SUMMARY: Marion Gruber, director of the FDA’s Office of Vaccines Research & Review, and deputy director Phil Krause will exit the agency because the White House is getting ahead of the agency on COVID booster shots. I would argue, however, that the FDA is a bureaucratic mess with changes needed at all levels of leadership.
SUMMARY: Online health seekers are increasing in number, but so is the prevalence of inaccurate health information. Drug side effects are among the most talked about in social media, and patients are more concerned about side effects. They may not be willing to risk potential side effects like pancreatitis. DTC marketers need to reassure their audiences that drugs have been thoroughly tested and are indeed “safe and effective.”
SUMMARY: Over half of all clinical trial sites are outside the U.S. 78 % of all subjects were enrolled outside the U.S. 87 % of all subjects in recent biologics trials were enrolled outside the U.S.. DTC may or may not work for clinical trial enrollment it really depends on the condition and risk as judged by the patient.
SUMMARY: Via Marci Hamilton is a professor at the University of Pennsylvania “the Constitution is not a suicide pact guaranteeing a right to harm others. The government has latitude to protect citizens from deadly conditions, especially when the science supporting vaccination is so clear”.
SUMMARY: There is a huge issue that’s challenging DTC marketers: online health misinformation. While we’re still trying to research the changes it has led to for DTC marketers, there are some observable behaviors taking place that we have examined through Google analytics. They paint a picture of people who are spending more time online looking to answer their questions and relying on HCPs to help sort out treatment choices.
SUMMARY: We, as a nation, can not afford people who chose not to get vaccinated because of misinformation. They are a danger to all of us and must be held accountable for their inaction. This includes financial penalties for making a terrible choice.
SUMMARY: Alabama’s Governor had one message for residents; “It’s time to start blaming the unvaccinated folks, not the regular folks. It’s the unvaccinated folks that are letting us down”. Last week “these people” even booed Trump when he told them to get vaccinated. This is a whole new level of stupidity.
SUMMARY: Not only do booster shots risk depriving millions throughout the world of the vaccine, but there is also is no evidence that additional shots meaningfully reduce death or hospitalization from covid-19 for healthy Americans. (William F. Parker is an assistant professor of pulmonary and critical care medicine at the University of Chicago and assistant director of the MacLean Center for Clinical Medical Ethics via the Washington Post)