FDA Approved Treatment for Postmenopausal Osteoporosis Get important product information on another FDA approved postmenopausal osteoporosis medication. 

June 29, 2010 — A new Endocrine Society scientific statement published in the July 2010 issue of the Journal of Clinical Endocrinology & Metabolism evaluates benefits and risks for postmenopausal hormone replacement therapy (HRT), now [...]]]> Laurie Barclay, M.D. – Medscape, LLC

 FDA Approved Treatment for Postmenopausal Osteoporosis
Get important product information on another FDA approved postmenopausal osteoporosis medication. 

June 29, 2010 — A new Endocrine Society scientific statement published in the July 2010 issue of the Journal of Clinical Endocrinology & Metabolism evaluates benefits and risks for postmenopausal hormone replacement therapy (HRT), now known as menopausal hormone therapy (MHT). The statement, entitled “Postmenopausal Hormone Therapy: An Endocrine Society Scientific Statement,” was also posted online ahead of print on June 21 and presented in San Diego, California, at ENDO 2010: The 92nd Annual Meeting & Expo.

Although MHT was in widespread use in the 1990s in hopes of lowering cardiovascular disease risk as well as to treat menopausal symptoms, the Women’s Health Initiative (WHI) Study showed that MHT was actually associated with an increased risk for heart disease, stroke, and breast cancer. However, recent evidence suggests that these risks may be affected by time after onset of menopause when MHT was started, a factor not considered in the WHI assessment of MHT safety and efficacy.

“Before the WHI, MHT was believed to prevent heart disease, fractures, memory loss and dementia in addition to relieving uncomfortable menopausal symptoms,” said task force chair Richard J. Santen, MD, professor of medicine at the University of Virginia in Charlottesville, in a news release. “Following the WHI reports of increased health risks associated with MHT, MHT use declined by 80%. New data however [show] that these health risks may not apply to all women using MHT, and that MHT may in fact be very beneficial to some women.”

Controversy regarding WHI’s applicability to women just entering menopause stems from the fact that the average age of participants was 63 years, and only 3.5% of the women were aged 50 to 54 years, which is the age range when women typically decide whether to start MHT. Furthermore, the WHI did not address menopausal symptom relief. Therefore, this scientific statement considered new data from later studies evaluating the effects of MHT in women aged 50 to 55 years.

Compared with women who begin MHT after age 60 years, those who begin MHT a short time after onset of menopause at ages 50 to 59 years appear to benefit. According to recent evidence, women in the short-time group using MHT for 5 years had a 30% to 40% reduction in mortality risk and no increased cardiovascular disease risk. In addition, they had a 90% decrease in hot flashes, overactive bladder, or other menopausal symptoms.

“Some women in the short-time group still developed breast cancer but only with the combination of estrogen plus a progestogen, not with estrogen alone,” Dr. Santen said. “This may be due to the stimulation and uncovering of very small, undiagnosed breast cancers, rather than causing these cancers de novo.”

Conclusions Reached

Evaluation of the new data along with WHI evidence led the task force to reach the following conclusions, with level of evidence A:

• “Standard-dose” estrogen used with or without a progestogen is associated with marked reduction in frequency and severity of hot flashes. For many women, lower doses of estrogen are also effective.
• An alternative hormonal therapy for postmenopausal vasomotor symptoms is tibolone, which is widely available worldwide, but not in the United States.
• For symptoms of vaginal atrophy, very low doses of vaginal estradiol are effective.
• Symptoms of overactive bladder may be reduced by estrogen given vaginally or systemically.
• Vaginal estrogen is associated with lower rates of recurrent urinary tract infections.
• Tibolone improves urogenital atrophy.
• For women in late postmenopause, estrogen given with or without a progestogen is as effective as bisphosphonate therapy for preventing early postmenopausal bone loss and increasing bone mass.
• Use of estrogen alone and estrogen plus a progestogen is associated with a lower incidence of hip and vertebral fractures.
• For osteoporotic women older than 60 years, tibolone is associated with significantly lower rates of vertebral and nonvertebral fractures.
• Treatment with the selective estrogen receptor modulator raloxifene is associated with increased bone mineral density and lower rates of vertebral, but not hip, fractures.
• Use of MHT containing estrogen plus a progestogen is linked to a lower risk for colon cancer.
• Raloxifene is associated with a lower risk for breast cancer.
• Mammographic density is increased in women taking estrogen alone or with a progestogen.
• Use of tibolone is associated with a greater risk for breast cancer recurrence.
• Sexual function is improved by physiologic amounts of transdermal testosterone, but not by dehydroepiandrosterone.
• Risk for venothrombotic episodes is approximately doubled in women using MHT, and this risk is multiplicative with baseline risk factors such as age, increased body mass index, thrombophilias, surgery, and immobilization.
• Use of raloxifene is associated with an increased incidence of venothrombotic episodes.
• In older, but not younger, women, tibolone is associated with an increased risk for stroke.
• Raloxifene is not associated with any increase in stroke risk.
• In older women with preexisting vascular disease, hormone use does not reduce stroke incidence.
• Although continuous estrogen plus a progestogen does not cause endometrial cancer, estrogen alone without a progestogen is associated with an increased incidence in endometrial cancer.
• Tibolone is not associated with an increased incidence of endometrial hyperplasia or carcinoma.
• Risk for gallbladder disease is increased in women using estrogen alone or with a progestogen.
• MHT started after age 60 years does not improve memory.

“It is important to remember that most women considering MHT are between the ages of 50 and 55 and in this group MHT may have many benefits,” Dr. Santen concluded. “Physicians and their patients need to re-think the use of [MHT] based on data pertinent to the 50-55 year old and therapy should be individualized based on symptoms and underlying risks of breast cancer and heart disease.”

Researchers at the Cleveland Clinic’s Lerner Research Institute (for those not “in the know”, the Cleveland Clinic is  a highly regarded institution)  are now conducting human trials of a breast cancer vaccine.  The vaccine specifically targets a protein common to breast cancer tumors (a-lactalbumin).

Studies upon mice (Sorry PETA, that’s what [...]]]> Source:  BBC Health; Journal Nature Medicine.

Researchers at the Cleveland Clinic’s Lerner Research Institute (for those not “in the know”, the Cleveland Clinic is  a highly regarded institution)  are now conducting human trials of a breast cancer vaccine.  The vaccine specifically targets a protein common to breast cancer tumors (a-lactalbumin).

Studies upon mice (Sorry PETA, that’s what they’re really good for) have demonstrated reason to be hopeful.  There are currently two cancer vaccines approved for use in the US, however neither of these actually prevent cancer.  One (Gardasil) prevents HPV while the other prevents Hepatitis B, both precursors to cancers.  If the breast cancer vaccine is effective in human trials it would be the first vaccine against cancer tumors.

Some background is in order.  Cancer actually describes a process of rapid and unrestrained cell growth.  The inability of the human body to switch off the growth of cells results in formation of clusters of cells forming tumors or spreading (metastasizing) throughout the body.  Where viruses are foreign to the immune system and defended against, cancerous cells are not.

The vaccine would target the proteins at the cellular level so that they can not continue to form tumors.  Unlike traditional chemotherapy (chemical agents) or radiation, which destroys not only cancer tissue but a good deal of healthy tissue and organs with it, a targeted vaccine would actually prevent one from ever developing breast cancer (in theory) in much the same way that the polio vaccine prevented generations of children from contracting polio.

Definitely one to watch.

~Posted by D.M. Schwadron, Esquire

I know what you’re thinking.  Yes, HPV (human papillomavirus or genital warts) is a sexually transmitted disease which has been related with a specific cancer.  Evidence appears to be mounting (sorry, I had to) that the incidence of oral HPV cancer has increased since the 70′s.  According to statistics in the International [...]]]> Source: Medscape Medical News

I know what you’re thinking.  Yes, HPV (human papillomavirus or genital warts) is a sexually transmitted disease which has been related with a specific cancer.  Evidence appears to be mounting (sorry, I had to) that the incidence of oral HPV cancer has increased since the 70′s.  According to statistics in the International Journal of Cancer (2009: 125:362-366) rates of HPV related oropharyngeal (mouth and throat) cancer were 23.3% in the 1970′s, 57% in the 199o’s and up to 93% in 2006-20007.

Why the increase in oral cancer?  According to researchers it’s due to an increase in oral in general.  Yes, some things do write themselves.  Apparently it can take from 15 to 30 years for HPV to develop into cancer.  While there is some concession that much of this is speculation as people are not necessarily candid in providing such information to researchers, the implications for treatment could be significant.

It is medically accepted that HPV causes cancer.  In fact, the molecular mechanisms are well known enough for the development of the available HPV vaccine.  Currently, the HPV vaccine is targeted to young women for the prevention of cervical cancer, which can originate from HPV.  The vaccine was also recently approved for use with young men to prevent genital wart infection.

But could the same vaccine eventually be used to prevent against HPV-related oral cancer?  Well, one would expect that it might, however, genital surfaces and fluids do differ from oral surfaces and fluids so no one is actually certain.  The efficacy of the currently available HPV vaccine appears clear.  But is it cost effective?  That is, will big pharma seek to develop a vaccine for something potentially ineffective and potentially socially problematic.

Not as unusual as it might seem given our Puritanical heritage.  Remember, if the studies correlating sexual behavior with increased incidence of oral HPV are correct this would seem to limit the transmission of this type of cancer to an act still defined as sodomy in many states in the United States and criminalized in some.

Perhaps the only other social-medical parallel would be with the medical marijuana debates going on in most states.  Where medicine and societal “norms” or “values” intersect is where we start getting into problem territory.  The manufacturers and marketers of the HPV vaccine took a lot of criticism for essentially targeting school-aged girls.  When one finally “gets over” the fact that school-aged girls are sexually active the criticism seems nonsensical.  A vaccine which could potentially prevent women from dying in their middle age from cancer inherently seems like a worthy investment.  We will follow the emerging debate on this one.

~Posted by D.M. Schwadron, Esquire

As it sometimes happens in medicine, a drug that has been proven to work in less than stellar ways for a given condition may have a completely unintended but surprisingly beneficial medical outcome.  What the heck am I talking about?  Some examples may be in order here.  You [...]]]> Source:  BBC Health; European Breast Cancer Conference, Barcelona

As it sometimes happens in medicine, a drug that has been proven to work in less than stellar ways for a given condition may have a completely unintended but surprisingly beneficial medical outcome.  What the heck am I talking about?  Some examples may be in order here.  You may have heard of a drug called Imitrex, used for the treatment of migraines.  Well it was originally formulated as an anti-seizure drug with mixed results.  A few accidental results and a new generation of migraine treatments was born.

Not familiar with that one?  Okay, you may have heard of a drug called Viagra which is fairly well-knonw (to the internet spam community in particular).  Well, Viagra, was an anti-hypertensive drug which despite years of development and testing did less for hypertension than it did for…well, you get the idea.

Enter beta blockers, a classification of blood pressure medications estimated to be currently prescribed to over two million people in the UK alone.  A team of UK and German researchers has found that in a study of women with breast cancer tumors, those taking beta blockers had a 71% lower chance of dying from metastatic (spreading) disease.

Granted the study was small, focusing upon some 466 European women with breast cancer.  However, the results could be significant.  Breast cancer remains the single largest killer of women, with some 30,000 diagnosed in the UK each year.  It is thought that beta blockers may also block hormones which trigger the spread of cancer cells beyond the breast.  The chances of curing breast cancer differ remarkably where cancer can be confined to the breast or to a small area of the breast.  Once cancer metastasizes (spreads) throughout the body, chances of a cure diminish.

Beta blockers attach to the same cancer cell receptors as metastatic associated hormones, thereby reducing the ability of the cancer cells to spread beyond the confines of a tumor.  So it may just be that the hope for a “new” drug to treat breast cancer exists in an old drug, beta blockers, which have been used for years now with relative safety.  It is hoped that a combination of existing chemotherapy drugs and beta blockers may offer breast cancer patients greater chance of cure and certainly greater chance of confining, and thereby surviving, breast cancer.

The even better news?  Unlike the introduction of a completely new drug, the re-purposing (If I may) of a drug isn’t as rigorous a process and it appears that the studies are well into the clinical trial stages.  Granted this is taking place in Europe and our FDA may not be as enlightened.  However, this also means that it might not take another 7 years for beta blockers to emerge as accepted treatment for breast cancer.

~Posted by D.M. Schwadron, Esquire

No, it is not anticipated that home testing for breast cancer, ovarian cancer or prostate  cancer will be available any time in the near future.  However cervical cancer is unique due to it’s associated risk with the human papillomavirus (HPV or genital warts), 13 of it’s 100 variants apparently cause cancer.

The issue [...]]]> Source:  BBC Health News

No, it is not anticipated that home testing for breast cancer, ovarian cancer or prostate  cancer will be available any time in the near future.  However cervical cancer is unique due to it’s associated risk with the human papillomavirus (HPV or genital warts), 13 of it’s 100 variants apparently cause cancer.

The issue is so serious that a vaccine for HPV was introduced in the past few years and made available to school-aged girls.  So then what role does testing play?  First, not all women are receiving vaccinations for HPV.  Second, not all women are undergoing routine screening for HPV at their gynecologist’s or primary care provider’s office.  For these women, the availability of a reliable home test could be an option.

HPV causes cellular damage even after the initial infection clears.  A simple swab may collect damage cells and tell doctors a great deal about a woman’s risk for the development of cervical cancer.  Were it only that all medical solutions were simple solutions.

~Posted by D.M. Schwadron, Esquire

Must be the wooden shoes.  Researchers from Vrije University (between Amstelveenseweg and De Boelelaan Streets in Amsterdam –Look it it up if you don’t believe me), have studied the development of eggs in over 500 Dutch women to determine why women over age 35 have twins more frequently than [...]]]> Source:  Journal of Human Reproduction;  BBC Health

Must be the wooden shoes.  Researchers from Vrije University (between Amstelveenseweg and De Boelelaan Streets in Amsterdam –Look it it up if you don’t believe me), have studied the development of eggs in over 500 Dutch women to determine why women over age 35 have twins more frequently than women under age 30.

Quick medical lesson:  Twins occur when 1 fertilized egg divides into 2 infants (identical) or when 2 eggs become fertilized instead of just 1 (non-indentical).  3/4 of all twin pregnancies are non-identical.  A hormone called FSH (Follicle Stimulating Hormone) starts the process of egg production in the ovaries.

Back to the study.  Of the 500 women, 105 developed multiple follicles.  Of those, 55 were found in women over age 35 while just 5 were to women under age 30. Why?  Well, it appears that prior to menopause women overcompensate (that’s NOT a value judgment) and produce higher levels of FSH.   Typically this will not result in multiples only due to the relative age of the eggs.  However, a number of women produce viable eggs late into their reproductive lives making this phenomenon possible.

So while advanced maternal age is more commonly associated with infertility, it is also associated with high fertility. The more you know…

~Posted by D.M. Schwadron, Esquire

Admittedly it was a small, focused study of 36 newborns, 17 of whose mothers smoked during pregnancy.  It is, however, alarming and instructive.  Babies that had been exposed to cigarette smoke in utero (While in Mommy’s belly) demonstrated abnormal heart rates and blood pressures.

But that’s not all. . .rather than [...]]]> Source:  BBC Health; Karolinska Institute (Sweeden)

Admittedly it was a small, focused study of 36 newborns, 17 of whose mothers smoked during pregnancy.  It is, however, alarming and instructive.  Babies that had been exposed to cigarette smoke in utero (While in Mommy’s belly) demonstrated abnormal heart rates and blood pressures.

But that’s not all. . .rather than dissipate with age, the abnormalities appear to have worsened from one week to age one. According to lead researcher, Dr. Gary Cohen, “Babies of smokers have evidence of persistent problems in blood pressure regulation that start at birth and get worse over time” and “[E]arly life exposure to tobacco can lead to long lasting reprogramming of the infant blood pressure control mechanism.”

And Dr. Cohen adds, this might be the mechanism which explains why infants of smokers are at increased risk for SIDS (Sudden Infant Death Syndrome) or “Cot death” as it is known in the UK.

~Posted by D.M. Schwadron, Esquire

Remember that post about the safety of prescription medications for pregnant women? http://www.medicalmalpracticelawyerblogphiladelphia.com/?p=528

Well, researchers in Washington (State not the Nation’s capital) have found in a study of 3,000 women, those taking selective serotonin reuptake inhibitors (SSRIs) into their 2nd and 3rd trimesters had an increased [...]]]> Source: Reuters Health; American Journal of Obstetrics & Gynecology, December 2009

Remember that post about the safety of prescription medications for pregnant women? http://www.medicalmalpracticelawyerblogphiladelphia.com/?p=528

Well, researchers in Washington (State not the Nation’s capital) have found in a study of 3,000 women, those taking selective serotonin reuptake inhibitors (SSRIs) into their 2nd and 3rd trimesters had an increased risk (14%) of giving birth prematurely.

Medications such as Zoloft, Paxil and Prozac were felt to have no appreciable impact during the 1st trimester, however benzodiazepines, such as Ativan and Xanax were linked with preterm labor, low birth weight, respiratory distress and low Apgar Scores.

Among the women in the study who did not take any such medications, only 9% gave birth prematurely as opposed to nearly half of the women taking benzodiazepines.

One might very well question why, with the prevalence of such prescriptions, studies such as this were not published earlier.

~Posted by D.M. Schwadron, Esquire.

Rates of new diagnoses and rates of death from all cancers combined declined significantly in the most recent time period for men and women overall and for most racial and ethnic populations in the United States.

The drops are driven largely by declines in rates of new cases and [...]]]> Source: U.S. Centers for Disease Control & Prevention

Rates of new diagnoses and rates of death from all cancers combined declined significantly in the most recent time period for men and women overall and for most racial and ethnic populations in the United States.

The drops are driven largely by declines in rates of new cases and rates of death for the three most common cancers in men (lung, prostate, and colorectal cancers) and for two of the three leading cancers in women (breast and colorectal cancer). New diagnoses for all types of cancer combined in the United States decreased, on average, almost 1 percent per year from 1999 to 2006. Cancer deaths decreased 1.6 percent per year from 2001 to 2006.

These findings are from a report authored by researchers from the National Cancer Institute (NCI), part of the National Institutes of Health, the Centers for Disease Control and Prevention (CDC), the American Cancer Society (ACS), and the North American Association of Central Cancer Registries (NAACCR). The report was published early online Dec. 7, 2009, in the journal Cancer.

Overall cancer rates continue to be higher for men than for women, but men experienced the greatest declines in incidence (new cases) and mortality (death) rates. For colorectal cancer, the third most frequently diagnosed cancer in both men and women, and the second leading cause of cancer deaths in the United States, overall rates are declining, but increasing incidence in men and women under 50 years of age is of concern.

With accelerated cancer control efforts to get more Americans to adopt more favorable health behaviors (such as quitting smoking) and higher use of screening (colonoscopy), as well as optimal treatment outcomes for colorectal cancer (read more effective chemotherapy), there could be an overall colorectal cancer mortality reduction of 50 percent by 2020.

“The continued decline in overall cancer rates documents the success we have had with our aggressive efforts to reduce risk in large populations, to provide for early detection, and to develop new therapies that have been successfully applied in this past decade,” said NCI Director John E. Niederhuber, M.D. “Yet we cannot be content with this steady reduction in incidence and mortality. We must, in fact, accelerate our efforts to get individualized diagnoses and treatments to all Americans and our belief is that our research efforts and our vision are moving us rapidly in that direction.”

“The continued decline in incidence and death rates for all cancers combined is extremely encouraging, but progress has been more limited for certain types of cancer, including many cancers that are currently less amenable to screening, such as cancer of esophagus, liver and pancreas,” said Betsy Kohler, executive director of NAACCR.

Long-term incidence trends for colorectal cancer have been fairly consistent for men and women, with major declines from 1985 to1995, minor increases from 1995 to1998, and significant declines from 1998 to 2006.

“This report shows that we have begun to make progress reducing colorectal cancer. Yet, colorectal cancer still kills more people than any other cancer except lung cancer,” said CDC Director Thomas Frieden, M.D.

Let’s hope this trend continues downward on incidence and upward on survival.

~Posted by D.M. Schwadron, Esquire