The Calcium – Vitamin D Supplementation Picture Gets More Confusing

As a geriatrician who believes strongly in prevention, my perspective is that the recent high volume of research on healthy aging, chronic disease and its association with Vitamin D and Calcium supplementation has done nothing but confuse the picture for us all. I have always been an advocate of healthy eating – a balanced diet that is prepared in a manner that retains and promotes the absorption of the foods nutrients. Also, I have supported the recommendations of blue ribbon panels to supplement the diets of women of child bearing age, peri-menopausal women and post menopausal women with 1200- 1500 mg of calcium per day in addition to dietary calcium to promote healthy bones.

I have read extensively about the lower measured values of Vitamin D in men and women who are ill and have many different types of acute and chronic diseases. I have not truly accepted the idea that raising their measured serum level of Vitamin D with pill supplements did anything to improve the disease state even if we did raise the measured serum Vitamin D level. I have been amazed by experts in Europe and Asia and in the World Health Organization setting a normal lower value of measured Vitamin D level at 20 while in the USA it is 28.  I am not convinced that healthy adults with healthy kidneys cannot get adequate Vitamin D levels by 10 minutes of sun exposure a few times per week in increments which will not dramatically increase the risk of lethal skin cancers.

This was made all the more confusing by the United States Preventive Services Task Force suggesting  that Vitamin D supplements reduce the risk for older people prone to falls and this month announcing that “there is no value for postmenopausal women using supplements up to 400 IU of Vitamin D and 1000 mg of calcium daily.”  This latest ruling was based on data which showed that at 400 IU of Vitamin D and 1000 mg of Calcium daily there was no effect on the incidence of osteoporotic fractures.

Much of the data used to reach this conclusion came from the Women’s Health Initiative Studies of more than 36,000 postmenopausal women.  The USPTF noted that at this dose of Vitamin D and Calcium there was a clear increase in kidney stones which they considered a harmful effect.  At the same time as this data was being discussed, the impartial Institute of Medicine (IOM) presented suggestions and data that Vitamin D at 600 IU daily plus 1200 mg of calcium per day prevented fractures in postmenopausal women.

For my postmenopausal patients I will continue to suggest they supplement their diets with 1200 mg of calcium per day as per the IOM suggestions unless they are prone to kidney stones. They will need to stay well hydrated while I ask them to take a daily 30 minute walk exposing their arms and legs to the sun for at least 10 minutes to allow their healthy kidneys to manufacture Vitamin D.

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.

Prostate Cancer Risk Can Be Predicted With a Single PSA Test

The highly acclaimed Institute of Medicine and now the U.S. Preventive Task Force have recommended against routine screening of asymptomatic men for prostate cancer. Now, a study presented by Christopher Weight, MD from the Mayo Clinic Department of Urology adds more information and confusion to the fire. Dr. Weight presented his data at a recent meeting of the American Urologic Association.

The Mayo Clinic followed men younger than 50 years old for 16.8 years.  They concluded that men at age 40 with a PSA value of less than 1ng/ml had a less than 1% chance of having prostate cancer at age 55. They had less than a 3% chance of having prostate cancer at age 60.  They concluded that men with a baseline PSA < 1% in their 40s appear to be able to safely avoid annual screening until age 55.  “Men with a baseline PSA greater than or equal to 1 have a substantial risk of subsequent biopsy and cancer diagnosis and should be followed annually.”

This is one of the first research studies to quantify the actual relationship of screening young asymptomatic individuals and the subsequent risk of developing the disease.  It is the type of research needed to help guide us to make safe and sane recommendations about the type of screening for prostate cancer and frequency of screening using blood tests, ultrasound and of course digital rectal examination to palpate the prostate. All the patients in the Mayo study received a PSA assessment, digital rectal exam and transurethral ultrasound of the prostate at study entry and biennially thereafter.

This study affirms the recommendation for performing a screening digital rectal exam on all men at age forty and subsequently. It begins to answer the question of who needs follow-up PSA testing and when.  However, more research is clearly needed.

Statistics For Dummies: Primary Care Doctors’ Inability to Understand Statistical Concepts …

An article and editorial have appeared in the Annals of Internal Medicine demonstrating that primary care physicians do not understand simple statistical data presented to them regarding screening tests for cancer. The consequences, as outlined in an editorial written by a former chairperson of the much maligned Institute of Medicine, is that primary care doctors are over-using cancer screening tests because they do not understand the statistical ramifications and conclusions presented in the study. The editorialist recommends improving statistical courses at the medical school level and improving the editorial comments in journals when these studies appear.

As a primary care physician, out of medical school for 36 years, let me make a suggestion.  Keep It Simple Stupid.   Medical school was a four year program.  The statistics course was a brief three week interlude in the midst of a tsunami of new educational material presented in a new language (the language of “medicalese”) presented en masse in between students being used as cheap labor at all hours of the day to fill in drawing bloods, starting intravenous lines and running errands for the equally overworked interns and residents who were actually being paid to perform these tasks.

While internship and residency included a regular journal club, there was little attention paid to analyzing a paper critically from a statistical mathematical viewpoint.  I suggest applying the KISS principle to analyzing medical research papers. Make the language and definitions clear cut and understandable for the non math majors and non researchers.  We have eliminated the use of Latin, medical abbreviations and other time honored traditions of the profession in the name of clarity and safety.  It’s time to do the same with statistical analysis of research papers. Let authors and reviewers say what they mean at an understandable level. Practicing clinicians do not use this vocabulary regularly enough to master it.

It’s time for creating a “Khan Kollege” You-Tube video on statistical analysis and medical paper review that clinicians can refer to routinely to buff up their understanding of medical research papers.  If the American College of Physicians or American Academy of Family Practitioners already have such programs on their websites I apologize for not knowing where to find it.

Each year the economic advisors who freely give advice to us PCP providers have asked me to add three patients per day per year to my schedule to economically be able to stay in the same place.  Amidst that high volume and need to stay current and need to have some balance in my life I admit my statistical analysis skills have grown rusty.  I believe many of my colleagues have suffered the same fate. When the Medical Knowledge Self Assessment syllabus arrives every other year, the statistics booklet is probably one of the last we look at because not only does it involve re-learning material but you must first re–learn a vocabulary you do not use day to day or week to week.

I will make my effort to re-learn statistics to better understand the literature. It is my professional responsibility to do so. I ask my colleagues in academia to do a better job, however, of explaining and teaching the concepts so the data and the logical conclusions are understandable.