TIME medicine

Woman Gives Birth After a Transplant of Her Own Frozen Ovarian Tissue

Case hailed as a scientific breakthrough

Over a decade ago, a bone marrow transplant left a Belgian girl infertile. Now, a transplant of her own frozen ovarian tissue has helped her get pregnant and give birth to a healthy baby boy, Sky News reports.

The scientific breakthrough is likely to benefit other sick children who lose their fertility through cancer treatments.

“Freezing ovarian tissue is the only available option for preserving their fertility,” Dr Isabelle Demeestere, a fertility specialist at the Universite Libre de Bruxelles, Brussels, told media. The details of the transplant were published in Human Reproduction, a medical journal.

The patient, who suffered from sickle cell anemia, was 13 when her ovary was frozen and she had yet to start her period.

A decade later, four pieces of the frozen tissue were transplanted onto the patient’s remaining ovary at her request. Two years after the transplant, she was pregnant, Sky News reports

Doctors reportedly expect the woman’s ovary function to remain normal, allowing her to have more children in the future.

[Sky News]

TIME medicine

The Next Big Drug to Treat Heart Disease

The Food and Drug Administration may soon approve blockbuster drugs that can lower cholesterol better than anything on the market today. Here’s what you need to know about the heart disease game changers.

There’s a well accepted dogma in heart disease: too much cholesterol flowing through the blood vessels can jam up heart byways and lead to heart attacks, stroke and other problems. So lowering cholesterol, by eating fewer high-fat foods or taking advantage of drugs that can keep levels under control, can protect you against heart trouble.

A drug that promises to drop cholesterol levels to unprecedented levels—some say to as low as those found in infants—has to be a good thing. That’s what a Food and Drug Administration (FDA) advisory committee decided after reviewing data on the first candidate in a new class of heart drugs since the cholesterol-lowering statins emerged in the 1980s. The committee looked at studies involving alirocumab, developed by Sanofi and Regeneron Pharmaceuticals, and will do the same for a similar compound, evolocumab from Amgen, on Wednesday. Another drug, developed by Pfizer, is further behind the approval process. All three belong to a new class called PCSK9 inhibitors, which work by pumping out more LDL cholesterol receptors on liver cells; these can pull cholesterol out of the blood like sponges and keep vessels clear of the artery-clogging fats.

The committee voted 13-3 to recommend approval of alirocumab, determining that it was safe enough and provided significant enough benefits over existing therapies that it should be approved. The FDA usually follows its advisory committee recommendations, but isn’t bound by the advice.

The recommendation isn’t a surprise given the encouraging data so far on the drugs, but it is a bit unusual because there aren’t any long-term data yet on how patients taking these drugs fare. Normally, the FDA likes to see studies that follow people taking heart drugs, for example, for several years, and that demonstrate that they have fewer heart-related events and are less likely to die from heart problems than people not taking the medications. But the PCSK9 inhibitors have a unique advantage on this issue that may have helped them shortcut that process.

Some people are born with mutations that make them deficient in the PCSK9 enzyme, which tends to eat up and degrade LDL receptors. These individuals are blessed with low LDL levels throughout their lifetime and don’t seem to show any other adverse health effects. “These people are effectively experiencing the functional equivalent of taking one of these drugs for their entire life,” says Dr. Elliott Antman, professor of medicine at Brigham and Women’s Hospital and Harvard Medical School and president of the American Heart Association. “They almost never get vascular disease and tolerate their low levels of LDL very well. So they were the inspiration for developing drugs that inhibit PCSK9.”

Further studies of the drugs that mimicked the effect of the genetic mutation showed that almost everyone taking them enjoyed a drop in LDL cholesterol levels of up to 65%. Some people in the trials have seen their LDL levels go down to 25 mg/dL or below; in previous guidelines, heart experts advised people without a history of heart events to aim for LDL levels of 100 mg/dL or below and for heart attack patients to shoot even lower, for 70 mg/dL or less.

“These drugs are a big deal,” says Dr. Steven Nissen, chariman of cardiovascular medicine at Cleveland Clinic who is leading a study on the Amgen drug to see if it can not only lower cholesterol, but actually reverse existing plaques in the arteries. The dramatic effect that PCSK9 inhibitors have on cholesterol is making doctors also rethink how they treat heart disease. The latest guidelines from the American Heart Association and the American College of Cardiology did away with target cholesterol levels, and the new class of drugs may support that trend, pushing doctors to advise patients to go as low—meaning as close to zero cholesterol in their blood—as they can.

“I think right now that will scare most people,” says Dr. Seth Martin, assistant professor of medicine and cardiology at Johns Hopkins School of Medicine. “But the science supports that it’s safe.”

The FDA would still have to determine for which patients the drugs should be prescribed. Some panel members recommended that the first indication include only those with genetic conditions that make them more vulnerable to abnormally high cholesterol levels, or those who can’t tolerate statins. Because statins are generally effective, the new drugs may also be recommended as second line therapy, to be used only after patients have failed to respond to statins, Unlike statins, which remain the best-selling prescription drugs in the U.S., the PCSK9 inhibitors need to be self-injected, either every two weeks or once a month.

If approved, even for a limited group initially, the drugs are likely to make their way into the broader-based heart-disease patient population—and quickly. “I have patients keeping an eye on this, who said to me, ‘This sounds pretty good, how can I get some now?’” says Antman. “They asked me to give them a call if it gets approved.” Not all of them have a genetic predisposition to high cholesterol levels, but, Antman notes, “they are sophisticated patients and say ‘I’ve had a good response to statins, so if I took this on top of the statin, I could cut my current LDL in half. Doesn’t that mean good things for reduction of my risk?’ And the answer is yes, it does.”

If the FDA does decide to approve alirocumab and other PCSK9 inhibitors, the agency will likely require the manufacturers to keep registries of patients using the drugs and monitor any side effects or other adverse events that may arise.

TIME medicine

See What Diseases You’re at Risk For Based on Your Birth Month

Researchers say there are sound and possibly scientific reasons to pay more attention to the month you were born in

“Whenever I present our work, I have to allow for laugh time,” says Nicholas Tatonetti, a scientist at Columbia University Medical Center.

Not a common practice for a serious academic researcher, but then again, Tatonetti studies something quite unfamiliar to those more accustomed to the intricacies of biological and molecular explanations for the human condition. “I study the month people were born in, to see if that changes their risk of developing disease in their entire lifetime,” he says. And in his latest report, published in the Journal of the American Medical Informatics Association, those results are pretty eye-opening.

By delving into the extensive database of patients seen at Columbia Medical Center over 14 years, beginning in 2000, Tatonetti and his team did a first-of-its kind look at whether birth month has anything to do with disease risk. Some previous studies have looked at the potential connection, but these investigations focused on individual conditions such as asthma and brain conditions, and therefore might have suffered from disease- or population-biases.

Tatonetti found that among 1,688 conditions for which patients were seen, 55 showed a strong relationship with birth month that could not be explained by chance alone. These included 20 conditions that were already described from previous, smaller studies, and 16 completely new associations. These included a surprisingly large number of heart-related diseases.

“Not only was it surprising that nobody had studied the relationship between heart disease and birth month yet, but we found not just one association but several with the same trend of increased lifetime risk of heart disease for those born in late winter and early spring,” says Tatonetti. “That’s suggestive of a mechanistic relationship, although we don’t yet know what that is.”

Earlier studies, for example, had connected birth in late summer or fall with asthma or respiratory problems, since mothers pregnant during the winter may be more likely to catch the flu or other respiratory infections. Tatonetti’s group is collaborating with 40 other institutions around the world to standardize patient electronic health records so the anonymized data can be studied for possible explanations of the birth month trends. The database will include environmental data as well, since it’s well known that environmental exposures — to things such as pollution, second hand smoke and more — can influence expectant moms and their developing fetuses.

He prefers to call what he does a study of seasonality rather than birth month. “Astrology puts a lot of stock on what month you were born in, and that really hurts this type of research, since there isn’t much scientific evidence to support that,” says Tatonetti. “But seasonality is a proxy for variable environmental factors present at the time of your birth, and we are learning more about the very large role that environment, and gene-environment interactions, plays in our development. This could be one way to start mapping out those gene-environment effects.”

To see which conditions you might be more vulnerable to developing, find your birth month in the wheel below.

Dr. Nick Tatonetti, Columbia University Medical Center

Read next: How Your Cat Could Make You Mentally Ill

TIME medicine

Memory Loss Not Caused By Cholesterol Drugs After All

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Chris Gallagher—Getty Images/Photo Researchers RM

Some cholesterol-lowering drugs, called statins, could contribute to short-term memory lapses, but new data suggest that risk may not be real

About 25 million Americans currently take a drug to lower their cholesterol, so it’s no surprise that the most popular among them, statins, consistently top the list of best-selling prescription medications. But recent studies hinting that they were associated with memory problems have led some patients to shy away from them.

According to the latest data, though, there’s probably no need to avoid taking statins for this reason if a doctor prescribes them to protect against heart disease. In a report published in JAMA Internal Medicine, Dr. Brian Strom, chancellor of biomedical and health sciences at Rutgers University, and his colleagues say that while statins may contribute to short term memory issues, these tend to resolve over the long term and that such memory problems are not unique to the statins.

MORE: Who Really Needs To Take a Statin?

Previous studies had reported a possible connection between statins and memory loss, but those studies compared statin users to non-statin users. In his study, Strom included another group for comparison: people prescribed cholesterol-lowering drugs that were not statins. Among a large group of 482,543 statin users, 26,484 users of non-statin cholesterol-lowering drugs and 482,543 controls who weren’t on any drugs, Strom and his team found that both cholesterol-lowering drug groups showed short-term memory problems in the first 30 days after they started taking their medications compared to the controls. For statin users, the increased odds of memory lapses was four-fold, and for the other drug group, nearly the same, at 3.6-fold.

Because both groups taking drugs showed similar memory effects, Strom says that it’s unlikely that statins are uniquely to blame for the short-term cognitive issues. And because statins and the other cholesterol-lowering drugs work in vastly different ways, it’s also unlikely that the effect can be blamed on the drugs themselves. Strom proposes that the groups’ short-term memory issues, which were recorded by doctors in the patients’ medical records, is more likely the result of these patients simply being more aware of and sensitive to any changes in their functions after starting a new medication. In other words, people may have been having memory issues before they started their medications, and the problems might have occurred if they had not started taking them, but the symptoms became more noticeable because the users were more attuned to changes after filling their new prescription. The control group might have been experiencing similar memory issues but didn’t report them to their doctors; therefore, the issues might not have been recorded. “People on new medicines are more likely to notice a problem, more likely to blame problems on the drug and more likely to go back to the doctor and report these problems,” Strom says.

MORE: Statins May Seriously Increase Diabetes Risk

While it’s possible that the drug-taking group is also at higher risk to begin with for memory-related problems, since they have more potentially vessel-blocking cholesterol in their blood that can also impede blood flow to the brain, the results remained strong even after the group adjusted for risk factors such as diabetes and other blood-related conditions.

What’s more, Strom and his team also looked at users who might have been prescribed statins, stopped taking them because they were uncomfortable with the short-term memory issues, and then were prescribed them again at a later time. These patients did not report memory problems at the same rate, suggesting that the effect has less to do with the drugs themselves than with a hyper-vigilance for any changes associated with new drugs—the second time around, the drugs weren’t novel any more. “If the memory problems were real, we would expect that those who took statins for the second time would develop memory problems again,” he says. “The fact that we saw this as a problem so infrequently in this group suggests that it was more because the statins were a new drug the first time around.”

Based on the results, Strom says he informs his own patients that for some, statins may be linked to a short-term memory issue but that these tend to disappear over the long term. He also warns that even the short-term problems may not be a true effect of the drugs but rather a misinterpretation of the studies. “People should not steer away from statins because of a fear of short-term memory problems,” he says, “because they probably are not real.”

TIME medicine

Explaining ‘Epigenetics': The Health Buzzword You Need to Know

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Atomic Imagery—Getty Images

Getting a bad genetic draw from mom and dad is the most common way to inherit risks for diseases like cancer and heart problems. But there’s another way to pick up genetic changes that researchers are starting to pay attention to

Most of us get an introduction—whether we remember it or not—to genetics in our first biology class. We learn that genes, made up of DNA, are the molecular blueprint that make us who we are, and that this DNA code is a unique combination of instructions from both our mothers and fathers. Which genes we pick up from mom and which from dad is somewhat random, and that genetic roulette in turn determines, at least in part, which disease we’re most at risk for developing during our lifetimes.

But in recent decades scientists have learned that DNA alone is not destiny, and they’ve been focusing on another layer of genetic inheritance called epigenetics, which also play a role in determining what our DNA blueprints look like (more on that below). And in a new study published in the journal Cell, researchers show how it’s possible to pass on these epigenetic changes — which are not permanent alterations to the genome — created by exposure to things like tobacco, environmental pollutants and diet, as well as lifestyle behaviors.

What are epigenetic changes?

Every cell in the body contains the entire complement of genes it needs to develop properly — and that includes instructing liver cells to become liver cells and bone cells to function as bone cells and so on. How each cell knows to turn on the right genes in the genome to assume its correct identity involves epigenetics. Every gene is regulated by a region called the promoter, and epigenetics involves the process of turning specific genes on or off in particular cells. The most common way of controlling this gene expression is by plunking a molecule known as a methyl group on the promoter region. Where these methyl groups end up and how many of them crowd a gene on the genome determines whether that gene is turned on or off, and if it’s turned on, how much it is expressed.

What controls epigenetic changes?

This is a question that researchers are still trying to answer, but some of the leading candidates include exposure to things like tobacco and environmental pollutants. Diet may play a role as well as things like stress.

Can these epigenetic changes be passed from parent to child?

Studies show that some epigenetic changes might be transmitted from one generation to the next, but, says Azim Surani of the Wellcome Trust/Cancer Research Gurdon Institute at the University of Cambridge, and senior author of the Cell paper. “It’s still an open question to what extent that happens.”

In his latest study, Surani and his colleagues studied how egg and sperm, known as germ line cells, are formed in an embryo. They found that these cells undergo a type of epigenetic erasure, in which any methyl groups added from the mother’s egg and the father’s sperm are removed, so the growing fetus can create its own, tabula rasa egg or sperm, depending on its sex.

“I would say this is an extremely robust erasure mechanism that’s unique to the germ line cells,” says Surani. “It’s really designed to clear out the epigenetic information before transmission of the genome to the next generation, almost like it’s trying to clean out the genome and prevention transmission of so-called aberrant epigenetic information being passed on.”

But about 5% of the methyl changes aren’t wiped out, and these escapees, as Surani calls them, may explain how some epigenetic changes re-appear in the offspring of parents, even if they aren’t permanent alterations to the genome but more like external modifications to how genes are regulated — similar to a renovation of a house whose original structure and layout remain the same.

Are there benefits or risks of having epigenetic changes passed from parent to child?

Surani’s results raise interesting questions about why epigenetic changes might be “inherited” in the first place.

Of the changes that they documented in the small sample of human embryos they studied, as well as among mice, they found that a certain core of genes may preferentially escape from the epigenetic cleansing. These genes are predominantly involved in nerve and brain cell function, as well as metabolic conditions, so they could preferentially impact conditions such as obesity and schizophrenia.

More work needs to be done before the exact role of epigenetics, and de-methylation, might play in these conditions, but the findings do point to an other potential contributor to these conditions, and possibly some helpful therapies.

But any epigenetic-based treatments are still a ways off, Surani says, since there is still a lot about methylation and de-methylation that remains a mystery. In addition to orchestrating which genes turn on and off and when, for example, methyl groups also have a very critical role in sitting on so-called jumping genes, or the dark matter of the genome. These are portions of DNA that are more mobile when the twisted strands of DNA open and close when cells divide. As they move around, these elements can cause mutations if they land in important genes and disrupt their function. Of the 5% of methylation that doesn’t get erased, most of it, says Surani, involves this dark matter of the genome.

So is that good or bad?

It may be that having some epigenetic changes escape from one generation to the next is a good thing, a defense mechanism of sorts, although what the right balance is for how much of the methyl groups should remain isn’t clear yet. “Future studies will start to illuminate some of the questions that these results raise now,” says Surani.

TIME medicine

The Vaccine for Type-1 Diabetes Is Moving Forward

A promising vaccine to reverse type 1 diabetes heads to a next level trial

A promising vaccine that has the potential to reverse the symptoms of type I diabetes—an autoimmune disease often diagnosed in childhood—is heading on to a phase II trial, which will test the vaccine on humans with the chronic disease.

The vaccine, called bacillus Calmette-Guérin (BCG) has succeed in reversing type 1 diabetes in a trial among mice and in a phase I trial in 103 humans. The new trial, which the researchers announced on Sunday at the Scientific Sessions of the American Diabetes Association, will last for five years and will test the effect of the vaccine on people with type 1 diabetes among adults between ages 18 to 60. The vaccine may be able to improve the disease in people who have small but detectable levels of insulin coming from their pancreas. Lead researcher Dr. Denise Faustman, director of immunobiology at Massachusetts General Hospital (MGH), estimates that about one million people with type 1 diabetes still produce some insulin.

BCG is already FDA-approved as a vaccine for tuberculosis and as a bladder cancer treatment. Researchers have shown that the vaccine can eliminates problematic white blood cells that lead to type 1 diabetes by destroying the beta cells that make and release insulin into the blood.

Previously, the study authors showed they were able to temporarily eliminate the abnormal white blood cells and provide a small return of insulin. The new trial will provide more frequent doses of the vaccine over a five year periods in 150 adults with the disease. The researchers hope that the vaccine will produce better blood sugar control and could be used to treat advanced disease.

“Type 1 diabetics are a pretty skeptical audience,” says Faustman. “There’s been a lot of disappointment [from other research].”

Faustman says the trial is ambitious because it is focusing on people who have had type 1 diabetes for many years. Other research has looked at treating people with diabetes close to diagnosis. Faustman says that the trial will also help determine what type of dosing may be needed for the vaccine to be successful.

TIME Viagra

A Female Viagra is One Step Closer to Reality

A tablet of flibanserin sits on a brochure for Sprout Pharmaceuticals in the company's Raleigh, N.C., headquarters.
Allen Breed—AP A tablet of flibanserin sits on a brochure for Sprout Pharmaceuticals in the company's Raleigh, N.C., headquarters.

FDA advisory group gives its go ahead to the drug for women with low sex drives

A U.S. Food and Drug Administration advisory panel gave its stamp of approval to a first-of-its-kind drug to treat lagging sexual desire in women–albeit with some warnings.

The advisory committee voted 18 to 6 to approve the drug, flibanserin, as long as steps are taken to minimize the risk of side effects.

The little pink pill–a fitting companion to Viagra’s memorable blue hue– would be taken every evening and would be approved for use in premenopausal women with what’s known as hypoactive sexual desire disorder. It’s a condition said to affect 7% of premenopausal women that results in an unusually low sex drive that’s not being caused by any disease or other condition, according to Sprout Pharmaceuticals, which owns the drug.

It’s unclear exactly how big the market would be for the drug. But, if Viagra is any benchmark, it could be a cash cow. Viagra brought in annual sales of more than $2 billion for Pfizer at the drug’s height.

MORE: Read about Pfizer on the new Fortune 500.

The FDA has already rejected flibanserin twice to date, arguing that its side effects don’t outweigh the risks. Some women’s groups claimed gender bias give that the governmental agency has approved drugs like Viagra for men but left half the population without an option.

However, the FDA countered in its previous reviews that the benefits were “numerically small but statistically significant” and not enough to counter the resulting low blood pressure, fainting, sleepiness, nausea and dizziness.

TIME medicine

FDA Panel Votes in Favor of ‘Female Viagra’

Whether flibanserin receives official approval remains to be seen

An FDA advisory panel on Thursday voted 18 to 6 in support of approving a drug that would help to increase libido in women who lack sexual desire.

The panel said the drug, flibanserin, should be approved if measures are taken to deal with side effects, the New York Times reports. The FDA will use the panel’s decision as a recommendation.

Flibanserin, which is owned by Sprout Pharmaceuticals, has been rejected by the FDA in the past. The drug is meant for women with low sexual desire, specifically Hypoactive Sexual Desire Disorder (HSDD), and many advocates for the drug’s approval have argued that women don’t have any drugs to treat sexual dysfunction while men have several. The FDA has had previous concerns about the drug’s side effects, which include nausea, sleepiness and, in rare cases, low blood pressure and fainting.

The drug is thought to work by targeting neurotransmitters in the brain involved with sexual desire. It temporarily lowers serotonin levels and raises the levels of dopamine and norepinephrine.

Some have argued that its benefit is slight. “I think it would be nice if a drug like this could work, having better sex is important to my patients,” Dr. Mary Jane Minkin, a clinical professor of obstetrics, gynecology and reproductive services at Yale School of Medicine, told TIME on Monday. “The earlier results showed it definitely increased desire, but the benefit was not overwhelming enough.”

But those who lack sexual desire said it’s worth it. Thursday’s meeting included about two hours of public testimony. Katherine Campbell, a married mother from Indiana who has not yet tried out the drug, said “critics say the improvement might only be modest, but oh what I would give for even a modest improvement.”

Whether the drug will receive approval is yet to be seen.

Read Next: Will the New ‘Women’s Viagra’ Finally Get FDA Approval?

TIME medicine

In The Latest Issue

Painkiller Addiction Time Magazine Cover
Photo-Illustration by Bartholomew Cooke for TIME

Why America Can’t Kick Its Painkiller Problem
The price we pay for relief

Will This Be America’s Next Economic Crisis?
The Fed kept the engine from stalling. Getting it to speed again will be harder

Democrats Get a Primary
Why candidates O’Malley and Sanders will make it a race

Burma’s Nowhere People
Thousands of migrants have fled oppression only to meet death on the seas—or face an uncertain future in refugee camps

Love in the Age of Like
Human beings have never had as many romantic options as they do now. Will that doom love or save it?

The Culture

Pop Chart

Hollywood’s New Domestic Divas
Finding a second act selling the good life

Melissa McCarthy: Bond Girl
Spy is this summer’s smart blockbuster

Review: The Gluten Wars
Two new books tackle today’s most controversial food

‘Open the Garage Door, Hal’
Talking gadgets are great at taking my orders. The trick is remembering that I’m still human

10 Questions With Barbara Bush
Turning 90, the former first lady reflects on her husband’s favorite pastime, the advantages of age and her second son’s jump into the 2016 race

Briefing

Payback Is Coming to Rand Paul
By outmaneuvering the Senate, he took on his own party

Making a Deal With Iran
Negotiating isn’t easy, but it’s the smart thing to do

Snoozing and Losing With Sleep Apnea
The disorder is increasingly common—but still often undiagnosed

Rick Perry’s Lone Star Do-Over
The former Texas governor has practically moved to Iowa. Why that may not be enough

Rising Violence
After decades of decline, crime ticks back up

Milestones

Beau Biden
American son

Dennis Hastert
Former Speaker

World

What Matters, what Doesn’t

Unmasking New Threats

Why Online Dating is a Boon for Women

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