Breast cancer & drugs

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51 Utahns pin cancer on drugs

By Brooke Adams

The Salt Lake Tribune

Article Last Updated: 02/12/2007 12:54:26 AM MST

 

 

 

A growing number of Utah women are alleging they developed breast cancer

after taking hormone therapy drugs to ease menopause-related problems and to

help keep them " feminine forever. "

Fifty-one women filed lawsuits in 3rd District Court in Salt Lake City in

December against drug manufacturers Wyeth Pharmaceuticals and Pfizer Inc.,

joining at least 24 other Utah women who previously sued the companies.

As with those cases, the new batch of lawsuits will be transferred to

federal court in the Eastern District of Arkansas, where Judge William R. Wilson

Jr. is presiding over the multidistrict Prempro products liability case. At some

point, the cases likely will return to Utah for trial.

Two large U.S. studies have found that long-term use of the hormone therapy

drugs increases the risk of breast cancer, cardiovascular disease, pulmonary

embolism, blood clots, strokes, heart attacks and ovarian cancer.

Heidi Hubbard, a Washington, D.C., attorney who represents Wyeth, said the

company's drugs are approved by the Food and Drug Administration, which means

they have been rigorously tested and are safe for treatment of menopausal

symptoms.

" Wyeth has acted and continues to act responsibly when providing information

about these medications to doctors and to women, " she said.

To date, approximately 5,000 lawsuits have been brought against Wyeth

alleging the

 

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drugs caused their breast cancer. Those cases involve 8,100 plaintiffs, a

company spokesman said. Hubbard said Wyeth plans to vigorously fight each

lawsuit.

" We just don't know what causes breast cancer, " she said, " and there is not

science to support the proposition that these medications cause breast cancer. "

The Utah women allege they took Prempro or Premarin alone or with Provera

for an extended period of time and then developed breast cancer. The 51 new Utah

plaintiffs include women who developed breast cancer after taking hormone

therapy drugs for periods that ranged from 12 to 41 years.

The boiler-plate filings say Wyeth failed to adequately test the drugs and

falsely promoted them as safe and effective.

Nationally, three similar cases have gone to trial, according to news

reports. In January, a Philadelphia jury awarded an Arkansas couple $1.5 million

in a verdict against Wyeth. The company successfully defended itself in another

case, arguing that package inserts and other information warn consumers and

physicians of the drugs' risks. The third case ended in a mistrial.

For decades, Wyeth promoted its drugs' " tranquilizing, " youth-inducing

effects and ability to prevent bone loss and cardiovascular disease, court

filings state.

In the 1960s, Wyeth's promotional materials drew from articles and the book

Feminine Forever, written by New York gynecologist Robert Wilson. Among other

attributes, Wilson praised estrogen for making women " adaptable, even-tempered,

and generally easy to live with, " the court documents state.

In the 1990s, a promotional video Wyeth distributed claimed estrogen

provided " long-term health protection. " That campaign helped make Premarin the

most prescribed drug in the country between 1990 and 1995.

In July 2002, the Women's Health Initiative (WHI) study prematurely ended

its Prempro trial after finding a significant increase in health risks among

women who took the drug for an average of 5.2 years. It specifically found

increases in breast cancer, strokes, heart attacks, blood clots and

cardiovascular disease.

While cases of colorectal cancer and hip fractures decreased, the study

concluded those benefits did not outweigh other health risks.

In a separate study, National Cancer Institute researchers reported that

women who took estrogen alone for an extended period - 10 to 19 years - had an

80 percent higher risk of developing ovarian cancer. WHI later found similar

risks of ovarian cancer with the combination drug.

James Esparza, a Salt Lake City attorney, is representing 15 women whose

lawsuits have been transferred to the Arkansas case and nine women who have sued

Wyeth in a Pennsylvania state court.

" My clients took hormone replacement therapy products, whether that be

Premarin, Provera or a combination pill, Prempro, for a substantial period of

time and all developed breast cancer, " Esparza said.

Wyeth now offers a lower dose of Prempro and Premarin and includes

" black-box warnings " that " did not exist when any of my clients took the

products, " Esparza said.

Hubbard, Wyeth's attorney, disputed that, saying Prempro has had a label

warning of an increased risk of breast cancer since it went on the market in

1994. Premarin, too, has had such a label since at least the 1970s, she said,

and has warned ''for many years that higher doses for longer periods of time may

increase risks of breast cancer.''

Still, Hubbard asserted, a person's chance of getting breast cancer from one

of Wyeths' hormone therapy drugs is about the same as their chance of getting a

brain hemorrhage from taking aspirin.

Since January 2003, Wyeth has advised doctors and consumers that hormone

drugs should be taken at the lowest dose for the shortest time possible.

Wyeth also now acknowledges that hormone drugs offer no protection against

heart disease or dementia and warns the drugs may increase risk of certain

health problems, including breast cancer.

A video presentation on Wyeth's Web site notes the health studies did not

evaluate the " proven benefits " of hormone therapy drugs for reducing hot

flashes, night sweats and vaginal dryness. They found risks for women whose

average age is 63, the site states, but don't give a " clear " picture for younger

women.

" It's your body, your health and your choices, " a doctor concludes in one of

its video testimonials.

Texas attorney Robert Schwartz, who also is representing the newest Utah

plaintiffs along with Lehi attorney Keith Barton, acknowledges the situation

remains confusing.

" Consult with your physician about the potential risks and have that

risk-benefit analysis, " Schwartz said. " We represent approximately 500 women who

took these drugs and are now breast cancer victims with horrible fears,

devastating disfigurement and a lifetime of worry. "

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* BROOKE ADAMS can be contacted at brooke or 801-257-8724. LISA

ROSETTA contributed to this report.

 

Women sue Pfizer, Wyeth over menopause therapy

Wyeth Pharmaceuticals makes Prempro and Premarin. Pfizer Inc. makes Provera.

Prempro is a combination of estrogen plus progestin; Premarin contains only

estrogen and Provera is a synthetic progesterone.

The number of women taking Wyeth's hormone therapy drugs has fallen from 11

million in 2002 to 4 million in 2005, according to company news releases. The

company now offers lower-dose versions of the two drugs.

The " Premarin family " of drugs is a profitable line for the company,

accounting for $1 billion of Wyeth's $20.4 billion in net revenues in 2006.

- Brooke Adams

 

 

 

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