FINDINGS: UCLA researchers and colleagues analyzed data for 2,213 women between the ages of 42 and 52 who participated in the bone sub-study of the Study of Women’s Health Across the Nation to determine whether women with vasomotor symptoms (VMS) – which include hot flashes and night sweats – had lower bone mineral density.

The researchers found that postmenopausal women with VMS had lower lumbar and total hip bone mineral density than those without VMS. Premenopausal women and early perimenopausal women who had VMS were found to have lower femoral neck bone mineral density than those without VMS.

AUTHORS: UCLA study co-authors Dr. Carolyn J. Crandall, associate clinical professor of general internal medicine and health services research; Gail A. Greendale, professor of medicine in geriatrics; and Yan Zheng, of the division of general internal medicine and health services research.

JOURNAL: The research appeared in the March/April 2009 issue of the journal Menopause.

FUNDING: The National Institute on Aging, the U.S. Department of Health and Human Services’ National Institutes of Health, the National Institute of Nursing Research, and the NIH Office of Research on Women’s Health supported this study.

Source:
Enrique Rivero
University of California – Los Angeles

©2012 An Inconvenient Woman. All Rights Reserved.

“Trav’lin’ along, here’s a song that we’re singing

Come on get happy!”

Wyeth Gets Important FDA for “New” Antidepressant

Faced with the looming loss of patent protection for its top-selling drug, the antidepressant Effexor XR, Wyeth received federal approval on February 29th for a successor drug, Pristiq, which the company hopes will also become a blockbuster.

With the Food and Drug Administration’s approval of Pristiq, Wyeth said the company planned a big sales effort to introduce the product to psychiatrists and primary care doctors.

Wyeth needs a product that will replace some of the revenue expected to be lost to generic competitors of Effexor XR, whose patent protection expires in 2010. Sales of Effexor XR last year were $3.8 billion.

Dr. Philip Ninan, a Wyeth vice president for neuroscience, said he thought that Pristiq, which is chemically similar to Effexor, would have similar benefits in treating major depression. But the company said the drug had distinct advantages over its existing product.

Among them are that patients can start taking Pristiq at the therapeutic dose of 50 milligrams. Frequently, antidepressants must be started at a low dose, then ramped up to the therapeutic dose, to test whether patients can tolerate the drug and to determine the correct dose for the individual. Another advantage is that Pristiq avoids a major metabolic pathway in the liver that is often used by other drugs, but it does not completely avoid being metabolized by the liver, Dr. Ninan said, so it is not as likely to interact with other medications metabolized by the liver.

“I think what’s important to understand in the depression category is that many patients fail to respond to anything that’s available,” said Geno Germano, Wyeth’s president of pharmaceuticals for the United States. “What’s important is that physicians and patients need multiple options available.”

But several analysts are skeptical of Pristiq, saying it has little advantage over other products on the market. And they raised questions about whether insurance companies would cover its cost in light of the availability of other drugs, including a less expensive generic version of Wyeth’s original version of Effexor that is already on the market.

Wyeth applied for F.D.A. approval of Pristiq in 2005. But in January 2007, the agency asked for additional information, a process that delayed approval until now.

During regular stock market trading on Friday, when most of the market was plunging, Wyeth’s shares were up more than 2.5 percent, closing at $43.62, in apparent anticipation of the F.D.A. approval.

Wyeth, based in Madison, N.J., has not yet announced how much Pristiq will cost. Effexor XR sells for about $120 for a 30-day supply, while the generic version of the original Effexor has been priced at less than half that recently on the Web site of one domestic chain pharmacy.

Dr. Timothy Anderson, a pharmaceutical analyst for Sanford C. Bernstein & Company, said that data Wyeth presented at a recent meeting of the American College of Neuropsychopharmacology failed to distinguish Pristiq from other marketed antidepressants.

“Payers are not likely to widely cover Pristiq in our view, and we forecast only low levels of sales,” Dr. Anderson wrote in a note to clients. He predicted the drug’s sales at $500 million by 2012, a relatively small figure in the antidepressant category.

And Dr. Daniel Carlat, a psychiatrist in Newburyport, Mass., who publishes the Carlat Psychiatry Report, said the release of Pristiq appeared mainly to be an effort by the company to, in effect, extend its patent for Effexor XR.

That is because Pristiq is a metabolite of Effexor — meaning it is the chemical compound that results after Effexor is swallowed and processed in the body.

“Is there a compelling public health reason for Wyeth to be releasing another antidepressant into the market, with no clear advantages over others?” Dr. Carlat said. “Not that I can see.”

Wyeth is also seeking FDA approval for Pristiq as a drug to reduce hot flashes in menopause. The agency has asked for more data for that use.

[Naturally, once they pull the FDA on-board, Wyeth will mount a mega-million, marketing campaign to convince women and their health care providers, that a NEW 'mommy’s little helper', would be just the thing — to help Wyeth bolster sales and raise profit margins, that is.] —HSCB

Maybe the ad campaign could go like this, “Hey, You can’t be flashing if your napping!” maybe sung to Partridge Family Theme Song, Come on Get Happy.

“Trav’lin’ along, here’s a song that we’re singing

Come on get happy”

Sources: Wyeth Press Release

FDA Press Release

Stephanie Saul, New York Times

©2012 An Inconvenient Woman. All Rights Reserved.

While Wyeth Wrings Profits From Womens BodiesHere’s some news that will make us all depressed – Wyeth has won FDA approval for its new antidepressant Pristiq. Yes, the same FDA who has just told us “bioidentical hormones” don’t exist, the same FDA who has told compounding pharmacists to stop using Estriol, the mildest of estrogens when it helped hundreds of thousands of women with menopausal symptoms. Yes, the FDA whose mandate is to protect the public has spoken again. This time, it didn’t take one of its hundreds of FDA approved dangerous flops off the market, this time it has added yet another antidepressant to an already endless list of drugs that don’t’ work to the market.

Unfortunately this is proof yet again that the FDA is more anxious to protect Wyeth’s profits than the wellbeing of the American public.

This is a particularly ominous development for women – Wyeth is also asking the FDA to approve Pristiq as a drug to reduce hot flashes in menopause.

Pristiq is the successor to Effexor XR, whose patent expires in two years. Sales of Effexor last year were $3.8 billion. By the way, Effexor is not exactly a great drug either. Just check my blog on the topic and read about its side-effects and disastrous record when it comes to attempting to get off it.

The new drug provides a lucrative new revenue stream for Wyeth. How lucrative? Well, on the day it won FDA approval (February 29) Wyeth stock soared 2.5% while the rest of Wall St tumbled 315 points.

Did I mention any benefits to patients? I would, if I could think of any. One thing I’d like to ask the FDA and Wyeth is how many people (women) have taken this drug for how long before it got through the approval process? And by the way, did anyone have any adverse reactions we might consider serious enough to skip the drug altogether?

The prospect of Pristiq being approved for menopause is truly disturbing and proves the FDA has relinquished any pretense of protecting women. Treating menopause with anti-depressants is ineffective and dangerous. If women are depressed during menopause it is because their hormones are depleted and most conventional doctors discard their symptoms and tell them they are just getting old and should just get over it and go away.

The sensible and caring way to deal with the problems of menopause is to help women understand what happened to their bodies, how their diets affect the way they feel, how exercise improves the symptoms, how stress management helps them get the sleep they need, how supplementing their hormones with bioidentical hormones can help them get their lives back on track and enlighten the world with the wisdom they acquired along the way.

The solution is not going to be found in giving them another drug to become dependent upon.

Instead, the FDA is making it harder for women to find safe, sensible alternatives.

You’d think they’d done enough favors for Wyeth.

Source: Bioidentical Hormones

©2012 An Inconvenient Woman. All Rights Reserved.

”What cigarette do you smoke, Doctor?”

Hey if a Camel® is good enough Doctors, surely cigarette smoke is safe?

Right! Who would question a doctor back in the golden days of black and white TV?

Western Medicine has a long and completely unapologetic history of being wrong. The are better ways of handling symptomatic behavior than ingesting chemicals a group a guys “think” won’t cause you harm.

”What cigarette do you smoke, Doctor?”

The following is a summary of an article that appeared on www.medscape.com.

The American Association of Clinical Endocrinologists (AACE) has released a statement on hormone replacement therapy (HRT) and cardiovascular risk, emphasizing that HRT does not appear harmful in younger women in early menopause and may indeed be beneficial in this group [1]. “With this in mind, and given the powerful effects of estrogen therapy in relieving menopausal symptoms, we believe that physicians may safely counsel women to use estrogen for the relief of menopausal symptoms. Each patient should be evaluated for the severity of her symptoms, her age, and specific risk factors that might impact on her use of hormonal therapy,” the statement concludes.One of the authors of the statement, past AACE president Dr Rhoda Cobin (Mount Sinai School of Medicine, New York), told ‘Heartwire’ that a review of all the available evidence suggests that younger women who are close to menopause have less to fear from HRT than older women in terms of cardiovascular risk. “We think the data offer some reassurance to women close to the menopause, with the suggestion that estrogen supplementation may even protect against heart disease in these younger women. And even if it is not protective, it doesn’t appear to be harmful so can probably be used safely to treat menopausal symptoms. There does appear to be a window of opportunity for use of estrogen.”

She added: “After all the negative publicity from the HRT trials, physicians are now fearful of prescribing estrogen at all. But we believe there are advantages and disadvantages to such treatment and that cardiovascular risk in particular is not the same for everyone. Each woman should be considered individually, and many factors should be taken into account when thinking about prescribing HRT. These include age, time from menopause, other cardiovascular and thrombotic risks, and menopausal symptoms.

“The evidence is particularly reassuring for estrogen-only therapy, which has not been associated with increases of either cardiovascular disease or breast cancer in younger women. So for women who have had an early hysterectomy and therefore do not have to have progesterone, they should not be deprived of estrogen replacement therapy,” Cobin commented.

The AACE statement notes that in animal studies, estrogen is effective in inhibiting progression of early-stage atherosclerosis but it is much less effective in inhibiting progression of more advanced atherosclerosis in older animals. After these observations, data from the major HRT studies were reexamined to determine the effect of treatment on cardiovascular risk when stratified by age or time from menopause.

The reevaluation of the Nurses’ Health Study found that women beginning hormone therapy near menopause had a significantly reduced risk of CHD (RR=0.66 for estrogen alone; RR=0.72 for estrogen with progestin). A recent meta-analysis of 23 trials of HRT that compared results in younger women (younger than 60 or less than 10 years since menopause) vs older women showed that HRT significantly reduced CHD events in the former (OR 0.68) but not in the latter (OR 1.03). And in the Women’s Health Initiative (WHI) trial, when stratified by time since menopause, the hazard ratios for CHD were 0.76 in the women fewer than 10 years from the onset of menopause, 1.1 in those 10 to 19 years from onset of menopause, and 1.28 in those women more than 20 years from onset of menopause. By age, the hazard ratios for cardiovascular disease were 0.93 for ages 50 to 59, 0.98 for ages 60 to 69, and 1.26 for ages 70 to 79.

The AACE statement notes that further data on HRT in younger women will come from the Kronos Early Estrogen Prevention Study (KEEPS), which is evaluating five years of HRT vs placebo in 720 women aged 42 to 58 years within 36 months of final menstrual period. The end points will include prevention of progression of carotid intimal medial thickness and accrual of coronary calcium, but results will not be available for several years.

Sources: American Association of Clinical Endocrinologists, Press Release January 2, 2008, “AACE Analysis shows no excess cardiovascular risk from hormone replacement therapy for most patients”

Sue Hughes, January 7, 2008 Heartwire.

©2012 An Inconvenient Woman. All Rights Reserved.

Gloria is a writer who has been researching and offering workshops on Menopause: A Women’s Rite of Passage for the past 5 years. A 53 year-old post-menopausal woman she has been running her workshops in New South Wales Australia and is open to invitations to other areas to carry on her work. Her great interest is for all women, and in particular older women, to reach their full power and potential.

She stresses the natural approach to Menopause, with discussion on diet, herbs and vitamins, exercise, relaxation and meditation, all of which can help you.

The following quotes are recorded from Gloria Graham’s workshops:

“You know how you feel, a week after your period ends, like you could slay dragons. That is how a post Menopausal woman feels all the time if she is conscious of it.”

— Elizabeth Stevenson, age of 54, a Jungian analyst at Cambridge University,

after using herbs, vitamins, as well as acupuncture for the relief of hot flushes.

“The heyday of a woman’s life is the shady side of fifty, when the vital forces come expended in other ways, are garnered in the brain. When their thoughts and sentiments flow out in broader channels, when philanthropy takes the place of family selfishness and when from the depths of poverty and suffering the wail of humanity grows as pathetic to their ears as once was the cry of their own children”.

— Elizabeth Cady Stanton,

who pursued justice for women well into her eighties

“All the strength you need to achieve anything is within you. Don’t wait for a light to appear at the end of the tunnel. Stride down and light the bloody thing yourself”.

— Sarah Henderson, an Australian cattle woman

Source: Menopause: A Women’s Rite of Passage

©2012 An Inconvenient Woman. All Rights Reserved.