Review Category : Top Stories

Researchers Return to Real World After Four Months on ‘Mars’

iStock/Thinkstock(HONOLULU) — Six researchers who have been living in a mock-up Mars habitat on a Hawaiian volcano returned to the real world Friday, feeling a breeze and hearing birds for the first time in four months.

The second Hawaii Space Exploration Analog & Simulation mission, known as HI-SEAS, ended 120 days of the Red Planet exploration on Hawaii’s Mauna Loa volcano.

Expedition leader Casey Stedman and his five crew members had been living inside their 1,000-square-foot solar-powered dome, which includes common areas such as kitchen, dining room, bathroom with shower, lab and exercise space.

“I haven’t seen a tree, smelled the train, heard a bird, or felt wind on my skin in four months,” Stedman posted on his Instagram account.

The crew have been cooking with dehydrated food that doesn’t require refrigerated food and venturing out of the dome only for simulated spacewalks in mock spacesuits.

“It’s really great to taste fresh fruit and vegetables again,” Stedman told ABC News on Friday.

“The main purpose of the project is to learn about the problems that might occur to crew members if they went to Mars,” Kimberly Binsted, principal investigator of the project, told ABC News.

Binsted said crew members have to deal with disagreements and conflicts with each other, and solve depression and anxiety.

“It’s not like if you have a problem with someone, you can go out for a run in a park on Mars,” Binsted said. “You have to get along with each other in a very small space.”

Not only were the members confined physically, they couldn’tt surf the internet to kill time either.

“Communication with the outside world has a 20-minute delay each way,” Binsted said. “So one click on the internet will take 40 minutes to refresh.”

Binsted said one of the technologies tested in the past four months is a device that detects the voice and proximity between two crew members.

“It was a really good experience,” Stedman said. “The first thing I wanted to do after I come outside was to squint.”

“We had little direct contact to the sun in the past four months,” Stedman said. “We wear our spacesuits when we go out, and the masks cover most of our face.”

“There weren’t really altercations among the crew,” Stedman said. “But even in a family vacation, you disagree with someone over something.”

Stedman said most disagreements were about procedures to get things accomplished.

“We all come from different backgrounds, so we have different interpretation of data,” Stedman said.

Stedman said he found sun dried tomatoes taste really good with mustard during the past four months.

“We have the dried and ground tomato powder,” Steadman said. “You can make a paste out of it.”

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More Russian Troops Mass Along Ukrainian Border

iStock/Thinkstock(WASHINGTON) — Russian troops are continuing to gather along the border with Ukraine, the U.S. says.

“The number of Russian troops across — along the border continues to steadily increase. We have seen that in the past few days, but have seen no indication that the Ukrainians have fired back,” State Department spokesperson Marie Harf said on Friday.

Her remarks came after U.S. Ambassador to NATO Douglas Lute said at the Aspen Security Forum on Friday that there are 15,000 Russian troops massed along the border.

That number is slightly higher than the estimate of 10,000 to 12,000 troops that had been reported this week.

Pentagon spokesman Col. Steve Warren told reporters Friday morning that the estimate has likely moved upwards to 12,000.

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Woman, Kids Evicted After Renting House from Fake Owner

iStock/Thinkstock(ATLANTA) — An Atlanta woman who said she was duped into renting a house from a fake homeowner has been evicted along with her children.

“I just don’t know what to do. I don’t know what to say,” Lyna McNeil told ABC News affiliate WSB-TV after she was forced to abruptly move out Thursday evening.

McNeil has eight children, but at least one of her kids is an adult. It’s not clear how many were living with her in the house.

Animal control officers were also on the scene, taking the family dogs because they no longer had a home.

“Animal Control came and took our dogs,” said McNeil, “The children are crying because they’re taking our dogs.”

Animal Control did not return calls to ABC News.

McNeil’s furniture and belongings were stacked in the yard Thursday evening and she spent the night in her car while her children stayed with friends, WSB-TV reported.

McNeil said that she moved into the northwest Atlanta neighborhood after renting the Caron Circle home from a man named “Shawn,” under the agreement that she would pay $750 a month after making minor repairs, WSB-TV reported.

After moving in, McNeil says she was contacted by the real homeowner, identified only as Mr. Carr, demanding that she and her eight children leave the house.

“I have offered to pay him rent. I’ve offered to pay him security deposits, but he doesn’t want that,” McNeil told the station.

The homeowner filed an intruder affidavit with the Superior Court of Fulton County demanding that McNeil be out by Thursday, a representative from the Fulton County Sheriff’s department told ABC News. Officers arrived at the scene “to keep the peace while the order was executed,” said the representative, who said the sheriff’s department could not comment on the issue any further.

A neighbor of the family told ABC News that the house the McNeils were living in had been empty for as long as she could remember, and the house had never been up for sale.

“I just don’t understand how somebody could rent a place that’s not theirs,” said the neighbor, who asked to remain anonymous.

“They were nice and polite,” the neighbor said of the McNeils. “I pray things work out for her.”

WSB-TV reports that McNeil is getting a lot of support from the community in finding a home.

McNeil could not be immediately reached by ABC News for comment.

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Woman, Kids Evicted After Renting House from Fake Owner

iStock/Thinkstock(ATLANTA) — An Atlanta woman who said she was duped into renting a house from a fake homeowner has been evicted along with her children.

“I just don’t know what to do. I don’t know what to say,” Lyna McNeil told ABC News affiliate WSB-TV after she was forced to abruptly move out Thursday evening.

McNeil has eight children, but at least one of her kids is an adult. It’s not clear how many were living with her in the house.

Animal control officers were also on the scene, taking the family dogs because they no longer had a home.

“Animal Control came and took our dogs,” said McNeil, “The children are crying because they’re taking our dogs.”

Animal Control did not return calls to ABC News.

McNeil’s furniture and belongings were stacked in the yard Thursday evening and she spent the night in her car while her children stayed with friends, WSB-TV reported.

McNeil said that she moved into the northwest Atlanta neighborhood after renting the Caron Circle home from a man named “Shawn,” under the agreement that she would pay $750 a month after making minor repairs, WSB-TV reported.

After moving in, McNeil says she was contacted by the real homeowner, identified only as Mr. Carr, demanding that she and her eight children leave the house.

“I have offered to pay him rent. I’ve offered to pay him security deposits, but he doesn’t want that,” McNeil told the station.

The homeowner filed an intruder affidavit with the Superior Court of Fulton County demanding that McNeil be out by Thursday, a representative from the Fulton County Sheriff’s department told ABC News. Officers arrived at the scene “to keep the peace while the order was executed,” said the representative, who said the sheriff’s department could not comment on the issue any further.

A neighbor of the family told ABC News that the house the McNeils were living in had been empty for as long as she could remember, and the house had never been up for sale.

“I just don’t understand how somebody could rent a place that’s not theirs,” said the neighbor, who asked to remain anonymous.

“They were nice and polite,” the neighbor said of the McNeils. “I pray things work out for her.”

WSB-TV reports that McNeil is getting a lot of support from the community in finding a home.

McNeil could not be immediately reached by ABC News for comment.

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John Kerry’s Proposed Seven-Day Gaza Truce in Limbo

State Department photo/Public Domain(CAIRO) — The “seven days of peace” that Secretary of State John Kerry envisions as a path toward a Gaza cease-fire remain as elusive as ever after last-ditch efforts to resolve the conflict.

“We don’t yet have that final framework, but none of us are stopping,” Kerry said Friday of negotiations between Israelis and Palestinians.

Addressing a news conference in Cairo, he said, “There’s a lot on the table, it didn’t get easy last night. But with good will and good effort, I think progress can be made.”

Kerry is now headed to Paris for another round of talks.

Mediators originally tried to sell this latest proposal as a week-long humanitarian truce designed to help the hundreds of wounded Palestinians. Israel wanted the deal to include a stipulation that some of its troops be allowed to remain in Gaza during the humanitarian cease-fire.

Kerry flew to Egypt and, later, Israel before returning to Cairo this week to help broker a deal alongside United Nations Secretary General Ban Ki-Moon.

He formally made the proposal to Israeli Prime Minister Benjamin Netanyahu Thursday evening and the Israeli Security Council held a meeting Friday afternoon to vote on the deal.

Hamas, the Palestinian militant group accused of firing hundreds of rockets into Israel throughout the 18-day conflict, had rejected an earlier cease-fire deal.

The conflict, which emerged after three Israeli teenagers were kidnapped and killed, eventually escalated and the Israeli Defense Forces launched Operation Protective Edge on July 8.

Hundreds of Palestinians and dozens of Israelis, mostly soldiers, have died in the conflict.

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Officials Issue Arrest Warrant for California Man with Tuberculosis

iStock/Thinkstock(SAN JOAQUIN COUNTY, Calif.) — Officials in Northern California issued an arrest warrant for a man with tuberculosis who has refused treatment.

Eduardo Rosas Cruz is putting the public at risk, according to Stockton Police, as a result of his failure to comply with a medical order.

The 25-year-old missed his last appointment at San Joaquin County Public Health. Officials are raising concerns as Cruz comes from a part of Mexico known for a drug-resistant strain of the disease, the Los Angeles Times reports.

He is described as a 5’4″ Hispanic man, weighing 130 pounds with brown eyes and black hair, according to law enforcement. A photo can be found on the Stockton Police Department’s Facebook page.

Anyone with information on Cruz’s location is asked to contact authorities or the San Joaquin County Public Health department at 209-468-3992.

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Pop Culture Drinks Surge in Popularity

iStock/Thinkstock(NEW YORK) — Like a particularly enjoyable form of Inception, you can now drink your Game of Thrones beer while you watch…Game of Thrones. Or, sip on 50 Shades of Grey wine while you read the book (or watch the movie trailer, for that matter), or Downton Abbey wine while you binge on the British series. The list goes on.

In recent months, instances of branded drinks have skyrocketed, and people are drinking them up.

Ommegang Brewery was approached by HBO — the network behind Game of Thrones — to produce a branded beer.

“The show exploded as you know. The first beer came out in March 2013, and I just had a meeting with HBO two days ago and our contact had a bottle up on his shelf and he was like, ‘Man, that was so hard to find; you remember that?’ because it just flew off the shelves,” Ommegang marketing director Bill Wetmore told ABC News. “It did so well and it exceeded our expectations so well that we quickly brewed as much as we could and rushed a second batch out there before that season ended.”

Besides the obvious increase in sales, the advantages for Ommegang were immediate. HBO broadcasts the partnership to its over 10 million Facebook fans, there have been over 200 million traditional media impressions on the project and they’ve increased sales of their other beers as a result.

“It’s just obviously exponential exposure for us. We work with a retail partner and say, ‘Okay I know you want 10 cases of Game of Thrones to feature and display in your account. You have an audience here that’s demonstrating an appreciation for good beer, an appreciation for our beer, so can we get you to feature five cases of our witte or our rare vos alongside?’” Wetmore said. “And so we get very good visibility and displays of our core products. We bring new drinkers in that way, and our core beers go up 25 to 45 percent when our Game of Thrones beers are out there. It’s really having an impact on growing our core business as well.”

But unlike what Wetmore calls “vanity” projects — other drinks just slapping a branded label on a drink that has nothing to do with the brand itself — Ommegang works closely with HBO to create flavors that make sense, something Wines That Rock does as well with their 50 Shades of Grey and Downton Abbey vintages.

“In almost every Downton Abbey, whether it’s Carson downstairs picking out the wine or they’re dining and celebrating upstairs, wine is all over the show. The one thing we believed and reason NBC Universal [who owns Downton Abbey] got excited about working with us is we wanted to be very transparent and authentic to the show and that period of England,” Wines That Rock partner and co-founder Ron Roy told ABC News. “They drank Bordeaux, and while our vineyard was in California, we ended up partnering with a winery in the Bordeaux region of France so these were authentic to the show. Even down to the packaging we were able to use the Downton Abbey brand and the castle and stay very pure to the experience.”

Author E.L. James herself was involved in the making of the 50 Shades of Grey wines, traveling to California and working with the winemakers to create the perfect blends.

It’s a gamble that has paid off for both companies, demonstrated through sales. The first run of 50 Shades of Grey wine sold out in four weeks and has consistently rated in the top 25 wines for sales on Amazon.com, while the Downton Abbey wine sold three times more than Wines That Rock anticipated and was among the top 10 selling wines on Wine.com after the winter holidays.

As for Game of Thrones, Ommegang plans to make four times as much product for the release of their next GoT branded beer, Valar Morghulis, in October than they did with the first beer only 18 months ago in March 2013.

“It just feels like a sweet spot of connectivity,” Wetmore said of the partnership. “It really seemed to strike a chord with the fans of the show and the fans of our beer.”

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One Dead in Pennsylvania Hospital Shootout

iStock/Thinkstock(DARBY, Penn.) — A patient opened fire at a hospital campus in Pennsylvania on Thursday, killing his case worker and wounding a psychiatrist, according to police.

District Attorney Jack Whelan announced charges Friday against Richard Plotts, the suspect in the deadly shootout in Darby.

Plotts had an appointment with his doctor, Lee Silverman, scheduled for 2:30 p.m., but showed up about an hour earlier.

Silverman had the suspect’s case worker, Theresa Hunt, meet him and the patient in the office. According to the doctor, Plotts was agitated, refusing to sit down. He removed the gun from his waistband and start to rant, then pointed the weapon at Hunt and shot her in the head.

In response, Silverman said he pulled out a semi-automatic gun he had in the office, and returned fire with the suspect. The doctor was shot through his thumb as he was covering his face, and was also grazed in the head, according to officials. He was treated and released Thursday night.

Another doctor and caseworker wrestled with Plotts to subdue him until police arrived.

The patient was found with an additional 39 bullets, which authorities believe indicate that he was going to reload and shoot others.

Plotts criminal history dates back to 1990 and he is prohibited from possessing a firearm.

“If it wasn’t for the heroic action of the doctor and the case worker, we believe he was there and going to reload that revolver, and continue to fire and continue to kill,” Whelan said.

Officials believe Plotts had an issue with a rule that banned guns from the medical facility.

He is being treated for his injuries, including two gun wounds to the stomach, and is sedated, according to Whelan.

The District Attorney’s Office is in the process of charging him with murder and the attempted murder of Silverman.

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Report Raises Safety Questions on Popular Blood Thinner

Hemera/Thinkstock(NEW YORK) — 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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Copyright 2014 ABC News Radio

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Report Raises Safety Questions on Popular Blood Thinner

Hemera/Thinkstock(NEW YORK) — 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.

Follow @ABCNewsRadio
Copyright 2014 ABC News Radio

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