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Tuesday, May 29, 2007

Menstrual cycle stoppage debated

Tuesday, May 29, 2007 - 12:07 AM
A birth-control pill that lets a woman skip monthly menstrual periods sounds like a good idea to Sarah Kimball.
"If my doctor recommends it for me, I would be more than happy to give it a whirl," said Kimball, 27, of Glen Allen. "The idea of never having a period is nice."
Federal officials last week approved Wyeth Pharmaceuticals' Lybrel, a birth-control regimen that eliminates monthly menstrual periods.
Lybrel's approval has gotten folks talking. Not all the discussions are favorable -- a question on many minds is whether this is a good thing or is it messing with Mother Nature with uncertain long-term consequences.
We contacted local experts to answer a few questions about Lybrel, which will be available in July. The experts are:
Dr. JoAnn V. Pinkerton, an associate professor of obstetrics and gynecology at the University of Virginia School of Medicine, and director of The Women's Place Midlife Health Center at U.Va.
Dr. Vienne K. Murray, an obstetrician-gynecologist at Virginia Women's Center, in the Richmond area.
Dr. Sulola Denloye Adekoya, an obstetrician-gynecologist at the Richmond Department of Public Health.
1. Women are already doing this, right?
Pinkerton: "Many women have been utilizing continuous cycles just by not taking their placebo pills. This pill is now providing a mechanism for something women are already doing, having a period when it suits them. . . . There is no need to bleed unless women want the security of having a monthly period."
2. Why would woman want to eliminate their periods?
Murray: "For women with debilitating, painful periods, heavy periods, this is a good idea."
Pinkerton: "There are some women who would be excellent candidates, such as women with [some types of] migraine headaches, women who have problems premenstrually. Certain medical problems will be helped: people with premenstrual syndrome, endometriosis, women with heavy bleeding. . . . Some women prefer not to have a monthly period, [including] athletes like swimmers, ballerinas."
Adekoya: "For convenience - summertime, when you go on vacation; women who have high-powered jobs and they don't want a cycle."
3. Who should not take Lybrel?
Pinkerton: "Women in general who should not take pills or women at risk for blood clots, stroke, who have had breast cancer or other estrogen-sensitive tumors, or migraines worsened by estrogen. Women who are comforted by regular cycles. Women who won't or can't be compliant with taking the pill every day. Smokers. Women who desire pregnancy."
4. What are the disadvantages? Side effects?
Adekoya: "The downside, for a couple of months you may have unscheduled bleeding. Some women will experience irregular spotting every now and then. You eventually get to a point where you don't have a [menstrual] cycle."
5. Is Lybrel safe? Are similar continuous dosing regimens safe?
Adekoya: "It's safe theoretically. The only caution is that you have to speak to your health professional. If you have medical problems, the same contraindications would apply - high blood pressure, blood clots."
Murray: "My only concern is how long can we put women on it. If indefinitely, I think the main issue would be future fertility. It would be extremely important for women to consider their future fertility."
Pinkerton: "We are lacking long-term safety data."
6. The pill is effective if taken correctly, but many women often forget to take a pill? Will this be a problem?
Adekoya: "It's really no different than with the other pills - you have to take it every day."
7. How soon after stopping Lybrel will periods resume?
Pinkerton: Fairly quickly, within about three months.
Contact staff writer Tammie Smith at tsmith@timesdispatch.com or (804) 649-6572 .


Don't fall for e-mail warning on ovarian cancer

By Marla KrauseSpecial to the TribunePublished May 27, 2007
The e-mail starts out innocuously enough; it's from a female friend concerned about health issues. But the type is big, so you quickly get the message that THIS IS IMPORTANT.Did you know, it asks, that there is a simple blood test for ovarian cancer that your doctor is not telling you about and that your insurance company doesn't want to pay for? And, it goes on, because the writer of this e-mail was denied the test, she is now battling peritoneal cancer, a disease similar to ovarian cancer that attacks the stomach lining.
But what appears to be the kind of information that gives women nightmares is really an urban legend, according to gynecologists, medical Web sites and Gilda's Club, a support community for people with cancer founded in memory of comedian Gilda Radner, who died of ovarian cancer in 1989."I have seen a version of this e-mail for many years," said Karyn Grimm Herndon, an ob-gyn with practices in Evanston and Glenview. "The CA-125 test is almost never an appropriate first-line test for ovarian cancer. If a person has risk factors, like a mother or a sister with ovarian cancer, or has previously been diagnosed, this test might be used, but it is not a recommended screening test for the average person.""We have gotten calls in the past about this e-mail story," said LauraJane Hyde, CEO of Gilda's Club Chicago. "We are all for a call to action that empowers women, but alarmist tactics like this don't help what we do."
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Thursday, May 24, 2007

Not all women cheer birth control that halts periods

New pill raises health-risk issues
May 23, 2007
Some metro Detroit women praised a new birth control pill that won U.S. Food and Drug Administration approval on Tuesday. But others said they were skeptical and wanted more long-term evidence that the pill, which eliminates monthly periods, is safe.
Christie Lockman, 20, of Royal Oak takes birth control pills to regulate her periods and said she would think about trying the new pill, Lybrel.
"Who wouldn't like to have fewer periods?" Lockman said. "That's what every woman would want, I would think."
But Julie Kupsov, 37, of Farmington Hills wasn't so sure. She is expecting her first child this month and was on the pill for several years. "I probably wouldn't go on something that hasn't been studied long term," she said. "It's appealing, but I probably wouldn't do it."
About 12 million American women now take contraceptive pills. For most, it is a way to prevent pregnancy, but for some it is a way to regulate periods or ease menstrual symptoms such as cramps and heavy bleeding.
Lybrel is the first pill approved that women would take every day that suspends periods indefinitely. The original birth control pill, introduced in the 1960s, had 21 days of hormone pills and seven days of sugar pills. The pills caused monthly bleeding that mimicked natural periods.
Newer versions of the pill introduced in the past few years, including Yaz and Seasonique, make menstrual periods shorter or cause them to occur only a few times each year.
Lybrel stops periods altogether, using the lowest dose yet of hormones. But doctors cautioned that Lybrel, like its predecessors, carries the same risks: blood clots, high blood pressure, stroke and heart attack, especially among women 35 or older and/or those who smoke. Some women may have spotting or breakthrough bleeding.
Wyeth, the pharmaceutical company that developed Lybrel, plans to start selling the pills in July. They contain two hormones, ethinyl estradiol and levonorgestrel.
The theory behind the lower dose is that it will reduce risks, said Dr. Susan Ernst, chief of obstetrics and gynecology at University Health Service in Ann Arbor.
Ernst said studies presented this month at national meetings showed that 99% of women reverted to natural periods or got pregnant when they stopped taking Lybrel, so there was no evidence it hurts fertility.
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Doctors say new contraceptive is safe - period

Dr. Henry Klapholz has been stopping women's periods for years.
They may be patients with endometriosis, heavy bleeding or frequent menstrual migraines. Some are women who would just prefer to do without the monthly mess entirely.
Klapholz, along with doctors around the country, would simply prescribe a low-dose birth control pill and advise patients to start the next package instead of taking placebo pills in the fourth week. It is an off-label use that this week won federal approval when the Food and Drug Administration OK'd Lybrel, the first birth control pill marketed as a method to stop menstruation.
"Medically, this is a good thing," said Klapholz, chief of obstetrics and gynecology at MetroWest Medical Center in Framingham. "We can help people who will otherwise end up with a hysterectomy or an ablation ... we can reduce surgeries and still eliminate their periods."
Methods to shorten periods are already on the market. The Mirena, an IUD that contains low doses of hormones, and the Depo-Provera shot can lighten or stop periods entirely. The birth control pills Yaz and Loestrin 24 shorten monthly periods to three days or less and Seasonale and Seasonique reduces them to four times a year.
The original birth control pill was developed in Massachusetts in the 1950s by researcher Gregory Pincus and Dr. John Rock, a Marlborough native. Rock, a devout Catholic, campaigned to have the method approved by the Vatican, basing his arguments, in part, on the fact that the pill mimicked a woman's natural cycle and allowed a period each month.
When the birth control pill first hit the market in the 1960s, the off week was considered necessary not only because of the higher dosage of hormones but also because women took comfort in having the menstrual proof that they were not pregnant.
"Some ladies, they like having a period or at least the reassurance that they have a period once a month," said Dr. Kerri Osterhaus-Houle, a gynecologist with Women's Health of Central Massachusetts in Marlborough.
Osterhaus-Houle expects the market for Lybrel to be equally divided between women seeking to combat a medical problem and women simply seeking the convenience of a menstruation-free life.
"I have some women who are very active - they just don't want the messy side effects of a period," she said. "At some point, it may be the wave of the future. Women will say, 'I don't want to have my period. There's no need to have it.'
"The biggest question from patients is, 'If I want to have kids someday, will my fertility be hurt by this?' And it doesn't appear to be the case," Osterhaus-Houle added. She noted studies have shown women on the nonstop pills, like women on the regular birth control pill, have their fertility fully restored three months after stopping it.
Klapholz has been prescribing continuous birth control pills for over 30 years while treating endometriosis patients. The treatment was referred to as a "pseudo pregnancy."
"The big difference has to do with the dosage of the pill," Klapholz said. "Years ago, we didn't have the ultra-low dose pills we have today. We had to continuously up the dosage to prevent breakthrough bleeding."
Breakthrough bleeding - spotting outside of a period - is also a side effect of Seasonale for the first few months, Klapholz said. The uterine lining thins out over time, however, which halts the problem. Breakthrough bleeding is also a reported side effect with Lybrel, which is expected to be on the market in July.
"Everyone is different," Klapholz said. "Some women like to have their periods every month for the reassurance ... it's really a very individual thing. Others think that it's an unnecessary pain - they get mood swings, they get PMS, they have heavy bleeding and cramping. Some women have days when they don't even want to leave the house because they're bleeding so heavily."

Monday, May 07, 2007

Berrin inspires Gulliver

Gulliver second baseman Valerie Berrin recently made one of her team's most important plays of the season.
Berrin robbed American Heritage's Tiffany DeFelice of a game-tying hit in a 1-0 Gulliver win two weeks ago. It was the Raiders' biggest win of the postseason so far.
For Berrin, playing in the game was a victory.
Since she was 7, Berrin has suffered from endometriosis, a rare condition in which the lining tissue of the uterus is found in other pelvic organs.
The main symptom of the disease, which is the most common cause of infertility for women, is severe abdominal pain during menstruation. The only treatment is surgery to clear the tissue buildup.
Berrin has had seven surgeries, including five during high school.
The surgeries leave Berrin weakened and unable to play softball for weeks. It forced her to miss her entire junior season and parts of her freshman and sophomore seasons.
''When it started, I remember thinking maybe there was something wrong with my stomach,'' Berrin said. ``I had all the tests you can think of done to me, and they didn't find anything.''
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Bradley Pharmaceuticals to Preview New Products at ACOG Meeting

FAIRFIELD, N.J., May 4 /PRNewswire-FirstCall/ -- Bradley Pharmaceuticals, Inc. today announced that it will preview two new FDA-approved products at the annual clinical meeting of the American College of Obstetricians and Gynecologists (ACOG) to be held in San Diego, California, from May 5-9, 2007. The Company's Kenwood Therapeutics division will be offering package inserts and product information about Elestrin(TM) (estradiol gel 0.06%), and Veregen(TM) (sinecatechins) Ointment 15%, both of which are scheduled to be launched this year.Veregen(TM) is a topical ointment used for the treatment of external genital and perianal warts. Veregen(TM)'s novel active ingredient, sinecatechins, is derived from the extract of green tea. Veregen(TM), approved in October 2006, is the first botanical and one of 18 new molecular entities approved by the FDA last year. The product is patent protected until 2017. Bradley in-licensed Veregen(TM) from MediGene AG (TecDax: MDG) of Frankfurt, Germany. Both Bradley's Kenwood Therapeutics division and Doak Dermatologics subsidiary are currently scheduled to begin detailing Veregen(TM) to OB/GYN physicians, dermatologists, college health departments, planned parenthood organizations, and public health programs during the fourth quarter of this year."We are pleased to have the opportunity to preview both Elestrin(TM) and Veregen(TM) at ACOG. This conference offers the largest exhibition in the country for obstetricians and gynecologists and related health care professionals," said John Knoop, Vice President and General Manager of Bradley's Kenwood Therapeutics division."Part of Bradley's expanded business strategy is to in-license Phase II and Phase III drugs and develop and bring to market products with long-term intellectual property protection. We accomplished this quickly last year after signing agreements for Elestrin(TM) and Veregen(TM) and receiving FDA approval for both products during the fourth quarter. We are looking forward to successful launches as we progress through the year," commented Daniel Glassman, President and CEO of Bradley Pharmaceuticals.Elestrin(TM) is indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause.Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.Long-term continuous administration of estrogen, with or without progestin, has shown an increased risk of endometrial, breast and ovarian cancers.Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. An increased risk of developing probable dementia in postmenopausal women 65 years of age or older was reported with estrogen-alone use, as well as, in combination with progestin.Estrogen-alone therapy has been associated with an increased risk of stroke and deep vein thrombosis. Estrogen plus progestin therapy has been associated with an increased risk of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli and deep vein thrombosis. Estrogens should be discontinued immediately if any of these events occur or are suspected.Estrogen with or without progestin should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the patient.An increase in gallbladder disease requiring surgery in postmenopausal women receiving estrogens has been reported. Estrogen therapy may lead to severe hypercalcemia in patients with breast cancer and bone metastases. Retinal vascular thrombosis has been reported in patients receiving estrogens. Estrogen products should not be used in women with undiagnosed abnormal genital bleeding; known, suspected or history of breast cancer; known or suspected estrogen-dependent neoplasia; active or history of deep vein thrombosis or pulmonary embolism; active or recent (within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction); liver dysfunction or disease; known or suspected pregnancy.Blood pressure should be monitored during estrogen use. Caution should be exercised in patients with hypertriglyceridemia, impaired liver function or a history of cholestatic jaundice, conditions that might be influenced by fluid retention, hypocalcemia, asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas. Patients dependent on thyroid hormone replacement therapy may require increased doses of such therapy. The addition of progestin should be considered in patients with residual endometriosis post-hysterectomy. Concomitant application of sunscreen and Elestrin(TM) to the same site for more than 7 days should be avoided.The most frequently reported adverse events in clinical trials were nasopharyngitis, breast tenderness, upper respiratory tract infection, and metrorrhagia.For additional important information, please request full prescribing information for Elestrin(TM) by contacting Bradley Pharmaceuticals.Important Product Safety Information About Veregen(TM):Veregen(TM) is indicated for the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older.Veregen(TM) is for external use only. Skin reactions including erythema, erosion, edema, itching, and burning at the application site are common. Should a severe local skin reaction occur, the ointment should be removed and further doses held.Veregen(TM) has not been evaluated for the treatment of urethral, intra- vaginal, cervical, rectal, or intra-anal human papilloma viral disease and should not be used for these conditions.The safety and efficacy of Veregen(TM) in immunosuppressed patients, in the treatment of external genital and perianal warts beyond 16-weeks, or for multiple treatment courses have not been established.Veregen(TM) is not a cure and new warts might develop during or after therapy. If new warts develop during the 16-week treatment period, these should also be treated with Veregen(TM).The effect of Veregen(TM) on the transmission of genital/perianal warts is unknown.Sexual (genital, anal or oral) contact should be avoided while the ointment is on the skin. Veregen(TM) may weaken condoms and vaginal diaphragms. Therefore the use in combination with Veregen(TM) is not recommended.In clinical trials, the incidence of local adverse events leading to discontinuation or dose interruption included: application site reactions (local pain, erythema, vesicles, skin erosion/ulceration), phimosis, inguinal lymphadenitis, urethral meatal stenosis, dysuria, genital herpes simples, vulvitis, hypersensitivity, pruritus, pyodermitis, skin ulcer, erosions in the urethral meatus, and superinfection of warts and ulcers.For additional important information, please request full prescribing information for Veregen(TM) by contacting Bradley Pharmaceuticals.Bradley Pharmaceuticals, Inc. was founded in 1985 as a specialty pharmaceutical company and markets to niche physician specialties in the U.S. and international markets. Bradley's success is based upon its core strengths in marketing and sales which enables the company to Commercialize brands that fill unmet patient and physician needs; Develop new products through life cycle management; and In-License phase II and phase III drugs with long-term intellectual property protection that upon approval leverage Bradley's marketing and sales expertise to increase shareholder value. Bradley Pharmaceuticals is comprised of Doak Dermatologics, specializing in therapies for dermatology and podiatry; Kenwood Therapeutics, providing gastroenterology, OBGYN, respiratory and other internal medicine brands; and A. Aarons, which markets authorized generic versions of Doak and Kenwood therapies.Important announcements:Bradley Pharmaceuticals will present at the 2007 UBS Global Generic and Specialty Pharmaceuticals Conference to be held at the Grand Hyatt in New York, NY, May 8-9, 2007.Bradley Pharmaceuticals will present at the Robbins Emerging Opportunities Investment Conference, to be held at The University Club in New York, NY, May 24, 2007.Bradley Pharmaceuticals will present at the Banc of America Securities Health Care Conference 2007, to be held at The Four Seasons Hotel in Las Vegas, Nevada, May 30 - June 1, 2007.Bradley Pharmaceuticals will present at the FTN Midwest Securities Health Care Conference 2007, to be held at the Four Seasons Hotel in New York, NY, June 5, 2007.Safe Harbor for Forward-Looking StatementThis release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements that address activities, events or developments that Bradley expects, believes or anticipates will or may occur in the future, such as Bradley's plans to in-license, develop and launch new and enhanced products with long-term intellectual property protection or other significant barriers to market entry, sales and earnings estimates, other predictions of financial performance, timing of payments on indebtedness, launches by Bradley of new products, market acceptance of Bradley's products, and the achievement of initiatives to enhance corporate governance and long-term shareholder value. Forward-looking statements are based on Bradley's experience and perception of current conditions, trends, expected future developments and other factors it believes are appropriate under the circumstances and are subject to numerous risks and uncertainties, many of which are beyond Bradley's control. These risks and uncertainties include Bradley's ability to: launch VEREGEN(TM) and ELESTRIN(TM) during 2007; predict the safety and efficacy of these products in a commercial setting; estimate sales; maintain adequate inventory levels; comply with the restrictive covenants under its credit facility; refinance its credit facility; access the capital markets on attractive terms or at all; favorably resolve the pending SEC informal inquiry; maintain or increase sales of its products; or effectively react to other risks and uncertainties described from time to time in Bradley's SEC filings, such as fluctuation of quarterly financial results, estimation of product returns, chargebacks, rebates and allowances, concentration of customers, reliance on third party manufacturers and suppliers, litigation or other proceedings (including the pending class action and shareholder derivative lawsuits), government regulation, stock price volatility and ability to achieve strategic initiatives to enhance long-term shareholder value. Further, Bradley cannot accurately predict the impact on its business of the approval, introduction, or expansion by competitors of generic or therapeutically equivalent or comparable versions of Bradley's products or of any other competing products. In addition, actual results may differ materially from those projected. Bradley undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
Bradley Pharmaceuticals, Inc.

Tuesday, May 01, 2007

Ease Patients' Suffering with Access to Medical Marijuana: A Cancer Survivor's Story

READ MORE: Connecticut, United States
This May, I will celebrate living cancer free for eleven years. I'm the first of three generations in my family to survive cancer following chemotherapy and radiation. As more young cancer survivors live on, we also face new health challenges. Last month I had surgery for endometriosis, a painful reproductive and immunological disease affecting over 7 million women and girls in the U.S., leaving me with chronic pain, affecting my ability to walk and live my daily life.
We all have these stories of our own experiences, or watching friends and family suffer from debilitating illnesses for months and years. We also know the lengths we would go to ease their pain and suffering.
For this reason, support for medical marijuana is overwhelming in Connecticut.
A 2004 UCONN poll revealed that 83% of all Connecticut residents believed doctors should have the ability to recommend marijuana to their patients. Over the past three years, advocacy groups, numerous politicians, the Connecticut Nurses Association and more than 500 doctors have expressed strong support
for passing medical marijuana legislation.
Support for medical marijuana is not limited to Connecticut . Over the last ten years, twelve states have passed laws supporting safe access to medical marijuana. Seriously ill residents of Vermont , Rhode Island and Maine have access to doctor recommended marijuana, and a bill in New Jersey is likely to pass this session with 86% constituent support.
Earlier this month, Gov. Bill Richardson signed a compassionate use bill in New Mexico, making him the first presidential candidate to actively support medical marijuana. But here in Connecticut, we haven't gotten it right -- yet.
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