Researchers at Medco Health Solutions Inc. studied an estimated 1,300 women and found that women who were taking antidepressants such as Paxil, Prozac or Zoloft along with tamoxifen for at least one year had a breast-cancer recurrence rate of 16 percent. Women who were not taking the drugs reported a 7.5 percent recurrence rate. Antidepressants such as Celexa, Lexapro and Luvox appeared not to have an increased cancer recurrence rate.

Tamoxifen is a commonly used treatment for estrogen-dependent breast cancer, one of the most common types of breast cancer and one that has been associated with the use of hormone replacement therapy, HRT.

“If we lower the effectiveness of tamoxifen, you’d get worse outcomes.” Says Dr. Julie Gralow, an associate professor in oncology at the University of Washington School. She says many doctors in the U.S. also prescribe aromatase inhibitors rather than tamoxifen to block estrogen in post-menopausal women to prevent breast cancer from returning, which also avoids the tamoxifen-antidepressant interaction.

An estimated 30 percent of the half million American women taking tamoxifen have also been prescribed antidepressants. Medco says it has found that some doctors who treat breast cancer patients are not aware of the increased recurrence risk for breast cancer patients taking tamoxifen and antidepressants.

Source: The Wall Street Journal

SOURCE: Hormone Replacement Therapy › Tamoxifen with antidepressants may raise risk of breast cancer recurrence

According to the story, attorney General Catherine Cortez Masto said in a news release, “When drug companies purposefully misrepresent the safety and efficacy of their drugs, or promote their drugs in a deceptive way, everybody loses. We’re confident we have the facts necessary to prove this case, and we hope this lawsuit and its outcome will deter improper drug company practices in Nevada.”

The suit claims that the drug company misled Nevada patients and their doctors about the safety and the effectiveness of the drugs Premarin, Prempro and Premphase, sold by Wyeth; and Provera, sold by Pfizer. That, the suit contends, resulted in the over-prescribing and drastic increase in hormone-positive cancers in women who had taken the drugs. The suit seeks $5,000 to $12,000 in damages for each violation.

Weyth’s HRT drugs Premarin and Prempro dominated the market for menopausal symptoms. However, since the Women’s Health Initiative of 2002, which found HRT increased a woman’s risk for breast cancer and other serious diseases and conditions, Wyeth has been faced with numerous lawsuits over its drugs Premarin and Prempro.

Last year, three Navada women won $58 million in compensatory and punitive damages after claiming Prempro caused their breast cancer. Wyeth also was ordered to pay $1.6 million in attorney fees. The drug maker has appealed the verdict to the Nevada Supreme Court.

SOURCE: Hormone Replacement Therapy › Nevada AG sues companies for misleading about HRT safety

Premarin is a low-dose mixture of estrogen hormones and is already available in pill form to treat symptoms of menopause such as hot flashes and vaginal dryness, burning and itching. Premarin and another Wyeth drug prescribed for menopausal symptoms, Prempro, dominated the hormone replacement therapy market until the Women’s Health Initiative of 2002 linked long-term use of HRT to an increased risk of breast cancer and other serious health problems. Wyeth has since been faced with numerous lawsuits concerning the drugs.

Dyspareunia is a disorder that follows the atrophy or thinning of the vagina and vulva, a condition that can occur in menopause.

The .5-gram cream has two dosing regiments – 21 days on followed by 7 days off, or twice weekly. FDA approval of the cream and its dosing regime was granted based on results from a multi-center clinical study that included a 12-week, randomized, double blind placebo phase followed by a 40-week open-label phase, according to the story.

Wyeth advises women considering the cream to review possible side effects with their physician, and to avoid the product if they fall into a high-risk category.

SOURCE: Hormone Replacement Therapy › FDA approves Premarin cream to treat dyspareunia

During menopause, sex drive can drop to very low levels, which some believe may be a result of lowered levels of estrogen, progesterone and testosterone in the body during menopause. Estrogen helps you to feel heightened sensitivity during sexual intercourse. Progesterone keeps your libido up. Testosterone boosts sexual desire and lubricates the vagina.

For relief from menopausal symptoms, women typically have been prescribed hormone replacement therapy (HRT), which is a medication containing female hormones such as estrogen. More and more women and their doctors are shying away from HRT as a result of recent studies which have found the use of HRT places women at a higher risk for breast cancer as well as other serious conditions.

The FDA has not approved the use of testosterone for low sexual function, though off-label use is allowed.

According to FoodConsumer.org, a Study by Swiss researchers titled “breast cancer risk in postmenopausal women using testosterone in combination with hormone replacement therapy” found that testosterone patches used for 24 weeks more than doubled monthly sexual episodes in women with low sexual desire and activities. However, in the one-year trail, breast cancer was diagnosed in four of the 534 women treated with the testosterone compared to none in the 277 women who were taking placebos.

Researchers concluded that “at present, there are no valid randomized or observational clinical studies that provide evidence that the addition of testosterone to conventional postmenopausal hormone therapy influences breast cancer risk.”

SOURCE: Hormone Replacement Therapy › Male hormone increases sex drive, cancer risk questionable

The changes, which go into effect immediately, are part of “Project Impact,” a restructuring plan announced by Wyeth in January that cuts 10 percent – or about 5,000 – of its workforce. As part of Project Impact, the company will narrow its focus to find more successful new drugs especially those for which no good treatments are available. Thus, it will scale back from research on 55 diseases to only 27.

Wyeth’s new focus will be on vaccines; cancer; inflammatory disorders such as rheumatoid arthritis, severe asthma and lupus; metabolic conditions such as diabetes and obesity; musculoskeletal disorders such as arthritis and spinal fracture; and neuroscience such as Alzheimer’s and Parkinson’s disease, depression, schizophrenia and chronic pain, according to the report.

Since the Women’s Health Initiative, which found hormone replacement therapy increased a woman’s risk for breast cancer and other serious diseases and conditions, Wyeth has been faced with numerous lawsuits over its hormone replacement drugs Premarin and Prempro, which dominated the market for menopause symptom treatments for years.

According to the report, Wyeth will continue with late-stage testing on experimental menopause drugs Aprela and Pristiq. (Currently, the FDA has demanded additional research data on Pristiq.) A study of 3,400 women indicated no evidence of increased breast cancer rates. Wyeth plans to submit Aprela for FDA approval in the second half of 2009.

SOURCE: Hormone Replacement Therapy › Wyeth to stop making HRT, focus on cancer research

Bone scans are used to check for osteoporosis, a disease in which bones become fragile and more likely to break. Women are typically four times more likely than men to suffer from osteoporosis. Because there is a direct relationship between the lack of estrogen after menopause and the development of osteoporosis, most doctors advise older women to have bone density tests every year along with a mammogram.

The University of Arizona’s eight-year study of 10,000 post-menopausal women found that the results of a routine bone density test not only could reveal osteoporosis, it also may provide important clues in predicting breast cancer risk in older, post-menopausal women. The study, which looked at hip-bone mineral density T-score, found older women with high bone density twice as likely to develop breast cancer.

“High bone density is a marker of increased risk for breast cancer. We can use that piece of information to predict your breast cancer risk in the future,” said Zhao Chen, Ph.D, MPH, University of Arizona epidemiologist.

Bone density often means a higher production of estrogen, which researchers say may explain the correlation between high bone density and breast cancer risk.

Conversely, KABC-TV reports that some osteoporosis medications have been shown to prevent and even curtail breast cancer. For example, raloxifene (Evista) has already been FDA approved to treat both osteoporosis and prevent breast cancer in postmenopausal women at high risk of developing the disease.

SOURCE: Hormone Replacement Therapy › Strong bones in menopause may increase risk of breast cancer

Prempro and Premarin , along with Provera, which is made by Pfizer, have come under attack in recent years as mounting evidence revealed that the drugs can increase the risk of developing breast cancer. Plaintiffs lodging claims against the drug makers argue that the manufacturers failed to voice sufficient warning about the increased risk of developing breast cancer that the drugs present. Approximately 5,000 women have filed lawsuits against Wyeth, contending that the company’s HRTs (hormone replacement therapies) caused them to develop breast cancer.

A study monitoring 3,400 recipients of Aprela indicated no evidence of increased breast cancer rates, compared with women who received Evista or placebo. Aprela recipients also showed the same relatively lower rates of breast tenderness and pain as Evista and placebo recipients – a significant benefit considering that breast discomfort is the main reason why stop using menopause drugs

Other studies revealed that Aprela recipients experienced better sleep and diminished hot flashes compared to women who were treated with placebo. Increased bone density, improved sexual function, and less vaginal dryness were also evident in late-stage tests of Aprela.

Wyeth will submit Aprela to the FDA for approved use in the second half of 2009. If approved, the drug may provide a better line of treatment for postmenopausal women. Its marketing would also help the company offset continual losses resulting from its Prempro suits.

SOURCE: Hormone Replacement Therapy › Wyeth developing another HRT 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

The jury also must decide whether Wyeth failed to adequately test their drugs Premarin, an estrogen replacement, and Prempro, a combination estrogen and progestin, before putting them on the market and whether it failed to warn doctors about the drugs’ risks.

“Wyeth didn’t do (breast cancer) studies because the results could be embarrassing and could be costly,” Zoe Littlepage, a lawyer for Jeraldine Scofield of Fallon, Arlene Rowatt of Incline Village and Pamela Forrester of Yerington, told the jury.

The company’s decision to produce, market and sell a dangerous product affected thousands of women, and the company should be held responsible, Littlepage said during her closing argument in Washoe District Court.

Wyeth lawyer Heidi Hubbard said microscopic analysis showed the cancers each of the three women suffered are different, and no one can say why they developed. But each woman had a list of risk factors that could have contributed to their diseases.

“So many women get breast cancer, and we don’t know to this day what causes it; and researchers are trying to find the cause so they can find the cure,” Hubbard said.

“This case is about a medication that’s an appropriate treatment option for many women,” she said. “To this day, (the drugs) are the most effective available for menopausal symptoms.”

Scofield, 75, Rowart, 67, and Forrester, 64, began taking hormone replacement drugs years ago to offset hot flashes and other discomforts associated with menopause. But when each developed breast cancer, they stopped the drugs and underwent treatment.

The lawyers for the three women, who have sat in the front row of the courtroom every day of the trial, said Wyeth knew there were links between their drugs and the cancers but ignored the dangers in favor of skyrocketing sales.

The warning labels the company put on the drugs sounded more like reassurances than alarms, Littlepage said. Doctors testified if they knew then what they know now about the breast cancer risks, they never would have prescribed the drugs long-term as the company promoted them, she said.

Dan Webb, another Wyeth lawyer, challenged those claims.

Wyeth helped sponsor or participated in 63 studies to look at whether hormone replacement drugs increased the risk of breast cancer, he said. When the results came in, the company followed a directive from the U.S. Food and Drug Administration and created warning labels that detailed the risks, he said.

“The FDA knows more about research on drugs than the plaintiffs,” Webb said. “When (the women) say we didn’t properly test, it’s not true. Wyeth clearly understood the breast cancer risk and put it on the label.”

The women’s civil lawsuit seeks unspecified damages, but Littlepage told the jurors that they should look at how the company spent its money to promote the drugs when considering an appropriate amount. Those totals were in the millions of dollars.

October 10th, 2007

SOURCE: Hormone Replacement Therapy › Prempro lawsuit goes to the jury