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THE SEARCHLIGHT MESSENGER

"The Affordable Care Act" (and Its Impact)

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.]












MERRY CHRISTMAS

Looking for that apple pie recipe? Just click on the apple and enjoy.

































SOLIDARITÉ




SOLIDARITÉ



My First Professional Football Game


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 Phase 3 Trial Reports 100% Bleed Control

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.

Efficacy and Safety of BAX 111

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

Sidebar: Hemostatic Efficiency Rating Scale

1 (Excellent)
 
• 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.

2 (Good)

• 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.

3 (Moderate)

• 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.

4 (None)

• 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.”

Addressing a Pressing Therapeutic Need

“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.

References
  1. Gill JC, Castaman G, Windyga J, et al. Hemostatic efficacy, safety and pharmacokinetics of a recombinant von Willebrand factor in severe von Willebrand disease. Blood 2015. DOI 10.1182/blood-2015-02-629873. http://www.bloodjournal.org/content/bloodjournal/early/2015/08/03/blood-2015-02-629873.full.pdf?sso-checked=true Advance copy pre-published online August 3, 2015. Accessed online August 4, 2015.
  2. Blood Publishes Phase III Data on Baxalta’s Investigational Treatment for Von Willebrand Disease, the Most Common Type of Inherited Bleeding Disorder [press release]. Deerfield, Illinois. Baxalta Incorporated August 3, 2015. http://www.businesswire.com/news/home/20150803005068/en/Blood-Publishes-Phase-III-Data-Baxalta%E2%80%99s-Investigational#.VcCXYfmUf4Z
  3. National Hemophilia Foundation website. von Willebrand Disease. https://www.hemophilia.org/Bleeding-Disorders/Types-of-Bleeding-Disorders/Von-Willebrand-Disease Accessed August 4, 2015.
  4. National Heart, Lung and Blood Institute. What is von Willebrand Disease? http://www.nhlbi.nih.gov/health/health-topics/topics/vwd Updated June 1, 2011. Accessed August 4, 2015.
  5. Burden A. Large cap PDUFA dates have been added to BioPharmCatalyst. http://www.biopharmcatalyst.com/2015/01/large-cap-pdufa-dates-have-been-now-added-to-biopharmcatalyst-20-in-total-today/  BioPharmCatalyst. Published January 26, 2015. Accessed August 4, 2015.