Tuesday, January 05, 2016 by Vicki Batts
According to current U.S. law, pharmaceutical companies may only market drugs for their FDA-approved conditions. That means if a product has only been approved for use in adults, it cannot be suggested for use in children.
Big Pharma giant GlaxoSmithKline (GSK) decided laws and safety aren’t really that important.
GSK influenced doctors to prescribe the antidepressant paroxetine (brand name Paxil) to kids and teenagers for years, despite it never having been approved for use in those age brackets by the FDA. That is what some circles would call “illegal.”
Why would doctors do that? Well, GSK funded a study which claimed to show that the drug was “well tolerated and effective” in kids.
A following study, not funded by the company, came to wildly different conclusions about the safety and efficacy of Paxil in teens and children – it was found to have serious side effects and even make children suicidal.
So, GlaxoSmithKline got a fine for misleading doctors to prescribe a drug for off-label, unapproved use.
And now, Big Pharma wants the law changed so they can freely advertise drugs for whatever purposes they want, without FDA approval. Two companies have sued the FDA for violation of their First Amendment right to free speech.
But, we the consumers, don’t have the right to know anything about the drugs they want us to take, other than that Big Pharma thinks its good for us to put money in their pockets.