In July 2009, Roy Kerry, M.D., who ordered the chelation therapy that killed five-year-old Abubakar Tariq Nadama, signed a consent agreement under which his medical license was suspended for six months, after which he must serve probation for 2 1/2 years. The agreement (shown below) also bars him from chelating anyone under age 18. During the probation period, he is required to undergo a fitness-to-practice evaluation and have his practice monitored by another doctor. Documents in the case indicate:
- The boy, who was autistic, died in July 2005 during his third chelation session at Kerry’s Advanced Integrative Medical Center in Portersville, Pennsylvania.
- Kerry diagnosed Tariq with “Autistic Syndrome, Heavy Metal Toxicity, Candidiasis, Multiple Food Allergies”
- The treatment included intravenous injections of disodium EDTA (Endrate) even though Endrate is not FDA-approved for the treatment of heavy metal toxicity.
- The Endrate was administered over a 5- to 10-minute period despite the manufacturer’s instructions that administration to children should take at least three hours because rapid administration can cause a fatal drop in blood calcium levels.
- Tariq’s autopsy showed that his death resulted from brain injury secondary to heart damage caused by a drop in blood calcium levels.
Tariq’s treatment was based on the unfounded notion that autism is caused by heavy metal intoxication and can be treated by chelation therapy.
COMMONWEALTH OF PENNSYLVANIA
DEPARTMENT OF STATE
BEFORE THE STATE BOARD OF MEDICINE
Commonwealth of Pennsylvania
Docket No. 1490-49-06
CONSENT AGREEMENT AND ORDER
The Commonwealth, by and through the Bureau of Professional and Occupational Affairs, hereinafter the “Bureau” and Respondent (Roy E. Kerry M.D.) stipulate as follows in settlement of the above-captioned case.
1. This matter is before the State Board of Medicine pursuant to the Medical Practice Act of December 20,1985,~P .. LA57,No;112, as amended.(“Act”), 63-P.S. §422.1,et seq.
2. At all relevant and material times, Roy E. Kerry, M.D. (“Respondent”) held a license to practice medicine in the Commonwealth of Pennsylvania, license number MD-008220-E.
3. For the purposes of settlement, Respondent admits that the following facts are true:
a. Respondent’s license is current through 12/31/09, but may be renewed thereafter upon the filing of the appropriate documentation and payment of the necessary fees.
b. Respondent’s last known address on file with the Board is 17 6th Avenue’ Greensville PA 16125.
c. Respondent practices in the Butler/Mercer County area.
d. Respondent treated Tariq from his offices in Pennsylvania.
e. Respondent’s offices are located in Greenville and Portersville.
f. Tariq was a 5-year-old boy during the course of treatment by Respondent.
g. Tariq died on August 23, 2005.
h. The medical chart of Tariq, maintained by Respondent, contains a “current complaint” notation that reads “wants to have iv . . . edta injection . . . an iv push. mother states Tariq is autistic due to immunization shots he was a normal pregnancy . . . 1st shots were given the day he was born . . . no sx noted until age 18 mo . . . has had 12 other inoculation by time he was 18 mo old/ . . . ”
i. The July 22, 2005 entry in Tariq’s medical chart reads, “We don’t have the entire record at all. Mother left her entire volume of his records home. But we have been in communication with Dr. Usman regarding EDTA therapy. He apparently has a very high aluminum and has not been responding to other types of therapies and therefore she is recommending EDTA, which we do on a routine basis with adults. We therefore checked him to it. . . But on testing for the deficiency indicator we find him only indicating the need for EDTA at the present time. Therefore we agree with Dr. Usman’s recommendation to proceed with the treatment. She recommends 50mg per kilo: He is 42 pounds today. So we’ll treat him as a 20-kilo child and give 1 gram of EDTA. We diluted it 1:1 with saline. Started the IV with saline. After a good blood flow in the right antecubital fossa with 3 other assistants and mother controlling him and the papoose board. Had a good IV return flow. We then introduced the EDT A. Checked return flows frequently during administration. Gave the IV over approx. 5 minutes. Then rinsed with saline. He had no difficulty tolerating it. No infiltration occurred. We’ll have mother collect the urine for 12 hours. The most important are the first 6 hours for toxic and essential minerals. When we get that report back we’ll proceed with further injections as indicated on approx. a weekly basis. Recheck the levels in 4-6 IV’s depending on his response. Initial Impression: Autistic Syndrome, Heavy Metal Toxicity, Candidiasis, Multiple Food Allergies … Roy E. Kerry, M.D.”
j. Respondent performed chelation therapy on Tariq on July 22, 2005.
k. Tariq received the chelation in a five to ten minute intravenous “push” (hereafter referred to as “IV push”).
l. The IV push facilitates fast delivery of drugs into the body of the patient.
m. Chelating agents bind with heavy metals such as lead, mercury and aluminum.
n. These agents mobilize metals in the body and enhance urinary excretion of metals thus decreasing the levels of these metals in the body of the patient.
o. Respondent used a form of Ethylene diamine tetra acetic acid ( hereafter referred to as EDTA), in chelating Tariq.
p. As a drug used in intravenous or chelation therapy, EDTA is sold in two formulas.
q. One formula is sold as Edetate Disodium (hereafter referred to as Disodium EDTAt
r. Tariq received chelation therapy on three occasions as ordered by Respondent.
s. Respondent ordered Disodium EDTA to chelate Tariq.
t. Disodium EDTA is a sterile solution of the disodium salt of the synthetic chemical, ethylenediamine tetra acetic acid (EDT A), and water for injection.
u. According to the FDA, Disodium EDTA injections are indicated, among other things, in patients requiring emergency treatment for hypercalcaemia and to control ventricular arrhythmias associated with digitalis toxicity.
v. Disodium EDT A increases excretion of heavy metals, and, to a lesser extent, minerals such as calcium.
w. Tariq was not diagnosed with hypercalcaemia.
x. Tariq was not diagnosed with digitalis toxicity.
y. The second formula of EDTA is Edetate. Calcium Disodium (hereafter referred to as CaNa2EDTA).
z. CaNa2EDT A is Edetate Disodium with added calcium and is intended for use in different circumstances than Disodium EDTA.
aa. CaN a2EDTA is indicated for the reduction of blood levels and stores of lead in order to treat lead poisoning (acute and chronic) and lead encephalopathy in both pediatric and adult populations.
bb. Respondent did not treat Tariq with CaNa2EDTA.
cc. . Respondent ordered a second round of Disodium EDT A chelation on August 10.2005.
dd. In Tariq’s medical chart, for the date August 10, 2005, Respondent wrote, “The last IV EDTA produced 15mcg of lead level per gram of Creatinine. We really expected a higher output. Recommend repeating the IV again. Use the 1 gram of EDTA . . . on the next IV we’ll do another collection . . . IV given in the right antecubital fossa with no difficulty over about a 5-minute span. He gets a little sleepy afterwards and then he recovers in about 5 minutes. Recheck in 2 weeks.”
ee. The August 10, 2005 chelation treatment was administered by a five to ten minute IV push.
ff. On August 23, 2005, pursuant to Respondent’s Orders, the third round of Disodium EDTA chelation therapy was administered to Tariq.
gg. T.B., a medical technician, administered the IV Disodium EDTA to Tariq.
hh. On the third occasion, T.B. requested Doctor Mark Lewis, D.O., to come to the treatment room to help restrain Tariq for the IV push of Disodium EDTA.
ii. Respondent was not present when Tariq received chelation on August 23, 2005.
jj. Tariq’s medical chart for August 23, 2005 reads “IV push ordered per Dr. Kerry and his protocol . . . prior to procedure patient was alert and oriented. No acute distress. Mother ·was present in room . . .”
kk. During the IV push, Tariq’s mother, Marwa Nadama, said that something was wrong.
ll. Doctor Lewis took Tariq’s vitals and then Tariq went limp.
mm. T.B. called 911 and helped with CPR while the ambulance was en route.
nn. Tariq was taken by ambulance to Butler Memorial Hospital where he was pronounced dead.
Subsequently, Respondent spoke to a Professional Conduct Investigator of the Bureau of Enforcement and Investigation concerning his treatment of Tariq.
pp. Respondent stated that EDTA is pretty rare to use on children.
qq. Respondent said he used Disodium EDT A to chelate Tariq.
rr. Respondent used the IV push because the Illinois physician instructed him to and he did not believe that Tariq would be able to remain still and tolerate the one and ½ hours it otherwise takes to complete the IV drip.
ss. Disodium EDTA carries the risk of upsetting the electrolyte balance of the blood in that it has the potential to remove calcium, magnesium, zinc and other trace metals and causes potassium excretion. If Disodium EDTA is rapidly infused, it may cause a precipitous drop in the serum calcium level and may result in fatality.
tt. The actions of the Respondent, described above, violated the Act at 63 P.S. Section 422.41 (8) (unprofessional conduct) in that Respondent ordered the treatment of a patient with a medication that was contraindicated in the manner and choice of delivery.
4. In mitigation, Respondent states:
a., Chelation therapy is legitimately used for purposes other than reducing high lead levels.
b. Some of physicians believe that there is a correlation between environmental factors, including heavy metal overload, and a propensity to develop autism.
c. The Nadamas have expressed their belief that Tariq developed autism from vaccines.
d. After coming to this country from the U.K. seeking help for Tariq, Mrs. Nadama took Tariq to several physicians and facilities for various treatments.
e. Tariq was brought by his mother to Respondent after the patient had been treated, in lllinois, by a physician who had reported having performed IV chelation therapy on autistic patients with impressive results.
f. Tariq’s mother specifically sought chelation therapy for Tariq.
g. Tariq’s mother did not bring Tariq’s medical records to Respondent at any time.
h. Tariq’s mother did not give the prescription for IV EDTA chelation she received from the Illinois physician to Respondent at any time.
i. Prior to treating Tariq, Respondent contacted the office of the Illinois physician for her instructions as to how to proceed with chelation on Tariq.
j. Respondent was told to proceed with EDTA [sic] via IV push.
k. The look-alike EDTA drugs at issue, Disodium EDTA and Calcium EDTA, have established names that are easily confused.
l. Both forms of EDTA are referred to in clinical practice as “EDTA.”
m. Respondent proceeded with using the medication he reasonably believed she had recommended via the administration method she recommended.
n. The exact same medication error has occurred recently in other parts of the country.
o. In a 2008 FDA Public Health Advisory, the FDA said, “These two drugs have very similar names and are commonly referred to as EDTA. As a result, the two products are easily mistaken for each other when prescribing, dispensing, and administering them.”
p. After each of the first two sessions of treatment noted above, Tariq demonstrated increased functioning in several areas of impairment, including improvement in verbal comprehension and communication.
q. Respondent believes Tariq most likely had a pre-existing medical condition(s) that caused, or contributed to, his death.
r. A search of the U.S. Library of Medicine uncovered not a single incidence of myocardial necrosis resulting from hypocalcaemia.
s. Tariq’s calcium level at time of death was 6.9 mg/dL, which is below the normal range for children (8.8 – 10.8 mg/dL,) but well above 6.0 mg/dL, which is generally thought to be fatal.
t. Respondent has not performed chelation on a child since Tariq’s death and does not intend to do so.
u. The Butler County D.A. brought criminal charges against Respondent, but all charges were dropped.
v. Respondent has already served two months of a voluntary suspension.
w. . Respondent has practiced medicine for more than 40 years without ever having been disciplined.
x. Respondent is a compassionate, active, strong member of his community.
y. Respondent is the only practitioner in the immediate area to provide the important medical services and options he provides.
z. Respondent is currently using his own funds to support his medical practice, which is losing money, because he believes strongly in providing continuing services to his loyal patients.
aa. Respondent has the support of thousands of patients who have benefited significantly from his services and want to see him continue to practice so he can continue to serve them and others .
5. The participants consent to the issuance of the following Order in settlement of this matter:
a. Respondent violated the Act at 63 P .S. Section 422.41 (8) (Wlprofessional conduct) in that Respondent ordered the treatment of a patient with a medication that was contraindicated in the manner and choice of delivery.
b. Respondent’s license, number MD-008220-E is SUSPENDED for THREE YEARS, of which six months shall be ACTIVE and the remainder of said suspension shall then be STAYED in favor or TWO AND ONE HALF YEARS of PROBATION.
c. As part of the corrective action imposed by the Board under this Consent Agreement and Order, Respondent shall take the following action: Respondent shall, within the next six months following entry of this Order, undergo an initial assessment and clinical skills assessment through the University of Wisconsin School of Medicine and Public Health program (hereafter referred to as “Wisconsin”). At the conclusion of the initial assessment and clinical skills assessment, in the event Wisconsin recommends a functional skills assessment and, if it deems necessary, a remedial or clinical skills refresher program, Respondent shall comply with any other individualized medical education programs recommended by Wisconsin to address any deficiencies and shall provide the Prosecution Division with documentation demonstrating successful completion of any program recommended by Wisconsin. Respondent shall bear all costs related to the evaluation and recommended programs associate with the Wisconsin program.
d. Respondent shall also provide to the Prosecution Division a copy of the full report from Wisconsin, and shall sign consents for Wisconsin’s release of information to the Board and the Prosecution Division. Respondent understands that the Prosecuting Attorney may provide relevant information to Wisconsin for consideration as part of the clinical skills assessment, provided Respondent is copied on whatever may be submitted. To permit the Prosecuting Attorney to provide suc~ information, Respondent shall immediately notify the Prosecuting Attorney of the assessment dates once the assessment is scheduled. Respondent shall participate in this program at his own expense. The assessment may include “a cognitive screening assessment, peer interview, and/or physical examination. Respondent, shall have completed all portions of the process for which he is responsible. In the event that Wisconsin states that it is unable to develop an educational” program that adequately addresses the issues identified in. the assessment, the program shall notify the Prosecuting Attorney of this fact, and the matter shall be returned to the Prosecution for further action. The results of the assessment shall be admissible as evidence in any subsequent proceedings in this action.
e. Respondent shall not perform IV chelation therapy on any minor (defined as anyone under the age 18 years of age), even if the parents consent to said treatment. If Respondent shall engage in the practice of medicine in violation of this provision, his license shall be subject to further discipline, including but not limited to revocation, upon substantiation thereof.
f. Should Respondent chelate adults, he shall tender an informed consent for chelation therapy to patients that must contain a statement that the therapy being offered has not been tested by the FDA for the purpose .for which it is presently being offered.
g. Respondent shall, at his own expense, retain a physician who is acceptable to the Board and Prosecution, to serve as a practice monitor, such acceptance not to be unreasonably withheld. The practice monitor shall be a Pennsylvania physician, licensed by the Pennsylvania State Board of Medicine. For the first year of the stayed suspension, the retained physician shall, on behalf of the Board, review Respondent’s patient charts as often as the retained physician shall determine is necessary to timely review the records, but not less often than once every three months, and shall report to the Board any conduct that may violate this Order or which may be negligent or unprofessional, in violation of any state or federal law or rule, or outside the standard of care. The retained physician’s sole duty is to the Board and prosecutor and not to any patient or third party. Respondent shall cooperate at all times with the retained physician including by timely paying any fees in full.
a. Respondent shall abide by and obey all laws of the United States, the Commonwealth of Pennsylvania and its political subdivisions and all rules and regulations and laws pertaining to the practice of the profession in this Commonwealth or any other state or jurisdiction in which Respondent holds a license to practice. Provided, however, summary traffic violations shall not constitute a violation of this Order.
b. Respondent shall at all times cooperate with the Bureau of Professional and Occupational Affairs (“Bureau”), any of its agents or employees and the Bureau of Enforcement and Investigation (“BEI”) and its agents and employees, in the monitoring, supervision and investigation of Respondent’s compliance with the terms and conditions of this Order, including Respondent causing to be submitted at his own expense written reports, records and verifications of actions that may be required by the Bureau, BEI or any of its agents or employees.
c. Respondent’s failure to fully cooperate with and successfully comply with the terms and conditions of this probation. shall be deemed a violation of this Consent Agreement and Order.
d. Respondent shall not falsify, misrepresent or make material omission of any information submitted pursuant to this Order.
e. Respondent shall notify BEI, in writing, within twenty (20) days of the filing of any criminal charges, the initiation of any other legal action pertaining to the practice of Respondent’s profession, th,e initiation, action, restriction or limitation relating to Respondent by the professional licensing authority of any state or jurisdiction, or the Drug Enforcement Agency of the U.S. Department of Justice, or any investigation, action, restriction or limitation relating to Respondent’s privilege to practice the profession.
f. Respondent shall notify BEI by telephone within 72 hours and in writing within ten (10) days of the change of his home address, phone number, place(~) of employment and/or practice.
7. Respondent’s failure to fully cooperate and comply with and successfully complete the terms and conditions of this Consent Agreement and Order shall be deemed a violation of this Consent Agreement and Order.
8. Respondent knowingly and voluntarily waives the right to an administrative hearing in this matter, and to the following rights related to that hearing: to he represented by counsel at the hearing; to present witnesses and testimony in defense or in mitigation of any sanction that may be imposed for a violation; to cross examine witnesses and to challenge evidence presented by the Commonwealth; to present legal arguments by means of a brief; and to take an appeal from any final adverse decision.
9. This Consent Agreement is between the Commonwealth, by and through the Bureau, and Respondent only. Except as otherwise noted, this Agreement is to have no legal effect unless and until the Office of General Counsel approves the contents as to form and legality and the Board issues the stipulated Order.
10. Should the Board not approve this Consent Agreement, presentation to and consideration of this Consent Agreement and other documents and matters by the Board shall not prejudice the Board or any of its members from further participation in the adjudication of this matter, but the Consent Agreement and all exhibits shall be withdrawn and shall be neither used nor mentioned, in any subsequent proceedings, nor shall any admissions contained herein constitute admissions in this or any other context, document or proceeding, used for any purpose other than the furtherance of this Consent Agreement. This paragraph is binding on the participants even if the Board does not approve this Consent Agreement.
11. Respondent agrees, as a condition of entering into this Consent Agreement, not to seek modification at a later date of the stipulated Order adopting and implementing this Consent Agreement without first obtaining the express written concurrence of the Prosecution Division, unless the Order varies in any way from the stipulations.
12. This Agreement contains the whole agreement between the participants. There are no other terms, obligations, covenants, representations, statements or conditions, or otherwise, of any kind whatsoever, concerning this Agreement.
13. Respondent verifies that the facts and statements set forth in this Agreement are true and correct to the best of Respondent’s knowledge, information and belief. Respondent understands that statements in this Agreement are made subject to the criminal penalties of 18 Pa.C.S. §4904relating to unsworn falsification to authorities.
Department of State
Dated: June 17, 2009
AND NOW, this 28th day of July, 2009 the State Board of Medicine adopts and approves the foregoing Consent Agreement and incorporates the terms of paragraph 5, which shall constitute the Board’s Order and is now issued in resolution of this matter.
This Order shall take effect immediately.
|BUREAU OF PROFESSIONAL AND
|STATE BOARD OF MEDICINE|
Basil L. Merenda
Ollice Bates Jr., M.D
|Date of mailing:||August 4, 2009|
|For the Commonwealth:||Andrew E. Demarest, Esquire
P. O. Box 2649
Harrisburg, PA 17105-2649
AI Augustine, Esquire
Richard W. Epstein, Esquire
This page was posted on January 12, 2010.