Name Game, Game Change?

I’m thinking “game” this weekend because the Patriots are in the Super Bowl, again, and I will need to watch it like the rest of Boston. I only watched my first football game two years ago when, surprise surprise, the Patriots were in the Super Bowl. Every sports fan knows the Patriots, I am told. It’s easy to cheer for your home teams when the names (Red Sox, Patriots, Bruins, Celtics) endure for decades. It’s harder when it’s the drug companies that make your factor concentrate. There’s a lot of game changing going on lately.

The news was announced just three days ago: Biogen, maker of Eloctate and Alprolix, has spun off its hemophilia division, which has now become an entirely separate and new company called Bioverativ.

Biogen’s two revolutionary products, the first ones with a longer half-life, were game changers. Now there are a few more choices for longer half-life products, but these were the first and were rolled out with much fanfare. Then boom! Three years later, Biogen doesn’t want them anymore.

This is just a reminder to us patients that this is a marketplace, and we are consumers. And companies need to make business decisions—hence the “game.” As consumers, it’s up to us to understand how the game is played, and who are the players. The names have been changing, more rapidly than I can keep up with in the specialty pharmacy arena, and those are truly game changers.

In the factor concentrate manufacturing arena, we had two name changes just in the last few months: Biogen to Bioverativ, and Baxalta to Shire. But this has been happening for years in our community, so here’s a review. It’s worth knowing the players—of which YOU, the consumer, are the most important!

Remember Alpha? Those of you who use Alphanate or Alphanine may wonder why these drugs are called that when sold by the Spanish company Grifols. Simple: Grifols bought Alpha Therapeutics hemophilia therapies years ago and simply kept the drugs’ names the same. (It’s hard to change a drug’s name.) In 2011, Grifols also bought Talecris, making it the third-largest global manufacturer of plasma-derived therapies. Oh, and Talecris? It was a spin-off from Bayer, which didn’t want to keep plasma-therapies anymore. Bayer’s plasma-product Koate-DVI went to Talecris, and Bayer kept Kogenate FS. If you look at the Koate-DVI packaging, you’ll still see the Bayer primary color line around the box!

Baxter Healthcare produced factor concentrates like Recombinate, Advate, Hemofil M and FEIBA. It spun off its hemophilia division, which became an independent company called Baxalta. That didn’t last long. Shire, an Irish pharmaceutical company, liked what it saw and scooped it up. All the former Baxter/Baxalta products now belong to Shire.

The biggest name changer is CSL Behring. I knew it in 1987 as Armour Pharmaceutical. Then in 1996, Armour and Behringwerke (a Geman company) formed a joint venture known as Centeon. Things happen fast: in 1999, Centeon became Aventis Behring. Why? Armour’s parent companies (Rhone-Polenc Rorer and Hoechst) merged to become Aventis. Meanwhile, CSL (an Australian plasma therapies manufacturer) acquired ZLB Blood Transfusion Services. In 2004, CSL acquired Aventis Behring, to form ZLB Behring, later called CSL Behring.

(There’s a comprehensive timeline of this interesting company here.)

Genetics Institute: anyone remember that? They developed BeneFIX and ReFacto (no longer on the market). It evolved into Wyeth, and then was bought by pharma giant Pfizer Inc.

Bayer is one that seems to have stayed the same, but it’s had name changes too. Bayer bought Cutter Labs in 1978 and Miles Labs in 1979. In 1995, they all became Bayer. I think Novo Nordisk (Denmark) has stayed the same… so far!
And some companies dropped out altogether, like the American Red Cross.  And new ones entered, like Octapharma (Switzerland) and Kedrion (Italy), tapped to distribute Koate DVI for Grifols. And Aptevo Therapeutics… oh, which was owned by Cangene (Canada) first, then Cangene was bought by Emergent Biosolutions in 2014! And they all originated from Inspirational Biopharmaceuticals, which in 2013 sold all its product rights to them, and dropped out of the game.

More passes than Tom Brady!

Whew! It’s amazing tracking the history of just the name changes: but we also need to know products. We are tracking who makes what on our website Hemophilia Factor Chart by Brand, available as a download. We are updating it all the time… a necessity to keep track of this ever-changing game, and business.

Hemophilia Myths and Facts

Myths are stories or beliefs created to explain phenomena when scientific knowledge is lacking. Sometimes they persist even when scientific explanations are available, because people can get emotionally impacted by myths. When it comes to blood, people have strong emotional beliefs and feelings, and this may prolong myths. So read this nifty list of myths which includes the facts that dispel the myth. You can download a pdf of this with graphics here.  Enjoy!
Hemophilia is a medical condition that impairs
the body’s ability to control bleeding. There are about 20,000 people with
hemophilia in the United States and with the condition being so rare, many
people may not know much about it. Below we dispel 10 common myths to help
you better understand hemophilia.
MYTH
FACT
If a person with hemophilia gets a minor cut,
they’ll bleed to death.
People with hemophilia don’t bleed faster, but
they do bleed longer because they’re missing a protein in their blood that
assists in forming stable clots. Minor cuts are not a cause for concern and
will usually heal on their own.1
Only males have hemophilia.
It’s true that hemophilia does primarily affect
males because it’s an X chromosome-linked medical condition.1,2
However, females who are carriers can also experience bleeding symptoms.
Though extremely rare, a daughter who is born to a father with hemophilia and
a mother who is a carrier can inherit the severe form of the condition.3
People with hemophilia always have a family
history of the condition.
Nearly one-third of hemophilia cases are not
genetically based and have no family history of the condition.1
All people who have hemophilia are diagnosed at
birth.
Due to a lack of bleeding at birth or because the
family doesn’t have a history of hemophilia, some people who have hemophilia
may not be diagnosed until months after birth, as toddlers, or even later,
depending on the severity of their
medical condition.4,5
Children with hemophilia will grow out of it.
Hemophilia is a lifelong condition, a bleeding
disorder caused by the absence of an essential blood clotting protein.1 While
there is no available cure for hemophilia, research continues to progress and
shows promise. Scientists are currently researching how gene therapy can help
the body produce its own clotting factor.2
Hemophilia is the same for all patients.
People can have hemophilia A, which is defined by
low levels of clotting factor VIII (8), or hemophilia B, defined by low levels
of clotting factor IX (9).1,3 The severity of hemophilia is
categorized as mild, moderate, or severe.1 Additionally, about 15% to 20%
of people with hemophilia will develop an antibody—also called an
inhibitor—which is one of the most serious complications of the condition.6
People with hemophilia shouldn’t exercise or play
sports.
Exercise is important for people with hemophilia
because it strengthens muscles, which helps protect joints, and reduces the
risk of being overweight, which places added stress on joints. They should
work with their health care professional to create a fitness plan that’s
right for them.7
Hemophilia is a “royal disease.”
While it’s true that in the 1800s hemophilia did
affect the royal family of Queen Victoria of England, hemophilia affects
people regardless of race, ethnicity or economic status.2,4
Hemophilia causes AIDS.
Hemophilia doesn’t cause HIV/AIDS. Unfortunately,
from 1978–1985, many people with hemophilia did contract HIV when they
received treatments made from tainted blood donations. The blood supply is
now much safer due to improved donor screening and advanced purification
methods, and also, many newer treatments aren’t made from donated human
blood. There hasn’t been a documented case of HIV from the use of hemophilia
treatments since 1987.2
People with hemophilia can’t live normal lives.
With proper treatment, most people with
hemophilia lead long, full, and productive lives.4
References
1.    National Hemophilia Foundation.
Hemophilia A. https://www.hemophilia.org/Bleeding-Disorders/Types-of-Bleeding-Disorders/Hemophilia-A.
Accessed November 3, 2015.
2.    National Hemophilia Foundation.
History of Bleeding Disorders.
https://www.hemophilia.org/Bleeding-Disorders/History-of-Bleeding-Disorders.
Accessed November 3, 2015.
3.    Midwest Hemophilia Association.
Myths and Facts About Hemophilia.

Myths and Facts About Hemophilia


Accessed November 3, 2015.

4.    Indiana Hemophilia &
Thrombosis Center, Inc. Hemophilia Awareness Month – Fast Facts for Patients.
http://www.ihtc.org/wp-content/uploads/2012/02/Hemophilia%20Awareness%20-%20Fast%20Facts%20for%20Patients.pdf.
Accessed November 3, 2015.
5.    Centers for Disease Control and
Prevention. Hemophilia Diagnosis.
http://www.cdc.gov/ncbddd/hemophilia/diagnosis.html. Accessed June 7, 2016.
6.    Centers for Disease Control and
Prevention. Hemophilia Inhibitors.
http://www.cdc.gov/ncbddd/hemophilia/inhibitors.html. Accessed June 13, 2016.
7.    National Hemophilia Foundation.
Playing It Safe: Bleeding Disorders, Sports, and Exercise.
https://www.hemophilia.org/sites/default/files/document/files/PlayingItSafe.pdf.
Accessed November 3, 2015.
Novo Nordisk is a registered trademark of Novo
Nordisk A/S.
© 2016 Novo Nordisk
          All rights reserved.
              
USA16HDM02573                 
July 2016

How to Handle a Bleeding Disorder During the School Year


The start of a new school year is a stressful and exciting time for both kids and parents. If you’re the parent or caregiver of a child with a bleeding disorder, you have a lot more to consider than just which school supplies to buy. There are precautions you can take before and during the year to ensure things go as smoothly and safely as possible. 
Talking to Your Child 
The best way to prepare for the new school year is to get together with your child, their doctor, and the school staff to agree on a plan. Start by having a one-on-one conversation with your child. Make sure they understand their condition and encourage them to speak up if they need help or are experiencing a bleed while in school. They should know how important it is to take care of their bleeds right away. 
Talking to a Physician 
Next, meet with your child’s hemophilia treatment center (HTC) doctor or nurse to come up with a treatment plan. Talk about your child’s participation in sports and other physical activities. You should sit down with the HTC doctor or nurse before any meetings you have with the school regarding bleeding disorders, because it is good to have an overall understanding of things yourself. 

Talking to the School Staff 
It is important to plan a meeting with the school staff before the school year is in full swing. If you haven’t done this yet, try to organize a meeting as soon as you can; don’t wait for back-to-school night when teachers will be busy meeting with many parents in one evening. 
Contact the school nurse, counselor, or principal to organize the meeting. You should talk about safety precautions, the storage and possible use of treatment in school, and the importance of not singling out or embarrassing your child. People who should be at the meeting include: 
  • You and your child 
  • Primary teacher(s) 
  • Gym teacher 
  • School nurse 
  • An administrator (eg, principal, vice principal) 
  • A previous teacher who has experience with your child’s condition (if available) 
What to Do During the Year 
During the school year, your child needs to be comfortable speaking up if or when bleeds occur, and teachers should be able to recognize bleed symptoms as well. Provide them with a checklist of basic symptoms, as well as an emergency contact list of whom to call if a bleed happens. The same goes for gym class and after school activities—if your child can participate in these activities, the staff should be on the lookout for bleeds or other issues. 
If the bleeding disorder causes absences or missed schoolwork, you, your child, and their teacher(s) should work together to figure out the best way to get caught up. Your child should know that it is okay if their condition prevents them from completing some work on time, but that bleeds are not an excuse to put off responsibilities. 
Working as a Team 
Perhaps the most important thing is to keep in mind that everyone involved is part of a team. You all have the same end goal: to help your child have a productive and enjoyable school year. The school staff may not have much experience with bleeding disorders, which is why it’s important that you all work together throughout the year to ensure your goals are reached. 
For printouts on bleed symptoms, emergency contact information, and other useful resources for the school and your child, visit the NovoSecure™ downloads page
This is a sponsored message from Novo Nordisk. 

Introducing Team Novo8™

Have you ever wanted to connect with someone who is going
through a similar experience as you? Well, Team Novo8™ patient ambassadors are
here to share their personal stories with the hope of encouraging, motivating,
and providing support in your journey living with and managing hemophilia. Team
Novo8™ consists of a variety of people who have hemophilia and who want others
affected by hemophilia to know that they are not alone.
Team Novo8™ is involved in the hemophilia community and
actively participates in speaking engagements and community initiatives on
behalf of Novo Nordisk. Team Novo8™ patient ambassadors hope to learn more
about the needs of the hemophilia community and better understand the
challenges and personal successes they have experienced.
Meet one of the Team Novo8™ patient ambassadors—Shawn. He is
an energetic public speaker, writer, musician, and health education instructor.
When he was 2 years old, Shawn was diagnosed with moderate hemophilia A after
his parents noticed some unexplained bruising. Because he was diagnosed at such
a young age, Shawn developed lifelong relationships with his doctors and
nurses. He travels with his partner, Gwenn, to speak at colleges about nurturing
loving relationships while living with medical conditions.
Brian, Alfredo, Arther, Shawn, Daniel, Tyler, and Eric
(clockwise from top left) live with hemophilia A
Team Novo8™ offers a unique perspective on managing
hemophilia. Overall, patient ambassadors from Team Novo8™ have found that
Novoeight® fits into their lifestyle and they want to help inspire other
patients and caregivers with their stories. Learn more about the patient
ambassadors on Team Novo8™ by visiting Novoeight.com.
A Hemophilia Community Specialist (HCS) is also an
excellent source of support and can direct you to many helpful resources,
including learning more about the Team Novo8™ ambassadors. Find your local HCS
by visiting Novoeight.com.
Team Novo8™.
Personal stories. Authentic connections.
Indications and Usage
Novoeight®
(Antihemophilic Factor [Recombinant]) is an injectable medicine used to control
and prevent bleeding in people with hemophilia A. Your healthcare provider may
give you Novoeight® when you have surgery.
Novoeight®
is not used to treat von Willebrand Disease.
Important Safety Information
You
should not use Novoeight® if you are allergic to factor VIII or any
of the other ingredients of Novoeight® or if you are allergic to
hamster proteins.
Call
your healthcare provider right away and stop treatment if you get any of the
following signs of an allergic reaction: rashes or hives, difficulty breathing
or swallowing, tightness of the chest, swelling of the lips and tongue,
light-headedness, dizziness or loss of consciousness, pale and cold skin, fast
heartbeat, or red or swollen face or hands.
Before
taking Novoeight®, you should tell your healthcare provider if you
have or have had any medical conditions, take any medicines (including
non-prescription medicines and dietary supplements), are nursing, pregnant or
planning to become pregnant, or have been told that you have inhibitors to
factor VIII.
Your
body can make antibodies called “inhibitors” against Novoeight®,
which may stop Novoeight® from working properly. Call your
healthcare provider right away if your bleeding does not stop after taking
Novoeight®.
Common
side effects of Novoeight® include swelling or itching at the
location of injection, changes in liver tests, and fever.
Please
click here for Prescribing Information.
Novoeight
is a prescription medication.
You
are encouraged to report negative side effects of prescription drugs to the
FDA.  Visit www.fda.gov/medwatch or
call 1-800-FDA-1088.

Mental Health Challenges in the Bleeding Disorders Community

Mental Health Awareness Week begins May 15, so it’s a perfect time to think about mental health challenges that individuals with bleeding disorders and their families may often face.

People with chronic illness experience difficulties that can contribute to the development of depression, and people with bleeding disorders such as hemophilia are no exception. As early as childhood, people with hemophilia may have difficulty forming and maintaining friendships due to frequent surgeries and hospital stays, or because they need to avoid activities that other children are free to enjoy. They may appear “different” from their peers because of bruises, needle marks, or swollen joints, which can make them targets for teasing or bullying. As a result, they may struggle with social isolation, body image issues, and chronic pain, which can contribute to depression.

Social isolation and its role in depression can be a problem for people with a bleeding disorder into adulthood. Indeed, lack of social support has been noted as an important risk factor for depression in a study of adult men with hemophilia. In the same study, lack of employment emerged as another important risk factor. With a bleeding disorder, there are additional challenges to finding and keeping a job, such as the need for flexibility, adequate medical insurance benefits, and an employer who supports the rights of someone living with a chronic disorder.

Another mental health challenge for people with a bleeding disorder relates to the use of opioid medications to manage pain associated with joint bleeds and surgeries. Because patients often need effective pain relief, opioids have a distinct place in their treatment. Some individuals may be concerned about addiction. For this reason, it’s important to work with a health care professional with an expertise in pain management when considering opioid treatment.

During Mental Health Awareness week and beyond, patients, parents, and caregivers should be aware of these mental health challenges. Together, we can support each other—and ourselves—throughout our bleeding disorder communities.


To get support, resources, and more to overcome challenges like mental health in your life, reach out to your local community chapter. Eligible individuals can also sign up for the HeroPath™ program and receive a personal mentor/life coach who can help keep you focused on your goals and what’s ahead. Learn more at www.mynovosecure.com.

This is a sponsored message from Novo Nordisk®.
Learn more at http://www.novonordisk.com.

HeroPath™ is a trademark of Likone Corporation.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.

ADVERTISEMENT