FDA Approves New Prostate Cancer Blood Test

The PSA blood test which has been used to screen for prostate cancer has come under a barrage of criticism in recent weeks. The PSA level increases in many non-cancer conditions and this has led to many biopsies and procedures that created more harm, and cost, than good. For this reason, the prestigious Institute of Medicine (IOM) and the U.S. Preventive Task Force have indicated that men should not be routinely screened for prostate cancer with the PSA blood test.

A new test may be on the horizon.  Beckman Coulter said its application for the Prostate Health Index test has been approved by the FDA. The test measures a PSA precursor protein known as [-2] pro-PSA in men with elevated PSA’s between the level of 4 and 10. This, coupled with the PSA and free PSA, helps create the Prostate Health Index.  The company’s data showed that by using the Prostate Health Index there were 31% fewer negative biopsies of the prostate.   The test will be commercially available by the fall of 2012.

We will make this test available when the commercial labs inform us that they are ready to perform it. It remains to be seen whether the health insurance companies will pay for it immediately.  We will need to monitor whether the promise and initial data are accurate when the test is introduced into the general public. We will also need guidelines on how often to follow this index.

Statins May Reduce Your Energy Level

Beatrice A. Golomb, MD, PhD. of the University of California San Diego and colleagues discussed the results of their ongoing studies in the Archives of Internal Medicine online edition regarding cholesterol lowering drugs Simvastatin and Pravastatin and recipients’ perception of their energy level. Their research suggested that Simvastatin might leave its users, especially women, feeling tired and drained after exertion.  The scores hinted that almost 40% of women felt more tired and fatigued during physical activity on Simvastatin than without the lipid-lowering drug.

The trial included 1,016 men and women with low-density lipoprotein (LDL) cholesterol screened at 115- 19- mg/dL who were randomized to receive 20 mg Simvastatin, 40 mg Pravastatin, or placebo each day for 6 months. These patients did not have documented heart disease, cardiovascular disease or diabetes.

There was a worsening of perceived energy level and exertion related fatigue in 4 of 10 women on Simvastatin. The effect was much less, and not significant, with Pravastatin or placebo.   In a recent review of statins and adverse effects in the Cleveland Clinic Journal of Medicine, the authors pointed out that muscles performing work required  fats and lipids as a source of fuel and energy to work successfully. They hypothesized the possibility that the goals of cardiology to reduce lipid levels to prevent cardiovascular disease to extremely low levels may create an environment in working muscles where the lipid levels are too low to generate the fuel or energy needed to perform the exercise and work needed to be done.

Clearly, further research needs to be done.  We must remember all these participants DID NOT have vascular disease and this is a primary prevention study to prevent them from developing cardiovascular disease.  Might there be other methods to achieve this?  Is Simvastatin the only statin to cause this type of problem or will the other statins do the same?  Is this a problem of the particular generic brand of Simvastatin used or is it an across the board effect of Simvastatin?  All these questions require additional research to obtain the answers that we need.