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Lupus Coping Corner

21st Century Cures: What to Know and What to DO!

Jessica Rowshandel, M.S.W.
Amy Caron
Project Director
Lupus Research Institute

The House of Representatives will vote on this important legislation this week! Act now and voice your support by using our Legislative Action Center.

Why voice support for 21st Century Cures?
21st Century Cures mainly addresses issues such as:  1) it takes too long to approve a new drug; 2) testing a potential drug is too costly; and 3) 95% of drugs fail during development. The bill supports patient-focused and innovative research to better understand the causes of complex diseases and lessen the time it takes for a new treatment to move from an idea to reality. We need better, safer treatments for lupus and we need to make bigger strides towards a cure for all, so this bill is great news for us.

What are some goals of 21st Century Cures?

  • Include patient participation in all stages of research and the regulatory process to approve a new drug. For example, we, as patients, would have a say in what types of side effects we’re willing to tolerate for a new, improved treatment.  Also new information from patients, a “patient reported outcome”, would be collected and reviewed as a part of the drug approval process.  If this bill passes, our voice would be heard when a new drug is reviewed for potential approval.
     
  • Help more scientists do more research in lupus and other complex diseases.  The National Institutes of Health (NIH) is the government agency responsible for biomedical and health-related research, and its budget has gone down to record lows. As a result, some studies had to stop before completion, while other studies still can’t get funded at all. This bill would help ensure that the NIH has enough funding to properly support the nation’s research.

The bill also establishes the “NIH Innovation Fund” to fund young researchers and “precision medicine” research.  Precision medicine involves creating a unique treatment for each individual patient based on their genetics and health history. We all know that no two cases of lupus are alike. Precision medicine research can help explain why lupus is so different for everyone, and help develop treatments that take into account the individual differences in genes, environment, and lifestyle for each person.

In addition, the bill supports drug repurposing, which means approving an existing drug for a new use. This can cut down the time it takes for a new treatment to become available to patients because it has already been tested.

  • Make conducting a clinical trial easier.  The bill would make the process of conducting a trial smoother and more flexible -- which doesn’t mean that we as patients aren’t protected, but that there will be less administrative burden in the application process and more room for innovation in clinical trial design.
     
  • Make clinical trials participation easier. Let’s face it, there will never be a new treatment for lupus unless we patients participate in clinical trials we qualify for; however, those can be very hard to find. Through this initiative, more patients will be able to easily find clinical trials that might be right for them by creating a detailed, up to date list of studies seeking participants on clinicaltrials.gov.

What’s next?
After a unanimous approval by the House Energy and Commerce Committee mid-May, the bill will be put to a vote by the House of Representatives this week.

For a bill to become law, it must first pass both the House and the Senate. This can be a lengthy process with much debate. The good news is that the Senate has similar legislation already in work, called the Innovation for Healthier Americans bill. If both of these bills pass, members of the House and Senate will then work together to create a single piece of legislation to be sent to the President to be signed into law.

There’s is still much work to be done, but we have momentum on both sides so it’s a perfect time to take action and contact your representatives.   

What can I do?
Join the SLE Lupus Foundation and 250 national, state, and local organizations and tell Congress you support patient partnership and engagement in research.  

It’s easy to take part by using the Lupus Research Institute’s Legislative Action Center  to send an email to your representative. A template is provided, so it’s easy to show your support.   

Our voice is important. Let’s do our part and make it heard.

About me:
I was diagnosed with lupus at age 23. At the time, I was working in the fashion industry, but my experiences as a patient drove me to a career switch with the goal of helping the healthcare system serve patients better. I got a master’s degree in public health from the CUNY School of Public Health and am currently Project Director for the Lupus Research Institute’s provider education initiative. 

Lupus Coping Corner

Disclaimer: The information provided by the S.L.E Lupus Foundation is for educational purposes only and should not be used for diagnosing or treating a medical or mental illness, nor be a substitute for professional care. Consult your healthcare provider if you have or suspect you may have a medical or mental health problem.

Amy Caron, MPH is a lupus patient and Project Director of the Lupus Research Institute provider education initiative.  She is not a physician or counselor.  The suggestions shared in this column are strictly opinions from the perspective of a lay person with lupus. Lupus is a very individualized illness; consult a healthcare professional before making any decisions about your care.

The S.L.E. Lupus Foundation does not provide any direct medical or psychological services nor recommend or endorse any particular treatment or therapy. The S.L.E. Lupus Foundation employees, consultants, and agents shall not be liable for any claims or damages, and expressly disclaim all liability of any nature for any action or non-action taken as a result of the information generated by the S.L.E. Lupus Foundation programs and its website, as well as the S.L.E. Lupus Foundation Facebook and Twitter pages.