The study was based on data from the Women’s Health Initiative (WHI), a research project into the mortality and morbidity of menopausal and post-menopausal women. One aspect of WHI looked into the benefits of HRT, but was halted in its early phases in 2002 when researchers found women on hormone therapy were at substantially higher risk of developing breast cancer than women who did not take HRT. The study also showed women were at greater risk for heart attacks, strokes and blood clots, which contradicted popular HRT-maker Wyeth’s claims that the therapy actually improved a woman’s risk for those and other conditions.

The new study on the connection between HRT use, breast tenderness and breast cancer involved 16,000 women, half of which were given estrogen-plus-progestin and the other half were given a placebo. The women who took the HRT who did not experience breast tenderness prior to therapy were three times more likely to report breast tenderness one year after beginning therapy, than women taking the placebo. Women on HRT who reported breast tenderness one year after beginning hormone therapy had a 48 percent high risk of developing invasive breast cancer than women also taking HRT who did not report new-onset breast tenderness at the one-year mark.

Researchers say more research needs to be done to understand the relationship between new-onset breast tenderness in women on HRT and breast cancer.

Source: Oncology Nursing News

SOURCE: Hormone Replacement Therapy › Women on HRT who experience breast tenderness at greater risk of cancer

The study, conducted by researchers at Northern California Cancer Center in Fremont, tracked overall incidence of invasive breast cancer from 2001 to 2004, and noted that the rate of breast cancer fell by 13.8 percent in urban areas but by only 7.5 percent in rural areas. Neighborhoods in high-income areas also reported 13 percent fewer incidence of breast cancer compared to a 9.6 percent decline in poor counties.

Breast cancer reports in rural counties peaked in 1999 and then steadily declined while breast cancer reports in urban counties didn’t reflect significant decline until after 2002. In 2002, the Women’s Health Initiative abruptly halted its trail on postmenopausal women and HRT after data indicated women on HRT were at greater risk for serious health concerns, in particular breast cancer.

Authors of the Cancer Center study say that the pattern of decline in the rate of breast cancer in rural versus urban counties is “consistent with the changing pattern of (HRT) prevalence and cessation or noninitiation.”

The study also indicated that breast cancer was most likely diagnosed in urban areas versus suburban or rural communities. While HRT appears to be the primary cause, the authors caution that some changes could be explained by “saturation or decreases in mammographic screening.”

Source: MedPage Today

SOURCE: Hormone Replacement Therapy › Greater reduction in HRT/breast cancer rates in urban, affluent towns

Prior to the initiative in 2002, more than 200,000 American women were diagnosed with breast cancer each year. After 2002, that rate dropped below 190,000 each year since. Statistics from other countries show similar results.

Despite the findings, some researchers aren’t convinced the drop is due to a decrease in hormone use. For one, mammography was increasing in the late 1990s, enabling physicians to detect breast cancer earlier than before. This is an argument favored by Joseph Camardo, senior vice president of global medical affairs for Wyeth, the maker of hormone replacement drug Prempro. Wyeth is facing lawsuits from more than 11,000 women who took Prempro. Other critics of the campaign against HRT say that the drop was far too sudden to be linked to to the WHI findings.

The new study is a response by doctors involved in WHI who stand firm on their belief that HRT lead to serious health risks for women.

“These are non-conventional analyses, but I think this is the best data we have,” Rowan Chlebowski, a University of California, Los Angeles doctor who led the new study, was quoted in the news story. “This really suggests there’s a great benefit to women for stopping, because the risk goes down almost immediately.”

SOURCE: Hormone Replacement Therapy › Drop in breast cancer rates linked to reduction of HRT use

Years ago, HRT was the method-of-choice for most women to combat annoying menopausal symptoms such as hot flashes, moodiness, night sweats and decreased sexual desire. The therapy also was thought to offer other benefits, such as a lowered risk of heart disease and breast cancer.

However, the Women’s Health Initiative (WHI) of 2002 changed popular opinion when it found that HRT greatly increased a woman’s risk of breast cancer, heart disease and other serious illnesses. Since then, HRT and its effects have continued to be a closely studied therapy.

University of California-Irvine senior statistician, Sarah F. Marshall, presented the findings of her study at the San Antonio (Texas) Breast Cancer Symposium. The study followed 2,800 postmenopausal women who developed breast cancer beginning in 1995 until their deaths or through the end of 2005.

It found that women who took HRT before they were diagnosed with cancer were more likely to be diagnosed with estrogen receptor-positive cancer, and that the cancer was smaller and detected at an earlier stage. Marshall says that this type of cancer – estrogen receptor-positive cancer – is easier to treat and as a result, women have a lower risk of dying.

SOURCE: Hormone Replacement Therapy › Estrogen receptor-positive cancer easier to treat, study says

Those who practice acupuncture say that the therapy can remedy a host of women’s health issues, particularly fertility, pregnancy support and menopause. While the holistic healthcare discovered in Asia more than 3,500 years ago is gaining popularity in the Western world, getting the world out has been challenging. In an effort to raise awareness, the National Certification Commission of Acupuncture and Oriental Medicine has deemed today and every October 24th National Acupuncture & Oriental Medicine Day.

The National Center for Complementary and Alternative Medicine, an outreach of the National Institutes of Health, one-third of adults in the United States uses some form of alternative medicine, according to the Ventura County (California) Star. The most common practices are acupuncture, acupressure, herbal medicine, tai chi and gi gong.

For Myerson, acupuncture was a godsend. After a few visits of targeted pin pushing, she felt like a new woman. And her night sweats stopped. But hard evidence that the practice actually does work is still inconclusive. The American Medical Association says there is little evidence for it to confirm the safety or efficacy of most alternative therapies. But some doctors and patients claim, if acupuncture helps relieve chronic symptoms, like uncomfortable and disruptive night sweats from menopause, then it is worth consideration.

SOURCE: Hormone Replacement Therapy › Acupuncture an alternative therapy for menopause

The U.S. Supreme Court will hear arguments today in the first of two cases this term that consumer advocates fear could shut courthouse doors to patients injured by FDA-approved drugs or medical devices.

Legal experts say the cases could also affect lawsuits already filed by tens of thousands of Americans challenging the safety of blockbuster drugs such as Celebrex and Prempro and a host of medical devices.

The case before the court today was brought by the family of a New York man who suffered severe medical complications when a balloon catheter burst during a procedure to clear his arteries. The second case, involving claims for injuries allegedly caused by Rezulin, a now-withdrawn drug used to treat diabetes, will be heard in February.

Pharmaceutical manufacturers have long complained that the expense of defending injury claims has slowed research into new medications and driven up costs for patients. Because Congress granted the Food and Drug Administration the authority to determine whether products are safe and effective, manufacturers argue that state judges and juries should not be allowed to second-guess the FDA once a product is approved for use.

State damage claims put pharmaceutical makers in a “Catch-22 between complying with FDA regulations on the one hand and still being subject to state liability on the other,” said Rob Clark, a government affairs director for Medtronic Inc., which made the cardiac catheter.

But plaintiffs’ lawyers and consumer groups say that the FDA has approved some drugs and devices based on sloppy or falsified test data, adding that lawsuits are the only way evidence of drug risks or drug maker fraud has come to light.

A report issued Friday by three members of the FDA’s own Science Boardfound that the agency was so poorly organized and short of funds that it could not adequately protect the public from dangerous drugs.

A ruling for Medtronic would “take away the last possible safety net against unfettered corporate misbehavior and negligence,” said Karen Barth Menzies, a Newport Beach lawyer who has represented plaintiffs in cases against drug makers.

Menzies sees these “preemption” cases as a new battlefront in the tort-reform wars in the wake of limits imposed by Congress and state legislatures in recent years on class actions and medical malpractice claims.

Charles Riegel sued Medtronic, claiming his injuries were caused by the catheter’s negligent design, manufacture and labeling, despite the fact the device had won FDA approval. Riegel died in 2004 of causes unrelated to the angioplasty, and his widow took over his claim. Her case was thrown out by a U.S. District Court judge and then by the U.S. Court of Appeals.

The prospect that the high court may bar injury claims for FDA-approved pharmaceuticals helped precipitate the $4.85-billion settlement of Vioxx claims last month, according to lawyers involved in the negotiations.

Lawyers representing plaintiffs who took the popular painkiller insisted on language that would allow the settlement to close and compensation be paid even if the high court sides with Medtronic. Vioxx maker Merck & Co. took the drug off the market in 2004 after a study showed it doubled the risk of heart attack and stroke in patients taking it for more than 18 months.

The question in the catheter case is whether Congress intended to bar state common law claims when it gave the FDA authority to regulate medical devices in 1976. Widespread injuries reported by women who used the Dalkon Shield intrauterine device and other products had earlier prompted California and a few other states to impose some labeling and design requirements in the absence of federal standards.

The 1976 federal statute specifically said that states couldn’t maintain requirements that were different from federal standards. But Congress didn’t specify that those federal standards preempted state common law claims, and device manufacturers didn’t argue that they did until recently, said Allison Zieve, a lawyer with Washington-based Public Citizen Litigation Group who will be arguing for Donna Riegel before the court.

In rejecting the Riegel suit, the lower courts reasoned that if the plaintiffs reached trial and won, the damages would amount to a state “requirement” different from FDA requirements because the complaint depended on state law.

Glenn Lammi, chief counsel with the Washington Legal Foundation, said continuing to allow injury claims under state law could create “a patchwork of rules” governing product design and use that “creates confusion among consumers” and raises costs. The foundation, a group that advocates restrictions on lawsuits, submitted an amicus brief on behalf of the company.

Beyond the issue of whether patients have the right to sue under state law, Medtronic’s Clark insisted the company was not responsible for Riegel’s injuries because his doctor used the catheter improperly, inflating the balloon beyond the pressure specified on the FDA-approved instructions.

Zieve disagrees that the label was adequate, calling the instructions “confusing and misleading.” However, she said the preemption argument was more central to the case, calling it “essentially a get out of jail free card.”

If the court upholds Medtronic’s position, Zieve said, it means that “no matter who messed up, you can’t sue the company.”

December 4th, 2007 by Molly Selvin with Los Angeles Times

SOURCE: Hormone Replacement Therapy › High court may bar claims for FDA-approved drugs