Misdiagnosis of Cancer

ByABC News

July 26, 2001 -- After a misdiagnosis of cancer when she was 22, Jennifer Rufer underwent debilitating chemotherapy and a hysterectomy that she did not need.

Though Rufer — who won a $16 million lawsuit against the hospital where she was treated and Abbott Laboratories, the company that makes the pregnancy test on which her initial diagnosis was based — will never live the life she imagined as a mother, her story was shared with millions of viewers on PrimeTime.

"If I could save one person from having to go through what I went through," says Rufer, "then it would be worth it to me."

And she has, according to at least two of the women who saw her story.

Saving Other Women

"Jennifer's story saved my life," says Michele Kachurak, whose initial cancer diagnosis was based on months of elevated HCG levels, a hormone that is elevated when a woman is pregnant, but also when there may be signs of a rare form of cancer.

"I got my fight back," says Kachurak, who was in her seventh month of chemotherapy when she saw Rufer's story. "I started pestering my doctors immediately after seeing Jennifer. I swore, I knew, I just knew I was fine."

So Kachurak sought another opinion at Memorial Sloan-Kettering hospital in New York. Doctors there now believe she never had cancer.

The ABCNEWS.com report on Rufer's story helped Sherri Bradford-Royle avoid undergoing potentially catastrophic medical procedures.

"That could have been me," says Bradford-Royle, a stay-at-home mom in Michigan who was about to start weekly chemotherapy. "Who knows what my doctors would have said would be the next step?"

She says that thanks to Rufer, "I have my life back."

High HCG Level

Rufer's ordeal began when she went to the doctor because of irregular bleeding. The doctor took a blood sample for the Axsym BHCG routine pregnancy test, one of the most common blood pregnancy tests in the country, made by Abbott Laboratories, one of the largest pharmaceutical companies in the world.

The test results came back positive, showing Rufer was pregnant. But her doctor could find no fetus. Additional Axsym pregnancy tests came back positive for Rufer, and still, there was no indication of a pregancy.

When a woman is pregnant, she produces high levels of a hormone called beta human chorionic gonadotropin, or HCG. But if there is no fetus, the elevated HCG levels can be a sign of a rare form of cancer called a gestational trophoblastic tumor. 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 chemotherapy 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, and she began chemotherapy immediately.

Her doctors say they had complete confidence in the HCG test results. "When you're managing the patient, using a test you've used before for years and years," says Dr. Steven Gabbe, who was then the chief of obstetrics and gynecology at the University of Washington Medical Center, where Rufer was treated, "you just don't question the test, especially given the patient's course."

Months of debilitating chemotherapy continued, 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."

False Positives

Laurence Cole, a Yale University researcher who published an article about women who are misdiagnosed with cancer based on incorrect pregnancy tests, found that Rufer is among the 10 percent of the population whose blood contains natural substances that can interfere with lab tests and cause results that are false positive.

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," says Cole, who saw 12 cases like Rufer's in the course of his 15-month study.

Since PrimeTime's report in April, Cole has confirmed 11 more cases of false positive pregnancy tests. He says he has now found 34 cases in all, 32 of which were measured exclusively or primarily on the Abbott test, though Abbott says that is because of a large market share.

Abbott's Response

In numerous statements to ABCNEWS, Abbott insists its test is no more prone to false positives than any other manufacturer's HCG test. The company says Cole's conclusions are seriously flawed, that Rufer's case is extremely rare, and that its test is approved by the Food and Drug Administration only as a pregnancy test — not to diagnose cancer.

Abbott also maintains that discussions about the problem of false positives with these kinds of tests have been in medical literature dating back 20 years. The company also says that information inserted in the test kits advises that if there are "consistently elevated" HCG levels, doctors should "confirm the results by an alternate method." The doctors, however, say it was not widely known about and say the inserts typically go to the labs rather than to the doctors.

Abbott has since added a line to the pregnancy test kit insert saying that the test should not be used to diagnose cancer, and in January, the company sent a letter reminding labs of this and asking them to share this with their customers.

But it is too late for Rufer. Her trial against the University of Washington Hospital and Abbott Laboratories lasted more than two months. Ultimately, the jury decided Abbott's test is not defective, but it did find Abbott negligent for failing to adequately warn doctors about false positives.

Rufer was awarded more than $16 million, half to come from the hospital and half from Abbott. She plans to use some of the settlement to try and harvest her eggs and use a surrogate mother to carry a child for her.

Abbott plans to appeal the decision, insisting that it was the doctors who failed to heed the company's warnings or read the medical literature about the problem of false positives.

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