https://youtu.be/fGjG_9EEeeA
Pharmacogenomics is the science that allows us to identify a patient’s response to drugs based on their genetic makeup.
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https://youtu.be/fGjG_9EEeeA
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http://www.wsbtv.com/news/news/local/shots-fired-during-armed-cvs-robbery/nnXf8/
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INDIANAPOLIS (WISH) — Indiana has a new distinction as the nation’s leader in pharmacy robberies with nearly 130, according to authorities.
An I-Team 8 investigation has found that the bulk of the robberies, more than 80, have occurred at CVS stores in Indianapolis.
CVS, up until five days ago, did not have time delay safes in any of their stores. This week, CVS executives were in Indianapolis installing those safes in all 150 stores in the Indianapolis area.
The pharmacy giant’s competitor, Walgreens, installed them more than a year ago and claims to have seen a significant reduction in pharmacy robberies in 13 states where they have been used, company officials told I-Team 8.
The time delay safes require pharmacists to activate the safes before they can gain access to highly sought-after medications like Oxycontin and Hydrocodone. The delay, company officials with both Walgreens and CVS contend, will lead to a reduction in robberies.
During an exclusive interview with I-Team 8 this week, CVS Vice President of Loss Prevention Michael Silveira said that the company has installed time delay safes in Indianapolis in direct response to the problem with robberies.
“In this particular case we know it’s been a successful deterrent for other retailers. We studied it over the summer and determined it was the best thing for us to do at this time,” said Silveira.
When asked why the company took more than a year to act after Walgreens, Silveira said “Well, we have a number of different protocols that we employ and after studying and revisiting our protocols, we considered time delay and figured it was time to do it after careful study.”
Sources tell I-Team 8 that the company has been somewhat hesitant to make changes, according to current employees who spoke on a condition of anonymity.
During the past year before CVS had installed the time delay safes, an I-Team 8 analysis of crime data found that pharmacy robberies occurred at more than 80 CVS pharmacies in the Indianapolis area; compared to less than 30 at Walgreens pharmacies, which had installed time delay safes in 13 states.
“It is a concern, but we are not relying solely on the time delay safes,” said Kara Williams, the pharmacy supervisor for the Indianapolis district.
Williams said she has spoke to CVS employees who said they were encouraged that the company was making efforts to address the high number of robberies.
“Potential robbers like to get in and get out as quickly as possible. With time delay safes, we will not have access to our narcotic medications on demand. There will be a wait period, which we’ve seen through studies has been a significant deterrent,” said Williams.
Four days into the new year, the CVS pharmacy at the corner of 38th Street and Illinois Street was robbed by a 16-year old suspect who police say used a note demanding pills and threatening to kill everyone if his demands weren’t met.
The robberies began in Indianapolis one day into the new year and have continued at a steady pace. In the 36 weeks marked off the calendar this year, pharmacy robberies have occurred in 32 of them, an I-Team 8 analysis found.
That same store at 38th Street and Illinois Street would be robbed four more times in the coming weeks.
It has happened again and again at other pharmacies all over Indianapolis.
In fact, the robberies are still happening. This year, Indianapolis has seen at least 112 pharmacy robberies, according to an I-Team analysis of crime data. I-Team 8 has created an interactive database which shows the dates and locations of each robberies, which can be found by clicking here.
When the surrounding feeder communities are factored into the equation, the number grows closer to 130, a figure that gives Indiana its own distinction – as the number producer in the United States of pharmacy robberies.
An I-Team 8 investigation has found that in many of the cases the suspects have walked in armed with only a threatening note and made off with thousands of dollars worth of prescription pills. At a robbery last month at a CVS pharmacy along East Washington Street, a police report notes the suspect made off with more than $6,000 worth of pills. Another one in early May along East 38th Street shows the suspect made off with $10,000 worth of pills, according to police records.
“The rate that they are happening now is unacceptable,” said Lt. Craig McCartt with IMPD’s robbery unit. “Many of these notes have essentially a laundry list of what they want, so they don’t have to remember anything. I just think it’s simple for them.”
While authorities cannot say with certainty why these are occurring at such a high rate, one theory among law enforcement agencies is that Indiana’s struggle with opiates – in particular heroin – has created a rich black market demand for more prescriptions pills on the streets.
“If that is in fact the case, if that scenario is accurate, then it’s an organized crime problem that’s fueling an addiction problem,” said Noblesville Police Chief Kevin Jowitt. “But to answer your question, is it unsettling? Yes it is.”
Noblesville Police Chief Kevin Jowitt was one of the arresting officers at a robbery at CVS pharmacy in Noblesville last month, a suburban town about 25 minutes north of Indianapolis. The community had not recorded a robbery in more than a year – until this summer where two have occurred in the last two months.
At the most recent robbery, court records 18-year old Shawn Baker went into the CVS store, handed over a note implying that he had “a gun and would shoot” and demanded Perocet, Roxicodone, Xanax and Hydrocodone. He was arrested a short time later at a nearby McDonald’s where police say he was attempting to make a phone call. Court records show Baker admitted to officers that he did not have a job and “needed the money.”
A not guilty plea was entered on his behalf at his initial court appearance. Baker is awaiting an October trial. He declined a request to be interviewed.
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WEST PALM BEACH — The wife of a West Palm Beach doctor who is accused of causing the overdose deaths of two patients wants her diamond jewelry back.
In a lawsuit filed last week in Palm Beach County Circuit Court, Misuk Christensen claims law enforcement officers wrongly seized nearly $139,000 worth of her jewelry when they raided her home along Flagler Drive in August 2011, seeking evidence against her husband, Dr. John Christensen.
The warrant agents used to enter the couple’s house did not authorize agents from the Palm Beach County Sheriff’s Office and the Florida Department of Law Enforcement to grab the jewelry, which included a $38,000 gold necklace with a 2.67-carat diamond, diamond earrings valued at $17,850 and a wedding ring, valued at nearly $30,000, according to the lawsuit filed by attorney Gary Dunkel, who represents Misuk Christensen.
While she asked for the jewelry back, her request was ignored, Dunkel claims. He is accusing the agencies of civil theft, which carries the possibility of triple damages.
Dr. Christensen, who for years operated A1A Health and Wellness Clinic on Broadway in West Palm Beach, was charged in 2013 with two-counts of first-degree murder and dozens of drug trafficking charges. Agents said he doled out oxycodone and other powerful narcotics like candy to drug addicts as part of a long-running pill mill operation.
Originally facing the death penalty, prosecutors were forced to reduce the murder charges to manslaughter. He posted a $600,000 bond and is on house arrest awaiting trial.
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To got this email this AM… even the STRONGEST can be intimidated… I wonder how many deaths/suicides this will cause ? Of course, no one in the judicial system will be considered guilty or contributing to those deaths. The judicial system TORTURES our citizens… to either secure their jobs or self affirm their own importance.
To our patients:
in solitary with Dr. Christianson, and in acknowledging the extreme hostility of the regulatory environment in which we are operating, Dr. ibsen will no longer be prescribing any pain medications to chronic pain patients. Dr. Ibsen will be taking some time off to plan the next safe course of action.
We wish you all the best.
Mark S Ibsen MD
Urgent Care Plus
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http://thinkprogress.org/justice/2015/09/01/3697394/carlos-mercado-diabetes-video/
The New York Times has obtained harrowing new jail footage of the final hours of diabetic Rikers Island inmate Carlos Mercado, who died because correctional officers had taken away his insulin.
Mercado, 45, was arrested in August 2013 for attempting to sell a small amount of heroin to an undercover officer. He died in in jail at Rikers Island 15 hours later, as corrections officers ignored his pleas for help and his quickly worsening symptoms.
The video shows Mercado collapse face-first when officers open the cell door. Rather than check his condition, officers step over and around his prone body. Later, he weaves around the jail, vomiting repeatedly and carrying a plastic bag of his own vomit.
Internal investigations found that Mercado repeatedly asked for a doctor and told the officers he was diabetic. According to the Department of Corrections report, officers dismissed his pleas, saying he was just withdrawing from drugs.
Mercado’s symptoms were somehow ignored even after New York paid out $17.5 million five years ago for denying insulin to another diabetic man, Jose Vargas. Vargas was kept in a holding cell for about 60 hours and went into a coma. He now has permanent brain damage and is confined to a wheelchair. When asked during the trial what he looked forward to, Vargas answered, “Nothing. I just sit there all day in the chair,” his lawyer told the New York Post.
The NYPD consistently poses a life-threatening danger to diabetics. Another diabetic man was arrested for putting his feet up on the subway while he injected insulin into his thigh. He nearly died during his 30-hour stint in a holding cell and was in the hospital for two days after being released.
Even Shepard Fairey, the celebrated street artist behind the iconic Obama “Hope” poster, has come close to dying in a New York jail because guards withheld insulin. “After two days without insulin, I started throwing up something that looked like radiator fluid,” he told Slamm Magazine in 2000. He now has a tattoo of the word “diabetic” because of the number of times he’s gotten sick after jailers have taken away his insulin.
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Lynn Webster, MD, is past President of the American Academy of Pain Medicine, vice president of scientific affairs at PRA Health Sciences, and one the world’s leading experts on pain management. He treated people with chronic pain for more than 30 years in the Salt Lake City, Utah area.
Dr. Webster’s new book, “The Painful Truth,” is a collection of stories involving several of his former patients, who struggled with the physical, emotional and financial toll that many chronic pain sufferers experience.
Pain News Network editor Pat Anson recently spoke with Dr. Webster about “The Painful Truth: What Chronic Pain Is Really Like and Why It Matters to Each of Us.” The interview has been edited for content and clarity.
Dr. Lynn webster
Anson: Dr. Webster, you’re no longer practicing medicine, but you’re still very involved in the pain community and in research. Why write this book now at this stage of your career?
Webster: It takes a lot of time to write a book, as you can imagine, and it’s taken me four years to get to this point. I think that at this stage in my career I can look back and put together a story about the people who I’ve taken care of for most of my career that I’m not sure I could’ve done in the middle of it. I think that’s given me the ability to look back and reflect and feel the heartache that patients have, and my inability to deliver to them everything that I wanted to deliver to them, because of all of the barriers and obstacles in healthcare.
I’m hoping that my book is going to be a seed that will contribute to a cultural change, a social movement that will bring some dignity and humanity to a large population of our country.
Anson: In your book you said the painful truth is that people in pain are treated shamefully. What did you mean by that?
Webster: When I was growing up on a farm I observed something as a young boy that always puzzled me and that was watching the injured or sick animals. We had all sorts of animals; cows, pigs, sheep, and chickens, and I could see that the injured somehow were always separated from the healthy ones. It wasn’t that the sick separated themselves from the healthy, but the healthy separated themselves from the injured or the ill.
I see that to some degree in people and I wonder if this hasn’t been a biological aspect of survival for man from the beginning. We as humans are better than that; we’re better than we may have been thousands of years ago.
Today, I think that it is shameful that people are stigmatized because they have pain, they’re isolated, and they’re denigrated often. Because of our healthcare system, at least in this country, they’re viewed as addicts, lowlife’s, and druggies. That’s rarely true and it absolutely prevents, it really contributes to the harm that pain sufferers feel towards themselves and their inability to get the type of care they need. I think that it hurts our society in so many different ways, but most importantly the people in pain.
Anson: A lot of your book is dedicated to telling the stories of some of the pain patients that you treated. Virtually every one went through what you just described, where they had trouble getting proper treatment, they had trouble with their jobs, with their families, and with their friends. Is that why you write the book in this way, so that their stories get across the point you’re trying to make?
Webster: Absolutely. It’s less important that a physician tells a story than a patient tells their story. I wanted this book to be felt by the readers, to understand what people in pain experience and the struggles they have.
Anson: You wrote that, “People in pain need to be both treated by medical professionals and supported by all the important people in their lives.” Is that happening?
Webster: No, of course not. There are some patients that have pain who have great support structures in their personal life. For example Alison, she is an individual who had what I thought was the quintessential family support. Were it not for her mother, father and sister, she could’ve gone down the path that too many others take, which would be resignation rather than resilience. It’s one where drugs are used to cope and to escape the pain, physical but also the emotional.
Too many people are separated and too few have the structure of the support system that Alison had. Our healthcare system is abominable. It shamelessly abandons them with limited resources, limited access and actually a labeling of the individual as if they’re a leper; they have a disease that is contagious.
Anson: Is the average physician in U.S. prepared to treat chronic pain?
Webster: No. I think it’s been reported that medical schools average less than 10 hours of education on pain and even less for addiction. Yet this is the number one public health problem in America and it’s not recognized by the CDC like many other disease states have been.
And so very few physicians understand what pain is. In fact, many think that it’s just a symptom and you never die from pain which is categorically wrong. As I write in my book, pain can be as malignant as any cancer and it can be just as devastating. It can take the soul but it also takes the life of some individuals when we ignore it and when we’re unable to provide them the relief that they deserve.
Anson: If you were a young man again in medical school and trying to decide what specialty to go into, knowing what you know today, would you go into pain medicine?
Webster: Without a doubt, there is no hesitancy in this response; I love the field that I’ve been in. As an anesthesiologist I could’ve stayed in the operating room and honestly the compensation of doing that would have been far better than the path that I chose. But the rewards I’ve received from trying to make a difference and the thank you’s that I’ve received will never be matched by any kind of financial or professional recognition in any other areas.
The most rewarding part of life is really to be able to make a difference in someone else’s life. And I think I’ve been able to do that with hundreds, if not thousands of individuals. That actually is the reason for the book. I’m hoping the book is going to make a difference for more people than I could physically touch in my clinic.
Most of the people that I saw as patients were already experiencing a large amount of pain, they’ve been through the mill and many had their chronic pain for years before they came to see me. We are basically going to be taking care of them the rest of their life. We do get to know them, much like a primary care person does to a family they’ve been caring for, and so we get to know them well. They get to know us. We also begin to see the struggles that they have in the system and with the rejection of their families sometimes, their friends, the isolation. And we become the only source that’s grounded, that gives them potential hope. I took that very seriously and I think that’s why it was so rewarding for me.
Anson: You wrote that you’re neither pro-opioid or anti-opioid. What do you mean by that?
Webster: My focus has never been about making opioids available or that they should be used. In fact ten years ago I started the first national campaign about the risk of opioids. My campaign was called Zero Unintentional Overdose Deaths and you can still find that on the Internet. I did a lot of work at trying to understand the potential risks and mitigate those risks so we can prevent people from harm because I knew one day that if we couldn’t prevent people from being harmed from opioids that there would be political response to this that could be very harmful to a large number of people who are not harmed by opioids.
I think the focus should always be about what’s best for a patient and not about whether a drug or a certain treatment is good or bad. All treatments have potential risks and complications, and we need to evaluate whether or not the potential benefit outweighs the potential risk or harm and it has to be patient centered. So my focus has never been about really any treatment, but it’s always been about what’s best for the patient. I’m more anti-pain than I am pro or anti-opioid.
Anson: You prefer a multi-disciplinary approach to pain treatment?
Webster: Yes, it’s been demonstrated that for people with moderate to severe chronic pain, the type that’s not likely to be resolved, it is best managed in a multi-disciplinary, integrative approach. I see the need for more cognitive behavioral therapy. We should always tap into the different treatments that have low risk associated with them before we ever tap into something that has more risk, for example opioids or even interventional treatments we as anesthesiologists and some of the other pain specialists can provide.
Much about pain is really learning how to cope, how to deal with it from day to day and how to manage the stress that’s associated with it because stress augments all pain. And so it’s really important that we use all of the resources that we have to manage the pain and not just a single modality, certainly not opioids or spinal cord stimulators, but look at how we can manage this in a more mindful way, even as clinicians. I use that word intentionally because mindfulness is really what the doctor needs to use as much as the patient in order to optimize the treatment with the lowest risk.
Anson: Has the pendulum swung too far against use of opioids?
Webster: I think there’s too much focus on opioids by almost everyone. And what it has done is it’s forgotten about people. Opioids can cause a great deal of harm, we see way too many people harmed from opioids. But certainly a vast majority of people who have been exposed to opioids are not harmed by them and there are countless number of people, a huge number of individuals who have been on opioids for decades, that believe very strongly that they’ve improved their lives and they could not live without them.
I think the focus is in the wrong place. Our focus should not be on opioids and whether they should or should not be prescribed, but what is the best treatment for the patient? And if opioids are inappropriate as a pain treatment, then I say all of the anti-opioid people as well as the individuals who are interested in helping people with pain should come together and demand that we have more money invested in research so we can replace opioids entirely.
We cannot always know who’s going to have an addiction triggered by exposure. As I pointed out in my book, Rachel just went in for an appendectomy and that initial opioid that she received lead her down a serious, dreadful path because she didn’t have the social support to keep her from taking that path.
I think that the anti-opioid people and those of us who are interested in bringing some dignity and humanity to a large population of people in pain need to come together and insist that we have a Manhattan Project basically and to discover safer and more effective therapies that are not addictive.
Anson: The final version of National Pain Strategy will soon be released, with the goal of advancing pain research, healthcare and education in the U.S. From what you’ve seen and heard so far about it, are they on the right track?
Webster: Yes, I think it’s an important step forward. I think that it brings most importantly the government into the picture, recognizing the need that we do something on a national scale and that alone is a big step forward.
It’s kind of like in my book there are three important words, “I believe you.” This is really the way the government can say, “I believe you.” There is a problem in this country with the way in which we treat pain and the National Pain Strategy is about how they’re going to address that. Having the federal government say I believe you, there is a problem, let’s see if we can change the way pain is treated in this country is a huge step forward.
Anson: Thank you, Doctor Webster.
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A drug epidemic is fueling crime in western Washington and now we know where it is coming from. The DEA has already seized more meth this year than ever before and it can be traced right back to the cartels.
Robert Dixon weighed just 129 pounds last November. His drugs of choice? Meth and heroin.
“It just gives you a burst of energy and it winds you up and you go and go,” said Dixon who is 45 days clean.
For 9 out of 10 heroin users, meth is their secondary drug of choice.
“Methamphetamine is a dark horse riding side by side with heroin,” said DEA Acting Special Agent in Charge Doug James.
The agency has seized more than 430 pounds of meth so far this year compared to 100 pounds in 2009.
Likewise, deaths have risen as well. In King County, there were 15 meth related deaths in 2009, 70 last year and the DEA says the drugs can be traced back to the Mexican Cartels.
“You know we’re 1,277 miles from the SW border, but that’s a 20 hour car drive, 20 hours they can have the drugs up here for distribution and this is a lucrative market here in the Pacific NW,” said James.
Calling them the greatest criminal drug threat to the U.S., a newly unclassified DEA intelligence report uses graphics to show which cartels are the most active here. The Sineloa cartel, led by Joaquin Guzman who escaped from a Mexican prison in July has the biggest presence. The cartel is active in Seattle, Tacoma, Yakima and Spokane.
“The Sineloa cartel is like a consortium of independent trafficking groups that have come together for a common goal. There are multiple heads to the organization with lieutenants. It’s run like a Fortune 500 company and if you cross them, they’re gonna do harm to you,” said James.
The DEA says next in size is the Beltran-Leyva cartel operating on the Canadian border in Bellingham. The Knights Templar cartel is operating in Seattle, Tacoma and Portland. The New Generation cartel has a small foothold in Seattle but is one of the most dangerous and fastest growing criminal organizations in Mexico. And the DEA worries could spread here.
“More often than not, we’re seizing weapons associated with large quantities of drugs and that’s alarming,” said James.
The DEA has set up a tip line where you can report dealers anonymously. Just text “TIP411” and start your message with “TIP-DEA.”
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Underlying the debate over marijuana legalization has been an equally fierce battle between marijuana and another so-called vice industry: alcohol.
As an increasing number of states look to join the four states and Washington DC in legalizing recreational marijuana, many in the alcohol industry have feared that legalized weed will cut into their existing profits.
But a few years into Colorado legalization, alcohol sales are up in the state, and those in the alcohol business have embraced their fellow industry.
In the 18 months since recreational sales were legalized in Colorado, “we’ve just seen phenomenal growth”, said Justin Martz, 32, who runs Mr B’s Wine & Spirits in downtown Denver. He noted that there was some concern initially about legalization, “but it’s really turned out to be a non-issue”. In fact, he said, “if anything it’s kind of helped us. A high tide lifts all boats.”
Bryan Simpson, spokesman for the Fort Collins craft brewery New Belgium, agreed that doomsayers in the alcohol industry were wrong. He argued that rather than alcohol and pot directly competing against one another for consumers’ dollars, the two can be mutually beneficial in boosting overall sales. “There’s definitely some crossover in the two communities of beer drinkers and herb enjoyers,” Simpson said. “But I don’t think people are doubling down in one category or the other.” To underscore that point, he noted that legal marijuana has had “no demonstrable impact at all in terms of sales” at New Belgium.
Tax records show that alcohol sales have continued to grow in Colorado despite the rapid rise of recreational marijuana. Even as tax revenues from marijuana nearly tripled between June 2014 through May 2015, alcohol sales continued to steadily increase as well, with alcohol excise taxes rising 2.1%, the same increase as the year prior.
This symbiotic relationship comes after the two groups went head-to-head in the fight over legalization.
Industry groups have feared that marijuana legalization would deplete interest in alcohol. “Consumer preferences and purchases may shift due to a host of factors,” including “the potential legalization of marijuana use on a more widespread basis within the United States,” warned the Brown-Forman Corporation, a publicly traded liquor manufacturer that produces many well-known brands including Jack Daniel’s and Southern Comfort, in a recent SEC filing.
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This fear is backed by some academic research, which has found that many consumers consider alcohol and marijuana to be substitutes. One study found that legalization of medical marijuana in many states led to sharp decreases in alcohol consumption. The alcohol industry is “smart to worry about it”, one of the study’s authors, University of Colorado Denver economics professor Daniel Rees, told the Denver Post.
In some cases, alcohol groups have openly opposed weed legalization initiatives and backed that opposition up with major campaign donations. In 2010, the California Beer & Beverage Distributors made a $10,000 contribution to Public Safety First, a group fighting Proposition 19, a measure to legalize recreational marijuana in the Golden State. The initiative ended up losing by seven points.
The marijuana industry has taken aim at alcohol as well. Nearly every marijuana legalization campaign bases its argument on comparisons to alcohol, contending that the plant is less dangerous and frequently using campaign name variations of “regulate marijuana like alcohol”.
In 2013, there was a big dust-up between the Marijuana Policy Project and the Beer Institute after the former put up advertisements in Portland, Maine with middle-aged people declaring: “I prefer marijuana to alcohol because it’s less harmful to my body” and “I prefer marijuana to alcohol because it doesn’t make me rowdy or reckless”. Chris Thorne of the Beer Institute responded that it’s misleading to compare marijuana to beer, because it’s “distinctly different both as a product and an industry”.
Part of the reason for the alcohol and marijuana industries’ success may be a boost in Colorado tourism. Though some state officials insist marijuana is not attracting new visitors, Colorado tourism set record highs in 2014, the first year of legalization, with 71.3 million visitors who collectively spent $18.6bn.
Many in the alcohol industry credit marijuana with helping boost tourism. Martz said he frequently asks tourists in his downtown store what brought them to Colorado. “Legalization adds to the overall draw,” he noted, even if most tourists don’t come solely for pot. Simpson concurred that the number of tourists visiting New Belgium has continued to increase steadily, including from some pot-inclined tourists.
And alcohol isn’t simply a remora to the marijuana shark; the two industries are even finding ways to help one another out. Many out-of-towners who visit Mr B’s Wine & Spirits ask Martz where the closest dispensary is. He’s not only happy to help direct them, but also has a stack of coupons from the dispensary in his shop to hand out.
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http://www.medpagetoday.com/special-reports/slipperyslope/52867
At 88-years-old, Gloria Glatz still embraced life.
The mother of three was an avid Scrabble player and made a phenomenal potato salad in between occasional visits to the casino.
Like as many as 5 million Americans, Glatz had atrial fibrillation, a known risk factor for stroke.
In December 2011, her doctor decided it was time to put her on an anticoagulant drug, but rather than choosing the decades-old standby, warfarin, the doctor prescribed Xarelto (rivaroxaban), which had been approved by the U.S. Food and Drug Administration just a few months earlier.
Xarelto is one of four anticoagulants approved since 2010 that make up a class of drugs known as novel (or newer) oral anticoagulants, NOACS (pronounced No-aks) for short. Widely promoted as more convenient than warfarin, the drugs came to market with much fanfare anticipating blockbuster status.
But unlike warfarin, which is a vitamin K antagonist that can be turned off in a bleeding emergency or prior to surgery by administering vitamin K, all of the NOACs were approved without an antidote, although packed red blood cells can slow their anticoagulation action.
When Glatz developed gastrointestinal bleeding, months after she started taking Xarelto, doctors could not make it stop. She died March 23, 2012 at a Kenosha hospital.
“They said there was nothing they could do,” said her daughter, Dottie Glatz.
Convenience: Yes, Antidote: No
Since 2010, more than 58,000 people have reported a serious side effect, such as a major bleeding episode, after using one of the anticoagulants designed to replace warfarin, a MedPage Today/Milwaukee Journal Sentinel investigation found.
At least 8,000 deaths have been linked to three of the new anticoagulant drugs since 2010, compared with about 700 for warfarin. Mortality data for the fourth drug, approved in January, is not yet available.
These numbers are drawn from the FDA’s adverse events reporting system, which is largely voluntary. Though the reports are not verified, the numbers suggest an imbalance: the three newer drugs accounted for less than 10% of all anticoagulant prescriptions, yet they were linked to more than 90% of deaths reported to the FDA since 2010.
Doctors are increasingly prescribing the newer, more expensive drugs to people with afib as a way to prevent strokes and also for short term use for both prevention and treatment of deep vein thrombosis (DVT).
A primary selling point to the drugs is that they don’t require regular INR testing. With warfarin, also known as Coumadin, patients must have regular INR testing, which can be done at a doctor’s office, an anticoagulation clinic, or can be monitored with home testing.
Patients must also follow dietary measures, such as not eating large or inconsistent amounts of foods that are rich in Vitamin K, which can lessen warfarin’s effectiveness. That includes spinach, kale and brussels sprouts.
Alcohol also should be limited to small amounts.
Marketing campaigns highlight the convenience of the new drugs, including a recent TV ad for Xarelto featuring comedian Kevin Nealon, who has atrial fibrillation, and golfer Arnold Palmer and NASCAR driver Brian Vickers, who both had blood clots in their legs.
The three sit at a table at a golf course.
“Let’s see, golf clinic or blood clinic?” Nealon says. “Ooh, that’s a tough one.
More than 10 million prescriptions for the new drugs, costing about $3.5 billion, were dispensed in 2014, according to data from IMS Health, a market research firm. Prescriptions for warfarin, which is a fraction of the price, went down slightly in 2014 compared with 2013 and 2012.
The NOAC Boom
The surge in use of the drugs has been bolstered by a new system for determining stroke risk that was devised by a British doctor who, the MedPage Today/Journal Sentinel investigation found, has extensive financial ties to companies that make or market the new drugs.
The new system was adopted as part of treatment guidelines by leading medical societies in the U.S. and Europe — ones that themselves have received millions from drug manufacturers.
In addition, many of the doctors who wrote those guidelines or issued other recommendations had personal financial ties to those companies, such as working as speakers or consultants.
Some 5.2 million Americans have atrial fibrillation, according to a 2013 paper published in The American Journal of Cardiology. That’s higher than past estimates of about 3 million.
How many qualify for an anticoagulant under the new guidelines?
Applying new scale, the number of Americans deemed in need of an anticoagulant jumped overnight from an estimated 3.7 million to 4.7 million, according to a paper published in May in the journal JAMA Internal Medicine.
Rita Redberg, MD, a cardiologist and editor of JAMA Internal Medicine, said she tells patients to wait a few years until the true risks and benefits of the new drugs are known.
“I don’t prescribe any of the newer oral anticoagulants,” said Redberg, a professor of medicine at the University of California, San Francisco. “My concern is that a lot of the people being put on the novel oral anticoagulants will have more harm than good.”
The new drugs have proven to be an expensive alternative to warfarin, now a generic, which remains more frequently used.
In 2013, taxpayers paid more than $1 billion for prescriptions of just two of the drugs, Xarelto and Pradaxa (dabigatran), according to an analysis of Medicare data. Warfarin was dispensed about six times more often, but cost taxpayers significantly less — $240 million.
The data for 2013 are the most recent available.
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