The Issue Whether Petitioner’s request for coverage of proton beam radiation therapy (“proton beam therapy” or “PBRT”) is a covered benefit pursuant to the State Employees’ Health Maintenance Organization (“HMO”) Plan (“Plan”), administered by AvMed.
Findings Of Fact Respondent is the state agency charged with administering the state employee health insurance program pursuant to section 110.123. At all times material hereto, Petitioner was a member of the Plan. AvMed is the third-party administrator for the Plan at issue in this cause. As the third-party administrator, AvMed provides claims processing, utilization, and benefit management services. The applicable benefit document is the State Employees’ HMO Plan, Group Health Insurance Plan Booklet and Benefits Document (“Plan Document”), effective January 1, 2019. Petitioner is a 66-year-old male who was diagnosed with prostate cancer in November 2017 and underwent a prostatectomy to remove his prostate on April 12, 2018. Subsequent to his initial surgery and treatment, Petitioner experienced increasing prostate specific antigen (“PSA”) in three follow-up tests. His prostate cancer had returned. Petitioner’s physician sought to treat his condition with PBRT, a form of external beam radiation utilizing protons, rather than traditional intensity modulated radiation therapy (“IMRT”), which is, without question, covered under the Plan. Medicare, a federal healthcare insurance program, agreed to pay 80 percent of Intervenor’s charges for PBRT, leaving Petitioner responsible for the remaining 20 percent being sought to be paid by Petitioner’s Plan. On July 3, 2019, Petitioner, through his healthcare provider, Maria-Amelia Rodrigues, M.D., and Intervenor, Miami Cancer Institute, submitted a request for coverage of PBRT to AvMed. On July 10, 2019, AvMed denied the preservice request for coverage on the basis that the therapy was experimental/investigational and, therefore, not medically necessary treatment for the member’s condition. The request was reviewed by Sri Gorty, M.D., a consultant radiation oncologist at Magellan Healthcare, which is under contract with AvMed. On July 23, 2019, Petitioner submitted a request for a Level I appeal to AvMed. The appeal was reviewed by Dr. Gregg Goldin, M.D., a consultant radiology oncologist at Dane Street, which is under contract with AvMed. He filed a report dated August 19, 2019. On August 20, 2019, AvMed denied the request for Level I appeal on the basis that the therapy was experimental/investigational and, therefore, not a medically necessary treatment. On November 19, 2019, Petitioner submitted a request for an “Expedited” Level II appeal to Respondent. The Level II appeal was reviewed by Dearline Thomas-Brown, a registered nurse and Level II appeal coordinator for Respondent. On November 21, 2019, Respondent denied Petitioner’s Level II appeal on the basis that the therapy is experimental/investigational and, therefore, not medically necessary for treatment of the member’s condition. Pursuant to the Plan Document, the Plan pays its share of the cost of covered services, if the services are: Ordered by a Network Provider (a provider who is in AvMed’s network); Considered Medically Necessary for the covered person’s treatment because of accident, illness, condition or mental health or nervous disorder; Not specifically limited or excluded under this Plan; and Rendered while this Plan is in effect. Pursuant to the Plan Document, Section I. Introduction: The Plan is not intended to and does not cover or provide any Medical Services or benefits that are not Medically Necessary for the diagnosis and treatment of the Health Plan Member. AvMed determines whether the services are Medically Necessary on the basis of terms, conditions, and criteria established by the Plan as interpreted by the state, and as set forth in medical guidelines. This chart provides a description of services and supplies covered under the Plan. Coverage Access Rules are specified under the Plan as follows: Cancer Services Diagnosis and Treatment Includes both inpatient and outpatient diagnostic tests and treatment (including anti-cancer medications administered by Network providers), including cancer clinical trials as set forth in the Florida Clinical Trial Compact. Does not include Experimental or Investigational Treatment. In order to be a covered benefit, the treatment must be “medically necessary,” not “experimental or investigational,” and it must not be specifically excluded by the Plan. “Medically Necessary” is defined as follows: The use of any appropriate medical treatment, service, equipment and/or supply as provided by a Hospital, skilled nursing facility, physician or other provider which is necessary for the diagnosis, care and/or treatment of a Health Plan Member’s Illness or injury, and which is: Consistent with the symptom, diagnosis and treatment of the Health Plan Member’s condition; The most appropriate level of supply and/or service for the diagnosis and treatment of the Health Plan Member’s condition; In accordance with standards of acceptable medical practice; Not primarily intended for the personal comfort or convenience of the Health Plan Member, the Health Plan Member’s family, the physician or other health care providers; Approved by the appropriate medical body or health care specialty involved as effective, appropriate and essential for the care and treatment of the Health Plan Member’s condition; and Not experimental or investigational. The service must meet all of the above-referenced criteria in order to be medically necessary. Given the above definition, if a service is experimental or investigational, then it cannot be medically necessary. Section VI. Limitations and Exclusions in the Plan Document specifically exclude services that are “experimental/investigational or not medically necessary treatment with the exception of routine care in connection with a clinical trial in cancer, pursuant to the Florida Clinical Trial Compact and the Patient Protection and Affordable Care Act.” “Experimental and/or Investigational” is defined as follows: For the purposes of this Plan a medication, treatment, device, surgery or procedure may initially be determined by AvMed to be experimental and/or investigational if any of the following applies: The FDA has not granted the approval for general use; or There are insufficient outcomes data available from controlled clinical trials published in peer- reviewed literature to substantiate its effectiveness for the disease or injury involved; or There is no consensus among practicing physicians that the medication, treatment, therapy, procedure or device is safe or effective for the treatment in question or such medication, treatment, therapy, procedure or device is not the standard treatment, therapy procedure or device utilized by practicing physicians in treating other patients with the same or similar condition; or Such medication, treatment procedure, or device is the subject of an ongoing Phase I or Phase II clinical investigation, or Experimental or research arm of a Phase III clinical investigation, or under study to determine: maximum tolerated dosage(s), toxicity, safety, efficacy, or efficacy as comparted with the standard for treatment or diagnosis of the condition in question. If any one or more of the above-cited criteria are met, then the treatment is experimental and/or investigational and is not a covered service. In making an adverse determination as to coverage in both the Level I and Level II appeals, Edwin Rodriguez, M.D. (note the slightly different spelling of Petitioner’s expert Dr. Maria-Amelia Rodrigues versus Dr. Edwin Rodriguez), and Nurse Thomas-Brown utilized AvMed’s Medical Coverage Guideline on PBRT. This coverage guideline regarding PBRT provides AvMed’s “Exclusion Criteria” explaining “PBRT is not covered, and is considered investigational, as to all other tumors not listed” in the guideline. PBRT is not an approved treatment option for localized prostate cancer under the NIA Magellan criteria. The Medical Technology Assessment Committee at AvMed drafts clinical policy guidelines and is responsible for maintaining or changing them as technology advances. AvMed’s policy on use of PBRT for the treatment of prostate cancer states that it is not medically necessary because studies have not shown clinical outcomes to be superior to conventional radiation therapy (i.e., IMRT). This policy was developed following extensive review of studies in peer-reviewed medical literature, available guidelines, technology assessments, and opinions from experts. The policy is updated on a yearly basis in order to take into consideration any new evidence. A recent review of the policy on PBRT resulted in no change in AvMed’s position on coverage for treatment of prostate cancer. The medical coverage guidelines are meant to be used in conjunction with the Plan Document to determine whether services are medically necessary and a covered benefit. Dr. Gorty, AvMed’s external reviewer from Magellan Healthcare, who was accepted as an expert in the field of radiation oncology, testified that his recommended denial of coverage of PBRT was informed by Petitioner’s medical records, Intervenor’s Letter of Medical Necessity, clinical trials, the model policy from the American Society of Therapeutic Radiation and Oncology (“ASTRO”), and the National Comprehensive Cancer Network (“NCCN”) guidelines. PBRT PBRT is a procedure that uses protons to deliver a curative radiation dose to a tumor, while reducing radiation doses to healthy tissues and organs, which results in fewer complications and side effects than IMRT. As stated earlier, Petitioner’s prostate was removed in April 2018. Thereafter, rising PSA levels indicated that he needed further treatment, and Dr. Rodrigues, a board-certified radiation oncologist at Miami Cancer Institute, became his treating physician. Dr. Rodrigues has been treating patients for 23 years, including prostate cancer patients. She was accepted as an expert in her field for these proceedings. Dr. Rodrigues determined PBRT to be the appropriate radiation treatment for Mr. Zolfaghari given his type of prostate cancer—recurrent prostate cancer. Dr. Rodrigues testified that recurrent prostate cancer occurs when a cancer has been treated and then reoccurs. In addition to PBRT, Dr. Rodrigues recommended, and Petitioner received, androgen deprivation therapy, generally referred to as hormone therapy, to be used in conjunction with PBRT. Dr. Rodrigues testified that the androgen deprivation therapy blocks the production of testosterone. She testified that patients with recurrent prostate cancer or certain high-risk patients have better overall survival when the two treatments are used in conjunction. As an additional aggravating factor to Petitioner’s cancer treatment, Petitioner was diagnosed with colon cancer leading to surgery in January 2020. Dr. Rodrigues testified that Petitioner’s colon cancer made his need for PBRT even more necessary, because now Petitioner is at a higher risk for adverse effects from the unwanted spread of toxicity common with IMRT. Dr. Rodrigues, as a Miami Cancer Institute physician, wrote letters requesting treatment and appealing denials of treatment as set forth above, and testified at the March 9, 2020, administrative hearing in support of Petitioner’s efforts to obtain coverage through AvMed for PBRT, which she considers to be a medically necessary treatment modality. Dr. Rodrigues was asked why she had not gone forward and provided Petitioner IMRT in order to prevent any further delay due to the passage of time from unsuccessful appeals of the denial by AvMed for the PBRT treatment of his recurring prostate cancer. She replied that she was attempting to secure a less toxic treatment modality, PBRT, for her patient who was already approved by Medicare for coverage of 80 percent of the cost of the treatment. MEDICAL NECESSITY OF PBRT VERSUS IMRT There is no dispute that IMRT is an accepted treatment modality for Petitioner’s recurrent prostate cancer, even bearing in mind his complicating factor of colon cancer surgery and treatment endured following his 2018 prostatectomy. The remaining dispute here is whether PBRT is both medically necessary and not an experimental and/or investigative form of radiation treatment. IMRT is a recognized form of treatment for Petitioner’s recurrent prostate cancer. Dr. Rodrigues testified that Miami Cancer Institute considered only candidates for PBRT as those who would qualify for IMRT, such as Petitioner. Given the availability of another treatment option, IMRT, which is the most widely recognized standard of care within the medical establishment for the treatment of Petitioner’s condition, Respondent’s experts conclude that PBRT is not medically necessary because it is not the most appropriate level of service in this case. While PBRT has been accepted by AvMed, according to its Plan, for certain types of cancer, the insurer has not yet authorized it for the treatment of prostate cancer. This is where the semantics of the contract come into play. Petitioner and Intervenor argued that Respondent mistakenly based its denial upon a diagnosis of “localized prostate cancer” (Dr. Rodrigues’ reading of the proscription of the use of PBRT for Petitioner) rather than “recurrent prostate cancer” (not specifically proscribed by the Plan according to her reading), combined with the fact that Petitioner’s unique medical condition requires lower toxicity in the specific type of radiation used. PBRT, she testified, offers lower radiation toxicity, which will have less of a harmful effect on Petitioner’s colon and rectum as a survivor of colon cancer surgery. Dr. Rodriguez, the AvMed senior medical director, testified that studies comparing PBRT to 3-D confirming radiation or IMRT are limited. Overall studies have not shown clinical outcomes to be superior to conventional radiation therapy. In addition to the preservice and Level I appeal reviews by AvMed, and Respondent’s Level II appeal review, an Independent Organization Review (“IRO”) was conducted by a licensed radiation oncologist employed by Independent Medical Expert Consulting Services. As a result of this independent review, the Plan’s denial was upheld. Dr. Rodrigues presented studies in her testimony and a letter of medical necessity which cited the potential for favorable outcomes with PBRT. Dr. Gorty, Respondent’s expert in radiation oncology, contradicted her testimony in that many of the studies she cited noted a need for further study regarding the safety and efficacy of PBRT for treatment, and all of these studies were based upon “localized prostate cancer,” rather than “recurrent prostate cancer.” Dr. Gorty also testified that Petitioner's records indicated that his cancer was localized, although it could also be "recurrent." Dr. Gorty testified that clinical studies show no significant difference in the toxicity between IMRT and PBRT. Further, Dr. Rodriguez explained that localized cancer can be recurrent. “Localized” refers to where the cancer may be found, while “recurrent” refers to a repeat or re-occurrence of a cancer, which might return to the same location or reappear in a different location. Paragraph 15 lists the criteria to determine whether a treatment or procedure is “medically necessary” under the AvMed policy. PBRT does not meet the third criterion of the definition of “medically necessary,” as PBRT treatment of prostate cancer is not in accordance with standards of acceptable community practice. Dr. Gorty testified that AvMed medical guidelines utilize IMRT as the “next generation” treatment, rather than PBRT. Further, Dr. Gorty testified that he was aware of several recent clinical trials concerning PBRT and IMRT, and these studies do not reach a conclusion that PBRT is preferable to IMRT. PBRT does not meet the fifth criterion of the definition of “medically necessary,” as PBRT has not been approved by the appropriate medical body or healthcare specialty involved as effective, appropriate, and essential for the care and treatment of prostate cancer. PBRT is not essential for the treatment of prostate cancer. There are several treatment modalities that are generally available for the treatment of prostate cancer and, as discussed above, several of those treatment options were reasonable treatment options for Petitioner. While Dr. Rodrigues believes PBRT to be preferable for Petitioner in this case due to, in her opinion, fewer adverse side effects of the treatment, she admitted that Petitioner is a suitable candidate for IMRT. Therefore, PBRT does not meet the sixth criterion of the definition of “medically necessary,” as it meets the definition of “experimental and/or investigational.” Specifically, criteria 2, 3, and 4 of the definition of “experimental and/or investigational” are met, which lead to the ultimate conclusion that PBRT is not medically necessary in this case. EXPERIMENTAL AND/OR INVESTIGATIONAL TREATMENT Paragraph 18 sets forth the criteria for determining whether a treatment or procedure is “experimental and/or investigational.” The second criterion from the definition of experimental and/or investigational treatment is met in this case. Insufficient outcomes data are not available from controlled clinical trials published in peer-reviewed literature to substantiate PBRT’s safety and effectiveness for treatment of prostate cancer. Dr. Rodriguez testified that there is a lack of peer-reviewed, published, randomized studies regarding proton beam therapy. Further, PBRT treatment is not the generally accepted standard of care. Dr. Rodrigues testified that only a handful of medical centers in the United States are using PBRT to treat cancer malignancies. Only two such programs are located in Florida—the University of Florida and Intervenor. Outside of Florida, only Massachusetts General and Loma Linda offer the treatment. Prior to Intervenor offering the treatment, Dr. Rodrigues referred her patients to one of these other facilities for PBRT when she deemed it appropriate to do so. Current randomized trials are on-going and being published in peer- reviewed medical literature. PBRT treatment for prostate cancer is considered investigational and not a standard of care option and, therefore, not medically necessary. Nurse Thomas-Brown testified that a treatment considered experimental or investigational is, automatically, not medically necessary. NIA Magellan Clinical Guideline Number NIA_CG_124, which was developed in July 2018 for implementation in January 2019 to assist physicians in the application of treatment, states that both surgery and radiation therapy should be used to treat organ confined prostate cancer, as well as prostate cancers extended into adjacent tissues. This guideline finds that PBRT is not an approved treatment option for localized prostate cancer as studies comparing it to 3-D conformal radiation or IMRT are limited. Leading organizations, such as NCCN and ASTRO, have noted insufficient data outcomes and a need for more study of proton beam therapy, which these organizations have not yet accepted as the standard of care. PBRT also meets the third criterion of the definition of “experimental and/or investigational.” There is no consensus among practicing physicians that PBRT is safe or effective for the treatment of prostate cancer or that PBRT is the standard treatment utilized by practicing physicians in treating other patients with the same or similar conditions. Both Dr. Gorty and Dr. Rodriguez testified that proton beam therapy is experimental and investigational and, therefore, not medically necessary for all forms of prostate cancer; two additional radiation oncologists reviewed the appeal and reached the conclusion that PBRT is not medically necessary. Additionally, there was uncontroverted evidence that IMRT, not PBRT, is the standard form of treatment utilized by practicing physicians for treatment of prostate cancer. Dr. Gorty testified that AvMed approved the NIA Magellan clinical guidelines for prostate cancer, which are based on the peer-reviewed studies; and he explained three such studies. His testimony noted that the second study from the University of Pennsylvania at Baltimore, Maryland, specifically matched Petitioner’s medical condition. This study compared 307 men and their comparative toxicity outcomes of PBRT verses IMRT for post-operative sites. It concluded that future prospective investigation and ongoing follow-up will determine whether dosimetric differences between treatment with IMRT and proton beam therapy convert to meaningful differences in long-term outcomes. As part of the appeal process on behalf of Petitioner, Intervenor also requested a review by an IRO. The review was completed by a board-certified radiation oncologist, and a report was generated on January 9, 2020. The “List of Materials Reviewed” is extensive and includes Petitioner’s medical records and Intervenor’s supporting documentation. The independent reviewer upheld the denial and noted that medical necessity has not been established. The IRO states that “until the current randomized trials ongoing are published in peer reviewed medical literature, proton beam treatment for prostate cancer is considered investigational and not a standard of care treatment option.”
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Management Services, Division of State Group Insurance, enter a final order denying Petitioner's request for coverage for proton beam therapy. DONE AND ENTERED this 4th day of May, 2020, in Tallahassee, Leon County, Florida. S ROBERT S. COHEN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 4th day of May, 2020. COPIES FURNISHED: Erica D. Moore, Esquire Thomas E. Wright, Esquire Department of Management Services 4050 Esplanade Way, Suite 160 Tallahassee, Florida 32399 (eServed) Abolghasem Zolfaghari 10910 Southwest 140th Avenue Miami, Florida 33186 Frank A. Florio, Esquire Maria D. Garcia, Esquire Latasha Gethers Hines, Esquire Kozyak, Tropin & Throckmorton, LLP 2525 Ponce de Leon Boulevard, Ninth Floor Coral Gables, Florida 33134 (eServed) William Chorba, General Counsel Office of the General Counsel Department of Management Services 4050 Esplanade Way, Suite 160 Tallahassee, Florida 32399-0950 (eServed)
The Issue Whether Respondent, a licensed physician, violated the applicable standard of care by diagnosing prostate cancer in four patients, and recommending and participating in a course of treatment for these patients, without confirming prostate cancer through tissue biopsy results; and, if so, what is the appropriate penalty?
Findings Of Fact Petitioner is responsible for the investigation and prosecution of complaints against medical doctors licensed in the state of Florida, who are accused of violating chapters 456 and 458 of the Florida Statutes. Respondent is licensed as a medical doctor in Florida, having been issued license number ME 46625. Respondent is not board-certified in any specialty recognized by the Florida Board of Medicine. Respondent has never had disciplinary action against his license to practice medicine. Respondent's Practice Since his residency concluded in 1985, Respondent has practiced urology. For more than 20 years, the focus of his practice has been prostate disease, its diagnosis, and treatment. In 2006, Respondent became the lead investigator for a General Electric study regarding its 3-Tesla magnetic resonance spectroscopy imaging machine (3T MRI-s) as part of an Institutional Review Board measuring the heat generated by the machine to ensure the safety of patients. Between 2006 and 2010, 1,600 prostates were scanned with a 3T MRI-s as part of the study. Respondent reviewed the results of each radiology report associated with these scans and compared them to the clinical data he had for each patient. Respondent also completed a double-blind study of 200 of these patients who had prostate biopsies during 2008 and 2009, as well as the 3T MRI-s, correlated the results of the biopsies and the scans, and became convinced that the 3T MRI-s technology alone is a positive predictor of prostate cancer 95 percent of the time. According to both parties' experts, as well as Respondent, the standard of care in Florida and throughout the United States is to use a needle tissue biopsy to identify prostate cancer. As admitted by Respondent, medical schools teach that needle biopsy is "the way" to diagnose prostate cancer. Absent a biopsy showing malignant tissue, it is not possible for a reasonably prudent physician to diagnose or treat prostate cancer. Biopsies are usually performed to diagnose prostate cancer if a man has a combination of risk factors, such as family history, an abnormal digital rectal exam, and/or increasing levels of Prostate Specific Antigen (PSA). However, needle biopsies for prostate cancer carry a false negative rate of 20 to 50 percent, which means that a standard 12-point needle biopsy (where 12 samples of tissue from different locations in the prostate are sampled) often misses cancerous tissue. Prostate needle biopsies are sometimes painful and carry a risk of complications, including common complications such as bleeding and infection, and the unlikely complications of septic shock and death. Respondent is convinced that there is a significant risk from a prostate needle biopsy to spread prostate cancer cells outside the prostate capsule, which is referred to as "seeding" or "needle tracking." Respondent's belief is founded upon a one-page 2002 article published in the American Urological Association, Inc.'s Journal of Urology (Journal), which refers to two cases in which a tumor was discovered in the rectal wall after prostate biopsies and cryoblation.1/ The tumors were suspected of being the result of needle tracking from prostate cancer biopsies. Significantly, this article makes clear that needle tracking resulting from prostate biopsies are rare and "exceedingly uncommon." Respondent's concern, regarding prostate biopsies spreading prostate cancer, is also in part founded upon a one-paragraph 1991 Journal abstract reporting a Johns Hopkins University School of Medicine study of 350 patients in which needle tracking was suspected in seven patients (two percent).2/ According to Respondent, his belief that prostate biopsies spread prostate cancer is "intuitive," although he acknowledges this is not the prevailing view in Florida. Respondent argues that doctors do not want to believe needle tracking takes place with prostate biopsies and suggests there is a financial motivation for doctors to require a positive biopsy before definitively diagnosing prostate cancer. Respondent is so convinced of the dangers of needle biopsies for prostate cancer that he published a book, Men at Risk: the Dirty Little Secret – Prostate Biopsies Really Do Spread Prostate Cancer Cells, in 2012, which he provides to all his patients. In his book, Respondent states: For me, a 3T MRI scan is the best objective marker to a diagnosis of prostate cancer. To summarize, patients must answer one question. Should I agree to a prostate biopsy procedure where it has been proven to spread prostate cancer cells or do I keep my fingers and toes crossed, hoping for the best? In two words, . . . "absolutely not." To me, the decision is easy – the literature validates avoiding random biopsies and supports imaging with a 3 T magnet. There is no other organ in the human body where diagnosis is dependent on sticking needles randomly and blindly into a delicate organ in an attempt to find cancer. This practice is archaic, patently barbaric, unacceptable and preferentially favored by virtually all urologists. Beyond the obvious benefit to being able to see a cancer and its pattern of invasion with the 3.0 Tesla MRI scan, there is no other exam or scan that competes in terms of diagnostic accuracy or predictability. The discerning patient will soon recognize that guessing where cancer is located, through random biopsies, is for the less informed.[3] Respondent refers to the use of 3T MRI-s as the "truth serum" of prostate cancer diagnosis. During all times material hereto, Respondent held himself out as a urologist who could diagnose and treat prostate cancer without a needle biopsy. In fact, the four patients at issue in this case found Respondent through an Internet search. Respondent defines his office, the Diagnostic Center for Disease (DCD) as, "A comprehensive prostate cancer diagnostic center in Sarasota, Florida specializing in non-invasive diagnostics (MRI/MRIS) without biopsy as an integral part of the diagnostic evaluation of prostate cancer."4/ Respondent also advertised himself as "a world expert in High Intensity Focused Ultrasound (HIFU), having diagnosed and treated more patients for prostate cancer from more countries than any other treating doctor in the world."5/ HIFU is a treatment alternative to brachytherapy (the insertion of radioactive seeds into the prostate), radiation, and prostatectomy (the surgical removal of the prostate gland) for prostate cancer and uses highly focused ultrasound waves in a small area to create intense heat, which destroys prostate cancer tissue. HIFU was not an approved treatment for prostate cancer in the United States until October 9, 2015, at which time the Food and Drug Administration (FDA) approved the use of the Sonablate machine for prostate tissue ablation. Prior to that time, Respondent referred his patients to treatment facilities in Mexico and the Caribbean where he performed HIFU treatments. The standard of care in Florida precludes treating prostate cancer with HIFU in the absence of a tissue biopsy confirming the presence of cancer. In order to be eligible for HIFU treatment, in addition to a positive diagnosis, the patient's prostate gland must be less than 40 grams. HIFU is not appropriate on patients with multiple calcifications in their prostate because they interfere with the treatment. Because a smaller prostate gland is easier to work with, prior to undergoing HIFU treatment, patients are often prescribed Bicalutamide (also known by its brand name, Casodex) and Trelstar. Bicalutamide suppresses the uptake of testosterone and Trelstar suppresses the production of testosterone, with both drugs having the effect of shrinking the prostate gland. Side effects of these drugs include hot flashes, weakness, and a sense of a loss of well-being. Facts Related to Patient G.P. Patient G.P., a 69 year-old retiree, had a prostate biopsy performed in December 2005 after a rise in his PSA level. This biopsy was negative for prostate cancer, but Patient G.P. was diagnosed with an enlarged prostate and benign prostate hyperplasty (BPH). In May 2008, Patient G.P. learned through a physical exam for a life insurance policy that his PSA level was elevated. After another check of his PSA level in November 2008, Patient G.P. was advised to undergo another prostate biopsy. Because his first prostate biopsy was painful, Patient G.P. searched the Internet for alternatives to biopsy and learned of Respondent and his use of the 3T MRI-s at the DCD in Sarasota for diagnosing prostate cancer. Patient G.P. traveled to Florida from Michigan to meet with Respondent on January 5, 2009. Patient G.P. underwent a 3T MRI-s scan at Respondent's office. Respondent told Patient G.P. that he was unsure of the results because they were consistent with BPH and not prostate cancer. However, Respondent advised Patient G.P. was considered "high risk" because his father died from prostate cancer in 2002. Rather than undergoing any treatment at that time, Patient G.P. was prescribed Avodart for his BPH and agreed to active surveillance (A.S.) whereby he would receive regular PSA screening. When Patient G.P.'s December 2009 PSA level went up after being on Avodart for most of the year, he was concerned and telephoned Respondent's office. Respondent prescribed Casodex based upon his telephone call with Patient G.P. on January 15, 2010. By February 2010, G.P.'s PSA level decreased significantly, but not as much as he believed it should have after taking Casodex for several weeks. Patient G.P. also experienced urinary frequency problems and pain. He returned to Respondent's office where Respondent performed an ultrasound and digital rectal exam. Respondent told Patient G.P. it was likely he had prostate cancer, but that he could not be sure without a biopsy. However, Respondent's medical records reflect that Respondent diagnosed Patient G.P. as having prostate cancer without a tissue biopsy.6/ Respondent offered to do a targeted biopsy based on an MRI scan. Respondent also discussed his concerns regarding needle tracking from biopsies with Patient G.P. Patient G.P. made it clear he did not want a biopsy, and he wanted to proceed to HIFU. Respondent advised Patient G.P. of the risk of erectile dysfunction following HIFU, but did not discuss the possibility of urinary stricture problems. In April 2010, Patient G.P. traveled to Mexico where the HIFU procedure was performed by Respondent. In March 2011, Patient G.P. saw a urologist in Michigan about his diminished urinary stream and pain. The urologist used a reamer to open Patient G.P's urethra, but on April 15, 2011, he went to the emergency room because he was completely unable to urinate. Patient G.P. was catheterized and subsequently underwent electro-vaporization on April 25, 2011, to relieve the urinary stricture. In August 2011, Patient G.P. also underwent hydro- dilating in an attempt to relieve the symptoms of his urinary stricture. In September 2011, Patient G.P. saw board-certified urologist Dr. Joel Gelman, who specializes in urethral reconstruction. At that time, Patient G.P. was advised that his urinary stricture, caused by the HIFU treatment, was a significant problem because his urethra was closed off almost to the bladder neck. Dr. Gelman performed a transurethral resection of the prostate (TURP). As part of the TURP procedure, Dr. Gelman took samples of Patient G.P.'s prostate tissue and no evidence was found of prostate cancer. Although Patient G.P. had no complaints regarding his course of treatment from Respondent, Dr. Gelman filed a complaint against Respondent because he was concerned that Respondent prescribed medications and performed HIFU on Patient G.P. for prostate cancer without a tissue biopsy. Facts Related to Patient J.W. Patient J.W., a 74 year-old retired dentist, had two biopsies performed in 2005 and 2007 ordered by his urologist in Alabama in response to elevated PSA levels. No evidence of malignancy was found. Patient J.W.'s PSA level was again elevated when tested in March 2012. He was reluctant to have another biopsy because the first two were painful. Patient J.W. was told about Respondent by a friend, and he viewed Respondent's website. Patient J.W. was interested in consulting with Respondent because Respondent advertised he had an MRI machine that could detect cancer cells, and Respondent believed prostate biopsies spread cancer. Patient J.W. traveled from Alabama to meet with Respondent at the DCD on May 14 and 15, 2012. After a sonogram and MRI, Respondent diagnosed Patient J.W. with prostate cancer. Respondent discussed a treatment plan which included what Respondent called "chemical castration" for a period of six months, to be followed with a trip to Mexico for HIFU treatment at the cost of $32,000.00. Respondent did not suggest any other treatment options to Patient J.W. or recommend a tissue biopsy. The idea of "chemical castration" scared Patient J.W., who sought a second opinion in June 2012 from another urologist, Dr. M. Eric Brewer. Dr. Brewer told J.W. that HIFU was not an accepted treatment in the United States for prostate cancer. Patient J.W. declined to go forward with treatment by Respondent. Dr. Brewer recommended A.S. and, as recommended by Dr. Brewer, Patient J.W. has his PSA level checked every six months. Patient J.W.'s PSA levels have decreased without any treatment. Dr. Brewer discussed Patient J.W.'s case with his partners, the tumor board, the president of the Southeastern Urological Association, and the president of the American Board of Urology, who unanimously advised Dr. Brewer to file a complaint with Petitioner against Respondent for cancer diagnosis and recommending treatment in the absence of a pathologic specimen. Facts Related to Patient K.S. Patient K.S. is a 62-year-old video producer and editor from Tennessee. He has no family history of prostate cancer. Patient K.S. had his PSA level tested in 2005 and 2009, at which time it was considered elevated. Patient K.S. was referred to a urologist by his primary care physician. After again showing elevated PSA levels, Patient K.S. underwent a prostate biopsy in 2011 and 2012. Neither biopsy was positive for prostate cancer. However, Patient K.S. and his wife were concerned about his rising PSA level and sought a second opinion. Patient K.S.' wife was concerned that if her husband had prostate cancer, his local urologist would recommend removal of the prostate. She researched alternative treatments on the Internet and found Respondent's website. On October 15, 2012, Patient K.S. and his wife traveled to the DCD in Sarasota to meet with Respondent. Respondent initially performed an ultrasound on Patient K.S. and then told Patient K.S. he was "concerned" Patient K.S. had prostate cancer. He recommended HIFU treatment to Patient K.S. Respondent made it clear to Patient K.S. that Respondent would not perform a needle biopsy because it pushes cancer further into the prostate. Respondent told Patient K.S. that the MRI would make it clear whether Patient K.S. had prostate cancer. Later that same day, Patient K.S. had an MRI performed at the DCD. Approximately a week later, Patient K.S. received a telephone call from Respondent with the MRI results who told Patient K.S. that based on the MRI, he had Gleason 7 prostate cancer, a fairly aggressive form of prostate cancer that could be treated with HIFU in Mexico the following month. This was followed up with an e-mail from the DCD to Patient K.S. demanding a payment of $32,000.00 within three days to schedule the HIFU procedure in Mexico. Patient K.S.' wife immediately secured a bank loan for the $32,000.00 Due to the seriousness of the diagnosis and the rush for payment for HIFU, Patient K.S. visited his primary care doctor for another opinion. Patient K.S' primary care doctor, Dr. Jeffrey Jump, told him that no one can diagnose prostate cancer as a Gleason 7 without a tissue biopsy. Further, it was a "red flag" to Dr. Jump that a cash payment of $32,000.00 was expected in such a short time frame to schedule treatment. After speaking to Dr. Jump, Patient K.S. decided not to have HIFU and instead opted for A.S. Subsequent PSA level tests for Patient K.S. have shown a decrease in his PSA level. Patient K.S.' wife filed a complaint with the Petitioner against Respondent. Facts Related to Patient V.P. Patient V.P. is a 63-year-old construction worker and guide from Alaska. He has no family history of prostate cancer. In August 2013, at age 60, Patient V.P. had his first physical examination. As part of the exam, he took a PSA test, which showed an elevated PSA level of 6.3. As a result, Patient V.P. was referred to a urologist who recommended a biopsy. Patient V.P. heard from friends that prostate biopsies are painful, so he looked on the Internet for alternatives. Patient V.P. found Respondent's website, which claimed Respondent could diagnose prostate cancer without a biopsy by using new MRI technology. Patient V.P. traveled to Sarasota to meet Respondent on September 11, 2013. Respondent performed a digital rectal exam and told Patient V.P. that his prostate was much enlarged. Respondent next performed a prostate ultrasound on Patient V.P. Immediately after the ultrasound, Respondent told Patient V.P., "I'm telling you right now you have prostate cancer." Respondent provided Patient V.P. with a prescription for Bicalutamide and Trelstar, which Respondent said would wipe out Patient V.P.'s testosterone and slow the growth of the cancer. Respondent told Patient V.P. that prostate biopsies are dangerous and metastasize cancer cells. Respondent said that even though he knew Patient V.P. had cancer, he wanted an MRI to see the amount of cancer. Respondent also offered Patient V.P. the opportunity to participate in a private placement offering for a HIFU company he was forming for a minimum investment of $50,000.00. The following day, Patient V.P. had an MRI and then met with Respondent to review the results. Respondent showed Patient V.P. his MRI images and pointed to areas of concern. Respondent told Patient V.P. he had extensive prostate cancer and that Patient V.P. did not have much time to decide whether to have HIFU because the cancer was about to metastasize. Respondent told Patient V.P. to take the Bicalutamide for ten days and then return for an injection of Trelstar to atrophy his prostate and make him ready for HIFU in 90 days. At Respondent's direction, Patient V.P. began the Bicalutamide and then returned to the DCD on September 20, 2013, for a three-month injection of Trelstar. During this visit, Patient V.P. questioned the cost if the HIFU was not successful in getting all the cancer and he needed further treatment. Respondent told Patient V.P. that he "doesn't miss," but an additional treatment of HIFU would cost another $10,000.00 to $12,000.00, in addition to the $32,000.00 for the initial treatment. Concerned about these costs, Patient V.P. asked about going to Loma Linda, California, for proton therapy as an alternative. Respondent told Patient V.P. that proton therapy would cause bladder cancer and any alternative to HIFU would require a needle biopsy first. Respondent actively discouraged Patient V.P. from any non-HIFU treatment for prostate cancer. As soon as Patient V.P. questioned Respondent about alternatives to HIFU, he was suddenly fast-tracked for HIFU scheduled October 24 through 26, 2013. He was told he needed to make a $10,000.00 deposit to hold the date and the total cost was $32,000.00. Despite his concerns regarding the expedited scheduling of his procedure and the cost of the HIFU treatment, Patient V.P. returned to the office with a check for $10,000.00 to cover the cost of the deposit to hold the October treatment date. While waiting to hand the check to Respondent's receptionist, Patient V.P. overheard Respondent on a speakerphone arguing with a radiologist concerning an MRI report. Respondent was insisting the radiologist include the word "cancer" on MRI reports and the radiologist insisted it was not possible for him to make such a diagnosis. After hearing this conversation, Patient V.P. immediately left Respondent's office with his check. Patient V.P. subsequently discussed his experience with a trusted friend who practiced as a nurse in a cancer clinic. She, too, expressed concerns about diagnosing and treating prostate cancer without a biopsy. Patient V.P. was referred by this friend to Dr. Vipul Patel, a physician specializing in urologic cancer in Orlando. Patient V.P. met with Dr. Patel on October 18, 2013. Dr. Patel advised Patient V.P. that it was not possible to diagnose prostate cancer without a biopsy. Dr. Patel also disputed that prostate biopsies can spread prostate cancer. Dr. Patel performed a digital rectal exam and found Patient V.P.'s prostate to be slightly enlarged (which is not abnormal for a man of Patient V.P.'s age), normal, and smooth. Dr. Patel told Patient V.P. that he doubted he had prostate cancer. Patient V.P. then underwent a prostate biopsy by Dr. Patel, which was negative for prostate cancer. This was surprising to Patient V.P. because Respondent led him to believe, based on the MRI, that his prostate was full of cancer. Patient V.P. experienced significant side effects as a result of taking the medications ordered by Respondent. The Bicalutamide caused Patient V.P. to experience overwhelming depression, shakes, hot flashes, tunnel vision, and headaches. The Trelstar caused erectile dysfunction, increased frequency of hot flashes, night sweats, and made Patient V.P. so weak he was unable to work for eight months. Standard of Care As discussed above, the experts who provided depositions or live testimony in this case were unanimous in their conclusions that the standard of care in Florida from 2008 through 2013 precluded diagnosis or treatment of prostate cancer in the absence of a tissue biopsy. A reasonably prudent physician would not tell a patient he had prostate cancer based upon an ultrasound and/or MRI. A reasonably prudent physician would not prescribe medication, suggest treatment, or participate in treating a patient for prostate cancer, based upon an ultrasound or MRI. Respondent claims that in each of these cases, he advised the patient that a needle biopsy was the definitive test for prostate cancer, but it was a method he did not favor due to the possibility of needle tracking. Respondent's testimony in this regard is not credible in light of the credible testimony of the three patients that Respondent made clear he would not perform a needle biopsy and actively discouraged them from anything other than diagnosis by MRI and subsequent HIFU treatment. Respondent's suggestion, that he offered needle biopsy as an option, is wholly inconsistent with the title, theme, and contents of his own book, and the manner in which he defined his method of diagnosing prostate cancer at the DCD in his book and on his website. It is self-evident that a patient's perceptions regarding the safety and efficacy of needle biopsies for prostate cancer detection are at least, in part, influenced by the discussion with the physician. Respondent's active efforts to dissuade these patients from having the one definitive test for prostate cancer, by dramatically over-inflating the infinitesimally small possibility of needle tracking, were wholly inconsistent with the standard of care. Respondent claims that these four patients insisted they did not want a needle biopsy, therefore, it was appropriate to diagnose them on the basis of "a preponderance of the evidence and concordance of data" and move forward with a treatment plan, including medications and HIFU. The standard of care in Florida during 2008 through 2013, for a situation in which a patient suspected of having prostate cancer refused a needle biopsy, was to prescribe a course of A.S., including regular and frequent PSA testing, and to offer no other treatment.7/ Ultimate Factual Determinations Petitioner established by clear and convincing evidence that Respondent committed medical malpractice in his treatment of Patients G.P., J.W., K.S., and V.P. by the following violations of the standard of care: failing to obtain and review prostate biopsy results before confirming the patient had, or diagnosing the patient with, prostate cancer (Patients G.P., J.W., K.S., and V.P.); prescribing Bicalutamide/Casodex to a patient without first confirming through a prostate tissue biopsy that the patient has prostate cancer (Patients G.P. and V.P); prescribing, injecting, or authorizing the injection of Trelstar to a patient without first confirming through biopsy results that the patient has prostate cancer (Patient V.P); recommending and/or attempting to facilitate HIFU treatment without first confirming through biopsy results that the patient has prostate cancer (Patients G.P., J.W., K.S., and V.P.); and participating in, and/or assisting with the performance of HIFU treatment for a patient without first confirming through biopsy results that the patient has prostate cancer (Patient G.P.). Accordingly, Respondent is guilty of the offense defined in section 458.331(1)(t), Florida Statutes.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order finding that Respondent violated section 458.331(1)(t), Florida Statutes, as charged in Amended Administrative Complaints; imposing a fine of $30,000.00; revoking Respondent's medical license; and imposing costs of the investigation and prosecution of this case. DONE AND ENTERED this 24th day of February, 2017, in Tallahassee, Leon County, Florida. S MARY LI CREASY Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 24th day of February, 2017.
The Issue Whether the medical services prescribed for the Petitioner are experimental or investigative under terms of the state insurance contract, and excluded from coverage.
Findings Of Fact The Petitioner, John M. Compton, is 55 years of age, and has been an employee of the State of Florida for 21 years and 2 months. Mr. Compton is a participant in the State of Florida Employees' Group Health Self Insurance Plan (Group Plan), and entitled to coverage in accordance with the provisions of the Group Plan. The Respondent is the Division of State Employees' Insurance, Department of Management Services (Department) which is charged with the administration of the Group Plan. BCBS is the contract administrative agency for the Group Plan, and makes recommendations to the Administrator regarding covered procedures. In February 1992, the Petitioner was diagnosed by Dr. Mark Currie, a physician who specializes in treatment of diseases of the blood and cancer, with multiple myeloma, a form of cancer which attacks the blood and bone marrow. Dr. Currie treated the Petitioner using chemotherapy with good results; however, recognizing that the prescribed chemotherapy would be effective for a finite, but unknown period of time, Dr. Currie suggested intensive chemotherapy treatment with stem cell support upon relapse. Stem cell support is another term for bone marrow transplants which today includes withdrawing the blood from the donor, extracting the stem cells which form bone marrow cells, freezing these cells, and reintroducing them into the donor. This would be done after the Petitioner had had high dose chemotherapy which would kill his existing bone marrow. Chemotherapy utilizing the drugs which would be used in this procedure has been conducted for many years and the maximum dosages, maximum toxicity, and similar information have been investigated and studied in trials which have been concluded. This therapy is standardized treatment of the type administered by Dr. Currie and presumably covered by the plan. Bone marrow transplants using the procedure described above is a relatively new procedure, compared with the chemotherapy, but has been performed for four to five years and has been accepted as a standard treatment. Dr. Currie referred the Petitioner to Dr. Robert Joyce at Baptist for assessment as a subject for treatment upon relapse using a combination of the two procedures described in paragraphs 5, 6, and 7, above. Dr. Joyce is a physician experienced in bone marrow research and the treatment of diseases of the blood and bone marrow using chemotherapy and bond marrow transplants. Dr. Joyce was the principal investigator and primary physician in the program to which the Petitioner was referred. After examination, testing and an initial series of chemotherapy using the drugs used in the high dose therapy, Dr. Joyce determined that the Petitioner is an excellent candidate for this procedure because he does not have many of the diseased cells in his system and they are destroyed by the drugs used in the chemotherapy. For the maximum benefit, the procedure must be undertaken before the number of diseased cells increase in the Petitioner's system. This is what creates the urgency in these proceedings. Dr. Joyce requested a predetermination of coverage for the proposed procedure from the Group Plan's administration, BCBS, which recommended to the Group Plan's Administrator that the coverage was excluded as investigative or experimental. See Subsection G.28 of the Insurance Plan Benefit Document, Respondent's Exhibit 3. By letter dated March 15, 1995, the administrator denied coverage. The denial letter states erroneously that the proposed procedure is a Phase II investigation, which gave rise to efforts at hearing to show that the proposed procedure was not a Phase I, II or III investigation or experiment. The benefit document, Respondent's Exhibit 3, defines "Experimental or Investigative" as meaning: . . . any evaluation, treatment, therapy, or device which involves the application, admin- istration or use, of procedures, techniques, equipment, supplies, products, remedies, vaccines, biological products, drugs, pharmaceuticals, or chemical compounds if, as recommended by the Servicing Agent and determined by the Administrator: such evaluation, treatment, therapy, or device cannot be lawfully marketed without approval of the United States Food and Drug Administration or the Florida Department of Health and Rehabi- litative Services and approval for marketing has not, in fact, been given at the time such is furnished to the Insured; such evaluation, treatment, therapy, or device is the subject of an ongoing Phase I, II, or III clinical investigation or under study to determine: maximum tolerated dosage(s), toxicity, safety, efficacy, or efficacy as compared with the standard means for treatment or diagnosis of the condition in question; that the consensus of opinion among experts is that further studies, research, or clinical investigations are necessary to determine: maximum tolerated dosage(s), toxicity, safety, efficacy, or efficacy as compared with the standard means for treatment or diagnosis of the Condition in question; that such evaluation, treatment, therapy, or device has not been proven safe and effective for treatment of the condition in question, as evidenced in the most recently published medical literature in the United States, Canada, or Great Britain, using generally accepted scientific, medical, or public health methodologies or statistical practices; there is no consensus among practicing Physicians that the treatment, therapy, or device is safe and effective for the condition in question; or such evaluation, treatment, therapy, or device is not the standard treatment, therapy or device utilized by practicing Physicians in treating other patients with the same or similar condition. The testimony of Dr. Currie and of Dr. Joyce established that this procedure was not a Phase I, II, or III investigation; that this procedure is safe and effective within the acceptable limits of such therapies; and that there is a consensus that the procedure is safe and effective for the condition. The testimony of Dr. Joyce established that under the protocols under which the Petitioner would received the proposed treatment, information would be gathered on toxicity and on the efficacy of this treatment compared with current treatments. Deposition of Dr. Joyce, Page 113, line 9. The evidence also establishes that the treatment proposed is not the "standard" treatment for this disease. See Petitioner's Exhibit 8, Letter of September 28, 1994, Dr. Joyce to Dr. McLear attached to letter dated October 13, 1994, Dr. McLear to Dr. Joyce. Although these conditions do not define the treatment as even a Phase IV investigation, it does place the treatment within the exclusions (b) and (c) cited in Paragraph 11, above.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law set forth herein, it is, RECOMMENDED: That the proposed procedure be excluded under the terms of the State Group Plan. DONE and ENTERED this 13th day of April, 1995, in Tallahassee, Florida. STEPHEN F. DEAN, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 13th day of April, 1995. APPENDIX TO RECOMMENDED ORDER Petitioner's Proposed Findings Paragraphs 1-9 Adopted and subsumed in paragraphs 1-8. Paragraphs 10-15 Adopted and subsumed in paragraphs 9-11. Paragraph 16 True, the plan does not name any specific procedure. Paragraph 17,18 There is no presumption regarding the proposed procedure as experimental. Paragraph 19,20 True, but unnecessary to resolve the legal and factual dispute. Paragraph 21-37 Subsumed in paragraph 12. Paragraph 38 Subsumed in paragraph 8. Paragraph 39 The study shows that the treatment is accepted as safe and effective, but does not address the issue of whether it is experimental. Further, the exclusion is not based upon the experimental nature of the procedure, but upon the fact that it would be excluded under specific language of the benefit plan. Paragraph 40,41 See comments to Paragraph 21. Paragraph 42-43 See comments to Paragraph 39. Paragraph 44 Subsumed in paragraphs 6,7. Paragraph 45-49 True, but not required for a determination of the issue. Paragraph 50 Subsumed in paragraph 8. Paragraph 51 Rejected as contrary to best evidence. Paragraph 52 Subsumed in paragraph 12. Paragraph 53-55 Rejected as argument. Paragraph 56 0True, but not required for a determination of the issue. Respondent's Proposed Findings Paragraphs 1-5 Paragraphs 1-4. Paragraphs 6,7 Not necessary for determination of the issue. Paragraphs 8-13 Paragraphs 3-8. Paragraphs 12 Deleted by Respondent. Paragraphs 14,15,16 Paragraphs 9-11. Paragraph 17 Paragraph 8. Paragraph 18 True, but not necessary for determination of the issue. The evidence tends to show that, notwithstanding the newness of the procedure, it is rapidly being accepted as the procedure of choice in treatment of this type of disease. Paragraph 19-23 Irrelevant. Paragraph 24 The information quoted is quoted from another source attributable to Dr. Joyce. Paragraph 25 Supports finding that the treatment is not standard, but is rejected for the purpose that it was apparently offered. Paragraph 26-29 Irrelevant. Paragraph 30,31 Conclusion of Law. Paragraph 32 Subsumed in findings that proposed procedure in not the standard treatment. Paragraph 33-39 Irrelevant. Paragraph 40 See comments to paragraph 32. Paragraph 41,42 Irrelevant. COPIES FURNISHED: Robert D. Newell, Jr., Esquire 817 North Gadsden Street Tallahassee, FL 32303 Augustus D. Aikens, Jr., Chief Benefit Programs and Legal Services Division of State Employees' Insurance 2002 Old St. Augustine Road, B-12 Tallahassee, FL 32301-4876 William H. Lindner, Secretary Department of Management Services Knight Building, Suite 307 Koger Executive Center 2737 Centerview Drive Tallahassee, FL 32399-0950 Paul A. Rowell, General Counsel Department of Management Services Knight Building, Suite 312 Koger Executive Center 2737 Centerview Drive Tallahassee, FL 32399-0950
The Issue Whether Respondent violated Subsections 458.331(1)(d), 458.331(1)(n), and 458.331(1)(t), Florida Statutes, and, if so, what discipline should be imposed.
Findings Of Fact Hammesfahr is a licensed physician in the State of Florida, having been issued Florida License ME 52212 on February 8, 1988. He is board-certified in neurology and pain management. Hammesfahr's office is located in Clearwater, Florida, where he maintains a practice treating patients who have had strokes. A stroke is a blockage of an artery in the brain that causes damage to the brain. As a result of the stroke certain cells within the brain will die, and the victim will develop a multitude of deficits, including paralysis, loss of vision, sensory loss, and memory problems. Between 1998 and 2000, Hammesfahr advertised his treatment for stroke patients and included the following statements in some of his advertisements: Using advanced technology, Dr. Hammesfahr has developed a sophisticated method to help restore blood flow to the damaged areas of the brain after a stroke. With increased blood flow to these areas, the brain can heal. Dr. Hammesfahr is the first physician to treat and successfully reverse the effects of stroke using vasodilators. These advertisements have appeared in Florida and in airline magazines, which travel throughout the country. In some of his advertisements, Hammesfahr indicated that based on an evaluation of the first 67 patients who went through the therapy 82 percent had major improvement, 11.9 percent had minor improvement, and 6 percent had no improvement. He further indicated that the study showing these results was peer-reviewed. Generally, Hammesfahr's treatment protocol is based on the concept of dilating blood vessels in the brain to optimize neurological function and neurological recovery. He uses vasodilator medications to dilate blood vessels in the brain and to increase blood flow into the brain. Various methods are used to monitor the therapy and improvement, including ultrasound, physical examinations, neuropsychological and physical therapy testing, EEG, transcranial Doppler, and blood pressure monitoring. Medications used to dilate the blood vessels include ACE inhibitors, calcium channel blockers, nitrates, alpha and beta blockers, and sympatholytics. After a stroke has occurred, brain cells in the center of the stroke are destroyed and cannot be revived. The area next to the stroke center is called the penumbra and consists of brain cells that are damaged and might recover. Hammesfahr does not claim that his treatment protocol can restore the brain cells that have been destroyed. He does claim that by using his protocol there may be some recovery in the damaged areas, where the blood vessels have restricted and narrowed. The medications dilate the vessels and increase the blood flow to the damaged areas. The recovery of a stroke patient consists of three phases: acute, subacute, and chronic. The acute phase occurs from the onset of the stroke to the next few days or weeks thereafter. The subacute phase starts at the end of the acute phase and lasts for approximately six weeks to three months. However, in certain cases it might last as long as 18 months. The chronic phase is the last phase, which commences at the end of the subacute phase and lasts for an indefinite period. Hammesfahr usually treats stroke patients who are in the chronic phase, but has also treated patients in the other phases of stroke recovery. When a patient contacts Hammesfahr concerning his stroke treatment, the patient will be sent a new patient package, which describes the phases of treatment, contains articles written by Hammesfahr concerning his treatment, and includes a fee schedule. Hammesfahr has different treatment plans from which the patient may choose to participate. The costs for the treatment vary according to the plan; the longer the patient is seen in Clearwater by Hammesfahr, the more costly the treatment. The average patient seen by Hammesfahr opts for the three-week plan. If a patient decides that he wants to be treated by Hammesfahr, the patient is required to see his primary care physician, provide the physician with the articles contained in the new patient package, and obtain his medical records from the physician. The primary care physician is to perform certain tests on the patient and give a medical clearance for the patient to travel to Clearwater, Florida, for treatment by Hammesfahr. The patient is also sent a package of materials, which includes a medical history form to be filled out by the patient and brought to Hammesfahr when the patient comes to Clearwater for treatment. When the patient initially presents for treatment at Clearwater, the patient is given an explanation of the treatment by Hammesfahr and his staff. Patients are advised that there are no guarantees that the treatment will be successful. An intake is performed to make sure that the needed forms are properly completed, including a history of the patient to determine that the patient's primary care physician has given the patient a clearance to come to Hammesfahr for treatment, and to review the medical records of the patient. A physical examination is performed on the patient. The patient is given a schedule for the time that the patient will be in treatment in Clearwater, and Hammesfahr's staff reviews the schedule with the patient. Tests are performed on the patient in Hammesfahr's office such as the transcranial Doppler ultrasound to generally determine the blood velocity. The patient is sent to Diane Hartley, a physical therapist, for testing of gross motor function, and to Dr. Alexander Gimon for neuropsychological testing. The tests given by Ms. Hartley and Dr. Gimon are standardized tests, for which the patient normally pays additional fees. The initial tests by Ms. Hartley and Dr. Gimon are given to form a baseline for a comparison with later test results. Those patients who are three-week patients will also have examinations by Ms. Hartley and Dr. Gimon at the end of their treatment period. The test results are compared with the test results taken at the beginning of the treatment period. The patient receives an orientation session in which the patient is informed of the responsibilities that the patient has during the course of treatment. Such responsibilities include taking blood pressure measurements at prescribed times of the day, charting the results of the blood pressure test, and seeing and providing the patient's primary care physician with the blood pressure readings. The patient must drink eight glasses of water a day, unless the patient has a heart disease, and must avoid certain types of foods that are vasoconstrictors. Once the patient completes the treatment at Hammesfahr's office, the primary care physician will take over the medical management of the patient's treatment. Hammesfahr's office will confer with the patient's primary care physician after the patient leaves Hammesfahr's office to discuss the monitoring of the patient and the altering of the patient's medication. One week after returning from treatment in Clearwater with Hammesfahr, the patient must see his primary care physician. In October 1999, a friend of M.T. mailed M.T. one of Hammesfahr's advertisements. As result of receiving the advertisement, M.T. contacted Hammesfahr's clinic and sought treatment from him for a stroke which she suffered in May 1999. Hammesfahr sent M.T. an information package and a videotape. The package contained articles written by Hammesfahr, a description of the different programs available, and a price list for the programs. M.T. decided that she would try a three-day program for $3,000. There was a dispute as to exactly which program M.T. received when she went to Clearwater. The only two programs which Hammesfahr listed as costing $3,000 were the Executive Stroke Prevention Program and the One-Week Evaluation and Treatment Program. The Executive Stroke Prevention Program was described as follows: This is a three (3) day program in which patients will undergo CAT scan and MRI at our facility, state of the art computerized EEG, and transcranial ultrasound to look at the blood vessels of the brain. They will undergo a comprehensive medical review and family review, as well as recommendations for lowering one's chances of a stroke or to treat if there has been a stroke in the past. This program is not covered by insurance. The One-Week Evaluation and Treatment Program was described as follows: This program is designed for those who want to start the stroke program and have the program advanced to a level which makes it significantly easier for the family physicians at home and neurologists to continue the program safely and rapidly. The first days [sic] involved in the initial evaluation, as well as any testing such as EEG and ultrasound testing, if necessary, and CT scans and MRIs as well as blood tests, followed by days two through five being involved in the initiation of medical treatment in that either treating the previous stroke or preventing future strokes. Recommendations are then made to the family physician or neurologists for caring through on this program. There was an additional three-day program, Initial Evaluation and Treatment, which listed for $2,000 and provided the following: This is a three (3) day consultation and evaluation with recommendations for treatment. This program is designed for patients who are interested in treatment of their stroke by their family physicians at home. A comprehensive evaluation will be made by our physicians as well as treatment recommendations. This evaluation will include review of CAT scans or MRIs and blood tests, and when appropriate, computerized EEG testing, neuropsychological testing, and ultrasound evaluations. The program is approximately three days. Prior to traveling to Hammesfahr's clinic, M.T. was directed by Hammesfahr to obtain medical tests from her primary care physician, which she did. The tests included a CT scan of the brain, a CMP, liver profile, CBC with different platelets, Westergren's sed rate, EEG, CVA, and EKG. She was also required to take and write down her blood pressure two times a day for a week before going to Hammesfahr's clinic. M.T. also filled out a medical history form and a system review checklist prior to her visit to Hammesfahr. In a letter dated February 12, 2000, to M.T. on Hammesfahr's letterhead, his office staff described the treatment that M.T. would receive as follows: Your first visits with us will be quite long. So, plan accordingly. On your first day, you will have a consultation with the doctor. The second day you will have diagnostic testing in our office, and an appointment with Dr. Gimon for a neuro- psychological evaluation and Diane Hartley for a physical therapy evaluation. Both of these doctors will be calling you to set up these appointments. The neuro-psychological testing will help us to evaluate any memory changes. You will probably see Dr. Gimon again towards the end of your treatment. On Tuesdays and Thursdays there is an orientation session outlining what we will be doing here in the office and [sic] explaining our treatment program will be given out. Each new patient must attend one of these sessions. Every day thereafter, your visit will be at least two (2) hours long. As you know, our treatment consists of sessions in this office each day Monday through Friday for the duration of your therapy. Please note: No warranties or guarantees can be made regarding the time, the degree, or the duration of improvement with this therapy. On February 20, 2000, M.T. signed a Waiver for Use of Medications, which stated: I am, or my caregiver is, aware that I have had a neurological disease and have failed to respond to other types of medications used in the conservative management of my condition. . . . Options available to me at this time are those now used at the Florida Neurological Institute. I am aware that the medications used in this therapy are medications that have FDA approval. However, I am also aware that the FDA has not approved these medications in the doses and number of medications used here at the Institute. I am aware that Dr. Hammesfahr has published many articles on his therapy. I am aware of the fact that, during the past two years, the Institute has treated many patients with similar conditions and that most have had at least some improvement in the symptoms associated with their problem. I have, and my caregiver has, been counseled regarding this theory under which this therapy is being promulgated. Upon arrival at the Florida Neurological Institute, I and my caregiver, will see and listen to the videotapes available regarding this therapy. I have, or my caregiver has, read this waiver and understands its contents. I am, and my caregiver is, aware that there is no indicated use for this therapy now. I have had all questions I may have concerning the use of these medications answered, I agree to undergo the use of these medications as outlined in the material presented to me. As stated above, I am fully aware of the fact that this therapy probably will not be covered by my insurance, but I wish to continue with this therapy as outlined to me in my training and information sessions. I also understand that no physician, or any other person in this office, can make any guarantees of success from this therapy. (Emphasis in the original) On February 28, 2000, M.T., accompanied by her husband, presented to Hammesfahr's clinic in Clearwater, Florida, for treatment. On her first day at the clinic, she received an orientation. She was required to pay $3,000 for her treatment. A staff member at Hammesfahr's clinic took M.T.'s blood pressure and directed M.T. to take her own blood pressure readings thereafter. On the second day of treatment, February 29, 2000, M.T. was sent to Dr. Alexander Gimon, a neuropsychologist, for a 30-minute evaluation. A staff member of Hammesfahr's clinic gave M.T. a transcranial Doppler, a carotid artery ultrasound, and an electrocardiogram. A Physician's Office Visit History and Physical Examination Form was filled out with a date of "2-28-00" struck through at the top of the form and the date of "2-29-00" placed next to it. At the end of the form appeared a physician's statement signed by Hammesfahr and dated February 22, 2000, a week before M.T. presented for treatment, stating that he had "examined this patient, reviewed his/her history, and consulted with him/her and the caregiver regarding the treatment planned here at Florida Neurological Institute." An Objective (Physical Examination) form was filled out, again with the date of "2-28-00" struck through at the top of the form and the date "2-29-00" placed next to it. The form does not indicate who performed the physical examination. The form does indicate that M.T.'s blood pressure and pulse readings were taken. M.T. met with Hammesfahr, who observed her gait and told her that he would send her back home and would work with her physicians. He did not prescribe any medications at that time and did not give M.T. any medications during her treatment at his clinic. On March 1, 2000, M.T. was supposed to meet with the physical therapist, Diane Hartley, for evaluation at 8:00 a.m. When she arrived at Ms. Hartley's facility, no one was there to let M.T. in the building. When M.T. went into the facility, she did not like the looks of the building, describing it as "shoddy looking." She decided that she did not want to stay for an evaluation and left. The fee Hammesfahr charged M.T. included the fees for Dr. Gimon and Ms. Hartley. On March 1, 2000, M.T. and her husband returned home with the understanding that Hammesfahr would be contacting her doctors in Alabama to arrange for the administering of the medications. M.T. was told to make an appointment with her primary care physician for the week after she returned from Clearwater. Hammesfahr first communicated with M.T.'s physicians by letter, dated April 5, 2000, asking them to administer the vasodilators and magnesium sulfate I.V.'s. M.T.'s physicians in Alabama refused to administer the medications. M.T. did not take the vasodilators, which Hammesfahr wanted her physicians to administer; nevertheless, M.T. improved. Based on the rate schedule presented to M.T. for Hammesfahr's various treatment programs, she should have received either the Executive Stroke Prevention Program or the One-Week Evaluation and Treatment Program. Hammesfahr was adamant that M.T. did not sign up for the Executive Stroke Prevention Program, and the evidence established that she did not receive this program. M.T. was given an itinerary that indicated that she would be treated by Hammesfahr for a week; however the evidence established that she did not receive the treatment that was supposed to be given in the One-Week Evaluation and Treatment Program, which promised that the initiation of medical treatment would be done on days two through five. Hammesfahr did not administer any medications or prescribe any medications for M.T. during her stay in Clearwater. The evidence does show that M.T. received the three-day Initial Evaluation and Treatment Program, for which she should have been charged only $2,000. Hammesfahr presented the expert testimony of Dr. Jacob Green, who is a board-certified neurologist, practicing in Jacksonville, Florida. He has been practicing for over 35 years. Dr. Green has written papers on the use of transcranial Doppler, and he is experienced in the treatment of acute and chronic stroke patients. Dr. Green is familiar with the protocol and procedure utilized by Hammesfahr in treating stroke patients. He has read articles written by Hammesfahr, reviewed patients' records, and spent a day in Hammesfahr's office observing Hammesfahr's practice and treatment protocol which is at issue in this case. While he was at Hammesfahr's clinic, Dr. Green observed Hammesfahr treat patients, reviewed medical records of patients when they first came to Hammesfahr for treatment, and compared the findings in those records to his observations of the patients' abilities. Dr. Green discussed the treatment and protocol with Hammesfahr. Based on his deposition testimony, Dr. Green had a good understanding of the treatment and protocol used by Hammesfahr for stroke patients. Dr. Green described the standard of care for a stroke patient as "to do good by the patient, do no harm." According to Dr. Green, Hammesfahr's care and treatment and protocol complied with the standard of care. Hammesfahr presented the expert testimony of Dr. William Scott Russell, Jr., a retired neurologist with 33 years of experience. In his practice, he had treated thousands of stroke patients. Dr. Russell retired in October 1998. Dr. Russell had first-hand knowledge of the protocol used by Hammesfahr when he treated Dr. Russell for an acute stroke. Prior to Dr. Russell's being treated by Hammesfahr, Dr. Russell had reviewed a paper written by Hammesfahr concerning Hammesfahr's treatment protocol for stroke victims using vasodilators. Dr. Russell considered the treatment protocol espoused by Hammesfahr to not be below the standard of care as of 1998. In 1996, Dr. Russell experienced a stroke. When he awoke one morning, he was confused. He went to work and had difficulty with his abilities to speak and write. Dr. Russell realized that he was experiencing a stroke and had a technician in his office run an EEG. He had peer-reviewed some of Hammesfahr's papers prior to his stroke and was impressed with Hammesfahr's work. So, he contacted Hammesfahr and presented at Hammesfahr's clinic for treatment the day he experienced the stroke. Hammesfahr performed a transcranial Doppler on Dr. Russell and administered nitroglycerine to dilate Dr. Russell's blood vessels. Ten minutes after the nitroglycerine was administered, Dr. Russell's symptoms disappeared. Within a reasonable degree of medical probability, the cause of his recovery was the use of the nitroglycerine. Nitrates are used for acute stroke patients when the patient has an extremely high blood pressure. The nitrates lower the blood pressure and are given intravenously so that the medication can be discontinued immediately if the blood pressure should fall too low. There was no evidence presented to determine whether at the time that Hammesfahr administered nitroglycerine to Dr. Russell that Dr. Russell's blood pressure was high. At the time of the final hearing, Dr. Russell felt that he had total recovery from the stroke deficits. He has reduced his intake of medications prescribed by Hammesfahr and has not had a return of the deficits. The Department presented the testimony of four expert witnesses concerning the standard of care for treatment of stroke victims: Dr. Harold Charles Friend, Dr. Steven Novella, Dr. David F. Scales, and Dr. Thomas Hoffman. Dr. Hoffman has been practicing neurology in Melbourne, Florida, since 1982. Approximately five to ten percent of his patients have had a stroke or a cerebral vascular disease. He has read some of Hammesfahr's advertisements and viewed Hammesfahr's article on Hammesfahr's Internet web site. Dr. Hoffman understands Hammesfahr's protocol to be the use of medications to increase the cerebral blood flow and the use of the transcranial Doppler to direct the medication treatment by measuring the cerebral blood flow. Dr. Hoffman does not agree that the use of vasodilators increases the blood flow to the brain. There is a loss of cerebral autoregulation when a stroke occurs. According to Dr. Hoffman, the use of vasodilators can decrease the blood flow to the brain and worsen neurological functioning in acute stroke patients. It is the opinion of Dr. Hoffman that Hammesfahr's treatment of stroke patients falls below the standard of care for acute, subacute, and chronic stroke patients. Dr. Steven Novella is a neurologist and an assistant professor at Yale University. He received his medical license in Connecticut in 1993 and obtained his board certification in neurology in 1998. He treats stroke patients and is familiar with the appropriate treatment for stroke patients. Dr. Novella understands that the treatment for stroke patients which Hammesfahr advocates is the administration of vasodilators to expand blood vessels which have an insufficient blood supply due to constriction. He disagrees with Hammesfahr's theory, espousing that the blood vessels in the area of the brain that is not receiving enough blood flow will dilate as far as they can go and that the blood vessels will not respond to the vasodilators because the blood vessels are already maximally dilated. Dr. Novella is of the opinion that vasodilators may be used for stroke patients to reduce the risk of another stroke when the patient is hypertensive, but that the vasodilators should not be used as a method of reversing deficits caused by stroke. Dr. Harold Charles Friend is a board-certified neurologist, who has been practicing neurology for 26 years. He practices in Boca Raton, Florida. Approximately five to eight percent of his practice is dedicated to treating stroke patients. He is currently treating in excess of 500 stroke patients. Dr. Friend has reviewed the charts of two patients of Hammesfahr, an article written by Hammesfahr, some of Hammesfahr's advertisements, some newspaper articles, and an article authored by Hammesfahr, which appeared on an Internet site. Dr. Friend also saw a patient in his office that had previously been treated by Hammesfahr. Based on the information from these sources, Dr. Friend incorrectly understood that Hammesfahr's methodology was to basically lower the blood pressure of his patients in an attempt to restore dead cells. He also concluded that the patients seen by Hammesfahr were also receiving physical therapy at the time of treatment. Dr. Friend opined that Hammesfahr's treatment of chronic stroke victims did not comport with the standard of care recognized in the medical community. He further concluded that given the medications that Hammesfahr administers to his patients, that one would expect some adverse effects or no effect on the patients. The only mention in the record of a patient's being harmed by Hammesfahr's treatment was by Dr. Friend. Dr. Friend reviewed a medical chart of a patient who had worsened after treatment by Hammesfahr and had to go to another physician, Dr. Nassar Elmansoury, to correct the problem. The patient had been prescribed Accupril, ten milligrams four times a day, and nitroglycerine cream. Both medications are vasodilators. When the patient presented to Dr. Elmansoury, the patient was feeling worse and experiencing chest pain, dizziness, and disequilibrium. Dr. Elmansoury eliminated the nitroglycerine cream and reduced the amount of Accupril. Within two weeks, the patient was improved. Dr. David F. Scales is a board-certified neurologist, who has been practicing for 34 years. He currently practices in the Jacksonville, Florida, area at the Jacksonville Neurological Clinic. About 50 percent of his in-patient practice consists of stroke patients. Stroke patients comprise about 20 to 25 percent of the entire practice. Dr. Scales has reviewed the medical records of two of Hammesfahr's patients, articles written by Hammesfahr, literature provided by Hammesfahr to his patients, and Hammesfahr's Internet web site. Dr. Scales understands Hammesfahr's theory to be that vasodilators are administered to dilate the blood vessels in the brain so that more blood flows through the penumbra, reactivating neurons that were in a suspended state of activation. He does not agree with Hammesfahr's theory because the blood vessels in the penumbra would be dilated to the maximum and the medications would dilate blood vessels in other parts of the body, which would in turn take away or steal the blood flow from the blood vessels in the penumbra. After reviewing the medical records of two of Hammesfahr's patients, M.T. and M.S., Dr. Scales was of the opinion that the treatment provided by Hammesfahr did not meet the standard of care for the treatment of stroke patients. Having considered the testimony of the experts presented by the parties, it is determined that the standard of care for the treatment of stroke patients varies according to the stage, type, and severity of the stroke. In the acute stage, the patient is admitted to the hospital. A medical history is taken and a physical exam is given, followed by appropriate laboratory and imaging studies to determine the site and cause of the stroke. For patients seen within three hours of the onset of the stroke, certain intravenous medications may be given in an attempt to break up the blood clot. For patients seen beyond the three-hour point, the treatment is maintenance of their blood pressure, monitoring of their vital signs, and treating any complications that may occur such as pneumonia and urinary tract infections. Patients may be given blood thinners to improve the flow of the blood, and medication to increase the blood pressure in the event the blood pressure is too low. Patients with severe hypertension, generally a blood pressure over 220 systolic or 120 diastolic, are given medications to lower their blood pressure. Patients with asymptomatic hypertension are treated judiciously during their hospital stay with anti-hypertensive medications, and the blood pressure is gradually lowered. The standard of care for subacute stroke patients is a continuation of the treatment given in the acute phase. Patients will be started on rehabilitation therapy, which may include speech, occupational, and physical therapy. The standard of care for chronic stroke patients, whom the physician is seeing for the first time, would be to take a history to determine what happened, review the medical records and any imaging studies that may have been done, and review the treatment they have had. The physician should assess the patients' risk factors for stroke such as hypertension, hyperlipidemia, diabetes, and smoking and manage those factors aggressively. Treatment with antiplatelets such as aspirin or an anticoagulation medication might be indicated. An assessment of their neurological functional abilities should be done to determine whether aids, braces, further therapy, or home care could be beneficial. Based upon the evidence presented, the treatment advocated by Hammesfahr is not within the generally accepted standard of care. However, the evidence is not clear and convincing that the treatment used by Hammesfahr is harmful to his patients. There is literature in the medical community that vasodilators can be used in the treatment of stroke as a measure to prevent future strokes. There is evidence that in over 200 patients seen by Hammesfahr that a large percentage improved after being treated by Hammesfahr. Dr. Gimon tested a group of 168 stroke patients seen at Hammesfahr's clinic during the period of November 1999 to May 2000 and another group of 163 stroke patients seen during October 2000 through February 2001. The same battery of tests was administered to both groups. Dr. Gimon evaluated these patients on nine separate neurological evaluations that are standard instruments recognized in neuropsychology. The tests measured identified areas of brain function, including verbal, visual, visual motor, and conceptual thinking. Both groups of patients were tested prior to the treatment by Hammesfahr. The patients were tested again approximately 18 to 21 days after they began treatment at Hammesfahr's clinic. The test results showed that many patients showed improvements in the areas tested. The improvements noted were measured as to a statistical difference so that the findings could not be attributable to testing error. Some patients showed no improvement in all areas. The test results revealed that there was no neuropsychological deterioration of the patients tested. Diane Hartley tested two groups of Hammesfahr's patients, who were treated at his clinic during the period of January to December 2000. Her tests were designed to measure functional motor improvement from a gross motor standpoint. She performed tests on the patients prior to their beginning treatment with Hammesfahr and again approximately two and one half to three weeks after the patients had begun treatment. Of the 242 patients tested by Ms. Hartley, 221 patients demonstrated improvement in one or more of the areas tested and 21 patients showed no improvement. Of the patients tested, ten received physical therapy from Ms. Hartley while they were being treated by Hammesfahr. These ten patients demonstrated a significant amount of improvement, which Ms. Hartley could not attribute solely to the physical therapy they received. The evidence establishes that Hammesfahr informed his patients by the use of videos, orientation sessions, literature, and a web site on the Internet of the nature of the therapy and did not guarantee that the patients would improve as a result of the treatment. Patients were able to make an informed decision on whether to try Hammesfahr' treatment.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that Hammesfahr did not violate Subsections 458.331(1)(d) and 458.331(1)(t), Florida Statutes; finding that Hammesfahr did violate Subsection 458.331(1)(n), Florida Statutes; placing Hammesfahr on probation for six months; and imposing a $2,000 administrative fine. DONE AND ENTERED this 20th day of November, 2002, in Tallahassee, Leon County, Florida. _____ SUSAN B. KIRKLAND Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 20th day of November, 2002.
Findings Of Fact Based upon the evidence adduced at hearing, and the record as a whole, the following Findings of Fact are made: Facts Found in DOAH Case No. 91-2811 The Parties in DOAH Case No. 91-2811 Respondent, the Agency for Health Care Administration (hereinafter referred to as the "Agency") is a state government licensing and regulatory agency. Irving Royce is now, and has been since 1962, a physician licensed to practice medicine in the State of Florida, holding license number ME 0010545. He is also licensed to practice medicine in New Jersey and New York. From 1948 to 1952, Dr. Royce attended the Chicago Medical School, from which he graduated with a M.D. degree. From 1952 to 1953, he had a rotating internship in a Newark, New Jersey hospital. After receiving his license to practice medicine in the State of New Jersey, Dr. Royce started a general medical practice there. He closed his practice in 1955 to begin training in his current primary specialty, psychiatry. He received such training from 1955 to 1960. He trained at Essex County Hospital in Cedar Grove, New Jersey, the New Jersey State Diagnostic Center in Menlo Park, New Jersey, the Veterans Administration Hospital in Lyons, New Jersey, Mount Sinai Hospital in New York, New York, and the Neuropsychiatric Institute in Princeton, New Jersey. From 1960 to 1971, Dr. Royce had his own psychiatric practice in Woodcliff, New Jersey. During the earlier portions of this period he also authored the following three articles which were published in the American Journal of Psychiatry: "Improving Insulin Therapy in Schizophrenia with Neostigmine" (May, 1961); "Improving Insulin Therapy with Calcium Gluconate" (February, 1962); and "Resistant Psychosis Treated Successfully by Indoklon" (February, 1962). In 1971, Dr. Royce moved his psychiatric practice to Florida, specifically 9145 Northwest 27th Avenue in Miami. He practiced psychiatry at this location in Miami until the early 1980's. In addition to his private practice, in 1972, Dr. Royce was the Director of the Methadone and Alcohol Unit at Reed Memorial Hospital in Miami. In October of 1973 and May of 1975, respectively, two articles that Dr. Royce had written, "Rapid Treatment of Opiate Addiction" and "The Post- Opiate Syndrome," were published in the Florida Journal of Medicine. Furthermore, from 1982 to 1984, he taught a "Fundamentals of Medical Science" course at Florida International University's Bay Vista Campus in North Miami, Florida. From July of 1983 to April of 1984, Dr. Royce was a staff psychiatrist at the Broward County Crisis Center in Pembroke Pines, Florida. Since leaving the staff of the Broward County Crisis Center in April of 1984, Dr. Royce has been practicing psychiatry, and, to a lesser extent, family medicine, at his office located at 17122 West Dixie Highway in North Miami Beach, Florida. In addition to his private practice, since approximately 1991, Dr. Royce has taught psychiatry courses at Nova Southeastern University in Miami. Although he teaches and practices psychiatry, he is not board certified in this specialty. Dr. Royce's Care and Treatment of Patient C.R. Overview From on or about October 2, 1984, to on or about July 8, 1985, (hereinafter referred to as the "treatment period") Dr. Royce provided medical care and treatment to patient C.R., a 35-year old overweight female with suicidal thoughts. C.R. initially presented to Dr. Royce with complaints of melancholia, irritability, nervousness and inability to control her weight. She explained that in the recent past her boyfriend had shot himself to death in her presence, her mother had passed away, and she had to put two of her cats to sleep, which events had led her to attempt to commit suicide by cutting her wrists. She further informed Dr. Royce that she expected to die and join her dead boyfriend in the near future. Dr. Royce diagnosed C.R. as having agitated depression with neurotic, not psychotic, features. He also concluded that she was suffering from obesity. Depression is a disorder with a predominant complaint of melancholia and depressed affect. A patient with agitated depression has features of melancholia, superimposed with anger and irritability. Agitated depression is more difficult to treat clinically than simple depression. During subsequent visits C.R. also complained of diarrhea, headaches, coughing spells, and pain associated with a fissure in her anal canal. Although C.R. made certain comments to Dr. Royce during the treatment period indicating that she used cocaine and consumed excessive amounts of alcohol, Dr. Royce reasonably believed, based upon the totality of circumstances, including other statements C.R. made to him and her appearance, demeanor and conduct during her visits to his office, that C.R.'s claims of cocaine and excessive alcohol use were "attention-getting" fabrications and that she did not have an addictive or abusive personality or a history of drug or alcohol abuse 5/ and he treated her accordingly. In doing so, Dr. Royce did not act in a manner that was inconsistent with what a reasonably prudent psychiatrist at the time would have done under similar circumstances. In the medical records that he maintained on C.R., Dr. Royce noted that C.R. had made claims of cocaine and excessive alcohol use, but he did not indicate that he disbelieved these claims. C.R.'s condition gradually improved during the treatment period. She lost weight, maintained a neater and cleaner appearance and became more outgoing. Overall Drug Regimen During the treatment period, Dr. Royce prescribed the following legend drugs for C.R.: Plegine, which contains Phendimetrazine, a Schedule III controlled substance; Didrex, a Schedule III controlled substance; Sinequan; Elavil; Valium, which contains Diazepam, a Schedule IV controlled substance; Librium, which contains Chlordiazepoxide, a Schedule IV controlled substance; Xanax, which contains Alprazolam, a Schedule IV controlled substance; Inderal; Ativan, which contains Lorazepam, a Schedule IV controlled substance; Placidyl, which contains Ethchlovynol, a Schedule IV controlled substance; Hycodaphen, which contains Hydrocodone, a Schedule III controlled substance; Darvocet, which contains Propoxyphene, a Schedule IV controlled substance; Percocet, which contains Oxycodone, a Schedule II controlled substance; Percodan, which also contains Oxycodone; Sudafed; Gantrisin; Paregoric; and Xylocaine (in ointment form). Dr. Royce also administered the legend drug Lasix to C.R. In addition, he administered to C.R. the following legend drugs as adjuncts to psychotherapy: Ketamine Hydrochloride (hereinafter referred to simply as "Ketamine"), which is sold under the brand name of Ketalar; Brevital, a barbiturate containing Methohexital, a Schedule IV controlled substance; and, on a single occasion, Seconal, another barbiturate, which contains Secobarbital, a Schedule II controlled substance. He further administered to C.R. Brevital and the legend drugs Atropine and Anectine in conjunction with non-convulsive electric current therapy. That Dr. Royce prescribed or administered the legend drugs specified in the preceding four paragraphs is reflected in the medical records that he maintained on C.R. Dr. Royce further indicated in these medical records the amounts of these drugs that were prescribed and administered. Dr. Royce's polypharmacy approach to treat the symptom clusters with which C.R. presented (and which were noted in the medical records that he maintained on C.R.) was not inappropriate and did not produce any significant, unwanted drug interactions. Furthermore, Dr. Royce did not prescribe or administer any drugs to C.R. 6/ in excessive amounts and he carefully monitored C.R.'s use of the drugs that he prescribed for her during her frequent office visits. Antidepressant Drug Therapy In the ordinary case, where time is not of the essence, a tricyclic antidepressant, such as Sinequan or Elavil, which Dr. Royce prescribed for C.R. on her second visit on October 9, 1984, is the medication of choice in attempting to combat depression. Sympathomimetic amines, such as Plegine and Didrex, are also used in treating depression. 7/ (In addition to helping fight depression, these amphetamine-like 8/ "mood elevators" also function as anorexic agents.) Unlike tricyclic antidepressants, which produce no immediate effect, sympathomimetic amines are very rapid acting. Therefore, if a patient suffering from depression is suicidal and in the throes of a life threatening crisis, as was C.R. when she presented to Dr. Royce, treatment with sympathomimetic amines is warranted because of the quick relief it provides. Because of C.R.'s desperate situation, Dr. Royce prescribed both Plegine and Didrex to treat her depression. That these sympathomimetic amines might also help C.R. lose weight was, in Dr. Royce's mind, an added bonus, but it was not the primary reason that he prescribed them. Neither Plegine nor Didrex should be prescribed for an individual who has an addictive or abusive personality or a history of drug or alcohol abuse. Dr. Royce, however, as noted above, reasonably believed that, in the case of C.R., he was not dealing with someone who had drug or alcohol problems. While there were occasions that Dr. Royce prescribed both Plegine and Didrex for C.R. on the same date, he never prescribed them for concomitant use. When he gave C.R., during the same visit, prescriptions for both Plegine and Didrex, he specifically instructed her to use them, not at the same time, but rather sequentially, for minimum periods of a week each. That he gave these instructions, however, is not reflected in the medical records he maintained on C.R. It is an acceptable practice to alternate the use of Plegine and Didrex in such a manner to determine which produces the best results for the patient. Dr. Royce found that Plegine was more effective than Didrex in combatting C.R.'s depression. He therefore stopped prescribing Didrex for C.R. The last time he prescribed Didrex for her was November 27, 1984. He continued to prescribe Plegine until June 18, 1985. Antianxiety Drug Therapy To reduce the anxiety that C.R. was experiencing, Dr. Royce appropriately prescribed the benzodiazepines Valium and Xanax and other antianxiety agents and sedatives, including Inderal, which he prescribed after C.R. reported having a "panic attack," and Placidyl, a strong hypnotic sedative or sleeping pill. These antianxiety agents were prescribed for concomitant use with antidepressant medication. Such concomitant use is appropriate where the patient is both depressed and anxious, as was C.R. in the instant case. Drug-Assisted Psychotherapy On approximately 40 separate occasions, from November 10, 1984, to June 11, 1985, Dr. Royce administered Ketamine to C.R. intravenously prior to a psychotherapy session in order to reduce her resistance to psychotherapy. 9/ Ketamine is a commonly used, 10/ relatively safe, 11/ FDA-approved 12/ anesthetic that is structurally similar to PCP. 13/ It is a legend drug. Unlike traditional anesthetics, which are general central nervous system depressants, Ketamine depresses some parts of the brain and stimulates others. In sufficient dosage, it provides anesthesia quickly. Its anesthetic effect lasts a relatively short period of time (approximately ten minutes) and there is generally rapid recovery, although postoperatively, some patients may hallucinate. While Ketamine remains in the bloodstream for approximately 24 hours, a patient who has received an anesthetic dose of Ketamine 14/ and suffered no complications, as a general rule, may be released two hours after having been anesthesized, provided instructions are given that the patient is not to operate a motor vehicle or other dangerous machinery or to make any major decisions immediately upon the patient's release. Aside from hallucinations, other possible side-effects from the use of Ketamine, according to the Physician's Desk Reference (hereinafter referred to as the "PDR"), include delirium, confusion, amnesia, tonic and clonic movements sometimes resembling seizures, anorexia, nausea and vomiting. Furthermore, because it tends to raise blood pressure, it should be used with caution where the patient is hypertensive. 15/ There is no evidence in the anesthesia literature that even the repeated use of Ketamine causes psychosis in normal patients. The impact that Ketamine has on the psyche induces an abreactive or dissociative effect in the patient and results in the patient becoming more verbal and expressive. Furthermore, like all anesthetics, Ketamine can be used as a tranquillizer to allay anxiety if administered in a dosage and manner that does not achieve an anesthetic outcome. 16/ Because of these features, there is reason to believe that Ketamine may help as an adjunct to psychotherapy. There are a number of authoritative, scientific articles, some dating as far back as the 1940's, which support such a view. Among them is a 1973 article, "The Use of Ketamine in Psychiatry," written by E. Khorramzadeh and A.O. Lofty (Respondent's (Dr. Royce's) Exhibit 11 in DOAH Case No. 91-2811) and a 1979 article, "Ketamine-Facilitated Induced Anxiety Therapy and Its Effect upon Clients' Reactions to Stressful Situations," written by A.A. Sappington, G. Corssen, A.T. Becker and M. Tavakoli (Respondent's (Dr. Royce's) Exhibit 10 in DOAH Case No. 91-2811). Dr. Royce reviewed these two articles before deciding to use Ketamine as an adjunct to C.R.'s psychotherapy. Notwithstanding the foregoing, Ketamine-assisted psychotherapy is not now, nor was it at any time material to the instant case, recognized as a standard or conventional treatment in the mainstream psychiatric community. It is not even mentioned in either the PDR or the American Psychiatric Association's four volume work on the treatment of psychiatric disorders. Furthermore, the FDA-approved label and package insert for Ketamine make no mention of the drug having any use in the practice of psychiatry. It is not necessarily inappropriate, however, for a physician to use a drug that has been approved as safe by the FDA for a purpose other than that which is indicated on the FDA-approved label and package insert. Before he used Ketamine in his treatment of C.R. as an adjunct to psychotherapy, Dr. Royce discussed the matter with C.R. and obtained her full, informed written consent. Such consent was given in a handwritten statement that C.R. signed on November 6, 1984. The statement, which Dr. Royce retained as part of his medical records on C.R., read as follows: Permit to Dr. Royce I, [C.R.], have been suffering from painful depression and nervousness. I have learned that Pentothal and Amytal (AMYTAL) Interviews, also known as TRUTH SERUM, have helped persons with symptoms such as mine. Dr. Royce who has been using Amytal interviews since 1957, has also had experience with the same technique using ketamine, a much safer drug than Amytal or Pentothal. The effect of ketamine (also known as KETALAR), wears off in less than 15 to 20 minutes. Therefore, a patient is able to leave the doctor's office hours sooner than would be possible with Amytal. Ketamine is also safer because it does not depress the cough or gag reflexes or respiration, as Amytal and Pentothal do. Because of these facts, I am now writing this statement with Dr. Royce's help to give permission to IRVING D. ROYCE, M.D. to treat me with psycho- therapy including intra-venous injections of ketamine. I expect that the ketamine will help me to feel less depressed and less agitated, at least for the 10 to 15 minutes during which time it will have an effect on me. If I am less distracted by my physical nervousness and my depression, I will at least be able to parti- cipate better in therapy with Dr. Royce. Also Dr. Royce has discussed with me studies involving persons who have shown improvement during psychotherapy using ketamine at the start of the therapy sessions. Since Dr. Royce will be using lower doses than described in the Physicians Desk Reference ("P.D.R.") to help control my physical agitation I do not expect that these added psychiatric benefits will positively occur. However, if my psychotherapy should happen to show some benefit because of the ketamine, then I shall be grateful for that. In my mind there is a narrow line dividing whether or not I can expect to evolate (EVOLATE) in time to be with David Clark in Heaven for New Year's Eve. I doubt that my fate can be changed. I already have some first-hand knowledge of the value and safety of ketamine because I used it quite a few times to clip the claws of my cats. Dr. Royce and I have discussed alternate treat- ments for overcoming my expectation to be dead before the end of this year. He favors electro- shock treatments in a hospital but I don't want to go through those seizures. We also discussed more frequent office visits and/or a higher dose of drugs for me, but I'd rather not change our pattern of having Dr. Royce evaluate my medications from one week to the next. We discuss how I feel each time and Dr. Royce adjusts the dose or changes medicines accordingly. I have told Dr. Royce that I expect to patch things up with David Clark as soon as I can get to him. I have to evolate (EVOLATE) as soon as possible to be with him before he returns to this life as somebody else. After his reincarnation (REINCARNATION), I may not be able to recognize who he really is. With or without any medication such as ketamine, I'm running out of time. The discussion of KETALAR in the P.D.R. says, "Ketalar has been studied in over 12,000 operative and diagnostic procedures, involving over 10,000 patients from 105 separate studies." Also, "Ketalar has a wide margin of safety." I feel confident now that Ketalar is a safe medication for me. In addition, Dr. Royce demonstrated to me how his Oxygen Resuscitator works in case he has to use it on me by breathing through it himself. Even when he held his breath, I could hear the machine cycling on and off, doing the breathing for him. Finally for thoroughness Dr. Royce and I made the following notes by referring to the P.D.R.: I will not become pregnant during the time when I am being treated. I will not take anything by mouth after midnight of the day before each Ketalar treatment. I will always bring some adult with me when I come here for the Ketalar treatments. I will take Valium 5 mg orally 45 minutes before the Ketalar instead of the 2 mg to 5mg intravenously described in the P.D.R. The valium is to help prevent "an EMERGENCE REACTION." I understand this reaction to be a period of emotional excitement which can occur in some instances when higher doses of Ketalar are used such as during surgery and where the prophylactic dose of Valium or some other sedative is not given to the patient before Ketalar. 17/ The initial does of Ketalar will be "from 0.5 mg to 2.0 mg per pound.["] Therefore at my present weight of 167 lbs., no more than 334 mg will be used. After the Ketalar Therapy, I will wait one hour in the office discussing whatever seems to be important to me with Dr. Royce's assistants (Mrs. Royce and/or their daughter Jacki.) After the one- hour period, I will be examined by Dr. Royce who will dismiss me if he sees that I have recovered completely from the Ketalar Treatment. I will not drive an automobile or operate electrical or hazardous machinery for at least 24 hours after each Ketalar treatment. I will report to Dr. Royce anything unusual which occurs to me in the interval between Ketalar Treatments, such as fever, rash, nausea, infection, or unusual thoughts, dreams, or daydreams. No guarantee of results has been given to me by Dr. Royce, Mrs. Royce or Jacki. The Ketamine-assisted psychotherapy sessions began on C.R.'s next visit, which was on November 10, 1984. On that same date, she signed another handwritten statement in which she acknowledged that she was borrowing copies of nine different "scientific" articles dealing with or related to Ketamine use and agreed to return these borrowed materials to Dr. Royce after she had "had time to read them." At no time during the treatment period did Dr. Royce administer Ketamine in a dosage or manner that was calculated to, or did in fact, anesthesize C.R. or subject her to undue risk or harm. On only two occasions, toward the end of the treatment period, did he administer more than 100 milligrams of Ketamine during a session: the April 26, 1985, session, when he administered 112.5 milligrams; and the June 6, 1985, session when he administered 125 milligrams. 18/ On each and every occasion, Dr. Royce administered the Ketamine slowly over a period of time to avoid anesthesizing C.R. There was no reason for Dr. Royce to believe that the interaction between the Ketamine and any of the other drugs he had administered to C.R. or prescribed for her would result in any adverse consequences. At no time did Dr. Royce teach C.R. how to self-administer Ketamine, nor did he ever approve or sanction such self-administration. Following each Ketamine-assisted psychotherapy session, which generally lasted at least an hour, C.R. remained in Dr. Royce's office, in the company of Dr. Royce's wife and/or his daughter Jacqueline, for a minimum of another hour to an hour and a half. C.R. was not permitted to leave until it was determined that it was safe for her to do so. The last Ketamine-assisted psychotherapy session was on June 11, 1985. Dr. Royce stopped using Ketamine as an adjunct to psychotherapy because he reasonably believed that, in light of the progress C.R. had made, she no longer needed to rely on the drug's abreactive or dissociative effect in order to engage in effective psychotherapy. Instead of Ketamine, he used Brevital for C.R.'s last seven drug- assisted psychotherapy sessions. The final drug-assisted psychotherapy session was held on July 9, 1985, which was the last time Dr. Royce saw C.R. Electric Current Therapy Electroconvulsive therapy is an accepted treatment for serious depression involving the delivery, to electrodes placed on the patient's skull, of a measured amount of electric current (on the average 350 millilamps) sufficient to produce a seizure or convulsion. Ordinarily, the patient is premedicated with an anesthetic and medication to modify the convulsion and its impact. Dr. Royce recommended that C.R. be hospitalized and receive in- hospital electroconvulsive therapy. C.R.'s reaction to the recommendation was a "very negative" one. She did agree, however, to undergo non-convulsive electric current therapy, which is helpful in treating anxiety and in facilitating effective psychotherapy. She gave her consent in two signed, handwritten statements, one dated November 13, 1984, and the other dated January 31, 1985. C.R.'s November 13, 1984, statement read as follows: Permit for a Series of Electric-shock Treatments This is to give permission to Irving D. Royce, M.D. and to members of his office staff to administer a series of Electric Shock Treatments to me to treat my mental illness. These treatments will be given to me in addition to the Psychotherapy and medica- tions prescribed for me. The treatment procedure will include having electrodes placed on my head. Then an electric current will flow through the electrodes. There will be no pain or danger of a convulsion because of the very low amount of amperes that will flow. Medications which may be used during the series of electric treatments may include Atropine, Anectine, Brevital or Pentothal, and/or oxygen. I understand that these treatments are frequently effective (especially in regard to anxiety and/or depression) because they theoretically modify the chemical reactions within the brain. Other possible therapies have been discussed with me by Dr. Royce, including anti-depressant medication, psychotherapy, behavior modification, and convulsive electro-shock treatments (plus combination of these techniques.) However, I prefer at this time to start a series of the electro-shock treatment described in the second paragraph above, anywhere from five to twelve in number to comprise the series. I also understand that these treatments are not effective 100 percent of the time. Dr. Royce has also warned me that there have been side-effects reported in the literature but that patients he has known have not had any persistent complaints. Adverse reactions which have been reported included excitement and sedation. The injections may also cause local irritation of the skin. I am not pregnant and shall wait until the treat- ments are completed before considering becoming pregnant, although pregnancy is not in my plans at this time or in the near-future. Also, I agree to wait in Dr. Royce's office for at least an hour after each treatment, until he advises me that I may safely allow a responsible person to drive me home. I have been advised not to drive an automobile, not to operate any machinery, and to stay at home for the remainder of the day after each treatment. The actions and possible side-effects of each medication listed above has been described to me by Dr. Royce. In addition, I have been advised of the antidepressant and other actions of TOFRANIL, ELAVIL, MARPLAN, NARDIL, PARNATE, AMPHETAMINE, PLEGINE, AND DIDREX. No guarantees have been given to me as to the results which may be achieved by this course of treatment. C.R.'s January 31, 1985, statement read as follows: Permission for Electro-shock Treatment I, [C.R.], hereby give permission to Irving D. Royce, M.D., and his assistants to give me a series of electro-shock treatments, using Anectine, Brevital, Pentothal, and/or Atropine and any related medication. I have occasional back pain from a previous injury. Dr. Royce retained C.R.'s November 13, 1984, and January 31, 1985, statements as part of his medical records on C.R. On seven different occasions, from January 31, 1985, to March 15, 1985, Dr. Royce administered non-convulsive electric current therapy to C.R. using a Reiter Electrostimulator (Model CW47). Before doing so he did not consult with any other physician. In administering non-convulsive electric current therapy to C.R. without consulting with and obtaining the agreement of another physician, Dr. Royce did not act in a manner that was inconsistent with what a reasonably prudent psychiatrist at the time would have done under similar circumstances. Given C.R.'s symptomatology, such therapy was not inappropriate. Rather, it was indicated. Some time after leaving Dr. Royce's office following the fifth non- convulsive therapy session on February 22, 1985, C.R. returned to the office for a second visit, during which she received Ketamine-assisted psychotherapy. Following the sixth non-convulsive electric therapy session on March 8, 1985, C.R. appeared to be disturbed about something and delayed leaving Dr. Royce's office. To help reduce her anxiety, Dr. Royce decided to have a Ketamine- assisted psychotherapy session with her before she left the office that day. These were the only occasions that Dr. Royce administered both non-convulsive electric current therapy and Ketamine to C.R. on the same date. 19/ In doing so on these two occasions, Dr. Royce did not act in a manner that was inconsistent with what a reasonably prudent psychiatrist at the time would have done under similar circumstances. The Reiter Electrostimulator that Dr. Royce used to administer electric current therapy had three different settings, only one of which, Setting 3, was designed to generate a current sufficient to produce a seizure or convulsion. Dr. Royce never used Setting 3 in treating C.R. He only used Settings 1 and 2, which produced non-convulsive stimulation. Although it was always Dr. Royce's intention to comply with C.R.'s wishes and administer non-convulsive, not convulsive, electric current therapy, Dr. Royce took the prudent precautionary measure before each electric current therapy session of premedicating C.R. with Brevital, Atropine and Anectine in the highly unlikely event that there was a mishap resulting in C.R. suffering a seizure or convulsion during a session. Such a mishap never occurred. At no time during any electric current therapy session did C.R. have a seizure or convulsion. Furthermore, she suffered no adverse reaction of any kind to the therapy. Nonetheless, the non-convulsive electric current therapy was discontinued because Dr. Royce felt that, in light of the improvement C.R. had made, his time with her would be better spent pursuing other treatment alternatives. Although the electric current therapy administered to C.R. was at all times non-convulsive in nature, Dr. Royce did not so indicate in the medical records that he maintained on C.R. In these records, Dr. Royce used the abbreviation "ECT" to refer to the non-convulsive electric current therapy he was administering to C.R. "ECT" was then, as it is now, understood by most practitioners to refer to electrconvulsive therapy, although it has also been used by some practitioners to indicate electric current therapy of any type. Therefore, at best, Dr. Royce's medical records convey that Respondent administered some form of electric current therapy in treating C.R., but leave the reader to speculate whether the therapy was convulsive or non-convulsive in nature. 20/ At worst, they inaccurately suggest that Dr. Royce administered electroconvulsive therapy to C.R. C.R.'s Rectal Fissure Dr. Royce never treated C.R.'s rectal fissure. Rather, he insisted that she be treated by a specialist. He provided her with medication for the pain she was experiencing as a result of the fissure only after she had made an appointment to see a specialist. In providing C.R. with such pain medication, Dr. Royce was not practicing outside the scope of his competence or expertise. In January and February of 1985, David Ornstein, M.D., an internist and gastroenterologist, provided C.R. with treatment for her rectal fissure. Following such treatment, Dr. Ornstein instructed C.R. to follow-up with her psychiatrist for psychiatric care. C.R.'s Death On July 11, 1985, C.R. was found dead on the floor in the kitchen of her apartment. She was sitting with her legs crossed and her upper body bent forward. Her head was almost touching the floor. Next to her, lying on the floor, was a telephone receiver. A search by police of the apartment and its contents revealed, among other things: hypodermic needles; syringes; two empty vodka bottles; a large number of empty, partially filled, and filled, labelled 21/ and unlabelled medication vials and containers; 22/ and labelled audio cassette tapes. 23/ An autopsy was conducted on C.R.'s body by the Dade County Medical Examiner's Office. The autopsy revealed the presence of neither alcohol, cocaine or Ketamine in C.R.'s bloodstream. Phenobarbital 24/ and Placidyl, however, were detected. The amount of the former, but not the latter, was in the fatal range. Other drugs, such as Valium, were determined to be present, but merely in insignificant trace amounts. C.R.'s lungs were congested. Such congestion is common in drug- related deaths. Small linear marks, which appeared to be needle track scars, were discovered on C.R.'s left arm. 25/ After the autopsy was performed, the Dade County Medical Examiner's Office determined that C.R.'s death was accidental, that the immediate cause of her death was acute "polydrug [to wit: Phenobarbital and Placidyl 26/] intoxication," and that "positional asphyxia" was a secondary contributing factor. There was no evidence that C.R.'s death was the result of chronic substance abuse. The Department of Professional Regulation's Investigation On or about August 14, 1985, the Department of Professional Regulation received a complaint from Roger Mittleman, M.D., Dade County's Associate Medical Examiner, concerning Dr. Royce's treatment of C.R. Dr. Mittleman's complaint was recorded on a Uniform Complaint Form, which contained the following "Analysis:" As a PSYCHIATRIST, SUBJECT [Dr. Royce] treated [C.R.] as a patient. Included in treatments were self-hypnotic drugs such as BREVITAL SODIUM (a barbiturate anesthetic), treatment for alcoh- olism, therapy for suicide tendencies. SUBJECT'S Business Card reads: Just Call "WHY SEXY (949-7399). SUBJECT allegedly dispensed unlabeled medications dating as recently as April 26, 1985; prescribed DARVOCET April 30, 1985; prescribed PLACIDYL, VALIUM, LIBRIUM BENADYRL, etc. and [C.R.] was reportedly taking up to 16 different prescribed medications daily, most of which were prescribed by DR. ROYCE. SUBJECT also was reportedly aware that [C.R.] had been self-injecting KET[A]LAR (which may have been obtained through DR. BERNSTEIN, VM, or DR. BLACK, VM). SUBJECT was reportedly aware of extreme dependency [C.R.] had on him, although SUBJECT continued to prescribe in high quantities to [C.R.] [C.R.] was found dead on her kitchen floor on July 1985 f[rom] a POLYDRUG OVERDOSE [ASPHYXIAL] POSITIONING. Documentation is available from Dr. Mittleman, Medical Examiner, and Detective Dellerson, North Miami Police Department. Possible excessive and inappropriate prescribing, and possible failure to practice psychiatric medicine according to peer standards- 458.331(1)(q)(t), F.S. Dr. Mittleman's complaint was assigned a Department case number, DPR Case Number 00-61481, and a Department investigation into the matter was commenced. As part of her investigation, the Department investigator working on the case, Allison Lichtenstein, interviewed Dr. Mittleman and then Dr. Royce. During her interview with Dr. Royce, Lichtenstein advised him of the substance of Dr. Mittleman's complaint and of the Department's investigation of that complaint. 27/ Thereafter, on or about April 18, 1986, Lichtenstein prepared a written investigative report (hereinafter referred to as "Lichtenstein's investigative report") summarizing what had transpired during the interviews. With respect to her interview with Dr. Mittleman, Lichtenstein stated the following in her report: On September 4, 1985 this investigator inter- viewed Dr. ROGER MITTLEMAN at his place of employment, the Dade County's Medical Examiner's office, located at 1050 N.W. 19th Street, Miami, Florida 33233, (305) 549-7342. Dr. MITTLEMAN relayed the following information which can also be found in the Medical Examiner Department's Investigative Report, (Exhibit Number 2). On July 10, 1985 [C.R.'s] aunt, [S.S.], telephoned the North Miami Police Department and asked that a unit be sent to [C.R.'s] address to check on her welfare. Police units responded to the scene and found [C.R.] to be "alive and well." On July 11, 1985 [C.R.] failed to report to her place of employment, an animal hospital located at 1119 N.E. 163rd Street, North Miami, Florida 33162. At the close of office hours Dr. LARRY BERNSTEIN sent two female employees to [C.R's] residence to check on her. The two female employees received no response from knocking at the door so they entered the residence through the unlocked door. [C.R.] was found dead on arrival sitting "indian style" on the floor with a telephone receiver in her hand. In addition a search of [C.R.'s] purse revealed nine containers of assorted medication including paregoric. According to friends [C.R.] was under psychiatric care and was "receiving injections" from Dr. ROYCE. On July 12, 1985, Dr. ROYCE spoke with the Medical Examiner's office and stated that he first saw [C.R.] on October 2, 1984 and began treating her for "depressive reaction" and "alcoholism." Dr. ROYCE stated that he last saw [C.R.] on July 9, 1985. Dr. Mittleman states then an autopsy and toxicology report reveals that at the time of [C.R.'s] death she had a high level of phenobarbital, as well as Placidyl, Valium and Paregoric present. In addition, [C.R.'s] urine contained opiates and she was "seen intoxicated prior to her death." Medications found in [C.R.'s] apartment at the time of her death consisted of Elavil, Percodan, Sudafed, Inderal, Paregoric, Desyril, Placidyl, Sinequan and Didrex, all prescribed by Dr. ROYCE. Assorted unmarked medications by Dr. ROYCE were also found. Also present were additional medications prescribed by various area physicians and veterinarians. With respect to her interview with Dr. Royce, Lichtenstein stated the following in her report: On September 6, 1986 28/ this investigator interviewed IRVING D. ROYCE, M.D. at his place of practice located at 17122 West Dixie Highway, North Miami Beach, Florida 33162, telephone (305) 949-7399. Dr. ROYCE states that he received his medical training from the Chicago Medical School and his psychiatric training at the Lyons Veteran Hospital in New Jersey. Dr. ROYCE states that he is not a board certified psychiatrist but that he is board eligible, (Exhibit Number 3). Dr. ROYCE states that he first treated [C.R.] on October 2, 1984 after she was referred by another of his patients, [F.G.]. According to Dr. ROYCE, [C.R.] was complaining about her weight which was 167 1/2 pounds for her 5'1" frame. In addition [C.R.] was nervous and suffering from "agitated depression." Dr. ROYCE states that in the year previous to [C.R.'s] first visit she experienced the death of her mother, the suicide of her boyfriend and had to put two of her pet cats to sleep. According to Dr. ROYCE [C.R.] made a previous suicide attempt which Dr. ROYCE did not deem a "serious attempt" due to no apparent "wrist scars." Although Dr. ROYCE states that [C.R.] had undergone previous psychotherapy he found her in "good affect" and an "agitated mood." Dr. ROYCE states that [C.R.'s] medical history consisted of having silicon placed in her chin and "having her nose done." Dr. ROYCE states that [C.R.] had no previous history of schizophrenia. During Dr. ROYCE's subsequent examinations of [C.R.] he prescribed Sinequan (an Anti-depressant) and Valium (for irritability). Dr. ROYCE states that "at one time she mentioned extreme drinking," however Dr. Royce did state that he did not feel [C.R.] had an abusive personality. When questioned as to [C.R.'s] death on July 11, 1985 Dr. ROYCE stated that [C.R.] had the idea that she would die before January 1985 and had even paid for her own burial plot and found alternate homes for her pet cats. Dr. ROYCE stated this along with information he received from friends of [C.R.] were "episodes of atten- tion getting." Dr. ROYCE stated that he would see [C.R.] twice weekly and that she would telephone him daily. According to Dr. ROYCE, [C.R.] was "definitely improving" in that she had lost forty pounds with the aid of Plegine, which "curbs the appetite and elevates the mood," and Didrex, a substitute for Plegine. Dr. ROYCE states that [C.R.] was a "tense person" but did not have an abusive personality." Dr. ROYCE bases this opinion on the fact he never saw [C.R.] "staggering, sleepy or with slurred speech." Of medications prescribed to [C.R.], Dr. ROYCE states that [C.R.] had a "rectal fissure, diarrhea and stomach cramps" for which he prescribed Paregoric. Dr. ROYCE states that he prescribed Percodan for [C.R.] when she was unable to see her Proctologist, Dr. DAVID ORENSTEIN, however, Dr. ROYCE did not verify [C.R.'s] treatment by Dr. Orenstein. Dr. ROYCE states that he did examine [C.R.] when she complained about stomach cramps. Dr. ROYCE also prescribed Placidyl to help [C.R.] "sleep and cope with the loss of DAVID" (her boyfriend who committed suicide). According to Dr. ROYCE he "saw her or spoke with her daily and would have known if she took an overdose of Placidyl." Dr. ROYCE stated he prescribed Darvocet for anal or abdominal pain or "possibly for headaches" associated with [C.R.'s] menstrual cycle. According to Dr. ROYCE he prescribed Darvocet after refusing to prescribe Percodan. Dr. ROYCE prescribed XANAX instead of Valium and Inderal for "panic attacks" instead of a sedative. According to Dr. ROYCE he prescribed both Valium and Librium to [C.R.] as a sedative due to the fact that when she exhibited tension she would "say something inappropriate and this would lead to a panic attack." Dr. ROYCE states that [C.R.] "had difficulty with interpersonal relationships" and that the medication would be "safe as long as I had this close contact with her." Dr. ROYCE also prescribed Benadryl when [C.R.] complained of itching in the vulva area and skin." Dr. ROYCE examined her skin only and felt it was "nerves" and recommended [C.R.] see a Gynecologist. According to Dr. ROYCE, [C.R.] needed medication during the day to function and at night to sleep. Dr. ROYCE states that [C.R.] was also receiving Ketamine therapy which according to Dr. ROYCE has "great use in helping a person uncover resistance." Dr. ROYCE states that he is not aware if [C.R.] had self injected and that the hypodermic needles found in her apartment could have been used for giving "shots to her cats." DR. ROYCE also states that he performed five shock treatments with [C.R.] and that these had a "dramatic improvement in her." Dr. ROYCE states that the final time he saw [C.R.] prior to her death was July 9, 1985 and he did not prescribe any medication, however, on July 8, 1985 Dr. ROYCE did prescribe both Xanax and Placidyl for [C.R.], (Exhibit Number 4). Appended as exhibits to Lichtenstein's investigative report were: the Uniform Complaint Form on which Dr. Mittleman's complaint against Dr. Royce was recorded (Exhibit 1); the report of the Dade County Medical Examiner's Office regarding its investigation of C.R.'s death (Exhibit 2); a copy of an appointment card and a letterhead used by Dr. Royce (Exhibit 3); and Dr. Royce's medical records on C.R. (Exhibit 4). On May 24, 1986, Matthew M. Cohen, M.D., made the following written recommendation to the Department after having reviewed the "case file" in DPR Case No. 00-61481: It is alleged that the subject [Dr. Royce] treated [C.R.] who committed suicide on July 11, 1985, at age 35. She had been under the care of the subject since October 2, 1984. The Medical Examiner felt that the patient suffered death from polydrug overdose. The case file consists of a lengthy Medical Examiner's report as well as office records from the subject. There may be existence of Probable Cause as it appears that the subject was aware that the patient abused/misused medications including injectable Ketamine which she may have obtained illicitly from her veterinarian employers. It would be my recommendation that the Department have this case file reviewed by a psychiatrist. It seems to me that the patient had significant pathology and significant suicidal risks. This would be best evaluated by a psychiatrist. The Department followed Dr. Cohen's advice. On June 10, 1986, it sent the following letter to Martin Rosenthal, M.D., a board-certified psychiatrist: This letter will confirm our telephone conver- sation of June 9, in which you agreed to act as a consultant in the case referenced above [DPR Case No. 00-61481]. Enclosed is a copy of the investigative file, including patient records sent to us by Allison Lichtenstein, Investigator in our Miami office. Please review this infor- mation and furnish your opinion on the following: Has Dr. Royce prescribed, dispensed, administered, mixed or otherwise prepared a legend drug, including any controlled substance, other than in the course of his professional practice? Has Dr. Royce practiced, or offered to practice beyond the scope permitted by law or accepted and performed professional responsi- bilities which he knows and has reason to know that he is not competent to perform? Would Dr. Royce's treatment of this patient constitute gross or repeated malpractice? If so, what would a reasonably prudent similar physician have done under similar conditions and circumstances? Would Dr. Royce's treatment of the patient constitute a failure to practice medicine with that level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances? If so, what would a reasonably prudent similar physician have done under similar conditions and circumstances? Please detail your reasoning in answering each of these questions to help us in preparing an appropriate recommendation for the Board's Probable Cause Panel. Should you need further information, please contact Ms. Lichtenstein at (305) 592-1165. By copy of this letter, I have notified her that this case has been sent to you. As you will recall, the information contained in this file must remain confidential, pursuant to Section 455.225(9), Florida Statutes, until ten days after probable cause has been found. We would appreciate receiving your report in this matter as soon as possible. Dr. Rosenthal responded to the Department's request by letter dated July 1, 1986. In his letter to the Department, Dr. Rosenthal stated the following: I have reviewed the file you sent me regarding the above designated physician [Dr. Royce] in relation to his treatment of C.A.R. The patient died on July 11, 1985, of "polydrug intoxication." Over a nine month period, the physician prescribed Elavil, Percodan, Percocet, Sudafed, Inderal, Paregoric, Desyryl, Plegine; and further, he administered Ketamine by injec- tion frequently, "to overcome resistance," in his office and may have sanctioned self administration of Ketamine at home by the patient. The review that the doctor gave indicated that she was treated for "depression and overweight." She had made prior suicide attempts which he did not take seriously, "because she had no scars on her wrists . . . at one time she mentioned extensive drinking." In his 10-23-84 note he wrote: "she tends to drink to the point of oblivion if she starts to drink." Yet, he said, he "did not consider her to be an addictive personality." However, further, in his 11-24-84 and 12-11-84 notes, he made reference to her utilizing "coke." He made reference on several occasions to the patient experiencing anxiety and "panic." There were references to the patient having had a rectal fissure, diarrhea and stomach cramps for which he prescribed Paregoric and Percodan. Further, there was notation of the patient having received five or six electric shock treatments (E.C.T) on 1-31, 2-1, 8, 15 and 22 and March 8, 1985. There was no evidence in the record presented of a second opinion consultation recommending shock therapy (as is required by Florida Statutes) nor was there confirmation of medical clearance for E.C.T. In addition, there was no description of the patient having been brought to and taken to the place of treatment by a responsible adult, a condition required after induction of intravenous anesthesia (Brevital) and exper- iencing of a major seizure, with presumably consequent post-treatment confusion. In the same span of time, when the patient was receiving electric shock therapy, in February, 1985, the doctor also noted several office treatments involving Ketamine injection with adjuvant sedatives being used. It should be noted that the use of Ketamine in psychiatry has been very controversial and limited; it is by no means standard. Ketamine, basically, is an anesthetic which can often induce euphoria, confusional states, halluci- nations and, reportedly, it has been subject to abuse. The package insert specifies the risks associated with Ketamine and the injunc- tion that "when used on an out-patient basis, the patient should not be released until recovery from anesthesia is complete and then should be accompanied by a responsible adult." Given the expected side effects inherent in the use of electric shock therapy, with immediate and then some sustained confusion, it is in my opinion quite questionable to use Ketamine for psychiatric induction purposes in the same span of time that shock therapy is administered. Actually, the use of Ketamine for these purposes is very questionable in even a non-drug dependent individual, but is especially questionable in a person who has demonstrated clearly a drug dependency problem. I note further, in a report by the Medical Examiner, Dr. Roger Mittleman (7-12-85) under history (paragraph three): "according to friends, her psychiatrist gave her injections and took her on trips." Further, in his note of 3-21-85, the Doctor noted that the patient had a balance of $4200.00. This merely raises the issue as to why he would continue treatment under these circumstances. "Dial-sexy" imprinted on the Doctor's business cards and prescriptions is superficially noted, and in my opinion this is not properly professional. On a more serious level, there appear to be several matters representing poor judgment: There is ample evidence that this patient should have been considered an addictive personality. The heavy use of alcohol as such should have established this. Thus, in such an abusing personality, the use of controlled substances, including Benzodiazepines, babiturates, amphetamines or congeners (Didrex, Plegine), Placidyl, Percodan and Percocet is inappropriate; the use of Ketamine is equally representative of poor judgment. In the face of severe anxiety and "panic" the prescription of central nervous system stimulants, such as Didrex and Plegine, is typically contraindicated. The psychiatrist treating rectal fissure, as such appears to be acting inappropriately, out of the reach of his expertise. In reference to your questions: Number 1 (Has the Doctor prescribed .. other than in the course of his professional practice?) There was the allegation in Dr. Mittleman's note that the Doctor "took her on trips." This would have to be verified or disproved, but if it were to have been the case, then the behavior and then the concurrent treatment and the prescription of drugs would be non-professional. Number 2 (Has the Doctor practiced beyond the scope or the level which he knows or should know that he is not competent to perform?) I [c]ite here the inappropriateness of his treating the rectal fissure condition, his use and circumstances of use of Ketamine (because it is so controversial, and inappropriate, particularly in an addictive personality). Further, the fact of his claim to have completed an approved three year residency in psychiatry should be verified. Number 3 (Would his treatment of this patient constitute malpractice?) In my opinion the physician should not have prescribed the plethora of controlled substances and to use Ketamine in an addictive personality; in my opinion, he should not have utilized both electric shock therapy and Ketamine treatments in the same period of time. The presence or absence of a second opinion consultation recommending electric shock treatment as per Florida statute should be verified one way or the other. Number 4 (Did the Doctor fail to practice with the level of care . .) In my opinion, he did not practice at the proper level of care. A prudent other physician would have referred this patient for hospitalization or to an alcohol or drug rehabilitation unit or at least to A.A. He would not have prescribed the variety of controlled substances to her. He would have clearly obtained a second opinion consultation recommending electric shock treatment. He would have unlikely used Ketamine at all, but particularly not so in a drug- abusing personality or in conjunction with electric shock treatment. In January of 1990, the investigation of Dr. Mittleman's complaint against Dr. Royce was still ongoing and another Department investigator, Louis Collado, was assigned to work on the case. In a written investigative report that he prepared (hereinafter referred to as "Collado's investigative report") Collado gave the following "synopsis" of the results of the investigative work he performed: This investigation was based upon a January 10, 1990 memorandum from DPR Legal, Tallahassee, Florida. Several items are requested, trans- criptions or copies of tapes, analysis of 3 unmark[ed] medications, a curriculum vitae from subject [Dr. Royce] and verification of the types of "trips" which the subject took with patient. Analysis of unmarked medications 29/ and Dr. ROYCE C.V. 30/ are attached, Exhibits Number 1 & Number 2. Medical Examiner, Dr. Mittleman states, of the 17-20 recordings only 4 cassette[] tapes are still available[;] the others were discarded because [they] contained mostly babbling. No attempts to make transcriptions of the 4 remain[]ing tapes, (Exhibits Number 4, Number 5, Number 6 & Number 7) were made because of the poor quality of the recordings and the lack of coherent conversations. Dr. MI[TT]LEMAN states the tapes were made by [C.R.] of herself. Apparently, C.R. was monitoring herself while she was under the influence of Ketamine injections. Most of the recordings consist of incoherent babbling (see Exhibit Number 3 page 21). The "trips" in question, according to former North Miami Police Detective, MARGIE DELLERSON, came from a statement from Dr. STEVE BERNSTEIN, who said that Dr. ROYCE had given [C.R.] injections that would send her to another plane, "like a trip," (see Exhibit Number 3, page 13). Attempts to contact witnesses, [C.R.'s] father, [E.R.] (deceased), Aunt [S.S.], Co-worker [C.V.] and Boyfriend [E.T.], were unsuccessful. Interview with former co-worker [W.W.] was unremarkable. "Exhibit Number 3," which, like the other exhibits referenced in Collado's "synopsis," was appended to his investigative report, was the City of North Miami Beach's report of its investigation of C.R.'s death (hereinafter referred to as the "police report"). On page 15 of the police report, which was authored by Detective Margaret Dellerson, Dellerson described a telephone conversation she had with Dr. Royce on July 15, 1985, four days after C.R.'s death, as follows: At 5:30 p.m. I contacted Dr. Irving Royce, 931-3363. He has treated the victim about 6 months. He stated she was progressing well in her therapy. She did have a "crush" on Dr. Bernstein but she has resolved that problem. He also was aware of the "affair" she was having with Ricky. When he was questioned about what type of drugs he was using for injections he stated "Brevital and Ben[a]dryl." He denied using Ketamine or Ketalar. He did state however that she had mentioned she saw it used as an anesthetic and that she could get some to use on herself. He states he strongly advised her against this practice. He did make a statement, however, that he would not be surprised to find she died with a "syringe in her arm." He advised on Wed. July 10, 1985 he did get 3 messages. He states two were from [C.R.] and one from Mrs. [S.]. He states he did try to call her back until late Wednesday night but got a busy signal. He did not realize it was any type emergency. He states he did know that she did take the phone off the hook from time to time when she did not want to talk on the phone and accepted this as being the case. He did not try to call the aunt back due to the late hour. He stated that she did drink heavily, vodka he believed. She was progressing, well until her boss got married and then she began to go backwards for a time. He suggested I speak with a girl name[d] "Sissy" that she use[d] to work with as he felt they were good friends. The January 28, 1991, Meeting of the Probable Cause Panel A three-member Board of Medicine probable cause panel met on January 28, 1991, to consider DPR Case No. 00-61481. The members of the panel were James Burt, M.D., David Wertheimer, M.D., and Pamela Campbell. M. Catherine Lannon, the Chief of the Attorney General's Administrative Law Section, served as the panel's legal advisor. She advised the panel members as to what their legal obligations were under the law. Also present at the meeting was Department attorney Lynne Quimby- Pennock. Prior to the meeting the panel members had reviewed various documents they had been furnished by the Department in connection with DPR Case No. 00- 61481, including the following: Lichtenstein's investigative report and the attached exhibits; Dr. Cohen's May 24, 1986, written recommendation; the Department's June 10, 1986, letter to Dr. Rosenthal; Dr. Rosenthal's July 1, 1986, letter to the Department; and Collado's investigative report and the attached exhibits. 31/ Acting reasonably and with substantial justification given the materials with which it had been provided, the panel voted unanimously to find probable cause and directed that an Administrative Complaint be issued against Dr. Royce. Thereafter, Dr. Burt, the chairperson of the panel, signed a Memorandum of Finding of Probable Cause, dated January 28, 1991, which read as follows: This matter was brought before the probable cause Panel membership composed of James Burt, M.D., David Wertheimer, M.D., Pamela Campbell, on the date set forth above. The panel, having received the investigative report, having care- fully reviewed that report, having reviewed the recommendation of the Department and having had the opportunity to inquire of counsel, and being otherwise duly advised in the premises thereof find that: Probable cause was found on the following statutory and rule grounds, including but not limited to Section(s): 458.331(1)(t), 458.331(1)(m), 458.331(1)(q), 458.331(1)(x), 458.331(1)(v), 458.331(1)(u), Fla. Stat. The Administrative Complaint On March 6, 1991, the Department issued an Administrative Complaint as directed by the probable cause panel. The Administrative Complaint contained six counts. It alleged that, in connection with his care and treatment of C.R. (who was referred to in the Administrative Complaint as "Patient Number 1"), Dr. Royce violated: Count One- Section 458.331(1)(m), Florida Statutes, in that "[Dr. Royce's] medical records of Patient Number 1 do not justify [Dr. Royce's] failure to diagnose Patient Number 1's abusive and addictive personality; [Dr. Royce's] medical records do not justify [his] inappropriate and excessive prescribing of controlled substances and other legend drugs, especially Ketalar, over a ten (10) month period; [Dr. Royce's] medical records failed to justify [his] failure to seek a consultation with another physician, and document said consultation [prior] to performing ECT 32/ on Patient Number 1; [and Dr. Royce's] medical records fail to justify [his] inappropriate use of Ketalar (Ketamine) treatment concomitantly with ECT;" Count Two- Section 458.331(1)(q), Florida Statutes, "in that [Dr. Royce] prescribed Plegine for Patient Number 1, when [Dr. Royce] knew or had reason to have known that said patient had a history of drug abuse; [Dr. Royce] inappropriately prescribed Plegine concomitantly with Didrex, a CNS stimulant, for Patient Number 1; [Dr. Royce] inappropriately administered Ketalar, in conjunction with ECT treatment; [Dr. Royce] inappropriately and excessively prescribed the following controlled substances: Benzodiazepines, Barbiturates, Amphetamines, and Ketalar;" Count Three- Section 458.331(1)(t), Florida Statutes, "in that [Dr. Royce] failed to diagnose Patient Number 1's addictive and abusive personality; [Dr. Royce] inappropriately and excessively prescribed legend drugs, most of which were controlled substances, over a ten (10) month period to Patient Number 1, without proper justification; [Dr. Royce] failed to acquire a consultation with another physician before ordering ECT for Patient Number 1; [Dr. Royce] inappropriately administered ECT treatments in conjunction with Ketalar therapy; and [Dr. Royce] utilized ECT treatments when they were not indicated;" Count Four- Section 458.325(2), Florida Statutes, and therefore Section 458.331(1)(x), Florida Statutes, in that "[Dr. Royce] failed to have Patient Number 1's treatment record reviewed, and the proposed Electroconvulsive Therapy agreed to by another physician, not directly involved with Patient Number 1, before the electroconvulsive therapy was administered to Patient Number 1;" Count Five- Section 458.331(1)(v), Florida Statutes, in that "[Dr. Royce] practiced outside his expertise by treating Patient Number 1's rectal fissure during the course of her psychiatric treatment;" and Count Six- Section 458.331(1)(u), Florida Statutes, in that "[Dr. Royce] treated Patient Number 1's psychiatric condition with Ketalar (Ketamine) and utilized Ketalar (Ketamine) in conjunction with ECT treatments" without "first obtaining full, informed and written consent" from the patient. Proceedings Before the Division of Administrative Hearings Dr. Royce denied the allegations of wrongdoing made against him in the Administrative Complaint and requested a formal hearing. On May 6, 1991, the Department referred the matter to the Division of Administrative Hearings for the assignment of a Hearing Officer to conduct the formal hearing Dr. Royce had requested. It was docketed as DOAH Case No. 91- 2811. The formal hearing in DOAH Case No. 91-2811 was held on August 24, 1993, and February 22, 24 and 25, 1994. 33/ At the hearing, the Department presented the live testimony of three witnesses: Dr. Mittleman, the board-certified anatomic, clinical and forensic pathologist who performed the autopsy on C.R.; Dr. Rosenthal; and Daniel Sprehe, M.D., who, like Dr. Rosenthal, is a board certified psychiatrist. The Department also offered eight exhibits (Exhibits 1 through 8) into evidence, all of which, except for its Exhibit 7, were admitted by the Hearing Officer. Among the Department's exhibits received into evidence were the transcripts of the depositions of James Hillman, M.D., a board certified toxicologist, and Margaret Dellerson, formerly of the City of North Miami Beach Police Department, which were offered in lieu of the deponents' live testimony at hearing. Dr. Royce testified on his own behalf at hearing and presented the testimony of six other witnesses: Melvin Simonson, M.D., a board certified psychiatrist; Kenneth Lasseter, M.D., a board certified clinical pharmacologist; Norman Craythorne, M.D., a board certified anesthesiologist; Jacqueline Royce, Dr. Royce's daughter; Carol Royce, Dr. Royce's wife and office manager; and Debra Mash- Geller, Ph.D., an Associate Professor of Neurology and Cellular and Molecular Pharmacology at the University of Miami School of Medicine. In addition, Dr. Royce offered various exhibits into evidence at hearing. All of these exhibits, except those that were subsequently withdrawn, were received into evidence. Among the exhibits of Dr. Royce received into evidence were the transcripts of the depositions of Dr. Ornstein, the certified internist and gastroenterologist who treated C.R. in early 1985 for her rectal fissure, and Lloyd Miller, M.D., a board certified psychiatrist. These depositions were offered in lieu of the deponents' live testimony at hearing. The Hearing Officer issued his Recommended Order in DOAH Case No. 91- 2811 on January 18, 1995. The Hearing Officer recommended that the Board of Medicine enter a final order finding Dr. Royce guilty of certain alleged recordkeeping violations, disciplining him for having committed these violations by issuing him a reprimand, and dismissing the remaining charges against him. Count One of the Administrative Complaint was addressed in Conclusions of Law 119 through 126 of the Recommended Order, which read as follows: Count One of the Administrative Complaint issued in the instant case alleges that, in connection with his care and treatment of C.R., Respondent [Dr. Royce] violated Section 458.331(1)(m), Florida Statutes, in that "Respondent's medical records of [C.R.] do not justify Respondent's failure to diagnose [C.R.'s] abusive and addictive personality; Respondent's medical records do not justify Respondent's inappropriate and excessive prescribing of controlled substances and other legend drugs, especially Ketalar, over a ten (10) month period; Respondent's medical records failed to justify Respondent's failure to seek a consultation with another physician, and document said consultation [prior] to performing ECT on [C.R.]; [and] Respondent's medical records fail to justify Respondent's inappropriate use of Ketalar (Ketamine) treatment concomitantly with ECT." Respondent correctly points out in his proposed recommended order 34/ that "Count [One] is flawed, in that it alleges a violation of Section 458.331(1)(m), Florida Statutes, in failing to keep written medical records justifying the course of treatment of the patient," but "[i]n fact, under the law in effect at the time (1984-1985) that Respondent treated the patient . . . Section 458.331(1)(m), [Florida Statutes, proscribed] soliciting patients through the use of fraud, intimidation, undue influence, or a form of overreaching or vexatious conduct." The flaw, however, is not, contrary to the position taken by Respondent, a fatal one warranting the dismissal of this count of the Administrative Complaint. The Department simply cited the wrong subsection of the version of Section 458.331, Florida Statutes, that was in effect at the time of the alleged violations. Instead of subsection (1)(m), it should have referenced subsection (1)(n) of the statute. This mistake in no way misled or otherwise prejudiced Respondent. Accordingly, it should be treated as a mere scrivener's error and not have any impact on the disposition or outcome of the instant case. See Danzy v. State, 603 So.2d 1320, 1322 (Fla. 1st DCA 1992); Sanders v. State, 386 So.2d 256, 257 (Fla. 5th DCA 1980); Youngker v. State, 215 So.2d 318, 322 (Fla. 4th DCA 1968); see also Seminole County Board of County Commissioners v. Long, 422 So.2d 938, 940 (Fla. 5th DCA 1982)("[a] complaint filed by an administrative agency is not required to fulfill the technical niceties of a pleading filed in a court of law;" "[s]uch an administrative complaint must only be specific enough to inform the accused with reasonable certainty of the nature of the charge"). At all times material to the instant case subsection (1)(n) of Section 458.331, Florida Statutes, authorized the Board to discipline a Florida-licensed physician for "[f]ailing to keep written medical records justifying the course of treatment of the patient, including, but not limited to, patient histories; examination results, and test results." 35/ This statutory provision does not purport to encompass "JCAH standards or those of a 'reasonably prudent physician;'" nor can it "be interpreted as authorizing disciplinary action for a physician's failure to document in a patient's medical chart a basis for not undertaking a particular course of treatment." Breesmen v. Department of Professional Regulation, Board of Medicine, 567 So.2d 469, 471 (Fla. 1st DCA 1990). It does impose upon the physician, however, an obligation to provide sufficient documentation "so that 'neutral third parties can observe what transpired during the course of treatment of a patient.'" Robertson v. Department of Profes- sional Regulation, Board of Medicine, 574 So.2d 153, 156-57 (Fla. 1st DCA 1990). In the instant case, Respondent failed to meet this obligation by not documenting the following in the medical records that he maintained on C.R.: his belief that C.R.'s claims of cocaine and excessive alcohol use were "attention-getting" fabrications and the basis of this belief; 36/ his instructions to C.R. that the Plegine and Didrex he pre- scribed for her during the same visit be used sequentially and not concomitantly; 37/ and the true nature of the electric current therapy he administered to C.R. 38/ His failure to have included such infor- mation in his medical records was a violation of former subsection (1)(n) of Section 458.331, Florida Statutes, for which he should be disciplined. In all other material respects, Respondent's records provide sufficient information to give "neutral third parties" a reasonably clear understanding of what Respondent did to treat C.R. during the time that she was under his care and the circumstances that led him to follow such a course of treatment. Accordingly, to the extent that Count One alleges that Respondent otherwise violated former subsection (1)(n) of Section 458.331, Florida Statutes, it is not supported by even a preponderance of the evidence and accordingly should be dismissed. Count Two of the Administrative Complaint was addressed in Conclusions of Law 127 through 130 of the Recommended Order, which read as follows: Count Two of the Administrative Complaint issued in the instant case alleges that, in connection with his care and treatment of C.R., Respondent violated Section 458.331(1)(q), Florida Statutes, "in that Respondent prescribed Plegine for [C.R.], when Respondent knew or had reason to have known that said patient had a history of drug abuse; Respondent inappropriately prescribed Plegine concomitantly with Didrex, a CNS stimulant, for [C.R.]; Respondent inappro- priately administered Ketalar, in conjunction with ECT treatment; Respondent inappropriately and excessively prescribed the following controlled substances: Benzodiazepines, Barbiturates, Amphetamines, and Ketalar." At all times material to the instant case, subsection (1)(q) of Section 458.331, Florida Statutes, has authorized the Board to discipline a Florida-licensed physician for "[p]rescribing, dispensing, administering, mixing or otherwise preparing a legend drug, including any controlled substance, other than in the course of the physician's practice" and has further provided as follows: "For the purposes of this paragraph, it shall be legally presumed that prescribing, dispensing, administering, mixing, or otherwise preparing legend drugs, including all controlled substances, inappropriately or in excessive or inappropriate quantities is not in the best interest of the patient and is not in the course of the physician's professional practice, without regard to his intent." It has not been established by even a preponderance of the evidence that: Respondent knew or had reason to believe that C.R. had a history of drug abuse; Respondent acted inappro- priately, that is, contrary to what a reasonably prudent similar physician would have recognized as being acceptable under similar conditions and circumstances, in concomitantly prescribing Plegine and Didrex (but for sequential, not concomitant, use); Respondent administered electroconvulsive therapy to C.R.; Respondent administered Ketalar (Ketamine) to C.R. "in conjunction with" electric current therapy of any type; Respondent's use of Ketalar (Ketamine) as an adjunct to C.R.'s psychotherapy was at any time, including February 22 and March 8, 1985, when it was administered following a non-convulsive electric current therapy session, either inappropriate or excessive; Respondent prescribed (rather than administered) Ketalar (Ketamine) for C.R.; Respondent prescribed, dispensed or administered any amphetamines; or Respondent prescribed, dispensed or administered any benzodiazepines, barbiturates or any other controlled substances inappropriately or in excessive amounts. Accordingly, Count Two should be dismissed in its entirety. Count Three of the Administrative Complaint was addressed in Conclusions of Law 131 through 134 of the Recommended Order, which read as follows: Count Three of the Administrative Complaint issued in the instant case alleges that, in connection with his care and treatment of C.R., Respondent violated Section 458.331(1)(t), Florida Statutes, "in that Respondent failed to diagnose [C.R.'s] addictive and abusive personality; Respondent inappropriately and excessively pre- scribed legend drugs, most of which were controlled substances, over a ten (10) month period to [C.R.] without proper justification; Respondent failed to acquire a consultation with another physician before ordering ECT for [C.R.]; Respondent inappropriately administered ECT treatments in conjunction with Ketalar therapy; and Respondent utilized ECT treatments when they were not indicated." At all times material to the instant case, subsection (1)(t) of Section 458.331, Florida Statutes, has authorized the Board to discipline a Florida-licensed physician for "[g]ross or repeated malpractice or the failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances." It has not been established by even a preponderance of the evidence that: in failing to conclude that C.R. had an addictive or abusive personality, Respondent acted in a manner that deviated from what a reasonably prudent similar physician would have recognized as being acceptable under similar conditions and circumstances; Respondent prescribed, dispensed or administered any legend drugs during the treatment period inappropriately, excessively or without reasonable justification; Respondent administered electro- convulsive therapy (as opposed to non-convulsive electric current therapy) to C.R.; the non- convulsive electric current therapy that Respondent administered to C.R. was at any time, including February 22 and March 8, 1985, when it was administered prior to a Ketamine-assisted psychotherapy session held later the same day, inappropriate or not indicated; a reasonably prudent similar physician would have consulted with another physician before administering such non-convulsive electric current therapy; or Respondent administered such non-convulsive electric current therapy "in conjunction with Ketalar therapy." Accordingly, Count Three should be dismissed in its entirety. Count Four of the Administrative Complaint was addressed in Conclusions of Law 135 through 139 of the Recommended Order, which read as follows: Count Four of the Administrative Complaint issued in the instant case alleges that, in connection with his care and treatment of C.R., Respondent violated Section 458.325(2), Florida Statutes, and therefore Section 458.331(1)(x), Florida Statutes, in that "Respondent failed to have [C.R.'s] treatment record reviewed, and the proposed Electroconvulsive Therapy agreed to by another physician, not directly involved with [C.R.], before the electroconvulsive therapy was administered to [C.R.]." At all times material to the instant case, subsection (1)(x) of Section 458.331, Florida Statutes, has authorized the Board to discipline a Florida-licensed physician for "[v]iolating any provision of this chapter." At all times material to the instant case, Section 458.325(2), Florida Statutes, has provided as follows: "Before convulsive therapy or psychosurgery may be administered, the patient's treatment record shall be reviewed and the proposed convulsive therapy or psychosurgery agreed to by one other physician not directly involved with the patient. Such agreement shall be documented in the patient's treatment record and shall be signed by both physicians." It is undisputed that Respondent did not take the measures prescribed by Section 458.325(2), Florida Statutes, at any time during the treatment period. He was not required to do so, however, inasmuch as he never administered electroconvulsive therapy to C.R. While he did administer electric current therapy during the treatment period, it was always of the non-convulsive type, to which the requirements of Section 458.325(2), Florida Statutes, did not apply. Accordingly, Count Four should be dismissed in its entirety. Count Five of the Administrative Complaint was addressed in Conclusions of Law 140 through 143 of the Recommended Order, which read as follows: Count Five of the Administrative Complaint issued in the instant case alleges that, in connection with his care and treatment of C.R., Respondent violated Section 458.331(1)(v), Florida Statutes, in that "Respondent practiced outside his expertise by treating [C.R.'s] rectal fissure during the course of her psychiatric treatment." At all times material to the instant case, subsection (1)(v) of Section 458.331, Florida Statutes, has authorized the Board to discipline a Florida-licensed physician for "[p]racticing or offering to practice beyond the scope permitted by law or accepting and performing professional responsibilities which the licensee knows or has reason to know that he is not competent to perform." It has not been established by even a preponderance of the evidence that Respondent treated C.R.'s rectal fissure. He simply provided her with medication for the pain she was exper- iencing as a result of the fissure. In doing so, he was performing a professional responsibility he was competent to undertake. Accordingly, Count Five should be dismissed in its entirety. Count Six of the Administrative Complaint was addressed in Conclusions of Law 144 through 147 of the Recommended Order, which read as follows: Count Six of the Administrative Complaint issued in the instant case alleges that, in connection with his care and treatment of C.R., Respondent violated Section 458.331(1)(u), Florida Statutes, in that "Respondent treated [C.R.'s] psychiatric condition with Ketalar (Ketamine) and utilized Ketalar (Ketamine) in conjunction with ECT treatments" without "first obtaining full, informed and written consent" from C.R.. At all times material to the instant case, subsection (1)(u) of Section 458.331, Florida Statutes, has authorized the Board to discipline a Florida-licensed physician for "[p]erforming any procedure or prescribing any therapy which, by the prevailing standards of medical practice in the community, would constitute experimentation on a human subject, without first obtaining full, informed, and written consent." While it is undisputed that Respondent used Ketalar (Ketamine) as an adjunct to psy- chotherapy in his treatment of C.R., it has not been established by even a preponderance of the evidence that he did so "in conjunction with ECT treatments." Moreover, Respondent obtained C.R.'s "full, informed, and written consent," in the form of her signed November 6, 1984 "Permit to Dr. Royce" (Respondent's [Dr. Royce's] Exhibit 6) before he engaged in Ketamine-assisted psychotherapy with her. Accordingly, Count Six should be dismissed in its entirety. The Board's Final Order Dr. Royce filed exceptions to the Hearing Officer's Recommended Order. The Board of Medicine issued its Final Order on May 10, 1995. It "approved and adopted, and . . . incorporated" in the Final Order all of the findings of fact and conclusions of law set forth in the Hearing Officer's Recommended Order, with the exception of Conclusion of Law 155, in which the Hearing Officer concluded that, "for having committed the violations of former subsection (1)(n) of Section 458.331, Florida Statutes, noted above, [Dr. Royce] should be issued a reprimand." The Board deemed the penalty recommended by the Hearing Officer to be "excessive" and "substitute[d] therefore as the penalty . . . , a Letter of Concern, based upon the limited nature of the violation." On May 11, 1995, the Board's Final Order was filed and a copy of the order was mailed to Dr. Royce . Dr. Royce's Status as a "Small Business Party" Dr. Royce is now, and has been at all times material to the instant case, including when the probable cause panel voted unanimously to find probable cause and directed that an Administrative Complaint be issued against Dr. Royce and when that Administrative Complaint was issued, the sole proprietor of an unincorporated professional (medical) practice with less than 25 employees (from which he derives a substantial portion of his total income), who is domiciled, and maintains his principal office in, the State of Florida. C.R. was a patient of Dr. Royce's practice. The treatment that she received while such a patient was the subject of the charges set forth in the Administrative Complaint issued against Dr. Royce.
The Issue Petitioner Department of Professional Regulation seeks to suspend, revoke, or otherwise discipline respondent's license to practice medicine on charges of professional misconduct violative of Chapter 458 Florida Statutes (1979). The issues for determination are: Whether respondent is guilty of gross or repeated malpractice or the failure to practice medicine with that level of care, skill, and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances, in his treatment of Verdi Hammond Burroughs ("Burroughs") and Charles Kirk ("Kirk") in violation of Section 458.331(1)(t), Florida Statutes (1979); Whether respondent's treatment of Burroughs and Kirk was fraudulent and constituted misrepresentation, and whether the treatment was medically beneficial to the exclusion of other forms of proper medical treatment and was, therefore, harmful to the patient in violation of Section 458.331(1)(1), Florida Statutes (1979); Whether respondent violated Sections 458.331(1)(1), 458.331(1)(h), Florida Statutes (1979) by failing to fully inform Burroughs and Kirk (in his prescribing and administering Amygdalin [Laetrile]) of alternative methods of treatment for their cancer, and the potential of these methods for cure; whether each patient failed to sign a written release releasing respondent from liability; and whether respondent informed each patient, in writing, that Laetrile has not been approved as a treatment or cure by the Food and Drug Administration of the United States Department of Health and Human Services; Whether respondent's treatment of Burroughs and Kirk, when measured by the prevailing standards of medical practice in the community, would constitute experimentation on a human subject without first obtaining full, informed, and written consent, in violation of Section 458.331(1)(u), Florida Statutes (1979); Whether respondent failed to comply with Sections 458.333 and 458.335, Florida Statutes (1979); Whether metabolic therapy is recognized by a respectable minority of the medical profession as a treatment for cancer. Background By an eight-count administrative complaint dated March 31, 1982, petitioner Department of Professional Regulation, Board of Medical Examiners (Department), charged respondent Daniel J. Clark with multiple violations of Chapter 458, Florida Statutes (1979), the "Medical Practice Act." Respondent disputed the charges and requested a Section 120.57(1) hearing. On April 29, 1982, the Department forwarded this case to the Division of Administrative Hearings for assignment of a hearing officer. Hearing was then set for September 22 and 23, 1982. At hearing, the Department presented the testimony of Evelyn Kuhn, Daniel Clark, Alvin Edward Smith, Tammy Thompson, Brenda Kempton, and Lois Ann White. Petitioner's Exhibit Nos. 1/ 1-5 were received into evidence. The respondent testified in his own behalf and presented the testimony of Rodrigo Rodriquez, Rebecca Scholz, and Allen Bernsten. Respondent's Exhibit Nos. 1-5 were proffered but not received into evidence. The parties filed proposed findings of fact and post- hearing briefs by December 1, 1982. Those proposed findings which are incorporated herein are adopted; otherwise they are rejected as unsupported by the evidence or unnecessary to resolution of the issues. Based on the evidence presented at hearing, the following findings of fact are determined:
Findings Of Fact I. Respondent Since 1976, respondent has been licensed to practice medicine in the State of Florida, holding license number ME0026861. (Tr. 269; Prehearing Stipulation) He received a bachelor of science degree from Georgia Southwestern College and a medical degree from Medical College of Georgia. In 1975, he trained for five months with a gynecological oncologist in Americus, Georgia. In 1978, he completed a three year residency program at University Hospital in Jacksonville, Florida. (Tr. 266-268). Since 1979, he has practiced medicine in Ormond Beach, Florida. Initially, his practice included gynecology, family practice, and general nutrition. He then began to treat cancer patients with metabolic (nutritional) therapy. The purpose of such therapy is to enhance the immunological and biological capacities of a patient--nutritionally, immunologically, and physiologically--in order to improve the patients performance in combating cancer. This cancer treatment includes the administration of Amygadalin (Laetrile), vitamins, herbal teas and detoxifiers, and the application of salves and packs to cause localized hyperthermia. It is not a conventional, orthodox, or widely practiced form of cancer treatment. No other physician in Volusia County uses it. Most accredited medical schools in the United States do not teach it. The American Medical Association (AMA) considers it to be experimental. Eventually, respondent's metabolic treatment of cancer patients began to account for 15 percent to 20 percent of his practice. (Testimony of Clark, Rodriquez; P-3) II. Respondent's Treatment of Verdi Hammond Burroughs In October or November 1979, Nelson Murray, a chiropractor, asked respondent to examine Verdi Hammond Burroughs, a patient who had complained to Dr. Murray about a lump in her right breast. (The offices of Dr. Murray and respondent were close together in the same building. And, in the past, Dr. Murray had referred patients to respondent for medical treatment.) (Testimony of Clark, P-3). Respondent, who considered it an "across-the-hall consult," agreed. He went to Dr. Murray's office, examined Ms. Burroughs' right breast, and noted a small lump. He recommended that she have a biopsy or that she see a surgeon for a second opinion, to make sure that the lump was not malignant. (Subsequently, she failed to follow this recommendation.) Although he did not refer her to a particular surgeon, he looked up the names of several who might be willing to operate on her, as she was a Jehovah's Witness. (Since Jehovah's Witnesses object to blood transfusions, many surgeons refuse to operate on them.) (Testimony of Clark, P-3) During this brief examination, respondent did not perform any diagnostic tests other than to manually examine the breast. Although he kept meticulous patient medical records, he did not open a patient record on Ms. Burroughs or have her complete a patient history form. He took no progress notes during the examination. He did not consider her his patient, did not assume responsibility for her treatment, and did not charge her a fee. (Testimony of Clark; P-1, P-3). Respondent had no contact with Ms. Burroughs until Dr. Murray asked him to reexamine her in February, 1980. The circumstances were similar. Respondent examined her in Dr. Murray's office, noted the breast lump was unchanged, made no medical reports, and charged no fee. He recommended that she undergo a laboratory test, including complete blood chemistry, SMAC 22, CBC, and sedimentation rate. For this purpose, he specifically referred her to Dr. Nelson A. Murray, a medical doctor and pathologist in Jacksonville, Florida. (At that time, she lived in Jacksonville, Florida.) He also recommended, again, that she have a biopsy performed--a recommendation which she, again, failed to follow. (Testimony of Clark; P-3). On September 22, 1980, almost eight months later, chiropractor Murray again asked respondent to come to his office and examine Ms. Burroughs right breast. Respondent's subsequent examination revealed that the entire breast was severely inflamed and the nipple was inverted or sloping downward. The breast had the appearance of an inflamed carcinoma. Respondent strongly suggested that she have laboratory tests (the same tests which he had recommended earlier) done as soon as possible and that she arrange to see him immediately thereafter. He, again, told her that she needed a biopsy and gave a preliminary diagnosis of breast cancer. This time, she followed his recommendation. Two days later, she had the complete lab tests done by Dr. Murray, the Jacksonville pathologist. (Testimony of Clark; P-3). Respondent still did not consider Ms. Burroughs his patient or assume any responsibility for her treatment. During this September 22, 1980, examination, he did not open a patient file, take notes, or charge a fee. There is no evidence that Ms. Burroughs-- at that time--believed that she was his patient--or he, her doctor. Nor is there evidence that either party misunderstood or was confused about their relationship or their respective responsibilities. (Testimony of Clark; P-3). Between the February, ,1980 and September 22, 1980, examinations, respondent did not contact Ms. Burroughs and did not discuss her condition with chiropractor Murray. Between the November, 1979 and the September, 1980, examinations, respondent did not order or perform any further diagnostic tests on Ms. Burroughs and did not attempt to check with her to see if she had followed his recommendations. Neither did he expressly inform her that he was not her doctor. The Department contends that his failure to take these actions violates a generally accepted standard of medical care. (Testimony of Clark; P- 3) This contention, however, is unsubstantiated. The evidence does not demonstrate that the generally accepted standard of medical care required respondent to take such actions. Conversely, it has not been specifically shown how, and in what ways, respondent's treatment of Ms. Burroughs between November, 1979 and September, 1980, fell below an acceptable standard of medical care. 2/ Ms. Burroughs became respondent's patient on October 7, 1980, when she came to his office for medical treatment. He performed a complete work up, physical examination, and medical history, and reviewed the results of the lab blood tests. He concluded that her condition was essentially normal except for her right breast, which was severely inflamed and the nipple retracted. In addition, the lymph nodes under her right armpit' were palpable and enlarged. His initial impression was that she had inflammatory carcinoma (cancer) of the right breast with lymph gland involvement. He then scheduled her for a biopsy, which was necessary before he could determine the type of cancer involved. (Testimony of Clark; P-3) The biopsy was performed on October 9, 1980 by Dr. Kluger, a St. Augustine physician. It indicated an inflamatory intraductal adenocarcinoma of the breast, primary. Dr. Kluger, who felt that surgery was inadvisable because of the lymph node involvement, subsequently recommended to respondent that Ms. Burroughs undergo radiation and chemotherapy. (Testimony of Clark; P-1, P-3). During the October 7, 1980, office visit, respondent explained to Ms. Burroughs the alternative methods of cancer treatment, including their potential for cure. The methods discussed included surgery, radiation, chemotherapy, and metabolic therapy. She refused to undergo radiation or surgical treatment, explaining that her husband died of lung cancer after receiving surgery, radiation, and chemotherapy. She agreed however, to consider chemotherapy in conjunction with metabolic therapy. He explained to her that metabolic therapy was not a treatment against the cancer, per se, but that it would help "build up her body to where her own immune system would help her fight the cancer." (P-1). She agreed to accept this treatment--chemotherapy with metabolic therapy--then signed four separate affidavits on forms provided by respondent. The affidavits acknowledged her consent to the ordering and administration of Laetrile. Respondent, however, did not inform Ms. Burroughs in writing (by these affidavits or any other documents), that Laetrile has not been approved as a treatment or cure by the Food and Drug Administration of the United States Department of Health and Human Services. She also did not sign a written release, releasing him from any liability from the administration of Laetrile. (Testimony of Clark; P-1, P-3) During the October 7, 1980, visitation--after the affidavits were signed--respondent began treating her with metabolic therapy, consisting of Laetrile I.V., Vitamin C, B Vitamins, B-15, B-12, and crude liver injections. Metabolic therapy was commenced without obtaining her prior written consent. (Testimony of Clark; P-1). Several days later, on October 13, 1980, respondent began treating her with small doses of chemotherapy in conjunction with the metabolic therapy. The chemotherapy treatment plan was based on a phone call to Dr. Donald Cole, a New York oncologist. Respondent described the type and extent of Ms. Burroughs cancer and Dr. Cole recommended small 100 milligram doses of 5-FU twice weekly, two to five milligrams of Laetrile twice weekly, and 50 milligrams of Cytoxin PO orally. Respondent administered this regimen until he discontinued chemotherapy at the end of November, 1980. (Testimony of Clark; P-3). These doses and intervals of chemotherapy did not conform to the manufacturers' recommended doses contained in the Physicians Desk Reference, a standard reference used by practicing physicians. The doses administered by respondent were lower than those normally used in chemotherapy and are considered to be in the research or experimental stage. (Testimony of Clark, Smith). Chemotherapy and metabolic therapy are incompatible-- they work at cross-purposes. Chemotherapy drugs are strong immunosuppressants. They are toxic and intended to poison cancer cells; 3/ their effect is to suppress the body's immunological system. In contrast, the purpose of metabolic therapy is to enhance that same immunological system. (Tr. 215-216). For this reason, the use of chemotherapy is not included within the protocols for metabolic therapy found in International Protocols in Cancer Management. 4/ Respondent concedes that this publication is authoritative and contains the standard protocols for metabolic therapy. (Testimony of Rodriquez, Clark). Ms. Burroughs chemotherapy stopped at the end of November, 1980, but her metabolic therapy continued. By March, 1981, her right arm was beginning to swell because of enlarging lymph nodes. On the March 2, 1981, office visit, respondent told her that Laetrile was not stopping the cancer, and discussed restarting chemotherapy. He increased her Vitamin C, and began administering herbal cleaners and botanical medicines containing red clover, chapparral, myrr, goldenseal, yellow dot, juniper berries, yuva, ursaberries, conch grass, and dandelion. Respondent categorizes these medicines as blood purifiers, lymph purifiers, liver cleaners, and kidney cleaners. (P-3). By June, 1981, respondent believed the cancer had metastasized to Ms. Burroughs' right lung. During office visits in early June, he rubbed herbal ointment or liniment, Vitamins E and F, into her rib cage area. He also prescribed herbal packs and poultices to cause localized hyperthermia (heat increase). He prescribed dark and yellow herbal salves and instructed her to apply them to her right breast and underarm area, explaining that they would draw out and break down the cancer tumor. (Testimony of Clark, Kuhn; P-3). These salves--strong and painful--caused pieces of gray tissue to fall off her breast and underarm area. Respondent reacted by encouraging her, telling her that the salves were breaking down the cancerous tumor. (He now admits, however, that the herbal ointments and salves would have been ineffective in treating the cancer which had metastasized to her lungs.) He also prescribed a tea which tasted like black pepper. She forced herself to swallow it because he had told her that it would break up the cancer in her body. This representation was also untrue. (Testimony of Clark, Kuhn, Smith.) In administering metabolic therapy to Ms. Burroughs, respondent also prescribed whole-body hyperthermia for the purpose of stimulating her immune system. This required her to totally submerge herself in bath water which was as hot as she could tolerate. According to the standardized protocols for metabolic therapy, as stated in International Protocols in Cancer Management, such "whole-body hyperthermia, while successful in some cases, is dangerous and considered experimental." (Tr. 320, Testimony of Clark). Respondent's metabolic and chemotherapeutic treatment of Ms. Burroughs failed to conform to the standard of care recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. It fell below the prevailing and generally accepted standard of care recognized by his peers in the medical community: a.) After the diagnosis, respondent made an improper and incomplete staging 5/ of the disease by failing to take a liver scan, which would have revealed the existence (or nonexistence) of liver lesion. Cancer of the liver is deadly and must be dealt with immediately. (Tr. 89-92). b.) After he diagnosed Ms. Burroughs breast cancer, he failed to prescribe surgery or a combination of surgery and radiation therapy, treatment methods which likely would have been beneficial and controlled the disease. (Surgery, such as a radical mastectomy, does not cause a significant loss of blood, so blood transfusions--something Ms. Burroughs opposed--could have been avoided.) If necessary, chemotherapy--using conventional doses--could also have been administered. The chemotherapy and metabolic therapy which respondent provided Ms. Burroughs was probably worthless. The herbal salves and teas which he prescribed were incapable of drawing out or breaking up the cancerous tumor. c.) When Ms. Burroughs' cancer was diagnosed, it was in an advanced and complicated stage. Under such circumstances, a general practitioner (such as respondent) should have referred her to or obtained a consult from an oncologist, a specialist in the treatment of cancer. Respondent did neither. (Testimony of Smith). Metabolic therapy is not approved or recognized as acceptable for cancer treatment by a respectable minority of the medical profession. This finding is based on the opinion of Alvin Edward Smith, MD., board certified in oncology and internal medicine, and a Fellow of the American College of Physicians. He has treated cancer patients since 1978. His opinion on this issue is considered more credible than the contrary opinion of Rodrigo Rodriquez, M.D., who practices medicine in Tijuana, Mexico, who is not licensed to practice medicine in the United States, and who--other than acting as a guest resident at Kings County Hospital in Brooklyn, New York--has never practiced medicine in the United States. (Testimony of Smith, Rodriquez). III. Respondent's Treatment of Charles Kirk Charles Kirk became respondent's patient on August 13, 1980, and died shortly thereafter on September 9, 1980. Mr. Kirk, a 77-year-old male, was having great difficulty swallowing food and had a history of recurring choriocarcinoma of the larynx or throat. Surgery had been performed on him several times, and his larynx (voice-box) had been removed. Respondent explained to him the alternative methods of treatment, including surgery, chemotherapy, radiation, and metabolic therapy. Mr. Kirk opposed further surgery and objected to chemotherapy and radiation. He requested Laetrile. After he signed an affidavit provided by respondent (the same form which had been provided Ms. Burroughs), respondent ordered Laetrile. (Testimony of Clark; P-2). Respondent then referred him to a general surgeon for the placing of a gastrostomy feeding tube, a device which would enable him to swallow food and liquids. The tube was successfully placed surgically, after which respondent began administering Laetrile to him as part of metabolic therapy. The treatment was brief, only nine or ten days. On September 26, 1980, Mr. Kirk died. (Testimony of Clark; P-2). Mr. Kirk's condition, when he first became respondent's patient, was essentially irreversible; he was in the final stages of a fatal cancer. (Testimony of Clark, Smith; P-2). Respondent administered Laetrile to Mr. Kirk without first obtaining from him a release of liability and without informing him, in writing, that Laetrile has not been approved as a treatment or cure by the Food and Drug Administration of the United States Department of Health and Human Services. (Testimony of Clark.)
Recommendation Based on the foregoing, it is RECOMMENDED: That respondent's license to practice medicine be suspended for one year, for violating Section 458.331(1)(h), (1), (t), (u), Florida Statutes (1979). DONE AND RECOMMENDED this 9th day of March, 1983, in Tallahassee, Florida. R. L. CALEEN, JR. Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 9th day of March, 1983.
The Issue The issue is whether Respondent failed to practice medicine at the level of care, skill, and treatment that is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances and, if not, the penalty.
Findings Of Fact Respondent is a licensed physician, holding license number ME 0026784. He is Board-certified in radiology. On January 30, 1997, T. D., a 30-year-old female who was eight months pregnant, presented to the emergency room of the Columbia Largo Medical Center complaining of pain in the left flank radiating to the left groin, together with nausea and vomiting. She also reported a prior history of kidney stones. A urologist diagnosed T. D. as suffering from kidney stones and severe hydronephrosis, which is the dilation of the kidney due to an obstruction in the flow of urine. The urologist was unable to pass a stent and catheter by the stones to drain the urine and relieve the pressure on the kidney, so he asked Respondent to perform a left percutaneous nephrostomy. A percutaneous nephrostomy is a procedure in which a physician places a tube through the skin and into the collecting system of the kidney to drain the kidney. The tube remains in place until the obstruction is removed. On February 1, Respondent performed a left percutaneous nephrostomy under local anaesthesia. For guidance in placing the tube, Respondent used ultrasound, rather than ultrasound and a flouroscopy. Respondent has performed 100-150 nephrostomies. As is the common practice, he normally does not rely exclusively ultrasound in guiding the placement of the tube in the kidney. In this case, the urologist asked that he not use a flouroscopy, in deference to the patient's pregnancy and the duration of x-ray exposure in a flouroscopy. Respondent was comfortable doing the procedure in this manner, although he decided that, if he encountered any problems in placement, he would resort to flouroscopy. Respondent proceeded to perform the percutaneous nephrostomy in the morning. As is typical, the radiology technician helped position T. D. on the table for the procedure. T. D.'s advanced pregnancy necessitated a slight adjustment to the normal posture of patients being prepared for this procedure, so T. D. lay slightly more up on her side than is usual. However, this did not change the point of entry chosen by Respondent. And, regardless of her precise position, the location of the spinal canal relative to the kidney relative to the point of entry into the skin remains constant: an imaginary line from the kidney to the spinal canal is perpendicular to an imaginary line from the point of entry to the kidney. The point of entry is on the lower back of the patient. T. D. is thin and her pregnancy did not manifest itself on her back, so the length of tube used by Respondent was relatively short. T. D.'s thin build makes it less likely that Respondent would have placed sufficient excess tube into the patient so as to permit the tube to run from the kidney to the spinal cord. Upon placement of the tube, at least 100 cc of fluid drained through the tube. This is well within the range of urine that would be expected under the circumstances. The color was well within the range of color for urine. The preponderance of the evidence indicates that the fluid was urine and that Respondent had placed the tube correctly in the kidney. At the end of the procedure, T. D. appeared a lot more comfortable. Late in the afternoon, someone called Respondent and told him that the drainage had slowed to a very small amount or nothing at all. This is not uncommon, as moving the patient or over-energetic nurses may accidentally dislodge the stent in the kidney. It is also possible that the tube has rested in a part of the kidney that does not facilitate maximum drainage. Using ultrasound, Respondent confirmed that the tube remained in place in the kidney, although he could not tell whether the stent had come to rest in a narrow place in the kidney or possibly even against a stone. Even with this uncertainty, Respondent still was able to determine that the stent was predominantly in the collecting system. Because T. D. was resting comfortably, she said that she felt fine, her fever was going down, and the hydronephrosis had decreased, Respondent decided to do nothing until after re-examining T. D. the next morning. However, at about 11:00 p.m. or midnight, Respondent, who was visiting a nearby patient, dropped in on T. D. The nurse said that she was fine and her kidney was draining a little better. T. D. also said that she was feeling fine. About three or four hours later, T. D. reported a feeling of some paralysis. Petitioner's expert testified that this was linked to the misplacement of the stent in the spinal canal, but he was unaware that T. D. had undergone a spinal block for the percutaneous nephrostomy and that a problem with the first anaesthetic procedure had necessitated a second. It is more likely that T. D.'s paralysis was in response to the two spinal blocks. At 9:00 a.m. the next day, Respondent returned and examined T. D. He found that she was still doing better, and her urologist was preparing to discharge her from the hospital. She looked better, and her urine flow had improved. He told her to call him if she had any problems, but he never heard from her again or even about her until he learned from the urologist that T. D. had been admitted to another hospital where a radiologist had inserted contrast material into the tube to locate the stent and found it in the spinal canal. The father of the baby picked up T. D. at the Columbia Largo Medical Center. He picked her up out of the wheelchair and placed her in the car. Her condition deteriorated once she got home. A hospital nurse directed the father to change the collection bag, if it filled prior to the visit of the home health care nurse. In the three or four days that T. D. remained at home, he changed the bag several times. He daily checked the site at which the tube entered T. D.'s skin and noticed that it had pulled out a little bit. However, he testified that he did not try to adjust the length of tube inside T. D., nor did he change the setting on the tube, which had "open" and "closed" settings for the pigtail at the end of the tube. The proper setting was closed, as the pigtail is not to be open once the stent has reached its destination in the kidney. On February 5, the father took T. D. to the emergency room of the Columbia St. Petersburg Medical Center, where she presented with complaints of severe back pain. An ultrasound confirmed the presence of kidney stones, whose removal had been deferred until the delivery of the baby. In an effort to locate the end of the tube, a radiologist inserted radiographic contrast dye, which showed that the end of the tube was in the intrathecal space of the spine. A urologist removed the tube. However, T. D. suffered a seizure. Another physician attempted an emergency C-section, but the baby did not live. There are two alternatives to explain how the stent at the end of the tube found its way into the spinal canal. First, Respondent placed it there during the procedure. Second, it migrated from the kidney, where Respondent placed it, to the spinal canal. If not unprecedented, both alternatives are extremely rare. The drainage during the procedure and initial improvement of the distended kidney are consistent with the proper initial placement of the stent. The difficulty of inadvertently turning a relatively short length of tube 90 degrees from the kidney to the spinal canal also militates against a finding that Respondent misinserted the tube. Problems with the first spinal tap may have contributed to some of the complaints, such as paralysis, that T. D. experienced after the procedure. Although unlikely, the migration alternative would be consistent with well-intended, but incorrect, attempts by the baby's father or a home health care nurse to ensure that the tube did not travel too far in or our of the point of entry. Migration would be facilitated if either the father or nurse misread the "open" and "closed" settings and turned to "open," in the hope of improving drainage, when such a setting opens the pigtail, which would increase the possibility that the stent could migrate into the spinal canal. In a case requiring proof that is clear and convincing, it is impossible to find that Petitioner has adequately proved that Respondent misinserted the tube during the procedure. Likewise, the evidence is not clear and convincing that Respondent should have recognized at anytime prior to T. D.'s discharge from the Columbia Largo Medical Center that something was wrong with the procedure that he had performed or that he needed to confirm by x-ray the location of the stent at the end of the tube.
Recommendation It is RECOMMENDED that the Board of Medicine enter a final order dismissing the Administrative Complaint. DONE AND ENTERED this 2nd day of August, 1999, in Tallahassee, Leon County, Florida. ROBERT E. MEALE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 2nd day of August, 1999. COPIES FURNISHED: Britt Thomas, Senior Attorney Agency for Health Care Administration Fort Knox Building 3, Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308 William B. Taylor, IV Macfarlane, Ferguson & McMullen Post Office Box 1531 Tampa, Florida 33601-1531 Angela T. Hall, Agency Clerk Department of Health Bin A02 2020 Capital Circle, Southeast Tallahassee, Florida 32399-1701 Pete Peterson, General Counsel Department of Health Bin A02 2020 Capital Circle, Southeast Tallahassee, Florida 32399-1701 Tanya Williams, Executive Director Board of Medicine Department of Health 1940 North Monroe Street Tallahassee, Florida 32399-0750
