Last Friday, I delivered one of the keynote addresses for the annual conference of the Academy of Anti-aging and Regenerative Medicine in Las Vegas. It was a huge conference and I was somewhat overwhelmed by the 3500 medical personnel who attended. The topic of anti-aging is certainly one of major concern to medical practitioners and patients worldwide and indeed there were participants from all over the world. As many of you know, I’m a fairly orthodox physician and want evidence-based medical data upon which to base testing, diagnosis, and therapy. So this was not an easy lecture for me to give. Much of the conference dealt with supplements, novel and “new age” testing and procedures and the use of bio identical, compounded medications. So when I PowerPointed my lecture with 35 slides and titled it “Slow Your Clock Down: on label, off label, gray label” I was aware that the topics and information could be controversial and even confrontational for a vast number of the participants.
I am not going to download the entire presentation but I thought I would detail a few of the slides: I started with our universal goal; health span not life span… That we “optimize the minutes and hours of our internal and external clocks so that we can savor our present and future bodies”. I then went on to delineate the issue of labeling and drug use as follows:
On-label (FDA approved): In order to achieve FDA approval drug companies pay for and perform laboratory and animal tests. They test humans to see if the drug works and whether it is safe and it provides a real health benefit. The data is then sent to the Center for Drug Evaluation and Research. A team then reviews the data and proposes labeling. If the review establishes that a drug’s health benefits out way it’s known risks, the drug is approved for sale.
Off-label: Adding additional indications for an already approved medication requires a supplemental drug application; if it is eventually approved the revenue from it may not offset the expense and effort for obtaining approval. Hence physicians often use FDA approved drugs for non-approved indications.
Gray-label: This indicates a non-FDA approved medication or one that has not yet undergone peer-reviewed studies and is not recognized by evidence-based medicine to treat an illness or perhaps positively impact health span.
I then discussed estrogen therapy, something I’m very comfortable with. First, I described on- label use and the North American Menopause Society (NAMS) recommendation that “current data supports initiation of hormone therapy around the time of menopause to treat menopause related symptoms and to prevent osteoporosis in women at high risk of fracture”. The current on-label systemic estrogen indications are moderate to severe vasomotor symptoms. The off-label estrogen indications are the ones that I often see and treat and they include sleep disturbances, skin changes and skin aging, memory issues, skin sensory issues, joint pain, mood changes and sexuality. I then went on to show several other slides, but the one that I want to emphasis on this website is the fact that the follow-up study of the Women’s Health Initiative (WHI) that included 93,676 women followed for up to 13 years found that neither estrogen therapy nor estrogen progestin therapy affected all-cause mortality.
I thought my next slide might cause some issues at the conference; it was titled “Grey-label: bio-identical hormones”. I presented the following NAMS statement.
Bio-identical hormones may offer patients unsubstantiated claims about safety and effectiveness
The term connotes that they are identical to hormones made in the ovaries, but the same is true of many of the FDA approved prescriptions for hormone therapy
These products may contain dyes, preservatives, contaminants, and vary in dose.
Just to be clear, I did go to discuss the fact that certain progesterones for hormone therapy as well as testosterone are not available as FDA or on-label approved therapies for women and when I feel there is an indication to prescribe them I do. (This made the folks at the meeting happier.)
And despite the fact that specialty vitamin companies were sponsoring many of the booths at the expo at the conference, I did put up a slide that stated that “Vitamins are definitely on the no-label list”. I posed the question: “Are antioxidant supplements associated with higher or lower all cause mortality?” The answer was given with the evidence based trials reported in the JAMA clinical evidence synopsis published September 2013. A review of almost 100 studies showed that beta-carotene, vitamin E and higher doses of vitamin A may be associated with higher all-cause mortality and does not lower mortality rates. And of course the media just covered studies and statements that came out (after the conference) that taking a multivitamin does not increase life span.
I just want to mention one more slide which had to do with exercise… I called it the best label of them all! There is ample evidence that exercise lowers risk of coronary heart disease, stroke, hypertension, type two diabetes, depression, osteoporosis and increases lifespan and health span. The national exercise guidelines state that we should get two hours and 30 minutes of moderate intensity exercise a week, or 75 minutes of vigorous activity (or both), and two sessions of muscle strengthening exercises that work major muscle groups.
This is just a part of my talk at the conference. (I would say brief summary, but once I typed it out it seems pretty long.) I’ve discussed all these topics and the studies that led to my statements in previous website articles but I hey, it’s the end of 2013 and a review a can’t hurt. Oh,and I received some positive comments in the end of my presentation…