Wall Street and the FDA Versus MDs???

If you didn't have the chance to read the Wall Street Journal today, then you missed a whopper of an article regarding Pharmacogenomic testing and how it can truly impact outcomes with medications.

The article presented several stories of Warfarin gone Awry. Trust me, I have seen more than my fair share of warfarin bleeding stories. Warfarin was a drug initially used as a rat poison. In fact it was only discovered as an anticoagulant when some depressed soldier tried to kill himself with the poison.

He survived, and so did one of the leading selling medications in the world. Leaving a trail of horror stories. When dosing this medication, there is an old adage that you start low and go slow. But in today's lack of reimbursement, this medication is getting started at higher and higher dosages. Why? Because the hospital only gets paid a certain amount by insurance for your stay. This is based on the diagnosis you give. Therefore, the quicker you leave the hospital, the more money the hospital gets to keep.

Enough about health economics, let's get back to coumadin. If you had read my previous posts regarding this testing, you know that it is safe, reliable, and pretty rapid. In addition, Harvard will soon release data showing the clinical efficacy of dosing according to genotype. This is Personalized Medicine at it's finest.

The Sherpa Says: This warning shot by the FDA is directed at physicians who have been inept at learning and applying genetics. At Helix Health of Connecticut we do just that, and help other physicians to do the same. If MDs don't smarten up, we will have Roche teaching laypeople how to dose adjust their medications. Not exactly my idea of health professionals........ Imagine that topsy turvy world!!!

Menopause, Hormones, and You

In the Wall Street Journal today there is a review article regarding recent literature published on menopausal hormone replacement. This article summarizes the debate regarding hormone therapy but does not get to the meat of an article published in the Journal of the American Medical Association(JAMA). The article has some controversy swriling around it. Mainly, that the p-value (likelihood of chance association) was adjusted after the analysis in response to a JAMA request. This is not usually standard practice for publishers as the p-value is usually accepted at 0.05. In this case it is 0.01. Either way the findings are what is interesting.

Traditionally the thought was that menopause and estrogen deficiency was a disease state. As such the "old time" doctors thought that hormone replacement helped prevent stroke and heart attack risk. This was flipped on its head in 2002 when the WHI released some findings which stated that you are actually at increased risk of heart attack or stroke while on the therapy!
This new study points out that there is a window of new onset menopause where therapy does lower risk, however in the elderly >70 years old there is an increased risk. I think that this study has some merit. However, the results can only be interpreted through a genomic eye. Recently data were released regarding ESR1(estrogen receptor alpha) and increased risk of heart attack in men. Currently there are no definitive data on whether estrogen PLUS some gene polymorphism put you at increased or decreased risk. When that data comes, rest assured that labs will be lining up the postmenopausal women. And when that data comes, you will hear it here First!