Cytotoxic testing—also called Bryan’s test, the Metabolic Intolerance Test, or sensitivity testing—was promoted during the early 1980s by storefront clinics, laboratories, nutrition consultants, chiropractors, and medical doctors. Advocates claimed it could determine sensitivity to food, which they falsely blamed for a huge list of health problems. To perform the test, a sample of the patient’s blood was placed in a test tube and centrifuged to separate the white cells. These were mixed with plasma and sterile water and applied to microscope slides that had been coated with a dried food extract like that used by allergists for skin testing. The cells were then examined under a microscope at various intervals over a two-hour period to see whether they had changed their shape or disintegrated—supposedly signs of allergy to the particular food. Typically, the test results were used to explain the patient’s symptoms and to design a “personalized diet program” that included vitamins and minerals—sold by those administering the test.
Several prominent professional groups have concluded that cytotoxic testing is not reliable for diagnosing allergies.
In the mid-1980s, the FDA and the attorneys general of California, New York, and Washington took action against leading marketers of the test.
Here is the consent agreement obtained in the Washington case:
IN THE SUPERIOR COURT OF ‘THE STATE OF WASHINGTON
FOR KING COUNTY
|STATE OF WASHINGTON,
MEDICAL SERVICE CENTER, INC.,
CONSENT DECREE AGAINST
Filed Aug 22, 1986
Plaintiff, State of Washington, having commenced this action on the 11th day of July, 1985 pursuant to RCW 19.86, the Consumer Protection Act, and defendants named herein having been duly served with copies of the Summons and Complaint; and
Plaintiff appearing by and through its attorneys, Kenneth O. Eikenberry, Attorney General, John R. Ellis, Deputy Attorney General and David B. Robbins, Assistant Attorney General, and defendants, Medical Service Center, Inc., Mark Lovendale, Mark Matulis and Carlton Schreiner appearing, and all of said parties to this action having waived notice of presentation of this Consent Decree; and
Plaintiff and defendants, having stipulated and agreed upon a basis for the adjudication of the matters alleged in the Complaint herein, and to the entry of this Consent Decree against I defendants without the need for trial or adjudication of any issue of fact or law, and the Court having determined that there is no just reason for delay in entry of final judgment in this matter and having directed entry of this Consent Decree as to defendants named above;
NOW, THEREFORE, it is hereby ORDERED, ADJUDGED, and DECREED, as follows:
1.1. Jurisdiction. This Court has jurisdiction over the subject matter of this action and of the parties thereto. The plaintiff’s Complaint states claims upon which relief may be granted under the provisions of RCW 19.86. The Attorney General has jurisdiction to bring this action pursuant to RCW 19.86.080 and RCW 19.86.140.
1.2. Defendants. As used herein, the term “defendants” shall mean Medical Service Center, Inc. (hereinafter “MSC”), Mark Lovendale, individually and as co-director of MSC, Mark Matulis, individually and as co-director of MSC, Carlton Schreiner, individually and as area director for MSC. Any reference to one named defendant shall be a reference to the other named I defendants. Unless otherwise indicated, any reference to “defendants” shall be construed to apply to the defendants I individually and collectively.
1.3. Notice. Defendants shall inform their officers, agents, representatives, and employees of the provisions of this Decree and shall direct such persons to comply therewith.
1.4. Bar to Action. Nothing in this Consent Decree shall be construed as to limit or bar any consumer from pursuing available legal remedies against defendants.
1.5. Non-Endorsement. Under no circumstances shall this Consent Decree or the name of the State of Washington, the Office of the Attorney General, the Consumer and Business Fair Practices Division, or any of their employees or representatives be used by any of the defendants or their officers, employees, representatives, or agents in connection with any selling, advertising or promotion of products or services or as an endorsement or approval of the defendants acts, practices, or conduct of business.
1.6. Non-admission. Nothing in this Consent Decree shall be construed as an admission by defendants of any violation of federal or state law.
1.7. Jurisdiction Retained. Jurisdiction is retained for the purpose of enabling any party to this Consent Decree to apply to the Court at any time for the enforcement or clarification of this Consent Decree.
1.8. Venue. At plaintiff’s option, enforcement of this Consent Decree may take place in King County or in any county in which an alleged violation occurs.
2.1. Application of Injunctions. The injunctive provisions of this Consent Decree shall apply to defendants and their agents, officers, servants, employees, representatives and all I persons or entities in active concert or participation with those who receive actual notice of this Decree.
2.2. Injunctions. Defendants, their officers, agents, servants, employees, representatives and all persons or entities in active concert or participation with them who have received notice of this Decree are hereby permanently enjoined and restrained in the State of Washington from directly or indirectly engaging in the following acts or practices:
A. Representing to consumers, health care professionals or others that cytotoxic testing is a proven, effective or non-experimental test for an individual’s food allergies or sensitivities.
B. Representing to consumers, health care professionals or others that cytotoxic testing will accurately identify foods to which an individual is allergic or sensitive.
C. Representing to consumers, health care professionals or others that by using results of cytotoxic testing defendants can prescribe a therapy program which mayor will ameliorate or cure any human diseases, conditions or afflictions, including but not limited to: migraine headaches, arthritis, asthma, premenstrual syndrome, drug addiction, alcohol abuse, scalp or skin disorders, influenza, common colds, depression, yeast or fungus infections, multiple sclerosis, anorexia nervosa, obesity, stuttering, indifference, juvenile and adult delinquency, epilepsy, high blood pressure, sinus infection and tachycardia.
D. Until such time as the federal Food and Drug Administration (hereinafter “FDA”) issues a contrary policy statement, failing to clearly and conspicuously disclose in any advertisement, brochure, flier, newsletter or other promotional literature that the FDA disapproves of the use of cytotoxic testing as a diagnostic tool.
E. Until such time as the American Academy of Allergy (hereinafter “AAA”) issues a contrary policy statement, failing to clearly and conspicuously disclose in any advertisement, brochure, flier, newsletter or other promotional literature that the AAA disapproves the use of cytotoxic testing as a diagnostic tool.
F. Until such time as the American Academy of Environmental Medicine (hereinafter “AAEM”) issues a contrary policy statement, failing to clearly and conspicuously disclose in any advertisements, brochures, fliers, newsletters or other promotional literature that the AAEM considers the results of cytotoxic testing alone to be insufficient for reliable diagnosis and treatment of food allergies or food sensitivities.
G. Representing to consumers, health care professionals or others that insurance companies will reimburse a health care insurance policy-holding consumer or physician for the cost of cytotoxic testing services pursuant to that policy.
H. Failing to provide to consumers, physicians or insurance companies an accurate and appropriate “current procedural terminology” (“CPT”) number or any other similar number or vernacular which insurance companies recognize as designating cytotoxic testing.
I. Representing to consumers, health care professionals or others that the cytotoxic test is “the doctor’s most cost effective medical tool for discovering damaging food reactions.”
J. Using or marketing cytotoxic testing services without having registered the cytotoxic testing devices with the FDA and having received FDA approval for the same; provided that defendants may use cytotoxic testing devices without FDA approval if FDA issues a statement specifically exempting defendants from such approval pursuant to applicable federal statutes, regulations, and policy guides.
K. Representing to consumers, health care professionals or others that any person or entity has endorsed the cytotoxic testing services offered by defendants, or is affiliated with defendants, without written permission of that person or entity to make such a representation.
L. Representing to consumers, health care professionals or others that any physician serves on MSC’s Board of Advisors without said physician actually serving on said Board or without defendants having received said physician’s express written consent to make such a representation.
M. Offering or undertaking to provide cytotoxic testing or other similar service unless the following conditions are met:
1) A medical doctor duly licensed by the State of Washington must make a written prescription for cytotoxic testing or other services for each of defendants’ prospective clients before such services are provided;
2) The results of the cytotoxic testing performed by defendants must be sent directly to the medical doctor who provided the prescription for said testing;
3) Defendants may provide nutritional counseling for a client only after that client’s medical doctor has had a reasonable opportunity to review the cytotoxic test results and makes a written request to defendants for such counseling;
4) Defendants’ written nutritional counseling recommendations to the client and the results of any tests performed by defendants or on their behalf must be forwarded in writing to the doctor who provided the prescription for said tests;
5) As part of any nutritional counseling provided, defendants shall recommend to each client that consultation be made with a duly licensed medical doctor to review the defendants nutritional recommendations; and
6) Defendants must promptly provide complete and accurate information regarding the procedures used by defendants in the preparation and performance of cytotoxic testing to any duly licensed medical doctor who requests such information.
N. Misrepresenting the terms or nature of this Consent Decree to consumers, health care professionals or others.
III. OTHER RELIEF
3.1. Civil Penalties. Pursuant to RCW 19.86.140, the plaintiff shall recover and the defendants shall jointly and severally be liable for and pay a civil penalty of THREE HUNDRED THOUSAND DOLLARS ($300,000) provided that this penalty shall be SUSPENDED upon the condition that defendants comply with all injunctions set forth in Section II above and permanently cease and desist conducting any business operations in Washington involving cytotoxic testing, nutritional counseling based on cytotoxic testing or other related service. If said condition is not complied with, all civil penalties shall become immediately due and owing to plaintiff.
3.2 Attorneys’ Fees and Costs. Pursuant to RCW 19.86.080, I the plaintiff shall recover and the defendants shall be jointly and severally be liable for and pay to the plaintiff the court costs and reasonable attorneys’ fees incurred in pursuing this matter in the amount of THIRTY THOUSAND DOLLARS ($30,000.00). Said amount shall be suspended upon the condition that defendants permanently cease and desist conducting any business operations in Washington involving cytotoxic testing, nutritional counseling based on cytotoxic testing or other related service. If said condition is not complied with, all attorneys’ fees and costs shall become immediately due and owing to plaintiff. Defendants shall bear all costs of enforcing this Decree should any enforcement action become necessary.
4.1. Compliance. For the purpose of determining or securing compliance with this Consent Decree representatives of the Office of the Attorney General shall be permitted, upon reasonable notice to any of the defendants:
a. Access for inspection and copying, during regular office hours, of any and all records or documents in the actual or constructive possession of defendants relating to any matters contained in this Consent Decree.
b. To question or depose any of the defendants or any other officer, director, agent, employee, representative or independent contractor of the defendants.
4.2. Violation. The violation of any of the terms of this Consent Decree shall constitute a violation of an injunction for which civil penalties may be sought by the Attorney General pursuant to RCW 19.86.140, provided that liability shall be ordered as joint and several only to the extent warranted by the underlying violation.
4.3. Dismissal of Action. With respect to defendants MSC, Lovendale, Matulis and Schreiner, this proceeding is in all other respects hereby dismissed and this Consent Decree is entered pursuant to RCW 19.86.080.
DONE IN OPEN COURT this 22nd day of August, 1986.
Eric L. Clauson
COURT COMMISSIONER P.T.
KENNETH O. EIKENBERRY
JOHN R. ELLIS
Deputy Attorney General
DAVID B. ROBBINS
Assistant Attorney General
Attorneys for Plaintiff
Approved as to form and
content; notice of
MARK LOVENDALE, individually
and on behalf of defendant
MEDICAL SERVICE CENTER, INC.