Science Policy For All

Because science policy affects everyone.

Science Policy Around the Web – March 13, 2015

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By: Thomas Calder, Ph.D


Drug Policy

F.D.A. Approves Zarxio, Its First Biosimilar Drug

For the first time in the U.S., the Food and Drug Administration has approved the use of a “biosimilar” drug, called Zarxio. This drug will be prescribed for cancer patients undergoing chemotherapy to help prevent infections. Biosimilar drugs are essentially generic versions of costlier drugs known as biologics, which are created from a living cell instead of a chemistry lab. Many European countries have already approved several biosimilar drugs, but the U.S. patent system has previously prevented their approval. The complex creation process of brand-name drug has essentially protected these drugs from competition. New technologies are allowing drug companies to create biosimilar drugs to overcome these patent rules, which may equate to big savings for the healthcare system. Zarxio is projected to reduce healthcare costs by $5.7 billion in the U.S. over the next 10 years. According to Dr. John K. Jenkins, director of the Office of New Drugs in F.D.A.’s Center for Drug Evaluation and Research, “The biological products tend to be products that have very high prices. With competition, one of the goals is to see hopefully lower prices to make access better for the patients who need these products.” Currently, 11 other biosimilars are in development, and if approved, Express Scripts estimates the U.S. will save $250 billion over the next 10 years. (Sabrina Tavernise and Andrew Pollack, New York Times)

Ebola Research

New Ebola drug trial starts in Sierra Leone

An experimental drug to combat Ebola is entering phase II trials. Researchers are testing the drug in Sierra Leone, which is still experiencing 10 new Ebola cases everyday. The drug consists of small RNA molecules that were coded to interfere with the replication process of the Ebola virus. These RNAs are encapsulated in a lipid nanoparticle that transports and delivers the RNA to its target. The researchers hope to enroll up to 100 patients for this trial, and potentially use non-enrolled patients as controls. There are several challenges to this clinical trial. First, the drug must be administered for 2 hours, and will therefore require a doctor or nurse to monitor the patient for long periods of time while wearing protective equipment in the intense tropical heat. Second, the drug may have dangerous side effects, such as an extreme immune response known as a “cytokine storm.” Third, new Ebola cases are continuing to drop and therefore, there is a short time frame to test this new drug and potentially begin phase III trials. According to Trudie Lang, a global health researcher at the University of Oxford, “We are looking for a big effect, and if there is a big yes or a big no, we hope to see that sooner.” If the drug is ineffective, the researchers hope to quickly test a different drug while there are still Ebola cases in western Africa—with the ultimate goal of saving lives in future Ebola epidemics. (Kai Kupferschmidt, ScienceInsider)

Federal Research Funding

Physical scientists offer outside-the-box idea for funding U.S. basic research

Federal funding for research and development (R&D) in the U.S. has been decreasing in recent years, when adjusted for inflation. The downward trend in buying power may continue into the future. In fact, the percentage of the federal budget that is dedicated to discretionary spending is projected to go from 36% in 2012 to only 23% in 2040. Therefore, strategies may need to be developed to support and maintain federally funded R&D programs. Two physicists, Michael Lubell and Scott Franklin, have proposed a unique idea of creating a $100 billion dollar endowment called the “Research Bank.” This endowment would provide roughly $7 billion every year for research funds. The scientists proposed that the original funds could come from taxes of overseas corporate profits. According to Lubell, convincing congress of this plan is a “heavy lift,” especially since taxing overseas corporate profits is highly controversial. While this funding strategy may never gain traction in congress, Lubell and Franklin are helping to foster policy discussions on R&D funding strategies. (Robert F. Service, ScienceInsider)

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Written by sciencepolicyforall

March 13, 2015 at 9:00 am

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