Polycystic Ovarian Syndrome (PCOS) sounds like a rare disorder but it is surprisingly common. This is a disorder with onset in early adolescence effecting up to 10% of young women. Characteristic signs and symptoms include increasing facial and body hair, hair loss from the scalp, muscular or heavy build, acne, thickening and darkening of the skin known as acanthosis nigricans, blood sugar problems including type 2 diabetes, high cholesterol and irregular menstrual cycles and infertility. In older women with PCOS coronary artery disease is more common. In severe cases deepening of the voice and enlargement of the clitoris (clitoromegaly) can be seen. Before the underlying hormone disorders were clarified, the main method of diagnosing this disorder was by finding multiple cysts on the ovary. We now understand that the main problem is not the ovarian cysts but metabolic disorders including insulin resistance and elevated male hormone levels (testosterone) in the blood.
Another misconception about PCOS is that it only occurs in overweight women. Obesity is common in PCOS but thin women are also capable of developing PCOS. The underlying hormone problems are complex but are thought to be at least in part due to high insulin levels in the blood resulting from insulin resistance. With insulin resistance the body requires high levels of insulin due to insensitivity of the tissues to insulin’s presence. What treatments are available for PCOS? There are very few, if any, drugs specifically approved for the treatment of PCOS. This is probably because of the low profit potential for treating this disorder. Drug companies cannot afford to invest millions of dollars in research because almost all of the existing standard therapies are generic drugs. Some of the most useful medications for treating PCOS are drugs used to treat type 2 diabetes because of their effect to reduce insulin resistance. These drugs are metformin and Actos. Metformin is the most popular oral medication for diabetes treatment in the U.S. Actos has been available for about 10 years but due to recent negative publicity about an unproven risk of bladder cancer, its popularity is declining. Neither drug is approved by the FDA for treatment of PCOS but multiple studies confirm the clinical and hormonal benefits of using these medications in this disorder. In 2011 research was published in the Journal of Clinical Endocrinology and Metabolism suggesting that the generic cholesterol lowering drug, simvastatin may also show benefits similar to metformin for the treatment of PCOS.
In the late 1980’s, I along with Dr. Lester Gabrilove at Mt. Sinai Hospital in New York, published our research showing that an anti-fungal medication, ketoconazole, could reverse the hormonal, physical and metabolic problems associated with PCOS. Due to the potential toxicity of ketoconazole this therapy never gained wide spread acceptance. The manufacturer refused to fund additional studies to determine how to more effectively use this drug, due to the low profit potential and liability concerns.
This information is strictly for educational puroses. Due to high risk of toxicity of medical therapy in young women who can potentially become fertile under treatment for PCOS, no drug should be taken without the close supervision of a physician. The reader agrees to the Terms of Service of this website, metabolism.com
One aspect of lifestyle that is often overlooked is time spent sleeping. Getting adequate sleep is often sacrificed due to the demands of job and family. In the Sleep Heart Health Study over 1400 men and women were surveyed about their sleep habits and its relationship to diabetes and prediabetes. It was found that sleeping less than 6 hours per night was associated with increased risk of having diabetes. Interestingly, in those sleeping more than 9 hours per night there was an increased risk of diabetes and prediabetes.The authors of the study recommend trying to get between 7 and 8 hours of sleep per night to minimize the chances of developing blood sugar problems. To learn more about ways of preventing diabetes see pages 90 to 98 in my ebook “Metabolism.com”
Maintaining ideal body weight with diet and exercise is also crucial for avoiding diabetes and prediabetes.In overweight adults for each2.2 pounds(1 kilogram) gained per year the risk of developing diabetes increases about 50% over the next ten years. By losing 2.2 pounds per year the risk of developing diabetes is reduced about33% for the next 10 years (J Epidemiol Community Health. 2000; 54(8):596-602).
Speak to your healthcare professional to find out if you are at risk for developing diabetes and to learn ways you can avoid it.
Gary Pepper M.D.
Editor-in-Chief, Metabolism.com
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Novartis Blood Pressure Medication Runs into Trouble by Gary Pepper, M.D. Editor, Metabolism.com In 2007 a new type of blood pressure lowering medication was brought to market by Novartis Pharmaceutical Company. This medication by the brand name Tekturna (aliskiran) works by blocking hormones that make up a circuit from the kidney to the blood vessels know as the RAAS system. This mechanism is distinct from all other blood pressure lowering medications available. By working via a completely novel pathway to lower blood pressure doctors were given another potent weapon in the war on high blood pressure. A second medication, Valturna, which combines an established blood pressure medication with Tekturna, was released by Novartis to the public in 2009. These drugs have been extremely popular due to their effectiveness and apparent freedom from serious side effects. A warning about this class of drug was issued by Novartis, 2 weeks ago when it was forced to end the Altitude drug study due to apparent unforeseen complications in patients using Tekturna and Valturna. The study found a small but significant increase in stroke in diabetics with renal disease who were using these drugs. Although the group of patients in the Altitude study are up to 12 times more likely to develop stroke or heart attack under normal circumstances, Novartis had no choice but to end the study and issue a warning to the health care community about limiting the use of these drugs.
In my own practice I have found Tekturna and Valturna to be extremely effective and well tolerated. A survey of my colleagues revealed the same findings. Diabetes and high blood pressure very commonly occur together and national guidelines stress the need for excellent blood pressure control for diabetics to help prevent heart, kidney and eye complications of this disease. For doctors treating diabetics who recognize these patients as particularly high risk, having to significantly cut back or eliminate the use of Tekturna and Valturna is creating major concerns. Within the past week I have had to counsel numerous individuals about these issues and the solution is far from easy. For instance, one man with diabetes and early kidney disease and heart disease, with borderline high blood pressure despite using 4 different types of blood pressure medication including Tekturna has to decide with me, which is the greatest risk, going off the medication resulting in a rise in his blood pressure or continuing a drug which may pose a risk of its own.
These discussions are going on in doctor’s offices throughout the country with no good solution in sight. The only certainty is a flood of ads by lawyers which begin, “Have you ever been on Tekturna or Valturna….”.
By Gary Pepper, M.D. Editor, Metabolism.com In the first article in this series, The HCG-Cancer Connection, I explained how HCG is made by some types of cancer and can serve as a marker for cancer activity. Now I want to explore another effect of HCG, the stimulation of male hormone (testosterone) production. Just to review, there is no evidence that HCG will cause cancer although conceivably certain cancer responsive tumors may grow faster due to its effect to increase estrogen and testosterone. Every woman who has had a normal pregnancy has been exposed to high HCG levels for many months so if it did cause cancer that effect would be very obvious. What concerns me is how HCG can influence the normal ovary and its hormone metabolism. HCG is a promiscuous hormone. It will hook up with different hormone “receptors” and masquerade as these other hormones. In the previous article I explained how at very high levels HCG can stimulate the thyroid to make thyroid hormone resulting in hyperthyroidism. Another hormone effect of HCG is to mimic LH (leutinizing hormone) which turns on the production of the sex hormones by the testicle in men and ovary in woman. Surprisingly the normal ovary makes testosterone which it then converts to estrogen. FSH (follicle stimulating hormone) from the pituitary helps the ovary change testosterone to estrogen. What happens when the ovary gets a lot of LH but not FSH? This is the situation when a woman gets HCG. Testosterone levels will rise more than estrogen levels. Research shows that after a single HCG injection a rise of 20% in testosterone levels occurs in normal women, confirming this theory. During pregnancy with HCG pumping in the blood from the placenta, testosterone levels can double, resulting in acne, oily skin and (in some women) an increase in sex drive. The situation would be far worse for a pregnant woman if the placenta wasn’t also pumping out 100 times the normal amount of estrogen to counteract all the male hormones. So why should women care if HCG makes their testosterone levels go up? Acne, oily skin and horniness are one thing but there are other effects which might be less acceptable. Testosterone is a mischievous hormone. While it causes hair growth where you don’t want it, it causes hair loss in places you want to keep it. Testosterone stimulates hair growth on the face, chest, back and abdomen. At the same time it causes hair loss from the scalp particularly at the temples and crown. This is referred to as male pattern baldness. Other effects of testosterone in women are the growth of the clitoris, known as clitoromegaly. A clitoris the size of a man’s thumb has been described in a woman due to excess testosterone exposure. Generally this degree of clitoromegaly is seen only in more extreme cases. So you may want to think twice before starting an HCG diet unless looking like Bruce Willis is your thing. In the final installment on the hazards of HCG I will focus on other possible nasty hormone effects of HCG such as fibroids, infertility and bulging muscles.
Last week Helen, a friend of the family, called to brag she had lost 12 pounds in 4 weeks and also to ask if she had given herself cancer in the process. What was the connection between her supposed miracle metabolism and cancer? Helen was taking HCG injections and just read this hormone was somehow related to cancer. I reassured her that I didn’t think she was giving herself cancer by taking HCG but I did let her know that very soon she was likely to resume her normal metabolism and regain the weight she lost. Unfortunately her wallet was never going to recover what it lost in this process. Many services prescribing HCG treatment for weight loss are charging $400 or more for a course of treatment.
Now what about the cancer-HCG connection?
HCG is a hormone normally produced by the fertilized egg in the earliest stages of fetal development and then later by the placenta itself. Since rising HCG level is one of the earliest hormone changes during pregnancy, measuring this hormone is the basis for the everyday pregnancy test. HCG also causes the ovary to make progesterone which is essential for preparing the uterus to become a nesting ground for the developing embryo. HCG may also suppress immune function so that the fetus is not rejected by the mother’s immune system.
The placenta forms at the onset of pregnancy to support the developing embryo and later the fetus. If a sperm fertilizes an empty egg at the onset of pregnancy a Hyditidiform mole can arise in conjunction with or instead of the normal placenta. This is also referred to as a molar pregnancy. HCG levels can rise to extreme levels in the presence of the Hyditidiform mole particularly if it goes on to become an invasive cancer known as a choriocarcinoma. Body chemistry gets a little weird at this stage. HCG is slightly similar in structure to TSH, the pituitary hormone that stimulates the thyroid. The result is that when HCG levels are extremely high as with a molar pregnancy, the thyroid can be stimulated to make excess thyroid hormone resulting in hyperthyroidism in the mother. Typical symptoms of hyperthyroidism can occur including feeling hot, shaky, sweatiness, palpitations, vomiting (which can be severe) and diarrhea. Curing the cancer will cure the hyperthyroidism as well.
Other cancers of the reproductive system can make HCG as well. Certain testicular cancers can make HCG. Since HCG is the hormone responsible for a positive pregnancy test, testicular cancer can sometimes be diagnosed in men by a positive pregnancy test. For tumors making HCG, measuring levels of this hormone during cancer treatment can aid doctors in determining whether therapy is working or not. Certain cancers are termed “hormone responsiveâ€. That means the cancer will grow more aggressively in the presence of a particular hormone. Tumors that grow faster in the presence of estrogen include receptor positive breast cancer and endometrial cancer. A tumor that grows faster in the presence of testosterone is prostate cancer. Since HCG is likely to increase these hormones, it is conceivable that should a hormone responsive tumor already exist in the body it could grow faster during HCG treatment.
So Helen, I don’t think HCG is going to give you cancer, but it may cause you to grow a beard. Why is that? I’ll be explaining my theory in the next article, “HCG is a Hairy Hormone”. Visit metabolism.com for more on this, in the very near future.
The mission of the The Thyroid Project is to encourage sharing of information and experience between the public and the medical community about the treatment of hypothyroidism (low thyroid function). For at least the past few decades there is a growing awareness of “something missing†in the way suffers of hypothyroidism are treated for their disease.
Too many patients, as documented in an on-line study of 12,000 individuals conducted by the American Thyroid Association published in June 2018, (https://doi.org/10.1089/thy.2017.0681) , complain of persistent symptoms of hypothyroidism despite what their doctors believe is successful treatment with levothyroxine (brands include Synthroid, Unithroid, Tirosent, Levoxl). We believe something needs to be done to resolve this conflict between patients and their doctors.
Diabetes can be defined simply as elevated blood sugar levels. What exactly is high blood sugar and when should someone be concerned about their level? Does having prediabetes mean diabetes is around the corner? Metabolism.com tackles this tricky but important topic in this comprehensive review.
By Gary M. Pepper, M.D. Ozempic, Rybelsus, Trulicity, Wegovy, Saxenda are the central players in the weight loss craze sweeping across the globe. Metabolisim.com has been monitoring this phenomenon from its beginnings in 2008 with its report “Lizard Spit Reduces Blood Sugar and Appetite”, regarding the first drug in this class, Byetta (exenatide). Caught In the middle of the current chaos are the medical experts who treat diabetes and have been prescribing these medications for more than a decade. Here is a brief commentary from one such board certified endocrinologist; “I started treating Type 2 diabetics with GLP-1 agonists more than 10 years ago. In some respects, these medications have revolutionized the treatment of diabetes by lowering blood sugar effectively and promoting weight loss at the same time, a unique combination of benefits. Not everyone benefits from these drugs to the same degree unfortunately, and I have seen lots of patients experience unacceptable side effects from them. Nothing though, has prepared me for what is happening now. Too often, I find myself confronting someone who expects me to prescribe one of these drugs just so they can lose weight. Sadly, one extreme example was someone who, despite battling a life threatening medical condition, was insistent on getting a prescription. At the same time my diabetic patients are scrambling to find a place to buy their medications if they can even afford it. It is disheartening, to say the least, and I dread the negative interactions with some of my patients I now face almost daily.”
Off- Label Use
The FDA is the U.S. government’s department tasked with evaluating and approving drugs for specific medical conditions. When a new medication is approved for treating a medical condition by the FDA the agency will, at the same time, set strict guidelines for exactly which patients may use the newly approved drug. When a medication is used “off-label” it means that these limitations are being overridden by the provider for a potential benefit which outweighs the drugs risks. It is a general misconception that off-label means illegal; it does not. This practice has been going on for ages and more than 20% of prescriptions in the United States are prescribed off-label. A common example is the use of beta-blockers (approved for heart problems) for the treatment of performance anxiety.
GLP-1 agonist drugs, as discussed recently by metabolism.com. were originally approved for the treatment of Type 2 diabetes in adults. In the past few years most of these same medications have gained unprecedented popularity for their “off-label” weight loss benefit. Of the 5 GLP-1 agents presently in U.S. pharmacies only Wegovy (semaglutide) and Saxenda (liraglutide) are FDA approved for treating obesity. Of these two, Wegovy is the newer and had been much more popular that its sister drug Saxenda, probably due to being dosed only once weekly compared to daily for Saxenda and less likely to cause side effects. Due to Wegovy’s soaring popularity, its manufacturer, Novo Nordisk, increased the price of Wegovy two times since its initial release.
by Gary M. Pepper, M.D. and Sam Jeans, MSc The global anti-obesity drug market, in 2021was valued at over $2 billion. Within one year this figure had skyrocketed to $8 billion and is expected to climb to nearly $ 20 billion by 2027. This astounding growth is a reflection of soaring obesity rates, and the arrival of a new class of weight loss medication fueling a craze both in the USA and across the world.
The FDA and global health regulators, until very recently, had maintained a very tight ship when it comes to treating obesity with medication, placing the emphasis on diet and exercise rather than weight loss drugs. Since the 80s, anti-obesity drugs continued to be controversial, and a more stringent FDA implemented ongoing safety trials along with other precautions. There is some speculation that a shift in attitude toward approval of weight loss medication by the FDA , is underway
Weight loss drug controversies are far from over and, in fact, may soon rival the amphetamine crisis of the 70’s. For that reason, metabolism.com has felt it important to provide our guide to weight loss drug issues, past and present.
Anti-Obesity Drugs Timeline
Prescription drugs for lifestyle diseases such as obesity were marketed heavily throughout the 1950s to the 1970s. Amphetamines entered the public domain after the Second World War where they were used extensively in the military.
In the 50s, walk-in clinics prescribed diet pills with other medications almost at random, with or without genuine concern for one’s weight. These brightly colored pills became known as “rainbow pills”.
In the 1960s and 1970s, the so-called “rainbow pill diet” of pills was finally coming to an end as the FDA began to systematically ban many of the drugs involved. A high-profile expose by investigative journalist Susanna Mcbee, published in Life magazine, brought attention to this new modern public health crisis.
The rainbow pill diet combined amphetamines, laxatives, thyroid hormones, and even diuretics to produce extreme weight loss, combined with benzodiazepines, barbiturates, and steroids to reduce side effects, and antidepressants to suppress medication-induced insomnia and anxiety.
In 1968, rainbow pills were linked to over 60 deaths, with numerous accounts of their devastating impact surfacing in the news and media. Within just two months, 48 million pills were seized and destroyed. Nevertheless, amphetamine-based diet pills remained extremely popular throughout the 1970s. In 1978, some 3.3 million prescriptions for amphetamines were written each year, with some 50 million pills a year ending up in the black market.
In 1979, the FDA banned amphetamines as a weight loss aid, but that is hardly the end of the USA’s love affair with obesity medication.
Here’s a brief timeline of recent anti-obesity drugs:
