Investigative Report on Warren Levin, M.D.


This report , written in December 2003, alleges that Warren M. Levin, M.D., while practicing in Connecticut, had engaged in illegitimate medical practices, falsely told patients he was doing research, and had staff members perform procedures for which they were not properly credentialed and licensed. Levin relocated to Arizona at about that time and let his Connecticut license lapse in August 2004. However, the Connecticut Department of Health obtained a consent agreement to ensure that if he reapplied for licensure in Connecticut, it could deny the application unless he could demonstrate that his practice would be legal, safe, and effective.


State of Connecticut
Department of Public Health
Division of Health Systems Regulation

INVESTIGATIVE REPORT
December 16. 2003

Petition No.: 2003-0114-001-005

Respondent's Name: Warren Levin, M.D.

Address: 13 Powder Horn Hill Rd.
Wilton, CT 06897

Licensure Information:

License No. 022405
Expires: 08/31/04
DOB: 08/20/32

Category: BP

Petitioner's Name: unknown

Investigated by: Jolanta M. Gawinski, Health Program Associate

Allegations:

  1. Respondent performs procedures and tests which are not medically legitimate_
  2. Respondent performs tests under the guise of a research study where there is no legitimate research study ongoing.
  3. Staff performing medical procedures and testing in respondent's office arc not properly credentialed and licensed to do so.

Introduction

The Department received an anonymous complaint regarding respondent's medical practice. Respondent lists Family Practice as his specialty in his licensure file. His Physician Profile does not list any hospital affiliations. It was determined (through internet research) that respondent focuses on "complementary" medicine and has offices in Wilton, CT and New York, NY.

A. Complaint (Exhibit A)

Analysis:
The anonymous petitioner informs that she/he witnessed patients receiving ozone therapy in respondent's office. She/he explains that during the procedure, a patient's blood is extracted via a catheter inserted into a vein in their arm. After the blood is extracted, it is mixed with ozone from a tank in a separate room and then re-introduced into the bloodstream via an LV. Petitioner names several patients who received this therapy.

Further, petitioner informs that technicians employed in respondent's office perform IVs, take blood samples and perform other testing without having the proper credentials. She/he names respondent's daughter, Beth Galan, and Luis Cruz, as some of the technicians.

In addition, petitioner states that Anoscopy, Prime Allergy Testing, and Darkfield Blood Analysis are done under the guise of a research study and are marked as such on the copies of bills given to patients.

Petitioner informs that there is no research study. The bills are marked as such to keep patients from submitting these bills to their insurance provider for reimbursement.

B. Deposition of Maryanne N. Guinta (Exhibit B)

In response to the Department's request for patient records, respondent, through attorney Jacques Simon, filed an injunction lawsuit against the Department. Atty. Simon requested to depose Maryanne N. Guinta, apparently a former employee in respondent's office. The deposition took place on 06/20/03.

Analysis:
Ms. Guinta testified that she was employed in respondent's office as an Office Manager from February through December of 2002. . . .

She assured that she did not file any complaints with the Department against respondent, nor did she know who might have done it.

Ms. Guinta stated certain procedures were performed in respondent's office that she felt were questionable and not sanctioned by the FDA. She named a rectal smear (Anoscopy), Prime Allergy test, Darkfield test and ozone therapy.

She felt those tests were also questionable because they did not have an ICD-9 (International Disease Classification code) or CPT (current procedural terminology) code assigned to them and were billed to patients as research study. These were not reimbursable by the patient's insurance company. Respondent was not affiliated with any insurance company and it \vas patients' responsibility to submit his bills to their insurance companies for reimbursement.

Ms. Guinta testified that Beth Galan, an employee in the office, acted as an IV. technician. Ms. Galan administered chelation therapy, l.V. drips, ozone therapy and blood draws.

Ms. Guinta testified that Rolando Cubela, a physician trained in a foreign country, but not licensed in USA, was practicing in the capacity of a technician. This person introduced himself to patients as "Dr." Cubela. He was in charge of interpreting the results of the Prime and Darkfield tests, performing and interpreting the results of Anoseoples, and doing the allergy testing.

Ms. Guinta testified that another person in the office, Louis Cruz, was also a foreign-trained physician; not licensed in the USA, introducing himself to patients as "Dr. Cruz." Mr. Cruz acted as an IV technician on days that Ms. Guinta was not in the office. Mr. Cruz would administer chelation therapy, vitamin drips and ozone therapy.

Ms. Guinta informed that she was also concerned that respondent's office was nor HIPPA compliant.  She stated that respondent assured her he was covered under "country doc clause" and did not have to comply with HIPPA regulations.

C. Response and records from respondent (Exhibit C)

Respondent provided proof of malpractice insurance.

1. During a telephone interview with the Department's representatives, in the presence of his attorney, respondent provided the following information:

Representation:
Respondent informed that in 1985 he conducted an FDA approved study in which he was the head researcher. The study included 50 patients in which simultaneous stool samples and anoscopy swabs were tested. He stated he reported on the study but had to discontinue because of lack of funding. He claimed his study showed that anoscopy swabs found more parasites than routine stool samples.

Respondent informed Roland Cubela performs Anoscopy and interprets it. Respondent admitted he might have introduced Mr. Cubela as "Dr." Cubela. He explained that Mr. Cubela is a medical school graduate from Mexico and is not licensed as a medical doctor in the US. Mr. Cubela's credentials were reviewed by the Department during laboratory inspection in respondent's office. Mr. Cubela attended a training course for parasitology and obtained a certification to that effect. He works as an independent contractor and is performing similar services to several doctors. Mr. Cubeb also does allergy testing—collects specimens for Prime Test.

Respondent verified that Beth Galan is his daughter and that she is a certified chelation therapist but not licensed by the Department. She mixes the solution for chelation, performs venipuncture and monitors patients during chelation. She a]50 performs Anoscopies to obtain the swab but does not interpret it

Respondent stated Louis Cruz is a foreign medical school graduate not licensed in the US. His duties include drawing blood, administering intramuscular and intravenous injections, administering LV. vitamin drips and performing Anoscopies (but not interpreting them). Mr. Cruz is introduced to patients as "Dr. Cruz."

Respondent informed that he orders chelation therapy for removal of all heavy metals—arsenic, mercury, iron, aluminun, lead. "Almost" all patients have a blood test prior to commencement of therapy to check for serum levels. He accepts patients of all ages and does order chelation therapy OD some pediatric patients. Respondent denied that chelation therapy is administered to patients while he is not in the office. Respondent stated that ozone therapy is administered in his office by Beth Galan and Louis Cruz. He explains that blood is collected via standard methods, mixed with anticoagulants, ozone is introduced and the mixture is infused back into the patient. Respondent orders this therapy to stimulate immune system, fight bacteria and viruses and to increase oxygenation to the brain to improve brain function.

2. Respondent's attorney argues that currently there are several types of recognized chelation methods, which are indicated, for a variety of toxic substances and heavy metals, including mercury, copper, antimony, zinc, manganese. He directs the Department to a US Department of Health publication titled Toxicological Profile for Mercury regarding diagnosis and chelation of mercury. He asserts that metals and substances chelated by respondent's practice fall within acceptable standards set by the US Health Department.

3. The Department requested and respondent provided records of twelve patients (including two pediatric) in his practice. These were forwarded to the Department's consultant for evaluation.

D. Review of respondent's CLIA application file (Exhibit D)

Analysis:
On 03/30/98. the Department received a CLIA application in the name of Americas Medical Center located in Ridgefield, CT, listing respondent as the applicant and Center's Director. Respondent requested certification for Microbiology, Diagnostic Immunology, Chemistry, Hematology, Immunohematology and Pathology. In 2000, respondent moved his office to Wilton, CT (Integrative Medicine of Connecticut).

In January 1999, respondent submitted lab personnel report indicating respondent as Director and Clinical Consultant and "Dr." Cubela as Technical Supervisor, General Supervisor and Testing Personnel.

After several visits/inspections of respondent's laboratory, several plans of correction, and numerous communications, it was determined that respondent's laboratory did not meet the CLIA requirements and performance standards.

Respondent was informed that Darkfield microscopy of whole blood (also called live cell analysis) is a clinical laboratory test that is not approved by the Connecticut Department of Public Health. He was informed that it is a new method that has not been shown to meet the accuracy, precision, and other performance requirements. He was informed that he 'would have to perform validation studies (i.e. clinical studies equivalent to the requirements for FDA approval) for Prime Testing. This test was not evaluated by the FDA for in-vitro diagnostic use. He was also told that he could meet the clinical laboratory licensure requirements for parasitology if an acceptable plan of correction was submitted to the Department. Among the correction requirements were training and experience verification for Mr. Cubela.

In November 1999, respondent was informed by Wendy Furniss, PHSM, that his laboratory failed to provide acceptable plans of correction and that his application for state licensure was denied. He was also directed to discontinue performing Darkfield and Prime testing for nutritional counseling or for any other assessment of health.

E. Consultative opinion (Exhibit E)

Adam L Seidner, MD, reviewed this case for the Department. Dr. Seidner specializes in family practice and preventive medicine.

Analysis:
The consultant does not recommend the Anoscopy procedure being performed by a technician, even if supervised by a qualified medical provider.

He also explains that many chemicals exert their effect at such low concentrations that they escape detection except by very sophisticated laboratory methods. A preferred approach is to use corroborative laboratory methods that measure biomarkers that arc specific indicators of the toxin. The consultant states respondent collected urine and hair for heavy metal and elemental analysis without analyzing for metabolites or biomarkers. In addition, the patient records submitted by respondent show no clinical indication to lest for any of these metals or elements. Some of these are essential elements and are required for normal metabolic and physiologic functioning. The consultant states that respondent's "diagnostic" tests do not indicate levels that would require chelation treatment.

The consultant states Prime test examines up to 220 items and allegedly works by combining a small sample of a person's white blood cells that is combined with food or chemical. If the white blood cells stay healthy, active and alive then the substance is not likely to cause a problem. If the cells burst open then this is allegedly an indicator for allergic reaction and the cause of the patient's problem. The consultant points out that the Prime Test is based On questionable science and the interpretation of the test does not appear to be based on sound scientific fact.

Regarding ozone therapy, the consultant informs it has been used as an alternative medical approach for nearly half a century to treat conditions without proper study. The consultant states that the efficacy of ozonated blood has not been definitively shown to enhance the immune system as the respondent alleges.

The tests performed in respondent's office have not been validated scientifically or substantiated independently and peer reviewed.

The consultant states that the documentation respondent provided regarding his involvement in research is unacceptable. Respondent's billing records suggest another motive for performing the tests. The material provided to support some of respondent's practices and tests, includes case series, testimonials and commentary. There is no evidence of randomized, blinded, or reproducible research. The research documentation respondent provided does not include the protocol used, informed consent, quality controls, signed statement of the investigator, the Institutional Review Board or the FDA's IND document. The consultant questions why were the patients involved in research required to pay for their tests and treatments.

Finally, the consultant states that the medical documentation in the pediatric records does not meet acceptable standards. There are no assessments or plans. The records document the respondent's use of questionable tests and supplements with their prices.

He feels that the credentials of respondent's staff do not meet any standards that he is familiar with. The certificates provided do not indicate competency, only completion of course work—there is no evidence of ongoing training.

The consultant states that after careful review of the documentation provided by respondent, it is his impression that respondent is providing marginal care and is deviating from the standards of practice. He points out that respondent has procedures performed by unqualified personnel, performs and orders tests that are not valid or validated, makes diagnoses that are unsubstantiated, and treats patients with unproven methods. It is the consultant's opinion that respondent may be involved in "quackery for profit. "

Note from investigator: During a telephone conversation with this investigator, the consultant indicated that respondent's practices may constitute an  immediate threat to the health and safety of the public.

F. Statements and facts related to allegations.

1. Respondent is a licensed physician practicing in Wilton, CT and New York, NY.

2. The Department received an anonymous complaint informing that respondent performs procedures and tests not medically legitimate; performs tests under the guise of a. research study where there is no legitimate research study ongoing; has staff performing medical procedures and testing in his office, who are not properly credentialed and licensed to do so.

3. A former employee in respondent's office, Maryanne Guinta. testified during deposition that respondent orders Prime testing, Darkfield testing, Anoscopies for parasite testing to be performed in his office. In addition, he orders chelation and ozone therapies to be done in his office. She testified all of the above are performed by Rolando Cubela, Beth Galan and Louis Cruz. She Stated that both Mr. Cubela and Mr. Cruz used the title "Dr." when being introduced to patients.

4. The credentials obtained from respondent's office indicate that both Mr. Cubela and Mr. Cruz are foreign-trained medical doctors. None of respondent's staff performing the testing, chelation or ozone therapies are licensed medical professionals.

5. The CTGS §53-341 forbids the use of the title "doctor" or any abbreviation thereof without being legally licensed in any branch of the healing arts.

6. Respondent asserts that he performs Anoscopy parasite testing as part of a research study. He admits Ms. Galan and Mr. Cruz mix solutions for, administer and monitor chelation therapy. He states he orders chelation therapy for removal of all heavy metals. He orders ozone: therapy to stimulate immune system and improve brain function.

7. In the past several years, respondent applied for and was denied licensing and CLIA certification for physician office laboratory. At the time of his application review and denial, he was informed that he may not continue to operate and provide laboratory testing for the assessment, diagnosis or treatment of patients. He was told he may perform testing for research purposes only.

8. The Department's consultant feels that respondent's practices deviate from the acceptable standardsof practice. He feels respondent's practices may constitute an immediate threat to the health and safety of the public.

This page was posted on August 17, 2005..

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