Berks County Medical Society Medical Record Spring 2015

Medical record BERKS COUNTY MEDICAL SOCIETY

Recognizing Service to Berks County Medicine

SPRING 2015

Dr. Gianfranco F. Toso, MD

58 Years

S E E PAG E 8

Coping with Malpractice Litigation

Marijuana:

Safe? Effective? Medicine?

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THE BERKS COUNTY MEDICAL RECORD Christina M. Ohnsman, MD, Editor

EDITORIAL BOARD

D. Michael Baxter, MD Lucy J. Cairns, MD Daniel B. Kimball, MD, FACP John Moser, MD Betsy Ostermiller

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1170 Berkshire Blvd., Ste. 100, Wyomissing, PA 19610 Phone: 610.375.6555 | Fax: 610.375.6535 Email: info@berkscms.org

The opinions expressed in these pages are those of the individual authors and not necessarily those of the Berks County Medical Society. The ad material is for the information and consideration of the reader. It does not necessarily represent an endorsement or recommendation by the Berks County Medical Society.

Manuscripts offered for publication and other correspondence should be sent to 1170 Berkshire Blvd., Ste. 100, Wyomissing, PA 19610. The editorial board reserves the right to reject and/or alter submitted material before publication.

The Berks County Medical Record (ISSN #0736-7333) is published four times a year by the Berks County Medical Society, 1170 Berkshire Blvd., Ste. 100, Wyomissing, PA 19610. Subscription $50.00 per year.

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Table of Contents SPRING 2015 FEATURES

Cover Feature

Recognizing Service to Berks County Medicine

BCMS President is Panelist for State of the Community Breakfast

Marijuana: Safe? Effective? Medicine?

Resources for Reliable Information and CME on Medical Marijuana: A Sampling HR Brief

Residents’ Day and Memorial Lecture

DEPARTMENTS

Editor’s Comments

12

Members in the News

26

Alliance Update

Events Calendar

14 16 20

27 28

6

Foundation Update Legislative Update

8

22 24 30

Content Submission Medical Record magazine welcomes recommendations for editorial content focusing on medical practice and management issues, and health and wellness topics that impact our community. However, we only accept articles from members of the Berks County Medical Society. Submissions can be photo(s), opinion piece or article. Typed manuscripts should be submitted as Word documents (8.5 x 11) and photos should be high resolution (300dpi at 100% size used in publication). Email your submission to info@berkscms.org for review by the Editorial Board. Thank YOU! Cover Photo: Dr. Gianfranco Toso Photographer: Dave Zerbe

Editor’s Comments Congratulations to Lucy Cairns, MD, our new BCMS President!

I’m honored to sit in for her this year as interim editor of the Medical Record, while she leads the medical society. Our future is in very capable hands!

I

’ve been in practice long enough to have seen some carved-in-stone medical concepts overturned.

For example, ulcer treatment was all about H2 antagonists, stress management, and diet; now, we use antibiotics against H. pylori. Low fat diets and statins were routinely prescribed for patients with high cholesterol; now, we are learning that dietary fat intake does not affect serum cholesterol levels. Hormone-replacement therapy was the norm for post-menopausal women; now, it is prescribed only in select cases for a limited time. Small incisions have revolutionized virtually every kind of surgery, from appendectomy to heart valve replacement to cataract extraction.

Christina M. Ohnsman, MD, Editor

It’s up to us, as physicians, to keep up with the literature and with new ways of thinking. Yet, doctors are notoriously resistant to changing their practice patterns. A meta-analysis evaluating the relationship between clinical experience and quality of health care suggests that physicians who have been in practice for more years have less factual knowledge, are less likely to adhere to appropriate standards of care, and may also have worse patient outcomes.1 This study found that physicians were least likely to adopt changes when they were based on paradigm shifts that contradicted what they had learned in training. This clearly shows the tendency to stick with what we’ve been taught, with what we think has always worked, even when we’re wrong! I don’t know about you, but that is a frightening thought as my years of experience accumulate.

We have to actively police ourselves, preventing ourselves from becoming outdated in our patient care decisions. We have to seek out challenging and effective continuing education opportunities, finding the gaps in our knowledge and filling them with the latest, evidence-based, best practices.

That’s not easy, especially considering that traditional continuing medical education may not be adequate in its present forms.1 We have to push ourselves out of our comfort zones to learn new procedures. It’s not that we purposely don’t want to change, learn, and grow. It’s often overwhelming to keep up with volumes of new research while dealing with the daily demands of patient care. It’s much easier to use our tried-and-true default treatment plans than to reinvent the wheel in the midst of our busy days. Perhaps the most fundamental reason that we lose our edge is that it’s hard to recognize what we don’t know.

“

“

The maintenance of certification process was designed, in part, to address this problem. As we’ve recently seen in the news, however, MOC is an imperfect work in progress, and the requirements don’t always enhance physician learning. Having recently completed the 10-year American Board of Ophthalmology MOC process, I can attest to the good, the bad, and the useless portions of the requirements. The point is that MOC forces us to systematically review our practices, hopefully helping us to identify some gaps in our knowledge along the way. Nevertheless, relying solely on MOC isn’t enough to stay on the cutting edge of our professions.

We have to think outside of the box to find meaningful ways to learn about and incorporate new standards of care into our practices.

6 | www.berkscms.org

Which brings us to the subject of our feature article: medical marijuana. I confess that I didn’t have an open mind to legitimate uses for marijuana at first, except possibly for compassionate use in chemotherapy-induced nausea. As an ophthalmologist, I knew that marijuana is not an effective treatment for glaucoma—its intraocular pressure-lowering effect only lasts for three to four hours-—despite claims to the contrary. Recently, however, some very legitimate medical uses have been identified, and patients’ lives have been dramatically improved, as reported by Sanjay Gupta, MD, in his documentaries, “Weed”2 and “Weed 2.”3 Our feature article by Lucy Cairns explores the road to legalization of medical marijuana in Pennsylvania, including a look at what constitutes a “medicine.” It’s fascinating reading, and a hot topic as the PA Medical Society is set to release a white paper and our state legislators are actively debating the subject.

So why do many physicians remain opposed to the legalization and regulation of medical marijuana? First, they are falling back on outdated ideas that are based on the incorrect classification of marijuana with dangerous, illicit, Schedule 1 drugs, instead of keeping an open mind and looking at the research for themselves. Perhaps they have unpleasant memories of stoners in high school or college, or they are suspicious that marijuana dispensaries are fronts for the sale of recreational weed. In addition, until marijuana is thoroughly researched to determine efficacy and accurate dosing for particular disease states, how

does one “prescribe” it—what type, what dose, what frequency?

Another stumbling block is the fear of addiction. While narcotic pain medications are addictive, and overdoses of narcotics are often lethal, none of us would consider withholding them from patients with cancer or postoperative pain. Instead, narcotics are regulated to ensure that they are available to patients who need them and, ideally, unavailable to those who wish to use them recreationally. On the other hand, no one has ever died from the direct effects of marijuana, yet it remains on the DEA’s Schedule 1.

It will be interesting to see where and how marijuana fits into the practice of medicine in the next few years, alongside other surprising advances and discoveries. We need to let the evidence show us the right answers, and we need to be open-minded to those answers. Let’s make it our mission to stay on top of medical progress, in order to best serve our patients. n 1. Choudhry NK, Fletcher RH, Soumerai SB. Systematic Review: The Relationship between Clinical Experience and Quality of Health Care.

Ann Intern Med. 2005;142:260-273.

2. Weed [special report]. CNN television. Available at: https://vimeo. com/105921747. Accessed March 20, 2015.

3. Weed 2 [special report]. CNN television. Available at: http://www. youtube.com/watch?v=i2qFDb8LExo. Accessed March 20, 2015.

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President’s Message

Dr. Gianfranco Toso

Installation Brunch Remarks By: Lucy J. Cairns, MD

2015 BCMS Officers Standing rear—Dr. Kristen Sandel, Dr. Michael Haas Seated ends L to R- Dr. Gregory Wilson, Dr. Andrew Waxler Seated L to R- Dr. Michael Baxter, Dr. Lucy J Cairns

Heather Wilson, Executive Director, PAMED Foundation

Dr. & Mrs Gerald Malick 8 | www.berkscms.org

Dr. Margaret Atwell

First, I must add my thanks to Dr. Sandel for her outstanding performance while serving as our President in 2014. Kristen, you hit one out of the park. No one could have brought more energy or commitment to the position or been more effective. The baseball team as a metaphor for our organization and the quotes you shared from baseball greats were on-target and inspirational.

As this day has approached I have lain awake at night trying to imagine a worthy follow-up theme.

A

nyone who has paid attention to the Medical Record since I became editor will be aware that my leisuretime passion is one that may seem, at first glance, a far cry from team sports: birding—learning about and observing birdlife. I’m here to tell you, though, that birding is a sport. It is an activity that involves physical exertion, a uniform of sorts, special equipment, and yes, even competition. How many of you know that the premier birding competition in the country and perhaps the world takes place every May in our neighbor state of New Jersey and is titled the World Series of Birding? Teams of birders begin a 24-hour marathon at midnight to see who can identify, by sight or sound, the largest number of bird species, with the entire state as the search area. Sponsors pledge a small contribution

Dr. & Mrs Andrew Waxler

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for each species their team finds. In 2014, there were 77 teams in the Series and over $600,000 was raised for conservation. That’s big league!

Outside of this 24-hour competition window, however, birders are all about sharing their knowledge and experience in order to help one another become better birders and advance science.

This is an ethic shared by all physicians worthy of the title, and it was propounded by the first President of the Medical Faculty of Berks County, Dr. Isaac Hiester, at its founding in 1824. There was no hospital in Berks County at that time to provide for regular contact among county physicians. Travel was hazardous and slow, and the means of communication were few. Dr. Hiester and others recognized the danger that physicians practicing in isolation would fall into a complacent stagnation. The Medical Faculty was formed to institute face-to-face meetings at which members shared knowledge and experience to advance their understanding of disease. The outcome of this improvement in communication among physicians was better medical treatment for county residents. In 1911, a second means of regular communication was established with a monthly publication titled the Bulletin, which has now evolved into the Medical Record.

New member, Dr. Michael Abboud

Dr. Michael Baxter and Dr. Gordon Perlmutter Dr. Kristen Sandel, outgoing President

L to R Dr. Michael Baxter, Dr. Eve Kimball, Dr. Dan Kimball, Jr.

Dr. Eve Kimball and Dr. Michael Baxter

Dr. Michael Baxter reading the Oath of Office to Dr.Gregory Wilson, Secretary while Dr. Raymond Truex, Jr. holds the Bible.

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Oath of Office being administered to Dr. Andrew Waxler, President Elect

Oath of Office being administered to 167th President, Dr. Lucy J.Cairns

Message of the 167th President, Dr. Lucy J Cairns

Dr. Raymond Truex, Jr. – left Dr. Gianfranco Toso-right

10 | www.berkscms.org

Award Recipients L to R Dr. Gordon Perlmutter, Dr. Margaret Atwell, DR. Gianfranco Toso, Dr. Daniel Kimball, Jr., Dr. C. Eve Kimball, Dr. Ronald Emkey…SEATED Dr. Patricia Innis

As medical knowledge expanded exponentially in the 20th century, specialization became a necessity and specialty societies assumed the role of helping members keep current in their fields.

The Berks County Medical Society’s mission became less focused on professional education and more about providing a framework for members to work together on other activities which protect and elevate our profession. In recent years these activities have included working to improve access to medical care for the most vulnerable of county residents, providing recognition for the contributions of young physicians in local post-graduate training programs, honoring physicians who have devoted their lives to providing top-notch care in our community, raising public awareness of the many contributions our members make to Berks County’s well-being, and working ceaselessly with the Pennsylvania Medical Society to obtain the best possible results in the field of legislation and public policy as it affects the practice of medicine. As impressive as this list is, it does not include the entire range of our activities.

Our ability to continue serving Berks County physicians and our patients depends upon our maintaining a strong and engaged membership. This is easier said than done in today’s increasingly demanding and complex practice environment. Communication is at the core of everything we do, but we struggle to communicate

Dr. Michael Baxter and Dr. Margaret Atwell

Dr. Patricia Innis

Dr. Michael Baxter & Dr. Ronald Emkey

the value of membership to some local physicians. More and more Berks County physicians are once again practicing in isolation from the benefits of collaboration with nearby colleagues for our common good and that of our patients. Unlike conditions in 1824, though, in 2015 we have an almost limitless number of relatively inexpensive communication channels literally right at our fingertips. I promise you that this year we will work to improve the way we communicate with members and—more importantly— the ways in which members can communicate with leaders and with each other.

Despite all the challenges, we are an exceptionally active county medical society with many accomplishments to be proud of, and not a few of our members have been or are now prominent leaders at the state and national level.

One of the key factors in our success has been our highly competent and hard-working staff. Betsy Ostermiller deserves special thanks for agreeing to expand her role and keep all our balls rolling during the present period while our search for a new Executive Director is in progress. Thank you for organizing today’s event and for everything you do, Betsy.

Finally, I would like to take this opportunity to acknowledge the amazing work done by the Berks County Medical Society Alliance, a group committed to improving the health and welfare of our community. We bask in the reflection of their good deeds and many of our patients benefit from their annual Health Project and charitable works. I am proud to support the Alliance with my membership in addition to contributing to their annual fundraiser, and encourage you to do likewise. n

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Foundation Update

Coping with Malpractice Litigation The Foundation of the Pennsylvania Medical Society is here for physicians during life’s most challenging moments

The phone rings in the middle of the night.

M

ark Lopatin, MD, has to decide whether to tell a frail, 79-year-old patient with Parkinson’s disease complaining of a fever whether to stay in bed, take Tylenol and drink plenty of fluids, or venture out into the cold night to his local emergency room. The decision should be easy, but Dr. Lopatin, who has dealt with malpractice litigation, says it is not.

Six out of every 10 physicians practicing today have been sued for malpractice at least once, according to the Foundation of the Pennsylvania Medical Society’s Physicians’ Health Programs (PHP). “The effects of malpractice on the individual should be taken seriously,” says Medical Director Jon

12 | www.berkscms.org

Shapiro, MD. “As physicians, it represents a major area of stress, because we so often link who we are to what we do.”

Kathleen Chancler, a principal in Post & Schell’s Professional Liability Practice Group in Philadelphia, agrees. “When a physician is named personally as a defendant in a malpractice suit, it’s often a difficult experience for them,” she says.

“Physicians enter the profession for altruistic reasons, and then find themselves entrenched in an adversarial litigation process that involves lawyers, depositions, and courtrooms, which ultimately takes them away from time with their patients.”

According to the PHP, a malpractice suit is business to many lawyers and judges—just part of their jobs. To the physician, a medical liability suit questions his or her professional competence. The outcome of the suit can affect the physician’s self-esteem and his or her standing among colleagues and in the community. Judges with numerous cases on the docket and attorneys who participate in multiple malpractice cases can afford a certain detachment, but it contrasts sharply with how the physician is affected.

“If you are facing the litigation process, you can turn to the PHP for information and support,” says Dr. Shapiro. “PHP staff are available by telephone to discuss your feelings on the case, refer you to someone who can give you more information about the legal system, and help you gain a better perspective on the claim or suit.

“Adaptive strategies can keep the suit from becoming a catastrophe,” Dr. Shapiro adds. “It helps to be able to talk to someone who has endured a common experience to realize you are not alone. That’s the benefit of organized medicine.”

Dr. Lopatin, like most physicians, has faced malpractice litigation.

He said the legal battle was traumatic. “My career and my license were at stake,” he says. “Counseling was key to getting through the experience. I’ve learned that the sun will come up the next day, and it is up to me as to how I will receive it.”

Joining the PAMED and getting involved with advocacy efforts regarding malpractice reform helped Dr. Lopatin feel like he was taking back some control. His participation as chair of the Montgomery County Medical Legal Committee provided him with further understanding of how the legal system works.

As for Dr. Lopatin’s patient who called in the middle of the night?

He stayed warm in bed and felt better by morning—a testament to the physician’s initial instincts. “I like to use this example when discussing how defensive medicine impacts decision-making, because the patient is actually my father,” Dr. Lopatin says.

“Had he not been a close relative, I absolutely would have sent the patient to the emergency room.”

More work needs to be done to address the political intricacies of malpractice liability in Pennsylvania. “In the meantime, it’s important to remember that the PHP can help physicians learn to deal with the anxiety and ultimately survive the pressure by turning the negative stresses of a lawsuit in a positive direction,” Dr. Shapiro says. n The Foundation of the Pennsylvania Medical Society provides programs and services for individual physicians and others that improve the well-being of Pennsylvanians and sustain the future of medicine. Visit the Foundation at www.foundationpamedsoc.org.

Reprinted with permission from Pennsylvania Physician Magazine (c) 2015.

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BCMS President is Panelist for State of the Community Breakfast

O

n February 3 the Greater Reading Chamber of Commerce and Industry hosted its annual State of the Community event to assess factors that affect the Reading area’s economic competitiveness. Dr. Lucy J. Cairns was one of seven panel members who took part in a discussion moderated by David Patti, President and CEO of the Pennsylvania Business Council. Dr. Cairns was asked whether all residents in our community have access to high quality health care close to home, how access to and the quality of health care facilities in our area compare to those of similar communities, and whether we are facing a shortage of physicians in general or of specialists in particular fields.

In the 6 minutes allotted to her response, she presented some statistics showing Berks County lagging behind Lancaster and Lehigh Counties, as well as Pennsylvania as a whole, in the ratio of primary care physicians to population (available statistics were from 2011). Regarding availability of mental health care, when physician and all non-physician providers were included, Berks County’s ratio was similar to that of Lancaster County, but much worse than Lehigh County and the state as a whole. The mere presence of 14 | www.berkscms.org

providers alone does not guarantee access, and the fact that (as of 2012) 25% of the residents of the City of Reading had no insurance of any sort is an indication that a significant minority of county residents face barriers to obtaining health care. In addition, with the rise in high-deductible health insurance plans in the private market (many with high co-pays and significant co-insurance provisions), more and more county residents with insurance are facing cost barriers to obtaining care.

Dr. Cairns then pointed out a number of factors that make a worsening physician shortage likely. These include the increased demand for medical services as the population ages and chronic diseases become more prevalent, the increased number of people with insurance as a result of the ACA, and the fact that 48% of local physicians indicated in a recent survey that they intend to retire sometime in the next 11 years. In addition, the number of residency training slots in the U.S. is not increasing to keep pace with expected demand for physicians, and Pennsylvania retains a smaller percentage of physicians who train here than all but 16 other states. Finally, local physician recruiters have pointed to Reading’s reputation as a high-poverty, high-crime city as a significant hurdle to persuading doctors to consider a job in this area. Berks County is fortunate to be home to two outstanding health systems and many excellent physicians and other providers, but much work remains to be done to assure access to high-quality care for all in our community. n

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Protect Public Health vs. Patient Autonomy Product Safety and Effectiveness vs. Product Availability

Marijuana:

Safe? Effective? Medicine?

I

By: Lucy J. Cairns, MD

n any public debate, it is helpful to examine the language used in order to better understand differing perspectives and improve communication. Many of those in favor of legalizing marijuana products for the treatment of disease apply the term ‘medicine’ to these substances. Since cannabis is an herb that represents a complex stew of chemicals whose exact composition, concentration, and effects on the human body are affected by many factors, it is understandable that many physicians recoil from including it in the same category as, say, metformin or propranolol.

The statute currently under consideration in Pennsylvania to legalize medical marijuana uses the word “recommend” rather than “prescribe” to indicate the action to be taken by a health care practitioner in authorizing patient access to these products. The act of prescribing a medicine is generally understood, by both physicians and lay persons, to involve a degree of exact knowledge of the medicine’s composition, purity, strength, effectiveness, and safe dosing that simply does not apply to most currently available cannabis-based products.

16 | www.berkscms.org

That being said, in states with medical marijuana laws physicians are treating patients with available products, and in Pennsylvania many physicians acknowledge the potential benefits of cannabisbased treatment for certain patients. Referring to the products that would become legal in Pennsylvania under Senate Bill 3 as medication, however, risks creating unfounded expectations on the part of the public and may be making it more difficult for legalization advocates to find common ground with the physician community.

The dictionary definition of the noun ‘medicine’ as a compound or substance used for the treatment or prevention of disease is a broad one. The issues of safety and effectiveness are given no place in this definition, and indeed for centuries medical practitioners utilized ‘compounds and substances’ with an understanding of their actions that was often incomplete and inaccurate. In modern times, thanks to the advance of science and its application to the field of medicine, we have become entitled to expect that available medicines have been proven to be reasonably safe and effective. In the U.S., this

expectation rests in large part on the work of the Food and Drug Administration (FDA), whose mission is to “Promote and Protect the Public Health.”

Within the FDA, the Center for Drug Evaluation and Research (CDER) is responsible for regulating both prescription and overthe-counter drugs. It is the CDER that reviews and evaluates applications from pharmaceutical companies for approval of new drugs. The application and review process encompasses information on the proposed manufacturing process as well as the results of laboratory, animal, and human testing, and the exact proposed labeling for the intended use of the drug. The human testing process proceeds in three phases:

• Phase 1 Clinical Trials: Designed to determine the metabolic and pharmacologic actions of the drug in humans, the side effects of increasing doses, and if possible to gain early evidence of effectiveness. Usually conducted in healthy volunteers, generally 20-80 people.

• Phase 2 Clinical Trials: Controlled clinical trials designed to obtain evidence on the effectiveness of the drug for the proposed indication and information on short-term side effects and risks.

Generally involve several hundred patients.

• Phase 3 Clinical Trials: Controlled and uncontrolled trials performed if Phase 2 results show reasonable safety and effectiveness. Designed to provide additional information on safety and effectiveness needed to evaluate the overall benefitrisk relationship of the drug and to provide an adequate basis for extrapolating the results to the general population. Several hundred to several thousand patients are usually studied.

• Phase 4 studies are carried out in some cases, after a drug is on the market, to gather information about issues such as long-term side effects and benefits.

A ‘controlled’ clinical trial is one in which the participants are randomly assigned to receive either the proposed new drug or either 1) standard treatment for their condition (if available) or 2) placebo (if no standard treatment is available).

Randomization is the means to ensure that the control group and the group receiving the new drug do not differ in the characteristics, other than the study intervention, that are likely to affect the outcomes. Since both safety and effectiveness can be affected by factors such as age, gender, race, and co-morbidities such as kidney disease, FDA regulations include requirements for collection of data to allow analysis by sub-group.

personal autonomy and between higher standards for safety and effectiveness vs. less availability of new products. It is a balancing act, but by the time a final decision is made about approval, a large amount of information that has been collected in a systematic and standardized way has been reviewed.

In the early 1960s a spotlight was shone on the importance of the FDA’s role by the epidemic of deformed babies born to women around the world who had been treated with the sedative thalidomide. FDA medical officer Dr. Frances Kelsey discovered that this drug had not been tested on pregnant animals to assess its potential effects on fetuses, and made sure it was never approved in the U.S. Congress then passed the Kefauver-Harris amendments to the Food, Drugs, and Cosmetic Act to strengthen requirements for proving the safety of new drugs and adding the requirement that new drugs also show evidence of effectiveness.

Due to the classification of marijuana as a Schedule I controlled substance by the DEA, development of cannabisbased medications in this country has been extremely difficult, and very few are currently available or in testing.

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In evaluating all the information obtained in this process, the CDER recognizes that no drug is completely free of possible adverse effects. The safety of a drug, as referred to in the Food, Drug, and Cosmetic Act, has been interpreted to mean that the benefits of a drug outweigh its risks when used as labeled.

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Marijuana: Safe? Effective? Medicine?

continued from page 17

Marinol (dronabinol) is a synthetic delta-9-THC medicine FDA-approved for treatment of anorexia associated with weight loss in patients with AIDS and for treatment of chemotherapy-related nausea and vomiting when conventional treatments are ineffective. Cesamet (nabilone) is another synthetic cannabinoid, similar to delta-9THC, which is FDA-approved for chemotherapy-related nausea and vomiting in patients who do not respond to conventional treatments. Other cannabis-derived medications are available only if being tested in an FDAapproved clinical trial. Sativex, an oral spray containing a 1:1 ratio of CBD:THC purified from cannabis plants, is being investigated for use in a variety of conditions, including pain control in advanced cancer and ADHD. Epidiolex is a purified cannabinoid (CBD) in liquid form that contains none of the psychoactive THC. It is undergoing FDAapproved trials for treatment of intractable childhood seizures.

“The risks must also be weighed against those of currently available treatments for specific conditions.�

Of course, the FDA approval process is just one of many sources of information about a drug’s usefulness. Once a drug is approved, it may continue to be studied for the FDA-approved indications or for other uses. In the case of cannabis, some research is going forward in states with medical marijuana laws on their books. Drug studies utilizing cannabis products carried out in other countries appear in the medical literature.

When physicians base treatment decisions on solid evidence, in collaboration with a well-informed patient, the odds of achieving the desired outcome increase. Evaluating the strength of the evidence in the medical literature requires a sophisticated understanding of the implications of study design and of the statistical analysis of the data collected.

Hierarchical grading systems applied to study design rate the strength of evidence that can be obtained from different methods for evaluating the effectiveness of a drug or other intervention. The type of study generally considered to provide the highest level of evidence is a systematic review of multiple double-blind, randomized, controlled clinical trials (RCTs). A single RCT provides the next highest level of evidence, followed by controlled observational studies.

Uncontrolled observational studies (case reports), followed by expert opinion, are the lowest levels of evidence.

Testimonials by individual patients, which abound on the websites of some medical marijuana advocacy groups, suggest the possibility of benefit but nothing more.

When the available literature on medical marijuana is reviewed by experts, it is often found wanting. A systematic review of RCTs of cannabinoids for epilepsy published by the Cochrane Collaboration in 2012 found only four small 18 | www.berkscms.org

trials, none of which measured freedom from seizures at 12 months, or three times the greatest interseizure period, or even responder rate at six months. No randomized clinical trials using highly purified CBD for childhood seizures had been completed as of early 2015, although a trial of Epidiolex is underway now in the U.S. For certain other conditions, such as neuropathic pain and MS-related muscle spasticity, the evidence is better. As experts are careful to point out, however, lack of high-quality evidence does not mean a specific treatment does not work, just that we cannot conclude that it does at this time.

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Questions about the safety of medical marijuana pertain both to the risk of adverse effects on the person utilizing it and the potential risks to public health. Use of the cannabis plant can cause side effects that include increased heart rate, hypotension, dry mouth, nausea, confusion, anxiety, and acute toxic psychosis. Addiction occurs at a rate of approximately 9% in adult users and 17% in adolescents. Withdrawal symptoms such as irritability, insomnia, and drug craving may occur. Driving under the influence of cannabis raises the risk of motor vehicle accidents. The American Academy of Pediatrics issued an updated policy statement this year opposing even limited legalization, since this would both send a message to teens that marijuana is not dangerous and make it more available to them. These individual and societal risks must be weighed against the potential medical benefits of cannabis-based treatments, which are acknowledged by the American Medical Association and by the Pennsylvania Medical Society, along with other medical organizations.

The risks must also be weighed against those of currently available treatments for specific conditions. In the case of chronic pain, medical marijuana’s side effect profile and risk level are undeniably more favorable than those of the opioids. Medical marijuana advocates claim that no deaths have ever been reported as a result of its use by medical marijuana patients, and they can point to many FDA-approved drugs which carry higher risks. Low risk of harm, however, is only half of the equation. If a prescribed drug or ‘recommended’ substance is not effective, harm is done in the form of monetary cost and time lost that could have been spent searching for a treatment that does work.

With momentum building for legalization of medical marijuana in Pennsylvania, there is a need for both the public and the medical community to become better informed regarding the available evidence for both potential benefit and potential harm. “Evidence-based medicine” has become a rallying cry for the improvement of medical practice in general, and the use of marijuanabased products should be held to the same standard as any other medical treatment. n

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RESOURCES FOR RELIABLE INFORMATION AND CME ON MEDICAL MARIJUANA: A SAMPLING 1) The Answer Page (www.theanswerpage.com) Doctors and other health care professionals can earn AMA PRA Category 1 CME credits. All content planned and implemented with the joint providership of the Massachusetts Medical Society.

The following educational content on use of marijuana for medical purposes is available: • Medical Marijuana Primer Week • Medical Marijuana Basics Week 2 • The FDA Drug Approval Process • Federal Marijuana Laws • Medical Marijuana Laws and Agreements • The Development and Evolution of the Cannabis Dispensary • Medical Marijuana Potpourri – Section 1 • Medical Marijuana Potpourri – Section 2 • The Pharmacology of Cannabis and Cannabinergic Medicines • Medical Cannabis in the Treatment of Chronic Pain Syndromes • Cannabis as a Substitute for Alcohol and Other Drugs • Cannabinoid Hyperemesis Syndrome 2) The Medical Cannabis Institute (www.themedicalcannabisinstitute.org) “To meet growing demand for sound, fair, balanced, and relevant medical cannabis education, The Medical Cannabis Institute has created an eLearning website with courses to help educate a growing global community of healthcare professionals, caregivers, and patients who want to learn about the science and clinical data behind medical cannabis. Most of the courses are approved for CME credit.” The original content providers for this website were The Society of Cannabis Clinicians and Patients Out of Time (an advocacy group).

3) MedlinePlus – Health Information from the National Library of Medicine (www.nlm.nih.gov/medlineplus) Enter “cannabis” or “marijuana” in the Search box to access a wealth of information, including a fact sheet from the American Academy of Neurology titled Medical Marijuana in Certain Neurological Disorders.

4) National Cancer Institute’s PDQ (Physician Data Query) Cannabis and Cannabinoids Includes a brief review of clinical studies in the field of cancer treatment.

20 | www.berkscms.org

5) Center for Medicinal Cannabis Research (www.cmcr.ucsd.edu) Reports on research funded by the State of California to “enhance understanding of the efficacy and adverse effects of marijuana as a pharmacological agent.”

6) Americans for Safe Access (www.safeaccessnow.org) An advocacy group whose mission is to ensure safe and legal access to cannabis for therapeutic uses and research. The section of the website ‘Resources for Medical Professionals and Researchers’ is hosted by Sunil D. Aggarwal, MD, PhD. Dr. Aggarwal co-authored Resource #7:

7) Cannabis for Symptom Control: Fast Facts and Concepts #279 By Sunil K. Aggarwall, MD, PhD, and Craig D. Blinderman, MD, MA Available at Center to Advance Palliative Care. (www.capc.org)

8) Information for Health Care Professionals: Cannabis (marihuana, marijuana) and the cannabinoids A monograph reviewing the endocannabinoid system, the clinical pharmacology of cannabis, dosing options, and potential therapeutic uses. Date of latest version: February 2013.

Prepared by the Controlled Substances and Tobacco Directorate at Health Canada and available in PDF form at www.hc-sc.gc.ca.

9) American Academy of Cannabinoid Medicine (www.aacmsite.org) A physician organization with the mission “to foster high standards in the practice of cannabinoid medicine.” Includes a library of articles, links to online CME, and links to information on medical marijuana programs in the states.

10) ProCon.org The mission of this organization is “to promote critical thinking, education, and informed citizenship by presenting controversial issues in a straightforward, non-partisan, and primarily pro-con format.” n

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Legislative Update By: Scot Chadwick, Legislative Counsel, State Legislative Affairs, Pennsylvania Medical Society

T

Controlled Substances Database Won’t Meet June 30 Effective Date

his was a week of disappointing news for those of us who are looking forward to the implementation of Pennsylvania’s new controlled substances database law.

You’ll recall that last October former Gov. Tom Corbett signed legislation authorizing the Department of Health to build and operate a database where prescribers of opioid medications can look to identify patients who may have a substance abuse problem or are scammers seeking drugs for resale on the street. The law set a June 30, 2015, effective date, giving the department eight months to get the database up and running.

This week we got public confirmation of what I’ve been hearing unofficially for some time— the database will be late, maybe very late.

Apparently there are two separate problems. The first is simply the magnitude of the project. Amy Worden, a spokesperson for the Department of Health, was quoted by WITF this week as saying, “This is a massive undertaking.

The Department of Health is essentially building a program and a database from the ground up.”

She said they still need to hire someone to set up the database, convene its 22 | www.berkscms.org

governing and advisory boards, and train doctors and pharmacists to use the system.

It’s hard to argue the point. The database will be receiving data inputs from thousands of dispensers, and will be accessed regularly by thousands of prescribers who are looking for real time information on their patients. However, I’d like to think that state officials can take advantage of the experiences of other states, since 48 of them currently have similar databases up and running.

The second problem is money, or more accurately, a lack of money to fund the project. When lawmakers passed the legislation establishing the database, the state was already almost four months into the current fiscal year, which runs from July 1 to June 30. No money was appropriated for the Department of Health to build and run a database that, at the time, hadn’t yet been enacted and was just a bill sitting in the House Health Committee.

Of course, work is under way on a new state budget for the coming fiscal year, and Gov. Wolf has proposed $2.1 million to fund the database. Unfortunately, there are early indications that the new budget may not be in place by the June 30 deadline.

Gov. Wolf, a Democrat, has been at odds with the Republican-controlled House and Senate over taxes and spending, and this week Wolf told the Philadelphia Inquirer that he expects a long, protracted budget battle. His blunt assessment to the Inquirer was, “I’m planning on spending the summer here, and the fall, and the winter.”

Now, I don’t expect funding for the database to be a point of contention in the budget negotiations, as the legislation establishing it had broad, bipartisan support. Nevertheless, the funding will be contained in the budget, and it looks like the budget may be late, possibly very late.

The bottom line is that the database won’t be available for prescribers and dispensers on June 30, as envisioned by the legislation. At this point it’s impossible to say when it actually will be up and running, and based on what we’ve heard I wouldn’t hold my breath.

As we learn more we’ll pass the information along, so check back often.

As always, you can reach me with comments or questions at schadwick@ pamedsoc.org or (717) 558-7814. n

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Alliance Update

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This will be difficult to surpass…”

T

he reviews are in from the Berks County Medical Society Alliance’s (BCMSA’s) program: Eating for Well-Being. Held this year on April 9, 2015, the annual BCMSA Health Project—open to the community – and approved for continuing education credits for educators and nurses—was a resounding success!

Speaker, Aparna Mele, MD, with fellow My Gut Instinct Steering Committee Members, Emily Bundy and Kate Murray (author of A SIlent Cure in My Backyard)

The exceptional speaker panel included Aparna Mele, MD, Founder of My Gut Instinct, nationally renowned expert on nutrition and fitness, Dr. Stella Volpe from Drexel College of Nursing and Health Professions, and health coach, Suzie Carpenter. A nutritious lunch and cooking demo by Suzie Carpenter was part of the program.

In addition, local Berks County vendors were on hand to demonstrate some of the best nutritional and fitness resources located right here in the county: B& H Organics; Pam Charendoff’s Healthy Cooking Classes; Dundore & Heister; Girls on the Run; My Gut Instinct; and A Silent Cure in My Backyard.

The program was informative, practical and above all, motivational. As one participant reported: “Because of this [program] I can be a healthier school nurse to the students and staff I serve!”

For more information about BCMSA, including its annual Health Project, check out: http://berkscmsa.org/. n

Local health coach and frequent speaker, Suzie Carpenter, held a cooking demo to conclude the event.

Impromptu pilates with nationally renowned nutrition and fitness speaker, Dr. Stella Volpe, provided a great photo opp!

24 | www.berkscms.org

Health Project Chair, Amy Impellizzeri, Alliance members, and participants pose with “Gutsy Girl” - mascot for Dr. Mele’s non-profit, My Gut Instinct.

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Practice what you preach! A healthy lunch was provided to all participants, including 2 recipes by speaker and health coach, Suzie Carpenter.

Alliance Member and Healthy Cooking Instructor, Pam Charendoff, talks healthy cooking with participants.

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Members in the News Thanks to Dr. Ganas and Dr. Truex, we have

2 new members of the Berks County Medical Society’s Executive Council.

They are Michael Abboud, MD, and H. Christopher Lawson, MD. Dr. Abboud is a General Surgeon with St. Joseph Medical Group. He did his residency and served as chief resident at Lehigh Valley Hospital & Health Network, and practiced in New Jersey before coming to this area.

Dr. Lawson’s home is Harrisburg, and he joined Dr. Truex’s group last Fall after attending Johns Hopkins undergrad and medical school and Michael Abboud, MD

staying at Hopkins for his residency training, then practicing in Baltimore.

H. Christopher Lawson, MD

A warm welcome to Dr. Abboud and Dr. Lawson.

It is with great sadness we note the death of Dr. Pat Innis. In January she was honored by the Berks County Medical Society at our Installation Brunch, having celebrated 50 years in medicine. Even though it was not easy for her to move about, she traveled with her friend from Allentown in an ice storm to receive her award. We are all very glad we were able to share that time with her.

Patricia A. Lockner Innis, MD 6/18/29 - 2/14/15

26 | www.berkscms.org

DID YOU KNOW?

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Conducting an employee benefits survey can help you discover what your employees really value.

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Employee Handbook Spring Cleaning Now that benefits open enrollment is finished, you may want to consider dusting off your employee handbooks for an annual review. Regularly reviewing employment policies and procedures is becoming increasingly important as workplace legislation and regulations continue to change.

Here are some things to consider when reviewing your employee handbook: •

•

•

Make sure that internal company policies and procedures are in line with actual practice. A policy that is not consistently enforced as it is written can become problematic if your organization is ever faced with litigation.

Ensure that policies on harassment, discrimination, leave, drugs and alcohol, sexual harassment and background checks are updated to reflect the most current federal and state laws.

Review the language in the handbook to ensure that your organization maintains

•

• •

flexibility in interpreting and applying policies. Wherever possible, use general language (such as “may,” “typically,” etc.) in place of more limiting language.

Make sure that the handbook includes a clear statement that the employment relationship is not a contract but “at will” and may be terminated at any time with or without cause.

Determine if there are any local or statespecific policies that must be added or updated, such as paid sick leave.

Consider updating the format and tone of the handbook to be consistent with desired company culture.

The above are suggested starting points and not an all-inclusive list of things that you should consider. It is important for the handbook review to be a collaborative process that includes not only your human resources department, but also the managers and supervisors who are enforcing and interpreting the policies on a daily basis.

Lastly, it is highly recommended that you have legal counsel review your organization’s employee handbook. The National Labor Relations Board (NLRB) has recently claimed that many employer policies relating to employee conduct and social media are unlawful, which can result in terminated employees being reinstated and given back pay. Having an employment lawyer review the handbook can help your organization avoid costly litigation.

Final Rule—FMLA Protections for Same-sex Spouses

On Feb. 25, 2015, the Department of Labor (DOL) issued a final rule that expands protections under the federal Family and Medical Leave Act (FMLA) for same-sex spouses. This final rule, effective March 27, 2015, revises the definition of “spouse” under the FMLA to:

•

•

Adopt a “place of celebration” rule, which is based on where the marriage was entered into, in place of the “state of residence” rule that applied under prior DOL guidance; and Expressly include same-sex marriages in addition to common-law marriages and encompasses samesex marriages entered into abroad that could have been entered into in at least one U.S. state.

Under the final rule, eligible employees in legal same-sex marriages will be able to take FMLA leave to care for their spouses, regardless of where they live.

Employers should review and update their FMLA policies and procedures as necessary, and they should train employees who are involved in the leave management process on the expanded rules for same-sex spouses under the FMLA.

SPRING 2015

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Residents’ Day and Memorial Lecture April 10, 2015

Guest speaker Nathaniel DeNicola, MD

I

n 1990 Dr. Dan Kimball initiated and coordinated the first Residents’ Day Program as a means to recognize the outstanding work of the residents at Reading Hospital and St. Joseph Medical Center. Presently, participating residents submit an abstract in poster form to be judged by a panel of physicians.

From the submissions four winners were chosen to present their posters to the audience at Residents’ Day and receive a monetary prize. This year’s winners and participants are as follows:

PSIGNIFIES

WINNER

P Treat those ear infections: A Case of bell’s palsy

in a child Dr. Parin Naik, Dr. Lan Do, Dr. Trushna Patel Reading Hospital, Family Residency Program

A Systematic Review and Meta- analysis Paras Karmacharya, MD, Dilli Ram Poudel, MD, Ranjan Pathak, MD, Smith Giri, MD, Leena Jalota, MD, Sushel Ghimire, MD, Anene Ukaigwe, MD, Asad Jehangir, MD, Shiron Shah, MD, Madan Raj Aryal, MD Reading Hospital, Internal Medicine Residency Program

P Effects of Statins on the mortality of critically ill patients:

P Universal cervical length screening with a cervicometer and treatment with vaginal progesterone to prevent preterm birth <34 weeks: a decision and economic analysis Rebekah J McCurdy, MD, Jason K Baxter, MD Reading Hospital, Department of OB/GYN

P End Stage Acquired Immunodeficiency Syndrome:

Textbook Illness in Post-HAART America Zachary McLaughlin, DO St. Joseph Medical Center, Family Medicine

Cheerful group of Residents

Drs. George and Kimball reviewing the poster of Dr. Rebekah McCurdy 28 | www.berkscms.org

A Case of Herpetic Encephalitis Dr. Trushna Patel, Dr. Tarandeep Grewal, Dr. Brittany Pracock Reading Health System, Family Residency Program Watch those platelets: Infant born to mother with ITP Dr. Lan Do, Dr. Nadia Terzaghi Reading Health System, Family Residency Program The Disappearing Act: A Case of Pyogenic Granuloma Brittany Peacock, DO, Ashley Secunda, DO Reading Hospital, Family Residency Program Chika-whaattt??! A Case of Chikungunya Parin Naik, MD, Ashley Secunda, DO Reading Hospital, Family Residency Program

Heparin Induced Thrombocytopenia following Coronary Artery Bypass R Khanal, MD, P Kaemacharya, MD Reading Hospital, Internal Medicine Residency Program Anticoagulation Management for Pulmonary Embolism: A Quality Improvement Project O Shogbesan, MD Reading Hospital, Internal Medicine Residency Program Long-Acting Reversible Contraception in Adolescents in sub-Saharian Africa Rebekah J McCurdy, MD, Xuezhi Jiang, MD Reading Hospital, Department of OB/GYN

Posterior Uterine Wall Rupture of an Unscarred Uterus in a Woman with History of Congenital Diaphragmatic Hernia Repair Anna Grassi, DO Reading Hospital, Department of OB/GYN

Transvaginal Ultrasound Training for OB/GYN Residents: Multi-Site Randomized Controlled Trial of Educational DVD Rebekah J McCurdy, MD Reading Hospital, Department of OB/GYN CREOG In-Training Exam Results: A Contemporary Use to Predict ABOG Written Exam Outcomes Brandon M. Lingenfelter, DO, PhD Reading Hospital, Department of OB/GYN

every body

Poster winners.Dr. Parin Naik, Paras Karmacharya, MD, Rebekah McCurdy, MD, Dr. Trushna Patel, Zachary McLaughlin, DO Two Residents viewing a winning poster

A Rare Case of Primary Pulminary Leiomyosarcoma Kristen Hess, DO, St. Joseph Medical Center, Family Medicine

To complement Residents’ Day, Dr. Michael Baxter initiated the idea of a memorial lecture in an effort to recognize and honor physicians who have dedicated their professional lives servicing the health care needs of this community. The “First Annual Memorial Lecture” was held in 2010 for this purpose.

Following lunch the physicians who passed away over the last year were recognized by Dr. Baxter. They included: Patricia A. Lockner Innis, MD Marion L. Jones, MD Mauro J. Paolini, MD Frank J. Szarko, MD Prior to the introduction of our speaker, Dr. Baxter recognized and thanked the sponsors that help make this event possible.

They are Reading Health System Medical Staff and St. Joseph Medical Center Medical Staff.

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Our guest speaker of the day was Nathaniel DeNicola, MD, MSHP. Dr. DeNicola completed the Robert Wood Johnson Clinical Scholars Program (VA) at the University of Pennsylvania, and is now a Clinical Associate with Penn Obstetrics & Gynecology. At Penn he is a member of the Health Innovation Center’s Social Media and Health Innovation Lab, and with AGOG he has been a consultant for adopting social media and producing educational material. Dr. DeNicola presented the topic of “Digital and Social Media in Medical Professionalism and Practice.” n The area’s leading residential & commercial security services company.

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Calendar of Events

SPRING Department of Family 2015 Medicine Lecture Series April 17

April 24

May 1

Population Health: Improving Patient Care by Looking at the Big Picture* James Plumb, MD, MPH Professor, Family & Community Medicine; Vice Chair, Community Medicine; Director, Center for Urban Health Jefferson University and Hospital *Rooms 6 and 7 Cervical Disc Disease: Not Just a Pain in the Neck H. Christopher Lawson, MD RHPN Spine & Brain Neurosurgery

8th Annual Conference on Primary Care and Child/Adolescent Psychiatry:

Adolescent Sexuality Details TBA

May 8 No Lecture â&#x20AC;&#x201C; Legislative Breakfast May 15

Cardiac Disease in Women Agneiska E. Mochon, MD Cardiology Associates of West Reading

May 22 Smoking Cessation

Cheryl Yates

Center for Mental Health

Reading Health System

May 29 The Acute Sports Injury: Can We Fix It?

Yes We Can!

Jeffrey Wang, MD

Department of Orthopedics and

Sports Medicine

IU Health Arnett Hospital

All lectures will be held in the Reading Hospital Conference Center, Rooms 1 and 2 at 8:00 a.m. unless otherwise noted.

Berks County Medical Society

Mark Your Calendars!

Wednesday September 16, 2015 Fall Golf Outing

30 | www.berkscms.org

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• We’ll review your existing benefit programs and determine which will be affected by the health care reform provisions now and in the future.

”

There will be dramatic changes in the future of the employee benefits landscape. is your company prepared and complying with new regulations? What do you need to know? What plan do you have in place? Are you heading in the right direction? Contact us today. We’ve gained the confidence of

over 450 local employers.

• We’ll determine the financial impact of healthcare reform to your organization.

We’ll steer you in the right direction and help you implement your company’s health care reform strategy.

610-685-1790 | www.pkbenefits.com | 999 Berkshire Blvd., Wyomissing L e A d e R s H i p | s u p p o R t | s o L u t i o n s