid your body of non-bioidentical hormones. The downstream metabolites of bioidentical hormones are usually beneficial while those of non-bioidentical hormones are not.

Tweaking Bioidentical Hormones

The bulk of the studies show that non-bioidentical hormones are safe and effective. But, there are potential pitfalls. Each tweak or modification away from the original or native bioidentical hormone has the potential to alter the function of the hormone.

A classic example of this is medroxyprogesterone acetate, or MPA, which was used in the Women’s Health Initiative. The brand name is Provera. The use of Provera explains the additional cases of heart attacks and breast cancer in the Prempro (Premarin plus Provera) arm of the study compared to Premarin alone arm.

Although MPA has “progesterone” in its name, it is actually a progestin – think of the GDR or German Democratic Republic, which was actually communist. It’s false advertising if you will. MPA differs from natural progesterone in two spots in its chemical structure. But, here are the differences in the effects between MPA and bioidentical progesterone on the body.

MPA

  • reduces risk of endometrial cancer
  • increases body weight
  • increases appetite and fluid retention
  • increases irritability and depression
  • increases breast cancer
  • increases blood pressure
  • increases LDL or bad cholesterol while lowering HDL or good cholesterol
  • decreases energy and sex drive
  • block the beneficial effects of estrogen on the heart

So, there’s one main benefit – the reduction in endometrial cancer which traditionally has been the main reason it’s been prescribed, but probably not worth the trade-off given the problems it causes. Many of these negative effects are cardiovascular in nature – so no surprise there were more heart attacks in the Prempro arm of the WHI (Women’s Health Initiative).

Bioidentical Progesterone

  • reduces risk of endometrial cancer
  • decreases blood pressure
  • lowers LDL cholesterol and raises HDL cholesterol
  • increases bone and hair density
  • increases metabolism
  • stimulates GABA receptors leading to calmness
  • has antidepressant effects

All of these effects are beneficial.

So that’s one example how tweaking a hormone structurally to get a patent alters the function of a hormone. But, it applies to the modification of any hormone. There is not much structural difference between estradiol – the “female hormone”, and testosterone – the “male hormone” but they sure do function quite differently, don’t they?

Why Do Physician’s Prescribe Non-Bioidentical Hormones?

We’ll offer a couple of potential answers to that problem. Pharmaceutical companies have much influence in medical education, not only during medical school training years, but throughout residency training and beyond. They sponsor or fund most studies on new drugs and new applications of old drugs. To varying degrees they help fund medical education up and down the ladder. They have a very vested interest getting physicians to use their pharmaceuticals and are very crafty at showing “the numbers” in the best light to garner support for use of their drugs. We don’t blame them for trying.

But, there is no major force out there to promote bioidentical hormones. Bioidentical hormones have no real lobbying group outside perhaps compounding pharmacies which are mostly mom and pop shops compared to pharmaceutical companies whose stocks are traded on Wall Street and which fund political campaigns.

Secondly, all non-bioidentical hormones are FDA approved as are those bioidentical hormones manufactured by pharmaceutical companies. What is not FDA approved are bioidentical hormones compounded by a compounding pharmacy – the bulk of bioidentical hormones prescriptions. So physicians find comfort in this FDA approval process not understanding the reasons that compounded bioidentical hormones are not FDA approved.

Compounding refers to the custom manufacturing of a medication for a single patient in response to a prescription from a physician. Compounding pharmacies can only use drugs and ingredients that are FDA approved in their compounded drugs, but the compounded drugs themselves are not FDA approved for a very practical reason.

To be FDA approved a drug company or pharmacy must show that their drug is what they say it is with respect to ingredients and dose. If a pill is 100 mg it has to be within a few milligrams in either direction.  Dose and ingredients are easy to verify when pills are made by the hundreds at a time and a few pills can be “sacrificed” for sampling and verification.

But, how do you spot check a sample of a compounded drug made for a single patient without destroying the drug for the patient’s use? That’s a major reason why compounded drugs are not and can never be FDA approved. Keep in mind that every IV bag that has something added to it (potassium, dopamine, an antibiotic, and so on) likewise is not FDA approved for the same reason. But, IV bags are ordered all the time by physicians without giving it a thought. Can a doctor be sure that the IV bag he ordered has 40 milli-equivalents of potassium in it? The answer is “no”.

Also, a vast majority of chemotherapy agents, most of which are quite toxic to the body, are also examples of compounded drugs as most of them are custom-made for a single patient taking into account a patient’s weight and liver and kidney function. Again, no one gives much thought that these chemotherapy agents are compounded drugs. They, too, are not FDA approved.

But, most doctors are leery of using compounding pharmacies for hormone replacement therapy, because no one has pointed out  these other examples of compounding and the inconsistency in their thinking.

Also, gaining knowledge in bioidentical hormones is something a physician pursues on his/her own after formal training as there is no or little training on the topic in medical school or residency training. And, unless a physician is going to make HRT a focus of his/her practice there’s little motivation to learn more.

Are Bioidentical Hormones Safer?

Logically, it seems that anything your body makes is safer than something your body does not make. But, that doesn’t satisfy most physicians. They want studies and more studies to convince them. There are far more studies on non-bioidentical hormones than bioidentical hormones mainly because of the expensive cost to perform a well controlled study – money that pharmaceutical companies have. But, there is evidence that bioidentical hormones are safer and more efficacious than non-bioidentical hormones. And, that will be the topic of discussion in the next article.

 

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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. Read more about Dr. Joe Jacko

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