Disciplinary Action against
James McGuckin, M.D.
Stephen Barrett, M.D.
In 2014, the Washington Medical Quality Assurance Commission charged James McGuckin, M.D., with unprofessional conduct related to his management of seven patients. The statement of charges (shown below) alleged:
- McGuckin, who specialized in vascular and interventional radiology, was the founder and Chief Executive Officer of Vascular Access Centers, which had facilities in several states.
- Between 2010 and 2013, McGuckin diagnosed patients with what he called chronic cerebrospinal venous insufficiency (CCSVI) and performed balloon angioplasties or inserted stents that he claimed would clear the blockage and improve their multiple sclerosis (MS).
- No randomized, controlled, blinded studies prove that CCSVI exists or that treating it with angioplasty or stenting is effective against MS. In 2012, the FDA warned that balloon angioplasty and stents were not effective in treating MS symptoms and pose risks to patients.
- In 2011, McGuckin created an unreasonable risk of harm to seven patients by conducting angioplasty and stent placement without evidence that they had a vascular disease. He also failed to meet the standard of care in performing an experimental treatment on MS patients without adhering to a proper Institutional Review Board protocol, failed to obtain an approved FDA Investigational Device Exemption, and misrepresented his findings in patient chart notes.
- McGuckin's documentation contained multiple discrepancies, improper patient assessments, and inaccurate procedure notes.
In 2015, McGuckin signed a consent order in which he agreed to (a) stop performing angioplasty or stenting for CCSVI or MS patients in the State of Washington, (b) pay a $17,500 fine, (c) issue refunds to refunds to certain patients, (d) successfully complete an ethics course, and (e) comply with monitoring provisions set by the Commission. The Commission's database indicates that McGuckin's medical license expired in November 2015 and was not renewed.
The CCSVI concept was developed by Palao Zamboni, an Italian physician who called his procedure "liberation treatment." In 2017, after completing a randomized clinical trial, he conceded that this approach does cure or mitigate the symptoms of multiple sclerosis. erebrospinal venous insufficiency treatment in multiple sclerosis patients.
STATE OF WASHINGTON
MEDICAL QUALITY ASSURANCE COMMISSION
In the Matter of the License to Practice as a Physician and Surgeon of:
JAMES MCGUCKIN, MD
STATEMENT OF CHARGES
The Executive Director of the Medical Quality Assurance Commission (Commission) is authorized to make the allegations below, which are supported by the evidence contained in file number 2011-156405. The patients referred to in this Statement of Charges are identified in the attached Confidential Schedule.
1. ALLEGED FACTS
1.1 On March 13, 2007, the state of Washington issued Respondent a license to practice as a physician and surgeon. Respondent's license is currently active. Respondent is board certified in radiology.
1.2 Respondent specializes in vascular and interventional radiology. Respondent is the founder and Chief Executive Officer of Vascular Access Centers (VAC) which has multiple facilities in several states. Respondent travels to different facilities, including the Tukwila, Washington, location to perform endovascular procedures. Between 2010 and 2013, Respondent treated chronic cerebrospinal venous insufficiency (CCSVI) in multiple sclerosis (MS) patients at the Tukwila facility.
1.3 The diagnosis and treatment of CCSVI is investigational and experimental. The CCSVI procedure should only be performed as a scientific research study under an Institutional Review Board (IRB) to ensure safety of human subjects. Furthermore, an IRB research study must have approval from the Food and Drug Administration (FDA) investigational Device Exemption program.
1.4 In 2010, the Hubbard Foundation sponsored a multi-center research study, or registry, for CCSVI treatment. The registry is an organized system that uses observational study methods to collect uniform data about a specific disease or treatment. Bio-Med IRB approved the registry and established a registry protocol outlining the study design and purpose. The protocol also outlined specific patient inclusion and exclusion criteria. Strict adherence to the protocol is crucial in order to ensure patient safety and for the registry data to have any scientific validity. Bio-Med IRS approved Respondent to be principal investigator for the CCSVI multi-center registry. However, Bio-Med IRS did not obtain the required FDA investigational Device Exemption (IDE) approval and failed to monitor Respondent's adherence to the registry protocol.
1.5 Respondent performed CCSVI procedures on patients without ensuring Bio- Med IRB obtained an approved IDE from the FDA. Moreover, Respondent represented to the Commission that he adhered to the Bio-Med IRS protocol when in fact he deviated from it. Respondent put patients' safety at risk, and his registry data is suspect. Respondent's participation in CCSVI research lacked any scientific rigor in determining the effectiveness of treating MS patients.
1.5.1 MS is an autoimmune chronic disease and not a circulatory disorder. MS lesions are caused by inflammatory injury of the nerve fibers in the brain and spinal cord resulting in significant and disabling neurological symptoms such as focal motor and sensory disabilities. The underlying cause of MS is unknown. MS diagnosis is determined by neurologic studies and magnetic resonance imaging (MRI) identifying lesions in nerve fibers. MS is treated with medication.
1.5.2 CCSVI is a theoretical condition based upon the hypothesis that blockage of the major veins in the neck and chest causes and contributes to the progression of MS. The CCSVI procedure purports to provide symptom relief to MS patients by treating these blocked veins to increase blood drainage from the brain and spinal cord. The CCSVI procedure poses risks and complications inherent to endovascular treatment.
1.6 The CCSVI procedure uses balloon angioplasty and sometimes stent placement to treat blocked veins. Significant venous blockage, or stenosis, is usually defined as vein reduction of at least 50% compared with normal adjacent veins. Stenosis may cause venous hypertension symptoms such as swelling, pain, warmth, skin discoloration, superficial varicosities, or interference with dialysis. In contrast, MS symptoms are neurological and cause visual, motor, and sensory disabilities.
1.7 In the CCSVI procedure, the skin is punctured, and a catheter is placed through the femoral vein and then guided to other veins in the body. Contrast is injected into these veins to identify vein abnormalities. If an abnormality is noted, a balloon is inserted and used to dilate the affected vein. In some cases, a stent may be placed to maintain widening of the veins. Though the invasive procedure is done on an outpatient basis without deep sedation, complications and risks exist.
1.8 Angioplasty and stenting of veins are long-standing and well-accepted therapies for venous blockages. Causes of these blockages include catheters, dialysis access, pacemaker leads, tumors, abnormal blood clotting, and bony compression. Complications and risks for CCSVI treatment and of angioplasty and stenting in general include: vein rupture; blood clotting and dissection within treated veins; need to surgically remove ruptured balloons; stent migration requiring surgical removal; stroke; nerve injury; paralysis; and death from bleeding. Both angioplasty and stent placement may also incite further narrowing of the treated vein or restenosis. These therapies are not recognized as stanoard or approved treatments for MS.
1.9 To date, there are no randomized, controlled, blinded studies proving the existence of CCSVI or the efficacy of treating it with angioplasty or stenting. On May 10, 2012, the FDA released a Safety Communication stating balloon angioplasty and stents are inefficacious in treating MS symptoms and pose risks to patients. Additionally, the FDA found no clear evidence that CCSVI exists or is linked to MS.
1.10 Respondent's reply letter to the Commission dated August 29, 2014, stated that as of May 2012, the scope of CCSVI practice is no longer listed on the VAC website and that VAC is not treating CCSVI patients. However, review of VAC's website reveals that CCSVI is still listed as a scope of venous practice.
Assessment and Treatment of Patients A, B. C, D, E, F, and G
1.11 Between March 2011 and September 2011, Respondent performed the CCSVI procedure at the Tukwila, Washington VAC facility on seven MS patients. In doing so, Respondent created an unreasonable risk of harm by conducting angioplasty and stent placement to treat a non-vascular disease. Respondent failed to meet the standard of care in performing an experimental treatment on MS patients. Respondent failed to adhere to the Bio-Med IRB protocol, failed to obtain an approved FDA Investigational Device Exemption (IDE), and misrepresented his findings in the patient chart notes. Respondent's diagnosis and treatment documentation contained multiple discrepancies raising concerns about proper patient assessment and accurate procedure notes.
1.12 Respondent failed to adhere to the registry protocol in the following ways:
1.12.1 Only patients diagnosed with MS through proper neurologic examination are to be included in the registry. Respondent represented to the Commission that CCSVl patients are admitted after a comprehensive intake process. However, patient records indicate Respondent's failure to obtain or review MS examination records from the patients' neurologist. None of the patients have a recorded neurologic exam before or after the CCSVI procedure. There is no documentation that patients obtained a required Expanded Disability Status Scale rating before and after the procedure.
1.12.2 Respondent failed to obtain required magnetic resonance imaging or Doppler testing post-procedure as required for Patients A through G.
1.12.3 Respondent failed to conduct adequate physical evaluations, and he relied on patients' self-reporting of MS diagnosis and symptoms in determining whether or not patients met the inclusion criteria.
1.12.4 Respondent failed to properly include Patient D in the registry and performed CCSVI treatment on her before the Bio-Med IRB protocol was approved.
1.12.5 Before using the Bio-Med IRB protocol, VAC established its own protocol outlining exclusions. Respondent failed to follow VAC's protocol. The exclusions include any patient with "previous vascular interventional procedures." However, Patients A B, E, F, and G, all had prior CCSVI treatments at other locations, yet Respondent included them in the registry and performed subsequent procedures. Between June 28 and July 26, 2011, Respondent performed two CCSVI procedures on Patient B.
1.12.6 The registry excludes patients with "abnormal kidney function." There is no documentation showing Patients A, C, and G underwent laboratory testing to assess kidney function prior to CCSVI treatment.
1.12.7 The registry lists Pregnancy as an exclusion. There is no documentation that Patients A, B, F, and G underwent laboratory testing to exclude pregnancy prior to the procedure.
1.12.8 Follow-up protocol states patients will be seen in the office and evaluated for complications and will undergo review of the procedure results. Respondent states that patients are typically seen the following day after the CCSVI procedure. However, Patients A through G's records do not indicate any office visit or physical evaluation by Respondent following treatment. Patient follow-up calls are noted as brief notations on a form by VAC staff. Respondent failed to conduct any physical evaluation of Patients A through G post-procedure.
1.13 Respondent diagnosed Patients A through G with CCSVI by listing chronic venous hypertension with complications, without corroborating reports or exams. Respondent failed to obtain Patient A, B, C, D, F, and G's MRI or magnetic resonance venography (MRV) reports identifying blood flow abnormalities. There are multiple discrepancies between the findings from the CCSVI procedure images and those Respondent noted in the procedure reports. Respondent inaccurately depicted the existence and/or severity of venous stenoses in Patients A through G.
1.13.1 In his procedure reports, Respondent reported stenoses to be more severe than those seen on the radiologic images. Review of patients' images demonstrated abnormalities that would not be considered significant or justified in requiring endovascular treatment.
126.96.36.199 For Patients A, B, C, D, and G, Respondent documented degrees of left common iliac vein stenosis ranging from 50% to 80%. Respondent performed left common iliac vein angioplasty on these patients and reported the treatment successful. Review of the patients' radiologic images revealed Patients A, B, C, D, and G had no significant left common iliac vein abnormality and no significant change following angioplasty. In fact, mild narrowing of the left common iliac vein from extrinsic effect of the overlying right common iliac artery is a frequent normal finding in asymptomatic patients. In rare cases, severe stenosis may cause symptoms such as leg swelling and pain, and in these cases the narrowings are not treated by angioplasty alone, but by stent placement, since the vein narrowings are caused by extrinsic pressure. Patients A, B, C, D, and G did not present with or complain of iliac vein compression symptoms.
188.8.131.52 Respondent documented that Patients B,, E, and F had left renal vein stenoses of 50% to 70%. Respondent performed left renal vein angioplasty on these patients and reported the treatment successful. Review of the images revealed Patient B, E, and F had no significant left renal vein stenosis and no change following angioplasty.
184.108.40.206 Respondent documented that Patients A, B, and F had azygos vein stenoses of 30% to 70%. Respondent performed azygos vein angioplasty on Patients A and B, and included stent placement in Patient F. Respondent reported the treatment successful. However, review of images revealed Patients A and B had no stenosis of the azygos vein, and Patient F had minimal irregularity but no significant stenosis.
1.14 Respondent required patients to pay for the procedure in full or obtain insurance payment approval prior to any treatment. Respondent billed Patients B, C, D, F, and G's insurance companies for the CCSVI procedure with billing codes typical for endovascular conditions even though Respondent was treating a neurologic disease. It is not evident that Respondent forwarded his procedure notes to Patients A through G's neurologist or primary care provider, or if Respondent ever established any post-procedure medical evaluation of patients to determine the efficacy or benefits of CCSVI treatment.
1.15 Between calendar years 2010 and 2013, Respondent performed CCSVI treatment on 233 patients, including Patients A through G, at the Tukwila facility. Only two patients had a physician referral for CCSVI, and none of the patients had a neurologist referral.
2. ALLEGED VIOLATIONS
2.1 Based on the Alleged Facts, Respondent has committed unprofessional conduct in violation of RCW 18.130.180(4), (7), (13), (16), (22), and 21 CFR § 56.103, 21 CFR § 812.100, and 21 CFR § 812.11 O(a), which provide in part:
RCW 18.130.180 Unprofessional conduct. The following conduct, acts, or conditions constitute unprofessional conduct for any license holder or applicant under the jurisdiction of this chapter:
(4) Incompetence, negligence, or malpractice which results in injury to a patient or which creates an unreasonable risk that a patient may be harmed. The use of nontraditional treatment by itself shall not constitute unprofessional conduct, provided that it does· not result in injury to a patient or create an unreasonable risk that a patient may be harmed;
(7) Violation of any state or federal statute or administrative rule regulating the profession in question, including any statute or rule defining or establishing standards of patient care or professional conduct or practice;
(13) Misrepresentation or fraud in any aspect of the conduct of the business or profession;
(16) Promotion for personal gain of any unnecessary or inefficacious drug, device, treatment, procedure, or service;
(22) interference with an investigation or disciplinary proceeding by willful misrepresentation of facts before the disciplining authority or its authorized representative, or by the use of threats or harassment against any patient or witness to prevent them from providing evidence in a disciplinary proceeding or any other legal action, or by the use of financial inducements to any patient or witnesses to prevent or attempt to prevent him or her from providing evidence in a disciplinary proceeding;
21 C.F.R. § 56.103 Circumstances in which IRB review is required.
(a) Except as provided in §§ 56.104 and 56.105, any clinical investigation · which must meet the requirements for prior submission (as required in parts 312, 812, and 813) to the Food and Drug Administration shall not be initiated unless that investigation has been reviewed and approved by, and remains subject to continuing review by, an lRB meeting the requirements of this part.
(b) Except as provided in §§ 56.104 and 56.105, the Food and Drug Administration may decide not to consider in support of an application for a research or marketing permit any data or information that has been derived from a clinical investigation that has not been approved by, and that was not subject to initial and continuing review by, an IRB meeting the requirements of this part. The determination that a clinical investigation may not be considered in support of an application for a research or marketing permit does not, however, relieve the applicant for such a permit of any obligation under any other applicable regulations to submit the results of the investigation to the Food and Drug Administration.
(c) Compliance with these regulations will in no way render inapplicable pertinent Federal, State, or local laws or regulations.
21 CFR § 812.100 General responsibilities of investigators.
An investigator is responsible for ensuring that an investigation is conducted according to the signed agreement, the investigational plan and applicable FDA regulations, for protecting the rights, safety, and welfare of subjects under the investigator's care, and for the control of devices under investigation. An investigator also is responsible for ensuring that informed consent is obtained in accordance with part 50 of this chapter. Additional responsibilities of investigators are described in subpart G.
21 C.F.R. § 812.110 Specific responsibilities of investigators.
(a) Awaiting approval. An investigator may determine whether potential subjects would be interested in participating in an investigation, but shall not request the written informed consent of any subject to participate, and shall not allow any subject to participate before obtaining IRB and FDA approval
22 The above violations provide grounds for imposing sanctions under RCW 18.130.160.
3. NOTICE TO RESPONDENT
The charges in this document affect the public health, safety and welfare. The Executive Director of the Commission directs that a notice be issued and served on Respondent as provided by law, giving Respondent the opportunity to defend against these charges. If Respondent fails to defend against these charges, Respondent shall be subject to discipline and the imposition of sanctions under Chapter 18.130 RCW.
DATED: November 25, 2014.
STATE OF WASHINGTON
DEPARTMENT OF HEALTH
MEDICAL QUALITY ASSURANCE COMMISSION
MELANIE DE LEON
KRISTIE BREWER, WSBA # 38494
ASSISTANT ATTORNEY GENERAL