Challenges Facing Holistic Medicine:
Your access to safe, natural hormones is under fire! How the FDA is launching its illegal attack and how you can fight back
Published in Jonathan V. Wright, MD, Nutrition and Healing Newsletter, Vol. 15, Issue 2, April 2008
Los Federales are at it again. The FDA has taken the first steps towards taking away your ability to safely reduce your risk of cardiovascular disease, lower your risk of Alzheimer�s disease and senility, and lessen your chances of osteoporosis�not to mention alleviate the unpleasant symptoms of menopause and slow the effects of aging on your appearance. The �first shots��the warning letters� in the war on bio-identical hormone replacement therapy and compounding pharmacies were fired on January 9, 2008.
In these letters, the FDA claimed that estriol (a major anti-carcinogenic estrogen naturally present in every woman�s body) is an �unap-proved new drug.� But aside from being just plain ridiculous (imagine arresting every woman alive for possession of an �unapproved new drug�), this move by the FDA is actually illegal. It directly contradicts the final ruling in a 2006 lawsuit known as Medical Center Pharmacy v Gonzalez, which determined that �compounded drugs do not fall under the new drug definitions.�
In that case, the Federal District Court judge also ruled that pharmacies are exempt from the requirement to submit to an FDA inspection of their records unless the FDA can demonstrate that the pharmacy is not compliant with applicable state laws, and does not operate as a retail pharmacy.
Of course, the FDA appealed the ruling. But instead of following the usual procedure of waiting for the outcome of their appeal, FDA has decided to try to enforce its own idea of the law.
True or false: Without a paycheck, it�s all the same to the FDA
For decades, the FDA has classified any statement�even a truthful one�made about the effects of a natural substance as a �false claim� unless the company making the statement pays the FDA an exorbitant amount of money to �approve� it. Without that approval, which is simply too expensive for most supplement manufacturers, companies can�t say anything at all about what their products can do. So essentially, the FDA has banned the truth, just as Popes in the Middle Ages banned certain books unless they �approved� of the information printed inside!
Here�s just one example: Even when another agency of los Federales, the Centers for Disease Control and Prevention (CDCP) announced that folic acid prevents serious birth defects, the FDA still wouldn�t allow supplement manufacturers and suppliers to print this fact on bottles of folic acid because the FDA hadn�t �approved� it yet (in other words, none of those companies had paid them yet)!
And it�s not just folic acid. The next time you�re at a pharmacy or supermarket, take a stroll down the vitamin aisle and look at the bottles on the shelves: You won�t see any information printed on the labels about what any supplement does to improve any symptom or illness. And any company that does print the truth on its label without paying the FDA for �approval� risks having their products seized and destroyed by the agency.
So this is the angle the FDA has used to skirt around the ruling made in the Medical Center Pharmacy v Gonzalez case in 2006: It�s attacking the pharmacies for making so-called �false claims� about bio-identical hormones. Here are some of the statements los Federales labeled �false claims�:
- bio-identical hormones are identical to hormones found in human bodies
- bio-identical hormones are better than and preferable to patentable molecules which are not identical to human body molecules
- bio-identical hormones have fewer side effects than patentable, synthetic hormones
- bio-identical hormones reduce the risk of heart disease, Alzheimer�s disease, and breast cancer
- bio-identical estrogens may improve memory, concentration, mood, energy levels, sleep patterns, and reduce blood pressure
- bio-identical progesterone is a natural diuretic and anti-depressant, and helps protect against endometrial and breast cancer
- bio-identical hormones help maintain muscle mass and strength
- bio-identical hormones have potential for treating multiple sclerosis
First of all, the term �bio-identical� is a definition, not a claim (let alone a false one). A �bio-identical hormone� is a hormone identical to a hormone found in the human body. So unless a pharmacy is committing fraud (which of course should be stopped), there is absolutely no grounds for the FDA to attack it for stating a simple definition�that bio-identical hormones are identical to hormones found in human bodies.
As for the second �claim,� of course supplemental hormone molecules identical to human hormone molecules are preferable to inexact copies. That�s why Nature and Creation put those molecules in our bodies from the very beginnings of humanity. Attacking compounding pharmacies based on this fact would be like preventing surgeons from re-attaching severed arms or fingers because they�re not FDA �approved,� and insisting that the surgeons attach FDA �approved� mechanical arms or fingers instead. To imply that inexact, mostly un-natural copies of human hormones (or body parts) are preferable to naturally occurring human molecules (or body parts) because they are FDA �approved� flies in the face of all logic and reason.
Let�s take the mechanical limb analogy one step further to counter the objection the FDA has to the third point on the list above: Original human arms and fingers would undoubtedly have fewer malfunctions and break-downs than mechanical arms and fingers�just like exact copies of human molecules undoubtedly cause less trouble than inexact copies. So of course bio-identical hormones have fewer side effects than inexact, mostly un-natural copies of human hormones.
The arguments against all the other items noted above are equally absurd, since there�s considerable research supporting each one: It�s 100 percent truthful to say that bio-identical hormones reduce risk of cardiovascular disease and Alzheimer�s disease, for both men and women. Estriol does reduce breast cancer risk, as well as risk of any other �estrogen-related� cancer (in fact, 2-methoxyestradiol�another bio-identical hormone�actually reverses the course of many cancers. See the February 2008 issue of Nutrition & Healing for more on that). Bio-identical testosterone does increase muscle mass and strength. (Note to FDA: that�s why most men have larger and stronger muscles than most women.) And it was UCLA researchers�not natural medicine doctors�who found that bio-identical estriol dramatically reduced brain lesions in women with relapsing, remitting multiple sclerosis, and I doubt they were making a �false claim� in their study.
Besides the ample clinical evidence supporting each and every statement made above about bio-identical hormones, there�s also a wealth of human experience to consider.
I�ve been working with bio-identical hormone replacement in women and men since the early 1980s, and I can�t even count how many times clients have told me that bio-identical hormones have improved memory, concentration, mood, energy levels, and sleep patterns. Literally hundreds of women have confirmed that bio-identical progesterone is a natural diuretic, an anti-depressant, and a natural tranquilizer. And any physician working with bio-identical hormone replacement can confirm my positive observations�� and likely add dozens if their own.
But in the bizarre world of the FDA, the all of this truth is a �false claim� until they say it isn�t!
�Approved� doesn�t mean �better�
The other major target of FDA�s warning letters is the bio-identical hormone estriol. As I mentioned earlier, the FDA is trying to classify this major estrogen naturally present in every woman�s body for as long as women have existed�an estrogen that soars to enormous heights during every pregnancy�as an �unapproved new drug.� But what they�re not telling anyone is that a patent medication company, Pipex Pharmaceuticals, is paying the FDA for �approval� of estriol to treat of one of the same things the FDA �warned� compoun-ding pharmacies not to write or talk about�multiple sclerosis (see the press release about it by visiting www.marketwire.com.
Even worse, Pipex�s version of estriol is an oral form, instead of a transdermal form. Published research shows that other types of oral estrogen significantly increase risk of blood clots, and raise levels of triglycerides and C-reactive protein (a marker of cardiovascular inflammation), while transdermal estrogens do not. And oral estriol itself has been shown to raise the risk of endometrial cancer�transdermal estriol doesn�t. Still, the oral version of estriol (renamed �Trimesta� by Pipex) is in stage 2 and 3 clinical trials, which means it could possibly be approved in 2009 or 2010.
Hmmmm�the FDA is trying to stop compounding pharmacies from offering safe, transdermal bio-identical estriol at a reasonable price for you and millions of other women, while at the very same time supervising the �approval� process of a potentially dangerous oral version of estriol for a patent medicine company�which is very unlikely to charge anything close to a reasonable price. Go figure�if you haven�t figured it out already!
If you want the option to replace the hormones previously naturally present in your body with precisely the same hormones�and to your lower your risk of cardiovascular disease, Alzheimer�s disease, and osteoporosis, to improve your mood, attitude and outlook on life, and (not un-importantly) to slow the physical signs of aging in the process, it�s time to �fire back� against the FDA�s shots at bio-identical hormones. See page 7 for details on how you can take part in the fight against this illegal power-grab, and start writing those letters and e-mails and making those telephone calls and personal visits to your members of Congress! Not just once, but very regularly until this threat to your good health is permanently eliminated.JVW
Source: As appears in April 2008 Dr. Jonathan V. Wright’s Nutrition & Healing Newsletter