TIME Obesity

Injecting This Drug Helps Patients Lose Weight

Daily shots of liraglutide (Saxenda), recently approved by the FDA, helps overweight or obese patients lose weight

In a study published in the New England Journal of Medicine, researchers say that the only injectable weight loss drug approved by the Food and Drug Administration (FDA) helps people to lose more than 12 pounds, more than twice as much as people taking a placebo.

The study is one of several that the FDA considered before approving the drug in 2014. It included data on 3,731 patients who were randomly assigned to take liraglutide or a placebo for just over a year. The trial continued to follow the patients for another year, and that data will be published soon.

MORE: This Pill Can Trick the Body Into Losing Weight, Study Finds

Liraglutide is similar to an already approved drug to treat type 2 diabetes, but is used in higher doses for weight loss. The drug mimics the effects of a hormone that works in the gut to signal the brain that you’ve eaten enough and feel full. As a diabetes drug, it helps the beta cells in the pancreas release insulin to keep blood sugar levels in check. In the NEJM study, none of the patients had diabetes, although some were pre-diabetic, and the FDA says liraglutide for weight loss should not be used together with the diabetes drug, also made by Novo Nordisk.

According to the study’s lead author, Dr. Xavier Pi-Sunyer, director of the obesity research center at Columbia University, liraglutide works as well as phentermine-topiramate (Qsymia), which doctors believe works by suppressing appetite. They key to making any weight loss medication effective, he says, is combining it with diet and exercise changes as well, which is what the participants in the study did. One advantage of liraglutide is that it can be used by women in their child-bearing years.

So far, the side effects of litaglutide, which include nausea, diarrhea, gall bladder abnormalities and pancreatitis, were minimal and did not outweigh the benefits of weight loss. But in approving the drug, the FDA asked the company to continue to study the drug to ensure that the adverse events remain within an acceptable range.

TIME medicine

Study Suggests Clue to Strange Link Between Swine Flu Vaccine and Narcolepsy

The immune system may have misidentified a protein in the vaccine

(WASHINGTON) — One vaccine used in Europe during the 2009 swine flu pandemic was linked to rare cases of a baffling side effect — the sleep disorder narcolepsy. Now new research offers a clue to what happened.

The vaccine Pandemrix never was used in the United States, and was pulled off the market abroad, but reports of narcolepsy in Finland and several other countries sparked questions globally about flu shot safety.

On Wednesday, an international team of researchers reported the problem may have been a case of mistaken identity by the immune system.

Narcolepsy is an incurable disorder that interferes with normal sleep cycles, leaving people chronically sleepy during the daytime and apt to abruptly fall asleep. No one knows what causes it, although patients have very low levels of a brain chemical named hypocretin that’s important for wakefulness. One theory is that a particular gene variant makes people susceptible, and that some environmental trigger, maybe an infection, pushes them over the edge.

About a year after mass vaccinations began against a new strain of H1N1 flu, called swine flu at the time, some European countries reported rare cases of narcolepsy in recipients of GlaxoSmithKline’s Pandemrix but not in people given other flu vaccines. Research found narcolepsy patients had that genetic predisposition, but no other explanation.

In the new study, Dr. Lawrence Steinman of Stanford University and colleagues found that the H1N1 virus contains a protein that is structurally similar to part of a brain cell receptor for that wakefulness chemical. They wondered if the flu-fighting antibodies generated by the Pandemrix vaccine might also latch onto those narcolepsy-linked receptors, leading to damage.

Colleagues in Finland sent blood samples that had been stored from 20 people diagnosed with vaccine-associated narcolepsy. Sure enough, 17 harbored antibodies capable of reacting both to flu and to those narcolepsy-linked receptors, Steinman’s team reported in the journal Science Translational Medicine. Recipients of another European vaccine, Novartis’ Focetria, didn’t harbor those cross-reactive antibodies.

Pandemrix contained much higher levels of the flu protein than Focetria, possibly because the two flu shots were made from different H1N1 subtypes, the researchers found.

The study doesn’t prove the link, Steinman stressed, calling for more research. It’s not clear how the antibodies could have gotten into the brain.

Moreover, some unvaccinated people who caught the flu harbor the antibodies, too, he said, and a study from China found H1N1 infection itself may increase narcolepsy risk.

It’s a plausible theory, said Dr. William Schaffner, a flu vaccine expert at Vanderbilt University who wasn’t involved in the new research.

Importantly, “this would also appear to be a solvable problem,” with manufacturing techniques to ensure that future vaccines don’t contain too much cross-reactive protein, he said.

However the narcolepsy puzzle turns out, the flu kills tens of thousands of people every year. “It’s really important to get vaccinated against flu,” Steinman said.

 

TIME medicine

How This Common Drug Can Have Lasting Effects on Kids

Antibiotics are prescribed for a range of childhood ailments, from ear to throat infections. But the drugs may be changing kids’ health in potentially unwelcome ways

In a study published in Nature Communications, scientists document the possible long-term effects of antibiotics when they’re used early in life. Their study involved mice, but the team used the drugs in doses and treatment regimens that mimic those frequently administered in young children.

Dr. Martin Blaser, professor of medicine and microbiology at New York University Langone Medical Center, and his colleagues tested three different antibiotic regimens: one involving amoxicillin, another involving macrolides and a final one that combined the two. They compared these animals to mice that received a placebo. The mice got antibiotics 10 to 15 days after birth, then again 27 days later and finally after day 39. They lived for 160 days, at which point they were sacrificed and their gut bacteria were studied.

MORE: Here’s What Eating Nothing But McDonalds for 10 Days Does to Your Gut Bacteria

Compared to the mice taking the placebo, the antibiotic-treated animals had less diverse communities of bacteria, and the proportions of the bugs living in their guts were also different. The macrolides seemed to have the biggest effect on reducing microbial richness, while amoxicillin led to abnormally large bones. The changes in the microbiome persisted even to the animals’ death, nearly four months after their last antibiotic dose.

“There are really long-term, probably permanent effects on the microbiome from antibiotics,” says Blaser. “We showed changes in the richness and the community structure, and also the genes present in the bacteria.”

MORE: Antibiotics Before Age 2 Increase Risk of Childhood Obesity

What this means for humans still isn’t clear from this study, but the findings do provide hints. Other studies that have analyzed the potential effects of antibiotics found that children receiving more rounds of the drugs because of early infections tend to be heavier and are more likely to be obese as adolescents and adults. And the earlier children are exposed to the drugs, the more likely their metabolism is to be affected.

Blaser notes that antibiotics are a necessary and potentially life-saving treatment for some, but for many infections, their risks might be greater than their benefits. “If what we found in mice is true for human children, then this is yet another reason to be cautious in using antibiotics,” he says. “We know there are kids who are severely ill who must have antibiotics. But there is a larger number of kids who are only mildly ill. The question is, what proportion of them really need antibiotics?” Based on the animal data, he says, the first two to three years of life are particularly important for development, and doctors and parents should be judicious about prescribing antibiotics during this sensitive time.

TIME medicine

Minnesota Takes Half Step Toward Legalizing Marijuana

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Getty Images

Pills and oils are approved, but smoking marijuana remains prohibited

Minnesota eased a statewide ban on medical marijuana products Wednesday, approving the use of pills and oils for seriously ill patients, while upholding a ban on products that can be smoked.

Under the new law, users will be able to use liquid and pill extracts of marijuana plants, provided they are suffering from serious conditions such as epilepsy, HIV and cancer, the Associated Press reports. The law also restricts sales to only eight dispensaries within the state.

While legalization advocates hailed the new rules as a step forward, they argued that Minnesota’s approach was unusually restrictive, potentially excluding patients living in rural areas or on tight budgets from obtaining the drugs.

[AP]

TIME medicine

This Drug Brought Pigment Back for Woman With Vitiligo

skin pigmentation arthritis
Dr. Brett King/Yale

A case study shows promise

Scientists have discovered an existing drug may be able to restore pigment into the skin of people with vitiligo.

Vitiligo is a disorder that causes the skin to lose its pigment, and few treatments are consistently effective. The late singer Michael Jackson is a well-known person who had the disorder.

In the study, which was recently published in the journal JAMA Dermatology, researchers gave a 53-year-old patient with vitiligo who had white spots covering her face, hands and body a drug called tofacitinib citrate, which is currently used to treat rheumatoid arthritis.

After just two months, pigment had partially returned to the woman’s face, arms and hands, and after five months white spots on her face were almost completely gone. She had a few spots that remained on other parts of her body.

The findings are encouraging, especially considering she experienced no adverse side effects while taking the drug. Since the study was only conducted with one woman, more research will need to be done to confirm efficacy and safety.

“While it’s one case, we anticipated the successful treatment of this patient based on our current understanding of the disease and how the drug works,” said study author Dr. Brett King, assistant professor of dermatology at Yale School of Medicine in a statement. “It’s a first, and it could revolutionize treatment of an awful disease.”

TIME health

4 Life Lessons a Doctor Has Learned From Patients

We never have as much time as we think

Answer by David Chan on Quora.

I’ve taken care of cancer patients for several decades and they’ve taught me something about life.

1. A job is just a job. I often get into discussions about life and living with my cancer patients who have a unique outlook because they are face to face with their mortality.

Not one single patient has told me that they wished they had worked more. I’ve taken it to heart and have made it a point to be there for important events for family and friends and to take vacation days.

2. I’m reminded daily to have a big picture view of life and to understand what is a real problem. It’s so easy to be caught up in day to day dramas that we lose sight of what is a real problem.

A real problem is finding a big lump in your neck, getting a scan, then a biopsy, and being told that it’s cancer. Virtually every other problem then goes away.

3. True wealth is measured in family and friends. I’m not talking about numbers. What I’m talking about is the small group of people that will really be with you when the shit hits the fan. I’ve had very wealthy patients with big families and a large group of friends that all disappeared when things went south. Nothing could be sadder to see. And I’ve had other patients who had 2 or 3 people in their lives that made incredible personal sacrifices of time and effort to help them through. I think of it as proof of a life well lived.

4. A corollary to #1 is that we never have as much time as we think. I’m reminded of a patient who was a young and very successful executive with pancreas cancer. He wasn’t curable and it was poorly treatable given his situation. His life expectancy went from 40 years to 6 months within the week of his diagnosis.

He’d never taken a vacation with his family; his wife and 3 school-aged kids.

We reviewed the pros and cons of treatment and he decided to forego treatment, rented a sailboat and took his family through the Caribbean Islands for about 3 weeks. Because of his cancer, he didn’t feel physically great but he told me that it was the best 3 weeks of his life.

I’m grateful for the lesson he and many other patients have taught me.

This question originally appeared on Quora: If you’re a medical practitioner, what revelations have you had about health and mortality since you’ve been working in this field?

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TIME Brain

Alzheimer’s May Begin 20 Years Before Symptoms Appear

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PASIEKA—Getty Images/Science Photo Library RM

The two decade mark is the earliest that scientists have placed the beginnings of the disease. The good news is that gives doctors a long window of time in which to slow down or reverse the condition

The latest breakthroughs in Alzheimer’s research focus on the time well before patients even know they might have the neurodegenerative condition. Studies so far have found evidence that the biological processes that cause the mental decline may begin 10 to 12 years before people first notice signs of cognitive decline. But in the most recent report published Wednesday in the journal Neurology, experts say that the disease may actually begin even earlier — 18 years earlier, in fact — than they expected.

MORE: Mental and Social Activity Delays the Symptoms of Alzheimer’s

For 18 years, Kumar Rajan, associate professor of internal medicine at Rush University Medical Center, and his colleagues followed 2,125 elderly people with an average age of 73 and who did not dementia. Every three years, the researchers gave the volunteers mental skills tests, and then compared these results over time.

When the looked at the group that went on to receive an Alzheimer’s diagnosis, they found that these people showed lower scores on their tests throughout the study period. In fact, their scores steadily declined with each test. For each unit that the scores dropped on the cognitive tests, the risk of future Alzheimer’s increased by 85%.

MORE: Many Doctors Don’t Tell Patients They Have Alzheimer’s

Rajan stresses that the results only link cognitive testing scores on broad, group-level risk, and can’t be used to predict an individual’s risk of developing the disease. For one, more research will be needed to find the range of decline that signals potential Alzheimer’s dementia. But the findings do set the stage for studying whether such a non-invasive, easily administered test can, or should be, part of a regular assessment of people’s risk beginning in middle-age.

That way, he says, people may have a longer time period in which to hopefully intervene to slow down the disease process. Rajan plans to study whether brain-stimulating activities like crossword puzzles or learning a new language and social interactions can improve the test scores, and in turn slow the time to diagnosis of Alzheimer’s. At the very least, he says, the current data shows that there is a longer window of time in which people might be able to intervene in these ways and potentially delay Alzheimer’s most debilitating effects.

TIME medicine

Here’s What Science Says About Medical Marijuana

It’s buyer-beware for medical marijuana users, since the data supporting the benefits of cannabinoids are still in flux, and most marijuana edibles aren’t well labeled

There’s a big difference between anecdotal evidence and scientific proof, and the field of medical marijuana research is filled with more of the former than the latter—in part because marijuana is notoriously difficult to study because it’s classified as a schedule-1 drug.

Scientists led by Penny Whiting from University Hospitals Bristol in the U.K. report in JAMA that there is only moderate-quality evidence supporting the benefits of medical marijuana, and only for certain conditions. The majority of studies involving medical marijuana are of lesser quality and therefore more likely to be biased and provide unreliable results.

MORE: Teens Don’t Smoke More Pot After Medical Marijuana Laws Passed, Study Finds

In all, Whiting and her colleagues analyzed 79 randomized trials, the gold standard in medical research in which volunteers are randomly assigned to take a cannabis-related product or a placebo. The studies evaluated marijuana’s ability to relieve a range of symptoms including nausea from chemotherapy, loss of appetite among HIV positive patients, multiple sclerosis spasms, depression, anxiety, sleep disorders, psychosis and Tourette syndrome. Most of the studies showed improvements among the participants taking the cannabinoid products over those using placebo, but in many, the scientists admitted that they could not be sure that the effect wasn’t simply due to chance since the association was not statistically significant.

MORE: The Great Pot Experiment

The strongest trials supported cannabinoids’ ability to relieve chronic pain, while the least reliable evidence involved things like nausea and vomiting from chemotherapy, sleep disturbances and Tourette syndrome. Cannabinoids were, however, connected to more adverse events such as nausea, vomiting, dizziness, disorientation and hallucinations than placebo.

Summing up the state of the evidence, Whiting and her colleagues write that “Further large, robust, randomized clinical trials are needed to confirm the effects of cannabinoids, particularly on weight gain in patients with HIV-AIDS, depression, sleep disorders, anxiety disorders, psychosis, glaucoma, and Tourette syndrome.”

MORE: Even in Colorado Medical Marijuana Can Still Get You Fired

That puts patients who try medical marijuana products at a crossroads — in 23 states and Washington, DC, laws allow doctors to recommend cannabis products for their patients for medical reasons. But with little in the way of solid scientific evidence for which products works best, and in which doses, it’s up to the patients to adopt trial-and-error to figure out which, if any cannabinoids help to relieve their symptoms.

Adding to the confusion for patients, another study published in the same JAMA issue shows that medicinal marijuana food products, which include things such as candies, brownies and teas, aren’t often labeled correctly when it comes to their most active cannabis ingredient, and that the amounts are inconsistent. Ryan Vandrey, associate professor of psychiatry and behavioral sciences at Johns Hopkins University School of Medicine and his colleagues evaluated the contents of 75 products from 47 different brands purchased at marijuana dispensaries in San Francisco, Los Angeles and Seattle, where medicinal marijuana use is legal. When they analyzed them for their content of THC and cannabinoids, the two most concentrated chemicals found in marijuana, they found wildly divergent amounts from what was noted on the products’ labels. Among them, only 17% were accurately labeled, with 23% of the products containing more of these compounds than listed, and 60% containing less than advertised. The labels noted that anywhere from 2 mg to 1000 mg of these agents were in the products, while the lab-based analysis revealed readings as low as 1mg to as high as 1237 mg. “When I have a health condition, and need to go buy my medicine, I want to make sure I know what I’m getting,” says Vandrey. “I want to make sure the dose I buy is the same today and the same the next time and the same the next time I buy it. I want reliability and accuracy so I don’t end up with problems.”

MORE: How Much Does Marijuana Impact Your Driving?

But medical marijuana products, he says, aren’t regulated by the same system that vets other pharmaceutical drugs. In fact, cannabinoids are not regulated at all, since the federal government still considers marijuana an illegal substance and therefore does not acknowledge that marijuana-based therapies exist at all. So far, 23 states have legislated such medicinal marijuana into legality, which means that legislation, and not scientific criteria, have “approved” these compounds for medical use. The results? “What we saw was that there cant’ be much if any consumer confidence within the cities we purchased and tested products,” says Vandrey.

For the larger medical marijuana distributors who see the emerging market as a profitable business, there’s the concern that profit motives may push them to under-deliver the amount of THC or cannabinoid they note on the label. And for the smaller outfits, it could be a matter of not knowing how to extract and measure the active ingredients from the cannabis plant and distribute it in a consistent way in a batch of tea or baked goods.

How can consumers know what they’re getting in a medical marijuana edible? They can do their homework and talk to other consumers and the dispensary about dosing of THC and cannabinoids, says Vandrey. Or they can try to test the products themselves, which some states offer in an effort to standardize and gain more control over these products. But ultimately, he says. “if states are going to supersede federal law and say we think there is medical benefit in marijuana, and we want it to be available to our residents, then it should also be the responsibility of the states to set up appropriate programs for regulating and overseeing the quality assurance and manufacturing standards for medications being sold.”

TIME medicine

Here’s How Skinny Jeans Are Hurting Your Health

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Adrianna Williams—Getty Images

They may help you look slimmer and be the perfect partner for tees, but skinny jeans may be damaging your nerves

If we had to point to an unhealthy fashion choice, we’d probably start at our feet, with sky-high heels. But a case study shows we may need to look a little higher, at the skinny jeans that have dominated the market for years.

In the Journal of Neurology, Neurosurgery and Psychiatry, researchers from Australia describe the case of a woman who experienced nerve damage severe enough to cause numbness and hospital care after a day of wearing skinny jeans.

The 35-year-old was helping a relative move, so she spent most of the day squatting while packing. Throughout the day, she felt her jeans get increasingly tight, until, while walking home in the evening, her feet went numb and she fell. Not able to get up, she spent several hours on the ground before she was taken to the hospital.

There, her legs and ankles had become so swollen that emergency room staff had to cut her jeans off. Her ankles and toes were weak, but the rest of her legs, including her knees and hips, were working normally.

When the doctors did studies on how her leg nerves were functioning, they found blockage of the nerve that directs the lower leg and feet. In fact, they say, any compression of the area just under knee can squeeze this nerve and cause weakness, numbness or pain by damaging this nerve. In her case, the squatting probably squashed the nerves feeding into each leg, and the skinny jeans didn’t help when the swelling started, further constricting them and crushing the nerves. After four days in the hospital with IV hydration, the bloating went down and the woman could walk again on her own.

Lesson: don’t wear skinny jeans if you’re going to do a lot of squatting or bending. They might not directly pinch the nerves in your legs but they can make the condition worse — enough to numb your feet and require several days in the hospital.

TIME medicine

Scientists Find a Gene That Regulates Sleep

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Vincent Besnault—Getty Images

It's a study in flies but it could have implications for us, too

Flies, it turns out, sleep about as much as young children do. Males need about 12 hours a day, while females can do with about 10 hours. To find out which genes might be responsible for guiding how much slumber flies get a night, Kyunghee Koh did a massive experiment that you can only do with fruit flies.

She and her team at Thomas Jefferson University reported in the journal Current Biology that they took 3,000 flies, introduced random mutations in them and then monitored how well they slept. That allowed them to zero in on the genes that most directly affected slumber, and they found one, taranis, that may become an important target for sleep-related research even in people.

Flies with abnormal forms of taranis only get about 25% of their daily sleep; removing the gene keeps the flies buzzing almost non stop.

Koh’s team found that taranis works with a couple of other proteins to balance sleeping and waking. Normally, taranis and cyclin A pair up to keep the activity of another enzyme down. That enzyme generally keeps the flies awake. So when all three are working in concert, taranis and cyclin A shut down the enzyme so flies can get 10 to 12 hours of sleep. But when taranis is mutated, it doesn’t do its job as well, and the enzyme keeps the flies alert and unable to sleep.

It turns out that taranis has a related gene in mammals that may work in similar ways. The gene typically controls the way cells divide, “We don’t know yet whether these genes have a role in sleep in mammals or humans, but our hope is that somehow these genes we find in flies may have similar roles in people, and might ultimately give us some novel drug targets to help us sleep better,” says Koh.

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