FDA Removes Informed Consent Protections from Some Human Clinical Trials
The U.S. Food and Drug Administration (FDA) has issued a final rule that authorizes some experimental human clinical trials to operate without first obtaining informed consent from participants. The new rule, which took effect on Jan. 22, 2024, allows clinical investigations that pose no more than a “minimal risk” and have appropriate safeguards to protect […]
CDC Reports Errors in RSV Vaccines Given to Pregnant Woman, Monoclonal Antibody Shots to Children
A new problem involving the RSV (Respiratory Syncytial Virus) vaccines given to adults over age 60 and monoclonal antibody shots given to infants and children has been highlighted in a recent emergency newsletter called the U.S. Centers for Disease Control and Prevention (CDC) Clinician Outreach and Communication Activity, which is distributed to health care providers.1 […]
Laxative Drug MiraLAX Side Effect Reports Include Brain Dysfunction in Children
In 2014, the U.S. Food and Drug Administration (FDA) awarded a grant of nearly $325,000 to the Children’s Hospital of Philadelphia (CHOP) to study the side effects of the osmotive laxative MiraLAX in children. The call for this investigation came after thousands of parents filed MiraLAX related adverse reaction reports and the advocacy group the […]
The First Amendment, Brought to You By Pfizer
Pfizer now claims the right of a corporate sovereign, arguing that states have “no legitimate interest in regulating” the company’s commercial speech while demanding the power to censor Americans’ newsfeeds. The call for pharmaceutical supremacy came in Pfizer’s response to Texas Attorney General Ken Paxton’s suit alleging that Pfizer committed fraud and “conspired to censor public discourse.” Pfizer embraces […]
FDA Adds Boxed Warning to Merck’s Asthma Drug Singulair About Suicide, Neuropsychiatric Side Effects
In 2008, the FDA issued a warning advising that it would investigate a possible risk of suicide associated with Merck & Co.’s asthma and allergy drug Singulair after there were many reports of increases in agitation, aggression, anxiety, depression and suicidal thoughts. Hallucinations also were documented for children and adolescents taking Singulair. When the drug’s […]
FDA Hasn’t Reviewed Some Food Additives in Decades
There’s a long list of chemicals and additives that are allowed in the U.S. but are banned in Europe and other places over health concerns. There are more than 10,000 chemicals and additives allowed in food in the U.S., often in small amounts. But many have not been evaluated by the FDA in decades. The […]
