• With Proper Safeguards, Biosimilars may be Safe, Cost-Effective Alternatives to Reference Biologics
    A public meeting was convened earlier this week by the Food and Drug Administration (FDA)’s Arthritis Advisory Committee to review the license application of CT-P13, a proposed biosimilar to infliximab (Remicade) for the treatment of rheumatic disease including rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis. If approved, CT-P13 would be the first such biosimilar available for sale in the US. At the meeting, the American College of Rheumatology (ACR) additionally offered its recommendations for policy guidelines for the licensing of future biosimilars. The safe adoption of biosimilars has been a key legislative priority for the ACR, in the interest of patient safety. Angus Worthing, MD, FACP, FACR, a practicing rheumatologist and member of the ACR Government Affairs Committee, commented “As more biologic drugs are used to treat rheumatic diseases, rheumatologists are increasingly concerned about their high costs and patients being able to afford them, so the ACR strongly believes that safe and effective treatment alternatives should be made to available to patients at the lowest possible cost. However, we need to be able to confidently prescribe these therapies to our patients and feel comfortable that proper mechanisms are in place for rheumatologists to monitor patient reactions to prescribed biosimilars.”  A news story about the ACR testimony, with link to the transcript of Dr. Worthing’s testimony, may be read here.
  • DOJ Alleges Fraud Targeting Veterans Health Insurance, Medicare, and Others
    An article published Sunday in The Wall Street Journal reports that the US Justice Department is investigating suspected fraud involving compounding creams that are being marketed to treat pain as well as other ailments. The marketing campaign, including televised promotions by retired NFL quarterback Brett Favre, have resulted in substantial increases in sales to athletes, the elderly, and others, although the products are alleged to have little or no therapeutic value. DOJ further believes that Tricare, the health insurance program for US military veterans and their families, may have been fraudulently billed for overcharged or automatically refilled prescriptions that were never ordered. World Health Industries, also doing business as Aspire Rx, and claiming to be “the pre-eminent provider of compounding pharmacy services in the U.S.” is one of the companies under investigation. Its product, Rx Pro has been promoted by Mr. Favre, who also claimed to be an investor in the organization, in a 2003 radio interview. Under federal law, compounding pharmacies don’t have to prove the efficacy or safety of their products. The industry is primarily regulated by states, which exercise varying degrees of scrutiny. Additionally, compounded creams frequently are not subject to FDA approval because it is considered impractical to test all the variations. The full article on the investigation may be read here Click here to link to the Wall Street Journal article.
  • Uncovering the Role of T-cells in Post-Workout Muscle Repair
    Repeated bout effect is the term for the well-known phenomenon by which exercise-induced muscle soreness tends to abate with successive workouts. Now, researchers at Brigham Young University report that they have discovered how the immune system acts to repair muscle damage and prevent additional injury. Writing in the journal Frontiers in Physiology, the team concludes that T-cells were found to infiltrate muscle fiber in response to exercise-induced damage. Although traditionally associated with response to infections, the presence of the T-cells in muscle fiber suggests that muscles become more effective at recruiting immune cells following a second bout of exercise and that these cells may facilitate accelerated repair. The team additionally noted that their study subjects exhibited increased inflammation after a second round of exercise—contrary to previous belief that inflammation goes down with repeated exercise, contributing to less soreness. Lead author Michael Deyhle commented, "Many people think inflammation is a bad thing. But our data suggest when inflammation is properly regulated it is a normal and healthy process the body uses to heal itself." An implication of this secondary finding is that the use of anti-inflammatory medications such as ibuprofen or aspirin after exercise may not be as effective as previously thought. To access the library of information about inflammation, click here. Read a news story about the findings here. The journal article may be read here.  
  • Functional MRI Provides More Objective Assessment than Patient Reports
    Results from a new study suggest that measuring the brain’s neural response to pain using functional magnetic resonance imaging (FMRI) may be useful in the evaluation of the effectiveness of new pain medications. The tool could provide the objective evidence needed to prevent the premature discounting of potentially useful therapeutic approaches, according to the researchers from the Nuffield Division of Anaesthetics, University of Oxford, UK. Lead author Vishvarani Wanigasekera, MD, commented, “Many potential pain relieving drugs identified in preclinical research fail to reach the market because of a lack of early objective evidence that shows whether a drug is effectively reaching target pain receptors in the body and regulating chronic pain mechanisms.” The results are published in the journal Anesthesiology. At present, the usual measure of efficacy used in drug development is patient reported degree of pain relief, which can be both subjective and context-dependent. Since early development studies typically involve a small sample size, this subjectivity can cause researchers to pass over compounds that might be effective in larger populations. In this study, using topical capsaicin to induce the characteristics of neuropathic pain, the team administered either gabapentin, ibuprofen, or placebo and assessed the impact on the brain’s neural response to pain using FMRI. Pain related neural activity was significantly reduced in the subjects who received gabapentin, even with extremely low subject numbers, highlighting the potential for FMRI to make a drug’s effect clear in small cohorts. For more about fMRI, click here. Read a news story about the findings here. The article abstract may be read here.
Daniel Carr, MD, FABPM
Pain Research, Education, and Policy Program
Department of Public Health and Community Medicine
Tufts Medical Center
Boston, MA


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