Disciplinary Actions against Joseph Py, D.O.
Stephen Barrett, M.D.
Joseph Py, an osteopathic physician who practices in Maine and Massachusetts, has been disciplined by the licensing boards of both states in connection with his use of intravenous hydrogen peroxide (IV H2O2) to treat diseases for which no scientific evidence exists that it is effective. The document below from the Maine Board of Osteopathic Licensure states:
- In June 2002, Py informed the Board that since April 2001, he had been involved a research study whose design had been approved by the institutional review board (IRB) of the International Bio-Oxidative Medicine Foundation (IBOMF).
- Py said he understood that the IBOMF IRB was approved by the FDA. The Osteopathic Board was unable to verify this.
- Py used an "informed consent" form supplied by the IRB along with a form titled "Side Effects of Peroxide Therapy," which stated that the treatment would "quite probably improve the condition for which you are under treatment, and . . . your overall health." FDA guidelines prohibit overly optimistic representations.
- The consent form also contained language that because "(IV H2O2) is regarded as experimental . . . . we cannot and do not offer this procedure to you except upon the condition you do release us from any legal responsibility for harm resulting from use in your case." FDA guidelines prohibit any such waiver.
When an organization designates itself as an IRB, it and its investigators are required to follow FDA guidelines intended to protect the experimental subjects. The FDA does not approve IRBs but has the authority to inspect what IRBs do. At the end of 1995 and the beginning of 1997, the FDA conducted inspections and found serious deficiencies with the IBOMF IRB. In June 1997, it ordered the IRB to stop approving new studies or permitting new subjects to enter any studies. The FDA's letter indicated that (a) the IRB had failed to maintain a membership of at least five members, (b) the "chairman," a chiropractor named Robert L. Santelli, said that he was the only member, (c) the IRB files did not contain complete information about the studies that it supposedly approved, and (d) the IRB had not held most of the meetings required to review the ongoing studies. In other words: (a) the IBOMF IRB was a sham run by a chiropractor who accumulated a few documents but did almost nothing that IRBs are supposed to do; (b) Py's "study" began four years after the FDA suspended the authority of IBOMF IRB to approve new studies; and (c) Py's statements to the Osteopathic Board were either flat-out lies or demonstrate extraordinary ignorance about the basic issues in human subject research.
In November 2002, Py and the board settled the charges against him with a consent agreement under which he would be restricted from doing IV H2O2 treatment outside of a valid research project and would be subject to board inspections if he resumed its use. Based on Py's assurance that he would not use IV H2O2 again, the board limited the term of the agreement to two years. In July 2004, Py and the Massachusetts Board of Registration in Medicine signed a similar consent agreement under which he can no longer use IV H2O2 therapy in Massachusetts.
MAINE BOARD OF OSTEOPATHIC LICENSURE
IN RE: JOSEPH PY, D.O.
AND BOARD ORDER
The State of Maine Board of Osteopathic Licensure (hereafter "the Board"). Joseph Py. D.O., and the Office of Attorney General enter into this Consent Agreement in order to resolve all matters related to a pending investigation and Board complaint regarding IV H2O2 therapy and the pending application for license renewal.
As a basis for this Agreement, the parties stipulate to the following findings:
1. Dr. Py is a licensed Osteopathic physician. who specializes in family practice, addiction medicine and environmental medicine and is Board Certified in Family Practice by the American Osteopathic Board of Family Practice and has been examined and certified by the American Society of Addiction Medicine. After training and certification by the International Oxidative Medicine Association (IOMA), Dr. Py ultimately treated 5 to 10% of his patients with certain conditions using intravenous hydrogen peroxide (“IV H2O2 therapy”) as part of an overall treatment plan. These conditions included: upper respiratory infections,"candida overgrowth", chronic fatigue immune dysfunction syndrome, asthma, influenza, chronic Epstein Barr Virus, Lyme disease, acute and chronic viral infections, hepatitis and colon cancer.
2. The Board has not promulgated any rules or regulations specifically related to alternative medical care or the administration of IV H2O2 therapy.
3. The patients treated with IV H2O2 therapy usually have previously tried conventional therapies, often unsuccessful1y, or sought IV H2O2 therapy because they do not want to be treated by use of conventional therapies. Dr. Py used IV H2O2 therapy as part of a broader treatment plan, and sometimes as an adjunct with more convcntiona1 therapies.
4. Dr. Py infused H202 (purchased from pharmaceutical companies specific for intravenous infusion) in a dilute solution consistent with protocols developed and recommended by the International Oxidative Medicine Association. In his experience, Dr. Py considered this treatment to be effective and beneficial for patients with the conditions identified in (1) above. At no time has any patient complained to the Board about adverse effects with IV H2O2 therapy administered by Dr. Py.
5. Prior to beginning IV H2O2 therapy with a patient, Dr. Py spoke with patients about IV H2O2 therapy and he provided patients with articles, materials and studies related to H2O2 and its administration. Additional, more technical materials were made available to patients whenever they wanted more information about IV H2O2, and he would also speak with patients about these materials and answer any other questions they had about IV H2O2 treatment. Dr. Py asked each patient to acknowledge in writing that he or she had read and understood the material. None of the material provided or offered to patients related to scientifically controlled. human studies or to the efficacy of this therapy for the specific conditions being treated, except as to one study regarding influenza.
6. Dr. Py informed the Board in June 2002 that since April 2001, he had been involved in an Institutional Review Board approved by the International Bio-Oxidative Medicine Foundation ("IBOMF") so the results of his IV H2O2 therapy of patients could be gathered and reviewed as part of a study. The design of the study was reviewed and approved by the IBOMF and its Institutional Review Board (“IRB”). Dr. Py understood that the IRB was approved and sanctioned by the FDA, which the Board has not been able to verify. The study did not involve a control group. It used the SF-36 Health Status Scale to assess patients.
7. In conjunction with the study. Dr. Py used an informed consent form that was approved by and based on a form that Dr. Py had received from the IBOMF IRB, along with a form entitled “Side Effects of Peroxide Therapy" (See Attachments A and B). The concluding paragraph of the "Side Effects of Peroxide Therapy" form stated: "Question: If there was nothing wrong with you, and you look peroxide therapy for no reason at all, would it be harmful? Absolutely not! It would act like a tune-up to your body'" The consent form did not specifically identify other conventional alternatives for the condition being treated nor did it enumerate risks of not pursuing other mote conventional or proven treatments. The form further represented that, “1t is believed in your case that IV H2O2 therapy is proper under these criteria, and you will quite probably improve in the condition for which you are under treatment, and in your overall health from its use. However, you must understand no one can or does guarantee or warrant the results in any manner.”
8. The "Hydrogen Peroxide Therapy Consent Form" that Dr. Py had patients sign before receiving IV H2O2 therapy under the IBOMF IRB included language that IV H2O2 therapy “is regarded as experimental for the reasons previously cited,” and "'we cannot and do not offer this procedure to you except upon the condition you do release us from any legal responsibility for harm resulting from its use in your case. The latter requirement did not comply with FDA regulations pertaining to experimental studies, 21 CFR § 50.20.
9. In September 2002, Dr. Py of his own accord discontinued offering IV H2O2 therapy to his patients. He has no intention at this time of providing this therapy to patients in the future.
10. Based On the above, the Board finds that Dr. Py did not demonstrate compliance with 32 M.R.S.A. § 2391-A(2)(F) by requiring patients to provide a release of liability as part of the informed consent before IV H2O2 therapy would be administered and by providing literature and other information to patients, in connection with the informed consent and the study that could have been misunderstood by patients regarding the efficacy of IV H2O2 therapy.
Based on the foregoing findings. Dr. Py's license to practice osteopathic medicine is issued subject to the following:
RESTRICTIONS RELATED TO IV H2O2 THERAPY
If Dr. Py intends to offer IV H2O2 therapy as part of his medical practice, be shall comply with the following restrictions: .
A. Dr. Py shall only offer IV H2O2 therapy to patients if he has them execute a consent form that has been reviewed and approved by the Board in accordance with Restriction 2 and
B. Dr. Py receives written confirmation from the FDA that he does not need to be involved in a study or an experiment sanctioned and approved by the FDA in order to offer IV H2O2 therapy to his patients for treatment of a medical condition. Dr. Py shall obtain clarification from the FDA on this issue prior to resuming the use of IV H2O2 should he decide to resume such treatment. Dr. Py shall copy the Board on any communication to or from the FDA on this specific issue. or
C. If the FDA confirms that Dr. Py needs to be involved in a study or an experiment in order to offer IV H2O2 therapy to his patients, Dr. Py will only provide this treatment to patients after he is enrolled in a study or an experiment that meets all the federal requirements applicable to informed consent, design of the study and is operating under the supervision of an Institutional Review Board that is active and in good standing with the FDA. Materials supporting this shall be provided by Dr. Py to the Board for its review.
2. Informed Consent Form for Patients Receiving IV H2O2 Therapy.
A. No patient shall be asked to waive any legal rights in order to receive IV H2O2 therapy
B. Dr. Py shall not make any representation about IV H2O2 therapy in the informed consent form that does not otherwise comply with federal rules for an informed consent form. Such informed consent form shall be provided in advance by Dr. Py to the Board for its review and approval. which shall not be unreasonably withheld.
C. At a minimum, the informed consent form shall include:
1) If a study is required by the FDA, all of the elements contained in 21 CFR §50.25 and any other applicable regulations.
2) If a study is nor required by the FDA,
a) the patient's condition that is being treated by this therapy;
b) potential conventional medical treatments and alternative procedures or courses of treatment;
c) the risks of not pursuing other more conventional or proven treatments;
d) that no clinical trials on patients have demonstrated the efficacy of IV H2O2 therapy for the patient's specific condition; and
e) the reasonably foreseeable risks or discomforts that the patient can expect from this therapy.
Dr. Py agrees that if he is treating patients using IV H2O2 therapy, an agent of the Board may make visits to Dr. Py’s medical practice, or to the place where his medical records are stored. during regular business hours, in order to monitor compliance with the restrictions related to this Consent Agreement and that this monitoring may include the review of chart entries since the effective date of this Consent Agreement in a random sample of records of his patients who have received IV H2O2 therapy. Such visits may occur no more frequently than quarterly, unless the Board is investigating a specific complaint related to IV H2O2 therapy. The Board may make copies of relevant portions of the records and shall maintain the confidentiality of these records consistent with applicable Maine and Federal laws and regulations.
A. Within one year of the effective date of the Consent Agreement. Dr. Py agrees to reimburse the Board for its investigative costs of $614.90 incurred by the Board. He may reimburse the Board in a lump sum or in installments.
B. Dr. Py further agrees to pay for all costs incurred in connection with carrying out his obligations under the terms of this Agreement and for any costs that may be incurred by the Board in connection with the enforcement of this Agreement, in accordance with 10 M. R.S.A.§ 8003-D.
Except as otherwise provided in this Agreement, requests for amendments of any provisions of this Agreement may be made by Dr. Py no more often than every six months.
A. The requests shall be submitted to the Board in writing. and supported by professional opinions, if available.
B. Requests for amendments will not suspend any obligations under this Agreement Dr. Py will be expected to comply with the terms of the Agreement until his request is acted upon favorably by Board vote and approved by the Office of Attorney General.
C. Amendments will be decided in the discretion of the Board with or without a hearing, and must have the approval of a representative of the Attorney General. There will be no appeal from the discretionary decisions regarding amendments of this Agreement.
D. . Any action by the Board seeking to increase the requirements of licensure, other than in those instances already specifically provided for above, can only be taken after hearing or by agreement of all parties.
If Dr. Py fails to comply with the restrictions or meet any of the other obligations of this Consent Agreement and Board Order, this shall be a ground for discipline and the Board may impose an of the sanctions or pursue any remedies found in Title 10 M.R.S.A. § 8003, Title 32 M.R.S.A. § 2591-A or other applicable law.
B. Resuming IV H2O2 Therapy without Notice to Board.
If after hearing or by agreement, it is found mat Dr. Py provided IV H2O2 therapy to a patient without first notifying the Board and meeting all the Restrictions related to IV H2O2 therapy imposed by this Consent Agreement, but no patient harm is found to have; occurred as the result of such use, Dr. Py's license shall be suspended for three (3) months or until such time as he has fully complied with all said Restrictions, whichever is later. If after hearing or by agreement, it is also found that a patient was harmed from the Use of IV H2O2 therapy, the Board may impose such other discipline as permitted by law.
4. Term of Board Order.
This Agreement shall be effective so long as Dr. Py continues to be licensed by the; Board. This Agreement may be terminated sooner if all parties agree based on a change in circumstances.
5. Waiver of Right to Appeal Board Decision and Certain Future Board Decisions.
Dr. Py waives any further hearings or appeal to the courts regarding this Agreement and the related Board Order. Nothing in this Paragraph will be deemed a waiver of Dr. Py's rights under rule, statute or the Maine or United States Constitutions, to appeal a decision or action taken by the Board subsequent to the execution of this Agreement, including other disciplinary action, except as Dr. Py may have agreed herein.
Any notices or other communication between the parties provided pursuant to this Agreement will be sent to the following:
- Board of Osteopathic Licensure
- 142 State House Station
- Augusta. ME 04333-0142142
- (207) 287-2480
- Fax: (207) 287-3015
- Joseph Py. D.O.
- 640 Brighton Avenue
- Portland, ME 04102
- (207) 828-4299
- Fax: (207) 828-5056
- Other: with a copy to Dr. Py's legal counsel:
- Kenneth W. Lehman, Esq.
- Bernstein, Shur, Sawyer & Nelson
- 100 Midd1e Street
- P.O. Box 9729
- Portland, ME. 04104-5029
Dr. Py agrees to promptly inform the Board of any changes in the information contained in this paragraph.
7. .Copies of Complaint
The Board agrees that if it provides a copy of the Complaint to any person that it will also provide Dr. Py's Response to the Complaint, by letters dated November 2001 and March 13, 2002 (without attachments).
I, JOSEPH PY, D.O., HAVE READ AND UNDERSTAND THE TERMS OF THE FOREGOING CONSENT AGREEMENT. I HAVE HAD AN OPPORTUNITY TO CONSULT WITH COUNSEL BEFORE SIGNING. I ENTER INTO THIS AGREEMENT VOLUNTAR1LY WITHOUT THREAT OR PROMISE. I UNDERSTAND THAT THJS CONSENT AGREEMENT CONTAINS THE ENTIRE AGREEMENT WITH THE BOARD OF OSTEOPATHIC LICENSURE AND THAT THERE IS NO OTHER AGREEMENT OFANY KIND, VERBAL,WRITTEN, OR OTHERWISE BETWEEN THE PARTIES.
This page was posted on July 24, 2004.