It’s been many long years since I graduated from my medical residency. I made Chief Resident so spent an extra year learning how to teach and manage doctors who are full of themselves.

I've seen it all. From the totally clueless senior medical student, to Hospital Chief of Staff. A long time to glean some perspective, and time for introspection. My generation of doctors, was the last to go to college, medical school, and train without computers or smartphones. We didn't even have the internet.

We didn't carry pocket ultrasounds, smartphones, or ophthalmoscopes. All we brought to the bedside was our own brains, a stethoscope, and a compassionate bedside manner. Times have changed. And although we are armed with all kinds of technology, doctors are still doctors, and there aren't very many of us. Moreover, it is predicted that by 2020, the United States will lose half of its physician workforce as doctors make there exodus from an industry that has forgotten about how important we are. Not just anyone can do this. If they could, we would just toss you a human "cookbook" and say "here you go! Fix it yourself!"

I get calls from colleagues everyday, asking how I was able to move into the Education Industry, they want out so badly. The three decades of training in a profession obligated to bring the tip of the sword in science, is a tough enough burden, let alone Corporate America and Ad Hoc Committees telling us how to practice (and they don't even have a License to practice). Throw in "CLIA, OSHA, Semiannual Blood-borne pathogens training, The internet, HIPAA, Managed Care, The doctor crushing Affordable Care Act, and "the straw", ICD-10 ( All of which were thrust upon us in a twenty year span), and you have an already hugely stressful occupation filled with PTSD ready to throw in the towel and say, "Try doing it without us!"

It is still a bold, proud, and academic profession, however, and continues to call to those men and women who can bring not only scientific knowledge, but an understanding ear that listens, holistic care, intelligence, integrity, and a steadfast compassion for mankind.

I continue to train young doctors. These students, interns, and residents are smart, they already know what hard work is, they are all "A" students, hugely ambitious and talented. Many of my conversations with them turn into advice. So this is what they hear.

1. People die; it’s not a personal failure on your part. Our weapons against disease cannot outlast the inevitable. Our interventions and therapies can make disease more manageable and prolong life, but death will always be the ultimate and natural conclusion of our efforts.

2. Your choice of specialty will not determine your ultimate life happiness. You are not doomed to misery should you chose not to sub-specialize nor are you guaranteed happiness if you do. Choose something you enjoy, Choose a specialty that provides a lifestyle congruent with your values. But don’t confuse intellectual intrigue with life happiness; there is so much more to the latter that has nothing to do with medicine.

3. Remember what it means to be a normal person. To retain a sense of awe in what you now get to do on a regular basis. To be able to explain things in non-medical terms the way you learned them before being indoctrinated. To feel sadness, joy, grief, loss, elation. To remember the viewpoint of suffering.

4. Keep friends outside of medicine. You’ll be more human. And more interesting.

5. Guidelines are helpful, but they are not strict rules. Don’t try to meet every guideline while losing site of the big picture. You wouldn’t want your 95-year-old grandma on a high dose statin to prevent a heart attack, metformin for the elevated fasting glucose only apparent within the past year and three blood pressure pills that make her feel dizzy all the time to achieve some magic number that no one agrees on anyway. Don’t subject someone else’s grandma to that either.

6. Retain your humility. When family members say, “Something’s not right with Grandpa,” listen to them. They are usually right. Ask questions when you don’t know the answer. It can be especially humbling to do so in front of your colleagues, but your pride is no longer your priority. Your priority is your patient, without exception.

7. Be kind in your comments about the “outside community doctor.” There is a high likelihood you will be that person at some point in your career. They usually aren’t as dense as you might think; they are just struggling to provide the same perfect care you are in a very imperfect system.

8. Burnout is inevitable. Plan for it. Write down what drew you to medicine in the first place. Use it to keep yourself motivated. Learn to unplug. Turn that thing you call "a phone" off. Don't overlook your own health. Mental or physical.

9. Other services are not your enemy. Be kind when someone calls you with a “dumb consult”; you have likely called one yourself.

10. Avoid perpetuating the cycle of abuse. The profession of Medicine has been built on a "train by intimidation" approach since Osler. We are well known to "pimp" each other in an effort to show academic prowess. Just because you were demeaned and humiliated as a student or resident does not mean you are entitled to do the same to your younger colleagues. They are no more “unmotivated,” “lazy,” or “arrogant” then you were. We are all a bunch of prima donnas. Turn it down a notch!

11. Think about how your orders affect your patients Holistically. How the orders may actually contribute to their suffering and discomfort. Nurses have been asking for us to do this for years.

12. Be mindful of the habits you cultivate. How you speak to patients, families, nurses. How you treat your family when you are stressed. Your eating habits, your spending habits, your sleep habits. These will follow you past residency, for better or for worse. Make sure they have been chosen with intention.

13. Medical training is expensive. Most of us have debt. Just because you have a big salary out of residency, doesn’t mean that you are wealthy. Do the math and avoid the temptation to increase your debt further immediately on graduation with a huge new house, car or other toys. A few years of frugal living will pay dividends later on.

14. It doesn’t automatically get better after residency. Hate to break it to you, but it’s the truth. But it can be great if you prioritize what’s really important. Just pick those priorities carefully.

Lastly, the advice I give to every young doctor I mentor: You must remember that the medical profession is like a jealous lover. It requires all of your time, and all of your energy. It will tolerate nothing less. The people who seek us, need us, and need to trust us. This trust can never be betrayed.

Always stand with a smile, never be impatient, and always give your patient hope. Be as passionate in your craft as you are gentle in friendship, and make everyone who crosses your path, glad they met with you today."

 

 

Dr. Counce

During Denver's roller coaster ride of a football season (and a fun one it was) four things remained consistent with the Super-champion Broncos: John, The Duke, Elway’s leadership, Kube’s Steadfast posture as an executive coach, Wade’s artistry as a defensive coordinator ( Yeah! He’s an Artist!) And finally, the deep talent and speed of Denver’s Defense.

Remember, this season Denver shut down an up-until-then, undefeated and playoff seasoned and very mobile Aaron Rodgers (his worst game ever), and then, shut down Tom Brady...... Twice!

Why would anyone think Cam Newton could fare any better? I'm scratching my head on that so-called expert prediction.

Cam Newton has no serious playoff experience. And when faced with Superdefense, Superman, turned into, well, mush. They scared the crap out of him, then ate him for supper!

From the coaches to the players, John Elway put together the best defense the Denver Broncos have ever paraded onto a football field. Yeah, even better than the Gradishar and Louie Wright Crush Boys! Next season, they're adding an offense. Just to make things interesting.

I've been watching this team with a microscope since I was a little kid in 1965. Seen everything from Tripuka, Tensi, and the M&M Connection, to Elway, Jake the Snake, and The Sheriff.

I can remember when Hank Stram would bring the Chiefs (Lenny Dawson, Ed Podolak, Willy Lanier, and Jim Lynch) into Denver, and just beat the crap out of the Broncos, they were so bad sometimes. It seemed like they came to Denver just to rack up their stats.

I was there at the Birth of the Raider rivalry in 1965 under Tom Flores heaved bombs, then got to watch the eventual reckoning the Raiders would suffer in 1977.

Oh, and who could forget the always inebriated “No Respect, Howard Cosell’s” stupid foot in the mouth comments, that whole season! What a dick! Oh, yeah, “That’s Right, Jackson”!

Yes! You hear me say that all the time! But the quote is actually from Don Meredith. He couldn’t stand him either. If you weren’t watching Monday Night Football in the Seventies, You have no idea what I’m talkin about. Too bad for you.

I have had the pleasure of watching all 10 Denver AFC Championship games. Yeah, ten! Here’s one!

One of my friends, Tim, had a neighbor and friend lose it, then run across the street to his house so he could sit in his “Lucky Chair”. There were only 5 minutes left in the AFC Championship game (played in the Cleveland “Dog Pound”) with Cleveland leading by a touchdown. Tim and all of us just waved at him, said “ Okay, buddy”, then turned around to continue watching the game and biting what was left of our fingernails. Then.... Boom!

We were witness to one of the greatest playoff comeback games in NFL history. “The Drive” and it’s legendary clutch third downs, exploded all over us! It was Epic, in your Face, Hostile Crowd throwing Dog Biscuits and Batteries, Mud with Blood streaked and splashed all over everybody, Duel To The Death Football! And it was The Browns fans who named it “The Drive”!

Every time I watch that 98 yard drive, I just smile. Quietly remembering..... “Lucky Chair! Lucky Chair!”

Then there’s “This One's For John”, which may have been the best Super Bowl ever! And I’ve seen damn near all of them. Another game won in the fourth quarter. Favre vs Elway! Davis vs that Green Bay Wall! They broke the NFC hold on the Championship. Yeah, the NFC had won every Super Bowl for thirteen straight years. Then the Broncos road into town. Dominated the Packers, who were picked to win by 12 points. Won the Championship! Are you kidding me?

And now this! The Coolest, most Dramatic, and even Historic Broncos season I've ever seen unfurl! And boy did it unfurl! Not only that, but SUPER BOWL 50!.... I’ve seen it all, man! You just Know there’s going to be a movie!

Since that November day at Bears Stadium in Denver when the Broncos and Raiders became arch-enemies in front of this little kid, I’ve been a card carrying Broncos Fan, even though I had to endure Lou Saban “in my formidable years”. Ha ha! .... You laugh!

Just ask Floyd “The Franchise” Little!

I met Little at a Howells Department Store quite by accident when I was in Junior High. I was there shopping for jeans, and I bumped into him. He was looking at suits. All I could do was talk about how great He was, and although Saban had drafted him (The only good thing that came from him), I thought Saban was a poor field tactician, and didn’t use Floyd right. Little was cool! He was reassuring. But little did he know... I knew better. So did every other fan out there.

Throughout my junior high and high school years, Floyd was all we had.

Thank God for John Ralston! Everything changed after him. He was the architect who designed, drafted, then built The Orange Crush defensive unit. By the way, why isn’t he on the Ring of Fame?

My how the Broncs have changed. From those really bad teams in the sixties to the “State of the Art” in professional football. The Broncos have won more games than any other team in the NFL since 1977, when they first made the playoffs with the Orange Crush. Bet you didn’t know that.

The year of the Super Defense and Giant Killers, Ladies and Gentlemen I give you, The Denver Broncos.

That’s Right, Jackson! I’m a fan!

Now that was fun!

Broncos Rule!

In the United States, The Affordable Care Act (ACA) is a health care ordinance established by the federal government (it is commonly referred to as Obamacare). The Act was adopted as a law by US President Barrack Obama on March 23, 2010.

The goal of this law is to reform the United States health systems by providing and improving access to quality and affordable health care, health insurance, and providing American citizens with more rights and protections by reducing health care expenditure for both individuals and the government. The law also aims at expanding private and public insurance coverage, as well as, regulating the insurance industry. It is a fantastic thought, if it only worked as planned.

As we all know now, it is not completely as advertised. For those of us in the middle class we have realized all too well that it crushes us. It means more taxes. A staggering Five Hundred Billion Dollars in increased taxes and fees. This is passed down to us through higher pricing on medical expenses that we need.

You must purchase insurance, if you do not, your federal income taxes will be penalized. You will no longer get the return that so many count on every year. If you are covered with insurance through your employer, you should tread lightly. Thirty-five million people could lose existing coverage because the government has created incentives for employers to drop insurance benefits.

There are higher premiums and costs associated with the ACA. For a family of four earning ninety thousand dollars annually, take home income would be about sixty-nine thousand dollars after local, state, and federal taxes have been taken out. If these families lose their workplace coverage and move into the exchanges, they could find themselves paying as much as twenty-five percent of their take home pay on an average policy. That is a seventeen-thousand-dollar hit to their annual pay. That's the money they could have used to buy a car, save for college, or payoff their house.

Throughout my research I have interviewed Doctor Kem Hor, Doctor Charles Counce, and have read many articles both for and against ACA. I have also learned that the ACA really hurts Doctors. At the beginning of 2014 it has dumped an additional twenty million Americans into Medicaid. I personally had to start receiving Medicaid. What I have noticed, is that it is very hard to find a Doctor who accepts new Medicaid patients, let alone see them at all. For my family of five, that is very difficult. We have three younger children who need medical attention from time to time, and it can be extremely difficult to get them seen, sometimes taking up to a month to get an appointment.

Doctors feel overran by Medicaid patients. Some have stated that they don’t have enough time with their patients any longer. It feels to some patients that we are just a number. It shouldn’t be that way. Doctors are healers. Sometimes a little extra time with the patients can go a long way. Medicaid only pays Doctors approximately fifty-six percent of what private insurance pays. [Understand that insurance systems are also a discount contracted with doctors to lower their fees to see a group of patients. This means that Doctors lose as much as eighty percent of their fee everytime they see a Medicaid patient. They can't even pay the overhead associated with the patient's visit.]

Doctors are put in a tough spot, whether to accept Medicaid patients at a lesser rate or not accepting Medicaid patients at all. America is projected to face a shortage of nearly ninety-two thousand doctors by the year 2020. Just here in the greater Colorado Springs area there is a shortage of two hundred sixty doctors. Many surveys state that doctors have a negative view on the ACA and its impact on the medical field. One survey found that the ACA on top of all the other mandates like Tort Law costs, Skyrocketing Liability Insurance, this year's "ICD10", "CLIA", "OSHA", and "HIPAA" has become too much to bear, motivating forty-three percent of doctors to move up their retirement within the next five years.

My overall thoughts on this Affordable Care Act, is that it might be a good idea on paper, but after seeing it in action, it has caused many more headaches than not. It has forced many doctors out of the field to pursue other options. Doctors should not have to wait four to six months to get paid by Medicaid or Medicare. I understand that doctors need to get paid for services rendered in a timely fashion. They have bills as well as employees to pay, in addition to college and medical school tuition loan obligations and bread for their table. It should not take patients a month to see a healthcare provider either.

I have been waiting to see a specialist (a ninety minute drive north to Denver) for two and a half months now. The system is not working, and should never have been approved in its present form. Unfortunately, it is here to stay. So says the Supreme Court. We will all have to get used to it.

Obviously the Affordable Care Act does need a lot of improvements to actually do what it was meant to do, giving Americans better access to quality healthcare. [It has managed to do almost the opposite, by draining our pocketbooks, and scaring away the only people who can care for us.]

Fall approaches, and Football is upon us. A sport I am hopelessly addicted to.

The first time I saw a professional football game in person, was in 1965. My family had just moved to Denver a year earlier. I was somewhat familiar with pro ball and had watched it with Dad on Television. But we were from Nebraska, and in the Fifties and Sixties, we were watching college ball most of the time.

Dad bought two tickets to see a “very young” Denver Broncos Football Club take on the Oakland Raiders in Denver. Understand, the American Football League was only in its fifth year, but the inklings of rivalry were already present when the Raiders were in town.

Denver was a mediocre team on the field, and on the books. Generally starting seasons well, then go into skids half way through. But we had nationally known stars: Frank Tripuka, Cookie Gilchrist, Willie Brown, and Lionel Taylor.

It was a beautiful sunny November day! We got to the stadium. It wasn't the famous “Mile High Stadium” yet. The Broncos’ home turf was the original Bears Stadium. Built for our New York Yankees farm team, the Denver Bears, it would later be reshaped into Mile High Stadium after a massive reconstruction, as Denver joined the National Football League when the AFL and NFL merged in 1970.

There I am with my Dad! At a ball game! Dad was great! He explained everything to me. Bought hot dogs and Royal Crown Colas (yeah! I know!). Oh, and popcorn!

The game was sold out. To this day, no other team in the NFL has had a longer sellout streak. Yeah, Denver is a football town!

Little did we know, that this game would become the foundation to the rivalry between these two young teams, and create in Denver fans, a distaste for anything “Raider”, and a feeling that it is always vengeance Denver seeks. We don’t want to just beat them, we want to Crush them! Period!

The Raiders have always been fierce opponents, as it should be. They were hugely successful in the old AFL and later in the NFL. Everyone who knows football, knows the legendary teams that came out of Oakland. Of all places! Have you ever been there? Yeah, I know.

Today was no different. Future Hall of Famers: Their headcoach was the Infamous Al Davis; At quarterback was Tom Flores, who would later take two Oakland teams as headcoach to the Superbowl, and win two world championships; His backup? Daryle Lamonica, would show up next year; “The Double Ought”, Jim Otto; The Ferocious, Ben Davidson, and rookie wide receiver, Fred Biletnikoff, “The Button Hooker”.

Kickoff! The game starts. Dad and I are in the East Stands, one tier up, on the Southside 30 yard line. A perfect football game spot! I can’t imagine what the cost of season tickets for this same area at Sports Authority Field would be today. Ginormous, I’m sure!

The teams went back and forth the first quarter. I’m eating hotdogs and drinking RC Colas. Yep! In hog heaven! Second quarter starts. Tom Flores, who establishes the Raiders legendary “Vertical Game”, heaves a bomb to Clem Daniels. Boooom! It sent shutters through me! The execution and pure poetry of it was beautiful. You had to respect it, even if you didn’t understand the game that well. Absolutely gorgeous pass to a tailback out of the backfield. Raiders 7 Broncos 0!

Broncs get the ball back, but sputter. The Raiders answer with a surgical drive ending with a touchdown strike by Flores again. I’m reaching for my RC. It’s 14 zip! How many times have you become tachycardic with this not so unusual and apparently traditional behavior of the Broncos? That’s what I’m sayin’! Denver answers right back with a well-orchestrated drive with Lionel and Cookie, finishing with a rushing touchdown.

But it wasn’t Cookie! I was upset! Yeah, Wendell Hayes ran it in. Yeah, but it’s 14-7. Game on! If you have ever been to a game of any kind, baseball or football, with your dad, you know exactly how I was feeling right then! A dad and his son watching a game that is unfurling before their eyes and taking on a life of its own, with 35,000 fans sitting next to us. You become hooked for life!

Halftime was popcorn and a marching band, having fun with Dad, and drinking RCs. And I had to pee a lot! So I got to know the concession area really well. The stadium staff started calling me by my first name. Just kidding.

Denver opens the second half with a Lionel Taylor airshow, ending with a touchdown strike to Taylor from John McCormick. Yeah, Frank wasn’t there anymore. But we put him on The Ring of Fame when we built Mile High. We even retired his Jersey, number 18. I think all Denver fans know that really cool story about Frank's insistence that "Peyton" wear his number. Denver 14 Oakland 14! Oh boy! And so it starts!

The third quarter ends still tied 14/14! I have to pee! The fourth quarter starts. Yep, the first of many nail biters to come. Denver’s marching down the field with a combination of Cookie built traps, and throws into the flat to Lionel, when, the “Cardiac Kids” strike again! The Raiders intercept the ball as the Broncos are moving into the red zone and run it back 70 yards for a touchdown. Wow! Raiders 21, Broncos 14. Fourth quarter. Sound familiar?

The teams exchange sputtering drives. Actually, two damn good defenses do their jobs. Denver gets the ball back. They’re marching. Then McCormick throws a hondo ball into the flat where a post coming out of the right seam was supposed to materialize, and it’s intercepted. You guessed it! Raiders run it back for a touchdown. Raiders 28 Broncos 14. Nobody leaves! Denver gets the ball back with only three minutes left. McCormick is replaced by Jackie Lee.

Known to have flashes of brilliance (I wonder if that’s because he wore Number 7), Lee is a good quarterback. He stands tall in the saddle, and a master of the step up when a throwing pocket collapses. Lee takes his opportunity and marches Cookie, Lionel, and the Broncos down the field. We’re running out of time! We need two scores! Everybody's standing! I'm standing on my seat! 35,000 fans chanting "Broncos"!

Jackie hits Lionel in the end zone for a touchdown!

It’s absolute bedlam in the stadium! People jumping up and down, stuff flyin’ everywhere! Popcorn all over the place. I have to pee! I look up at Dad! He looks down at me! We just smiled at each other! Then turned our heads back to the field of battle. The smell of beer, and cola all over the place! Yeah! I know!

Coach Speedie (yeah that’s his name), was known for his out of the box style and on field gambles. Here we go again. Rather than to kick a point after, he elects to go for 2, because he doesn’t want a tie, Mac Speedie wants to win. Remember, the NFL didn’t have the 2 point conversion then, but the AFL did.

It’s a roll out! Jackie throws. Whenever I think about it, it's always in slow motion. The stadium seemed silent forever to me, this little kid.

A lasting and realistic picture of “The Underdog” was forever imprinted on me. That’s right. You knew it! The receiver dropped it! Oh my God!

Raiders 28 Broncos 20 hit hard. Eerily, another primer of famous even legendary games to come.

Wait! .... Wut? .... It’s not over! .... Everyone is still in their seat, and now standing! Mac has called an onside kick! Are you kidding me? …….. The Broncs kick! ……. They recover the ball! Oh my God! ……. And here it comes……. It’s too late!

 Wut? .... Yep! The clock expired! The game is over! .... Wow! ....  The crowd just stood there, silent!

I didn’t care about the loss. That sting would hit me later. This was a day I would always remember!

The emotions that wash over us as sports fans! The anticipation! The elation! The heartbreak! The smells! The sounds! The mass of faces before you, all working as one! Asking for “Just One More Inch……. Please”! ……. The game you’ll never forget! I have to pee!

A rivalry is born! I’m hooked on the Broncos for the rest of my life! I have the best Dad in the world!

Fifty years ago! That’s how long I have been a fan of the Denver Broncos. You heartbreakers you! Just have fun, okay? But beat the shit out of the Raiders. I mean it!  Period! Thank you.

GO BRONCOS!!

Von Willebrand disease (VWD) is an inherited, genetically and clinically heterogeneous hemorrhagic disorder caused by a deficiency or dysfunction of the protein called Von Willebrand factor (VWF). This protein is a necessary step in the coagulation cascade, but also involved in the initiation of platelet aggregation for proper blood clotting.

Consequently, defective VWF interaction between platelets and the vessel wall impairs primary hemostasis. Von Willibrand factor circulates in blood plasma at concentrations of approximately 10 mg/mL. In response to numerous stimuli, VWF is released from storage granules in platelets and vascular bed endothelial cells.

VWF performs two major roles in hemostasis, wether intrinsic or extrinsic. First, it mediates the adhesion of platelets to sites of vascular injury. Second, it binds and stabilizes the procoagulant protein factor VIII (FVIII).

The disease is divided into three major categories: Partial Quantitative Deficiency (type I), Qualitative Deficiency (type II), and Total Deficiency (type III). VWD type II is further divided into four variant conditions (IIA, IIB, IIN, IIM), based on characteristics of dysfunctional VWF.

According to data pre-published online August 3rd, 2015, in Blood, successful management of bleeding episodes were observed in 100% of subjects treated with BAX 111 for von Willebrand disease (VWD) during a recently completed Phase 3 clinical trial.

Bleeding-episode-management success was the primary endpoint of the clinical trial.

BAX 111 is a highly purified recombinant von Willebrand factor (VWF) analog manufactured by Baxalta, Inc.

VWD is a rare, inherited, incurable, gene-based bleeding disorder in which a missing or defective clotting protein (VWF) fails to bind with platelets in blood vessel walls.

Normally, a blood-vessel tear initiates bleeding and  VWF assists in the repair. When VWF is absent or under-represented, the formation of platelet plugs are inhibited during the clotting process, resulting in excessive bleeding and easy bruising.

In more severe forms of VWD, the bleeding can be life-threatening and require emergency treatment.

Gill et al derived their findings from a Phase 3, multicenter, international, open-label study which evaluated the safety, efficacy and pharmacokinetics of BAX 111 in 37 patients with severe VWD.

Study participants evidenced a mean efficacy rating of < 2.5 on a 4-point scale wherein lower numbers correlated with a higher degree of bleed control (see sidebar below). Bleed control for all treated bleeding events (N=192 bleeds in 22 subjects) was rated as good or excellent (96.9% excellent; 119/122 minor, 59/61 moderate, and 6/7 major bleeds). In 81.8% of bleeds, 1 infusion was sufficient to attain control. For major bleeds, the infusion median was

 
• Minor and Moderate Bleeding Events

o Actual number of infusion less than or equal to estimated number of infusion required to treat that bleeding episode. No additional VWF-containing/coagulation factor containing product required.

• Major Bleeding Events

o Actual number of infusion less than or equal to estimated number of infusion required to treat that bleeding episode. No additional VWF-containing/coagulation factor containing product required.

• Minor and Moderate Bleeding Events

o 1 to 2 infusions greater than estimated required to control that bleeding episode. No additional VWF-containing/coagulation factor containing product required.

• Major Bleeding Events

o Less than 1.5x greater than estimated required to control that bleeding episode. No additional VWF-containing/coagulation factor containing product required.

• Minor and Moderate Bleeding Events

o 3 or more infusions greater than estimated used to control that bleeding event. No additional VWF-containing/coagulation factor containing product required.

• Major Bleeding Events

o Greater than or equal to 1.5x greater than estimated used to control that bleeding event. No additional VWF-containing/coagulation factor containing product required.

• Minor and Moderate Bleeding Events

o Severe uncontrolled bleeding or intensity of bleeding not changed. Additional VWF-containing/coagulation factor containing product required.

• Major Bleeding Events

o Severe uncontrolled bleeding or intensity of bleeding not changed. Additional VWF-containing/coagulation factor containing product required.References:
 

Safety and tolerability outcomes - evaluated via clinical assessments of adverse events, hematology panels, coagulation panels, serum chemistry, urinalysis, viral serology and immunological assessments - were also encouraging. With the exception of 1 patient, adverse events were minor or unrelated to treatment. No thrombotic events or severe allergic reactions occurred, and none of the participants developed anti-VWF binding or neutralizing antibodies to VWF.

Researchers concluded that the data offer evidence that BAX 111 is “safe and hemostatically effective in severe VWD patients in a variety of clinical bleeding presentations.”

“Von Willebrand disease is the most common hereditary bleeding disorder, yet few treatment options exist,” noted John Orloff, MD, Head of Research & Development and Chief Scientific Officer, Baxalta. BAX 111, Dr. Orloff asserted, “has the potential to transform the standard of care for patients with severe von Willebrand disease by offering an effective, individualized treatment option.”

Both the FDA and the European Medicines Agency granted orphan drug designation to BAX 111 back in November 2010.2 Currently, BAX 111 remains under FDA review, a pending Biologics License Application having been filed in December 2014.5 While no official Prescription Drug User Fee Act (PDUFA) date has been set, December 22, 2015, has been cited by industry insiders as a speculative estimation.

The PDUFA date is an FDA approval deadline for new drugs. If approved, BAX 111 would become the first recombinant replacement treatment indicated for the management of VWD-related bleeding episodes.

 

On February 3, 2015, many physicians received a surprising email from Richard Baron, MD, MACP, president and chief executive officer of the American Board of Internal Medicine (ABIM). Referring to the board’s controversial maintenance of certification (MOC) program, Baron wrote, “ABIM clearly got it wrong. We launched programs that weren’t ready and we didn’t deliver a MOC program that physicians found meaningful…We got it wrong and sincerely apologize. We are sorry. ”

Baron’s email— which went to the approximately 200,000 internists and practitioners of 20 sub-specialties who have obtained their board certifications from the ABIM—followed by a few weeks (and many believe was at least partially in response to) the announcement a new organization, the National Board of Physicians and Surgeons (NBPAS), with the announced goal of giving doctors “an alternative route for continued board certification.” It is led by Paul Teirstein, MD, chief of cardiology at the Scripps Clinic in La Jolla, California, and an outspoken MOC critic.

While the controversy surrounding MOC remains far from settled, it seems clear that critics of the process and of ABIM have scored some significant gains, by forcing ABIM to review or scrap some elements of MOC, and by possibly opening new paths to maintaining certification.

The creation of NBPAS and the ABIM’s apology are but the latest developments in a long-simmering dispute over how doctors should best keep their skills and knowledge up-to-date—and prove that they are doing so. The controversy dates to the 1990s, when the ABIM instituted a policy whereby, beginning in 2000, physicians who certified after 1990 would have to recertify every 10 years. (Until then certification had been life-long.) The change was subsequently adopted by the other 24 boards comprising the American Board of Medical Specialties (ABMS).

The 10-year maintenance requirement produced some grumbling among doctors, but no organized resistance. That changed at the start of 2014 when ABIM announced that doctors would need to earn accreditation points on a continual basis over the 10 years between taking the recertifying examination. Moreover, doctors who had board certified before 1990 would be listed as “certified, not meeting MOC requirements” on the ABIM’s web site.

For Teirstein and many of the physicians boarded by the ABIM, these latest changes were the final straw. They were further incensed by what they regarded as the excessive growth of the nonprofit ABIM—whose budget exceeded $59 million—and the nearly $29 million spent on salaries, benefits and “other expenses” during the ABIM’s 2014 fiscal year. A few months later Teirstein launched an online petition opposing the MOC requirements that to-date has garnered more than 23,000 signatures, he says.

In addition, he says, “I began getting comments like, ‘it’s great we have all these signatures, but what do we have to show for it? Have they [the ABIM] actually changed anything?’ And they had not.”

 

Teirstein’s response was to found the NBPAS, a nonprofit organization with what he describes as “a much less expensive, much simpler approach to life-long learning.” In the news release announcing its formation, the organization says it is “committed to providing certification that ensures physician compliance with national standards and promotes lifelong learning.” Among the requirements for continued certification are that a candidate be previously certified by an ABMS-member board and have completed 50 hours of CME in the past two years.

Teirstein describes NBPAS as a “grass- roots organization,” one that is funded entirely by its members. Membership fees are $85 per year or $169 for two years, and cover all specialties and sub-specialties covered by the ABMS. “Right now we’ve got about a thousand members and we’re making ends meet doing that,” he says. Teirstein is taking no salary.

As of mid-April none of the nation’s hospitals were accepting NBPAS certification as a basis for admitting privileges, but Teirstein notes that the process usually involves approval from numerous boards and committees and thus will take some time. “I’m of the firm belief that the as long as the medical community is willing to stand up and say this is what they want we’ll figure out a way to make it happen, but it won’t be overnight,” he says.

Teirstein and other NBPAS board members say they support the notion of physicians keeping their knowledge and skills up to date, but think CME offers the best method for accomplishing that. Teirstein notes that CME courses must be accredited by the American Council for Continuing Medical Education (ACCME) to count towards license renewal. “We’ve decided the best compromise is where you can have lifelong learning which doctors don’t consider onerous,” he says. “The doctors can choose which offerings to attend. They’re not going to pay and take time to go to something that’s not relevant.”

Harry Sarles, MD, FACG, an NBPAS board member and past president of the American College of Gastroenterology objects to what he calls the “esoterica” on the certification examinations. “It’s not good learning. It’s learning for the test,” he says.

“ABIM should not be allowed to set the bar, make the rules, and then provide all the CME that can only be accepted to meet their rules,” he adds. “I’m answering to my hospital, my state, my patients, the health plans, in terms of my quality being measured and monitored. And now ABIM steps in and says you should be doing something for us too. I felt like I was in the middle of a shakedown.”

“When I took my certification I felt proud and driven to continuously improve myself,,” he says. “But everything ABIM has instituted since then, to my way of thinking, has really been about themselves and not what’s best for physicians.”

Sarles endorses the idea of physicians demonstrating quality and a commitment to ongoing education, but wants to see “multiple pathways” for doing so. “I’m all for competition, because it will make us all better,” he says. “If we only had one kind of car to buy it would probably be a crappy car. Whatever your criteria are, competition is very healthy and I believe in it.”

 

ABIM’s February 3 statement, while not directly acknowledging NBPAS, did appear to address some of its complaints and those of others who have been critical of the MOC process. It said that the board will:

In addition, according to the statement, “ABIM will work with medical societies and directly with diplomates to seek input regarding the MOC program” via meetings, webinars, forums, and other venues. “We are embarked on a whole new way of doing business and much more engagement with our community,” Baron said in a phone interview with Medical Economics.

As evidence, he cites implementation of “a sub-specialty board structure that involves depth in each of the disciplines in internal medicine,” and that includes physicians in community practice as well as patients and other public stakeholders.

“Those groups have been reaching out to colleagues and members of their societies,” Baron says. “And what we’re hearing is that lots of the activities we had either as board products or expectations maybe are being done by other people in the [healthcare] delivery system better than we’re doing them. And in that case we want to learn more about those and figure out how to give people credit for the work that they’re doing during their day jobs and avoid redundancy and wasting members’ time.”

Responding to the complaint that MOC tests doctors on knowledge and skills they don’t encounter in their practice, Baron says he took the exam a year ago and acknowledges that it included topics he’d not seen in his general internist/geriatrics practice. On the other hand, he says, “I think all of us in practice confront that there’s a difference between what we use every day and what we might need to use some time.”

Baron recalls joining the ABIM’s test-writing committee in the summer of 2001 and being surprised to find the test included a question on anthrax. But several months later it was a board-certified internist in Miami, Florida (Larry Bush, MD) who first identified anthrax as the mysterious substance being sent through the mail that was sickening—and in the case of Bush’s patient, killing—recipients was anthrax.

”That’s a doctor who had a piece of knowledge that he didn’t use every day, but fact that he had it made a huge difference for a patient,” Baron says. (Bush subsequently coauthored an article about the incident in The New England Journal of Medicine.)

Regarding the fees associated with MOC, Baron says, “Nobody likes to write checks, and when I was in practice there were a lot of things I wished I didn’t have to pay for. But I want to acknowledge that it’s really hard for doctors in practice now and every check is a painful check. We are looking at ways to reduce the cost.”

As evidence, he points to the February 3 announcement regarding enrollment fees. “We are taking time to listening to physician feedback about all aspects of our program before announcing any additional changes,” he says.

“We know that doctors need to experience more value in the program, and the areas we pulled back on were those that doctors were in effect saying, ‘I’m not getting much out of this,’” he says.

 

Underlying much of the controversy surrounding MOC is the question of how much—or even whether—the process as currently structured actually improves physician performance and/or patient outcomes. A great many internists clearly believe it does not, according to a study published in the January 2015 issue of JAMA Internal Medicine.

The authors assembled a focus group consisting of 50 board-certified primary care and subspecialist internal medicine and family medicine physicians in an academic medical center and community sites. They found that “at present, MOC is perceived by physicians as an inefficient and logistically difficult activity for learning or assessment, often irrelevant to practice, and of little benefit to physicians, patients, or society.”

Data on the effectiveness of certification since the institution of time limitations is sparse, consisting largely of a handful of studies published over the past 15 years in Academic Medicine, the Journal of the American College of Cardiology and JAMA, among others. And while MOC supporters say the studies support MOC’s effectiveness, in a debate earlier this year with Baron and Lois M. Nora, president and chief executive officer of the ABMS, Teirstein maintained that the studies’ results are, at best, ambiguous.

He cited, for example, the results of a 2014 investigation published in JAMA comparing clinical outcomes among patients at four Veterans Administration hospitals treated by internists with time-limited and time-unlimited certifications (i.e. those who were grandfathered out of the ABIM’s 10-year certification requirements and those who were not.) The authors found “no significant differences” between the two groups on 10 primary care performance measures.

“If you say we have data that supports our MOC process, you’d better have the data,” Teirstein said in his interview with Medical Economics. “And if you look at the papers they cite, they’re very unconvincing.”

Baron acknowledges that the evidence in support of MOC “could be stronger,” but also notes “at least one of the studies he (Teirstein) criticized met rigorous methodological standards.”

“I don’t think it’s unusual to have good faith people arguing about whether the evidence shows ‘x’ or ‘y,” Baron says. “Every clinician operates all the time in an environment where the patient didn’t walk out of an article in a journal. You have to navigate between what you know you know and how close the patient before you gets to that.”

Teirstein says NBPAS has no plans to try and link ongoing education and training to quality and patient outcomes. “I just don’t think you can measure this adequately,” he says. “Would randomizing really work? A doctor might be more inspired to do a good job because he wants to prove you don’t have to do this [maintain certification.] It’s just not the kind of thing that lends itself to scientific study.”

Looking ahead, Teirstein envisions the NBPAS playing a watchdog role for the ABMS and its member boards, in addition to providing certification. “We’ll be keeping an eye on things and making sure everyone knows physicians are not just going to take whatever they’re given. We’re going to react and try to make our voices heard.”

 

Headache is one of the most common pain disorders seen in outpatient practice, and the authors of the current study provide a brief overview of the epidemiology and larger consequences of headache. Nearly everyone experiences headache at some point, and the prevalence of recurrent, severe headaches approaches 25%.

The high prevalence of headache is associated with substantial societal costs. There are approximately 12 million clinician office visits for headache per year in the United States, and headaches are estimated to cost the US economy $31 billion per year. The evaluation of headache accounts for some of this financial cost, but it can also have severe medical consequences. One study estimated that 4000 additional cancers were promoted by the 18 million computed tomography (CT) scans of the head performed in the United States in 2007. Another study found that the majority of all CT imaging of the head and brain were inappropriate, based on current recommendations. Most inappropriate CT imaging was ordered for headache.

The inappropriate use of resources in the management of headache has led to recommendations to reduce the use of brain imaging and physician referral, as well as limited use of opioids and barbiturates in the treatment of headache. But are clinicians following these recommendations? The current study by Mafi and colleagues explores this issue.

Contrary to practice guidelines, clinicians treating patients with headache are increasingly ordering costly imaging tests and referring patients to other physicians, and they are doing less counseling on lifestyle changes, authors of a new review suggest.

The researchers found an almost doubling of the use of CT and magnetic resonance imaging (MRI) in a recent 10-year period.

Although given the nature of the study they could not determine which referrals or imaging studies were not appropriate, the trend toward a doubling of these tests is concerning, said lead study author John N. Mafi, MD, fellow, general internal medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts.

"We have no reason to suspect that headache is a disease that epidemiologically or pathophysiologically has changed over the past decade, so this, we think, is inappropriate changes in physician practice patterns."

The study was published online January 8 in the Journal of General Internal Medicine.

Researchers used data from the National Ambulatory Medical Care Survey (NAMCS) and the National Hospital Ambulatory Medical Care Survey (NHAMCS) from January 1, 1999, to December 31, 2010. Both surveys obtain nationally representative samples of ambulatory patient visits across the United States.

From these surveys, researchers identified ambulatory visits (excluding emergency department visits) with a chief complaint and/or a primary diagnosis of headache. They also included those with secondary complaints and diagnoses of headache but unrelated primary reasons for the visit (eg, hyperlipidemias).

In the group of patient visits with a chief complaint of headache (80.8%), the surveys provide duration or context of symptoms in 5 categories: new onset (<3 months), acute-on-chronic flare-up, chronic routine, routine/preventive, and preoperative or postoperative visit.

Researchers studied 4 types of measures: use of advanced imaging, including CT and MRI; referrals to other physicians; counseling on diet, nutrition, exercise, mental health, and stress management; and use of medications.

The analysis included 9362 visits related to headache, which represented approximately 144 million visits during the study period. Almost 75% of the patients were women, and their mean age remained the same during the study, at approximately 46 years.

The study showed that advanced imaging, including CT or MRI, increased from 6.7% of visits in 1999-2000 to 13.9% in 2009-2010 (P < .001), as did referrals to other physicians, which rose from 6.9% to 13.2% (P = .005).

Although rare, there are "real concerns" about kidney injury due to use of contrast dye and radiation during imaging tests, commented Dr Mafi.

The study showed that during the same study period, counseling for headache prevention declined from 23.5% to 18.5% (P = .041).

But there were also somewhat encouraging results. For example, use of opioids and barbiturates, which are not recommended for headache, remained the same at approximately 18%.

"That's still quite a high number for a discouraged medication, so there's lots of room for improvement," commented Dr. Mafi.

Also, preventive medication for migraine, such as verapamil, amitriptyline, propranolol, and topiramate, nearly doubled — from 8.5% to 15.9% (P = .001). Abortive therapies, such as triptans and ergot alkaloids, rose from 9.8% to 15.4% (P = .022).

Use of nonsteroidal anti-inflammatory drugs and acetaminophen remained stable at roughly 16%.

The trends remained after adjustment for age, gender, race, geographic region, insurance status, symptom duration, urban location, and whether the physician was identified as the primary care practitioner. As well, there were similar trends between visits related to migraine vs nonmigraine headache, although patients with migraine received triptans/ergot alkaloids and preventive therapies more often, and their use of opioid or barbiturates was higher.

Use of CT/MRI rose more rapidly for those with nonmigraine headache, as did referrals to other physicians.

As for acute vs chronic headache, again the trends were similar. Use of CT/MRI appeared to rise more rapidly among patients with acute symptoms, although this difference did not achieve significance.

In addition, patients with chronic headache had lower adjusted odds of receiving referrals to other physicians (odds ratio [OR], 0.59; 95% confidence interval [CI], 0.42 - 0.82) or undergoing advanced imaging (OR, 0.47; 95% CI, 0.35 - 0.63) compared with other presentations. However, there were no significant differences across time as trends in referrals and imaging still nearly doubled for both groups.

Numerous factors are driving these trends, including a growing number of assertive and demanding patients, the authors suggest. "They come in and say 'I need an MRI for my headache' as opposed to 'I have a headache'," said Dr Mafi, adding that MRI and CT are more available now than ever before.

As well, physicians have an incentive to make patients happy because they are increasingly being rated on satisfaction surveys, said Dr Mafi.

There are also financial incentives for physicians to do more testing and concerns about legal liability if tests are not ordered.

Time constraints are another contributing factor. "There is simply not enough time during the visit to counsel" patients on making lifestyle modifications to help treat their headache, said Dr Mafi.

Reversing the trends will require a change in approach to reimbursement that relies less on the physical clinician visit and more on new technologies, said Dr Mafi.

"Rather than lengthen the visit or pay doctors more, I think we need to move away from that 20th-century mindset and really think about reimbursing care across a continuum of time," he said. "We need to think about reimbursing high-quality care at any time, whether it's electronic or through a secure email message between the patient and physician, or an electronic visit or telemedicine visit where patients can contribute to their records online and have the doctor provide feedback."

For a comment, Medscape Medical News reached out to Elizabeth Loder, MD, chief, Division of Headache and Pain, Brigham and Women's Hospital, Boston, Massachusetts, and immediate past president, American Headache Society (AHS), who headed the AHS "Choosing Wisely" project that looked at opioid prescribing.

The new study was well done, has "some fascinating findings," and is important in light of the fact that headache treatment and management trends are a neglected medical problem, said Dr Loder.

However, she raised several issues about interpretation. For one thing, she pointed out that the NAMCS and NHAMCS do not provide information that would help determine whether imaging studies were appropriately or inappropriately ordered.

"In clinical practice, we see both underuse and overuse of imaging studies. Patients with complex, refractory chronic headache problems frequently have multiple — usually unnecessary — imaging studies. In contrast, it remains common for us to see in a headache clinic patients with worrisome presentations of headache who have not been imaged."

The data suggest that much of the increase in imaging may be due to an increase in acute as opposed to chronic headache, said Dr Loder. "This is exactly the situation where imaging is most likely to be appropriate."

As well, the results show that imaging is more common in patients with nonmigraine headache rather than migraine headache. "Again, this is a situation where imaging may well be appropriate."

Dr Loder stressed that when the AHS formulated its "Choosing Wisely" recommendations, the committee felt that evidence to discourage imaging was strong only for patients with stable headache who met criteria for migraine.

According to the recommendations, imaging in patients without migraine is not necessarily inappropriate.

"The proportion of scan abnormalities is higher in patients with nonmigraine headaches and we did not feel evidence was sufficient to discourage imaging in those cases."

Dr Loder also noted that the increase in imaging and referrals has occurred alongside an "enormous downward pressure" on the time physicians can devote to patient concerns during an office visit. Physicians have to spend more time on paperwork, electronic medical record "meaningful use" requirements, and other things, she said.

"Ordering tests and making referrals are both relatively quick ways to demonstrate concern for a patient's symptoms and maintain patient satisfaction."

She pointed out that although some guidelines or recommendations encourage physicians to counsel about diet, nutrition, and lifestyle, these are based only on expert opinion. "The evidence that this type of counseling actually improves patient outcomes is thin to nonexistent."

She also noted that the "Choosing Wisely" recommendations were developed on the basis of processes that are less rigorous and detailed than those used to create actual guidelines (eg, those developed by the American College of Physicians in 2000), and the two probably should not be confused.

"'Choosing Wisely' recommendations are intended to identify practices that often — although not always — represent low-value care and that patients and physicians should discuss and question," said Dr Loder. "That is not the same thing as saying they are always inappropriate."

According to these recommendations, situations exist where the use of opioids and barbiturates may be appropriate, although they should not be first-line treatments in most situations, said Dr Loder. Similarly, the recommendations encourage the use of advanced imaging with MRI rather than CT in nonemergent headache for which imaging was thought to be appropriate.

"I think the authors are overstating the case for limiting imaging studies when they say that there is 'broad agreement' on these issues and characterize these things as 'low-value services.' They are not inherently low value — they are low value only in specific contexts."

Dr Loder found it "very interesting" that among those presenting with headache, women were significantly less likely than men to have imaging studies.

Dr Mafi and Dr Loder have disclosed no relevant financial relationships. Dr Loder is acting director of research at the BMJ but noted that although she is paid for that work, her comments do not necessarily reflect the views of the BMJ, the AHS, or Brigham and Women's Hospital.

J Gen Intern Med. Published online January 8, 2015. Abstract