Pradaxa...The Truth is Out There but Still Hidden.....

Anticoagulant Dabigatran Bleeding Deaths Raise Safety Concern.


MedPage Today (11/3, Kaiser) reports that according to an article in the German publication Die Zeit, "the anticoagulant dabigatran [Pradaxa] has been linked to about 50 deaths from bleeding in atrial fibrillation patients," which is raising concern "but the drug's manufacturer said the safety profile is where it should be." Boehringer Ingelheim said, "The clinical effectiveness and favorable safety profile of Pradaxa is positive and remains unchanged in light of recent reports about fatal cases of bleeding in the media." The company said "the bleeding events and fatal bleedings reported to date are considerably fewer than expected based on the trial data that support the use of Pradaxa in clinical practice," citing two studies (N Engl J Med 2009; 361: 1139-1151 and N Engl J Med 2010; 363(19): 1875-1876).

Well, it seems that what I said six months ago is coming to life....Pradaxa may indeed have more bleeding complications then seen during the original drug trials.  That's the problem with post marketing problems.  You don't know about it until problems arise.  Still nothing you can do if the patient comes in and has a brain bleed or GI  (internal bleeding) to reverse the effects like Coumadin.  So, you really need to weigh the risks and benefits...

Pradaxa...A Dangerous Drug?

Lately, I have made reference to a recent new drug that was approved by the FDA called Pradaxa (trade name).  This drug is licensed as a blood thinner to be used specifically in patients who may develop blood clots as a result of an abnormal and irregular heart rhythm known as atrial fibrillation.  The more commonly used drug is Coumadin or warfarin.  The problems with using the latter is that frequent blood tests need to be conducted to monitor the level of "blood thinning" and many patients need frequent adjustments in their dosing.  A common problem is that people forget to have the blood test performed or inappropriately take the wrong doses because many adjustments need to be made.  If patients' levels are too high, it increases their bleeding problems if they were to develop a bloody nose, GI bleed, or head injury as the result of a fall.

When people are taking Coumadin and their levels are too high and they suffer an injury or complication, the level of "blood thinning" can be reduced if they are actively bleeding by administering Vitamin K and blood product, the most common known as fresh frozen plasma.  These will "reverse" the level of blood thinning and return levels back to normal depending on how much "antidote" is given.  This is especially important if one falls and hits his or her head and develops bleeding ot hemorrhaging in their brain which often is fatal.  Of course if the effects are reversed, the patient is then put at risk for developing clots from the atrial fibrillation which can cause a stroke.  Obviously, the benefits outweigh the risks if someone is actively bleeding.  This is especially true with life threatening bleeding from accidents, nose bleeds, or GI bleeding (ulcer or rectal which tend to increase as one gets older).  Blood tests can also be performed to ascertain the level of "blood thinning."

With the use of Pradaxa, the level of "blood thinning" cannot be accurately determined with a blood test.  Likewise, there is no immediate antidote.  So if a patient is taking the oral medication and develops an injury or bleeding problem, there is little that can be done other than replacing the blood with additional blood transfusions.  Most people who are taking Pradaxa are older and have co-morbid underling medical conditions which inherently place them at higher risks for bleeding complications.

Physicians in Emergency Departments are often the first ones to encounter such complications. I have personally cared for patients who have become hypotensive (low blood  pressure) secondary to hemorrhage from nose bleeds and GI bleeds (rectally) that have nearly exsanguinated (bleed to death) because I could not give them blood fast enough.  If these patents were on Coumadin, I would have at least been able to try to successfully counteract the effects with antidotes.  With Pradaxa, you have to basically wait for the drug to be excreted out of the body.  There have been very limited studies to suggest that renal dialysis may help.

I suspect that as more patients are placed on Pradaxa, we will eventually see more serous side effects of the drug...time will tell, but I suspect at the cost of additional lives.

Where Have I Been....

Well I admit, after many many months, I have returned to write some more. I guess the frustrating part about writing blogs is that I haven't figured out how to get people to read my blog! And, of course, hence the circular reasoning...no one reads what you post so why bother posting!



Sooo where should I begin...Obama care has done nothing for my patients or my practice...people still come to the ED with and without insurance whether they need to be here or not...but time will tell...



Perhaps the most frustrating part of the health care reform act is the placement of patients into Medicaid-like plans...Yes, people will be insured...but insurance does not equal access. Take for example the current standing for Medicaid...in my state physicians are paid almost the lowest in the country to the tune of approximately $27 per patient for an ED visit...but when you factor in operating expenses, malpractice, benefits for physicians, billing costs, etc. the $27 does not even cover the overhead. Sooo...how can you expect ED physicians to cover their expenses? Some will argue that $27 is better han nothing (and I agree that is true) but if the volume of patients visiting ED's increases and these patients would never have been in the ED because they did not have insurance, then the loss experienced by physicians will even be greater. This does not take into account the fact that the physician needs to cover his malpractice premiums to have the privilege of caring for patients covered by Medicaid...and they have the right to malpractice claims if the patient suffers a bad outcome (regardless of who is to blame)....

More to come on Medicaid and access issues...dealing with reality...

Bleeding Penis...Where Do I Go...Am I Going to Die?

Well, this was a good one...Working the night shift, picked up a chart with a chief complaint of "I"m bleeding from my penis." The patient was a 24-year-old male. I walked into the room and he was with a young woman approximately his age at the bedside. He was lying on the stretcher wearing sweat pants and had his hand in his pants holding his crotch. You can't make this shit up!

I said, "I understand that you have some bleeding from your penis."

His reply, "Yeah and it hurts," with some anxiety.

"OK, does it hurt when you try to urinate?" I asked inquisitively.

"Well, no, I'm afraid to try," he replied with more anxiety. "Do you think I will be able to have children?"

I replied with some reassurance, "Well, I think so, but let me take a look. Where you doing anything when this happened?"

Timidly he responded, "Well, ahhh, no not really." His fiancee, replied, "You have to tell him, it's OK." So I'm thinking...this is going to be a good one...

"Well its kind of embarrassing (with a blush). I was having sexual intercourse and I felt pain and when I took out my penis there was blood all over the place, I lost a lot of blood and it hurts, I want to have kids, were engaged," rather embarrassingly.

So...to make a long story short...I checked his equipment out and he had a small laceration of his foreskin which needed a few stitches. Hey, anything is possible. I actually see more vaginal trauma following sex then penile, but all bets are off. Guys are always freaked out about their apparatus working properly! This guy was going to be fine and he survived the stitches, not that bad with local anesthesia since I'm really not that heavily handed with any potentially painful procedures. I think he was happy that he was going to live. I actually never saw anyone die of penile hemorrhage but anything is possible. This guy was in no danger, but I had a chuckle for the rest of the shift. Sometimes I tell people, "I decided to be an emergency medicine physician since I find humor in the misfortune of others." Something I call "black humor." But seriously, I do smile...there is so much other misfortune in this field...

That said...why am I commenting on this patient? Well, first, it's funny, not for the patient, but certainly funny from my perspective. Guy has sex...hurts penis...gets freaked out that he will never have an erection...thinks he's bleeding to death...etc. But all joking aside, that's why I'm here to help people like this.

What bothers me is all the politicians and policy makers who think that visits to the ED like this are unnecessary. Hmmm maybe not if it was their penis or vagina....There was a recent study published concerning the health care in Massachusetts which cited that many ED visits were unnecessary. The researchers took the discharge diagnosis for patients and retrospectively judged whether or not the patient could be treated by a primary care physician. Honestly, if you have a good primary care physician, this problem could be taken care of by that person. Most primary care physicians - internal medicine physicians don't do stitching in my area...What is a person suppose to do at 1:00 a.m. I know if they called their physician they would be instructed to go to the ED. Sooooo, despite what politicians think, there aren't as many unnecessary ED visits...certainly this patient perceived an ED visit!

The Internet and Emergency Care...

I suspect that the use of the Internet has saved many lives. With extensive search engines like Google and Wikipedia, people have easy access to information (not necessarily accurate information). There is a tremendous amount of medical information sites, some with great information and others with not so great info. Nevertheless, people use the Internet every minute of the day.

It is not uncommon for me to see a patient in the ED who comes in and says, "You know, I just didn't feel right, I developed some chest discomfort or indigestion, and I went on the Internet and the site suggested that I seek out medical attention." Well in general, that's a good thing since, for example, many woman do not have typical symptoms of a heart attack such as "crushing chest pain" but rather fatigue which they downplay and do not often seek timely medical attention. Clearly, when someone is having a heart attack or MI (myocardial infarction), "time is tissue" meaning the shorter the duration of seeking medical care the better chance of saving heart muscle. And, that is no different for strokes or "small" strokes (TIA's). With strokes, many people are not educated on the symptoms and often neglect them until it's too late.

On the other hand, the Internet has also driven up the cost of health care for ED visits. Frequently, I'm scratching my head at 4 a.m. when a patient presents with a variety of symptoms, and I'm trying to figure out exactly what is going on. Why did the person decide to come to the emergency department at 4:00 a.m. with a constellation of symptoms that don't make sense other than generalized anxiety. I often ask the question, "I'm curious, the way you're feeling started at 10 p.m. last night, what changed for you to come in at 4:00 in the morning?"

Often I hear, "I couldn't sleep, so I went on line and plugged my symptoms in and I thought I had cancer!" Something that wouldn't change at 4:00 a.m. but adds to the patient's anxiety.

Where in the world could you get a reasonable answer to your medical concerns 24/7. Try calling your physician at 4:00 a.m. to tell him or her of your symptoms and let them know you think you have cancer...see what the response is...sometimes it's "go to the ED" (so they could go back to bed)!

More Expensive Medical Care & Duplication of Testing...

So I spoke about the poor integration of information systems in medicine...and here's even more. The technology is out there to convert radiology imaging and other ultrasound imaging into an electronic format. Some hospitals have that capability. You no longer have to get a copy of an x-ray and stick it on a view box, rather it's transmitted to a computer terminal and you view it on a screen. Systems can be very sophisticated where you can essentially connect via secured Internet sites with encrypted information) to view these studies in your office or even in your home called teleradiography.

The biggest issue however, is if you are not a part of a hospital (meaning you don't have privileges as a physicians) you do not have access to the information. There is a total lack of integration. There is also a concern that somehow, people will get sensitive health care related information, and inappropriately disseminate it. Where this is true with any electronic data, there are enough mechanisms in place to assure security.

Let me give you an example of how ridiculous this is for the EM physician. Mr. A presents to the ED at Hospital B with a chief complaint of chronic headaches for the last few months on a Friday at 6 p.m. He states he was called by his doctor, physician C, who had ordered an MRI of his head and was told that he has an abnormality and needs to go to the hospital - perhaps a brain tumor and he has had the MRI at hospital D's outpatient department. You call physician C, but physician E, a covering doctor, does not know anything about the patient or the results and cannot get in touch with physician C. You call hospital B, only to find that they cannot give you the information because the MRI department is closed. It closed at 5 pm. So, what are stuck doing - you can either repeat the MRI, which is an extremely expensive test and not easy to get even in your hospital at 6 p.m. or you perform a CT scan of the head (less expensive but still expensive and has a small risk for radiation exposure). Hours later you get the results of the CT scan - a brain tumor, you still need the results of the MRI but that can wait tonight since you have a diagnosis and the patient needs to be admitted to the hospital for a biopsy and treatment.

And you ask, why did the patient not go to hospital D's ED after the call...the answer, "because your hospital has a better reputation" but I lived closure to hospital D to get the MRI and it was easier....Of my God, not easier for the poor physician working in Hospital B's ED trying to care for the poor patient (who by the way, will ultimately probably die within a year despite chemotherapy, radiation, and surgery) all further expensive care with a low yield for survival.

Again, do you really think that physicians enjoy working this way?

Robust Medical Information Systems...an Oxymoron!

Sometimes policy makers and elected officials are right on...and one of the truths to medicine is "there is too much diagnostic testing performed." There are many reason for this...medical liability...lack of research to guide physicians into best practices, comfort level of the physician, pressure from patients, the lack of an integrated records system, etc.

Today, I want to focus on the latter - the lack of integration of medical records. It amazes me that there is some "computer in the sky" or "big brother" who has all my financial information...credit reports, balances, the ability to go to a bank on the east coast and withdraw money from the west coast bank, etc. What we are lacking in health care is that same ability (at least as a nation) for health records. Most physicians are in private practices and these practices may be a solo practitioner or small groups (at least in the majority of the country). Most hospitals are nonprofit entities with small systems, again the majority in this country. Despite what you may think, the profit margin (as a provider) is not much and therefore people have limited funds to integrate an electronic record.

What this means, is that there is limited financial resources (and lack of motivation) to have a well organized record keeping system that is in an electronic format. The financial industry can transmit much information electronically and the systems have a unified way in which a combination of systems can operate (thus, the above bank analogy). But many hospitals and the majority of physicians do NOT have electronic records. In fact, it was only in the last few years that my hospital incorporated a partial electronic record. Not only is there a lack of systems, but many of the systems (within a hospital) don't have the capability to speak with one another. I know for those involved in business, it is hard to believe, but when a hospitals profit margin is only 1-2% per year, you can see there is little revenue or incentive to modernize!

Add to this the ablity to integrate with independent practitioners' records in the community is a disaster. Again, it wasn't until a few years ago could physicians in my area get outpatient lab results that were performed at the hospital.

Think about it, Mrs. A cannot have labs done at lab B because her insurance company doesn't participate so she has to go to lab C but lab C sends the results by mail and there is no lab interface directly with Doctor D, so he not only can't get the results (unless he calls - an added step) but no one else caring for Mrs. A has access to the records (especially when Doctor C's office is closed) and Mrs. A does to the ED at Hospital D...get the big picture! And do you think that most emergency medicine physicians like to practice this way...more to follow tomorrow...