When I reviewed the history of natural progesterone cream research, there were clear indications of the deniers' influences. They produced one FAILED study, and have been using it as the proof that natural progesterone cream is no good ( see Med J Aust. 2005 Mar 7;182:237-239 Transdermal progesterone creams for postmenopausal women: more hype than hope? by Barry Wren). From a purely scientific point of view, one failed study does not prove anything. It simply means they failed. There can be a million reasons an experiment can fail. There might have been some mishandling of the materials, data, instruments; the preparations might have been inferior, etc. for example. When it fails, it does not prove there is no effect, unless it is replicated many times by other researchers. Of course, there are studies that successfully demonstrated the efficacy of natural progesterone cream, and in the presence of those successful studies, a failed study is just that, a failed study. (See a review by George R. Gillson, MD, PhD, David T. Zava, PhD, A Perspective on HRT for Women: Picking Up the Pieces After the Women's Health Initiative Trial - Part 2 )
The next stage is to dismiss; "When the scales begin to tip and the tactic starts to fail, then switch to dismiss. Accept that the problem exists but insist either that nothing can be done about it or..."
Well, even after the WHI's PremPro clinical trials have shown clear health hazards of the fake hormones in 2002, they are still trying to deny the problem by unscientific claims that Provera and Premarin (PremProm) are safe for early post menopausal women if used for less than 5 years. If you are persuaded by such arguments, you have a serious science IQ deficiency. It took 5 years to reach the preset statistical hazard ratio, but there were people who became sick in less than one year, and they developed more severe symptoms than non user cancer victims. "...the WHI study found that, among 10,000 women taking estrogen plus progestin for one year, there will be 8 more cases of breast cancer among the hormone users than if they had not taken the therapy"is what the researchers said. So, it is only as safe as Russian roulette, I would say. The lethal effects did not disappear even when the age (years since the onset of menopause) was taken into consideration in the reanalysis. Scientifically, it was a total waste of time and tax pair's money to even contemplate any possibility of favorable results from these fake hormones, who's contributions to the disease processes are known at molecular level (see a review by Holtorf, el al. 2009). I hope the recent outcome of the Wyeth breast cancer lawsuit will make doctors think twice before prescribing them. It is a shear madness that Wyeth, the pharmaceutical company of PremPro is still allowed to sell those fake hormones, which generated $1.1 billion in 2008. We, the general public is paying the bill as higher medical costs, reduced productivity, and disrupted lives the victims and the people around them ultimately suffer.
They are also shifting the gear to the next dismiss stage by saying there is nothing better, and the safety of bio-identical hormones are not proven (see the policy statements of American Medical Association, North American Menopause Society, American Endocrine Society, The American College of Obstetricians and Gynecologists (ACOG). "No Scientific Evidence Supporting Effectiveness or Safety of Compounded Bioidentical Hormone Therapy" is the exact words from ACOG NEWS RELEASE, which is "blatantly false" and qualifies as "scientific fraud". An increasing number of doctors are coming out to publicly accuse those medical associations they belong themselves. At the forefront of this battle are the doctors who have been treating both male and female patient with a wide variety of natural hormones based on decades worth of scientific and clinical studies. It is not just female hormones estrogen and progesterone, but male hormone testosterone, adrenal hormone cortisol, and thyroid hormone thyroxine all have this natural=bioidentical against fake=synthetic hormone issues. And it is about time the consumers as well as doctors were informed of the differences, the hazards of fake hormones, and how to use the real bioidentical-to-human's hormones (see Hormones: Dos and Don'ts)
According to David Suzuki, next stage is delay. Some has declared the bio-identical hormone debate is over. As far as the science is concerned, it's long been over, but that does not mean it will be embrace by everyone concerned right away. It's not just feet dragging and blindfolding that is going on. Those who have financial stakes in those fake hormones seem to be fighting it to the bitter end. The best defense is an offence. The battle seems to be escalating and the tactics getting dirtier.
Perhaps most of us did not have enough imagination to anticipate how dirty they would get. Although it was not the first time he was harassed by government regulators, this time the attacks against Jonathon Wright MD and his fellow holistic=natural=real medicine doctors were coordinated attacks (In Washington state, there are 15 doctors who belong to American College for Advancement in Medicine and 5 of them were persecuted by trumped up absurd charges). Now he is fighting back at various levels, counter attacking against the so called mainstream medicine doctors who control American Medical Associations and FDA and have been acting as big pharma's mouth piece, according to Jeffrey Dach MD BioIdentical Hormone Blog
Doctors aren't the only target. In October 2007 FTC also harassed Seven Online Sellers of progesterone cream, totally dismissing the pioneering study by Dr. Jone R. Lee (Lee, John R., M.D., "Osteoporosis Reversal: The Role of Progesterone," International Clinical Nutrition Review (1990), 10:384-391.). If they are truly serious about protecting consumers from false claims, they should go after Fosamax. Compounding pharmacies were also attacked. They had to fight against FDA's move to restrict doctors' access to natural hormones through compounding pharmacy, which was reversed (see Virginia Hopkins Health Watch and Patients, Doctors, Pharmacists Praise Bipartisan House Resolution On Compounded Hormones Containing Estriol).
As maddening and shameful as they are, these episodes will no doubt go down in the science and medical history footnotes, along with the Intelligent Design and the monkey trial, as the collateral damages of W. Bush's presidency and the Republican rule that turned America into a land of greed and voodoo science.
Late Dr. John R. Lee began his fight in late 1980's, long before the PremPro study was abruptly terminated in 2002. I was glad the study was terminated and shocked the world. Finally the truth is out, I thought. But I was naive. The very next year, when I read September 2003 position statement of The North American Menopause Society I realized what was going on; deny and dismiss. Today, 8 years later, not much has changed on the surface. Their position statements indicate they still think they can get away with it.
September 2003 position statement of The North American Menopause Society said:
"In the absence of clinical trial data from each estrogen and progestogen, the clinical trial results for one agent probably should be generalized to all agents within the same family, especially with regard to adverse effects." And they claimed that it is "the most up-to-date and scientifically based recommendations currently available on the clinical use of ET/EPT in peri- and postmenopause."
The AMA 2008 statement says:
"There is no credible evidence that bio-identical hormones are safer than traditional estrogen and progesterone products (Premarin and Provera)".
There have been too few real attacks against their blatant unscientific claims for so long. There are many people other than the doctors and the victims, namely scientists, politicians, and journalists who could have examined the issue and raised the public awareness. Where have they been? Why doesn't FDA have competent scientists? May be most of them are bought? What are the insurance companies doing? Both health and malpractice insurance companies should discourage doctors from prescribing the fake hormones and encourage the use of bio-identical hormones. Don't they have enough mathematicians and statisticians to see the implications? While the American doctors have been blindfolded, large scale safety studies have been carried out and published in other parts of the world, such as French E3N cohort study (see reviews listed below fore more). They can save a bundle if they did. Isn't that the promise of this free market system? Or are they colluding with the big phama too? If the 2002 PremPro results did not clearly tell them the party is over, may be 9,000 lawsuits will.
Some of the Websites I found helpful and inspiring:
Website of Late Dr. John R. Lee: is still open thanks to his wife.
Jeffrey Dach MD : His blog is my inspiration.
- The Battle for BioIdentical Hormones by Jeffrey Dach MD (He can use some coaching on his presentation style, thought.)
- Natural Medicine 101: How to Win the Medical Information War and Take Control of Your Health
- The Truth about Hormone Therapy in Wall Street Journal Opinion page
- CNBC segment on male menopause treatments, and other numerous media appearances
- The definitive review: The Bioidentical Hormone Debate: Are Bioidentical Hormones (Estradiol, Estriol, and Progesterone) Safer or More Efficacious than Commonly Used Synthetic Versions in Hormone Replacement Therapy?
Virginia Hopkins : The coauthor and editor of late Dr. John R. Lee's books and newsletters
David T. Zava, PhD: Expert on breast cancer and hormone tests. Coauthored:
- What Your Doctor May Not Tell You About Breast Cancer , by John R. Lee, M.D. David Zava, Ph.D, and Virginia Hopkins, 2002 Warner Books.
- George R. Gillson, MD, PhD, David T. Zava, PhD, A Perspective on HRT for Women: Picking Up the Pieces After the Women's Health Initiative Trial - Part 1 , International Journal of Pharmaceutical Compounding Vol. 7 No. 4 July/August 2003
- George R. Gillson, MD, PhD, David T. Zava, PhD, A Perspective on HRT for Women: Picking Up the Pieces After the Women's Health Initiative Trial - Part 2, International Journal of Pharmaceutical Compounding Vol. 7 No. 5 September/October 2003
PremproCounsel Legal Team
My hormone pages
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