• Progesterone: The Second Domino to Fall after Testosterone

    BioBalance Healthcast episode 65, Progesterone loss and how it affects women

    In episode 65 of the BioBalance Healthcast, we talk about progesterone. Our discussion is based on a chapter of my upcoming book, I Want What She’s Having. The following is an excerpt from the draft.

    There is a cultural myth that women are emotionally reactive and unstable. The Myth has it that every 28 days or so women become raving emotional biohazards. This is beyond their control and everyone in their sphere of influence can only duck and cover until the storm has passed. We sometimes think that if men were the ones with this reputation and concern, medicine would have found a solution for the problem years ago!

    I started practicing medicine in 1981, when PMS was considered a psychiatric disease, and thought to be unrelated to the hormone progesterone. It was not until the 1990s that alternative doctors initially suspected that there was a hormonal imbalance causing this condition, specifically by a lack of progesterone. During the 1980s, I was treating women who had PMS with pure bioidentical progesterone and vitamins containing large amounts of magnesium. This treatment was remarkably successful. Even though mainstream medicine called this treatment crazy, I had a very high success rate when treating PMS with progesterone. I have always been willing to challenge the status quo and test new treatments with good scientific controls to actually see whether or not they were efficient and effective forms of intervention.

    I consulted with a compounding pharmacist, who I still work with. I credited him with helping me decide how to treat my patients with bioidentical progesterone for PMS. In the beginning, I first prescribed progesterone in the form of rectal suppositories, then vaginal suppositories, progressing to vaginal tabs and currently prefer sublingual (under the tongue) tablets or pure progesterone pellets that are placed below the skin. This widely-researched and confirmed source of PMS currently in 2012, is still not accepted by the American College of OBGYN as a condition that is secondary to the loss of progesterone, and one that can be cured by the addition of natural progesterone between day 14 and 28. If an OBGYN applicant answers that question on the National Board exam with progesterone insufficiency, and natural progesterone as the treatment, they will get it marked wrong! Yet, twenty plus years of practice in the field by myself and other practicing OBGYNs have proven otherwise for millions of women.

  • Low testosterone in men causes a variety of poor health conditions.

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    Podcast 63 is about Erectile Dysfunction. Men and women both make testosterone but men show benefits of higher bone density which leads to less cases of osteoporosis in men.

    In the last 5-6 years testosterone has been huge subject in research. The Sexual Medicine Journal in 2009 said the risk for cardio vascular disease in men is about 1 and a half times more likely in men with slight erectile dysfunction and more than two times more likely in those with severe erectile dysfunction.

    Testosterone helps prevent erectile dysfunction and cardio vascular disease. Viagra doesn’t help with lack of testosterone. It helps with blood flow. Nitric acid is the chemical you need to have an erection which is what is in many medications that treat ED. However it’s important to not just treat the erection issues.
    Doctors should offer testing for heart disease in patients with ED. They need to look for compromise of the vessels. If a man has fat layers on the inside of his vessels, it causes those vessels to become very small. If his heart has the same problem, he’s at risk for stroke. If his pelvis has this problem, he’s at risk for ED. When men are younger they have higher testosterone levels so they don’t have this inflammation problem.

    Men under 50 have who have ED, have a 50 fold increase in the risk that they’re going to have a heart attack in the next 10 years. Heart disease, cancer and respiratory failure all increase dramatically with the decrease of testosterone. If you take care of the maintenance of testosterone, it can help avoid later diseases and conditions.

    BioBalance Healthcast episode 63, testosterone and men

  • Discussion of a CNN Health article that says anti-aging medicine is risky.

    BioBalance Healthcast episode 62 Current Topics in Anti-aging Medicine

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    In episode 62 of the BioBalance Healthcast we continue the discussion we started in the previous episode that reviewed an article  titled “The risks of anti-aging medicine” that was published on the CNN Health website on Wednesday December 28, 2011.

    The author states that anti-aging doctors are generally not as well trained as other medical specialist. I am an excellent example of the many anti-aging doctors who are well trained and qualified to offer these services that include advancements that make it possible for us to live longer lives. Anti-aging treatments—especially bioidentical pellet therapy that we offer her at BioBalance Health—let’s us enjoy better health and mobility for many years past the onset of menopause in women and andropause in men.

    Dr. Thomas Pearl, quoted in the article, was referring to treating geriatric patients, which is not what I focus on. Instead, I normally start hormone therapy long before patients reach that age, and not when they too old for the therapy to make a difference. By offering this therapy, doctors can prevent many diseases that are secondary to hormone loss. Many diseases can be offset for 10-20 years with bioidentical hormone pellets.

    HRT is a treatment for a syndrome, not symptoms, and often save money and time. Chelation therapy for heavy metal toxicity is not offered at BioBalance Health. Chelation has risks of renal and liver problems. There are alternative supplements to rid patient of heavy metals. Baby boomers have higher chance of heavy metal toxicity due to lead, mercury, and other harmful substances in food and the environment.

    Compounding pharmacies used to be popular 70 years ago before drugs were made by pharmaceutical companies. Current compounding pharmacists have the ability to compound drugs prescribed by a physician. I supervise the use of compounding pharmacies for my patients. My estradiol and testosterone pellets are made at a compounding pharmacy that is reputable and trusted. If your physician writes a prescription for a drug and sends you to a compounding pharmacy, be certain he/she has a relationship with the pharmacy they use. The FDA does oversee compounding pharmacies.

    The article sites information based on the Women’s Health Initiative study which since released has been discredited. Dr. Goldstein is using a bad argument, a bad study, bad information and miss-representing the use of bioidentical hormone therapy.

    To wrap up our podcast, we discuss the term “the standard of care,” which means the least amount of medical treatment that is acceptable by a physician. It’s the lowest standard of care you can give and not get sued.

  • Base your health decisions on reliable information, not just media resources.

    BioBalance Healthcast episode 61 Current Topics in Anti-aging Medicine

    People are often influenced by the news media, and sometimes make medical decisions based only on what they read on the internet. A recent article published December 28, 2011 by CNN Health made some statements and quoted some experts that would lead readers to the conclusion that anti-aging medicine is generally unsafe.

    In the article, titled The risks of anti-aging medicine, CNN Health reported that a 56 year old California woman injected human growth hormone into her thighs six times a week. Six months after starting the treatment, she died of liver cancer.

    The problem with this report is that it allows the reader to confuse correlation with causation, inferring or implying that the treatment is responsible for the patient’s death. The experts quoted do not say conclusively that the HGH treatment caused this women’a death.

    In this episode of the BioBalance Healthcast Brett Newcomb and I walk through the article and explain why it may not be totally accurate or objective, and how you might think about medical-related articles you in the future, especially when you are considering healthcare issues.

    Episode 62 will continue this discussion.

    Visit BBH.com for more info about bioidentical hormones/anti-aging/skin care.

  • Bioidentical testosterone pellets can cure chronic fatigue.

    BioBalance Healthcast episode 58, Treating Chronic Fatigue with Bioidentical Hormone Pellets

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    On episode 58 of the BioBalance Healthcast, Brett Newcomb and I talk about chronic fatigue, the symptoms, diagnoses and treatment with bioidentical testosterone pellet therapy.

    The symptoms associated with chronic fatigue are severe fatigue following a flu-like illness, abrupt onset of fatigue after the viral infection, exhaustion after any exertion or exercise. Night sweats occur in half of the patients with chronic fatigue.

    The sources of this medical problem are immune system dysfunction, low cortisol, low ACTH and a low level testosterone.

    The diagnostic tests essential for evaluation are CBC (blood count), thyroid panel, ANA, 8 AM Cortisol level and ACTH level, testosterone levels, and growth Hormone levels.

    If you have been told that you have chronic fatigue, and traditional medical therapy has not worked for you, BioBalance Health Testosterone therapy will improve the immune system, and therefore improve many symptoms of chronic fatigue. Many patients who thought they would have to live mired down with fatigue, have found the answer with us. Patients who have been struggling with this syndrome, tell me that they have their lives back, by replacing the hormone they needed testosterone!

  • Depression and anxiety can be caused by hormonal imbalance.

    BioBalance Healthcast episode 57 Depression, Anxiety and hormone imbalance

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    In episode 57 of the BioBalance Healthcast we talk about some of the medical and emotional causes of depression. Last week we talked generally about Depression and Anxiety. This episode focuses more specifically on the role hormone imbalance can play in causing anxiety and how it can often be treated with bioidentical hormone pellet therapy. The discussion is in part based on a chapter of my book, I Want What She’s Having. Following is an excerpt of the draft manuscript.

    Anxiety and Hormones

    Anxiety. Worry. Fear. Anxiety is a term most people use loosely to describe “over worry,” but when intermittent worry, turns into constant fear or recurrent episodes of fast heart rate, sweating and/or the feeling of impending doom, that won’t go away with deep breathing or the many anti-anxiety drugs on the market, a true medical condition called Anxiety is the best label. The many and varied symptoms of anxiety are listed below. A patient with anxiety can have one or the majority of these symptoms.

    Here are some of the symptoms of Anxiety:

    • Fast pulse
    • Feeling of impending doom
    • Irritability
    • Sometimes cyclic, in the last week of a menstrual cycle
    • Temper outbursts
    • Insomnia waking at 2 am with heart racing
    • Lack of ability to concentrate
    • Unreasonable worry
    • “Flying off the handle” without provocation
    • Hyperventilation and chest discomfort
    • Flight of ideas
    • Mind is racing

    There are many causes of the disease known as anxiety. The one cause responsible for anxiety in women over 40, is testosterone loss and after 50 estradiol deprivation. Before using bioidentical hormones to treat the other symptoms of hormone loss, I treated anxiety like any other doctor; with medications like Xanax, or Ativan, to treat the symptom, but never really looking at the cause that began the process. This is the one symptom that I never in my wildest dreams considered to be related to the loss of testosterone or estradiol!

    I was trained to replace these hormones in the most natural way, to alleviate many other symptoms, but anxiety was not one of them. Soon after I began to use Bio-identical testosterone pellets, my patients came to report on their success. At the end of the conversation, they would usually add a statement like this, “I thought that the many symptoms of menopause and peri-menopaus would be gone, but it was so weird…I don’t have anxiety attacks, or I don’t have anxious worry anymore! Why do you think that is?”

    After going through the research I found papers on the fact that elevated FSH and LH prior to menopause can cause atypical “hot flashes”. They were described in many ways, one of which was an anxiety attack or overwhelming anxiety, and worry all the time. The anxiety attacks were related to brief elevations of FSH and LH from the pituitary that did not feel hot or generally sweaty (although sweating could accompany the anxiety), like a hot flash, but was perceived as an anxiety attach with fast heart rate, fear and jitteriness. The surge of FSH/LH destabilized the neurotransmitters of the brain and instead of stimulating the temperature center, it stimulated the area of the temporal lobe that controls mood, causing a brief but potent anxiety attack. By replacing testosterone and estradiol (after menopause), the surges subsided and so did the anxiety attacks. Even now, some of my patients can tell their testosterone pellets are wearing off because their anxiety attacks start up again!

    Just to be complete, other psychiatric and medical illnesses can masquerade as anxiety, and are not responsive to replacement with hormones. The most likely illnesses that appear like anxiety can be, Bipolar disorder, Attention Deficit Disorder, and personality disorders, to mention a few. It takes a physician, lab work and a few sessions in the office to decide which disease is the primary issue.

    In the case of long standing anxiety,(appearing earlier than age 40) a genetic component can be integral to the appearance of anxiety in a particular patient. In some cases the cause is a gene that translates into low serotonin and norepinephrine levels. It can also be from genetically low testosterone levels, and in that case the history of a low sex drive is typical as well.

    Lastly, a few other hormones can be guilty of hyper-secretion, causing anxiety. Cortisol and Thyroid are the two most likely suspects. Longstanding high cortisol is called Cushings, and increases anxiety, energy, decreases immunity, and allergies, but can exhibit the anxiety with anger and irritability, as well as sleep.essness. If hyperthyroidism is the cause, an auto immune thyroid condition stimulates the thyroid so temperature, pulse, rate of breathing increase as well as anxiety. Most often weight drops rapidly and sleep is not necessary to function.

    Now for the women who are dealing with this symptom and have no idea that it could be related to hormones,the characteristics of anxiety caused by testosterone deprivation have some telltale signs that are characteristic to loss of testosterone as the primary cause.

    Helen Hormonal is a 43 year old working mother of three who sits down quickly in her doctors office, drums her fingers on the desk and sighs over and over again before she starts to discuss her problem. Helen feels very different than she did a few years ago and her biggest worry is that she feels anxious all the time, punctuated with severe anxiety attacks, especially at night that feel like she is having a heart attack. Helen tells her doctor, “I worry more than ever before, in fact, all the time, but when I try to sleep, or relax in the evenings I get surges of anxiety that come and go, lasting a few minutes at a time. I feel my heart beat quickly, I sweat and get chest pressure and feel like I’m going to die, right there!” Helen is clearly afraid she has heart disease, but she has already had a cardiac work up and it is negative. She is asked about other symptoms that are new; Helen remembers that she wake up at 2 am and can’t go back to sleep, and she is not interested in sex any more. Helen thinks awhile and tells her hormone doctor that she has noticed that the more severe episodes of anxiety occur when she is having her period. She remembers that her mom had the same thing when she was in her 40s, and was given valium. She finally asks her doctor,” None of the anti-depressants or antianxiety pills that my primary care doctor gave me help, and some even made me worse. I don’t get it, my life is great, I have had nothing to be anxious about. What is wrong with me?”

    Helen is the typical patient who needs testosterone replacement. She knows there is something physical wrong with her, but the traditional treatments for the symptoms she is having don’t work. Her anxiety is new since she turned 40, and she wants an answer and a treatment for the cause of her symptoms.

    Specifically following is the diagnosis of Helen’s symptom list: The hormonal reason behind her symptoms of anxiety are complex, but include surges of FSH and LH stimulated by low testosterone levels causing an increase of these hormones that cause an atypical hotflash. The anxiety attack is cause by the surge of FSH and LH that cause tachycardia, sweating and shortness of breath. The low testosterone decreases the amount of seratoinin and Norepinephrine that is produced in the brain, and in return makes the woman feel depressed and anxious from lack of neurotransmitters. Many women treat their anxiety by having regular sex to improve endorphins, but as libido disappears their unconscious self-treatment goes with it.

    • Symptoms that are typical of anxiety caused by Testosterone Deficit include:
    • New onset of symptoms after age 38
    • Increased episodes at night and during the period
    • Lack of life events typical of situational anxiety
    • Other symptoms of Testosterone Deprivation

    Body Composition

    Oh, forgive me but I forgot the most common source of depression in ,my previous chapters…weight gain! The change in our bodies after we turn 40 is the most external sign that we are aging, and if you are a doctor the most obvious symptoms that testosterone has decreased! There are very few women in America who can avoid this physical change without replacing the lost hormones or exercising to excess or both.

    Helen Hormonal came to her hormone doctor for her second visit before she had started her hormonal replacement.

    “I am so freaked out! I looked in the mirror and my mother looked back at me! I have her sagging double chin, and none of my clothes fit…I have tried every diet and my belly keeps getting bigger! I am so depressed and it is so unfair! If I had a sex drive I would still be too embarrassed to have sex because of my body! I got married at 120 lbs and now I’m 165! Aaagghhh!”

    Helen has a lot of company! Her doctor consoles her and tells her that she will give her the missing hormones back and write a script to replace her flagging thyroid, but she has to do her part as well. “Helen, you are going to have to stop eating 6,000 calories of fast food, and carbohydrates a day. You won’t need it to medicate your miseryanytmore.” Helen looks like she lost her best friend…her Cherry Coke! “ Helen, you will feel better in a month or so and then I want you to exercise 3 times a week, no excuses. Exercise means sweating too! I also want you to begin a low carb,6 feedings a day, diet. It took a long time to get here and it will take a while to work your way back to health!” Helen nods and considers her dilemma. Dr. Hormone reassures her that with her replaced hormones she has a chance to regain her health, and her body, and she will soon feel more like exercising when she is not so tired.

    Here’s some of what you might be seeing in the mirror:

    • Decrease in muscle mass
    • Increase in abdominal fat
    • Increase in cellulite
    • Decrease in skin quality and tautness
    • Increase in wrinkles and sagging “waddle”
    • Dry and translucent skin with visible veins
    • Loss of hair on your head and in the pubic area
    • Cellulite

    When we are young we take our beauty, youth and our hormones for granted. Some of us did destructive things to ourselves, like smoke, drink, and eat too much of the wrong things, but youth protected us. Now everything fails all at once and aging plus our bad habits show up all over our body. What happened and what can we do?

    Much of what has happened is the result of declining levels of free testosterone, estradiol, progesterone, and growth hormone, and possibly thyroid, combined with increased levels of estrone and androstenedione from the adrenal gland.

    Helen hormonal wants a reason for all of this. She asks her hormone doc why this happens in the middle of our lives?
    “ We were built to live about 40 years. Now our intelligent medical minds have given us a longer life, but we were built to last 40 years. When our ability to reproduce decreases after 40 the outward appearance was a sign that we were no longer fertile. Both pregnant and older women lose their waistlines….that is why having a small waist is so important to men and women. It is a sign of youth and fertility. Some things don’t change, but we can outsmart an outmoded system. We can restore our minds and bodies with replacement hormones and give us back a quality life instead of a sick, but long life!”
    Helen was so excited to understand the cause of this seemingly senseless mess!

    Take a look at the list of functions of estradiol and testosterone do for our tissues:

    • Stimulate collagen production
    • Reduce cellulite
    • Increase dermal (skin) thickness
    • Increase skin moisture and natural oil
    • Increase thickness of scalp hair and eyebrows
    • Accelerate healing
    • Increase blood flow to the skin, muscle and connective tissue
    • Increase the volume and definition of muscle and support for the skin layer
    • Increase lean body mass
    • Decrease our waistline

    The addition of all three of your missing hormones into your health regimen increases the collagen and the supportive tissues for your skin. This improves your body composition to a more youthful figure over about 12 months. Of course, damage from sun and smoking is not reversible in this manner and must be dealt with in other ways.

    Cellulite is a function of a low-oxygen-environment surrounding superficial fat. The largest areas of cellulite on women are the fatty areas covering the large muscles of the thigh, hip and gluteus (buttocks). When testosterone decreases, muscles shrink, and do not demand as much oxygen. The fat lying on top of those muscles are “starved” for oxygen, and they succumb to scarring areas of muscle in response to a low oxygen environment. These scars pull the skin down and “dimple” the skin overlying the hypoxic fat. This is where cellulite comes from. All treatments for treatment of cellulite are aimed at oxygenating the fat. The best oxygenator is replacing the testosterone so blood and oxygen is drawn to the working and growing muscles. This heals the cellulite from the inside out. For severe cases or faster repair, I-Lipo laser or radiowave cellulite treatments help stimulate the bloodflow quickly and helps dissolve the fat as well.

    Restoration of our previous youthful body requires patience, time, work, a Mediterranean low carb diet and exercise. First, hormonal replacement restores tissue integrity. Weight remains stable, rather than inching upward, as muscle builds and fat decreases for one year. Clothing size, and waist measurement decreases as muscle builds. Finally, weight begins to decrease after one year of therapy, and continues until you reach ideal weight.

    Remember, it took years of hormone insufficiency to get here, it will take at least a year to get back. It will be easier than you think once you get your energy back. It is truly amazing to watch the reformation of your figure after you follow this treatment plan.

    Dry Eyes and Testosterone

    Dry eye syndrome is defined as a decrease in the production of tears or poor quality of the tears, e.g., tears that break down too quickly to be of benefit. It can also be excessive tear evaporation. When tears are lacking or of poor quality, the cornea becomes dry and vision is distorted. This condition can prevent you from wearing contacts and cause you to have difficulty preventing corneal abrasions. This is not a minor symptom of testosterone deficiency.

    There are other causes for dry eyes, but the one cause that is most prevalent is the loss of testosterone that occurs after 45 y.o in women. Every gland that produces “wetness”, like lacrimal ducts (tears), salivary glands (saliva), sweat glands (sweat), among others dry up when the level of testosterone becomes critical. This is a recent finding in the literature and has been discussed and evaluated mostly by opthamologists. Because they don’t replace hormones, and it is kind of tricky, they have used topical drops with testosterone, but they were only mildly successful.

    The real treatment for this condition, when secondary to low testosterone levels is systemic testosterone, that is replaced 24/7. Many of my patients have been happily surprised when they could throw away their “cheaters”, and put their contacts back in, after being treated with testosterone pellets for other reasons. Some opthamologists send me their most difficult patients to treat for dry eyes, with testosterone pellets, however there are generally multiple causes in the worst cases, and it has not been as successful as in the patient who presents for some other testosterone deprivation syndrome.

    If you think this is a minor problem compared to lost libido and memory loss, then think again. The statistics about dry eyes might surprise you. Did you know that 3.2 million American women over 50 suffer from dry eyes? One point six million American men over 50 do, as well. Hispanic and Asian women are at higher risk than other ethnic groups.

    Symptoms of dry eye syndrome:

    • Red, scratchy eyes
    • New intolerance to contact lenses
    • Burning and stinging of the eyes
    • Stringy mucous from the eyes
    • Blurred vision
    • Frequent infections
    • Frequent abrasions of the cornea
    • Decreased night vision

    Testosterone is essential to the health of the lachrymal duct and is crucial to the production of tears. Decreased testosterone causes increase in “cytokines” which are an inflammatory chemical in the blood and tears. Once the lachrymal duct is inflamed it stops producing tears.
    There are conditions other than testosterone deprivation that can cause dry eye syndrome, as well:

    • Autoimmune disorders like rheumatoid arthritis, Sjögren’s, and Lupus (SLE)
    • Diabetes
    • Pregnancy
    • Dry air
    • Contact lenses
    • Car air-conditioning ducts
    • Allergies
    • Medications, e.g., high blood pressure, antihistamines, sleeping pills, some pain relievers
    • Lasik, blepharoplasty, and other corneal eye surgery

    Pregnancy is a notable cause of dry eyes. “A significant proportion of women report dry-eye syndrome during pregnancy, especially when they have had at least one prior birth.” Joel Schechter, Ph. D., reported, “…In Dr. Evans’ study, symptoms were four times more likely to be worse during pregnancy than before it.” “During pregnancy, androgens are deficient, causing insufficient lachrymal gland function.”

    But pregnancy isn’t the only hormonal culprit – there’s also menopause. “Dry eyes occur most frequently in older persons and more often in women than men. The androgens that are released normally by the lachrymal gland help maintain the gland’s structural integrity.”1 This substantiates the connection between dry eyes and the endocrine system.

    Women are forced to stop wearing contact lenses just when bifocals are needed! We have noticed for years that patients taking testosterone pellets resolved or improved their dry eyes. Now research has proven that parenteral (IV or IM or pellets) replacement can relieve dry eye symptoms. 2 Testosterone eye drops are also being compounded for patients who cannot take testosterone pellets, but are found to be less effective than pellet therapy.”

    1 All from Evans, Jeff, “Study shows dry eyes a problem in pregnancy,” AMA News,

    2 0062 Schaumberg DA, et al, “Prevalence of dry dye syndrome among US women,” Am Journal of Ophthalmol, 2003 Aug;136 (2):318-26; Schaumberg DA, et al, “Hormone replacement therapy and dry eye syndrome.” JAMA 2001 Nov 7; 286(17): 2114-9.

  • The Federal Drug Administration regulates testosterone as a treatment for symptoms of menopause.

    BioBalance Healthcast episode 52 on Off-label Use of Medicines as it Relates to Testosterone

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    Episode 52 of the BioBalance Healthcast features a conversation about the use off-label medicines and how that relates to treating symptoms of menopause with bioidentical testosterone. If you missed it, you might want to watch episode 51 titled Testosterone and the FDA.

    Bioidentical Testosterone is safe and legal as a treatment for symptoms of menopause.

    Off-llabel Drug Use is the common practice of using drugs for purposes not originally approved by the Food and Drug Administration. Terbutaline is a great example. It is an FDA-approved generic asthma drug that was also used an effective way to stop premature labor.

    Ramifications of off-label use are sometimes significant beyond the expansion of drug use. Terbutaline is a good example. It has been replaced in the last decade with a similar and more expensive drug for its non-approved use, prevention of pre-term labor. As a result, it was never approved by the FDA for this purpose; until it was replaced, however, it saved the lives of millions of babies.

    If a medication has become generic, then it is not patentable, or “own-able” exclusively by any company. As a result, there is no opportunity for profit. It is therefore no longer cost-effective for a pharmaceutical company to pay for this high cost of research on the second use of the drug when the company has no possibility of realizing a return on the investment, much less a profit. And if there is no pharmaceutical company championing a drug for a certain disease, it is unlikely the FDA will approve it for that that purpose, regardless of its proven effectiveness!

    Hormones like testosterone fall into a similar category as generic drugs. Because hormones are natural, they are not “unique, and hence not patentable. With no financial incentive to produce unpatentable drugs, there are no investment dollars to support testing in a way the FDA requires. So generic drugs and natural hormones like testosterone remain untested for any but a narrow set of uses.

    The first issue centers around the age and medical condition of the patient using it. Most negative reports are related to the use of testosterone in young, healthy men – usually athletes and body builders — who naturally have excellent levels of testosterone, and who are attempting to artificially augment their testosterone beyond normal physiologic levels to increase muscle mass, strength or athletic skill.

    This misuse of testosterone is indeed very dangerous, and richly deserving of its bad press, because it turns off the user’s own production of testosterone from the testicles and adversely affects the function of adrenal gland. This can in turn lead to infertility, adrenal failure and a life-long struggle to regain health.

    Because testosterone is in demand for these illicit purposes, but can only be obtained legally from a licensed physician, a black market has arisen on the internet where weight lifters and athletes can obtain “forms” of testosterone for injection from the eastern bloc countries. I have interviewed body-builders and lifters who get their “testosterone” to improve their bodies or their competitive edge, but they usually have no idea what is really in these injections except what the “seller” says is in them. Nevertheless, in their desire for a better body than God gave them, or for an illegal leg up on the competition, they inject these knock offs, with risks and side-effects too alarming and too numerous to discuss here.

    This, then, is the scariest of all uses of a product labeled “testosterone,” because it is most likely not the same safe, effective, testosterone regulated by the FDA and administered by licensed physicians. It is more than likely a truly unknown testosterone-based substance. Equally concerning is the fact that it is usually administered by an untrained and unlicensed individual, usually a coach or the athlete himself.

    If bio-identical hormones like testosterone are essential and helpful, why are they “FDA regulated, but not approved” for hormone replacement in women? The answer is the same as that for generic or other non-patentable drugs: no company has petitioned the FDA to test and approve testosterone replacement for women.

    The FDA’s simple regulation of the drug is enough for me at this time. Because bio-identical hormones have been “grandfathered” into the FDA oversight, physicians are free to prescribe them, as I do, for off-label uses. Consequently, millions of women can and do legally and safely use bio-identical hormones, including testosterone, for hormone replacement therapy. Many cannot tolerate any other hormone preparation than pellets.

    As the ultimate pharmacists, physicians have the training to look at a drug like testosterone and say, “I know it works for the FDA-approved diagnosis, but this may also work for another condition, or another population (i.,e. women) because of its chemical and physiologic properties.”

  • The Federal Drug Administration regulates testosterone as a treatment for symptoms of menopause.

    BioBalance Healthcast episode 50 on testosterone and the Federal Drug Administration

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    Episode 51 of the BioBalance Healthcast begins a discussion of how the Federal Drug Administration—or FDA—regulates drugs, and in particular, testosterone for women.

    Testosterone is a Legal Drug
    Testosterone has been in medical use since the early 1930s, and has never been illegal. It is not only legal when administered in synthetic and bioidentical forms by a licensed physician for certain approved conditions, it is an essential hormone that should be replaced in both women and men who suffer from hormone deficiency.

    In addition to be being legal under appropriate medical conditions, testosterone is regulated, in every form in the United States by the FDA, the Food and Drug Administration. Canada has a similar agency that regulates all drugs.

    This FDA regulation of synthetic testosterone production by drug companies and pharmacies ensures that:

    • the product is pure
    • the dose on the label is consistent with the drug
    • it is dispensed in a way that leaves a paper trail
    • there are lot numbers and expiration dates on the drug in case there is a recall.

    Approved? Regulated?
    The term “approved by the FDA” is different than “regulated by the FDA”. Approval represents yet another level of restriction beyond regulation. When the FDA approves, or “sanctions” drugs, it approves them for a particular purpose or set of purposes, and only that specific purpose or set of purposes. This, however, does not restrict usage beyond those approved parameters.

    Off Label Use?
    Although bioidentical hormones such as testosterone are not approved for women in pellet form as they are for men, this highly safe and effective treatment is legally, openly, safely and economically available for “off-label use” for women for the treatment of hormone deficiency, just not as widely as it would be were it FDA approved for this purpose.

    Sometimes Dr.’s Don’t realize it is Off Label
    Many physicians, including these conservative ones, often don’t even recognize that some of the medications they routinely prescribe are in fact not approved by the FDA for the disease for which they are using it. The reason is that the use of that drug for that particular purpose, though not approved, is so common that they may even have been trained in medical school to use it for that purpose. It may never come up that the FDA has never approved it.

  • Pellets are the best vehicle for bioidentical hormones.

    BioBalance Healthcast episode 49 Patches, Pills or Pellets best method for bioidentical hormones image

    Download the transcription of this podcast.

    In episode 49 of the BioBalance Healthcast, we continue our series dealing with bioidentical hormones in the news. Brett Newcomb and I discuss a recent news report that compared patches and pills. We add important detail to the discussion of these methods and then describe my preferred hormone delivery system, bioidentical pellets.

    Patches carrying estradiol, or estradiol and progestin, are applied to the hip or addomen to provide the body with the additional hormones transdermally—or through the skin. Pills that are swallowed go from the stomach to the liver where they are broken down to make estrone—or “old lady estrogen.” Estrone is just what menopausal women don’t need more of because it causes several negative effects. Estradiol pellets that are inserted into the vagina are designed to deliver estrogen just to the vaginal wall so it is not a good way to get the hormone distributed throghout the body.

    The best delivery method is—and the one I use almost exclusively—is bioidentical estradiol and testosterone pellets inserted subcutaneously, in the fatty portions of the hip or thigh, three or four times per year.

    The overall conclusion in regards to bioidentical hormone therapy is that patches are healthier than pills, but not as good as pellets.

  • Endocrine Society reports heavier women experience fewer hot flashes.

    BioBalance Healthcast episode 48, Obesity and Hot Flashes in Menopause image

    Download the transcription of this podcast.

    In episode 48 of the BioBalance Healthcast, Brett Newcomb and I discuss obesity and hot flashes in menopause, a subject recently mentioned in a report issued by the Endocrine Society that hot flashes may be fewer in older, heavier women

    It is true that women with a higher BMI may have fewer hot flashes, something I have observed throughout my practice of 25 years as an OB/GYN. The fact is, that even though obese women may think they’re better off by not suffering hot flashes, they are prone to gaining more weight, have a higher incidence of breast cancer and suffer from diabetes and other dangerous health conditions.

    In this podcast we explain how women’s hormones work and what happens when the ovaries shut down in menopause. In obese women, the body fat produces estrone, or what I call “old lady estrogen.” Estrone production is what prevents the hot flashes from occurring. Women in menopause who have minimal body fat don’t have the estrone in their system. Their bodies receive no hormonal signals from the brain to stop the hot flashes.

    If your BMI is over 30, you don’t have hot flashes because you’re fat is producing the estrone that keeps them at bay. Women with obesity have the greatest risk of breast cancer—thin women have a lower risk of breast cancer. There is also risk of heart disease because estrone is bad for cholesterol.

    Incidence of diabetes also increases in menopause. It’s difficult to loose weight after menopause unless you replace estradiol—young women’s estrogen—and testosterone, which makes you leaner. Estradiol and testosterone help make you leaner and stop that process.

    The study looked at women with a body mass index (BMI) of over 30. They proved that women with higher BMI had fewer hot flashes. The way the story hit the press made it sound like the heavier women were healthier.

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