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Third Obesity Drug Wins FDA Okay

Following an earlier snub, the FDA finally approved the weight-loss drug Contrave, a combination of bupropion and naltrexone, the agency announced.

The drug, marketed by Takeda and Orexigen, is approved for patients with a body mass index (BMI) of 30 or greater or a BMI of 27 and up with at least one weight-related comorbidity.

It will, however, carry a boxed warning on suicidal ideation, and the companies will be required to conduct several postmarketing studies.

It’s been a long road to approval for Contrave. An early favorite among a triumvirate of three investigational obesity drugs, both Qsymia (phentermine/topiramate) and Belviq (lorcaserin) won approval first and had a head-start on getting into the marketplace.

Contrave was denied FDA approval in February 2011, even though an advisory committee had voted favored of approval. The agency required that the company conduct a cardiovascular outcome trial before it would approve the drug.

Results of that study were released in November 2013, and the company had been awaiting word from FDA ever since. An initial PDUFA date of June was pushed to September.

The FDA said it based its decision on a series of trials that involved some 4,500 obese and overweight patients. It urged clinicians to assess whether the drug has helped patients lose at least 5% of their body weight by 12 weeks, and, if not, to take patients off the drug.

The drug will carry a boxed warning on the risk of suicidal thoughts, behaviors, and neuropsychiatric events — mostly tied to to the antidepressant component, bupropion.

FDA listed several other cautions with Contrave, including the fact that it may raise heart rate and blood pressure, and is thus contraindicated in patients with uncontrolled hypertension. It can also cause seizures in patients with seizure disorders, and shouldn’t be prescribed to those already on opioids.

The most common adverse events included nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth, and diarrhea.

FDA will also require several postmarketing studies:

A cardiovascular outcomes trial to assess cardiovascular risk
Two efficacy, safety, and clinical pharmacology studies in pediatric patients
An animal juvenile toxicity study looking at growth and development as well as behavior, learning, and memory
A study looking at the effect on cardiac conduction
A dose evaluation in patients with hepatic or renal impairment
A study on potential interactions between Contrave and other drugs

Obesity experts will now have three new obesity medications to choose from when treating patients — a bounty compared with the state of the market just a few short years ago when the only diet drug left standing was orlistat (Alli, Xenical).Following an earlier snub, the FDA finally approved the weight-loss drug Contrave, a combination of bupropion and naltrexone, the agency announced.

The drug, marketed by Takeda and Orexigen, is approved for patients with a body mass index (BMI) of 30 or greater or a BMI of 27 and up with at least one weight-related comorbidity.

It will, however, carry a boxed warning on suicidal ideation, and the companies will be required to conduct several postmarketing studies.

It’s been a long road to approval for Contrave. An early favorite among a triumvirate of three investigational obesity drugs, both Qsymia (phentermine/topiramate) and Belviq (lorcaserin) won approval first and had a head-start on getting into the marketplace.

Contrave was denied FDA approval in February 2011, even though an advisory committee had voted favored of approval. The agency required that the company conduct a cardiovascular outcome trial before it would approve the drug.

Results of that study were released in November 2013, and the company had been awaiting word from FDA ever since. An initial PDUFA date of June was pushed to September.

The FDA said it based its decision on a series of trials that involved some 4,500 obese and overweight patients. It urged clinicians to assess whether the drug has helped patients lose at least 5% of their body weight by 12 weeks, and, if not, to take patients off the drug.

The drug will carry a boxed warning on the risk of suicidal thoughts, behaviors, and neuropsychiatric events — mostly tied to to the antidepressant component, bupropion.

FDA listed several other cautions with Contrave, including the fact that it may raise heart rate and blood pressure, and is thus contraindicated in patients with uncontrolled hypertension. It can also cause seizures in patients with seizure disorders, and shouldn’t be prescribed to those already on opioids.

The most common adverse events included nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth, and diarrhea.

FDA will also require several postmarketing studies:

A cardiovascular outcomes trial to assess cardiovascular risk
Two efficacy, safety, and clinical pharmacology studies in pediatric patients
An animal juvenile toxicity study looking at growth and development as well as behavior, learning, and memory
A study looking at the effect on cardiac conduction
A dose evaluation in patients with hepatic or renal impairment
A study on potential interactions between Contrave and other drugs

Obesity experts will now have three new obesity medications to choose from when treating patients — a bounty compared with the state of the market just a few short years ago when the only diet drug left standing was orlistat (Alli, Xenical).

Botox ‘may stunt emotional growth’ in young people

Picture of an injection given to the forehead

Botox is the most well-known version of this drug and is made using a toxic protein

Giving young people Botox treatment may restrict their emotional growth, experts warn.

Writing in the Journal of Aesthetic Nursing, clinicians say there is a growing trend for under-25s to seek the wrinkle-smoothing injections.

But the research suggests “frozen faces” could stop young people from learning how to express emotions fully.

A leading body of UK plastic surgeons says injecting teenagers for cosmetic reasons is “morally wrong”.

Botox and other versions of the toxin work by temporarily paralysing muscles in the upper face to reduce wrinkling when people frown.

Mimicking to learn

Nurse practitioner Helen Collier, who carried out the research, says reality TV shows and celebrity culture are driving young people to idealise the “inexpressive frozen face.”

But she points to a well-known psychological theory, the facial feedback hypothesis, that suggests adolescents learn how best to relate to people by mimicking their facial expressions.

She says: “As a human being our ability to demonstrate a wide range of emotions is very dependent on facial expressions.

“Emotions such as empathy and sympathy help us to survive and grow into confident and communicative adults.”

But she warns that a “growing generation of blank-faced” young people could be harming their ability to correctly convey their feelings.

“If you wipe those expressions out, this might stunt their emotional and social development,” she says.

The research calls for practitioners to use assessment tools to decide whether there are clear clinical reasons for Botox treatment.

Several assessment scales exist that take into account how thick the skin is, how sun-damaged it appears, and the depth of any wrinkles, but experts warn that some Botox clinics are putting financial gain first.

Natural emotions

Ms Collier calls on therapists to spend time helping young people boost their confidence rather than reaching for injections.

She adds: “Though most of the effects of the toxin are temporary, research suggests the muscles don’t fully recover from injections.

“We really need to understand the consequences of starting treatments too soon.”

Dr Michael Lewis, a researcher in psychology at Cardiff University, says: “The expressions we make on our face affect the emotions we feel.

“We smile because we are happy, but smiling also makes us happy.

“Treatment with drugs like Botox prevents the patient from being able to make a particular expression and can therefore have an effect on our learning to feel emotions naturally.”

Rajiv Grover, president of the British Association of Aesthetic Plastic Surgeons, says: “Injecting teenagers with Botox for cosmetic purposes is morally wrong and something that no ethical practitioner would do.

“This can only exacerbate body image issues at a vulnerable time.”

Failed fertility in women who want children linked to worse mental health

Around one-third of couples who embark upon fertility treatment are not successful in their endeavor, leaving them to adjust to an unfulfilled child-wish. Now, a new study published in the journal Human Reproduction suggests women who have difficulty accepting that they will not conceive a child after fertility treatment have worse long-term mental health than those who are able to let go of their desire to reproduce.
Woman with counselor
“It is quite striking to see that women who do have children but still wish for more children report poorer mental health than those who have no children but have come to accept it,” says Dr. Sofia Gameiro.

Researchers from the study, led by Dr. Sofia Gameiro of the School of Psychology at Cardiff University in the UK, say theirs is the first to use a large group of women to assess the different factors that could affect mental health a decade after unsuccessful fertility treatment.

“It was already known that people who have infertility treatment and remain childless have worse mental health than those who do manage to conceive with treatment,” says Dr. Gameiro. But she adds that previous research did not consider other factors for why this is.

As such, for their study, the researchers included other circumstances, such as whether or not they have children, whether they still want children, their diagnosis and medical treatment.

To conduct their research, the team – which included colleagues from the Netherlands – analyzed questionnaire answers from over 7,000 women who initiated fertility treatment at hospitals in the Netherlands between 1995-2000.

Because the questionnaires were sent to the women between January 2011-2012, their last fertility treatment would have been between 11-17 years prior to answering the questionnaire.

The questionnaire inquired about age, marital status, education, menopausal status, whether the infertility was due to them, their partners or both, and what fertility treatment they had received. They also completed a mental health questionnaire that asked how they felt during the past 4 weeks.

Women who still wanted children years later had worse mental health

In addition to the questionnaires, the researchers asked the women whether they had children, and if so, whether they were biological or adopted, as well as whether they still wished for children.

Though the majority of women had accepted the failure of their fertility treatment, the researchers found that 6% of them still wanted children at the time of the questionnaire, and this coincided with worse mental health.

In fact, Dr. Gameiro notes that the women who still wanted to have children were up to 2.8 times more likely to have mental health problems than those women who had accepted their circumstances.

She further explains:

“The strength of this association varied according to whether women had children or not. For women with no children, those with a child-wish were 2.8 times more likely to have worse mental health than women without a child-wish.

For women with children, those who sustained a child-wish were 1.5 times more likely to have worse mental health than those without a child-wish. This link between a sustained wish for children and worse mental health was irrespective of the women’s fertility diagnosis and treatment history.”

The findings also revealed that when infertility was due to male factors or had an unknown cause, women tended to have better mental health. Additionally, women who started fertility treatment at older ages had better mental health than those who started younger.

“It is quite striking to see that women who do have children but still wish for more children report poorer mental health than those who have no children but have come to accept it,” adds Dr. Gameiro.

Study has certain limitations

Though their sample size was large and nationally representative, the researchers note a limitation to their study: women without psychological data were less likely to have biological children, and nearly 16% of women who did not respond deemed the questionnaire too confronting or replied that it elicited too many emotional memories.

As such, the researchers say this could have resulted in an underestimation of the proportion of women with a continued child-wish.

The team also says their findings only show that there is a connection between an unfulfilled child-wish and worse mental health, not that the unfulfilled wish is the cause of the mental health problems.

Still, the researchers say their findings show the importance of psychological care for infertility patients and that more attention should be paid to the adjustment over longer periods of time.

Migraine sufferers may find meditation helps

Asmall randomized controlled trial of patients in the US suggests migraine sufferers might find relief in a type of meditation designed to reduce stress.
Meditation
Though larger studies need to be conducted, this latest study suggests MBSR meditation could help migraine sufferers.

Researchers from Wake Forest Baptist Medical Center, Winston-Salem, NC, and Harvard Medical School in Boston, MA, report their findings in the journal Headache.

Lead author Rebecca Erwin Wells, assistant professor of neurology at Wake Forest Baptist, explains why they carried out the pilot study:

“Stress is a well-known trigger for headaches and research supports the general benefits of mind/body interventions for migraines, but there hasn’t been much research to evaluate specific standardized meditation interventions.”

The main purpose of the study, which involved 19 adult participants, was to evaluate the safety, feasibility and effects of mindfulness-based stress reduction (MBSR) for migrainesufferers.

Migraines are recurring moderate to severe headaches felt as a throbbing or pulsing, often on one side of the head. During migraines, people are very sensitive to light and sound and may also become nauseated and vomit.

According to the US National Institute of Neurological Disorders and Stroke, migraine is three times more common in women than in men and affects more than 10% of people worldwide.

There is evidence that MBSR can help alleviate chronic pain but not much evidence on its effect on migraines.

Study showed MBSR safe and may reduce frequency and severity of migraines

MBSR is a standardized 8-week program that teaches people to become more mindful through learning mindfulness meditation, body awareness and yoga. It was developed by Jon Kabat-Zinn, a professor at the University of Massachusetts Medical School, as a way to help people cope with stress, anxiety, pain and illness.

For their study, Prof. Wells and colleagues randomized the 19 adult participants to one of two groups. One group received standard medical care, and the other group took part in an 8-week MBSR program during which they attended one instruction class a week and practiced MBSR at home for 45 minutes on at least another 5 days a week.

Before and after the trial period, the participants completed evaluations of disability, self-efficacy and mindfulness. During the trial, they logged their headaches, noting their frequency, severity and duration.

The researchers found that the patients who completed the MBSR program tended to have 1.4 fewer headaches per month that were less severe.

However, because of the small size of the pilot, this was not statistically significant, meaning the number is not big enough to be sure it was the program and not just chance that created the reduction.

“Secondary effects included headaches that were shorter in duration and less disabling, and participants had increases in mindfulness and self-efficacy — a sense of personal control over their migraines,” Prof. Wells explains. “In addition, there were no adverse events and excellent adherence.”

The team concludes that their pilot study shows MBSR is a safe and feasible therapy for adults with migraines.

Larger trials needed to evaluate MBSR as a treatment for migraine

They now call for larger studies with more participants to evaluate the effect of MBSR on migraine headaches.

Prof. Wells says:

“For the approximate 36 million Americans who suffer from migraines, there is a big need for non-pharmaceutical treatment strategies, and doctors and patients should know that MBSR is a safe intervention that could potentially decrease the impact of migraines.”

Funds from the American Headache Society Fellowship and the Headache Research Fund of the John Graham Headache Center, Brigham and Women’s Faulkner Hospital helped finance the study.

In March 2014, the US Food and Drug Administration announced its first approval of a device for preventing migraine headaches. The device, a headband that delivers a nerve-stimulating low electrical current through the skin, may bring relief to patients who cannot tolerate current migraine drugs.

Written by Catharine Paddock PhD

The reason Ebola isn’t being stopped

When she was an undergraduate at Princeton University, books like “The Hot Zone” and “Virus Hunters” captivated Rebecca Levine, inspiring her to become a disease detective.

Fifteen years later, Lt. Rebecca Levine, a newly minted officer with the U.S. Public Health Service, stepped off a plane in West Africa to fight Ebola, ready to implement the key strategy she’d been taught: contact tracing.

The process that’s helped stop diseases like SARS and smallpox seems simple: Find everyone who had close contact with infected individuals and track them for 21 days. If any of these contacts comes down with the disease, isolate them from the community and repeat the process by tracking the contacts’ contacts.

But tracing works only if you have a list of the contacts and their addresses. When Levine arrived at a Ministry of Health office in Sierra Leone, she found that the database she needed was “pretty much in shambles.”

Many contacts’ addresses were missing or were vague like “down by the farm road.” In all, only 20% to 30% of the contacts in the database had a usable address.

This inability to do complete contact tracing is a major reason — perhaps the major reason — that the Ebola outbreak continues to spiral out of control, according to public health officials and experts.

“There’s a lot of infection out there. Contact tracing breaks down. Then you have a real problem.” Dr. Bruce Aylward, assistant director-general of the World Health Organization, said August 28.

Top WHO officials have said there aren’t enough contact tracers to get the job done, and the organization forecasts an “exponential increase” in the number of Ebola cases in the coming weeks.

Donald Thea isn’t surprised that the system is breaking down in many areas. An infectious disease epidemiologist at the Boston University School of Public Health, he’s worked in Africa for more than 25 years.

Like Levine, he often found that people had no address — or had one that even locals couldn’t decipher. Residents moved a lot, and when they did, many times they took their doors and locks with them to save money. They wouldn’t change the number on the door, so the streets ended up with a mishmash of addresses.

Add that to the fact that people are often uncooperativewith the tracers, sometimes even throwing stones at health care workers. They fear that they or their loved ones will be put in the hospital; they’ve seen firsthand that people who go there often don’t return.

“The community perceives this as a death sentence,” he said. “Relinquishing your loved one is tantamount to death.” And health care workers have very little to offer people as an incentive to cooperate. “With smallpox, we could offer people a vaccine, a carrot in essence to induce them to be cooperative. With Ebola, we have nothing,” Thea said.

Photos: Ebola outbreak in West Africa
Photos: Ebola outbreak in West Africa

In Sierra Leone, Levine, an officer with the Epidemic Intelligence Service at the Centers for Disease Control and Prevention, remembers the words of her agency’s director, Dr. Tom Frieden. Battling Ebola is like fighting a forest fire: Miss even just one contact, and you could be leaving behind a burning ember that will reignite the outbreak.

When Levine arrived in Sierra Leone on August 17, she brought software on a thumb drive to manage cases and contacts. The software was designed by the CDC and was far more effective at organizing thousands of names than the unwieldy Excel spreadsheet that the local health care workers had been using.

With the help of other organizations, she also got the workers more computers and training in how to do contact tracing. Now, hundreds of contact tracers are assigned to go out into the neighborhoods in her district every day.

She says the death and illness all around her spur her on.

“Each one of these heartbreaking stories just makes me want to cry,” she said. “It’s more reason to try harder and think of more creative solutions.”

Magic mushrooms’ help smokers quit, and other studies you missed

The hallucinogenic chemical found in
The hallucinogenic chemical found in “magic mushrooms” could help cigarette smokers quit.

Here’s a roundup of five medical studies published this week that might give you new insights into your health. Remember, correlation is not causation — so if a study finds a connection between two things, it doesn’t mean that one causes the other.

Even a few extra pounds can hurt your blood pressure

The extra five pounds you gained on vacation this summer can do more harm than you think.

Even a small amount of weight gain can cause your blood pressure to go up, according to new research that was presented at theAmerican Heart Association’s High Blood Pressure Research Scientific sessions.

High blood pressure can lead to a stroke and/or heart attack, among other problems.

The small eight-week study constantly monitored the blood pressure of 16 people who were considered to be at a normal weight.

Scientists fed the group an extra 400 to 1,200 calories a day in the form of a chocolate bar or a shake. They gained about 5% in weight over the study period and saw their blood pressure rise.

Their systolic blood pressure increased from 114 to 118 mm Hg. While 118 is still considered healthy, the fact that it went up even with a slight weight gain is a concern. The people who gained the weight around their middle saw the biggest increase in blood pressure.

‘Magic mushrooms help smokers kick the habit

New research published in the Journal of Psychopharmacologysuggests anti-smoking drugs on the market today could use a little magic.

The term “magic mushrooms” is usually used to describe mushrooms from the genus Psilocybe that are known to cause differences in mood, perception and behavior. Cigarette smokers who were given a pill with the hallucinogenic chemical found these mushrooms had nearly twice as much success quitting smoking than those taking approved anti-smoking drugs.

The study followed 15 volunteers who were given two to three doses of the hallucinogenic. Of those 15, 12 quit smoking and still hadn’t smoked after six months.

It’s a small study, and there was no control group, so the scientists at Johns Hopkins will do some follow-up work that will include brain scans to try and see what is happening in these quitters’ brains.

To read more: Johns Hopkins

The secret to a happy marriage

Turns out the phrase “happy wife, happy life” may be true. What makes the most difference for married couples’ general happiness is if the female partner in the relationship is happy, a new study in theJournal of Marriage and Family suggests.

Researchers looked at the lives of 394 couples. At least one member of the couple had to be older than 60.

If the female partner described the marriage as high quality, then the male partner’s life satisfaction went up, even if he reported being unhappy about the marriage itself.

The authors believe the imbalance may be related to how women typically provide “more emotional and practical support to husbands than vice versa,” co-author Deborah Carr said. “So even unhappily married men may receive benefits from the marriage that enhance his overall well-being.”

To read more: University of Michigan

A new way to stop aging

The cure to ending aging may be lurking in your cells.

That’s what researchers at UCLA suspect after finding the key to activating a gene called AMPK.

When turned on in the lab, this gene boosts the mechanism in cells that helps keep them clean and gets rid of cellular garbage such as plaque. Protein plaque buildup is believed to play a role in diseases that often come along with aging such as Alzheimer’s and Parkinson’s.

You won’t be seeing this technology at your doctor’s office any time soon, unfortunately. The scientists were only able to do this with fruit flies, not humans.

The good news is that activating the gene increased a fruit fly’s life by almost 30%. Even better news: the fly stayed healthy long into old age.

Researchers also saw that when they activated the cell in one part of the fruit fly, such as the central nervous system or in the intestine, it slowed aging throughout the body, rather than just being confined to the one area.

To read more: UCLA

Can your blood type affect your memory?

A study published online Thursday in Neurology, found that people with type AB blood were 82% more likely to develop memory problems. Type AB is found in only about 4% of the population.

The study followed 30,000 healthy people over three years. Investigators looked at blood type and measured a blood protein known as factor VIII. This compound helps blood to clot.

They found the higher the amount of factor VIII in the blood, the more likely the patient would develop memory problems. Researchers also noted those with AB blood had a higher average level of factor VIII than people with other blood types, so the two may go hand in hand.

The study authors say more research is needed to better understand the connection.

Experts say this study shows it’s important for people to know what their blood type is and how it can affect their health. Previous studies have found that certain blood types are also related to other vascular conditions like stroke.