Case of the Unlicensed Vaccine

Nothing stirs medical attention--and controversy--as vigorously as a new treatment for cancer. The 15 years of Krebiozen controversy ended only last year. Now, in a strangely reminiscent case, the Government has asked the U.S. District Court in Cleveland to issue a permanent ban on the manufacture and interstate shipment of the latest invention against the dread disease, the "Rand cancer vaccine."

The vaccine was developed by employees of H. James Rand, a grandson of the founder of Remington Rand Inc., and his Rand Development Corp.* The theory underlying its development was propounded by Dr. Norbert Czajkowski of Detroit's Wayne State University. Patients with advanced cancer have few antibody-forming or other immune mechanisms to combat their disease.

Dr. Czajkowski reasoned that if an essential protein component of a person's cancer cells could be combined with an unrelated protein and injected, the patient's system might react by making three types of antibody, one against the foreign protein, one against the cancer factor and a third against the combination. A tailor-made vaccine could thus be created to make each patient immune to his own cancer. The Czajkowski theory is attractive and plausible to many researchers but remains unproved.

Trouble with Theory. At the Rand laboratory in an old carriage house outside Cleveland, the theory was subjected to a great leap forward. Suppose, speculated the Randmen, that cancer antigens (antibody-creating agents) from many types of diseases in many patients could be combined. Couldn't the pooled substance be used to make a vaccine that would work on victims of various forms of cancer? Cancerous cells were thereupon collected from patients all over the country and put through an extraction process. The remaining protein was combined with gamma globulin from rabbit serum in the hope of producing an all-purpose vaccine. The trouble with this imaginative theory is that so far there is no accepted evidence for the existence of such widely effective antigens in unrelated cancers.

Nevertheless, Rand made and bottled a vaccine. The bottling was done in a room 5 ft. by 8 ft., a Food and Drug Administration inspector testified last week, by a woman who wore no covering on her hair and no sterile gown or gloves. Several Government witnesses testified that they had found bacterial contamination in batches of the vaccine. Dr. Roderick Murray of the U.S. Public Health Service's Division of Biologics Standards said that Rand's report on tests of the toxicity of the vaccine covered only one horse, twelve rabbits and 40 mice. There was evidence that the vaccine had moved across state lines to New York, Idaho, Wisconsin, Washington and Florida without having FDA approval.

U.S. Attorney Merle M. McCurdy, mindful of the quicksand of medical testimony in which the Government got mired in the Krebiozen case, was careful to raise no question of the efficacy of the Rand vaccine. All he asked for was a restraining order to stop traffic in the vaccine until--if ever--it is proved safe for human use, found free of contamination, and is licensed for interstate commerce.

* Not to be confused with the Rand Corp. of Santa Monica, Calif., which holds Defense Department contracts for many advanced technology projects.

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