FDA pushes for stronger warnings about breast implant risks, including cancer

sergey02/iStock(NEW YORK) — The Food and Drug Administration issued new breast implant guidance on Wednesday, recommending that manufacturers include serious warning labels about the potential complications and risks.

The administration recommended that breast implants carry a “boxed warning,” its strongest form of warning, to inform consumers about links to cancer and other risks in an effort to better inform women who are considering breast augmentation, according to a statement.

“We believe women should have thoughtful and balanced discussions with their health care providers about both the benefits and risks of breast implants based on clear and current information,” the statement said. “We have heard from many women that they are not fully informed of the risks when considering breast implants. They’ve stated that they need more information to facilitate meaningful conversations with their doctors and to make appropriate decisions for themselves.”

The recommendations, which have now been put forward for public review, come months after officials linked certain implants to hundreds of U.S. cases of breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL, which is a rare form of cancer that affects the immune system.

In July, pharmaceutical company Allergan recalled several models of its textured breast implants that were directly linked to BIA-ALCL. The company announced the decision following a recommendation from the FDA. It said the risk of BIA-ALCL in patients with Allergan BIOCELL textured implants is around six times higher than the risk of it in patients with textured implants from other manufacturers in the U.S.

In its statement on Wednesday, the FDA said manufactures should identify the risks of developing the rare cancer, along with other risks, in the boxed warning. It said the chances of developing complications increase the longer a patient has the implant.

The administration also recommends that manufacturers include a patient decision checklist at the end of a patient informational booklet or brochure.

“A checklist gives patients the opportunity to acknowledge individual risks of breast implants, such as potential risks from the surgery, the risk of BIA-ALCL and risk of implant rupture, among others,” the statement said. “Taken as a whole we believe this draft guidance, when final, will result in better labeling for breast implants that will ultimately help patients better understand breast implant benefits and risks, which is a critical piece in making health care decisions that fit patients’ needs and lifestyle.”

Once the guidance is finalized, manufacturers will have the option to either follow the recommendations or choose other methods of labeling, “so long as the labeling complies with applicable FDA laws and regulations,” it added.

Copyright © 2019, ABC Audio. All rights reserved.

Kid skateboarding sensation with cerebral palsy ‘loves life so damn much’

lzf/iStock(NEW YORK) — João Vicente is a viral sensation. A video of the 7-year-old skateboarding with the help of his mom has more than 12 million views on Twitter.

João rides an adaptive skateboard, created by Ricardo Almeida, a skateboarder and dad who created it so his daughter could ride with him.

That invention was eventually adopted by the organization Skate Anima, which is how João came to use it.

“João was born and raised as a typical child,” his mom, Lau Patrón, told ABC News’ Good Morning America.

She and João live in Brazil in a town called Porto Alegre, in the state of Rio Grande do Sul. But when João was not quite 2 years old, something happened.

“At 1 year and 8 months his body collapsed. We found that he has a rare autoimmune syndrome — SHUa,” she said. “He suffered a severe stroke due to the crisis of the syndrome and it was there that he got cerebral palsy.”

Patrón said João, however, always wanted to skateboard.

“He was always the happier, curious boy and liked adrenaline. The dream of skateboarding was old. And the stroke has not changed that,” she said.

So with the the help of the Skate Anima project, his dream came true.

“They cater to many children with various types of disabilities and have found suitable adaptations for each of them,” Patron said. “So that they can feel. It is a very powerful and beautiful work. It is necessary. “

Patrón is a best-selling author, diversity activist and TEDx speaker. She is passionate about her son, whom she called “an amazing, brave, funny boy.”

João now rides a skateboard with Skate Anima once a month.

“I love sports and I love my son, who loves to experience the world and life so damn much. He’s a boy like any other,” Patron said.

Her message to others: Inclusion is not a favor.

“What tools are we building to make the world belongs to everyone?” she said. “How long will we accept the absurd? Kids growing up suffocated by a world that pretends not to see them? We need to change our point of view — understand that places that don’t welcome everyone are disabled, ideas are disabled, planning, education, design. Not people.”

She hopes the joy her son experienced in the video “wakes up” other people.

“I think it is so thrilling to see a boy like João skateboarding, happy, full of life, because we live in a sick society where we often forget the purpose of being here,” she said. “I am so grateful and touched by the love that is coming to us. I have said that love, as a lens and as a filter, is our most technological tool, but one we know the least to use. May João’s smile wake up other people. Diversity is our strength.”

Copyright © 2019, ABC Audio. All rights reserved.

More moms are buying ‘black-market’ baby formula, but should they?

dragana991/iStock(NEW YORK) — Search “black-market baby formula” in Google’s shopping search engine and among the top results will be brands including Holle and HiPP — European baby formulas.

For most moms, feeding baby formula comes down to a decision between the U.S. big brands such as Similac or Enfamil. They’re sold in the local grocery store or online at major retailers, are subject to FDA regulation and and reasonably priced, at least when compared with European brands.

So why are moms, many in large cities, choosing so-called black-market brands instead? Social media groups like the UES Mommas with 36,000 members are abuzz with advice and discussions on how parens can get their hands on European baby formula like HiPP and Holle.

“European standards for organic formulas are better than American fda approved that is controlled by lobbies,” wrote one mom in response to a post asking the group their thoughts on the European brands.

That’s a common sentiment in these groups and one New York City mom Marisa Rose agrees with.She gave her baby HiPP from when he was five months until he turned one. She told Good Morning America” that a major consideration was that the European brand did not have corn syrup as an ingredient.

“I wanted to give him the healthiest start possible,” she said. Rose told GMA she had difficulty with breast milk supply and since supplementing was necessary, she “wanted to do anything I could to feel better” about not breastfeeding exclusively.

Though not FDA-regulated, Rose told GMA she was able to get the formula easily on a website called BabyKindMarket. “It was like ordering anything else online,” she said. “It arrived in two days.”

HiPP and Holle do not distribute directly to the U.S. but BabyKindMarket, plus many more web sites like it, make it easy for American parents to order the formula. One storefront in Brooklyn, New York, called Yummy Ganics, promotes itself on Facebook as “your go to shop for all your Holle HIPP” needs. The company delivers same-day locally via Uber.

“Our products are not made to be compliant with US regulations. Holle baby food products are not specially licensed to the US market and we don’t have an active distribution to the United States,” a Holle representative said in an emailed statement to GMA. “I’m truly sorry but for legal reasons I’m not allowed to give you, as a US resident, any information or advice regarding Holle products, which could lead to import or consumption in your country.”

GMA also reached out to HiPP, but has yet to receive a response.

Rose said HiPP smelled cleaner than U.S. formulas and her son did well on HiPP. The only thing Rose didn’t love about it was the cost, she said. European formulas cost about a third more than the organic U.S. brands.

“We have no way of knowing for certain that they are meeting nutritional and safety standards,” said Dr. Edith Bracho-Sanchez, a primary care pediatrician and assistant professor of Pediatrics at Columbia University

“There are also practical implications as the labels are sometimes in other languages and traditional mixing ratios are different from American formulas,” she said. “Formula that is not properly mixed can have very serious consequences to a baby’s health.”

Still, some parents aren’t deterred by any warnings. Besides local moms groups, there are several national groups dedicated solely to Eurorpean baby formulas. The HiPP & Holle Formulas Parent Support Community Facebook group has 13,000 members and the HiPP & Holle – European Baby Formula Support has more than 4,000 .

While the trend toward the pricier formulas seems most prevalent among wealthier parents, Bracho-Sanchez said the bottom line is familes who can’t afford to experiment with European brands aren’t missing out. Her advice? “I strongly recommend families steer away from these formulas and either try to breastfeed if they’re able, or discuss with their pediatrician the best option for their baby.”

Copyright © 2019, ABC Audio. All rights reserved.

Google searches skyrocket for CBD: What to know about the latest wellness trend, and does it work?

Tinnakorn Jorruang/iStock(NEW YORK) — It seems like everywhere you look, they’re selling CBD.

The non-hallucinogenic marijuana plant extract is found in everything from skin creams to dog treats, all with claims of miracle-like results.

Interest in CBD as a potential treatment for health issues including anxiety, Parkinson’s disease and seizures is also now higher than ever, new research shows.

In April alone, there were 6.4 million Google searches for “CBD” or “cannabidiol,” according to the research published Wednesday in the Journal of the American Medical Association (JAMA).

Researchers saw a 160 percent increase in CBD searches during 2018 compared to previous year. They described Google searches for CBD as now reaching the numbers for yoga and e-cigarettes.

But what is CBD, and is the hype actually real? Let’s have a look.

What is a Cannabinoid?

There are three types of cannabinoids. Endocannabinoids, which are produced naturally in the body; man-made cannabinoids, which can be really dangerous; and the most popular, cannabinoids such as THC and CBD, which come from the marijuana plant.

All three kinds of cannabinoids bind to cannabinoid receptors in the body. CB1 receptors, located primarily in the brain, are believed to control mood, memory, sleep, appetite and pain. CB2 receptors are located in parts of the body that produce blood cells, such as the spleen, and are believed to affect inflammation.

What is CBD?

CBD is short for cannabidiol, and it’s one chemical compound found in the Cannabis sativa plant — in both marijuana and hemp. CBD differs from THC (tetrahydrocannabinol) because it doesn’t cause the intoxicating, euphoric “high” associated with marijuana.

What are the health benefits?

Though there are claims of health benefits wherever you go, the science isn’t quite there yet — most of the research that has found benefits was done on animals. That’s because researching marijuana legally is difficult. Marijuana is a schedule I controlled substance, defined as having “no accepted medical use and a high potential for abuse.”

Still, there’s a lot of anecdotal evidence. One case: Charlotte Figi.

A robust and active toddler, Charlotte began having seizures early in life — up to 50 per day. She was diagnosed with Dravet syndrome, a seizure disorder that can be uncontrollable with typical medications. After exhaustive research, Charlotte’s mother found that the best treatment was a combination of CBD extract with Charlotte’s normal antiepileptic drug regimen. This cut the seizures down to two to three per month, allowing her to live a normal childhood.

In June 2018, the FDA approved a CBD-containing seizure medication called Epidiolex, which can be used for the uncontrollable seizures caused by diseases such as Dravet Syndrome.

CBD is also widely used to treat pain and anxiety. Scientists are quick to say they are still unsure of the way this works, but they believe it may be due to CBD altering some brain pathways linked to these symptoms.

In skin care, CBD has been reported to treat itchiness, acne and allergic dermatitis — a skin reaction to allergies. While the mechanisms here are also unknown, scientists think it may be due to cannabinoid receptors in the skin which, when activated, work to reduce inflammation.

As states move to legalize these compounds to the public, all of these claims will need to be studied.

How do people use CBD?

Many CBD products are sold as oils or balms, but they are also available in lotions, facial serums, lozenges or as part of cocktails. Although manufacturers claim there is an appropriate dose for the products they make, that is up for debate. The nutrition and supplement business, in general, is highly unregulated and this includes CBD products, even in states with legal marijuana.

What are the risks?

Both the benefits and risks of CBD lack substantiated research. As with any supplement, there is always a risk for unintended drug interaction. A small number of studies on animals indicate that CBD could potentially affect cell health and the breakdown of drugs in the liver. In humans, a study that investigated CBD’s effect on seizures noted side effects including diarrhea, vomiting, fatigue, and increased sleepiness.

Why is it popular now?

In a word: marketing.

Similar to vitamin C and kale, CBD is undergoing a rise to fame just similar to the way that kale has been labeled a “superfood,” which is a non-medical buzzword. And with celebrities publicizing anecdotal benefits, there’s been easing tension surrounding CBD’s stigma.

But most importantly, as mentioned, it’s being marketed as a fix for various ailments.

Is it legal to use CBD?

Not Exactly. As mentioned, marijuana is still a schedule I substance, and that includes CBD.

The issue of legality comes down to how the CBD is obtained. The THC portions of the cannabis plant include the flowering tops (buds), the leaves and the resin of the plant. The remainder — the stalks and sterilized seeds — is where most CBD comes from. However, producers can also obtain it from the THC portions in which case it might yield a mixture of THC and CBD.

According to Katherine Pfaff, a spokesperson for the DEA, “If the product does cause THC to enter the human body and/or contains greater than 0.3 percent of THC, it is an illegal substance that may not be manufactured, sold or consumed in the United States. If, however, the product does not cause THC to enter the human body and contains less than 0.3 percent THC, it is a non-controlled substance that may lawfully be sold.”

The National Institutes of Health lists over 150 studies involving CBD as a treatment for various diseases. The World Health Organization concluded in a press release that CBD is not harmful. And in the sports world, the World Anti-Doping Agency removed it from its prohibited substances list.

To top this off, CBD is widely available online as well as in countless bars and coffee shops nationwide. This legal ambiguity undoubtedly confuses consumers, and it won’t change until further research trickles in.

The bottom line is there are countless claims regarding CBD’s ability to cure common ailments and there are also many places to buy CBD over the counter. But while there are many people willing to answer for CBD, the reality is there are still many questions that the industry itself needs to answer.

Copyright © 2019, ABC Audio. All rights reserved.

Doctor introduces the ‘pegan’ diet in a new book

Courtesy Nicole Franzen(NEW YORK) — Many families struggle figuring out what to make for dinner even when they have a fridge stocked with food that they can easily make into a meal.

But one doctor is helping others tackling the question in a new book that introduces the “pegan” diet.

“One out of every two Americans — actually it’s 60% now — are sick,” Dr. Mark Hyman told ABC News’ Good Morning America. “Seventy-five percent of us are overweight. And it’s the food we’re eating.”

Hyman, the author of Food: What the Heck Should I Cook? coined the term “pegan” after realizing that there were certain principles from vegan and paleo diets that are beneficial for people as well as the planet.

“It’s universal principles for how to eat well if you’re a human being,” Hyman told GMA. “It includes all the food categories that people eat, but in each category it tells you which are the foods you should choose in that category.”

The secret to the pegan diet is non-starchy veggies, like broccoli, asparagus and greens.

“Vegetables have very few calories, but lots of nutrients. So they’re high in fiber,” he said.

Hyman recommends that 75% of your plate should be filled with non-starchy vegetables, followed by healthy fats like avocados and nuts; high-quality protein, such as pasture-raised chicken and grass-fed meat; and starchy vegetables like potatoes and winter squash.

He said, “It’s also important to understand that the quality of the food you eat matters most. And that’s really what pegan is about. It’s about the quality of the food.”

In his new book, The New York Times bestselling author features more than 100 recipes to promote weight loss and lifelong health. He hopes to inspire others to eat food that they love and food that’s nourishing, healing and good for the planet.

Copyright © 2019, ABC Audio. All rights reserved.

Five women share what it’s like to have a miscarriage

ake1150sb/iStock(NEW YORK) — If you or your partner haven’t had a miscarriage, statistics indicate that you likely know someone who has.

For women who know they’re pregnant, 10 to 20% will experience a first-trimester loss, according to the Mayo Clinic. That number is likely higher, many experts said, as it’s common for a woman to miscarry before she even knows she’s expecting.

What’s more, one recent study indicated that 43% of mothers reported having had one or more first-trimester losses.

And still, miscarriage remains a taboo topic.

“It’s one of the many topics in medicine that we need to de-stigmatize and we need to bring out of the shadows,” said ABC News Chief Medical Correspondent Dr. Jen Ashton, a board-certified obstetrician and gynecologist. “It’s so common and so many people, unfortunately, experience it.”

Five of these women, from all around the country, opened up to ABC News’ Good Morning America about their experiences.

Lauren Riggs, 24, Nashville, Tennessee

“I am actually oldest of seven and just from a very early age knew that I wanted to be a mom. My husband and I got married in 2017, and we started trying for a baby in April 2018. I found out I was pregnant at the end of July. We got to see the baby when I was seven weeks along, got to see its heart beat at the bottom of the screen. It was just so surreal knowing that we had created something so beautiful living inside of me. We were just completely over the moon.

“We passed the 12-week mark and decided to share with social media that we were pregnant. The day after, I started bleeding pretty heavily, so I called my OB-GYN and was kind of reassured that sometimes it’s normal [to bleed], and not to panic. She said if it persisted over the next few weeks to call and make an appointment. So for the next week, I tried to do that — just stay calm and trust that everything was gonna be OK.

“A week after I started bleeding, I woke up to a lot of blood and I just knew something wasn’t right. I went to my OB-GYN and they scheduled an ultrasound. When the ultrasound tech came in, she pointed the screen away from me. After about five minutes of silence, I said, ‘You see the baby, right? The baby’s there, right? Is everything OK?’ And she said, ‘I see the baby. I’m taking measurements. I’ll get you back to the doctor.’ I didn’t get to see the baby that day. I just kept telling myself everything was fine. She saw the baby. Everything’s fine, because I passed my 13-week mark. Everything was supposed to be perfect at that point.

“My doctor came in and she told me that there wasn’t a heartbeat. I just remember feeling like someone had thrown me into deep hole and slowly started to pour rocks on me because it was just crushing. Every second was worse than the last. It was just devastating.”

“The next day my doctor called me and I told her I wanted to try to miscarry naturally. She prescribed some pills for me, so I could try to pass the baby as naturally as possible. A few hours later I started passing blood clots and cramping, and my doctor told me to go to the hospital and to make sure everything passed correctly. When we did, they did another ultrasound and found that we hadn’t passed anything. My husband and I just stared at the screen; it was just so much different than what I had seen the first time, when I saw it moving around the screen. The next day we picked up the medicine and I started the process again. The medicine just didn’t work.

“My husband and I made the decision to have a D&C done. We found out on Monday; this was Friday, so it was a very long, drawn-out process. I don’t remember anything from the day I had my D&C, and I think it was a gift because I was so emotionally tired. I do remember telling every single person I saw, ‘I really don’t want this to happen. I really want you to just fix it.’ I just wanted to have my baby back.

“We started trying again in April of this past year and found out we were pregnant June 28. A week later, we found out we were miscarrying again, and that process was a lot different. I was not as far along. We decided after that we were just gonna start trying again immediately. There’s a part of you that just doesn’t want to do it again because it’s so terrifying and there’s a part of you that wants to know that you have the ability to do this. I don’t think I’ll ever have a normal pregnancy where I’m happy all the time and never feel any fear or anxiety. I’ve learned that it’s OK. I have to let myself heal how I have to heal.”

Kate Lemmon, 28, Boston

“I’m originally from San Antonio, Texas, and I’ve been living in Boston for seven years now. I live with my husband; we celebrated our third wedding anniversary in April, and we’ve been together for six years. I’m lucky to have him; he’s been a super rock through this whole thing. I don’t know how I would’ve gotten through this without him.

“We tried starting in January, found out I was pregnant right in July, and then I miscarried about three weeks later, at about 6 1/2 weeks.

“I expected that a miscarriage was a very real possibility. In fact, I Googled the miscarriage statistics every single day that I was pregnant because it was always a fear, but no sort of awareness beforehand could’ve prepared me for exactly how much miscarriage threw us for a loop. We had put so many hopes and dreams into this pregnancy. Each cycle was a crushing blow on its own, so when we finally did get the positive test in July — this was after six months of the whole fertility journey — I was so excited that we had come to the end of the trying part and we were passing into the pregnancy part. I was just so excited to be starting our family.

“I only knew I was pregnant for three weeks, but in those three weeks our entire lives changed. In the instant that you find out that you’re pregnant, you’re already a mom. You instantly start to bond with your baby and everything is based around pregnancy. So when I miscarried I felt like all of that came shattering down all at once. It wasn’t just the baby, which is obviously so sad to lose because I had dreamed about this for so long, but I think it was also for us the loss of first pregnancy. I know that miscarriage is hard for people no matter what, but I felt like there was something especially tricky about having a miscarriage for our first pregnancy, just because I lost the ability to have an innocent pregnancy in the future. I know now, if we are lucky enough to have another child, it would be filled with a lot of fear and anxiety at least at first.

“My husband and I grieved in different ways. I wish I’d known that was OK at the time, because immediately following the miscarriage, I was crying all day and couldn’t get out of bed, and I think he was waiting for more official news from the doctor. He was processing it in a different way. I wish I could tell myself, ‘Even though your husband is grieving in a different way, doesn’t mean the loss hurts any less for him.’ I wish we had worked harder in those initial days to understand each other’s grief.

“I wish I had some sort of happy ending to give you but to be honest, the part after miscarriage, which we’re immediately in, has been stressful for the two of us. In a way it’s brought us closer together because we’ve had some really deep conversations and planned a lot for the future. But in other ways, there’s no glamorous way to put it: We’re just kind of tired. Grief is tiring and trying again is tiring. It’s been a long year for us. I’m thankful that our marriage has come through this and it seems like it’s stronger than ever, but it’s a journey I wouldn’t have chosen. I’m still trying to find things to be grateful for in the middle of it.”

Aftan Sylvester, 34, Glen Burnie, Maryland

“My husband and I found out that I was expecting at the very end of March or the beginning of April of this year. I’m obese, I’d been diagnosed with hypertension and my 35th birthday was near my due date, so I was considered a high-risk pregnancy and they were keeping a watch on me. I had my first appointment and sonogram at six weeks when it was confirmed that I was pregnant, and then I kept going every other week after that. Everything seemed to be normal. In fact, my doctors were really excited because my blood work looked so good, but I did have a little bleeding. It looked like old blood.

“I went in for my 10-week checkup, and when I was checking in, I told the nurse about the brown blood. Because of that, after the doctor did his exam he asked if I had time to do an ultrasound. I did.

“I’d been seeing the sonogram tech every other week, so I’d was getting to know her. I knew immediately something wasn’t right; her demeanor changed. She got really somber. She switched over so she could see the heartbeat and all you saw were lines. She said that she needed to talk to the doctor and I probably sat in that room alone for about 10 or 15 minutes. I just knew that my baby was gone and I could not stop crying.

“Finally, the doctor came in and he said, ‘I’m very sorry to have to tell you this, but it’s evident that your baby doesn’t have a heartbeat.’ I could not believe that this had happened.

“I drove to my husband’s job to tell him face to face, and on the way, I started feeling anxiety. I was like, ‘How am I going to tell him this? And why do I have to tell him this? Why is this happening to us?’ When I got there, I couldn’t even look at his face, but I could hear in his voice that it was cracking. He took the rest of the day off of work.

“The doctor had been pushing for me to go ahead to have a D&C but I didn’t feel comfortable in making that decision right away. Once I was home, I researched it versus letting it happen naturally, and decided that for me, it was better to just get it over with. I felt like the D&C was a way for me to just be able to move on.

“When I checked in for the surgery, my husband went with me and I remember feeling like a failure. I wasn’t prepared for the amount of grief that I felt. It’s crazy to have that much grief for a child that you never met. When you find out that you’re pregnant you have all these hopes and you start planning for the future. What if it’s a girl? What if it’s a boy? You think about nursery colors and your baby shower. When you find out the baby didn’t make it, all of that stops abruptly. If you’ve never gone through this you will never be able to understand how much it really hurts.

“We started trying again after my post-op appointment, two weeks after my D&C. I found out the day after Father’s Day that I was pregnant again. It happened very quickly and we were happy, but cautiously so. I felt like I could not allow myself to get attached to the baby in the beginning. I knew I was pregnant but I kind of put it in the back of my mind because, it was like, what’s gonna happen this time? Will it happen again? I felt like I needed a sonogram every week just to make sure the child was alive. And then, at 12 weeks, I passed a blood clot. I was freaking out, but it was fine. I have no idea what happened and the doctor doesn’t either, but he said it’s not uncommon to bleed at that time. It’s nerve-wracking even still, though, and I’m 18 weeks now. My husband said he’s going to worry until the baby comes out.”

Chelsea Caris, 28, Oakdale, California

“I’ve had four losses total. My husband and I recently went through infertility treatments that didn’t work. Twice we were able to to conceive and would be pregnant for three or four weeks and then I would miscarry. Those were very early on. The miscarriage that I usually talk about are the twins. I was almost 20 weeks along when I lost them.

“My husband and I conceived naturally the first time. Twins don’t run in either of our families; it was one of those luck of the draw things. At the time, we didn’t want to do extra testing because we felt it was unnecessary. What ended up happening threw us: At about 19 1/2 weeks, I started feeling really heavy cramping. I didn’t have any bleeding, but it was just a really odd feeling — almost an intuition kind of thing. We went to the doctor and found out that I was having a molar pregnancy, which essentially means that [the fetuses] had benign tumors growing on their bodies at a very fast and abnormal rate.

“Sadly, if you have a single fetus, the molar pregnancy can take over and you will miscarry. Most women who have it don’t even know they have it because they’ll miscarry on their own. Because we had twins, the molar pregnancy started on one fetus and the other kept the pregnancy going, which is why my pregnancy lasted as long as it did. I had to deliver them. One delivered and the other had to be removed surgically. It was surreal — we got all the information and then I was in surgery two days later. There was no real moment to accept it. I knew there were high-risk pregnancies but you never think it’ll be you, especially if you’re healthy and never had issues before.

“Once we lost our twins, we tried again for two whole years, and we got nothing. We didn’t understand what happened. My doctor told us that my uterus healed just fine and there shouldn’t be any reason why we couldn’t conceive again. It was so confusing. When I started my Instagram, I looked up how many people were going through infertility who’d had miscarriages and there were so many. I remember telling my husband, ‘I can’t believe how common this is.’

“Infertility doesn’t just cause issues with your fertility. It causes issues everywhere else too: your social life, your sex life, your relationships, your financial situation. It literally affects everything else. It causes problems with your husband, your friends who have kids, the money you have to save for procedures and medications — even your self-worth. You ask, ‘Why is my body broken and hers isn’t?’ You think people who are battling infertility are only having one problem, but no, they’re having a very loaded problem.

“I felt like nothing would ever be OK again, ever, but my husband and I are pregnant now after undergoing IVF. We just got past our first trimester. My stepson, Silas, is really, really excited. He’ll kiss my belly and he’ll talk to it and say, ‘You need to come out this time. I need a brother this time.’

“I still have my moments where I panic. We’ve done extensive testing on this baby and everything looks fine, but there are moments where I’ll break down and need my husband to reassure me that it’s gonna be OK, no matter what happens. That’s what I need — the faith part. Because when you lose a child, your faith just goes out the window. One of the best things that I ever heard was, ‘Losing a child like that is like losing an arm or some other limb: You can survive it, but it’ll never be the same. You just adapt to the missing part.’ There’s no silver lining there. You heal but it’s just not the same anymore. You just adapt.”

Heather Hodnicki, 30, Hamilton, New Jersey

“My son, Cole, just turned 1 in August. Probably when he was about 10 months old, I got my first cycle back. At that time my husband and I made the decision to start trying and we actually got pregnant on the first try. I did have some light bleeding for three days before we got a positive pregnancy test, but they say you can have implantation bleeding. Two weeks later, at about six weeks [gestation], I had a blood test where they tested my HGC and progesterone levels and that came back very reassuring. We weren’t going to have an ultrasound until eight weeks, two days, and then we were going to leave for a family vacation the next day. We were planning to have the ultrasound and then tell our families the good news.

“At the appointment, they did a transvaginal ultrasound and everything looked different from the first [with Cole]. The ultrasound tech asked if I’d had any bleeding, and I had had intermittent bleeding but it was brown blood which they say isn’t worrisome. My friend had bleeding her entire first trimester and her pregnancy was fine. The ultrasound tech said, ‘There’s a hematoma, a little hemorrhage, around the baby,’ but at that point the baby had a great heart rate. The techs can’t tell you much more than that. We followed up with the doctor and he told us what we already knew: The subchorionic hematoma could reabsorb or the pregnancy could go on to be normal. I said, ‘I know you can’t give me an answer, but if you could, what are the chances that this will be a full-term pregnancy?’ He said, ‘Let’s say 50/50.’ I cried because you start to love that potential baby as soon as you pee on the stick and see two lines. The heartbeat made it more real.

“That Wednesday I started feeling crampy. I went to the bathroom and saw a little bit of red blood. I put a pad on and kept it to myself. I tried to tell myself, ‘It’s just the hematoma coming out. The baby’s going to be fine.’ But the bleeding kept getting heavier and the cramps were still there.

“I made my husband break the news to his family. He said, ‘Hey, we’re pregnant, but before you get excited, I think we’re miscarrying. Heather’s going through this right now.’ That night, I kept running back and forth to the bathroom wondering, ‘When is it gonna stop?’ Finally a large clot of tissue came out and I knew that was it. My husband tried to walk into the bathroom and I pushed the door closed and locked him out because I was scared. I didn’t want it to be true.

“The next day we had an ultrasound at an radiologist affiliate place and they wouldn’t let my husband into the room. You’d think at that point you’d want the female to have her partner with her but I guess they had their reasoning. Once they put the probe in you could obviously see what’s going on. As a nurse, I knew right away. I said, ‘I can’t see anything.’ The ultrasound techs aren’t supposed to give you medical information — it’s supposed to come from a doctor — but she was actually able to exchange her miscarriage story with me while she was finishing her measurements and I was just crying. It was comforting talking to her. It’s weird, because you’re not happy that someone else went through it but it’s nice to know that you’re not the only one in this position.

“I have a negative blood type, so within 72 hours, I had to get a RhoGAM shot to protect myself from antibodies that could attack my next pregnancy. That process drove on til Friday. On Sunday we went home, and that’s when I started to process things more. Earlier I had to sweep it under the rug — be a mom, and be happy on vacation. I was supposed to go to work on Monday but I wasn’t ready. I felt fine physically, but emotionally I was a mess. I was on YouTube searching for how people felt: am I supposed to feel this way? Am I supposed to be over this by now? What am I expected to feel like? It’s hard to find answers.

“Miscarriage humbles you. It makes me so sad to think that some people have miscarried so many times in a row and I’m sitting here and it’s like, ‘Why should I feel so sad? I have my son and some people don’t have any kids, and some people can’t have kids. Do I even have a right to feel sad when I was lucky enough to have the child I have?’ It’s crazy the places that your mind goes.

“But I felt empty, physically and emotionally. There are so many things to be thankful for, but no matter how beautiful everything is, you still feel like something’s missing. And it’s OK to feel that way because something is.

“This past Monday I made a doctor’s appointment because I wanted someone to to tell me I’m OK. My gynecologist was very comforting, and one of the questions I asked was when I could try for the next baby. We want to try to conceive again as soon as possible. Let’s say I do get pregnant in October or November: that baby wouldn’t have existed if I hadn’t had the miscarriage. I can’t wait to give my son a brother or sister.”

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FDA approves ‘miracle’ treatment for cystic fibrosis

Olivier Le Moal/iStock(WASHINGTON) — “Imagine waiting 28 years for a miracle, and then it suddenly happens.”

That’s how Gunnar Esiason, a 28-year-old graduate student at Dartmouth College, described the approval of Trikafta, a new drug for cystic fibrosis.

Esiason has been living with CF since 1993, and, in an interview with ABC News, said that the disease didn’t significantly affect his life until he was a college student.

“In 2013, things got pretty ugly for me,” he said. He started to have new pulmonary symptoms, waking up most days coughing up blood. He began losing weight. Since then, he’s been in and out of the hospital with repeated infections and undergone more than two dozen medical procedures.

That all changed in 2018 when he enrolled in a clinical trial for Trikafta.

Cystic fibrosis is a progressive genetic disorder that results in a dysfunctional protein called CFTR that transports chloride and water across cell membranes. Patients with CF have thick mucus that clogs the lungs, leading to infections, inflammation and ultimately respiratory failure. Additional symptoms include decreased sweating, gastrointestinal upset, poor growth and infertility. More than 30,000 people suffer from CF in the United States, with 70,000 affected worldwide according to the Cystic Fibrosis Foundation. Roughly 90 percent of patients with CF have at least 1 F508del mutation that causes their illness.

That’s why there was great excitement in the cystic fibrosis community when the U.S. Food and Drug Administration approved Trikafta on Monday, the first triple-combination therapy available to treat patients with the most common cystic fibrosis mutation.

The drug’s approval is “making a novel treatment available to most cystic fibrosis patients, including adolescents, who previously had no options and giving others in the cystic fibrosis community access to an additional effective therapy,” acting FDA Commissioner Ned Sharpless said in a statement.

Trikafta, manufactured by Vertex Pharmaceuticals, helps defective CFTR protein in patients with 1 or 2 F508del mutations function more effectively. The medication has been approved for patients 12 and older.

Its approval was fast-tracked via four different FDA programs that aim to provide treatments for rare or serious illnesses with unmet medical needs. This came after two clinical trials, the first of which showed improved measures of lung function in patients compared with a currently available drug. The second trial also showed improved lung function along and increased sweat production and body mass index in patients vs. a placebo. Adverse reactions in the trials included headaches, upper respiratory tract infections, abdominal pain, diarrhea, rashes and increased liver enzymes.

Esiason said that when he began his Trikafta trial, it “started working almost instantaneously.” In the first few days, he noticed an improvement in his breathing and appetite. Within the first few weeks on the drug he started to gain weight and his pulmonary function tests improved. These developments made him hopeful.

“I started to think about what’s next in my life. That’s when I decided to start at Dartmouth,” where he’s pursuing his Masters of Business Administration.

Dr. Joan DeCelie-Germana, director of the Cystic Fibrosis Center at Northwell Health, has been treating patients with CF for over 30 years. In an interview with ABC News, she called the drug’s approval “very exciting.” Her center participated in the initial studies for Trikafta and also serves as the site of a current trial of the drug in patients 6 to 11.

Discussing initial trial results, she added that “patients had an improvement in lung function and less illness” and that “they will enjoy more days without antibiotics and better quality of life.”

She underscored the impact of this new development: “It’s inspirational. I couldn’t have even thought of this 30 years ago. It’s not a cure, but it’s the closest thing we have.”

Trikafta is Vertex’s fourth FDA-approved drug for CF since 2012. It will be available through specialty pharmacies in two weeks with an annual cost of $311,000. A representative from Vertex said current CF medications are “widely reimbursed by private insurers and Medicaid/Medicare” and that the same is expected for Trikafta.

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In dramatic turn, Biogen seeks FDA approval for experimental Alzheimer’s drug

Ildar Imashev/iStock(CAMBRIDGE, Mass.) — In a surprising turnaround, Biogen Inc. announced Tuesday it would seek approval for an experimental Alzheimer’s treatment from the Food and Drug Administration.

The announcement comes as a shock because Biogen killed studies of the same drug, known as aducanumab, in March of this year on the grounds that the drug was unlikely to work.

“With such a devastating disease that affects tens of millions worldwide, today’s announcement is truly heartening in the fight against Alzheimer’s,” Michel Vounatsos, Biogen’s CEO, said in a statement.

The treatment is not a cure for Alzheimer’s disease. Instead, it’s intended to slow decline associated with the condition among those who have early-onset Alzheimer’s disease.

Aducanumab, which is injected intravenously, travels through the body to brain, where it targets plaque, a contributing factor in Alzheimer’s disease, explained Dr. Andrew Budson, a neurology professor at Boston University School of Medicine.

Budson said patients of his who were enrolled in the initial aducanumab trial were “very” disappointed when the trial stopped. When the studies repeatedly failed, Budson and others were starting to wonder whether the strategy was helping patients at all.

“It was like another nail in the coffin of the hypothesis,” he said.

The turnaround “sends a message of hope for those in the study, as well as to the field as a whole,” Budson added. “When you have an incurable neurodegenerative disease that literally robs people of their thinking and memories — their minds — anything that can help is a wonderful thing.”

Since there are currently no therapies available for reversing the effects of Alzheimer’s disease, which affects at least 5.7 million Americans, according to the Centers for Disease Control and Prevention, any promising development is likely to capture the attention of the public.

Shares of Biogen jumped more than 35 percent after the announcement. The biotech company plans to send its application to the FDA early next year.

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Shortage of critical cancer drug forcing some children to go without

michaelquirk/iStock(NEW YORK) — When 4-year-old Milo Sligh, of Charleston, South Carolina, was diagnosed with childhood acute lymphoblastic leukemia the word “cancer” was frightening, but the prognosis was hopeful, according to his mother, Marisa.

The diagnosis of a childhood cancer is a life-changing and highly emotional experience for families and the affected child, but the chemotherapy medication vincristine is a tried and true regimen effective for treating many childhood cancers, including leukemia, lymphoma and brain tumors. But instead of the simple remedy, the Slighs — and many other families — fears’ are multiplied now that the low-cost, generic medication is in short supply and doctors have started rationing its usage.

The shortage is especially frightening because there is no known drug available that is equally effective.

“We are greatly concerned that some children are already being impacted by this shortage and by the understandable anxiety this creates for all families of children with cancer,” Dr. Peter Adamson, chair of the Children’s Oncology Group, said in an open letter to the childhood cancer community just days ago. He went on to say this is “an unacceptable crisis” and he is “infuriated that this situation has occurred at all.”

“Every child with cancer whose treatment requires vincristine should receive the drug as scheduled,” he added.

A petition on WhiteHouse.gov has over 73,000 of the 100,000 signatures required in 30 days to get the White House to respond. The petition includes language like, “Our children are going to start relapsing and dying at higher rates if we do not do something about this shortage immediately!”

Earlier this month, pharmacists started raising concerns about the ability to obtain vincristine. Pfizer, now the only supplier of the drug in the U.S., reported experiencing a shortage due to manufacturing delays. According to the U.S. Food and Drug Administration, Teva Pharmaceuticals made “a business decision” to stop supplying the medication in July 2019.

Kelley Dougherty, vice president of corporate communications for Teva, told ABC News in a statement the company “alerted the FDA of its decision [to stop manufacturing vincristine] in March 2019.”

Pfizer told ABC News in a statement, “We are expediting additional shipments of this critical product over the next few weeks to support three to four times our typical production output.”

Acute lymphoblastic leukemia is the most common childhood cancer, impacting about 3,000 children a year, most aged 2 to 5 years old. It occurs when the bone marrow makes too many immature white blood cells. Symptoms may include fever, fatigue, easy bruising, bone pain, bleeding from the gums, swollen lymph nodes and frequent infections. Children need to be treated quickly with chemotherapy once a diagnosis is made.

In addition to chemotherapy, treatments can include radiation and targeted therapies, and “around 98% of children with ALL go into remission within weeks after starting treatment and about 90% of those children can be cured,” according to St. Jude Children’s Research Hospital.

Patients are considered cured after 10 years in remission.

Milo has responded well to his treatment, but Marisa worries that she may be told he can’t get vincristine at his appointment in two months because of the shortage.

“Every time a dose is missed his chance for cure is decreased,” she said.

The FDA says on its webpage that it expects vincristine to start shipping by the end of October and supplies will reach recovery levels by January 2020.

“We are working closely with [Pfizer] and exploring all options to make sure this critical cancer drug is available for the patients who need it,” the FDA said in a statement to ABC News.

Marisa is anxious because of the posts on her tight-knit Facebook group from other families who have not received vincristine, or got a smaller dose than usual.

Laura Brewer is part of the Facebook group for parents of children with ALL. She lives in Kansas City, Missouri, and her 5-year-old son, Titus, also has acute lymphoblastic leukemia and is in remission. She said his appointment for treatment next Thursday will not include vincristine, because the doctors told her they need to ration it, perhaps for someone with a newer diagnosis.

“It is terrifying as a mom that a drug your child needs is not available,” Brewer said.

Her biggest fear for Titus after turning the corner is that his cancer will return: “You pray and hope to God nothing shows up [in future testing].”

Vincristine has been on the market since 1963 and is a staple drug in the treatment of ALL, but most kids will need to get intravenous infusions of vincristine for two to three years for maintenance treatment to keep them in remission.

Dr. Damon Reed, adolescent oncologist at the Moffitt Cancer Center in Tampa, Florida, said that vincristine is used in “greater than 50% of cancers in pediatrics” and “fewer than 3% of adult cancers.”

“Every [hospital] has a vincristine story,” Reed remarked.

Without refills arriving to their center soon, Reed said his cancer center may run out by November or December. Drug shortages force doctors and pharmacies to ration drugs, which is never beneficial for all patients. He said that he has experienced several cancer drug shortages in his years of practice. The reason may be because the tried and true generic medications aren’t very profitable.

In his open letter demanding action, Adamson said that the frequency of drug shortages has increased in the past 10 years.

According to FiercePharma, “With margins on generics having gotten very thin in recent years, many drugmakers have given up production of products where they are not dominant in the marketplace. There are currently 202 drug discontinuations listed on the FDA Drug Shortages website.”

One potential reason was the Medicare Prescription Drug, Improvement and Modernization Act of 2003, which capped the amount that hospital systems are reimbursed for intravenous cancer drugs.

Dr. Roger Bate, a scholar at the think tank American Enterprise Institute said there is a “lack of competition” among manufactures because of the historical “slowness of the FDA [generic] approval process.” Lack of competition means that there are fewer suppliers and consumers are dependent on one company, or a few, to get the drug. Another reason may be that “manufactures are not making enough profit” and some drugs “are too cheap.” The average price for vincristine is “about $5,” according to Adamson.

Bate also noted that generics, or bioequivalents, frequently face issues with quality control, which makes it difficult for companies to continue to produce the product. As a result, they may stop making the drug and shortages happen.

Dr. Marty Makary, author of The Price We Pay, said “flimsy supply chains” can create drug scarcity. An illustration of this was the normal saline deficit that affected the entire country after the destruction of factories in Puerto Rico during Hurricane Maria. The FDA formed the Drug Shortages Task Force in July 2018 in response to increased drug shortages. They hosted a public meeting in November 2018 to perform a root-cause analysis and developed immediate and long-term strategies for these situations.

The hope for Milo and Titus is that their survival will not be impacted by the current shortage of vincristine, but the drug is only one example of the current problem the U.S. is facing in regards to generic drug manufacturing and shortages.

“While we are infuriated that this situation has occurred at all, we should do our best to have advocacy efforts stay focused on solutions,” which may include short-term importation from other countries, according to Adamson.

“I am hopeful we can take this unacceptable crisis and move toward better answers, always keeping the interests of patients and families central to our efforts,” he added.

For any family that is currently having difficulty obtaining vincristine for their child, the FDA recommends that you contact them at drugshortages@fda.hhs.gov.

Copyright © 2019, ABC Audio. All rights reserved.

What to say to someone who’s had a miscarriage

nicoolay/iStock(NEW YORK) — Miscarriage, or the loss of a pregnancy, is disturbingly common — so much so, that if you haven’t had one, you likely know someone who has.

Though it’s impossible to say how many pregnancies end in miscarriage, as many occur before a woman knows she’s expecting, the Mayo Clinic reports that at least 10% to 20% of pregnancies result in a loss.

Still, it can be difficult to know how to comfort those who are grieving.

According to Dr. Ivy Margulies, a Santa Monica, California-based clinical psychologist who specializes in pregnancy and infant loss, the most important thing is to acknowledge what happened.

“Don’t ignore the obvious. Silence is worse than anything,” Margulies told ABC News’ Good Morning America. “People think, ‘She’ll be upset if I say something,’ but it’s actually the opposite. By discussing it, you’re validating the experience and honoring the grief, however you conceptualize conception. It’s about holding space for the emotional experience around grief and trauma.”

Of course, some words are more helpful than others. Here are the dos and don’ts from experts and women who have experienced pregnancy loss:

1. Be present, literally

Lauren Riggs has suffered two miscarriages, and wishes others knew that they didn’t have to actually say anything to her.

“Nothing anyone said was going to fix anything,” she said. “What I wish someone would’ve down was come and sit with me, especially in those first few weeks. I spent a lot of time by myself and I had people I could text, but I couldn’t bring it upon myself to say to someone, ‘Look, I really need someone to come to my house because I’m home alone, crying in bed.'”

The best thing close friends did, she explained, was show up and maybe bring dinner. “That really helped,” she added.

2. Don’t assume a loss is being processed in a specific way

Many women internalize their miscarriages as the loss of a baby, but others do not.

“I’m always respectful about how people want to understand that loss for themselves,” Margulies said.

3. Check in regularly

Margulies encouraged people to check in with the grieving person or couple regularly, and not to worry that you’ll ruin a “good day.” However, she warned, a grieving person may not be overly responsive.

“Say, ‘You don’t need to respond, but I’m here for you if you need anything,'” Margulies advised.

4. Avoid statements that can be misconstrued as dismissive

Dr. Jennifer Ashton, ABC News’ Chief Medical Correspondent and a board-certified obstetrician and gynecologist, said that comments like, “You can always try again,” or, “You can always have another baby,” can be damaging, even if they’re well-intentioned.

“A miscarriage in any trimester is a loss, and that is incredibly emotional and painful,” she said.

Phrases that begin with “at least” (“At least it happened early,” “At least you can get pregnant”) should be avoided, too.

“There’s no ‘at least,'” said Chelsea Caris, who has experienced two early miscarriages and a second trimester loss of twins. “There’s no silver lining there.”

5. Realize that optimism can be seen as unempathetic

Riggs pointed out that sometimes when people would try to cheerlead, they came across as unfeeling.

“I found it to be so hurtful when people say, ‘You’re so young! It’ll happen again,'” she said. “It’s a lot scarier trying again and people don’t realize that. There’s a lot of extra anxiety and stress that comes with it.”

6. Understand that everyone grieves differently

Aftan Sylvester said that after her miscarriage, she was told, “You just have to dust yourself off and try again.”

“You just don’t dust things off like that,” she told Good Morning America. “Be gentle with a person, because everybody has different triggers. Know that it may not be a big deal to you, but for them it was a big deal.”

7. Validate the person’s feelings

“Don’t feel like you need to ‘fix it’ or ‘make it better.’ Just say, ‘Wow, that sounds really hard. Do you need a hug?'” Margulies said. “Keep it simple: ‘Is there anything I can do to support you?'”

8. Know that a new pregnancy won’t “fix” things

Caris learned she was pregnant a few months ago, and said that it’s been fraught.

“We’re so excited, but I still have my moments where I panic,” she admitted. “I’ll break down and I need my husband to reassure me, like, ‘Hey, it’s gonna be OK, no matter what happens.’ … When you lose a child, your faith just goes out the window.”

9. Ask questions

Margulies said that especially in the event of a stillbirth or later loss, it can be helpful to ask if the baby was given a name.

“It’s a really kind thing to ask and validates that baby’s life,” she said. “Their name matters.”

10. If you’ve had a similar experience, try sharing it

Many women interviewed by GMA said that it was comforting to talk to others who had experienced pregnancy or infant loss.

“I really encourage women to seek out support, especially with other women who have gone through what they’ve gone through, so they find their tribe,” Margulies said.

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