Disciplinary Action against
Edward Tobinick, M.D.
Stephen Barrett, M.D.
Edward L. Tobinick, M.D., operates the Institute of Neurological Recovery (INR), which has offices in Boca Raton, Florida and Los Angeles, California. Tobinick, who is board-certified in internal medicine and dermatology, has for many years offered to treat spine-related pain and various neurological conditions with a drug that is FDA-approved for other purposes. He and several other authors have published many papers supporting his off-label use of Enbrel, but his work remains controversial.
In 2004, the Medical Board of California became concerned about his marketing practices and filed an accusation, which was amended in 2005 and again in 2006. The second amended accusation (shown below) stated:
- From about 2000 to 2002, Tobinick, owned and operated a medical practice under the name "Institute for Neurological Research" in Los Angeles and Newport Beach.
- During those years, Tobinick promoted and advertised a new off-label use for an FDA-approved drug, etanercept (Enbrel). He referred to his drug as DiskCure® and advertised it as "a new and innovative approach for back or neck pain without surgery," and as a "breakthrough" in the treatment of disc-related back and neck pain.
- Enbrel is a genetically engineered protein and immune response modifier approved by the FDA for treating several types of arthritis but not for back pain. Tobinick's treatment involved injecting it near the spine.
- Until May 2002, there had been no published, peer-reviewed, scientific studies showing the effectiveness of the treatment for back pain in humans. Nor had there been an approved, pending, or investigational drug application for this use of etanercept.
- Tobinick's advertisements for DiskCure constituted unprofessional conduct under the California Business and Professions Code.
- Tobinick had also failed to obtain a fictitious name permit for the Institute for Neurological Research as required by law.
The case was settled in 2006 with a stipulation under which:
- Tobinick understood that the charges and allegations in the Second Amended Accusation, if proven at a hearing, constitute cause for imposing discipline upon his Physician's and Surgeon's certificate.
- Tobinick admitted that the Board could present a prima facie case of the charges contained in the Second Amended Accusation concerning violations of Business and Professions Code sections 2238 and 2285, and waived his right to present a defense thereto.
- Tobinick gave up his right to contest that cause for discipline existed based on that charge.
- The Board agreed that there were three mitigating circumstances: (1) Published, peer reviewed scientific studies since May 2002 had provided evidence that perispinal etanercept was effective for treatment of disc-related pain; (2) Tobinick had discontinued his advertising for DiskCure three years previously; and (3) Tobinick had published his results of other uses for perispinal etanercept without advertising them.
- Tobinick agreed to serve 1 year on probation during which he was required to complete courses in ethics and prescribing practices and have his practice monitored by another physician or complete a professional enhancement program.
In 2006, three doctors who had worked for Tobinick at the Institute for Neurological Research between 2000 and 2002—Susan Davoodifar, M.D., Ronesh Sinha M.D. and Chaim Vanek, M.D.—signed stipulations under which they agreed to be reprimanded for failing to adequately evaluate patients before administering Enbrel injections. All three were required to complete a professional enhancement program and Davoodifar and Sinha were required to complete a course in medical ethics. Tobinick's probation period ended in 2008.
BILL LOCKYER, Attorney General of the State of California
JOHN E. RITTMAYER, State Bar No. 67291
Deputy Attorney General
California Department of Justice
300 S. Spring St., Suite 1702
Los Angeles, CA 90013
Telephone: (213) 897-7485
Facsimile: (213) 897 -9395
Attorneys for Complainant
DIVISION OF MEDICAL QUALITY
MEDICAL BOARD OF CALIFORNIA
DEPARTMENT OF CONSUMER AFFAIRS
STATE OF CALIFORNIA
In the Matter of the Accusation Against:
EDWARD LEWIS TOBINICK, M.D.
Physician and Surgeon's Certificate No. G37710,
Case No. 06-2001-127668
SECOND AMENDED ACCUSATION
FILED: September 18, 2006
1. David T. Thornton (Complainant) brings this Second Amended Accusation solely in his official capacity as the Executive Director of the Medical Board of California, Department of Consumer Affairs.
2. On or about July 31,1978, the Medical Board of California issued physician and Surgeon's Certificate Number G37710 to Edward Lewis Tobinick, M.D. (Respondent). The Physician and Surgeon's Certificate was in full force and effect at all times relevant to the charges brought herein and will expire on October 31, 2007, unless renewed.
3. This Accusation is brought before the Division of Medical Quality Division) for the Medical Board of California, Department of Consumer Affairs, under the authority of the following statutes and regulations. All references are to the Business and Professions Code (Code) unless otherwise indicated.
4. Section 2220 of the Code provides:
"Except as otherwise provided by law, the Division of Medical Quality may take action against all persons guilty of violating this chapter [Chapter 5, the Medical Practice Act]. The division shall enforce and administer this article as to physician and surgeon certificate holders, and the division shall have all the powers granted in this chapter for these purposes including, but not limited to:
"(a) Investigating complaints from the public, from other licensees, from health care facilities, or from a division of the board that a physician and surgeon may be guilty of unprofessional conduct. The board shall investigate the circumstances underlying any report received pursuant to Section 805 within 30 days to determine if an interim suspension order or temporary restraining order should be issued. The board shall otherwise provide timely disposition of the reports received pursuant to Section 805.
"(b) Investigating the circumstances of practice of any physician and surgeon where there have been any judgments, settlements, or arbitration awards requiring the physician and surgeon or his or her professional liability insurer to pay an amount in damages in excess of a cumulative total of thirty thousand dollars ($30,000) with respect to any claim that injury or damage was proximately caused by the physician's and surgeon's error, negligence, or omission.
"(c) Investigating the nature and causes of injuries from cases which shall be reported of a high number of judgments, settlements, or arbitration awards against a physician and surgeon."
i. Section 2227 of the Code, in pertinent part, provides:
"(a) Protection of the public shall be the highest priority for the Division of Medical Quality ... and administrative law judges of the Medical Quality Heating Panel in exercising their disciplinary authority."
6. Section 2238 of the Code provides:
"A violation of any federal statute or federal regulation or any of the statutes or regulations of this state regulating dangerous drugs or controlled substances constitutes unprofessional conduct."
7. Section 2241.5 of the Code provides:
"(a) Notwithstanding any other provision of law, a physician and surgeon may prescribe or administer controlled substances to a person in the course of the physician and surgeon's treatment of that person for a diagnosed condition causing intractable pain.
"(b) 'Intractable pain,' as used in this section, means a pain state in which the cause of the pain cannot be removed or otherwise treated and which in the generally accepted course of medical practice no relief or cure of the cause of the pain is possible or none has been found after reasonable efforts including, but not limited to, evaluation by the attending physician and surgeon and one or more physicians and surgeons specializing in the treatment of the area, system, or organ of the body perceived as the source of the pain.
"(c) No physician and surgeon shall be subject to disciplinary action by the board for prescribing or administering controlled substances in the course of treatment of a person for intractable pain.
"(d) This section shall not apply to those persons being treated by the physician and surgeon for chemical dependency because of their use of drugs or controlled substances.
"(e) This section shall not authorize a physician and surgeon to prescribe or administer controlled substances to a person the physician and surgeon knows to be using drugs or substances for nontherapeutic purposes.
"(f) This section shall not affect the power of the board to deny, revoke, or suspend the license of any physician and surgeon who does any of the following: "
(1) Prescribes or administers a controlled substance or treatment that is nontherapeutic in nature or nontherapeutic in the manner the controlled substance or treatment is administered or prescribed or is for a non therapeutic purpose in a nontherapeutic manner.
"(2) Fails to keep complete and accurate records of purchases and disposals of substances listed in the California Controlled Substances Act, or of controlled substances scheduled in, or pursuant to, the federal Comprehensive Drug Abuse Prevention and Control Act of 1970. A physician and surgeon shall keep records of his or her purchases and disposals of these drugs, including the date of purchase, the date and records of the sale or disposal of the drugs by the physician and surgeon, the name and address of the person receiving the drugs, and the reason for the disposal of or the dispensing of the drugs to the person and shall otherwise comply with all state recordkeeping requirements for controlled substances.
"(3) Writes false or fictitious prescriptions for controlled substances listed in the California Controlled Substances Act or scheduled in the federal Comprehensive Drug Abuse Prevention and Control Act of 1970.
"(4) Prescribes, administers, or dispenses in a manner not consistent with public health and welfare controlled substances listed in the California Controlled Substance Act or scheduled in the federal Comprehensive Drug Abuse Prevention and Control Act of 1970.
"(5) Prescribes, administers, or dispenses in violation of either Chapter 4 (commencing with Section 11150) or Chapter 5 (commencing with Section 11210) of Division 10 of the Health and Safety Code or this chapter.
"(g) Nothing in this section shall be construed to prohibit the governing body of a hospital from taking disciplinary actions against a physician and surgeon, as authorized pursuant to Sections 809.05, 809.4, and 809.5.
8. Section 2285 of the Code provides:
"The use of any fictitious, false, or assumed name, or any name other than his or her own by a licensee either alone, in conjunction with a partnership or group, or as the name of a professional corporation, in any public communication, advertisement, sign, or announcement of his or her practice without a fictitious-name permit obtained pursuant to Section 2415 constitutes unprofessional conduct. This section shall not apply to the following:
"(a) Licensees who are employed by a partnership, a group, or a professional corporation that holds a fictitious name permit.
"(b) Licensees who contract with, are employed by, or are on the staff of, any clinic licensed by the State Department of Health Services under Chapter 1 (commencing with Section 1200) of Division 2 of the Health and Safety Code.
"(c) An outpatient surgery setting granted a certificate of accreditation from an accreditation agency approved by the medical board.
"(d) Any medical school approved by the division or a faculty practice plan connected with the medical school."
HEALTH AND SAFETY CODE
9. Section 110403 of the Health and Safety Code, in relevant part, provides:
"Except as otherwise provided in Section 110405, it is unlawful for any person to advertise any drug or device represented to have any effect in any of the following conditions, disorders, or diseases:
". . .
"(c) Bone or joint diseases.
10. Etanercept (Enbrel)—used to treat rheumatoid arthritis, juvenile arthritis, psoriatic arthritis, and ankylosing spondylitis1 is a dangerous drug within the meaning of Business and Professions Code section 4211.
1Enbrel is the trademark name for etanercept. Developed and manufactured by the Immunex Corporation, Enbrel is a genetically engineered protein and immune response modifier. It was approved by the Food and Drug Administration (FDA) for treating of rheumatoid arthritis (1998), juvenile rheumatoid arthritis (1999), psoriatic arthritis (2001), and ankylosing spondylitis (2003). To obtain FDA approval, the manufacturer must submit a detailed application in accordance with the Federal Food, Drug and Cosmetic Act (FDCA) (21 U.S.C. § 301 et seq.) and the regulations promulgated by the Food and Drug Administration (FDA) (21 U.S.C. § 355(b)(1); 21 C.F.R. §§ 314.1-314.3,314.50). Among other information, the application for a new drug or for a new use must include "substantial evidence" that the drug is "safe and effective—that is, "evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved on the basis of which it could fairly and reasonably be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof." (21 U.S.C. § 355(d); 21 c.F.R., §314.126.) For example, the major efficacy trial of etanercept for ankylosing spondylitis was a randomized, double-blind, placebo-controlled study of 277 patients. The study excluded patients with the most severe forms of ankylosing spondylitis. Following a six month period of twice weekly treatments, 58% of patients who received etanercept showed significant improvement on a scale that measured pain, function, and inflammation compared to 23% of the patients who received a placebo. A comparable efficacy trial of Enbrel for back pain was not attempted by Respondent.
Enbrel is supplied as a sterile, white, preservative-free, lyophilized powder for parenteral administration after reconstitution with 1 ml of the supplied sterile bacteriostatic water for injection, USP (containing 0.9 benzyl alcohol). Each single-use vial of Enbrel contains 25 mg etanercept, 40 mg mannitol, 10 mg sucrose, and 1.2 rnatromethamine.
FIRST CAUSE FOR DISCIPLINE
11. From 2000 to 2002, Respondent, owned and operated a medical practice under the name, "Institute for Neurological Research" (INR), at 100 UCLA Medical Plaza, Suites 205-210, and also at an office in Newport Beach.
12. During those years, Respondent promoted and advertised a new off-label use for an FDA-approved drug, etanercept (Enbrel), which he had patented, among other uses, in 1999. He administered the drug perispinally, using the name, DiskCure®, which he advertised as "a new and innovative approach for back or neck pain without surgery," and as a "breakthrough" in the treatment of disc-related back and neck pain.
13. Until May 2002, there had not been published, peer-reviewed, scientific studies showing the effectiveness of the treatment for back pain in humans. Nor had there been an approved, pending, or investigational drug application for this use of etanercept.
14. Respondent's advertisements for DiskCure® violated California Health and Safety Code section 11403 subdivision (c), and constituted unprofessional conduct under California Business and Professions Code section 2238.
SECOND CAUSE FOR DISCIPLINE
(Unprofessional Conduct—Failure to Obtain a Fictitious Name Permit)
15. Complainant refers to and, by this reference, incorporates herein, Paragraphs 1 through 14, above, as though fully set forth.
16. Respondent failed to obtain a fictitious name permit tor the INR, as required by Business and Professions Code section 2415. This failure constitutes unprofessional conduct under Business and Professions Code section 2285.
WHEREFORE, Complainant requests that a hearing be held on the matters herein alleged, and that following the hearing, the Division of Medical Quality issue a decision:
1. Revoking or suspending Physician and Surgeon's Certificate Number G37710, issued to Edward Lewis Tobinick, M.D.;
2. Revoking, suspending or denying approval of Edward Lewis Tobinick, M.D. 's, authority to supervise physician's assistants, pursuant to Business and Professions Code section 3527;
3. Ordering Edward Lewis Tobinick, M.D., if placed on probation, to pay the Division of Medical Quality the costs of probation monitoring; and,
4. Taking such other and further action as deemed necessary and proper.
DATED: September 18, 2006
DAVID T. THORNTON
Medical Board of California
Department of Consumer Affairs
State of California
This page was revised on July 5, 2013.