April 11, 2018. An independent investigation by the HHS Inspector General is necessary to ensure public confidence in the integrity of the investigation and that all culpable NIH officials are held accountable.
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.
Statement Regarding FDA Restrictions on Essure Sterilization Device of Dr. Diana Zuckerman, President of the National Center for Health Research
April 9, 2018. The FDA announced restrictions on the sale and distribution of Essure and a requirement that women receive risk information. But, the checklist that is meant to help inform women has clear problems, and the information in it has been questioned by experts in the field.
Read More »NCHR Testimony at FDA on Eversense Continuous Glucose Monitoring System
March 29, 2018. In conclusion, patients with insulin dependent diabetes need better solutions to monitor and manage their disease. There is currently no proof that the benefits of Eversense outweigh the risks. We need additional clinical evidence before the FDA should decide whether or not to approve it.
Read More »NCHR Testimony at the FDA about a Drug for Opioid Withdrawal Symptoms, Lofexidine
March 27, 2018. Patients undergoing opioid withdrawal need non-opioid effective treatment alternatives. In order to ensure the we are doing more good than harm, the FDA must ensure that treatments show substantial evidence of effectiveness. Current data indicate that lofexidine can successfully provide short-term relief of patients’ opioid withdrawal symptoms following abrupt discontinuation. However, due to cardiac safety risks, this drug should not be indicated for individuals with existing cardiac conditions, and if approved, there should be a clear warning on the drug’s label. Finally, the sponsor has not provided sufficient evidence that lofexidine increases the likelihood that individuals will complete withdrawal treatment and, ultimately, move toward ending their physical dependence on opioids. We believe they must do so in order to receive this indication.
Read More »NCHR Letter to the Senate on Right To Try
March 23, 2018. We are writing to urge you to vote against the Right to Try bill that recently passed the House of Representatives (HR 5247) despite strong opposition from the Democratic leadership. Although HR 5247 includes some potentially useful requirements that the results of patients’ access to experimental drugs be made available to the FDA, so that they will be aware of serious harm that could be caused, there is no enforcement mechanism to make sure that information is made available.
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