Posted by on July 11, 2014 - 9:30am
Women may soon bid farewell to birth control pills and welcome a new type of contraception in the form of microchip implants. An MIT startup backed by the Bill Gates Foundation plans to start pre-clinical testing for the birth control chip next year and pave the way for a possible market debut in 2018.

The fingernail-size microchip implant holds enough 30-microgram daily doses of levonorgestrel—a hormone already used in several contraceptives—to last for 16 years. Women who received the implant under the skin of buttocks, upper arm or abdomen would also get a remote control that allows them to halt or restart the implant whenever they like, according to MIT Technology Review.

MicroCHIPS, the MIT startup behind the birth control implant, developed a clever design for a titanium and platinum seal that temporarily melts when an internal battery sends an electric charge running through the seal. That lasts just long enough for the melted seal to release the daily dose of levonorgestrel from the microchip reservoirs.

The microchip technology's latest mission first came about when Bill Gates visited the MIT lab of Robert Langer and challenged researchers to come up with a birth control method that women could control themselves and would also last for many years. Langer, an MIT professor who already holds 1,050 patents worldwide, thought of using the controlled release microchip technology that he and his colleagues had developed in the 1990s.

MicroCHIPS had previously demonstrated how the microchip technology could release daily doses of an osteoporosis drug during human clinical trials detailed in the 16 Feb 2012 online edition of the journal Science Translational Medicine. The new application for the microchips—each measuring 20 x 20 x 7 millimeters—could potentially revolutionize the level of control women have over their birth control technologies.

The biggest difference that the MicroCHIPS technology brings comes from giving women control over starting and stopping birth control regimens that can otherwise work for years without requiring regular attention. By comparison, existing contraceptive implants require a trip to the local clinic or hospital for removal if a woman wants to stop using the implant.

Any device offering wireless control for its users also runs the risk of being hacked. But Robert Farra, president and CEO of MicroCHIPS, told BBC News that their technology included secure encryption to prevent outsiders from blocking or reprogramming the implants wirelessly. As an added precaution, the remote control can only communicate with the microchip implant across a distance equivalent to skin contact.

Source:  IEEE Spectrum  By Jeremy Hsu

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Posted by on July 10, 2014 - 9:10am

Most people know that human clinical trials are critical to prove safety and efficacy in new medications.   This is also true for medical devices yet a recent study indicated that only 14% of device studies included sex as a key outcome measure, and only 4% included a subgroup analysis for female participants.    The differences in anatomy and physiology, as well as other factors in men and women,  can lead to devices working less effectively and safely.

The FDA's Office of Women's Health  recently supported a study of clinical trials conducted on cardiac resynchronization therapy (CRT), a pacemaker therapy for patients with heart failure.  Only 22% of the clinical trial participants were women.   By combining multiple studies and mining the multi-study data, the FDA Center for Devices and Radiological Health (CDRH) found that women benefited more than men from CRT.

This particular study demonstrates that we need adequate samples of men and women in studies early in the research process.   The good news is the FDA is taking two steps to insure more sex inclusion is built int0 future studies:

  • The FDA will finalized a guidance document that provides a clear framework for the inclusion of women in device studies
  • Mandated by Congress, the FDA will release an Action Plan, that will further address the analysis of data on women and product and safety data in labeling for drugs and devices.

How can you help??  Ask you doctor if there are clinical studies looking for subjects or contact your local medical school.    If you live in Illinois, you can join the Illinois Women's Health Registry  a gateway to clinical trials in Illinois.

Source:  FDA VOICE, June 23, 2014

Posted by on July 6, 2014 - 11:31am

Women who had their last child at age 33 years or older were more likely to reach extremes of longevity, according to an analysis published online June 23 in Menopause.
Women who had their last child when they were aged 33 to 37 years were twice as likely to reach the extreme fifth percentile of longevity compared with women who had their last child before that age.

"Prolonged fertility may be a marker of slower aging," write the authors, led by Fangui Sun, PhD, from the Department of Biostatistics at Boston University in Massachusetts. Previous studies, including some on historical data in the 17th, 18th, and 19th centuries, had found that women who had their last children late in life tended to live longer and to have siblings who lived longer.

Dr. Sun and colleagues analyzed data from the Long Life Family Study, whose participants have multiple family members who have reached extremes of longevity. The population includes sets of siblings selected because of their collective longevity scores, along with their spouses and children. The families were recruited between 2006 and 2009 in Boston; Pittsburgh, Pennsylvania; New York City; and Denmark.

One hypothesis to account for the association between maternal age and longevity, write Dr. Sun and colleagues, is that women whose bodies use energy more efficiently are able to both avoid age-related diseases and have increased fertility. The authors suspect these women would also be more likely to have more children, but in this study, they found a nonsignificant association in the opposite direction: having 3 or more children decreased the likelihood of extreme longevity.

The authors note that twin studies have suggested that genetics only explain about 20% of variation in longevity but that the influence of genetics increases at older ages. In other words, environmental and behavioral factors may influence a person's likelihood of living to their mid-80s, but in the extremes of old age, genetics play more of a role. They suggest that studying the genetics of fertility may reveal genes that influence longevity.

The Long Life Family Study was funded by the National Institute on Aging/National Institutes of Health.
Menopause. Published online June 23, 2014.

Posted by on July 3, 2014 - 11:24am

The heart is more forgiving than you may think -- especially to adults who try to take charge of their health, a new Northwestern Medicine® study has found.

When adults in their 30s and 40s decide to drop unhealthy habits that are harmful to their heart and embrace healthy lifestyle changes, they can control and potentially even reverse the natural progression of coronary artery disease, scientists found.

“It’s not too late,” said Bonnie Spring lead investigator of the study and a professor of preventive medicine at Northwestern University Feinberg School of Medicine and a member of the WHRI Leadership Council.  “You’re not doomed if you’ve hit young adulthood and acquired some bad habits. You can still make a change and it will have a benefit for your heart.”

On the flip side, scientists also found that if people drop healthy habits or pick up more bad habits as they age, there is measurable, detrimental impact on their coronary arteries.“If you don’t keep up a healthy lifestyle, you’ll see the evidence in terms of your risk of heart disease,” Spring said.

“This finding is important because it helps to debunk two myths held by some health care professionals,” Spring said. “The first is that it’s nearly impossible to change patients’ behaviors. Yet, we found that 25 percent of adults made healthy lifestyle changes on their own. The second myth is that the damage has already been done -- adulthood is too late for healthy lifestyle changes to reduce the risk of developing coronary artery disease. Clearly, that’s incorrect. Adulthood is not too late for healthy behavior changes to help the heart.”

The bad news is that 40 percent of this sample lost healthy lifestyle factors and acquired more bad habits as they aged.“That loss of healthy habits had a measurable negative impact on their coronary arteries,” Spring said. “Each decrease in healthy lifestyle factors led to greater odds of detectable coronary artery calcification and higher intima-media thickness. Adulthood isn’t a ‘safe period’ when one can abandon healthy habits without doing damage to the heart. A healthy lifestyle requires upkeep to be maintained.”

Spring said the healthy changes people in the study made are attainable and sustainable. She offers some tips for those who want to embrace a healthy lifestyle at any age:

  • Keep a healthy body weight
  • Don’t smoke
  • Engage in at least 30 minutes of moderate to vigorous activity five times a week
  • No more than one alcoholic drink a day for women, no more than two for men
  • Eat a healthy diet, high in fiber, low in sodium with lots of fruit and vegetables

The study was published June 30 in the journal Circulation.

Source:  Northwestern News Center.  By Erin White

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Posted by on July 1, 2014 - 1:03pm

Yesterday, in a 5-4 decision, the Supreme Court ruled that “requiring family-owned corporations to pay for insurance coverage for contraception under the Affordable Care Act violated a federal law protecting religious freedom.” Justice Samuel A. Alito Jr. conceded that the government does have a “compelling interest in making sure women have access to contraception,” but that there are ways of providing that access without “violating the companies’ religious rights.”

Justice Ginsburg’s dissent put into words what many onlookers felt. Justice Ginsburg stated that requiring contraception coverage is vital to women’s health and reproductive freedom. Furthermore, Justice Ginsburg stated this may invite “for-profit entities to seek religious-based exemptions from regulations they deem offensive to their faiths,” including some medical procedures and drugs, vaccinations, and even blood transfusions—procedures which certain religions denounce. While there is no evidence yet to support this claim that corporations will begin splitting hairs over other medical procedures, it does raise important questions about where the line is drawn between business and religion.

Those who disagree with the Supreme Court decision state that requiring all insurance plans to include coverage for contraception improves not only public health, but also ensures that “women have equal access to health care services.” Therefore, this blow was particularly shocking. If other family-owned corporations follow this ruling, the cost for contraception coverage will likely become a barrier for many women. IUD’s, for instance, can coast more than $1,000 once medical exams, insertion, and follow-up visits are added—and it is likely that this may cost too much for some women to pay without insurance coverage.

While the full repercussions of this decision are not yet clear, it is important to develop protective measures that defend women’s healthcare and their access to a range of contraception options.

Source: The New York Times

Posted by on June 28, 2014 - 12:02pm

The use of certain acne products containing the active ingredients benzoyl peroxide or salicylic acid can cause rare but serious and potentially life-threatening allergic reactions or severe irritation according to the Food and Drug Administration (FDA). The acne products the FDA is warning about are sold over-the-counter (OTC) and applied to the skin (topical). Their serious allergic reactions differ from the less harmful irritations already included in the product Drug Facts labels, which include burning, dryness, itching, peeling, redness, and slight swelling where the product is applied.

“There is currently no mention of the possibility of these very severe allergic reactions on the product labels,” says Mona Khurana, M.D., a medical officer at FDA. “It’s important that consumers know about them, and that they know what to do if they occur.”

Consumers can find out if an OTC topical acne product contains benzoyl peroxide or salicylic acid by looking at the Active Ingredient(s) section of the Drug Facts label on the product package.

Products of concern are marketed under different brand names such as Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, and Clean & Clear. They are available as gels, lotions, face washes, solutions, cleansing pads, toners and face scrubs.

To learn more, visit HERE.

Posted by on June 26, 2014 - 8:25am

Disturbing reports about mismanagement at the Veteran's Affairs (VA) medical centers had led to Congressional action.  One of our Leadership Council members at the Women's Health Research Institute, Melina R. Kibbe, MD, a vascular surgeon at the Feinberg School of Medicine and the Jesse Brown Veterans Medical Center in Chicago is a co author of a JAMA commentary that makes some well-thought out recommendations for change.  While outrage is running rampant, it's time for everyone to concentrate on fixing the system  that is critical to the men and women who defend our country.  To view the commentary, visit HERE.

Posted by on June 25, 2014 - 10:32am

Research presented at the European Congress of Rheumatology indicated that “women have different predisposing risk factors for gout than do men, who more often fit the stereotypical profile of patients with gout who consume foods that increase the risk of the disease.” The research, “based on data collected from participants in the Consortium of Rheumatology Researchers of North America (CORRONA) gout registry,” indicated that “women with gout were more likely to have taken predisposing medications and to have more gout-associated comorbidities, whereas men were more likely to consume foods linked to the disorder, such as alcohol and red meat, according to Dr. Leslie Harrold, scientific director of the CORRONA gout registry.” This is just one more area that needs more exploration of sex differences! Source:  Rheumatology News (6/25, Sullivan)  

Posted by on June 24, 2014 - 12:31pm

Delinquency in youth predicts a significantly higher rate of violent death in adulthood -- especially from firearms -- and females are among the most vulnerable, reports a new Northwestern Medicine® study.

Delinquent females died violently at nearly five times the rate of those in the general population, according to the study, while delinquent males died at three times general population rates.

Death rates in Hispanic males and females were five and nine times more than the general population rates, respectively.

This is the first large-scale study to look at death rates in delinquent females and adds new data on Hispanics, now the largest minority group in the U.S. The paper will be published June 16 in the journal Pediatrics.

In addition, violent death up to age 34 was predicted by three risk factors in adolescence: alcohol use disorder, selling drugs and gang involvement, according to the study.

"Our findings are shocking," said lead author Linda Teplin, the Owen L. Coon Professor of Psychiatry and Behavioral Sciences at Northwestern University Feinberg School of Medicine. "Death rates in our sample of delinquent youth, ages 15 to 19, are nearly twice those of troops in combat in wartime Iraq and Afghanistan."

Source:  Northwestern, Science Daily 6/16/2014.

 

Posted by on June 23, 2014 - 1:21pm

Bone health in women has raised a lot of concern and generated many recommendations. Current guidelines from the U.S. Preventive Services Task Force (USPSTF) recommends that women ages 65 and older be screened routinely for osteoporosis. To reduce bone loss and decrease risk of fractures, calcium and vitamin D recommends have been outlined as well; premenopausal women should consume at least 1,000 mg per day and postmenopausal women should consume 1,200 mg per day (total diet and supplement). But are women taking too much calcium?

A new study recently published in the journal of The North American Menopause Society has shown that usual supplements may cause blood levels too high for some women. A randomized, placebo-controlled trial examined 163 caucasian women ages 57 to 90, who initially had vitamin D levels too low. Participants took calcium citrate tablets at a variety of doses, to meet their recommended intake of 1,200 mg per day.

About 9% of the participants ended up with hypercalcemia, or too high of calcium in the blood, and 31% of the participants developed hypercalciuria, or too high of calcium levels in their urine. None of the participants took excess doses of supplements, and every participant was inspected to rule out hyperparathyroidism (body increases calcium-regulating hormone).

Excess levels of calcium in the blood and urine can lead to kidney stones and symptoms such as depression, nausea, fatigue, and irregular heartbeats. Thankfully, the investigators of this study found that women who developed excess levels tended to have higher 24-hour urine calcium levels when starting the study. Women with a 24-hour urine calcium level above 132 mg had a risk of developing excess urine calcium 15 times higher than those with lower levels.

To prevent excess levels of calcium, keep track of the foods you eat and ask a physician to incorporate your diet prior to taking a hefty calcium supplement. Furthermore, watch for the side effects that occur when there is too much calcium in the body. To learn more about the negative side effects of excess calcium and other ways to augment bone health during menopause, visit Northwestern's menopause website here.

Source: John Christopher Gallagher, Lynette M. Smith, Vinod Yalamanchili. Incidence of hypercalciuria and hypercalcemia during vitamin D and calcium supplementation in older women. Menopause, 2014; 1 DOI:10.1097/GME.0000000000000270

 

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