May 2016 by SMCMA

S a n M at e o C o u n t y

May 2016

Physician

IN S ID E

S A N M AT E O C O U N T Y M E D I C A L A S S O C I AT I O N

Volume 5 Issue 5

PSA testing: Is it dead? Should it be?

Health, dog walking, and the GGNRA

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S a n M at e o C o u n t y

Physician Editorial Committee Russ Granich, MD, Chair; Judy Chang, MD; Uli Chettipally, MD; Sharon Clark, MD; Carri Allen Jones, MD; Edward Morhauser, MD; Gurpreet Padam, MD Sue U. Malone, Executive Director Shannon Goecke, Managing Editor

May 2016 - Volume 5, Issue 5 Columns President’s Message: Volunteering: It’s a win-win situation..................... 5 Michael Norris, MD

SMCMA Leadership Michael Norris, MD, President; Russ Granich, MD, President-Elect; Alexander Ding, MD, SecretaryTreasurer; Vincent Mason, MD, Immediate Past President Alex Lakowsky, MD; Richard Moore, MD; Michael O’Holleran, MD; Joshua Parker, MD; Suzanne Pertsch, MD; Xiushui (Mike) Ren, MD; Sara Whitehead, MD; Douglas Zuckermann, MD; Dirk Baumann, MD, AMA Alternate Delegate; Scott A. Morrow, MD, Health Officer, County of San Mateo;

Editorial/Advertising Inquiries San Mateo County Physician is published ten times per year by the San Mateo County Medical Association. Opinions expressed by authors are their own and not necessarily those of the SMCMA. San Mateo County Physician reserves the right to edit contributions for clarity and length, as well as to reject any material submitted. Acceptance and publication of advertising does not constitute approval or endorsement by the San Mateo County Medical Association of products or services advertised.

Feature Articles PSA testing: Is it dead? Should it be?.. ..................................................... 6 Robert Q. Ho àng, MD, FACS

Health, dog walking, and the GGNRA.................................................... 10 Dean Kardassakis, MD

Of Interest Upcoming events, classified ads, index of advertisers........................14

For more information, contact the managing editor at (650) 312-1663 or smcma@smcma.org. Visit our website at smcma.org, like us at facebook.com/smcma, and follow us at twitter.com/SMCMedAssoc. © 2016 San Mateo County Medical Association

Cover photo by Christopher White, LittleBlueMarbleGallery.com

4 SAN MATEO COUNTY PHYSICIAN | MAY 2016

President’s Message

Michael Norris, MD President

Volunteering: It’s a win-win situation In my March 2016 column, I discussed the growing concern about physician burnout. Since then, I received a note from Dr. Tanya Spirtos, an OB-Gyn specialist in Redwood City. Tanya is also a CMA trustee, and is very involved with issues affecting the practice of medicine. She told me about her experiences volunteering at an overseas clinic, noting that giving back to those less fortunate can help combat the development of the symptoms of burnout. A very good point.

The passing of the torch...

Many of our colleagues lead or participate in teams serving underdeveloped or underserved countries, with great patient outcomes and the satisfaction of a job well done. One tireless team organizer, Dr. Henry Hamilton, is a prior recipient of SMCMA’s Distinguished Service award.

This year we prepare to honor Dr. David Goldschmid for his leadership contributions at the local, state and national levels, and for his current role as medical director of the Clinic by the Bay, which provides medical services to uninsured patients in San Francisco and San Mateo Counties. The clinic staff includes several retired physicians, “giving back” to the communities where they once practiced. We’ll present Dr. Goldschmid with the SMCMA Distinguished Service Award at our annual meeting on Thursday, June 23, at the Hiller Aviation Museum in San Carlos. We have other retired colleagues who serve as volunteer faculty at UCSF and Stanford, teaching medical students and residents. This week I met Dr. Jason Wong, the medical director of the Samaritan House Medical Clinics in Redwood City and San Mateo. At a meeting of the SMCMA Board of Directors, Dr. Wong described the care offered at Samaritan House, including dental and pharmacy services Joining Jason were two volunteer physicians, Sophie Cole and Alexander Moldanado, primary care doctors in private practice—not retired—who volunteer days away from their busy practices to provide care to the uninsured. I came away from our meeting greatly impressed.

Like my fellow doctors, I have more I can offer and, just as important, much to gain from volunteering.

I will retire one of these days. I will need to re-think my plans to spend my idle days on a golf course somewhere. Like my fellow doctors, I have more I can offer and, just as important, much to gain from volunteering. Time spent away from EHRs, Medicare guidelines and penalty threats, insurance hassles—sounds like a good RX for burnout to me. ■

MAY 2016 | SAN MATEO COUNTY PHYSICIAN 5

PSA Testing: Is it dead? Should it be? by Robert Hoàng, MD, FACS Nearly 30 years after the prostate specific antigen (PSA) screening test was introduced for detecting prostate cancer (1987), physicians and their patients currently face questions and confusions regarding the effectiveness and benefit of prostate cancer screening. While the number of deaths from prostate cancer has decreased since the dawn of the PSA era, the relative contributions of screening and treatment-pattern changes are not known. One thing about widespread screening is certain, however: it clearly resulted in over-diagnosis, and in many cases, over-treatment of low-risk prostate cancer. In May 2012, the U.S. Preventive Services Task Force (USPSTF) reported its statement, recommending against prostate-specific antigen (PSA)-based screening for prostate cancer (1). Giving the PSA test a grade of “D,” the USPSTF concluded that “there is moderate certainty that the benefits of PSA-based screening for prostate cancer do not outweigh the harms.” As an early result, relatively less PSA testing is being done, and new prostate cancer diagnoses have been reported to have declined by 30%, including the number of new diagnoses of intermediate- and high-risk prostate cancer. More recently, in November 2015, the Centers for Medicare & Medicaid Services (CMS) presented for stakeholder comments on a clinical quality measure drafted by Mathematica Policy Research, entitled “Non-Recommended PSA-Based Screening: The percentage of adult men who were screened unnecessarily for prostate cancer using a prostate-specific antigen (PSA)-based screening test” (2). The majority of early responses or comments have essentially stated beliefs that Medicare officials are considering a measure that could penalize doctors who order prostate-cancer screening tests for their patients, as part of a federal effort to define and reward quality in health-care services. The Obama administration has been quoted to have said it plans to tie 50% of Medicare payments to such quality measures by 2018.

6 SAN MATEO COUNTY PHYSICIAN | MAY 2016

Is PSA testing dead? Should it be? The ultimate goal of cancer screening is to detect a cancer before it progresses beyond the point that it would cause a cancer death. For many years, the PSA test was used for widespread routine screening, generally based on age. And so a lot of men mostly between the age of 50 and 70 (and many older) were tested. We were all initially excited as we saw the number of men presenting with advanced stages of prostate cancer dropping fast into the single-digit percentage. We were equally excited with the very large number of men (including many 70 and older) being diagnosed with small-volume prostate cancer at relatively early stage, and therefore viewed as very favorable candidates for our available treatments. So it seems.

Unfortunately, our historical practice of PSA-based prostate cancer screening, particularly when used to screen everyone, at best, had very little impact on the prostate cancer death rate (28,000 deaths per year). Perhaps a contributing factor, with the common practice of very few

men tested before age 50, the most aggressive cancers have already spread (grossly or microscopically) by the time they are identified. These cancers are mostly beyond cure. When used to screen every man age 50 to 70 (in reality many older) in a population, early detection of small and early-stage prostate cancers has been noted to be counter-intuitive. The test is really good at leading urologists to find low-risk or seemingly “non-lethal” cancers that aren’t likely to go anywhere or do any harm. This is consistent with data from studies (autopsy data mostly) that have noted over half of men age 60 and older to have small, indolent, non-lethal prostate cancer, few have potentially-deadly ones. So most men who get screened are not destined to die due to prostate cancer, and do not appear to experience any benefit from screening. These are the findings of the National Cancer Institute’s Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial, in which 76,000 men were followed for 10 years or longer. It is also worth noting that this study also showed the rate of death from ischemic heart disease was 17 times greater than that of prostate cancer, even though the patient population under study was, overall, healthier than people of similar age in the general U.S. population (3). The reality is doctors haven’t been able to reliably identify or determine which cancers will become lethal. The truth is also that it had been a slippery slope that began the moment a man learned of his elevated PSA, which lead him to have a biopsy because he worried about having cancer. If the biopsy showed cancer, the most common reaction from the man and/or his family (particularly in the United States) was to do something soon or immediately. So many men diagnosed with prostate cancer did decide or were advised to undergo treatment, most commonly, surgery and radiation. In 2009, a reliable source (4) reported an estimation of at least one million men had decided to treat cancers destined to never bother them, with many having endured post-treatment urinary incontinence, sexual dysfunction, and bowel problems.

Refining screening for prostate cancer Fact: Prostate-specific antigen (PSA), less commonly known as gamma-seminoprotein or kallikrein-3 (KLK3), is a glycoprotein enzyme encoded in humans by the KLK3 gene. PSA is a member of the kallikrein-related peptidase family and is secreted by the epithelial cells of the prostate gland. Currently, it remains the most studied and arguably the most important biological marker of the prostate gland. Particularly among physicians who have directly provided care for men who succumbed to or suffered from this disease, it would be rare to hear of anyone of us who would prefer to return to the days before PSA testing. However, for all of us who have screened, evaluated, diagnosed or treated men for prostate cancer, we all have to admit that our historical use of the PSA test was poor. A limited test used poorly usually does not yield

ideal results. No longer should it be simple, a check-off or a click on test panels. PSA testing is not harmful, but the actions a man may take after receiving test results that indicate high serum PSA levels sometimes are. Currently, risk stratification for PSA-based screening in targeted populations are advocated by many leading stakeholders. Current positions or guidelines from these societies are as follows: The American College of Physicians recommends discussion about risks and benefits of PSA screening in men between the age of 50 and 69 years. The American Society of Clinical Oncology recommends discussion about risks and benefits of PSA screening in men with a life expectancy >10 years. The American Cancer Society recommends discussion about risks and benefits of PSA screening in men: over the age of 50 years for men who are at average risk of prostate cancer and are expected to live at least 10 more years, over the age of 45 years for African Americans and men who have one first-degree relative diagnosed with prostate cancer at an age younger than 65 years, and over the age of 40 years for men with more than one first-degree relative diagnosed with prostate cancer at an age younger than 65 years. The National Comprehensive Cancer Network recommends discussion about risks and benefits of PSA screening in men over the age of 45 years. The American Urological Association recommends discussion about risks and benefits of PSA screening in men between the age of 55 and 69 years, and in men 40 to 54 years who are African-American or have family history of prostate cancer.

My current practice At first glance, this recently-proposed clinical quality measure of “non-recommended PSA-based screening” may feel like a threat to penalize. After further consideration, I currently see it really as something emphasizing what physicians would want, more critical thinking for the benefit of our patients. We want to focus on how to reduce potential harm as well as improving our effort to those we can help.

Over the last 30 years of PSA testing, we have learned its clinical strengths. Unfortunately, it took a lot of years of practice to be convinced of its weaknesses. But this learning process is not uncommon for many screening and diagnostic tests as well as many of our medical and surgical therapies. Furthermore, when trying to strike

MAY 2016 | SAN MATEO COUNTY PHYSICIAN 7

a balance between harms and benefits, similar to other disease screenings, there are a lot of nuances. DRE and PSA testing: With the above-mentioned guidelines in practice, I favor more focus to initiate screening of younger men, in particular instances even before age 40. The most obvious reason, from my perspective, is there are still young men (age 40-50) who are walking into my office for the first time with very advanced disease (grossly or likely microscopically metastatic) that are not able to be cured with any currentlyavailable therapy. Earlier detection may be the only hope for these young men. For the young men who do present early to us for medical care or routine health examination, doing a digital rectal examination (DRE) maybe particularly helpful for those we identified as higher risk (African-American, positive fam-

Similarly, as an acute need, its usefulness is also limited for most men presenting with acute urinary retention. The one important exception is when a man (typically elderly) who presents with urinary retention also has frankly suspicious DRE, and possibly with signs and symptoms of bone metastases. PSA testing for this particular situation usually serves to confirm clinical suspicion, allowing reasoning for initiation of therapy (usually medication therapy), most commonly for the purpose of palliation.

More recent additions to the “confusion” The PSA test is a simple test but it does not give any clear yes or no answer regarding prostate cancer. When the result is considered abnormal, a man faces not-so-simple decision-making. In the last 5 or so years, there has been increasing use of biomarkers and imaging for all phases of prostate cancer care (screening, after diagnosis for making decision of various treatment options or surveillance, and for use after treatment or at the time of failure of therapies). For screening, whether the use of biomarkers and imaging positively affects decision-making for prostate biopsy is one particularly important question. Prostate biopsy (most commonly trans-rectal) is not trivial, and realistically, it should be considered to be the beginning of potential harm. Associated complications include bleeding, infection (acute bacterial prostatitis/ bacteremia/sepsis), acute urinary retention, pain, and endocarditis. The 30-day risk of acute hospitalization or acute care after biopsy for any cause has been estimated to be approximately 4%, of which three in four are for infections.

Biomarkers

ily history). The younger men who present with persistentlybothersome urinary symptoms (lower urinary tract symptoms of frequency/urgency) that cannot be explained by infection or physical findings, should also be considered for early screening. PSA testing for these particular men (probably the very first PSA test for most of them), I would favor. This practice is more likely to allow earlier identification of young men who harbor aggressive disease. These are the men who stand to benefit most from prostate cancer screening. PSA testing based on age and/or patient’s desire remains clinically-reasonable, but not necessarily needed yearly. Statistically, for men without any particularly high-risk factors, especially if 60 years or older, PSA < 1.5 suggests low-risk. When PSA testing is not usually helpful: There is no acute clinical need for PSA testing when a man of any age presents with typical signs and symptoms of a lower urinary tract infection. The result of the test is not reliable or clinically-relevant, and it certainly does not and should not affect the acute management or the initially-prescribed treatment.

8 SAN MATEO COUNTY PHYSICIAN | MAY 2016

Several serum-, urine-, and tissue-based biomarkers have been touted to address current clinical decision-making challenges such as: (a) whom to biopsy or re-biopsy (screening and detection), (b) whom to offer certain therapies and who may be the best candidate for active surveillance (after diagnosis decision-making), and (c) decision-making for adjuvant or salvage therapy after initial treatment or at the time of failure of therapies. As a group, the currently-available tests (particularly those that are screening tests) represent first-generation assays that are expected to provide only incremental improvement as they are mostly variations of play on known statistical-predictability of disease presence. And, interpretation of these test results use the same statistics that were originally derived from PSA test results. More recently, for screening, the “4Kscore” test (5) looks to have the potential to significantly reduce prostate biopsies in men with abnormal PSA levels and/or DRE results. One recent study of community and academic urology practices noted the actual percentage of cases not proceeding to biopsy were 94.0%, 52.9%, and 19% for men who had low-, intermediate-, and high-risk 4Kscore Test results, respectively. The study observed an overall 64.6% reduction in prostate biopsies. Higher 4Kscore Test results were more likely to be associated with high-grade prostate cancer pathology in men who underwent prostate biopsy.

Appropriately, current use of these tests are almost always as an adjunct to PSA. I would say that use should only be considered after formal urologic consultation. Some of these tests cost 10+ times as much as the regular PSA test.

Imaging Like for other cancers, advances of diagnostic imaging are increasingly-used tools for prostate cancer. Multi-parametric MRI prostate scanning has been most studied, with current knowledge and data deriving mostly from studying men who were diagnosed with cancer from prior biopsy and from those who were subsequently evaluated after an initial negative biopsy despite strong clinical suspicion (relatively high PSA). Use of magnetic resonance imaging (MRI) of the prostate has evolved over the years from use for primarily disease-staging, to disease-localization, and more recently, to disease-screening. Currently, MRI scans can detect cancers as small as 3 mm. This improvement of disease localization gives more confidence when patients are choosing focal ablation therapy over total-prostate irradiation, other forms of ablation (cryotherapy, radiofrequency, HIFU, injectable toxins) or radical prostatectomy. And it also gives a positive expectation for fewer or milder side-effects, and lower cost. For disease screening, optimal use of imaging is far from any consensus. The ability to detect small or tiny tumors does not help to minimize over-diagnosis of low-risk cancers. In addition, current limited ability to differentiate low- and high-risk pathology is another argument for limited use for disease screening. For these reasons, in recent years, there is increasing support for targeted biopsies, specifically using MRI-Ultrasound Fusion Biopsy techniques, theoretically offering relative advantages over random biopsy and template-guided biopsy. By combining the detailed imaging of MRI scans with the immediacy of 3-dimensional, real-time ultrasound, fewer biopsy samples are needed, and possibly with better clinical information. Limited centers have reported use this technology to perform trans-perineal biopsy which is expected to reduce infection risk when compared to the more commonly used trans-rectal approach.

I personally believe, while these technological advances are important and should continue to be supported (at this time,

meant, stated or un-stated, to maximize usage, and everything else may be secondary. CUI BONO? In summary, despite facing some hard realities of our poor use of the PSA test, I truly believe that our fight and management of prostate cancer is better today than in the prior era. In 2016, the serum-based PSA test should remain the most commonly used biomarker for risk-adjusted screening, and to monitor patients after therapy and those on active surveillance. New generation of prostate cancer biomarkers is emerging, and will likely supplement the PSA test or replace it over time. Some leading experts and researchers are optimistic that we may be just a few years away from having more prescribed or recommended markers that are within the main flowchart of guidelines such as the NCCN. Advances of imaging will continue improving in the years to come, hopefully to allow sufficient accuracy and certainty of disease information, along with less invasiveness of disease screening, evaluation, and treatment. This will happen. In the meantime, wee well! ■

Notes 1. http://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/prostate-cancerscreening 2. http://cqrcengage.com/aacu/file/yc3eNmm9F28/CMS-PSAQuality-Measure_PSA%20Screening_Framing%20Document.pdf 3. Andriole GL, Crawford ED, Grubb RL III, et al. Mortality results from a randomized prostate-cancer screening trial. N Eng J Med. 2009; 366:981-990. 4. Prostate Cancer Diagnosis and Treatment After the Introduction of Prostate-Specific Antigen Screening: 1986-2005,http:// jnci.oxfordjournals.org/content/101/19/1325.full http://jnci. oxfordjournals.org/content/101/19/1325.full.pdf+html 5. The 4Kscore Test incorporates measured blood levels of four kallikrein proteins: total PSA, free PSA, intact PSA, and human kallikrein 2 plus clinical information (age, DRE findings, and a history of prior negative biopsy result) into a proprietary algorithm to calculate an individual man’s percentage risk (<1% to >95%) of having Gleason 7 or greater if a prostate biopsy were to be performed.

ought to be private-funding and/or government-grants), much more validation is needed for certainty of positive and negative predictive values. MRI, at this point in time, is not a standard of care, certainly according to guidelines, and still cannot take place of a biopsy. Specifically, for prostate cancer screening, doing an upfront MRI before any biopsy is not supported by any data. To this point, I currently object to direct consumer advertising, as increasingly being done by

About the author Robert Q. Hoàng, MD, FACS, is a boardcertified urologist practicing in San Mateo and Belmont. His interests include enlarged prostate (BPH), laparoscopic nephrectomy, laparoscopic robotic pyeloplasty, laser prostatectomy, neurogenic bladder, radical prostatectomy, robotic prostatectomy, and voiding dysfunctions.

hospitals including near-by academic centers, which is really MAY 2016 | SAN MATEO COUNTY PHYSICIAN 9

2016 smcma annual meeting Thursday, June 23, 2016 6:30 - 9:30 p.m. Hiller Aviation Museum 601 Skyway Road San Carlos Please join us on as we welcome the 2016 SMCMA Board of Directors and honor the recipient of our Distinguished Service Award, David Goldschmid, M.D. Our venue this year will be the Hiller Aviation Museum in San Carlos, a Smithsonian Affiliate museum featuring more than 50 aircraft from throughout aviation history. During the cocktail reception you are invited to view the aircraft and practice your flying expertise on a flight simulator.

$65 per person 650-312-1663 www.smcma.org/ annualmeeting2016

10 SAN MATEO COUNTY PHYSICIAN | MAY 2016

Health, dog walking, and the GGNRA by Dean Kardassakis, MD The Golden Gate National Recreation Area (GGNRA) was established in 1972 to bring an urban park to San Mateo, San Francisco, and Marin counties. It covers tens of thousands of acres of park land and has over 100 miles of trails that have historically welcomed dogs with their owners. However, since 1979, the GGNRA has been working to limit where dogs are allowed and where they can be off leash. The National Park Service recently proposed a rule for dog management that would permanently alter where dogs will be allowed (both on and off leash) throughout the entire GGNRA. Public comment was invited through the end of May. The final rule is expected to be finalized by December 2016 and implementation would begin in early 2017. This now may be a good time to consider some of the medical implications should such restrictions be finalized. Physicians and surgeons invested in the health of patients are stakeholders in any attempt to limit areas where dogs and humans can exercise together. Significant health benefits of dog ownership have been well documented in the medical literature. Dog owners have a significantly higher 1-year survival rate following myocardial infarctions than patients without dogs. According to a scientific statement from the American Heart Association, dog ownership is probably associated with decreased cardiovascular disease risk. Some studies even show an effect of lowering blood pressure. As many dog owners will attest, dog ownership often has a positive effect on human physical activity. We are currently in an epidemic of asthma. Part of the cause of this appears to be the adoption of an indoor lifestyle. Several studies have shown dog ownership in early childhood decreases the risk of developing asthma. Part of the explanation of this might be related to favorable changes in the human microbiome with dog exposure.

The proposed dog rules will not supersede the Americans with Disabilities Act (ADA). Service animals will still be permitted at the GGNRA. However, in order to qualify, a dog must be trained to do work or perform tasks for the handler with a disability, and this has to be directly related to the disability. So, if a dog has been trained to fetch for a person who is wheelchair bound, they are allowed. Other examples of allowed categories are seeing eye dogs and dogs for the hearing impaired. Dogs can be successfully trained to sense hypoglycemia in type 1 diabetes. The Department of Defense even has a service dog training program for the treatment of posttraumatic stress disorder. The number of assistance dogs overall is increasing in California. Part of this increase may be in dogs used for psychiatric assistance that do not qualify as service dogs under the ADA, as they have not been specifically trained to assist patients. The current pet proposal does not allow any special access for emotional support animals. (San Mateo County does not recognize dogs whose sole function is to provide comfort or emotional support; the City and County of San Francisco recognizes support animals for the purpose of allowing an animal in a rented home as a â&#x20AC;&#x153;reasonable accommodationâ&#x20AC;? for a disability, although a medical professional may have to write a letter to verify the disability.) As might be expected with an issue that may limit the rights of dog owners, there are political considerations. Congresswoman Nancy Pelosi supports off-leash dog walking at the GGNRA. The San Francisco Board of Supervisors voted to

Continued on page 14

MAY 2016 | SAN MATEO COUNTY PHYSICIAN 11

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Health, dog walking, and the GGNRA continued from page 11 oppose the new restrictions. The Marin Humane Society ex pressed its strong disagreement with the proposed rules. Even if the current rules are adopted, they might not be the end of the restrictions. The proposed rules have a clause that give the superintendent wide discretion to impose additional closures or restrictions.

About the author Dean Kardassakis, MD, is a board-certified allergist and immunologist practicing in Burlingame. He is a Fellow of both the American Academy of Allergy, Asthma and Immunology, and the American College of Allergy, Asthma and Immunology.

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