Report and Recommendation In the Matter of Jack E. Slingluff, D.O.

Page 2

II.

Appearances A. On behalf of the State of Ohio: Jim Petro, Attorney General, by Kyle C. Wilcox, Assistant Attorney General. On behalf of the Respondent: Elizabeth Y. Collis, Esq.

B.

EVIDENCE EXAMINED I. Testimony Heard A. Presented by the State Jack E. Slingluff, D.O., as if upon cross-examination B. Presented by the Respondent 1. 2. 3. 4. II. Jack E. Slingluff, D.O. Cindy Boylan Tammy Sue Dallas John Blend

Exhibits Examined A. Presented by the State 1. 2. States Exhibits 1A through 1N: Procedural exhibits. States Exhibit 2: Transcript of the May 25, 2004, sentencing hearing held in the United States District Court for the Northern District of Ohio, Eastern Division, in United States v. Slingluff, Criminal Action No. 4:04CR00074. States Exhibit 3: Transcript of the March 16, 2004, plea hearing held in the United States District Court for the Northern District of Ohio, Eastern Division, in United States v. Slingluff, Criminal Action No. 4:04CR00074. States Exhibit 5: Certified copies of documents maintained by the United States District Court for the Northern District of Ohio, Eastern Division, in United States v. Slingluff, Criminal Action No. 4:04CR00074. (Note: The Hearing Examiner numbered the pages.)

3.

4.

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5.

States Exhibit 6: Certified copy of a transcript of an August 22, 2002, meeting with Dr. Slingluff, conducted as an undercover operation by the Food and Drug Administration. (Note: At the request of the parties, the Hearing Examiner redacted notations that had been added to the transcript. See Hearing Transcript at 8-10.)

B.

Presented by the Respondent 1. 2. Respondents Exhibit A: Curriculum Vitae of Jack E. Slingluff, D.O. Respondents Exhibit B: Form for Consent for Participation in a Clinical Research Study; Trial to Assess Chelation Therapy (TACT). (Note: The Hearing Examiner numbered the pages.) Respondents Exhibit C, C1, C2: Copies of documents demonstrating Dr. Slingluffs participation in continuing medical education. Respondents Exhibit D: Letters written in support of Dr. Slingluff. (Note: the State did not have an opportunity to cross-examine the authors of these letters.) Respondents Exhibit E: Unsigned Release of All Claims Concerning Laetrile Treatment. Respondents Exhibit F: August 30, 2004, Affidavit of Patient 1, with attached copy of Patient 1s signed Release of All Claims Concerning Laetrile Treatment.

3.

4.

5.

6.

C. *

Board exhibits: 1. Board Exhibit Z: Patient key.

Note: All exhibits marked with an asterisk [*] have been sealed to protect patient confidentiality.

PROCEDURAL MATTERS The hearing record in this matter was held open until September 7, 2004, to give the Respondent an opportunity to submit additional evidence. Additional evidence was timely submitted and entered into the record as Respondents Exhibit F. (See Hearing Transcript at 109-110).

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SUMMARY OF THE EVIDENCE All exhibits and transcripts of testimony, even if not specifically mentioned, were thoroughly reviewed and considered by the Hearing Examiner before preparing this Report and Recommendation. 1. Jack E. Slingluff, D.O., testified that he had attained his bachelors degree in science from Kent State University in 1956, and his degree in osteopathic medicine from Kansas City College of Osteopathic Medicine and Surgery in 1961. He also stated that, before attending medical school, he had been a graduate student in mathematics at John Hopkins University for one semester in 1956. (Hearing Transcript [Tr.] at 20-21; Respondents Exhibit [Resp. Ex.] A). Dr. Slingluff testified that, after medical school, he had been an intern for a little over a year, from 1961 through 1962, at Green Cross Osteopathic Hospital in Cuyahoga Falls, Ohio, and Youngstown Osteopathic Hospital in Youngstown, Ohio. (Tr. at 21; Resp. Ex. A). Dr. Slingluff stated that, after completing his internship, he had returned home to Canton, Ohio, and opened a general family practice. He testified that he had also worked with other osteopathic physicians in the area to open Doctors Hospital of Stark County in 1963 or 1964. He testified that, at the hospital, he had run the emergency room for some time; performed minor surgeries on his patients; assisted with surgeries; and practiced obstetrics for 14 years. (Tr. at 21-22). Dr. Slingluff testified that after deciding to cease practicing obstetrics, because babies were too active at nighttime, he had concentrated on his general practice. He advised that Doctors Hospital is still open today, and that he still has privileges there. However, he testified that he no longer performs or assists surgeries. (Tr. at 22-23, 51). Dr. Slingluff stated that his practice has been at its present location in Canton since late 1979 or 1980. He testified that he is the sole physician and that he has five staff members. (Tr. at 23-24). He described his current practice: My practice is a general practice. In general, we see patients with all types of diseases. I have a sizeable number of patients who havehave high blood pressure, they also have cholesterol problems, diabetics, and a variety of colds and that type of thing. You know, we treat virtually all those. We treat people with chelation therapy. * * * [W]ere treating people for heavy metal toxicity and a variety of other types of treatments like the

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osteopathic treatment. We do manipulation and we do prolotherapy, which is a procedure of relieving pain through injections, that type of thing. (Tr. at 23). Dr. Slingluff advised that, in addition to his Ohio license, he had also previously been licensed to practice osteopathic medicine and surgery in Florida and Missouri, but that those licenses had lapsed due to nonpayment of fees. He advised that he plans to reactivate his Florida license, because he may retire there. (Tr. at 19, 55-56). 2. On March 16, 2004, in the United States District Court, Northern District of Ohio, Eastern Division, Dr. Slingluff pleaded guilty to one misdemeanor count of introduction or delivery for introduction into interstate commerce of an unapproved drug, to wit: 30 vials of the unapproved new drug Amigdalina B-17 (AKA Laetrile) to be shipped from West Palm Beach, Florida, to Salem, Ohio, in violation of Title 21, Sections 331(d), 355(a), and 333(a)(1), United States Code. (States Exhibit [St. Ex.] 3, 5). On May 25, 2004, Dr. Slingluff was sentenced to one year of probation. He was not fined, but he was assessed a $25 fee and the costs of the prosecution. He testified that he reports to a probation officer once a month through a written form or a phone call. He is not required to submit to drug testing. Dr. Slingluff advised that his probation will end in May 2005. (Tr. at 38, 40, 67-68; St. Ex. 2 at 7-8). 3. Dr. Slingluff explained what Laetrile is: Laetrile, its an extract of apricot pits and really also apple seeds and a variety of other sources of Laetrile. Its part of the seeding process in those plants, and its been used inby Central American Indians for the treatment of cancer for about 300 years. It was in the 1898 Pharmacopedia as a treatment of cancer, as a matter of fact. Later on, it was refined by Doctors Krebs and Krebs, who obtained a process patent for purifying or putting it in the form to be used injectably as well as orally. And I dont know the exact date of that, but sometime prior to 1970, Im sure. (Tr. at 24-25). Dr. Slingluff acknowledged that Laetrile is not approved by the Food and Drug Administration [FDA], and that the FDA disapproves certain medications because of safety concerns. He testified that he believes that one of the reasons that Laetrile has not been approved is because it may convert to cyanide after being ingested. (Tr. at 25-28).

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4.

Dr. Slingluff testified that he had become interested in Laetrile as a cancer treatment in the 1970s, when his mother had died of ovarian cancer. In the late 1970s, he had met with Laetrile experts, visited clinics in Mexico that administered Laetrile treatments, and met with groups who were working to legalize Laetrile in Ohio. Also in the late 1970s, he had testified before the Ohio State Senate and House of Representatives in favor of having Laetrile legalized in Ohio. (Tr. at 29, 57-59, 77). Dr. Slingluff testified that, despite the FDAs refusal to approve Laetrile, and the potential for Laetrile to convert to cyanide, he believes that Laetrile is safe and beneficial to cancer patients. Dr. Slingluff testified that he has been administering Laetrile to cancer patients since the late 1970s. He advised that, in his use of Laetrile, none of his patients has had any reaction from the cyanide group. He stated that he had monitored his patients for heightened cyanide levels. (Tr. at 28-29, 41, 57, 65-66, 77-29). Dr. Slingluff also stated that he does not believe that Laetrile is a cure for cancer. He explained that he believes that Laetrile enhances a patients condition, and improves survivability. (Tr. at 75). He testified: Now the two things that have developed from [Laetrile treatments in Mexico] is very long survivability on coming back from Mexico and continuing the treatment along with the nutritional program. For instance, I have at least three patients who have, apparently, terminal cancer, and were treated possibly in Mexico at the time, and theyre now 25 year survivors. And when I started treating people with lymphomas, I was delighted to find out that these people, in the short term, started to come out of their symptoms. They became stronger, and they were able to function better. And in many cases, they survive well past the five-year waiting point. (Tr. at 41-42).

5.

6.

Dr. Slingluff testified that his typical patient has been through conventional cancer treatments and has been told that he or she does not have long to live. He advised that he starts such a patient on a program of nutritional IVs, three times per week, for a total of ten weeks. He advised that he also monitors each patients blood work. (Tr. at 34-35). Dr. Slingluff advised the following about the nutritional IVs: Generally, theyre a lactated ringer solution, and then we use a variety of different vitamins, B complex, B-12. We add certain minerals like calcium and magnesium, if necessary.

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*** Basically, it enhances their lack of nutrition, which is what seems to be with their cancer, and we follow this with blood work to see if everything is good. For instance, many people come in with anemia; so we want to stimulate their system to build more blood cells. (Tr. at 64-65). Dr. Slingluff testified that, in addition to the nutritional program, he had also referred many cancer patients to clinics in Mexico for Laetrile treatments. He further stated that he had administered Laetrile to cancer patients by adding it to the nutritional IVs. (Tr. at 33-35, 41, 57-59). 7. Dr. Slingluff further testified that patients who request Laetrile treatments are required to sign a release form. (Tr. at 75). The release form states, in part: J.E. Slingluff, D.O., has fully described to you the method of administration of Laetril; the purpose of its administration in your case; its potential for good, and its potential for harmful side effects; and you have indicated a desire to undertake this procedure in your case. It is now my purpose to stipulate our full and complete understanding with reference to such therapy and to place a limitation upon my legal liability in the event it is unsuccessful. You have been advised that Laetril is an EXPERMENTAL drug that is not legally recognized[;] that it is not a cure; and has been used chiefly in research. I cannot and do not guarantee or warrant the results in any manner. (Resp. Ex. E). 8. Dr. Slingluff testified that he does not advise patients to abandon conventional cancer treatments; rather, most of his patients come to him after they have exhausted conventional options. He also testified that he advises patients to comply with any recommendations that they have received for conventional treatments. Further, he stated that he does not advise patients that Laetrile is a cure for cancer. (Tr. at 42-43, 59, 75). During an FDA investigation of Dr. Slingluff, two individuals working undercover visited Dr. Slingluff under the pretense of inquiring about Laetrile treatments for prostate cancer. The transcript shows that Dr. Slingluff had made several negative comments to the undercover patient about conventional treatments, while his comments about Laetrile

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were much more positive. However, he never directly advised the patient to abandon conventional treatment, and he explained that Laetrile is not a cure for cancer. For instance, despite his negative comments, Dr. Slingluff told the patient: Chemotherapy, radiation, and surgery are tools. And I think theyre very effective on some, some diseases. So you have to weigh that according to the individual. (St. Ex. 6 at 1, 11-12, 18-20, 27-29, 33-35, 37). At hearing, Dr. Slingluff acknowledged two misstatements that he had made during the patient visit: that he had treated 2,000 cancer patients mostly with Laetrile and that Laetrile was 13 times safer than aspirin. He explained that he had not treated 2,000 patients, although he may have administered 2,000 IVs over the years. He further explained that he believes that he had learned at a lecture that Laetrile was less toxic than aspirin, but he conceded that 13 times might be incorrect. (Tr. at 46-47; St. Ex. 6 at 19-20, 34, 37). 9. Dr. Slingluff testified that he does not advertise. He stated that he believes that his patients are usually referred to him by other patients. (Tr. at 44). Cindy Boylan, Dr. Slingluffs office manager, testified that the price for each nutritional IV is $110 or $145. She advised that there is no additional charge if Laetrile is added to the nutritional IV. She further advised that insurance companies generally do not cover nutritional therapy, and that, therefore, the office does not usually submit claims to insurance companies for nutritional IVs. (Tr. at 88, 91, 95-97). Ms. Boylan also testified that the office does not purchase or supply Laetrile; that each patient receiving Laetrile treatment must sign the release form; and that less than one percent of Dr. Slingluffs patients had received Laetrile treatments. (Tr. at 91-92, 95-96). 10. Dr. Slingluff testified about his previous understanding of the legal ramifications of the FDAs refusal to approve Laetrile. He advised that, prior to the criminal action against him, he had believed the following: The use of Laetrile had not been banned; rather its importation into the United States had been prohibited. In the late 1970s, a federal court had decided that an individual could bring Laetrile into the United States after being treated with Laetrile in Mexico, providing that the individual had an affidavit from a physician averring that the individual had a malignancy. Dr. Slingluff also explained that thousands of people are treated with Laetrile in Mexico.

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In the late 1970s or 1980s, pharmacists had begun compounding Laetrile, including pharmacists in the State of Ohio. Although Laetrile could not be brought into Ohio, compounding Laetrile in Ohio had not been illegal.

(Tr. at 26-27, 32-33, 59-61). Dr. Slingluff and Ms. Boylan testified that Dr. Slingluffs office had never purchased or supplied Laetrile; rather Dr. Slingluff had administered Laetrile to patients who had obtained Laetrile for themselves. Dr. Slingluff testified that some of his patients had obtained Laetrile during treatments in Mexico. He further testified that his office had also provided patients with a telephone number as a contact to obtain Laetrile. He testified that he had believed that this had been the contact number for a pharmacist who compounded Laetrile in Ohio. (Tr. at 32-33, 95). Dr. Slingluff testified that his criminal charge was based upon his offices assistance to Patient 1 in obtaining Laetrile by providing her with the contact number. Dr. Slingluff further testified that the pharmacist, unbeknownst to Dr. Slingluff, had apparently moved from Ohio to West Palm Beach, Florida. Ms. Boylan testified that, although Dr. Slingluff had not usually kept Laetrile in his office, two of Patient 1s Laetrile vials had been stored at the office because she had left them behind after an appointment. These vials were discovered by federal investigators during a January 2003 search of Dr. Slingluffs office. (Tr. at 30-33, 37, 61-63, 67, 93-94). 11. Dr. Slingluff testified that Patient 1 had been a 24-year-old female suffering from an advanced malignancy of the descending colon. He explained that she had been at a Stage 2 or 3 when she had requested Laetrile treatments. (Tr. at 30-31, 63-64). An August 30, 2004, affidavit of Patient 1 was submitted by Dr. Slingluff. In the affidavit, Patient 1 averred the following: She had been treated with Laetrile by Dr. Slingluff. Dr. Slingluff had advised her that Laetrile was an experimental drug that was not legally recognized for treatment of cancer. She had reviewed and signed Dr. Slingluffs release form before being treated with Laetrile.

(Resp. Ex. F). 12. Dr. Slingluff testified that, before his misdemeanor conviction, he had never been charged with any crime, apart from speeding. He further testified that he has never been sued because of his use of Laetrile, and that he has never been disciplined by the Board. However, he stated that he had been investigated by the Board in the early 1980s because

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of his use of Laetrile and chelation therapy. He advised that he and his attorney had met with Board representatives to discuss these issues, and that he had brought Laetrile and chelation therapy experts with him to the meetings. He testified that, after the meetings, he had never been advised by the Board to cease his administration of Laetrile treatments. (Tr. at 53-56, 77, 82). Dr. Slingluff testified that, aside from Laetrile, he has not knowingly administered any medications that are unapproved by the FDA. He further testified that he had not knowingly violated the law. He stated that, had the authorities requested him to cease his Laetrile treatments, he would have done so. Dr. Slingluff further stated that he has not administered Laetrile since he learned of the FDA investigation. He testified that he will not administer Laetrile in the future, unless he becomes involved in a government-sponsored Laetrile research project, or unless Laetrile is approved by the FDA. (Tr. at 27, 39, 41, 81). 13. Dr. Slingluff testified that he is 73 years old, and that he would like to continue practicing for as long as his health allows. Dr. Slingluff advised that he currently sees around 50 patients a week. He explained that the number of patients that he sees has significantly decreased in the last few years due to the illness and death of his wife, who had been vice president and office manager of the practice. (Tr. at 50-52, 90). Dr. Slingluff also testified about a clinical research study, known as TACT, with which he is involved. TACT, which stands for Trial to Assess Chelation Therapy, is sponsored by the National Institutes of Health. Dr. Slingluff testified that TACT is a seven-year program, with about two years completed. He stated that, as a participant in the study, he provides chelation therapy to patients who are over 50 and who have suffered a heart attack within the last six months to seven years. (Tr. at 69-70, 85; Resp. Ex. B at 1). The Consent Form for Participation in TACT advises the patient that the purpose of the study is to determine that effectiveness of chelation therapy for patients who have survived a heart attack. The Consent Form further advises that, [c]helation therapy, as used in this study, consists of 40 treatments through a vein in your arm (infusion) of a solution of vitamins and dissolved minerals that are thought to bind specific toxic elements circulating in your blood. (Resp. Ex. B at 1). Dr. Slingluff testified that he would like to complete the TACT study and to become involved in other research projects. He advised that he would also like to bring another physician into his practice, so that the new physician could take over Dr. Slingluffs practice after Dr. Slingluff retires. (Tr. at 44, 80-81). 14. Tammy Sue Dallas and John Blend, two of Dr. Slingluffs patients, testified on his behalf. Ms. Dallas testified that she had been very ill with two very rare forms of yeast infection, which Dr. Slingluff had successfully treated with nutritional IVs along with antibiotics and

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regular medicine. Ms. Dallas stated, If I dont have Dr. Slingluff as a doctor, I dont have a doctor. (Tr. at 101-103). Mr. Blend testified that he is an 86-year-old retired police captain. He advised that Dr. Slingluff had treated him with Laetrile for colon cancer about five years ago. He stated that, prior to his Laetrile treatments, he had been treated with chemotherapy, which had made him very sick, and a surgery that had removed 18 inches of his colon. Mr. Blend testified that he is currently cancer free. Mr. Blend testified that he would like to continue seeing Dr. Slingluff as his doctor, and that he hopes that Dr. Slingluff is around for another ten years. (Tr. at 105-109). Dr. Slingluff also submitted support letters written by patients and family members of patients. Several of the supporters noted that Dr. Slingluff takes his time with patients, and that he is always willing to answer questions and fully discuss any issues that patients have. Several of the letters also praised Dr. Slingluffs alternative approach to cancer treatment. (Resp. Ex. D).

FINDINGS OF FACT On March 16, 2004, in the United States District Court, Northern District of Ohio, Eastern Division, Jack E. Slingluff, D.O., pleaded guilty to one misdemeanor count of introduction or delivery for introduction into interstate commerce of an unapproved drug, to wit: 30 vials of the unapproved new drug Amigdalina B-17 (AKA Laetrile) to be shipped from West Palm Beach, Florida, to Salem, Ohio, in violation of Title 21, Sections 331(d), 355(a), and 333(a)(1), United States Code.

CONCLUSIONS OF LAW 1. The acts, conduct, and/or omissions of Jack E. Slingluff, D.O., individually and/or collectively constitute [s]elling, giving away, personally furnishing, prescribing, or administering drugs for other than legal and legitimate therapeutic purposes or a plea of guilty to, a judicial finding of guilt of, or a judicial finding of eligibility for treatment in lieu of conviction of, a violation of any federal or state law regulating the possession, distribution, or use of any drug, as those clauses are used in Section 4731.22(B)(3), Ohio Revised Code. The acts, conduct, and/or omissions of Dr. Slingluff, individually and/or collectively, constitute [a] plea of guilty to, a judicial finding of guilt of, or a judicial finding of eligibility for intervention in lieu of conviction for, a misdemeanor committed in the course of practice, as that clause is used in Section 4731.22(B)(11), Ohio Revised Code.

2.

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Dr. Slingluffs misdemeanor drug conviction is based upon conduct that was motivated by his desire to help patients, rather than financial gain. Dr. Slingluff appears to be a compassionate physician who administered Laetrile for no other reason other than that he believes that it is beneficial to cancer patients. Further, Dr. Slingluff testified that he had not knowingly engaged in any illegal activity, and that he has not administered Laetrile since he learned of the criminal investigation. He stated that, had the authorities simply asked him to cease his conduct, he would have done so. Dr. Slingluff does not seem to be a physician who will defy the law because he disagrees with it. Indeed, he testified that he will not administer Laetrile again unless he becomes involved in a government-sponsored research project or unless Laetrile is approved by the FDA. For all of these reasons, minimal discipline is appropriate.

PROPOSED ORDER It is hereby ORDERED that: A. SUSPENSION OF CERTIFICATE, STAYED; PROBATION: The certificate of Jack E. Slingluff, D.O., to practice osteopathic medicine and surgery in the State of Ohio shall be SUSPENDED for a period of thirty days. Such suspension is STAYED, subject to the following PROBATIONARY terms, conditions, and limitations for a period of at least one year. 1. Obey the Law and Terms of Criminal Probation: Dr. Slingluff shall obey all federal, state and local laws, and all rules governing the practice of medicine and surgery in Ohio, and all terms of probation imposed by the United States District Court for the Northern District of Ohio, Eastern Division, in criminal case number 4:04CR00074. Declarations of Compliance: Dr. Slingluff shall submit quarterly declarations under penalty of Board disciplinary action or criminal prosecution, stating whether there has been compliance with all the conditions of this Order. The first quarterly declaration must be received in the Boards offices on or before the first day of the third month following the month in which this Order becomes effective. Subsequent quarterly declarations must be received in the Boards offices on or before the first day of every third month. Personal Appearances: Dr. Slingluff shall appear in person for an interview before the full Board or its designated representative during the third month following the month in which this Order becomes effective, or as otherwise directed by the Board.

2.

3.

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Subsequent personal appearances must occur every three months thereafter, and/or as otherwise requested by the Board. If an appearance is missed or is rescheduled for any reason, ensuing appearances shall be scheduled based on the appearance date as originally scheduled. 4. Tolling of Probationary Period While Out of State: In the event that Dr. Slingluff should leave Ohio for three consecutive months, or reside or practice outside the State, Dr. Slingluff must notify the Board in writing of the dates of departure and return. Periods of time spent outside Ohio will not apply to the reduction of this probationary period, unless otherwise determined by motion of the Board in instances where the Board can be assured that the purposes of the probationary monitoring are being fulfilled. Noncompliance Will Not Reduce Probationary Period: In the event that Dr. Slingluff is found by the Secretary of the Board to have failed to comply with any provision of this Order, and is so notified of that deficiency in writing, such period(s) of noncompliance will not apply to the reduction of the probationary period under this Order.

5.

B.

TERMINATION OF PROBATION: Upon successful completion of probation, as evidenced by a written release from the Board, Dr. Slingluffs certificate will be fully restored. VIOLATION OF THE TERMS OF THIS ORDER: If Dr. Slingluff violates the terms of this Order in any respect, the Board, after giving him notice and the opportunity to be heard, may institute whatever disciplinary action it deems appropriate, up to and including the permanent revocation of his certificate. REQUIRED REPORTING TO EMPLOYERS AND HOSPITALS: Within thirty days of the effective date of this Order, or as otherwise determined by the Board, Dr. Slingluff shall provide a copy of this Order to all employers or entities with which he is under contract to provide health care services or is receiving training; and the Chief of Staff at each hospital where he has privileges or appointments. Further, Dr. Slingluff shall provide a copy of this Order to all employers or entities with which he contracts to provide health care services, or applies for or receives training, and the Chief of Staff at each hospital where he applies for or obtains privileges or appointments. REQUIRED REPORTING TO OTHER STATE LICENSING AUTHORITIES: Within thirty days of the effective date of this Order, or as otherwise determined by the Board, Dr. Slingluff shall provide a copy of this Order by certified mail, return receipt requested, to the proper licensing authority of any state or jurisdiction in which he currently holds any professional license. Dr. Slingluff shall also provide a copy of this Order by certified mail, return receipt requested, at the time of application to the proper

C.

D.

E.