August 14, 2014. A new study shows that the contaminated drinking water at USMC Base Camp Lejeune from the 1950s to 1985 was deadly to civilians working there as well as the active military and their family members living there.
Read More »We’re Speaking Out on Health Issues
NCHR scientists and health policy experts provide written and oral statements on a wide range of topics.
Here are many of the ways we have been Speaking Out on Health Policy Issues for the last few years. Whether the topic is legislation intended to cure diseases, proposed bans on BPA or other chemicals that disrupt your hormones, the importance of including women, people of color, and patients over 65 in clinical trials, or many other topics, you’ll gain a better understanding of our evidence-based analyses by reading these letters, statements, and testimony.
Here are the ways we have been Speaking out on Medical Treatments and Products, such as prescription drugs and medical devices that the FDA is considering approving, or is considering taking off the market because of serious risks. Whether the topic is Chantix, Addyi, Yaz, Essure, or medical products you’ve never heard of, you can find out more about what is known and not known about the safety and effectiveness of a wide range of products by looking through this section of our website.
Patient, Consumer, and Public Health Coalition Comments on Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices
August 11, 2014. Members of the Patient, Consumer, and Public Health Coalition appreciate the opportunity to comment on the draft guidance for the Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices. The draft guidance states that the use of consensus standards will “streamline premarket review” and “facilitate market entry for safe and effective medical products.” We support a more efficient process, but are concerned about the potential for lowering the standards for safety and effectiveness since the draft guidance states that one of the purposes of declaring conformance with a consensus standard is to “reduce the amount of supporting data and information that are submitted to FDA.”
Read More »Patient, Consumer, and Public Health Coalition Comments on Proposed Rule to Allow FDA to Regulate All Tobacco Products
August 8, 2014. As members of the Patient, Consumer, and Public Health Coalition we are writing to comment on various aspects of the proposed rule to extend FDA’s jurisdiction to tobacco (including made or derived from tobacco) products other than cigarettes, including e-cigarettes. It is essential that the proposed rule be strengthened, since nicotine is highly addictive.
Read More »NCHR Testimony at FDA Advisory Panel on TissuGlu
August 1, 2014. The product was NOT studied on cancer patients and definitely should not be approved for them. In fact, the label should specify that it has not been studied on cancer patients.
Read More »NCHR Testimony on Ablatherm High-Intensity Focused Ultrasound Device
July 30, 2014. Prostate cancer is a very common cancer and all the current treatments have serious side effects that harm men’s quality of life. The question today is whether the Ablatherm high-intensity focused ultrasound device is safe and effective for the treatment of low-risk, localized prostate cancer. Most men diagnosed with localized, low-risk prostate cancer will not die from prostate cancer, but from something else.
Read More »