Health The latest Health news and blog posts from ABC News contributors and bloggers. Tue, 26 Aug 2014 22:09:16 +0000 en hourly 1 2 African Ebola Patients to Be Discharged From Hospital After Getting ZMapp Tue, 26 Aug 2014 22:01:21 +0000 Richard Besser gty zmapp processing plant kbp kb 140826 16x9 608 2 African Ebola Patients to Be Discharged From Hospital After Getting ZMapp

The logo for Kentucky BioProcessing LLC is displayed at the facility in Owensboro, Kentucky, on Aug. 5, 2014. ZMapp, developed by Mapp Biopharmaceutical Inc. and manufactured by Kentucky BioProcessing, has been used to treat the Ebola virus. (Luke Sharrett/Bloomberg via Getty Images)

MONROVIA, Liberia – Two African health workers who received doses of the experimental Ebola drug ZMapp are set to be discharged from the hospital later this week, a Liberian health official told ABC News today.

Ebola Wards See Flood of Patients, Outflow of Bodies

Looking for Hope in a Hot Zone

Three African health workers — two African doctors and one physician’s assistant — received the drug after contracting the virus earlier this month, according to Dr. Moses Massaquoi, who heads Ebola case management at Liberia’s health ministry.

Though they were all showing signs of improvement at first, one of the doctors died on Aug. 24. He also had diabetes and hypertension, Massaquoi said.

The remaining two patients improved soon after receiving the first of three doses of ZMapp — a cocktail of three antibodies meant to attack the virus. They are expected to be discharged on Friday.

Click here for more headlines from the Ebola outbreak.


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Could Medical Marijuana Laws Cut Painkiller Deaths? Mon, 25 Aug 2014 21:19:51 +0000 ABC News By Dr. Jamie Zimmerman

States that have legalized medical marijuana may be reaping an unintended benefit from easing up on restrictions: They appear to have nearly 25 percent fewer deaths from overdoses involving prescription painkillers, a new study found.

The  study, published today in the journal JAMA Internal Medicine, comes at a time when the United States finds itself in the throes of a growing painkiller abuse crisis. About 100 Americans die every day from narcotic painkiller overdose, according to statistics from the U.S. Centers for Disease Control and Prevention.

The researchers behind the new study suggest that because legalizing medical marijuana makes it more available to chronic pain patients, it provides a potentially less lethal alternative to pain control on a long-term basis.

Three states had medical marijuana laws prior to 1999, and an additional 10 states passed laws providing some legal access to marijuana during the study period. Today, 23 states and the District of Columbia have laws allowing access to medical marijuana.

Lead study author Dr. Marcus Bachhuber said that while he and his team expected to find differences in painkiller-associated deaths among states with different medical marijuana laws, they did not anticipate such dramatic differences.

“We [found] it surprising that the difference is so big,” said Bachhuber, who is a physician and researcher at the University of Pennsylvania.

Bachhuber and his colleagues analyzed data on all 50 states from 1999 to 2010 and found that, while opioid overdose rates continued to climb across the United States, the numbers climbed much slower in states with medical marijuana laws. As a result, these states had 25 percent fewer deaths from opioid overdose.

Also, this effect increased in the years after the laws were enacted, suggesting the laws themselves may cause the difference.

“In my practice, I take care of a lot of people with chronic pain,” Bachhuber said. “Sometimes, people with chronic pain would say only marijuana worked or they tried marijuana as a painkiller and found it worked better than prescription pills.

“One day, talking with colleagues, we wondered how this would work in states where marijuana is legal.”

The findings lend additional weight to the idea that medical marijuana legalization may protect some patients who take it from the potentially harmful side effects of other medications, experts not involved with the research said.

Dr. Igor Grant, chair of psychiatry at the University of California-San Diego and director of the Center for Medical Cannabis Research, said one possible explanation for the link seen in the new study is known as the “opioid-sparing effect.”

In other words, pain patients may benefit from combining opioid painkillers with less toxic medications that also provide pain relief.

“This isn’t a new idea,” Grant said. “Physicians have used combination drugs for a long time, such as acetaminophen with an opioid. By putting several different pain medications together, they are able to reduce the overall opioid dose, and thus decrease the risk of overdose.”

The other side of the coin to more permissive medical marijuana laws, however, is the effect it may have on recreational use of the drug. Research has shown that legalizing medical marijuana tends to increased use among adults.

Even study author Bachhuber agreed that this is a potential problem to consider. “This study raises the possibility that there is an unintended public health benefit of medical marijuana laws, but we still need to collect more information to confirm or refute what we’ve found,” he said.

Grant, too, said legalizing medical marijuana comes with serious considerations. But studies like these suggest that there may be unanticipated benefits as well, he said.

“Not to say cannabis is trivial and couldn’t have a bad public health impact,” Grant said. “But, we shouldn’t jump to conclusions.”

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Woman Credits Hypnosis for 140-Pound Weight Loss Thu, 21 Aug 2014 14:10:25 +0000 ABC News  

Is the secret to weight loss simply tricking your mind into thinking you had gastric bypass surgery?

That’s what happened to Julie Evans, an overwhelmed mom of two small children, who at her biggest weighed 287 pounds.

Evans claims hypnosis helped her begin craving healthy foods instead of junk.

“All I wanted was spinach,” Evans, 35, told ABC News. “I wanted salad. It was the creepiest feeling in the whole wide world.”

She admits it sounds crazy, but says hypnosis was her trick to shedding 140 pounds and actually keeping it off.

“I was the biggest skeptic ever,” she explained. “I haven’t had fast-food since. I don’t even crave it.”

Back in 2006, however, Evans ate fast-food and junk food every day. It wasn’t until a vacation to Hawaii that she realized she was too embarrassed to show her body in a bathing suit and decided it was time for a change.

“I was at that point where this was holding me back from living,” she said.

Evans’ mom convinced her to try hypnosis and, although skeptical, she went to a seminar featuring hypnotherapist Rena Greenberg.

“We have a lot of old patterns that are bombarding the mind and what we’re doing is sort of rewriting the script,” Greenberg said of her tactics.

Greenberg says she has her clients visualize pushing the plate away because you’re no longer hungry or going to the gym instead of binging on cookies. And after only one session, Evans says it changed the way she ate.

“I would pause and think about what I’m putting inside of me,” she recalled.   

Still, critics say it won’t work for everyone.

“It’s unproven,” Rebecca Solomon, a dietician and nutritionist, explained. “It doesn’t work for all and the studies do show you have to believe it’s going to work for it to work.”

For Evans however, she’s going to the gym for the first time in her life and listens to her hypnosis CDs when she feels like she’s getting off track. She has successfully kept the weight off for seven years and tells the skeptics not to judge until they’ve tried it.

“It worked for me,” she said. “But I do think you have to have an open mind and be willing to listen.”

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When Your Daughter Can’t Stop Eating: Raising a Child with Prader-Willi Syndrome Fri, 15 Aug 2014 14:05:04 +0000 ABC News

Tonya Wilkinson and her family were recent subjects of a ABC’s “20/20″ piece. Tonya’s 14-year-old daughter Hannah was born with a rare condition called Prader-Willi syndrome, caused by a chromosomal flaw. Prader-Willi syndrome, which strikes only one in 15,000 people, can cause learning issues, muscles weakness and a slow metabolism. Below, Tonya reflects on a day in Hannah’s life and what it’s like to raise a child with Prader-Willi syndrome.

HT hannah mom jef 140814 16x9 608 When Your Daughter Cant Stop Eating: Raising a Child with Prader Willi Syndrome

Hannah Wilkinson, left, shown here with her mother, Tonya Wilkinson, right, was born with a rare condition called Prader-Willi syndrome.

A typical day in a Prader-Willi Syndrome household is nothing like that of a family with “normal” teenagers.

Sure, most teens will say they have an insatiable appetite, but for Hannah, food is literally on her mind all the time and that genetically driven obsession is something we confront all day long.

Hannah usually gets out of bed at 6 a.m. (sometimes earlier) to wake me up to tell me she is starving and that she needs breakfast. If it’s too early, I encourage her to watch TV or play on her iPad, because I know if she eats breakfast too early that the day will be more stressful for her between meals. Even if Hannah can wait a little bit in the morning, the next 30 minutes or so will be a barrage of, “Mom, can I eat yet?” “Mom, I’m hungry!” and “Mom, is it time yet?” That will go on about every five minutes until I fix her breakfast.

The breakfast process starts with the unlocking of the pantry and fridge so I can prepare Hannah a low calorie breakfast. Typical breakfast options are turkey sausage and one egg with six ounces of milk, or maybe one cup of cereal, or a half cup of low fat yogurt with a small amount of fruit. We target 200-240 calories for breakfast. Breakfast prepared, the pantry and refrigerator are locked again.

Inevitably, 10 minutes or so after breakfast Hannah will say, “Mom, I am hungry – how long till I can have a snack?” I tell her it is only 7 a.m. and she doesn’t get a snack for three hours. I know it’s going to be a long morning and I know I will hear “How much longer till snack,” “What will I get for snack today,” and “What are we having for dinner?” frequently for the rest of the morning. All she thinks about is food – it consumes her life. Even on her iPad is an entire folder of food games. She always wants to know what’s for breakfast, for lunch, for dinner, when can she eat, and how much can she eat. It can be frustrating to answer her, but I try to remember how she must feel and how much stress and anxiety these food questions will cause her all day.

At snack time Hannah might get 16 low fat wheat thins or 10 grapes for her snack. This is never enough and she gets upset and will cry because she’s still hungry. I have to distract her and have her go play in her room and do crafts or she will look up animal rescue facilities in Arizona so she can see what dogs are available. (Hannah and “Siri” have a great relationship – at least until Siri doesn’t look up what Hannah wants. Whether it’s a speech misunderstanding or Hannah’s query is too complex for Siri, it gets her frustrated and she could have a meltdown or a “non-epileptic event” that can last up to hours at a time. And the questions never stop. I still hear “Mom, when is lunch,” “Mom, what’s for lunch,” “Mom, what’s for dinner,” and “Mom, what’s for dinner tomorrow?”

For lunch, I try to keep her lunch very low calorie. If it’s a school day I pack her lunch for her – she’s not allowed to eat at school. I have to unlock the pantry and refrigerator and relock it all back after her lunch is made. Lunch is typically a half turkey sandwich on low fat, low calorie bread with a little mustard, a 10-calorie jello, 100-calorie bag of chips or crackers, and a 5-calorie juice.

After lunch, the questions about her next opportunity to eat will start again, and the questions won’t stop until dinner is on the table. I try keeping her busy during the afternoon as it helps keep her mind off the food a little. Hannah likes to swim if we are able to, play with her baby dolls, do crafts or make her Chihuahua go through some “therapy” (the same kids of instruction she’ll do in her OT or PT sessions typically). The busier we can keep her, the better as I might only get questions every 20 minutes instead of every 10 minutes.

If we need to go to the grocery store this afternoon, I have to watch Hannah closely as she’s apt to steal food off the shelf and take it into the bathroom to eat it – she needs to be watched 24/7.

Dinner is similar to her other meals: healthy and low calorie. And we all eat the same as Hannah, maybe some grilled chicken breast, salad, a vegetable and a bottle of water. Even though she has had half or less of what a normal 14-year-old would eat she has probably has had around 1,000 calories today which means she will probably not lose any weight. After dinner is exercise: We might go for a one mile bike ride, a one mile walk or we might try and do some aerobics in the house if it’s too hot outside. We try to get her to keep moving for at least 30 minutes each day.

Now the day is almost over. I have to help her after her shower with personal care, because of her weight she has a lot of skin break down and I need to make sure it gets dried and has medicine on. I need to help her dry off and brush her hair. And the questions are still coming: “What’s for breakfast tomorrow,” “I am still hungry, can I have a popsicle,” “do we have stuff ready for lunch for tomorrow,” “What are we doing tomorrow,” and “What time are we going to the store?”

Hannah will get a little bit of TV, iPad or game time before bed. Just before bed, I tell her and show her everything is locked up so she doesn’t have stress and anxiety all night that she can get to any food. Usually though, I hear her yell from her room asking again about what will be in her meals tomorrow. I am exhausted and need to get some sleep because it all starts again at 6 a.m..

This is a weekend for us. During the week we have to also integrate work, school and therapies into our schedule.

Prader-Willi syndrome is a very hard and complex syndrome to have and live with. It’s very hard on those who have it and the family members who care for them. Hannah is 14-years-old and, but has the understanding of an 8-year-old.

She is going into the ninth grade because of her age, but will be doing second grade level school work. At 340 pounds, she’s not able to do the things she would like to do, such as baseball or cheerleading.

Our children don’t want to have Prader-Willi syndrome and it doesn’t make them who they are. Hannah is my whole world and has taught me so much in these past 14 years. She has taught me to love deeper, forgive easier, and that tomorrow is another day. It can be frustrating at times, but she will inevitably come up or say something really funny and makes me smile. She’s my baby, she’s an amazing girl, and I just want to do whatever I can to help her. I love this kid more than anything.

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‘NY Med’ Neurosurgeon Was ‘Bitten by the Doctor Bug’ Thu, 14 Aug 2014 13:48:32 +0000 ABC News abc guy mckhann mt 140814 16x9 608 NY Med Neurosurgeon Was Bitten by the Doctor Bug

Dr. Guy McKhann is a neurosurgeon at NewYork-Presbyterian/Columbia University Medical Center. (Image credit: ABC/NY Med)

By Dr. Guy McKhann

People often assume that coming from a family of doctors, I chose medicine as a natural career path. But it was not that easy.

My great-grandfather was an Ohio family doctor, my grandfather was an academic pediatrician and my father is an academic neurologist. Nevertheless, no children in my generation were bitten by the doctor bug. After growing up on the water, I planned on being a marine biologist, and it was only after I realized that there are at least 100 plankton geneticists for every Jacques Cousteau that I switched my interests into human neuroscience research and eventually medicine.

In medicine, I always knew I wanted to work on the brain. Some of this may have been passed on from my father, but much of it came from an appreciation of how much we do not know about brain function. As the scientific community learns more about the brain, medicine is able to advance how we treat neurological diseases.

No matter how much I know or learn, there is always a new frontier being advanced and novel treatments being applied. This combination makes neurosurgery an incredibly exciting and dynamic field.

As demonstrated on ABC’s “NY Med,” training and working in the world-class academic setting of New York-Presbyterian/Columbia University Medical Center is a privilege. My co-faculty and the residents that we train are incredibly intelligent and intellectually creative people.

In New York, we care for a diverse range of patients with complicated brain problems, many of whom have amazing personal stories. Dealing with the stresses of our occupation forges very tight interpersonal bonds and fosters an environment of friendship and cooperation. We spend as much or more time together as we do with our families. We share our successes and microanalyze our failures.

Equally importantly, we laugh and smile, a lot. Our job is way too hard to not have fun and enjoy what we are doing!

Being filmed for “NY Med” for the first season and again now was a great experience. All of the crew from the top down are very nice people, intensely hard working and really skilled. They were here all hours of day and night and seamlessly blended into the background, allowing us to carry out our day-to-day patient care activities. They captured the range of humanity that makes our job an emotional roller coaster.

Medicine is changing, some for the good and some for the not so good. When I was training, we were always on call, 24/7, with one weekend off per month. We knew our patients like the back of our hands.

Now, with changing work-hour restrictions, residency has become more like shift work. The discontinuity in patient care makes it harder for the residents to train.

But on the other hand, residents and attending physician now have much better personal lives. It is no longer a sign of weakness to adapt your schedule to take family time off. I coached all my sons and try to make it to as many of their activities as possible in behavior that is now encouraged rather than hidden.

Now, I’ll have to wait and see if any of them follow in my footsteps.

Dr. Guy McKhann is a neurosurgeon at NewYork-Presbyterian/Columbia University Medical Center in New York City.  McKhann graduated Phi Beta Kappa and magna cum laude from Duke University, with Research Honors for his investigations into brain tumor immunobiology. He attended Yale School of Medicine where he was AOA, cum laude, a Farr Scholar and one of five recipients of the medical school’s highest thesis award. McKhann trained in neurological surgery at the University of Washington, as well as Atkinson Morley’s Hospital in Wimbledon, England.

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It’s the Real-Life ‘Grey’s Anatomy’ Fri, 08 Aug 2014 18:18:23 +0000 ABC News I am a “Registered Entrepe-nurse,” as my brother calls me.

I love the ER because it is a constant adrenaline rush. The wheels of my brain have to keep turning or I get bored quickly, which is why I chose emergency nursing. But who would have ever known in the midst of treating patients and saving lives that there would be a camera following me around, and that one day the footage would end up on a national television network?

Well, here we were, and when producers approached me again to ask  if I would be interested in being filmed for a second season, it was one of the hardest decisions I’ve ever made.

I had already had a camera in my face for almost a year straight, every day.  All eyes were on me — from patients to patients’ relatives to coworkers to management. And just when I thought it was all over, we were doing it all again.

Well, how could I have refused? The response after the first season of NY Med was overwhelming, but in an amazing way. To think that I have inspired people to go into nursing school is the best feeling in the world. The public eye finally gets to see what it’s really like working in one of the busiest hospitals in NY. It’s the real life Grey’s Anatomy.

I think patients opened up more when they knew they were being filmed. Most memorably, I happened to meet a handful of amazing, funny, witty, smart, and very experienced elderly women who are happily married for over 60 years. And when I say happily married, they were so cute they had me in tears. It gives me hope. It really does – to see firsthand that happiness in relationships can last that long. I learned to always ask what the secret is – and you’d be surprised to hear the advice these women have given me on how to maintain a successful, happy, long lasting marriage.

During filming for Season 2 of NY Med, I experienced a personal life crisis which kept me out of work for 3 months and unable to live my outgoing and exciting life. Due to this unfortunate incident, I have learned that as a healthcare professional, you truly never know how it feels to be in a patient’s shoes until you have actually been there. I am now back to work and realized that this situation has truly humbled me.

Marina Dedivanovic, RN, is ER Nurse at NewYork-Presbyterian Hospital /Weill Cornell Medical Center. She was born and raised in Bronx, New York and now lives in New York City. Dedivanovic completed her nursing degree with honors at Dorothea Hopfer School of Nursing and has worked at NewYork-Presbyterian for the past eight years. She now appears on ABC News’ Season 2 of “NY Med.”

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Exclusive: US Students Stranded in Liberia ‘Safe,’ Want to Come Home Thu, 07 Aug 2014 22:53:03 +0000 Steve Osunsami In an exclusive interview with ABC News, six students from Alabama’s Tuskegee University, stranded in the center of the Ebola danger zone in Africa, said they are “safe” and “healthy” but eager to get home.

The students participated in a study abroad program but got stuck in Monrovia, Liberia, after their flights back to the US were suspended by British Airways because of the Ebola outbreak.

Related: Liberia health workers face angry residents over Ebola deaths.
Related: Liberia’s medical conditions dire even before Ebola outbreak.
Related: Survivor tells how she lived through Ebola.

The students told ABC News today that they had spoken with their parents and had urged them to remain calm.

The group is staying at the residence of a university president in Monrovia.

“We have not had any contact with anyone that has contracted Ebola,” student Aristotle Jones said. “We are in a safe environment, where everyone is completely safe and clean.”

The university said there had been “no signs of illness reported among the students.”

The six students were in Liberia, building wells and teaching math and science to teenagers. They called it an “amazing trip” and said it was “unfortunate it was overshadowed” by the health crisis.

Nearly 1,000 people have died from the virus in four West African nations, including Nigeria, since Monday, according to the World Health Organization.

Liberia, where the death toll has risen to 282 people, is a ground zero for the catastrophic outbreak.

“We are also taking preventive measures, such as carrying around hand sanitizer and washing our hands frequently,” student Jazlyn Fuller said.

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Young Nurse Needs Pacemaker, Becomes Patient on ‘NY Med’ Fri, 01 Aug 2014 22:03:00 +0000 ABC News By Diana Costine

Filming the second season of NY Med was very different for me than filming season 1, because I found myself in a unique position of role reversal: going from treating patients to being a patient myself.

I had surgery this season to implant a pacemaker into my heart.  Being only 29 when I found out that I needed a device to make my heart work properly, I was devastated.  I felt as though I had failed in some way, like my body had failed me. I had to face the fact that I was no longer in control of my body, which is terrifying in itself.  The consequences to not having this surgery outweighed my reluctance.  I didn’t really have a choice.  I could forgo the operation, but then I’d have to walk all over New York City, hoping that I don’t faint in front of a subway train.  In all honesty, it was only a matter of time before something really bad happened.

The day of my surgery, I was terrified.  Being an ER nurse, all we do is control chaotic situations, and make things better.  But here I was, in a situation that I couldn’t control.

I was lucky enough to have my amazing mom and boyfriend there with me.  They were both incredibly supportive, but the real person who got me through that day was Isaac: the director of photography for “NY Med,” who I’ve known for over four years now. Isaac was the main videographer assigned to me through both seasons 1 and 2.  Because my schedule in the ER was often Isaac’s schedule, I sometimes referred to him as, “my work husband,” due to the fact that I saw him more than I actually I saw my own boyfriend at the time.  Since Isaac and I had worked together for over four years, it felt appropriate that he be the one to film my surgery.

So the day of my surgery came, Isaac was there, and did his usual things: interviewed my family, my doctors, me.  But by the time I was being wheeled into the OR, my anxiety had skyrocketed.  As I lay on the table, waiting for them to begin, I started to cry.  I was just so overwhelmed, and felt so out of control and alone.  I wasn’t supposed to be on this end.  I’m usually the caregiver, not the patient.  As I lay there, silently crying, I felt someone grab my hand.  It was Isaac.  He had put his camera down, and came over and stood by my bed, holding my hand as they administered the medication to make me sleepy.  It was one of the last things I remember.

It always comes down to human connection.  We want people to be there with us, and be present, and know that we are heard, especially during times where we feel so out of control and lost, which is often when we or our families are in the hospital.  The fact that Isaac took a minute without his camera, sat with me in that OR, holding my hand while they put me to sleep meant volumes to me.  I felt like I truly had a friend there with me that day, not just some cameraman.

It’s been over a year now since my surgery, and I have never felt better.  It’s funny to look back at how scared I was, compared to how amazing I feel now.  It is truly one of the best things I’ve ever done for myself.  I’ve had no fainting episodes since, and feel like I have this new outlook on life.  I can’t thank my cardiologist at NewYork-Presbyterian Hospital enough, along with my amazing family and friends, who were all so supportive. But special thanks will always go to Isaac.

Diana Costine, R.N. is an emergency department nurse at NewYork-Presbyterian Hospital.

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Report Raises Safety Questions on Popular Blood Thinner Fri, 25 Jul 2014 13:17:58 +0000 ABC News By Suneel Kamath, MD

A scientific study released Wednesday suggests the makers of the blood thinner Pradaxa may have held back information that may have prevented serious bleeding complications among some of the million or so Americans using it.

Meanwhile, the maker of Pradaxa, German pharmaceutical giant Boehringer Ingelheim, vehemently denied that it held back important safety data.

Boehringer Ingelheim introduced Pradaxa in 2010 as a replacement for the older drug Coumadin, which had been in use for decades. A major selling point was that Pradaxa offered the benefits of stroke prevention without the hassle of frequent blood monitoring needed with Coumadin.

As with any blood thinner, the concern with Pradaxa was the increased risk of bleeding in patients taking it. Major bleeding with Pradaxa at its currently recommended dose occurs in 3.11 percent of patients taking it each year, according to the major trial that led to FDA approval of the drug. The total incidence of bleeding events with use of the drug, including minor and major bleeding, is 16.42 percent per year.

Research on Pradaxa suggests that it carries a lower risk of bleeding into the brain than Coumadin does, along with a lower risk of life-threatening bleeds and minor bleeding. A large Medicare study published in May confirmed prior knowledge that Pradaxa carries a higher risk of major stomach and intestinal bleeding events.

Researchers at the University of Ottawa’s Institute for Safe Medication Practices (ISMP) wanted to find out whether monitoring the levels of Pradaxa in the blood of patients using it would help doctors avoid bleeding complications. To do this, they looked at Boehringer Ingelheim’s own data exploring the impact of blood level monitoring in conjunction with Pradaxa use.

These researchers said the data show that up to 40 percent of all deaths and serious bleeding events related to Pradaxa could have been avoided by simple blood testing. Checking blood levels periodically, they said, might have allowed doctors to lower the dose of Pradaxa or temporarily stop it in patients with dangerously high levels. This in turn might have prevented some bleeding complications. The paper was published Wednesday in BMJ.

Additionally, the researchers say that Boehringer Ingelheim had this information before Pradaxa was approved in 2010, but that they left it out of the safety information presented to the FDA during the drug’s approval process. Specifically, they said they found internal reports showing that the company’s scientists raised safety concerns about serious bleeding, but that these concerns may have gone unheeded by their superiors

In a statement released Wednesday, Boehringer Ingelheim said that the simulations that served as the basis for these concerns were preliminary and not reliable, and that it would have been inappropriate to report the simulations. They said they did provide the raw data to the FDA.

When asked by ABC News, the FDA declined to comment on the BMJ report. It also did not say how often pharmaceutical companies choose not to report the results of simulations like these to regulators.

This May, Boehringer Ingelheim reached a settlement worth $650 million with about 4,000 people related to alleged bleeding problems with Pradaxa.  In a statement released in connection with the settlement, Boehringer Ingelheim’s counsel said the company stands behind that drug and believes the claims lacked merit, but decided to settle to avoid protracted litigation.

The study authors, Drs. Thomas Moore, Donald Mattison and Michael Cohen, have extensive backgrounds in drug safety, representing the senior leadership of ISMP. Moore and Mattison have testified against pharmaceutical companies in prior litigations and Mattison also works for a risk management firm.

Moore, the lead scientist behind the ISMP study, said the problem is that blood levels of Pradaxa can vary significantly from patient to patient. Even if both take the same dose, one person’s blood level could be more than 400 times higher than another’s.

Moore said he turned his attention to Pradaxa in early 2011, the first few months after it was approved by the U.S. Food and Drug Administration.

In those three months, there were 505 cases of significant bleeding linked to Pradaxa, according to ISMP data, compared to 176 cases of bleeding related to Coumadin during the same period. “The biggest surprise to me was that the FDA, which is overall an excellent safety regulator, chose to almost entirely ignore opportunities to reduce the bleeding risk of this treatment.”

According to the report, the information allegedly withheld by Boehringer Ingelheim at the time may have affected the drug’s chances of approval. As evidence, the report offers a 2011 draft of the company’s study on the drug. In it, the investigators note, “Monitoring of plasma concentrations or antithrombotic activity… would be required to identify these patients,” referring to those who would potentially have dangerously high blood levels of the drug even under normal dosing situations.

According to the new report, this information was omitted from the formal presentation to the FDA. The authors of the new report say emails sent between Boehringer Ingelheim employees show that the company knew that advertising the need for blood monitoring with Pradaxa would drastically reduce the number of people who used the drug instead of Coumadin.

In a statement released in response, Boehringer Ingelheim called the BMJ article biased and misleading. The company said the drug is safe , and that the report could lead to patients going off of their medications and potentially putting their lives at risk. The company further noted that the “FDA reaffirmed Pradaxa’s positive benefit-risk profile” following a study of 134,000 Medicare patients with atrial fibrillation.

“Boehringer Ingelheim made a robust effort to find ways to utilize plasma levels to further improve the risk/benefit profile of Pradaxa and it is irrational to suggest otherwise,” said Dr. Sabine Luik, Boehringer Ingelheim’s senior vice president of Medicine & Regulatory Affairs, in the release. “The truth is the totality of scientific evidence does not support dosing decisions for Pradaxa based on blood levels.”

The FDA stands by its communication from May of this year stating that Pradaxa has a favorable benefit-to-risk profile and there are no plans to change the labeling of the drug to require or recommend blood monitoring.

Dr. Sonal Singh, a Johns Hopkins cardiologist who was not involved with the BMJ report, said that though it raises important questions, it is too early for a final verdict on Pradaxa or the actions of Boehringer Ingelheim.

“We still don’t understand who bleeds,” he said. “Is it older people, are they younger people…the specificity questions have not been answered.”

Doctor’s Take:

Regardless of what this new report tells us, Pradaxa is a useful – and often life-saving – drug for those who take it. Importantly, this report should not cause people to stop taking their needed medications.

What the report does offer is an opportunity for patients to discuss their treatment and their concerns with their doctors. As with most conditions, there are options for treatment. Only through a one-on-one discussion with a medical professional can you determine the best treatment choice for you.

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How ‘NY Med’ Neurosurgeon Prepares Patients for ‘New Me’ Thu, 24 Jul 2014 10:00:05 +0000 ABC News ht nymed phillip steig kb 140723 16x9 608 How NY Med Neurosurgeon Prepares Patients for New Me

Philip Stieg is a professor and chairman of the Department of Neurological Surgery at Weill Cornell Medical College and neurosurgeon-in-chief at NewYork-Presbyterian Hospital. (Image credit: NYMed/ABC)

By Philip Stieg, PhD, MD

As chief of neurosurgery at a major teaching hospital, I am used to being observed — I always have students and residents watching me. Teaching is something I love to do, and nothing is more rewarding than mentoring the next generation of talented surgeons.

I am also very accustomed to observing others, not only when I’m overseeing the work of my students, residents, and young neurosurgeons, but also when I’m talking with my patients and their families. I need to evaluate their physical health, of course, but I also need to develop an understanding of who they are, and how they are likely to respond to surgery.

Brain surgery is completely different than any other kind of surgery. We are invading the very core of an individual’s being, so the risks are magnified far beyond those of other procedures. That means that the conversations I have with patients are incredibly challenging. I need to be absolutely sure that they understand the benefits they will receive by having surgery, along with the risks that go along with any neurosurgical procedure.

I often find myself explaining that the “me” the patient experiences before surgery may not be the same as the “me” after surgery. There are risks of cognitive and personality changes inherent in any brain surgery that can be wrenching and bewildering if the patient has not been well prepared. And as you can imagine, for some people this is a very profound existential dilemma. It can also be confusing for family and friends to navigate. How will they interact with this “new me” who emerges?

That’s why our role as neurosurgeons goes far beyond our skill in the operating room. It’s about the relationships with our patients and doing everything in our power to make their lives as productive as possible. Getting my patients back to their daily lives is what keeps me energized and excited about the work I do.

It was certainly an honor to be chosen to participate in ABC’s “NY Med” because it allowed me to share some of the intricacies of what I do. Some people might think it would be distracting for a neurosurgeon to be followed by cameras, but it wasn’t.  I am accustomed to staying laser-focused on what I do, regardless of what’s going on around me, and I was happy to be able to show what we do every day on the front lines of neurosurgery.

Philip Stieg, PhD, MD is the Professor and Chairman of the Department of Neurological Surgery at Weill Cornell Medical College and Neurosurgeon-in-Chief at New York-Presbyterian Hospital.

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