The author of Bad Pharma does an excellent job of shining a light on the truths that the drug industry wants to stay hidden.
Those truths include how they mislead doctors and the medical industry through sales techniques, and manipulate consumers into becoming life-long drug customers. (For doctors that industry influence begins in medical school and continues throughout their practice.)
We also learn truths about the internal workings of the medical academia, the U.S. FDA, and medical journals publishing. Here are a few highlights from Bad Pharma.
Manipulating Clinical Drug Trials
As consumers, how do we really know which drugs are best? The U.S. FDA protects us, right? Well sort of. Read how trials for drugs and their perceived usefulness can be manipulated, poor trials go unpublished or outright suppressed, and underperforming trials are stopped early or the trial period extended.
One way to manipulate clinical trials starts at the beginning―the design of the trial. Often, few comparison studies are done. Far more common are new drug studies going against placebo pills (that everyone knows don’t work). This helps inflate findings, makes new drugs look more effective than older drugs―because they were never compared against each other.
Bad Pharma & the Cost of Doing Business
Learn how pharmaceutical companies legitimately funnel $10 million to $20 million a year to major medical journals including the New England Journal of Medicine and the Journal of the American Medical Association. So, are we surprised then that studies funded by the pharmaceutical industry are much more likely to get published by these influential journals?
Direct to Consumer Drug Sales
Did you know drug companies spend twice as much on marketing and advertising as on researching and developing new drugs? (I was shocked.)
Of special interest to me is the ‘Direct to Consumer’ drug sales which has significantly increased drug sales in the U.S. ‘Direct to Consumer’ drug sales is so misleading that it is banned in all countries except two: the U.S. and New Zealand. (No wonder that 70% of drug companies’ profit comes from the U.S.)
To be specific, I hate those misleading TV commercials that target A-Fib patients. What these ads for anticoagulants don’t tell you is:
• You are on their meds for life! (they want lifelong customers!)
• These meds do nothing to treat your A-Fib (only your risk of stroke)
• A-Fib can be cured (you don’t have to be on meds for the rest of your life)
These ads for anticoagulant medications imply if you just take their pill once day, you’ve taken care of your A-Fib. Wrong!
Well Written, Easy to Understand
Bad Pharma, is written in an easy-to-understand manner (you don’t need a medical or science degree). If you wish, you can skim through the book to get an overview, then stop and read a topic of interest. Or you can dig in for a full read, including the authors’s research and other references (documented in footnotes with citations.)
Check on Your Doctor
After reading how big Pharma may be influencing your doctor, you can now find out. In the U.S., with the passing of the Sunshine Act (part of the 2010 Patient Protection and Affordable Care Act), we can now research if a doctor has received pharma money to prescribe their products. Just go to the Open Payments or Dollars for Doctors website.
One of our tenets at A-Fib.com, is ‘Educate Yourself’! If you want to be a more savy consumer of health care services, I highly recommend Bad Pharma. I also recommend Ben Goldacre’s other book, Bad Science.
Bonus Idea: If you pair this book with “Know Your Chances: Understanding Health Statistics” by Steven Woloshin, you’ll have a complete course on how the drug industry skillfully markets their products.
How to See Through the Hype in Medical News, Ads, and Public Service Announcements
By Steven Woloshin M.D.M.S.
Review by Patti J. Ryan
Every day we are bombarded by television ads, public service announcements, and media reports warning of dire risks to our health and offering solutions. But many of these messages are incomplete, misleading, or exaggerated, leaving the average person misinformed and confused. They use fear to make us feel vulnerable.
Know Your Chances: Understanding Health Statistics is for those who look for the footnotes when reading about healthcare claims, who question the facts behind today’s bombardment of health risk messages.
Discover why some studies should be viewed with suspicion, learn to interpret the numbers behind the messages, find the credible information—if any, and what questions patients need to ask before choosing a treatment.
Know Your Chances is written in a simple, straightforward style and can be easily understood by readers without a medical degree.
It’s a fast read. The core content of the 158 page book is only 113 pages. Includes quizzes, a glossary, summaries and other resources. Take the mystery out of medical statistics and become a better consumer of health messages.
Buy or Read for FREE
*A service of the U.S. National Library of Medicine, National Institutes of Health
By Travis Van Slooten
This is an update to our February 2015 review. We welcome guest blogger, Travis Van Slooten, publisher of Livingwithatrialfibrillation.com. An active user of the AliveCor Kardia, he is sharing his review and opinions.
As someone that battled a-fib for 8½ years prior to having a successful ablation, the Kardia Mobile heart monitor by AliveCor really helped me and gave me peace of mind.
The Kardia monitor is a FDA-approved device that works with your smartphone and allows you to take an ECG recording of your heart from the comfort of your home, office, or anywhere.
The Kardia consists of two parts. There is the device itself, a small, wireless component that attaches or sits in close proximity to a cell phone or tablet. It syncs to the second component, a smartphone app.
It’s very straight forward to use the device. After you download the app to your smartphone, open and click on “Record Now”; then press your fingers to the device.
As soon as you click on the green “Record Now” button, with your fingers on the device, the app displays an ECG reading of your heart in real-time and records it.
The default setting is 30 seconds, but you can record up to 5 minutes if you want.
I recommend the one-minute recording, because 30 seconds is too short and anything over one minute is longer than necessary to get the data you need.
Three classifications. When completed, AliveCor’s built-in filter will tell you immediately if you are potentially in afib or not. The three classifications you’ll potentially get are:
• Possible Afib
|VIDEO: AliveCor Kardia Review by Actualidad iPad
Best footage I could find of the Kardia app screen. Shows actual capturing of the ECG signal with an inset image showing the users hand positions on the Kardia device. He repeats and adjusts his hands and you see the results on the screen. Watch 1st 3:00 min. Followed by report screen, emailing, etc. In Spanish (can mute audio).
Legally, AliveCor’s filter can’t say you are definitely in afib; so if you’re in afib, it will say, “Possible Afib.” If you get this message, you’ll want to share the ECG with your doctor, which you can easily do within the app. You can also send the ECG to AliveCor’s ECG analysis service from within the app for a fee to get an interpretation.
The “normal” classification is self-explanatory. If your heart is in normal sinus rhythm (NSR), you’ll get this message. This is the classification you hope to see!
The “unclassified” classification is a bit trickier. This means one of two things. You’re either having an arrhythmia other than afib such as PVCs, PACs, tachycardia, bradycardia, etc., or the device wasn’t held properly so an accurate recording wasn’t taken.
If you get the unclassified message, there are a couple things you can do. You can try another recording to see if you get the same message, or you can send the ECG to your doctor or AliveCor’s ECG analysis service for interpretation. Usually when I get this message, I find out I’m having PVCs and PACs.
Why Should Every Person with Afib Own This Device?
Let me explain how it helped me.
When I would go into afib, I knew I was in afib! I was highly symptomatic. However, I always turned to my Kardia Mobile monitor to confirm I was indeed in afib before I would take my medication. I was taking Flecainide at the time as a pill-in-the-pocket approach to treating my atrial fibrillation. This is a very powerful antiarrhythmic drug, especially at the doses I was taking (300mg), so I didn’t want to take it unless I was absolutely sure I was in afib.
I would then use the AliveCor monitor afterwards to confirm I was back in NSR. For me, it would usually take 4-6 hours before the Flecainide would work. It was great to have the monitor to confirm when the episode was over. I would share this information with my doctor, which helped him to determine if our treatment approach was working.
Since my successful ablation back in March 2015, I haven’t had a need to use the Kardia monitor for afib specifically, but now I use it in my battle with PVCs and PACs.
Sometimes these get so intense that I feel like I’m having a minor afib episode (if there is such a thing as a minor afib episode). I use the monitor extensively to confirm I’m having just PVCs and PACs and not afib. I also use the data to keep a historical record of the number of PVCs and PACs I’m having.
As I’m sure you can see by now, this little device can provide a lot of useful information for you and your doctor.
The Drawbacks of the Kardia Mobile Monitor
I’m a big advocate of this device, but it isn’t perfect. My primary complaints about the device are that it can be very touchy at times and can provide inaccurate or misleading classifications.
Must hold the monitor “just right”. The Kardia monitor requires that you stay perfectly still to get the cleanest and most accurate ECG reading. If you move around or if you move your fingers, or if you hold the device too hard or too soft, you can get a “dirty” ECG reading or an inaccurate classification. This can be annoying as it can sometimes take 2-3 attempts to get a good reading.
Misleading classifications can be common as well. There have been many times when the app shows “Possible Afib” when I’m just having PVCs and PACs. And when I’m having PVCs and PACs, it will almost always say “Unclassified.” It would be nice if it said PVCs and/or PACs instead of leaving me in the dark with an “Unclassified” message or indicating I might be in afib.
ECG analysis service fees adds up. My other minor complaints are that the ECG analysis service is expensive, and there is no ambulatory (continuous) monitoring. Through the app, you’ll pay $9 for a technician only analysis or $19 for a cardiologist analysis and recommendation. If you’re having a lot of your ECG recordings analyzed, this can add up quickly!
Can’t monitor your heart while walking or sleeping. Given the nature of the device – having to hold it perfectly still when you want to take a recording – there is no ambulatory monitoring available. For example, you can’t monitor your heart while walking or exercising. You can’t monitor your heart while sleeping. It would be great if future versions include some kind of wearable tech to allow continuous monitoring for these situations.
Bottom Line: Still the Best Consumer Heart Monitor. Despite these drawbacks, the Kardia device is still the best available monitor of its kind in the consumer market, in my opinion. If any of these drawbacks were improved upon, it would just make the monitor that much better!
What the Future Holds for the Kardia Monitor
Just recently, AliveCor partnered with Omron. You can buy a Bluetooth-enabled Omron blood pressure monitor and store that information in the Kardia Mobile app. This will give you additional useful data of your heart health that you can use and share with your doctor.
There is also the Kardia Band that AliveCor is waiting for the approval of by the FDA. This is a band for the Apple watch. Instead of carrying the device in your pocket or attaching it to your phone like you have to now, you’ll be able to wear this band with your Apple watch and just place your thumb on it to take a recording. How convenient that will be!
If you have atrial fibrillation and you don’t own this device, I highly recommend you get one. It’s another tool in your “afib toolbox” that can help you manage your condition and give you peace of mind.
We are grateful to Travis for sharing his first-hand experience and opinions. Visit his blog for a more extensive review of the AliveCor Kardia.
Travis Van Slooten is a blogger, internet marketer and atrial fibrillation patient who has been passionate about providing knowledge, inspiration, and support to fellow afibbers ever since his diagnosis in 2006. You can follow him on his blog or his afib Facebook page.
by Patti J. Ryan, October 2016
Called ‘Broken Heart Syndrome’, a new study finds that the death of a partner is linked to a heightened risk of developing atrial fibrillation. The risk seems to be greatest among the under 60s and when the loss of the partner was least expected.
The researchers looked at a national registry in Denmark of 88,612 people who were diagnosed with atrial fibrillation and 886,120 healthy people matched for age and sex, and between 1995 and 2014. Other factors that might influence atrial fibrillation risk were included as well.
They found that people who had lost a partner were 41% more likely to develop atrial fibrillation in the first month after losing their partner. The risk seemed to be greatest 8 to 14 days following a death and gradually subsided during the following year.
More Evidence of Mind-Heart Link
Experts suspect acute stress may directly disrupt normal heart rhythms and prompt the production of chemicals involved in inflammation.
This study adds evidence to the growing knowledge that the mind-heart link is a powerful association.
What can be done about this risk? The answer requires more research but may focus on the way the body deals with stress.
Recommended Reading: The Anatomy of Hope: How People Prevail in the Face of Illness, by Jerome E. Groopman.
Written by an oncologist and citing actual patient cases (mostly cancer), Dr. Groopman explores the role of hope in fighting disease and healing. Top scientists are interviewed who study the biological link between emotion and biological responses; the most relevant studies are reviewed.
The author shows how hope, belief and expectations can alter the course of our lives, and even of our physical body. HOPE works! (For more read my review on Amazon.com.)
Are you using the latest AliveCor ‘Kardia™ Mobile’ heart monitor? The current model (Model 1141) has been out since February. I want to update our February 2015 review.
The AliveCor Kardia attaches to an android or Apple device. And by pressing the sensors with your fingers (or thumbs), it capture single-lead, medical-grade EKGs in just 30-seconds. Instantly it shows if your heart rhythm is normal or if atrial fibrillation is detected.
How is the AliveCor Kardia Working for You?
If you are using the AliveCor Kardia, how do you typically use it? Regularly? Or only when you think you’re in A-Fib?
Do you take readings just for your own peace of mind or do you transfer the data to your doctor? Are you satisfied with its performance? Do you recommend the Alivecor Kardia or other brand monitor to others with A-Fib?
Share Your Insights
Do you have first-hand experience? I’m asking any A-Fib.com readers using the latest AliveCor Kardia model to share your product experiences with me. Just send me an Email with your impressions.
Other Heart Monitors: I’m also interested if you are using another brand of handheld heart monitor, such as the BodiMetrics Performance Monitor.
By Patti J. Ryan
Do you struggle with the daily mix of supplements and prescriptions you take? Some are small, but some are horse-pill size! Some you take in the AM, others you take in the PM.
Trying to find the right pill organizer has been a trial for me. Most often the compartments are too small and hard to open.
I Found the Best Organizer
After years of trial and effort, I’ve FINALLY found a great pill organizer―the EZY Dose AM/PM 7-Day Push Button organizer.
This 7-day organizer has two rows for AM/PM dosages with large letters for the days of the week.
Compartments are extra large―about 1 1/8″ wide by 1 3/8″ deep. That’s large enough for those ‘horse pill’ size tablets. The compartments have rounded bottoms― making it effortless to get the pills out. And the cherry on top? Push button lids―easy open and easy close.
Do you carry your meds with you? The EZY Dose is also compact and portable for carrying in your purse or jacket pocket.
Note: If you take pills four times a day, there’s an EZY Dose for you too: 7-Day XL Medtime Planner
Use our Link to Amazon.com and Support A-Fib.com
For my needs, I bought two 7-Day EZY Dose organizers from Amazon.com, so I’m set for two weeks at fill up time.
Use our Amazon.com portal link: Here’s a link to get two EZY Dose AM/PM 7-Day Push Button organizers and Free Amazon Prime shipping. (Purchases through our portal link helps support A-Fib.com―at no extra cost to you!)
The EZY Dose AM/PM 7-Day organizer is also available from other retail and online sources.
A-Fib Patient Story #88
My A-Fib Story: The Healing Power of Prayer
By firstname.lastname@example.org, August 2016
A-Fib Medications Didn’t Work
I struggled with A-Fib for almost eight months in the year of 2011. It began in January, and I had episodes of it throughout the year. My episodes weren’t too bad—as in I never had any side effects of the A-Fib like fainting or clotting. The only real thing I had during the episodes was an irregular heartbeat and a fast heart rate.
Being as young as I am and having a family of my own, it was a lot to have on my shoulders.
I wanted the A-Fib gone, and the medication I was taking did not make it go away.
My Pastors Prayed for My Healing
I knew of another way that the A-Fib could go away—by God supernaturally healing me. Well, in August of 2011 I asked the pastors of my church to pray for me that God would heal me. After the Sunday service they prayed for me. And a week after that my A-Fib was gone. I was healed by prayer.
I haven’t had an episode or problem since 2011! It’s a miracle!
Helped by Great Physicians Too
I am not writing this to refute your book, Steve, nor am I saying that the medical field should not be called upon for help in the time of need.
If it wasn’t for the great physicians here where I live on the East Coast, I would be in bad shape—who knows what would have happened if they didn’t break those episodes I had. And, I’ve read testimonies of others where medicine helped them with, if not cured, their A-Fib episodes.
I simply wanted to share with you my experience – since it included A-Fib. Who knows—maybe God can bless you through my e-mail.
At A-Fib.com one of our volunteer groups is a Positive Thought/Prayer group comprised of wonderful people worldwide. If you would like their support, especially at the time of your ablation or surgery, please email us your request. It’s comforting to know that others who’ve had A-Fib care about you and wish you well.
How to Send Your Request: Send your request to our coordinator, Barbara. Write to barbara: babareeba(at)aol.com (substitute an “@” for the “(at)”).
Join our Group: We invite you to join our ‘A-Fib Positive Thought/Prayer’ group. Learn more on our page: The Healing Power of Hope, Belief and Expectations. All are welcome.
by Jerome E. Groopman
There’s more to hope than we thought. Hope triggers biochemical changes.
Written by an oncologist and citing actual patient cases (mostly cancer), Dr. Groopman explores the role of hope in fighting disease and healing. Top scientists are interviewed who study the biological link between emotion and biological responses; the most relevant studies are reviewed.
The author shows how hope, belief and expectations can alter the course of our lives, and even of our physical body. HOPE works! (Read Patti’s review on Amazon.com.)
If you find any errors on this page, email us. ♥ Last updated: Friday, December 2, 2016
One such product is the FDA-approved AliveCor now in its third-generation (no longer requires a doctor’s prescription). Attached to your cell phone and with the proper app, it can display your an EKG (ECG) signal.
In this report, Frances Koepnick shares her experience with the AliveCore, some of the problems and some of the benefits. Read Frances’ report->(corrected link)
Of late, there have been several new consumer heart rate monitors on the market of interest to A-Fib patients. One such product is the FDA-approved AliveCor. Attached to your cell phone and with the proper app, it can display your an EKG (ECG) signal. In this report, Frances Koepnick shares her experience with the AliveCore, and the pros and cons. Note: models shown may vary.
What is the Alivecor?
FDA-cleared for detection of atrial fibrillation (A-fib), the AliveCor Heart Monitor when combined with its AliveECG App provides a 30-second, one lead electrocardiogram (ECG) that is In addition to an ECG, this monitor also determines heart rate in beats per minute (BPM). This easy-to-use device attaches to iPhones (models 4 thru 6) by means of a phone case. It is also available for some compatible smartphones and mobile devices other than Iphones.
This technology is now in its third generation and is available for purchase without a prescription on AliveCor’s website at www.alivecor.com.
The items required include an AliveCor Heart Monitor and the specific phone case which attaches the heart monitor to your smartphone. Prices vary according to the make and model of smartphone or mobile device. A Third Generation AliveCor Heart Monitor with case for the iPhone 6 will be available for $84.99.
“In clinical studies, the AliveCor Heart Monitor has been shown to be accurate and efficacious. The Heart Monitor is FDA-cleared and as such has shown equivalency to other ECG machines”.1 Two studies done in 2013 and published in peer reviewed journals document the accuracy of the AliveCor Heart Monitor.2,3 Furthermore, this technology has successfully detected undiagnosed A-fib when placed in pharmacies.4
How to Use the Alivecor
Setting up your Alivecor is not covered here. See your Alivecor instructions and/or visit the AliveCor website.
What You Can Do With Your Recording
You can print, obtain a PDF or email an ECG to your physician at no charge directly from your smartphone. There is also an AliveCor function available whereby a physician can set up a “provider dashboard” to review their patients’ ECG recordings by means of a free web-based application. All of the above functions “travel with you” via your smartphone. Consequently, ECG data can be shared on an international basis.
Expert Review of a Specific Recording
If you want to obtain an expert review of a specific ECG recording, you can do so for a fee by simply tapping on the “ANALYSIS” icon. There are two choices available from AliveCor depending on the credentials of the reviewer:
A clinical analysis and report by a U.S. Board Certified Cardiologist costs $12 and is “best suited for patients with limited technical ECG knowledge”.5 This analysis has a 24-hour turnaround time and contains a doctor recommended course of action.
A preliminary finding by a U.S.-based cardiac technician costs either $2 for a 24-hour turnaround or $5 for a 30-minute turnaround. This analysis contains preliminary technical findings by non-physicians with no recommendations for a course of action.
My Experience with AliveCor on my iPhone 4S
This technology is certainly easy to use and as convenient as the proximity of your cell phone.
However, the ECGs which I have recorded on my AliveCor Heart Monitor are usually not flagged as “possible A-fib”. I sent one of my “unflagged” ECGs for review by an AliveCor cardiac technician and the result was reported as “Atrial Fibrillation Sustained”. When I reported this discrepancy to AliveCor’s Customer Service, they agreed that the ECG which I had submitted should have been “flagged” as A-fib. Their reply also indicated that “every (ECG) recording we get helps us improve our algorithms to better serve our customers”.
In spite of the discrepancy which I have experienced with the AliveECG algorithm, I do recommend the AliveCor Heart Monitor.
About the AliveCor, App and Compatiable Cell Phones
Although the AliveCor Heart Monitor was originally developed for the iPhone, it is also available for other compatible devices. Currently, this monitor is available for the iPhone 6/6 Plus, iPhone 5/5S/5c, iPhone 4/4S, iPod Touch 5G, iPad Air and iPad mini. Other compatible devices include the Samsung Note 3, Galaxy S3/S4/S5, HTC One, and Jitterbug Touch 2/Touch 3.
The AliveECG App is free and this software can be downloaded from the Apple App Store or the Android App on Google Play. Before downloading the AliveECG App, be sure that your smartphone’s operating system has been updated to the minimum version required for use with this app. See the instructions with your AliveCor or visit AliveCor.com.
About the author: Frances Koepnick, M.A. is a retired medical microbiologist and current A-fib patient. She previously taught microbiology, anatomy and physiology at the community college level.
Last updated: Friday, March 6, 2015
- Is the AliveCor Heart Monitor accurate? http://www.alivecor.com/getstarted:↵
- J.K. Lau et al., iPhone ECG application for community screening to detect silent atrial fibrillation: A novel Technology to prevent stroke, International Journal of Cardiology, Vol. 165:193-194, 2013.↵
- L.A. Saxon et al., Ubiquitous wireless ECG recording: A powerful tool physicians should embrace, Journal of Cardiovascular Electrophysiology, Vol. 24: 480-483, 2013.↵
- Nicole Lowres et al. Thrombosis and Haemostasis, Vol. 111, Issue 6: 1167-1176, 2014.↵
- http://www.alivecor.com/why-use-it: ECG analysis.↵
by Steve S. Ryan, PhD, Update July 2014, June 2015, October 2015
“I’ve read about people bleeding to death in the ER because they are on the new anticoagulant Pradaxa. Doctors can’t stop the bleeding, even from minor cuts. Is that true? Doesn’t Coumadin carry the same risk? What about the other new anticoagulants Xarelto and Eliquis?”
You’re correct about Pradaxa and the reported bleeding deaths (See “Stop Prescribing or Taking Pradaxa: Suspect in 542 deaths.”) None of the new anticoagulants (including Xarelto and Eliquis) has a proven, reliable antidote or reversal mechanism. But, Pradaxa, in particular, has been associated with tragic deaths in the ER where doctors are helpless and can only watch as someone bleeds to death.
Most would agree that the worst thing that can happen to a patient with A-Fib is a life-altering stroke. A stroke often causes death or permanent disability. Thus the importance of anticoagulation therapy for A-Fib patients.
For many years, there was only one proven therapy for stroke prevention in A-Fib patients at high or intermediate risk for stroke: the anticoagulant Coumadin (warfarin). It’s readily available and inexpensive.
But maintaining correct Coumadin levels is difficult especially over the long haul (studies indicate around 30% of people will stop taking Coumadin).
But maintaining correct Coumadin levels is difficult especially over the long haul (studies indicate around 30% of people will stop taking it).
In addition, Coumadin taken over several years may lead in microbleeds in the brain and dementia. (Read about the post-ablation patient on anticoagulation therapy for 10 years who develops cerebral microbleeds and early dementia: The New CHA2DS2-VASc Guidelines and the Risks of Life-Long Anticoagulation Therapy )
For patients at low or intermediate risk of stroke (including younger patients without any additional stroke risk factors) aspirin may be prescribed, or no anticoagulation therapy at all.
Read about the post-ablation patient on anticoagulation therapy for 10 years who develops cerebral microbleeds and early dementia: The New CHA2DS2-VASc Guidelines and the Risks of Life-Long Anticoagulation Therapy
The NOACs Trials
For over 20 years there have been extensive efforts to replace warfarin with other drugs. In the US, we have four new anticoagulants to consider: Pradaxa (dabigatran), Xarelto (rivaroxaban), Eliquis (apixaban), (added January, 2015) and the recently approved (January, 2015) Savaysa (edoxaban)).
The data on the new anticoagulant come from three randomized controlled trials involving more than 50,000 A-Fib patients:
Each study compared one drug against warfarin (not against each other). Taken together, these studies consistently revealed that A-Fib patients who took the non-warfarin blood thinners suffered fewer strokes, intracranial bleeds, and serious bleeds than those who took warfarin.
All of these drugs are at least as good as warfarin for preventing stroke and all are better than warfarin in reducing your risk of serious bleeding in the brain. But none have antidotes or reversal agents (at this time).
Note: Each of these NOAC trials had a questionable bias toward the new drug when compared against warfarin. Warfarin users are notoriously non-compliant, up to 50% are inconsistent in managing their diet, monitoring their INR levels and taking the correct dosage.4 Each of the three trials compared a group of compliant patients against a group of inconsistent warfarin patients. So results should be viewed with a critical eye.
For a more in-depth look at the clinical trials of the new NOACs, see 2013 BAFS: The New Anticoagulants (NOACs).
Three Notable Concerns
The new anticoagulants offer several advantages over warfarin. They are fast acting. And when stopped (i.e., for surgery), they just as quickly clear your body (a short “half-life). There’s a broad therapeutic window (wide range of safe use), and they have minimal drug or dietary interactions. They can be administered in fixed doses without monitoring, making them potentially more convenient to use than warfarin.
Remember: The goal of anticoagulation therapy is to reduce your risk of life-altering stroke.
Enthusiasm for the new anticoagulants, (NOACs), however, must be tempered by three notable concerns in patients taking these drugs:
1. No readily available means for assessing the degree of anticoagulation
2. No readily available reversal strategy
3. Life-threatening bleeding complications can occur after an injury
(Added May, 2015) Dr. Stephen Kimmel of the Un. of Pennsylvania discusses a fourth concern—stomach problems and gastrointestinal bleeding. “If you have a history of stomach problems or gastrointestinal bleeding, you may want to avoid Pradaxa and Xarelto—both medications have the highest risk for those complications.”5
No Way to Measure Effectiveness
One of the problems with the newer anticoagulants (NOACs) is we don’t have a good way to measure how effective they are or how much of an anti-clotting effect there is at a given point in time. (For example, in treating trauma patients, ER doctors can only use the elapsed time from the last dose to estimate the clotting effect.)
With Coumadin (warfarin), on the other hand, we can measure how effective it is by its level in the blood stream measured in INR (International Normalized Ratio). A person not on anticoagulants will have an INR slightly above 1 (the author’s INR is 1.1). Someone with A-Fib on Coumadin should have an INR between 2.0 and 3.0. At this INR level a person will bleed more than someone with an INR of 1.0, but the blood will still clot.
With an INR below 2.0 you are more in danger of having an ischemic (clotting) stroke, the kind that most often occurs in A-Fib. With an INR of 4.0 and above, there is much more risk of blood not clotting and of developing a hemorrhagic stroke.
But the INR blood test doesn’t work with the new anticoagulants which affects only one particular stage in the anticoagulation process. Pradaxa, for example, is a direct thrombin inhibitor, whereas Coumadin affects nearly every stage in the anticoagulation process. (Thrombin is an enzyme that converts soluble fibrinogen into insoluble fibrin. Fibrin is a fibrous protein involved in the clotting of blood. It forms a mesh or clot over a wound.)
The lack of a readily available method to determine the degree or current level of anticoagulation is a major challenge for ER physicians and staff treating trauma patients.
Are the NOACs Too Effective?
Pradaxa, in particular seems to work almost too well.
Pradaxa, in particular seems to work almost too well.
Coumadin on the other hand has several proven, time-tested reversal or antidote strategies.6
Pradaxa (dabigatran) won the FDA sweepstakes by being the first new anticoagulant to get FDA approval and consequently captured a significant share of the anticoagulant market. Pradaxa comes in two doses in the United States, 150 mg twice daily or 75 mg twice daily. It’s large and harder to swallow, comes in a bottle with a 30-day shelf life once opened (or in blister packs which eliminates the shelf-life problem.) And it’s expensive.7 In the RELY trial, Pradaxa was not only equal to warfarin, but it proved to be superior to it in preventing stroke. Bleeding rates in the head were lower with Coumadin. However, bleeding from the stomach or bowels was higher. The most common side effect was stomach pain.
In addition to the bleeding deaths in the ER mentioned above, Pradaxa’s own fact sheet states common side effects of Pradaxa include:8
• Indigestion, Upset Stomach, or Burning
• Stomach Pain
[These statements don’t capture the actual human toll—burning throat, roiling intestines, diarrhea, burning anus, lasting intestinal damage, etc. that Pradaxa can produce in some people.]
Xarelto and Eliquis Test Better
Xarelto (rivaroxaban) was the second drug available in the United States. Xarelto comes in two doses, 20 mg daily or 15 mg daily. In contrast to Pradaxa, it is a small pill taken once-a-day that doesn’t seem to cause a lot of intestinal problems. In the Rocket AF trial, Xarelto also significantly lowered the risk of bleeding in the brain and head compared to Coumadin. Like the other new anticoagulants, Xarelto also doesn’t have a reversal agent; but anecdotally we don’t seem to see a lot of deaths in the ER from Xarelto.
Eliquis (apixaban) was third to be approved, comes in two doses, 5 mg twice daily or 2.5 mg twice daily (the lower for A-Fib patients with kidney dysfunction). Similar to Xarelto, the risk of bleeding in the brain and head was lower versus Coumadin. However, this drug was unique in that bleeding from other sites including the stomach, bowels, and bladder was less. In the Aristotle trial, Eliquis was at least as good and tended to be better than warfarin at preventing stroke. Eliquis is the only drug that can claim that survival improved with its use compared to warfarin.
Xarelto and Eliquis, just like Pradaxa, are also very expensive.
The reported bleeding events tend to occur mainly in elderly patients (median age of 80) which raises a question regarding safe dosing and monitoring in older patients. Elderly patients often have mild to moderate renal impairment, which can cause plasma levels of the NOAC to increase to up to three times those in normal renal function.
“One-size-fits-all” dosage of these new anticoagulants may need to be re-examined for elderly patients. (The FDA rejected the lower 110-mg twice-daily dose of Pradaxa (dabigatran) tested in the RE-LY trial, instead approving a 75-mg twice-daily dose just for patients with severe renal impairment.)
Lack of a proven, reliable antidote or reversal mechanism creates a major challenge for trauma staff.
With a relatively short elimination half-life, for now, time may be the most important antidote for NOACs.
Eliquis Earns Best Safety Score
Through an analysis of data from the FDA Adverse Event Reporting System by AdverseEvents, Inc., Eliquis has received an “RxScore” safety score of 39.45 on a 100 point scale, with 100 representing the highest risk. In comparison, warfarin had a score of 67.57. Pradaxa (dabigatran) had a score of 67.15, Xarelto (rivaroxaban) 67.08.9,10
The FDA’s database comprises all the reports made by doctors, patients and other healthcare providers, which means it’s not a “scientific” finding with the authority of a clinical trial. AdverseEvents applies logic, math and software to the database to sift out the important data.
For Eliquis, “the rate of suspect cases was lower in every type of adverse-event report, from hospitalization to death.” For example, among Eliquis patients reporting side effects, only 21% cited hospitalization, while Pradaxa had 39%, Xarelto 43% and warfarin 50%.
The results all point to the same general conclusion: Eliquis may be a safer choice among the new NOACs.
Update May 2014: Pradaxa
Since it was approved for use in 2010, Pradaxa has been linked to more than 500 patient deaths. More than 1,600 individuals have filed lawsuits in state and federal courts in the United States alleging they suffered bleeding events caused by the drug.
In May 2014, Boehringer-Ingelheim, the privately held German company that makes Pradaxa, settled 4,000 Pradaxa lawsuits and will pay $650 million. The lawsuit states that Pradaxa can cause bleeding events that cannot be controlled and are sometimes fatal.11
Pradaxa has generated $1 Billion in revenue for Boehringer-Ingelheim. So, will this $650 million settlement hurt BI’s bottom line and affect its marketing of Pradaxa? (BI’s revenues in 2012 were $1.5 billion). Probably not.
If you’re conscientious and are pretty good at staying in the proper INR range, stick with Coumadin if you can. It may not be as convenient and easy to use as the newer anticoagulants, but we know Coumadin works if you stay within the proper INR range. And there are proven reversal agents for Coumadin, unlike for the newer anticoagulants. The cost of Coumadin is significantly lower when compared to the new anticoagulants.12
Update June 2015: Instead of the above statement, I suggest you talk with your doctor about switching from warfarin (Coumadin) to the NOAC Eliquis (apixaban). Studies show that warfarin produces arterial calcification and plaque which damage your heart over time. (See Stop Taking Warfarin! Switch to Eliquis.) Eliquis doesn’t block Vitamin K like warfarin, it tested better than the other NOACs and is safer.
If you struggle with staying in the proper INR range13, can’t juggle the diet restrictions or monthly monitoring, you should talk with your doctor about switching to Eliquis. It has no interactions with food (not even spinach) and requires NO monitoring (no more finger stick checks). Though be aware of Eliquis’ much higher monthly price.14 You will need to judge if the benefits outweigh the costs.
When choosing an anticoagulant, you need to consider which is worse: the risk of uncontrolled bleeding or the risk of a debilitating stroke.
Update October 26, 2015: FDA Approves Reversal Agent for Pradaxa (dabigatran)
In a new study of 90 patients who had uncontrolled bleeding with Pradaxa, Praxbind (idarucizumad) stopped this bleeding within minutes. No serious side effects were reported.
We have previously reported on the reversal agent Andexanet Alfa which is on FDA fast track approval as an antidote to the Factor Xa inhibitors Xarelto and Eliquis. FDA approval is pending.15,16
Last updated: Saturday, March 26, 2016
- Connolly SJ, et al. RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361(12):1139-51. Last accessed July 10, 2014 URL: http://www.ncbi.nlm.nih.gov/pubmed/19717844↵
- Patel MR, et al. ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365(10):883-91. Last accessed July 10, 2014, http://www.ncbi.nlm.nih.gov/pubmed/2183095↵
- Granger CB, et al. ARISTOTLE Committees and Investigators. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011; 365(11):981-92 Last accessed July 10, 2014↵
- Ansell J, et al. Descriptive analysis of the process and quality of oral anticoagulation management in real-life practice in patients with chronic non-valvular atrial fibrillation: the interactional study of anticoagulation management (ISAM) J Thromb Thrombolysis 2007; 23: 83—91. Last accessed July 10, 2014↵
- Kimmel, Stephen. The Truth About Blood Thinners, Bottom Line/Health, May 2015, p. 11↵
- Coumadin reversal or antidote strategies: Vitamin K antagonist, Fresh Frozen Plasma, Prothrombin Complex Concentrate (PCC), and the newly FDA-approved Kcentra.↵
- Pradaxa costs about $250 a month; By comparison, warfarin (Coumadin) costs about $60-$80/month when you add in INR monitoring once a month. Last accessed July 10, 2014↵
- Pradaxa: Highlights of Prescribing Information. Boehringer-Ingelheim website. Last accessed March 13, 2014 URL: http://tinyurl.com/PraxadaInfo↵
- Examining the Comparative Safety of Blood Thinners: An Analysis Utilizing AdverseEvents Explorer, February 2014, Special Report Download. http://info.adverseevents.com/special-report-blood-thinner Last accessed July 10, 2014↵
- Staton, Tracy. Eliquis earns best safety score in its class in analysis of FDA adverse event reports. FiercePharma, February 26, 2014. Last accessed July 10, 2014, http://www.fiercepharma.com/story/eliquis-earns-best-safety-score-its-class-analysis-fda-adverse-event-report/2014-02-26↵
- Feeley, Jef. Boehringer Pays $650 Million to End Blood-Thinner Cases. May 28, 2014. Bloomberg.com. Last accessed July 10, 2014, URL: http://www.bloomberg.com/news/2014-05-28/boehringer-pays-650-million-to-end-blood-thinner-cases.html↵
- Your insurance provider will have a direct say into which drug you take.↵
- Consider a warfarin sensitivity test. About a third of the people who take warfarin are at a higher risk of bleeding because their genes make them more sensitive to warfarin. If a family member experienced side effects, talk to your doctor about taking a genetic warfarin sensitivity test.↵
- For those in the US and on Medicare with Part D coverage, the monthly cost may range from $30 to $50.↵
- Marzo, Kevin. Blood thinner Antidote. Bottom Line Health, Volume 29, Number 9, September 2015, p. 1.↵
- Mundell, E.J.. Drug May Be Antidote to Bleeding Tied to Blood Thinner Pradaxa. Medline Plus. Monday, June 22, 2015. http://www.nlm.nih.gov/medlineplus/news/fullstory_153206.html↵
At least 43% of patients with Atrial Fibrillation suffer from Obstructive Sleep Apnea (OSA) as well.
Sleep Apnea is a common disorder in which you have one or more pauses in breathing or shallow breaths while you sleep. Breathing pauses can last from a few seconds to minutes. They may occur 30 times or more an hour. Typically, normal breathing then starts again, sometimes with a loud snort or choking sound.
A-Fib anD Risks of Untreated Sleep Apnea
It is now established that there’s a correlation between Sleep Apnea and A-Fib.
If you have untreated Sleep Apnea, you are a greater risk of having a more severe form of A-Fib or of not benefiting from an A-Fib treatment .
For example, after a successful catheter ablation, patients with untreated sleep apnea have a greater chance for recurrence of their A-Fib.
The In-Lab Sleep Study
In the standard lab test for sleep apnea, you to go to a hospital-like room, put on cumbersome sensors, then try to go to sleep in this unfamiliar environment. And this test isn’t cheap ($1100-$2,000).
It requires extensive monitoring to measure airflow, chest/abdominal movements, electromyography, electrocardiography, and oxygen saturation levels. The formal name for this test is polysomnography (PSG).
At Home Sleep Tests (HST)
A home sleep test (HST), also called ‘Unattended Sleep Study’, is a sleep study tool that is used for the diagnosis of obstructive sleep apnea. Most HST devices are portable —about the size of a telephone handset. A home sleep test is more affordable at $250-$300.
Itamar Medical’s WatchPAT™
The WatchPAT is an FDA-approved wrist-worn sleep study device you can use in the comfort of your own bedroom to determine if you have sleep apnea. (PAT is short for Peripheral Arterial Tonometry [pressure measurement].)
It assesses respiratory disturbances and indirectly detects sleep apnea by measuring volume changes in the peripheral arteries along with pulse oximetry (oxygen desaturation) and respiratory arousals. (When you have sleep apnea, your breathing often stops till you have to gasp for breath. This is called “respiratory arousal.”)
Another HST is the Philips Respironics Alice NightOne, an FDA-cleared Type III device. It features a belt that goes around your chest with a nasal cannula (short two-prong nose tube) which you place in your nostrils and a Pulse Oximeter which you wear on your finger. Read more about the Philips Respironic Alice NightOne at SingularSleep.com.
Other HSTs include Ares by Watermark and ResMed’s ApneaLink™ Plus.
How to Choose a Home Sleep Test Provider
According to Dr. Joseph Krainin, founder of SingularSleep.com, it’s important your interpreting physician review the entire record to make sure of the proper diagnosis.
Insist that your interpreting physician be a fellowship-trained, board certified sleep physician (who has one full year training in sleep medicine and passed a rigorous national examination).
Before signing up with a HST provider, make sure to ask how long it will take to get results. And if your first encounters with a company’s customer service isn’t first-rate, steer clear of this provider.
Note: Dr. Joseph Krainin offers online sleep doctor telemedicine consultations.
What Patients need to know
Everyone with A-Fib should be tested for sleep apnea. It’s now available at a fraction of the cost of an in-lab sleep study ($250-$300 vs. $1100-$2,000). And it’s convenient (especially if being away from home overnight is problematic). Talk to your EP. With OSA home testing now available, there is no excuse for not doing a sleep study.
Return to Diagnostic Testing
Last updated: Wednesday, November 9, 2016