Iowa Sen. Charles E. Grassley, a member of the Senate Finance Committee, is leading the investigation into the drug industry’s influence on doctors. As part of the investigation, Sen. Grassley has sent letters to Wyeth and DesignWrite, a medical writing company, asking for details on scientific reports that were prepared by DesignWrite for Wyeth and to describe the authors’ extent of involvement and any fees paid.

“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,” Sen. Grassley wrote to Wyeth’s chairman and chief executive, Bernard J. Poussot, according to the New York Times story.

Prempro was one of the more widely used hormone replacement therapies prescribed for women to combat symptoms of menopause, such as hot flashes, night sweats, mood swings and decreased sexual desire. It was thought that hormones had an added benefit – that taking HRT reduced a woman’s chance of breast cancer and heart disease. However, the Women’s Health Initiative in 2002 found that taking HRT measurably increased a woman’s risk for serious conditions including breast cancer, ovarian cancer and heart disease. Since then, Wyeth has faced numerous lawsuits claiming the drug company misled the public about the safety of its hormone therapy.

SOURCE: Hormone Replacement Therapy › Study finds Wyeth paid ghostwriters to promote Prempro

Most doctors prescribed HRT for women experiencing bothersome symptoms of menopause such as hot flashes and night sweats, mood swings and decreased sexual desire. Just a few years ago it was believed that long-term use of HRT was safe and offered other benefits, such as protecting against osteoporosis and heart disease.

However, preliminary results of the 2002 Women’s Health Initiative (WHI) showed that the complications of HRT far outweighed the benefits. WHI researchers found that women on hormones were at an even higher risk for serious diseases and conditions such as breast cancer, ovarian cancer, cardiovascular disease, stroke and blood clots.

The new study is the first follow up to the landmark WHI. The analysis focused on women’s health three years after stopping HRT. Researchers have found that women who stopped HRT still had an increased risk of cancer – especially breast and lung cancers. The report also found a decreased risk of heart disease.

During the second and third years after the end of WHI, researchers noticed that women who took hormones but stopped were 24 percent more likely to develop cancer than women who had taken placebos during WHI.

Researchers say the analysis results show that women who have stopped taking hormones need to be vigilant about getting cancer screenings and mammograms.

SOURCE: Hormone Replacement Therapy › Cancer risk still elevated even years after stopping HRT

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

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

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

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

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

To further complicate matters, ovarian cancer is hard to diagnose in its early stage. Only about 20 percent of ovarian cancer is found at the early stage. When found early, the survival rate is 95 percent over five years. Approximately 75 percent of ovarian cancer cases are diagnosed at an advanced stage after the cancer has spread beyond the ovary.

But a new method devised by researchers at the Fred Hutchinson Cancer Research Center in Seattle, Wash., has been found to increase the diagnosis of the disease by one third, according to FoodConsumer.org. The process used both a questionnaire on symptoms and blood tests. Using the questionnaire alone led to the discovery of early stage ovarian cancer in 60 percent of the cases. The blood test alone reported to same percentage of results. However, both the questionnaire and the blood test combined resulted in an early stage diagnosis in 80 percent of the cases.

Symptoms include bloating, pelvic and abdominal pain, difficulty eating or feeling full quickly, and urinary urgency or frequency. Additional symptoms may include fatigue, indigestion, back pain, pain with intercourse, constipation and menstrual irregularities. Blood tests to diagnose ovarian cancer include the CA-125. Other diagnostic tests include physical exam, pelvic exam, ultrasound and biopsy.

SOURCE: Hormone Replacement Therapy › New method found to detect early stage ovarian cancer

According to the lawsuit filed in St. Clair County Circuit Court, Gray used Prempro from Jan. 19, 1998, through Oct. 15, 2005. She was diagnosed with left breast cancer on Nov. 14, 2005.

They claim the drug was defectively designed and that the defendants failed to warn users of its danger.

“…Defendants failed to perform adequate testing and study HRT (hormone replacement therapy) drugs prior to marketing it or properly analyze and warn based upon studies and testing,” the complaint states.

The defendants failed to warn the plaintiff that use of HRT drugs carried a risk of ovarian cancer.

In a claim for loss of consortium, the lawsuit alleges the marital association of the Grays has been altered causing great mental anguish.

November 26th, 2007

SOURCE: Hormone Replacement Therapy › Prempro user claims drug caused breast cancer

Scharlotte Fitzgerald says she began taking hormone replacement drugs in 1994. In 2001 she was diagnosed with breast cancer.

Fitzgerald and her husband Larry filed a personal injury suit against the drug companies in the Beaumont Division of the Eastern District of Texas on Nov. 2. They are seeking in excess of $75,000 in damages.

“This lawsuit asserts claims for negligence; strict product liability for failure to warn, strict product liability for design defect; and breach of implied warranty against the defendants responsible for the design, manufacture, production, testing, study, inspection, mixture, labeling, marketing, advertising, sales, promotion and/or distribution of those hormone therapy products that caused her breast cancer,” the plaintiffs’ original complaint states.

The plaintiffs’ claim that the defendants had an obligation to provide warnings about risks and side effects of their hormone therapy drugs as soon as it was aware of them. The suit alleges that the drug companies failed to disclose “an increased incidence and risk of strokes, blood clots, heart attacks, breast cancers and ovarian cancer from these drugs.”

Plaintiffs also assert that the defendants made claims regarding health benefits of the drugs and should have known “that these claims were false and misleading.”

The defendants also gave a false impression that adequate pre-marketing clinical testing and research and post-marketing surveillance had been done, the plaintiffs claim.

“Plaintiff would not have ingested the hormone therapy drugs … or would have discontinued their use, or would have used safer alternative methods, had defendants disclosed the true health consequences, risks, and adverse effects, including the increased incidence and risk of breast cancer and other illnesses, caused by their hormone drugs,” the complaint states.

In the first claim against defendants, the plaintiff alleges that the companies were negligent by failing to exercise reasonable care in designing, manufacturing, testing and distributing the hormone replacement drugs.

“Defendants knew or should have known that their hormone therapy drugs caused unreasonable harm and dangerous side effects that many users would be unable to remedy by any means,” the petition states. “Despite this, defendants continued to promote and market their hormone therapy drugs for use by consumers, including plaintiff, when safer and more effective methods of countering the negative health effects of menopause were available.”

The petition also includes claims for strict liability through failure to warn and design defect.

“These hormone therapy drugs were each dangerous to an extent beyond that which would be contemplated by the ordinary consumer who purchased them,” the suit says. “They were more dangerous than plaintiff contemplated. The risk of each of these hormone therapy drugs outweighs its utility.”

The companies also breached implied warranty, the suit said, because the sold the drugs as being of “merchantable quality and safe and fit for their intended use.”

Scharlette Fitzgerald is seeking damages to exceed $75,000, attorney fees, costs of suit and other relief that the court may deem just and proper.

Her husband, Larry Fitzgerald is also seeking monetary damages for his loss of spousal services, society and companionship.

SOURCE: Hormone Replacement Therapy › Lawsuit filed over HRT drugs blamed for breast cancer

Minnie Louise Gray and her husband John E. Gray filed an 11-count suit against Wyeth, Inc. over its drug Prempro, which is used by post-menopausal women. The suit also names Walgreen as a defendant for having sold the drug to Gray.

According to the lawsuit filed in St. Clair County Circuit Court, Gray used Prempro from Jan. 19, 1998, through Oct. 15, 2005. She was diagnosed with left breast cancer on Nov. 14, 2005.

The lawsuit claims the drug was defectively designed and that the defendants failed to warn users of its danger.

“…Defendants failed to perform adequate testing and study HRT (hormone replacement therapy) drugs prior to marketing it or properly analyze and warn based upon studies and testing,” the complaint states.

The lawsuit claims the defendants failed to warn the plaintiff that use of HRT drugs carried a risk of ovarian cancer.

In a claim for loss of consortium, the lawsuit alleges the marital association of the Grays has been altered causing great mental anguish.

October 23rd, 2007

SOURCE: Hormone Replacement Therapy › Prempro user claims drug caused breast cancer

Brett Hendricks, a former sales representative for Wyeth, provided riveting testimony regarding his twenty-one year career with the largest manufacturer of hormone replacement therapy drugs that outlined the organized deception of doctors and patients that plaintiffs contend overstated the benefits of HRT therapy while concealing the risks.

“That’s how we were trained,” Hendricks said. “To offset any bad publicity, we would redirect and emphasize the benefits of the product and say the benefits far outweighed any problems that might be out there.”

On the stand, Hendricks confirmed Wyeth’s marketing strategy that had already been laid out in the millions of pages of documents produced by Wyeth and others in the HRT litigation that has been pending for more than five years. Wyeth sales representatives were encouraged to engage in aggressive, one-on-one sales tactics with prescribing physicians to supplement the manufacturer’s advertising plan which included overselling the benefits of HRT drugs, discrediting scientific studies that raised any questions about safety (especially breast cancer risks), criticizing physicians who chose safer alternative drugs or counseled their patients on the option of not taking any HRT drugs at all, and pushing menopausal women to take combination hormone product drugs from the onset of menopause (or perhaps even before) and to continue taking the drugs throughout the rest of their lives.

In July of 2002, the Women’s Health Initiative (“WHI”) study was published and confirmed what many had long suspected – that Prempro and combination hormone replacement products (including Wyeth’s Premarin taken in combination with Pfizer’s Provera or another progestin such as medroxyprogesterone) are associated with an increased risk of hormone-positive breast cancers as well as other health risks, including heart attacks, strokes, blood clots, and ovarian cancer, etc.

The WHI Study (which was funded by the United States government, after manufacturers of hormone replacement drugs failed to conduct proper studies to evaluate the risks of HRT-induced breast cancer) led to a fundamental shift in the manner in which HRT drugs were prescribed. Today, physicians and patients are being told that HRT is not right for every woman, and instead should only be considered by those for whom the symptoms of menopause are severe and interfering with their lives. In addition, patients have been encouraged to use HRT drugs for the shortest time possible and at the lowest possible doses.

In fact, the Prempro product ingested by most women prior to 2002 no longer exists, and instead was replaced by a lower dose product (although it is not yet known whether a lower dose actually equates to a lower breast cancer risk). There is also a strong movement in the medical community to investigate other drugs for menopausal symptoms and osteoporosis, including SERMs (selective estrogen receptor modulators) and natural or bioidentical hormones that more closely resemble those that are made by a woman’s body. Prempro, for example, includes an estrogen compound derived from the urine of pregnant horses and chemically synthesized progestin (which is a necessary additive since estrogen alone has long been known to cause uterine cancer, but also eliminates many of the benefits that have been shown with use of estrogen alone and increases the risks of breast cancer).

The pharmaceutical industry has long maligned alternative therapies for menopausal patients, but evidence continues to mount that the HRT-induced breast cancer epidemic noted in recent breast cancer registries might have been avoided if women had been given more information in order to make meaningful decisions regarding treatment options years ago.

The Reno HRT trial is expected to last for a few more weeks. Alley, Clark, Greiwe & Fulmer will be trying the first HRT case in Florida in Pinellas County in June of 2008. This will be the first wrongful death claim to be brought to trial in the national litigation. The case was brought on behalf of a Clearwater grandmother who was diagnosed in early 2002 at the age of 59 with hormone-positive lobular breast cancer (the type most strongly associated with use of HRT drugs), just months prior to announcement of the WHI study results. Her cancer was very aggressive and had already spread to brain and bones by that time. After fighting valiantly for several years, she lost her battle and died late last year before her case was scheduled for trial. The lawsuit is now being prosecuted by her loving husband of forty-one years on behalf of her estate and survivors.

October 5th, 2007

SOURCE: Hormone Replacement Therapy › HRT sales rep whistleblower admits improper promotion