On behalf of the Coalition members at the March 1st meeting, Dr. Diana Zuckerman offered our support to the Commissioner and the FDA, and thanked the Commissioner for his efforts to improve the Accelerated Approval program by requiring confirmatory trials be started prior to granting accelerated approval. Patricia Kelmar discussed members’ support for the FDA to regulate lab-developed tests to ensure their accuracy. Kim Witczak and Suzanne Robotti discussed possible improvements to the FDA Advisory Committee process, based on their perspectives as consumer representatives on two FDA Advisory Committees. After the meeting was completed, Coalition members who were attending in person had informal discussions with several FDA officials.  

FDA attendees: Robert Califf (Commissioner, virtual due to exposure to viruses), Peter Marks (Director, CBER, virtual), Owen Faris (OPEQ Principal Deputy Director, CDRH, virtual); In person: Julia Tierney (Chief of Staff, Office of the Commissioner), Jacqueline Corrigan-Curay, (Principal Deputy Director, CDER), Dayle Cristinizio (Director, Stakeholder Engagement, Office of External Affairs), Hilary Maston (Chief Medical Officer), Namandje Bumpus (Chief Scientist, AdCom responsibilities), Kaveeta Vasisht (Assoc Commissioner for Women’s Health), Jennifer Dooren (Director Communications and Public Engagement, Food Safety).

Coalition Attendees: In Person: Thomas Eagen (NCHR), Maria Gmitro (BISA), Denise Hyater-Lindenmuth (NWHN), Patricia Kelmar (U.S. PIRG), Suzanne Robotti (MedShadow), Kim Witczak (WoodyMatters), Diana Zuckerman (NCHR). Virtual: Tahir Amin (I-MAK), Wendy Dolin (MISSD), Helen Haskell (MAME), Rex Johnson (WAPS), Katherine Leon (SCAD Alliance), Judy Norsigan (OBOS), Linda Radach (PSAN), Reshma Ramachandran (DFA), Brian Ronholm (Consumer Reports), Tess Schulman (Medical Device Problems), Robin Strongin (NCL), Dru West (USAPN), Sophia Phillips (on behalf of the Coalition).

MISSD founder, Wendy Dolin, and board advisor, Kim Witczak, were pleased to join a coalition of consumer safety advocates from various public health organizations who spoke to the Food and Drug Administration (FDA) last week. The coalition encouraged the FDA to improve the Accelerated Approval program by requiring confirmatory trials be started prior to granting accelerated approval. Safe patient advocates also alerted the FDA of the need to regulate lab-developed tests to ensure their accuracy and asked that the agency make improvements to its Advisory Committee process.

It’s good to see the benzo podcast taking off. Listen and learn from experts by experience, some of whom have also been on MISSD’s Akathisia Stories podcast. Read the full article at https://markets.financialcontent.com/stocks/article/abnewswire-2023-2-17-the-benzodiazepine-podcast-is-about-fighting-gaslighting-of-protracted-benzo-withdrawal-sufferers. Listen at https://thebenzodiazepinepodcast.drleeds.com/

Harvard Health Publishing has really missed the boat when describing akathisia in this MSN Q&A. To call it a movement disorder and fail to mention the inner symptoms of akathisia–symptoms of inner restlessness and delirium that can cause violence and death is shockingly disappointing. See https://www.msn.com/en-ca/health/medical/what-is-akathisia-and-how-to-treat-it-harvard-health-publishing-weighs-in/ar-AA17oDhT?li=AAggV0S.

Like many families who have lost loved ones to akathisia-induced death, Kristina explains how her teenage daughter’s akathisia symptoms were missed and misdiagnosed. Natalie, who died ten years ago this week, knew something was terribly wrong but didn’t know her Zoloft-induced symptoms had a medical name. Listen and learn at https://www.studiocchicago.com/akathisia-stories-blog/episode-3-kristina-gehrki.

One out of seven people who try to stop depression pills will experience withdrawal problems, which can include akathisia. Informed consent can reduce medication-induced death.

“The principle of informed consent dictates that people must be told all this when first offered these drugs.” –John Reed, Professor of Clinical Psychology, London. See https://www.theguardian.com/science/2023/jan/31/informed-consent-for-antidepressants

Many people who try to discontinue depression pills suffer from withdrawal symptoms, including withdrawal akathisia. Their symptoms are signs of adverse drug effects but are often misdiagnosed as signs of mental illness. After 11 years, the UK’s drug regulators are finally updating their drug info. Will USFDA catch up, too?

Read the full article at https://www.theguardian.com/society/2023/jan/17/antidepressants-should-be-reduced-in-stages-to-avoid-withdrawal-symptoms

Researchers estimate that between 40% to 60% of people who take antidepressants experience emotional blunting as a side effect. https://www.forbes.com/sites/anuradhavaranasi/2023/01/22/why-antidepressants-might-make-users-feel-emotionally-numb/?sh=79dc4e4d3283

Akathisia sufferers sometimes have difficulty explaining their symptoms, ranging from a general feeling of unease to unbearable emotional turmoil and physical restlessness. See MISSD’s public health video, “What Does Akathisia Look Like?” to learn more at https://www.youtube.com/watch?v=ER4JGnRssSk.