Cytotoxic Test for Diet Under Heavy Fire by U.S. and State
Georgia Starr, a 42-year-old Santa Ana homemaker, has spent the last 20 years trying to lose the extra pounds she said she’s been carrying around since her 20s.
She gained five pounds in five weeks on Weight Watchers. She tried doctors, protein drinks, Overeaters Anonymous, the Scarsdale Diet and every fad advertised.
Weight wasn’t Starr’s only problem. She was always tired, and unfounded anxieties ruled her life, she said.
“I’d get claustrophobia in the grocery store,” Starr said. “I was afraid to drive on the freeways. For a while there, I was afraid to go anywhere, and if anyone came in, I was afraid, too. . . . I finally decided I couldn’t live this way the rest of my life.”
After losing faith in doctors, Georgia Starr started praying and was led, she said, to the Irvine-based Medical Service Center--a laboratory and nutritional counseling center where a controversial technique called cytotoxic testing is performed.
After she took the tests, Starr was told she was allergic to 97 of the most common foods, including tap water. Giving those foods up has transformed her life, she said. She has more energy, her fears are gone, she said, and she has shed 29 pounds in four months.
“I’ve spent 20 years looking for an answer, and doctors never gave it to me,” she said. “Cytotoxic testing has been the answer. It’s been a success for me.”
But the state attorney general’s office and the federal Food and Drug Administration contend that cytotoxic testing is a fraud and that the centers offering it are bilking unsuspecting customers out of thousands of dollars.
The agencies, along with the attorneys general in the states of New York and Washington, have closed down one Orange County-based lab, Bio-Health Centers Inc. They are trying to put Medical Service Center out of business and are investigating several other cytotoxic testing centers in Southern California and the San Francisco Bay Area.
“This is an absolutely useless test,” said Irene Caro, a Los Angeles-based consumer affairs officer with the Food and Drug Administration. “If you’ve got money to throw away, it’s not going to hurt you, but it does absolutely nothing.”
Proponents of the blood test, however, contend that they are pioneers in a growing new field and are being persecuted by the traditional medical establishment which fears they will steal patients.
“The whole issue is traditional medicine versus new, 1980s nutrition,” said David Diem, president of the now-defunct Bio-Health Centers Inc. “The political issue stems from the fact that allergists have been very unsuccessful with dealing with food allergies. We really make them look bad. And it’s the medical community that has put the pressure on the agencies to stop us.”
Cytotoxic testing was invented in 1955 by Dr. Arthur Black, who contended that certain foods caused a variety of reactions beyond those normally experienced by people allergic to those foods.
So Black created the cytotoxic test, which he said could quickly and easily screen people for a huge spectrum of food sensitivities. To do the test, a blood sample is taken, the red and white cells are separated, and tiny amounts of different foods are mixed directly with the white cells.
Called Valuable Test
When the white cells stay healthy and active, Black contended, the food is compatible with the person’s body. When the white cells begin to wrinkle, crack, burst open and die, the food is not compatible.
Proponents of the test laud it as a scientific breakthrough with a high success rate. “After investigation into the test, we found it was probably the most valuable nutritional test available in the world,” Diem said. “We conducted the test on hundreds of people and (when the test was combined with nutritional counseling) had an abnormally high success rate--high 80% to low 90%.”
Dr. Barbara A. Solomon is a Baltimore-based physician who was charged with incompetence and using unproven treatment techniques in 1981 by the Maryland Commission of Medical Discipline. She came under fire for using cytotoxic testing in the diagnosis and treatment of vertigo, anxiety, rage, schizophrenia and psoriasis.
But after a 90-hour hearing before the commission, she was allowed to continue using the test, and in September, 1984, her medical license was reinstated with no restrictions.
Test Called Worthless
“I tried not using it (cytotoxic testing) to see if I could function without it,” Solomon said in a telephone interview. “I tried it for three months and I felt very handicapped. There were certain types of conditions I could not help without the test. For diagnosing food reactions, it is the most illuminating and most helpful technique.”
But opponents of the controversial test contend that it is worthless.
“In general, the cytotoxic test is really felt, by those who are familiar with it in the fields of allergy and immunology, not to be a test that can measure anything,” said Dr. Abba Terr, clinical professor of medicine and director of the allergy clinic at Stanford University Medical School.
“There is no good scientific basis to the test,” he said. “When you eat a food, it goes into the stomach and intestines, is digested and goes to where it is needed in the body. When you put food directly in the white cells, it really cannot tell you anything.”
Dr. Ernest Tucker, director of the Immunology Reference Laboratory at Scripps Clinic and Research Foundation in La Jolla, said: “Even if the test is good, it is at a stage whereby the claims that are made just cannot be substantiated. My feeling about it is that it’s one of these types of things on the same order as therapies that claim to cure cancer or arthritis, like Laetrile.”
The American Academy of Allergy and Immunology, a professional society, said in a 1981 policy statement that cytotoxic testing is unproven scientifically and should be used for experimental purposes only.
And even the American Academy of Environmental Medicine, which test proponents contend is on their side, does not entirely embrace cytotoxic testing.
“We don’t advocate the test,” said Dr. Del Stigler, president of the Denver-based society. “Several years ago, the cytotoxic test was widely used by a number of members of the society. But since about ’72 or ’73, it has only been used as a research tool by members. The use of the test as a blanket indictment of foods is something I don’t use or approve of. I don’t even use it as a clinical tool anymore.”
According to the FDA, the test was not widely used until the 1980s, when a Beverly Hills company began touting it in newspapers nationwide as an ideal investment.
Ad Attracted Investors
“GET RICH,” said one Wall Street Journal advertisement. “BE FIRST in your area to open a very lucrative allergy testing center--an ALL-CASH-UP-FRONT moneymaker which uses a scientific breakthrough--a blood test that charts 245 food allergies simply and efficiently.”
Caro of the FDA said the ad campaign spawned a nationwide rash of storefront allergy centers that charged an average of $350. The clinics claimed that cytotoxic testing and abstinence from offending foods could help alleviate everything from hay fever, ear aches, canker sores, heart palpitations, cramps, constipation and chronic fatigue to overweight or underweight, multiple sclerosis, hallucinations, confusion, indifference, schizophrenia and drug addiction.
The FDA, which has jurisdiction over products and interstate marketing but not the practice of medicine, first started investigating cytotoxic testing centers in early 1984. By July, the agency had released its first policy statement aimed at stopping the test centers.
“All medical diagnostic products, like the ones used in the cytotoxic test kit, require FDA pre-market approval if there is not a product like it marketed before,” said Bruce Brown, a Washington-based agency spokesman. “No manufacturer has requested approval for the kinds of tests being advertised; therefore, any product being promoted commercially would be suspect of being illegal under the federal Food, Drug and Cosmetic Act.”
Tests Not Prohibited
That early enforcement effort cleared out most franchises, Brown said, and the company that touted cytotoxic testing as an investment folded. Although the FDA was investigating the centers for operating over state lines and marketing unapproved products, private physicians are not prohibited from using the test as a small part of their regular practices, he said.
But late in 1984, FDA investigators in New York state began seeing advertisements for Bio- Health Centers Inc.--a Huntington Beach-based cytotoxic testing center with a staff that flew to 20 to 30 states, gave nutritional seminars and drew patients’ blood for testing.
The blood was then flown back to California for analysis, and the patient was mailed an analysis and a diet plan, Brown said. But no seminars were ever held. Instead, Brown said, customers were told to send $50 to Bio-Health, and they were sent a kit to have their blood drawn and returned to Huntington Beach. The analysis cost $325.
A Buffalo, N.Y.-based FDA investigator sent for a test kit and filled the enclosed test tube with cow’s blood from a local slaughterhouse. The analysis that was sent back, Brown said, showed that the test could not differentiate between cow’s blood and human’s blood. It indicated that the blood’s owner was allergic to a variety of foods, including cow’s milk, yogurt and cottage cheese.
New York’s Action
As a result, the New York attorney general’s office sued Bio-Health, Diem and staff doctor Roger Palmieri, charging them with operating as a medical establishment without a proper license, said a spokesman from the attorney general’s office.
In May, 1985, a New York court imposed a permanent injunction against the company, prohibiting it from doing business in that state. The California attorney general’s office also sued, charging Bio-Health with eight civil counts ranging from fraud, false advertising and conspiracy to practicing medicine without a license and operating as a clinical laboratory without a license.
In July, 1985, an Orange County Superior Court judge imposed a preliminary injunction against Bio-Health, prohibiting it from operating in the state until a trial is held on the charges against the company.
“In our opinion, this is not a reliable test,” said Barry Ladendorf, deputy attorney general. “A nutritional test, they call it, but it has absolutely nothing to do with nutrition.”
The test itself does not hurt people, Ladendorf said, but “if customers are misled with regard to their health problem and rely on the representations made by these companies, they may substantially delay seeking proper medical attention.”
Civil Charges Filed
Identical charges were filed against the Medical Service Center in San Diego on July 21. The Irvine-based company has branches in San Diego, Bakersfield, Fresno and Seattle, Wash. In addition, the Washington state attorney general’s office has filed similar civil charges against Medical Service Center.
Courts in California and Washington have not yet imposed injunctions against the company, but spokesmen for the attorneys general said such sanctions are in the works.
Legal battles have not been the only problems faced this year by the proponents of cytotoxic testing.
In April, the FDA published its strongest policy statement against the test, proclaiming in the Federal Register that " . . . the cytotoxic test is unreliable as a diagnostic tool and is not generally recognized by qualified experts as effective.”
In its July, 1985, newsletter, the American Academy of Allergy and Immunology urged its members to report any cytotoxic testing centers to the FDA offices in their regions.
And as of Aug. 5, the federal Health Care Financing Administration ruled that cytotoxic testing for food allergies must be excluded from Medicare coverage because available evidence does not show that the tests are safe and effective.
But Diem and Mark Lovendale, director of Medical Service Center, said they will fight what they contend are the unfair charges against them. Lovendale has started a drive urging his clients to sign petitions in favor of allowing the test’s use.
“They (the attorneys general) are not only trying to put us out of business but they also are trying to threaten doctors who work in this field,” he said. “The lawsuit not only charges us with practicing medicine without a license but it also charges the doctors who work with us with being unprofessional in their practice, and threatens their right to continue working as doctors. It’s not right.”
And Diem has filed a $350-million suit against the State of California, charging libel, negligence and defamation, among other things.
“The State of California, by announcing publicly that they were out to stop cytotoxic testing, has, in effect, eliminated it because they’ve raised in the public eye the opinion that it is somehow fraudulent,” said Scott Hanssler, Diem’s attorney. “The attorney general put out press releases on the same day they filed the complaint against us. They tried the matter prior to any court hearing.”