Wyeth - Prempro: "no boundaries, no limits to your selling effort"

This from Theresa Agovino (Associated Press) in law.com:

Linda Reeves thought it was a good idea to take hormone replacement therapy to help prevent the osteoporosis that plagued her mother.

But doubts surfaced six years ago when she was diagnosed with breast cancer and her doctor instructed her to stop taking the pills.

The 67-year-old endured a mastectomy, and while Reeves said she feels fine now, she fears her cancer may return.

"I think about it an awful lot. It is something that is there in the back of my mind," said Reeves, a secretary living in Benton, Ark.

Reeves blames her cancer on roughly eight years of taking Prempro, an estrogen-progestin combination made by Wyeth and prescribed to relieve menopausal symptoms such as hot flashes.

Next month, Reeves will face Wyeth in a federal court in Little Rock, Ark., in the first of approximately 4,500 lawsuits filed against the company over hormone replacement therapy. Key to her case are internal marketing documents her lawyers claim show Wyeth put profits ahead of patients.

The case marks the beginning of what could be a long process that could compound the financial fallout Wyeth suffered from a clinical study halted in 2002. The Women's Health Initiative study found Prempro patients had a higher risk of breast cancer, stroke and coronary heart disease. Prempro sales, along with those of sister drug, estrogen-only pill Premarin, dropped to $909 million last year from $2.07 billion 2001.

Wyeth heads to court Aug. 21 after finally reaching settlements for most of the lawsuits over the former diet drug combination fen-phen with a price tag of $21 billion to date. Analysts don't believe its liability over HRT will reach anywhere near that because WHI showed only a slight increase in health risks and proving a connection to an individual's breast cancer or heart disease will be difficult. Plus, they've seen no proof that Wyeth deliberately misled doctors and patients about HRT's safety profile.

Analysts and legal experts say the case against Merck & Co. over its now-withdrawn pain reliever Vioxx appears stronger because of the number of studies linking the drug to health problems, a more pronounced risk and some damaging internal documents. Liability estimates have reached $50 billion.

Reeves lawyers insist evidence abounds that Wyeth willfully ignored HRT's dangerous side effects, including numerous studies which found it doubles patients' risk of breast cancer, and sales representatives who'll testify they were ordered to minimize the drugs' risk while promoting them for unapproved uses such as cardiovascular health and Alzheimer's prevention. Most of the cases are about breast cancer risk, Wyeth said.

Plaintiffs attorneys say Wyeth never really explored the issue of breast cancer risk, a charge the company denies.

"They (Wyeth) wanted doctors to look at the benefits and not the risks," said James A. Morris Jr., one of Reeves' lawyers. "They corrupted the science."

Wyeth maintains it always acted responsibly, noting the HRT's label warned of breast cancer risk and the drugs are still on the market and prescribed by doctors.

"This is an incredibly valuable treatment. There are really benefits to this medication," said Heidi Hubbard, a lawyer for Wyeth.

Now HRT is typically prescribed at low doses for short periods while before 2002 women often took it indefinitely at higher doses. The breast cancer warning is now more forceful and prominently displayed on the drug label.

Dr. Andrew Good of the Mayo Clinic said he was aware of the studies linking HRT with breast cancer but noted there were others that found no connection.

"I've been hearing the speeches (from Wyeth) since 1970," said Good. "No one ever sold this as 'Don't worry about breast cancer.'"

The only issue the two sides appear to agree upon is that the WHI study had limitations, so its role in the Reeves' case is unclear. It found that for each year 10,000 women took Prempro, there would be eight more cases of breast cancer than if they were all taking a placebo. Over the 5.2 years of the trial, the increase in adverse events including breast cancer, heart attacks and stroke was about one in 100. That may not sound like much but doctors say it adds up, given the millions of women who took HRT.

Reeves lawyers said other studies which show a stronger correlation between HRT and breast cancer will be crucial to their case. They're also planning to introduce company documents and testimony from sales reps to bolster their allegations that Wyeth recklessly promoted the drug to boost sales.

One is a letter a former Wyeth salesman wrote to company executives, concerned about how HRT was being promoted. His testimony may be included at the trial.

"The desire for increased sales has overruled our company's ethical responsibility to promote our products safely," he said in a letter dated July 18, 2000, to the Office of Ethics and Business Conduct of American Home Products, Wyeth's former name.

He wrote that he was instructed to promote HRT for unapproved uses such as preventing Alzheimer's and cardiovascular disease and believed that it was unethical since many studies showed the drugs could increase the incidence of breast cancer and heart attack while having little effect on Alzheimer's.

The sales rep wrote the potential liability from such practices could "pale in comparison" to the suits over the diet drugs. He added his managers accused him of insubordination when he complained.

Hubbard insisted the situation described in the letter was an isolated incident. Some of those involved were demoted or are no longer with the company, Wyeth said.

Plaintiffs lawyers also plan to introduce a transcript from a Prempro launch party where Wyeth's current chairman and CEO Robert Essner (pic) told sales representatives that the company was creating an "HRT revolution" that would keep women on the drug from menopause to death and that there should be "no boundaries, no limits to your selling effort."

"To some degree, it (HRT) was marketed as the elixir of youth," said Dr. Joseph Ramieri, chairman of the OB/GYN departments of Morristown Memorial and Overlook Hospitals in New Jersey. Yet, he doesn't believe Wyeth ever crossed a line or promoted the drug fraudulently, noting it does help prevent osteoporosis and women said it helped their skin quality.

Even if jurors are disturbed by marketing evidence presented at the trial, plaintiffs still need to link each specific case of breast cancer to HRT and experts say that won't be easy.

Plaintiffs lawyers say they have been careful to only accept cases where the plaintiffs' cancer cells have receptors that bind to estrogen and progestin, which they say can prove a link to HRT.

But experts say that because the cancer is fueled by hormones doesn't mean it was triggered by HRT.

"There is no way to prove the HRT caused the cancer," said Dr. Alison Estabrook, Director of the Comprehensive Breast Center at St. Luke's-Roosevelt Hospital Center in New York. However, she does believe the HRT stimulates the cancer to grow faster.

Still, Reeves said she deserved to be warned about the studies that connected HRT with breast cancer risk and now believes she is entitled to compensation. "If there was even a possibility of breast cancer I wanted to know," she said. Now she says the best she can hope for is that her trial helps warn other women and that her cancer doesn't return.