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April 19, 2001 -- Diagnosed with cancer at 22, Jennifer Rufer underwent debilitating chemotherapy and a hysterectomy.
"I can't have kids," she says, "and I desperately want to have a family." Adding to her physical and emotional pain, doctors have discovered Rufer never had cancer at all.
Rufer is part of a class-action lawsuit against Abbot Laboratories, claiming that flawed results from their test led to unnecessary cancer treatments. [Separate from the class-action lawsuit?] she is suing her doctor, the hospital and its lab as well as Abbott Laboratories. (The hospital and Abbott are also suing each other.)
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Three years ago, soon after Rufer was married, she went to the doctor because of irregular bleeding. The doctor took a blood sample for a routine pregnancy test, one of the most common blood pregnancy tests in the country, called the Axsym BHCG. The test, used in millions of pregnancy tests every year, is made by Abbott Laboratories of North Chicago, one of the largest diagnostic and pharmaceutical companies in the world.
The test results came back positive, showing Rufer was pregnant. But her doctor could find no baby. Additional Axsym pregnancy tests came back positive for Rufer, but still, there was no baby. When a woman tests positive on a pregnancy test, it means she has elevated levels of a hormone called human chorionic gonadotropin (HCG). But if there is no baby, the elevated HCG levels can be a sign of a rare form of cancer called choriocarcinoma. If untreated, it can spread rapidly and kill. If treated early with chemotherapy, it is highly curable. In fact, early treatment is so important that doctors sometimes order chemo even if there is no evidence of a tumor.
Rufer was referred to a cancer specialist at the University of Washington Medical Center in Seattle for more extensive tests. Though scans showed no sign of a tumor, her HCG level continued to be alarmingly high. Doctors diagnosed her with cancer [BASED SOLELY ON THE HCG LEVEL?), and she began chemotherapy immediately.
"I looked like a completely different person," says Rufer. "I was grey in color ? I had a lot of people call me sir because they thought I was a man ? I was sick all the time."
Chemotherapy continued for four months, but Rufer's HCG levels on the Abbott test remained between 250 and 350, while a normal level is less than five. She was told she would have to have a hysterectomy.
"I didn't want to?not be able to have children," says Rufer who has always wanted to be a mother. "But I just felt if I have the surgery, then I won't have to be sick anymore and I won't die."
Tissue samples after her hysterectomy showed no evidence of cancer. At first, her HCG levels dropped, but then went back up. Then, doctors saw two suspicious spots on her lung scan, so she had additional surgery. Doctors still found no cancer and yet her HCG levels remained elevated.
Then came a stunning relevation: "They ended up finding out that I have never had cancer," says Rufer. "That this test was faulty from the beginning, and that I had never had this disease. I had been treated for no reason at all."
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Rufer is not the first to be misdiagnosed like this.
"Over 15 months we saw 12 cases," says Dr. Laurence Cole [CATHERINE - IS HE AN MD OR A PHD?], a Yale University researcher who published an article about women who are misdiagnosed with cancer based on incorrect pregnancy tests. "We've seen many more since."
Rufer's doctors sent her blood samples to Cole, who found she is among the10 percent of the population whose blood contains natural substances that can interfere with lab tests and cause results that are false positive.
"Something needs to be done to make sure that no more people are hurt," says Cole. "All because of a badly made test."
No lab test is 100 percent perfect, and other companies that make pregnancy tests measuring HCG have also shown false positives. But Cole, who has become an expert witness in cases against Abbott, believes the company has a greater problem.
"We are still to this day hearing about false positive results in the Abbott Axsym test," he says.
In numerous statements to ABCNEWS, Abbott insists its test is no more prone to false positives than any other test on the market. The company says Cole's conclusions are seriously flawed, that the problem is extremely rare and that the FDA approved its test only as a pregnancy test.
But according to Abbott's own documents, the company's Axsym HCG team asked for almost $2 million in 1999 for "proposed fixes" to the test ? to "eliminate the potential to diagnose patients incorrectly." The proposal was rejected. Abbot says it was "merely exploratory" and concluded that the HCG test was "performing properly" as a pregnancy test.
Abbott also points to information inserted with the test kit advising that "Infrequently, HCG levels may appear consistently elevated?If there is a question? confirm the results by an alternate method." Moreover, in January, after the lawsuits were filed, Abbot sent a letter to hospital lab directors, telling them not to use their test for the diagnosis of cancer, but they leave it to the labs to share the information with doctors.
Rufer, whose case goes to trial next week, still wonders how many other women have suffered like she has. "I just don't want this to happen to anyone," she says.