FDA Panel Rejects Rimonabant 14-0: Why?

Is this a post-Avandia knee jerk response or is it a bad drug?

I was more than a little bit surprised that an FDA advisory panel nixed use of the appetite-suppressant rimonabant. The drug acts in the central nervous system to inhibit a cannibus receptor, thereby decreasing appetitie (maybe you didn’t know that people who use marijuana typically have huge appetites). The drug has been available in other countries, including most of Europe for some time under the name Accomplia (it was to be called Zimulti for the U.S. market). Apparently the main concerns are related to the reports of depression and even suicide in some people who have taken the drug (not entirely surprising given the psychological effects of marijuana). Whether these serious side efects of the medication are specific for patients who can be identified as “at high risk” or not remains to be clarified.

Studies have shown that the drug does promote weight loss but the results have been somewhat disappointing, particularly given the enormous enthusiasm for the drug when it was first introduced. Not surprisingly, stock in the company that makes the drug, fell after the FDA announcement.

Where to go from here?

Clearly, the FDA needs more information about the drug’s side effects but I hope they will not summarily reject use of the drug in certain circumstances. For example, perhaps the drug can be used prior to considering bariatric surgery in very overweight patients (e.g, BMIs >40)? In such patients, surgery has many risks and perhaps rimonabant is “the lesser of two evils?”

Big Breasts in Boys: Just A Minor Cosmetic Issue?

I can’t believe it’s been so long since my last entry- about two weeks. It’s not really been “writer’s block,” more like “writer’s ennui.” I just couldn’t get inspired to write about anything and now I have a long list, just since this morning. I want to start with an article published in the New York Times today written by Alex Kuczynski entitled “A Sense of Anxiety A Shirt Won’t Cover.” The article appeared in the Thursday Styles section, page E1. The gist of the article is that many boys and young men are having surgery to reduce their enlarged breasts. The procedure is called a reduction mammoplasty and is generally performed by a plastic surgeon.

What is this all about?

Almost all males develop some breast enlargement early in puberty. Typically, a 12 or 13 year old male notes breast enlargement and some tenderness. The breast tissue is generally not more than 1-2 cm (less than an inch) in diameter, and disappears over the next 1-2 years. Occasionally, we see much more striking breast enlargement which requires careful medical evaluation. As an endocrinologist, I have seen many boys and young men for evaluation of gynecomastia. The minor degrees of breast enlargement are easy; generally reasurance is all that is needed. It is the patients with exraordinary breast enlargement that present a dilemma.

First, a detailed medical history and physical examination need to be performed, then perhaps some laboratory studies. The article listed some of the medical conditions that can cause gynecomastia, which include liver disease, certain medications (e.g, psychotropic drugs), hormonal disorders (e.g., congenital adrenal hyperplasia, estrogen-secreting tumors, any condition with low testosterone levels), and illicit drug use (e.g., marijuana). The condition is common in a condition called Klinefelter syndrome- males with a chromosomal disorder, XXY. Not surprisingly, overweight males often have prominent breasts, but in many instances it is simple fat deposition rather than true glandular breast tissue (fat does secrete estrone, a form of estrogen which does stimulate breast tissue formation). Often gynecomastia is hereditary; what do they say-”like father like son?” Rarely does one ever find a specific medical cause for the breast enlargement. The question then becomes what to do about the condition. If there is considerable breast enlargement, it is not surprising that the patient might be quite distraught and even have significant psycholological problems (imagine a 14 year old male with breasts as big as Anna Nicole Smith’s!).

What to do?

In the “old days” we tended to tell patients that their massive gynecomastia would go away if they just gave it time. We now know that that is not true- breast enlargement greater than 4-5 cm. in diameter is not likely to regress much. So, why wait? Why not have an experienced plastic surgeon remove the tissue IF it is a major concern to the patient (some patients are not bothered much by anything)? The argument in favor of waiting is that over time the breast enlargement will go away and that a better surgical result can be obtained by waiting several years. In typical adolescent gynecomastia, I would agree with those arguments, but not when there is a great deal of breast tissue. I do not consider this a simple “cosmetic” issue given the psychological problems that are so common in these patients.

I believe the New York Times article may have done a disservice to these patients- the article focused mainly on the transient nature of the problem and the desire for some males to have surgery to look more “buff.” I am not talking about those types of situations, but rather, males with a large amount of breast tissue who are having psychological problems. Tincture of time and watchful waiting will not improve the situation for these unfortunate patients. Over the years we have been quite succesful in getting insurers to cover the procedure once they understand the situation- a photo often does the trick..