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MichaAbelesBiosimilarUsageRheumaticDiseases

Recommendations Issued about Biosimilar Usage for Rheumatic Diseases

The treatment of choice for rheumatic diseases has traditionally been the use of biological agents called bio-originators. These agents are derived from microorganisms, animals or humans. The increasing cost of these agents has put effective treatment out of the reach of many disease sufferers.

A group of international rheumatologists, patient representatives and specialists in related fields conducted a scientific review to determine if the use of “biosimilars” can help give patients greater access to treatment. Biosimilars are substances that have been approved by the FDA because they are so similar to bio-originators that are already in use.

The task force addressed three questions. The first was the matter of cost. Biosimilars introduce more competition in the market and are expected to result in lower prices. It was predicted that the savings would be about 35 percent. In the United States, for a product with only one biosimilar available, the savings was only about 15 percent. The task force hopes that as more biosimilars become available, the cost savings will be more fully realized.

The second question was in regard to extrapolation. An example is the best way to explain extrapolation. If a bio-originator is used to treat conditions A, B and C, full extrapolation would mean that as soon as the FDA approves the biosimilar for condition A, it could also be used to treat conditions B and C. The task force was in agreement that the more cautious route of doing additional testing for each condition should be followed.

The third question investigated by the task force looked at the implications of having a patient switch from the bio-originator to a biosimilar. The data regarding biosimilars for rheumatic diseases strongly suggest that this switch is safe and produces no drop in effectiveness. The decision to switch from one to the other, however, should only be made by the doctor in consultation with the patient.

One topic that still requires further research is the question of interchangeability. Interchangeability means that the biosimilar is truly equivalent in every meaningful way to the bio-originator. This can only be determined if patients are switched from one to the other and back at least three times. If there are no differences found regarding safety, effectiveness, reaction of the immune system, or side effects between a group that undergoes the switching and a group that only uses the bio-originator, the two products can be called interchangeable.

MichaAbelesBoostLupusResearch

A Boost for Lupus Research

On June 29, the U.S. House of Representatives passed the Fiscal Year 2018 Department of Defense (DoD) Appropriations bill, which funds the country’s military and medical activities. Within that legislation, $5 million in funding was allocated to the Lupus Research Program — in addition to the $5 million that Congress provided earlier this year for 2017! With a total of $10 million in funds, this will certainly provide a boost for lupus research.

First of all, what is lupus?

According to The National Resource Center on Lupus by the Lupus Foundation of America, lupus is a chronic autoimmune disease that affects your immune system. With lupus, your body can’t tell the difference between foreign bacteria or viruses and your body’s healthy tissues, therefore, your body can attack and destroy its own healthy tissue. This can cause inflammation, pain, and damage to all parts of your body — meaning skin, organs, and even joints can be affected.

How does this relate to rheumatology?

Because lupus is a disease that affects the joints, rheumatologists are commonly the doctors lupus patients see. Although people typically associate rheumatologists with arthritis, they also treat autoimmune diseases of the muscles and bones — such as osteoporosis and lupus. Throughout their schooling, rheumatologists are trained to spot signs and potential causes of joint inflammation, and can often diagnose a patient with lupus.

What were the driving forces behind getting this funding?

Conveniently, this funding was passed a few days after the Lupus Foundation of America’s National Policy Summit and advocacy day in Washington, D.C. With activists visiting over 200 Congressional offices, and thousands of others virtually participating, the U.S. government heard the message loud and clear: more funding needs to go towards lupus research.

What will the money be used for?

For years, research into this disease has been stagnant because the cause of lupus is so difficult to diagnose, and the true cause of it still remains unknown. However, this boost in funding will provide a plethora of new hypotheses to explore in terms of why and how people get lupus. For example, new and promising signs of potential breakthroughs in diagnostics, adult stem cells, environmental triggers, personalized treatments and more will be explored. In addition, clinical trials of medications will become more efficient and effective with new streamlined and modernized technologies that will developed.

With continued support from the community, government, and fellow rheumatologists, lupus can soon be defeated. This monetary boost will do wonders into research for the disease, and hopefully soon we will have a cause and appropriate treatments for lupus.

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