Back in the news: the link between hormone replacement therapy (HRT) and breast cancer. This time, the connection is seemingly more conclusive than before, when some argued that many factors influence the risk of breast cancer, that HRT could not do the job all on its own.

Now, two separate studies offer up powerful evidence that HRT is linked to tumor growth. Case in point: when use of the therapy drops, so do incidences of breast cancer.

New figures in the New England Journal of Medicine suggest there have been 16,000 fewer cases of breast cancer nationwide since mid-2002, when women stopped taking their hormone pills following the federal Women's Health Initiative announcement connecting the therapy with increased risk of breast cancer, stroke, and heart attack.

Many did not want to believe HRT was to blame for so many breast cancer diagnoses. And maybe it's not the actual cause of the disease, but the fuel for tumors trying to grow.

These new findings do not appear to be a statistical fluke, says one doctor. Numbers have been computed and re-computed, and the message is clear: HRT is strongly implicated as the guilty party. There is just no other culprit, says a statistician at the National Cancer Institute.

Wyeth, maker of Premarin and Prempro -- two forms of hormone therapy -- continues to caution women against drawing any conclusions about HRT and breast cancer. There still may be broader explanation for the decline in cases, say their spokespeople.

The Food and Drug Administration (FDA) will take an additional three months to review Wyeth's kidney cancer drug Torisel -- the first of five new medications the company plans to introduce this year.

The FDA needs more time to investigate data on tumor growth in patients taking Torisel. If all goes well, the drug will be one of only three to effectively hold off incurable kidney cancer. The other two drugs are Pfizer's Sutent and Bayer AG's Nexavar.

Robert Ruffolo, president of Wyeth Research, says he is encouraged by the review process so far. And he is optimistic about launching the product in late 2007.

Studies show Torisel, which will cost patients about $30,000 per year, prolonged survival by 50 percent in those faring poorly with kidney cancer. The sickest kidney-cancer patients were essentially kept alive for 10.9 months, compared with 7.3 months with interferon drugs. Torisel also postponed tumor growth for 5.5 months. This is 77 percent longer than with interferon.

Sutent and Nexavar, both on the market since last year, also slow tumor growth. All three kidney-cancer medicines are of the variety that block the growth of cancer cells -- different from standard chemotherapy which kills tumors and harms nearby tissues too.

Wyeth is relatively new to the oncology market. And soon, the company hopes to launch three more cancer drugs. One, called CMC-544, treats non-Hodgkin's lymphoma. Another, SKI-606, is for chronic myelogenous leukemia. And the third, HKI-272, is for breast cancer.

About 51,000 Americans will be diagnosed with kidney cancer this year.

Wyeth officials say their hormone replacement therapy Prempro is not the cause of one Ohio woman's breast cancer. But two jury decisions prove otherwise.

The first jury, in October, awarded Jennie Nelson and her husband $1.5 million in compensatory damages, validating Nelson's claim that her breast cancer -- resulting in a double mastectomy, chemotherapy, and radiation -- was caused by the Prempro she took for six years. When this verdict was thrown out due to a mistrial, a retrial began.

The retrial concluded yesterday -- with a Philadelphia jury awarding the Nelsons this time with $3 million.

"Both times this case has been heard on terms established by Wyeth and still the juries have clearly found that Prempro causes breast cancer," says Nelson's attorney Tobias Millrood, adding that Wyeth puts sales ahead of patient safety.

Wyeth respectfully disagrees and argues that it acted responsibly in the promotion of its hormone replacement products and in disclosing with doctors and patients all therapy-associated health risks.

Millions of women have used Wyeth's hormone replacement therapies to control the effects of menopause, and the company, sanctioned in January to pay $1 million to an Arkansas breast cancer survivor, now faces more than 5,000 lawsuits of this same nature.

Despite a large-scale study revealing drugs like Prempro increase the risk of breast cancer if used for five years or more, the drug still remains on the market. And Wyeth is so sure their drug is not at fault for causing Nelson's breast cancer that they plan to appeal yesterday's verdict.

An Arkansas woman claiming the hormone replacement drug Prempro caused her breast cancer just won her legal battle against Wyeth, the maker of the drug.

Mary Daniel was awarded $1 million in compensatory damages thanks to a Philadelphia jury decision stating Wyeth acted with malice or reckless disregard for selling Prempro -- the drug Daniels took for 16 months to relieve hot flashes. The next step for Daniels, whose husband will receive $500,000, is a hearing to consider punitive damages.

Wyeth's lawyer argues that Prempro -- a combination of estrogen and progestin -- is still prescribed to women and suggests Daniel's breast cancer was caused by other risk factors, such as family history of the disease.

2006 will forever be the year linking the decline in breast cancer cases to the decline in use of hormone replacement therapy (HRT). This was big news on the cancer front, and while some argue other forces helped drive the breast cancer drop, there is still much speculation that the use of HRT somehow increases the risk of developing the disease. Even so, it is predicted that Wyeth's sales of hormone replacement drugs will have reached more than $1 billion as of yesterday, the last day of 2006.

Even more interesting is the prediction by analysts that revenue from the pills -- used to treat symptoms of menopause -- will rise five percent annually for the next several years.

It seems the sales growth, despite the overall decline in the HRT market, is primarily due to increased demand from wholesalers and price increases too.

It's hard to tell what will happen to the world of HRT in the year 2007 -- will women embrace what is considered the best therapy around for menopausal issues? Will they abandon the controversial treatment altogether? Will they find variations of HRT that meet their needs while minimizing risk for disease? Only time will tell.