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WRONG DIAGNOSIS LED TO UNNEEDED SURGERY

Jul 28, 2001

Mobile Register - July 28, 2001

Mobile woman urges others to be skeptical of lab tests showing cancer related to pregnancy

Michelle Cole of Mobile wants every woman of child-bearing age to know one thing: If a lab test shows you have a deadly form of pregnancy-related cancer, get a second opinion. Then get a second type of test.

An early-pregnancy test from a drugstore will suffice as a backup, said Cole, a 32-year-old who had a hysterectomy in May, underwent chemotherapy and must take hormone medication for the rest of her life - all unnecessarily and all because of what she says was negligence on the part of her physician, a blood test manufacturer and Springhill Medical Center.

"I want to prevent this from happening to more and more women," Cole said Friday, two weeks after she filed a lawsuit against Abbott Laboratories, which manufactured the blood test that allegedly produced the false-positive results, against Springhill, where the testing was done, and against gynecological cancer specialist Dr. Kenneth Brewington of Mobile, who diagnosed her with cancer.

"I have to relive what I've been through every day, every time I reach for my bottle of hormone pills," Cole said. "But who knows how many other women may have died from the toxic chemotherapy when they didn't even have cancer in the first place?"

Brewington declined comment for this article, and an Abbott Laboratories spokeswoman could not be reached Friday. Springhill's chief executive officer, Bill Mason, said the hospital plans to fight the charges in court.

"We feel like Springhill did nothing wrong," Mason said.

Cole's case, filed in Mobile County Circuit Court, is strikingly similar to a Seattle lawsuit in which a jury last month awarded $16 million to a woman who underwent a hysterectomy and had part of her lung removed after doctors incorrectly diagnosed her with cancer.

The doctors' decision was based in part on an Abbott Labs test that produced erroneous results, the jury decided. The jury ruled that half of the judgment must be paid by a Seattle hospital and half is to be paid by Abbott Labs. Both defendants have said they will appeal.

"Here's somebody that went for medical help and ended up getting hurt," a juror in that case told the Associated Press after the verdict was announced.

Now, Cole and her attorney want to know why her doctors and others weren't aware of the suspected problems with the Abbott blood test, which is known as the Axsym beta-HCG test, and which may be one of the most widely used pregnancy blood tests in the country, according to news reports.

The Seattle case was filed in 1999, and at least six similar cases have been filed since then.

Yale University and New Mexico researchers also have been sounding the alarm since early last year, when they published a study in the Lancet, one of the world's foremost medical journals.

"My question is, if the manufacturer knew there was a problem, why wasn't it fixed so that there wouldn't be these false-positive results?" asked Cole's attorney Skip Finkbohner of Mobile. "Beyond that, why was there such a breakdown in communication" between those who suspected the test was inaccurate, and the doctors who relied on it for a diagnosis? he asked.

In recent news reports, Abbott Labs officials have said that hospital laboratories and pathologists around the country were notified in January of the potential for false readings with the Axsym beta-HCG blood test, the equipment that Springhill used in Cole's case and continues to use. Abbott says it warned pathologists to use the equipment only for pregnancy diagnoses, not for cancer testing, and to verify results with another type of test.

But Springhill's laboratory manager, Tom Sweeney, said Friday that the hospital's lab had "not received a letter from Abbott, nor has an Abbott representative contacted the laboratory."

Cole's ordeal began in January, when she went to her gynecologist for her yearly examination. To her amazement, she found out she was 5 weeks pregnant. Cole was amazed because she had a tubal ligation after having two children, Lauren, age 3, and Amelia, 21 months.

After Amelia was born, Cole and her husband David, a car salesman, decided they couldn't afford any more babies. Ligation, a surgical procedure designed to prevent future pregnancies, is not always foolproof, Cole said. But the procedure is reversible, she pointed out.

"We weren't planning on getting pregnant again, but then we decided to go ahead with it, and we were actually excited about it," she said. "We asked Lauren if she wanted a baby brother or a baby sister." David really wanted a son, Cole said.

Then, a week later, Cole miscarried.

After miscarriages, doctors routinely check for levels of a hormone called beta human chorionic gonadotropin, or b-HCG. The hormone is produced during pregnancy, and its presence after a miscarriage can indicate the mother's body may not have discharged all of the fetus, and a medical procedure may be recommended.

Relying on the Abbott Labs testing equipment at Springhill Medical Center's pathology lab, Cole's doctors believed that her HCG levels rose, then dropped, then spiked again, she said.

Doctors then performed exploratory surgery, but could find no signs of fetal tissue, she said. Without a fetus, elevated levels of HCG also can indicate the presence of choriocarcinoma or gestational trophoblastic disease, rare but extremely invasive forms of cancer that can quickly lead to death if not treated early, according to the USA HCG Reference Service, based at the University of New Mexico. Medical textbooks recommend immediate and aggressive treatment, even if no tumors can be seen with scanning equipment.

With the blood tests continuing to show high levels of HCG in Cole's body, Brewington recommended chemotherapy. When that didn't bring the levels down, he went ahead with the hysterectomy - the complete removal of the uterus, rendering Cole incapable of ever having children again.

Then, two days later, Cole's physicians told her the happy but baffling news that they could still find no signs of cancer cells in any of the tissue removed from her body.

Nonetheless, her HCG levels were still high, and the doctors were about to put Cole on a three-month regimen of ultra-high-dose chemotherapy, chemicals that can kill cancer cells but also poison the body and destroy other cells, leaving the patient bald and the immune system devastated.

"How long down the line would I have kept going like that?" Cole asked.

By that time, early June, Cole and her friends and family had begun their own research into the cancer. What she found saved her from the massive doses of chemotherapy, but came too late to save her from the hysterectomy.

Through an Internet Web site devoted to helping women diagnosed with cancer, Cole's sister found Dr. Laurence Cole of the University of New Mexico, one of the researchers who had written the Lancet study about false positives. He's not related to Michelle Cole, but Michelle Cole considers him to be something of a savior.

She told her doctor, Brewington, about Cole. At first, she said, Brewington was skeptical about Internet-based information. But about two hours later, Brewington called Michelle Cole back and urged her to contact the New Mexico specialist. She did, and Laurence Cole advised her to go to a drugstore and buy the Clear Blue Early Pregnancy Test, a popular urine test considered the most sensitive of the store-bought brands, Michelle Cole said.

The results showed up negative, meaning she did not have elevated levels of HCG after all, Michelle said Friday. To be sure, Brewington had samples of Michelle Cole's blood sent to the Mobile Infirmary Medical Center, which uses a blood test manufactured by Hoffman-La Roche Inc., which has shown to have very few false positives, news reports suggest.

That test, too, showed Michelle Cole did not have elevated levels of HCG. She did not have cancer. The hysterectomy, she said, had been completely unwarranted.

"I was absolutely shocked," she said. "But I was also relieved. Then I started crying. I had been through hell for months."

Without her uterus producing hormones, Michelle Cole faces increased risk of bone-density loss, more hot flashes, more mood swings, a higher risk of breast cancer and other complications, according to medical reports. That's one reason she said she filed the lawsuit and has been eager to speak to the news media.

"There's anger in me," she said. "Other women need to know about this. How many women have slipped through the cracks like I did?"

Cole's lawsuit, filed July 10, has not been set for trial.

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