What is the problem with drug approvals in the USA?
I noticed a hysterical headline in the USA the other day. “New anti-obesity drugs could stunt kinds’ brains”. Apparently, researchers at MIT have found that young mice do not grow as well if they are force-fed anti-obesity drugs. Well, what a surprise! The very idea that any responsible adult mouse would feed its children a high-powered drug is absurd. Now scale that up to human beings. No regulatory authority in the world has given approval for any anti-obesity drug to be given to young children. But, this headline is a symptom of the real prejudice to overcome in the drug approval system in the USA.
For example, the Food and Drug Administration (FDA) signalled that it would refuse acomplia when psychological side effects were identified in early trials. More clinical trials are underway to quantify the risks but, to date, there is no evidence to support a significant risk of clinical depression or, more extreme, suicide in people who take acomplia. Sanofi-Aventis expects to resubmit the application for approval in 2009. In fact, there are many medications currently approved in the USA which have significantly greater risks of psychological damage and suicide but no-one talks about them.
Several European manufacturers complain about the new protectionism in the FDA’s reaction to “foreign” manufacturers and now suggest they may ignore the US market in future. There has also been a more general politicisation of the approval process after the failure of Vioxx which makes the FDA more cautious. Whatever the reason, the US is being denied access to medications such as acomplia which have proved safe and effective in Europe and elsewhere. Were it not for online pharmacies, American patients might suffer. As it is, acomplia and other excellent European medications are freely available at excellent prices.