There is a general consensus that the Food and Drug Administration is more responsive to the needs of pharmaceutical companies than to the citizens it is mandated to protect. The drug companies are asked to submit their own research, rather than have research on safety and efficacy done by independent agencies. They are also relied upon to submit truthful reports of adverse effects of their medication. In both of these areas, there have been shortfalls in the truthfulness of their reporting. The pharmaceutical companies have cherry-picked the studies they submit to the FDA that support their drug’s use, and they discard those that do not. Good examples of this problem are the new anticoagulant drugs: Pradaxa (dabigatran etexilate), Eliquis (apixaban) and Xarelto (rivaroxaban) to prevent blood clots in those with non-valvular atrial fibrillation, to protect people from strokes. There is a need for an easier-to-use and less risky long-term anticoagulant than Coumadin (warfarin). But these drugs may also cause irreversible internal bleeding that can lead to hospitalization and death. They are more likely to cause bleeding into the brain than Warfarin, and there is no antidote to stop the effects of the anticoagulant properties. (Warfarin’s anticoagulant effect can be partially reversed with the use of vitamin K injections and the infusion of fresh frozen plasma [FFP].) Lawsuits have already been filed against the manufacturers of these drugs for their catastrophic adverse effects.
Conclusion: ANY drug new on the market has not had enough testing for safety and efficacy to risk unknown side effects. 1 in 5 new drugs causes serious “black box” harm. (The term “black box” refers to FDA- mandated printing of a warning with a black box around it in the drug’s package insert or drug literature.) 90% of new drugs are not an improvement over current drugs.
128,000 people a year die due to adverse drug responses to properly prescribed drugs. 2.7 million people are hospitalized due to these responses.