Regulatory issues involving cGMP violations at Wyeth's plant in Guayama, Puerto Rico last summer have been resolved, according to news reports today. Pharmalot offered this update, as well as updates on BIO, Bill Clinton's position on Thailand and Brazil, and, from yesterday, a brief interview with New Jersey mom and professional nurse Lisa van Syckel, who just testified before the House this morning during a hearing on drug safety, bringing personal perspectives to the whole issue.
Ms. Van Syckel has stressed the need for more information on antidepressant safety and clinical trial results (her testimony, and a video showing her family's story---her daughter attempted suicide, allegedly after taking antidepressants--- is included in the first part of a video of the entire hearing, which can be downloaded from the House subcommittee web site via this link.)
She also discussed the practice, now going on, of administering infants (12 months and older) antipsychotics and antidepressants. She argues for an independent Drug Safety office and improved Medwatch program.
