In part one of this series we looked at the cause of polycystic ovarian syndrome (PCOS) and the many complications it causes. Weight gain, acne, excess hair growth on the face and body, high cholesterol and high blood sugar due to insulin resistance are among the problems associated with PCOS. One particular area of concern for PCOS sufferers is infertility due to lack of ovulation. PCOS is the cause of anovulatory infertility in 3 out of 4 cases. Before the acceptance of medical therapy for infertility due to PCOS a surgical approach referred to as a wedge resection of the ovary was performed which allowed patients with PCOS to ovulate and conceive normally. Low success rates with this procedure, complications of surgery and improved medical therapies have all resulted in the end of this type of treatment in most situations. At present, treatment of infertility associated with PCOS generally consists of using a drug to combat insulin resistance known as metformin often in combination with the fertility drug clomid, which has a high rate of success.
Treatment of the excess hair growth associated with PCOS often consists of using the drug spironalactone and the use of birth control pills. Spironalactone is a very interesting drug used for decades as a salt depleting diuretic but also has an effect to block the action of the male hormone testosterone. The action of spironalactone to block testosterone was discovered when it was noticed that men using this diuretic developed tender nipples and breast enlargement (gynecomastia). Oral contraceptive agents are also useful to combat hirsutism because these agents also cause reduce testosterone levels by putting the ovary in a dormant “resting” state. Cosmetic procedures are always another option to treat unwanted hair growth. Laser hair removal appears to be replacing the older modality of electrolysis for this purpose.
Can PCOS be cured? Once PCOS develops it can be controlled but not cured unless the ovaries are removed. At menopause PCOS-related problems diminish as the ovary stops making sex hormones including testosterone which is one of the culprits during the reproductive years. A recent study published this year in the journal Pediatric Endocrinology showed that using metformin treatment in pre-adolescent girls thought to be at risk for PCOS reduces the risk and/or the severity of PCOS in later years. It may do this by blocking fat accumulation in the abdomen and liver which seems to set off the insulin resistance. Metformin is not FDA approved for this purpose and as a generic drug there is little profit potential in developing this treatment. I expect it will be many years before preventive therapy for PCOS will come before the FDA for approval .
This information is strictly for educational purposes. 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
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….”.
Many members here at metabolism.com have shared their thoughts and experience on ways to stop smoking. There have been many who feel defeated because they can’t beat the weight gain that accompanies their efforts. SweetiePie has a clear message about how not to beat yourself up while achieving the goal of a smoke free (and healthier) life.
Here’s what SweetiePie has to say;
Hello:
55 Year old female here, 200 lbs, hypothyroid smoke free for 6 months. Feeling great about being smoke free and this time its permanent and for real.
I have quit smoking and relapsed so many times in my life. And dieting, on again and off again for 40 years. Pfffft…..This time what prompted me to go to the doctor and quit was that my heart feels heavy and hurts sometimes. Not angina yet, but scary and depressing. I’m fine, it turns out, but I definitely needed to quit smoking and still need to exercise more and lose weight . I am no expert in the weight loss department, having had limited success with that over the years. I can see from this interesting thread that I am not as weight conscious as most of you, but I still thought I’d share what my doctors told me because it may help and inspire you the way it did to me: When I tried to bring up the weight gain and the overweight with doctors heres what they said: CARDIOLOGIST told me I’d have to be about 100 lbs over my ideal weight of 145 for the weight to be as stressful and damaging on my heart and cardiovascular as SMOKING, GP #1 told me the key was, instead of focusing on an ideal weight and size, was to focus on preventing DIABETES through NONSMOKING, AND EXERCISE just as important as wholesome diet, and GP #2 (I moved and needed a new doctor for my thyroid perscription) told me, after my bloodwork tested all ok, “why don’t you just forget about losing weight for a little while and focus on quitting SMOKING? Well, I took all of that advice, and this time, it worked! I’ve really kicked the smoking habit and finally found freedom from that deadly addiction. The “permission†from doctors to stop beating myself up about my weight freed me up mentally to do what I needed to do (giving myself plenty of rewards, including food treats and being lazy treats!) in order to become smoke free and never going back! I am ready now to step up to exercise and weight loss this year with the same strategy: Increased exercise first, food modification instead of deprivation. The reason for my post is to say stick with it but your QUIT is SO IMPORTANT – don’t ever let your desire to be thinner or to get back down to an ideal outweigh your resolve to stay SMOKE FREE. SMOKING is the singlemost damaging behavior -don’t lose sight of that! Never take another puff! Oh, btw I gained about 5% while quitting and my first goal is to go back down 5%.
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:
