october 2009
official publication of the san diego county medical society
Clinical Trials Improving Patient Care and Our Ability to Provide It
County of San Diego 2008 STD Report P.16 icd-10-cm final implementation P.20 who’s in charge? Lessons from litigation P.24 “ P H Y S I C I A N S U N I T E D F O R A H E A LT H Y S A N D I E G O ”
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Contents VOL. 96 | NO. 10
Clinical Trials Improving Patient Care and Our Ability to Provide It
6 Is Personalized Medicine on the Way? 26 From Trial and Error to Rational Drug Prescription: More Routine and More Widespread in the Coming Years 30 Translational Medicine: The Next Frontier 32 Interview With William P. Hitchcock, MD 36 Improving Patient Care Through Clinical Research 40 Clinical Trial Resources: Registries, Results, and More …
[ D e pa r t m e nt s ]
4 6 8 10 12 16 2
Contributors
This Issue’s Contributing Writers
guest editor’s column SDCMS’ 2009 Seminars and Events Community Healthcare Calendar briefly noted
Ask Your Office Manager Advocate and More …
public health
San Diego County STD 2008 Annual Report
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20 22 24 39 42 44
Practice Management
ICD-10-CM Final Implementation
SDCMS Foundation
Third Saturday Surgery Day
risk Management Who’s In Charge?
SDCMS Endorsed Partner spotlight Physician marketplace Classifieds
History of medicine
The Return of the Lowly Leech
Pacific Highlands Ranch Recreation Center
Manzanita Trail Residences 1 & 2
Derby Hill, Residence 3
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Contributors Gary S. Firestein, MD Dr. Firestein, SDCMS and CMA member since 2009, is dean of translational medicine, professor of medicine/chief, rheumatology, allergy and immunology, and director of the UC San Diego Clinical and Translational Research Institute, UC San Diego Health Sciences. Deborah Grider Ms. Grider is the vice president of strategic development for the American Academy of Professional Coders. William P. Haney, MD Dr. Haney, a retired ophthalmologist, has held a longtime interest in the history of medicine, often contributing articles to San Diego Physician. WILLIAM HITCHCOCK, MD Dr. Hitchcock, SDCMS and CMA member since 1988, is a board-certified pediatrician who has practiced in San Diego for more than 21 years. He is a fellow in the American Academy of Pediatrics, founder of La Jolla Pediatrics and La Costa Pediatrics, assistant clinical professor of pediatrics at UCSD, and an attending at Rady Children’s Hospital of San Diego. Dr. Hitchcock has been involved in clinical research for more than 12 years in the areas of asthma, allergy, infectious disease, and vaccines. Karen Heskett Ms. Heskett is the instruction coordinator for the UC San Diego Biomedical Library and liaison to the Moores Cancer Center. Alisha Mann Ms. Mann is the SDCMS Foundation’s Saturday Surgery Days program manager.
Ravindra Mehta, MD Dr. Mehta, SDCMS and CMA member since 2005, is professor of clinical medicine, associate chair for clinical research, Department of Medicine, UC San Diego Health Sciences, and director of UC San Diego CREST (Clinical Research Enhancement Through Supplemental Training) and Masters of Advanced Studies in Clinical Research programs.
Marketing & Production Manager Jennifer Rohr Sales Director Dari Pebdani Project Designer Lisa Williams Copy Editor Adam Elder SDCMS Board of Directors
Robert E. Peters, PhD, MD Dr. Peters, SDCMS and CMA member since 2000, is a family physician in private practice. He is a member of SDCMS’ GERM Commission, co-chairs Sharp HealthCare’s Primary Care Conference, is a member of the bioethics committee at Sharp Memorial Hospital, and sits on CMA’s Council on Ethical Affairs. Dr. Peters also serves as a consultant to biomedical and pharmaceutical companies. David B Troxel, MD Dr. Troxel is medical director on the board of governors for The Doctors Company, SDCMS’ endorsed partner for professional liability insurance. Lauren Wendler Ms. Wendler is your SDCMS office manager advocate. She can be reached at (858) 300-2782 or at LWendler@SDCMS.org with any questions your office manager may have. Wilma J. Wooten, MD, MPH Dr. Wooten, SDCMS and CMA member since 2006, is the public health officer for the County of San Diego, Health and Human Services Agency (HHSA). She is board certified in family medicine and has a master’s degree in public health. ✚
Send your letters to the editor to Editor@SDCMS.org 4
Managing Editor Kyle Lewis Editorial Board Van Cheng, MD, Adam Dorin, MD, Robert Peters, MD, PhD, David Priver, MD, Roderick Rapier, MD
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Officers President Lisa S. Miller, MD Immediate Past President Stuart A. Cohen, MD, MPH President-elect Susan Kaweski, MD Treasurer Robert E. Wailes, MD Secretary Sherry L. Franklin, MD geographic directors East County William T. Tseng, MD, Heywood “Woody” Zeidman, MD Hillcrest Roneet Lev, MD, Thomas V. McAfee, MD Kearny Mesa Adam F. Dorin, MD, John G. Lane, MD La Jolla J. Steven Poceta, MD, Wayne Sun, MD North County Arthur “Tony” Blain, MD, Douglas Fenton, MD, James H. Schultz, MD South Bay Vimal I. Nanavati, MD, Anna Sanchez Seydel, MD At-large Directors John W. Allen, MD, David E.M. Bazzo, MD, V. Paul Kater, MD, Jeffrey O. Leach, MD, Mihir Parikh, MD, Robert E. Peters, MD, PhD, David M. Priver, MD Communications Chair Theodore M. Mazer, MD Young Physician Director Kimberly Lovett, MD Retired Physician Director Glenn Kellogg, MD Medical Student Director Jane Bugea CMA Trustees Theodore M. Mazer, MD, Albert Ray, MD, Robert E. Wailes, MD, Catherine D. Moore, MD, Diana Shiba, MD AMA Delegates Robert E. Hertzka, MD, James T. Hay, MD AMA Alternate Delegates Albert Ray, MD Lisa S. Miller, MD
Opinions expressed by authors are their own and not necessarily those of San Diego Physician or SDCMS. San Diego Physician reserves the right to edit all contributions for clarity and length as well as to reject any material submitted. Not responsible for unsolicited manuscripts. Advertising rates and information sent upon request. Acceptance of advertising in San Diego Physician in no way constitutes approval or endorsement by SDCMS of products or services advertised. San Diego Physician and SDCMS reserve the right to reject any advertising. Address all editorial communications to Editor@SDCMS.org. All advertising inquiries can be sent to DPebdani@SDCMS.org. San Diego Physician is published monthly on the first of the month. Subscription rates are $35.00 per year. For subscriptions, email Editor@SDCMS.org. [San Diego County Medical Society (SDCMS) Printed in the U.S.A.]
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Guest Editor’s Column
By Robert E. Peters, PhD, MD
Is Personalized
Medicine on the Way?
Yes!
F
rom the earliest days of “medicine” to the days of chemists, druggists, and apothecaries, we have used “drugs” — natural extracts, tinctures, mixtures, lotions, and ointments — to treat our patients’ diseases and discomforts. As physicians, our role remained somewhat consistent as the source of our treatment materials moved from the local forest to the chemist and then to the pharmaceutical industry. We continued to make treatment decisions based upon observed symptoms as we improved our diagnostic methods and tools. Our strategic approach to diagnosing and treating patients isn’t going to change — our treatment tools, i.e., our drugs, however, are.
The pharmaceutical industry is beginning to think of the development of drugs in terms of individual groups of patients, rather than maintaining its “blockbuster drug” mentality. Soon there will be a dramatic change in the therapeutic tools available to us as a result of advances in science with respect to new “genomic level” diagnostic tools and therapeutic modalities. The driver of this change is our increasing ability to identify and describe an individual patient’s problem not only from symptoms but at a molecular level, and to understand and appreciate the great magnitude of differences in the causative factors — and appropriately different interventions — for different patients who present with essentially the same set of symptoms. The pharmaceutical industry is beginning to think of the development of drugs in terms of individual groups of patients, rather than maintaining its “blockbuster drug” mentality. The age of moleculartargeted cancer therapeutics has already arrived. Recent regulatory communications from the FDA confirm that oncology
6
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drug developers will now need to develop and deliver, for all new oncology drugs, a “biomarker” for use with the drug to select and subset oncology patients before prescribing the new drug. We are narrowing the target population of patients to that group already identified to be relevant for that drug. What we have observed in recent years — with emerging biotechnologies and genomics, proteomics, metabalomics, transcriptomics, and other “-omics” — is the gathering of more and more data confirming that one drug does not fit all patients with a given diagnosis or symptom set. We are now seeing the leading edge of truly personalized medicine, not individually tailored therapies, but rather improved strategies to identify smaller groups of patients with common gross symptoms to permit us to get the right drug to the right patient at the right dose level. Pharmaceutical companies are already beginning to change and will conduct more specific clinical trials with smaller numbers of more adroitly identified patients. The predictable end result is increased efficacy. Soon we will identify only patients within the broader “symptom” category who share the same underlying molecular structure — maybe a similar molecular abnormality — and treat only those patients with the relevant therapy. We are on the threshold of a new era in medicine, an era in which we will have both the intent and the tools to treat patients on a “personalized medicine” basis. The pharmaceutical industry’s focus is moving away from the “blockbuster drug” mentality and recognizing the value of “-omics” in identifying, selecting, and treating patients as much smaller groups rather than merely identifying them by broad symptomatic categories. Tomorrow — and it is coming soon — we will match molecularly targeted drugs with molecularly defined patients. ✚
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A bo ut the Auth o r : Dr. Peters,
SDCMS and CMA member since 2000, is a family physician in private practice. He is a member of SDCMS’ GERM Commission, co-chairs Sharp HealthCare’s Primary Care Conference, is a member of the bioethics committee at Sharp Memorial Hospital, and sits on CMA’s Council on Ethical Affairs. Dr. Peters also serves as a consultant to biomedical and pharmaceutical companies.
N OF THE PUbLICATIO OFFICIAL
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SDCMS Members-only Benefits
2009
Seminars, webinars, and Events
Free to Member Physicians and Their Office Staff! Don’t See What You Need? Let Us Know!
october
november
“10 Strategies for Economic Survival” Seminar/Webinar on Oct. 15 (Thu.) From 11:30AM to 1:00PM
“Preparing to Practice: What You Need to Know BEFORE You Begin Your Practice” Resident and New Physician Workshop on Nov. 14 (Sat.) From 8:30AM to 3:30PM
“Become a Certified Medical Coder in Five Days!” Certified Medical Coder Course on Oct 23, 30 and Nov. 6, 13, 20 (all Fridays) From 8:00AM to 4:00PM
For further information, visit SDCMS.org or contact Lauren Wendler at (858) 300-2782 or at LWendler@SDCMS.org.
*
SDCMS is currently scheduling its 2010 seminars, webinars, and events. Please let us know which topic or topics you’d like us to cover by sending us an email at
Editor@ SDCMS.org 8
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“Electronic Health Records: Are You Ready?” Risk Management Webinar on Nov. 18 (Wed.) From 6:30PM to 7:30PM “Electronic Health Records: Are You Ready?” Risk Management Webinar on Nov. 19 (Thu.) From 11:30AM to 12:30PM
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Community Healthcare Calendar To submit a community healthcare event for possible publication, email KLewis@SDCMS.org. All events should be physician-focused and should take place in San Diego County.
4th Annual Clinical Update on Heart Failures and Arrhythmias: From Prevention to Cure Oct. 17–18 • Hilton La Jolla Torrey Pines • scripps.org/conferenceservices
9th Annual Destination Health: Renewing Mind, Body, and Soul Oct. 18–23 • Marriott Kauai Resort, Kauai, Hawaii • scripps.org/conferenceservices
Collaborative Care: Treating the Whole Person (Mental Health America of San Diego County) Oct. 21 • San Diego Marriott Hotel Mission Valley • mhasd.org/programs.htm
The 12th Annual School Health Leadership Conference: “Back to School” Oct. 24 • Naval Medical Center San Diego Auditorium (Building 5) • aapca3. org
Southern California Health Care Summit Oct. 29 • Ontario Convention Center • socalhealthsummit.com
2009 San Diego Day of Trauma Oct. 30 • Joan B. Kroc Institute for Peace and Justice, USD • scripps.org/ conferenceservices
XVII World Congress of Psychiatric Genetics Nov. 4–8 • Manchester Grand Hyatt • (858) 534-3940, ocme@ucsd.edu
Fresh Start’s Surgery Weekend Nov. 7–8 • Center for Surgery of Encinitas • freshstart.org
New Developments and Best Practices in Colorectal Cancer Screening
The Faces of Chronic Fatigue Syndrome
Nov. 14 • Admiral Baker Clubhouse (Presidio Room) • (858) 458-9439, sbazzo@ sandiegoafp.org.
Oct. 26–Nov. 1 • Westfield County Fair, Escondido • cfids.org/sparkcfs/healthprofessionals.asp
Melanoma 2010: 20th Annual Cutaneous Malignancy Update
20th Annual Coronary Interventions
Jan. 16–17 • Hilton San Diego Resort and Spa • scripps.org/conferenceservices
Oct. 28–30 • Hilton La Jolla Torrey Pines • scripps.org/health-education
7th Annual Natural Supplements: An Evidence-based Update Jan. 21–24 • Paradise Point Resort and Spa • scripps.org/conferenceservices
Scripps Cancer Center’s 30th Annual Conference: Clinical Hematology and Oncology Feb. 13–16 • Omni San Diego Hotel • scripps.org/conferenceservices ✚
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Noted
Office Manager
Your
advocate
Has the Answers!
By Lauren Wendler
Group Purchase of Prescription Drugs • Tracking Medical Record Releases • Terminating Disorderly Patients
Q
UESTION: Can a corporation
of physicians purchase prescription drugs as a group and deduct the fees from each physician’s paycheck based on the amount each physician dispenses?
ANSWER: Drugs may be furnished by a physician only to his or her own patients (Business & Professions Code §4170; Health & Safety Code §111500.) The Board of Pharmacy has interpreted the law to mean that physicians in group practice may not dispense drugs from a common stock unless a specific exception applies. The Board adopted 16 C.C.R. §1783, which it interprets to prohibit manufacturers or wholesalers from furnishing prescription drugs or devices to a medical group; rather they must be forwarded to “a physician.” Although many attorneys disagree with the interpretation of the Board of Phar-
12
macy and find no statutory authority for the conclusion that physicians in group practice may not receive or dispense drugs from a common stock, physicians who fail to follow the Board of Pharmacy’s interpretation may be subject to referral to the Medical Board of California for investigation. For further information, consult CMA ON-CALL document #0505, “Drug Dispensing (Not Schedule II-V Drugs),” available free to SDCMS-CMA members at CMANet.org.
Q
their legal representatives on request an “accounting” of certain types of disclosures of that patient’s protected health information (PHI) the physician has made. This obligation extends to the disclosures made by the physician’s “business associates,” that is, outside contractors who act on the physician’s behalf with respect to a function or activity involving the use or disclosure of PHI. To ensure compliance with the accounting requirement, the HIPAA Privacy Rules also require the maintenance of a disclosure accounting log that contains the mandatory elements that must be included in the accounting. A sample “Disclosure Accounting Log” and further information may be found in CMA ON-CALL document #1122, “Accounting of Disclosure,” available free to SDCMS-CMA members at CMANet.org.
Q
UESTION: How do we terminate
a disorderly patient who uses foul language to the staff and threatens to sue if he is unable to see the physician?
ANSWER: To terminate a patient, the physician should send a written notice to the patient by certified mail, return receipt requested. The letter should instruct the patient as to how to obtain the medical records compiled during the patient’s care (whom to contact, how, and where) and inform the patient that, upon the patient’s written authorization, the physician will send a copy of the patient’s medical record to the new provider or that, alternatively, the physician will provide the patient with a copy of the record or a detailed summary. In order to reduce the risk of liability, you should treat the patient until the patient has had a reasonable time to find an alternative source of care. The Medical Board of California advises that physicians must provide patients with at least 15 days of emergency treatment and prescriptions before the termination. For further information, consult CMA ON-CALL document #0805, “Termination of the Physician-Patient Relationship,” available free to SDCMS-CMA members at CMANet.org. ✚
UESTION: Should our office
track every time we release any medical records to a patient or thirdparty agency?
ANSWER: Yes. Among the requirements imposed by the HIPAA Privacy Rules is the requirement that physicians covered by HIPAA provide patients or
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About t h e Au t h o r: Ms. Wen-
dler is your SDCMS office manager advocate. She can be reached at (858) 3002782 or at LWendler@ SDCMS.org with any questions your office manager may have.
SDCMS Events In September
Left: SDCMS physicians and their staff meet with leading EMR vendors at SDCMS’ second EMR/EHR Trunk Show, held on Sept. 17, 2009.
EMR Trunk Show Right: Drs. Wailes, Mazer, and Hay, SDCMS physician leaders, lead the discussion at SDCMS’ Sept. 15, 2009, healthcare reform townhall.
Healthcare Reform Townhall Left: SDCMS physician leaders and staff sign up 106 first-year medical students for SDCMSCMA membership at UCSD’s school of medicine orientation on Sept. 10, 2009.
First-year Medical Student Orientation
Get in Touch Your SDCMS and SDCMSF Support Teams Are Here to Help! SDCMS Contact Information Address: 5575 Ruffin Road, Suite 250, San Diego, CA 92123 Telephone: (858) 565-8888 Fax: (858) 569-1334 Email: SDCMS@SDCMS.org Website: SDCMS.org • SanDiegoPhysician.org CEO/Executive Director: Tom Gehring at (858) 565-8597 or at Gehring@SDCMS.org COO/CFO: James Beaubeaux at (858) 3002788 or at Beaubeaux@SDCMS.org Director of Membership Development: Janet Lockett at (858) 3002778 or at JLockett@SDCMS.org Director of Membership Operations and Physician Advocate: Marisol Gonzalez at (858) 300-2783 or at MGonzalez@ SDCMS.org Office Manager Advocate: Lauren Wendler at (858) 300-2782 or at LWendler@ SDCMS.org Director of Engagement: Jennipher Ohmstede at (858) 300-2781 or at JOhmstede@ SDCMS.org Director of Communications and Marketing: Kyle Lewis at (858) 300-2784 or at KLewis@SDCMS.org Specialty Society Advocate: Karen Dotson at (858) 300-2787 or at KDotson@ SDCMS.org administrative assistant: Betty Matthews at (858) 565-8888 or at BMatthews@SDCMS.org Letters to the Editor: Editor@SDCMS.org General Suggestions: SuggestionBox@ SDCMS.org
SDCMSF Contact Information
H1N1 Physician Email Request H elp U s K eep You I nformed ! In an effort to promulgate H1N1 updates and resources as quickly and as broadly as possible, SDCMS is asking San Diego County’s physicians to share with us an email address we can use for just such a purpose. If we do not already have your email address, please send it to me, Tom Gehring, SDCMS executive director, at Gehring@SDCMS.org. Thank you. SDCMS email policy: Our policy at SDCMS as concerns email addresses is to never, under any circumstances, release your email address unless you specifically give us written permission to do so.
O c t o b e r
Address: 5575 Ruffin Rd., Ste. 250, San Diego, CA 92123 Fax: (858) 560-0179 Executive Director: Kitty Bailey at (858) 300-2780 or KBailey@SDCMS.org Associate Executive Director: Tana Lorah at (858) 300-2779 or at TLorah@SDCMS.org Patient Care Manager: Barbara Rodriguez at (858) 300-2785 or at BRodriguez@ SDCMS.org Patient Care Manager: Brenda Salcedo at (858) 565-8161 or at BSalcedo@SDCMS.org Program Manager, Surgery Days: Alisha Mann at (858) 565-8156 or at AMann@ SDCMS.org Healthcare Access Manager: Lauren Radano at (858) 565-7930 or at LRadano@ SDCMS.org
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Noted Annual Meeting of the David Hoffman Society for Medical History October 28, 2009 What: The David Hoffman Society for Medical History, with more than 100 members, invites you to attend its annual meeting.
The Faces of Chronic Fatigue Syndrome Oct. 26-Nov. 1, 2009
T
he U.S. Centers for Disease Control and Prevention (CDC) estimates that chronic fatigue syndrome (CFS) affects between 1 and 4 million Americans. CFS, also known as chronic fatigue and immune dysfunction syndrome (CFIDS), is a debilitating and complex illness that results in profound fatigue and a number of other chronic symptoms that can be challenging to diagnose and treat. These challenges often leave both patients and healthcare providers locked in a cycle of frustration. The CDC, together with The CFIDS Association of America, has launched a national public health education campaign to increase understanding of CFS among
individuals experiencing symptoms of the illness, the general public, and healthcare professionals. As part of that campaign, the CFIDS Association will bring a national traveling photo exhibit called “The Faces of Chronic Fatigue Syndrome” to Westfield North County Fair in Escondido from Oct. 26 to Nov. 1, 2009. This exhibit features the portraits (shot by celebrity photographer George Lange) and stories of CFS patients, family members, and healthcare professionals. Healthcare providers can visit SDCMS.org to be directed to an array of tools to enable them to communicate with, confidently diagnose, and capably treat patients with CFS. Offerings include the CFS Toolkit for Healthcare Professionals, which includes quick-read fact sheets from the CDC. The toolkit and other resources for medical professionals and patients are free and available in print or online. Professionals are encouraged to request or download copies for themselves and colleagues, residents, students, and patients by visiting SDCMS.org, by emailing meded@cfids.org, or by calling the CFIDS Association at (704) 364-0016. ✚
Thank You, Dr. Nicholas A. Zubyk
First Physician to Renew His SDCMS-CMA Membership for 2010!
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When: Wednesday, Oct. 28, 2009. Cocktails at 6 p.m. and dinner at 6:30 p.m., followed by Dr. Marshall Orloff’s presentation at 7:30 p.m. Where: The Imperial House Restaurant, 505 Kalmia Street, San Diego, CA 92101-1629. Telephone (619) 234-3525. Cost: $70 to be paid at the door, which includes the meal and wine for two and an 18% gratuity and tax. There is only room for 60 guests, so please sign up early. Speaker: Marshall J. Orloff, MD, FACS, Distinguished Professor of Surgery, UCSD Topic: “The Birth Pangs of UCSD’s Medical School and Department of Surgery” Further Information: The Orloff Chair of Surgery at UCSD is named after its founding chairman. This presentation will be videographed and presented to the San Diego Historical Society. The Hoffman Society especially invites Dr. Orloff’s contemporaries to come and participate in a colloquy for the benefit of future historians and house officers. To Register: Email Ralph R. Ocampo, MD, at ocamporr@cox. net or all (619) 702-2064. ✚
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Physicians:
Get Noticed! Wish Your Legislators a Happy Birthday! Let your legislators know that you’re paying attention and that you vote — by wishing them a happy birthday!
Senator Mark Wyland California State Senate P.O. Box 942848 Sacramento, CA 94248-0038 T: (916) 651-4038 F: (916) 446-7382 E: senator.wyland@sen.ca.gov Birthday: Oct. 27 Congressman Darrell Issa United States Congress 2347 Rayburn House Office Building Washington, DC 20515 T: (202) 225-3906 F: (202) 225-3303 E: www.house.gov/issa Birthday: Nov. 1 Assemblywoman Lori Saldana California State Assembly P.O. Box 942849 Sacramento, CA 94249-0076 T: (916) 319-2076 F: (916) 319-2176 E: assemblymember.saldana@assembly.ca.gov Birthday: Nov. 7 Senator Barbara Boxer United States Congress 112 Hart Senate Office Building Washington, DC 20510 T: (202) 224-3553 F: (202) 228-2382 E: www.boxer.senate.gov Birthday: Nov. 11 Assemblyman Kevin Jeffries California State Assembly P.O. Box 942849 Sacramento, CA 94249-0066 T: (916) 319-2066 F: (916) 319-2166 E: assemblymember.jeffries@assembly.ca.gov Birthday: Nov. 24 Congressman Duncan D. Hunter United States Congress 1429 Longworth House Office Building Washington, DC 20515 T: (202) 225-5672 F: (202) 225-0235 E: www.hunter.house.gov Birthday: Dec. 7
Do You Know of Any Physician Volunteer Opportunities? O c t o b e r
If you know of any volunteer opportunities for physicians in San Diego County, California, across the United States, or anywhere else in the world, please email the information to Editor@SDCMS.org. SDCMS will publish all physician volunteer opportunities free of charge on our website at SDCMS.org.
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County Public Health Officer’s Update By Wilma J. Wooten, MD, MPH
County of San Diego
Sexually Transmitted Diseases 2008 Annual Report
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F
rom 2007 to 2008, reported chlamydia cases increased by 11 percent and reported gonorrhea cases decreased by 15 percent in San Diego County. These diseases are most common among youth in their teens and 20s; 64 percent of chlamydia cases and 46 percent of gonorrhea cases were between the ages of 15 and 24 years. According to a national, population-based study conducted by the Centers for Disease Control and Prevention (CDC), one in four teenaged girls in the United States is infected with a sexually transmitted disease (STD). Many STDs are often asymptomatic — approximately 75 percent of women and 50 percent of men infected with chlamydia do not have symptoms, and most women infected with gonorrhea are also asymptomatic. If left untreated, chlamydia and gonorrhea infections can lead to serious complications such as pelvic inflammatory disease (PID). In the United States, more than 1 million women develop PID and more than 100,000 women become infertile due to PID each year. This underscores the need for frequent screening.
CDC recommends that all women under the age of 26 be screened at least annually for chlamydia; women of any age should be screened periodically based on risk factors such as new or multiple partners, substance abuse problems, or a previous STD. Persons with a chlamydia or gonorrhea infection should be retested approximately three months after the original diagnosis as repeat infections are common. For the first year since 2002, the number of primary and secondary syphilis cases
but may be decreasing, as there were 35 percent fewer cases in the first quarter of 2009 as compared to the first quarter of 2008. This decline is due in part to the ongoing efforts of County of San Diego communicable disease investigators (CDIs) who work with clinicians to interrupt the spread of disease. CDIs investigate every syphilis case and work not only to ensure that each case receives adequate treatment, but that sexual partners are diagnosed and treated as well.
According to a national, population-based study conducted by the Centers for Disease Control and Prevention, one in four teenage girls in the United States is infected with a sexually transmitted disease. in San Diego County did not increase but, rather, remained stable (345 cases in 2007; 344 cases in 2008). Preliminary data for January–March 2009 suggest that case numbers are not just leveling off in the county,
The majority of primary and secondary syphilis cases in San Diego County were men who have sex with men (MSM; 78 percent). Co-infection with HIV was common among reported cases (50 percent
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15000 15000
4000 3500
12000
NUMBER OF CASES
NUMBER NUMBER OFOF CASES CASES
12000
Chlamydia Cases by Year, San Diego, 1993–2008
9000 9000 6000 6000 3000
Gonorrhea Cases by Year, San Diego, 1993–2008
3000 2500 2000 1500 1000
3000 500 0 0
1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008
0
1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008
YEAR OF REPORT YEAR OF REPORT
Because of the higher burden of disease in the MSM community, the State of California STD Control Branch recommends screening sexually active MSM every three to six months.
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YEAR OF REPORT
of all syphilis cases were HIV-positive), with MSM cases having a higher rate of co-morbidity (57 percent) as compared to females (8 percent) and heterosexual males (10 percent). Methamphetamine use was reported by 18 percent of cases (women: 33 percent; MSM: 18 percent; heterosexual men: 14 percent). These data emphasize the importance of obtaining sexual and behavioral histories to determine the syphilis screening frequency appropriate for each individual. Because of the higher burden of disease in the MSM community, the State of California STD Control Branch recommends screening sexually active MSM every three to six months. Syphilis Screening in Men Who Have Sex With Men In an effort to drive down the prevalence of syphilis among gay men and other MSM, the County of San Diego, HIV, STD, and Hepatitis Branch (HSHB) of Public Health Services, in conjunction with the California Department of Public Health STD Control Branch, formed the San Diego Syphilis Elimination Community Task Force in August 2008. This task force, which is comprised of members of the affected community as well as representatives from organizations that support and serve the community, decided that increasing the number of gay men and other MSM who access routine syphilis testing and increasing the awareness of the need for such screening were priority activities. In order
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to accomplish those goals HSHB hosted a series of free syphilis screening events targeting this at-risk population during April 2009. The screening events were held at local partner organizations as well as establishments that the target population frequents. The screening events were promoted in the local community paper and through a website that was developed as a part of this initiative: SDSoreLoser.com. In June 2009 the website was used to launch a syphilis symptom recognition awareness campaign targeting gay men and other MSM. The goal of the campaign, which is funded by the California STD Control Branch, is to increase MSM understanding of the different symptoms that can be present during the primary and secondary stages, and provide resources for syphilis testing. In addition, on July 18 and 19, HSHB once again offered syphilis and rapid HIV testing at the San Diego Lesbian, Gay, Bisexual, and Transgender Pride festival in Balboa Park. ✚
About t he Aut ho r: Dr. Woo-
ten, SDCMS and CMA member since 2006, is the public health officer for the County of San Diego, Health and Human Services Agency. She is board certified in family medicine and has a master’s degree in public health.
Chlamydia and Gonorrhea Cases by Age Group, San Diego, 2008 6000
Primary and Secondary Syphilis Total and MSM Cases by Year, San Diego, 1988–2008
500
12000 5000
Chlamydia
4000 9000
Gonorrhea
3000 6000 2000
NUMBER OF CASES
NUMBER OF OF CASES NUMBER CASES
15000
400
Other
300
MSM
200
3000 100
1000 0
1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008
0
<10 <10
10-14 10-14
15-19 15-19
20-24 20-24
25-29 25-29
30-34 30-34
35-44 35-44
45+ 45+
0
1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008
YEAR OF REPORT
YEAR REPORT AGEOF GROUP
To report an STD case, call (619) 692-8520 or fax information to (619) 692-8541. To contact the County of San Diego STD Clinic, call (619) 692-8550 or fax (619) 692-8543.
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Practice Management By Deborah Grider
ICD-10-CM
Final Implementation:
October 1, 2013 What’s Your Game Plan?
T
he final implementation date for ICD-10-CM has been set for October 1, 2013, and it is important that every medical practice, whether large or small, begin to formulate a “game plan” for ICD-10-CM implementation. A systematic approach is the best method in a successful conversion to ICD-10. The impact from a three- to five-digit level of specificity up to a seven-digit level of specificity is enormous. In addition, before we can convert to ICD-10, we must convert from the 4010 electronic transaction standard to 5010 by January 1, 2012. Version 5010 addresses currently unmet business needs, including, for example, providing on institutional claims an indicator for conditions that were “present on admission.” Version 5010 also accommodates the use of the ICD-10 code sets, which are not supported by Version 4010/4010A1. Ramping up for ICD-10 will be costly.
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Physicians will have to bear the cost of changing their systems and, perhaps, even their practice management software. The unknown is whether information systems
The sooner your organization begins planning for ICD-10 implementation, the smoother transition it will be. vendors will be able to accommodate ICD10-CM. Add to that the burden and cost of retraining coders, physicians, and others, and the potential loss of productivity, even if it’s just a temporary setback. Implementing ICD-10 is more than a matter of calling the software vendor and flipping the switch; you have to look at your office pro-
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cesses, your front office staff, your billing and coding staff, as well as the physicians. And then there are the payer contracts, a lot of which are tied to certain diagnoses and conditions. Now we also have quality reporting and quality measures, which insurance carriers are expecting. Ongoing changes in implementation of ICD-10 require taking a closer look at internal systems to ensure the organization has the capability of moving forward with implementation. Does your organization have enough hard drive space to house two codes sets (ICD-9-CM and ICD-10-CM) simultaneously for a period of time before and after implementation? The organization must orient information systems technology (IT) personnel as to specifications necessary for the code sets for successful transition. Preparation must include information on the length of characters necessary for
ICD-10-CM and ICD-10-PCS codes. Prepare not only for the extra digits but also to include the alphanumeric entries. Concerns to share with IT on this area include: • character case-sensitivity • placement of decimals for reporting • increased number of codes and characters • supporting ICD-9-CM and ICD-10CM simultaneously • the conversion from 4010 to 5010 Make sure that IT performs a comprehensive review of information systems and an audit for ICD-10 implementation by inventorying all the databases in the organization, giving special consideration to implementation hurdles such as: • how to accommodate mapping; • how to stop assignment of ICD-9-CM codes from being used after implementation; • how to interface between coding conventions; • and what the timelines are for the testing of system readiness. The ICD-10 planning phase is the time to determine whether current systems can accommodate the required software changes. Waiting to address these issues could very well hinder implementation, could be costly, and could interrupt cash flow in the organization without thoughtful preparedness. All systems, whether the practice management system, the electronic medical record system, or other systems or databases in the organization that house coding data must be able to handle the change for successful ICD-10 implementation. By performing this assessment, it will ensure an accurate budget can be developed and the organization has the tools necessary when ICD-10-CM “goes live.” Today, claims are often delayed because carriers need to ensure that the procedure was medically necessary. If ICD-10 is used appropriately, more specifics of the diagnosis will be captured. Keep in mind that 2013 is not that far away, and the sooner your organization begins planning for ICD-10 implementation, the smoother transition it will be. ✚
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N OF THE PUbLICATIO OFFICIAL
SAN DIEGO
mEDICAL COUNTY
2009 • mARCH SOCIETY
teeriSM n VOlun PhySiCia
off
advertising in this publication.
A bo ut the Autho r : Ms. Grider is the vice president of strategic development for the American Academy of Professional Coders (AAPC).
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SDCMS Foundation By Alisha Mann
Clockwise from top: Gastroenterology volunteers (L–R) Barbara Jones, Daniel “Stony” Anderson, MD, and Elvie Gonzalez. Patient Theresa Waller of El Cajon. The anesthesiology crew (L-R) Sharon Hirako, CRNA, Willie Aquinde, CRNA, Rose Drew, CRNA, Don Drew, MDA, Jackie Hannah, CRNA, Becky Graul, CRNA. Volunteers (L–R) Lety Cordero and Marco Hermosillo assist patient Berenice Vasquez of Oceanside.
Third Saturday Surgery Day Held August 22, 2009 helping san diego county’s uninsured patients
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B
ecause of gallstones, Berenice has been to the emergency room more than seven times in the past 12 months. Her primary care physician told her she’d end up needing an emergency cholecystectomy, an expensive and dangerous procedure, if she didn’t have her gallbladder removed soon. On Aug. 22, 2009, Sandra L. Freiwald, MD, of Kaiser Permanente, performed a low-risk, outpatient gallbladder removal, thereby relieving Berenice of the pain and discomfort associated with gallstones and allowing her to spend her days caring for her children.
“Thank you for helping my mom with her surgery! Thanks to all of you, she won’t have that pain anymore.” Berenice’s surgery was donated as part of the San Diego County Medical Society Foundation’s third Saturday Surgery Day, held Aug. 22, 2009, at Kaiser Permanente’s Otay Mesa Outpatient Medical Center. Saturday Surgery Days are an ongoing partnership between the SDCMS Foundation, Kaiser Permanente, and the Alliance Healthcare Foundation. Since December 2008, 98 patients have received donated procedures, including cholecystectomies, hernia repairs, lipoma removals, colonoscopies, and flexible sigmoidoscopies. A variety of specialty surgeries have also been donated, including cataract removals, ovarian cyst removals, carpel tunnel surgeries, and septoplasties. All patients are low-income, uninsured San Diego County residents who are referred to Saturday Surgery Days by their community clinic physicians. Kitty Bailey, executive director of the SDCMS Foundation, states, “Twenty-five percent of San Diego County adults do not have health insurance of any kind. For people in these circumstances, trying to arrange for non-emergency but necessary surgery can be a long and frustrating process. Through this partnership, patients are able to get the surgeries they need so they can get back to caring for their families and working.” The patients are extremely grateful for these life-saving and life-enhancing surgeries and procedures. Thank-you notes from patients include the following:
• (translation) “I want to thank the Foundation for giving me this opportunity to receive a free surgery and for all of your excellent services. I also want to thank every single person that makes this project happen that helps people like me with low economic resources that can’t pay for a surgery. Thank you very much! May God bless you for your good heart.” — Berenice Vasquez (patient) • “What a pleasant experience! Everyone was kind. We were overwhelmed with kindness.” — Marcenna Wilson (patient) • “This is a blessing I never thought was coming.” — Curt Laird (patient) • “I give thanks to the doctors for giving her this surgery. I didn’t think programs and people like you existed.” — Son of Isabel Hernandez (patient) • “For everyone, the doctors, nurses, thanks again, and may God bless you all for what you are doing.” — Magdalena Sanchez (patient) • “I give thanks to Kaiser for their great attitude and quality of work. I’m very thankful that there is a project like this in the community that helps people like us with our medical problems.” — Norberto Quezada (patient) • “Thank you for helping my mom with her surgery! Thanks to all of you, she won’t have that pain anymore.” — Daughter of
Rosa Espinoza (patient) As an offshoot of Saturday Surgery Days, Beckman Coulter, Inc., has donated 2,000 Hemoccult SENSA fecal occult blood tests to screen eligible adults for colorectal cancer for free at Neighborhood Healthcare in Escondido. Any patient that has a positive screen is automatically enrolled into the next Saturday Surgery Day, scheduled for December 5, 2009, for a free colonoscopy. Mary Guan, senior marketing specialist with Rapid Testing, Business Center, Beckman Coulter, Inc., states, “Our company is dedicated to improving patient health and reducing the cost of care. We are happy to be part of this worthy project that may help save lives of medically underserved individuals through early detection.” ✚
Abou t t h e Aut ho r: Ms. Mann
is the SDCMS Foundation’s Saturday Surgery Days program manager.
Left: Daniel Terhorst, MD, explains the procedure to patient Jaime Aleman of National City. Below: (L–R) Roderick Rapier, MD, Jonesa Jones, RN, patient Jose Garcia, and his son, Jose Garcia, of San Diego.
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Risk Management By David B. Troxel, MD
Who’s in Charge? Lessons From Litigation
A
68-year-old female went to the hospital ED on May 8 complaining of left flank pain following recent removal of a left ureteral stone by lithotripsy. An intravenous pyelogram (IVP) was negative for stones, a blood culture grew E. coli, and a urine culture grew E. coli < 10,000 CFU/ml. She was placed on antibiotic therapy and continued on Coumadin for chronic atrial fibrillation. On May 10 she was sent back to the hospital by her physician because of worsening left flank pain. She was afebrile, pulse 92, BP 130/70, and respirations 18. A complete blood count, urinalysis, and blood/urine cultures were ordered. She was admitted by hospitalist A with a diagnosis of probable acute pyelonephritis, placed on IV fluids, and given Dilaudid and Zosyn. On May 11 the blood culture grew E. coli; the urine culture was negative. The urinalysis report was missing and wasn’t reordered. That evening the patient fell in the bathroom, subsequently stating that her legs “gave way.” The nurse reported this to on-call hospitalist B, who ordered fall precautions but did not examine the patient. On May 12 at 11 a.m., hospitalist A saw the patient and learned of the fall. He assumed it
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was caused by the Dilaudid and reduced the dosage; he did not perform a neurological exam. At 12:30 p.m. she fell again, and hospitalist A ordered a head CT scan, which was negative; he did not see the patient. She was seen by physical therapy at 3:30 p.m., who charted she was unable to stand and had diminished left lower extremity strength (2/5 vs. 4/5 on the right). At 5:30 p.m. the nurse charted that the patient was confused, incontinent, and complaining of severe pain in her back and legs. On-call hospitalist C was notified at 7 p.m. about the PT and nursing notes and gave a phone order to add Percocet and Haldol. At 9:45 p.m. a nurse charted that the patient had bilateral leg numbness, external rotation of the left leg, and “electric shock” pain in the groin. On-call hospitalist C examined the patient and charted that the patient had good strength in both legs with normal sensation. On May 13 she complained of severe lower back and left thigh shooting pain. At 3 p.m., PT charted that the patient was unable to complete her exercises because of pain and bilateral leg weakness. Hospitalist A was notified about the PT findings and ordered a lumbar spine X-ray, which was negative. On May 14 at 12:15 a.m. the patient be-
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came more confused, hallucinated, could no longer lift her feet, complained of shooting pains in both legs, and was unable to plantar flex on the left. She remained incontinent. She was seen by hospitalist D, but her neurological status was not assessed. At 9 a.m. she was seen by hospitalist A, who noted that the international normalized ratio was 5.1. The Coumadin was discontinued, and she was given vitamin K. He consulted a neurologist by phone, and a stat cervical and thoracic spine MRI was ordered. The neurologist saw the patient at 8 p.m. and felt she was developing a progressive T4 myelopathy. The stat MRI had not been performed, so he reordered it ASAP. His differential included epidural hematoma due to the episodes of falling with an INR of 5.1 and epidural abscess. On-call hospitalist D called a neurosurgeon, but the neurosurgeon was unwilling to operate because of the INR of 5.1 and the absence of an MRI. At 10:30 p.m. the MRI was attempted, but the patient was unable to cooperate and the study was nondiagnostic. Hospitalist D called the neurologist but spoke with the on-call physician, who said a repeat MRI could wait until morning. On the morning of May 15, an MRI
showed discitis with osteomyelitis at T7-8, with an epidural abscess compressing the spinal cord. The patient was taken to surgery for spinal decompression and fusion. After a lengthy rehabilitation, she remained paraplegic with bowel and urinary incontinence. What Is the Standard of Care? Both defense and plaintiff experts opined that the patient had an epidural abscess at admission caused by the E. coli bacteremia, which probably originated from the urinary tract. The physicians failed to consider epidural abscess in their differential diagnosis — and to order an MRI of the spine and a neurology consult. The standard of care required the hospitalists to read nurses’ notes and PT assessments and to conduct thorough neurological examinations to evaluate the evolving neurological deficits. When the patient was admitted on May 10, hospitalist A failed to review the ED record containing the urine culture report < 10,000 CFU/ml and did not perform a neurological examination. On May 11 he failed to reorder the missing urinalysis, which would not have supported the diagnosis of acute pyelonephritis — and when the admission urine culture was negative, he should have considered the possibility of epidural abscess. On May 12 he failed to examine the patient after receiving a call about the second fall and failed to conclude that the patient was deteriorating neurologically. Hospitalist B failed to review the chart and nursing entries from admission and the ED visit. He should have examined the patient on May 11 when her legs “gave way” and she fell. Hospitalist C should have examined the patient when first notified on May 12 of her 2/5 LLE weakness and bowel and bladder incontinence. When he examined her later that night, he failed to detect the neurological deficits in her legs. Hospitalist D’s failure to do a neurological assessment, order an MRI, and obtain a neurology consult after midnight on May 14 delayed the diagnosis by nine hours, thereby decreasing the patient’s chance to regain neurological function. Should This Claim Be Tried? While the admission diagnosis of acute pyelonephritis was reasonable, the urine culture was negative, and when the pain became more severe and progressive neurological symptoms developed, spinal epidural abscess should have been considered. An MRI of the spine and a neurology consultation would have led to the diagnosis, and definitive treat-
ment could have been performed prior to developing irreversible neurological deficits. Despite progressive neurological findings, the insureds failed to order an MRI or neurology consult until May 14. Defense expert reviews were nonsupportive for both the standard of care and causation. At the hospitalist group’s request, the claim was settled within their policy limit. What Can Be Learned From This Claim? Spinal epidural abscess (SEA) requires prompt diagnosis and treatment to prevent serious neurological complications. While infrequently encountered in clinical practice, SEA is not infrequently seen in malpractice claims. The alleged negligence is usually a delay in diagnosis resulting in paraplegia with urinary and/or bowel incontinence. The delay typically results from failure to consider SEA in the differential diagnosis in a patient with progressive neurological deficits and severe low back pain. Some claims result from a delay in obtaining an MRI when SEA is considered, either because the hospital doesn’t have an MRI and there is delay in transferring the patient to another facility or because an MRI can’t be done at night or on weekends. SEA is rare among the many causes of back pain. Fever is an important diagnostic clue because it is not present in most cases of musculoskeletal back pain, such as herniated disc. Fever in a patient with severe, localized back pain, especially if the pain is worsened by percussion, suggests the diagnosis of SEA. Routine laboratory studies are seldom helpful; the leukocyte count may be elevated or normal. Once the diagnosis is considered, spinal imaging is imperative. MRI is preferred because it is positive early in the infection. CT scanning with gadolinium contrast is an acceptable alternative. Plain radiographs of the spine may reveal osteomyelitis or discitis but are rarely diagnostic of SEA. The classical diagnostic triad consists of fever, spinal pain, and neurological deficits. However, few patients have all three components at presentation. Over time, if untreated, symptoms progress in a typical sequence: • Back pain, often focal and severe, then • Root pain, described as “shooting” or “electric shocks” in the distribution of the affected nerve root, then • Motor weakness, sensory changes, and bladder or bowel dysfunction, and then • Paralysis, which may quickly become irreversible. Irreversible paraplegia occurs in up to 22 percent of patients, and recovery is unlikely if paralysis is present for more than 24 hours prior to surgery.
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SEAs typically begin in the thoracolumbar spine as an infection involving the vertebral disc or the junction between the disc and the vertebral body. The abscess then extends longitudinally in the epidural space, and damage to the spinal cord results from direct compression, thrombophlebitis of epidural veins, or interruption of the arterial blood supply. Epidural catheter placement is a common risk factor for SEA (risk is lower when catheters are placed for short time periods). Other risk factors include diabetes mellitus, HIV infection, trauma, tattooing, acupuncture, local spinal injections, and bacteremia secondary to distant infection or intravenous drug use. The approximate frequency of the bacterial causes of SEA (excluding mycobacteria) is Staphylococcus aureus, 63 percent; Gram negative bacilli, 16 percent; Streptococci, 9 percent; coagulase-negative staphylococci, 3 percent (mostly in patients with prior spinal instrumentation); and anaerobes, 2 percent. Approximately one-third of patients have no identifiable source for the infection. Among the two-thirds with an identifiable portal of entry, the most common sites are infections of the skin and soft tissues and complications of spinal surgery or other invasive procedures, including epidural catheters left in place for pain control. Up to one-third arise from hematogenous infection. With SEA, the approximate frequency of positive cultures in abscess contents is 90 percent; venous blood, 62 percent; and cerebrospinal fluid (CSF), 19 percent (Gram stain of CSF is usually negative). Surgical decompression and drainage with systemic antibiotic therapy is the treatment for most patients. ✚ References: • The following reference is from UpToDate, Rose BD (Ed), UpToDate, Waltham, MA 2008. Copyright 2008 UpToDate, Inc. Accessed on March 16, 2009. For more information, visit www. uptodate.com. • Durack DT, Sexton DJ. Epidural abscess.
Abou t t h e Au t h o r: Dr. Troxel is medical director on the board of governors for The Doctors Company, SDCMS’ endorsed partner for professional liability insurance. Most SDCMS members are eligible for a 5 percent discount on insurance premiums and a 7.5 percent dividend credit. To learn more, contact Janet Lockett at SDCMS at (858) 300-2778 or at JLockett@ SDCMS.org.
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Clinical Trials
Trial
rror E from
and
to Rational Drug Prescription
More Routine and More Widespread in the Coming Years
By Robert E. Peters, PhD, MD
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“Mass-production medicine,” one of the results of standardized healthcare, frequently ignores the metabolic and biochemical uniqueness of individuals. It does so specifically with respect to prescribed medications. Emerging genomic data and accumulating knowledge about how to utilize those data suggest that we will, in the future, be able to identify and consider the metabolic uniqueness of individuals prior to prescribing many medications. To do so would improve the delivered efficacy of many prescribed drugs. One unintended but very common result of medicine as practiced today is the frequent serial prescription of different medications to the same patient over several office visits, toward attempts to successfully treat a presenting pathology or symptom. It is not unusual for a patient to face at least two prescriptions and two or more office visits over a period of several months prior to getting the prescription “right,” i.e., the correct medication at the correct dose. The anti-hypertensive medications, anti-depressant medications, and lipid-lowering drugs are, about as often as not, incorrectly prescribed the first time the patient is seen by the physician. Emerging molecular diagnostic tools, many of them outgrowths of the Human Genome Project, present new opportunities to correct or avoid at least some of these problems. These new molecular tools can potentially be applied first where we know our success rate is poorest in matching the patient to the proper prescribed drug. Applying these new molecular-level patient-assessment tools will result in a new in vitro diagnostics market segment that has already begun to emerge and one that will grow significantly in the next six to eight years. This new market segment will result from the expanding role that laboratory diagnostics will play in generating information that will better match patients to efficacious drugs. It will involve the use of techniques such as identification of single nucleotide polymorphisms (SNPs) and other nucleic acid test methods to identify which medication (or medication class) is best for a particular patient. Information regarding dosage selection and potential side effects will also be obtainable in many cases. New test methods will extend beyond those currently available. In many circumstances the initial availability of nucleic acid test methods will result in the development of simpler, faster, and lessexpensive enzyme or antibody-based tests to accomplish the physician’s objective of matching the right medication at the proper dosage to each patient. Why is “Trial and Error Prescription” routine in today’s medical practices? To a significant degree it is because of repetitive, routine pressures within the healthcare system of most nations to a) reduce the contact time between patient and physician, and b) practice “one-size-fits-all” medicine, including the prescription of drugs. We are, more and more frequently, treating all patients, regardless of sex, age, ethnicity, etc., who present with a given malady as if their metabolisms, biochemical pathways, body parts, and the available medications are essentially interchangeable. The result is that “bell curve” medicine is often practiced. We script medications documented to benefit most of the patients most of the time. Following this strategy, one would expect to achieve the “average” treatment objective for the “average” patient. Unfortunately, patients are often
led to expect optimal, rather than average, results. In this bell curve analogy, for the patient who falls to the “left end” of the -2 sd range, the medication may have no therapeutic benefit whatsoever. For a patient at the other end of the curve, the +2 sd range, the drug may result in hyper-susceptibility, unacceptable side effects, or toxicity. This lack of efficacy for a significant percentage of patients may occur with many more types of medications than we realize. The feedback signals indicating a lack of efficacy may be more subtle for many medications, but the lack of efficacy is just as common as it is for initial prescriptions of, e.g., anti-depressants where it can be readily seen. The extent of the waste of healthcare resources may far exceed anything we anticipate or that anyone has attempted to quantitate. Lack of efficacy is, of course, not always the result of metabolic differences between patients. In some cases side effects may prohibit use of a drug for some patients. Or a physician may have misdiagnosed the patient and prescribed inappropriate medication. Lack of patient compliance is another significant problem that reduces delivered efficacy. However, even with proper physician diagnosis and optimal patient compliance, many times the initially prescribed drug does not deliver therapeutic benefit for a patient because of the metabolic uniqueness of that patient. Can this be avoided? Yes! It can be avoided by using the knowledge we are continually gaining from ongoing pharmacogenomic studies. But it will require re-thinking of the drug prescription process. As a reference point for the concept of “Rational Drug Prescription,” let’s think about “Rational Drug Design,” a term popularized about 10 years ago within the pharmaceutical industry. The underlying notion of Rational Drug Design was that instead of the random screening of compounds or targets when looking for a new drug, it would be more efficient to first understand the drug and the drug target at the molecular level, then “rationally” design, or select, a compound to fit the particular drug target. The analogous concept with respect to prescribing medication is to obtain additional data regarding a patient’s clinical responsiveness to a medication prior to prescribing it. Rational Drug Prescription is having the data to prescribe the right drug for each patient at the right dose the first time the patient is seen by a physician. I believe that this new prescription mechanism will significantly improve both the delivered efficacy for scripted medications as well as provide business growth opportunities for the clinical labs that do the testing. We are now beginning to see the first examples of prescribing medications using this rational approach. The physician selects the drug and the dosage only after he or she knows, at the molecular
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level, that the patient will benefit from the medication. Herceptin (used to treat breast cancer in patients whose tumors overexpress the Her2 marker and which is ineffective in those that don’t) is a prime example of such a prescription strategy. We are also seeing similar uses of this approach for selection of therapy for patients who have cardiac disease, high cholesterol, depression, some cancers, HIV, and a variety of other conditions. In fact, about 10 percent of drugs approved by the FDA today carry pharmacogenic information on their labels to help physicians target patients for whom these drugs will be efficacious. Let’s consider the economic implications of this system. Even if a physician is designating generic drugs at the least possible cost per prescription, a first-time success rate of only 40–60 percent “correct” medications and dosages — as it is for some of the most frequently scripted medications — represents a dramatic waste of healthcare resources. Rational Drug Prescription is considered a logical concept by most people with whom I have discussed the topic, including physicians who must currently make the empirical script-writing decisions. Logic, however, doesn’t always drive the reimbursement process. Who will pay for the incremental lab testing required to accomplish Rational Drug Prescription? Answer: the insurers — Medicare, Blue Cross, Prudential, Kaiser and others will pay. Why will third-party insurers be willing to pay for additional lab testing? Because for many patients it will cost less to do the testing than it costs to do things as we do them now. The lab test will often cost the insurer less than multiple office visits and serial incorrect prescriptions. Outcome studies for these lab tests from clinical trials will of course be required to demonstrate both the clinical and the economic advantages of Rational Drug Prescription, and these are happening more and more frequently. While the incremental
Additional office visit(s), additional prescriptions filled, continued patient illness or symptoms, days lost from work — these are the major hidden costs of Trial and Error Prescriptions. The insurer is already paying many of these costs. Rational Drug Prescription will lower the insurer’s total costs for many types of prescribed medications.
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cost of the additional lab test is immediately apparent, the major incremental costs currently incurred by our healthcare system resulting from “Trial and Error Prescription” are hidden. These hidden costs are generated by the additional healthcare infrastructure contacts required for the patient while the patient remains ineffectively treated. I believe that for many categories of patients, these hidden costs will be shown to often far outweigh the cost of additional lab testing. Additional office visit(s), additional prescriptions filled, continued patient illness or symptoms, days lost from work — these are the major hidden costs of Trial and Error Prescriptions. The insurer is already paying many of these costs. Rational Drug Prescription will lower the insurer’s total costs for many types of prescribed medications. The tension regarding getting an insurer to reimburse for anything — a new lab test, a new surgical procedure, a new drug — is all about “who pays?” and “who saves?” When the payer is also the saver, it becomes a relatively simple economic decision. The insurance industry is very good at economics. Insurers will pay for a new lab test if it identifies the right drug at the right dosage to be delivered to a patient the first time because it will cost less to do so from the perspective of total cost of patient management, even with the added cost of the new lab test. Consider the economics of capitation payments in managed care systems. Most of these programs begin to lose money if a patient is in contact with healthcare resources more than about 1.6 to 1.8 times per year. The specific details vary by plan and by the particular population covered, but it is gener-
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ally fewer than two visits per year or the patient becomes not profitable for the insurer. From the insurer’s point of view, in the best scenario, the capitated patient wouldn’t use healthcare resources at all during the covered year. If there is to be use of these resources, then the most cost-effective strategy is to see the patient once, manage the problem as efficiently and effectively as possible, and send the patient home. So the third-party payer should have no problem with the math. Insurers can determine when additional lab results become cost-effective. Any insurer can figure out whether adding a lab test at a given cost on a first visit will or will not cost less than two additional office visits and more potentially incorrect prescriptions, and that is without consideration of the quality of care for the patient. Rational Drug Prescription will be less expensive than Trial and Error Prescription because it will reduce office visits, reduce total healthcare resource consumption, and improve patient care. It will be less expensive even if it does add some new lab testing to the mix, and it will be reimbursed because for many patient circumstances it will reduce the total costs of care.
We are entering a new era of how prescriptions will be written. It’s already started, and it will result in an expanding category of in vitro diagnostic products and a new market segment in the clinical laboratory market. So, as you monitor the opportunities and the dynamics for pending new medications in the coming years, be aware of the hidden costs of “Trial and Error Prescription.” Be aware of the economic advantages of “Rational Drug Prescription.” These kinds of tests are already beginning to be used. It is going to become more routine and more widespread in the next few years. We are entering a new era of how prescriptions will be written. It’s already started, and it will result in an expanding category of in vitro diagnostic products and a new market segment in the clinical laboratory market. ✚ A bout the Au t h o r : Dr. Peters, SDCMS and CMA member
since 2000, is a family physician in private practice. He earned a PhD in biochemistry at the University of California, Riverside, with postdoctoral fellowships in endocrinology and cancer immunology, and his MD from Loma Linda University School of Medicine. Dr. Peters is a member of the SDCMS GERM Commission, co-chairs Sharp HealthCare’s Primary Care Conference, is a member of the bioethics committee at Sharp Memorial Hospital, and sits on CMA’s Council on Ethical Affairs. Dr. Peters also serves as a consultant to biomedical and pharmaceutical companies.
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Clinical Trials
The history of clinical research spans the centuries. One of the first systematic clinical trials was conducted in the1700s
by Dr. James Lind, who
demonstrated on board the
HMS Salisbury that adding
citrus fruits to the diet of sailors could prevent and cure scurvy. This was a classic, controlled clinical experiment in which the proof of success was the positive response seen in the sailors who were fortunate to be in the group given oranges and lemons as a dietary supplement, as opposed to those who were given vinegar, cider, garlic paste, or sea water. Today, purists might critique the study design due to the lack of a double-blind control, but the results were so clear that even skeptics would probably accept it as evidenced-based. Amazingly, it took four decades after Lind’s experiment before the British Admiralty ordered the use of citrus juice on board ships. Translation of clinical research into community practice still lags today, although the timelines are obviously more compressed, and we are working to close the gap even further.
Translational
Medicine the next frontier
By Gary S. Firestein, MD
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The New Paradigm: Translational Research Over the years, the controlled clinical trial model has been a foundation of research. In the simplest construct, once we have identified a potentially useful intervention, we treat the patient, perhaps with a promising new medicine, usually comparing the active therapy with a control group. We carefully document the clinical course of each group to determine outcome of the treated patients vs. the controls. Well-designed clinical trials following this model have advanced modern medicine and led to breakthroughs in the prevention and management of disease. But, in today’s complex world, traditional clinical research is only part of the equation. Today, we are entering a new era of medical advances based on the spectrum of integrated research-and-development efforts known as translational research. This is the continuum that allows us to move laboratory discoveries into clinical application as quickly, safely, efficiently, and cost-effectively as possible. And, based on feedback from patients and clinicians, researchers are
by Ellen Beck, MD
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stimulated to continue seeking answers to new questions — from bench to bedside and back. At a time when healthcare costs are spiraling out of control, and the considerable expense of drug development is a significant factor in the willingness of public agencies and private industry to sponsor projects, our objective is to shrink the gap between concept and completion of a novel therapeutic intervention that will benefit patients. With translational research, we apply powerful new technologies to the study of new drugs, first in tissue or pre-clinical models, and then in human subjects. The goal is to learn at the earliest possible point in drug development if a promising new treatment is safe, and if it can improve or save lives. We hope to short-circuit the traditional paradigm by using modern technology to get a signal of efficacy using much smaller numbers of patients compared with a standard clinical trial. Centers like UC San Diego’s Clinical and Translational Research Institute (CTRI) provide a framework to facilitate collaboration among basic scientists, clinical investigators, private industry, community-based clinicians, and patients to accelerate the development of new therapies (our website is http://ctri.ucsd. edu). San Diego is fortunate to have a robust pharmaceutical and biotechnology community to participate in these endeavors, in addition to our region’s status as one of the world’s leading biomedical research centers. These assets, along with a highly engaged healthcare community, with health systems and physicians throughout the county committed to providing patients access to advanced care and promising clinical studies, position San Diego as a leading center for drug and technology discovery and development. Three emerging technologies in particular are changing the way we approach clinical research and drug development: biomarkers; advanced imaging technologies; and biomedical informatics. Biomarkers are molecular flags that can be used to monitor biological systems in the context of a clinical trial. Common examples of biomarkers include cholesterol for cardiovascular disease and hemoglobin A1c for diabetes. More sophisticated biomarkers looking at gene expression, proteomics, or metabolomics can provide a detailed look at the effect of an experimental agent on biological processes. For instance, in my own area of specialty, we could assess whether an agent that blocks a particular enzyme in a disease like rheumatoid arthritis might decrease TNF production in a patient. Because TNF blockade is very effective in this disease, this could be a signal that predicts efficacy in a larger clinical study examining joint swelling and tenderness. As we understand more about pathogenesis and an individual’s predisposition to disease, biomarkers also have the potential to be used diagnostically at the earliest stages of disease development, or as predictive indicators of a patient’s likely response to certain interventions. If we can determine what subsets of patients are most likely to respond to certain therapies, this will also allow us to improve patient selection as we move forward with a clinical trial. Advanced imaging technologies give us the same opportunity for early diagnosis and measurement of disease progression, enabling us to begin treatment before the patient has suffered irreversible damage. Through the CTRI, under the leadership of Dr. Robert Mattrey, professor of radiology and director of our Im-
aging Resource, we can monitor the effects of intervention with standard or experimental therapy utilizing a range of imaging capabilities. These include molecular imaging that can assess cell function, enzyme activity, and gene function, as well as MRI and functional MRI, PET, SPECT, and ultrasound to monitor functional systems such as blood flow and metabolism, anatomical structures such as organs and the musculoskeletal system, and abnormalities such as tumors and damaged neurons. These technologies can give us early insight into whether a novel, therapeutic approach alters disease progress or promotes healing. Biomedical informatics is the information bridge that has become key to broad-based collaboration and to compiling, mining, and rapidly analyzing the massive data sets collected across disciplines and continents. Biomedical informatics tools enable us to recognize patterns in data that were previously impossible to analyze, and tap into large populations to expedite large-scale studies, engaging study subjects and investigators around the globe. For example, the increasing use of electronic medical records (EMR) in hospitals and medical group systems provides
Today, modern technology supports a virtual superhighway of research activities, leading from molecule to man, resulting in discoveries that will redefine 21st century medicine. a rich repository of clinical information that can be accessed through HIPAA-compliant systems and correlated to biomarkers, imaging, and clinical responses. The data mining and computational capabilities available through the CTRI’s Biomedical Informatics Resource led by Dr. Lucila Ohno-Machado, professor of medicine, and resources like the San Diego Supercomputer Center, California Institute for Telecommunications and Information Technology, and the National Biomedical Computation Resource, all based at UC San Diego, allow us to conduct preliminary validation studies as well as large-scale clinical trials with speed and accuracy never before possible. With these and other technologies, those of us who are involved in research to prevent and cure disease are excited about the future. The dialogue and collaboration between laboratory scientists, clinical researchers, bioinformatics experts, and physicians committed to improving patient care is bolstered by this arsenal of new technologies. The basic principles of clinical research forged by Dr. Lind when he fed citrus fruits to a few sailors suffering scurvy still hold true. But today, modern technology supports a virtual superhighway of research activities, leading from molecule to man, resulting in discoveries that will redefine 21st-century medicine. ✚ Abou t t he Aut ho r: Dr. Firestein, SDCMS and CMA
member since 2009, is dean of translational medicine, professor of medicine/chief, rheumatology, allergy and immunology, and director of the UC San Diego Clinical and Translational Research Institute, UC San Diego Health Sciences.
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Clinical Trials
interview with
William P. Hitchcock, MD 32
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Dr. Hitchcock, SDCMS and CMA member since 1988, is a boardcertified pediatrician who has practiced in San Diego for more than 21 years. He is a fellow in the American Academy of Pediatrics, founder of La Jolla Pediatrics and La Costa Pediatrics, assistant clinical professor of pediatrics at UCSD, and an attending at Rady Children’s Hospital of San Diego. Dr. Hitchcock has been involved in clinical research for more than 12 years in the areas of asthma, allergy, infectious disease, and vaccines. San Diego Physician: How did you get involved in clinical trials? Dr. Hitchcock: Initially, I was approached by a few companies to look at eardrops for swimmer’s ear and a new, once-a-day antibiotic for strep throat. Once you start to do one or two studies, your name gets out there, and the companies approach you.
San Diego Physician: How did they first find you? Dr. Hitchcock: I think in the beginning it was word-of-mouth. Sometimes you get invitations by email from, for lack of a better term, headhunters, who will somehow have gotten your name and will approach you. Also, I’ve published articles related to infectious disease vaccines and asthma, and I think some companies saw my name and knew I was interested in that area, and they approached me.
San Diego Physician: What if a physician wanted to become involved? Does she have to wait to be approached? Dr. Hitchcock: No. All active clinical trials by any company or any vaccine-related trials are online with the FDA, CDC, and other organizations. There are two committees within the American Academy of Pediatrics that I’m involved with: the Pediatric Research in Office Settings (PROS) and the Quality Improvement Innovation Network (QuIIN). These are groups of primary care physicians that are interested in getting involved in clinical trials, many of which aren’t product-based or pharmaceutically based, but rather based on looking at management areas or outcomes.
San Diego Physician: Talk about the recruitment of patients a little bit. Is it difficult? Dr. Hitchcock: We currently recruit directly from our own patient population. I do send out announcements to other practices to inquire if they have any patients that are interested. We also post flyers in our office and have recordings on our answering machine giving information about trials. If I have patients that potentially meet the criteria for a given clinical trial, then I approach the parents. Recruitment has not been difficult in our practice so far. Some physicians do use the media to advertise clinical trials. I haven’t tried this yet.
San Diego Physician: Do you suspect any internal industry bias, however unintentional, in the design of clinical studies? Dr. Hitchcock: I haven’t been involved with any trial where I thought there was internal bias, mainly because it’s usually a new product compared with a placebo and I’m blinded. In a clinical trial, we’re producing and gathering the data, but then it’s the pharmaceutical company that analyzes the data and then presents that data to the FDA. So if there might be any bias, that’s probably the level it might occur. I think the FDA over the last five years has gotten much more critical of data, and, at times, maybe too critical or too demanding, but I think that’s important to avoid internal bias and to make sure the product is as safe as possible once it’s licensed to the public.
San Diego Physician: Talk about the different individuals involved in a clinical trial. Dr. Hitchcock: First you have a principle investigator. That person basically is responsible for everything: reviewing the contract, reviewing the protocol, reviewing any inclusion/exclusion criteria, making sure all of the data is entered and recorded correctly. Whenever there are queries by the IRB or by the drug company itself, this principle investigator is ultimately responsible to make sure questions get answered. Any particular results, lab work, cultures, and so forth have to be reviewed by the principle investigator. You can have sub-investigators as well. This may involve other physicians, physician assistants or nurse practitioners who also gather data, recruit patients and administer the product you are studying. The study coordinators are responsible for collecting and recording data whether it’s a hardcopy binder or online. Many studies require online data entry. If there are any questions or queries, those initially get handled by the coordinator.
San Diego Physician: Do you have to have a coordinator? Dr. Hitchcock: Some simple studies may not require a coordinator, but most studies require one. Any companies that approach you want to make sure you have someone who’s designated at least 50 percent of their time. Often the review board will meet monthly
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with the research coordinator to go over any questions. At this time data will be reviewed to determine if it’s been entered according to protocol. If there are protocol violations or deviations, they have to be explained.
San Diego Physician: What do you need in your office to conduct a typical clinical trial? Dr. Hitchcock: You have to have online ability to enter data from the chart into the study database. Electronic medical records would certainly be ideal — although it’s not an absolute requirement, it might be in the near future. You certainly need staff. If the study involves a drug, you must have storage space that’s secure. When it comes to vaccines or culture specimens, you need a designated refrigerator which must be monitored for temperature and stability.
San Diego Physician: Describe the typical trial. How many patients? How long does it last? Dr. Hitchcock: It really varies depending on the duration of the study and budget. Some studies can be as short as six weeks. Others can last 12 months or longer. Studies can involve 10 to 100 patients or more.
San Diego Physician: Talk about budget for a little bit. How do you work out the payment with the company? Dr. Hitchcock: The company gives you a budget proposal, then you estimate the amount of time that’s needed, the cost of your staff, equipment, supplies and handling. The budgets are really quite variable. Some companies may offer several hundred dollars per patient; others may offer several thousand.
San Diego Physician: What are your motivations for being involved in clinical trials? Dr. Hitchcock: Personally, I’m interested in anything that might improve the care of my patients and my ability to provide care. When it comes to new medications or vaccines, I feel very comfortable discussing them with parents if I’ve been involved in the primary research. It also improves my base of knowledge and my understanding of disease states, and it exposes me to people that are specialists in certain areas. Being able to have dialogue and exchange with these people makes me a more knowledgeable and better physician. ✚
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Clinical Trials
Improving Patient are
C
Through Clinical Research
By Ravindra Mehta, MD
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As practitioners, we play the role of detective. In order to do what’s best for our patients, we are constantly asking questions and forming hypotheses, from diagnosis to selection of the best course of treatment. Physicians inherently look beyond what is obvious. We don’t say, “Here’s the edge of the frontier, I’m going to stop here.” We always ask, “Am I offering the best I can, or are there new avenues, new knowledge I can offer? Are there other ways to attack and solve this problem?” Clinical research gives us the opportunity to integrate research into our practice and contribute to medical progress by developing new approaches to preventing and treating disease and injury in our patients. Not everyone chooses to pursue a researchfocused career, but that doesn’t mean we can’t all be engaged in clinical research. In fact, private practice clinicians are at the front line of approaching patients to become involved in clinical studies, which is a vital ingredient in the transfer of research into the clinical setting, and also in bringing questions back to the researchers who are working to develop new therapeutics. Our ability to gain greater understanding leading to new interventions that make a difference in people’s health is dependent on a well-informed population — people who not only support clinical research but who are willing to participate. More than ever, today’s research paradigm depends upon a broad spectrum of research activities and research partners, including collaborators and volunteers representing a wide range of ethnic, cultural, and socioeconomic groups, ages, and genders. The National Institutes of Health Roadmap describes four basic steps in the research continuum: from preclinical studies to humans (safety studies); to patients (controlled observational studies); to practice (dissemination and implementation research); to outcomes evaluation, where new questions and gaps in care are identified. For these last steps, the involvement of a diverse community well beyond the academic or research enterprise is critical. But what does the average patient think of when he or she hears the word “research,” and as clinicians how can we help our patients participate in research if they are interested? When many of our patients hear “clinical research,” they often think first of experimentation, but that isn’t necessarily true. Clinical research can involve studying a new drug or therapy, but it can also be outcomes or quality improvement research, or largescale epidemiology studies. Participants in such a study might be asked just to give a tissue sample or fill out a questionnaire. UC San Diego’s Institutional Review Board (IRB) has a database of more than 3,500 active human research protocols. More than 650 of these are clinical trials involving FDA-regulated drugs and devices. Collectively, these studies offer a variety of options for participation, from clinical trials of promising new therapies for specific diseases, including surgical interventions, to studies of behaviors and other factors associated with disease risk in large, or very specific, populations. A few examples: • The UC San Diego Shiley-Marcos Alzheimer’s Disease Research Center is launching a phase 2 clinical trial to test a gene therapy treatment for Alzheimer’s disease called CERE-110, which has been shown to safely induce long-term production of Nerve Growth Factor (NGF), a natural brain cell-survival molecule. CERE-110 will be injected directly into the nucleus basalis of
Meynert (NBM) of the brain, the site of the cholinergic system, where neuron death occurs in AD. Exposing these cells to NGF may preserve function, prevent further cell loss, and potentially slow intellectual decline seen in Alzheimer’s patients. • Researchers at the Moores UCSD Cancer Center are using a modified herpes virus to treat advanced melanoma, hoping to kill the cancer cells while boosting immune defenses against the disease. Dr. Gregory Daniels and his team are comparing OncoVEX GM-CSF to general immune system stimulation with the immune-boosting protein GM-CSF in an international phase 3 trial. The injected virus appears to preferentially infect cancer cells, leading to tumor death. The expression of the GMCSF protein may also direct an immune attack against infected and non-infected tumors. • A new clinical trial is evaluating whether or not diet intervention, prompted by phone calls, may be effective in managing bladder cancer. Evidence suggests that dietary counseling can be beneficial in weight loss, smoking cessation, and breast and prostate cancer prevention. This study, open to men and women over 50 who have bladder cancer, will provide phone-based dietary counseling or print materials to guide nutritional decisions. • Drs. Santiago Horgan and Mark Talamini and colleagues are conducting clinical trial surgeries to evaluate the safety and effectiveness of performing abdominal procedures through the body’s natural openings. The experimental procedure, called Natural Orifice Translumenal Endoscopic Surgery (NOTES), involves passing surgical instruments and a tiny camera through a natural orifice, such as the mouth or the vagina, to the diseased organ such as the gallbladder or appendix, which can then be removed through the orifice. This study and others involving single-incision surgeries are providing scientific evidence to show whether minimally invasive techniques that avoid major incisions through the skin, muscle, and nerves result in quicker recovery with less pain and scarring, and reduced-risk of postoperative hernias. • In 1972, UC San Diego professor Elizabeth Barrett-Connor launched a long-range population study involving 6,000 residents of Rancho Bernardo. Health and lifestyle data collected from participants over several decades have been analyzed by scores of investigators, resulting in more than 400 scientific papers, and greatly inEvery physician creasing our knowledge of cardiovascular disease, can play a role diabetes, cancer, osteopo- in changing and improving the rosis, and exogenous and endogenous hormones. practice of medicine. The robust database con- You don’t have to commit a great deal tinues to provide a basis for ongoing studies, and of time to becoming the connections between a “researcher” to get involved in clinical lifestyle, behavior, and research. healthy aging.
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For the clinician interested in getting involved in research, there are a number of options. As a starting point, you can provide information to a patient who might be interested in or benefit in some way from joining a clinical trial. When advising patients about volunteering for a research study, it’s important to ensure they understand that a clinical trial isn’t the same as clinical care, and it may or may not be beneficial. But I find that many people want to participate in helping to gather new knowledge and in driving innovation. The physician can explore these possibilities with the patient and assist the patient in finding appropriate studies. A more active approach is actually recruiting patients into a study; and more active still is to learn methodology and become a collaborator. When evaluating an opportunity to be engaged in a research study, carefully review the protocol and the sponsor, and do a feasibility assessment. Ask questions: Is the protocol ethical and scientifically sound? Is it consistent with clinical practice? Do I have an adequate and appropriate patient population, or will I need to recruit? What are the staffing and budgetary needs of this study, and can I cover the costs? Physicians interested in becoming more engaged in clinical research should consider enhancing their skills and knowledge
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of clinical trials principles and methodology as a first step. There are courses available, such as the UC San Diego master’s degree in clinical research, designed for healthcare professionals seeking advanced training in research methods and protocols. Further details on the MAS program can be accessed at http://clre. ucsd.edu. Next, learn about what research opportunities are available by contacting commercial research organizations, pharmaceutical companies, or academic centers like UC San Diego. Attending lectures and symposia is another way to get information and to engage with a clinical and translational research network. My message to colleagues is that every physician can play a role in changing and improving the practice of medicine. You don’t have to commit a great deal of time to becoming a “researcher” to get involved in clinical research. ✚ Abou t t he Aut ho r: Dr. Mehta, SDCMS and CMA member since 2005, is professor of clinical medicine, associate chair for clinical research, Department of Medicine, UC San Diego Health Sciences, and director of UC San Diego CREST (Clinical Research Enhancement Through Supplemental Training) and Masters of Advanced Studies in Clinical Research programs.
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Clinical Trials
Two of the most comprehensive databases for finding clinical trials information — ClinicalTrials. gov and the National Cancer Institute’s (NCI) PDQ database — have been available since the mid-1990s, but these tools primarily focused on trials related to life-threatening diseases. However, a trend over the past few years is the establishment of national and international clinical trial registries for all types of conditions and diseases. Not only can these registries direct clinicians and patients to active clinical research, but the trial registry number allows for easier connection between the published literature and the trial protocol. In 2007, the FDA Amendments Act required the registration of and basic results reporting for all clinical trials of drugs, biological products, or devices conducted in the United States, whether privately or government-funded research, and additional efforts by the World Health Organization have helped spur these efforts. The ClinicalTrials.gov database from the National Institutes of Health and National Library of Medicine is now the required repository for FDA-mandated registration and results reporting. One can search for trials that are recruiting, completed, terminated, or active/not yet recruiting. For completed trials, within one year of their final collection of data, a report must be filed that includes basic trial results, and published articles should in-
Clinical Trial Resources registries, results, and more
By Karen Heskett
clude the unique registry number. More than 4,000 articles in PubMed are linked to a ClinicalTrial.gov registry number. The PDQ database from NCI (Cancer.gov/clinicaltrials) is a cancerspecific resource that includes a variety of trials, from interventional to observational to supportive care research. These two databases, with their freely available information, feed many other clinical trial resources — both internationally and within the United States, including sharing information with each other. A variety of tools for finding clinical trials information have sprung up from nonprofit companies as well as for-profit companies, each with some interesting or unique features. The following highlight just a few of the key players along with some unique resources.
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• CenterWatch (CenterWatch.com): The CenterWatch Clinical Trials Listing Service, although mostly U.S.-centric, is a tremendous database of clinical trials from government- and industryfunded research, and also includes “healthy patient” trials. The general clinical trial database is a free resource, but the Drugs in Clinical Trials Database is available by subscription only. • Center for Information and Study on Clinical Research Participation (CISCRP) (SearchClinicalTrials.org): This is a fairly new resource that includes trial information from pharmaceutical companies, ClinicalTrials.gov, and CenterWatch, including the healthy patient trials. CISCRP’s key objective is patient education; the center offers its database as part of that mission. The database has a basic search form with three handy tabs for searching for trials, trial results, or trial news. • International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) (http://clinicaltrials.ifpma. org): Another far-reaching database of ongoing and completed trials with a recent focus on pediatric trials. The IFPMA Clinical Trials Portal includes results of studies and, given its strong industry connection, may prove to be a very valuable site for trial results. The information is pulled from ClinicalTrials.gov, Current Controlled Trials (http://controlled-trials.com), Japan Pharmaceutical Information Center, and many U.S. pharmaceutical companies. • WHO International Clinical Trials Registry Platform (ICTRP) (who.int/ictrp/en): This site is primarily a trials registry but also offers a search portal for open and recruiting trials and is the most comprehensive international resource. The cooperating countries include Australia, China, Germany, India, Iran, the Netherlands, New Zealand, Sri Lanka, and the United States. Since its inception in 2007, more than 1,200 articles are indexed in PubMed covering trials back to 2001. • PhRMA Clinical Study Results Database (ClinicalStudyResults.org): This registry is unique in that it presents results information only, and the focus is trials involving approved drugs. Information is submitted by pharmaceutical companies using
a standardized report form that provides details in a standardized, easy-to-read format. With the data from ClinicalTrials.gov and the PDQ freely available, many disease-specific organizations have repackaged that data and developed interesting tools to further disseminate clinical trial information and recruit prospective patients. The following are just two examples of disease-specific clinical trials websites:
A trend over the past few years is the establishment of national and international clinical trial registries for all types of conditions and diseases. • BreastCancerTrials.org: Designed for patients, this site has a very user-friendly design as it walks a patient through a detailed information form in order to help them find a trial that meets their specific needs. It also offers a browsable list with easily understood trial summaries with links to the full trial details when needed. • Parkinson Pipeline Project and PDTrials.org: Started as a grassroots volunteer organization, it now maintains a database of trials from pre-clinical development (laboratory studies and animal testing) to clinical trials and FDA approval. It combines information from ClinicalTrials.gov with information from the PDTrials.org clinical trial site. The pipeline database also keeps a “scorecard” of a trial’s most recent status. ✚ Abou t t he Au t h o r: Ms. Heskett is the instruction co-
ordinator for the UC San Diego Biomedical Library and liaison to the Moores Cancer Center.
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Trial Search Tool
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Tools for Alerts?
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Classifieds CLINICAL STUDIES CLINICAL STUDY: Dr. Timothy Bailey, boardcertified endocrinologist and ACRP-certified physician investigator, invites you to participate in a research study to determine if treating obstructive sleep apnea (OSA) may lead to improvements in diabetes control and other health benefits for people with type 2 diabetes. Tests results obtained from wearing a sleep-screening device in your home overnight may indicate whether or not you have OSA. If positive, you will be scheduled for an overnight visit to a sleep clinic and then assigned to sleep apnea therapy and lifestyle counseling or you will receive lifestyle counseling with sleep apnea therapy occurring upon completion of the study, if you would like treatment. If you are interested in this study or would like more information, please call (877) 567-2627 or email us at info@amcrinstitute.com. [731] OFFICE SPACE BEAUTIFULLY APPOINTED MEDICAL OFFICE SPACE to sub-lease and share with established plastic surgeon near Alvarado Hospital campus. Spectacularly upgraded and furnished, slate floors, custom ceiling, lighting, marble accents, and wall painting. 1,200 usable square feet that includes three exam rooms and office/consultation room. Separate reception and front desk space, rest room, and patient entrance. Option to share our staff. Contact office manager at (619) 286-6446 or email aips@ sbcglobal.net. [756]
NEW MEDICAL BUILDING ALONG I-15: Pinnacle Medical Plaza is a new 80,000 SF building recently completed off Scripps Poway Parkway. The location is perfect for serving patients along the I-15 from Mira Mesa to Rancho Bernardo and reaches west with easy access to Highway 56. Suites are available from 1,000—11,000 SF and will be improved to meet exact requirements. FREE RENT INCENTIVES and a generous improvement allowance is provided. For information, contact Ed Muna at 619-702-5655, ed@lankfordsd.com www.pinnaclemedicalplaza.com OFFICE SPACE AVAILABLE FOR A DERMATOLOGIST LOOKING TO EXPAND OR START A PRACTICE: The successful RiverView MD medical-dental spa is entering its second year of service to the public and is looking for the right fit with a physician with a cosmetic practice. To enquire, contact our office manager, Nancy, our dentist-owner, Shirin Dorin, DDS, or our medical director-owner, Adam Dorin, MD, MBA. The facility number is (619) 456-4555. [753]
Leasing, Renewals & Sales: Call the Healthcare Real Estate Specialists at Colliers International for a complete inventory of all available medical office space for lease or for sale in your area, or for valuable vacancy and absorption information. Use our knowledge and expertise to help you negotiate a new lease, renewal, or purchase to assure you obtain the best possible terms. There is no charge for our consulting services. Contact Chris Ross at 858.677.5329 email chris.ross@colliers.com OFFICE SPACE AVAILABLE FOR A DERMATOLOGIST LOOKING TO EXPAND OR START A PRACTICE: The successful RiverView MD medical-dental spa is entering its second year of service to the public and is looking for the right fit with a physician with a cosmetic practice. To enquire, contact our office manager, Nancy, our dentist-owner, Shirin Dorin, DDS, or our medical director-owner, Adam Dorin, MD, MBA. The facility number is (619) 456-4555. [753]
DOWNTOWN OFFICE SPACE AVAILABLE: Family practice physician in downtown San Diego has office space available. If interested, please call (858) 270-7633. [735] SCRIPPS ENCINITAS CONSULTATION ROOM/ EXAM ROOMS: Available consultation room with two examination rooms on the campus of Scripps Encinitas. Will be available a total of eight half days per week. Receptionist help provided if needed. Contact Stephanie at (760) 753-8413. [703] NORTH COUNTY INLAND OFFICE SPACE TO SHARE: We have a busy, long-established family practice that is centrally located near I-15 and Poway Road in the North County Inland area of San Diego in the attractive Sabre Springs neighborhood, and we have office space and exam rooms available. Traditional medical practice preferred, please no esthetics, etc. Contact Dr. Wickes at awickes@sbcglobal.net. [751] ENCINITAS OFFICE SPACE SUBLEASE: Beautiful, top-floor office on the Scripps Encinitas Hospital campus has available space to sublet part time or full time. Set up well for any specialty. Available at competitive rates. If interested please contact us at (760) 753-1104, ext. 1107. [745] VISTA TRI-CITY OFFICE BUILDING: For more relaxed patients and staff… Beautiful new 1,420ft2 building ready for improvements. Convenient access and parking for patients and staff. Nicely landscaped and windows throughout for a low-stress
patient experience. Street signage included. Very close to Tri-City Hospital and Scripps Coastal Medical Center with nearby freeway access. $2.50/ft2 Triple net. Please contact RBrombacher@msn. com or (760) 716-4639. [742] PHYSICIANS WANTED TO SHARE OFFICE IN CLINIC, YUMA, AZ: Directly across from new Yuma Regional Medical Center. Prime location. Several office spaces available. Your private office would be in a fully operational clinic. Shared services include reception/billing, X-ray, exam rooms, and more. Ample onsite parking, public transportation nearby. Located at 2475 S. Avenue A. For tour and questions, direct inquiries to (858) 3492007 or dottie.surdi@svn.com. [741] MEDICAL OR PROFESSIONAL OFFICE SUITES FOR LEASE, EL CENTRO, CA: In historic downtown area, near County offices, courthouse, and El Centro Regional Medical Center. Prime location; build to suit, and competitive rates with tenant incentives. 6,000ft2 can be divided; with private entrances. Near I-8 and public transportation with ample parking. Located at 441 W. State St., El Centro, CA. Direct inquiries to (858) 349-2007 or dottie.surdi@svn.com. [686]
NEW MEDICAL OFFICE BUILDING: Now leasing! Gateway Chula Vista is a new 230,000 SF SMART complex with COX Fiber broadband equipped. Conveniently located near I-5 & I-805 Freeways in Downtown Chula Vista, across and adjacent to Scripps Mercy Hospital & Sharp Rees-Stealy Urgent Care. Suites available from 950 – 20,000 SF and include generous Tenant Improvement Allowances provided. Free onsite & ample parking (Over 4 per 1000 SF). For additional information please contact James Pieri, Jr., (619) 422.8400, jamesd@mountainwest.com www.mountainwest.com MEDICAL OR PROFESSIONAL OFFICE SUITES FOR LEASE, YUMA AZ: Directly across from new Yuma Regional Medical Center. Prime location; build to suit, and competitive rates with tenant incentives. Ideal for sole practitioners. 1,000ft2 suite with private entrance or 150ft2 to 4,000ft2 within the clinic. Ample onsite parking, public transportation nearby. Located at 2475 S. Avenue, Yuma AZ. Direct inquiries to (858) 3492007 or dottie.surdi@svn.com. [685] SUITES FOR LEASE, MISSION VALLEY PROFESSIONAL MEDICAL/OFFICE BUILDING: Prime location, build to suit, and competitive rates with tenant incentives make this a fabulous value. Suites approximately 1,000ft2. At RT 15 and RT
To submit a classified ad, email Kyle Lewis at KLewis@SDCMS.org. SDCMS members place classified ads free of charge (excepting “Services Offered” ads). Nonmembers pay $150 (100-word limit) per ad per month of insertion.
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Classifieds 8, just minutes from six major hospitals. Ample parking. Easy freeway access and public transportation nearby. Visit website for Riverview Center, 3633 Camino del Rio South at http://lease.svn. com/3633Camino. Contact (858) 349-2007 or dottie.surdi@svn.com. [684] PROFESSIONAL OFFICE SPACE TO SHARE OR LEASE: Up to 1,400ft2 in a medical complex, near Alvarado Hospital, SDSU college area. Ample parking, high visibility street location, ideal for any specialty or allied medical professionals. Call (858) 243-2425 or Jim at (619) 441-1115. [733] MIRA MESA MEDICAL OFFICE SPACE AVAILABLE: Three exam rooms, two staff stations, one office/consult room, space is available three weekday afternoons. If interested, please contact our office manager at (858) 458-0940 or fax a letter of interest to (858) 458-3688. [732] LA JOLLA OFFICE SPACE FOR LEASE: Newly remodeled medical office space for lease in La Jolla. Shared space with orthopaedic surgeons. Preferably part-time needs. Convenient location near the Orthopaedic Surgery Center in La Jolla. Contact Jo Turner for more information at (619) 733-4068 or email jo@lajollaspine.com. [641] LA MESA OFFICE SPACE TO SHARE: Over 6,000ft2 OB/GYN office of three doctors, with space available immediately. Ideal for a medical practice or clinical studies and is located on Grossmont Hospital campus. Contact La Mesa OB/GYN at (619) 463-7775 or fax letter of interest to (619) 463-4181. [648] REAL ESTATE INCREDIBLE OCEAN, MOUNTAIN, AND PASTURE VIEWS make this one of the most unique and tranquil parcels in all of San Diego County, with several magnificent building sites on the property to choose from. A tapestry of La Jolla and San Diego County lights can be seen from the distant southwest on most nights to highlight the end of the day in the quaint hillside of Julian. Contact (561) 716-7577 or dave.a.sanderson@gmail.com. http://visitorscreening.net/jim/julian.html [754] PHYSICIAN POSITIONS AVAILABLE FAMILY MEDICINE / HIV PHYSICIAN: Sharp Rees-Stealy Medical Group, a 400+ physician multispecialty group in San Diego, is seeking a half-time job share BC/BE family medicine physician with HIV management experience to join our staff. We offer a first-year competitive compensation guarantee and an excellent benefits package. Please send CV to SRSMG, Physician Services, 2001 Fourth Avenue, San Diego, CA 92101. Fax: (619) 233-4730. Email: Lori.Miller@sharp.com. [752] FAMILY PRACTICE DOCTORS NEEDED: Full time and part time. Days, nights, weekends available. Fax CV to La Costa Urgent Care at (760) 6037719. [750]
PHYSICIAN EMPLOYMENT OPPORTUNITIES: Part-time and full-time openings for primary care physicians. Board-certified family practice or internal medicine physicians wanted to join our successful, prominent East County private medical group. Located on the Grossmont Hospital campus, our primary care group practices full spectrum family medicine, including hospital care. Sharp Community Medical Group providers. Ownership opportunities available. Interested applicants please send CV to eva.leonard@gfmg.net. For further information, visit us at www.gfmg.net. [747] OB/GYN PHYSICIAN SITE DIRECTOR: Founded in 1972 and located in North San Diego County. We provide the highest quality services in five different locations throughout Vista and Oceanside. Vista Community Clinic is a private, nonprofit medical, dental, and social services center, including advocacy and education programs. We serve people who experience social, culture, or economic barriers to healthcare in a comprehensive, high-quality setting. We are currently looking for a director of our OB/GYN department. This individual will be responsible for oversight of all obstetrics and gynecological services by directing and providing care for clinic and hospital patients. Providing clinical and administrative leadership for OB/GYN multi-provider clinic and multi-physician hospital group. Cover a minimum of one 24-hour per week panel shift and two clinic shifts per week. Oversee panel scheduling. Participate in clinical alliances. Must hold current CA license, DEA license, CPR certification, and be board certified in obstetrics and gynecology. Five years post-graduate clinic experience. A minimum of four years administrative experience. Bilingual English/Spanish is helpful. Malpractice coverage is provided by the clinic. May apply for state/federal loan repayment programs. Forward resume to hr@vistacommunityclinic.org or fax to (760) 414-3702. Visit our website at www.vistacommunityclinic.org. EOE/M/F/D/V [748] CHIEF MEDICAL OFFICER TO SERVE FIVE FEDERALLY QUALIFIED HEALTH CENTERS: MHCS is a mission-driven organization that serves both rural and urban residents of San Diego County. We have been in business for 35 years and offer a competitive salary, medical benefits, vacation, paid holidays, sick time, CME reimbursement, and license reimbursement. Board certified, family practice, and bilingual English/Spanish preferred. This position will require 60 percent clinical and 40 percent administrative. Send CV to tfindahl@ mtnhealth.org or (619) 478-9164. You may contact HR directly at (619) 478-5254, ext 30. Visit www.mtnhealth.org. [738] FAMILY PRACTICE PHYSICIAN FOR A BUSY FEDERALLY QUALIFIED HEALTH CENTER: MHCS is a mission-driven organization that serves both rural and urban residents of San Diego County. We have been in business for 35 years and offer a competitive salary, medical benefits, vacation, paid holidays, sick time, CME reimbursement, and license reimbursement. Board certified and bilingual English/Spanish preferred. Send CV to tfindahl@mtnhealth.org or (619) 478-9164. You
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may contact HR directly at (619) 478-5254, ext 30. Visit www.mtnhealth.org. [737] SOUTHERN INDIAN HEALTH COUNCIL INC. IN ALPINE IS SEEKING A BOARD-CERTIFIED MEDICAL DIRECTOR/PHYSICIAN: Great benefits and competitive wages! Please call (619) 4451188, ext. 291, for details or visit our website at http://www.sihc.org — look under “Employment” and then “Medical.” [736] PRIMARY CARE JOB OPPORTUNITY: Home Physicians is a fast growing group of doctors who make house calls. Great pay ($60–$100+/hour), flexible hours, choose your own days (full or part time). No weekends, no call, transportation and personal assistant provided. Call Chris Hunt, MD, at (858) 279-1212. [711] PHYSICIAN POSITION WANTED OPHTHALMOLOGIST: Retired early, given current events. Board certified. Spent entire ophthalmology career in San Diego. Seeks part-time office association. Very flexible. Impeccable local references. Email MJB6520@sbcglobal.net or call cell (858) 382-0552. [715] PULMONARY/CRITICAL CARE/SLEEP MEDICINE PHYSICIAN: Would like to join similar group or solo physician. Highly experienced in critical care (fellowship at Cook County Hospital in Chicago). Also certified in GI. Fax: (619) 934-4566. [743] NONPHYSICIAN POSITIONS AVAILABLE BILLER WANTED: Looking for biller with ambulatory billing experience. If interested, call Mira at (619) 464-9876 or email your resume to mirap@ pacbell.net. [749] EXPERIENCED MEDICAL BILLER NEEDED: Experienced medical biller needed immediately. Four to five years experience required. Full-time position, M–F. Benefits include health insurance and pension. Must be organized, reliable, detail oriented, and work independently. Please call (858) 292-7527 or email resume to sdddc5@yahoo.com. [744] MEDICAL EQUIPMENT/OFFICE FURNITURE MEDICAL EQUIPMENT: Bone densitometer, hologic, full-size hip and spine, slightly used, $19,000. Call (760) 703-0691. [755] OFFICE FURNITURE FOR SALE: Chairs $10.00 each, desk $50.00, exam stools $10.00, and two exam tables. Call (619) 585-0476. [746] THREE FULL-SERVICE EXAMINATION TABLES: Excellent condition. $1,000 each. Call (619) 585-0476 and ask for Cindy. [739] ✚
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History of Medicine By William P. Haney, MD
animal is repulsive and disgusting. Delicate and sensitive persons find it difficult to overcome their repugnance to contact with the cold and slimy reptile.” Most of us today can include ourselves in this “delicate and sensitive” group. All of which makes it very difficult to understand the astounding popularity of leeches in 18th and 19th century France. In Paris alone as many as 6 million leechings were performed annually! Hundreds of leech farms were established to meet the demand. The leech was still in short supply. The demand led to some of the most bizarre instruments that can be found in the annals of medical history, the “leech machines.” These unbelievable contraptions included the “Heurteloup leech, Damoiseau’s terabdella, Sarlandiere’s bdellometer, and Tiemann’s automatic piston,” among others.
They’re Back! The Return of the Lowly Leech
I
n his Academy Award performance of years past, star Humphrey Bogart hauls himself out of the murky swamp water and onto the deck of the African Queen. He discovers that he is covered with leeches. The horror and disgust he shares with co-star Katherine Hepburn is a reaction to the loathsome little creatures common to mankind since the Stone Age. Yet these slimy, wriggly little bloodsuckers have enjoyed a medical history that can be traced almost without interruption back to the second century BCE. Bleeding, cupping, and leeching were grouped together under the term “bloodletting,” the most common medical practice performed by physicians from antiquity to the late 19th century, a span of 2,000 years. Its popularity began to decline when George Washington died following treatment for a throat infection. He had been bled four times in two days, losing four pounds of blood. Even his close friend and personal physician Dr. James Craik felt bleeding may have been at least partly to blame for Washington’s death. “Bloodletting” thereafter began to fall from favor. Recently, however, the indefatigable leech has resurfaced, enjoying approval by the FDA for a handful of medi-
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cal maladies. Look for jars of these hungry, ugly little things to reappear on pharmacy shelves. The word “leech” is derived from the Anglo-Saxon word “loece,” meaning to heal. The ancient physician was called a leech and his textbook of therapy a leechdom. It is an interesting play on words. Leech is no longer a laudatory term. Today a leech is one who deliberately benefits from another’s work without offering anything in return. He is a parasite or “free rider”! The leech is a freshwater, parasitic, invertebrate belonging to the same phylum as the earthworm. A large sucker at one end attaches to the victim, or patient as the case may be, and makes a small triangular puncture. About one ounce of blood is removed in one hour. The satiated animal then drops off. However, the wound continues to bleed, in distinction to other small wounds in which the blood coagulates rapidly. In 1884 this curious difference led the English chemist Haycroft to discover in the leech saliva one of the earliest anticoagulants, “hiruden!” Yet even in its heyday, the leech was not for the meek or faint hearted. From an 18th century text: “The appearance of the
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“Leech” is derived from the AngloSaxon word “loece,” meaning to heal. The ancient physician was called a leech and his textbook of therapy a leechdom. Therapeutic bloodletting was largely cast aside by physicians more than 100 years ago. But looking back over so solid a cornerstone in the history of medical therapeutics, one finds a quote by no less noteworthy a physician than William Harvey, the discoverer of the circulation of the blood. In 1628 he wrote, “Daily experience satisfies me that blood letting has a most salutary effect in many diseases.” Harvey was a careful observer, but it is still very difficult for the modern doctor to fully comprehend such a statement. With some misgivings then, let us welcome back the trusty leech. Apparently, there is little that is new under the sun! ✚
About t he Au t h o r: Dr. Haney, a retired ophthalmologist, has held a longtime interest in the history of medicine, often contributing articles to San Diego Physician.
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Introducing MyCME from NORCAL Mutual. Review our wide array of risk management resources and services. Register for and complete CME courses at your convenience. Submit your Attestation Form online. Print transcripts and certificates…everything from one easy-to-navigate website.
Learn more at www.norcalmutual.com/cme or call 800.652.1051, ext 2244.
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