Letter to the Editor

Author: Kim Schofield

Many people in Savannah live with serious diseases everyday including cancer, diabetes, HIV/AIDS and arthritis. They depend on pharmaceuticals, particularly biologics, to live a better quality of life. As a patient battling lupus, I know that biologics are helping many people and we need to make sure it stays that way. Biologics especially hold a lot of promise for patients with lupus since there have not been any pharmaceuticals introduced in the last 40 years designated to treat lupus.

Even though they hold promise, they are complicated because they are made up of living organisms and are typically injected. The process of creating a biologic is very complex and hard to replicate. Because it is nearly impossible to replicate the manufacturing process, a follow-on biologic (for analogy-sake, a “generic” biologic) will not be the same as an original biologic. Without proper testing, they pose a serious threat to the people who depend on them.

Current scientific methods are unable to establish that biologic products made by two different manufacturers are identical. Any legislation establishing a regulatory approval pathway for follow-on biologics should require clinical trials to demonstrate that the follow on product is safe and effective, rather than allowing an abbreviated approval process similar to generic medications.

With hope on the horizon for those of us with lupus – a hope that we have not realized in 40 years – I would hate to have a generic “equivalent” compromise my safety and the safety of others because of inferior testing requirements.

Kim Schofield has been in charge of organizing the LACES Lupus Support Group for more than five years. She is a trained professional who not only lives with lupus but also supports lupus patients, friends and family members throughout the state. LACES provides participants with an opportunity to receive introductory information about lupus, encourages the expression of concerns, provides an opportunity to share experiences, encourages and supports positive coping strategies and emphasizes the importance of medical treatment. Kim has been a strong advocate for not only lupus patients but other patients who have to deal with serious health concerns on a daily basis. Kim Schofield’s phone: 404-966-6397.

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