You may have recently read about a report featured in PLOS One that stated testosterone supplements are linked to increased risk of heart attack in men. BioTE® Medical founder and president Gary Donovitz, MD made an official response that debunks the PLOS One study. The response from Dr. Gary Donovitz can be located here.
Here is what you need to know about the PLOS One study:
- It is flawed in design: The study misrepresents data from a previous JAMA study in a careless and irresponsible way. This data was flawed initially, not taking in to account possibly hypo gonadal males.
- It isn’t comprehensive: The PLOS One study completely omitted a key factors – subcutaneous testosterone therapy (like the variety used in the BioTE® Method) is not featured at all in the study. Creams and gels don’t feature the same dosage optimization as pellets.
- It neglects key data: This study focuses solely on the synthetic hormones produced by “Big Pharma” and doesn’t take in to account the benefits of natural hormone replacement therapy (bio-identical hormone replacement therapy).
In essence, the PLOS One study represents an incomplete look at a complex issue. Numerous other studies have demonstrated natural testosterone pellet therapy can reduce the risk of a variety of important health complications.
Without inclusive data about all modalities of testosterone replacement therapy, the PLOS One study is hopelessly incomplete.
Iodine deficiency is occurring at an epidemic rate across the United States. The consequences of iodine deficiency are severe: mental retardation, lowered IQ, ADD/ADHD, infertility, thyroid problems; cancers of the breast, prostate, ovaries, thyroid and uterus. Approximately 1.5 billion people, about one-third of the earth’s population, live in an area of iodine deficiency as defined by the World Health
The WHO ascertains: Iodine deficiency disorder is the most common preventable form of mental retardation known. There is no doubt that this deficiency is responsible (at least in-part) for the epidemic of cancers of the breast and prostate as well as thyroid disorders. Clinical experience has clearly shown that it is impossible to treat these disorders as well as other chronic illnesses such as autoimmune diseases without ensuring adequate iodine intake.
Unfortunately, a lot of misinformation exists about iodine. People are afraid to use iodine because of unsubstantiated rumors about this nutrient. For more than 100 years, iodine has been known as the element that is necessary for thyroid hormone production. However, it is rare to see any further mention of iodine’s other effects. Iodine is found in each of the trillions of cells in the body. Without adequate iodine levels, life itself is not possible.
Iodine is not only necessary for the production of thyroid hormone, it is also responsible for the production and receptor activity of all of the other hormones of the body. Adequate iodine levels are necessary for proper immune system function. Iodine contains potent antibacterial, anti-parasitic, antiviral, anti-oxidant and anticancer properties.
Breast Cancer and Iodine
Decades before the advent of chemotherapy drugs, breast tumors were treated and shrunk with iodine therapy. Recently, researchers have reported that the preferred iodine/iodide combination (Lugol’s iodine) has been shown to ALTER gene expression in estrogen-responsive breast cancer cells and LOWERED several estrogen responsive genes. Iodine depletion in rats has shown for decades to alter breast tissue towards pre-cancerous cells; moreover when iodine restriction was LIFTED, normal breast tissue structure returned.
The ovaries concentrate large amounts of iodine, and deficiency increases ovarian production of estrogen; that, coupled with iodine deficiency increases estrogen receptor activity in the breast- a “double whammy” for the majority of American women. Iodine is also highly effective for treating fibrocystic breasts (a pre-cancerous state) and ovarian cysts. We have reversed several cases of fibrocystic breast disease in our practice with iodine therapy alone. Remember this point: Fibrocystic breast disease is NOT an ibuprofen deficiency state! (Ibuprofen is the mainstay of treatment for this condition).
Since iodine has been removed from baked goods in the 1960-1970s, breast cancer rates have raised from one in 25 to one in 7. Mounds of research evidence show a direct correlation between iodine deficiencies and ALL cancers, breast cancers topping the list.
How Much Iodine Do You Need?
The best way to ascertain how much iodine you need to take is to figure out the body’s iodine status. Iodine levels can be checked in the blood or urine. Most adults will do well taking iodine/iodide combination in the range of 25-50 mg/day. Children need lower doses and can be dosed appropriately based on their size.
And if you think iodized table salt will get you enough, think again! The thyroid gland ALONE needs 3 mg of iodine per day, moreover about 3 weeks after opening iodized table salt, the iodine has evaporated from it! Not only are you consuming a useless chemical, not REAL salt, you aren’t even getting the iodine!
A final note: Always consult with an iodine literate practitioner to ascertain your specific supplementation needs. When undertaking an iodine supplementation program, it is important to use iodine from a reputable company and a combination of iodine and iodide. Furthermore, the best results are found by using iodine as part of a comprehensive holistic regimen that includes balancing vitamins, minerals, and all hormones, naturally.
Important information: The FDA is compiling a list of drug substances compounding pharmacies will be allowed to use (as part of the Drug Quality and Security Act) to compound medications.
We strongly urge BioTE providers to comment on the approved Bulk Drug Substances list, insisting that pharmacies and outsourcing facilities be allowed to continue compounding medications including BHRT.
This will allow you to continue prescribing the compounded preparations you deem necessary for patient treatment.
How do I comment on the allowed "Bulk Drug Substances" list?
You can comment on the "Bulk Drug Substances" list online or by mail
All submissions must include: FDA and Docket No. FDA-2013-N-1523
Comment on the allowed "Bulk Drug Substances" list online by clicking the link below and selecting the blue "Comment Now!" button in the upper right corner of the screen.
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
What is happening?
The new Drug Quality and Security Act gives the FDA authority to restrict the bulk drug substances pharmacies and outsourcing facilities may use to compound medications. Already, the FDA has issued a "Do Not Compound" list containing prohibited drugs the FDA has deemed "unsafe or not effective" for patient use.
The FDA is currently accepting nominations for drugs that should be included on the "Bulk Drug Substances That May Be Used to Compound Drug Products" list ("approved Bulk Drug Substances list").
This list may affect many of the preparations your practice is able to prescribe, including bio-identical hormone therapies (BHRT) which have already been brought up in reference to the "Do Not Compound" list.
How can I help?
Your practice can make a difference. The FDA is allowing physicians and healthcare providers to comment on the proposed approved Bulk Drug Substances list until March 4, 2014. Please take the time to submit comments to the FDA that show why BHRT and other preparations are effective and necessary treatments.
The most convincing comments might include descriptions and examples of the therapeutic uses of these preparations in your practice and any studies or evidence that demonstrates their safety and effectiveness.
The recent report that testosterone supplements are linked to increased risk in heart attack risk in men in PLOS ONE is both misleading and inaccurate. As the Medical Director of the largest and most comprehensive hormone replacement companies in the United States, BioTE Medical, I find this study flawed in design and harmful to the public who will be misled by its conclusions.
The study looked at 55,593 men retrospectively. The study was limited to men using testosterone gel and creams and some synthetic testosterone injections. It did not consider data for men receiving subcutaneous bio-identical testosterone pellet therapy. Furthermore, there was no lab data pre or post therapy.
Numerous studies have shown that natural testosterone pellet therapy can reduce the risk of heart disease, type 2 diabetes mellitus, Alzheimer’s disease, osteoporosis, and prostate cancer. A key component of this treatment is an accurate interpretation of a patient’s laboratory values. In the PLOS One study, this data was not considered. Bio-identical testosterone pellet therapy also includes the optimization of each patient’s hormone levels to achieve a level that is above a discriminatory zone that reduces heart disease and the other diseases noted above. Dosage optimization is not possible with creams and gels.
It is troubling that the authors cite the Veterans Administration Study reported in The Journal of the American Medical Association (JAMA 2013), because their conclusions completely misstate their own data. Cardiovascular events occurred in 21% of males not taking testosterone and 10% of those males on testosterone. In addition, the males with testosterone levels in excess of 300 ng/dl were excluded from the study. Many of these males were clearly hypo gonadal and would have benefitted from appropriate therapy.
There have been multiple studies demonstrating that aromatizable testosterone administered to men will result in an increased blood flow to the coronary arteries and a decrease in plaque and inflammation in the coronary arteries. Based on BioTE Medical data from the treatment of over 10 thousand male patients and after optimization of testosterone levels in hypo gonadal males from 35-78 years of age, with or without heart disease, there was no increased risk of cardiovascular disease.
It is time for us to finally recognize the difference between the heavily advertised synthetic products from “Big Pharma” and the untold story regarding the benefits of bio-identical hormone therapy. It is also critical that we hold medical studies accountable to present complete information that takes into consideration all modalities that are currently available to patients.
Dr. Gary Donovitz
Founder – Medical Director
In his February 3, 2014 OP-ED piece in The New York Times, Dr. John La Pluma says “men feel the loss” if their testosterone is lower than 220 to 350 ng/dl. La Pluma’s misstatement of laboratory values is consistent with his glaring lack of knowledge relative to testosterone deficiency.
As the Medical Director for the largest hormone replacement company in the country with more than 500 highly trained and certified practitioners, I am abhorred that Dr. La Pluma has the nerve to call such an important problem a “trumped up disease”. The fact is that 40 percent of males over the age of 45 have low testosterone. Moreover, this deficiency alone puts them at increased risk for heart disease, Alzheimer’s disease, Type 2 Diabetes Mellitus, Prostate cancer, and osteoporosis.
Men who see providers with proper training to interpret lab work can begin the process of hormone optimization and individualized therapy. Through hormone optimization, which includes testosterone, thyroid and nutraceuticals, men can actually reduce their risk of heart disease Alzheimer’s disease, osteoporosis, diabetes, type-2 hypothyroidism and prostate cancer.
To compare proper hormone optimization in males with bio-identical testosterone to the Women’s Health Initiative, where women were treated with harmful synthetic hormones, is ludicrous. There are numerous studies showing the cardiovascular benefits of properly administered testosterone therapy. The coronary arteries receive greater blood flow, plaques are diminished, and inflammation in the coronaries is reduced. Men with low testosterone have increased insulin resistance and higher incidence of type-2 diabetes. They also have difficulty losing “belly fat” even with diet and exercise. Testosterone is protective to the nerves in the brain and can help prevent Alzheimer’s disease. Proper hormone optimization also reduces the development of osteoporosis and can protect against prostate cancer.
The big pharmaceutical companies are not helping us combat these diseases. The heavily marketed testosterone creams and gels cannot achieve adequate blood levels to achieve disease prevention. They are winning by advertising their way into the pocket books of millions of American males who are in search of healthier aging. The pharmaceutical balance sheets are doing well but their patients are not. In the most recent study reported in PLOS ONE, they reported an increase in non-fatal myocardial infarctions in elderly males. There was no lab work done, most patients were on creams and gels, and no optimization was done.
Regarding the side effects of testosterone purported by Dr. La Pluma, I again challenge his accuracy. At BioTE Medical we optimize over 1,000 males per month. Approximately 1 percent has increased red cell mass necessitating blood donation. There is a reduction in sperm count but this is reversible and not a common complaint in aging males. And the 10-15 percent shrinkage in testicular size is not a common complaint of the patient. And, we have had no increase in cardiovascular events.
I would suggest that men who want to have better energy levels, sleep better, increase muscle mass and have better sexual performance would benefit from having their testosterone tested by an expert. In the long run, why wouldn’t men want to reduce their risk of cardiovascular disease, Alzheimer’s disease, diabetes, prostate cancer, diabetes and osteoporosis?
I urge Dr. La Pluma to check the facts, understand the obvious flaws of the research he cited and truly learn the difference between the Big Pharma synthetics and bio-identical testosterone therapies. With this understanding, he’ll be better equipped to make viable recommendations.
Dr. Gary Donovitz
Founder & Medical Director
Yes, many FDA-approved drugs and medications serve an important function, but the truth, according to one study, is simple: FDA-approved drugs have caused over 100,000 deaths (source: JAMA 1998), while FDA unapproved supplements have caused zero deaths (source: GAO report).
This information should inform how we think about both FDA-approved drugs and natural supplements.
What BioTE provides, including pellet therapy, vitamins and supplements, are natural solutions to a variety of health issues. Natural vitamins and supplements don’t go through the FDA approval process, but may provide a bounty of health benefits for issues both large and small.
Many FDA-approved drugs, on the other hand, can carry a variety of harmful side-effects and a much higher mortality rate. Over-the-counter acetaminophen alone is responsible for nearly 500 deaths per year (source: GAO report)! In essence, FDA approval can’t be used as a dividing line between what is and isn’t an effective treatment.
While the FDA considers itself an arbiter of all that is “healthy,” these statistics prove that natural supplements shouldn’t be written off; they are providing so much good to patients nationwide.
BioTE medical provides natural healthcare solutions. If you would like to locate the nearest BioTE provider, please visit www.biotemedical.com. If you would like to become a BioTE provider, visit www.joinbiote.com.