Irritable bowel syndrome (IBS) is an uncomfortable intestinal problem that affects nearly one in five Americans, most of whom are women. Unfortunately, known treatments only help with IBS symptoms, not the cause. More so, these treatments often have dangerous side effects. How is it that these drugs are still on the market if they are unsafe? The answer is because of a drug development process known as “treatment IND” (Investigational New Drug). The most recent of these treatment INDs involves a medication known as Zelnorm. What are the dangers, and should you take it for your IBS?
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NCHR Testimony at the FDA about Antibiotic for Inhalation, Cipro DI
January 11, 2018. It is important that any drugs should clearly demonstrate efficacy and a good long-term safety profile before they are approved. Cipro DI has clearly not yet met that standard.
Read More »NCHR Testimony at the FDA about New Spine Device, Barricaid Anular Closure
December 12, 2017, Patients who suffer with back pain need better alternatives for long term relief. The Barricaid device might be the answer, but the limited data provided suggests it is unlikely to offer the kinds of benefits that patients need. The study indicates substantial device failures. Its use in limited discectomy remains unknown, because most subjects had more extensive surgeries. In addition, the short-term benefits appear to be modest and wane after 24 months. Long term studies with blinding conducted inside the US may provide more certainty, but at this time the data are insufficient to recommend approval.
Read More »Letter to Zoetis to Concerning Antibiotics for Food-Producing Animals
December 15, 2017. Organizations urge Zoetis to request voluntarily that the Food and Drug Administration (FDA) withdraw the approval for use in food-producing animals of Zoetis products that contain drugs in the polymyxin class.
Read More »Letter to Ramaswamy at USDA NIFA on Funding for Research on Antibiotic Resistance
December 15, 2017. We ask that NIFA continue to support research into antibiotic resistance at least at the current levels and specifically include antibiotic resistance among the areas to be funded as part of the AFRI requests for applications for FY2018.
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