Insurer Uses Unproven Cancer Test : Transamerica Life Tracking Thousands to See if the Technique Works
Nearly 50,000 people who have applied for life insurance from Transamerica Occidental Life Insurance Co. since late 1990 are being tracked without their knowledge, the company has disclosed, in what appears to be a large field study of an experimental cancer test.
The test, developed by a prominent Santa Monica researcher, is said to detect cancer in its earliest stages, long before the disease is evident through X-rays or physical exams. By following policyholders, in some cases to the grave, Transamerica expects to learn if the test works.
The testing program, disclosed in a series of interviews with The Times, raises questions about the limits of insurance testing, an area mostly ignored by government regulators. While it is not unusual for life insurance companies to test applicants for various health conditions, the tests used are generally accepted by the medical community.
The cancer test used by Los Angeles-based Transamerica is obscure, even among cancer researchers. It has not been approved by the government for clinical use.
Dr. Paul Goldfarb, immediate past president of the American Cancer Society in California, said Transamerica’s actions are improper. He said the company should not be allowed to use an unapproved test on applicants, and said the program raises privacy issues similar to those surrounding AIDS testing.
Transamerica’s medical director, Dr. John Elder, responded: “Anyone who buys life insurance becomes a bit of data.”
Transamerica administers the test to people applying for insurance. Applicants are asked to sign ordinary-looking consent forms, consenting to blood tests for “tumors.”
The forms do not specify that the test is meant to detect cancer. There is no indication that the test is experimental and unapproved for clinical use. Transamerica said that because the test is experimental, most applicants who test positive are not told the result.
There is now no approved blood screening test for cancer, the second-leading cause of death in the country after heart disease. An accurate, simple-to-use blood test would be a boon to the insurance industry, helping to reduce claims arising when newly insured people die unexpectedly from cancer.
If Transamerica’s test works, the insurer would reap other benefits. A medical laboratory part-owned by Transamerica has an exclusive option to market the test to the insurance industry, a potentially lucrative venture.
In interviews, Transamerica officials stressed that the test also benefits policyholders.
Officials said the test has helped them identify recovered melanoma patients eligible for lower-cost insurance. Elder said that Transamerica may offer lower-cost insurance to former breast cancer patients.
Transamerica said the test has helped save lives. In one case, a woman turned down for insurance sought medical attention and learned she had breast cancer, a company spokeswoman said.
Goldfarb, the former Cancer Society official and a San Diego oncologist, scoffed: “Transamerica is in the business of reducing its risk, not saving lives.”
Medical testing is regulated by the U.S. Food and Drug Administration, but the agency has long focused its attention on diagnostic tests sold to doctors, hospitals and laboratories. Diagnostic tests cannot be sold until the FDA accepts them as safe and effective, a process that can take years.
FDA actions involving the insurance industry are rare. In a move that attracted wide attention, in part because it was so unusual, the FDA two years ago ordered medical laboratories serving the insurance industry to stop using an unapproved oral test for AIDS, a fatal disease. Life insurance companies preferred the oral test because it was less expensive than an approved blood test for AIDS.
An FDA spokeswoman said the agency was unfamiliar with Transamerica’s test and could not comment.
Transamerica does not test everyone who applies for insurance. Because the tests are expensive, more than $50 each, the company tests applicants based on their age or the amount of insurance coverage sought.
The test detects the presence in the blood of proteins associated with cancerous tumors. The test cannot identify the type of cancer or where it lurks in the body.
Preliminary results from Transamerica’s program raise questions about the test’s accuracy. The company said 9% of people tested were positive for cancer. According to the American Cancer Society, about 3% of the U.S. population has cancer, or has recovered from it. In a year, 0.5% of the population develops cancer.
Transamerica emphasized that it has not rejected any applicants solely on the basis of the test. Applicants who test positive are put through a battery of back-up tests for specific types of cancer. Transamerica said it has rejected 299 applicants who tested positive on the back-up tests.
But in another development that raises questions about the test, Transamerica reversed itself in 30% of those cases, selling insurance to 68 applicants it had initially turned away. In each of those cases, physical exams paid for by the applicants showed they were cancer-free.
Dr. Ronald Heberman, a prominent cancer researcher at the University of Pittsburgh, said Transamerica has probably turned down healthy people.
Heberman, an expert on blood tests for cancer known as tumor markers, said no test is reliable enough for insurance decisions. He said Transamerica’s use of similarly flawed back-up tests “compounds the problem.”
Dr. Sheila Taube, a scientist at the National Cancer Institute, reviewed a scientific paper on the test at the request of The Times. She noted that in a high percentage of cases, the test failed to detect cancer in people known to have breast cancer or lung cancer or even melanoma.
Controversial Cancer Test
Nearly 50,000 people who have applied for life insurance from Transamerica Occidental Life have taken an experimental blood test for cancer as part of a program to see how well the test works. Transamerica hasn’t rejected applicants on the basis of the test alone. Applicants are turned away only if a more conventional backup test confirms the result. Here’s how the test works: 1. The bottom of a test tube is lined with antibodies from mice. Antibodies are proteins produced by the body to fight off disease. 2. Blood serum, the part of blood that carries antibodies, is collected from an insurance applicant and added to the test tube. If cancer is present, the theory goes, the serum will contain a cancer protein linked to a human antibody. 3. The mouse antibodies act like flypaper, catching any cancer proteins joined to human antibodies. 4. When the test tube is emptied, the presence of the cancer proteins and human antibodies is thought to indicate cancer.
Source: Dr. Donald Morton, John Wayne Cancer Center, Santa Monica
