A Review of Bioidentical Hormone Replacement Therapy (BHRT) Manufactured by Compounding Pharmacists

Two industries peddling hormone replacement drugs became involved in a conflict with one another on October 6, 2005, when the pharmaceutical company Wyeth filed a petition with the FDA urging the agency to “counter flagrant violations of the law by pharmacies compounding Bioidentical Hormone Replacement Therapy Drugs (BHRT)”. The compounding pharmacies responded swiftly to Wyeth’s petition, alleging that Wyeth’s only motive in filing the petition was profits. The full text of Wyeth's petition is available on the FDA’s Web site.

According to the FDA:

Pharmacy compounding, by definition, involves making a new drug whose safety and efficacy have not been demonstrated with the kind of data that FDA ordinarily would require in reviewing a new drug application.... In some cases, we have reason to be concerned about the quality of the drugs being compounded and the potential risks to patients who may take them. In some instances, compounders may lack sufficient controls (equipment, training, testing, or facilities) to ensure product quality or to compound difficult products such as sterile or modified release drugs. If compounding ...is not done properly, compounders can expose large numbers of patients to health risks associated with unsafe or ineffective medications.

This appears to be the classical David versus Goliath story with the giant Goliath being Wyeth, maker of the conjugated estrogen PREMARIN (conjugated estrogen) and the same chemical with medoxyprogesterone called PREMPRO (conjugated estrogen with medroxyprogesterone). The Davids are the supposedly small compounding pharmacies and health providers who fight to prescribe “safe” BHRT to women to keep them young and normal. Unfortunately, in this case both David and Goliath are mainly on the wrong side and are both engaging in many anti-woman marketing ventures.

Menopause is not a disease; it is one stage in a woman’s normal life. Drugs such as PREMARIN and PREMPRO are at least approved by the Food and Drug Administration (FDA) to manage the symptoms of menopause in the short term at the lowest possible dose. They are effective for this use. Any product produced by a compounding pharmacy is not FDA-approved for any purpose.  

Wyeth had taken a hit in the wallet when the results of a large randomized controlled clinical trial, called the Women’s Health Initiative, showed that hormone replacement therapy (HRT) with Wyeth’s drugs increased the risks of cancer, stroke, blood clots and heart disease when used long term in postmenopausal women. Sales of PREMARIN were $1 billion in 2002 and dropped to $850 million in 2004. They recovered to $908 million in 2005.

But compounding pharmacies have their own financially driven interest in selling untested BHRT drugs. The pharmacies do, in fact, make unsubstantiated claims about the safety and effectiveness of their BHRT products. The overhead is probably quite low for producing, promoting and selling drugs that are not FDA-approved and are made from bulk drug substances (powdered drug) of unknown quality from sometimes questionable sources.

There are more similarities, such as economic motives and morals, than differences between Wyeth and compounding pharmacies. Both have advertised directly to consumers claiming that their respective products are safe because they are “natural.” Conjugated estrogens, the active ingredient in PREMARIN, are derived from the urine of pregnant horses, a “natural” product.

The compounding pharmacies promote the terms “bioidentical” and “natural” to describe their products because they use hormones claimed to have the same chemical makeup as human hormones. In reality, though, these products are not “natural” to humans. They are plant-derived and processed to resemble human hormones.

Wyeth also has a history of misleading the public into thinking that “natural” supplements could keep women young, healthy and attractive. According to a 2002 New York Timesarticle, the son of Dr. Robert Wilson — author of the 1966 best seller, Feminine Forever— said Wyeth paid his father’s expenses for writing the book and paid him to lecture women’s groups. Dr. Wilson was to say that estrogen could keep women young and was safe because it was “natural,” having been derived from pregnant mare urine — hence the name PREMARIN.  

It is astonishing that the FDA allows a shadow drug industry to operate within the U.S., selling what are essentially unregulated products like BHRT and other products produced by compounding pharmacies. Remember, not long ago, the FDA was warning the public about the dangers of prescription drugs regulated by the Canadian government. Yet the agency has done nothing to warn women about the dangers of BHRT. In 1991, Public Citizen’s Health Research Group published the Women’s Health Alert. The largest chapter in the book was on hormone replacement therapy. By then, the evidence was clear that these drugs caused breast cancer and very serious doubts had been raised about their ability to protect against heart disease. The first sentence in this chapter began:

Female replacement hormones may someday be remembered as the most recklessly prescribed and dangerous drugs of this century.

This prediction came to pass with the results of the Women’s Health Initiative. But have we learned our lesson?

Proponents of BHRT, those benefiting economically from their sale, maintain that the right of women and their doctors to choose must be protected. This is a perversion of consumerism often put forward by producers of shoddy products. There is a more fundamental right that is being violated by compounding pharmacies: the right to a marketplace free of potentially dangerous untested products promoted for unsubstantiated uses.

What You Can Do:

Women should refrain from using bioidentical hormone replacement therapy (BHRT) made by compounding pharmacies because they have not been FDA-approved or tested for their safety or efficacy.