• rss

Join Us on Social Networks!

Lovegra vs Addyi (Flibanserin): What Is More Effective for Women?

Comments Off

Category : News

Indian Lovegra in a Few Words

How does it function?

lovegraThe action of female Lovegra in physiological aspect is based on the impact of PDE5 inhibitor that helps to increase the level of blood circulation in vascular system of female pelvic organs. Active action of nitrogen oxide expands smooth muscle cells of arteries and fills the labia and clitoris with a large amount of blood. Moreover, a woman feels an increase in the functionality of mucous glands starting a strong lubrication process in vagina. Breasts plump up and become firm and elastic; there is a perceptible blush on cheeks, and a woman feels the rush of strength and energy. Then the level of arousal starts to increase and there is an urgent need for sexual contact. Lovegra is the best way to combat sexual dysfunction in the representatives of the beautiful half of humanity.

Application method

The action of Lovegra begins within 30-40 minutes after administration and lasts up to 5-6 hours. Daily dose must not exceed 100 mg of active ingredient (1 tablet per day). If necessary, a lady can reduce the dose to 25 mg (if there are a number of contraindications or some side-effects were experienced) or increase it to 150 mg (if the effect has minimal manifestation). Tablets are taken orally and drunk with a glass of water. It is not recommended to use Lovegra along with alcohol and fatty, salty, spicy or overly sweet food. The dosage of Lovegra must not be exceeded without particular necessity or prior consultation by a specialist. Self-medication and uncontrolled use of the medicine are prohibited.

Discover more about medications for women: L-Dopa, Lovegra and Female Viagra to Chemically Boost Her Desire

Indications for use

Lovegra is prescribed to those women who have the following conditions:

  • regular manifestations of sexual dysfunction in the body;
  • prolonged experience of orgasmic disorders;
  • complete or partial impairment of  sexual attraction to a man;
  • malfunction of reproductive or genitourinary systems;
  • dissatisfaction with sexual relations with a partner;
  • absence of sexual drive and desire to initiate sex;
  • inflammation, acute soreness or severe dryness in vaginal opening;
  • short sexual intercourse;
  • constant irritation, apathy, drowsiness;
  • nervous or stressful state;
  • complete absence of pleasant sensations when orgasm is achieved;
  • a negative reaction to sexual arousal.

Before starting to use the drug, it is advisable to undergo a clinical examination by an attending physician.

Composition

Lovegra is produced in India in the form of tablets that have the shape of a diamond and are covered with a safe red coating. One blister contains 4 tablets of Lovegra. The active substance making a woman’s reproductive system work is sildenafil citrate. This component is found in tablets equivalent to 100 milligrams of sildenafil. In the meantime, Lovegra consists of the following substances: calcium hydrogenphosphate, crystalline cellulose, sodium carmellose, magnesium stearate, lactose and triacetin. The use of all elements is safe and clinically proven.

Contraindications

Pregnant and lactating women are not allowed to take Lovegra. The results or its use in these cases can be the most deplorable. Treatment with Lovegra can cause significant harm to an undeveloped fetus and cause genetic abnormalities. If you do not want to harm your child, it is recommended to refuse Lovegra application for this period.

Lovegra should be taken with caution by those patients who have renal and hepatic diseases, cancer, heart disease, low or high blood pressure, peptic ulcer and anatomical deformations of vagina. Also, the drug is contraindicated to children and girls who have not reached adulthood. Usually it is not prescribed to patients who are completely contraindicated to have sexual activity for any reason. Viagra is contraindicated to women who are currently taking nitrogen oxide donors. To exclude the possibility of an acute form of side-effects, a lady should conduct an additional sensitivity analysis to the medicinal substances added to the drug.

Possible side-effects

Before passing the course of treatment with this drug, a woman should undergo a qualified examination by her attending doctor. In order to avoid the occurrence of adverse side-effects from the use of Lovegra, a specialist must identify the patient’s individual intolerability to any component of the drug, including sildenafil citrate.

Overdose

Lovegra was subjected to various experiments and studies resulting from which it was found out that the drug is indicative to women having severe sexual disorders. To date, the remedy continues to be tested. Cases of an overdose of Lovegra were not identified. However, with occurrence of the slightest symptoms of side-effects, a woman should immediately stop taking the medication, if possible, rinse the stomach with a weak solution of potassium permanganate and contact a medical center. Self-medication and subsequent application of tablets are strictly prohibited. Incorrect or untimely treatment can lead to development of more serious diseases.

Flibanserin Summary

Addyi development

The drug Addyi (flibanserin) was officially launched in the United States. This means that all women with a hypoactive disorder of sexual desire are able to adjust their sex life by means of this magic remedy. The Food and Drug Administration (FDA) approved the production of Addyi with only the fourth attempt. Sprout Pharmaceuticals Inc. was trying to launch a project to produce flibanserin back in 2010, but at that time the effect of the drug was not clinically proven. And then the pharmacists went to the trick. Along with the best marketers, they launched the campaign with the slogan proclaiming that there are twenty-six official drugs for male impotency, whereas there are none of them for female sexual disorders. The motto “26-0 in favor of men” allowed the producers of flibanserin to exert pressure on the public. Masterfully having played a card of sexual discrimination of women, Sprout Pharmaceuticals Inc received powerful support from various legal organizations. After numerous petitions and lobbying of politicians on this issue the production of the drug was approved from the fourth attempt.

How does flibanserin work?

In order to understand the way this drug works, first it is important to find out the meaning of a hypoactive disorder of sexual desire. So, if the incomprehensible scientific terminology is avoided, low sexual desire of a woman is the result of a malfunction or imbalance in the production of hormones and mediators. Sexual function requires a complex interaction of several neurotransmitters and hormones, both centrally and peripherally. Sexual desire is considered as a result of a complex balance between suppressive and stimulating signals in cerebrum. For example, the hormones dopamine, estrogen, progesterone and testosterone play an exciting role, while prolactin and serotonin act as inhibitors (or suppressors).

Flibanserin is a multifunctional agonist-antagonist of serotonin capable of restoring sexual desire by affecting the prefrontal cortex of brain. Therefore, flibanserin acts by increasing the level of neurotransmitters dopamine and norepinephrine in the prefrontal cortex, and by reducing the action of serotonin.

Was flibanserin ever tested?

Since the first attempts to start the project, the company Sprout Pharmaceuticals (official website sproutpharma.com) Inc conducted a large-scale, randomized, placebo-controlled trials that involved 2400 women of pre- and post- menopause (average age was 36 years). Women who took 100 mg of flibanserin reported a slight increase in sexual desire. At the same time, according to the results in the North American group of volunteers, the number of ‘sexually satisfying cases’ increased from 2,7 to 4,6 during the test period, as opposed to placebo . These data were enough to convince the FDA that Addyi is indeed effective, despite the side-effects among which the most common were nausea, dizziness, fatigue, drowsiness, insomnia, dry mouth, hypotension, low blood pressure and even loss of consciousness during orgasm. The latter effect was particularly pronounced when the drug was administered with alcohol.

Despite the numerous critical opinions, flibanserin is set into production. However, by the decision of the FDA, Sprout Pharmaceuticals Inc is required to conduct a study to further assess health risks associated with the interaction of flibanserin with alcohol. In the United States, the drug is available for women only after prescription from certified health professionals and certified pharmacies depending on the availability of health insurance.

What does a woman feel after Addyi application?

The effective dosage of flibanserin is 100 mg. Administration is carried out within a month once a day before bedtime. When taking female Viagra, dopamine is released in blood, and the level of estrogen and testosterone elevates which results in increase of sexual activity and attraction. Under the action of the drug blood circulation in genital area increases and blood flow into pelvic organs gets enhanced resulting in impact on sensory nerves located in erogenous zones. These nerve endings transmit impulses to spinal cord and brain faster and stronger. Producers assure that regular intake of the drug contributes to the development of vaginal secretion that allows a woman to reach a bright and strong orgasm.

Is It Possible to Put a Sign of Equality between Lovegra and Addyi (Flibanserin)?

First of all, the drugs are based on different active substances that affect diverse mechanisms in female body to ensure sexual drive. This is a critical discrepancy that is allows never put the equality mark between Lovegra and Addyi. These active substances cause difference side-effects and have particular contraindications.

Moreover, many experts are skeptical about the very definition of the drugs as “female Viagra”. Associate Professor of the University of Victoria in British Columbia believes that sexual problems of women during the menopause are less physiologically-oriented than men’s ones. Frigidity is caused by external factors, such as interpersonal relationships, necessity to make social decisions, pressure associated with characteristics of female sexuality, inferiority complexes, stress at work, etc. And it would be rather reckless to argue that the influence of all these factors can be leveled by taking one pill. No diagnostic test has revealed any biological links between brain-hormone-genital blood stream in women’s sexual problems. Low sexual desire in women reflects the difference in desire between the two partners, and it is unethical and unscientific to associate the differences in the couple’s desires solely with hormone deficiency in a woman during menopause. Viagra relieves men of erectile dysfunction short-term – this is a proven fact. However, there is no evidence that flibanserin or sildenafil is an antidote to lowered libido in women, since sexual desire is a more complex and amorphous condition than the mechanism of erection.

Anticonvulsants

(0)

Category : News

Anticonvulsants

Little is known about the effects of anticonvulsants on sexual functioning in bipolar patients despite their many years of use. Although there are some reports addressing anticonvulsant effects on sexual function in patients with epilepsy, evaluating this limited information is difficult because sexual dysfunction often accompanies epilepsy. There are a few case reports of ejaculatory failure related to carbamazepine and gabapentin, but the frequency of this possible effect is unknown. Little is known about sexual side effects of the commonly used anticonvulsant, divalproex. At best there are a few case reports suggesting that divalproex may reduce libido or the ability to achieve orgasm in women, though there are no prospective controlled studies to delineate the extent of this possible problem. There is a suggestion that lamotrigine may have some advantages over the other anticonvulsants regarding sexual side effects, but this is preliminary. Read more about female viagra here.

In one study of 62 patients, women and men showed modest overall improvement in sexual function scores when switched from another anticonvulsant to lamotrigine. Because of the lack of control group and the possible confound of epilepsy of sexual function, it is difficult to extend these findings to patients with mood disorders, though it suggests that lamotrigine may have fewer sexual side effects than other anticonvulsants.

Phenytoin and carbamazepine induce metabolism of androgens, while divalproex inhibits this metabolism. This would suggest that phenytoin and carbamazepine could be problem prone and valproate less problem prone, though prospective study is lacking. Valproic acid has not been studied prospectively in samples of patients with bipolar disorder for its effects on androgens and sexual functioning. There are, however, several case reports of reduced libido or orgasm inability in patients with mood disorders treated with divalproex.

A cross-sectional, nonrandomized study of 75 men with epilepsy found that sexual dysfunction was more commonly associated with phenytoin (n = 25) and carbamazepine (n = 25) than with control patients (n = 25) or lamotrigine (n = 25) treated patients. Lamotrigine-treated patients reported sexual symptoms at approximately the same rate as a normal control group. In this study, patients rated sexual functioning on a rating scale that measured ‘sexual interest and potency’ as well as had blood measured for gonadal hormones, including luteinizing hormone, follicle-stimulating hormone, prolactin, testosterone and estradiol. Mean sexual function scores for lamotrigine were slightly higher, and statistically greater compared with the carbamazepine and phenytoin groups. The effect size, however, was quite small. Additionally, testosterone concentrations were lower in the carbamazepine- and phenytoin-treated patients compared with the lamotrigine treated patients, which were similar to controls. Although this information may not be extended to patients without epilepsy, it appears that lamotrigine is less prone toward causing sexual dysfunction than carbamazepine and phenytoin, though none of the anticonvulsants may seriously affect sexual functioning.

Anxiolytic Drugs

Benzodiazepines
The benzodiazepines have not been prospectively studied regarding their effects on sexual function. There are a number of retrospective reports suggesting that clonzepam may be problematic for sexual functioning, though other reports suggest that it might not be problematic. All of the benzodiazepines have been suggested to cause sexual dysfunction, but there are no prospective studies examining sexual function in patients taking this class of medication for an anxiety disorder. Considering the frequency of their use, the lack of reports suggests that the side effects may be of minor importance. Moreover, without baseline measure before drug initiation, some of the reported sexual dysfunction may be related to the mood or anxiety disorders for which they are prescribed. The few reports available for review are cross-sectional or retrospective in small samples and rating scales were not necessarily employed. Decreases in libido, arousal, and orgasm have all been reported. In one study, detailed in the ‘Lithium’ section above, the authors found that benzodiazepines combined with lithium in the treatment of bipolar disorder patients caused 40% of patients to experience sexual side effects, which was considerably higher than the 14% rate in patients taking only lithium. The study did not evaluate if the effects were specifically associated with arousal, orgasm or libido for the combination of lithium and benzodiazepines. On the other hand, an early small placebo-controlled study in normal patients without anxiety found that diazepam ‘facilitated sexual behaviors in normals’. Viagra in Canada

While some sexual dysfunction in patients with anxiety disorders taking benzodiazepines may be attributable to benzodiazepines, the effects of benzodiazepines on sexual function clearly need further prospective study to determine the extent and clinical relevance.

Buspirone
Buspirone is an anxiolytic that does not appear to have sexual side effects, though it has not been specifically studied in prospective studies for its propensity to cause sexual side effects. Interestingly, as noted in the antidepressant section, buspirone may reverse sexual dysfunction associated with serotonin reuptake antidepressant use. It appears that this benefit is only with relatively high doses, approximately 45–60mg per day. Without further study, it remains unknown if buspirone monotherapy causes any adverse or salutary sexual effects.

Women’s health news: Recent Weight Gain may be Ignored by Young Women

(0)

Category : News

Recent Weight Gain may be Ignored by Young Women

A new study finds that young women commonly fail to recognize recent weight gain of as many as 11 pounds, which puts them at risk for cardiovascular disease and other obesity-related conditions.

Self-perception of weight gain also appears to be significantly influenced by race, ethnicity and contraceptive methods.

In the study, University of Texas Medical Branch (UTMB) researchers found that a significant number of women evaluated at six-month intervals did not recognize recent gains in weight.

Overall, nearly one-third and one-quarter of women did not recognize gains of approximately 4.5 and 8.8 pounds during a six-month interval, respectively.

However, black women and DMPA users (depot medroxyprogesterone acetate, commonly known as the birth control shot) were more likely to recognize weight gain than their counterparts.

Researchers surveyed a sample of 466 women with an average age of 25. Approximately 37 percent of the subjects were Hispanic, 35 percent non-Hispanic white and 29 percent non-Hispanic black women.

Roughly 39 percent of the women used DMPA, 36 percent used an oral contraceptive and 25 percent were non-hormonal contraceptive users.

“We were surprised to find that race and ethnicity are determinants of accurate recognition of weight gain, predictors that have never before been reported,” said lead author Dr. Mahbubur Rahman, M.B.B.S., Ph.D., M.P.H., Assistant Professor in the Department of Obstetrics and Gynecology.

The study found that DMPA users are likelier to recognize weight gain, and Rahman believes the finding may be attributed to the fact that DMPA has been widely reported to be associated with weight gain and that users may be engaging in more mindful and continuous weight monitoring.

He noted that further studies using detailed measures that include cultural, psychological and perceptual aspects of weight change in women are needed to explore this relationship.

The study was published online and in the March issue of the Journal of Women’s Health.

Women Health Expert GC-Rise Debuts at JPMorgan’s Healthcare Conference in US

GC-Rise Pharmaceutical Co. Ltd, in which European healthcare venture capital firm INVENTAGES holds a majority stake, has debuted at J.P. Morgan’s 30th annual Healthcare Conference in the United States.

Beijing-headquartered GC-Rise, which focuses on women’s health in China, aims to take the opportunity to share its growth stories and seek collaborations with potential partners to help them tap China’s big market.

The Healthcare conference, the industry’s largest, is held from January 9-12 in San Francisco, California, GC-Rise’s founder & chief executive officer Wren Zhang presented the company’s growth roadmap at a luncheon on January 10.

“We offer exclusive agreements with producers of medicine, helping them with distribution and building their presence in China. Most of our partners come from the developed world – Japan, the United States and Europe. We provide one-stop services for them, from policy interpretation, public affairs management to patient education, from local registration, clinical trials, pricing to market promotion and brand-building,” Zhang said.

China’s female health care market is expected to grow at an annual compound rate of 20% between 2010 and 2015. Some segments, like anti-aging and reproductive health, will see growth as high as 35%, with the market expected to hit 247 billion RMB, Zhang cited data from the Ministry of Health.

GC-Rise, invited as one of the emerging fast-growth companies by J.P. Morgan, saw its operating revenues rising more than 270% on average per annum from 2008 to 2010, and was recently listed as one of the Deloitte & Touche’s 50 top-performing Chinese high-tech companies.

The company is solidly positioned in five rapidly growing segments: anti-aging products, reproductive health products, tumor products, dermatological and beauty products, and mental health treatments.

“We are confident of strong demand in the 2010-2015 period, giving us annual compound growth of 61%,” said Zhang.

The healthcare investment symposium brings together more than 300 companies, both public and private, and the companies, including global industry leaders, emerging fast-growth companies, innovative technology creators have delivered presentations to more than 4,000 investors.

About GC-Rise Pharmaceutical Co. Ltd

GC-Rise Pharmaceutical Co. Ltd, established in 2008, is a wholly-owned foreign enterprise invested by INVENTAGES, a major European healthcare and biotechnology venture capital investor, focuses on women’s health. Taking “Devoted to human healthcare and a better life” as our mission, the company makes full use of the business networks of our strategic partners in the United States, Europe and Japan, their rich experiences in clinical development, clinical trials and registration in China and their strong strength in distributions, hospital sales and marketing, so as to provide safe, novel and highly efficient medical products and treatment ideas for Chinese women patients.

Three Most Ignored Health Problems That Demand Your Attention in 2012

Atlanta, GA (January 17, 2012) — While many Americans are focusing on the most popular health resolutions – to lose weight, eat better, exercise more or quit smoking – far too many will overlook three commonly ignored but critically important health priorities. OBGYN and women’s health expert Dr. Ken Taylor explains why three commonly ignored health issues deserve top billing for health resolutions in 2012.

1) Focus on your digestive health. Millions of Americans suffer daily from common digestive problems such as heartburn, bloating, constipation, diarrhea, reflux and other gut conditions that would make Clint Eastwood blush. What’s worse: many people don’t even know their digestive health is suffering or don’t understand how it affects their overall health – from allergies, acne and chronic fatigue to arthritis, autoimmune diseases, cancer and more.

“The intestines make up the inner tube of life and play an essential role in maintaining a healthy immune system,” explains Dr. Taylor. Seventy percent of the body’s immune system resides in the digestive tract. More than 100 million Americans have digestive problems. In addition, digestive problems are very costly – many of the top-selling drugs are for digestive problems, there are more than 200 over-the-counter remedies for digestive disorders and intestinal-related conditions are among the top reasons for visits to primary care physicians. Dr. Taylor says the resolution to improve digestive health in 2012 can begin with such steps as:

* Pay attention when you go. That’s right: you can learn a lot from your elimination. Observe everything from how often you go and how regularly you go to what it looks like when you go. For example, does your poop float? That’s a no-no and a sign of potentially serious health problems.

* Get more fiber. Depending on your age and gender, you should get from 26-38 grams of fiber per day. Taylor explains that, with today’s fast-paced lifestyle and diet habits, it’s very difficult for most people to get the required daily fiber from natural food sources. He recommends fiber supplements like Metamucil and Metafiber.

* Drink plenty of water and avoid sugary drinks and too many caffeinated drinks. Limit alcoholic drinks to no more than two per day.

2) Start planning early to guarantee healthy bones. Bone health is another health priority that many people think about when it’s too late. Bone fractures can be extremely painful and take months (an average of 12 weeks) to heal. Osteoporosis and osteopenia bone disorders affect forty-four million Americans, and plague one in two American women. “It’s never too early to start thinking about and fortifying your bone health. Young people, as early as teenage years, have calcium needs that can’t be rectified later in life,” says Dr. Taylor.

So, what 2012 resolutions can help improve bone health?

* Start moving. Like muscle, bone is a living tissue and is strengthened through exercise. Weight-bearing exercises, that force you to work against gravity, are the best kind for your bones. Good examples include weight training, hiking, jogging, climbing stairs, tennis, and dancing.

* Get your calcium…dairy-free that is. Your body continually removes and replenishes calcium from your bones. If you don’t replenish enough calcium, your bones will become weaker, more brittle and dense. Dr. Taylor says dairy-free sources of calcium are best for several reasons: calcium contains animal proteins that can actually contribute to bone loss; causes digestive problems and aggravates irritable bowels; is full of saturated fat; and is often enhanced with dangerous, cancer-feeding hormones. Better sources of calcium include: dark green, leafy vegetables like spinach, kale, broccoli and bok choy; almonds; soybeans and soymilk; and figs, to name a few.

* Boost your Vitamin D intake. Your body needs vitamin D in order to absorb calcium. Some studies actually show Vitamin D is more important than calcium in preventing fractures. The best ways to get vitamin D are: sunlight, food, and supplements. Foods like fatty fishes, orange juice and soymilk are excellent sources of vitamin D. And, natural supplements are helpful for filling in the gap.

3) Guard your oral health: the gateway to your body. The mouth is the first point on your digestive path, but it’s also the point that many people skip. Dr. Taylor says oral health is a mirror of your overall health. Your mouth is a hotbed of bacteria, which are normally contained and managed by good oral health. Oral infections like tooth decay and gum disease can weaken your body’s defenses and allow harmful bacteria to grow out of control. Oral health is also connected to heart health. Research shows chronic gum disease is directly associated with heart disease. In addition, poor oral health can affect your saliva flow, which is necessary to protect your teeth and aid in food digestion. The good news is you can guard your oral health in 2012 with some simple steps:

* Start with proactive prevention. The American Dental Association recommends brushing your teeth twice a day, flossing between your teeth daily and replacing your toothbrush every three or four month. It seems simple enough, but it’s easy to get into a routine of brushing only once a day or using the same toothbrush a month or two too long.

* Get to know your dentist. Schedule regular dental appointments for cleanings, fluoride treatments and other preventive measures. If you are one of the thousands who suffer from dental phobia or dental anxiety (really on laughing matter), there are many online resources to help you overcome this fear and get better acquainted with a local dentist you can trust.

“There are understandable reasons why these health priorities are often ignored and don’t usually make the resolutions list,” said Dr. Taylor. “However, they are high on the list of health problems that have significant quality and length of life impact, and can be easily addressed and prevented. My hope is that more people will move them to toward the top of their lists for 2012 – right up there with getting married, traveling more and getting out of debt.”

Women’s Health News: Feds Deny Women’s Health Renewal

(0)

Category : News

Feds Deny Women’s Health Renewal

In a letter dated Dec. 12, the U.S. Department of Health & Human Services’ Centers for Medicare & Medicaid Services denied Texas’ application to renew the successful Women’s Health Program, citing the state’s impermissible narrowing of the provider base to exclude Planned Parenthood from any participation.

The WHP is a Medicaid-waiver program that offers low-income and uninsured women ages 18-44 who wouldn’t otherwise be eligible for Medicaid an opportunity, unless pregnant, to receive preventative health and family planning care. The program, devised by lawmakers in 2005, was conceived as a way to save the state money and to prevent unwanted pregnancies. It has so far done just that: In 2009, according to the state’s Health & Human Services Commission, the program averted 10,300 Medicaid-paid births, saving the state roughly $46 million in all funds. Indeed, the program is paid for by a 90-10 match from the feds – for every $1 the state kicks in, the feds throw in $9. In other words, it’s a great deal for Texas, especially when you consider that 56% of all Texas births are paid for by Medicaid; in 2009 alone, that cost the state $2.7 billion.

But the future of the program is now in jeopardy. At issue is new language crafted to eliminate Planned Parenthood from providing any WHP services. This is no small issue, given that in 2008 PP was the single largest provider of such services. But because some PP clinics provide legal abortion services – though none with tax money – lawmakers directed HHSC to ask the feds to reauthorize the program, but with new language that redefines the word “affiliate” in an effort to squeeze PP out of the loop. Because the WHP is a waiver program, it is up to the feds to consider whether the language fits with legal restrictions for funding under Title XIX, which funds Medicaid.

The prevailing wisdom coming from providers and health care advocates was that targeting and excluding a specific provider – in this case PP – based on its providing legally protected abortion services to private-pay clients would not pass legal muster. Indeed, in the Dec. 12 letter, the Centers for Medicare & Medicaid Services concludes that the new “affiliate” language does just that. The feds “will not approve the State’s request for authority to deviate from the requirements of [Medicaid] in order to restrict beneficiary choice of family planning providers,” CMS Director Cindy Mann wrote.

Although the initial WHP waiver contained a provision excluding abortion providers from participation, that measure was never enforced as a wedge to exclude PP. Last year, Sen. Robert Deuell, R-Greenville, asked Attorney General Greg Abbott if it would be legal to enforce that provision and to exclude PP; Abbott agreed that it would. As such, state health officials this spring began a process of rewriting the definition of the word “affiliate” in order to eliminate PP as a health care provider choice for women; under the new definition, being affiliated with an abortion provider means any connection – so PP clinics that don’t offer abortion care would nonetheless be banned since they are essentially members of the same umbrella nonprofit.

According to stats provided to the Health & Human Services Commission’s Medical Care Advisory Committee this summer by commission staff, almost 30% of then-current program clients – just less than 130,000 in May alone, according to HHSC – are served by PP clinics. Although Kay Ghahremani, deputy director of Medicaid policy development for HHSC, told the committee that 98% of clients live within 10 miles of another provider, she had no information about whether the remaining providers had the ability to pick up tens of thousands of clients that would lose their provider should the prohibition on PP stand (based solely on May enrollment numbers, that would be roughly 39,000 women). According to an August report from HHSC, last year 80,430 women accessed WHP services at family-planning clinics, including PPs, while just over 9,000 women were seen at federally qualified health centers, one-stop medical shops that Deuell routinely champions as being the best place for women in need of preventative health and family-planning services and a replacement for the women’s health care system that relies so heavily on PP for services.

Seeing the WHP crash and burn would not be good for Texas women. With the number of enrollees increasing significantly each year – from a total of 91,683 clients served in 2007 to 183,537 in 2010, and expected to top that this year – the program is both a health care and financial success. And with the Legislature’s draconian cuts to the state’s family-planning budget for the current biennium – stripping roughly two-thirds of the budget historically used to provide low-income and uninsured women with access to gynecological exams, cancer screenings, and birth control, among other services – the WHP was seen by many as a light in an otherwise dark landscape, a potential way for women cut from the traditional family-planning program to obtain much-needed services. According to a 2008 Guttmacher Institute report, approximately 1.5 million women in Texas are in need of these health services; before the family planning cuts made in April, the state was on average serving roughly 15% of those women. With the budget cuts in place, tens of thousands of women stand to lose access to health care. Should the WHP dissolve, potentially nearly 200,000 will also lose coverage.

According to the CMS letter, the agency remains open to working with Texas to ensure that the WHP will be renewed, and has agreed to allow the program to continue through the end of March 2012 – it was set to expire, pending renewal, on Dec. 31. Whether Texas will be willing to compromise on the “affiliate” language in order to see the program live on is unclear. According to HHSC spokeswoman Stephanie Goodman, the agency is disappointed by the CMS decision, “which is inconsistent with federal law that gives states the authority to establish qualifications for Medicaid providers,” she wrote in an email. “HHSC will continue to work with CMS to continue this important program and enforce the state’s right to establish provider qualifications for the program that reflect the values of our state.”

Indeed, it seems that Gov. Rick Perry agrees that the state should be able to evict from the program any provider with which lawmakers have political differences, regardless of that provider’s ability to provide the medical services sought. According to a statement released last week, Perry apparently agrees that by denying women their choice of providers, the state is helping to protect unborn children. “We are committed to protecting life in Texas, and state law prohibits giving state dollars to abortion providers and affiliates – a fact the Obama Administration ignores,” he said. “I strongly urge the administration to do the right thing and grant this waiver, so Texas women can access critical preventative health services, including breast and cervical cancer screenings, rather than making them pay the price for its pro-abortion agenda.”

The news did not sit well with other lawmakers, including San Antonio Democratic Rep. Mike Villarreal, who has been an advocate for the WHP and who hopes that the state will work with CMS to ensure the program lives on. “Instead of playing politics with women’s health, state leaders need to use this time to find a way to continue the critical health services that Texas women rely on,” he said.

2011 Prevention of top health threats

Top issues of health that can be prevented

Women today are paying more attention to their health from getting the proper amount of physical activity to trying to consume healthy foods, watch their stress levels and more. All those are great for living a healthy lifestyle but there still threats to women’s health and they can be prevented.

Heart disease is the top messenger of death for both men and women today. According to the CDC it claims the life of 29% of women. According to Cindy Pearson, executive director of the National Women’s Health Network, death is not the problem in itself the problem is in disability and premature death. The good news is you can reduce your risk for heart disease by modifying your lifestyle.

We are all aware of a healthy diet with fruits, vegetables, whole grains, high fiber and lean protein such as fish. But there are other changes that can help. If you smoke quit, ask your practitioner for help or if you want to go the natural route use hypnotherapy which carries a high success rate.

Manage any chronic conditions you may have such as high cholesterol or diabetes. Make sure you have physical activity daily even if it is just a brisk walk around the block. Keep a health weight anything over 30 pounds is considered obese. Drink in moderation and manage your stress, try deep breathing exercises you learn in yoga class.

Breast Cancer affects women the most next to lung cancer which is the number one cause of death. It is vital to do a self breast exam on a regular basis. It is also important to have breast screening especially if breast cancer runs in the family it is important to follow your practitioners advice. If your worried about radiation you do not have to, the year 2012 brings different types of breast imaging, discuss with your practitioner which ones would be best for you. Among the risks besides heredity or having had the disease there are other factors which come into play such as age and race it shown that Caucasian women are more at risk for getting the disease while women of African heritage have a greater risk for dying from the disease.

A healthy lifestyle, diet, exercise, weight control and non-smoking can decrease your chances. Some health care practitioners who are familiar with a holistic approach include nurses, alternative medicine practitioners, homeopathic doctors, nutritionists, acupuncturists and even chiropractors who are noted as primary care doctors. If you wish to rid yourself of those menopausal symptoms and rather not have HRT try herbs such as Black Cohosh which has been demonstrated to be effective.

Osteoporosis is among the list. Osteoporosis affects 44 million Americans and out of the 44 million 68% are women. Osteoporosis can be delayed and avoid totally. If your over thirty you may wish to increase your vitamin D and calcium in your diet to build bone and maintain bone density and above all to avoid the disease. Check with your healthcare provider for more information.

Diabetes affects 12.6 million women aged twenty and older according to the American Diabetes Association. The most common type is type 2 diabetes and prevention is a vital key especially if your at a higher risk such as it is in the family history or if your overweight.

Prevention is not that difficult to achieve a few easy changes will avoid problems later on in life. Diabetes can cause serious health problems such as kidney and heart damage.

The American Diabetes Association offers a few simple tips to help.

Get regular physical activity and in turn you lose excess weight, lower your blood sugar and boost your insulin sensitivity. Aerobic exercise and resistance training can aide in managing diabetes and has been demonstrated by research.

Let the fiber in your diet and in return your reduce your risk for the disease by improving blood sugar control, lowers the risk for heart disease and leaves you feeling full so you will not tend to overeat. Even though it is not totally known why whole grains help but they just may decrease your risk for diabetes and they help maintain blood sugar levels.

Twelve million women in the United States experience clinical depression each year and one in eight will experience clinical depression in their lifetime according to Mental Health America. Sometimes we simply cannot avoid depression but we can minimize its effects. Learn the signs of depression and you will be able to minimize the effects. WebMD Depression Center can give you all things you know about recognizing the signs.

One way to reduce your risk of depression according to Dr. Doreen Lynn, PhD, psychologist and author of Getting Sane Without Going Crazy suggests having a reason to get up in the morning things such as beloved pets, your job, community and volunteering are all great reasons to face the day.

These are just some of the women’s health concerns. So eat right, get exercise and live a happy healthy life.

Women’s Health News: November, 4

(0)

Category : News

Women smokers face tougher odds than men after a heart attack

Women who smoke have heart attacks at younger ages and are more likely than men to suffer complications months after a cardiac event, according to a new University of Michigan Cardiovascular Center study.

Elizabeth Jackson, M.D., M.P.H., cardiologist at the University of Michigan Cardiovascular Center

Although fewer women than men smoke in the United States, the gender gap is decreasing and the U-M findings suggest the toll of smoking is greater on women’s health.

“Smoking is not good for men or women but our analysis shows that women who smoke do worse six months after a heart attack than men,” says senior study author Elizabeth Jackson, M.D., M.P.H., cardiologist at the U-M Cardiovascular Center. “We were not able to look at the basic biological mechanisms that would account for this, but other studies can give us some ideas.

“The ideologies of acute coronary syndrome may be different and the atherosclerotic burden greater for women,” Jackson says.

Smoking reduces circulation by narrowing the blood vessels and contributes to an atherosclerotic build-up of plaque in the arteries. Cigarette smokers are two to four times more likely to develop heart disease than non-smokers.

Jackson, a member of the U-M Women’s Heart Program team, and lead author Michael Howe, M.D., a cardiology fellow at the U-M Health System, conducted a study to examine smoking status of patients during and six months after an acute coronary syndrome event, such as a heart attack.

They used the U-M Health System’s acute coronary event registry which has data on 3,588 patients admitted to the U-M Medical Center from Jan. 1, 1999 to Dec. 31, 2006 with a diagnosis of ACS.

A reported 24 percent of patients were actively smoking. Male smokers were nine years younger than non-smoking men when admitted for their cardiac event. Women smokers were 13 years younger than non-smoking women when admitted.

Among smokers, gender was a significant factor for risk of complications after a heart attack. Six months after their cardiac event, 13.5 percent of female smokers needed emergency treatment to restore blood flow compared to 4.4 percent of male smokers who needed an unscheduled revascularization.

“The differences in outcomes among women smokers may reflect inherent biological differences between genders, or possibly less aggressive medical management of women that’s been described by other investigators,” Howe says. “Either way, it clearly emphasizes the need for increased physician awareness and vigilance, in women in particular, after an acute coronary event.”

The good news is that by quitting smoking, the risk of heart disease and stroke can be cut in half just one year later and continues to decline until it’s as low as a nonsmoker’s risk, according to the American Heart Association.

The gender differences study was published online ahead of print in the American Journal of Cardiology.

A Focus on Prevention, Early Detection During Breast Cancer Awareness Month

Washington, DC — Breast cancer consistently tops the list of health concerns for many women and fear of developing the disease can be a tremendous source of anxiety. Fortunately, preventive measures can reduce a woman’s risk of breast cancer and early detection can improve her chances of survival. During National Breast Cancer Awareness Month in October, The American College of Obstetricians and Gynecologists (The College) urges women to move beyond fear and into action by reducing personal breast cancer risk factors, having regular mammograms, and tuning in to breast changes that warrant further assessment.

Breast cancer remains the second leading cause of cancer death among women after lung cancer. In 2011, it is estimated that more than 230,000 women will be diagnosed with breast cancer and more than 39,000 women will die from it. While these figures are alarming, there is much good news.

“There’s still a lot more to be done in the fight against breast cancer, but we have come a long way,” said James N. Martin, Jr, MD, president of The College. “Advances in early detection and improved treatments have led to a steady decrease in breast cancer-related deaths since the 1990s. The 2.5 million breast cancer survivors in the US serve as proof that more women are beating breast cancer than ever before. Women diagnosed with breast cancer also have a wider variety of breast-conserving treatments and reconstruction options to consider. And an increasing body of research suggests that women can make a difference in preventing or detecting cancer early.”

Being a woman and getting older are the two main, non-modifiable risk factors for breast cancer. Family history, personal history of certain cancers, no pregnancies or first pregnancy later in life, beginning menstrual periods before age 12 or menopause after age 55, obesity, heavy alcohol intake (defined as more than seven drinks per week), and use of some types of hormone therapy can also increase a woman’s risk. A woman’s individual risk factors can help guide her efforts in preventing cancer.

“There’s a reason why so many doctors preach the gospel of living a healthy lifestyle. In addition to lowering the risk of breast cancer, it can have a significant impact on a woman’s risk for many cancers and other illnesses, such as diabetes and heart disease,” Dr. Martin said. The American Institute for Cancer Research estimates that almost 40 percent of the breast cancer cases in the US—about 70,000 cases a year—could be prevented if women maintained a healthy weight, exercised, and limited the amount of alcohol they drink. Getting 30-90 minutes of exercise on most days, consuming a well-balanced diet, and drinking less than one alcoholic drink per day is a great start for most women.

Women should also take family history into account. Roughly 20 percent of women with breast cancer have close relatives such as siblings, parents, or grandparents who have also had the disease. Women with a strong family history should talk to their doctor about interventions such as beginning mammography before age 40 and prophylactic medication therapy or surgery to reduce their risk.

In some instances, women who’ve done everything that they can to avoid breast cancer still develop the disease. This is why regular mammography screening is so critical. “We know that mammograms are central to early detection in all women, regardless of risk factors,” Dr. Martin said. Mammograms can detect changes in the breast as small as a pinhead, often one to two years earlier than when a lump can be felt and before the cancer has spread to other parts of the body. The five-year survival rate for cancer caught at this stage is 98 percent, a compelling reason to get screened. The College recommends that women 40 and older be offered annual mammograms. Clinical breast exams performed by a physician are also recommended yearly for women 40 and over and every one to three years among women ages 20-39.

Nearly one half of all cases of breast cancer in women 50 years and older and more than 70% of cases in women younger than 50 years are discovered by women themselves, frequently unintentionally. Instead of traditional breast self-exams, The College now recommends that women develop breast self-awareness, meaning that they become more familiar with what’s normal for their breasts and better able to detect changes. Women who experience changes such as lumps in the breast or underarm, dimpling, breast pain, redness or thickening of the nipple or breast skin, or anything else that looks or feels different should quickly report them to their doctor.

“Awareness of and commitment to doing what’s best for your body can make a big difference in your health,” Dr. Martin said. “Do what you can to reduce your risk, because your actions do make a difference.”

To learn more about taking control of your breast health, The College’s “Spotlight on Breast Cancer” is available online.

NHS told to improve care of pregnant women carrying twins or triplets

The NHS has been told to improve its care of pregnant women carrying twins or triplets in order to reduce the significant medical risks involved for both mothers-to-be and their babies.

The National Institute for Health and Clinical Excellence, which sets standards for the NHS, has issued its first guidance on how health professionals should manage multiple births after discovering wide variations in the quality of care provided by different parts of the NHS.

Improvements and new procedures are needed in order to give women who conceive twins or triplets better and more consistent care, minimise the number of unnecessary caesarean deliveries among them and reduce the number of twins and triplets who require specialist care at birth.

About 11,000 women a year in England and Wales give birth to twins, triplets or, more rarely, four babies or more simultaneously. Multiple births account for 3% of the 700,000 live births a year.

The number of women giving birth to two or more babies at the same time rose from 10 per 1,000 in 1980 to 16 per 1,000 in 2009, mainly due to the increased use of assisted reproduction, especially IVF.

Mothers with a multiple pregnancy need specialist care in order to safeguard against the many problems and complications that can affect the mother or babies.

While many women carrying twins or triplets will experience a straightforward pregnancy, such patients are known to be at much greater risk of miscarriage, anaemia, hypertension, vaginal bleeding, premature birth and needing an assisted delivery or caesarean.

For example, while 4.8 per 1,000 of every pregnancy involving a single child end in stillbirth, 11.2 per 1,000 of those involving twins end in stillbirth, as do 27.9 per 1,000 of those involving triplets.

Babies of multiple births, meanwhile, are similarly at higher risk of poor outcomes including being born prematurely, having a low birthweight, admission to a neonatal intensive care unit, congenital malformations, cerebral palsy and impaired physical and cognitive development.

In its guidance released on Wednesday, Nice recommends that all women having an uncomplicated twin or triplet pregnancy should be cared for by a multidisciplinary team of medical experts who are experienced in such pregnancies, including obstetricians, midwives and ultrasonographers as well as a mental health professional, infant feeding specialist, dietitian and women’s health physiotherapist.

They should also undergo a risk assessment before the birth to establish whether the babies are identical siblings, where they come from the same egg and share one placenta, or have a placenta each, and undergo careful management from then on.

Identical siblings in utero involve a much higher risk of stillbirth, foetal complications and a condition called twin to twin transfusion syndrome.

Woman carrying multiple foetuses should also be given ultrasound scans in the first three months, more antenatal visits and monitoring of their babies for signs of intrauterine growth restriction after they are 20 weeks’ pregnant.

“We know there is a real clinical need for this guideline because NHS antenatal care for women expecting twins or triplets appears to vary considerably across England and Wales”, said Dr Fergus Macbeth, the director of Nice’s centre for clinical practice.

“For example, not all women with multiple pregnancies are cared for in dedicated settings such as ‘twin clinics’ or by multidisciplinary teams of healthcare professionals. This can lead to higher than necessary rates of assisted birth and caesarean sections and also means that women are not appropriately assessed for possible risks during pregnancy.”

Macbeth added: “Although many women will have a normal pregnancy and birth, it is well known that there are higher risks involved for these types of pregnancy and so it is important to get it right. We hope this guideline will set the standard of high-quality care, which should be provided to all women pregnant with twins or triplets.

“Implementing these clear recommendations will help women to feel supported and well looked after at a time when they can be feeling anxious.”

Keith Reed, chief executive of the charity Twins and Multiple Births Association (Tamba), said: “Sadly the care some expectant multiple birth mothers currently receive does not meet their needs. These important guidelines are a landmark in the antenatal care of multiples.

“They will undoubtedly produce better clinical outcomes as well as reducing anxiety for those women who have been told their pregnancies are ‘high risk’.”

Jane Denton, director of the Multiple Births Foundation, said the new standards would “transform” care.

“The news of a twin or triplet pregnancy is often a great shock for parents and the risk of complications during the pregnancy and preterm birth, as well as the practical and financial implications for the family, can cause great anxiety.

“Although much of the care at present is very good, there are many inconsistencies … these recommendations address all of these concerns and will give mothers confidence that they are receiving the highest standard of care.

Women’s Health News: September, 23

(0)

Category : News

Why Many With Breast Implants Fail at Breast-Feeding

Women with breast implants who think breast-feeding will change how their breasts look are less likely to nurse their babies successfully, according to a new study.

Researchers from the American Society of Plastic Surgeons (ASPS) pointed out that the number of pregnancies a woman has — not whether she breast-feeds — is what causes breasts to sag over time.

“If a woman believes that breast-feeding will adversely affect her breast appearance, she decreases her chances of successful breast-feeding,” study author Dr. Norma Cruz, said in an ASPS news release. “This misconception is unfortunate. Reassuring women that breast-feeding won’t harm their breast appearance, and that it has significant health advantages for both mother and baby, is vitally important.”

Researchers studied the breast-feeding habits of 160 mothers with breast implants. They found that 86 percent of the 97 mothers who failed at breast-feeding thought that it would make their breasts look worse. The researchers noted that this misconception had a direct impact on their success.

On the other hand, of the 63 women studied who exclusively breast-fed their babies for two weeks or more, only 13 percent believed it would harm how their breasts looked.

“It makes sense that breast augmentation patients would be concerned about the effect breast-feeding could have on the appearance of their breasts. After all, these women have invested both time and money into them,” said Cruz, an ASPS member surgeon. “However, available evidence tells us that although breasts sag more with each pregnancy, breast-feeding doesn’t seem to worsen these effects in women with or without breast implants.”

The findings are troubling, the researchers noted, because the U.S. Department of Health and Human Services Office on Women’s Health reports that not only does breast-feeding help strengthen the mother-child bond, it is linked to a number of health benefits for women, including lower risk of type 2 diabetes, breast cancer, ovarian cancer and post-partum depression. The agency adds that breast milk also helps children build their immune systems and fight diseases.

“Now that we know breast augmentation patients’ views on how breast-feeding will impact the look of their breasts, patient education becomes critical to improving perceptions and strengthening the health and lives of both mother and child,” concluded Cruz.

The study was slated to be presented at the American Society of Plastic Surgeons’ annual conference in Denver. The data and conclusions should be viewed as preliminary until published in a peer-reviewed journal.

GOP Presidential Hopeful Rick Perry’s Record On Women’s Health Scrutinized

As the GOP presidential primary campaign continues to heat up, news outlets focus on Texas Gov. Rick Perry’s state policy record: An NPR report today examines his funding for women’s health. Meanwhile, Michele Bachmann offers her take on employer-sponsored health insurance.

NPR: Gov. Perry Cut Funds For Women In Texas
Only 48 percent of Texans have private health insurance and more than a quarter of the state’s population has no insurance at all, more than any other state. To fill this gap, the state’s hospital emergency rooms and dozens of women’s health clinics have stepped in to serve the uninsured across Texas. To understand the health care landscape in Texas it helps to start with context, and perhaps nobody is better suited to explain it than Tom Banning. He is the CEO of the Texas Academy of Family Physicians, a group of about 6,000 doctors and whose members reach into every part of the state (Goodwyn, 9/20).

CBS: Michele Bachmann Says Tax Breaks Should Replace Employer Health Plans
Back in her hometown Monday, Republican presidential contender Michele Bachmann waxed nostalgic for an era when people were responsible for purchasing their own insurance, rather than being tethered to an employer for coverage. “When I grew up here in Iowa, we owned our own health insurance. We didn’t necessarily have it from our employer,” she said. Asked in a round-table with workers at OMJC Signal, a family-owned public-safety equipment manufacturer, how small businesses can afford health care for their employees, the Minnesota congresswoman said they shouldn’t have to buy it. “I think you should be able to own your plan, so your employer doesn’t own it — you get to own it, and you buy it with your own tax-free money,” Bachmann responded. She added, “You should be able to set aside whatever amount of your income you need to purchase the kind of health care you need for yourself, for your family,” (Huisenga, 9/19).

Finally, the HPV controversy continues —

The Associated Press: Bachmann Says Vaccine Retardation Claim Not Hers
Republican presidential candidate Michele Bachmann said Monday she was not arguing that a vaccine intended to prevent cervical cancer caused mental retardation when she repeated the scientifically unfounded claim last week. The Minnesota congresswoman said she was relaying what a distraught woman told her after a GOP presidential debate in Florida in which Bachmann criticized rival Rick Perry for ordering the vaccine in Texas (Beaumont, 9/19).

NPR: HPV Vaccine: The Science Behind The Controversy
Many find the public health case for HPV vaccination compelling. Cervical cancer strikes about 12,000 U.S. women a year and kills around 4,000. Strong backers of the vaccine include the American Academy of Pediatrics, the American Academy of Family Physicians and the Centers for Disease Control and Prevention.The vaccine requires three shots over six months and costs upwards of $400, which is not always covered by insurers or government agencies (Knox, 9/19).

Health Buzz: Depression Ups Stroke Risk

Depression may raise the risk of stroke, a new study suggests. Researchers at the Harvard School of Public Health and Brigham and Women’s Hospital analyzed 28 studies involving more than 317,000 people ages 18 and over who were followed for anywhere from two to 29 years. They found that participants with depression were 45 percent more likely to have a stroke and 55 percent more likely to die of stroke than those without the mood disorder. The study authors speculate that depression inflames hormones in the nervous system, which could increase stroke risk, according to findings published today in the Journal of the American Medical Association. Also: People with depression are likelier to smoke, eat unhealthily, and be overweight—all risk factors for stroke. “We think that in the future, depression should be considered as a risk factor for stroke,” study author An Pan, a research fellow in the department of nutrition at the Harvard School of Public Health, told Time. “We still need more evidence to see whether such screening will be beneficial for patients, but I think our study provides convincing evidence to support further research.”

Stroke: 7 Signs You Could Be at Risk of a Brain Attack

Stroke can hit like a deadly lightning bolt. And if the victim survives, the aftermath can be debilitating—affecting functioning from movement to speech. While stroke is the third-leading cause of death and the leading cause of adult disability in the United States, it trails behind other major diseases in awareness and recognition of symptoms. Being informed, however, can protect you from suffering either an ischemic stroke, caused by a blood clot and the most common form of stroke, or the less common hemorrhagic stroke, caused by bleeding in the brain. Know the factors that may be putting you at risk:

Uncontrolled high blood pressure. As for all cardiovascular disease, high blood pressure is a major risk factor for stroke. The American Heart Association estimates that only 45 percent of people with high blood pressure actually have it under control, U.S. News reported in 2009. Female stroke victims, in particular, tend to have uncontrolled blood pressure, and in general, women who suffer strokes don’t seem to be treated as aggressively as men. High blood pressure doesn’t have any outward telltale signs, so getting it measured by your healthcare provider is essential to determine if you should make lifestyle changes or take medications to bring it down.

Smoking. Puffing on cigarettes is associated with a host of ills. An increased risk of stroke is one of them. When compared to nonsmokers, smokers have double the risk of ischemic stroke. Heavy smokers face an even greater risk: A study of women ages 15 to 49 published in the journal Stroke found stroke risk was proportional to the number of cigarettes smoked per day. The women who smoked two or more packs a day had nine times the risk of stroke of a nonsmoker. And a study in Neurology found that smokers with a family history of brain aneurysm, abnormal bulging of an artery in the brain, are six times as likely to have a subarachnoid hemorrhage, a kind of stroke caused by a bleed between the brain and the tissue that covers it. These types of stroke are deadly nearly 40 percent of the time.

Women’s Health News: September, 14

(0)

Category : News

FDA panel unclear on osteoporosis drug labels

Labels on bisphosphonates, a type of medication used to treat and prevent osteoporosis, should further clarify how long patients can take them, an FDA advisory panel voted today.

But the panel backed off giving any specific time limits.

Bisphosphonates include Aclasta, Actonel, Altevia, Boniva, Fosamax, and Reclast. Four million to 5 million Americans fill prescriptions for the drugs every year, according to the FDA

The FDA convened the meeting because of emerging safety concerns related to long-term use — generally considered more than three to five years — of bisphosphonates.

In particular, the agency has received reports of osteonecrosis, or bone death, of the jaw and unusual fractures of the femur, or thigh bone, in women who had taken the drugs for several years or more.

Meanwhile, some research suggests that because bisphosphonates remain in bone for years, women could still benefit after they stop taking them.

More Information Needed on Labels

The panel, made up of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee, voted 17 to 6 in favor of recommending additional labeling information about the drugs’ long-term safety and effectiveness.

The FDA usually but not always follows its advisory committee’s recommendations.

The agency’s own analysis concluded that in women who continue bisphosphonate therapy after five years of use there’s no clear benefit or evidence of harm and no subset of patients who have a “clear and consistent” reduced fracture risk, FDA scientist Theresa Kehoe, MD, told the panel.

Bisphosphonate labels mention that safety and effectiveness information is based on one to four years — depending on the drug — of clinical trial data, Kehoe said, but optimal length of use is unknown.

“This is really an issue that’s front and center in primary care,” said Douglas Bauer, MD, a University of California, San Francisco, primary care doctor invited by the FDA to address the advisory panel.

While not an ideal study to examine long-term use, the only published study to do so involved Fosamax, Bauer said. That study randomly assigned women who’d taken Fosamax daily for five years in a clinical trial to either continue taking the drug for another five years or stop.

For fractures other than those of the spine, there was no evidence overall of continued benefit after five years, Bauer said.

But there was a 55% reduction in spine fracture risk in women who continued taking Fosamax for the extra five years, said Arthur Santora, executive director of clinical research for diabetes and endocrinology drugs at Merck, which makes the drug.

And in studies of up to 10 years of use, Santora said, there were no reports of jawbone death and no difference in the risk of unusual thigh fractures between women who took the drug and those who didn’t.

Long-Term Use of Bisphosphonates

Panelists noted that it’s difficult to predict which women will benefit from long-term bisphosphonate use. The Fosamax study did find that women’s bone mineral density at the time they discontinued the drug was strongly related to their fracture risk over the next five years, Bauer told panel members.

The findings probably can be generalized to weekly dosing of Fosamax, he said, but it’s unclear how they relate to other bisphosphonates.

Paul Miller, MD, medical director of the Colorado Center for Bone Research, noted that long-term use wasn’t an issue when bisphosphonates first came on the market. At that time, “we didn’t treat a lot of women in their 50s or early 60s with bisphosphonates,” said Miller, who was representing Warner Chilcott, maker of Actonel. “We treated sicker women in their 70s and 80s.”

In July 2002, the first published results from the Women’s Health Initiative changed all that, he said. The study found that Premarin, the top-selling brand of postmenopausal estrogen, increased heart attack, stroke, and breast cancer risk. Postmenopausal women who had been on hormone therapy to protect their bones flooded doctors’ offices in search of an alternative, Miller said.

Most of the bisphosphonate patients who testified before the panel about their unusual thigh fractures said they had started taking the drugs in their 50s or 60s. Some of the women said they’d been prescribed the drugs for osteopenia, which means their bone mineral density was lower than normal but not low enough to be classified as osteoporosis.

Advisory committee member Clifford Rosen, MD, director of the Center for Clinical and translational Research at the Maine Medical Center Research Institute in Scarborough, questioned the wisdom of prescribing bisphosphonates simply to prevent osteoporosis, as opposed to treating it.

“A prevention indication, I think, is being revisited all the way around, including by the FDA,” Kehoe said in response. “Certainly it’s something we’re struggling with and dealing with.”

Women’s Health pushes out one-shot pregnancy mag Bump

Pacific Magazines is targeting pregnant women with a new one-shot magazine titled Women’s Health Bump.

The extension of Women’s Health will be on sale from next Monday for the next three months at newsagents and selected supermarkets.

Felicity Harley, editor Women’s Health said: “Our research tell us that there is a gap in the market for a magazine that’s just about the woman’s pregnancy experience.”

“Women’s Health Bump won’t tell you about prams, baby bags and cots, but rather it’s the personal journey through the three stages of pregnancy – before, during and after.”

The title will feature editorial on fertility, bump-friendly fitness, health and nutrition as well as beauty, style, sex and love.

Michelle Meyercord, senior vice president, Rodale International added: “Bump is another example of how this team [Women’s Health] has grown this brand and how they continue to make Women’s Health the most relevant and engaging brand for women in Australia.

“We expect it will connect with readers and we are looking at ways we can expand this great idea to markets all around the world.”

Expo teams up with Women’s Wellness Initiative

On Saturday, Oct. 1, the Civic Arena will bring wellness and fashion together under one roof.

As both target the same audience, the 2011 Josephine Expo and Heartland Health’s Women’s Wellness Initiative decided to coordinate their annual events this year.

The ninth Women’s Wellness Initiative, “Just Her Health,” will be held in the south side of the arena. Its doors open at 9 a.m., and Dr. Jane Schwabe will welcome guests at 9:30 a.m.

Venue and time of year rank among the Initiative’s biggest changes. For the past few years, it’s been held at Missouri Western State University and touted as a “holiday prep camp.” Doctors’ panels to discuss women’s health topics, such as arthritis, heart disease, cancer and weight loss, will remain the same. Cardiovascular specialist Dr. Francisco Lammoglia and medical oncologist Dr. Rony Abou-Jawde are among the specialists who will answer questions.

An afternoon panel on weight loss will highlight success stories and surgical options for patients offered by recent hire, bariatric surgeon Dr. Phillip Hornbostel.

“Most people really like it,” Dr. Schwabe said of the physician panels. “They get new information. I think they really like the open forum, asking doctors questions in a not-very-threatening format. So if there’s some question they’ve got that they’re very curious about, we’ll do our best to try to answer it.”

Women who pre-register for the free health event by calling (816) 271-4098 will get a free pass to the Expo. The Initiative will break for the Expo’s fashion show, held at 11 a.m., and give participants time to explore the vendors. Participants are also free to come and go as they please, Dr. Schwabe noted, particularly as this year’s Initiative will be on the same day as Paint the Parkway Pink, and the Initiative doesn’t want to compete with it or the Expo.

Those who bring five or more canned goods to benefit Second Harvest Community Food Bank are invited to attend a Zumba session following the Initiative and the end of the Expo at 4 p.m.

Expo doors open at 10 a.m. for women who do not want to participate in the Wellness Initiative. Tickets cost $5 and can be purchased at Hy-Vee and at the News-Press. Children age 12 and under are free.

The 2011 Expo, with the theme “Just Her Style,” will feature around 100 booths and vendors, along with the East Hills’ sponsored fashion show. The popular show, performed again at 2 p.m., will showcase items from Dillard’s, Sears, J.C. Penney, Charming Charlie and Rue 21, among other stores.

“We see it as no matter what your style is, whether it’s fashion or personal, we’ll have something at the Expo for you,” said Carole Dunn, special projects advertiser for the News-Press and co-coordinator of the event.

One of the sponsors, Randy Reed, will have the Chevy Volt, an electric car, on display. Live music will also be performed throughout the day; The Phil Vandel Band will play at 10 a.m., Marcus Words at noon and the Wood Pile at 3 p.m.

Women’s Health News: July, 26

(0)

Category : News

Veterans’ column: VA hospitals doing more for women’s health

A special supplement of the journal Women’s Health Issues, published July 13, details the growth and diversity of women’s health research by the U.S. Department of Veterans Affairs in recent years.

Its publication coincides with the VA recognizing July as Women Veterans Month.

“VA has had a longstanding commitment to improving women’s health,” VA Secretary Eric Shinseki said in a news release. “This supplement shows the tremendous progress we’ve made by making that commitment to women veterans a top priority across the department.”

Titled “Health and Health Care of Women Veterans and Women in the Military: Research Informing Evidence-based Practice and Policy,” the supplement features commentaries examining the role, history, and future of women’s health research.

In an opening commentary, Elizabeth Yano, Ph.D., and Dr. Susan Frayne discuss the heightened focus on health-services research, with more articles published between 2004 and 2008, the first four years after the VA Office of Research and Development established its women’s health agenda, than in the previous 25 years combined.

The supplement also includes 18 peer-reviewed research articles addressing the changing demographics and demands of VA health care presented by the recent surge of women veterans into the VA system.

Among the topics addressed are: gender differences and disparities in care; mental health, including military sexual trauma and substance abuse; post-deployment health, including post-traumatic stress disorder; quality and delivery of care; and special populations, including homeless women veterans and those with traumatic brain injuries.

“With women expected to make up 10 percent of the veteran population by 2018,” said Dr. Robert A. Petzel, VA undersecretary for health, “our goal of excellence in health care for all of our nation’s veterans makes it imperative that we prepare now to meet future demands.”

Women’s Health Issues is a bimonthly peer-reviewed journal of the Jacobs Institute of Women’s Health at the George Washington University School of Public Health and Health Services. The journal focuses on applied research in women’s health care and policy issues.

Big step forward for women’s health

Adequate health insurance coverage has too long been out of reach for many women. Their health—and often the health of their families—has suffered.

That’s why the recommendations made last week by the medical and scientific experts convened by the Institute of Medicine are a major step forward for women. They help address some of the long-standing discriminatory practices and barriers women have faced in the health care system.

The experts determined that the full range of FDA-approved contraception, yearly well-woman visits, support for breast feeding, counseling for sexually transmitted infections, and screening and counseling for domestic violence are essential women’s preventive health services and should be covered by health insurers with no co-pays.

The Affordable Care Act requires all new health insurance plans to cover a list of preventive health services, as identified by the Department of Health & Human Services, and provide them with no out-of-pocket expenses for women. Based on the recommendations, HHS is to determine which screenings and services will be included.

These new guidelines are historic and will go a long way to protecting and promoting women’s health.

But opponents of contraception have sounded the alarm and are likely to make political demands to undermine this protection. The Institute of Medicine, however, merely acknowledged what most of us already know: Contraception is basic, essential health care. Overwhelming majorities of women use contraception to protect their health and prevent unintended pregnancy, and we virtually all are likely to use contraception at some point in our lives.

Nearly all women aged 15-44 who have had sexual intercourse have used at least one form of contraception, according to research from the non-partisan Guttmacher Institute. Among the 43 million fertile, sexually active women who don’t now want to become pregnant, 89 percent are using contraception. It is a normal, mainstream fact of life.

There is nothing new or novel about requiring health insurers to cover contraception. For more than 10 years, civil rights laws have made explicit that employers who provide health insurance plans that cover other preventive health care and prescription drugs must cover contraception. Twenty-eight states now require contraceptive coverage in private plans. The Medicaid program has also long required that contraceptives be included as part of the coverage for beneficiaries.

In addition to recognizing the fact that contraceptive coverage is already standard practice in both public and private health insurance plans, the non-partisan, independent panel of experts based its determination on a review of the medical and scientific evidence about unintended pregnancy; similar recommendations by numerous health care professional groups and other organizations, as well as the federal government itself, and the effectiveness of contraceptives.

Research also shows that costs—including co-payments and other cost-sharing requirements—play a key role in the contraceptive behavior of substantial numbers of women, often leading them to use less effective methods, or pay for contraception at the expense of other essential needs.

We are confident that Health and Human Services Secretary Kathleen Sebelius will follow this expert panel’s recommendations, and stand with the millions of women who depend on affordable, comprehensive health insurance.

Quest Diagnostics to Unveil Extensions to its Women’s Health and Personalized Medicine Test Offerings at the 2011 AACC Annual Meeting and Clinical Lab Expo

Athena Diagnostics’ spinal muscular atrophy (SMA) testing menu is broadly available nationally to Quest Diagnostics’ clients for the first time

Quest Diagnostics will also present novel scientific research and host the “What’s New in Laboratory Medicine?” scientific speaker series in booth 3130

MADISON, N.J., July 25, 2011 /PRNewswire/ — Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic testing, information and services, today announced it will unveil extensions to its women’s health and AccuType® pharmacogenetic test menus, give eight scientific presentations and host six scientific speakers during the American Association of Clinical Chemistry (AACC) annual meeting and Clinical Lab Expo, to be held in Atlanta, July 26-28, 2011 (Exhibit number 3130).

Spinal Muscular Atrophy Testing Now Available Broadly in the U.S.

The extensions to the company’s women’s health menu feature Athena Diagnostics’ spinal muscular atrophy (SMA) testing menu, believed to be the most comprehensive in the diagnostics industry. The services, which include adult-carrier screening and pre- and post-natal disease assessment testing, are now nationally available for the first time to physicians, laboratory directors and other clients of Quest Diagnostics. The offerings also position Quest Diagnostics as the only national major laboratory to provide testing services to assess SMA disease severity based on Athena’s analysis of the number of copies of an SMA-associated gene.

Athena Diagnostics, which Quest Diagnostics acquired in April 2011, is the leader in neurology diagnostics and a pioneer in SMA testing, which it has performed since 1996. Prior to the acquisition, select Quest Diagnostics’ business units had offered Athena Diagnostics’ SMA testing services in select regions only.

The SMA adult-carrier screening test detects a defective survival motor neuron (SMN) 1 gene, which determines an individual’s risk of passing SMA to offspring. The pre- and post-natal disease assessment tests identify the number of copies of the SMN2 gene, which affects disease severity.

SMA, a neuromuscular disease, is the second most common fatal autosomal-recessive disorder, with an estimated prevalence of one in 10,000 live births and an estimated carrier prevalence of about one in 40 to 60 individuals. If each parent possesses a defective SMN1 gene, there is a one in four chance their offspring will inherit the disease. SMA disease severity is affected greatly by the number of SMN2 gene copies. While many affected individuals will die by the age of two, others may live well into adulthood with significant or mild disability, in part based on SMN2 copy-number status.

With the Athena Diagnostics offering, Quest Diagnostics is now the only major national laboratory in the U.S. to provide testing services for identifying the number of SMN2 gene copies. The company’s women’s health menu also includes testing, counseling and interpretation services for aiding the detection of several developmental disorders, including cystic fibrosis, fragile X syndrome and autism spectrum disorders.

“When it comes to personal and family health, women and their physicians rightly expect their clinical laboratory to offer the comprehensive testing options, expertise and quality needed to make well-informed decisions,” said Charles M. Strom, M.D., Ph.D., senior medical director, genetics, Quest Diagnostics, and a board-certified pediatrician. “The addition of Athena’s SMA tests to Quest Diagnostics’ menu enables us to offer the broadest range of genetic women’s health testing and expert interpretative counseling services.”

AccuType Pharmacogenomic Testing Now Includes Four Services

At its exhibit, Quest Diagnostics will also showcase its AccuType family of pharmacogenomic testing services for personalizing medicine. These include two tests Quest Diagnostics launched this year: AccuType Metformin, a service designed to help physicians predict if a patient with Type II diabetes or at risk for Type II diabetes will respond to metformin, and its AccuType IL28B test, designed to aid in the prediction of response to the widely used pegylated-interferon alpha-based therapy for treating hepatitis C virus infection. The AccuType line also includes tests introduced in recent years to aid in predicting patient response to the blood thinners clopidogrel (Plavix®) and warfarin.

Scientific Presentations and Speakers

In addition, the company’s medical experts will give eight poster presentations providing novel data on vitamin D by liquid chromatography tandem mass spectrometry (LC/MS/MS), free T4 method comparison, and CYPC219 allele prevalence by ethnicity. As part of the company’s “What’s New in Laboratory Medicine?” in-booth speaker series, Quest Diagnostics scientists and external academic and other experts will address topics of interest in clinical and laboratory medicine, including genetics and heart disease, vitamin D, endocrine disorders, infectious disease and prescription drug monitoring.

For a complete list of poster presentations and the speaker series agenda, please visit: QuestDiagnostics.com/2011AACC.

About Quest Diagnostics

Quest Diagnostics is the world’s leading provider of diagnostic testing, information and services that patients and doctors need to make better healthcare decisions. The company offers the broadest access to diagnostic testing services through its network of laboratories and patient service centers, and provides interpretive consultation through its extensive medical and scientific staff. Quest Diagnostics is a pioneer in developing innovative diagnostic tests and advanced healthcare information technology solutions that help improve patient care.

Women’s Health News: July,23

(0)

Category : News

Women’s Health Care and Your Taxes

When it comes to government decisions about women’s health, women in the United States have not had a good year. Funding has been cut at the Federal level and in most states. Planned Parenthood, with its low cost health services, has been under sustained attack since the new congressional freshmen took over. New abortion restrictions have passed in a couple of dozen states. Any way you look at it, women’s rights, particularly the rights of poor women, have taken a beating.

So it was a complete and pleasant surprise when the Institute of Medicine announced its proposed guidelines for what women’s health services would be covered under the Affordable Care Act with no out of pocket expense to those covered. (As a side note ‘no out of pocket expense’ is not the same as ‘free’)

The guidelines proposed that eight services be covered for all US women. These include birth control (including sterilization), screenings for gestational diabetes, cervical cancer and HPV, counseling to help women prevent pregnancies and to help women space pregnancies further apart, counseling and equipment to promote breastfeeding, annual well-woman visits, counseling and screening for HIV and other STDs, and screening and counseling for domestic violence.

Women’s groups including Planned Parenthood praised the guidelines, while certain religious groups, including so-called ‘pro-life’ groups and the Family Research Council, condemned them.

I say ‘so-called’ pro-life in this context because by any standard, the guidelines would clearly save lives, and improve the lives of women and children. When an organization stands against improved health care for women, it cannot accurately be termed ‘pro-life’.

These groups are raising the old argument that they shouldn’t have to pay taxes for something they’re morally opposed to. Hey, what a great idea! I propose that those of us who are really pro-life stop paying our taxes toward:

Wars in Afghanistan and Iraq
The imprisonment of large numbers of US citizens for non violent drug offenses in the so-called ‘war on drugs
Subsidies to oil companies, mining companies, and others who through negligence cause the deaths of thousands of humans and other creatures on a regular basis
‘Faith based’ ‘pray away the gay’ therapy paid for with Medicaid funding that has been shown to actually be harmful to participants.
Part of living in a democracy (or democratic republic) is that our taxes sometimes pay for things we don’t approve of. It’s the nature of the beast. If you don’t like it, you’re free to lobby against it, you’re free to protest, you’re free to attempt to get representatives to lead you that will support your viewpoint – but you’re not free to pretend that a democratic republic is rule by consensus. It is not. Consensus requires 100% agreement.

A democracy rules by majority, and that means that no matter who you are, no matter what your political views are, sometimes you will not agree with the laws you live under. Deal with it or not, but don’t come crying martyr to me. I pay my taxes, too. And I happen to think that making it easier for women to get health care is seriously pro-life.

Hospital Merger To Affect Women’s Health Services

The merger of University Hospital with Jewish and St. Mary’s is creating some controversy.

The hospital group will be 70 percent owned by Catholic Health Initiatives, and the merging systems have agreed to honor the Catholic Church’s rule against sterilizations.

That means a woman having her tubes tied as part of a C-section delivery would not be an option at University Hospital.

“No one should fear that they will not be able to get the full range of reproductive health services. We are a public university and we will serve the people from whom that support comes,” said Dr. Edward Halperin of the UofL School of Medicine.

That’s one of several promises the University of Louisville has made in a pending merger with Jewish Hospital and St. Mary’s healthcare.

The university also says it will honor the Catholic Church’s rules against reproductive procedures, such as tubal ligations, vasectomies and in-vitro fertilization.

“How is it possible? The same way it’s been possible in multiple other mergers in US and their various structures one does to maintain CHI’s wish to not be in violation of the Council of Bishops and our promise to provide service,” Halperin said.

UofL said faculty will continue to conduct abortions, tubal ligations, vasectomies, and stem cell research, though not within the merged facilities.

Officials would not elaborate on how those hospitals have solved the issue of women delivering by C-section and wanting their tubes tied in the same surgery, saying they are still exploring a number of possibilities.

“That’s one of hundreds of questions to be solved, but it will be solved,” Halperin said.

“Obviously, women’s health is not a priority to the university of Louisville Hospital,” said Honi Goldman.

Goldman said since 10 a.m. Wednesday, hundreds of people have signed up protesting of the merger stipulation.

“It is just amazing what happens when you get when you have people that are angry about something and they band together, and that’s exactly what happened,” she said.

Their names will be displayed in an ad along with information on contacting the hospital leaders.

“We want UofL to go back to the table and say, ‘This provision, this stipulation is not going to happen; it’s off the books,’” she said.

Officials said it would be about a year before the merger takes effect.

The ad in protest runs this weekend.

Health Group: Get Mammograms At 40, Not 50

One of the nation’s biggest women’s health groups is changing its position on breast cancer screenings.

The American College of Obstetricians and Gynecologists is now telling women to start getting annual mammograms when they turn 40 years old rather than 50.

By making the change, the group is siding with the American Cancer Society and the American College of Radiology.

A government panel however, is standing by its controversial recommendation against routine screenings for women in their 40s.

Why One IOM Committee Member Dissented on Women’s Health Report

The Institute of Medicine’s much-anticipated recommendations for which women’s health services should be covered by health plans without co-pays or deductibles came out yesterday. Among the eight services it recommends insurers cover at no extra charge — HHS will make the final decision — are all forms of approved contraception, breastfeeding support and breast-pump rentals and domestic-violence screening.

One member of the committee charged with coming up with the recommendations, however, had several issues with how the report was developed — so much so that he filed a dissent rather than endorsing the report.

You can read the dissent by economist Anthony Lo Sasso, a professor and senior research scientist in the division of health policy and administration at the University of Illinois at Chicago’s School of Public Health, on p. 207 of the report. It’s followed by a response from the other 15 committee members.

We caught up with Lo Sasso by phone today and chatted with him about his objections. First, he thinks the time frame provided for coming up with recommendations was too short — “barely six months” from the time the group came together to when the final report was submitted, his dissent says.

Lo Sasso also objects to what he calls a lack of a systematic approach to weighing the evidence for different services. His dissent says it’s “impossible to discern what factors were most important in the decision to recommend one service versus another.”

And he tells us the recommendations reflect “a mix of objective evidence combined with subjective evidence” that reflected the preferences of committee members. Lo Sasso wouldn’t go into specifics, saying that the members of their committees and their affiliations are a matter of public record.

Lo Sasso also thinks cost-effectiveness and other non-clinical analyses, while not part of the committee’s charge, should have been considered. For example, one rationale for preventive services is that they will reduce the need for more intensive inpatient services later on. If that doesn’t actually happen in real life for a given service, that should be part of the conversation about whether to require it be covered, he says.

“In general, when you have mandates in health insurance coverage for particular services, one needs to … worry about unintended consequences,” he tells the Health Blog. Otherwise premiums could end up going up for everyone.

The committee’s response to the dissent notes that while cost considerations were “outside the scope” of the committee’s charge, HHS may consider cost when it develops its coverage decisions. It also says the dissent includes “inaccurate statements regarding the committee process and its approach.” And it notes that “no other member shares the opinion that report recommendations were not soundly evidence-based.”

Committee chair Linda Rosenstock, dean of the UCLA School of Public Health, noted on a conference call with reporters yesterday that there was “an extremely strong consensus” on the report’s findings.

Women’s Health News: July, 19

(0)

Category : News

RCOG calls for reform to women’s health services

A radical shake-up of women’s health services in the UK is necessary if the NHS is to cope with changing demands, according to a new report.

The Royal College of Obstetricians and Gynaecologists (RCOG) has published a document that highlights concerns over the effect financial pressures and wider NHS reforms will have on women’s healthcare, particularly in the face of demographic changes and rising complexity.

It is therefore recommending that a series of major changes are implemented, including services provided by managed clinical networks, universal standards and a life-course approach to health, leveraging every interaction women have with the NHS.

These and other initiatives have been recommended in order to ensure that a new healthcare paradigm is embraced that is centred on prevention, rather than intervention.

Dr Tony Falconer, president of the RCOG, said: “There is scope for significant improvement and an urgent need to elevate the standards of care in all parts of the UK.”

Last month, the organisation called for women with congenital heart disease to be referred to clinics where they can seek advice on contraception and fertility, which will help them to stay aware of potential risks.

Anti-abortion groups push for further restrictions in Kansas

Anti-abortion groups are planning to seize the momentum of spring victories in the Kansas Capitol and push for more restrictive measures, even ahead of the 2012 legislative session.

A petition has begun circulating for Gov. Sam Brownback to convene a special session this fall to consider a so-called “heartbeat bill” that would ban abortions when a fetal heartbeat is detected.

Another group plans to introduce a bill calling for a state constitutional amendment guaranteeing the rights of personhood to every human being from the beginning of biological development, including fertilization.

Both measures would defy Roe v. Wade, the 1973 U.S. Supreme Court decision that affirmed a woman’s right to have an abortion until the fetus would be viable outside the womb, usually at 22 to 24 weeks.

The measures are scorned by abortion-rights groups and considered controversial even among some abortion foes who say such measures overreach and would lead to setbacks in the courts.

But Mark Gietzen, board chairman of the Kansas Coalition for Life, who is pushing for the “heartbeat bill,” cited the numerous anti-abortion measures that Brownback recently signed into law and said, “What else can we do? We’ve got just about everything else covered.”

Kansas lawmakers passed bills that set new licensing requirements for medical facilities that provide abortions; banned abortions after 21 weeks based on the disputed notion that fetuses can feel pain then; required minors seeking an abortion to obtain the notarized written consent of both parents or a legal guardian; restricted private insurance coverage for abortions; and redirected federal family planning funds from Planned Parenthood to other health care agencies.

The new licensing requirements and the stripping of federal funds from Planned Parenthood already are in the courts.

Twin efforts to get more stringent laws such as a “heartbeat bill” and a personhood measure aren’t a surprise to opponents.

“It is the same as all of the other anti-reproductive rights legislation,” said Julie Burkhart, founder and director of Trust Women, which hopes to open a clinic offering first-trimester abortions and other women’s health services in Wichita in about a year.

“It’s about denying access to pregnant women who are in need of reproductive health care. It’s a further step toward the re-criminalization of abortion services for women.”

Will Kansas be first?

Attempts to get both bills passed are likely to keep Kansas at the forefront of the national debate over abortion. Although other states have considered each measure, none has passed one into law yet, and Kansas could be the first state to do so.

A “heartbeat bill” in Ohio made it through the House but must be voted on in the Senate.

Gietzen, who said a heartbeat law would stop about 85 percent of abortions in the state, thinks Kansas can beat Ohio with a special session, which he hopes to have Brownback convene in October.

Brownback’s office did not respond to questions about whether he would call for a special session.

Personhood petitions are active in all 50 states, but no state has approved an amendment yet.

Personhood amendments were soundly defeated in Colorado twice, in 2008 and 2010. One is up for vote in Mississippi in November.

Bruce Garren, committee chairman of Personhood Kansas, thinks Colorado wasn’t as receptive to personhood as Kansas, where a constitutional amendment would require a two-thirds vote in the House and Senate. If passed, it would then go before voters in the 2012 general election.

“We just think the people of Kansas ought to have the right to vote on this,” Garren said.

Passage of either measure would face potentially costly court challenges.

“These types of laws are just blatantly unconstitutional,” said Gretchen Borchelt, senior counsel for the National Women’s Law Center in Washington, D.C. “They’re just trying to provoke court challenges to Roe v. Wade.”

The goal is to overturn that decision, she said, but it’s an expensive undertaking for a state facing a severe budget crisis.

“There’s not the public support, there’s not the legal support. It’s just an extreme overreach to push a challenge,” Borchelt said.

A spokeswoman for the Center for Reproductive Rights in New York City, which filed a lawsuit against the state’s new clinic licensing regulations on behalf of the Center for Women’s Health in Overland Park, said the center “will monitor any measures that threaten to cut off women’s access to reproductive health services.”

The center doesn’t comment on its litigation plans, she said.

Planned Parenthood of Kansas and Mid-Missouri, which has sued the state to retain its federal funding, didn’t respond to questions about how it would respond to the proposals.

Conflict over strategy

Anti-abortion groups in Kansas disagree about pushing more restrictive measures.

Troy Newman, president of Wichita-based Operation Rescue, which came up with the personhood idea, doesn’t think personhood will pass in Kansas.

He cited its double defeat in Colorado, where opponents effectively argued it would outlaw women’s contraceptives such as IUDs, which prevent implantation of a fertilized egg.

A more reasonable approach is to continue to focus on regulating clinics that perform abortions, he said.

The anti-abortion organization Kansans for Life, which has offices in Overland Park, Wichita and Topeka, recommends taking more incremental action, such as education and working to elect lawmakers who oppose abortion.

“We want change to be lasting change, not try to throw the Hail Mary passes,” said Mary Kay Culp, executive director.

Her organization plans to push for introduction of a bill in the next legislative session that protects the rights of health care workers who want to refuse to participate in situations they find morally objectionable. Culp said President Barack Obama’s health care law weakens their rights to act on their consciences.

A more gradual approach may not be exciting, Culp said. “But it’s also not as apt to be turned on its head,” she said.

More restrictive measures require much thought, Culp said.

“Just because you have a governor that might sign it should it pass both bodies, there’s lots to be considered,” she said. “Is it right for the long run? It’s going to be sued, so where are you going? You end up in the U.S. Supreme Court, where you’re still short a vote.”

Gietzen said he would welcome a high-court test of heartbeat legislation because he thinks the justice who is perceived as the swing vote on abortion, Anthony Kennedy, has shown signs of returning to an anti-abortion stance he had when he was nominated to the court.

Issues are clouded

Problems over defining personhood and determining when, exactly, a heartbeat can be detected in a fetus are bound to complicate the issues.

Attempts to define personhood raise questions such as whether frozen embryos are persons, said Rep. Barbara Bollier, a Republican from Mission Hills.

She is a former physician who taught bioethics courses that wrestled with definitions of personhood. “You run into all these gray areas. It’s incredibly difficult,” she said.

In spite of the complexities, Bollier — who voted against the state’s new “fetal pain” bill because she believed that accepted medical literature doesn’t support the claim that fetuses feel pain at 22 weeks — said both measures were likely to pass in Topeka.

“I think that anything that has to do in some way with limiting people’s choices for abortion has a significant chance of going through,” she said.

Rep. Randy Garber, a Republican from Sabetha, is sponsoring the personhood legislation, but he isn’t sure how that vote will turn out.

“Some strong pro-life people think it’s the wrong way to go. I think it’ll be a very close vote,” he said.

But Garber, a pastor, is determined to get it passed. He said that he tells critics of the approach, “This is why God put me in the Legislature. I really prayed about it.”

And he isn’t concerned about legal ramifications. “If we believe God is in charge,” Garber said, “we should try to legislate the way God would want us to.”

Critics of heartbeat legislation say a fetal heartbeat can be detected within three to six weeks of conception, before women even know they’re pregnant. Factors such as the woman’s body fat, the fetus’s position in the womb and the type of detection method used vary, they say.

A woman could have a window of two weeks or less to find out she was pregnant, make a critical decision about whether to have an abortion, get any required approvals and schedule a procedure. Women who have irregular menstrual cycles may find out too late to do anything but continue the pregnancy.

Such bills don’t factor in the health of the mother, said Burkhart of Trust Women. “Let’s say you can detect a heartbeat in three to six weeks,” she said. “At that point, you don’t have viability of a fetus.”

Gietzen admits issues regarding heartbeat detection are problematic.

His bill hasn’t been written yet, he said, but it would be modeled on Ohio’s bill, which requires that a person who intends to perform an abortion must determine whether the fetus has a heartbeat, then inform the woman regarding the probability of bringing the unborn child to term.

The Ohio bill doesn’t provide exceptions for rape and incest. An abortion would be allowed only in a medical emergency.

Petition drives begun

Gietzen, of Wichita, has launched a petition drive to gather 15,000 signatures from around the state asking Brownback to call a special session. The petition has few signatures so far, but Gietzen announced it only two weeks ago and hasn’t geared up a major campaign yet.

Gietzen said he would ask lawmakers to convene the session at no cost to the state. He thinks they can deal with the bill in two days.

He doesn’t want to wait for the regular session in January because legislation usually gets pushed to the end of the session, he said.

“If we miss October, you’re looking at June, or a year from now, before a bill would go into effect,” Gietzen said.

John Willke, president of the Life Issues Institute in Cincinnati, has written letters to Brownback and legislators supporting the heartbeat effort, Gietzen said.

But Gietzen also has received negative feedback from other abortion foes who want him to support personhood instead. Gietzen said he would support personhood, but the country isn’t ready for it.

“We can pass heartbeat legislation now. We cannot get personhood legislation passed,” Gietzen said.

Skinvisible Licensee Launches First Prescription Product in the USA

Skinvisible Pharmaceuticals, Inc. (otcqb:SKVI) is pleased to announce that its licensee, Women’s Choice Pharmaceuticals LLC, a specialty pharmaceutical company based in Gilbert, Arizona, has launched ProCort(R), Skinvisible’s first prescription product in the United States. ProCort(R) is a topical treatment for hemorrhoids formulated with Skinvisible’s patented polymer delivery system Invisicare(R). Invisicare enhances the delivery of active ingredients by controlling the release and provides superior binding properties. ProCort(R) is made of a combination of hydrocortisone acetate and pramoxine hydrochloride. ProCort(R), launched this week, is a prescription product focused on the women’s health market.

Women’s Choice Pharmaceuticals has been granted the exclusive rights to commercialize Skinvisible’s product within the United States. Skinvisible has received a development fee and now will receive a license fee paid in milestones plus on-going royalties based on product sales. Women’s Choice Pharmaceuticals’ revenue forecast for ProCort is $20 million by its third year.

According to the U.S. Department of Health, hemorrhoids are most common among adults over 45 and in pregnant women. They state that approximately 75 percent of people will have hemorrhoids at some point in their lives. The U.S. hemorrhoid market, estimated at $85 million in 2006, is growing by approximately 1 million new cases diagnosed every year.

“ProCort(R) is Skinvisible’s first prescription product launched in the United States and we are very confident Women’s Choice Pharmaceuticals will gain market share quickly, as it has with its other product launches,” said Mr. Terry Howlett, President and CEO. “This is an example of how Skinvisible’s Invisicare technology can meet the growing need for patent-protected options for pharmaceutical companies in dermatology and other markets.”

Women’s Choice Pharmaceuticals is an innovative specialty pharmaceutical company whose primary focus is to provide high quality prescription products to healthcare providers in the United States. Their nationwide sales target more than 30,000 OB/GYNS and selected other medical specialties. Their managed markets division will target PBM’s, HMO, GPO, CMS and other managed care organizations ensuring their products are covered under drug benefit plans.