Dr Zava provides his personal viewpoint on the Bassett Healthcare Study.

Hi Catherine,

In April 2004, the Cleveland Plain Dealer re-printed a story by Anahad O?Connor of the New York Times titled ?Progesterone creams may pose risk, researchers say?. It targeted the research by Dr. Anne Hermann at Bassett Healthcare in Cooperstown, NY saying that Pro-Gest cream and Prometrium pills delivered the same progesterone in their bloodstreams. She presented the results at the American Society for Clinical Pharmacology and Therapeutics in Florida.

The article starts out saying ?A popular cream that eases the symptoms of menopause exposes women to higher levels of the hormone progesterone than has been commonly thought, researchers have found.?

Susan Cruzan, for the FDA said that Natural Progesterone is considered to carry some of the same health risks as its synthetic version ?until research shows otherwise? until we have that information, women who use any of these products should work with their doctors to use the lowest effective dose for the shortest duration of time.?

I believe that there is mis-information that needs to be cleared up with the news media and the FDA. First of all the results of the test could be said to PROVE that progesterone is getting through the skin and into the body. However, it is not the blood result that really matters but the result from saliva tests showing the available fat based progesterone that is being used by the organs. Secondly, Prometrium pills are synthetic and not progesterone but a progestin that has different side effects than Natural Progesterone. Thirdly, there is no research that shows that Natural Progesterone is linked to a higher risk of breast cancer and heart disease.

If this article has not been brought to your attention, I thought you?d want to know. I credit Natural Progesterone Cream for improving my health. ~ Jennifer

I have just read about the published Bassett Healthcare study that says the over-the-counter progesterone creams are dangerous. The woman who conducted the study comes to this conclusion because these creams successfully opposed estrogen, just like the synthetic versions in prescription hormone drugs. She is apparently a little confused about the many differences between natural progesterone and synthetic Provera, as is indicated in this report. I would like your comments, please. And so far, I haven’t seen one single pro-natural progesterone advocate make any rebuttals. ~ Jade

Dear Ladies,

The findings of the Bassett Healthcare study, first published in March of this year, suggest that “a popular, over-the-counter progesterone cream (Pro-Gest) is absorbed into the blood to the same extent as FDA approved progesterone capsules, meaning that progesterone cream is as strong as the pills.”

We’ve be saying as much for years! Bioidentical progesterone, when applied transdermally at a dose as low as 2% ~ 20mg per 1 gram application (such is the case with Pro-Gest), WILL replace the hormone progesterone in our body. And it will do this MINUS all the side effects and health risks of an artificial progestin.

But then, typically, these same scientists begin losing whatever ground they might have gained in this debate but citing “multiple studies show that combined hormone replacement therapy?estrogen plus progestin?or progestin alone for five years or longer is associated with a 26-53 percent increase in breast cancer and other side effects.”

Bioidentical progesterone is NOT the same as an artificial progestin.

An artificial progestin has a different molecular configuration to that of bioidentical progesterone. That’s how drug companies get their progestins patented in the first place … by manipulating the progesterone molecule way beyond its ‘natural’ state.

Major pharmaceutical companies ‘tamper’ with the molecular structure of USP progesterone to produce progesterone’s synthetic cousin - progestin - that the body no longer sees as bioidentical. Typically, our doctors insist on prescribing artificial progestins despite new emerging evidence that these unnatural-to-the-body, synthetic analogues of progesterone ineptly replace our natural hormones, and have been found to increase the risk of heart disease, cancer and blood clots.

Bioidentical progesterone has a signficant safety margin because the body see as ‘natural’ that which has the same molecular configuration.

Bioidentical progesterone IS chemically identical in every respect to the progesterone produced by our ovaries each month. Conversely, an artificial progestin is unnatural-to-the-body and, not surprisingly, is associated with considerable ‘risks’ and ’side effects’.

Real progesterone carries NONE of these ‘risks’ and ’side effects’. This is born out every day in fertility clinics around the globe, where bioidentical progesterone is routinely used to help achieve and sustain pregnancy in high-risk situations.

Artificial progestins, on the other hand, such as Provera?, are contraindicated in pregnancy (either for diagnosis or therapy). Progestins can be used to abort a pregnancy during its early days, and they can cause birth defects. The data sheet on this drug reads: “If the patient is exposed to medroxyprogesterone during pregnancy or if she becomes pregnant while taking the drug, she should be apprised of the potential risk to the fetus.”

To lump both bioidentical progesterone and artificial progestins in the same basket is, in my humble opinion, “stupid science”.

Ms Virginia Hopkins, in her response to the Bassett study earlier this month (Hopkins Health Watch), makes the following analysis, “The good news is that finally an excellent study has been done which shows that when we use progesterone cream, the progesterone is very well absorbed into the blood and from there into the cells. This should effectivly put any further doubts or debates about this matter to rest. The bad news is that the conclusions drawn from the study are based on an incomplete understanding about the difference between progestins and progesterone.”

Dr Zava’s personal viewpoint hits at the heart of the matter, “I’m suspicious about the organization that did this study. Bassett is trying to make headlines by publishing something sensational. This is how these organizations raise money, get grants, and even more insidious, get perfectly safe OTC products off the market.

“My intuitive feeler also tells me something else is going on here. Bassett is loosely affiliated with Michael Levine, who developed Crinone a Columbia. Crinone was a bust-stupid product, but the idea of delivery through the skin isn’t.

“If I were a pharmaceutical company think tank I would set up a front to first get other competitors off the market (ie, OTC progesterone) by scare tactics. I would do this by saying that a) topical progesterone is far more potent than we ever thought (duh-we have been saying this for years); b) recent studies show that progesterone in combination with estrogens leads to increased health problems (false statement but most docs don’t know the difference between medroxyprogesterone acetate and progesterone); c) because of a and b indicating the potency and potential danger of progesterone, OTC progesterone should be banned and only used by prescription.

“It would be interesting to ask Bassett why they embarked on this project and what were their long term goals. The PI on this study had never done anything like this before?? Who is she fronting for?”

An ?official? rebuttal from Dr Zava is in the pipeline.

In the meantime, Dr. Jane Murray, a respected M.D. in the States and former President of the American Academy of Family Physicians and author of a Women’s Health in Primary Care paper Natural Progesterone: What Role in Women’s Health Care? calls this study ?just plain irresponsible and wrong.? Dr. Murray argues there have been no studies to date that document harm to women from real progesterone. “Apparently the scientists who conducted this research are not aware of the huge differences physiologically between identical progesterone and synthetic, laboratory created progestins, like Provera?, which was implicated in the WHI studies,? she said.

Our reader ‘Jade’ writes, “As predicted, the drug companies speak out. Solvay Pharmaceuticals makes Prometrium … a prescription-only micronized natural progesterone. Isn’t it ironic, Catherine? Doctors called this stuff snake oil or insisted it was all in our head if natural progesterone cream helped with menopause. Five years ago, my own Dr. told me, “That’s a lot to pay for a skin cream but it’s your money”. I can still see that smug look on his face. I guess we should be careful what we wish for, huh? It’s just peachy that a major study finally proved nat. progesterone’s absorbency……but it may be at the expense of making it unavailable to thousands of women.”

PS: Jennifer, you state above that “Prometrium pills are synthetic and not [natural] progesterone but a progestin.” This isn’t correct. Prometrium is actually an oral form of bioidentical progesterone available only on prescription from your doctor.