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Should Anyone Take Hormones? 

  Survey Halted, Drug Makers Seek to Protect Hormone Sales


By:
MELODY PETERSEN
NY Times, July 17, 2002

 

 When female patients have asked in recent days whether they should continue taking Prempro, the hormone replacement therapy, doctors have told roughly half of them to stop taking the drug or to switch to an alternative treatment, a survey of doctors has found.

The survey of 338 doctors, conducted last Friday by ImpactRx, a drug marketing intelligence firm, bodes poorly for sales of Prempro and for the drug's maker, Wyeth.

The stock price of Wyeth plummeted early last week when researchers announced that they had stopped a long-term study of women taking Prempro after finding that patients had a small but increased risk of breast cancer, heart attacks, strokes and blood clots.

Timothy A. Margraf, the president of ImpactRx, said yesterday that it was far too early to tell how many women would stop taking the drug, which earned Wyeth about $900 million in sales last year.

Primary-care physicians surveyed told about 42 percent of the patients who asked them about Prempro last week that they should remain on the drug. Doctors said they told about 37 percent that they should stop taking it. Some 11 percent of patients were told to switch to another therapy.

ImpactRx conducted the survey, Mr. Margraf said, to see how Wyeth and makers of competing products were reacting to the Prempro study ≈ known as the Women's Health Initiative.

The survey showed, for example, that sales representatives from Wyeth who promote Prempro tripled the number of doctors they visited last week compared with the week before the study came out.

Some competitors have also jumped at the opportunity to gain sales as women seek alternative treatments. For example, the survey found that representatives from Pfizer, who were promoting FemHRT, a hormonal therapy similar to Prempro, doubled the number of doctors they visited last week compared with the week before.

Some of those Pfizer representatives told doctors about the Prempro study and suggested FemHRT as an alternative, the survey found. It found a similar increase in physician visits last week by sales representatives at Pharmacia, who were promoting a similar hormone treatment called Activella.

At Wyeth, Dr. Victoria Kusiak, vice president for global medical affairs, said the company was finding that most doctors were making decisions on whether to continue prescribing Prempro, based on each patient's circumstances.

The company stressed in letters sent to doctors last week that the Women's Health Initiative study had found a higher risk of breast cancer in women who had taken the drug for four years or more and that it had not questioned the drug's ability to relieve hot flashes, night sweats and other problems suffered by women entering menopause.

Dr. Kusiak said that the company had asked its sales force to call on all the significant prescribers of Prempro to let them know that the study was coming out and to explain its findings. "The doctors were anxious to hear from our reps," she said.

She said it was too soon to say how many women would stop Prempro.

A Pharmacia spokeswoman, Caroline Bullock, confirmed that the company's representatives had increased calls to physicians about Activella last week.

"Women are going into doctor's offices and asking to come off Prempro, but they still need alternative treatments," she said.

The part of the Women's Health Initiative study that was halted included only Wyeth's Prempro, which contains a mixture of estrogen and progestin. While the hormonal treatments that compete with Prempro contain forms of estrogen and progestin chemically different from Prempro, there is no evidence yet that they are safer than Prempro.

The makers of nonhormonal drugs used to treat osteoporosis are also trying to take advantage of the Prempro study. Besides helping to relieve symptoms of menopause, one of Prempro's approved uses is the prevention of osteoporosis.

For example, sales representatives from Eli Lilly told doctors they visited last week that the company's drug Evista was a safe alternative to hormone therapy, according to the ImpactRx survey.

"We're doing a lot of education," said Lauren Cislak, a Lilly spokeswoman. She said the company wanted to make sure that patients and doctors knew that Evista did not include estrogen or progestin, like Prempro and the other hormonal treatments.

Merck & Company ran a full-page ad in The New York Times on Sunday, promoting Fosamax, another drug that treats osteoporosis. The ad made it clear that Fosamax is a nonhormonal treatment.

"We're encouraging women to have a discussion with their doctor," said Gregory Reaves, a spokesman for Merck.

Mariann Caprino, a spokeswoman for Pfizer, said the company's discussions with physicians about FemHRT might have increased as doctors who were curious about the study asked the company's sales representatives for more information.

"There is tremendous complexity involved in understanding this study," Ms. Caprino said. She said Pfizer did not talk about the number of visits its sales representatives were making or other marketing strategies. Pfizer is in a $60 billion deal to buy Pharmacia.

Plaintiffs' lawyers have begun filing lawsuits against Wyeth because of its marketing of Prempro. A suit filed on Monday by Kenneth B. Moll, a lawyer in Chicago, seeks compensation for thousands of women around the country who may have been injured by the drug.

A spokeswoman for Wyeth said the company did not think there were any legal or factual bases for such lawsuits.


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