SEPTEMBER / OCTOBER 2018
VOLUME 24 | NUMBER 5
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BULLETIN THE
Official magazine of the Santa Clara County Medical Association and the Monterey County Medical Society
700 Empey Way • San Jose, CA 95128 • 408/998-8850 • www.sccma-mcms.org
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Feature Articles
22 CURES Mandatory Consultation – FAQs 26 Monterey, Butte Counties Focus of Collaboration to Create Future Health Care Model 28 Is Silicon Valley Meeting the Needs of Our Cancer
Health Information Technology Resources
Survivors? 30 Medical Staff Prevails in Legal Battle Over Medical Staff
House of Delegates Representation Human Resources Services
8 Wireless Silent Spring
Self-Governance 34 Opioid Advocacy Update from CMA President 36 Speech Pathology and Ankyloglossia: Coordinated Team
Legal Services/On-Call Library
Approach
Legislative Advocacy/MICRA Membership Directory APP for the iPhone
Departments
5 TPO’s 2019 Employment Law & Leadership Conference
6 Message From the SCCMA President
Resources and Education
7 Message From the MCMS President
Professional Development
27 In Memoriam: Tribute to Robert S. Seipel, MD, FACS
Publications
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32 Medical Times From the Past
Physicians’ Confidential Line Practice Management
Membership Directory/Website Reimbursement Advocacy/ Coding Services Verizon Discount SEPTEMBER / OCTOBER 2018 | THE BULLETIN | 3
The Santa Clara County Medical Association OFFICERS
CHIEF EXECUTIVE OFFICER
COUNCILORS
President Kenneth Blumenfeld, MD President-Elect Seema Sidhu, MD Past President Seham El-Diwany, MD VP-Community Health Cindy Russell, MD VP-External Affairs Erica McEnery, MD VP-Member Services Open VP-Professional Conduct Faith Protsman, MD Secretary Martin Wong, MD Treasurer Anh Nguyen, MD
April Becerra, CAE
El Camino Hospital of Los Gatos: Lewis Osofsky, MD El Camino Hospital: Gloria Wu, MD Good Samaritan Hospital: Vinit Madhvani, MD Kaiser Foundation Hospital - San Jose: Hemali Sudhalkar, MD Kaiser Permanente Hospital: Open O’Connor Hospital: Cathy Angell, MD Regional Medical Center: Heather Taher, MD Saint Louise Regional Hospital: Scott Benninghoven, MD Stanford Health Care / Children's Health: John Brock-Utne, MD Santa Clara Valley Medical Center: Clifford Wang, MD
CMA TRUSTEES - SCCMA Thomas M. Dailey, MD (District VII) Kenneth Blumenfeld, MD (District VII)
BULLETIN THE
Official magazine of the Santa Clara County Medical Association and the Monterey County Medical Society
THE MONTEREY COUNTY MEDICAL SOCIETY
Printed in U.S.A.
OFFICERS
Managing Editor Pam Jensen
Opinions expressed by authors are their own, and not necessarily those of The Bulletin, SCCMA, or MCMS. The Bulletin reserves the right to edit all contributions for clarity and length, as well as to reject any material submitted in whole or in part. Acceptance of advertising in The Bulletin in no way constitutes approval or endorsement by SCCMA/MCMS of products or services advertised. The Bulletin and SCCMA/MCMS reserve the right to reject any advertising. Address all editorial communication, reprint requests, and advertising to: Pam Jensen, Managing Editor 700 Empey Way San Jose, CA 95128 408/998-8850, ext. 3012 Fax: 408/289-1064 pjensen@sccma.org © Copyright 2018 by the Santa Clara County Medical Association.
4 | THE BULLETIN | SEPTEMBER / OCTOBER 2018
President Maximiliano Cuevas, MD President-Elect Christopher Burke, MD Past-President Craig Walls, MD PhD Secretary Alfred Sadler, MD Treasurer Steven Harrison, MD
CHIEF EXECUTIVE OFFICER April Becerra, CAE
DIRECTORS E. Valerie Barnes, MD David Holley, MD Jeffrey Keating, MD William Khieu, MD
Phillip Miller, MD Walter Mills, MD James Ramseur, MD Stephen Saglio, MD
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Change
L
ife is everchanging. As creatures of habit and routine many of us resist change. But we avoid change about as well as we can avoid death and taxes. So, I like to think of change as exciting and healthy, more of an opportunity than a stressor. Here are some of my favorite quotes:
• “To improve is to change; to be perfect is to change often.” – Winston Churchill
President, Santa Clara County Medical Association
KENNETH S. BLUMENFELD, MD, FAANS
MESSAGE FROM THE
SCCMA PRESIDENT
• “Change is a law of life. And those who look only to past and present are certain to miss the future.” – John F. Kennedy
• “If you don’t like something, change it. If you can’t change it, change your attitude.” – Maya Angelou You might be wondering at this point why I would choose to wane philosophical in an article for The Bulletin. The answer is simple. Our SCCMA is in a period of transition. We have a new CEO and leadership. For some this may feel uncomfortable. However, I would argue that much as our greatest leaders have noted, change is healthy and much needed. Moreover, it is an exciting opportunity to make our
Kenneth S. Blumenfeld, MD, FAANS is the 20182019 president of the Santa Clara County Medical Association. He is a boardcertified Neurological Surgeon with Sutter Health/Palo Alto Medical Foundation and is currently practicing with South Bay Brain and Spine. He also is adjunct clinical professor in Neurological Surgery at UCSF.
organization more vital and relevant for our members and their patients. We are about to have our first Council Meeting. Through the summer months we have been brainstorming on new activities and directions for SCCMA to pursue. New relationships and restored collaboration with other county medical societies and associations are planned. Joint ventures and events with the community have been discussed. Value added programs for the membership are in the works. In the coming weeks we will be launching new activities and discussing others. There might also be changes in the frequency and way we meet. Lastly our advocacy efforts are due for restructuring. There is much work to be done. Get ready, be prepared, and be engaged. Come with a mindset of opportunity and growth. We will be looking for greater participation. Think about joining a committee or council. Better yet consider getting involved with leadership. SCCMA is changing.
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CEO of Paradise Medical Group and former CMA President This article was originally printed in The Californian – www.thecalifornian.com. California is a land of innovation, technology and discovery, and our state is home to cutting-edge ideas that improve our quality of life and transform how we do business. However, our health care delivery system is a dated model. Patients, particularly those living away from major cities, face issues getting access to physicians, language barriers and disconnected digital communications between their physicians. With limited resources and growing administrative responsibilities, physicians are asking: How do we continue to innovate and reinvent our business model to better serve patients? A new collaboration by Blue Shield of California and the California Medical Association (CMA) has been designed to help answer that question. Blue Shield has committed $30 million to work with CMA to invest in pilot projects in Monterey and Butte counties to help bring health care into the digital age. The goal is to create a patient-centered experience through home- and community-based services to meet people where they are and address all their health needs. It will utilize new technology to help physicians reduce their administrative burden (time and costs). Blue Shield serves all 58 California counties with its benefit plans. The CMA represents 43,000
President, Monterey County Medical Society
and Dr. Richard Thorp,
MAXIMILIANO CUEVAS, MD, FACOG
Monterey County Medical Society President
physicians statewide. Both see the need to help physicians help patients and deliver enhanced quality care that’s sustainably affordable. A 2016 study by the Annals of Internal Medicine found for every hour physicians provide care to patients, nearly two additional hours are spent on electronic health records and desk work. This is just as frustrating for doctors as it is for patients who deserve to be given quality face time during their office visits. In addition, rural communities like ours have less health care providers to meet patient demand and significant challenges in attracting physicians to practice. California Health Care Foundation estimates there is an average of about 43 primary care physicians per 100,000 people in Butte and Monterey Counties, significantly less than urban and metropolitan areas where the ratio reaches as many as 60 physicians per 100,000 people. Blue Shield and CMA are supporting this innovative collaboration, which is the latest in a series of investments made by Blue Shield to transform our current system into the health care system of the future – one that delivers quality and affordable care to all Californians. Having health plan assistance with infrastructure can help attract talent to these rural communities as well as enhance the practice of existing physician practices, which will greatly expand patient access to quality health care. We need more creative thinking and innovative ideas to change how we provide health care to all Californians. Blue Shield and CMA have stepped up to the challenge, and we are thrilled to be a part of their innovative pilot program because it will not only benefit all Californians, but also bring to rural communities a health care model of the future.
MESSAGE FROM THE
By Dr. Maximiliano Cuevas,
MCMS PRESIDENT
Monterey and Butte Counties to Pilot Health Innovation
Maximiliano Cuevas, MD, FACOG is the 2018-2019 president of the Monterey County Medical Society. He is currently the Chief Executive Officer at Clinica de Salud del Valle de Salinas.
SEPTEMBER / OCTOBER 2018 | THE BULLETIN | 7
By Cindy Russell, MD VP Community Health, SCCMA
8 | THE BULLETIN | SEPTEMBER / OCTOBER 2018
“Those who dwell among the beauties and mysteries of the earth are never alone or weary of life.” Rachel Carson, Author Silent Spring
IN THE WAR ON INSECTS: NATURE BECOMES SILENT Our ill-fated desire to control nature as well as our tendency to ignore our own complicity in its destruction for profit was the focus of a seminal 1962 book, “Silent Spring.” This publication is widely credited with ushering in the modern environmental movement. (1) Rachel Carson, a marine biologist, and author of “Silent Spring,” was first a lover of nature and a poet. Through her astute observations of nature, careful documentation and gifted writing, she was able to bring attention to the devastating and long lasting effects of pesticides which continue to impact all wildlife and species, including humans. Her book contains story after story showing the annihilation of birds, squirrels, fish, earthworms, and beneficial insects after the introduction of ever more toxic pesticides to fight invasive insects such as the Japanese beetle. Funds were endless from the Department of Agriculture who declared that these pesticides were perfectly safe as planes deposited hundreds of pounds of pellets into yards, schools and farms. Water turned into poison and rivers of death for salmon and other species. Bird populations of robins, pheasants, and meadowlarks plummeted along with rabbits, muskrats and cats. Farm animals who were exposed withered and many died. Dogs even fell ill. The Japanese beetle survived, however, as most insects cleverly and rapidly become resistant to these chemicals, which can persist in the soil and waterways for years. While species targeted biologic methods of control and integrated pest management tools have been developed, more and more pesticides have been created leaving us an economically profitable but toxic legacy – DDT, Chlordane, Dieldrin, 2-4 D- Malathion, Glyphosate. There are many similarities between the silent spring created in cities and farms from pesticides and that of wireless technology with the rapid and widespread adoption of cell towers. Let’s examine the effects of this technology that biologists have found on wildlife and then compare the histories, mechanisms and impacts between pesticides and wireless radiation.
SEPTEMBER / OCTOBER 2018 | THE BULLETIN | 9
“And it’s not just pigeons — have you seen any sparrows or parrots around, since these towers started springing up?” K. Pazhaniappan, Secretary, New Madras Racing Pigeon Association (43) WIRELESS RADIOFREQUENCY AFFECTS NAVIGATION OF BIRDS AND BEES It is well known that magnetite, a form of iron ore, is found in a wide variety of organisms. It has been shown that this substance is used to sense the earth’s low energy magnetic field as a directional reference. (Cadiou and McNaughton 2010). Magnetite acts as an internal compass. For over 50 years, scientists have known that migratory birds use the earth’s magnetic field to navigate. As it turns out, a diverse array of animal life also relies upon this geomagnetic field as their GPS for breeding, feeding, migration and survival. Biologists have unexpectedly discovered that wireless radiofrequency radiation (RFR) disturbs internal magneto-receptors used for orientation. In addition, this non ionizing radiation can have profound impacts on the natural environment by disruption of other complex cellular and biologic processes in mammals, birds, fish, amphibians, insects, trees, plants, seeds and bacteria. Reported adverse effects from radiofrequency radiation that have been identified include abnormal behavior, developmental abnormalities, diminished reproduction and increased mortality. The effects of this radiation may not be immediately apparent with a slow decline in the health of wildlife seen over time with cumulative exposure, adding a new environmental toxin contributing to silent springs in cities, orchards and farms. The more towers, the more additive mix of radiation frequencies saturating the environment, creating an increasingly toxic air space. Non thermal biological effects are not considered in current guidelines. Appropriate safety testing and regulation of this technology is lacking, however, invention, commercialization and deployment of cell towers marches on – 1G, 2G, 3G, 4G, 5G.
THE SKRUNDA RADIO LOCATION CASE Firstenberg (2017) in his fascinating and well-referenced book, The Invisible Rainbow: A History of Electricity and Life, describes both observations and biological controlled experiments performed, mostly in Europe, where a high power early warning Radio Location Station tower was in place for over 25 years. (12) Studies performed during and after the tower was removed demonstrated that it caused not only human symptoms including documented memory, attention and motor deficits in children, but also affected widespread forest health with loss of birds, thinner growth rings on trees, poor seed germination, and loss of duckweed, among other effects. (3) When these towers were removed, not only did the health of the local residents improve, the forest recovered.
BIRD MIGRATION DISRUPTED MORE BY WEAK MAGNETIC FIELDS Biologists have discovered that birds’ magnetic compass orientation
10 | THE BULLETIN | SEPTEMBER / OCTOBER 2018
appears more vulnerable to weak broadband electromagnetic fields. Pakhomov (2017), Schwarze (2016), Wiltschko (2015). A German scientist, Svenja Engles (2014) lead the research project to confirm this effect. He and his German graduate students exposed migratory European robins to the background electromagnetic noise present in unscreened wooden huts at the University of Oldenburg city campus and found the birds were confused and could not orient using their magnetic compass. If grounded or screened with aluminum their orientation reappeared, but disappeared again if broadband radiofrequencies were generated inside the huts. He did not believe the effects at first and repeated the same double-blinded experiment many times in seven years and with different graduate students to confirm the effect before publishing his results.
WHEN HOMING PIGEONS CAN’T FIND HOME Modern communications systems with a proliferation of cell towers in cities and now in rural areas, create continuous pulsating artificial radiofrequency wave mixtures that can alter local magnetic fields and thus impair bird migration and orientation of pollinators. In a straight line, sight cell towers can transmit 20 miles or more. In 1998, soon after cell towers were installed in Pennsylvania, pigeon races ended in disaster as up to 90% of birds were disoriented and lost their navigational skills. This was reported in a New York Times article December 6, 1998, “When Homing Pigeons Don’t Go Home Again.” (2) The problem of lost homing pigeons is becoming commonplace, leaving pigeon racing aficionados very concerned. (6)(13) A 2013 British Pigeon Insider article notes that pigeon keepers in England reported the loss of dozens of pigeons during races, as well as abnormal frantic behavior near cell towers and declining pigeon reproduction as cell towers have been reproducing in cities and farms. Another article in Wired magazine cites one pigeon fancier who lost two-thirds of his pigeons after a tower was installed next to his farm.
FATAL ATTRACTION: COLLISIONS WITH CELL TOWERS The Audubon Society reports that each year up to 50 million birds, representing 230 different species, die in collisions with communication towers at night. (8) This occurs when they hit the tall, antenna-sporting structures or associated guy-wires that support the cables. It has been found that at night birds are lured into the deadly metal structures by the steady beam of red lights on the tops of the towers. The lights are required by law for airline safety but the birds see this as a guiding light and shift from using geomagnetic signals and instead head straight for the beam. An FAA study showed that small migratory birds become confused when they reach the light and either hit the tower or they continue to fly
cell towers were placed on their fire stations. A pilot study of firemen was completed in 2004 and brain scans confirmed those with symptoms had evidence of adverse brain alterations. Because of this, the International Association of Firefighters has developed a policy to ask for exemptions from cell tower placement on or adjacent to fire stations with new cell tower legislation. (19) It is codified in California’s AB57 (2015). (18)
THE DECLINE OF BIRDS, BEES AND WILDLIFE WITH INCREASING RADIOFREQUENCY RADIATION
around the tower until exhausted and they fall to the ground. Flashing red lights seem to reduce the number of fatal bird collisions. (11) Longcore (2013) studied the numbers and types of birds killed by cell towers in the U.S. and Canada and found “Neotropical migrants suffer the greatest mortality; 97.4% of birds killed are passerines, mostly warblers (Parulidae, 58.4%), vireos (Vireonidae, 13.4%), thrushes (Turdidae, 7.7%), and sparrows (Emberizidae, 5.8%). Thirteen birds of conservation concern in the United States or Canada suffer annual mortality of 1–9% of their estimated total population.” A 2015 FAA guideline strongly encouraged operators of all tall cell towers to switch to flashing red lights by 2016. In November of 2016 about 750 tall towers (above 350 feet) had been switched, leaving about 15,000 more to go, according to an American Bird Conservancy report. (24)
CELL TOWERS NOT HEALTHY FOR BIRDS OR FIREMEN Government agencies, however, are becoming more aware. The Department of Interior wrote a letter in 2014 to the National Telecommunications and Information Administration regarding the DOI concerns about the First Responder Network Authority (FirstNet) and their regulations regarding cell towers and the protection of wildlife, especially migratory birds.(15) FirstNet is a public-private partnership with AT&T and because of its stated duty to public safety it has significant preemptions. (17) The DOI stated, “the proposals lack provisions necessary to conserve migratory bird resources, including eagles. The proposals also do not reflect current information regarding the effects of communication towers to birds.” FirstNet noted that the DOI “requested that FirstNet’s procedures include a process for ensuring compliance with the Bald and Golden Eagle Protection Act (‘BGEPA’), Migratory Bird Treaty Act (‘MBTA’), and Executive Order (E.O.) 13186, Responsibilities of Federal Agencies to Protect Migratory Birds.” (16) The DOI is not the only one concerned about FirstNet towers. Although public safety is important, what happens when the device intended for safety causes an unintended threat to others? Some firemen have experienced a variety of neurologic symptoms consistent with electrosensitivity (headaches, dizziness, brain fog, sleep deprivation, irritability) when
Researchers are now attributing wireless radiation from cellular communications to be a significant contributing cause of bee “colony collapse disorder,” insect disappearance, the decline in house sparrows in London (Balmori 2007) (Everaert 2007), as well as the steady deterioration of the worlds bird population with now more than 40% of bird species under critical threat. Insects are not only important pollinators, they are the base of the food chain for birds, amphibians, reptiles and mammals. A Yale report highlights a 2014 study by Stanford professor Rudolfo Drizo, which revealed that 42% of the 3,623 terrestrial invertebrate species on the International Union for Conservation of Nature [IUCN] Red List, are classified as threatened with extinction. He notes, “human impacts on animal biodiversity are an under-recognized form of global environmental change.” (5)
WIRELESS RADIATION AND COLONY COLLAPSE DISORDER Bees are a critical pollinator species for agricultural productivity. (20) Of the 100 crops that provide 90% of the world’s food supply, 71 are pollinated by bees, according to the U.N. Environmental Program, #Friday Fact. (21) The report also notes that to produce 1 kilogram of honey, a bee must visit four million flowers and fly a distance equivalent to going around the Earth four times. Bee numbers have plummeted in Europe, the United States and around the world in the last two decades. Contributing factors affecting the health and reproduction of bees include pesticides, global climate change, loss of habitat and air pollution with new research pointing towards microwave radiation as an important and yet unrecognized cause for concern. Bees, as well as birds, contain magnetite magneto-receptors in their abdomen. Electromagnetic microwave radiation has been shown to disrupt bee behavior and may cause worker bees to emit a piping signal to swarm. The bees have also demonstrated aggression after 30 minutes of cell phone exposure. Favre (2017) A cell phone placed next to a bee hive appears to cause a slow destruction of the hive. (Dallo 2015) concludes in his research, “significant decrease in colony strength, honey stores, pollen reserves, number of foragers returning to their hives and egg laying capacity of queens in test colonies. Cell phone radiations disturbed navigational skills of foragers.” Lazaro (2016) looked at the effect of mobile communication antennas
SEPTEMBER / OCTOBER 2018 | THE BULLETIN | 11
on the abundance and composition of wild pollinators, including wild bees, hoverflies, bee flies, remaining flies, beetles, butterflies, and wasps on two Greek islands with variable distances from cell towers, carefully measuring the radiofrequency radiation. He found negative effects in all groups except butterflies. Belgian entomologist Marie-Claire Cammaerts (2017) has done a number of studies on RFR and found that insects are particularly sensitive. She writes, “Before the invention of the wireless technology, plenty of active insects fed on crops, flowers, fruits, where they ate, drank, collected nectar, and numerous dead insects were found crushed on cars. Nowadays, all this no longer occurs at such an extent [2]. Bees may be particularly affected by manmade electromagnetism [21,22,23] – When crossing such electromagnetic fields, bees may no longer remember their way, may no longer fly in the correct direction, and may become unable to go back to their hive.” These are truly alarming findings and serve as a dire warning on further wireless expansion, especially with regards to sensitive wildlife areas and agricultural rural zones that depend on pollination.
5G ESPECIALLY HARMFUL TO INSECTS: THE RESONANCE EFFECT AND PHASED ARRAYS Proposed 5G millimeter wavelengths are a similar size to insects and this creates a damaging vibrational effect known as resonance on the organism. Resonance is a well-known phenomenon in physics. A common example is that of a wine glass which shatters when an opera star reaches a high C note, vibrating air molecules matching the glasses natural oscillating frequency. In general, mechanical resonance occurs when the frequency of an oscillation matches the system’s or its subcomponent’s natural frequency and this results in increasingly intensified additive vibration with more energy being absorbed, causing more disturbance of the system. At low power an effect is greatly magnified. Thielens (2018) looked at this effect on four different insects exposed to electromagnetic fields from 2 to 120 GHz. He noted, “The insects show a maximum in absorbed radio frequency power at wavelengths that are comparable to their body size – This could lead to changes in insect behavior, physiology, and morphology over time due to an increase in body temperatures, from dielectric heating.” In addition, a newer technology previously used in the military for
early warning missile radar systems, PAVE PAWS, is incorporated into these 5G systems and called phased arrays. (29) These powerful “beam steering” arrays scan back and forth from tower to device for easier connection with an individual’s movement, to detect the device, similar to the surface-to-air missile systems. (30) They are also used in AM and FM Broadcast stations and planned for automotive sensors and satellites. What effect will this increase in power and density of environmental radiation have on our beneficial insects and pollinators?
REVIEW STUDIES POINT TO WILDLIFE HARM Balmori (2015) states in his latest review “Current evidence indicates that exposure at levels that are found in the environment (in urban areas and near base stations) may particularly alter the receptor organs to orient in the magnetic field of the earth. These results could have important implications for migratory birds and insects, especially in urban areas, but could also apply to birds and insects in natural and protected areas where there are powerful base station emitters of radiofrequencies. Cucurachi (2012) in reviewing 113 peer-reviewed publications revealed, “In about two thirds of the reviewed studies ecological effects of RF-EMF was reported at high as well as at low dosages. The very low dosages are compatible with real field situations, and could be found under environmental conditions.” The Ministry of Environment and Forest in India (MOE 2010) examined all available peer reviewed research on the impacts of wireless radiofrequency (RF) on living organisms at the time, including birds and bees. They found that 593 of the 919 articles showed adverse impacts. In each category of organism, over 60% of the research indicated harm to that biological species.
TREES DAMAGED BY CELL TOWERS Aspen trees reproduce primarily from sprouting from the roots. If a stem dies, another fresh shoot is sent up. “Clones” of tree stands are thus created that can live hundreds to thousands of years. The health of Aspen tree stands is determined by mature trees with shoots and saplings in between. In Colorado, Aspen trees have been on the decline for decades but rapid mortality has been observed in clones since 2004. (25) A preliminary experiment on trembling Aspen trees points to ambient elec-
“The exponential increase of mobile telephony has led to a pronounced increase in electromagnetic fields in the environment that may affect pollinator communities and threaten pollination as a key ecosystem service.” Lazaro 2016
12 | THE BULLETIN | SEPTEMBER / OCTOBER 2018
“When crossing such electromagnetic fields, bees may no longer remember their way, may no longer fly in the correct direction, and may become unable to go back to their hive.” Marie-Claire Cammaerts (2017) tromagnetic radiation from a variety of sources (cell towers, satellites, RF from electric power generation) causing poor growth and smaller leaves. Seedlings shielded from surrounding low level background RF radiation produced vigorous shoot growth, no necrotic lesions and rich pigmentation in the leaves due to anthocyanin production, versus unshielded seedlings which had a high percentage of leaf necrotic tissue and a reduction in shoot length. (Haggerty 2009) Waldmann-Selsam et al (2016) clearly demonstrated, in a robust four year study with accurate RF emission testing, cell tower radiation causing the death of nearby trees over time. He notes, “These results are consistent with the fact that damage afflicted on trees by mobile phone towers usually start on one side, extending to the whole tree over time.”
ARE BEE DRONES THE ANSWER? “SMART” OR DUMB POLLINATION? Wireless technology, however convenient, has consequences. High tech has invaded every corner of our lives and will soon be used in agriculture to pollinate crops as bee colony collapses disorder worsens. In a CNN article “This ‘bee’ drone is a robotic flower pollinator” the developer notes “It could conceivably be used in large-scale farming, even in hydroponic farming.” (22) As cell towers and wireless systems proliferate, will we continue to ignore their role in harming life sustaining ecosystems? Will we create dead zones in cities where urban or rural farmers will not be able to grow food or have a vegetable garden? Agriculture is already under siege from many other environmental threats. Without bees there will be no pollination or
honey. Without birds there will be no seed dispersal. The tech industry may advise us to use the very technology that is harming ecosystems by using bee drones to pollinate our crops. Walmart has already filed a patent for a robotic bee. (23) These high tech insects would be directed by 4G or 5G radiation to operate via the Internet of Things. Because the size of 5G frequencies matches that of insects, this radiation acts as an insecticide (Yadav 2014). What about ownership of drones, privacy, security and adverse effects on sensitive native bees and flowers, e-waste and energy consumption with the use of these drones? Many questions with no answers but predictable negative consequences. We have been there before with pesticides, asbestos, lead, mercury, with new emerging toxins being regularly introduced. The fallout on public and environmental health continues.
SCIENTISTS APPEAL TO THE UN FOR PROTECTIVE HEALTH AND ENVIRONMENTAL STANDARDS Scientists who study radiofrequency radiation note a serious lack of monitoring and protocols to study the impacts of wireless technology and biologists are calling for precaution in the placement of cell towers with further expansion of wireless broadband. As of August 30, 2018, 244 EMF scientists from 41 nations have signed an Appeal calling upon the United Nations, the WHO and the UNEP to address the public health and environmental concerns raised in an extensive and growing body of scientific evidence on the broad adverse impacts of wireless radiation. (33)
GETTING SMARTER: PREVENTION VERSUS TREATMENT Solving the real problems causing the decline in wildlife seems smarter than always trying to develop a new and potentially more toxic industry to fix it. Indeed, pesticides, habitat loss, over fishing, overhunting, overpopulation, global climate change, environmental toxins, plastics in the ocean have had a devastating impact on species. The World Wildlife Fund and the Zoological Society of London reports that over half of the earth’s wildlife has been lost in the last 40 years. (27) Prevention is far easier and more economical than treating a problem, especially if the problem becomes irreversible (global climate change). Physicians prescribe medications to treat chronic diseases of our modern cul-
SEPTEMBER / OCTOBER 2018 | THE BULLETIN | 13
“Everything is reversible because everything is unfortunately of humankind’s making.” Tris Allinson, Bird Life’s senior global scientist, on the decline of birds ture. They are now recognizing, however, that many of these synthetic medications, while useful, can cause side effects that may be worse than the disease being treated. Current medical care is focused more on cure or treatment than prevention or precaution, causing continuing escalation of health care costs. Would it be better, instead, to encourage lifestyle changes to promote health and wellness with a holistically healthy diet, exercise and policies to reduce environmental toxic exposures?
WHAT IS A SAFE LEVEL OF RADIOFREQUENCY? STANDARDS ONLY LOOK AT HEAT
tic biologically based radiofrequency exposure standard to replace the 20-year-old thermal (SAR) standard, which is far too permissive and not protective of human or environmental health.
WIRELESS SILENT SPRING: PARALLELS BETWEEN PESTICIDES AND WIRELESS RADIATION
In rereading Rachel Carson’s book, Silent Spring, I was struck by the many similarities between pesticides and wireless radiation.
BOTH ARE INVISIBLE
Current guidelines for radiofrequency exposure are set at levels that cause tissue heating, the assumed cause of harm from this radiation. The balance of scientific evidence now indicates that there are significant adverse effects of this wireless radiation at non-thermal levels. (Belpomme 2018) Environmental effects on wildlife and plants confirms this. The mechanism has been found to be related to calcium channel membrane effects and oxidation.
Pesticides act as an invisible poison that works on a cellular level and can abruptly or slowly cause disease. You cannot see or taste it on your food or smell it as it drifts through the neighborhoods and enters creeks. Wireless radiation is similarly silent to most. You typically cannot hear, feel or see radiofrequency radiation unless you are electrosensitive. Cellular and biologic damage however is occurring.
BIOINITIATIVE REPORT
BOTH ARE UNIVERSAL IN OUR ENVIRONMENT
Sage, Carpenter, Blank and other scientists note in the BioInitiative Report that non-thermal bio-effects are clearly established. The Bioinitiative Report reviewed studies looking at the lowest levels of non-thermal, non-ionizing radiofrequency that did not cause harmful biological effects. Their conclusions, based on peer reviewed research, indicated that there should be a “scientific benchmark of 0.003 uW/cm2 or three nanowatts per centimeter squared for ‘lowest observed effect level’ for RFR is based on mobile phone base station-level studies.” They also suggest “Applying a ten-fold reduction to compensate for the lack of long-term exposure – or for children as a sensitive subpopulation.” This would be a recommended precautionary action exposure level of 0.0003 uW/cm2. (Bioinitiative 2012) Our current U.S. guideline is 200 uW/cm2 to 1000 uW/cm2 for RF radiation depending on frequency. This is a substantial difference and indicates a need for re-evaluation of FCC safety standards and consideration of published scientific research indicating non-thermal effects. (NTP 2018)
INDEPENDENT SCIENCE IGNORED Professor Emeritus of Biochemistry at Washington State University, Dr. Martin Pall, has written extensively on this subject. In a recent paper “5G: Great Risk for EU, US and International Health,” he looked at eight distinct types of harm from electromagnetic field exposure. This included DNA damage, carcinogenicity, endocrine, nervous system and reproductive effects. Of 22 robust independent research review papers on non-thermal EMF effects published on or before 2013, 20 were ignored by the latest report of the European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR). There is an urgent need for government agencies to adopt a realis-
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Pesticides are routinely sprayed in homes, gardens, on trees, in forests to strike insects far and wide. Biomonitoring studies nationwide and in California show pesticides still present in blood, urine and breast milk. (California Biomonitoring) (CDC Biomonitoring NHANES) Wireless radiation is found almost ubiquitously in homes, businesses and schools to connect us to the world and with each other instantaneously. This is supported by well over 300,000 cell towers in the U.S. not counting private cell towers. The continuous pulsating waves of radiation stray into any nearby living organism, be it human, pet or wildlife.
LIFE LONG EXPOSURES: CRADLE TO GRAVE Pesticides and their sometimes more toxic residues are now found in all human cord blood, urine and breast milk, and in children who do not eat organic foods. (Bradman 2003) (Curl 2003) (Lu 2006) (Salama 2017) (CDC Biomonitoring) Exposure to wireless radiation now begins in the fetus with cell towers along with a host of wireless devices in the homes (i.e. cell phones, Tablets, Wi-Fi routers, smart meters, and now baby toys, smart cribs and wearable technology).
NON SELECTIVE TARGETS TO LIVING ORGANISMS WITH INDISCRIMINANT HARM Pesticides are sprayed in large areas to kill a few flying insects but end up harming all species and the balance of nature with ecosystem effects. (EPA Persistent Organic Pollutants) Wireless radiation is sprayed in all directions to find the intended device but also penetrates all living organisms causing cellular damage with ecosystem effects. (Balmori 2010), (Cucurachi 2012) (Sivani S and
Saravanamuttu 2013) (NTP 2018)
BOTH CAUSE A VARIETY OF ADVERSE BIOLOGICAL EFFECTS Pesticides can have many toxic biologic impacts and are associated with malignant, neurodegenerative, respiratory, reproductive, developmental, and metabolic diseases in humans. DDT and its metabolite DDE was found to cause blindness in fish and can act as an endocrine disruptor, mutagen and carcinogen. Women exposed to DDT before puberty are five times more likely to develop breast cancer. Glyphosate is linked to cancer. (Creesey 2015) (Soto 2015) (Mostafalou S and Abdollahi M 2013, 2017) Wireless 2G radiation was found to cause DNA damage and increase the risk of cancer of the heart and brain in a recent 10 year, $25 million dollar National Toxicology Program study (NTP 2018). Non-ionizing radiation from 3G and 4G cell towers have been found to cause nonspecific symptoms of electrosensitivity in some living within 300 meters of a cell tower including insomnia, dizziness, brain fog, fatigue, depression and heart palpitations. Cell phone radiation has been associated with harm to the reproductive system, neurologic system, immune system and hematologic system. (Bioinitiative Report 2014) (Oceana Report)
BOTH ARE CHILDREN OF WAR Pesticides were first developed as agents of chemical warfare. They happened to kill the research insects and thus became commercialized for that purpose after the war. We can now buy pesticides in the grocery store. Radiofrequency microwave technology was developed in World War II. Known as radar, it has many military uses including for surveillance, missile control, air traffic control, moving target indication, weapons location and vehicle search. (39) At the end of the war, microwave ovens were developed after an engineer discovered a candy bar in his pocket had melted when he was near the magnetron power source. (38) Millimeter technology (95GHz) has been developed for crowd control (Active Denial System). (40) The recent health problems of Cuban, Canadian and Chinese diplomats and their families has been attributed to microwave radiofrequency radiation effects from either RF surveillance or deliberate attacks. (36). Our homes typically have many wireless devices such as cell phones, cordless phones, Wi-Fi, smart meters as well as microwave ovens.
BOTH ARE BIOACTIVE: TOXICITY THROUGH OXIDATION Pesticide toxicity can take various forms with a direct neurotoxic effect, DNA damage, immune suppression and endocrine disruption through disturbance of many cellular processes. (Mostafalou S and Abdollahi M. 2013, 2017) Newer research on the mechanisms of toxicity of pesticides is focusing on oxidative damage (free radical formation) as the
result of a multistep process causing cellular disruption, tissue damage, chronic disease and cell death. (Agrawal 2010) Antioxidants have been shown to lessen the toxic effects of pesticides as well as chemicals. (Akefe 2017) Wireless radiofrequency radiation has also been shown to have a primary mechanism of harm from oxidation. Yamenko (2016) looked at 100 studies of RF radiation both in vivo and in vitro and found 93 showed oxidation as a mechanism of toxicity. Research on antioxidants including curcumin, vitamin C, vitamin E, melatonin show protection against the effects of non-ionizing radiation with a reduction in oxidative stress.
ADDITIVE TOXIC MIXTURES MORE HARMFUL Pesticide exposure does not happen in isolation. Typically, we are exposed to a mix of pesticides in the food we eat. These pesticides circulate in our system for a variable length of time from hours to years and can be stored in our fat or breast milk. The toxic interactions can be long term. A conventional potato has 41 pesticides, 14 of which are classified as carcinogens. (44) EWG tested strawberries and found about 22 pesticides in a conventionally grown berry. Research has shown that mixes of chemicals and pesticides have additive and synergistic toxic effects. For approval, however, these pesticides are studied only one at a time and without their “inactive” ingredients. The more pesticides we are exposed to the greater the mix of adverse effects on the immune system, reproduction, carcinogenicity, as our protective enzyme and antioxidant mechanisms are overwhelmed. One pesticide can act as a mutagen, the next an endocrine disruptor and the next suppress your immune system to promote cancer. A true toxic triad of effects. Wireless technology has continued to evolve and expand. The 1G analogue system worked well but did not carry much data. While new generations have been introduced to the marketplace to serve our unquenchable appetite for instant wireless information and communication, the old will still be in place – 2G, 3G, 4G. With the latest proposed 5G technology and the Internet of Things, industry aims to integrate this with other wireless generations, and even open up any remaining radiofrequency spectrum, creating a blanket of mixed frequency wireless radiation wildlife and humans will be exposed. Radiation emissions are not only from cell towers, but also in remotely-controlled stratospheric balloons (Loon Project) and proposed low orbiting satellites, greatly increasing ambient levels of electromagnetic radiation (EMR). Like pesticides there has been inadequate research into the mix of frequencies we are exposed to. The 2018 NTP study, which found clear evidence of carcinogenicity, looked only at 2G technology. There are no government plans for testing of 3G, 4G or 5G individually or in combination. Synergistic effects of wireless radiation and toxic chemicals has
SEPTEMBER / OCTOBER 2018 | THE BULLETIN | 15
“Doubt is our product since it is the best means of competing with the “body of fact” that exists in the minds of the general public. It is also the means of establishing a controversy.” (22) Tobacco executive, from Doubt is Their Product, David Michaels also not been attempted. Despite a virtual research vacuum on 5G high frequency radiation, federal and state legislation is being introduced and quickly approved to ensure the rapid deployment of this technology by removing local jurisdiction and limiting fees for cities and counties to use the public right of way. (32)
SENSITIVE HUMAN POPULATIONS IN BOTH Pesticides appear more toxic to some people who do not have the metabolic pathways to transform and excrete them. For organochlorine pesticides such as DDT and Lindane it has been shown that there are genetic variations in the cytochrome P450 system to break down these pesticides, causing increased risk of disease. (Docea 2017) Those pesticide workers with paranoxonase genetic polymorphism suffer chronic toxicity exhibited by nausea, dizziness, headaches, fatigue and gait disturbance. Symptoms in those individuals with multiple chemical sensitivity are similar. (Lee 2003) (Rossi 2018) Wireless radiofrequency radiation is observed to cause non-specific symptoms of headaches, dizziness, insomnia, nausea, irritability, depression and heart palpitations in those who are electrosensitive. This was first reported by NASA in military personnel working on radar and was called “microwave illness.” (NASA 1981) Although some claim this could be a psychologic condition, researchers have identified a high correlation of symptoms to inflammatory and other biomarkers which can aid the diagnosis. Belpomme (2015) conducted a large clinical study and found laboratory biomarkers that connect multiple chemical sensitivity to electrosensitivity. It also has been noted that having these conditions causes predictable isolation and fear which can lead to neuropsychiatric symptoms. (41)
INDUSTRY DECEPTION Pesticides have been well protected by the industry that created them. An investigation of over 20,000 documents including internal scientific studies, meeting minutes and memos from federal regulatory agencies and manufacturers was led by the Center for Media and Democracy and the Bioscience Research Project resulting in “The Poison Papers” of 2018. (46) Concealment, political manipulation, cover-up and collusion were found, along with suppression of fraudulent independent research and secrecy of the toxic effects of chemicals and pesticides. Wireless telecommunications have been regulated by the Federal Communications Commission (FCC) since the 1996 Telecommunica-
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tions Act was passed. The Environmental Protection Agency was relieved of their oversight duty of radiofrequency radiation prior to that. This 1996 Act assumed, even before testing, that there were no health or environmental effects of this radiation. It is specified in the law that health and environmental effects cannot be used as an argument to deny cell tower placement. This has hampered attempts to monitor or identify health effects in the United States. Harvard’s Center for Ethics investigation of the wireless industry, written by Norm Alster, resulted in a publication called “Captured Agency: How the Federal Communications Industry is Dominated by the Industries it Presumably Regulates.” (47) Highlighted is industries exorbitant lobbying influence to the tune of about $400 million a year according to the Center for Responsive Politics. A revolving door in Washington was also noted with telecom industry executives filling the critical “independent” government positions. In her book, “Disconnect,” Dr. Devra Davis documents industry manipulation along with discrediting of scientists who have identified and published literature on the adverse health effects of wireless radiation. (48)
OUR FATE IS THAT OF NATURE We are just beginning to understand the fragile biologic complexities of the earths living creatures as we simultaneously document natures decline under the dismissing hand of mankind. Many have warned that our fate will follow that of nature. The expansion of wireless technologies for human convenience will require more cell towers on every street corner. This will threaten natural ecosystems in favor of immersive and invasive technology which is contributing to both negative environmental, physical and mental health effects, especially on our youth.
SAFER SECURE ALTERNATIVES: FIBEROPTIC, CABLE AND LANDLINES
The internet has become a necessity to most people. It can be provided in a safer manner to reduce EMR exposure. Alternatives such as fiberoptic networks and cable exist that are faster, more fire resistant, use less energy and are cheaper in the long run. (49) Traditional copper landlines are reliable in emergencies, are cheap, already built, and connect everyone without risk. Why remove them? We can have the benefits of faster, dependable and more private communications without compromising public or environmental health.
Recommendations by Biologists and Scientists in a 2010 Report by the Ministry of Environment and Forests in India to Protect Wildlife from EMR (paraphrased) (MOE 2010)
1. Electromagnetic radiation (EMR) should be recognized as a pollutant. 2. Create laws to protect urban flora and fauna from EMR. 3. Create protected areas with no cell towers. 4. Require bold signs on the dangers of radiation to be displayed on all cell tower structures. 5. Perform regular independent auditing of EMR/RF in urban localities – schools, hospitals, residential, recreational and ecologically sensitive areas. 6. Require blinking red lights on cell towers to protect birds at night. 7. Create laws to enable removal of existing problematic mobile towers to protect human or environmental health. 8. Require ecological assessment and review of sites identified for installing towers before their installation in wildlife, ecologically sensitive or conservational important areas. 9. Strictly control installation of mobile towers near wildlife protected areas, breeding areas, bee colonies, zoos, and identify with scientific studies appropriate distances from tower structures as part of pre-installation review. 10. The locations of cell phone towers and other EMF radiating towers along with their frequencies should be made available on public domain. This information would help in monitoring the population of birds and bees in and around the mobile towers and also in and/or around wildlife protected areas. 11. Public consultation to be made mandatory before installation of cell phone towers in any area. The Forest Department should be consulted before installation of cell phone towers. The distance at which these towers should be installed should be studied on a case by case basis. 12. The government should educate the public about the dangers of EMR and need for precaution, placing signs in wildlife areas and zoos. 13. To prevent overlapping high radiation fields, new towers should not be permitted within a radius of one kilometer of existing towers. 14. If new towers must be built, construct them to be above 80 feet and below 199 feet tall to avoid the requirement for aviation safety lighting. Construct un-guyed towers with platforms that will accommodate possible future co-locations and build them at existing ‘antenna farms,’ away from areas of high migratory bird traffic, wetlands and other known bird areas.
ABUNDANCE OF LIFE AND DIVERSITY OR A WIRELESS SILENT SPRING? Natures communication systems evolved using minute electromagnetic signals in tune with the earth and each other. They are being overwhelmed now with manmade artificial electromagnetic radiation, that in combination with other well established environmental threats spells di-
saster. Rachel Carson called for humans to “act responsibly, carefully, and as stewards of the living earth.” Science and observation is warning us that a thoughtful approach to all of man-kinds activities is imperative, to favor the protection of biodiversity over profit, innovation or convenience. We need to take a lesson from nature that acts slowly and deliberately to create a healthy balance. Rapid shifts in technology are changing our social structure and separating us from reality, each other and the natural world. There are no limits to “disruptive” 21st century wireless technology nor any meaningful safeguards. If we don’t slow down and think about the risks as well as the benefits of high tech, will it quietly lead us to a wireless silent spring and then to a silent Earth?
REFERENCES SCIENTIFIC LITERATURE
• Agrawal A et al. Pesticides induced oxidative stress in mammalian systems: A review. International Journal of Biological and Medical Research. 2010. https://www. researchgate.net/publication/202037053_Pesticides_induced_ oxidative_stress_in_mammalian_systems_A_review • Akefe IO. Protective Effects of Antioxidants in Chlorpyrifos Toxicity. Research and Reports on Toxicology. Vol 1 1:4 2017. http://www.imedpub.com/articles/protective-effectsantioxidants-in-chlorpyrifos-toxicity.pdf • Balmori A. Anthropogenic radiofrequency electromagnetic fields as an emerging threat to wildlife orientation. (2015) Science of the Total Environment. Vol 518-519, 15 June, 2015. Pages 58-60. 68. https://www.sciencedirect.com/science/ article/pii/S0048969715002296 or https://www.researchgate. net/publication/273121908_Anthropogenic_Radiofrequency_ Electromagnetic_Fields_as_an_Emerging_Threat_to_Wildlife_ Orientation • Balmori A and Hallberg O. The Urban Decline of the House Sparrow(Passer domesticus): A Possible Link with Electromagnetic Radiation. (2007) Electromagnetic Biology and Medicine, 26: 141–151, 2007. https://www.ncbi.nlm.nih.gov/ pubmed/17613041
For a full report of all references, please visit www.sccma-mcms.org and click on the "Committees" tab.
SEPTEMBER / OCTOBER 2018 | THE BULLETIN | 17
18 | THE BULLETIN | SEPTEMBER / OCTOBER 2018
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REPRINTED WITH PERMISSION FROM THE MEDICAL BOARD OF CALIFORNIA What does ‘mandatory use of’ or ‘consultation of’ CURES mean? This requirement means that unless an exemption exists in law, a physician must query the CURES database and run a Patient Activity Report (PAR) on each patient the first time a patient is prescribed, ordered, or administered a Schedule II-IV controlled substance. The PAR must be run within twenty-four hours, or the previous business day, before prescribing, ordering, or administering the controlled substance. In addition, a physi22 | THE BULLETIN | SEPTEMBER / OCTOBER 2018
cian must also query the database at least once every four months if the controlled substance remains a part of the patient’s treatment plan. Please go to the Board’s website for more information.
What does ‘first time’ mean? ‘First time’ is defined as the initial occurrence in which a health care practitioner intends to prescribe, order, administer, or furnish a Schedule II-IV controlled substance to a patient and has not previously prescribed a controlled substance to the patient.
What actions constitute successfully meeting the requirement to “consult CURES?” For example, can a staff member or other proxy consult CURES on behalf of the physician? Consulting CURES means the physician prescribing, ordering, administering, or furnishing the Schedule II-IV controlled substance has received a Patient Activity Report (PAR) and has reviewed the information on the document. While a physician can have a registered delegate request the CURES report, the report will go into the physician’s dashboard on CURES so the physician can review the PAR prior to prescribing, ordering, administering, or furnishing.
How do I document that I checked CURES prior to prescribing, is a note in the chart sufficient or do I print the CURES report and put it in the patient’s file? If a physician consults CURES, it is not required to note it in the patient’s file; however, the Board recommends the physician do so. It is up to the physician to determine how to document that he or she consulted CURES, e.g., document it in the chart or print the report and place it in the patient’s file.
How do I document I had an exemption and did not need to check CURES? Most exemptions do not require a physician to document that he or she did not consult CURES because an exemption applied; however, the Board still recommends that a physician document the patient’s record with the reason for not consulting CURES. Documentation of an exemption is required if it is not reasonably possible for a physician to access the information in the CURES database in a timely manner, another physician, who can access the CURES database, is not reasonably available, and the quantity of the controlled substance does not exceed a non-refillable five-day supply of the controlled substance.
Can the Board audit CURES to determine physician compliance? Yes, the CURES Program has the ability to audit the activity of users within the system and the Board has access to this activity.
How will the Board know that I did not check CURES and what are the consequences or administrative sanctions of non-compliance with mandatory use? The Board can receive information about non-compliance through a number of ways. The Board may receive a complaint from a patient, another licensee, or any other source that the physician is not consulting CURES as required. In addition, during the review of any investigation into a physician’s care and treatment, the investigator, as part of the investigation process, will ensure CURES was consulted prior to prescribing, ordering, administering, or furnishing controlled substances as required by law. Failing to consult CURES is a violation of the law and it could result in the issuance of a citation and fine, or could be a cause of action in an accusation that leads to disciplinary action. Disciplinary action could be a public reprimand, suspension, probation, or revocation. Each violation of the law is reviewed on a case-by-case basis.
Can a medical assistant or nurse be a delegate as listed in the CURES Program? The law requires the prescribing physician consult the CURES database. Consistent with DOJ procedures pursuant to Business and Professions Code section 209, a physician may authorize a delegate to order reports from CURES. However, it is important to note that the delegate can only request the Patient Activity Report (PAR). The report will be sent to the physician’s dashboard and only the physician can go in and review the PAR. Please remember that a physician may not provide his/her CURES password to anyone.
We are “this type” of a facility. Do the physicians in our facility have to run a CURES report prior to prescribing? It is the Board’s recommendation that you review the specific sections of law for each of the facility types and determine if your facility is exempt while the patient is admitted to your facility or if the patient is seen at your facility for a surgical procedure. You may choose to seek legal counsel to assist in your review of the appropriate sections of law. To assist with your review, here are the specific links for each facility type where an exemption may apply: Licensed clinic: http://leginfo.legislature.ca.gov/faces/codes_displaySection.xhtml?lawCode=HSC&sectionNum=1200 Outpatient setting: http://leginfo.legislature.ca.gov/faces/codes_displayText.xhtml?lawCode=HSC&division=2.&title=&part=&chapter=1.3. &article Heath facility: https://leginfo.legislature.ca.gov/faces/codes_displaySection.xhtml?sectionNum=1250.&lawCode=HSC County medical facility: https://leginfo.legislature.ca.gov/faces/ codes_displayText.xhtml?lawCode=HSC&division=2.&title=&part=&ch apter=2.5.&article=1 Place of practice: https://leginfo.legislature.ca.gov/faces/codes_displayText.xhtml?lawCode=BPC&division=2.&title=&part=&chapter=4.& article=3.5.
In a teaching clinic, or similar setting, often providers have to write prescriptions for other providers who may be out. If I am writing a prescription for a Schedule II-IV controlled substance, which the record confirms the patient has previously received, will I have to check CURES? Yes, each physician is required to consult the CURES database prior to prescribing, ordering, or administering.
If I am covering for one of the other physician’s in my practice and a patient requests a refill, and I fill it, do I need to consult CURES? What if the other physician consulted CURES recently? Yes, you must consult CURES unless one of the exemptions apply. Even if the other physician recently consulted CURES, if this is t h e first time you prescribed to the patient or is over four months from the last time you consulted CURES for this patient for this controlled substance, you must consult CURES. SEPTEMBER / OCTOBER 2018 | THE BULLETIN | 23
CURES - Frequently Asked Questions - Continued from page 23 If a patient is given a non-refillable 5-day prescription for a Schedule II-IV controlled substance from the surgical unit as part of a surgical procedure, the physician does not have to consult CURES as this is an exception. However, if the patient is seen in followup one week later and needs an additional refill of medication for pain control, does the physician have to consult CURES? Yes, the physician must consult CURES. The law states that a physician, who previously had an exemption, must consult the CURES database prior to subsequently prescribing a Schedule II-IV controlled substance to the patient and at least once every four months thereafter if the substance remains part of the treatment of the patient.
If my patient was admitted to a hospital for nonsurgical treatment and was receiving a Schedule II-IV controlled substance in the hospital, do I have to consult CURES to prescribe a Schedule II-IV controlled substance at discharge from the hospital or am I exempt if I only prescribe a non-refillable seven-day supply? If you have not previously consulted CURES, you would be required to consult CURES at discharge no matter the number of days supplied. The exemption only pertains to controlled substances administered while the patient is admitted to or during emergency transfer between facilities specified in law.
I am a hospitalist at a facility specified in the law. Am I exempt from checking CURES if I am discharging a surgical patient and the prescription for the Schedule II-IV controlled substance is not more than a five-day supply? According to the law, if the prescription is part of the patient’s treatment for the surgical procedure, the physician does not need to consult CURES as long as the supply does not exceed a non-refillable five-day supply.
What actions should be taken if the physician recognizes excessive prescribing or that the patient may be abusing controlled substances? The physician needs to follow the standard of care when reviewing the patient’s controlled substance history. It is important that the patient receive appropriate care, which could include substance abuse treatment, discussion regarding pain management, titration of controlled substances, etc., depending upon the circumstances. In addition, if a physician believes another physician is excessively prescribing controlled substances to a patient, the Board recommends that you report that physician to the Board for appropriate action.
What is the threshold for determining compliance with this statute? (Given the logistics of a typical practice, it will be impractical that 100% compliance will be achievable.) The law requires complete compliance unless there is an exemption. The Board will review each violation on a case-by-case basis and take action as appropriate.
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If a physician is titrating up a medication, for example starts with Oxycontin 5mg and then titrates up to 10mg, is this considered a ‘new prescription’ and is CURES consultation required with each titration? No, this is not a new ‘controlled substance’ as it is still the same drug, just a different dosage and therefore another check is not required for four months if that controlled substance remains a part of the patient’s treatment.
Some of our clinics are using pharmacists to assist with medication reconciliation and other functions at the time of outpatient visits. As part of this process, the pharmacist will print out a Patient Activity Report (PAR) from CURES (using their own log-on) for any patients that have controlled substances on their active medication list. These printouts are given to the physician for review during the appointment, saving time for the physician. Will this satisfy the “mandatory consultation requirement” and would the physician need to file the CURES report in the chart in case of audit? The law says the physician must consult the CURES database, which means the physician must log into the database to view a PAR. This is true even if the physician authorizes a delegate to request a PAR.
I write less than ten Schedule II-IV controlled substances a year. Do I have to do anything with the CURES Program? While you may not prescribe that often, the law requires that if you have a DEA registration that authorizes you to prescribe Schedules II - IV controlled substances, you must be registered in CURES. Here is a link to a website regarding CURES registration https://cures.doj.ca.gov/registration/confirmEmailPnDRegistration.xhtml. In addition, as of October 2, 2018, the first time you prescribe a Schedule II - IV controlled substance to a patient, you must consult the CURES database prior to prescribing, with limited exemptions. You must also consult CURES every 4 months thereafter if that controlled substance remains a part of the patient’s treatment. Here is a link to the website with more information regarding that requirement http://www.mbc.ca.gov/Licensees/Prescribing/CURES/Mandatory_Use.aspx.
I am a physician who holds a license in California but I also hold a license in Montana and practice in Montana. Do I have to be registered in CURES and do I have to consult CURES? If a physician holds a renewed and current license in California and is authorized to prescribe Schedules II-IV controlled substances in California, they must be registered in the CURES Program. In addition, if the physician is prescribing to a California patient (potentially via telemedicine), the physician would have to consult CURES unless one of the specified exemptions applied.
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Monterey, Butte Counties Focus of Collaboration to Create Future Health Care Model Blue Shield of California, California Medical Association team up to create new health care model By James, Herrera Monterey Herald Searching for ways to update and improve an aging business model to better serve patients, Blue Shield of California and the California Medical Association are collaborating to build a health care model of the future in Monterey and Butte counties. They say their goal is to give Californians access to quality, comprehensive and sustainably affordable care that improves the health of individuals and their communities. Dr. Maximiliano Cuevas, president of the Monterey County Medical Society, and Dr. Richard Thorp, CEO of Chico’s Paradise Medical Group and a former California Medical Association president, recently wrote about the collaboration when it was launched in June. “The task for Clinica de Salud del Valle de Salinas and our partners is to increase access to quality health care at a price that is affordable for working families in Monterey County,” said Cuevas. “This is an opportunity to work with our partners to explore putting in place a health care delivery system that removes the fragmentation of care that currently exists, and replaces it with a system that easily coordinates care between physicians, hospitals, emergency departments and social service agencies.” Patients, particularly those living away from major cities, face issues getting access to physicians, dealing with language barriers and tackling disconnected digital communications between their physicians. Blue Shield will invest $30 million to support the initiative, beginning with two pilot projects in Monterey and Butte counties designed to bring health care into the digital age, tie pay to value and create a patientcentered experience through home- and community-based services, according to Cuevas and Thorp in speaking about the initiative. Rural communities have fewer health care providers to meet patient demand and significant challenges in attracting physicians to practice. California Health Care Foundation estimates there are an average of 43 primary care physicians per 100,000 people in Monterey and Butte counties, significantly less than urban and metropolitan areas where the ratio reaches as many as 60 physicians per 100,000 people. “(This) is part of Blue Shield’s ongoing effort to create a health care system worthy of our family and friends and sustainably affordable. We
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do this by collaborating with physicians, hospitals, clinicians and other health care leaders to put people at the center of the health care system,” said Paul Markovich, president and CEO of Blue Shield of California. “We are starting small but thinking big.” A new technology infrastructure will need to be built so physicians can concentrate on care delivery rather than administrative tasks. The collaboration will work to scale the projects statewide with a focus on supporting independent physicians. The nonprofit health plan will work closely with California Medical Association leadership and physicians in those local communities to build new models of care that will: • Bring health care into the digital age: Use the latest technology to create a real-time, automated environment, reducing physicians’ administrative burden and facilitating personalized health care for members, such as real-time transcription services that complete the electronic medical record on behalf of the physician without any additional data entry. • Tie pay to value: In collaboration with physicians and hospitals, identify clinical best practices and ensure health care providers are rewarded for using them, such as use of best available testing to ensure the optimal treatment options are considered for cancer patients. • Create a patient-centered experience: Focus on all the factors that influence an individual’s health status including their housing, food security, transportation, social, emotional and physical well-being. Mobilize, organize and deliver a personalized solution for each patient so they have their best chance to live the healthiest possible life, such as establishing a health care advocate who helps those in need receive the necessary support to optimize their health; home care for chronically and seriously ill patients; and shared decision making with providers to choose the right care. • Improve physicians’ ability to practice: Greatly reduce the capital requirements and financial burdens on physicians as they move into value-based care and alternative payment models. Reprinted with Permission from the Monterey County Herald (www. montereyherald.com)
Tribute to
Robert S. Seipel, MD, FACS By James G. Hinsdale, MD, FACS Past President, Santa Clara County Medical Association Past President, California Medical Association Recently, on July 29, one of the most respected members of our SCCMA, Robert S. (Bob) Seipel passed away. Bob had a highly-respected surgery practice in Santa Clara County through the 1960’s, 70’s and 80’s and touched many lives. He was revered by his patients, family, and friends. Most importantly, he touched many lives of fellow surgeons, serving as a clinical teaching surgeon for us Stanford residents at Valley Medical Center, and providing mentoring to many other surgeons, whether mature or learning, in his role on the staffs of major hospitals, including San Jose Hospital, Good Samaritan, and Santa Teresa. I was fortunate to have received valuable teaching from Bob as chief resident at Valley Medical Center when he volunteered his time for the Stanford Residents. He not only came in at night to help us with emergencies, he attended our teaching conferences on Tuesdays and gave invaluable and practical insight in the care of difficult patients. Bob, as a leader, did it the old-fashioned way: He led by example. When we did case review, he did not suffer double talk from fellow surgeons. Many don’t know that surgeons can be fairly blunt with one another in questioning the difficult decisions that we need to make. Bob could cut through the dissembling and sidestepping of surgeons who were in denial about blowing a decision – and gently guided his fellow surgeons to face the facts and vow to try to do things differently in the future. Not an easy task for the egos of surgeons. Bob was a product of our nearby rival (UCSF), but he never got into the non-productive rivalry between UCSF and Stanford, something I liked. He, along with his mentor, Alan Johnson, were UCSF champions, and we were glad to have them united with us here in the South Bay. It is worth recognizing the other community surgeons whose help for the Stanford residents at Valley Medical Center echoed Bob’s leadership. They include: Hugh Elliott, Rick Slavin, Steve Duwe, Jim Kornfield, and, of course, Bob’s own mentor, Alan Johnson. The dean and leader of all of our community surgeon teachers and mentors was the late George Armanini, who will remain legendary for Stanford Surgery trainees. There are numerous places and named lectureships remaining in Santa Clara County in Dr. Armanini’s honor. Bob and Alan’s partner, Harvey Knoernshield, provided another cog in the very respected group they established here in San Jose for decades. I would also mention Crane Charters, who led the residency at VMC for many years, and, with Dave Oakes, put together the great teaching cadre we had that diffused out fine surgical products into our county for decades. There is not enough space to describe Bob’s personal attributes, so I’ll attempt a few. For one, he was one of the finest technical surgeons around, and everybody knew it. He got good results, and that’s why he was
probably the busiest surgeon. He was honest to a fault, personable, and would get out of bed at night when many other surgeons talked themselves out of needing to come in. He took care of a lot of other doctors. That should say enough. In the early 1980’s when I was trying to recruit key specialists to our trauma center at San Jose Medical Center, Bob and his wife, Joan, graciously sponsored a dinner for our vascular recruit at their home in Saratoga. He didn’t need to do that, and such stuff one never forgets. I spent a lot of hours on various lounge couches in pre-op areas, waiting to start cases along with Bob. What I remember best: one of the most honest surgeons I have ever met. What’s more, he had one of the finest, most intelligent, sense of humor of any surgeon I had ever conversed with. And he could do it all with a twinkle in his eye. He could keep me in stitches (no pun, please). I missed Bob from the day he retired from practice back in 1992. We haven’t had anyone like him, who could guide us with intelligence and honesty, in a long time. He led an exemplary life with his wife, Joan and their family. Many may not know that his daughter, Tracy, is a nationally recognized writer in science/medicine for the San Jose Mercury. I always perk up to any column she writes. I have respected Bob greatly. His leadership as a surgeon and practicing doctor was something that will be hard to equal for a long time. My affection for him has always been undisguised, and I, and I’m sure all of us, will miss him very much.
SEPTEMBER / OCTOBER 2018 | THE BULLETIN | 27
Is Silicon Valley Meeting the Needs of Our Cancer Survivors?
I
By Rob Tufel, MSW, MPH
n 2006 The Institute of Medicine (IOM) published a groundbreaking report entitled “From Cancer Patient to Cancer Survivor: Lost in Transition.” This report outlined the lack of support adult cancer patients received once they finished active treatment and provided recommendations for improving care and quality of life. Since the report was published, the number of cancer survivors continues to increase. Nearly forty percent of American men and women will be given a cancer diagnosis at some point in their lives. In fact, 1.7 million newly diagnosed cases of cancer are projected to occur in the United States in 2018 and 178,130 new cases are projected to be diagnosed in California in 2018. In Silicon Valley (defined as Santa Clara and San Mateo Counties), just over 10,000 people are diagnosed with cancer each year. In the 1930s, the five-year survival rate was one in five; today that number is three in five. As of January 2016, there were an estimated 15.5 million cancer survivors in the United States and just under 1.5 million in California. As more and more individuals with a cancer diagnosis live longer lives, the impact of cancer on long-term health has come into greater focus. Since 2012, Cancer CAREpoint, a nonprofit community-based organization, has provided free non-medical support to over 5,000 cancer patients and their families in Silicon Valley throughout the course of their disease— from diagnosis, through treatment and post treatment. Support services include counseling, support groups, nutrition classes, exercise classes, meditation, guided imagery, therapeutic massage, healing touch, art therapy, a Wig Bank and educational workshops. In providing these support services, we have become acutely aware of the growing number and needs of cancer survivors. Among the clients we served, we observed and gained insight into the gaps in survivorship care, lack of psychosocial support,
trauma associated with the diagnosis and treatment, wide-ranging fears about recurrence and the challenges in transitioning to post-cancer life. In response, Cancer CAREpoint developed a curriculum-based program for patients who have completed active treatment and for patients who have metastatic or recurrent disease. This multi-week workshop addresses the psychosocial impact of a cancer diagnosis with the goal of helping cancer patients understand and transition to their lives post cancer diagnosis. Since starting the program in 2014, over 200 patients from across Silicon Valley have participated. Cancer CAREpoint has partnered with local medical centers to offer the program as well as developed nutrition classes for those who deal
following “I wish my medical team had discussed or informed me about the possibility of a cancer survivorship care plan. I think it would have helped, especially right after treatment.” In addition, during their first year after treatment, 41% of cancer patients reported receiving zero, or only one or two incidences of supportive follow-up care related to on-going survivorship issues. Nearly 76% of respondents indicated that their main form of support came from family members. One survey participant suggested that “some form of counseling should be included in the treatment program after active treatment is completed” because it is “a difficult transition from cancer patient to survivor.” Twelve years have passed since the publication of the Institute of Medicine’s report highlighting the lack of care for adult cancer survivors. Cancer CAREpoint’s survey demonstrates that cancer survivors in Silicon Valley are still experiencing a lack of adequate survivorship care to help them maintain and monitor their health. Many of our local cancer survivors are dealing with anxiety, depression and other psychosocial issues and side effects related to their diagnosis that are disrupting their quality of life. A growing aging population, high cost of living and a diverse population are issues that particularly impact the provision of supportive care for cancer survivors in Silicon Valley. Without adequate direction and care, cancer survivors’ needs will continue to increase. Under the status quo, Silicon Valley is not prepared or able to handle the influx of cancer survivors. Unless a coordinated effort is made among local medical institutions, the county health system and community-based organizations, we will find ourselves at a crisis point in meeting the needs of this growing population. To read the complete version of Cancer CAREpoint’s report “Cancer Survivors in Silicon Valley: Still Lost in Transition” visit www.cancercarepoint.org. For more information about upcoming survivorship programs for your patients, please contact Cancer CAREpoint at 408/402-6611 or info@cancercarepoint.org.
One of the scariest times for me was the time right after treatment. When I was in treatment, I felt good because I was actively doing something about my cancer. After treatment, I felt lost. Cancer survivor in Silicon Valley with cancer as a chronic issue and a “Eating for Health” nutrition series designed for survivors. Cancer CAREpoint was interested in learning how cancer survivors in Silicon Valley were being supported and whether there were gaps in care. Responses from a survey conducted by Cancer CAREpoint of more than 300 cancer patients in Silicon Valley demonstrated that once patients complete active treatment, they are not receiving adequate support for on-going issues including fear of recurrence, treatment of side effects and psychosocial issues. In our survey, 71% of cancer patients reported not receiving a Survivorship Care Plan outlining the guidelines for maintaining and monitoring their health which was one of the recommendations of the IOM. One participant in the survey noted the
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Job Title: Psychiatrist Job ID: 24727 Full/Part Time: Full-Time Regular/Temporary: Regular Job Code: 7750 Department: Student Health Center -----------About the Position *Qualified applicants may be offered a 10, 11, or 12-month position. Options for Full-Time or Part-Time status will also be discussed.* The Student Health Center (SHC) provides limited psychiatric services for students as an augmented service to regularly registered students. Psychiatric services may include diagnosis and treatment of acute and chronic psychiatric illness. A SHC Psychiatrist is expected to obtain a detailed intake assessment, as well as to order any appropriate laboratory tests to support diagnostic evaluations. A SHC psychiatrist may, when appropriate, refer students, to other practitioners with the SJSU Health / Wellness Center. Chronic psychiatric illness may require referral to community resources for more extensive follow-up and treatment. To apply, please visit: http://www.sjsu. edu/hr/careers/jobs and search for Job ID: 24727. Equal Employment Statement: SJSU is an Equal Opportunity Affirmative Action employer. We consider qualified applicants for employment without regard to race, color, religion, national origin, age, gender, gender identity/expression, sexual orientation, genetic information, medical condition, marital status, veteran status, or disability. It is the policy of SJSU to provide reasonable accommodations for applicants with disabilities who self disclose.
SEPTEMBER / OCTOBER 2018 | THE BULLETIN | 29
By Tina Tedesco
T
ulare, California is a small town in the Central Valley best known as the milk producing capital of America. More than half of its 60,000 residents are enrolled in Medi-Cal and served by a small, 108-bed health care district hospital – Tulare Regional Medical Center (TRMC) – with a separate medical staff of about 175 physicians. Two years ago, this small agricultural community became ground zero in a high-profile battle testing the legal scope of a hospital medical staff’s independence and right to be self-governing. Fundamentally, the question was raised who should be in charge of patient care and safety in a hospital – lay administrators or physician leaders? In 2016, hospital administrators at TRMC executed a coup to take unilateral control over patient care at the hospital by terminating the entire medical staff and its duly elected officers. The hospital then adopted new medical staff bylaws in secret and without input from physicians at the hospital. The hospital installed hand-selected individuals to serve as leaders of the new medical staff, dictated standards of medical care, seized control of the disciplinary process without legal or factual justifications, and prohibited members of the terminated medical staff from voting on medical staff matters or holding leadership positions in the replacement staff. The California Medical Association (CMA) supported the medical staff in its lawsuit against the hospital. CMA and the medical staff sought to enforce California law requiring all hospitals to recognize and honor the self-governance rights of their medical staffs. Had TRMC’s actions been left unchallenged, it would have created a dangerous precedent that could have had a negative effect on patient care across the country. This July, a favorable settlement of the lawsuit was reached that dissolved the replacement medical staff and fully reinstated the original medical staff, its officers and bylaws. The hospital also consented to a stipu-
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lated judgment agreed upon by the parties and issued by the Tulare superior court that, among other things, expressly recognizes that the 2016 actions of the hospital board violated the medical staff’s rights to self-governance under California law. “The Tulare case was not just about one hospital medical staff that was being wrongly treated by its governance structure,” said Theodore M. Mazer, MD, CMA president. “It’s about every medical staff. It’s about autonomy of physicians to make medical decisions and the clear division of power between a governing body, which is administrative, and the medical staff and making sure that that separation of powers and duties and responsibilities stayed in place was important for Tulare and every medical staff in California and frankly, in the nation.” “Medical staff is there to oversee the quality of care provided to patients in the hospital,” said Damodara Rajasekhar, MD, CMA Board Trustee, Organized Medical Staff Section. “That role is not designated to the CEO of the hospital or the board members.” “What the hospital was doing was a blatant violation of very clear law in California that requires hospitals to honor a medical staff’s independence and self-governance,” said Long Do, JD, CMA Director of Litigation. CMA worked with the medical staff’s attorneys and filed two amicus briefs to support the medical staff and take on the hospital, which had loaded up its defense from three different law firms. “This was a case involving 125 doctors. There’s no possible way they could have afforded to prosecute the case themselves,” said John Harwell, JD, the medical staff’s attorney. “It’s only by the collective action of organized medicine through the California Medical Association that this was possible.” “This case moved quickly in large part because we were there to help the medical staff and then to seek outside resources and help in getting this resolved,” said Dr. Mazer. In collaboration with CMA, the Litigation Center of the American Medical Association (AMA) and State Medical Societies provided significant legal and financial support in the California medical staff’s lawsuit. “The narrative, when the case started, was that this was a group of troublemaking doctors who were making it impossible for the hospital to run as an efficient hospital,” said Michael Amir, J.D., lead trial attorney. “We had to dispel that notion.” TRMC filed for bankruptcy before closing arguments in the medical staff’s trial could take place, closing its doors and significantly chal-
lenging the availability of care to the community. “It was very devastating for the community to have the hospital close,” said Anil Patel, MD, immediate past chief of staff of Tulare Regional Medical Center. “But they knew that they had to wipe out all the previous administration, the board.” Patients seeking care at other hospitals reportedly had to wait 10 to 15 hours for care. The lawsuit, however, enabled the medical staff to get its story out to the community. In turn, the community changed hospital leadership, which ultimately resulted in the favorable settlement. As part of the settlement, TRMC has also agreed to: • Not recognize the replacement staff, its leaders or bylaws. • Reinstate the original medical staff, its duly-elected officers, with all the privileges, rights and status that existed before the January 26, 2016 termination. • Reinstate the pre-existing medical staff bylaws, rules and policies. • Pay $300,000 for the TRMC medical staff’s attorneys’ fees and costs. • Waive all rights to appeal or challenge the settlement’s validity. Perhaps most importantly, the settlement allows for the hospital to begin the process of reopening its doors and once again serving its community. “The importance of this case is it’s an example of what will happen to a hospital and the hospital’s leadership when it tries to trample the rights of the medical staff,” said Amir. “Doctors can take comfort that when their rights get trampled and their autonomy, self-governance is questioned, they have a remedy.” This case sends a message well beyond Tulare; it will likely have ramifications statewide, if not nationwide. The support of CMA and AMA enabled the medical staff to stand up to a large and well-funded hospital. In fact, AMA’s contributions to the litigation in this case represent the single largest legal contribution in the history of the AMA. “I learned a lot what CMA means. It’s not only an organization, it is a partner,” said Abraham Betre, DO, chief of staff of Tulare Regional Medical Center. “The litigation fund that is housed in the CMA Center for Legal Affairs is the bloodline of our work. Without the support from medical staffs and individual physicians, CMA would not be able to advocate for doctors,” said Do. It cannot be understated how grave the consequences could have been on patient care and safety if the hospital’s illegal actions were left to stand. Medical staff self-governance would become meaningless if a hospital can pick for itself a replacement medical staff and eschew the large
body of laws and regulations that require a truly independent medical staff that is self-governing and democratic. If your medical staff is interested in contributing to CMA’s Legal Defense Fund, which is used to litigate cases of critical importance to physicians, please email Nathan Skadsen at NSkadsen@cmadocs.org.
The Importance of Medical Staff SelfGovernance
Medical staff self-governance is a vital part of a carefully crafted system designed to ensure the delivery of quality patient care. This system recognizes that the hospital’s medical staff is the only body with the medical expertise to conduct quality assurance activities integral to the health and welfare of the public. Under state law and Medicare regulations, hospitals are required to have an independent, self-governing medical staff charged with the professional work of the hospital. The medical staff works with the hospitals to ensure quality of care and insulate medical decision makers from undue influences driven by profit motives or other reasons unrelated to patient care. To preserve this autonomy, medical staffs have a variety of rights provided for under California law, including the ability to retain legal counsel, elect leadership, conduct peer review and manage a separate bank account dedicated to medical staff funds. Medical staff associations also have the option to sue a hospital, should they feel their right to self-governance has been violated. “Many physician members of a hospital’s medical staff often are not fully aware of the California laws that establish medical staff self-governance,” said Long Do, JD, CMA Director of Litigation. “CMA offers informational materials and makes speakers available to educate medical staffs of the importance of self-governance.” CMA provides hospital physicians with a variety of resources to help medical staffs maintain and assert self-governance. If you are interested in consulting with representatives from CMA’s Center for Legal Affairs or would like to schedule a CMA speaker on this topic, contact the CMA Member Service Center, (800) 7864262 or medstaffhelp@cmadocs.org.
SEPTEMBER / OCTOBER 2018 | THE BULLETIN | 31
History of In Vitro Fertilization By Gerald E. Trobough, MD Leon P. Fox Medical History Committee The year 2018 marks the 40th Anniversary of the birth of the first IVF baby, Louise Brown. This remarkable achievement has resulted in many couples with hopeless infertility to have children. It also expanded the knowledge of the complex physiology of the ovary, ovulation, fertilization, and embryo development.
EARLY RESEARCH
The first attempts of In Vitro Fertilization (IVR) were conducted in the early 1930s. Dr. Gregory Pincus and M. C. Chang (developers of the first oral contraceptive pill) of the Worcester Foundation of Biological Research in Massachusetts, began trying to fertilize rabbit eggs without success. The first studies on human IVF began in the 1940s. Drs. John Rock and Miriam Menken conducted studies at Harvard University and they also had no success. In the late 1950s, the first IVF success occurred in rabbits. Almost simultaneously, three groups of researchers had successful pregnancies in rabbits. Robert Edwards of England, Charles Thibaud of France and M.C. Chang of the United States using IVF techniques achieved fertilization of
rabbit eggs. Robert Edwards was the only one of the three to pursue IVF in humans.
ROBERT GEOFFREY EDWARDS
Robert (Bob) Edwards was born in Yorkshire, England in 1925. He initially studied agriculture at the University but he quickly switched to Zoology. In 1955, he enrolled at the University of Edinburgh and obtained a PhD in genetics and embryology. He came to America and spent one year in a postdoctoral fellowship at the California Institute of Technology in Pasadena, California where he perfected his knowledge of Embryology. In 1960, Bob Edwards set out on a quest to study and understand human fertilization. For the next five years, Edwards traveled to various Medical Centers in the United Kingdom trying to persuade gynecologists to provide him with
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human ovarian tissue so he could harvest their eggs. During that time he was unable to achieve fertilization of an egg. In 1965, at the suggestion of his wife Ruth, Edwards made his way to Johns Hopkins Medical School. He worked with Drs. Howard and Georgeanna Seeger Jones, a husband and wife team, who were also studying human fertilization. He spent six weeks in Baltimore and he learned some new techniques but still had no eggs that fertilized. Two significant breakthroughs occurred in
the early 1968. One of Edwards PhD students Barry Bavistar, had successful fertilizations of hamster eggs using a new culture media he developed. In March 1968, Dr. Edwards was successful in fertilizing nine of twelve human eggs. The other major development was meeting Dr. Patrick Steptoe. Dr. Steptoe was a gynecologic surgeon who had been pioneering laparoscopic surgery in the United Kingdom. Edwards thought this technique would make it easier to get the tissue he needed to conduct his research. Some barriers stood in their way. Steptoe’s surgical practice was in Oldham and Edwards’ laboratory was in Cambridge. Edwards had to load up his car for each retrieval with equipment, including microscopes and culture media and drive to Oldham. After isolating the oocytes he stored the eggs in a container that was strapped to his body and drove back to his laboratory in Cambridge. Edwards had repeated successful fertilizations over the next year. The next important phase was to get cleavage and formation of a blastocyst. By the end of 1970, they had perfected the culturing techniques to get blastocysts. In 1971, despite their laboratory successes, the Medical Research Council of England refused to support Edwards’ and Steptoe’s work in human reproduction. The Council had doubts about ethical aspects in the proposed investigations in humans. The Council would give full support to their work if it were done in primates. This decision did not deter the two scientists and they pushed ahead. Between 1971 and 1975, Steptoe and Edwards began transferring embryos to the uterus. They tried medications to stimulate the ovary and uterus. After 150 laparoscopic egg retrievals, they had a pregnancy but it was a tubal pregnancy. In 1977, Edwards stopped using ovarian hyper-stimulation drugs and converted all cycles to natural cycles. Embryo transfer was based on LH surges tested in the urine. There had now been over 300 egg retrievals before they switched to natural cycles. On November 10, 1977, Lesley Brown had a laparoscopic egg retrieval. It was timed 26 hours after the LH surge was detected in the urine. There
was a single three cm. follicle in her left ovary that Dr. Steptoe aspirated, and retrieved an egg. Edwards wanted the embryo to reach the eight cell stage before transfer. The time of John and Lesley’s embryo transfer was midnight on November 12, 1977. The resulting pregnancy was uneventful. On July 25, 1978, Louise Brown was delivered by Dr. Steptoe at 23:47. This was the first IVF baby conceived and delivered in the world. The second pregnancy was delivered in Scotland when Allister MacDonell was born January 14, 1979. From January, 1969 to August, 1978, there were 250 patients with 457 cycles. There were 112 embryos resulting in 5 clinical pregnancies and 2 live births. I was in attendance at the American Fertility Society Annual Meeting in San Francisco in February 1979 when Professor Robert Edwards was introduced. The 4,000 attendees in the auditorium gave him a 20 minute standing ovation. In October 2017, I was fortunate to meet Louise Brown at the American Society of Reproductive Medicine Annual Meeting in San Antonio, Texas. What a thrill! Dr. Patrick Steptoe retired from medicine two months after Louise Brown was born in September 1978. After a decade of failure, success finally came. Some have speculated that after a few more months of failure, with Steptoe’s impending retirement, the IVF program may have stopped.
IVF IN THE UNITED STATES
Dr. Howard and Georeanna Jones left Johns Hopkins due to mandatory retirement in 1978. They settled in Norfolk, Virginia at the Eastern Virginia Medical School and formed The Jones Institute. The Jones’ had the first IVF pregnancy in America on December 28, 1981. Elizabeth Jordan Carr was the 15th IVF baby born in the world. During the past 40 years, more than eight million babies have been born with IVF, a truly tremendous medical accomplishment. Happy 40th Anniversary!
SEPTEMBER / OCTOBER 2018 | THE BULLETIN | 33
BY THEODORE M. MAZER, MD CMA PRESIDENT From the beginning of the opioid epidemic, the California Medical Association (CMA) has been one of the most engaged and determined stakeholders working to strike a balance between patient access to necessary medicine and preventing and addressing abuse. CMA has been a leader in advocating for increased funding, access and availability of preventive services, opioid-use disorder treatment programs and non-opioid therapies, including mental health services and medication-assisted treatment (MAT). We have successfully worked to stop legislation that interferes with the practice of medicine and creates barriers to care, such as government-mandated dosage and duration limits. Over the last few years, the changing landscape surrounding prescribing opioids has been dizzying as payors, legislators, pharmacies and medical boards seek ways to be proactive in addressing the opioid epidemic – sometimes ignoring the actual realities of medical practice and creating barriers to good care. And as you’re aware, California physicians have been engaged in the debate since the beginning, on behalf of our patients and profession. CMA released a white paper, “Opioid Analgesics in California: Re34 | THE BULLETIN | SEPTEMBER / OCTOBER 2018
lieving Pain, Preventing Misuse, Finding Balance” in 2013. Developed through CMA’s Council on Science and Public Health, it has been the cornerstone of our work to educate physician colleagues, guide the medical board and policymakers, and help health care stakeholders navigate the evolving science related to opioids. At its core is the premise that care must be evidence-based and reflect the individual needs of the patient – ultimately, allowing physicians to make proper care decisions. CMA’s emphasis on these principles has remained constant, including advocacy on opioid-related activities in 2018, which include: Controlled Substance Utilization Review and Evaluation System (CURES): CMA has been working with the state for years to ensure adequate educational and technical support for physicians who will have to check CURES as part of their prescribing workflow, starting on October 2, 2018. CMA has advocated for sustained user outreach and educational efforts by the state that provide clarity of this new law, as well as prioritize the clinician perspective on an ongoing basis following implementation. We will continue to engage as the new requirement to consult CURES is implemented and work with stakeholders to ensure CURES has adequate support.
Ensuring Fair Enforcement: The Medical Board of California is examining deaths associated with the use of prescription opioids and is reviewing whether the care and treatment provided by physicians to those individuals met the standard of care. As part of a “routine” review, the board sent letters to physicians who were identified as prescribing opioids in a manner that, after physician review, merited further investigation, and requested that those physicians submit additional information including a summary of the care provided, the patient’s medical records, and any additional materials that would be pertinent to the board’s investigation. CMA has raised concerns about the board’s process and will continue to work with the board to address physician concerns, monitor the board's process to determine whether disciplinary actions are based on the appropriate standard of care, and if the process used to identify physicians subject to these inquiries needs additional transparency or modification. Physicians who are under review may contact CMA (800-786-4262, CMAdocs.org) for information about the disciplinary process and their legal rights. Access to Medication-Assisted Treatment and Overdose Reversal Medications: To help reduce the rates of overdose and stigma associated with opioid-use disorder, CMA sponsored AB 2384 (Arambula), which would have removed barriers to coverage of MAT services and naloxone to ensure that people who face addiction have better access to treatment. Governor Jerry Brown vetoed AB 2384, claiming a need for utilization controls and barriers to patient access of life-saving treatments. In response, CMA issued a statement expressing disappointment and concern, while reiterating our intention to work with the next governor to make this issue a priority in 2019. The federal opioid bill continues to push treatment in the right direction by providing grants to improve access to MAT and codifying the ability for physicians to prescribe MAT for up to 275 patients, which is critical since the current caps are far too limiting and leave many patients on waiting lists for years. Individual Patient Care: At the federal level, CMA successfully fought back against legislation that would have required one-size-fits-all medicine by mandating prescription drug dosage and duration limits. California legislators also sought to statutorily limit dosages and durations of opioid pain relievers through AB 2741 (Burke) and AB 1998 (Rodriguez), using arbitrary and minimal amounts. Both bills were defeated earlier this year. Federal Funding and the Congressional Opioid Crisis Response: Earlier this year, Congress approved $10 billion in new funding for states to address opioid-related education, prevention, treatment and law enforcement issues. The House and Senate reached an agreement on the “Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act,” and they will send it to President Donald Trump soon. It is a comprehensive package of more than 300 bills that, among other things, provides grants to states to address prevention and treatment, as well as stop the flow of illicit drugs, such as fentanyl. It also expands the number of Institute for Mental Diseases inpatient Medi-Cal beds available for opioid substance abuse disorder treatment and enhances Medi-Cal patient access to non-opioid options. Medicare coverage for treatment has been expanded, with new Medicare payment and delivery demonstration projects approved for comprehensive management of opioid-use disorder. Unfortunately, the bill package also includes a mandate for physicians to e-prescribe controlled substances for Medicare patients after January 1, 2021. However, it includes many exceptions, and it directs the Centers for Medicare and Medicaid Services to implement additional exceptions. In a major win, the Drug Enforcement Administration (DEA) has been man-
dated to update its antiquated and burdensome process for e-prescribing. While more than 90 percent of physicians e-prescribe, only 21 percent e-prescribe controlled substances, largely due to the DEA’s burdensome requirements. The state mandate takes effect in 2022. Physician Education on Safe Prescribing and Treatment: Governor Brown recently signed AB 2487 (McCarty), which originally mandated all California physicians to take an eight-hour course required to qualify for a federal waiver to the Drug and Addiction Treatment Act of 2000 in order to allow physicians to prescribe MAT drugs, like buprenorphine, outside of an opioid treatment center. After CMA-led negotiations with the author, the bill was amended to allow physicians who seek to prescribe MAT to fulfill their annual continuing education requirement by completing the DATA-Waivered Physician course along with four additional credit hours on treating substance use disorders. Successful advocacy prevented additional and mandatory continuing education. The road has been long and hard-fought, and California’s comprehensive approach has focused on safe prescribing, naloxone distribution, public education campaigns, local opioid safety coalitions and increasing access to treatment, including MAT. This approach has produced promising results. From 2013-2017, California experienced over a 24 percent decrease in opioid prescriptions, and is only one of five states with a multi-year decrease in prescription opioid overdoses. California is now tied for the lowest per capita opioid prescription rate in the country, while opioid prescribing has decreased for the fifth year in a row. More work remains, as the drugs responsible for these overdose deaths are changing and have been spurred by illicit fentanyl. CMA will continue to work with policymakers, elected officials and health care stakeholders to ensure your voice – and your patients’ voices – are heard. I want to thank our physician members for their dedication to finding a balance between prescribing controlled substances safely and effectively to relieve pain, while simultaneously reducing the risk of prescription medication misuse, addiction and overdose. SEPTEMBER / OCTOBER 2018 | THE BULLETIN | 35
Medical
Dental
Speech
Randy Ligh, DDS, MA, FAAP, FACD, CLEC Christine Bacon, MA, CCC/SLP Margaret De Villiers, MD HISTORY- BACKGROUND INFORMATION
The patient presented to the dental office with a chief concern of “not being able to pronounce certain sounds” and “not being able to stick her tongue out.” Breastfeeding and latching were difficult historically and Mom resorted to bottle feeding and supplementation with formula. The appropriate consultations and discussions with medical and speech pathology were initiated.
MEDICAL
Syndromes such as Beckwith Wiedemann, Smith-Lemli- Opitz (x-
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linked), x-linked cleft palate (TBX gene mutation) and Van Der Woude Syndrome all have a higher incidence of ankyglossia but they were ruled out. There have been possible genetic links of tongue tie and other midline defect associated with the MTHFR gene but this was also ruled out.2 Syndrome identification is important for treatment planning so that there is an awareness of the progression of the disorder and even lifespan. Problems may develop later that are not related to management errors, but are intrinsic to the syndrome itself and its course.3 The “cascade effect” of interventions and history at birth were reviewed.4 There was no history of an unusually fast or slow delivery, forceps or vacuum extraction.
Delivery was by cesarean section. No mention was made of torticollis or “moulded baby syndrome.” 5
SPEECH
Central auditory processing issues were negative. Social/environmental influences were not a factor. Age appropriate articulation skills were determined. Evaluation of language development, language fundamentals, vocabulary, voice and fluency were determined. Resistance exercises were recommended 2-3x/day for 6 months with periodic office visits to monitor and support the progress.
elevation of tongue, extension of tongue, cupping of tongue, peristalsis (progressive contraction) and snapback of tongue. Appearance criteria include: appearance of tongue when lifted, length of lingual frenum when lifted, elasticity of lingual frenum and attachment of lingual frenum to tongue. Location of lingual frenum to the inferior alveolar ridge is the last assessment. Treatment recommendations are based on scoring. Scoring on this patient was in a non-polarized zone or non-indicative scoring. Measurements were taken using a grooved director and a Boley gauge and tabulated in millimeters (mm). These measurements were re-evaluated after a course of speech therapy to gauge quantitative progress.
Figure S1 Resistance exercises
Figure S2 Resistance exercises
Measurements of patient’s tongue: A) Maximum opening of mouth with tongue at rest -34 mm. B) Maximum opening of mouth with tongue touching incisive papillae – 19 mm. C) Maximum protrusion of tongue from lower incisors -15 m
Figure S3 Resistance exercises
A) Maximum opening of mouth with tongue at rest.
DENTAL
The oral cavity evaluation has its basis from Alison Hazelbakers protocol.1 It is a valid and reliable instrument. The determination of tongue tie has its basis first on function and second on appearance. A substantial body of research shows that functional criteria supersede appearance criteria.1 Palatal configuration of the mouth was assessed. Functional criteria include: lateralization,
B) Maximum opening of mouth with tongue touching incisive papillae (palate area).
C) Maximum protrusion of tongue from lower incisors.
RECOMMENDATIONS
Joint discussion between the disciplines decided upon a period of speech therapy and then a follow-up in five months to decide if a surgical frenectomy would still be necessary. It was felt that a quantitative as well as a qualitative end point would be appropriate. Measurements of the patient’s tongue were made. These same measurements would be made again longitudinally to determine the patient’s progress with speech therapy. If it was felt that the patient at that time had not achieved the desired quantitative as well as qualitative improvements surgery would then be recommended and again measurements be made. Several clinical measurements have been suggested in the literature to provide a more objective basis for making pre-op and post-op comparisons and to help decide if surgery is indicated. Fletcher and Meldrum advocate linear sublingual measurements cast into a statistical ratio.8 Williams and Waldron propose three linear measurements of the anterior, inferior segments of the tongue including the lingual frenum.9 Kacar and Cakmat suggested four reference points taken from photographs and placed into a computer program to generate “geometric morphometric.”10 Horton echoes the philosophy of three linear measurements.11 Ruffoli recommended a morphofunctional assessment to correlate the severity of ankyglossia.12 Despite the numerous diverse views regarding its significance Messner states that some children with tongue-tie are able to develop normal speech, compensating for limited tongue mobility, however speech articulation was noted to improve in the great majority of patients who were documented to have a preoperative articulation problem.13 One citation mentions ‘just because a child can extend the tongue for a moment to demonstrate for a professional doesn’t mean that position will be comfortable enough to maintain in steady conversation.” The operative word here is “comfortably.”15 Diadochokinesis or rapid repetitive lingual movements is often assessed by measuring
SEPTEMBER / OCTOBER 2018 | THE BULLETIN | 37
rapid repetitive syllable production. “Quantification of repetitive syllable production provides an objective comparison to normative data as well as permitting pre- and post- operative comparisons.8 Measurements of patient’s tongue after course of speech therapy lasting five months: A. Maximum opening of mouth with tongue at rest – 37 mm. B. Maximum opening of mouth with tongue touching incisive papillae – 22 mm. C. Maximum protrusion of tongue from lower incisors – 20 mm. Blue represents the pre-speech therapy values. Orange represents the post-speech therapy values. After the five month speech therapy trial, the patient was evaluated by the speech language pathologist. The patient’s range of motion was appropriate for feeding, oral hygiene, developing rotary chewing pattern and production of age-appropriate phonemes (/k/ and /g/). Patient could produce /k/ and /g/ in all positions of words at the sentence level and these sounds were emerging in spontaneous conversation. She was also able to achieve tongue tip elevation for production of /l/. Given the patient’s progress, a reevaluation by her pediatric dentist was warranted. Follow up measurements by the pediatric dentist showed improvement in all categories. Maximum opening of the mouth with the tongue at rest changed from 34 to 37 mm. Maximum opening of the mouth with the tongue touching the incisive papillae changed from 19 to 22 mm. Maximum protrusion of the tongue from the lower incisors changed from 15 to 20 mm. One citation stated that when the difference between values A) and B) was one half or more the frenulum was considered normal. This however is only looking at the frenum from a morphological/quantitative perspective. Because of this surgery was not recommended at this point and we would continue to monitor the patients progress to determine if there are any relapses which would direct us to reconsider any necessary measures. Follow up appointments would be made with the speech, dental and medical offices involved. Improvement in tongue elevation and protrusion are often not fully noticeable for a variable period of time. Our particular patient was highly motivated and her mother was equally supportive. As in any health care endeavor, optimal results often reflect patient compliance and adherence to instructions.
BIBLIOGRAPHY
1. Hazelbaker, Alison TONGUE –TIE MORPHOGENESIS, IMPACT, ASSESSMENT AND TREATMENT (Adam and Eve Press, Columbus, Ohio, 2010) 2. Lynch, B. “MTHFR GENE” www.mthfr.net 3. Kulkarni, G.; Klaiman, P.et al “Speech and Language In A Developing Child” American Academy of Pediatric Dentistry Annual Meeting, National Harbor, Maryland (2017) 4. Batacan, J. “The “Cascade Effect” of Interventions” www. MothersAnd BabiesFirst.com
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5. Rubio, A.S. et al “The moulded baby syndrome: incidence and risk factors regarding 1001 neonates” EUROPEAN JOURNAL OF PEDIATRICS (2009) 168: 605-611 6. Messner, A.H.; Lalakea, M.L. “The effect of ankyglossia on speech in children”OTOLARYNGOLOGY -HEAD AND NECK SURGERY (November 2002) pp.539-545 7. Guilleminault, C. et al “A frequent phenotype for paediatric sleep apnoea: short lingual frenum” ERJ OPEN RESEARCH (2016) 0:00043, pp. 1-7 8. Fletcher, S.G.; Meldrum, J.R. “Lingual function and relative length of the lingual frenum” JOURNAL SPEECH HEAR RES (1968) 2: pp. 382-390 9. Williams, W.N.; Waldron, C.M. “Assessment of lingual function when ankyloglossia (tongue-tie) is suspected” JOURNAL OF THE AMERICAN DENTAL ASSOCIATION Volume 110, March 1985 pp. 353-356 10. Kacar, D. et al “Evaluation of Lingual frenum Using Geometric Morphometrics” INT. JOURNAL MORPHOL. 29 (2) 2011; pp.313-317 11. Horton, CE; Crawford, HH et al “Tongue-Tie” CLEFT PALATE JOURNAL (1969) 6: pp. 8-23 12. Ruffoli, R. et al “Ankyglossia: a morphofunctional investigation in children” ORAL DISEASES 11, pp.170-174 13. Lalakea, M.L.; Messner, A.H. “Ankyglossia : Does it matter?” THE PEDIATRIC CLINICS OF NORTH AMERICA 50 (2003) pp. 381-397 14. Marchesan,I.Q.;” Lingual Frenulum: Classification and Speech Interference” INTERNATIONAL JOURNAL OF OROFACIAL MYOLOGY Volume 30, Nov. 2004, pp.31-37 15. Hamaguchi, P.A. CHILDHOOD SPEECH, LANGUAGE AND LISTENING PROBLEMS (Third Edition) (John Wiley and Sons, Inc. New Jersey, 2010) 16. Savery, D.; Fun,T. “Impact of Early Feeding and Health Problems on Speech and Language – Impact of Health concerns on Speech From Birth to 5 Years” University of Central Florida Department of Communicative Sciences and Disorders 17. Ballard, J.L.; Auer, C.E. et al “Ankyglossia: Assessment, Incidence, and Effect of Frenuloplasty on the Breastfeeding Dyad” PEDIATRICS Volume 110 Number 5 November 2002 pp. 1-6 18. Ghaheri, Bobby blog posts “ …” www.drghaheri.com 19. Kotlow ,L.A. TOTS – TETHERED ORAL TISSUES (Troy Book Makers, New York, 2016) 20. Chang, C. “ Tongue Tie (Ankyglossia) and Its Treatment ” www. fauquierent.net 21. Academy of Orofacial Myofunctional Therapy “Frenulum Inspection Workshop, Infants, Adolescents, and Adults “ Los Angeles January 2017 22. Messner, A.H.; Lalakea, L. “The Effect of Ankyglossia On Speech in Children” OTLARYNGOLOGY – HEAD AND NECK SURGERY November 2002; pp.525-545
ABOUT THE AUTHORS
• Randy Q. Ligh, DDS, MA, FAAP, FACD, CLEC Private Practice, San Jose, California • Christine Bacon, MA, CCC/SLP Private Practice, San Jose, California • Margaret De Villiers, MD Private Practice, Los Gatos, California
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