Yourlawyer.com (Premarin News) http://www.yourlawyer.com/topics/overview/premarin Sat, 18 May 2013 08:43:22 -0400 pixel-app en Pfizer Settles More Premarin, Prempro Breast Cancer Lawsuits http://www.yourlawyer.com/articles/read/18653 Tue, 20 Dec 2011 00:00:00 -0500 http://www.yourlawyer.com/articles/read/18653 Nearly 5,000 of the 10,000 breast cancer lawsuits Pfizer faced over its Prempro and Premarin hormone therapy drugs have been settled.  According to a Bloomberg News report, Pfizer disclosed the Prempro and Premarin settlements in its latest 10Q report filed with the U.S. Securities and Exchange Commission (SEC) on November 10.

Pfizer inherited thousands of Prempro lawsuits when it acquired Wyeth in 2009, and at one time faced as many as 10,000. In a May filing with the SEC, Pfizer disclosed it has set aside $772 million to settle the lawsuits which it said represented “the minimum expected costs to resolve all of the other outstanding” lawsuits.  At the time, the company said it had settled roughly 3,300 Premarin and Prempro lawsuits

Now, in the November filing, Pfizer put the number of settled lawsuits at almost 5,000. The company also reported that it had added $68 million to the $772 million it already reserved.  About $260 million remains, but Pfizer acknowledged that “additional charges may be required" to resolve the remaining complaints.

Hormone therapy drugs like Prempro and Premarin, which are used to treat the symptoms of menopause, became controversial in 2002, after a study linked them to a higher risk of breast cancer. More than 6 million women took Prempro and related menopause drugs before that study was released.

Prempro and Premarin lawsuits claim Wyeth did not adequately test the drug, and that the company failed to adequately warn that they may increase the risk of breast cancer. 

 

]]> Pfizer Eyeing Prempro Lawsuit Settlements http://www.yourlawyer.com/articles/read/18357 Tue, 17 May 2011 00:00:00 -0400 http://www.yourlawyer.com/articles/read/18357
It looks like Pfizer has had enough of the litigation surrounding its hormone therapy medication, Prempro.   According to a filing with the Securities and Exchange Commission (SEC), Pfizer disclosed it has set aside $772 million to settle hormone therapy lawsuits which it says is “the minimum expected costs to resolve all of the other outstanding” lawsuits.

Pfizer inherited thousands of Prempro lawsuits when it acquired Wyeth in 2009, and at one time faced as many as 10,000.  The $772 million mentioned in the SEC filing includes $300 million the company paid out in a previous round of settlements, and $172 million in reported settlements last quarter.  The final $300 million will settle the last round of lawsuits this quarter, however, Pfizer said more might be required if its estimates are off.

“The decision to settle cases reflects a business decision by the company to avoid the cost and distraction of prolonged litigation,” Chris Loder, a Pfizer spokesman, said in an e-mailed statement to Bloomberg.com.

Pfizer did not disclose how many lawsuits it would settle.  So far,  settlements have provided average payouts of about $150,000 per woman, according to a Bloomberg.com report.

Hormone therapy drugs like Prempro, which are used to treat the symptoms of menopause, became controversial in 2002, after a study linked them to a higher risk of breast cancer. More than 6 million women took Prempro and related menopause drugs before that study was released.

Prempro lawsuits claim Wyeth did not adequately test the drug, and that the company failed to adequately warn that Prempro may increase the risk of breast cancer. 

]]> High Court Denies Wyeth's Appeal in Premarin, Prempro Lawsuit http://www.yourlawyer.com/articles/read/17839 Tue, 22 Jun 2010 00:00:00 -0400 http://www.yourlawyer.com/articles/read/17839 Pfizer Inc.’s Wyeth unit won’t be able to have a full new trial in a case involving its hormone replacement therapy drugs, Prempro and Premarin. Yesterday, the U.S. Supreme Court left in place a 2009 appeals court decision that denied Wyeth a second chance to argue it wasn’t liable at all for the plaintiff’s injuries.

However, according to The Wall Street Journal, Wyeth is still entitled to a partial new trial to determine how much money it owed in punitive damages, as per the 2009 ruling.

Hormone therapy drugs like Prempro, Premarin, and Provera are used to treat the hot flashes and other symptoms that accompany menopause. In 2002, the Women’s Health Initiative (WHI) a major study conducted by the National Institutes of Health (NIH) determined that Prempro and similar drugs significantly increased the risk of stroke, blood clots, heart attacks and breast cancer.

The results were so alarming that the NIH canceled the study, citing risk to the study’s participants. The authors of the study suggested that many of the women who used the medications should quit and talk to their doctors about alternatives. After the WHI was released, thousands of breast cancer victims sued Wyeth, claiming the hormone drugs had caused the disease. While the drugs remain on the market, their labels include a Black Box warning about the risk of breast cancer.

According to The Wall Street Journal, back in 2008, a federal jury in Arkansas had awarded Donna Scoggins $2.75 million in compensatory damages from Wyeth and another Pfizer unit, Pharmacia & Upjohn Co. She was also awarded another $19 million from Wyeth and almost $8 million from Upjohn for punitive damages. Scoggins who had taken Wyeth’s Premarin and Prempro, as well as Upjohn’s Provera separately over an 11 year period, claimed the drugs caused her to develop breast cancer.

On appeal, the 8th U.S. Circuit Court of Appeals in St. Louis said the trial judge improperly allowed testimony from one of the plaintiff’s experts – a former Food & Drug Administration official – during the punitive damages phase of the original trial. However, the court ruled Wyeth could be still held liable for punitive damages, but said Upjohn was not. It then ordered the separate proceeding for Wyeth on punitive damages.

In its appeal to the U.S. Supreme Court, Wyeth argued the 8th Circuit violated constitutional protections by allowing a new jury to consider only the punitive damages.

According to the Journal, the Supreme Court denied Wyeth’s petition without comment. Chief Justice John Roberts backed out of consideration of the appeal because he owns Pfizer stock.

]]> Dismissal of HRT Lawsuits Reversed http://www.yourlawyer.com/articles/read/17474 Thu, 07 Jan 2010 00:00:00 -0500 http://www.yourlawyer.com/articles/read/17474 Plaintiffs in 100 lawsuits involving Prempro and other hormone replacement therapy drugs got a reprieve yesterday, when the 8th U.S. Circuit Court of Appeals reinstated the complaints and sent them back to state court in Minnesota.

In 2008, a district court ruling had not only dismissed the Prempro lawsuits in Arkansas federal court, but had prevented them from being sent back to a Minnesota state court. In reinstating the complaints and sending them back to the state court, the 8th circuit said that since the proper venue for the lawsuits was a state court, the district court judge did not have jurisdiction to dismiss them. It also reversed the dismissal of dozens of cases that the lower court ruled should not have been part of the litigation because they duplicated claims pending in California, the Associated Press said.

According to the Associated Press, most of the lawsuits reinstated by the 8th Court of Appeals involve Prempro, which is manufactured by Wyeth Pharmaceuticals Inc., a division of Pfizer Inc. A total of a dozen companies, including Wyeth, Pfizer, Barr Laboratories Inc. and Mead Johnson & Co., are defendants in the Arkansas cases. The suits were filed by women or their survivors who claimed that the hormone replacement drugs caused breast cancer.

Hormone therapy drugs like Prempro, Premarin, and Provera are used to treat the hot flashes and other symptoms that accompany menopause. In 2002, a major study conducted by the National Institutes of Health (NIH) determined that Prempro, Premarin and similar drugs significantly increased the risk of stroke, blood clots, heart attacks and breast cancer. The results were so alarming that the NIH canceled the study, citing risk to the study’s participants. The authors of the study suggested that many of the women who used the medications should quit and talk to their doctors about alternatives.


]]> Breast Cancer Survivor Files Suit Over Premarin, Prempro http://www.yourlawyer.com/articles/read/17466 Tue, 05 Jan 2010 00:00:00 -0500 http://www.yourlawyer.com/articles/read/17466 A Virginia breast cancer survivor says her use of the hormone therapy drugs  Prempro and Premarin caused her disease.  Tina Griffin of Manassas is now suing Wyeth, a division of Pfizer Inc., seeking damages for medical bills, as well as pain and suffering.

Griffin had taken Prempro and Premarin for less than six years when she got her breast cancer diagnosis.  Doctors had to remove 14 lymph nodes, and she endured almost six months of radiation therapy. While she is now cancer free, Griffin only has limited use of her right arm because of the surgeries.

Wyeth and Pfizer have been named in nearly 10,000 similar lawsuits. In November, we reported that Pfizer Inc. has been ordered to pay punitive damages totaling $103 million in two lawsuits involving Prempro. In the first case, a Philadelphia jury awarded $28 million in punitive damages to a 66-year-old woman who claimed her breast cancer was the result of taking Prempro and Provera. The second case, also heard in Philadelphia, resulted in a punitive damage award of $75 million , and $3.5 million in compensatory damages.

Hormone therapy drugs like Premarin, Prempro, Premphase and Provera are used to treat the hot flashes and other symptoms that accompany menopause. In 2002, a major study conducted by the National Institutes of Health (NIH) determined that Prempro, Premarin and similar drugs significantly increased the risk of stroke, blood clots, heart attacks and breast cancer. The results were so alarming that the NIH canceled the study, citing risk to the study’s participants. The authors of the study suggested that many of the women who used the medications should quit and talk to their doctors about alternatives.

 

 

]]> HRT Study: Tenderness May Be Breast Cancer Warning Sign http://www.yourlawyer.com/articles/read/17117 Tue, 13 Oct 2009 00:00:00 -0400 http://www.yourlawyer.com/articles/read/17117
"We report that an increase in breast tenderness, easily detected by physicians or patients, identifies a population at particular risk for breast cancer," said Dr. Carolyn Crandall of the University of California Los Angeles and colleagues, quoted Reuters, citing the Archives of Internal Medicine.

The team looked at data from over 16,000 women who took estrogen-plus-progestin as part of the widely publicized Women's Health Initiative, or WHI study, which was initiated in 1991 and stopped in 2002 after, said Reuters, researchers discovered that healthy women in menopause and on HRT were likelier to develop breast cancer. Since, an array of adverse effects has been associated with HRT.

According to Reuters, most of study participants were taking either Wyeth’s Premarin or Prempro.

The team looked at 8,506 women who took estrogen plus progestin and 8,102 who took a placebo, said Reuters, explaining that participants underwent mammograms and breast exams at the beginning of the trial and annually thereafter. As part of the study, the women reported on breast tenderness at the beginning of the trial and, again, the following year, according to Reuters. The team determined that women on HRT had a three-fold risk of experiencing breast tenderness, with those women experiencing a 48 percent increased risk of developing invasive breast cancer. "We need to figure out what makes certain women more susceptible to developing breast tenderness during hormone therapy," Crandall said in a statement, quoted Reuters.

The researchers said that the tenderness while on HRT "may be a marker of increased breast cancer risk," and urged women with breast tenderness after HRT to discuss the issue with their physicians, wrote Reuters. Over 400,000 women die from breast cancer worldwide every year, with most—75 percent—diagnosed as estrogen-receptor positive, said Reuters, which explained that that type of cancer is “fed by” the hormone estrogen.

Meanwhile, we recently wrote that WebMD reported that HRT has been linked to an increased risk of women dying from lung cancer and pointed out that women on combined HRT also exhibited increased risks for heart disease and stroke, breast cancer, and other adverse health events.

We have been following outcomes from the WHI and issues with HRT and recently wrote that while HRT has long been linked to female cancers and fatal blood clots, another study just concluded that women on HRT might be doubling their skin cancer risks. Yet another study revealed a connection with how HRT shrinks the brain. In addition to an increased risk of stroke and cerebrovascular disease in post-menopausal women on HRT, the WHI Memory Study also found that post-menopausal women on HRT suffered from a higher risk of dementia and memory problems.

]]> Unsealed Docs In Prempro, Premarin Lawsuits Highlight Wyeth Ghostwriting Efforts http://www.yourlawyer.com/articles/read/16845 Wed, 05 Aug 2009 00:00:00 -0400 http://www.yourlawyer.com/articles/read/16845 The New York Times, the articles were published under the bylines of doctors who did not contribute much to the actual piece.

According to the Associated Press,  a federal judge overseeing hormone replacement therapy lawsuits on Friday ordered that thousands of pages of documents regarding Wyeth's ghostwriting practices be unsealed.  The New York Times was among the parties that had petitioned to have the documents unsealed.   Over 8,000 lawsuits have been combined before U.S. District Judge Bill Wilson that focus on Wyeth's hormone replacement drugs Premarin and Prempro,  and their link to  breast cancer, the Associated Press said.

According to the Associate Press, "ghostwriting is when a drug company conjures up the concept for an article that will counteract criticism of a drug or embellish its benefits, hires a professional writing company to draft a manuscript conveying the company’s message, retains a physician to sign off as the author and finds a publisher to unwittingly publish the work".  The published articles are then presented to "physicians as independent proof that the companies’ drugs are safe and effective". As we have reported in the past, critics claim it is a common practice.

According to the New York Times, Wyeth managed to publish 26 such ghostwritten articles supporting hormone replacement therapy. In many cases, the articles purported to analyze existing research and offer treatment recommendations, the Times said.  The true authors of the articles were not disclosed.  They emphasized the benefits of hormone therapy and de-emphasized the risks.

The 26 articles were published in 18 medical journals including The American Journal of Obstetrics and Gynecology and The International Journal of Cardiology between 1998 and 2005, the Times said.

We have long been reporting on the frequent use of ghostwriting by drug makers. For instance, earlier this summer we reported that Zyprexa maker Eli Lilly apparently asked doctors to put their names on articles written by company officials in an effort to promote the drug. The company’s alleged strategy to use ghostwritten articles to increase Zyprexa sales was revealed when more than 10,000 pages of internal documents were unsealed in May in lawsuits alleging Eli Lilly exaggerated Zyprexa’s effectiveness.

Last April, the Journal of the American Medical Association published analysis of court documents uncovered in the course of Vioxx injury lawsuits that found that Merck & Co. employees worked alone or with publishing companies to write Vioxx study manuscripts and later recruited academic medical experts to put their names as first authors on the studies.

According to the Times report, Wyeth adopted a policy in 2006 requiring that listed authors must become involved early in the publication process.  Under the policy, financial assistance by Wyeth or contributions by medical writers must be acknowledged in the published text.

]]> More Evidence Links HRT to Breast Cancer http://www.yourlawyer.com/articles/read/16003 Thu, 05 Feb 2009 00:00:00 -0500 http://www.yourlawyer.com/articles/read/16003 Prempro and an increase in some cancers.  Now, emerging evidence has more clearly linked the medication protocol to breast cancer, reports BBC News.

The BBC said the study found that the risk of breast cancer dropped significantly when HRT was stopped, according to New England Journal of Medicine research.  Also, an expert in the United Kingdom concluded that a 50 percent drop in HRT use likely prevented about 1,000 annual cases of breast cancer, said the BBC.

Up until now, said the BBC, findings from 2002’s broad Woman’s Health Initiative (WHI) study that said the combination of two hormones—oestrogen and progestin—were linked to an increase in breast cancer; however, experts have been unable to agree on this finding.  Frightening, because the estrogen-progestin combination is the most popularly prescribed HRT in the United Kingdom, said the BBC.  The United States stopped, for the most part, prescribing the combo HRT protocol in 2002.

The team said their research ends the questions, especially since the number of American breast cancer cases saw a steep decline following the end to combined HRT in 2002, further cementing the breast cancer-HRT link, reported the BBC.

The research followed 15,000 women who took part in the original WHI study and who ceased HRT in 2002, revealing heightened breast cancer incidences in the five years prior to 2002, but a stark drop to 28 percent in the 12 months after HRT was discontinued, said the BBC.  The team also reviewed data on women not involved in the study and who had also not been told to stop HRT and found that the 50 percent decline in those who opted to stop HRT also saw a 43 percent decline in breast cancer rates between 2002 and 2003, alone, said the BBC.  Women in this second group who continued HRT saw an increased breast cancer risk, with a doubling seen each year following the first five years. "This is very strong evidence that oestrogen plus progestin causes breast cancer.  You start women on hormones and within five years their risk of breast cancer is clearly elevated.  You stop the hormones and within one year their risk is essentially back to normal.  It's reasonably convincing cause-and-effect data, Dr. Marcia Stef
anik, from Stanford University said, quoted the BBC.

The Press Association noted that the findings present “powerful new evidence” linking breast cancer risks to post-menopausal women on long-term HRT.  The WHI trial established links between not only breast cancer and HRT, but also between HRT and blood clots and strokes, with results so convincing that the WHI was stopped three years earlier than planned, said the Press Association.  Following release of WHI trail data, HRT use declined rapidly—from 60 million to 20 million prescription from 2001 to 2005.  At the same time, breast cancer rates saw a sharp decline, which led many experts to believe there was a link between the drugs and cancer.  Some critics argued that the decline was due to an increase in mammography screenings; however, this new evidence points to an HRT link, said the Press Association.

Reuters noted that this study data presents the “strongest case yet” of the HRT and breast cancer link adding that most of the women involved in the WHI had been prescribed Wyeth’s Prempro, a combination estrogen-progesterone HRT pill.

]]> Brain Shrinkage Seen with Hormone Replacement Therapy http://www.yourlawyer.com/articles/read/15859 Wed, 14 Jan 2009 00:00:00 -0500 http://www.yourlawyer.com/articles/read/15859 Premarin and Prempro, especially as a result of the massive Women’s Health Initiative (WHI) study.  Now, it seems that HRT may shrink the brain.

According to two studies that reviewed the same group of women, while HRT does seem to shrink the brain, it has not yet been linked with early cerebrovascular disease, said HealthDay News.  In other words, HRT affects the size of the brain but does not seem to contribute to so-called “silent strokes.”  Both studies were published in the January 13 issue of Neurology.

"These are a nice companion to cognitive studies reported earlier. This is now neuroradiological evidence that, together, suggest that the effect [of hormones] may be more degeneration than vascular," said Miriam Weber, an assistant professor of physical medicine and rehabilitation and of neurology at the University of Rochester Medical Center, according to HealthDay News.

Last year, Reuters reported that historically, doctors believed HRT could protect women from chronic diseases, especially heart disease.  But use of HRT plunged after the 2002 Women's Health Initiative study found that HRT could raise the risk not only of breast and ovarian cancer, but also of strokes and other serious conditions.  Research since also indicates that the incidence of breast cancer dropped by 8.6 percent between 2001 and 2004 in the United States, in conjunction with the decline in HRT use.  HealthDay News also noted that in addition to an increased risk of stroke and cerebrovascular disease in post-menopausal women on HRT, the WHI Memory Study found that post-menopausal women on HRT suffered from “an increased risk of dementia and memory problems.”

The two new studies were conducted to look at the link between a higher risk of dementia and women being treated with CEEs—conjugated equine estrogens, which is hormone treatment with either estrogen or estrogen plus progestin.  In the first, the team looked at brain scans from 1,400 women who took part in WHI’s Memory Study.  Those women had been on HRT fro between four and six years, said HealthDay News.  The second study looked at MRI scans from the same population, who HealthDay News said, is now between 71 and 89 years old, and found brain shrinkage in both the hippocampus and frontal lobe area.  Both areas have to do with memory and cognitive function, said HealthDay News.

"Much to our surprise, we found a small but significant decrease in the hippocampal and frontal volumes, and a nonsignificant trend towards reduced total brain volume in women who had been randomized to hormone therapy," reported Susan M. Resnick, lead author of the second paper and a senior investigator with the Intramural Research Program at the U.S. National Institute on Aging, quoted HealthDay News. "The negative effects were most evident in women who already may have had some memory problems before using hormone therapy … so, it suggests that hormone therapy may be accelerating processes that have already begun."  Also, it seemed that the HRT effect was especially significant in women with more brain lesions, "… in women who were already having some problems, the hormone therapy did have an adverse effect," Resnick said.

]]> Wyeth Ghostwriting Allegations Investigated http://www.yourlawyer.com/articles/read/15720 Mon, 22 Dec 2008 00:00:00 -0500 http://www.yourlawyer.com/articles/read/15720
In his December 12 letter to Wyeth, Grassley wrote that the Senate Finance Committee had obtained documents from recent lawsuits involving Wyeth’s hormone drugs that relate to articles published in the American Journal of Obstetrics and Gynecology, Obstetrics and Gynecology, and Primary Care Update for OB/GYNs.  Grassley wrote that he was concerned that researchers listed as authors of those articles weren’t deeply involved in their writing.  

According the Senator, Wyeth may have paid DesignWrite Inc. of Princeton, New Jersey to write the articles. Grassley also wrote a similar letter to DesignWrite seeking information about its involvement in the allegedly-ghostwritten articles.

According to The Wall Street Journal Health Blog, one of the journal article in question was published a year after the Women’s Health Initiative linked Prempro hormone-replacement product to an increased risk for breast cancer. The May 2003 article, which was published in the American Journal of Obstetrics and Gynecology, said there was “no definitive evidence” for that link.

Elsevier publishes the American Journal of Obstetrics and Gynecology.  According to The Wall Street Journal, the publishing company said  Grassley’s charges “are a significant concern” and added, “as with any charge of misconduct or inappropriate publishing acts, The Journal has launched its own investigation into the claims of ghostwriting and undisclosed financial support.”

Other drug makers have been the subject of ghostwriting accusations in the past, and industry critics claim it is a common practice.  For example, last April an analysis of court documents uncovered in the course of Vioxx injury lawsuits found that Merck & Co. employees worked alone or with publishing companies to write Vioxx study manuscripts and later recruited academic medical experts to put their names as first authors on the studies. According to the analysis, which was published in the Journal of the American Medical Association, Merck’s involvement in producing the data wasn’t disclosed in many cases.

]]> Wyeth Accused of Using Ghostwriters for Prempro, Pemarin Studies http://www.yourlawyer.com/articles/read/15672 Mon, 15 Dec 2008 00:00:00 -0500 http://www.yourlawyer.com/articles/read/15672 Prempro.

Grassley is the top Republican on the Senate Finance Committee.  He has been on something of a crusade to uncover the manner in which pharmaceutical companies use their vast financial resources to influence medical research, and the way results of studies are presented.

In his letter to Wyeth, Grassley wrote that his Committee had obtained documents from recent lawsuits involving Wyeth’s hormone drugs that relate to articles published in the American Journal of Obstetrics and Gynecology, Obstetrics and Gynecology, and Primary Care Update for OB/GYNs.  Grassley wrote that he was concerned that researchers listed as authors of those articles weren’t deeply involved in their writing.

According to The Wall Street Journal Health Blog, one of the journal article in question was published a year after the Women’s Health Initiative linked Prempro hormone-replacement product to an increased risk for breast cancer. The May 2003 article, which was published in the American Journal of Obstetrics and Gynecology, said there was “no definitive evidence” for that link.

“Any attempt to manipulate the scientific literature, that can in turn mislead doctors to prescribe drugs that may not work and/or cause harm to their patients, is very troubling,” Grassley wrote in his letter to Wyeth.

Grassley also wrote a similar letter to DesignWrite seeking information about its involvement in the allegedly-ghostwritten articles.

Other drug makers have been the subject of ghostwriting accusations in the past, and industry critics claim it is a common practice.  For example, last April an analysis of court documents uncovered in the course of Vioxx injury lawsuits found that Merck & Co. employees worked alone or with publishing companies to write Vioxx study manuscripts and later recruited academic medical experts to put their names as first authors on the studies. According to the analysis, which was published in the Journal of the American Medical Association, Merck’s involvement in producing the data wasn’t disclosed in many cases.

]]> Hormone Drugs Linked to Breast Cancer, Again http://www.yourlawyer.com/articles/read/15673 Mon, 15 Dec 2008 00:00:00 -0500 http://www.yourlawyer.com/articles/read/15673
Hormone therapy drugs like Premarin, Prempro, Premphase and Provera are used to treat the hot flashes and other symptoms that accompany menopause.  The drugs have been linked to breast cancer by various studies. Wyeth Pharmaceuticals, the maker of Prempro and Premarin, faces more than more than 5,000 lawsuits filed by and on behalf of women who blame the drugs fro their breast cancer.

Accoring to Time/CNN, the new WIH findings are “the most dramatic evidence yet of the dangers of these” medications, noting that when women took estrogen and progestin pills for short periods, they still experienced an increased risk of developing cancer.  The study did find that once the women discontinued the therapy their prognosis improved, falling to a normal risk about two years after stopping the therapy, said Time/CNN.

According to the Department of Health and Human Services’ National Institutes of Health’s National Heart, Lung, and Blood Institute, the WHI was a 15-year research program, consisting of a variety of clinical trials and studies that was launched in 1991 and involved 161,808 healthy post-menopausal women; the women were generally in their 60s and past menopause.  The WHI trials were developed to look at the effects of a variety of issues relative to this population, including HRT.  The hormone trial consisted of two studies.  One was an estrogen-plus-progestin study of women with a uterus and the other was an estrogen-only of women with no uterus.  The studies were ended early; however, the women involved in the original initiative continue to participate in a follow-up that is expected to last until 2010.  Time/CNN reported that the study was halted in 2002 when researchers noted an unusually high risk of cardiac problems and breast cancer in hormone users.

Since the WHI was initiated, experts have long argued about the risks that affect women who begin HRT upon entering menopause—which usually takes place as women enter their 50s—and going on HRT for short time frames, said Time/CNN.

The AP reported that the results of the new study clearly indicate that HRT risks are, in fact, greater than the benefits and noted that the recent drop in breast cancer rates see, to be linked to a decline in HRT use, according to Dr. Rowan Chlebowski of Harbor-UCLA Medical Center in Los Angeles.  Also, the AP, quoting Dr. Claudine Isaacs of Georgetown University's Lombardi Comprehensive Cancer Center, reported that Isaacs said, in response to the new results that, “It's an excellent message for women: You can still diminish risk (by quitting), even if you've been on hormones for a long time, it's not like smoking where you have to wait 10 or 15 years for the risk to come down."  The recent study analysis was discussed this weekend at the San Antonio Breast Cancer Symposium, said the AP.

The Wall Street Journal stated that the research team reviewed the point at which breast cancer occurred, noting that the risk increased when hormones were initiated and declined following HRT cessation.

]]> Premarin, Prempro, Other Hormone Drugs Named in Nevada Lawsuit http://www.yourlawyer.com/articles/read/15546 Thu, 20 Nov 2008 00:00:00 -0500 http://www.yourlawyer.com/articles/read/15546 Premarin, Prempro and Premphase.  This time, the state of Nevada is charging that Wyeth used deceptive practices in selling the drugs.  The Nevada attorney general has also targeted Pfizer, Inc.'s Provera.

The Nevada lawsuit charges that Wyeth and Pfizer misled consumers about the safety and effectiveness of the hormone therapy drugs.  The lawsuit claims that the deception  resulted in over-prescribing and a dramatic increase in hormone-positive breast cancers in post-menopausal women.

"When drug companies purposefully misrepresent the safety and efficacy of their drugs, or promote their drugs in a deceptive way, everybody loses," Attorney General Cortez Masto said in a statement. "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."

Hormone therapy drugs like Premarin, Prempro, Premphase and Provera are used to treat the hot flashes and other symptoms that accompany menopause.  In 2002, a major study conducted by the National Institutes of Health (NIH) determined that Prempro, Premarin and similar drugs significantly increased the risk of stroke, blood clots, heart attacks and breast cancer. The study results were so alarming that the NIH canceled the study, citing risk to the study’s participants. The authors of the study suggested that many of the women who used the medications should quit and talk to their doctors about alternatives.

According to a press release issued by Masto's office, the attorney general's lawsuit was filed in conjunction with private law firms representing victims of Premarin, Prempro, Premphase and Provera.  Those firms have been litigating similar cases on behalf of individual Nevada women for over four years, resulting in numerous settlements and a 2007 verdict in Reno on behalf of three women with breast cancer, the release said.

]]> HRT May Make Joint Replacement More Likely http://www.yourlawyer.com/articles/read/15406 Tue, 28 Oct 2008 00:00:00 -0400 http://www.yourlawyer.com/articles/read/15406 Premarin and Prempro are used to treat menopause symptoms.

The findings are a bit surprising because HRT is a popular preventative measure for osteoporosis, thinning of the bones.  The Oxford team said that while the results are baffling, they may be due to the effect of the oestrogen in HRT on the joints.  Meanwhile, other experts challenged the findings, noting that separate research on HRT shows it improves joint elasticity.  The research team believes HRT probably enables women to stay fitter for longer, resulting in greater demand for joint replacements as compared with their more sedentary counterparts.  The newest findings were published today in the journal Annals of the Rheumatic Diseases and are the result of a survey of 1.3 million middle-aged British women.

As part of the survey, the researchers asked women how old they were when they had their first and last periods, how many children they had given birth to, and whether they had used oral contraceptives and HRT.  The women were monitored for about six years to determine if they were admitted to a hospital for a knee or hip replacement for the joint disease osteoarthritis.  In the period studied, over 12,000 women required a hip replacement; slightly less than 10,000 required a knee replacement.  Those women who gave birth to a lot of children and who experienced puberty early also showed a higher chance of requiring joint replacement.  Onset of menstruation at or before age 11 increased the probability of both types of replacement surgery by between nine and 15 percent.  Another increasing factor for replacement surgery was each birth—for hips, by two percent per child and for knees by eight percent per child.  Although oral contraceptives do supply the body with additional oestrogen, previous use had no affect on the need for joint surgery.

Researcher Dr. Bette Liu said, “These findings, along with other evidence, strongly suggest that the female sex hormone oestrogen plays a role in the development of osteoarthritis of the hip and knee and the subsequent need for joint replacement.”  Many experts feel that women taking HRT are better off and better educated and could be receiving joint replacements because they make more use of health services.

Dr. Liu noted that, ‘There is not enough evidence to recommend women change their use of HRT because they may be worried about developing osteoarthritis or having a joint replacement.”  Meanwhile, Dr. John Stevenson, chairman of the charity Women's Health Concern, pointed out that previous studies using MRI scans found HRT users had more cartilage in knee joints than non-users, which would help prevent osteoarthritis.  “There is no plausible biological reason for this finding when we know oestrogen protects bones,” he added.  “If it's correct then it may demonstrate that women on HRT who tend to be more active may eventually need a replacement as a result of more wear and tear, especially as they tend to live longer than women not taking HRT.”

]]> Another HRT Drug Linked to Stroke Risk http://www.yourlawyer.com/articles/read/14958 Fri, 15 Aug 2008 00:00:00 -0400 http://www.yourlawyer.com/articles/read/14958 Food & Drug Administration (FDA) in 2006.  

Hormone replacement therapies (HRT)  have long been problematic medications.  In 2002, a major HRT study conducted by the National Institutes of Health (NIH) determined that Prempro and similar drugs significantly increased the risk of stroke, blood clots, heart attacks and breast cancer. The study results were so alarming that the NIH canceled the study, citing risk to the study's participants. The authors of the study suggested that many of the women who used Prempro and other estrogen and progestin combinations HRTs should quit and talk to their doctors about alternatives.

HRT medications  are meant to help relieve serious symptoms of menopause, such as hot flashes and vaginal dryness and other menopause symptoms.  In some cases, they are also used to prevent osteoporosis in those at high risk for fractures who can't take other drugs.   The reduction of the hormone estrogen that occurs during menopause is linked to the bone disorder.

Livial contains estrogen and two other hormones.  The study included 4,538 women in 22 countries. Half were given Livial daily while the other half were given a placebo for almost three years.  Women taking Livial had a 2.2 times increased risk of stroke. This increased stroke risk caused the study to be stopped in February 2006, before the trial was complete.

On the positive side, women ages 60 to 85 who took Livial had 45 percent decreased risk of spinal fractures and a 68 percent reduced risk of breast cancer compared with those taking a placebo, according to research to be published in yesterday's New England Journal of Medicine.

Despite those benefits, the drug shouldn't be used in women over the age of 60, particularly those with an increased risk for stroke, lead researcher Dr. Steven R. Cummings, of the California Pacific Medical Center Research Institute in San Francisco Cummings told "USNews and World Report". "For older women, you should stop taking tibolone or not consider starting it," he said.

]]> Wyeth Settles Premarin, Prempro Lawsuits http://www.yourlawyer.com/articles/read/14762 Wed, 16 Jul 2008 00:00:00 -0400 http://www.yourlawyer.com/articles/read/14762 Premarin and Prempro, has settled lawsuits with two Nevada women who blamed the Hormone Replacement Therapy (HRT) drugs for their breast cancers. Wyeth faces more than more than 5,000 lawsuits over the menopause drugs, which are still on the market.

HRT is used to treat the hot flashes and other symptoms that accompany menopause.  In 2002, a major HRT study conducted by the National Institutes of Health (NIH) determined that Prempro, Premarin and similar drugs significantly increased the risk of stroke, blood clots, heart attacks and breast cancer. The study results were so alarming that the NIH canceled the study, citing risk to the study's participants. The authors of the study suggested that many of the women who used HRT should quit and talk to their doctors about alternatives.

Vesta Woodhouse, 71, and Annie Woods, 61, were among the millions of women who used HRT.  Their lawsuits claimed Wyeth failed to adequately warn them about the drugs' breast cancer risks. Woodhouse took Prempro for 19 months before developing breast cancer. Woods took Premarin, Provera and then Prempro for about five years before developing breast cancer.   Provera is an HRT medication marketed by Pfizer.  Wyeth settled with both women for an undisclosed amount, but Woods still has a lawsuit pending against Pfizer.   That lawsuit is scheduled to go to trial this week.

According to a report on Bloomberg.com, Wyeth has lost four of seven cases over menopause drugs Premarin and Prempro since they began going to trial in 2006. Upjohn has lost both cases that have gone to trial over Provera, which came on the market in 1959. New York-based Pfizer acquired Upjohn in 2003 as part of the $54 billion acquisition of Pharmacia Corp.

]]> Another HRT Study Cites Breast Cancer Risk http://www.yourlawyer.com/articles/read/14485 Fri, 30 May 2008 00:00:00 -0400 http://www.yourlawyer.com/articles/read/14485 Prempro and Premarin - taken for more than five years, increases one’s breast cancer risk, confirming earlier findings out of the United States.

Over 10,000 people between 50 and 74 were studied over six years: 3,464 breast cancer patients and 6,657 healthy women.  The German survey was prompted by the "MARIE" case-control study carried out by the German Cancer Research Center (DKFZ) and the University Hospitals in Hamburg-Eppendorf, Germany.  The study’s goal, which was financed by the German Cancer Aid (Deutsche Krebshilfe), was to determine hormone effects—on their own and with other factors—on breast cancer risk.

The study found that women who have already been treated with menopausal HRT have a 37 percent higher risk of breast cancer than women who never took HRT; during actual use, the risk increases by 73 percent.  Within five years after cessation, the risk in former HRT users falls back to the same level of women who never used HRT.  "These results of the MARIE study confirm findings of two U.S. and U.K. studies (Women's Health Initiative Study and Million Women Study) that caused a stir in 2002 and 2003," says Professor Dr. Wilhelm Braendle of Hamburg-Eppendorf University Hospitals, who headed the study.

"It has often been argued that the results of the U.S. study could not be applied to Germany where prescription practices are completely different.  Therefore, we captured the various hormone preparations, especially the various progestins, very precisely.  We have obtained similar results as the U.S. researchers," Professor Dr. Jenny Chang-Claude of DKFZ summarizes.  "With our new data, we provide physicians in Germany with solid information that will help them to advise their patients about the benefits and risks of hormone replacement therapy."

The study confirms that different preparations have different effects.  When compared to the risk of women who never used HRT, a combined estrogen and progestin therapy doubles the risk of breast cancer, while estrogen alone (estrogen replacement therapy) raises the risk by 15 percent.  In both cases, the risk increases when hormones are taken for more than five years.  "Hormone replacement therapy also appears to have a different influence on different types of breast cancer," Braendle explains. "The risk of developing one of the less common lobular or tubular breast cancers increases twice as much under HRT as the risk of the common type of ductal carcinoma, which constitutes 40 to 75 percent of all malignant tumors of the breast."

In January, U.S. researchers reported HRT significantly raises the risk of lobular breast cancer four-fold in women who took combined estrogen/progestin HRT for three years.  That study is one of dozens looking to clarify the dangers of taking HRT to treat menopause symptoms.  "Previous research indicated that five or more years of combined hormone-therapy use was necessary to increase overall breast-cancer risk," said Dr. Christopher Li of the Fred Hutchinson Cancer Research Center, who led the study.  "Our study, the first specifically designed to evaluate the relationship between combined HRT and lobular breast cancers, suggests that a significantly shorter length of exposure to such hormones may confer an increased risk," he added.

]]> HRT Can Significantly Increase Stroke Risk http://www.yourlawyer.com/articles/read/14307 Wed, 30 Apr 2008 00:00:00 -0400 http://www.yourlawyer.com/articles/read/14307 hormone replacement therapy (HRT) can increase post-menopausal women’s stroke risk regardless of when the HRT begins.  While the risk for stroke seems to be lower in younger women taking HRT and in women taking the lowest doses of estrogen, Harvard researchers say women who took high hormone doses experienced an increased stroke risk by as much as 62 percent.

"If you take medium to higher doses of hormone therapy, you are at increased risk of stroke," said Dr. James Liu, chairman of the Department of Obstetrics and Gynecology at MacDonald Women's Hospital, University Hospitals Case Medical Center in Cleveland.  "If you are on estrogen, the risks of clotting abnormalities are slightly increased versus if you are not on estrogen," Liu said. "So, the risk of stroke is increased."  The report was published in the April 28 edition of the Archives of Internal Medicine.

Francine Grodstein and colleagues at Brigham and Women's Hospital and Harvard Medical School collected data on 121,700 women who participated in the Nurses' Health Study from 1976 to 2004.  Researchers looked at the link between HRT and stroke and found that 360 women who had never used HRT had strokes compared with 414 women taking hormones.  "This increased risk was observed for women initiating hormone therapy at young ages or near menopause and at older ages or more than 10 years after menopause," the researchers wrote.

Women taking HRT for less than five years and at younger ages did not have a clear increase of stroke.  The researchers noted that this could have been because only a small number of cases were studied.  "The incidence of stroke was relatively low in younger women and the attributable risk in women aged 50 through 54 years indicated approximately an additional two cases of stroke per 10,000 women per year taking hormones," the researchers added.

Liu noted that older women, in general, are at an increased risk of stroke due to their age, whether or not they are taking HRT.  Also, higher estrogen doses were associated with an increased risk for stroke and women taking high estrogen doses increased their risk of stroke by 62 percent.

"In summary, our findings in the Nurses' Health Study indicate that hormone therapy is associated with an increased risk of stroke, regardless of the hormone regime or the timing of hormone therapy initiation," the researchers concluded.  "However, in younger women, who are at lower absolute risk of stroke, the attributable risk of stroke owing to hormone use is modest, and our data suggest that risk might be further minimized by lower doses and shorter duration of treatment."

Earlier this month, another study—Dose-Response Effect of Estrogen on the Kidney and Heart—revealed that estrogen replacement therapy (ERT) may increase the risk of cardiovascular disease and found moderate and high doses of ERT increased problems in the kidney and heart, suggesting ERT dosage may be an important factor in a woman’s overall health.

]]> HRT Increases Risk of Benign Breast Disease http://www.yourlawyer.com/articles/read/14191 Thu, 10 Apr 2008 00:00:00 -0400 http://www.yourlawyer.com/articles/read/14191 hormone replacement therapy (HRT) during menopause more than doubled their risk for certain types of benign breast disease—for example, benign proliferative breast disease—as compared with women who took a placebo—over an average follow-up of almost seven years.  Benign proliferative breast disease is relatively common and has also been linked with an increased risk of breast cancer.

The clinical implication for women contemplating the use of supplemental estrogen "doesn't really change," said study author Dr. Tom Rohan, chairman of the department of epidemiology and population health at the Albert Einstein College of Medicine in New York City.  "It's the idea that women need to balance the benefits and risks," he said.  This new finding does point to an added risk, however, Rohan added.  Rohan’s team published the study online on April 8 in the Journal of the National Cancer Institute.

Until now, there have been no randomized studies—considered the gold standard of scientific testing—on the effect of conjugated equine estrogen (CEE), a type of HRT, and its link to the risk of developing benign proliferative breast disease.  This data is generated from the huge Women's Health Initiative (WHI) CEE trial, in which almost 11,000 postmenopausal women were randomly assigned to receive CEE or a placebo.

Experts believe invasive breast cancer can result from a succession of conditions, with benign proliferative breast disease without atypia (cell abnormalities) sometimes followed by proliferative disease with atypia before development of in situ (localized) cancer.  This study did not see an increase in the risk of developing invasive breast cancer but the progression from benign proliferative breast disease to invasive breast cancer could take a decade and this study was not long enough to note that change.  The progress of the women in the trial is still being followed, the researchers noted.

The WHI also found women taking estrogen with progestin experienced increased risk of breast cancer and benign proliferative breast disease after about five years of follow-up, suggesting progestin may be linked to breast cancer development.  "This makes perfect sense," said Dr. Jay Brooks, chairman of hematology/oncology at Ochsner Health System in Baton Rouge, La.  "Estrogen does stimulate breast tissue activity and my concern is that, if you do move along a continuum as the hypothesis states, as you stimulate the breast are you going to be able to predict which women are going to develop into something worse and women who are going to stay in a benign state. I can't predict which of those women will develop [breast cancer] down the line but we know that this agent is highly stimulatory to breast tissue so the question is, do you want to be taking an agent that stimulates breast tissue?"

Last month, also as a follow-up to the up to the WHI, research revealed that while heart problems linked with combination HRT in postmenopausal women decreases when hormones are stopped, the breast cancer risk increases after women stop HRT.

]]> Prempro, Provera Makers Must Pay $27.1 Million in Punitive Damages for Arkansas Woman's Breast Cancer http://www.yourlawyer.com/articles/read/13997 Fri, 07 Mar 2008 00:00:00 -0500 http://www.yourlawyer.com/articles/read/13997 Prempro and Provera hormone replacement therapy (HRT) drugs was awarded more than $27 million  in punitive damages  by an Arkansas jury.  The jury had found that Wyeth, the maker of Prempro, and Pfizer Inc/, the maker of Provera, were responsible for her breast cancer.  This is the second time that Wyeth has been ordered to pay out punitive damages in  lawsuits filed over Prempro and its other HRT drug, Premarin.

Prempro is a hormone replacement therapy (HRT) that consists of a combination of estrogen and progestin.  Prempro was introduced by Wyeth Pharmaceuticals in 1996, and it is used to treat hot flashes and other symptoms of menopause.  In 2002, a major HRT study conducted by the National Institutes of Health (NIH) determined that Prempro and similar drugs resulted in a 26 percent higher chance of developing breast cancer. The study results were so alarming that the NIH canceled the study, citing risk to the study's participants. The authors of the study suggested that many of the women who used Prempro and other estrogen and progestin combinations should quit and talk to their doctors about alternatives.

Earlier this week the NIH issued a follow-up to the 2002 study that found that women who had ended combination HRT therapy still faced an increased risk of breast cancer.  Women who took estrogen and progestin during the study but stopped in 2002 were still about 27 percent more likely to develop breast cancer than the women who did not take the hormones at all. Researchers also noted a 24 percent increased risk in developing any form of cancer, chiefly lung cancer, among women who had been in the hormone group. Overall, there were 63 more diagnoses of cancer during the follow-up study, or three per 1,000 participants per year, according to the NIH.

Wyeth and Pfizer Inc. were ordered to pay the Arkansas women $27.1 million in punitive damages.  The jury had found that Wyeth's Prempro and Pfizer's Provera had caused her to develop breast cancer, and further determined that the companies had shown ``reckless disregard'' for the health risks posed by their HRT drugs and should be punished.  Wyeth's share of the punitive damages came to $19.3 million, while Pfizer's amounted to $7.7 million.

This is not the first time Wyeth has been ordered to pay punitive damages because of its HRT drugs.  In October 2007, a Nevada Jury awarded $99 million in such damages to three women after finding that the treatments caused their breast cancers. A judge slashed the award to $58 million last month.  In all, Wyeth faces 5,300 lawsuits over its HRT drugs, and has lost four cases since 2006.

]]> HRT Breast Cancer Risk Increases Long After Therapy End http://www.yourlawyer.com/articles/read/13983 Wed, 05 Mar 2008 00:00:00 -0500 http://www.yourlawyer.com/articles/read/13983 Premarin and Prempro, could increase a woman's breast cancer risk long after she has finished HRT.  A new hormone study—the first follow-up to the landmark Women's Health Initiative (WHI)—reveals that although heart problems linked with combination HRT in postmenopausal women decreases when the hormones are stopped, the risk of breast cancer increases even after women stop HRT.  This finding was published in the March 5 issue of the Journal of the American Medical Association.  The original trial, which studied 16,608 postmenopausal women, was abruptly stopped in 2002 when links were revealed between postmenopausal women taking combination HRT—estrogen and progestin—and an increased risk of cardiovascular disease, stroke, blood clots, and breast cancer.

"Within a couple of years, the [raised] risk for stroke, serious blood clots, and heart attack disappears, but so do the benefits to bone," added study author Marcia Stefanick, a professor of medicine at Stanford University.  "The concerning issue is the risk for all cancers remains significantly elevated, mostly because of breast cancer."  A study in the Archives of Internal Medicine last week found women taking combined HRT for about five years had a higher risk of abnormal mammograms and breast biopsies, which may decrease the effectiveness of these methods for detecting breast cancer.  Stefanick is chairwoman of the WHI investigator group, and Liu was the principal investigator for the WHI in Cincinnati until 2001.

That the associated heart trouble may not be permanent is promising.  The new risks for other cancers—specifically lung tumors—in women who were on estrogen-progestin treatment for about five years, has researchers and other experts concerned.  Those risks "were completely unanticipated," said Dr. Gerardo Heiss of the University of North Carolina in Chapel Hill, lead author of the follow-up analysis.

The new study involved 15,730 of the original WHI participants for an average of three years after that trial ended and found the risk of cardiovascular problems was similar in the HRT and placebo groups; however, there was a greater risk of overall cancer in the HRT group as compared with the placebo group.  During that time, those who'd taken hormones but stopped were 24 percent more likely to develop any kind of cancer than women who'd taken dummy pills during the study.  Death from any cause was 15 percent higher in the HRT group than in the placebo group.  Putting all these factors together, the risks of combined HRT exceed the benefits, the authors stated.  "The really important message for women is they need to get a mammogram if they've stopped using hormones," Stefanick said.  "They shouldn't think everything is fine. They need to get a mammogram to make absolutely sure. Once they've stopped the hormones, you have a better chance of detecting them."  Follow-up data in the estrogen-alone portion of the WHI is not yet available.

The authors said the new results send the same message they've been advocating ever since the study ended which is that health risks from estrogen-progestin pills outweigh their benefits and should only be used to relieve hot flashes and other menopause symptoms in the lowest possible dose for the shortest possible duration.

]]> Prempro, Premarin Judgment against Wyeth Reduced by Nevada Judge http://www.yourlawyer.com/articles/read/13906 Wed, 20 Feb 2008 00:00:00 -0500 http://www.yourlawyer.com/articles/read/13906 Prempro and Premarin patients in Nevada was reduced substantially by a District Judge in that state. The three plaintiffs had claimed that Prempro and Premarin had caused them to develop breast cancer.  A Nevada jury agreed, and had originally ordered Wyeth, the maker of Prempro and Premarin, to pay the three women $134 million.  But Washoe County District Judge Robert Perry granted Wyeth’s motion to find the damages excessive. He ordered them reduced to about $58 million total.

Prempro and Premarin are Hormone Replacement Therapy (HRT) drugs.  Prempro combines estrogen and progestin into one pill, while Premarin is an estrogen replacement medication.  The drugs are prescribed to treat women experiencing menopausal symptoms that include mood swings, hot flashes, night sweats, vaginal dryness and osteoporosis.  In 2003, a large federal study linked HRT drugs like Prempro and Premarin to an increased risk of breast cancer. Within months, millions of women stopped taking HRT.  In 2007, a study by the National Cancer Institute found that breast cancer incidence rates in women in the United States fell 6.7 percent in 2003 from the previous year and have since stabilized.  Many experts attributed the drop in breast cancer rates to the fact that many women quit using HRTs once they were linked to breast cancer.

Jurors in the Reno case had awarded Jeraldine Scofield, 74, Arlene Rowatt, 67 and Pamela Forrester, 65, a combined $35 million for medical expenses and physical and emotional pain and suffering. The same panel then awarded the women $99 million in punitive damages. But in his ruling, Judge Perry said he was concerned that the Jury’s decision in the case was influenced by "passion and prejudice".  He reduced the award to $23 million in compensatory and $35 million in punitive damages.

The new judgment awards Rowatt $7.6 million in compensatory and $10 million in punitive damages. Forrester was awarded $8 million compensatory and $13 million punitive, and Scofield gets $7.3 million compensatory and $12 million punitive.  According to the Associated Press, the award against Wyeth still stands as the largest personal injury award in Nevada history, and it is the largest award to date against Wyeth, which faces about 5,300 similar lawsuits across the country in state and federal courts.

Lawyers for the women told the Associated Press that the reduced award did nothing to mitigate Wyeth’s liability for the any plaintiff’s injuries.  "Wyeth has been exposed for its role in causing countless breast cancers in thousands of women across the country, and today's verdict reduction to just short of $60 million does nothing to change the gravity of Wyeth's wrongdoing," one of the lawyers said.

Despite his decision to reduce the judgment, Judge Perry seemed to agree with this assessment.  In his opinion, the Judge wrote, "There was substantial evidence from which the jury could conclude that Wyeth knew that its product could cause breast cancer, that it intentionally failed to conduct adequate tests, that it financed and manipulated scientific studies and sponsored articles in professional and scientific journals that deliberately minimized the risk of cancer while over-promoting certain benefits and citing others which it knew to be unsubstantiated.”

]]> Hormone Replacement Therapy – Even for Short Periods – Raises Breast Cancer Risk http://www.yourlawyer.com/articles/read/13693 Wed, 16 Jan 2008 00:00:00 -0500 http://www.yourlawyer.com/articles/read/13693 breast cancer.  The study found women who took combined estrogen/progestin HRT for three years or more had four times the usual risk of lobular breast cancer.  The study, published in the January issue of Cancer Epidemiology, Biomarkers and Prevention, is one of dozens of studies looking to clarify the dangers of taking HRT to treat menopause symptoms.  "Previous research indicated that five or more years of combined hormone-therapy use was necessary to increase overall breast-cancer risk," Dr. Christopher Li of the Fred Hutchinson Cancer Research Center, who led the study, said.  "Our study, the first specifically designed to evaluate the relationship between combined HRT and lobular breast cancers, suggests that a significantly shorter length of exposure to such hormones may confer an increased risk," he added.

According to the American Cancer Society, lobular breast cancer accounts for about 10 percent of all invasive breast cancers, the cancers that most threaten to spread to other parts of the body.  The cancer can be treated with hormone-based therapies such as tamoxifen, but the tumors are more difficult to detect by mammograms, so that the cancer is generally diagnosed in more advanced stages.

Li's team asked over 1,500 post-menopausal women in western Washington whether or not they had used HRT; 1,044 women had breast cancer and 469 did not.  The researchers found that women currently taking HRT were about three times as likely as other women to be among the cancer patients and those who used combined HRT for three or more years had a higher risk of lobular cancer.  They also said that the incidence of invasive lobular cancer rose by 52 percent in the United States between the years 1987 to 1999.  Also, cases of ductal-lobular breast cancer rose by 96 percent during and ductal cancer rates rose by three percent over the same time period.  "Our research suggests that the use of post-menopausal hormone-replacement therapy, specifically the use of combined estrogen-plus-progestin preparations, may be contributing to this increase," said Li.

Historically, doctors believed HRT could protect women from chronic diseases, especially heart disease.  But use of HRT plunged after the 2002 Women's Health Initiative study found that HRT could raise the risk not only of breast and ovarian cancer, but also of strokes and other serious conditions.  Research since also indicates that the incidence of breast cancer dropped by 8.6 percent between 2001 and 2004 in the United States, in conjunction with the decline in HRT use.  Today, doctors stress that younger women who need the drugs to relieve serious symptoms of menopause should still consider taking HRTs because new, lower-dose formulations are available and doctors now know to prescribe them for short periods of time.

"These findings are still of considerable public-health importance considering the estimated 57 million prescriptions for menopausal hormone therapy that continue to be filled in the United States," Li said.

]]> Hormones can raise breast cancer risk http://www.yourlawyer.com/articles/read/12775 Thu, 19 Apr 2007 00:00:00 -0400 http://www.yourlawyer.com/articles/read/12775
New U.S. government numbers showed that breast cancer rates leveled off in 2004 after plunging in 2003 the year after millions of women stopped taking hormones because a big study tied them to higher heart, stroke and breast cancer risks. Experts said the leveling off shows that the 2003 drop in the cancer rate was real and not a fluke.

From 2001 to 2004, breast cancer rates fell almost 9 percent a dramatic decline, researchers report in Thursday's New England Journal of Medicine. The trend was even stronger for the most common form of the disease tumors whose growth is fueled by hormones. Those rates fell almost 15 percent among women ages 50 to 69, the group most likely to have been on hormone pills.

At the same time, a study of nearly 1 million women in the United Kingdom showed that those who took hormones after menopause were 20 percent more likely to develop ovarian cancer or die from it than women who never took the pills. That study was published online by the London-based journal The Lancet.

For consumers, the new research doesn't change the advice to use the lowest dose for the shortest time possible for hot flashes and other menopause symptoms that can't otherwise be controlled.

For cautious scientists, the new breast cancer numbers were more evidence of the hormone-breast cancer link.

"The story has gotten stronger," said Dr. Peter Ravdin, a biostatistician at the University of Texas M.D. Anderson Cancer Center in Houston who led the research.

Some were skeptical several months ago when Ravdin and National Cancer Institute researchers first reported the 2003 drop in the breast cancer rate. The new numbers, which add 2004, prove this was no fluke, said Dr. Julie Gralow, a spokeswoman for the American Society of Clinical Oncology and cancer expert at the University of Washington in Seattle.

"Because it didn't bump back up again," it supports the idea that the rate has stabilized at a new lower level, said Gralow, who had no role in the study.

Brenda Edwards, one of the journal authors who is a National Cancer Institute researcher, agreed. "Now we have a statistically significant decline" over three years and clear proof of a trend, she said.

Although some recent analyses suggest heart risks from menopause hormones are not as great as had been believed for younger, newly menopausal women, the statistics out this week add to the worries about cancer.

After rising steadily through the 1990s, the breast cancer rate dipped from 2001 to 2002, from 138 cases to 135 cases per 100,000 women. After the federal Women's Health Initiative study reported in July 2002 on the health risks of hormones, use of the pills plunged.

So did the breast cancer rate the following year to 126 cases per 100,000 women. It was the steepest fall since the government started keeping records in the 1970s.

The drop was seen in all of the cancer statistics registries reviewed in the study, and no other cancer rate changed as dramatically strong signs that hormones were playing a role, specialists said.

The 2004 rate held steady at about 126 cases per 100,000.

Stopping hormone use may have stopped some cancers from growing and caused them to disappear, scientists speculate. Or it may have just slowed them down so that they won't appear until years later, said Ahmedin Jemal, an American Cancer Society researcher. Only time will tell which is true, he said.

Wyeth Pharmaceuticals, which makes top-selling hormone pills Prempro and Premarin, criticized the study as overly speculative. Company spokesman Dr. Joseph Camardo said hormone prescriptions continued to fall in 2004 but breast cancer rates did not decline proportionately.

Ravdin said the company's criticism does not invalidate the cancer trends.

Breast cancer is the most common major cancer in American women and the second leading cause of cancer deaths in women. About 180,000 new cases are expected to occur in the United States this year and more than 1 million worldwide.

Ovarian cancer is far less common. The British study found that even with the 20 percent greater risk from hormones, the actual risk was very low: 2.6 of every 1,000 hormone users developed ovarian cancer over five years compared to 2.2 in 1,000 non-hormone users.

Still, that means about 1,000 extra ovarian cancer deaths from 1991 through 2005, said study leaders at the Cancer Research UK Epidemiology Unit in Oxford.

Hormone use has declined already, and the new report should cause it to fall further, Dr. Steven Narod of the University of Toronto wrote in an editorial accompanying the study in The Lancet.

"We hope that the number of women dying of ovarian cancer will decline as well," he wrote.

Camardo, Wyeth's spokesman, said hormone labels already warn about an elevated risk of ovarian cancer.
]]> US drop in breast cancer linked to reduced hormone use http://www.yourlawyer.com/articles/read/12776 Wed, 18 Apr 2007 00:00:00 -0400 http://www.yourlawyer.com/articles/read/12776
The research, based on data from the National Cancer Institute, shows that the breast cancer incidence rates in women in the United States fell 6.7 percent in 2003 from the previous year and have since stabilized.

The drop corresponds with a rapid decline in prescriptions for hormone replacement therapy (HRT) at the time following headline-grabbing reports that post-menopausal women who were using HRT that included both estrogen and progestin showed increased risks of breast cancer, heart disease and stroke.

The number of prescriptions written for the two most commonly prescribed forms of HRT in the United States plunged from 61 million in 2001 to 21 million in 2004, the study's authors reported in the April 19 issue of the New England Journal of Medicine.

According to the research team led by Donald Berry of the University of Texas, the decline in breast cancer incidence began in mid-2002 and leveled off after 2003.

The researchers, comparing breast cancer rates from 2001 and 2004, found a decrease in annual incidence of 8.6 percent.

The decrease only occurred in women over 50 and were more pronounced in women with cancerous tumors that were dependent on estrogen to grow and multiply, they said.

Of other risk factors the researchers considered including rates of mammography screening and changes in diet HRT was the only risk factor that changed markedly from 2002 to 2003 "and provides a possible explanation for this trend," the National Cancer Institute said in a statement.

"The speed at which breast cancer rates declined after the Women's Health Iniatiative announcements may indicate that extremely small ER-positive breast cancers may have stopped progressing, or even regressed after HRT was stopped," the institute, a part of the National Institutes of Health, said.

The head of the institute, John Niederhuber, recalled that breast cancer is the most frequently diagnosed cancer among women in the United States but all its causes remain unknown.

"Breast cancer rates had been increasing for two decades up to 2002. Finding the simple ways, such as limiting HRT use to decrease breast cancer risk, is a step forward," Niederhuber said in the statement.]]> Woman wins $3 million verdict in case over Prempro link to cancer http://www.yourlawyer.com/articles/read/12573 Tue, 20 Feb 2007 00:00:00 -0500 http://www.yourlawyer.com/articles/read/12573
More than 5,000 women have sued New Jersey-based Wyeth over its hormone drugs Premarin and Prempro. Wyeth has won two cases and lost two cases, which have been heard in Arkansas and Philadelphia.

Both drugs remain on the market and carry the approval of the U.S. Food and Drug Administration, and both continue to be prescribed annually to hundreds of thousands of menopausal women.

But the lawsuits pending against Wyeth accuse the company of minimizing the drugs' risks.

Wyeth said it would appeal Tuesday's ruling. It maintains that it is impossible to prove that Prempro caused individual cancer cases.

"We respectfully disagree that there is any scientific basis to support the jury's finding of a causal link between Wyeth's hormone therapies and the plaintiff's breast cancer," Wyeth's attorney, Barbara R. Binis, said in a statement.

Nelson originally won a $1.5 million jury award in the fall, but a judge declared a mistrial. The second trial began Jan. 11.

"The jurors in this case understood how important it was to evaluate all of the evidence, and to let Wyeth know that dangerous products need adequate warnings," Nelson's lawyer, said in a statement.]]> Wyeth Loses Another Prempro Case http://www.yourlawyer.com/articles/read/12574 Tue, 20 Feb 2007 00:00:00 -0500 http://www.yourlawyer.com/articles/read/12574
Jennie Nelson was diagnosed with breast cancer in 2001, six years after she began taking Prempro. She’d won a $1.5 million verdict last fall in the case, but a judge declared a mistrial over concerns of juror misconduct. The new verdict doubled her award, offering $2.4 million in damages to her, plus an additional $600,000 to her husband. The jury found that Wyeth’s product warnings were inadequate and vague and that her use of the hormone replacement therapy (HRT) had a direct effect on her development of invasive breast cancer.

“We are very grateful to the members of the jury who carefully considered the facts in Mrs. Nelson’s case,” said plaintiff attorney Tobias Millrood. “We also find it especially rewarding that two separate juries have believed in the merits of the case and found for Mrs. Nelson. Both times this case has been heard on terms established by Wyeth, and still the juries have clearly found that Prempro causes breast cancer.”

Last month, the pharmaceutical giant was ordered by another Pennsylvania state jury to pay $1.5 million in compensatory damages to an Arkansas woman, Mary Daniel, and her husband who held Prempro responsible for the woman’s breast cancer. In that case, the jury cited conduct by Wyeth that was “malicious, wanton, willful, or oppressive, or showed reckless indifference.” Her attorneys argued that Wyeth had known for decades about Prempro’s breast-cancer risk factor in postmenopausal women, but acted negligently by failing to provide adequate warnings or conduct sufficient testing.

In 2002, a Women’s Health Initiative study sponsored by the National Institutes of Health (NIH) found that the use of an estrogen-progestin combination (like Prempro) led to a 41 percent increase in strokes, a 29 percent increase in heart attacks, a doubling of rates of blood clots, a 22 percent increase in total cardiovascular disease, and a 26 percent increase in breast cancer. Wyeth is still allowed to sell the drugs, and sales of its HRTs topped $1 billion last year.

Added Millrood, “The evidence presented at trial revealed that Wyeth has known for decades that postmenopausal hormone therapy causes breast cancer but that Wyeth chose to avoid testing this dangerous hormone combination and delayed stronger warnings for fear of flagging sales. We hope that this verdict sends a clear message to Wyeth
]]> Reduced Use of Prempro and Other Hormone Replacement Drugs Linked to Lower Breast Cancer Rates http://www.yourlawyer.com/articles/read/12384 Thu, 14 Dec 2006 00:00:00 -0500 http://www.yourlawyer.com/articles/read/12384
Medical researchers has exected about 200,000 cases of breast cancer in 2003; but only 14,000 were actually diagnosed with the disease. Because breast cancer takes years to form, experts think that withdrawing hormones mostly caused small tumors that had been growing to stop or shrink, making them no longer detectable on mammograms. Whether this is true or will result in fewer cases over the long run will take more time to tell.

Cases declined most among women 50 and older, with tumors whose growth is fueled by estrogen the age group and type of cancer most affected by hormone use. Researchers looked for a similar drop in other cancers, which could indicate something other than hormones was at work, “and we didn’t see anything,” said Kathy Cronin, a National Cancer Institute statistician who worked on the analysis.

Doctors estimate that half of women who were taking hormones stopped after July 2002, when the federal Women’s Health Initiative study was halted because more women taking estrogen/progestin pills developed breast cancer or heart problems.]]> Long-term estrogen users face increased breast cancer risk, study finds http://www.yourlawyer.com/articles/read/11669 Tue, 09 May 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/read/11669
But the research, reported in the Archives of Internal Medicine, found no increased risk of breast cancer in women who had taken estrogen for less than 10 years.

"This says, at least for the shorter-term users, you don't need to panic," said Dr. Wendy Chen, an oncologist and epidemiologist at Brigham and Women's Hospital and the Dana-Farber Cancer Institute in Boston, who led the study. "But for the longer-term users, you need to think about why am I still taking estrogen for this long of time, and are there alternatives?"

Just last month, researchers in another long-term study, the Women's Health Initiative, published results of a seven-year study that found no increased risk of breast cancer in women who took the hormone, but there were other significant health risks, such as strokes and blood clots.

Estrogen-alone supplements are given only to women who have had their uteruses removed, because the hormone has been linked to an increased risk of uterine cancer. A woman with an intact uterus can take estrogen combined with progestin, another hormone that seems to prevent women from getting uterine cancer.

The latest study involved more than 28,000 women who were part of the Nurses' Health Study conducted by researchers at two Harvard-affiliated hospitals in Massachusetts.

For women who had been on estrogen for at least 15 years, the risk of hormone-responsive breast cancer the most common type in the United States climbed 48 percent. At 20 years, the risk of all types of breast cancer rose 42 percent.

Of the 934 invasive breast cancers that developed over the duration of the study, 708 were in women taking estrogen at the time, the study showed. Among the women who never used hormones, 226 developed breast cancer.

The risk of breast cancer also appeared to rise between 10 and 15 years of use, but the increase was not statistically significant, the researchers said.

"This is exactly what I would have expected," said Dr. Stefan Glück, clinical director of the Braman Family Breast Cancer Institute at the University of Miami's Sylvester Comprehensive Cancer Center. "Look at smoking. After two years, there's no increase [in cancers]. You need many, many years [of exposure] to cause damage. Biology is a continuum, so starting 10, 15, 20 years is when you see an effect."

Before the Women's Health Initiative, doctors routinely prescribed hormone supplements at menopause. The prevailing theory was that estrogen or estrogen with progestin would prevent heart disease and other vagaries of aging. Instead, the study found an increased risk of heart disease, dementia, stroke, blood clots and other serious illnesses. More than 161,000 women participated, including 3,000 in South Florida.

Glück said the body of evidence on hormone replacement is sufficient for women and their doctors to make good choices.

"There are so many studies now, the picture is getting clearer," he said. He recommended that women whose menopausal symptoms are not severe not take any hormone supplements, and those with severe symptoms should take them for a short time and then taper off them gradually so the body has time to adjust.

"Women who are overweight or obese when they go through menopause or have a hysterectomy tend to suffer more hot flashes, night sweats, and other menopausal symptoms than thin women, he said.

"In Asia, in Japan, there is not even a word for menopause," Glück said. "Maybe it's the healthier diet, lifestyle, the green tea. We don't know."

Lifestyle changes can help to ease some of the symptoms of American women, he said.

"Go to the beach and swim, golf more, go to the gym, eat healthier food. These are all things that help, but occasionally they are not enough," Glück said. "If a woman really suffers so much, [she can take] these drugs for awhile, then taper them off."
]]> Long-term estrogen use raises risk, study finds http://www.yourlawyer.com/articles/read/11670 Tue, 09 May 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/read/11670
Researchers said the findings should be reassuring for women who want to use estrogen for a short time to relieve menopausal symptoms, such as hot flashes and vaginal dryness.

Hormone supplements were once thought to help postmenopausal women postpone age-related ills. But the government's Women's Health Initiative study in 2002 contradicted those beliefs for estrogen-progestin supplements, finding an increased risk of breast cancer, strokes and heart attacks. That led millions of American women to stop taking supplements.

Later, a WHI study of estrogen alone -- an option only for women who have had a hysterectomy -- linked the supplements to strokes and memory problems. But it found that using estrogen alone for seven years does not raise the risk of breast cancer.

The new findings came from the less-rigorous but longer-running Nurses' Health Study, overseen by Harvard-affiliated researchers.

It found no increased risk of breast cancer in women who had taken estrogen for less than 10 years. But for women who had been on estrogen for at least 15 years, the risk of hormonally driven breast cancer (the most common type in the United States) climbed 48 percent. At the 20-year mark, the risk of any type of breast cancer rose 42 percent.

"This says at least for the shorter-term users, you don't need to panic" about breast cancer, said lead author Dr. Wendy Chen, an oncologist and epidemiologist at Brigham and Women's Hospital and the Dana-Farber Cancer Institute in Boston.]]> Study Links Estrogen, Breast Cancer Risk http://www.yourlawyer.com/articles/read/11667 Mon, 08 May 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/read/11667
Researchers said the findings should be reassuring for women who want to use estrogen for a short time to relieve menopausal symptoms such as hot flashes and vaginal dryness.

Hormone supplements were once thought to help postmenopausal women postpone age-related ills. But the government's Women's Health Initiative study in 2002 contradicted those beliefs for estrogen-progestin supplements, finding an increased risk of breast cancer, strokes and heart attacks. That led millions of American women to stop taking supplements.

Later, a WHI study of estrogen alone an option only for women who have had a hysterectomy linked the supplements to strokes and memory problems. But it found that using estrogen alone for seven years does not raise the risk of breast cancer.

The new findings came from the less-rigorous but longer-running Nurses' Health Study, overseen by Harvard-affiliated researchers.

It found no increased risk of breast cancer in women who had taken estrogen for less than 10 years. But for women who had been on estrogen for at least 15 years, the risk of hormonally driven breast cancer (the most common type in the United States) climbed 48 percent. At the 20-year mark, the risk of any type of breast cancer rose 42 percent.

"This says at least for the shorter-term users, you don't need to panic" about breast cancer, said lead author Dr. Wendy Chen, an oncologist and epidemiologist at Brigham and Women's Hospital and the Dana-Farber Cancer Institute in Boston. "But for the longer-term users, you need to think about why am I still taking estrogen for this long of time, and are there are alternatives I could take instead?"

The risk of breast cancer also appeared to rise between 10 and 15 years of use, but the increase was not statistically significant, the researchers said.

The study, published in Monday's Archives of Internal Medicine, involved 28,835 women who were postmenopausal, had had a hysterectomy and reported their estrogen use every two years. Just 3.2 percent of the women, or 934, developed breast cancer during the study.

The researchers said it is unclear how many American women are taking estrogen for 15 or 20 years, especially in light of the WHI findings and doctors' recommendation since then that women who want to use the pills take them for the shortest possible duration.

Dr. Carolyn D. Runowicz, president of the American Cancer Society, said a few women in her practice have chosen to remain on estrogen for a long time because they feel the improvement in their quality of life outweighs the risks.

Runowicz called the study reassuring for short-term estrogen use but also said it underscores the need for patients to regularly "justify every medication" they take with their doctors.

"Is it estrogen forever? That's what we thought in the 1970s," said Runowicz, director of the Cancer Center at the University of Connecticut Health Center, "but we've completely reversed our thinking on that."

Estrogen-alone supplements are given only to women who have had their uteruses removed, because the hormone can spur uterine cancer. Other women get estrogen plus progestin, to counteract the risk of uterine cancer.

The Women's Health Initiative was a clinical trial in which women were randomly assigned estrogen pills or placebos. Scientists consider that approach the gold standard. The new study relied on nurses who reported on their own health every two years.

Runowicz said nurses could differ somewhat from women in the general population perhaps they are healthier, for instance but she said she had no reason to doubt the validity of the data, especially because its conclusions regarding short-term estrogen use are backed up the WHI findings.

Wyeth, which produces the estrogen pill Premarin, considers the Nurse's Health Study a well-respected study and the most recent research a "fairly reasonable trial," said Dr. James Pickar, assistant vice president for clinical research and development.

Pickar said he sees the results as good news for women because they back up the WHI findings that found no increased breast cancer risk for short-term estrogen users.

"I think it's very important for women to talk to their physician and review on a regular basis whether they need to continue therapy," Pickar said. "Each patient has an individual risk profile that only they and their physician can evaluate."]]> Study Finds Elevated Risk of Urinary Incontinence in Women on Hormone Replacement Therapy (HRT) http://www.yourlawyer.com/articles/read/10917 Wed, 09 Nov 2005 00:00:00 -0500 http://www.yourlawyer.com/articles/read/10917
Currently over 40% of postmenopausal women are afflicted with urinary incontinence. Urinary incontinence includes both stress incontinence, when the bladder leaks urine as a result of pressure on it from exercise, laughing, or coughing and urge incontinence, where there is a frequent urge to urinate.

The study conducted by Dr. Jody Steinauer and her colleagues from the University of California at San Francisco relied on data from a Heart Estrogen/progestin Replacement Study to evaluate the side-effect of urinary incontinence.

The 4-year observational study followed 1,200 women who reported no episodes of incontinence in the week prior to starting HRT or a placebo.

Results showed 64% of women using HRT reported weekly incontinence compared with 49% of those taking a placebo. The symptoms began at 4 months and continued for the duration of the hormone therapy, regardless of age.

HRT was found to elevate the risk of both urge and stress incontinence by 50% and 70%, respectively. The excess risks of weekly urge and stress incontinence attributed to HRT were 12% and 16%, respectively.

According to researchers, these findings contrasted with physiologic data which indicated HRT might have a beneficial impact on incontinence.  The results did, however, confirm previous randomized trials that found postmenopausal women taking HRT might develop urinary incontinence or experience exacerbated symptoms if they already had the condition.
]]> Study Claims Alcohol Raises Breast Cancer Risk in Women on HRT http://www.yourlawyer.com/articles/read/10887 Fri, 04 Nov 2005 00:00:00 -0500 http://www.yourlawyer.com/articles/read/10887
Results of the study, which was published in the Journal of the National Cancer Institute, indicate an elevated risk for estrogen receptor positive breast cancer, the most common kind, but not for the less frequent estrogen receptor negative type.

The study was conducted by Professor Alicja Wolk and her colleagues and reviewed records on alcohol consumption collected from 1987 to 1990 and in 1997. The data was taken from 51,847 postmenopausal women. By the middle of 2004, 1,188 breast cancer cases were reported.

According to Wolk, the findings indicate a combination of HRT and alcohol increases breast cancer risk. She advised that "for those women who have to take hormones, what they can do is avoid alcohol so it will not have a multiplier effect on the risk for cancer."

Increasingly, women have become wary about HRT after reports in 2002 and earlier this year that claimed it could have serious negative side effects including elevated risk of heart attack, stroke, and breast cancer.
Currently, breast cancer is the most common cancer in women worldwide with more than a million cases diagnosed - and 400,000 deaths - each year.

Many factors beside alcohol and HRT can contribute to increased risk. Women with a family history of breast cancer, an early puberty, late menopause, obesity, and not having children may also be at increased risk of developing breast cancer.
]]> Cancer Risk of HRT 'Known For Years' http://www.yourlawyer.com/articles/read/10478 Wed, 10 Aug 2005 00:00:00 -0400 http://www.yourlawyer.com/articles/read/10478
In the last few years a number of major studies have linked HRT used to combat menopausal symptoms to an increased risk of breast cancer and also stroke.

The revelations led many women to abandon treatment due to fears they faced a much greater risk of cancer.

Now researchers from the US have questioned why the results of the recent studies have been seen as so shocking when the potential dangers of hormone treatments have been known about for decades.

Writing in the Journal of Epidemiology and Community Health, they outlined the results of a meeting of historians, doctors, biologists and women's health advocates to discuss the recent reaction to the HRT studies.

Controversy about the use of hormones in medicinal treatments has existed since the 1930s.

Back then scientists carried out animal experiments which provided evidence that sex hormones could be carcinogenic causing cancer.

"For clinicians, these studies translated to debates about the correct dose to be given, as hormones were viewed as 'natural' and thus not intrinsically harmful," the team from the Harvard School of Public Health in Boston said.

Further controversy arose in the 1960s and 1970s, triggered by new fears about oral contraceptives, oestrogen only HRT and the risk of endometrial cancer.

New concerns are currently being discussed about the cancer-causing potential of HRT, and disputes over whether it does or does not reduce the risk of cardiovascular disease.

The researchers said the conventional wisdom was that the latest concerns were new concerns, only recognised in the last few years with the publication of major trials.

They said the question that needed to be answered was: "Why, for four decades, since the mid-1960s, were millions of women prescribed powerful pharmacological agents already shown, three decades earlier, to be carcinogenic?"

Industry 'collusion'

The researchers questioned why repeated warnings were ignored and not translated into health policies to protect women.

They suggested that the pharmaceutical industry, doctors and researchers "colluded" to promote the view that the menopause was a "deficiency disease" and women needed long-term HRT to "prevent illness, loss of sexuality and ugly ageing".

The researchers said: "Use of drugs shifted from being 'curative' to being a tool of 'risk management', requiring long-term administration to an ever-expanding - and hence profitable - market of ageing users."

They also said that other factors that played a part in the problem included the failure of regulatory agencies to act and too much focus on individual risk rather than broader societal issues.

The researchers claimed that hormones had been "gendered" with treatment targeted at women and their reproductive capacity - in a bid to regulate their sexually.

In contrast, men had been ignored in creating these treatments. Last week research in the British Medical Journal suggested that a woman's risk of developing breast cancer while on HRT may be lower than people think.

The Australian researchers said that many women may have stopped taking HRT unnecessarily.

Hazel Nunn, cancer information officer at Cancer Research UK, said: "HRT remains an effective treatment for menopausal symptoms and may also lessen the risk of osteoporosis.

"Taking HRT slightly increases a woman's risk of developing breast cancer while she is taking it, but risk returns to normal around five years after she stops.

"Cancer Research UK feels it is important for women to be aware of the risks of taking HRT and should discuss their individual circumstances with their doctor so that they can make an informed decision.

"We also recommend that women take HRT for only as long as it is necessary to combat their symptoms."]]> U.N. Classifies Hormone Replacement Therapy (HRT) as "Carcinogenic” http://www.yourlawyer.com/articles/read/10343 Sat, 30 Jul 2005 00:00:00 -0400 http://www.yourlawyer.com/articles/read/10343
After years of research, analysis, and debate, the International Agency for Research on Cancer, the U.N.’s cancer research agency, has reclassified HRT from “possibly carcinogenic” to “carcinogenic.”

The panel of 21 scientists concluded that the evidence from several recent studies was consistent and reliable enough to link HRT to breast cancer thereby fully justifying the reclassification. The normal risk of a woman (not on HRT) developing breast cancer is slightly more than 14%. Long-term use of HRT raises that risk to almost 17%.

The panel also concluded that HRT slightly increases the risk of endometrial cancer when progestin is taken fewer than 10 times per month.

While most experts agree with these conclusions and see no real departure from what was already generally accepted with respect to HRT, the panels finding that a common form of birth control pill was linked to a slightly increased risk of certain cancers was met with skepticism by many doctors.  

HRT has been a long-standing and widely accepted treatment for women experiencing some of the more uncomfortable effects of menopause. In the past few years, however, this popular therapy has come under fire as a result of evidence linking HRT to many serious health risks.

A number of studies suggest that women undergoing HRT are exposing themselves to long-term harm that far outweighs the severity of the symptoms being treated.

For some women, HRT might consist of an estrogen-only treatment while others are given a combination of estrogen and progestin. This latter option is slightly less common but is still a popular solution to menopausal discomfort. Both types of HRT are used by an estimated 13.5 million women in the United States alone.

HRT has been around since the early 1940s when women began taking high doses of estrogen to counteract many of the temporary, but recurring, discomforts of menopause. In the 1970s, however, it was discovered that this particular form of estrogen therapy created an unacceptably high risk of uterine cancer. This prompted the trend by doctors to prescribe progestin along with significantly lower doses of estrogen.

Recent studies now show that there are too many health risks associated with HRT to justify its being used automatically as a “cookie cutter” treatment of choice or as if it were a woman’s only available option.
Women should consult their physicians to discover whether HRT would be a benefit or a detriment given their own particular circumstances. While HRT undoubtedly alleviates a number of menopausal symptoms in many women, for some, the cost of that immediate relief may include unwanted long-term effects.

Prempro and Premarin:

Prempro and Premarin are the two major HRT drugs. Both are manufactured by Wyeth Pharmaceuticals. Prempro is a combination estrogen-progestin treatment and Premarin is an estrogen-only treatment. There are approximately 6 million women taking Prempro and 11 million women taking Premarin. In 2003, the two drugs had combined sales of $2.1 billion.

Although Premarin, the first HRT drug, was introduced in 1942 for the purpose of alleviating symptoms of menopause such as hot flashes and vaginal dryness, a study in the Journal of American Medical Association (“JAMA”) has linked it to ovarian cancer.

Prempro, on the other hand, has been linked to various serious side effects including dementia, Alzheimer’s disease, stroke, blood clots, pulmonary embolisms, lupus, heart attack, and breast cancer.

Women taking Prempro have a 29% higher risk of heart attack, a 41% higher risk of stroke, and a 26% higher risk of breast cancer. Those figures alone should prompt women to consult their physicians regarding alternative treatments or methods of treatment. This is especially so for women who experience only minor symptoms of menopause such as vaginal dryness for which respond to alternative treatments such as creams and vitamin E.

The most important thing stressed by researchers and medical professionals alike is that Prempro, Premarin and other HRT drugs should be taken in the smallest dosages (that produce effective results) for the shortest duration as possible.
In addition, women who are only experiencing minor symptoms of menopause might want to forego HRT therapy altogether.
Finally, even women seeking relief from more severe symptoms should do their own benefit/risk analysis by asking questions, reading available reports, and keeping in mind the potential risks associated with HRT.
Harmful Effects of HRT:

As Prempro and Premarin are the two major existing HRT drugs, the following information is primarily related to the usage of one or the other. However, other drugs and treatments may have the same harmful effects.

Dementia:

HRT medications can double the risk of vascular dementia and Alzheimer’s disease, especially in women over 65. Short rather than long-term use is recommended in order to avoid this unwanted side-effect.

This information was first made public in an issue of the Journal of American Medicine released in May of 2003. The Women’s Health Initiative Memory Study, which was funded by Wyeth, analyzed data from about 4,500 women, aged 65, who had not been diagnosed with dementia before the study.

During the five-year study, each woman took Prempro daily. The results found that of the 61 women who developed dementia, 40 (66%) had been given the hormones while only 21 (34%) had taken the placebo.

Another study published at the same time revealed that, in addition to the increased risk of dementia, HRT may have harmful effects on the general cognitive function of older women leading to mild memory loss amongst other things.

While these increased risks are numerically small, they do represent a significant increase in the percentage involved. (Obviously, 19 additional cases of dementia in 4,500 participants [40 to 19] is a small “number” but it does represent almost a 50% differential [66% to 34%]).

Thus, this particular increased risk should be taken seriously and a physician should be consulted by any woman planning to begin HRT or already undergoing HRT and experiencing any symptom of this side-effect.

Heart Attack:

Combination therapy consisting of estrogen and progestin, such as Prempro, has now been linked to an increased heart attack risk of up to 81% in the first year of treatment.

One possibility for this newly discovered heart attack risk is that HRT might cause more rapid clotting and therefore, a woman with one or more narrowed blood vessels would be at risk if there was a sudden clotting of the blood in those constricted areas.

While it was previously believed that combination estrogen-progestin drugs could actually prevent heart attack, a recent study found that hormones do not slow the clogging of arteries. In fact, all women who take hormones appear to be at a higher risk for heart attack.

The Women’s Health Initiative (“WHI”), a federally sponsored organization, conducted a study to determine the risks associated with HRT. (The study was actually abruptly aborted in 2002 as too many women were being put in harm’s way and experiencing a variety of severe side-effects such as heart disease, stroke, blood clots, and breast cancer.)

Of the 16,608 women who participated in the study, there were 190 incidents of heart attack and 39 fatalities among the group given Prempro. The placebo group had 148 heart attacks and 34 fatalities.

Again, the numerical increase in the risk does not seem so great. However, the overall percentage increase in the heart attack risk is about 30% which is significant enough to be taken into account when making the decision about HRT.

Many experts believe the discovery of this increased heart attack risk should prompt doctors to be more careful about whom they are placing on HRT therapy. Healthy, middle-aged women are the ideal candidates for drugs like Prempro as they are not usually at an increased risk for heart attack before beginning treatment.

Women who are already at greater risk, including those with high cholesterol or those with a personal or family history of cardiac problems are not good candidates for HRT. It should be remembered, however, that the increased risk applies to all women.

Breast Cancer:

Estrogen-progestin pills such as Prempro are now being linked to an aggressive form of breast cancer. The WHI study was responsible for discovering crucial information regarding this dangerous risk.

Of the 16,608 women in the study ranging from ages 50-79, breast cancer developed in 245 women who used estrogen-progestin pills and 185 women in the placebo group.

Collectively, the women on hormones had larger tumors which began to spread to nearby tissue and distant parts of the body in about 25% of hormone users with cancer as opposed to only 16% of the women with cancer in the placebo group. Tumors may also grow at a faster rate in women taking hormones.

A similar longitudinal study conducted in Britain concluded that women who were receiving HRT had a greater risk of developing breast cancer in comparison to women not receiving therapy. The study involved 1 million women between the ages of 50 and 64.

Those who took the hormones demonstrated a 66% greater risk of developing breast cancer and a 22% greater risk of dying from it within 6 years. Women who took estrogen alone had only a 30% increased risk of developing breast cancer leading some experts to conclude that the original (estrogen only) option is a safer one despite the fact that it, too, has been shown to increase the risk of breast cancer.

The researchers determined that, over a decade, HRT would be responsible for 10,000 extra cases of breast cancer in England and an extra 100,000 cases in the United States among menopausal women ages 50-64.

Yet another study conducted in Sweden concluded that women who were receiving HRT were more prone to new and recurring cancer. This study was also stopped due to the unacceptably dangerous risks posed to the 345 women participating in the study.

Perhaps the most dangerous risk regarding HRT and breast cancer is the newfound risk of inaccurate and abnormal mammograms.

Out of the estimated 3 million women on HRT in the United States, about 120,000, or 4%, could experience abnormal mammograms related to the HRT.

Combined HRT, such as Prempro, causes the breast tissue to increase in density thereby making it more difficult to obtain a clear and accurate mammogram. In cases where there is a delay in detecting the cancer treatment, options are more limited and the prognosis is less favorable.

In an editorial from the Feinberg School of Medicine at Northwestern University, Peter H. Gann and Monica Morrow summed up this disturbing finding by stating: “The ability of combined hormone therapy to decrease mammographic sensitivity creates an almost unique situation in which an agent increases the risk of developing a disease while simultaneously delaying its detection.”

Note: Ovarian and uterine cancers have also been linked to HRT even though it was previously thought that hormones would help to prevent the onset of such cancers.

Herbal Remedies:

Some women who are skeptical of the pharmaceutical solutions to menopausal symptoms have sought alternate treatments such as herbal remedies. But some herbal hormonal treatments may also increase the risk of breast and uterine cancer for women, especially those with a history or a family history of these cancers.

Herbs such as clover, motherwort, palmetto, and rhodiola can actually have such a powerful estrogenic effect that, just like other HRT treatments, they can cause estrogen-related cancers. Extracts of maca root, cramp bark, and tumeric root can also be harmful if taken in large amounts.

Warnings and Labels:

Due to the mounting evidence suggesting that HRT is not the best option for menopausal women, the FDA and other health advisory groups have issued several warnings and label requirements in order to keep the public informed about the recent developments relating to Prempro, Premarin, and any other estrogen or estrogen-progestin drugs.

In response to the results of various studies, there has been a significant decrease in the number of women taking and asking for conventional HRT treatments.

•    1/09/03: The FDA approved new labels for Wyeth which included an updated warning that explains the increased risk of heart disease, heart attacks, and breast cancer. The new label emphasizes that the drugs do not prevent heart disease. In addition, doctors were advised to prescribe the lowest dose possible for the shortest amount of time. The FDA’s actions also apply to any product containing estrogen alone or a combination of estrogen-progestin.

•    2/03/03: The head of the American Cancer Society released a statement to the effect that it is “unwise” for women with a history of breast cancer to undergo HRT.

•    1/09/04: The Canadian Cancer Society urged women to avoid estrogen-progestin therapy since it causes an increased risk of breast cancer, especially when used over an extended period of time. They advised women not to take the drug(s) unless they are suffering severe menopausal symptoms and have not responded to any other form of treatment.

•    2/10/04: The FDA proposed that manufacturers of hormone replacement drugs change their warning labels once again to include warnings for dementia and abnormal mammograms. The new labels should also list the approved usages of the drugs and instruct doctors to pursue alternatives with their patients.

•    The number of Australian women using HRT declined rapidly after new information regarding health risks was made public.

•    A 71 year-old woman, along with 15 other women, from Houston, Texas, sued Wyeth claiming that Premarin caused her to develop breast cancer. The suit alleges that, despite the fact that Wyeth knew, or should have known, that Premarin was responsible for the development of estrogen-related cancers; it continues to market the product as a “fountain-of-youth” drug.

•    Ten Ohio women filed a lawsuit in May 2004 against several major pharmaceutical companies three with offices in Cincinnati saying the hormone therapy drugs manufactured by the companies caused their breast cancer and, in one case, a debilitating stroke.

•    July 29, 2005: U.N. cancer agency reclassifies HRT as a carcinogen.

 Conclusion:

In the past few years there has been extensive evidence to suggest that HRT is not the safest option for women over 50 experiencing unpleasant menopausal symptoms. Studies have shown that there are undeniable health risks for women who take estrogen or a combination estrogen-progestin drug on either a short or long-term basis.

Some doctors, however, argue that there is still not enough persuasive evidence from which to conclude what negative effects are linked to short-term use. Nonetheless, there is ample proof to strongly suggest that HRT is a risky treatment for the woes of menopause and that its use should be carefully considered on a case by case basis.

Those women already on HRT should carefully monitor their health and be on the lookout for any possible condition which may be associated with the drugs they are taking. In either situation, women should discuss the pros and cons of HRT with a qualified doctor especially in light of complicating health factors, personal and family medical history, and dosage size and treatment duration.

Presently, there are not many alternatives to HRT with respect to the more severe symptoms of menopause.

In February, 2004, the FDA approved a product manufactured by Solvay Pharmaceuticals called EstroGel. EstroGel is an estrogen gel which is absorbed through the skin of the arm. There are now a few other similar alternatives such as hormones in the form of lotions and skin patches.

Although the FDA has approved these products, it is not certain if these alternatives are any safer than pills.

Perhaps the revelation which most convincingly demonstrates the serious nature of the risks associated with HRT is the early termination of the studies discussed above.

It is a sobering thought indeed that studies to determine the dangers associated with a drug were stopped in mid-course because of the extreme risks posed to the participants in the study itself.

Despite controversial evidence and mounting concerns, HRT is still being used by millions of menopausal women worldwide. The drugs have not been taken off the market and may still be legally prescribed to any woman seeking relief from problems associated with menopause.

Even the U.N. cancer agency said that women should not automatically stop using HRT; a conclusion agreed with by many experts and practicing gynecologists.
]]> HRT Cancer Causing, Says WHO Body http://www.yourlawyer.com/articles/read/10349 Wed, 29 Jun 2005 00:00:00 -0400 http://www.yourlawyer.com/articles/read/10349
The combined menopause therapy was previously said to be "possibly" cancer causing, but the agency said women should not automatically stop using it.

The scientists also warned the combined contraceptive pill slightly increased the risk of a greater number of cancers than originally thought.

UK experts said the HRT findings did not add anything to what is known.

A group of 21 scientists from the International Agency for Research on Cancer reviewed published evidence on both drugs before coming to their conclusions.

On combined estrogen-progestogen HRT, they said studies had demonstrated an increased risk of breast cancer. The risk exceeded with duration of use.

And they said use of the combined estrogen-progestogen contraceptive pill slightly increased the risk of breast, cervix and liver cancer. Past studies have already linked the pill to liver cancer, but only in hepatitis B-endemic countries.

But the scientists said it decreased the risk of endometrial and ovarian cancer.

'Complicated'

Agency official Vincent Cogliano said: "It's a complicated picture. It doesn't mean women should stop taking the treatment. There are still other reasons to take it.

"Each woman has to discuss it with her doctor and with the risks and benefits."

Dr Anne Szarewski, clinical consultant for Cancer Research UK, said: "We are unaware of any studies that have shown that the contraceptive pill causes breast or cervical cancer.

"Studies have only shown that there is an association.

"Regarding HRT, this statement does not add anything to the information that has already been published in recent studies."

UK drugs regulator, the Medicines and Healthcare products Regulatory Agency, said the warnings added nothing to what was already known. 
]]> Hormone Pills Put On Cancerous List http://www.yourlawyer.com/articles/read/10366 Sun, 29 May 2005 00:00:00 -0400 http://www.yourlawyer.com/articles/read/10366
The International Agency for Research on Cancer said that based on consistent evidence from studies in recent years, it was reclassifying hormonal menopause therapy from "possibly carcinogenic" to "carcinogenic."

The declaration from the World Health Organization's cancer agency, which is widely regarded as the international authority on cancer-causing agents, comes after several recent high-profile studies linking combination hormone replacement therapy, or HRT, to breast cancer.

The analysis, conducted by a panel of 21 scientists, concluded that estrogen and progestin therapy for menopause also slightly increases the risk of endometrial cancer when progestin is taken fewer than 10 days a month.

Research has indicated that the chance of a woman developing breast cancer during her lifetime is about 1 in 7. A landmark study used in the U.N. agency's analysis suggested that long-term use of hormones raises the lifetime risk to about 1 in 6.

The cancer research agency also concluded that a common type of birth-control pill, taken by about 10 percent of women of reproductive age, increases the risk of more types of cancer than previously thought.

Some doctors cautioned that the conclusion was based on studies of higher-dosage pills and said they wouldn't change their advice to young women.

The agency had previously determined that the pill combining estrogen and progestin can cause liver cancer.

Now, further research has demonstrated that it also slightly increases the risk of breast and cervical cancer, the agency said.

However, the investigation also confirmed that the pill protects against endometrial and ovarian cancers.

"It's a complicated picture," said Vincent Cogliano, head of the agency's department that evaluates the cancer risk of chemicals.

"There are still other reasons to take it. Each woman has to discuss it with her doctor and weigh the risks and benefits" for either the contraceptive pill or hormone replacement therapy."
]]> Hormone, Dementia Risk Found http://www.yourlawyer.com/articles/read/8181 Thu, 24 Jun 2004 00:00:00 -0400 http://www.yourlawyer.com/articles/read/8181
"We did not find any protective effect of hormone therapy, and there was a trend towards an increased risk of dementia," said Claudine Legault, an author of the study and director of the Women's Health Center of Excellence at Wake Forest University in Winston-Salem, N.C.

The findings, from the Women's Health Initiative Memory Study, appear in the June 23/30 issue of the Journal of the American Medical Association.

The memory study was established to look at whether hormone therapy, either estrogen alone or estrogen plus progestin could reduce the risk of dementia in women ages 65 to 79. The memory study is part of the larger Women's Health Initiative, which looked at the effect of hormone therapy on a variety of health outcomes. The estrogen plus progestin arm of the study ended in July 2002 when it became clear that women taking hormones were having more serious side effects. The estrogen-only arm was terminated on Feb. 29, 2004, because of an excess risk of stroke in women taking active hormones.

This study looked at the effects of estrogen alone (Premarin) or estrogen plus progestin (Prempro) in 7,479 women, all of whom had had a hysterectomy. The women were divided into those with probable dementia, those with mild cognitive impairment, and those with no dementia.

Compared with the placebo group, women in the estrogen group had a 34 percent higher risk of being diagnosed with mild cognitive impairment. This increased risk was not considered to be significant. Women on estrogen had a 38 percent greater risk of having either mild cognitive impairment or probable dementia, compared with women in the placebo group.

Outside experts are careful to point out that this study does not pertain to all women or to all hormones.

"This is not a study about women. This is about older women, so this cannot be extrapolated to women who have recently undergone menopause who want to go on hormone therapy," said Dr. Alan M. Altman, an assistant professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School. Altman was not involved in the research.

This also does not mean that hormone therapy doesn't have a place. "It's clear that use of hormones to prevent dementia or cognitive decline in women 65 or older is not recommended," Dr. Gary Stiles, executive vice president and chief medical officer at Wyeth Pharmaceuticals, said during a teleconference Monday. Wyeth makes Premarin and Prempro.

"The most appropriate reason that women initiate the therapy is for symptomatic relief of menopausal symptoms, and that was not studied in this study," Stiles said. "We believe that these drugs have their appropriate use." ]]> Study: Estrogen-Only Pills May Raise The Risk of Alzheimer's http://www.yourlawyer.com/articles/read/8182 Wed, 23 Jun 2004 00:00:00 -0400 http://www.yourlawyer.com/articles/read/8182
The findings contradict the long-held belief that estrogen pills can help keep older women's minds sharp.

The results came from a government study called the Women's Health Initiative and were published in Wednesday's Journal of the American Medical Association.

The research involved nearly 3,000 women, ages 65 to 79, who had had hysterectomies and had taken daily estrogen-only pills, sold by Wyeth Pharmaceuticals as Premarin, for an average of about five years.

Dementia was diagnosed in 28 women who took estrogen, compared with 19 taking dummy pills. Those results were not statistically significant because the numbers were so small, but the trend was troubling, said co-researcher Stephen Rapp, a professor of psychiatry and behavioral medicine at Wake Forest University.

"Translated to a population of 10,000 older women taking estrogen alone, there would be an additional 12 cases of dementia per year," said lead author Dr. Sally Shumaker of Wake Forest University.

In addition, 76 women on estrogen developed mild bouts of forgetfulness, compared with 58 women in the placebo group.

Pooling those results with the dementia group, the researchers found estrogen users faced a 38 percent increased risk of developing dementia or forgetfulness, and those results were statistically significant.

"No matter which outcome we're looking at, there is no evidence of benefit," Rapp said. The pills offer "no protection against dementia, and in fact the likelihood increases on hormone therapy."

The research "succeeded in resolving the important issue that hormone therapy should not be given to women older than 65 years to prevent or delay onset of dementia, or with any expectation for meaningfully improving cognitive function," said Dr. Lon Schneider of the University of Southern California.

Whether different results would be found in younger women or with lower estrogen doses is unknown.

Dr. Gary Stiles, Wyeth's chief medical officer, called the results disappointing and said Wyeth is continuing to develop new products for treating menopause symptoms, which can include hot flashes and vaginal dryness.

Estrogen-only pills have been linked to uterine cancer. Because of that, most women who take hormones at menopause have used combined estrogen-progestin pills.

But use of both types has dropped steeply in the past two years as the WHI results have trickled out. Worldwide sales of Wyeth's estrogen and progestin pills fell from $2.1 billion in 2001 to $1.27 billion last year.

Most doctors now advise women to take the lowest possible dose for the shortest possible time.

The initial WHI results, announced in 2002, found that Wyeth's estrogen-progestin pills, sold as Prempro, increased older women's risk of breast cancer, strokes and heart attacks.

The WHI study was government-funded. The analysis by Shumaker, Rapp and colleagues was funded by Wyeth and Wake Forest. Shumaker has served as a consultant for Wyeth.]]> Hormone Drug Basis For Lawsuit http://www.yourlawyer.com/articles/read/8076 Fri, 21 May 2004 00:00:00 -0400 http://www.yourlawyer.com/articles/read/8076
The lawsuit was filed in Hamilton County Common Pleas Court. Other cases with similar allegations have been filed recently in U.S. District Court.

Named as defendants are: Wyeth and its division Wyeth Pharmaceuticals Inc. of Columbus; Pharmacia and Upjohn Corp. of Cleveland and Pharmacia Inc. of Cleveland; Pfizer Inc. of Cincinnati; Greenstone Ltd. of Cincinnati; Solvay Pharmaceuticals Inc. of Cleveland; Barr Pharmaceuticals of Columbus; and Duramed Pharmaceuticals Inc. of Cincinnati and Columbus.

Duramed, now owned by Barr Pharmaceuticals, has a plant in Pleasant Ridge.

The women accuse the pharmaceutical companies of negligence, producing a defective product, not providing adequate warnings and misrepresenting themselves.

The case centers on the drug Prempro, a hormone therapy medication marketed to menopausal women.

Wyeth could not be reached for comment Thursday night. The company Web site cautions that estrogen increases chances of a heart attack, stroke, breast cancer and blood clot.

In 1942, the FDA approved Premarin, an estrogen drug made by Ayerst, now Wyeth and Wyeth Pharmaceuticals.

The company has promoted the hormone therapy by sponsoring medical journal articles, using sales representatives and hiring experts to speak to doctors, and through press releases and advertisements, according to the lawsuit.

"Through its marketing and advertising efforts, Wyeth convinced doctors and patients that menopause was not the natural process of aging, but instead turned this process into a disease in need of drug treatment," the lawsuit said.

With regard to breast cancer risks, Wyeth represented in a video seminar that the benefits of taking estrogen far outweighed the risks for women unless they faced a particularly high risk of breast cancer.

From 1990 to 1995 Premarin became the most frequency dispensed prescription drug in the United States as a result of the marketing, the lawsuit says.

In 1994, Wyeth got approval for Prempro, a once-a-day pill that combines estrogen and progestin.

Some studies now show hormone therapy poses substantial health risks.

"It is clear these warnings and labels provided by manufacturing defendants were inadequate, misleading and inaccurate," the lawsuit said. "Manufacturing defendants minimized the risks of these drugs to the prescribing physicians and ultimate users while simultaneously exaggerating the purported benefits. ]]> The Risks of Hormone Therapy http://www.yourlawyer.com/articles/read/7989 Thu, 29 Apr 2004 00:00:00 -0400 http://www.yourlawyer.com/articles/read/7989
Maureen McCormack sits with Drake, her 2-year-old Pekingese, at her Vestal home. McCormack is part of a class-action lawsuit over hormone replacement therapy. She was diagnosed with breast cancer after taking the hormone treatment Premarin.

Desperate for relief from the hormone rushes and lightheadedness, McCormack, in 1991, asked her gynecologist if anything could ease her discomfort. She received a prescription for the hormone treatment Premarin, which she took until 1998.

McCormack, now 57, was only vaguely aware of potential risks associated with the so-called hormone replacement therapy. Mainly, the Vestal resident was thankful to have some relief for her symptoms.

Then, after seven years of taking Premarin, she was diagnosed with breast cancer.

"You don't think you're going to be one of the people who are going to come down with this awful disease," McCormack says today. "When they discovered the breast cancer, they immediately told me, 'Stop taking Premarin.' I was very angry."

In a 2002 study, the Women's Health Initiative, affiliated with the federal National Institutes of Health, reported that women who underwent certain hormone replacement therapy showed an increased incidence of breast cancer, stroke and other problems.

Those findings caused hormone replacement therapy for menopause to become one of the most controversial subjects in medicine. Because it is so effective in treating the symptoms of menopause, gynecologists still swear by it and continue prescribing the pills for millions of women. But the doctors also are determined to inform patients about recent information regarding risks.

"All the physicians are talking to the patient more about this issue," said Dr. Achala H. Amin, a Binghamton obstetrician and gynecologist. "Most of the women now, they know the risks, and they still want to take it for the quality of their life."

At least four Southern Tier women are suing Premarin maker Wyeth Pharmaceuticals in federal court, claiming millions of dollars in damages for allegedly causing their breast cancers and other health problems. The lawsuits suggest that the drug companies knew about the dangers years before they warned doctors and patients.

Binghamton lawyer Ronald Benjamin, who is representing the four Southern Tier patients and about 40 others, called the drug companies' marketing strategies "downright misleading" in allegedly playing down the risks while emphasizing benefits. Each plaintiff is asking for damages of as much as $65 million to $72 million.

"I'm encouraging women to come out and exercise their rights to go after Wyeth and the other pharmaceutical companies for what I believe is a flagrant abuse of their power," Benjamin said.

Wyeth officials said they could not comment directly on the lawsuits. A company expert on hormone replacement therapy said the Women's Health Initiative data are still being analyzed, and some of the earlier risk findings have turned out not to be statistically significant. The treatment can vary from woman to woman depending on her particular needs and other health problems.

"The therapy has to be individualized," said Dr. Ginger Constantine, Wyeth's vice president of women's health and bone clinical research and development. "It's hard to know if a risk identified by the WHI is a risk associated with the therapy or a risk that the patient otherwise has."

The 2002 findings caused demand for Premarin to plummet. Wyeth projects sales of $1 billion for the product line in 2004, a far cry from the $2.1 billion in revenue in 2001.

Wyeth, based in Collegeville, Pa., has used drug labels, literature, "dear doctor" letters and presentations from sales representatives to emphasize any new knowledge about potential risks from the hormone medications in a timely manner, Constantine said.

"We've clearly, fortunately, stayed on top of the science and changed the label as new science has become available," Constantine said. "The label has been strengthened as new risks have been identified."

Constantine and Amin both said it's important for each woman to weigh the benefits and potential for risk in determining whether to take the pills.

"Many women suffer from so many (menopause) symptoms that they can't live without the hormone therapy," said Dr. Nicole Kerner, a Johnson City native who is an obstetrician and gynecologist and associate professor at Albany Medical College.

"It affects them so much that they can't have a normal life," Kerner said. "The bottom line that you have to get across to women is they have to talk about the individual risk with the doctor. You have to go through the family history and the woman's personal history."

The most troubling symptoms for women experiencing menopause often are hot flashes and vaginal dryness and discomfort.

"If they are so disturbed by the hot flashes and lack of sleep at night and they are tired during the day all the time or have very painful intercourse or discomfort during intercourse, these are the women who should consider hormone therapy," Amin said. "Decreased libido is a real big issue. It can be very painful for these young menopausal women who still want to be intimate with their husbands."

To reduce risks, Wyeth now produces a product with hormone doses that are 52 percent lower than earlier versions. And physicians endeavor not to keep women on the medication for years and years.

"We try to treat the symptoms for as short a time as possible now," Kerner said. "I say, 'Let's see what happens in six months. Let's see what happens after one year.'"

Studies have shown that the hormone therapies have certain additional benefits. They apparently reduce the incidence of hip fractures and development of osteoporosis, Kerner said. The women in the federal study also had fewer cases of colorectal cancer.

Scholars suspect that the estrogen may have accelerated the development of breast cancer. "Estrogen, theoretically, can make the breast cancer show up quicker and grow quicker, but does it cause breast cancer? We don't think so," Kerner said.

But McCormack said she believes the hormone therapy caused her breast cancer, because there's no history of breast cancer in her family.

"You trust your doctors, and I really did," McCormack said. "But I'm not blaming doctors. I'm sure the manufacturer did know a little bit more" about the risks.

Most of the pending lawsuits handled by Benjamin were filed in November in federal court in New York City. One, filed in state court in Onondaga County, may go to trial by the end of this year, he said. Pfizer Inc. also is a defendant in a few of the suits because one of its recently acquired divisions made the Provera brand. Other brands mentioned in the lawsuits are Prempro and Premphase.

McCormack is one of Benjamin's clients in the federal lawsuits. She's healthy now, after undergoing a lumpectomy, 37 radiation treatments and other uncomfortable procedures. Her doctors are careful to monitor her progress through annual mammograms and pap smears.

"I'm not really someone who's out for suing," McCormack said. "I would love to have money, but I don't think that is the main thing. I think they have to be forced to get more information out there to let people know what can happen."

There are alternative treatments to taking the hormones. Antidepressants can reduce hot flashes, Kerner said. A few women are trying vitamin E supplements or herbal remedies containing soy or black cohosh. Others are asking their gynecologist about natural so-called "bioidentical" hormone replacement described in the book The Sexy Years by actress and breast cancer survivor Suzanne Somers, Kerner said.

Less research is being done to evaluate the effectiveness of the alternative treatments because they offer less profit potential for pharmaceutical manufacturers, Kerner said.

Much more clinical research is under way or is planned to help determine exactly how risky the hormone therapies are to women of various age groups. The Women's Health Initiative patients, who are still being evaluated, had a mean age of 62.7. The Kronos Longevity Research Institute in Arizona has begun a five-year study on a younger group of patients; most women who take hormone therapy start when they're in their 50s.

This month, an ongoing Women's Health Initiative analysis determined that estrogen-only therapy does increase the risk of stroke in postmenopausal women and doesn't prevent heart disease. Many women receive combination hormone replacement therapy, involving estrogen with progestin.

This weekend, the American College of Obstetricians and Gynecologists will devote a major session of its annual clinical meeting in Philadelphia to the debate on hormone replacement therapy and its relation to breast cancer and the cardiovascular system.

For McCormack, though, the debate is settled.

"I learned the hard way," she said. "Talk to your doctor and make sure you understand completely what the medicine will do and what the side effects are. When you go in and you're so miserable and you want some help, maybe you should stop and think twice.

"Knowing what I know now, I wouldn't take it."

McCormack has one more bit of advice for women: "Get a mammogram. Don't be afraid. And make sure you have one every year." ]]> Researchers Stop Estrogen Study Over Stroke Fears http://www.yourlawyer.com/articles/read/7715 Wed, 03 Mar 2004 00:00:00 -0500 http://www.yourlawyer.com/articles/read/7715
However, the results, released yesterday by the NIH, were seen as positive for US drugmaker Wyeth, maker of hormone products including estrogen treatment Premarin, as the study did not find increased risks of cancer.

The study was the second part of the Women's Health Initiative research on long-term hormone replacement therapy for post-menopausal women. The first, which studied a combination of estrogen and progestin, shocked the medical community and dramatically changed women's use of HRT after the study was stopped in July 2002.

The first part, which used Wyeth's combination therapy Prempro, linked the treatment to increased risk of heart attacks, strokes and breast cancer after five years' use. That increased risk has slashed Wyeth's HRT drug sales by 50 per cent from more than $2bn in annual sales expected in 2002 to about $1bn this year.

Wyeth's Premarin was the focus of the second part, which sought to explore previous theories that hormones could help prevent heart disease in women over the long term.

Wyeth had already included labelling warning of possible increased stroke risk with Premarin.

The second study did not find increased risks of breast cancer or heart attacks - something that caused concern after the study on Prempro. Premarin, the NIH said, increased the relative risk of stroke by a similar degree as Prempro - eight more strokes per year in 10,000. It decreased the risk of hip fractures and did not increase the risk of breast cancer.]]> NIH Halts Study of Estrogen Therapy http://www.yourlawyer.com/articles/read/7717 Wed, 03 Mar 2004 00:00:00 -0500 http://www.yourlawyer.com/articles/read/7717
Preliminary review of the study's findings indicates that estrogen does protect women from hip fractures, but also may slightly increase the risk of developing dementia or mild cognitive impairment, NIH officials said.

In July 2002, the study known as the Women's Health Initiative halted research into the other form of hormone replacement therapy, estrogen coupled with progestin, after researchers determined the combination increased risks of breast cancer, strokes, heart attacks and blood clots in postmenopausal women.

Together, the findings turn what had long been conventional medical wisdom on its ear, puncturing the myth of hormone replacement as an elixir of youth and healthfulness for women.

"This reinforces the previous recommendation that women should not take hormone therapy to prevent heart disease," said Dr. Barbara Alving, director of the Women's Health Initiative and acting director of the National Heart, Lung and Blood Institute of the NIH.

If women are considering estrogen therapy for relief of severe menopausal symptoms such as hot flashes, she said, "they should use it at the lowest doses, for the shortest period of time."

Hormone replacement had been commonly recommended not just as effective therapy to ease the transition to menopause but as a long-term preventive health measure believed to confer a wide array of health benefits, from preventing heart disease and osteoporosis to possibly protecting cognitive function.

At its peak, some 15 million American women were taking some form of estrogen or combination pills. More than 8 million continue to take estrogen or the combination formula, the majority on estrogen only. Officials with Wyeth-Ayerst, maker of Premarin, said that before 2002, 6.4 million women were taking Premarin, its brand of estrogen pills, while 3.4 million took its brand of estrogen-progestin, Prempro. The numbers have fallen to 4 million on Premarin and 700,000 on Prempro.

Responding to news of the study results yesterday, Cynthia Pearson, executive director of the National Women's Health Network, a nonprofit health organization that pressed for the trials in 1990, said, "The era of replacement therapy is over. It was a theory that made a lot of sense biologically but there wasn't all that much data to back it up."

Hormone treatments are still approved for relief from moderate to severe hot flashes and symptoms of vulvar and vaginal wasting. And though it is effective for preventing osteoporosis, yesterday NIH officials discouraged it for women unless they are at high risk and cannot take other medications.

The estrogen-only study followed 11,000 healthy postmenopausal women, aged 50 to 79, who had previously undergone hysterectomy. It became apparent fairly early that women taking estrogen faced a slightly higher risk of stroke than the control group taking a placebo pill, NIH officials said, and participants were warned about the increased risk.

Women taking estrogen had eight more strokes a year for every 10,000 women, an increase in risk similar to the increased risk of women taking a combination of estrogen plus progestin, NIH officials said.

And estrogen did not confer the promised protection against heart disease.

"This is a sea change from the beliefs in the early 1990s when we got started on the trials," said Dorothy Lane, principal investigator for the Stony Brook University Hospital Women's Health Initiative Clinical Center. "Since the results came out on estrogen plus progestin, it's less surprising, but there still was the hope that the estrogen alone findings would be different."

But, she said, "Estrogen, and estrogen plus progestin, are not the answer."

Some 125 women are enrolled in the estrogen-only part of the trial at the Stony Brook center, according to Lane. They are among 11,000 participants nationwide who have received letters telling them to stop taking the pills. They were randomly assigned to either Premarin, a daily dose of 0.625 mg of conjugated equine estrogen, or a placebo.

Only women who have undergone hysterectomy are treated with estrogen alone, because so-called unopposed estrogen increases the risk of uterine cancer.

The NIH decided to stop the estrogen alone study on Feb. 2, after the initiative's Data and Safety Monitoring Board, an independent advisory committee that regularly reviews data and oversees safety, reviewed the latest data. The advisory committee was split about whether the study should continue or be stopped, but the NIH decided to halt it, Alving said.

One intriguing finding was that estrogen alone, long suspected as a culprit in breast cancer, did not increase the risk during the time period of the study. "We were surprised," Alving said. "There was a great deal of conjecture about this."

More detailed analysis of data from the study will be reported in the next two months and published in medical journals, NIH officials said.

"I wasn't surprised about the results," said Sydell Urdang- Pizzo, 74, of Shirley, who has participated in the study since 1995. "I had a hysterectomy at 45 and was put on Premarin."

But her doctor discontinued it after three months, she said, and Vitamin E helped her with the estrogen depletion.

She learned yesterday that she had been taking a placebo during the study.

"I think it's a beautiful thing for all the women yet to be," she said of the Women's Health Initiative. "It's the only study in this country that's exclusively for postmenopausal women."

A separate report will have information on women 65 and over who took part in the WHI Memory Study (WHIMS), an ancillary study of the hormone trials. Preliminary data suggest those on estrogen face a "trend toward increased risk of probable dementia and/or mild cognitive impairment." In 2003, WHIMS reported an increased risk of dementia in women 65 and over taking estrogen plus progestin.

Wyeth-Ayerst Research provided the active hormone for the estrogen alone study and funded the WHIMS study.

The Women's Health Initiative has involved more than 160,000 postmenopausal women at 40 clinical sites across the country.

Other ongoing WHI trials are studying a low-fat eating pattern and calcium and Vitamin D supplements. ]]> Estrogen Linked to Stroke, Dementia Risk http://www.yourlawyer.com/articles/read/7709 Tue, 02 Mar 2004 00:00:00 -0500 http://www.yourlawyer.com/articles/read/7709
Using estrogen alone as roughly 5.6 million women who've undergone hysterectomies do doesn't appear as risky as taking it with the hormone progestin. Use of estrogen alone for seven years didn't increase women's risk of breast cancer or heart attacks, while taking the two-drug combination for even shorter periods did.

The findings, announced by the National Institutes of Health, may make it more difficult for women to decide whether to take some form of hormone therapy at menopause and, if so, for how long. Already Tuesday, gynecologists reported patients asking if they should abruptly quit their pills.

Estrogen, either alone or with progestin, remains the most effective treatment for such menopausal symptoms as hot flashes and night sweats. For now, the NIH's best advice: If you need it for that reason, take as low a dose as works, for as short a duration as possible.

"This isn't an emergency," said Dr. Barbara Alving, director of the NIH's Women's Health Initiative. But for women who have used estrogen for many years, "this provides them with an opportunity to say, 'Do I really need to be on this still?'"

The big question is whether the stroke concern is relevant to today's average estrogen user, a 50-something woman. The average study participant was 70 and NIH didn't study menopause symptoms, only estrogen's effect on heart disease.

Also, women today can choose much lower estrogen doses than those that were studied, and no one yet knows if lower doses are safer.

"It certainly adds to the confusion, I'm sorry to say," said one of the study's leaders, Dr. Norman L. Lasser of the University of Medicine and Dentistry of New Jersey.

"It sounds cliche to say do more studies, but I don't think we should give up on estrogens," he added. If doctors could learn to predict who was most likely to have an estrogen-caused side effect, he said, other women could safely use it.

Other doctors stressed the good breast-cancer news.

"I think it's reassuring," said Dr. Catherine Stika, obstetrics and gynecology chief at Northwestern Memorial Hospital in Chicago, who wishes NIH had continued the study another year to completely settle the question. Still, "I can more confidently work with my (hysterectomy) patients and offer them the option of estrogen replacement for a short period of time 'short' to be defined."

Only women who have undergone a hysterectomy can take estrogen alone; in other women, progestin prevents estrogen-spurred uterine cancer.

Doctors long thought that hormone therapy would keep women generally healthier after menopause, by reducing heart attacks and keeping the brain sharp.

But in 2002, a major NIH study concluded that the estrogen-progestin combination not only didn't prevent heart disease but long-term use actually raised the risk of breast cancer, strokes and heart attacks. A second study found it increased the risk of dementia, too.

The news led women to quit using hormones in droves, from 15 million users of either estrogen or combination therapy in 2002 to 8.5 million today, according to leading hormone maker Wyeth Pharmaceuticals.

Until now, scientists weren't sure whether estrogen alone was as risky, holding out hope that maybe progestin was the culprit.

But Tuesday, the NIH ended its study of estrogen-only therapy, saying:

Estrogen alone increased the risk of a stroke as much as estrogen-progestin does. For every 10,000 women, those taking hormones suffered eight more strokes a year than women who didn't use hormones.

Preliminary data from a related study suggested women taking estrogen are more likely suffer dementia than those taking a placebo.

On the good side, estrogen alone clearly is less risky than combination therapy because it didn't increase odds of a heart attack or breast cancer, Lasser said.

Like combination therapy, estrogen alone also prevented bone-thinning osteoporosis, but NIH stressed that there are safer osteoporosis treatments.

"It really is true that this therapy needs to be individualized for every woman," with regular checks to see if menopause symptoms have diminished enough to quit, stressed Wyeth's Dr. Victoria Kusiak. "It's not a lifelong commitment."

The NIH released only preliminary data; details are scheduled to be published in a medical journal in mid-April.]]> Estrogen Trial Halted Early http://www.yourlawyer.com/articles/read/7713 Tue, 02 Mar 2004 00:00:00 -0500 http://www.yourlawyer.com/articles/read/7713
The trial part of the federally funded Women's Health Initiative also showed that taking estrogen did not lower the risk of heart attacks. This was a primary reason for undertaking the trial in the first place, said Dr. Barbara Alving, director of the Women's Health Initiative at the National Institutes of Health.

The announcement is more bad news for hormone replacement therapy. It follows the abrupt termination in 2002 of a larger segment of the Women's Health Initiative in which women with uteruses took both estrogen and a second hormone, a progestin.

That trial was halted after a safety monitoring board concluded that taking the two drugs conferred more risk than benefit. The hormone combination slightly raised risks for strokes, breast cancer and in the early years heart attacks, while slightly lowering the risk of fractures and colorectal cancer.

In the estrogen-only trial of 11,000 women who lack uteruses, risks for breast cancer and heart disease were not detectably raised over the average of seven years that women took the hormones. Fracture rates were slightly reduced.

However, preliminary data suggest that the risk for dementia and other cognitive decline was also slightly raised in women taking estrogen compared with those taking a placebo.

Experts said that the new findings, which will be published in detail within two months, further weaken the rationale for women taking estrogen, with or without progestin, except for a short period around the time of menopause to treat symptoms such as hot flashes.

But they noted that the risks are slight, and that women do not need to rush to abandon the therapy. They should first consult with their doctors before deciding.

"Hormone replacement, including either estrogen and estrogen plus progestin, still has a place in the treatment of symptoms," said Dr. Diana Petitti, director of research for Kaiser Permanente Southern California. "But as a global preventive agent, as an agent for preventing coronary heart disease, I think both drugs are on terminal life support."]]> Hormone Supplements, Asthma May Be Linked http://www.yourlawyer.com/articles/read/7645 Mon, 23 Feb 2004 00:00:00 -0500 http://www.yourlawyer.com/articles/read/7645
The study was not as rigorous as landmark research halted in 2002 after more hormone users developed heart problems and breast cancer than women given dummy pills. And the overall risk of developing asthma late in life is slim.

Still, the findings might be something women will want to consider when debating whether to take hormones for hot flashes and other menopause symptoms, said lead researcher Dr. R. Graham Barr of Columbia Presbyterian Medical Center.

The findings appear in Monday's Archives of Internal Medicine.

"For women who have severe asthma that develops later in life, they may want to consider a trial of stopping hormone replacement therapy to see if this alleviates their condition," Barr said.

The study was part of the Nurses' Health Study by Harvard's Brigham and Women's Hospital and involved more than 70,000 women in their 40s and older. They were questioned about hormone use and any diagnosis of asthma. They were followed for about 10 years, until 1998.

During that time, 342 women developed asthma. Current users of either estrogen alone or estrogen plus progestin supplements were about twice as likely to develop asthma than nonusers.

The increased risk was found mainly among current users, not past users, suggesting that stopping hormone treatment can even the odds, Barr said.

The study follows the government's landmark Women's Health Initiative study, which reported the link with heart problems and breast cancer and led many doctors to recommend limiting hormone treatment to low-dose, short-term use for menopause symptoms.

WHI researcher Jennifer Hays of Baylor University questioned whether hormones cause asthma and said there are other possible explanations for the link. It might be that something about the lifestyles of hormone users puts them at increased risk for asthma, Hays said.

The researchers acknowledged that women who take prescription hormones might be more likely to be diagnosed with asthma simply because they might have more doctors' visits than nonusers. But they also found an increased asthma risk among hormone users who had few doctors' visits.

Asthma involves inflammation that constricts muscles in the airways, causing attacks of wheezing and shortness of breath. An estimated 20 million Americans, including 14 million adults, are affected.

Barr said the exact relationship between hormones and asthma needs further study.

But estrogen tends to make cells retain more fluid, which might narrow lung airways, he said. Also, some data have shown that hormone supplements can increase levels of certain inflammatory markers in the blood, which might also affect asthma risk, he said.]]> FDA Updates Hormone Replacement Warnings http://www.yourlawyer.com/articles/read/7571 Tue, 10 Feb 2004 00:00:00 -0500 http://www.yourlawyer.com/articles/read/7571
Since last year, products containing estrogen and progestin have had to bear warnings that the hormone combination increases the risk of breast cancer, heart attacks and strokes. Those risks were discovered in a landmark study in 2002 that overturned years of conventional thinking that postmenopausal hormones were generally beneficial.

Estrogen remains an effective treatment for menopausal symptoms such as hot flashes, night sweats and vaginal dryness, but the Food and Drug Administration written labels urge women to use the lowest possible dose for the shortest amount of time to minimize the risks.

Tuesday, FDA asked manufacturers to add to those labels the results of another study that found hormone supplements don't keep women's brains sharp, as was long believed — long-term users over age 64 actually had a higher risk of dementia.

It isn't known if using estrogen alone causes similar risks; studies are under way to tell.

But since 2002, FDA has seen a trend by manufacturers toward lower doses of hormone products, said agency medical officer Dr. Theresa Van Der Vlugt.

Also Tuesday, Solvay Pharmaceuticals announced FDA approval of EstroGel, the first gel formulation of estrogen, which is absorbed through the skin of the arm. Hormones delivered through lotions and skin patches also are available.

The FDA doesn't know if transdermal versions of hormones are safer than pills, but does advise women with vaginal menopause symptoms to consider using vaginal cream versions. ]]> FDA Updates Hormone Therapy Information for Post Menopausal Women http://www.yourlawyer.com/articles/read/7576 Tue, 10 Feb 2004 00:00:00 -0500 http://www.yourlawyer.com/articles/read/7576
The suggested updated labeling and a revised labeling guidance include information about current approved uses of the drugs: estrogen and combined estrogen with progestin products are effective for treating moderate to severe hot flashes and night sweats, moderate to severe vaginal dryness, and prevention of osteoporosis associated with menopause. The suggested label states that if these products are prescribed solely for vaginal symptoms, health care providers are advised to consider the use of topical vaginal products. The suggested label recommends that if the products are prescribed for osteoporosis, women should be at significant risk for osteoporosis and non-estrogen treatments should be considered inappropriate.

FDA is also advising women and their health care providers that hormone therapy has never been approved for prevention of cognitive disorders such as Alzheimer's disease or memory loss.

"Postmenopausal women need to know about recent results of the Women's Health Initiative, because this information can have a significant public health impact," said FDA Commissioner Mark McClellan, M.D., Ph.D. He added, "After thoroughly evaluating the WHIMS data, FDA is updating the risk and benefit information in product labels to help women and health professionals make informed choices about hormone therapies."

FDA advises women to talk with their health care providers, and if they decide that hormone therapy is appropriate, they should use the lowest effective dose of for the shortest duration to reach treatment goals.

The results of the WHIMS study were published in May 2003 in the Journal of the American Medical Association (JAMA). The study included 4,500 (of the 16,000) WHI participants women between 65 and 79 years of age; half were taking Prempro and half were on placebo.

Sixty women were diagnosed with dementia. Of these, 39 (65%) were in the estrogen with progestin group and 21 (35%) were in the placebo group. Although these findings are statistically significant, the risks to individual women are small. Participants in the study were at least 15 years older than the typical newly menopausal woman. FDA is working with manufacturers to add the WHIMS data to the labels of these drugs and at the same time, the agency is releasing its updated labeling guidance for industry, which includes the revised information.

* Manufacturers should include WHIMS data in the existing Black Box that contains WHI data on cardiovascular risks based on the WHI study. WHIMS found an increased risk of developing probable dementia in postmenopausal women age 65 years of age or older during 4 years of treatment with oral conjugated estrogens plus medroxyprogesterone acetate compared to placebo. It is unknown whether this finding applies to younger postmenopausal women taking estrogen alone.

* FDA also advised manufacturers to add the WHIMS data to the clinical studies section.

* Additional information being added from WHI about mammography includes: "The use of estrogen with progestin may result in an increase in abnormal mammograms requiring further evaluation.”

* Manufacturers must specify the lowest effective dose or state that the lowest dose of their drug has not been determined.

FDA will include this new information in the educational materials developed for the "Menopause and Hormones Information Campaign” that was launched last fall. FDA will also continue to engage the National Institutes of Health as well as manufacturers to pursue research on questions addressing the safe and effective use of estrogen with progestin therapies.]]> HRT Increases Recurrence of Breast Cancer http://www.yourlawyer.com/articles/read/7563 Mon, 09 Feb 2004 00:00:00 -0500 http://www.yourlawyer.com/articles/read/7563
Swedish researchers embarked on the study in part because more women are surviving the disease and therefore subject to the same menopausal symptoms as other women. The study was expected to involve around 1,300 women over five years. After the initial 345 women in the study were followed for about two years, however, results showed 26 of those randomized to receive HRT experienced a new or recurring cancer, compared to just seven in a placebo group. The risk was deemed unacceptable, and the study was halted on December 17, 2003.

Noting some doctors prescribe HRT for their breast cancer patients with severe menopausal symptoms because observational studies have suggested no harm from the treatment, Harmon J. Eyre, M.D., chief medical officer of the American Cancer Society, comments, "This study will no doubt change that. It is large enough and clear enough to show that HRT appears to increase the chance of a new or recurring breast cancer. Because of that, offering HRT to women with a history of breast cancer would be unwise."

In an accompanying commentary to the study, Rowan T. Chlebowski, from Harbor-UCLA Research and Education Institute in Torrance, Calif., and Nananda Col, from Brigham and Women's Health Hospital in Boston, Mass., agree, noting, "Alternative safe and effective strategies for the difficult problem of menopausal symptoms in these women now need to be developed."]]> Women Warned To Avoid Hormone Therapy http://www.yourlawyer.com/articles/read/7400 Fri, 09 Jan 2004 00:00:00 -0500 http://www.yourlawyer.com/articles/read/7400
Women with a personal or family history of breast cancer should be particularly leery, according to the new recommendations.

"Current research shows the risks of combined HRT including the increased risk of breast cancer outweigh the benefits," Heather Logan, the society's director of cancer control policy, said.

The recommendations draw renewed attention to a bombshell study published in July, 2002, showing that the combination of estrogen and progestin, the standard treatment for menopausal symptoms for decades, is fraught with health risks. In addition to hiking a women's breast-cancer risk, HRT increases the risk of heart disease, stroke, blood clots in the lungs and dementia. However, the drugs reduce the risk of hip fractures and colorectal cancer and can be effective in treating some symptoms of menopause, such as hot flashes.

Mrs. Logan stressed that the Cancer Society was not giving medical advice and that every woman should make an individual decision after consulting with her physician.

New research, however, shows that women are abandoning HRT in droves.In the United States, prescriptions for HRT have plummeted by almost 40 per cent since July, 2002, according to a study in this week's edition of the Journal of the American Medical Association.

There are no comparable Canadian figures, but a small poll conducted one year ago by Pollara revealed that 44 per cent of women using HRT had stopped taking the drugs and another 32 per cent said they would discontinue HRT in the future. According to Statistics Canada, about 1.2 million women took HRT in 2001.

U.S. researchers estimate that prescriptions for hormone treatments will total about 57 million for 2003, down from 91 million in 2001.

Deborah Grady, a researcher at the University of California, San Francisco, said three in four women suffered virtually no symptoms when they stopped HRT. Most physicians recommend tapering off the pills over a period of six to 12 months rather than going cold turkey.

The researcher noted that postmenopausal women looking for alternatives to HRT are increasingly turning to low doses of antidepressants such a Prozac. Some drugs used to treat insomnia and high blood pressure have also proved effective for menopausal symptoms. The herb black cohosh is also a popular alternative.

In an effort to help women understand the risks associated with taking combination hormone-replacement therapy, the Canadian Cancer Society published a chart comparing the theoretical rates among two groups of 10,000 women, one of which takes HRT, and the other, which does not. The analysis shows that, each year: eight more women will develop invasive breast cancer (38 taking HRT, 30 not taking HRT); seven more will have heart attacks (37, 30); eight more will have strokes (29, 21); 18 more will develop blood clots in a vein (34, 16); six fewer will develop colorectal cancer (10, 16); and five fewer will suffer hip fractures (10, 15).]]> Premarin Side Effects Lawsuits | Side Effects: Ovarian Cancer, Heart Attack, Strokes http://www.yourlawyer.com/topics/overview/premarin Fri, 09 Jan 2004 00:00:00 -0500 http://www.yourlawyer.com/topics/overview/premarin CLICK HERE TO DOWNLOAD OUR PREMARIN INFORMATION PACKAGE

Premarin Side Effects Could Result In Ovarian Cancer Lawsuits

Premarin | Lawsuits, Lawyers | Side Effects: Ovarian Cancer, Heart Attack, Strokes

Premarin (Generic: Conjugated estrogens) has been linked to the following serious side effects: Ovarian Cancer, Lupus, Scleroderma, Gallbladder Cancer and Stroke. Premarin is an estrogen-only hormone replacement therapy (HRT) used to treat the symptoms of menopause. Premarin is typically prescribed for women without a uterus.

Recently, the National Institutes of Health stopped a trial of women taking Premarin estrogen replacement therapy after finding the pills not only failed to reduce the risk of heart disease, but that they raised the possibility of a stroke. The Premarin trial was the second large trial of hormone replacement therapy to have been halted in two years. In July 2002, women taking Prempro (estrogen and progestin) were told to stop because of the risk of heart attack, stroke and some forms of cancer.

In a report published in the Journal of American Medical Association, doctors report that women who take estrogen-only hormone replacement therapy such as Premarin for a long period of time have a higher-than-average risk of developing ovarian cancer. Women who took estrogen HRT's like Premarin for longer periods of time had a higher risk of developing ovarian cancer, and the researchers noted a 7% increase in risk associated with every extra year of estrogen HRT use. Those who took estrogen for at least 10 years were twice as likely to develop ovarian cancer, and those who used the drugs for 20 or more years were three times as likely to develop ovarian cancer as those who did not take the hormone, the report indicates.

Premarin was the first hormone replacement therapy (HRT) drug to hit the market. Premarin was first marketed in 1942 to alleviate the symptoms of menopause in women. Today, Premarin is still the most popular HRT drug, and is one of the most prescribed drugs in the world. There are approximately 11 million women currently take Premarin. The popularity of this drug is due both to its extensive history and an aggressive marketing campaign by Wyeth.

Legal Help For Victims Affected By Premarin

If you or a loved one took Premarin and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney or call us at 1-800-LAW-INFO (1-800-529-4636).

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