A Look Through the Therapeutic Window

I am often asked by patients with hypothyroidism (low thyroid hormone levels), “What is the right thyroid hormone dose for me”.  Of course, a physician wants to find the appropriate dose of medication to treat each condition a patient has. When it comes to thyroid disease however, this can be a complex question. Not only is there an issue of whether T4 alone or combination T3 and T4 will be required to treat a particular individual but the therapeutic window of these hormones must also be considered. (more…)

National Organizations Fail to Recognize New Approach for Treatment of Hypothyroidism

The 2013 guidelines issued by the American Association of Clinical Endocrinologists and the American Thyroid Association reiterated their long standing opinion that only a single hormone, T4 (Synthroid, levothyroxine) is advised for treatment of  hypothyroidism. These key organizations

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What You can Learn from Sarah’s Struggle With Hypothyroidism

Every so often I like to bring attention to someone who has struggled to get properly treated for hypothyroidism. Not everyone shares the same dilemma regarding treatment of hypothyroidism because T4 by itself may be sufficient in many instances. But for those who continue to experience symptoms of hypothyroidism despite T4 treatment, adding T3 can be a life changing experience.

Here is Sarah’s story:

I was diagnosed with hypothyroidism in my early twenties and Synthroid did not help. I did not know at the time that many of my symptoms were due to hypothyroidism. After changing to my long time physician, I told her of my original diagnosis some years back. She did only the TSH and told me I was no longer hypothyroid! So for some 15 years after being in her care and continuing to feel crummy, then for the last 8 steadily gaining weight and feeling worse, I was not on any medication. I begged her for Cytomel several years back and was denied…she said she didn’t treat with that. When I finally was deemed hypo by her, she put me on the smallest dose of levothyroxine. It did not help. I finally went to see a shrink and he put me on 25 mcg of Cytomel. For the first time in my post pubescent life, I feel like living. My dose was upped to 50, and I felt even better but my thyroid levels were off, so we are now working on that and I am back to 25 mcg per day. If you can’t get Cytomel from your regular physician, you might get a psychiatrist to prescribe it. It changed my life and I finally feel alive. I’ve since switched primary physician because she wouldn’t listen to me, and she didn’t like that I was on Cytomel. I don’t know what it is about this medication that regular physicians don’t like and make them refuse to treat with it, especially when so many can benefit from it. I’ve lost only 12 lbs since being on it, but I gained nearly 35 unnecessarily while not being properly treated and was told to eat less and exercise more…I only ate about 1500 calories a day and walked my dog 2 miles each day, so I don’t feel it had anything to do with my diet!

Don’t Expect New Weight Loss Meds for 10 Years or More

As a culture we don’t plan for a sudden halt in scientific advancements. Our tendency is to expect progress to be rapid and continuous. My prediction is that in certain areas of medical science we are likely to see not only a halt in progress but a slipping backward. In particular, the realm of medical weight management is in complete disarray at this time. Two new drugs designed to induce weight loss have been shot down by the FDA in the last few months. The first is Qnexa, developed by Vivus Inc. Interestingly, Qnexa combines two drugs already approved for use in the U.S. One of the drugs is phentermine which is a medication used for decades as an appetite suppressant. The other is a common drug used to treat seizures with the brand name Topamax (topiramate) which also induces weight loss. The drug performed admirably in clinical trials with most participants losing over 10% of body mass. The FDA cited excessive risks of the drug in its statement of rejection. One wonders why the drugs are still being marketed separately if they are so dangerous.

The latest drug to be rejected by the FDA is Lorgess (lorcaserin), developed by Arena Pharmaceuticals. This drug, not as effective as Qnexa, produced 5% body mass loss in about half of participants in clinical trials. Lab animals showed a tendency to develop breast tumors when exposed to the medication, adding to the FDA’s decision to reject the drug application based on safety concerns.

I am a strong advocate of drug safety and regulation. On the other hand we know obesity, and with it Type 2 diabetes, is epidemic in the U.S. I regard weight loss as the “holy grail” when treating type 2 diabetes and yet it is the most difficult goal to achieve. Any drug which could assist in weight loss is highly desirable in the treatment of Type 2 diabetes. Not only does blood sugar improve with weight loss but also blood pressure and cholesterol readings show declines. All three of these parameters are known to be prime contributors to the main cause of death in diabetics, cardiovascular disease.

It has already been 10 years since the last drug was approved specifically for a weight loss indication. The failure of these two latest medications to achieve approval is certain to cause the pharmaceutical industry to severely curtail if not abandon further investment in this type of drug development.

Why is the FDA so reluctant to approve a weight loss pill? This is a complex issue but requires an answer. A new weight loss inducing medication is certain to be highly anticipated and widely prescribed. Therefore, from the very first day of approval the FDA must take responsibility for the well being of millions of people who are likely to take the medication. We are a society which demands our medications deliver miraculous cures with no side-effects. If someone perceives they have been injured by a medication our legal system is primed to unleash brutal retribution on everyone remotely involved in the approval process. Abuse and injury with a medication designed to cause weight loss is almost a certainty. This is a no-win situation for the administration of the FDA.
I predict it will be at least another 10 years before a medication for weight loss is approved by the FDA. Unless there is a change in the climate of litigation in this country it will take longer than that. In the meantime the only new developments in weight loss drugs will be the result of exploiting appetite suppressant effects which are the “side-effect” of medications approved for other purposes.

Gary Pepper, M.D.
Editor-in-Chief, Metabolism.com

Growth Hormone Deficiency Tied to Obesity and Accelerated Aging in Young Adults

Due to the potential for abuse and high cost, growth hormone treatment in adults is the subject of much controversy. I believe that treating adults with growth hormone deficiency is many times an appropriate and beneficial choice. Firming up my conviction for treating adult growth hormone deficiency is a recent study conducted in the Netherlands and UK published in the Journal of Endocrinology and Metabolism (JCEM 95:3664-3674, 2010). The researchers compared Body Mass Index (BMI), waist circumference, triglycerides, and HDL (good cholesterol), between normal adults and those with low growth hormone levels due to deficient pituitary function (hypopituitarism). All measurements of obesity and lipid metabolism were significantly worse in the young adults (younger than 57 years) with growth hormone deficiency compared to normal adults of a similar age.

As I pointed out in previous articles at metabolism.com, growth hormone levels naturally decline as we get older. The authors of the present study note that growth hormone levels decline 14% per decade in adults. I conceive of this as one of the ways nature gets rid of us after we complete our biological/reproductive functions, since without growth hormone our muscles, immune and nervous systems, decline, leading to death. It’s planned obsolescence… what is typically referred to as aging. In the recent study senior citizens have equivalent levels of obesity and abnormal lipid metabolism as young adults with growth hormone deficiency. The authors note the effect on the body of growth hormone deficiency in young adults is equivalent to 40 years of aging. The theory that growth hormone functions to preserve our tissues during youth and aging results from its absence, appears confirmed by these results.

Most normal young adults aren’t growth hormone deficient and the population that would qualify for growth hormone treatment from this group is small. What about older adults with low growth hormone who are troubled by the “natural” decline in their body function? Should or could we treat this much larger population with growth hormone? It is my experience that private and federal insurers will not pay for this treatment regarded as “cosmetic”. On the other hand, there will be physicians who will comply with a request for growth hormone treatment from individuals who possess enough cash and motivation. Less affluent or determined individuals will have to contend with natural aging just as our ancestors have done for thousands of years.

This information is for educational purposes only and is not intended as medical advice or treatment.

Gary Pepper, M.D.
Editor-in-Chief, metabolism.com.