Emerging research underscores the critical need to protect compounded bioidentical hormones. Action Alert!
Almost six million Americans suffer from Alzheimer’s disease, and it is projected to afflict many more in coming years. Big Pharma has been unable to produce drugs that treat this debilitating disease. New research, however, is suggesting that Alzheimer’s is more complex than previously thought, requiring an individualized approach that can include hormone replacement therapy. Unfortunately, the FDA is poised to eliminate consumer access to compounded, bioidentical hormones. We must continue to voice opposition to a ban on these important treatments.
Leading the charge on this new approach is Dr. Dale Bredesen (here is a link to his book on Amazon). The prevailing wisdom about Alzheimer’s is that it is caused by buildup of amlyloid plaque in the brain. Drug trials have been targeted at removing these plaques. But according to Dr. Bredesen and his colleagues, this is wrong. Dr. Bredesen has suggested that the buildup of amlyloid plaque is a symptom, rather than the cause of Alzheimer’s.
Further, Dr. Bredesen thinks there are three forms of Alzheimer’s with at least 36 contributing factors to the disease. Individualized protocols must be developed to address these factors. Dr. Bredesen uses an analogy of a leaky roof with 36 holes to illustrate his approach, where the size of the different holes depends on genetics and environment. Each “hole” will be a different size in each person, meaning some may not need to be addressed while others do. But plugging just one of the holes will not stop the rain from getting in—this is why Big Pharma’s approach fails. One drug may address one of the contributing factors for Alzheimer’s, but the rest of the “holes” remain.
Dr. Bredesen identifies three types of Alzheimer’s. One type is caused by inflammation; another is caused by a lack hormones and nutrients necessary to maintain brain plasticity; another type is caused by exposure to stress and environmental toxins, like mercury or mycotoxins from mold.
Hormones are particularly important for addressing the second type of Alzheimer’s disease. Dr. Bredesen writes that estriol, estradiol, and progesterone have brain-protective effects and a “direct effect on the molecular balance that drives Alzheimer’s disease.” Dr. Bredesen says that, “Reaching optimal hormone levels is one of the most effective and most critical parts of [the Bredesen Protocol].”
Other research has shown that estrogen plays an important role in the brain, including the modulation of synaptogenesis, increased cerebral blood flow, mediation of important neurotransmitters and hormones, anti-inflammatory actions, and antioxidant properties. Dr. Bredesen emphasizes the importance of taking these hormones transvaginally, since oral administration can lead to liver problems—something conventional medicine often misses. He also emphasizes the importance of optimizing testosterone levels to support the brain.
To restore proper hormone function, Dr. Bredesen recommends bioidentical hormones as opposed to synthetic hormones, as bioidentical hormones are identical to the hormones produced by the human body.
Note that many of the FDA-approved bioidentical hormone products are taken orally, not vaginally as Dr Bredesen and most integrative doctors recommend, and for estriol there is no FDA-approved product, meaning it must be made at compounding pharmacies. This emphasizes the importance of having compounded bioidentical hormones as an option. Unlike FDA approved hormone drugs, compounded hormones can be customized to a patient’s specific needs: pharmacies can make medicines using doctor-preferred delivery mechanisms (i.e. creams for hormones), allergen-free formulations, and they can personalize dosages. Bioidentical hormones also appear to be safer, particularly estriol.
As explained above with the leaky roof analogy, the Bredesen Protocol is tailored to the individual and includes cleaning up the diet (cutting out simple carbs and eating more vegetables and fruits); getting enough sleep; exercising regularly; ensuring hormone levels are correct, regular fasting; proper supplementation; and much more. The protocol is individually tailored depending on which “holes” need to be plugged in the leaky roof.
Using this protocol, Dr. Bredesen has been able to help improve Alzheimer’s in over 200 patients. He is attempting to fundraise for a larger clinical study, but as this isn’t a drug protocol and isn’t a one-size-fits all solution, funding can be difficult to come by.
Other research has supported the notion that hormones have a role in Alzheimer’s:
- One study found a 12 percent lower risk of dementia for women who had three or more children compared to women who had one child.
- Another study showed that women who begin menstruating earlier and went through menopause later have a lower risk of developing dementia.
- A study of 133 elderly women found that the more months of pregnancy meant a lower risk for developing Alzheimer’s.
The connection between pregnancy and reduced Alzheimer’s risk further suggests estriol’s role in protecting against the disease, as during pregnancy estriol levels rise significantly—in fact it is the most produced estrogen during that time.
This promising research gives hope to the millions of Americans who suffer from Alzheimer’s as well as their families and loved ones. It is also a stunning endorsement of integrative medicine that utilizes and individualized approach to treating illness (Dr. Bredesen is a conventionally trained physician who was introduced to integrative medicine by his wife, Dr. Aida Lasheen Bredesen).
It is a scandal that the FDA is considering a ban on compounded bioidentical hormones like estriol, estradiol, progesterone, and testosterone—medicines that could help Alzheimer’s patients, in addition to the 2.5 million women who rely on these medicines to manage menopause.
The FDA must continue to hear from the public about the urgent need to retain consumer access to compounded bioidentical hormones.
Action Alert! Send a message to the FDA and Congress telling them not to ban compounded bioidentical hormones. Please send your message immediately.
Mold is very harmful and improvement is better!
Please do not ban compounded biodentical hormones.
Do not ban compounded bioidentical hormones. Please give us hope that this Might help me and others like me!
Stop this intrusion into our medical freedom to choose what we will in order to preserve our health. Big pharma is more of a health hazard!
As a long time and now retired psycho-therapist, I was on the “ground floor”, when our beginning awareness about this tragic disease first began to mushroom. Identifying patients who needed to be tested for Alzheimer’s became an increasing phenomenon, in my practice, which was largely geriatric. Since then, I have been active in following and participating in research concerning this disease. NO ONE KNOWS FOR SURE WHETHER DR. BREDESEN’s APPROACH IS ON TARGET OR NOT BUT TO STIMY THE COMPOUNDS USEFUL FOR HIS WORK AND WHICH HAVE OTHER USES, IN SUCH AN ATMOSPHERE OF UNCERTAINTY, IS CRIMINAL, without conclusive evidence for the need to do so. If this is done, I could only hope the criminals who would do such a thing would be the first to suffer the disease, without the availability or advantage of new treatments that might offer new hope for patients in need.
Bioidentical hormones are necessary for many physical ailments and particularly Alzheimer’s and NOT manmade recreated hormones because of all the dangers they pose.
Put this medicine out on all of the shelves.
Protect bioidentical hormones!
There is an urgent need to retain consumer access to compounded bioidentical hormones. Compounded bioidentical hormones may be the new way of treating Alzheimer’s. I urge you to give hope to the millions of Americans who suffer from Alzheimer’s as well as their families and loved ones. It is also a stunning endorsement of integrative medicine and compounding medicine that utilizes an individualized approach to treating illness.
I urge you to retain consumer access to compounded bioidentical hormones, which translates into better treatments and cures.
Thank you for considering my request.
Ruth Amernick
El Cerrito, CA 94530
It appears that – in this particular administration- aid is distributed according to how it serves the very specific self interests of the legislators in question. I am personally -rapidly- falling victim this disease which has been unfolding -ever so slowly- for my entire lifetime. However, this administration only serves only it’s agenda. Point? First order of business: a wholesale “counter-assault” on the GOP – clean house, regain our humanity which is in absolute “tatters” in the hands of “Greed, Inc.” – i.e, corporate America and the GOP.
I am so sorry that you choose to make this a political issue. The FDA has long been “banning” natural healthy products and procedures long before the current administration. Just go back to the administration prior to this one. Wake up, dig down and look at history before making erroneous statements such as this. BTW I am an Independent. If anything or anyone drives these things it has been Big Pharma. It seems that if some item in nature or products that do not need to have a prescription will perform just as well as the prescription one(s) then the drug companies want it gone. This has been going on for numerous generations.
You support the right of a woman (without the consent of the father – who contributed 50% of the life of the unborn child) to kill that child for no good reason. By the way, how many methods of birth control are there now available to sexual partners?
Yet you would ban our right to access safe and tailored bio-identical hormones for our health.
Is there anyone in Congress who has not been bought by the Pharmaceutical companies? Aren’t the pharmaceutical companies the biggest contributors of any industry to politicians.
Since the FDA does not protect us against harmful chemicals in our food sources that are banned in almost all other countries; since it restricts helpful substances that would compete with much more costly patented substances with adverse side effects, why are we working to pay tax dollars to support the FDA? They certainly are not working in our best interest.
Actually, the cell that divides and divides and divides…. and after some time begins to divide into cells that start to differentiate… etc and becomes a new creature is the egg cell. A sperm is just a speck next to a sperm cell. One sperm cell cannot fertilize an egg, even if that sperm cell is placed directly onto the surface of the egg. The egg opens and brings in the DNA from one of the millions of sperm cells present, and discards the rest.
That DNA does not even make up half of the DNA, or genes, of the fertilized egg. The DNA of the mitochondria which provide the energy to cells, is from the egg and only comes from the female parent.
When a man has sexual intercourse with a woman, is he not willing giving his semen? If he has not had a vasectomy or castration, of course (yes, many men who have been castrated after sexual maturity can still have sex). Or, at the least, using a condom.
Squirting his semen into a woman does not give a man control over that woman’s body or her life.
It is a scandal that the FDA is considering a ban on compounded bioidentical hormones like estriol, estradiol, progesterone, and testosterone—medicines that could help Alzheimer’s patients, in addition to the 2.5 million women who rely on these medicines to manage menopause.
The second paragraph says it all! Drugs treat symptoms and that is mostly what pharmaceutical companies seem to go after. Most medical doctors are into that as well. “here’s you a pill to relieve the pain.” Uh, what about the cause of the pain, Doc?
please don’t ban bio identical hormones
I urge you to retain consumer access to compounded bioidentical hormones.
I request that you do not ban compounded bioidentical hormones.
This is very important medicine especially with a hope that it may treat Alzheimer’s patients! Please do not affect the usage of this important medicine!!
Dear FDA,
The odds that yourself or people you live and work with closely are developing Alzheimer’s right now. Other than cancer I cannot think of a worse way to go while getting old. Our memories makes us who we are as individuals. This methodology of utilizing hormones appears to be the best thought out process yet to keep us functioning.
Please do not ban bio-identical hormones!! They have helped my health significantly!!
I use compounded bioidentical hormones to keep myself feeling good. I NEED these medications!
There exist many patients who have inherited familial drug sensitivities. The serious and severe side effects and/or lack of effectiveness experienced when they use prescribed synthetic drugs are very real issues. When an allopathic endocrinologist recognizes this and prescribes compounded bio-identical hormones, then banning these drugs leaves their patients without adequate, and in many cases, with no proper treatment at all. It’s time for the pharmaceutical industry and their paid agency, the FDA, to stop interfering with the doctor/patient relationship and allow doctors to determine the best treatments for their patients, including safe bio-identical drug and hormone treatments. If not, then it is clear to many that they are choosing to promote profit over patients. My family and I need these or we will be left with no treatment options in many cases, including thyroid and adrenal disease (which would become life-threatening), and other hormonal imbalances.
As a pharmacist for over 45 years I have continually seen the FDA( backed by the congress) to do whats right for the Drug companies and not what’s right for the American people. Maybe if the drug companies were not allowed to buy off the congress-things might change—We use to compound a injection to prevent miscarriage -a 10 week supply -$100.00
FDA said no you can’t do that anymore-we are letting a drug company do it–price from drug company for 10 week supply–$20,000 dollars. It doesn’t take a genius to figure out whose interest they are looking out for. What about the drug company( Astra-I think) who lied about clinical trials resulting in deaths of thousands-FDA fines them some money and lets them go on there way.
We need the continued use of individualized compounded bioidentical hormones as prescribed by a physician who is skilled and knowledgeable in their application. One size doesn’t fit all.
Alzheimer’s disease is called by some researcher’s ‘Tye 3 diabetes’. Not just because of the damage caused by excess sugar, which bonds to most all types of tissue in the body. This glycation of tissues results in permanent damage.
Also, as the brain becomes insulin resistant, their is abundant sugar in the brain (glucose), but without insulin, which the blood-brain barrier no longer lets in, the glucose cannot get into the brain cells, and they malfunction and eventually die from lack of energy.
Ketone bodies, from dietary fats, are excellent fuel for brain cells, but when blood sugar and insulin levels are high, the body cannot make these. In other words, the body can burn sugar or burn fat, (and running on fat creates less oxidative damage), but it cannot run on both at the same time.
(Volek, Phinney)
What most of us, including medical professionals, were not taught is that starch is made of sugar. Glucose molecules hooked together, which quickly come apart after we eat them. Bread, cereals, ‘healthy whole grains’, potatoes, pasta, and even high sugar fruits will overload our bodies with sugar. (Yes, fruit contains both fructose- which is stores in the liver as fat, leading to fatty liver disease. HFCS and table sugar are both roughly half and half glucose and fructose.)
Since the blood stream only holds about 1 heaping teaspoon of sugar, the rest is stored as fat. Chronic high blood sugar and/or frequent spikes in blood sugar and/or insulin causes high blood pressure and can also lead to strokes, heart disease, damage to nerves (tingling, pain, and/or numbness), blindness, wounds that don’t heal, chronic inflammation, and other health issues.
How have we allowed the government to dictate how we care for ourselves and our families? And what methods or materials we use to do this?
It seems that in the name of safety and ‘enterprise’ we have allowed the government and for-profit corporations to take control of our health.