Hum 115 - Points of View

AnneMarie Rivera

Points of View

HUM/115

February 27, 2015

Points of View

     I feel that prescription drug safety is an issue in the United States that is not being brought to the front lines and taken as seriously as it should. We have had plenty of medicines that after billions of dollars in sales and millions of prescriptions written, have been pulled off the market due to severe side effects that with more extensive clinical trials and research, could have been avoided. Drug safety is such an important issue for me. The Food and Drug Administration (FDA) should not go approving certain drugs without sufficient long-term testing and safety data. Granted, post-marketing safety is vital, but drugs should not be approved before adequate long-term safety data is gathered and tested numerous times, and in different ways if applicable. We should not be used as lab rats just to provide the industry with revenue. This topic hits close to home for me as within the last decade, two medicines (Vioxx and Avandia) have been pulled that my mother was taking for certain illnesses, which in turn caused side effects that left long lasting issues that she deals with today.

     I read an article titled “Clinical Stories Are Necessary for Drug Safety”, which referred to an evaluation done on marketing reports of suspected adverse drug effects (ADRs). These reports were pulled from VigiBase, a global individual case safety report database. Based on their findings, only a small amount of their samples contained data that was crucial to the ADR assessment. The majority of the samples provided data that could lead to misinterpretation of case reports that could in turn lead to wrongful regulatory decisions and have useful information denied to healthcare providers and practitioners.

     The second article I read, Post-Marketing Surveillance of Prescription Drug Safety, was regarding the war in the FDA between safety and speed when it comes to clinical testing and the release of new drugs to the public. It refers to the pulling of the medicines Vioxx and Avandia, and how the speedy release of drugs affect the public both positively and negatively. On one hand, the speed in which these drugs are being approved and released undoubtedly sacrifices the level of safety of those medications. On the other hand, delaying the release of drugs for further testing and trials could cheat a patient of a possible life-saving treatment.

     I feel that the data I read in these articles supports and strengthens my opinion on these issues, because they are backed by facts and results of their assessments and investigations. My opinion has not changed regarding drug safety; not just because of what I read but from what I continue to see every day. As I’m watching television, I see two or three commercials for new medications an hour, and the side effects far outweigh the benefits. With more extensive research and analysis, they may be able to analyze those ADRs better and maybe even simplify their list. I've also taken medicines for one issue or illness, and have developed other issues because of it, which is why I am not a fan of taking medications now, and would much rather go with a more holistic or natural method when tending to certain illnesses. I also feel that more detailed reports with all the data regarding the tests and trials should be entered into the appropriate databases, like VigiBase. This would allow practitioners to make more informed decisions when prescribing new medications to patients. All data, whether they consider it to be useful or minute, should be provided to those that recommend and prescribe medicines for us.