Controversial Cancer Institute to Open Lab in La Jolla
An unusual medical institute that offers the latest experimental cancer therapies to patients willing to pay for them will open a research laboratory here, medical officials announced Thursday.
The new facility of Biotherapeutics Inc. of Franklin, Tenn., will be headed by UC San Diego medical professor Dr. Robert O. Dillman, who also was named Thursday to direct the experimental cancer program at the Scripps Clinic and Research Foundation in La Jolla. Biotherapeutics and Scripps Clinic announced agreement Thursday on jointly supporting specific research efforts in the field by Dillman.
The private company, set up in May, 1985, has proved controversial because it represents a major departure from established procedures for testing new cancer drugs and therapies. Clinical trials traditionally have been financed by government health agencies, private groups such as the American Cancer Society, and drug companies.
But Biotherapeutics has consciously gone against the traditional ethical rationale of research medicine, which dictates that volunteers in experimental treatment programs should not be charged for participation because the safety and efficacy of new therapies are largely unknown, and since they may not benefit from them. The costs of receiving treatments at the Franklin laboratory can run up to $35,000, depending on the particular therapy selected for the patient.
The firm’s founder, Dr. Robert K. Oldham, told The Times earlier this year that advanced cancer patients should not be deprived of therapies that scientists believe hold promise, as long as standard precautions are taken to let patients know the risks.
Charging patients for clinical research violates no Federal Food and Drug Administration regulations as long as unfounded claims are not made for the therapy. FDA officials have ruled that the firm’s programs fall under the practice of medicine, and therefore are within the jurisdiction of the American Medical Assn., not the FDA.
Biotherapeutics specializes in the new class of therapies known as biological response modifiers, which attempt to enhance the body’s natural capacity to fight cancer. Oldham established and headed the program in that area at the National Cancer Institute, where he worked until 1984.
The new laboratory in La Jolla will continue in the area of response modifiers. Dillman, the new director, has had extensive laboratory and clinical experience with monoclonal antibodies and other such modifiers. He was assistant director of the UC San Diego Cancer Center from 1980 to 1984 and at present serves as chief of hematology and oncology at the Veterans Administration hospital in La Jolla, which is affiliated with the UCSD School of Medicine.
The department chairman of basic and clinical research at Scripps Clinic, Dr. Ernest Beutler, said Thursday that Dillman’s expertise will enhance its cancer therapy.
Added Oldham, “(Dillman), and this program with Scripps, will play a major role in our efforts to expand our laboratory service capabilities and put into place technologies and processes necessary to develop and implement programs for more individual cancer patients.”
Oldham’s method of attempting to individually tailor treatments for patients also goes against the grain of standard experiments in cancer therapies. Researchers generally select antibodies for their specificity in attacking a type of cancer rather than a particular patient’s cancer. But Biotherapeutics bases its program on the concept that cancers among people are more different than alike and that each tumor in each patient is different.
Scientists at the National Cancer Institute have questioned whether customizing treatments such as monoclonal antibodies is possible or makes any difference in helping a patient.
But the area of response modifiers itself is considered highly promising in cancer treatment. Just last month, researchers at the national institute announced that a new experimental treatment for advanced cancers appears to have been far more potent in laboratory mice than another promising biological therapy now being tested in humans.
About 100 patients are participating in testing of the response modifier interleukin-2 at six medical centers nationwide, including the City of Hope, near Los Angeles, in Duarte. But several thousand persons hoping to take part were turned away for various reasons. Researchers usually require specific types of patients whose physical and mental health are compatible with the conditions dictated by the sponsors of the study, usually the government or private groups.
But Biotherapeutics has far fewer restrictions, as long as the patient no longer responds to conventional therapy and is healthy enough to withstand the rigors of research treatment and able to afford the costs.
