Caroline Bradford

NCHR comments on the FDA Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products Draft Guidance

May 2, 2022: NCHR supports FDA’s draft guidance’s research design considerations to reduce bias in externally controlled trials. However, FDA should be much more explicit about the criteria that must be met to ensure that externally controlled trials are only used when absolutely necessary.

Public Comment of Dr. Diana Zuckerman, President National Center for Health Research At the FDA Advisory Committee meeting on Rexulti for Alzheimer’s patients April 14, 2023

April 14, 2023: Rexulti is already FDA approved as an atypical antipsychotic and FDA held an Advisory Committee meeting in April 2023 to consider approving it for agitation in dementia patients, many of whom are in nursing homes. We expressed concerns about Rexulti’s well-known risks of death for dementia patients. Why isn’t FDA more concerned about safety?

NCHR’s Comments on AHRQ’s Draft Systematic Review on Cannabis and Other Plant-Based Treatments for Chronic Pain and Subacute Pain

April 20, 2023: NCHR supports the goals of the review and agrees that there is a need for a systematic review of the effects of cannabis and other plant-based treatments for chronic pain. However, there are several important limitations of the report that were either not adequately addressed.

Testimony of Diana Zuckerman at the FDA Advisory Committee Meeting on Extended-Release/Long-Acting Opioid Analgesics Post-marketing Requirements

April 19, 2023: FDA has worked with industry to propose a clinical trial to determine safety and efficacy of extended release (ERLA) opioids for chronic pain. We criticized the proposed study due to bias, poor study design, and ethical considerations for patients who could be harmed by the study. We urge the FDA to revise the labels to restrict the use of these opioids for chronic pain, based on current data and not wait for what could be an inevitably flawed study to be completed.

FDA’s new plan to study opioids’ effectiveness faces resistance

STAT, April 19, 2023: An FDA proposal to study whether opioids are effective as a chronic pain treatment is facing major resistance from addiction and pain care experts who are not paid by industry. We told STAT that the proposed clinical trial is unethical because it will provide no new information and would make some patients more dependent on opioids.