Data and safety monitoring boards work under a cloak of secrecy meant to prevent undue influence by stakeholders, such as companies or the government. In the Trump era, some worry the anonymity could actually invite it.
The FDA, under pressure from the Trump administration, has authorized broader use of convalescent plasma for emergency treatment in COVID patients. But several major hospitals are resisting, saying they’ll opt instead to use the scarce resource to complete a clinical trial.
The nation’s top infectious disease official is confident that an independent panel will base vaccine approval on science, not politics.
President Donald Trump touted the Food and Drug Administration’s approval of this unproven COVID-19 treatment for emergency use. That set off reactions ranging from excitement and optimism to scientific concerns and criticism that the decision was politically motivated.
Josie and George Taylor of Everett, Washington, are two of the first people in the U.S. to recover from novel coronavirus infections after joining a clinical trial for the antiviral drug remdesivir.
MDMA, the psychoactive ingredient in the club drug known as molly or ecstasy, is being tested in combination with therapy as a treatment for severe trauma.
California’s stem cell agency, created by a $3 billion bond measure 15 years ago, is almost out of money. Its supporters plan to ask voters for even more funding next year, even though no agency-funded treatments have been approved for widespread use.
In March, a chemical cousin of the anesthetic and club drug ketamine was approved for the treatment of patients with intractable depression. But critics say studies presented to the FDA provided at best modest evidence it worked and did not include information about the safety of the drug, Spravato, for long-term use.