Moran Amendment

A message from the Lupus Research Institute

Urge Your Senators Now To Protect
The Future of America’s Biomedical Research

We urge the lupus community to send a strong and immediate message to the U.S. Senate to support an amendment to the Senate Budget Resolution that would increase funding for NIH research in the coming year.

Between today and the weekend, the U.S. Senate is expected to take a final vote on its Fiscal Year 2014 budget resolution.  At some point in the debate, the Senate will consider an amendment by Senator Jerry Moran (R-KS) to increase funding for biomedical research funded by the National Institutes of Health (NIH).  The Moran Amendment would increase NIH funding by $1.4 billion – strengthening the agency’s capacity to fund the research necessary to deliver new treatments and find cures for lupus as well as the many other chronic diseases plaguing so many Americans.

Please help and express your support for Senator Moran’s Amendment by either telephoning or emailing your Senator today or tomorrow. Urge your Senators to vote for the Moran NIH Amendment to the budget resolution.

Use this link to the Lupus Research Institute website to send an email directly to your Senator. Click here to find your Senator’s telephone number and suggested messages to convey.

Here is a summary of the Moran Amendment from his office for your reference:

Funding for the NIH, the focal point of our nation’s medical research, has remained virtually level since FY2010. However, when adjusting for inflation, the FY2012 budget is $3.6 billion lower than the peak year of FY2003.  Success rates for grants have fallen more than 13.6 percent in the past decade and the NIH is projected to fund 3,000 fewer grants this year than it did ten years ago. 

If the United States is to continue its leadership role in providing the medical breakthroughs to develop cures and treat disease, we must commit to supporting funding for biomedical research.  If researchers cannot rely on consistent support from Congress, we will jeopardize our current progress, stunt our nation’s global competitiveness, and lose a generation of young researchers to other careers and other countries. 

Only through steady, sustainable, and predictable funding can the NIH sustain the highest quality biomedical research to help improve the health of all Americans.  In addition, the NIH plays a critical role as an economic engine, supporting approximately half a million jobs nationwide.  Our commitment to the NIH will remain an important factor in saving and improving lives, bolstering the nation’s economy and driving U.S. global competitiveness.

Diva’s note: Political beliefs aside, research is the only route to discovering ideal treatments for lupus. We, as patients, have a chance to be proactive and get involved.

stay FABULOUS!

Posted from the Diva on the road or (most likely) in bed.

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Lupus Biologic Drug Guide

There is not ONE pill for lupus; there are many!  Rarely will you find two lupus patients that share the exact same drug regimen, Why? Because we do not share the same symptoms. Lupus is a complex disease. Many of the drugs we are prescribed are the same drugs that are prescribed for other disease, including arthritis, cancer, and etc. Major case in point: being prescribed Plaquenil — an ANTI-MALARIA drug!

I came across this article from Arthritis Today that gives a great description of the popular drugs prescribed to control lupus. You can sign up for email alerts and receive some great information that is endorsed by the Arthritis Foundation.

Today, I have copied and pasted the “Biologic” portion by Donna Rae Siegfried. This was compiled with the Arthritis audience in mind, so I have included some lupus-friendly information in the right place.

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BIOLOGICS: (By Donna Rae Siegfried)

[Diva note: Benlysta falls in the biologic category]

What are biologics?

In general, biologics are genetically engineered medication made from a living organism, such as a virus, gene or protein, and then used to treat a problem occurring in a different organism, such as a human. Vaccines are one type of biologic agent. In contrast, other drugs are synthesized chemicals.

What conditions do biologics treat?

Because the biologics block triggers of inflammation, they are used to treat autoimmune forms of arthritis, such as rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), ankylosing spondylitis or psoriasis/psoriatic arthritis. Inflammation is the result of the immune system’s errant attack on the body’s tissues, causing joint pain and destruction, as well as other systemic effects, such as fatigue and heart and lung damage. Some biologics approved for rheumatoid arthritis are approved for, or are in development for, other conditions, ranging from Crohn’s disease to cancer.

How are biologics used?

Some biologics are used after a patient has “failed,” or not responded adequately to, traditional disease-modifying anti-rheumatic drugs (DMARDs) or other biologics. When a biologic drug is used for treatment, it is used often in combination with a traditional DMARD, such as methotrexate, for greater effectiveness.

Will biologics cure RA or other conditions?

Unfortunately, no! But the biologics, which work for about two-thirds of people who have rheumatoid arthritis, can induce remission in most people who respond favorably. A clinical remission is defined as fewer than 15 minutes of morning stiffness, and no tender or swollen joints for at least three months. Treating rheumatoid arthritis and other inflammatory forms of arthritis aggressively with DMARDs, including biologics, as soon as possible after diagnosis increases the chance of remission, as well as minimizes the risk of limited function due to permanent joint destruction.

Why can’t two biologics be taken together?

Biologics and other DMARDs decrease inflammation and disease activity by impairing the immune system’s activity. But suppress the immune system too much, and an overwhelming infection could take hold. Limited studies suggest that taking two biologics at the same time would increase the risk of infection markedly, without an increase in therapeutic benefit.

Why are biologics so expensive?

The materials required to create these agents are more expensive, and the manufacturing processes using live organisms are more complex than are required for traditional chemical pharmaceuticals. Other factors include the high cost of research and development.

All of the current biologics are still under patent protection. After a traditional drug patent expires (20 years from the date the company applies for it), other companies can produce generic versions that cost less.

It’s not clear yet how generic biologics – frequently called “follow-on biologics” – will be handled. The unique process of producing copies of biologic agents presents issues of consistency, as well as proof of safety and effectiveness. The U.S. Food and Drug Administration (FDA) currently has no authority to approve a follow-on biologic for the marketplace, but there are bills in Congress to change this.

Why can’t biologics be taken in pill form?

The biologics currently approved by the FDA must be injected or infused (that is, given intravenously) because they are made up of large protein molecules that cannot be absorbed if taken orally. Seven oral rheumatoid arthritis drugs made from small molecules are now in early stages of development and testing.

Do all biologics work the same way?

Although the goal of biologics is the same – to stop damaging inflammation – they interrupt the complex cascade of cellular events that drive inflammation at different stages. Belimumab (Benlysta) blocks different inflammatory proteins than does the RA-biologics. Belimumab is a human monoclonal antibody that inhibits a protein necessary for the maturation of B-lymphocytes, cells involved in the autoimmune response that underlies lupus. Rituximab (Rituxan), another lupus-biologic hopeful, stops the activation of a certain type of white blood cell called B cells. It was originally approved to treat tumors, then rheumatoid arthritis, and most recently vasculitis. Evidence thus far is mixed regarding its use as a treatment for lupus (and lupus nephritis). Although randomized clinical trials (gold standard of evidence) have not found it to be superior to standard regimens, there are many signs that it may be effective [Appel GB. Clevel Clin J Med 2012– contact me if you would like to see full article]. For both of these biologics, the theory is the same: With fewer B cells, the overactivity of the immune system decreases.

On the horizon: Abatacept (Orenicia), a “co-stimulation” blocker, is undergoing clinical trials in lupus nephritis. Results shuold be available shortly. 

Diva note: Overall, biologics are a serious drug, and not for everyone! The decision to take it requires: 1) a balancing act of the risks and benefits AND consideration of all factors (i.e., cost, convenience, risks and overall potential benefit), 2) making sure these medication characteristics are in alignment with your preferences, 3) a good talk with your doctor, and 4) good adherence strategy– remember to do your part as a patient. Doctors can only do so much for us.

Stay Fabulous!

Research news from the LUPUS FOUNDATION OF AMERICA

Keep up-to-date on the latest research on lupus.

In each category below, you can find summaries that explain the importance of recent research studies. All summaries provide access to the article abstract; select summaries provide access to the full journal article.

http://www.lupus.org/webmodules/webarticlesnet/templates/new_empty.aspx?articleid=3065&zoneid=76

As suggested by the lupus foundation, feel free to discuss any of this with your doctor.

Remember to actively participate in your medical decision-making with your doctor. That means ask your questions and express your concerns. At the end of the day, as the patient, the disease affects you and you are the one taking the treatments. Therefore, your medical appointments should serve as a setting for great collaboration between you and your doc. This is called shared decision-making.

If you want more information regarding shared decision-making, please let me know! I have an extensive bibliography on this topic, as this is my field of research.

Posted from the Diva on the road