Big Pharma are in the spotlight again as a company has been discovered to have pushed a dangerous antidepressant aimed at teens into the market. Their claim to its suitability for treating specific conditions that were never FDA approved, highlights a call for tougher laws.
Under current U.S. laws, the marketing of pharmaceuticals by companies can only advertise their drugs relevant to their FDA approved conditions.
GlaxoSmithKline (GSK), a Big Pharma player, funded their own research for the antidepressant drug paroxetine (Paxil), publishing their findings in 2001 in a study known as Study 329. The study demonstrated a good effect in children, and was “well tolerated.”
An independent study founded very different conclusions to the safety of Paxil in teenagers, highlighting a risk of suicide and self-harm, as the drug had no extra benefit than that of a placebo.
“A major reanalysis just published in The BMJ of tens of thousands of pages of original trial documents from GlaxoSmithKline’s infamous Study 329, has concluded that the antidepressant paroxetine is neither safe nor effective in adolescents with depression,” the independent study stated.
The independent researchers also discovered that Study 329 had some fundamental flaws where GSK researchers manipulated data, as well as misleading doctors through marketing ploys, into prescribing the drug to over 2 million adolescents in 2002 alone.
Since the fines against GSK in 2012, two other companies have endeavored to sue the FDA, claiming violations to their First Amendment rights of free speech. One was the closely watched Amarin case, where a federal court ruled in favor of their promotion of fish oil for off-label cases. The other was Pacira.
Pacira Pharmaceuticals, the drug company that the FDA sent a letter to demanding they cease promoting their drug for causes not approved, filed a case for their continuation of marketing. The drug in question constituted $197.6 million in revenue. The ruling was in favor of Pacira, “that drug companies’ truthful speech to doctors is protected by the First Amendment, even if it is intended to promote off-label use,” according to a report by Reuters.
Discerning the difference between evidence based science and marketing ploys are becoming increasingly more difficult in the bid for Big Pharma pushing their new drugs into society. The boosting of their sales far outweighs the laws, morals, and ethics that once governed science. Now the bottom dollar is all about the shareholder, disregarding the consequences to our health.