An article caught my attention on bioidentical hormones appearing in the June 7 Los Angeles Times. The writer, Chris Woolston, is a medical journalist with a master's degree in biology, and a surprising command of the topic. I found his article more balanced than a previous article by AP writer Marilynn Marchione which could be described as junk journalism. Nonetheless, Woolston's article contains a number of omissions, errors and falsehoods that deserve correction:
He writes: "Over the decades, millions of women have taken some form of hormone therapy to relieve symptoms of menopause... The treatment typically included Premarin, estrogen isolated from the urine of pregnant mares, combined with Provera, a synthetic version of the hormone progesterone."
Above left image: Boris Karloff as Frankenstein's Monster in 1931 film. Courtesy Wikimedia. Synthetic Hormones such as Prempro are Monsters.
Woolston correctly states that millions of women have taken hormone preparations to relieve symptoms of menopause. However Woolston presents the biased and narrow viewpoint that all of these women took "synthetic" chemically altered hormones in the form of Provera and Premarin. These are chemically altered hormones sold by the major drug companies. The reality is that millions of women have taken and continue to take human bioidentical hormones for relief of menopausal symptoms.
The Women's Health Initiative Study
Woolston then discussed the Women's Health Initiative Study, halted early because the study showed that synthetic, chemically altered hormones (Premarin and Provera) cause cancer and heart disease. In this, he is quite correct.
"But when a six-year study of more than 16,600 postmenopausal women that was part of the Women's Health Initiative found that the combination of Premarin and Provera seemed to increase the risk of breast cancer, stroke and heart disease, doctors and patients suddenly had to consider other options."
Although this is correct, I would remove the word, "seemed" from the text. The synthetic hormones, Premarin and Proveradidn't "seem" to cause cancer and heart disease. They DID cause cancer and heart disease in the WHI study. That's why the study was terminated early, a small fact Woolston conveniently left out of the story.
"Soon after the WHI made headlines, some pharmacies, alternative health clinics and a few outspoken doctors started heavily promoting so-called "bioidentical hormones" for the treatment of menopausal symptoms. Unlike Premarin or Provera, bioidentical hormones -- which are produced in laboratories using yam and soy phytoestrogens as a starting point -- exactly match the hormone made by human ovaries."
After the revelations of the WHI study were made public in 2002, millions of smart women abandoned synthetic hormones and switched to bioidentical hormones. This switch was not a product of a massive advertising campaign of the type we see on television for drugs like Lipitor and SSRI antidepressants. As a matter of fact, there was no TV advertising for bioidentical hormones, so I would disagree that bioidentical hormones were "heavily promoted". They weren't. The massive switch was more a product of the rank and file American Physicians who stopped writing prescriptions for Medroxyprogesterone (MPA), also called Provera, the synthetic hormone used in the WHI study. What Woolston conveniently left out of the story is that this sudden drop in MPA prescriptions in 2003 created a sudden drop in breast cancer rates. The reference for this assertion is The Decrease in Breast-Cancer Incidence in 2003 in the United States NEJM Volume 356:1670-1674 April 19, 2007 Number 16 by Peter M. Ravdin et al.
Woolston is quite correct in the statement that bioidentical hormones are exactly the same as the hormones made by the ovaries.
FDA Approved Bioidentical Hormones
"The Food and Drug Administration has approved several prescription-only drugs that contain bioidentical hormones, including Estrace pills, Estrasorb topical cream and the Alora patch. But many health clinics and pharmacies also sell non-approved creams that contain bioidentical estrogen and/or progesterone. These creams are often custom-made -- or "compounded" -- for each patient, sometimes based on the results of a saliva test that measures a woman's hormone levels."
Here Woolston is partially correct. FDA approved bioidentical hormone preparations are available at the corner drugstore. However, Woolston omits the fact that compounding pharmacies are regulated at the state level, not by the federal government, so FDA approval is not required or even desired for compounded hormone preparations. Insisting on FDA approval for compounded hormone preparations is similar to insisting that your state driver's license is invalidated because it was not issued by the federal government.
FDA approval is sometimes waved about like a majestic frond, as if it grants magical qualities to a drug. In reality, FDA approval does not automatically mean the drug is effective or desirable. Ten percent of all FDA approved drugs are later recalled or banned and designated as "bad drugs ". Another ten per cent of FDA approved drugs later receive black box warnings. FDA approval means a major drug company has paid a lot of money for studies showing efficacy over placebo. Sometimes these studies are fudged.
Catch 22 for Natural Substances
Another important fact omitted by Woolston is that the FDA approval process is so expensive that it makes financial sense only for patented drugs with prospects for large returns. It is unlikely that any drug company will invest the millions for FDA approval studies when the drug in question is a natural substance such as a bioidentical hormone that cannot be protected by a patent. Even the publicly financed Women's Health Initiative study sponsored by the NIH was done with patented hormones, Premarin and Provera, not the natural non-patentable bioidentical hormones. This no doubt reflects drug company control over NIH research dollars. The NIH should be studying natural substances like bioidentical hormones, and they are not doing it.