Research Shows Potential For Novel Treatments Of Uterine Fibroids

Dr. Enrique Jacome

Uterine leiomyomata, or fibroids, are benign tumours that nevertheless affect the health of millions of women. They may cause, for instance, pain, bleeding and infertility. Fibroids are also the most common reason for a hysterectomy; for example, some 8,000 hysterectomies are made in Finland each year. 

Scientists at the Academy of Finland's Centre of Excellence in Cancer Genetics Research have identified the molecular mechanisms underlying the onset of common leiomyomata. The results of their research were published in the top medical journal New England Journal of Medicine in early June. 

"These new findings are essential for the further development of pharmacological treatments for this type of tumour," says Academy Professor Lauri Aaltonen, who heads the Centre the Excellence based at the University of Helsinki. 

Aaltonen's team has demonstrated how the genome of benign uterine leiomyomata differs from normal uterine tissue. Very little was known about the aetiology of leiomyomata before the team's research. The team has previously identified a gene defect that explains more than half of these tumours. The present whole-genome sequencing proved that most of the rest of the tumours develop as a result of chromosome fragmentation and rearrangements. 

"Complex chromosomal rearrangements are a major cause of cellular changes that contribute to the onset of benign uterine leiomyomata," Aaltonen states. 

Similar changes resulting from chromosomal rearrangements are normally identified in malignant tumours. The results of Aaltonen's team suggest that the same mechanisms may also underlie the onset of non-cancerous tumours. 

"Our research also indicates what mechanisms may prevent benign tumours from becoming malignant," Aaltonen adds. 

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Plan B One-Step Fight Over, Now All Ages Can Get It

Dr. Enrique Jacome

The FDA has approved the morning after pill for women of any age as an over-the-counter medication and with no point-of-sale restrictions. Over-the-counter (OTC) means that no prescription is required.

The FDA said the approval is for "women of child bearing age potential", i.e. any female who can get pregnant.

The approval of Plan B One-Step (levonorgestrel) as an OTC medication for all women of all ages complies with the April 5th, 2013 order by the US District Court of New York.

What is Plan B One-Step?

Plan B One-Step (levonorgestrel), also known as the morning after pill is an emergency contraceptive a female takes to reduce her chances of pregnancy after either unprotected sexual intercourse or suspected contraceptive failure. An example of a (suspected) contractive failure could be a condom that leaked.

Experts say that the term "morning-after pill" is a misnomer, because the pill is most effective when used shortly after sex.

Plan B One-Step is now available OTC for all women of childbearing age potential

According to Teva Women's Health, the makers of Plan B One-Step, the drug can be used within 72 hours after sex, but ads that the sooner it is taken, the more effective it is.

Plan B One-Step contains levonorgestrel, the same ingredient that is used in many birth control pills and works similarly by stopping ovulation (stops the release of an egg from the ovary). It has a higher level of levonorgestrel than other contraceptive pills that doctors have been prescribing for decades.

Teva Women's health emphasizes that Plan B One-Step:

• Is not an abortion pill (an RU-486)
• Is ineffective if the woman is already pregnant
• Should not affect/terminate an existing pregnancy
• Is not intended as a regular form of birth control
• Will not protect the woman from HIV or other STDs (sexually transmitted diseases)

The FDA says that it notified a US District Court judge in New York that it intended to comply with the court's order. The Agency asked Teva Women's Health to submit a supplemental application for approval of Plan One-Step B to be made available OTC with no restrictions. The FDA says it has now fulfilled its commitment to the court.

Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, said:

"Over-the-counter access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States."


In July 2009, Plan B One-Step was approved by the FDA as an OTC medication for females aged at least 17 years, and as a prescription-only product for younger patients.

The FDA later approved Plan B One-Step as an OTC product for females aged 15+ yearsearlier this year.

In an online communiqué yesterday, the FDA wrote "With this approval, the product is now available without a prescription for use by all women of reproductive potential."

The FDA reminded young women who are sexually active and do not plan or intend to become pregnant to see a health care provider for routine checkups. The health care provider should advise them about, and test them for STDs, as well as discuss effective methods of birth control.

The following side effects are associated with Plan B One-Step usage:

• nausea
• vomiting
• stomach ache
• headache
• dizziness
• breast tenderness

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Long-Term Stress Suffered By Women Often Will Manifest In Physical Symptoms

Dr. Enrique Jacome

In four out of ten cases, long-term stresssuffered by women leads to some form of physical complaint. This is shown by a study of 1,500 women carried out at the Sahlgrenska Academy, University of Gothenburg, Sweden. 

Within the Population Study of Women in Gothenburg, researchers at the University of Gothenburg's Sahlgrenska Academy have followed around 1,500 women since the late 1960s. 

The latest study within the project, which focuses primarily on stress linked to psychosomatic symptoms, showed that one in five middle-aged women had experienced constant or frequent stress during the last five years. The experience of stress was highest within the 40 to 60 age range, and those women who were stressed were more often single and/or smokers. 

Among those women who reported stress, 40 percent had psychosomatic symptoms in the form of aches and pain in their muscles and joints, 28 percent suffered from headaches ormigraines, and the same proportion reported gastrointestinal complaints. 

"Even when the results have been adjusted for smoking, BMI and physical activity, we can see a clear link between perceived stress and an increased incidence of psychosomatic symptoms," says Dominique Hange, researcher at the Sahlgrenska Academy, University of Gothenburg. 

Of those women who experienced long-term stress but who did not report any stress-related problems when the study began in 1968-69, 27 percent had new symptoms in the form of muscular and joint pain when they were followed up 12 years later, and around 15 percent experienced new complaints in the form of headaches and/or gastrointestinal problems. 

"Since 1968, women's lifestyles have changed in many ways," continues Dominique Hange. "For example, many more women now work outside the home. Naturally, these changes can affect the experience of stress. But although we've used exactly the same question ever since 1968, we can't take it for granted that the term 'stress' has exactly the same meaning today. It might also be more socially accepted today to acknowledge one's experience of stress." 

The researchers have been able to follow all 1,500 of the women who took part at the beginning of the study in 1968 up until today, including information about cause of death. The studies do not show any clear signs that stress leads to an increased risk of an early death. 

"The most important conclusion is that single women, women who do not work outside the home and women who smoke are particularly vulnerable to stress. Here, we see a greater need for preventive measures from society." 

The next stage will involve the researchers evaluating which methods can be used within healthcare, particularly within primary care, in order to help the individual to deal with stress-triggered complaints and illnesses, and to study how the individual and society can reduce the risk of exposure to stress at work. 

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Infant Brains Benefit From Breastfeeding

Dr. Enrique Jacome

A new study by researchers from Brown University finds more evidence that breastfeeding is good for babies' brains. 

The study made use of specialized, baby-friendly magnetic resonance imaging (MRI) to look at the brain growth in a sample of children under the age of 4. The research found that by age 2, babies who had been breastfed exclusively for at least three months had enhanced development in key parts of the brain compared to children who were fed formula exclusively or who were fed a combination of formula and breastmilk. The extra growth was most pronounced in parts of the brain associated with language, emotional function, and cognition, the research showed. 

This isn't the first study to suggest that breastfeeding aids babies' brain development. Behavioral studies have previously associated breastfeeding with better cognitive outcomes in older adolescents and adults. But this is the first imaging study that looked for differences associated with breastfeeding in the brains of very young and healthy children, said Sean Deoni, assistant professor of engineering at Brown and the study's lead author. 

"We wanted to see how early these changes in brain development actually occur," Deoni said. "We show that they're there almost right off the bat." 

The findings are in press in the journal NeuroImage and available now online. 

Deoni leads Brown's Advanced Baby Imaging Lab. He and his colleagues use quiet MRI machines that image babies' brains as they sleep. The MRI technique Deoni has developed looks at the microstructure of the brain's white matter, the tissue that contains long nerve fibers and helps different parts of the brain communicate with each other. Specifically, the technique looks for amounts of myelin, the fatty material that insulates nerve fibers and speeds electrical signals as they zip around the brain. 

Deoni and his team looked at 133 babies ranging in ages from 10 months to four years. All of the babies had normal gestation times, and all came from families with similar socioeconomic statuses. The researchers split the babies into three groups: those whose mothers reported they exclusively breastfed for at least three months, those fed a combination of breastmilk and formula, and those fed formula alone. The researchers compared the older kids to the younger kids to establish growth trajectories in white matter for each group. 

The study showed that the exclusively breastfed group had the fastest growth in myelinated white matter of the three groups, with the increase in white matter volume becoming substantial by age 2. The group fed both breastmilk and formula had more growth than the exclusively formula-fed group, but less than the breastmilk-only group. 

"We're finding the difference [in white matter growth] is on the order of 20 to 30 percent, comparing the breastfed and the non-breastfed kids," said Deoni. "I think it's astounding that you could have that much difference so early." 

Deoni and his team then backed up their imaging data with a set of basic cognitive tests on the older children. Those tests found increased language performance, visual reception, and motor control performance in the breastfed group. 

The study also looked at the effects of the duration of breastfeeding. The researchers compared babies who were breastfed for more than a year with those breastfed less than a year, and found significantly enhanced brain growth in the babies who were breastfed longer - especially in areas of the brain dealing with motor function. 

Deoni says the findings add to a substantial body of research that finds positive associations between breastfeeding and children's brain health. 

"I think I would argue that combined with all the other evidence, it seems like breastfeeding is absolutely beneficial," he said. 

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Some Newborns Benefit From Early Formula, Helping Mothers To Breastfeed Longer

Dr. Enrique Jacome

Recent public health efforts have focused extensively on reducing the amount of formula babies are given in the hospital after birth. But in the first randomized trial of its kind, researchers at UC San Francisco have found that giving small amounts of formula in the first few days of life to infants experiencing high levels of early weight loss actually can increase the length of time their mothers end up breastfeeding. 

"Until now, we haven't explored if it is possible to identify babies who might benefit from early formula use. This study provides the first evidence that early limited formula (ELF) can provide important benefits to some newborns," said lead author Valerie Flaherman, MD, MPH, an assistant professor of pediatrics and epidemiology and biostatistics at UCSF and a pediatrician at UCSF Benioff Children's Hospital. "Based on our findings, clinicians may wish to consider recommending the temporary use of small amounts of formula to new moms whose babies are experiencing significant early weight loss."

Study findings are published online by the journal Pediatrics, and will appear in an upcoming print issue of the journal. 

"Formula use has the potential to be a slippery slope to breastfeeding discontinuation, but ELF is a different way to envision using it," said Flaherman. "Rather than giving full bottles of formula that make it hard for the baby to return to the breast, ELF is a small amount of supplementation with a clear end point that alleviates some of the stress new mothers feel about producing enough milk." 

Breastfeeding is known to offer wide-ranging preventive health benefits for babies, reducing their risk for infections and allergies, and providing the perfect balance of nutrients to help infants grow into strong and healthy toddlers. The American Academy of Pediatrics currently recommends that healthy mothers and infants should breastfeed exclusively for the first six months for maximum health benefits. 

Women do not immediately produce high volumes of milk after childbirth. Instead, at first mothers secrete small amounts of colostrum, which contains high concentrations of nutrients and antibodies for the baby. During this period, babies often lose weight and new mothers may be concerned that their babies appear fussy or hungry. "Many mothers develop concerns about their milk supply, which is the most common reason they stop breastfeeding in the first three months," said Flaherman. 

"But this study suggests that giving those babies a little early formula may ease those concerns and enable them to feel confident continuing to breastfeed," she said. 

The study enrolled 40 full-term newborns between 24-48 hours old who had lost more than 5 percent of their birth weight. The babies were randomly assigned either to receive early limited formula (ELF), which consisted of one-third of an ounce of infant formula by syringe following each breastfeeding, or to continue with their intention to breastfeed exclusively. . So as not to interfere with breastfeeding 8 to 12 times a day, the ELF babies were only given small amounts of formula. The syringe was used to avoid the babies developing nipple confusion - when a baby develops a preference for a bottle nipple over the breast. The ELF babies stopped the formula when their mothers began producing mature milk, approximately two to five days after birth. 

At the one week assessment, all the babies in both groups were still breastfeeding. However, only 10 percent of the ELF babies had received formula in the last 24 hours, compared with 47 percent of the control group. 

After three months, 79 percent of the babies in the study who received early limited formula in the first days of life were still breastfeeding, compared with 42 percent of the babies who did not receive early limited formula. Additionally, 95 percent of the babies who received limited formula in the first few days were breastfeeding to some extent at three months, compared with 68 percent of the babies who did not receive early limited formula. 

While impressed with the results of this small study, the authors urged caution in interpreting their results. "It will be important to see whether these results can be confirmed in future, larger studies and in other populations," said senior author Thomas Newman, MD, MPH, a professor of pediatrics and epidemiology and biostatistics at UCSF and a pediatrician at UCSF Benioff Children's Hospital. 

The authors stress that the goal of this study is to help babies breastfeed for a longer duration, because breastfeeding is the best method for feeding infants. For some infants with high, early weight loss, this small study is the first to suggest that infant formula used at just the right time, in limited amounts, may help achieve the goal of long-term breastfeeding. 

"The results of this study are provocative and challenge conventional wisdom," said James Taylor, MD, medical director for the University of Washington Medical Center's Newborn Nursery, who was unaffiliated with the study. "It is crucial that we have more randomized controlled trials on interventions to increase breastfeeding rather than relying on heavily confounded observational studies or biased expert opinion." 

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Breast Milk Ingredient May Prevent Deadly Intestinal Problem In Preemies

Dr. Enrique Jacome

An ingredient that naturally occurs in breast milk might be used to prevent premature babies from developing a deadly intestinal condition that currently is largely incurable, according to researchers at the University of Pittsburgh School of Medicine and Children's Hospital of Pittsburgh of UPMC in this week's online early edition of theProceedings of the National Academy of Sciences. 

The story begins with a baby who is born too early, meaning before 36 weeks gestation, said senior author David Hackam, M.D., Ph.D., Watson Family Professor of Surgery, Pitt School of Medicine, and co-director of the Fetal Diagnosis and Treatment Center at Children's Hospital. Once stable, typically the baby is fed with formula because often breast milk is not readily available to premature infants. 

"Within about 10 days of birth, the baby starts to vomit and a few hours later, the belly becomes distended and discolored," Dr. Hackam said. "It becomes clear that the child has developed a major problem in his or her tummy, and an X-Ray will usually confirm the diagnosis of necrotizing enterocolitis, or NEC, in which the intestinal tissue is dying. We have no choice but to remove the dead parts of the intestine, but despite surgery, half of these preemie babies still die from the condition." 

Dr. Hackam and his team noted NEC occurs when the intestines start getting colonized with bacteria, a process that occurs normally after birth. They focused on toll-like receptor 4 (TLR4), an immune protein that is involved in recognizing microbes and which they recently discovered plays a role in gut development. In the current work, Hackam and colleagues found that TLR4 is present in higher amounts in the blood vessel lining in preemies than in full-term babies. 

The study shows that unlike normal mice, those bred to lack TLR4 in their blood vessels did not develop NEC in a model designed to induce the condition. The findings indicate that bacteria in the blood activate TLR4 leading to a reduction in nitric oxide, which in turn narrows blood vessels and decreases blood flow, Dr. Hackam said. 

"This pathway can be dangerous when the preemie's immature gut becomes inflamed from exposure to the bacteria normally present in the intestine," he said. "Abundant TLR4 triggers a shutdown of the blood supply to the intestine, leading to tissue death or necrosis." 

Premature babies who are nursed rather than formula-fed are more likely to survive NEC, so co-author and nitric oxide expert Mark Gladwin, M.D., chief, Division of Pulmonary Allergy and Critical Care Medicine, Pitt School of Medicine, and director of Pitt's Vascular Medicine Institute, and the team took a closer look at the components of breast milk. 

They found that breast milk contains high levels of sodium nitrate, which is converted to nitrite by gut bacteria. Nitrite can be directly converted to the vasodilator nitric oxide, which can both protect the intestinal lining and improve blood flow. 

"The additional nitrite appears to overcome the effects of TLR4 activation and corrects the blood flow problem," Dr. Gladwin said. "When we gave formula supplemented with a sodium nitrate and nitrite analog to the premature mice, we saw improved blood flow in the intestine, and NEC did not develop." 

Drs. Hackam and Gladwin are testing the compound, which is FDA approved for other uses, in other models of NEC with the hope that it could be routinely added to formula fed to premature infants to prevent NEC. 

"This condition is frightening for parents and frustrating for doctors because currently there is little we can do to treat it," said Dr. Hackam, a pediatric surgeon. "I look forward to one day putting myself out of business and having a therapy that truly saves these children." 

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Morning After Pill Available Over The Counter For Females Over 15

Dr. Enrique Jacome

The emergency contraceptive "Plan B One-Step", also known as "the morning after pill", has just been approved by the FDA for use among women and girls at least 15 years old, without the need of a doctor's prescription.

Teva Women's Health, Inc. had previously made an application for Plan B One-Step to be available for sale over the counter, without the need of a prescription, to all women (of any age) last year, but the FDA did not approve it.

Plan B One-Step was approved by the FDA in 2009. 

The company then decided to amend their application to make it available over the counter strictly for women 15 years of age and older. This new, amended application, did receive approval.



In order to ensure that the pills aren't sold to any girls younger than 15, the product will include the following labeling "not for sale to those under 15 years of age *proof of age required*, not for sale where age cannot be verified."

Cashiers, pharmacists and shop-assistants will be required to ask for the customer's age.



Plan B One-Step will be widely available as the company says it will distribute the pills to many retail outlets that have an onsite pharmacy, where they expect it to be sold in the family planning area. This way the contraceptive will be available during the retailer's operating hours regardless of whether or not the pharmacy is open. 

Plan B One-Step is intended to be used as an emergency contraceptive, only in cases where the primary birth control (such as a condom) appeared not to have been effective. It will be available as a single 1.5 mg tablet to be taken within three days of having unprotected sex. 



If a woman is already pregnant and takes Plan B One-Step it will not stop the pregnancy and there is no evidence of it harming a developing fetus. 



 The FDA Commissioner Margaret A. Hamburg, M.D., said:



"Research has shown that access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States.

The data reviewed by the agency demonstrated that women 15 years of age and older were able to understand how Plan B One-Step works, how to use it properly, and that it does not prevent the transmission of a sexually transmitted disease."

The FDA approved Plan B One-Step without a prescription solely for women 15 years or older because of evidence suggesting that women of that age are likely to understand the product is not intended to be used on a routine basis and that it doesn't protect against sexually transmitted diseases.

It's especially important that women continually check for HIV or AIDS or other sexually-transmitted diseases and seek guidance for the best form of birth control.

The FDA stresses that emergency contraceptives such as Plan B One-Step aren't to be used on a routine basis.




To ensure that the age limitation is adhered to, Teva has said that it's willing to conduct an audit of age verification practices after the product has been approved.




A federal judge, in early April this year ordered the Agency to grant a 2001 citizen's petition that wanted OTC access to PLAN B legalized for women of all ages, and/or make Plan B One-Step available as an OTC medication with no restrictions on either age or point of sale. Teva's application to market PlanB One-Step for females aged 15+ years had been pending before the federal judge's ruling.

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