NCHR’s Comment on EPA’s Proposed Lead and Copper Rule Improvements (LCRI)

February 2024: In its public comment, NCHR supported EPA’s proposed lead and copper rule improvements (LCRI) and suggested strengthening safeguards such as lowering the action lead level to 5 ppb or less, more attention to schools, daycares, and afterschool facilities, better enforcement, and not replacing lead pipes with PVC or other dangerous pipes.

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NCHR Public Comment on Communications From Firms to Healthcare Providers Regarding Scientific Information on Unapproved Uses of Approved Medical Products

December 26, 2023: We responded to the FDA’s request for public comment about the scientific information (SIUU) that firms can provide to healthcare providers about the unapproved uses of approved medical products. Promotion for unapproved (off label) uses were prohibited years ago, but that has been loosened over the decades and the FDA’s new draft guidance is worrisome because it is not as specific as it should be about how to ensure that the information the companies provide is accurate and not misleading. We agree with some of the guidance but urge more careful wording to ban the use of poor quality data and misinterpretation.

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Dr. Diana Zuckerman’s Testimony at the FDA Advisory Committee on NurOwn for ALS Treatment

September 27, 2023: NCHR’s Diana Zuckerman’s testified at FDA’s Advisory Committee meeting on September 27, 2023 about tripling of deaths and no benefits of NurOwn treatment for ALS. Improvements were identical for placebo compared to NurOwn treatment, and patients should not have to pay for unproven treatment. Experimental treatment should be free through clinical trials or expanded access.

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Do Antidepressants Increase Suicide Attempts? Do They Have Other Risks?

Research shows that antidepressants can increase suicide risk in people. When depressed people become somewhat less depressed, they feel less hopeless and more able to attempt suicide. But there is evidence that antidepressants may also increase the risk of suicide for other reasons, such as akathisia. Other risks from antidepressants include blood clots and birth defects. Antidepressants also have a “placebo effect” that makes the drugs seem more effective than they really are. Safe and effective alternatives include cognitive behavioral therapy and physical activity.

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