No Need For Routine Pelvic Exams?

Woman Sitting with Tea CupThe American College of Physicians created controversy and discord with the American College of Obstetrics and Gynecology by stating that women without symptoms of pelvic disease and of average risk” do not benefit from pelvic exams as part of routine care.” This recommendation received major media coverage. ACP panelist Russell Harris MD of the University of North Carolina in Chapel Hill in an interview with the University of Pennsylvania on line journal MedPage Today added further confusion to the recommendations by saying that “Our guidelines really have to do with women who do not have symptoms, who do not have a discharge or bleeding or pain. Our guidelines talk about screening of asymptomatic women who are not pregnant. Those women simply don’t need the exam. It’s not something that is useful for them.” The article goes on to say that “the guideline also does not apply to women who are due for cervical cancer screening.”

The concern is that the exam is intrusive in a private area and most findings lead to evaluations that lead one down an investigative path that is expensive, invasive and studies show very little yield in terms of finding preventable disease. This is based on the groups’ review of 52 published studies between 1946 and 2014.

Once again organized medicine has shown a way to be confusing, divisive and contributing to the appearance that the right hand does not know what the left hand is doing. The ACP and the American College of Obstetrics and Gynecology should have discussed this issue and released a joint recommendation which makes sense. The ACP guidelines suggest we should be visually inspecting the cervix which requires a speculum exam and using cervical swabs for cancer and or human apillomavirus. How much extra time and cost is involved if the clinician with the patient’s pre approval digitally and manually palpates the uterus, ovaries and rectum for the presence of unsuspected anatomical abnormalities? Is this, in fact, another effort by the American College of Physicians, and the American Board of Internal Medicine, to dumb-down and accelerate the training of future physicians? If we do not perform a certain number of pelvic exams on normal individuals how is one going to recognize an abnormal exam? This is the same type of short sighted thinking that led to the Institute of Medicine and US Preventive Task Force recommending that we do not teach women how to perform breast self -examination to detect breast irregularities? It reminds me of the recommendations years ago to stop doing chest x rays on smokers for the detection of lung disease and lung cancer because it was low yield and not cost effective. Funny how 20 years later the recommendations now call for screening low dose CT Scans of the Chest on smokers 55 years or older who have been smoking for many years.

I will continue to discuss the issue of a pelvic exam with my patients and suggest they discuss it with their gynecologist as well. I believe that 15 -20 years down the road the guidelines will once again insist on examinations of the uterus and ovaries when the politics of the times is not solely set on reducing health care costs! Hopefully those new suggestions will not be fueled by an increase in advanced gynecological cancer due to 20 years of no one examining their patients.

Are Older Women Receiving Too Much Calcium?

CalciumThe June issue of Menopause, a peer reviewed medical journal, carried an original research article by Margery Gass, MD and colleagues which indicated that older women are taking too much Vitamin D and Calcium. She conducted a randomized and placebo controlled trial of 163 women with low Vitamin D levels. The age range of the study group was 57 to 90. They were given Vitamin D and Calcium citrate tablets to reach the recommended daily amount of 400 to 4800 IU per day of Vitamin D and 1200 mg of calcium per day. Follow-up lab studies revealed that almost 10% of the women developed elevated blood calcium levels. More disturbing was the fact that 31% developed elevated levels of calcium in their urine predisposing them to kidney stones.

The lead author suggested that every patient calculate how much calcium they are getting daily in their normal diet before supplementing it with extra calcium. Her group pointed out the benefits of clinicians periodically measuring patients 24 hour urine calcium level. Those with a level > 132 mg were at much higher risk of developing hypercalcemia and its complications and need to reduce their supplemental calcium intake. We will begin suggesting 24 hour urine collection in our patients in the near future.

Trained Dogs More Accurate Than Lab Tests for Diagnosing Prostate Cancer

Service DogIn a report to the American Urologic Association meeting last month, Gianluigi Taverna, MD, of Humanitas Research Hospital in Milan, Italy presented data that specially trained dogs outperformed available lab tests to diagnose prostate cancer. Two German shepherds were trained to recognize the smell of volatile organic substances to distinguish the smell in urine of prostate cancer from healthy individuals and those with other illnesses. The study involved 900 people including 320 prostate cancer patients. All study participants provided a urine specimen which the two dogs smelled. One dog had 100% sensitivity for prostate cancer, 97.8% specificity and 98.9 % accuracy. The 2nd dog had a sensitivity of 98.6%, a specificity of 95.9% and an accuracy of 97.3%. The researchers admit they do not know what chemical or molecule in the urine the dogs smell to achieve such dramatically accurate results. They now begin the difficult task of trying to find it and then create machines that can replicate that accuracy.

While I applaud the study and the curiosity of the researchers I believe we already have the technology available and they are called dogs. From a cost effective standpoint training more of “mans’ best friend seems to be the most cost effective way to accurately detect prostate cancer.

Testosterone Therapy and Low T – “Does Anybody Really Know What Time It Is?”

Low T v2The Food and Drug Administration (FDA) will now be requiring pharmaceutical manufacturers to label testosterone products with a warning that says that the use of this product is associated with an increased risk of blood clots in the veins. These venous emboli can break off and travel downstream causing lung emboli (pulmonary emboli) and even strokes. It had long been known that in men with polycythemia, a thickening of the blood due to increased red blood cells which is a side effect of testosterone therapy, have an increased risk of venous thrombosis.

The study of the effect of testosterone on veins is independent of the current FDA evaluation of the effect of testosterone on arterial clots, coronary artery disease and stroke. A Veterans Affair (VA) study showed a 29% increased risk of those events in veterans taking testosterone. A 2.19 fold higher risk of heart attack in older men and a 2.90 fold elevated risk in younger men with pre-existing heart disease was noted in another VA study. This data was refuted by testosterone advocates in their industry in an observational study suggesting a decreased risk of heart disease in users.

Testosterone supplementation is clearly indicated in criteria outlined by the American College of Endocrinology for hypogonadism. This requires measurement of the patient’s early morning testosterone level on 2 separate occasions. If the value is below a certain level supplementation is appropriate to restore your testosterone to normal functional levels. The problem is that anti-aging advocates have created a fire storm of outpatient enhancement clinics blitzing neighborhoods with advertising that supplementing your low but within the normal range testosterone enhances your quality of life, reduces unwanted body fat and invigorates the patient. There have been insufficient randomized controlled trials to answer the question of whether this practice makes you feel better but is detrimental to your health or if this is something aging men need to think about trying. The FDA investigation is now being joined by the European Medicine Agency to try and assess benefits versus risk of this form of therapy. At the recent meeting of the American Academy of Urology a lively panel debate was held reviewing what is known about testosterone therapy and whether current usage had reached abusive levels? There was broad agreement that more research is needed and until then the guidelines of the American College of Endocrinology should be the gold standard for initiating testosterone therapy safely.

American Cancer Society Issues Prostate Cancer Survivor Guidelines

Prostate CancerThe American Cancer Society issued guidelines on how prostate cancer should be followed once treatment has been provided with the bulk of the responsibility falling on primary care providers. There are 240,000 new prostate cancer diagnoses in United States each year. Most of these malignancies are localized or regional disease in older men with five year survivals approaching 100%. The guidelines are quite simple. Prostate cancer survivors should have a PSA measured every six months for the first five years after treatment. After five years an annual PSA level is considered sufficient. If the PSA is increasing a referral should be made to a specialist either a urologist skilled in treatment of prostate cancer or an oncologist. An annual digital examination should be part of the regimen of all survivors of prostate carcinoma. These new guidelines are consistent with recommendations made by the Institute of Medicine and the National Comprehensive Cancer Network.

As treatment of cancer becomes more successful we can expect to see more guidelines on how to medically screen and follow survivors. The recommendation that the responsibility fall on the shoulders of primary care physicians comes at a time when the nation faces a shortage of future primary care physicians. At the same time that recommendations call for PSA evaluation every six months for the first five years in prostate carcinoma survivors, there are no recommendations to screen healthy males for prostate cancer with PSA measurements. That is a separate and distinct controversial issue.

The Importance of the Physical Examination

Physical ExamMedical Schools and residency training programs are beginning to realize that they must devote more attention to training young physicians in the skills of physical examination. In recent years the tendency has been to concentrate on the technology rather than taking a thorough history and performing a comprehensive examination. Abraham Verghese M.D., a chairperson at Stanford’s medical program has been instrumental in creating the Stanford Medicine 25 program which emphasizes 25 physical exam skills that all students must learn, demonstrate and then teach. Prior to the program Verghese felt that ,” If you come to our hospital missing a finger, no one will believe you until we get a CT scan, an MRI and an orthopedic consult.” Steven McGee M.D., of the University Of Washington School Of Medicine is author of a book on evidence based diagnosis based on physical examination. He believes a physical exam can be as accurate as technology citing instances where evaluating patients’ eye movements are as accurate as an MRI scan in differentiating vertigo due to an inner ear problem as compared to dizziness from a stroke. W. Reid Thompson M.D. of the John Hopkins Pediatric Cardiology Division launched Murmurlab, a website containing the heart sounds of 1300 people to train his students how to distinguish which cardiac findings require further evaluation and an echocardiogram and which do not.

These physicians believe tests lead to tests and more tests and may obscure the diagnosis when a simple physical exam might provide the answer. They cite examples such as the 40 year old woman in a Northern California hospital who was being evaluated for a blood clot to her lungs with a CT scan because she had extremely high blood pressure and was confused. A simple examination of her breasts which had not previously been performed revealed bilateral hard non moveable malignant masses which were in fact the source of her problems.

Not all leaders in medical education feel the need to teach physical examination more effectively. Robert Wachter MD, the father of hospitalist medicine and former head of the American Board of Internal Medicine disagrees and feels more time should be spent on developing critical thinking skills than on physical diagnosis. Dr Wachter is part of a movement to shorten medical school education and shorten residency training. He believes in educating new physicians in a much narrower specialty oriented manner. Under his influence and leadership the Internal Medicine Board Examination is now a separate exam for doctors practicing in hospitals and those practicing outside hospitals.

I have been a faculty member teaching medical history taking and physical diagnosis to medical students for over a decade at the University Of Miami Miller School Of Medicine and the Charles E Schmidt College of Medicine at Florida Atlantic University. These two institutions have managed to teach both critical thinking skills and excellence in physical diagnosis without shortchanging either skill. There is no reason to narrowly train doctors when the fund of knowledge and technology is dramatically increasing. The goal to shorten medical school and residency seems to be an economic goal designed to reduce the costs of education and training a doctor and produce a class of physicians who can be compensated at a lower level. If anything today our future physicians need a broader more comprehensive training to improve understanding and communication regarding the increasingly complex and aging patient population they care for.

DNA Test to Replace Pap Smear

DNAThe Pap smear or Papinicolou Cervical Cancer Test is designed to detect early cancer of the cervix. It requires expert technique in obtaining the specimen during a speculum pelvic exam, expertise in applying the swab obtained specimen to a glass slide and preparation of the slide for transport to a cytology lab for microscopic evaluation. The microscopic evaluation is supposed to be performed by a specially trained and certified cytologist but they are in very short supply. The result is that there is great variability and suspected variation of accuracy in this test.

We now know that cervical cancer is a sexually transmitted disease (STD) of the human papilloma virus particularly HPV strains 16 or 18. Roche Molecular Systems has obtained FDA approval for its HPV DNA molecular test looking for fourteen high risk HPV strains. If a woman is found to have strain 16 or 18 health care professionals are advised to proceed to testing with colposcopy. If one of the other strains is found it is suggested that a Pap smear be performed to screen for the need for colposcopy. The FDA approval came after testing 48,000 women and comparing the accuracy of Pap Smears versus the DNA testing.

The new FDA approval allows clinicians to use the HPV testing alone or in conjunction with Pap smears.

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