Healthy Skepticism Library item: 7152

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Publication type: news

Cortez MF, Rapaport L.
Wyeth Hormone Sales Rise Even After Linked to Cancer
Bloomberg.com 2006 Dec 20
http://www.bloomberg.com/apps/news?pid=20601202&sid=a8xZNiDY7l8I&refer=healthcare

Abstract:

Wyeth’s sales of hormone-replacement drugs may climb to more than $1 billion this year even after being linked to an increased risk for breast cancer.

Revenue from the pills, used to treat symptoms of menopause, is expected by analysts to rise about 5 percent annually for the next several years. A study last week said reported cases of breast cancer in the U.S. dropped by 7 percent after use of Wyeth’s hormone drugs fell by half from 2002 to 2004.

Women and doctors shied away from the hormone products Premarin and Prempro after a U.S. study of 17,000 women in 2002 linked the pills to the cancer and heart disease. Sales are advancing again as Madison, New Jersey-based Wyeth is increasing the price and selling lower-dose versions women use for shorter intervals. Doctors say other treatments aren’t as good at preventing the effects of menopause, such as hot flashes.

``Hormone-replacement therapy prescriptions have been moving in a positive direction, and I don’t think that is going to change,’‘ Anthony Butler, an analyst with Lehman Brothers Holdings Inc. in New York, said in a Dec. 15 telephone interview. ``There really isn’t anything better out there to relieve symptoms of menopause.’‘

The company’s shares were unchanged at $51.40 as of 4:01 p.m. in New York Stock Exchange composite trading. They’ve gained 37 percent since the end of 2002, trailing the 62 percent jump in the Standard & Poor’s 500 Index and surpassing the 14- member Standard & Poor’s 500 Pharmaceutical Index, which has risen 26 percent.

$2 Billion Products

Wyeth reported $789 million from sales of the medicines in 2006 through the end of September. The drugs had generated more than $2 billion annually, making them Wyeth’s best-selling products, before they were linked to cancer in July 2002 by the U.S. government’s Women’s Health Initiative study.

More than 5,000 lawsuits were filed against the company because of the drugs’ cancer link.

Sales of Premarin and Prempro dropped to $1.3 billion in 2003 and fell to $880 million in 2004. The medications generated $910 million last year. Butler estimates worldwide revenue for the drugs will top $1 billion in 2006.

Last week, researchers from the University of Texas M.D. Anderson Cancer Center in Houston said about 14,000 fewer women in the U.S. were diagnosed with breast cancer in 2003 than in 2002. The number of women taking Premarin, a product containing the female hormone estrogen, fell to 3.9 million in June 2003 from 6 million in July 2002, according to Wyeth.

`Preliminary Data’

The new study, presented at a breast cancer conference in San Antonio Dec. 14, stems from an analysis of U.S. data on cancer nationwide. While the investigators say they suspect the decline in hormone treatment use is why the cancer rate fell, Wyeth says there were other reasons.

Michael Dey, president of the Wyeth women’s health unit, said fewer women sought menopause treatment from physicians after the WHI study came out, leading to less screening for breast cancer. Fewer tests may explain the lower number of tumors detected, he said.

``We’re looking at very preliminary data this week about breast cancer rates,’‘ Dey said in a Dec. 15 telephone interview. ``There are other explanations.’‘

Mammography rates were leveling off during the same period as the study, which could mean fewer small, early cancers were being caught by doctors, said Michael Thun, chief epidemiologist at the Atlanta-based American Cancer Society, in a telephone interview.

`Fluff?’

``Until you can run a trial and prove the link, the speculation just tends to be fluff,’‘ said Scott Henry, an analyst at Oppenheimer & Co. in Boston, in a telephone interview. ``These things tend not to change the long-term trends,’‘ particularly because the risks are already spelled out on the drugs’ labels, he said.

Henry said Wyeth is boosting revenue by raising the drugs’ price by 3 percent to 5 percent a year.

``Sales growth has been primarily due to increased demand from wholesalers, as well as price increases,’‘ said Wyeth spokeswoman Candace Steele in a telephone interview yesterday. ``The U.S. hormone replacement therapy market continued to decline overall, but at a slower rate.’‘

About 215,000 women will be diagnosed with breast cancer in 2006, making it the most-common tumor in females, and 41,000 will die from it, according to the cancer society.

Something Wrong

The decline in cancer rates reported last week began in August 2002 and continued throughout 2003, said Brenda Edwards, associate director of the surveillance research program at the National Cancer Institute in Bethesda, Maryland. Her group typically analyzes data based on full-year findings, and she has looked only at preliminary counts for 2004.

``As a statistician, when we saw the drop, I said there must be something wrong with my data,’‘ Edwards said.

The Women’s Health Initiative report in 2002 found the cancer link highest in women using a combination of estrogen and another hormone, progestin, contained in Wyeth’s drug Prempro.

Edwards’ report will attract scrutiny when it is published in a peer-reviewed medical journal. Two journals previously declined to publish the analysis she first had in March, Edwards said. She wouldn’t identify the journals, saying both wanted additional information.

One reason for the continued use of hormone replacement therapy, called HRT, is that a second U.S. government report from 2004 found that estrogen alone, the hormone in Premarin, didn’t increase cancer rates. That means that HRT, with limited use of progestin, may benefit many women, said Julie Gralow, associate professor of medicine at the University of Washington in Seattle.

Symptoms

``We may just be giving HRT the wrong way,’‘ she said. ``I still believe that there can be a role for hormone replacement therapy in the short term to get women through all the hot flashes and mood swings and night sweats.’‘

Patients are now taking lower doses of Premarin and Prempro to limit their exposure to the hormones. Prempro is a combination pill that uses progestin to lower the risk of uterine cancer from taking estrogen. Premarin, an estrogen only pill, is given to women who have had hysterectomies, or removal of the uterus.

Some doctors say they don’t know whether the drop in hormone use prevented cancers or just made them harder to spot.

By cutting off the estrogen that feeds some breast cancers, newer tumors might not have grown large enough for detection, said Gralow, a spokeswoman for the American Society of Clinical Oncology. In that case, the cancers are still present. They just won’t be detected for a few years until they are larger.

``From the first time a cell goes a little haywire to the time we actually see it or feel it or diagnose it, it’s probably a five- to 10-year evolution,’‘ Gralow said. ``We all believe the hormones had something to do with this drop, but we need to wait for another year or two to see if it was real.’‘